roll / opentrials-clinicaltrailsgov-data

Injecting configuration and compiling... Injecting scraper and running... 2015-10-09 20:52:02 [scrapy] INFO: Scrapy 1.0.3 started (bot: clinicaltrials) 2015-10-09 20:52:02 [scrapy] INFO: Optional features available: http11, ssl 2015-10-09 20:52:02 [scrapy] INFO: Overridden settings: {'BOT_NAME': 'clinicaltrials', 'DOWNLOAD_DELAY': 1.0, 'NEWSPIDER_MODULE': 'spiders', 'SPIDER_MODULES': ['spiders']} 2015-10-09 20:52:02 [scrapy] INFO: Enabled extensions: CloseSpider, LogStats, TelnetConsole, AutoThrottle, CoreStats, SpiderState 2015-10-09 20:52:02 [scrapy] INFO: Enabled downloader middlewares: HttpAuthMiddleware, DownloadTimeoutMiddleware, UserAgentMiddleware, RetryMiddleware, DefaultHeadersMiddleware, MetaRefreshMiddleware, HttpCompressionMiddleware, RedirectMiddleware, CookiesMiddleware, ChunkedTransferMiddleware, DownloaderStats 2015-10-09 20:52:02 [scrapy] INFO: Enabled spider middlewares: HttpErrorMiddleware, OffsiteMiddleware, RefererMiddleware, UrlLengthMiddleware, DepthMiddleware 2015-10-09 20:52:02 [scrapy] INFO: Enabled item pipelines: Normalize, Database 2015-10-09 20:52:02 [scrapy] INFO: Spider opened 2015-10-09 20:52:02 [scrapy] INFO: Crawled 0 pages (at 0 pages/min), scraped 0 items (at 0 items/min) 2015-10-09 20:52:02 [scrapy] DEBUG: Telnet console listening on 127.0.0.1:6023 Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. 2015-10-09 20:52:06 [twisted] CRITICAL: Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. From cffi callback <function infoCallback at 0x7f5a9614e500>: Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1059, in infoCallback connection.get_app_data().failVerification(f) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1589, in get_app_data return self._app_data File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1148, in __getattr__ return getattr(self._socket, name) AttributeError: 'NoneType' object has no attribute '_app_data' 2015-10-09 20:52:06 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011> (referer: None) 2015-10-09 20:52:09 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:09 [scrapy] DEBUG: Filtered duplicate request: <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011> - no more duplicates will be shown (see DUPEFILTER_DEBUG to show all duplicates) 2015-10-09 20:52:13 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363739?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=6&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:13 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:13 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:13 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:13 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:13 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363739?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=6&resultsxml=true> {'acronym': u'PROVETTA', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n -1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a\n role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of\n metastatic colorectal cancer patients. The present study aims to prospectively evaluate the\n predictive role of this polymorphism in metastatic colorectal patients receiving the same\n treatment.\n ', 'brief_title': u'Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": "Colorectal Neoplasms"}}', 'conditions': '[{"condition": "Metastatic Colorectal Cancer"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line\\n treatment"}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - Histologically confirmed colorectal adenocarcinoma;\\n\\n - Measurable metastatic disease according to RECIST criteria;\\n\\n - Patients receiving BV plus FOLFIRI as first-line treatment;\\n\\n - Written informed consent;\\n\\n - Availability of blood samples for genetic analysis.-\\n\\n Exclusion Criteria:"}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'265', 'firstreceived_date': u'May 31, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Bevacizumab"}}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "VEGF polymorphism Bevacizumab"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Italy"}]', 'locations': '[{"location": {"facility": {"name": "Polo Oncologico Azienda Ospedaliero, Universitaria Pisana", "address": {"city": "Pisa", "zip": "56126", "country": "Italy"}}, "status": "Recruiting", "contact": {"last_name": "Fotios Loupakis, MD", "phone": "050992466", "phone_ext": "+39", "email": "fotiosloupakis@gmail.com"}, "investigator": {"last_name": "Alfredo Falcone, MD", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363739', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u'Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients', 'org_study_id': u'3108', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Italy: Ethics Committee", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "Progression-Free Survival", "safety_issue": "No", "description": "Progression free survival (PFS) is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Alfredo Falcone", "organization": "Azienda Ospedaliero, Universitaria Pisana"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Response Rate", "safety_issue": "No", "description": "Response Rate (RR) is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST)"}}, {"secondary_outcome": {"measure": "Overal survival", "safety_issue": "No", "description": "Overall survival (OS) is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point"}}]', 'source': u'Azienda Ospedaliero, Universitaria Pisana', 'sponsors': '[{"lead_sponsor": {"agency": "Azienda Ospedaliero, Universitaria Pisana", "agency_class": "Other"}}]', 'start_date': u'April 2009', 'study_design': u'Observational Model: Cohort, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363739', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:15 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363882?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=5&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:15 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:15 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:15 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:15 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:15 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363882?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=5&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Standard NIV", "arm_group_type": "Active Comparator", "description": "Noninvasive ventilation (NIV) will be initiated and managed as per current standard of practice guided by the American Academy of Neurology (AAN) Practice Parameters (updated in 2009), in all subjects with amyotrophic lateral sclerosis (ALS) and a forced vital capacity of <50% predicted. Sleep studies will be performed at baseline, 2 weeks, 1, 3 and 6 months, but will not influence management of the NIV."}}, {"arm_group": {"arm_group_label": "Sleep study titrated NIV", "arm_group_type": "Experimental", "description": "ALS subjects in this arm, who are offered NIV for Forced Vital Capacity (FVC) <50% as per AAN Practice Parameters, will have their initial level of NIV determined polysomnographically. They will be followed with sleep studies at 1 month, 3 months and 6 months to reassess NIV efficacy and NIV will be adjusted as necessary to optimize parameters of oxygenation and ventilation."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Use of noninvasive ventilation (NIV, also known colloquially as "Bipap") has been associated\n in some studies with improvement in pulmonary function, quality of life and survival. NIV is\n typically applied during sleep, and without the benefit of sleep study to determine the\n optimal settings. The investigators have shown that when NIV is used in this fashion,\n failure of nocturnal oxygenation and ventilation is prominent. This study is randomizing\n patients to standard application of NIV vs application guided by use of sleep study data to\n determine the effect of titrated therapy on pulmonary function, quality of life and\n survival.\n ', 'brief_title': u'Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": ["Amyotrophic Lateral Sclerosis", "Motor Neuron Disease", "Sclerosis"]}}', 'conditions': '[{"condition": "Amyotrophic Lateral Sclerosis (ALS)"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS) per El Escorial\\n criteria\\n\\n - Between ages of 18 and 80 yrs old\\n\\n Exclusion Criteria:\\n\\n - Inability to clear secretions from the airway\\n\\n - Life expectancy < 6 months from a comorbid condition\\n\\n - Dementia sufficient to impair ability to use NIV, perform respiratory muscle pressure\\n testing (PFTs), or complete Health-related Quality of Life (HRQOL) instruments\\n\\n - Inability to follow up at the ALS Center on a regular basis\\n\\n - Previously diagnosed obstructive Sleep Apnea"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "80 Years", "healthy_volunteers": "No"}}', 'enrollment': u'40', 'firstreceived_date': u'March 28, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Other", "intervention_name": "Sleep study-guided adjustment of NIV", "description": "Sleep studies will be performed at baseline, within 2 weeks to initially titrate NIV, and at 1, 3 and 6 months to assess NIV performance and adjust it as necessary based on oxygenation and ventilation parameters.", "arm_group_label": "Sleep study titrated NIV"}}, {"intervention": {"intervention_type": "Other", "intervention_name": "Standard initiation of NIV", "description": "NIV will be initiated and managed as per current standard of practice. Sleep studies will be performed at baseline, 2 weeks, 1, 3 and 6 months to gather data but will not influence NIV management. NIV will be adjusted by a respiratory therapist or the subject\'s primary physician per waking symptoms.", "arm_group_label": "Standard NIV"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Amyotrophic Lateral Sclerosis"}, {"keyword": "Noninvasive Ventilation"}, {"keyword": "Respiratory Dysfunction"}, {"keyword": "Positive Pressure Ventilation"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Columbia University Medical Center", "address": {"city": "New York", "state": "New York", "zip": "10032", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363882', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Progression of Respiratory Dysfunction in Amyotrophic Lateral Sclerosis (ALS) Patients: A Comparison of Standard of Practice vs Polysomnography-Directed Nocturnal Non-Invasive Positive Pressure Ventilation', 'org_study_id': u'AAAC6753', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Robert C Basner, MD", "role": "Principal Investigator", "affiliation": "Columbia University"}}', 'overall_status': u'Active, not recruiting', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'January 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Change from baseline in spirometric, respiratory muscle strength, and gas exchange measures", "time_frame": "Up to 6 months after starting NIV", "safety_issue": "No", "description": "FVC (forced vital capacity), FEV1 (forced expiratory volume in 1 second), MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Robert Basner, MD; Professor of Clinical Medicine", "organization": "Columbia University College of Physicians and Surgeons"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Duration that the Mental Component Summary (MCS) is maintained above 75% of baseline score for the Medical Outcomes Study Health Survey (SF-12)", "time_frame": "Up to 6 months after starting NIV", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Survival", "time_frame": "Up to 6 months after baseline", "safety_issue": "No", "description": "Whether sleep study-titrated NIV is associated with trends to improved survival, compared with standardly prescribed (non-titrated) NIV"}}, {"secondary_outcome": {"measure": "Nocturnal oxygenation and ventilation", "time_frame": "Up to 6 months after starting NIV", "safety_issue": "No", "description": "Nadir oxygen saturation, number of oxygen desaturations of 3%/hr (ODI3), % time of sleep spent with oxygen saturation <90%, apnea-hypopnea index, asynchrony index"}}, {"secondary_outcome": {"measure": "Modified Borg dyspnea score (see description)", "time_frame": "Up to 6 months after baseline", "safety_issue": "No", "description": "The Modified Borg Dyspnea Scale is a 10-point Likert scale asking subjects to rate perceived shortness of breath, ranging from 0 (no breathlessness at all) to 10 (maximal breathlessness)"}}]', 'source': u'Columbia University', 'sponsors': '[{"lead_sponsor": {"agency": "Columbia University", "agency_class": "Other"}}, {"collaborator": {"agency": "ALS Association", "agency_class": "Other"}}]', 'start_date': u'February 2008', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363882', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:16 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363960?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=4&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:16 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:16 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:16 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:16 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:16 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:16 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363960?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=4&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "neonates with retinopathy of prematurity", "description": "all neonates meet the criteria:\\na BW of less than 1501 gram (g)\\nborn at a GA of 34 weeks (wk) or less and\\nselected infants with an unstable clinical course were included"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The aim of the study is to evaluate our 10 year experience of retinopathy of prematurity\n screening.\n ', 'brief_title': u'Retinopathy of Prematurity:Summary of a Decade', 'clinical_results': '{}', 'completion_date': u'December 2010', 'condition_browse': '{"condition_browse": {"mesh_term": ["Retinal Diseases", "Retinopathy of Prematurity"]}}', 'conditions': '[{"condition": "Retinopathy of Prematurity"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "neonates with Retinopathy of of prematurity"}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - Neonates either with a BW of less than 1501 gram (g) or born at a GA of 34 weeks (wk)\\n or less\\n\\n - selected infants with an unstable clinical course were included"}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'609', 'firstreceived_date': u'May 27, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Incidence"}, {"keyword": "neonatal care"}, {"keyword": "retinopathy of prematurity"}, {"keyword": "risk factors"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "http://www.ncbi.nlm.nih.gov/pubmed", "description": "retinopathy of prematurity"}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Turkey"}]', 'locations': '[{"location": {"facility": {"name": "Gulhane Military Medical School Training Hospital", "address": {"city": "Ankara", "zip": "06010", "country": "Turkey"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363960', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': '', 'org_study_id': u'Retinopathy of prematurity', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Turkey:Gulhane Military Medical School Local Ethical Committee", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': u'December 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Number of neonates developed retinopathy of prematurity", "time_frame": "ten years", "safety_issue": "No"}}, {"primary_outcome": {"measure": "risk factors contributing to ROP development", "time_frame": "ten years", "safety_issue": "No", "description": "mechanic ventilation. oxygen therapy, respiratory distress syndrome, sepsis, intraventricular, hemorrhage, blood transfusion v.s"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Murat K\\u00dc\\u00c7\\u00dcKEVC\\u0130L\\u0130O\\u011eLU, MD", "organization": "Gulhane Military Medical School"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Gulhane Military Medical Academy', 'sponsors': '[{"lead_sponsor": {"agency": "Gulhane Military Medical Academy", "agency_class": "Other"}}]', 'start_date': u'March 1999', 'study_design': u'N/A', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363960', 'verification_date': u'June 2009', 'why_stopped': ''} 2015-10-09 20:52:18 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01364155?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=3&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:18 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:18 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:18 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:18 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:18 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01364155?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=3&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "600 mg LIM-0705 BID for 28 days", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "Placebo LIM-0705 for 28 days", "arm_group_type": "Placebo Comparator"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Preliminary research suggests that LIM-0705 improves insulin sensitivity with neutral\n effects on weight in obese and diabetic rodent models. Results from a Phase 1b clinical\n study, conducted in healthy volunteers, indicate that LIM-0705 and a major metabolite may be\n potential insulin sensitizers by OGTT.\n ', 'brief_title': u'Safety, Tolerability, PK, and PD of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR', 'clinical_results': '{}', 'completion_date': u'August 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Glucose Intolerance", "Insulin Resistance"]}}', 'conditions': '[{"condition": "Impaired Glucose Tolerance"}, {"condition": "Insulin Resistance"}]', 'detailed_description': u'\n The primary objective of the study is to evaluate the safety and tolerability of LIM-0705\n administered for 28 days in adult males and females with impaired glucose tolerance or\n abnormal HOMA-IR.\n\n Secondary Objectives include:\n\n - examine the pharmacokinetics (PK) of LIM-0705\n\n - explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with\n impaired glucose tolerance (defined as two-hour plasma glucose levels of \u2265140 to \u2264199\n mg per dL [7.8 to 11.06 mmol/L] on the 75-g oral glucose tolerance test [OGTT]) or\n abnormal HOMA-IR (HOMA-IR value \u2265 2.5) as measured by change in response to\n hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27\n\n - explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared\n to baseline levels\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - males and females, age 18-75 years old, able and willing to provide written informed\\n consent to participate in the study\\n\\n - obesity-induced impaired glucose tolerance or abnormal HOMA-IR\\n\\n - waist circumference of 40 inches or greater (men) or 35 inches or greater (women)\\n\\n - good physical health based on EKG, electrolytes, LDH, creatinine, urea, AST, ALT,\\n alkaline phosphatase, and renal function\\n\\n - male subjects who are sexually active with a female partner of childbearing age must\\n agree to use of 2 effective methods of contraception, including the use of a condom,\\n throughout the course of the study or provide proof of surgical sterility. The second\\n method of contraception must be the use by their female partners of any of the\\n following: a diaphragm with spermicide, a cervical cap with spermicide, an IUD, a\\n female condom, or an approved hormonally based contraceptive (e.g., an oral,\\n transdermal, or implanted estrogen or progestin). Female subjects must be post\\n menopausal or surgically sterile.\\n\\n Exclusion Criteria:\\n\\n - BMI equal to or greater than 40 kg/m2\\n\\n - allergy to onions or red wine\\n\\n - strict vegetarians\\n\\n - use of any non-study medications other than thyroid replacement hormone or\\n anti-hypertensives. Use of cardesarten cilexetil is not permitted. Note:\\n acetaminophen should not be administered.\\n\\n - use of chemotherapy agents or history of cancer, other than non-metastatic\\n non-melanoma skin cancer that has been completely excised, within 5 years prior to\\n the screening visit"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "75 Years", "healthy_volunteers": "No"}}', 'enrollment': u'50', 'firstreceived_date': u'May 25, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "LIM-0705", "arm_group_label": "600 mg LIM-0705 BID for 28 days"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Placebo capsules", "arm_group_label": "Placebo LIM-0705 for 28 days"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Profil Institute of Clinical Research, Inc.", "address": {"city": "Chula Vista", "state": "California", "zip": "91911", "country": "United States"}}, "status": "Recruiting", "contact": {"last_name": "Linda Morrow, MD", "phone": "619-409-1268"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01364155', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Randomized, Single-Blind, Placebo-Controlled Phase 2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LIM-0705 in Subjects With Impaired Glucose Tolerance or Abnormal HOMA-IR', 'org_study_id': u'LIM-0705-CL-2001', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Linda Morrow, MD", "role": "Principal Investigator", "affiliation": "Profil Institute of Clinical Research, Inc."}}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 2', 'primary_completion_date': u'August 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Evaluate the safety (number of subjects with adverse events) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR", "time_frame": "28 days", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Linda Morrow, MD", "organization": "Profil Institute for Clinical Research, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Examine the pharmacokinetics (PK) of LIM-0705 as measured by area under the curve (AUC).", "time_frame": "28 days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Explore the pharmacodynamics (PD) of LIM-0705 in obese adult males and females with impaired glucose tolerance or abnormal HOMA-IR as measured by change in response to hyperinsulinemic clamp, mixed-meal tolerance test (MMTT) between Days -2 and 27", "time_frame": "28 days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Explore the effect of LIM-0705 on fasting lipid, insulin and glucose profiles compared to baseline levels", "time_frame": "28 days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Evaluate the tolerability (BID) of LIM-0705 administered to adult males and females with impaired glucose tolerance or abnormal HOMA-IR", "time_frame": "28 days", "safety_issue": "No"}}]', 'source': u'Limerick BioPharma', 'sponsors': '[{"lead_sponsor": {"agency": "Limerick BioPharma", "agency_class": "Industry"}}]', 'start_date': u'May 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01364155', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:19 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01364532?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=2&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:19 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:19 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:19 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:19 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:19 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:19 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:19 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01364532?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=2&resultsxml=true> {'acronym': u'AURA', 'arm_groups': '[{"arm_group": {"arm_group_label": "Transulnar arterial access", "arm_group_type": "Experimental", "description": "Transulnar arterial access for coronary angiography, ad-hoc or elective PCI"}}, {"arm_group": {"arm_group_label": "Transradial arterial access", "arm_group_type": "Active Comparator", "description": "Transradial arterial access for coronary angiography, ad-hoc or elective PCI"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The transradial route is increasingly used as an access site in percutaneous coronary\n interventions, as it is considered equivalent to transfemoral approach in terms of efficacy\n but with a decreased vascular complication risk. Information concerning the efficacy and\n safety of transulnar approach is sparse. This is a prospective, randomized,\n investigator-initiated study to compare transradial versus transulnar approach as a default\n strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention\n (PCI). Consecutive eligible patients with an indication for coronary angiography, will be\n randomized after written informed consent in a 1:1 ratio to either transradial or transulnar\n access. Assessment of angiographic and procedural characteristics(including amount of\n contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular\n or other peri-procedural complications of the cases enrolled, will be performed. After\n hospital discharge, all patients will return at Day 60 \xb15 days for Doppler ultrasound\n assessment of the forearm vessels and documentation of major adverse cardiovascular events\n (defined as death, myocardial infarction, target vessel revascularization and stroke.\n Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500\n or 5000 IU of unfractioned heparin.\n ', 'brief_title': u'Transradial Versus Transulnar Artery Approach for Coronary Interventions', 'clinical_results': '{}', 'completion_date': u'September 2011', 'condition_browse': '{}', 'conditions': '[{"condition": "Arterial Access in Percutaneous Coronary Angiography or Intervention"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Age>18 years\\n\\n - Plan for Coro- and ad hoc PCI, if necessary\\n\\n - Written informed consent\\n\\n Exclusion Criteria:\\n\\n - Cardiogenic shock, haemodynamic instability, Killip class III\\n\\n - Chronic hemodialysis\\n\\n - Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery\\n (IMA) or bilateral radial artery use"}, "gender": "Both", "minimum_age": "19 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'572', 'firstreceived_date': u'May 27, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Transulnar arterial access", "description": "Transulnar arterial access in coronary angiography, ad-hoc or elective PCI", "arm_group_label": "Transulnar arterial access"}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "Transradial arterial access", "description": "Transradial arterial access for coronary angiography,ad-hoc or elective PCI", "arm_group_label": "Transradial arterial access"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "transulnar arterial access"}, {"keyword": "transradial arterial access"}, {"keyword": "percutaneous coronary intervention"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Greece"}]', 'locations': '[{"location": {"facility": {"name": "Patras University Hospital", "address": {"city": "Patras", "state": "Rion", "zip": "26500", "country": "Greece"}}, "status": "Recruiting", "contact": {"last_name": "George Hahalis, MD", "phone": "00306932751222", "email": "ghahalis@otenet.gr"}, "investigator": {"last_name": "George Hahalis, MD", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01364532', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions', 'org_study_id': u'PATRASCARDIOLOGY-5', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Greece: Ethics Committee", "has_dmc": "No"}}', 'phase': u'Phase 3', 'primary_completion_date': u'September 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60\\u00b1 days", "time_frame": "The primary end point will be assessed within 60\\u00b15 days after randomization", "safety_issue": "Yes", "description": "MACEs are considered both vascular and coronary ischemic complications. Vascular complications include arterial occlusion, local arterial perforation, compartment syndrome, pseudoaneurysm, fistula formation, major bleeding, hematoma of at least 10cm length, or any vascular damage requiring prolonged hospitalization or intervention.\\nCoronary ishcemic complications include cardiac death, non fatal myocardial infarction, urgent repeat revascularization and stroke."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "George Hahalis", "organization": "Patras University Hospital"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Fluoroscopy time", "time_frame": "Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention", "safety_issue": "Yes", "description": "Fluoroscopy time (in seconds) assessed within 1 minute after the end of coronary angiography or coronary intervention"}}, {"secondary_outcome": {"measure": "Amount of contrast medium", "time_frame": "The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention", "safety_issue": "No", "description": "Volume of contrast medium (ml) will be assessed within 1 minute after the end of coronary angiography or coronary intervention"}}, {"secondary_outcome": {"measure": "Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation", "time_frame": "Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention", "safety_issue": "Yes", "description": "Vascular complication (defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation of at least 10 cm length, compartment syndrome) will be assessed 6 hours after the end of coronary angiography or intervention"}}, {"secondary_outcome": {"measure": "Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)", "time_frame": "Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention", "safety_issue": "No", "description": "Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)will be assessed within 1 minute after the end of coronary angiography or coronary intervention"}}]', 'source': u'University of Patras', 'sponsors': '[{"lead_sponsor": {"agency": "University of Patras", "agency_class": "Other"}}]', 'start_date': u'April 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01364532', 'verification_date': u'April 2011', 'why_stopped': ''} 2015-10-09 20:52:20 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01364688?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=1&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:20 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:20 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:20 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:20 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01364688?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=1&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Treatment", "arm_group_type": "Experimental", "description": "oral alfacalcidol"}}, {"arm_group": {"arm_group_label": "Control", "arm_group_type": "No Intervention", "description": "No drug"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Active vitamin D at therapeutic dose may prevent vascular calcification but in\n supraphysiologic dose may precipitate it.\n ', 'brief_title': u'Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease', 'clinical_results': '{}', 'completion_date': u'December 2012', 'condition_browse': '{"condition_browse": {"mesh_term": ["Arteriosclerosis", "Calcinosis", "Coronary Artery Disease", "Kidney Diseases", "Renal Insufficiency, Chronic", "Vascular Calcification"]}}', 'conditions': '[{"condition": "Vascular Calcification"}]', 'detailed_description': u'\n Active vitamin D compound is used frequently in the treatment of hyperparathyroidism in\n chronic kidney disease. Recent evidence from animal studies suggested that low dose of\n active vitamin D may be protective against vascular calcification, whereas high dose could\n precipitate it. The present study will examine the effect of low dose oral alfacalcidol on\n coronary artery calcification in predialysis chronic kidney disease patients with\n hyperparathyroidism.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Predialysis chronic kidney disease with GFR < 90 mL/min/1.73m2\\n\\n - PTH above the upper limit of normal\\n\\n - serum calcium and phosphate below the upper limit of normal\\n\\n Exclusion Criteria:\\n\\n - changes in GFR>15% during the past 3 months\\n\\n - receive elemental calcium>500 mg/day\\n\\n - currently taking active vitamin D, oral calcium with elemental calcium>500 mg/day or\\n bisphosphonate"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'80', 'firstreceived_date': u'May 26, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Alfacalcidol", "Hydroxycholecalciferols"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "oral alfacalcidol", "description": "Oral alfacalcidol 0.5 microgram per day", "arm_group_label": "Treatment"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "no drug", "description": "no drug", "arm_group_label": "Control"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "coronary calcification"}, {"keyword": "vascular calcification"}, {"keyword": "active vitamin D"}, {"keyword": "alfacalcidol"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Thailand"}]', 'locations': '[{"location": {"facility": {"name": "Faculty of Medicine, Ramathibodi Hospital, Mahidol University", "address": {"city": "Phayathai", "state": "Bangkok", "zip": "10400", "country": "Thailand"}}, "status": "Recruiting", "contact": {"last_name": "Sinee Disthabanchong, MD", "phone": "+662011116", "email": "tesdb@mahidol.ac.th"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01364688', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Randomized Control Trial of Oral Alfacalcidol and Coronary Artery Calcification in Predialysis Chronic Kidney Disease', 'org_study_id': u'25-05-2011', 'other_outcomes': '[]', 'overall_contact': '{"overall_contact": {"last_name": "Sinee Disthabanchong, MD", "phone": "+6622011116", "email": "tesdb@mahidol.ac.th"}}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Thailand: Mahidol University", "has_dmc": "No"}}', 'phase': u'Phase 2', 'primary_completion_date': u'November 2012', 'primary_outcomes': '[{"primary_outcome": {"measure": "Change in Coronary Artery Calcification", "time_frame": "6 months and 12 months", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Sinee Disthabanchong, MD", "organization": "Division of Nephrology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Ramathibodi Hospital', 'sponsors': '[{"lead_sponsor": {"agency": "Ramathibodi Hospital", "agency_class": "Other"}}]', 'start_date': u'May 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01364688', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:21 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:22 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:23 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01296685?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=20&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:24 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:24 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:24 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:24 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:24 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:24 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01296685?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=20&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "oxygenator with arterial filter"}}, {"arm_group": {"arm_group_label": "arterial filter"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The goal of the study is the evaluation of the air handling of a "new" type of oxygenator\n versus the standard model. The new type has an integrated arterial filter. The standard\n model has a non integrated arterial line filter. If the air handling is as effective/ better\n than in the standard model this can lead to reduction of cardiopulmonary bypass circuits\n with their initiation of systemic inflammatory response and improve cardiopulmonary bypass\n safety.\n ', 'brief_title': u'Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{}', 'conditions': '[{"condition": "Cardiovascular Surgical Procedure"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "All children with body surface area between 0.25 and 0.5 m\\u00b2 who need cardiac surgery with\\n cardiopulmonary bypass. Urgent and norwood procedures are excluded."}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - All children with body surface area between 0.25 and 0.5 m\\u00b2 who need cardiac surgery\\n with cardiopulmonary bypass.\\n\\n Exclusion Criteria:\\n\\n - Urgent and norwood procedures."}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'40', 'firstreceived_date': u'February 14, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "cardiovascular surgical procedure"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[]', 'locations': '[]', 'nct_aliases': '[]', 'nct_id': u'NCT01296685', 'number_of_arms': '', 'number_of_groups': u'2', 'official_title': u'Clinical Evaluation of Air Handling in Baby fx Oxygenator With Integrated Arterial Filter Versus Baby rx Oxygenator With Non Integrated Arterial Line Filter', 'org_study_id': u'S 52937', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Layth Al Tmimi, Dr.", "role": "Principal Investigator", "affiliation": "University Hospitals Leuven"}}', 'overall_status': u'Not yet recruiting', 'oversight_info': '{"oversight_info": {"authority": "Belgium: Ethics Committee", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[]', 'reference': '[]', 'removed_countries': '[{"country": "Belgium"}]', 'responsible_party': '{"responsible_party": {"name_title": "Dr. Al Tmimmi", "organization": "University Hospitals Leuven"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Universitaire Ziekenhuizen Leuven', 'sponsors': '[{"lead_sponsor": {"agency": "Universitaire Ziekenhuizen Leuven", "agency_class": "Other"}}]', 'start_date': u'March 2011', 'study_design': u'Observational Model: Case Control, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01296685', 'verification_date': u'February 2011', 'why_stopped': ''} 2015-10-09 20:52:25 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01325272?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=19&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:25 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:25 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:25 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:25 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:25 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:25 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01325272?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=19&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "preterm newborn"}}, {"arm_group": {"arm_group_label": "term newborn"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and\n preterm infants who had transient otoacoustic emissions and verify if the presence of\n response is related to gestational age, gender or risk factors for hearing loss.\n ', 'brief_title': u'Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions', 'clinical_results': '{}', 'completion_date': u'September 2009', 'condition_browse': '{}', 'conditions': '[{"condition": "Cochlear Function"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Children born in this institution"}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - born in this institution\\n\\n - have presence of transient otoacoustic emission\\n\\n Exclusion Criteria:"}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "5 Months", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': '', 'firstreceived_date': u'March 28, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "otoacoustic emissions in newborns"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Brazil"}]', 'locations': '[{"location": {"facility": {"name": "Faculdade de Medicina de Botucatu", "address": {"city": "Botucatu", "state": "SP", "zip": "18603970", "country": "Brazil"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01325272', 'number_of_arms': '', 'number_of_groups': u'2', 'official_title': u'Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions: Indication of Cochlear Damage in Newborn.', 'org_study_id': u'upeclin/HC/FMB-Unesp-53', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Daniela Polo Camargo da Silva, Mestre", "role": "Principal Investigator", "affiliation": "Faculdade de Medicina de Botucatu"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Brazil: Ethics Committee", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Daniela Polo Camargo da Silva", "organization": "Faculdade de Medicina de Botucatu"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'UPECLIN HC FM Botucatu Unesp', 'sponsors': '[{"lead_sponsor": {"agency": "UPECLIN HC FM Botucatu Unesp", "agency_class": "Other"}}]', 'start_date': u'March 2009', 'study_design': u'Time Perspective: Retrospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01325272', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:26 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01336179?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=18&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:27 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:27 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:27 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:27 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:27 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01336179?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=18&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Miswak, dental plaque and gingivitis", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "Toothbrush, dental plaque and gingivitis", "arm_group_type": "Active Comparator"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and\n the toothbrushes on plaque removal and gingival health.\n ', 'brief_title': u'Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Gingivitis"}}', 'conditions': '[{"condition": "Plaque Induced Gingivitis"}]', 'detailed_description': u'\n Dental plaque removal is essential in maintaining oral health. Methods for oral hygiene vary\n from country to country and from culture to culture. The use of a wood stick (miswak or\n chewing stick) for brushing the teeth is considered an important tool for oral hygiene care\n in many Afro-Asian communities. The aim of the study is to compare the effect of the chewing\n stick (miswak), and toothbrushing on plaque removal and gingival health. The participants\n comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University\n in Saudi Arabia. The study was designed as a single, blind, randomized split-mouth study.\n Professional tooth cleaning was conducted, and after six weeks use of either the miswak or\n toothbrush on each quadrant, modified plaque and gingival indices, were recorded.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy individuals\\n\\n - presence of at least 14 teeth\\n\\n Exclusion Criteria:\\n\\n - Subjects on medications (antiinflammatory or antibiotics)"}, "gender": "Male", "minimum_age": "20 Years", "maximum_age": "30 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'18', 'firstreceived_date': u'April 6, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Salvadora persica", "description": "twice daily use, two minutes interval", "arm_group_label": "Miswak, dental plaque and gingivitis"}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "Toothbrush", "description": "Twice daily use two minutes interval", "arm_group_label": "Toothbrush, dental plaque and gingivitis"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "gingivitis"}, {"keyword": "dental plaque"}, {"keyword": "oral hygiene"}, {"keyword": "toothbrush"}, {"keyword": "chewing sticks"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Saudi Arabia"}]', 'locations': '[{"location": {"facility": {"name": "Faculty of Dentistry Taibah University", "address": {"city": "Almadinah", "zip": "04", "country": "Saudi Arabia"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01336179', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial', 'org_study_id': u'UTFD201127021', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Tareq AS Abu Saleh, MSc, MRD", "role": "Principal Investigator", "affiliation": "Assistant professor in Periodontics, Taibah University"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Saudi Arabia: Ministry for Higher Education", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': u'April 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Miswak is useful for removing plaque and preventing gingivitis", "time_frame": "6 weeks", "safety_issue": "Yes", "description": "Miswak will be compared to toothbrush as a mechanical plaque control device, by calculating plaque index and gingival index scores for participants after 6 weeks of use."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dr Tareq Abu Saleh", "organization": "Department of Preventive Dental Sciences, Faculty of Dentistry, Taibah University"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Taibah University', 'sponsors': '[{"lead_sponsor": {"agency": "Taibah University", "agency_class": "Other"}}]', 'start_date': u'March 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01336179', 'verification_date': u'April 2011', 'why_stopped': ''} 2015-10-09 20:52:28 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01338844?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=17&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:28 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:28 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:28 [spiders.trials] DEBUG: responsible_party: must be string or read-only buffer, not None 2015-10-09 20:52:28 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:28 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:28 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01338844?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=17&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "D-Chiro-inositol", "arm_group_type": "Experimental", "description": "Patients will receive 1.2g/day of D-chiro-inositol"}}, {"arm_group": {"arm_group_label": "Myo-inositol", "arm_group_type": "Active Comparator", "description": "Patients will receive 4g/day of myo-inositol"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Controlled ovarian hyperstimulation with gonadotropins is an integral part of the various\n stimulation protocols for patients undergoing in-vitro fertilization (IVF) and other\n Assisted Reproductive Technologies (ART) such as intracytoplasmic sperm injection (ICSI).\n\n The hormonal control of multiple follicular growth and maturation is a critical part of ART\n procedures since it maximizes the yield of embryos to be transferred, thus increasing the\n cumulative pregnancy rate.\n\n Recent studies have shown the efficacy of myo-inositol (MI) supplementation as a simple and\n highly effective treatment in order to improve oocyte quality in patients undergoing IVF.\n Indeed, it was previously shown that MI follicular fluid (FF) concentration is a reliable\n predictor of oocyte quality. High MI concentration in the FF directly correlates with high\n oocyte and embryo quality.\n\n Another stereoisomer of Inositol was successfully used into clinical practice\n D-chiro-inositol (DCI). In particular, DCI supplementation was used to restore ovulation in\n hyperglycemic PCOS patients.\n\n In the present study we aim to compare MI versus DCI supplementation on oocyte quality of\n women undergoing IVF-ET\n ', 'brief_title': u'Role of Myo-inositol and D-chiro-inositol on Oocyte Quality', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{}', 'conditions': '[{"condition": "Infertility"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - women undergoing IVF treatments\\n\\n - Body mass index <28\\n\\n - FSH <10IU/L\\n\\n - Normal uterine cavity, anatomy and functions\\n\\n Exclusion Criteria:\\n\\n - PCOS\\n\\n - Stage III or IV endometriosis\\n\\n - Premature ovarian failure\\n\\n - Poor responder"}, "gender": "Female", "minimum_age": "25 Years", "maximum_age": "45 Years", "healthy_volunteers": "No"}}', 'enrollment': '', 'firstreceived_date': u'April 14, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Inositol"}}', 'interventions': '[{"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Myo-inositol", "arm_group_label": "Myo-inositol"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "D-chito-Inositol", "arm_group_label": "D-Chiro-inositol"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Poor oocyte quality"}, {"keyword": "IVF failure"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Italy"}]', 'locations': '[{"location": {"facility": {"name": "San Raffaele Hospital", "address": {"city": "Milan", "country": "Italy"}}}}, {"location": {"facility": {"name": "Research Center for Reproductive Medicine Villa Mafalda", "address": {"city": "Roma", "country": "Italy"}}}}, {"location": {"facility": {"name": "Agunco", "address": {"city": "Rome", "country": "Italy"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01338844', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Prospective, Randomized, Double Blind, Study on the Clinical Efficacy Myo-inositol Versus D-chiro-inositol in Women Undergoing in Vitro Fertilization Embryo Transfer.', 'org_study_id': u'MI_vs_DCI_Oo_q', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Gianfranco Carlomagno, Ph.D.", "role": "Principal Investigator", "affiliation": "AGUNCO Obstetrics and Gynecology Centre"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Italy: National Institute of Health", "has_dmc": "No"}}', 'phase': u'Phase 4', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "number of morphologically mature oocytes"}}, {"primary_outcome": {"measure": "Total international units (IU) of recombinant FSH administrated"}}, {"primary_outcome": {"measure": "number of grade 1 embryos"}}]', 'reference': '[{"reference": {"citation": "Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6.", "PMID": "12042283"}}, {"reference": {"citation": "Unfer V, Raffone E, Rizzo P, Buffo S. Effect of a supplementation with myo-inositol plus melatonin on oocyte quality in women who failed to conceive in previous in vitro fertilization cycles for poor oocyte quality: a prospective, longitudinal, cohort study. Gynecol Endocrinol. 2011 Nov;27(11):857-61. doi: 10.3109/09513590.2011.564687. Epub 2011 Apr 5.", "PMID": "21463230"}}, {"reference": {"citation": "Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.", "PMID": "20712264"}}, {"reference": {"citation": "Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2. Review.", "PMID": "19800728"}}, {"reference": {"citation": "Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-4. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7.", "PMID": "18462730"}}, {"reference": {"citation": "Nestler JE, Jakubowicz DJ, Reamer P, Gunn RD, Allan G. Ovulatory and metabolic effects of D-chiro-inositol in the polycystic ovary syndrome. N Engl J Med. 1999 Apr 29;340(17):1314-20.", "PMID": "10219066"}}]', 'removed_countries': '[]', 'responsible_party': '{}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'AGUNCO Obstetrics and Gynecology Centre', 'sponsors': '[{"lead_sponsor": {"agency": "AGUNCO Obstetrics and Gynecology Centre", "agency_class": "Other"}}, {"collaborator": {"agency": "Research Center for Reproductive Medicine Villa Mafalda", "agency_class": "Other"}}, {"collaborator": {"agency": "San Raffaele University Hospital, Italy", "agency_class": "Other"}}]', 'start_date': '', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01338844', 'verification_date': u'April 2011', 'why_stopped': ''} 2015-10-09 20:52:29 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01348646?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=16&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:29 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:29 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:29 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:29 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:29 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:29 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:29 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01348646?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=16&resultsxml=true> {'acronym': u'TuNAMI', 'arm_groups': '[{"arm_group": {"arm_group_label": "Lifestyle counseling", "arm_group_type": "Other"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study was to see whether a brief intervention given in adolescence has\n an effect on smoking in adulthood. The investigators also wanted to clarify the significance\n of some known psychosocial risk factors of smoking in adulthood.\n ', 'brief_title': u'Adult Follow-up of Preventive Study With Brief Smoking Intervention for Adolescents', 'clinical_results': '{}', 'completion_date': u'May 2010', 'condition_browse': '{}', 'conditions': '[{"condition": "Smoking"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Born on 1979.\\n\\n - Living in Vaasa, Pietarsaari, Kokkola or Sein\\u00e4joki at school age.\\n\\n Exclusion Criteria:\\n\\n - Other year of birth."}, "gender": "Both", "minimum_age": "12 Years", "maximum_age": "29 Years", "healthy_volunteers": "No"}}', 'enrollment': u'2582', 'firstreceived_date': u'May 4, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "Brief intervention", "description": "The adolescents were shown a series of photographs of discoloured teeth caused by smoking. Then a mirror was given to the adolescent to let him/her see if similar stains could be seen on his/her teeth. Non-smoking adolescents also received positive feedback for being non-smokers. Duration of a single brief intervention was 2-3 minutes.", "arm_group_label": "Lifestyle counseling"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Smoking"}, {"keyword": "Adolescence"}, {"keyword": "Brief intervention"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Finland"}]', 'locations': '[{"location": {"facility": {"name": "Department of General Practice, Medical School, University of Tampere, Finland", "address": {"city": "Tampere", "state": "Pirkanmaa", "zip": "33100", "country": "Finland"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01348646', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': '', 'org_study_id': u'R08017', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["Finland: Ethics Committee", "Finland: Ministry of Social Affairs and Health"]}}', 'phase': u'N/A', 'primary_completion_date': u'May 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "being a smoker", "time_frame": "29 years", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Aila K\\u00e4tk\\u00e4", "organization": "Tiedetoimikunta/PSHP:n tiedekeskus"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "state of dental health", "time_frame": "29 years", "safety_issue": "No", "description": "Decayed Missing and Filled Teeth (DMFT, DMF), Decayed teeth (DT, D), Community Periodontal Index of Treatment Need (CPITN, CPIN)"}}, {"secondary_outcome": {"measure": "daily smoking", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "amount of cigarettes smoked", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking mother", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking father", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking sister", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking brother", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking best friend", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "smoking best friend", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "willingness to experiment with smoking", "time_frame": "15 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "self-perceived health", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "asthma diagnosis", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "recurrent airway tract infections", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "self esteem", "time_frame": "15 years", "safety_issue": "No", "description": "A 10-step questionnaire"}}, {"secondary_outcome": {"measure": "smoking time", "time_frame": "29 years", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "received 1-4 brief interventions at school age (Yes/No)", "time_frame": "12-15 years", "safety_issue": "No"}}]', 'source': u'Tampere University Hospital', 'sponsors': '[{"lead_sponsor": {"agency": "Tampere University Hospital", "agency_class": "Other"}}, {"collaborator": {"agency": "Medical Research Fund of the Tampere University Hospital, Finland", "agency_class": "Other"}}]', 'start_date': u'May 2008', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01348646', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:30 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01349855?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=15&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:30 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:30 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:30 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:30 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01349855?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=15&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Cohort 1", "arm_group_type": "Experimental", "description": "Dose Level 1"}}, {"arm_group": {"arm_group_label": "Cohort 2", "arm_group_type": "Experimental", "description": "Dose Level 2"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Primary Objective:\n\n To assess the safety and tolerability of two dose levels of a new insulin glargine\n formulation in a once-daily multiple dosing regimen\n\n Secondary Objective:\n\n To compare the pharmacokinetic and pharmacodynamic properties of two dose levels of a new\n insulin glargine formulation with 0.4 U/kg Lantus\xae in a once-daily multiple dosing regimen\n ', 'brief_title': u'Repeated Dosing Study With a New Insulin Glargine Formulation and Lantus\xae in Patients With Type 1 Diabetes Mellitus', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Diabetes Mellitus", "Diabetes Mellitus, Type 1"]}}', 'conditions': '[{"condition": "Type 1 Diabetes Mellitus"}]', 'detailed_description': u'\n The study duration per patient will be 33 to 68 days including 2 treatment periods of 10\n days each separated by a wash-out period of 7-21 days.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion criteria:\\n\\n - Male or female subjects, between 18 and 65 years of age, inclusive, with diabetes\\n mellitus type 1 for more than one year, as defined by the American Diabetes\\n Association\\n\\n - Body weight between 50.0 kg and 110.0 kg,\\n\\n - Body Mass Index between 18.0 and 30.0 kg/m2 inclusive\\n\\n - Stable insulin regimen for at least 2 months prior to study\\n\\n - Certified as otherwise healthy for Type-1 Diabetes mellitus patient by assessment of\\n medical history and physical examination\\n\\n - Women of childbearing potential must have a negative pregnancy test and must use a\\n highly effective method of birth control. During the entire study female subjects of\\n child bearing potential must use two independent methods of contraception. The\\n accepted double contraception methods include use of an intra-uterine device or\\n hormonal contraception in addition to one of the following contraceptive options: 1)\\n condom; 2) diaphragm; cervical/vault cap; 3) spermicide.\\n\\n Exclusion criteria:\\n\\n - Any history or presence of clinically relevant cardiovascular, pulmonary,\\n gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1),\\n hematological, neurological, psychiatric, systemic (affecting the body as a whole),\\n ocular, gynecologic (if female), or infectious disease; any acute infectious disease\\n or signs of acute illness\\n\\n - More than one episode of severe hypoglycemia with seizure, coma or requiring\\n assistance of another person during the past 6 months\\n\\n - Presence or history of a drug allergy or clinically significant allergic disease\\n according to the Investigator\'s judgment\\n\\n - Participation in a trial with any investigational drug during the past three months\\n\\n - Symptoms of a clinically significant illness in the 3 months before the study, which,\\n according to the investigator\'s opinion, could interfere with the purposes of the\\n study\\n\\n - Regular use of any medication other than insulins in the last month before study\\n start with the exception of thyroid hormones, lipid-lowering and antihypertensive\\n drugs, and, if female, with the exception of hormonal contraception or menopausal\\n hormone replacement therapy; any vaccination within the last 28 days\\n\\n - Known hypersensitivity to insulin glargine or excipients of the study drug\\n\\n - Any history or presence of deep leg vein thrombosis or a frequent appearance of deep\\n leg vein thrombosis in first degree relatives (parents, siblings or children)\\n\\n The above information is not intended to contain all considerations relevant to a\\n patient\'s potential participation in a clinical trial."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "65 Years", "healthy_volunteers": "No"}}', 'enrollment': u'30', 'firstreceived_date': u'April 15, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Glargine", "Insulin", "Insulin, Long-Acting"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Insulin glargine HOE901", "description": "Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous", "arm_group_label": ["Cohort 1", "Cohort 2"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Germany"}]', 'locations': '[{"location": {"facility": {"name": "Investigational site number 276001", "address": {"city": "Neuss", "country": "Germany"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01349855', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Assess the Safety and Tolerability of Two Dose Levels of a New Formulation of Insulin Glargine and to Compare Its Pharmacodynamic and Pharmacokinetic Properties With 0.4 U/kg/Day Lantus\xae in an 8-days Multiple Dosing Regimen in Patients With Diabetes Mellitus Type 1', 'org_study_id': u'TDR11626', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Clinical Sciences & Operations", "role": "Study Director", "affiliation": "Sanofi"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Germany: Ethics Commission", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory", "time_frame": "up to day 10 of each period", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Trial Transparency Team", "organization": "sanofi-aventis"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "2010-023771-26"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Glucose infusion rate", "time_frame": "up to day 10 of each period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Pharmacokinetic parameter : Cmax", "time_frame": "up to day 10 of each period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Pharmacokinetic parameter : Tmax", "time_frame": "up to day 10 of each period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Pharmacokinetic parameter : AUC", "time_frame": "up to day 10 of each period", "safety_issue": "No"}}]', 'source': u'Sanofi', 'sponsors': '[{"lead_sponsor": {"agency": "Sanofi", "agency_class": "Industry"}}]', 'start_date': u'March 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01349855', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:32 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01353144?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=14&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:32 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:32 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:32 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:32 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01353144?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=14&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "esomeprazole", "arm_group_type": "No Intervention", "description": "esomeprazole (40 mg/day) for 8 weeks"}}, {"arm_group": {"arm_group_label": "esomeprazole plus aspirin", "arm_group_type": "Active Comparator", "description": "esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of\n aspirin-related peptic ulcers.\n ', 'brief_title': u'A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers', 'clinical_results': '{}', 'completion_date': u'May 2008', 'condition_browse': '{"condition_browse": {"mesh_term": ["Peptic Ulcer", "Ulcer"]}}', 'conditions': '[{"condition": "Peptic Ulcer"}]', 'detailed_description': u'\n The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in\n the treatment of aspirin-related ulcers.\n\n Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40\n mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up\n endoscopy was carried out at the end of the eighth week. The primary end point was the\n healing of peptic ulcers.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - aspirin users who have a peptic ulcer confirmed by endoscopy\\n\\n Exclusion Criteria:\\n\\n - serious medical illness (including cardiovascular events within 6 months before\\n endoscopy)\\n\\n - acute gastrointestinal bleeding\\n\\n - a history of gastric or duodenal surgery\\n\\n - allergic to the study drugs\\n\\n - require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs\\n (NSAIDs), antiplatelet agents, or anticoagulant agents\\n\\n - pregnancy"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'232', 'firstreceived_date': u'May 11, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Aspirin", "Esomeprazole"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "aspirin", "description": "aspirin, 100 mg, qd x 8 weeks", "arm_group_label": "esomeprazole plus aspirin", "other_name": "aspirin protect"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "aspirin"}, {"keyword": "peptic ulcer"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Taiwan"}]', 'locations': '[{"location": {"facility": {"name": "Chung-Ho Hospital", "address": {"city": "Kaohsiung", "zip": "807", "country": "Taiwan"}}}}, {"location": {"facility": {"name": "Kaohsiung Veterans General Hospital", "address": {"city": "Kaohsiung", "zip": "813", "country": "Taiwan"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01353144', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers', 'org_study_id': u'VGHKS96-CT4-26', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Kwok-Hung Lai, MD", "role": "Study Chair", "affiliation": "Kaohsiung Veterans General Hospital."}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Taiwan: Institutional Review Board", "has_dmc": "Yes"}}', 'phase': u'Phase 4', 'primary_completion_date': u'May 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "rate of ulcer healing", "time_frame": "8 weeks", "safety_issue": "No", "description": "ulcer healing rate at week 8"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "PING-I HSU/Dr.", "organization": "Kaohsiung Veterans General Hospital"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "rate of peptic ulcer bleeding", "time_frame": "8 weeks", "safety_issue": "No", "description": "rate of peptic ulcer bleeding within 8-week study period"}}]', 'source': u'Kaohsiung Veterans General Hospital.', 'sponsors': '[{"lead_sponsor": {"agency": "Kaohsiung Veterans General Hospital.", "agency_class": "Other"}}]', 'start_date': u'June 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01353144', 'verification_date': u'January 2008', 'why_stopped': ''} 2015-10-09 20:52:33 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01361282?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=13&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:33 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:33 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:33 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:33 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:33 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01361282?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=13&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Triple Procedure", "description": "All qualifying patients will have received DSAEK with concurrent cataract extraction and intraocular lens placement. Data collection will occur between 6-18 months post-operation."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n Many patients with endothelial dysfunction also present with cataracts. It is therefore\n common practice to perform cataract extraction and intraocular lens (IOL) implantation\n during the same operation and immediately prior to Descemet's Stripping Automated\n Endothelial Keratoplasty (DSAEK), in order to minimize trips to the operating room and the\n associated risks of ocular surgery. However, the unique posterior corneal anatomy of the\n DSAEK recipient makes it difficult to predict pre-operatively the proper power of IOL to\n place, and some patients end up with a mismatched lens that requires spectacle correction.\n The current gold standard for IOL power calculation (A-Scan optical biometry) takes\n measurements of the anterior surface of the cornea and makes assumptions about the posterior\n surface that are violated by the unique hourglass shape of the donor DSAEK graft. New\n optical coherence tomography (OCT) technology provides us with the ability to measure\n curvature in both the anterior and posterior aspects of the cornea in order to generate an\n IOL calculation that has the potential to give more accurate results for our DSAEK patients.\n\n The investigators will be using the Optovue to perform corneal power analysis on patients\n who have already received DSAEK and cataract surgery, in order to compare the post-op\n Optovue power calculations to the pre-operative power calculations provided by the A-Scan.\n If the OCT is shown to provide accurate IOL power calculations, then some patients might be\n better served by a two-stage procedure where DSAEK is performed and then followed six months\n later by cataract surgery using the OCT to calculate IOL power.\n ", 'brief_title': u'Using the Optovue OCT to Select IOL Power', 'clinical_results': '{}', 'completion_date': u'December 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Fuchs\' Endothelial Dystrophy"}}', 'conditions': '[{"condition": "Fuchs\' Endothelial Dystrophy"}, {"condition": "Cataract"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "All study subjects will have received Descemet\'s Stripping Automated Endothelial\\n Keratoplasty (DSAEK) for Fuchs\' Endothelial Dystrophy, together with concurrent cataract\\n surgery. Data collection will occur between 6 and 18 months following surgery."}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - 18 year of age or older\\n\\n - Diagnosis of Fuchs\' Endothelial Dystrophy with cataract\\n\\n - Recent history of DSAEK with concurrent phacoemulsification & intraocular lens (IOL)\\n implantation\\n\\n Exclusion Criteria:\\n\\n - Diagnosis of ocular comorbidity that might be limiting to visual acuity (glaucoma,\\n retinal disease, surface irregularities, etc.)"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'54', 'firstreceived_date': u'May 25, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Total Corneal Power"}, {"keyword": "Optical Coherence Tomography"}, {"keyword": "Descemet Stripping Endothelial Keratoplasty"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Devers Eye Institute", "address": {"city": "Portland", "state": "Oregon", "zip": "97210", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01361282', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u"Evaluation of Total Corneal Power Calculations for Intraocular Lens Selection Using the Optovue OCT in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) Patients", 'org_study_id': u'LEBO-2011-1', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Mark A Terry, MD", "role": "Principal Investigator", "affiliation": "Devers Eye Institute"}}', 'overall_status': u'Enrolling by invitation', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'December 2011', 'primary_outcomes': '[]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Mark A. Terry, MD", "organization": "Legacy Health System"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Legacy Health System', 'sponsors': '[{"lead_sponsor": {"agency": "Legacy Health System", "agency_class": "Other"}}, {"collaborator": {"agency": "Devers Eye Institute", "agency_class": "Other"}}, {"collaborator": {"agency": "Optovue, Inc.", "agency_class": "Other"}}, {"collaborator": {"agency": "Lions VisionGift Research", "agency_class": "Other"}}]', 'start_date': u'December 2010', 'study_design': u'Observational Model: Case-Only, Time Perspective: Cross-Sectional', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01361282', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:34 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01362998?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=12&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:34 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:34 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:34 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:34 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01362998?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=12&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Preservative free morphine", "arm_group_type": "Active Comparator", "description": "This group will receive 3mg of preservative free morphine epidurally during the procedure."}}, {"arm_group": {"arm_group_label": "Fentanyl infusion", "arm_group_type": "Active Comparator", "description": "This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot\n epidural preservative free morphine with a continuous epidural fentanyl infusion. The\n investigators will be comparing the patient's pain level and satisfaction with the two\n techniques, as well as the side effects that the patients experience, such as itching,\n nausea, back pain and respiratory depression.\n ", 'brief_title': u'Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section', 'clinical_results': '{}', 'completion_date': u'June 2012', 'condition_browse': '{}', 'conditions': '[{"condition": "Pain"}]', 'detailed_description': u'\n Included in the study will be all healthy (ASA I or II) woman having elective Cesarean\n sections who are candidates for regional anesthesia. Exclusion criteria include morbid\n obesity (BMI > 40), age less that 18 years, history of sleep apnea, and abuse of or\n intolerance to opioid analgesics.\n\n All patients will also receive 100 micrograms of fentanyl once epidurally during the\n Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours\n after the Cesarean section. The patients will be visited twice a day postoperatively for two\n days. The epidural morphine will be expected to last only approximately 20 hours, while the\n fentanyl infusion will be kept in place for two days after the procedure. Additional\n analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for\n breakthrough pain.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients having an elective Cesarean section\\n\\n - Healthy women (ASA I or II)\\n\\n - Regional anesthesia candidates\\n\\n Exclusion Criteria:\\n\\n - Morbid obesity (BMI>40)\\n\\n - Sleep apnea\\n\\n - Age under 18\\n\\n - Intolerance or addiction to opioids"}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "50 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'200', 'firstreceived_date': u'May 27, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Fentanyl", "Morphine"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Preservative free morphine", "description": "3mg given epidurally during the Cesarean section.", "arm_group_label": "Preservative free morphine", "other_name": "Duramorph"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Fentanyl", "description": "An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.", "arm_group_label": "Fentanyl infusion", "other_name": "PCA fentanyl"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "fentanyl, morphine, duramorph, Cesarean section, epidural"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "University Hospitals Case Medical Center", "address": {"city": "Cleveland", "state": "Ohio", "zip": "44106", "country": "United States"}}, "status": "Recruiting", "contact": {"last_name": "Evan Goodman, MD", "phone": "216-844-5300", "email": "evan.goodman@uhhospitals.org"}, "investigator": {"last_name": "Evan Goodman, MD", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01362998', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia', 'org_study_id': u'goodman-2', 'other_outcomes': '[]', 'overall_contact': '{"overall_contact": {"last_name": "Evan Goodman, MD", "phone": "2168445300", "email": "evan.goodman@uhhospitals.org"}}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Evan Goodman, MD", "role": "Principal Investigator", "affiliation": "University Hospital Case Medical Center"}}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': u'June 2012', 'primary_outcomes': '[{"primary_outcome": {"measure": "Postsurgical pain", "time_frame": "During the 48 hours after Cesarean section", "safety_issue": "No", "description": "Participants will be asked to rate their pain on a 10 point visual analog scale."}}]', 'reference': '[{"reference": {"citation": "Sarvela J, Halonen P, Soikkeli A, Korttila K. A double-blinded, randomized comparison of intrathecal and epidural morphine for elective cesarean delivery. Anesth Analg. 2002 Aug;95(2):436-40, table of contents.", "PMID": "12145067"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Evan Goodman, M.D.", "organization": "University Hospitals Case Medical Center"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Nausea", "time_frame": "During the first 48 hours after Cesarean section", "safety_issue": "No", "description": "The patient will be asked whether she has nausea, and if so, whether it is mild, moderate or severe. It will also be noted from the nurse\'s notes whether the patient received any maedication for the nausea."}}]', 'source': u'Goodman, Evan, M.D.', 'sponsors': '[{"lead_sponsor": {"agency": "Goodman, Evan, M.D.", "agency_class": "Other"}}]', 'start_date': u'March 2011', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01362998', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:36 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363375?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=11&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:36 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:36 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363375?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=11&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "normal foot", "description": "Subjects with normal foot structure"}}, {"arm_group": {"arm_group_label": "flat foot", "description": "Subjects with flat foot structure."}}, {"arm_group": {"arm_group_label": "high arch foot", "description": "Subjects with high arch foot structure."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Excessive repetitive loading concentrating upon plantar fascia is considered as the most\n influential factor in plantar fasciitis development. Abnormal foot structure may lead to\n high risk of plantar fasciitis. However, the biomechanical factor that may cause plantar\n fasciitis has not been thoroughly investigated. Orthotic device is a common treatment used\n for plantar fasciitis. However, there is no direct and quantitative data, such as stress and\n strain distribution of plantar fascia for patient with foot orthosis during gait. Therefore,\n the aim of this three-year project study is to investigate the biomechanical mechanism of\n different foot structures and to understand the biomechanical response of plantar fascia\n during stance phase of gait cycle by dynamic finite element analysis, gait analysis as well\n as plantar pressure measurement. In addition, the efficacy of foot orthoses will be\n evaluated by the same research process. The hypotheses are that flat foot and high arch foot\n may result in higher stress and strain upon plantar fascia during gait; the foot orthosis,\n such as total contact insole, carbon fiber plate and rocker bottom sole, would reduce stress\n and strain distribution around the calcaneal medial tuberosity; rigid and curved geometric\n bottom will be able to relief plantar fascia stretching during push-off phase.\n ', 'brief_title': u'Effects of Different Foot Structures on Plantar Fasciitis and Therapeutic Footwear Intervention', 'clinical_results': '{}', 'completion_date': u'July 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Fasciitis", "Fasciitis, Plantar"]}}', 'conditions': '[{"condition": "Fasciitis"}]', 'detailed_description': u'\n The plantar fascia has long been considered to play an important role in the weight-bearing\n foot, both in static stance and in dynamic function. Various functional and structural roles\n have been indicated by virtue of its anatomical attachments. Excessive repetitive loading\n concentrating upon plantar fascia is considered as the most influential factor in plantar\n fasciitis development. Abnormal foot structure may lead to high risk of plantar fasciitis.\n However, the biomechanical factor that may cause plantar fasciitis has not been thoroughly\n investigated. Orthotic device is a common treatment used for plantar fasciitis. However,\n there is no direct and quantitative data, such as stress and strain distribution of plantar\n fascia for patient with foot orthosis during gait. Therefore, the aim of this three-year\n project study is to investigate the biomechanical mechanism of different foot structures and\n to understand the biomechanical response of plantar fascia during stance phase of gait cycle\n by dynamic finite element analysis, gait analysis as well as plantar pressure measurement.\n In addition, the efficacy of foot orthoses will be evaluated by the same research process.\n\n In this research, a plantar fascia specific finite element foot model with tibia will be\n reconstructed from magnetic resonance images obtained from subjects with normal foot, flat\n foot and high arch foot structures. The same subject will also serve for plantar soft tissue\n material property testing, gait analysis as well as plantar pressure measurement. The\n kinematic and kinetic data from both gait analysis and plantar pressure measurement will be\n used to validate the accuracy of dynamic finite element analysis. In addition, 20 normal, 10\n flat foot and 10 high-arch foot subjects will also be recruited for gait analysis and\n plantar pressure measurement. The kinematic and kinetic data from both gait analysis and\n plantar pressure measurement will be compared with the results of finite element analysis.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Subjects with normal foot structure or abnormal foot structure (flat foot or high arch\\n foot) will be invited to participant this study."}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n 1. With normal bilateral foot arch structure, unilateral flat foot or unilateral high\\n arch foot\\n\\n 2. With no more musculoskeletal disorders or malalignment\\n\\n 3. With no degeneration of low-extremity joint\\n\\n 4. With no diabetes mellitus or peripheral neuropathy\\n\\n 5. With no injury and pain of low-extremity in recent three month.\\n\\n Exclusion Criteria:\\n\\n 1. Painful disorders\\n\\n 2. Foot related disorders or deformity\\n\\n 3. Dorsal or plantar wound and trauma\\n\\n 4. Poor proprioception\\n\\n 5. Obvious abnormal gait pattern, such as midfoot strike"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "65 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'40', 'firstreceived_date': u'May 10, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Carbon fiber"}}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Foot orthosis, footwear", "description": "flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe", "arm_group_label": "normal foot", "other_name": ["Carbon fiber enhancement", "Rocker sole shoe"]}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "Foot orthosis, Footwear", "description": "flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe", "arm_group_label": "flat foot", "other_name": ["Carbon fiber enhancement", "Rocker sole shoe"]}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "Foot orthosis, footwear", "description": "flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe", "arm_group_label": "high arch foot", "other_name": ["Carbon fiber enhancement", "Rocker sole shoe"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Plantar fascia"}, {"keyword": "Plantar fasciitis"}, {"keyword": "Foot orthosis"}, {"keyword": "Finite element analysis"}, {"keyword": "Gait analysis"}, {"keyword": "Plantar pressure measurement"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Taiwan"}]', 'locations': '[{"location": {"facility": {"name": "Chang Gung Memorial Hospital@ Taoyuan", "address": {"city": "Taoyuan", "zip": "33342", "country": "Taiwan"}}, "status": "Recruiting", "contact": {"last_name": "Shih-Cherng Lin, Master", "phone": "+886-3-3196200", "phone_ext": "2253", "email": "scherng@adm.cgmh.org.tw"}, "investigator": {"last_name": "Chih-Chin Hsu, MD,PhD", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363375', 'number_of_arms': '', 'number_of_groups': u'3', 'official_title': u'The Investigation of Biomechanical Mechanism of Different Foot Structures on Plantar Fasciitis and the Evaluation of Efficacy on Therapeutic Footwear', 'org_study_id': u'NSC 97\uff0d2320\uff0dB\uff0d027\uff0d002\uff0dMY3', 'other_outcomes': '[]', 'overall_contact': '{"overall_contact": {"last_name": "Shih-Cherng Lin, Master", "phone": "+886-3-3281200", "phone_ext": "3846", "email": "scherng@adm.cgmh.org.tw"}}', 'overall_contact_backup': '{"overall_contact_backup": {"last_name": "Weng-Pin Chen, PhD", "phone": "+-886-2-27212171", "phone_ext": "2082", "email": "wpchen@mail.ntut.edu.tw"}}', 'overall_official': '{"overall_official": {"last_name": "Chih-Chin Hsu, MD, PhD", "role": "Principal Investigator", "affiliation": "Chang Gung Memorial Hospital @ Keelung"}}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Taiwan: Institutional Review Board", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': u'July 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Gait parameter, plantar pressure.", "time_frame": "1 day", "safety_issue": "No", "description": "Gait parameter, such as MTP joint range of motion(degree), meidal longitudinal arch angle(degree), hindfoot eversion/inversion angle(degree).\\nPlantar pressure, such as peak pressure(kPa), center of pressure trajectory(mm/s)."}}]', 'reference': '[{"reference": {"citation": "Boyer KA, Andriacchi TP. Changes in running kinematics and kinetics in response to a rockered shoe intervention. Clin Biomech (Bristol, Avon). 2009 Dec;24(10):872-6. doi: 10.1016/j.clinbiomech.2009.08.003. Epub 2009 Sep 9.", "PMID": "19744753"}}, {"reference": {"citation": "Van Bogart JJ, Long JT, Klein JP, Wertsch JJ, Janisse DJ, Harris GF. Effects of the toe-only rocker on gait kinematics and kinetics in able-bodied persons. IEEE Trans Neural Syst Rehabil Eng. 2005 Dec;13(4):542-50.", "PMID": "16425836"}}, {"reference": {"citation": "Brown D, Wertsch JJ, Harris GF, Klein J, Janisse D. Effect of rocker soles on plantar pressures. Arch Phys Med Rehabil. 2004 Jan;85(1):81-6.", "PMID": "14970973"}}, {"reference": {"citation": "Caravaggi P, Pataky T, G\\u00fcnther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.", "PMID": "20646107"}}, {"reference": {"citation": "Caravaggi P, Pataky T, Goulermas JY, Savage R, Crompton R. A dynamic model of the windlass mechanism of the foot: evidence for early stance phase preloading of the plantar aponeurosis. J Exp Biol. 2009 Aug; 212(Pt 15):2491-9. doi: 10.1242/jeb.025767.", "PMID": "19617443"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Chih-Chin Hsu", "organization": "Department of physical medicine and rehabilitation, Chang Gung Memorial Hospital at Keelung"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Foot MRI image, foot plantar soft tissue material property.", "time_frame": "1 day", "safety_issue": "No", "description": "Foot plantar soft tissue material property, such as elastic modulus(N/mm^2)."}}]', 'source': u'Chang Gung Memorial Hospital', 'sponsors': '[{"lead_sponsor": {"agency": "Chang Gung Memorial Hospital", "agency_class": "Other"}}, {"collaborator": {"agency": "National Science Council, Taiwan", "agency_class": "Other"}}]', 'start_date': u'June 2009', 'study_design': u'Observational Model: Case Control, Time Perspective: Cross-Sectional', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363375', 'verification_date': u'February 2008', 'why_stopped': ''} 2015-10-09 20:52:37 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363414?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=10&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:37 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:37 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:37 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:37 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363414?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=10&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Artificial tear", "arm_group_type": "Experimental", "description": "One drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye"}}, {"arm_group": {"arm_group_label": "Control", "arm_group_type": "Placebo Comparator", "description": "one drop of sterile 0.9% sodium chloride solution in the other eye"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Eyes with abnormal tear film function have been found to show larger optical aberrations\n than normal eyes which may be attributed to the unstable and irregular tear film, uneven\n ocular surface, and increased scatter due to the exposure of the rough surface of corneal\n epithelium after tear break-up.\n\n These hypotheses have been supported by the findings that instillation of artificial tears\n (sodium hyaluronate preparation) in dry eye patients reduces both corneal and ocular\n aberrations, improving the optical quality of the retinal image.\n\n However, the previous studies only evaluated the short-term effects of a single\n administration of an artificial tear but did not determine the duration of action or\n inflection point at which the ocular aberrations increase back to baseline. Also, there has\n clearly been no such clinical trial that has been a well randomized controlled study to\n date.\n\n This report is the first randomized controlled trial that investigated the long-term effects\n of a single dose of sodium hyaluronate-based artificial tears on wavefront aberrations in\n patients with dry eye.\n ', 'brief_title': u'Sodium Hyaluronate and Wavefront Aberrations in Dry Eyes', 'clinical_results': '{}', 'completion_date': u'September 2010', 'condition_browse': '{"condition_browse": {"mesh_term": ["Dry Eye Syndromes", "Keratoconjunctivitis Sicca"]}}', 'conditions': '[{"condition": "Dry Eye"}]', 'detailed_description': u'\n Parameters used to determine treatment outcomes included ocular aberrations and severity of\n dry eye symptoms.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n 1. Male or female patients aged 18 years or over.\\n\\n 2. Documented history of bilateral dry eye for at least 3 months.\\n\\n 3. Schirmer\'s I test (without anesthesia) less than 10 mm wetting/5 minutes for each\\n eye.\\n\\n 4. Tear film break-up time (TBUT) less than 10 seconds for each eye.\\n\\n 5. Good compliance with the study regimen and availability for the duration of the\\n entire study period.\\n\\n Exclusion Criteria:\\n\\n 1. Pregnant or lactating women.\\n\\n 2. Contact lens wear.\\n\\n 3. Non-mydriatic pupil size less than 5.0 mm.\\n\\n 4. Other ocular surface pathologies or coexisting ocular diseases.\\n\\n 5. Ocular surgery or trauma within the past 4 months.\\n\\n 6. Use of concomitant eye drops or eye ointments within the past 2 weeks.\\n\\n 7. Abnormality of the nasolacrimal drainage apparatus.\\n\\n 8. Permanent or temporary occlusion of lacrimal puncta in any eye.\\n\\n 9. Known hypersensitivity to hyaluronic acid or any component used in the study.\\n\\n 10. Taking the following systemic medications within the previous 2 months: tricyclic\\n antidepressive agents, anti-histaminic agents, phenothiazines, cholinergic agents,\\n antimuscarinic agents, NSAIDs, beta-blockers, immunomodulators, anti-acneic agents,\\n diuretics, corticosteroids and tetracyclines.\\n\\n 11. Very severe dry eye causing inaccurate aberrometry measurements."}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'50', 'firstreceived_date': u'May 27, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Hyaluronic Acid"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "0.18% sodium hyaluronate", "description": "one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye", "arm_group_label": "Artificial tear", "other_name": "Vislube\\u00ae/ Vismed\\u00ae"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "0.9% sodium chloride solution", "description": "one drop of sterile 0.9% sodium chloride solution in the other eye", "arm_group_label": "Control", "other_name": "0.9% NSS"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Dry eye"}, {"keyword": "Ocular aberration"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Thailand"}]', 'locations': '[{"location": {"facility": {"name": "Ramathibodi Hospital", "address": {"city": "Bangkok", "zip": "10400", "country": "Thailand"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363414', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Randomized Controlled Trial of the Effects of Sodium Hyaluronate on Wavefront Aberrations in Dry Eye Patients', 'org_study_id': u'SVS20-THAI-05-01', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Kaevalin Lekhnaont, MD", "role": "Principal Investigator", "affiliation": "Ramathibodi Hospital"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Thailand: Ethical Committee", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'June 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Ocular aberrations", "time_frame": "120 minutes", "safety_issue": "No", "description": "A Zywave\\u00ae II aberrometer which is a wavefront-sensing device based on the Hartmann-Shack principle was used to analyze monochromatic wavefront aberrations of the whole eye."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Kaevalin Lekhanont", "organization": "Department of Ophthalmology, Ramathibodi Hospital"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Severity of dry eye symptoms", "time_frame": "120 minutes", "safety_issue": "No", "description": "Dry eye symptoms in both eyes were graded separately by an interview based on a questionnaire inquiring about 12 symptoms: soreness, scratchiness, dryness, grittiness, burning, itchiness, ocular fatigue, lid heaviness, blurred vision, photophobia, discharge, and excess tearing, using a 0-100 mm visual analogue scale (VAS) (0 = no symptoms to 100 = severe symptoms)"}}, {"secondary_outcome": {"measure": "Adverse reactions and complications", "time_frame": "120 minutes", "safety_issue": "Yes"}}]', 'source': u'Ramathibodi Hospital', 'sponsors': '[{"lead_sponsor": {"agency": "Ramathibodi Hospital", "agency_class": "Other"}}]', 'start_date': u'January 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363414', 'verification_date': u'September 2010', 'why_stopped': ''} 2015-10-09 20:52:38 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363427?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=9&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:38 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:38 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:38 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:38 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:38 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363427?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=9&resultsxml=true> {'acronym': u'Crohn 2', 'arm_groups': '[{"arm_group": {"arm_group_label": "Crohn\'s disease", "description": "Patients with initially diagnosed Crohn\'s disease"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine\n in recently diagnosed patients with Morbus Crohn by retrospective data collection.\n ', 'brief_title': u"Retrospective Data Analysis in Crohn's Disease", 'clinical_results': '{}', 'completion_date': u'July 2010', 'condition_browse': '{"condition_browse": {"mesh_term": "Crohn Disease"}}', 'conditions': '[{"condition": "Crohn\'s Disease"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Private practices"}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - therapeutic need according to SPC\\n\\n - written informed consent"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'161', 'firstreceived_date': u'May 30, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Germany"}]', 'locations': '[{"location": {"facility": {"name": "Investigational Site, Ehrenfelsstra\\u00dfe 47", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M\\u00f6llendorfstra\\u00dfe 111", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M\\u00fcnchner Stra\\u00dfe 64", "address": {"city": "Dachau", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Karlsbader Stra\\u00dfe 7", "address": {"city": "Dinkelsb\\u00fchl", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Heiligengrabstra\\u00dfe 16", "address": {"city": "Hof", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Am Tiefen Weg 2", "address": {"city": "Karlstadt", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Erdbeerfeld 8", "address": {"city": "Kiel-Altenholz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hohenfelder Stra\\u00dfe 20", "address": {"city": "Koblenz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Graseggerstra\\u00dfe 105", "address": {"city": "K\\u00f6ln", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Funkenburgstra\\u00dfe 19", "address": {"city": "Leipzig", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Franz-Kail-Stra\\u00dfe 2", "address": {"city": "Leverkusen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Bahnhofplatz 2", "address": {"city": "Mainz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Uferstra\\u00dfe 3", "address": {"city": "Minden", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hammer Stra\\u00dfe 95", "address": {"city": "M\\u00fcnster", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Weiltinger Str. 11", "address": {"city": "N\\u00fcrnberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Marktplatz 23", "address": {"city": "Rottenburg", "country": "Germany"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363427', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u"Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries", 'org_study_id': u'FE 999907 (Pentasa)', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Clinical Development Support", "role": "Study Director", "affiliation": "Ferring Pharmaceuticals"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Germany: Ethics Commission", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Response to Mesalazine: measured by time to step up therapy", "time_frame": "12 to 48 months", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Clinical Development Support", "organization": "Ferring Pharmaceuticals"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Identification and characterisation of the responding sub-population", "time_frame": "12 to 48 months", "safety_issue": "No", "description": "measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2)"}}]', 'source': u'Ferring Pharmaceuticals', 'sponsors': '[{"lead_sponsor": {"agency": "Ferring Pharmaceuticals", "agency_class": "Industry"}}]', 'start_date': u'March 2007', 'study_design': u'Observational Model: Case-Only, Time Perspective: Retrospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363427', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:39 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363453?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=8&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:39 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:39 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:39 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:39 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:39 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363453?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=8&resultsxml=true> {'acronym': u'CARE', 'arm_groups': '[{"arm_group": {"arm_group_label": "Patients with Ulcerative Colitis"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The aim of the non-interventional study is to document the daily doses in acute and\n remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage\n forms are added and, when and how long steroids are given.\n ', 'brief_title': u'User Surveillance in Ulcerative Colitis', 'clinical_results': '{}', 'completion_date': u'July 2008', 'condition_browse': '{"condition_browse": {"mesh_term": ["Colitis", "Colitis, Ulcerative", "Ulcer"]}}', 'conditions': '[{"condition": "Ulcerative Colitis"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Private practices"}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - therapeutic need according to SPC\\n\\n - written informed consent\\n\\n Exclusion Criteria:\\n\\n - contraindications according to SPC"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'500', 'firstreceived_date': u'May 30, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Germany"}]', 'locations': '[{"location": {"facility": {"name": "Investigational , Karlsplatz 18", "address": {"city": "Aalen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Goethestra\\u00dfe 5", "address": {"city": "Ansbach", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Elisenstra\\u00dfe 32", "address": {"city": "Aschaffenburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Haingasse 22", "address": {"city": "Bad Homburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Blankenburger Chaussee 86", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Etkar-Andr\\u00e9-Stra\\u00dfe 8", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Karl-Marx-Stra\\u00dfe 46", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Martin-Luther-Stra\\u00dfe 134", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Mohrenstra\\u00dfe 6", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Myslowitzer Stra\\u00dfe 49", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Pl\\u00fcgerstra\\u00dfe 75", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Sch\\u00f6nhauser Allee 129", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hauptstra\\u00dfe 13 - 15", "address": {"city": "Birkenfeld", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Kurt-Schumacher-Platz 4", "address": {"city": "Bochum", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Am Burgweiher 54", "address": {"city": "Bonn", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Kasernenstra\\u00dfe 22 - 24", "address": {"city": "Bonn", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M\\u00fcnsterstra\\u00dfe 18", "address": {"city": "Bonn", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Trauerberg 27/28", "address": {"city": "Brandenburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hermann-Hesse-Platz 3", "address": {"city": "Calw", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Moritzstra\\u00dfe 19", "address": {"city": "Chemnitz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Osterstra\\u00dfe 44", "address": {"city": "Cloppenburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Leipziger Stra\\u00dfe 45 b", "address": {"city": "Cottbus", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M\\u00fcnchner Stra\\u00dfe 64", "address": {"city": "Dachau", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Sch\\u00e4fergraben 5 H", "address": {"city": "Delitzsch", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hans-B\\u00f6ckler-Stra\\u00dfe 20", "address": {"city": "Dinslaken", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Schadowstra\\u00dfe 42", "address": {"city": "D\\u00fcsseldorf", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Simrockstra\\u00dfe 56", "address": {"city": "D\\u00fcsseldorf", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Ludwig-Sandberg-Stra\\u00dfe 4", "address": {"city": "Eberswalde", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Neuzeller Landweg 1", "address": {"city": "Eisenh\\u00fcttenstadt", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M\\u00fchlendamm 23", "address": {"city": "Elmshorn", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Franz-Busbach-Str. 8", "address": {"city": "Erftstadt", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Neuwerkstra\\u00dfe 2", "address": {"city": "Erfurt", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Lehmanns Brink 5", "address": {"city": "Essen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Steeler Stra\\u00dfe 204", "address": {"city": "Essen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Viktoriastra\\u00dfe 5", "address": {"city": "Euskirchen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Sorauer Stra\\u00dfe 56", "address": {"city": "Forst", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Im Pr\\u00fcfling 23", "address": {"city": "Frankfurt Main", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Pfingstweidestra\\u00dfe 4", "address": {"city": "Frankfurt Main", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Finkenstra\\u00dfe 31", "address": {"city": "Freising", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Bahnhofstra\\u00dfe 16", "address": {"city": "Fulda", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Bahnhofplatz 11", "address": {"city": "F\\u00fcrth", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Stra\\u00dfburger Weg 4", "address": {"city": "Gelsenkirchen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hinter der Mauer 105", "address": {"city": "Goch", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Waldweg 1", "address": {"city": "G\\u00f6ttingen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Buscheystra\\u00dfe 15 a", "address": {"city": "Hagen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Drosselstra\\u00dfe 6 A", "address": {"city": "Hamburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Eppendorfer Baum 35-37", "address": {"city": "Hamburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Fontenay 1 d", "address": {"city": "Hamburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Propst-Paulsen-Stra\\u00dfe 2", "address": {"city": "Hamburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Schweriner Stra\\u00dfe 1", "address": {"city": "Hamburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Rathausplatz 4", "address": {"city": "Ha\\u00dfloch", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Kurf\\u00fcrstenanlage 34", "address": {"city": "Heidelberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Luisenstra\\u00dfe 18 a", "address": {"city": "Hettstedt", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hohensachsener Str. 2", "address": {"city": "Hirschberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Robert-Koch-Stra\\u00dfe 2", "address": {"city": "Hofheim", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, M.-Grollmu\\u00df-Stra\\u00dfe 10", "address": {"city": "Hoyerswerda", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, J.-Lange-Stra\\u00dfe 20, Haus 7", "address": 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{"city": "Lindau", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Potsdamer Stra\\u00dfe 120A", "address": {"city": "Ludwigsfelde", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Rheing\\u00f6nheimer Str. 121", "address": {"city": "Ludwigshafen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Wei\\u00dfdornhag 2", "address": {"city": "Ludwigshafen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, K\\u00f6nigstra\\u00dfe 81", "address": {"city": "L\\u00fcbeck", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Pfeifferstra\\u00dfe 10", "address": {"city": "Magdeburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Wei\\u00dfliliengasse 31", "address": {"city": "Mainz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Auf dem Sand 76a", "address": {"city": "Mannheim", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Zum Schotzberg 1 a", "address": {"city": "Merzig-Schwemmlingen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Zur Stadthalle 2", "address": {"city": "Merzig", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Oldenkirchener Stra\\u00dfe 43", "address": {"city": "M\\u00f6nchengladbach", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Irisstra\\u00dfe 23", "address": {"city": "M\\u00fcnchen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Theodolindenstra\\u00dfe 97", "address": {"city": "M\\u00fcnchen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hammer Stra\\u00dfe 95", "address": {"city": "M\\u00fcnster", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Unterer Markt 26/27", "address": {"city": "Neumarkt in der Oberpfalz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Bahnhofstra\\u00dfe 11", "address": {"city": "Nieder-Olm", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Glogauer Stra\\u00dfe 42", "address": {"city": "N\\u00fcrnberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Kleinreuther Weg 88", "address": {"city": "N\\u00fcrnberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Weiltinger Stra\\u00dfe 11", "address": {"city": "N\\u00fcrnberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hauptstra\\u00dfe 19", "address": {"city": "Oldenburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Lutherstra\\u00dfe 22", "address": {"city": "Oschatz", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Neue Mitte 6", "address": {"city": "Pohlheim", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Allee nach Sanssouci 7", "address": {"city": "Potsdam", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Dortustra\\u00dfe 4", "address": {"city": "Potsdam", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Gro\\u00dfbeerenstra\\u00dfe 301", "address": {"city": "Potsdam", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, R.-Breitscheid-Stra\\u00dfe 56", "address": {"city": "Potsdam", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hohenzollernstra\\u00dfe 7", "address": {"city": "Recklinghausen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Bundesstra\\u00dfe 56", "address": {"city": "Roetgen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, St.-Petersburger Str. 18c", "address": {"city": "Rostock", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Heinz-Meise-Stra\\u00dfe 101", "address": {"city": "Rotenburg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Tegernseer Str. 100", "address": {"city": "Rottach-Egern", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Hoerstra\\u00dfe 42", "address": {"city": "Rottweil", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Neustadter Stra\\u00dfe 61", "address": {"city": "Sonnenberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Wintersp\\u00fcrer Stra\\u00dfe 11", "address": {"city": "Stockach", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Fichteplatz 1", "address": {"city": "S trausberg", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Am Wallgraben 99", "address": {"city": "Stuttgart", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Industriestra\\u00dfe 4", "address": {"city": "Stuttgart", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, R\\u00f6hre 1", "address": {"city": "Sundern", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Olgastra\\u00dfe 139", "address": {"city": "Ulm", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Am Stutenteich 8", "address": {"city": "Waltrop", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Langenbeckplatz 2", "address": {"city": "Wiesbaden", "country": "Germany"}}}}, {"location": {"facility": {"name": "Investigational Site, Stra\\u00dfe von Triptis 12", "address": {"city": "Zell", "country": "Germany"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363453', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u'Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine', 'org_study_id': u'FE999907', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Clinical Development Support", "role": "Study Director", "affiliation": "Ferring Pharmaceuticals"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Germany: Federal Institute for Drugs and Medical Devices", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "Prescription habits measured by daily dose of Mesalazine", "time_frame": "0 - 8 weeks", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Clinical Development Support", "organization": "Ferring Pharmaceuticals"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Compliance measured by questionnaire for drug intake", "time_frame": "0 - 8 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Quality of Life measured by EuroQol Questionnaire", "time_frame": "0 - 8 weeks", "safety_issue": "No"}}]', 'source': u'Ferring Pharmaceuticals', 'sponsors': '[{"lead_sponsor": {"agency": "Ferring Pharmaceuticals", "agency_class": "Industry"}}, {"collaborator": {"agency": "Ferring Arzneimittel GmbH", "agency_class": "Industry"}}]', 'start_date': u'October 2007', 'study_design': u'Observational Model: Case-Only, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363453', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:41 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01363726?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=7&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_s=05%2F31%2F2011&lup_e=05%2F31%2F2011) 2015-10-09 20:52:41 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:41 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01363726?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=7&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "2", "description": "Jewish and Bedouin children < 5 years of age in southern Israel"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to monitor diarrheal disease and observe changes after the\n introduction of the rota vaccine.\n ', 'brief_title': u'Surveillance of Rotavirus Gastroenteritis in Children <5 Years', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": ["Gastroenteritis", "Rotavirus Infections"]}}', 'conditions': '[{"condition": "Gastroenteritis"}, {"condition": "Rotavirus Infections"}]', 'detailed_description': u'\n Monitoring of diarrheal disease and observe changes after the introduction of the rota\n vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the\n introduction of the rota vaccine into the national immunization program\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Survieillance of Rotavirus Gastroenteritis Among Children Bedouin and Jewish < 5 years\\n with gastro enteritis visiting the ER in southern Israel"}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n 1. Children < 5 years with\\n\\n 2. Gastro enteritis\\n\\n 3. Visiting the ER\\n\\n 4. Residents of southern Israel\\n\\n 5. Signed informed concent -\\n\\n Exclusion Criteria:\\n\\n Not all of the above"}, "gender": "Both", "minimum_age": "N/A", "maximum_age": "5 Years", "healthy_volunteers": "No"}}', 'enrollment': u'30000', 'firstreceived_date': u'May 30, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "surveillance Rotavirus Gastroenteritis Children"}, {"keyword": "< 5 years of age"}, {"keyword": "southern Israel"}, {"keyword": "Signed informed concent"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Israel"}]', 'locations': '[{"location": {"facility": {"name": "Pediatric infectious disease unit Soroka U medical center", "address": {"city": "Beer Sheva", "zip": "84101", "country": "Israel"}}, "status": "Recruiting", "contact": {"last_name": "David Greenberg, MD", "phone": "97286400547", "email": "dudi@bgu.ac.il"}, "contact_backup": {"last_name": "Oshrit Sabach", "phone": "97286400547", "email": "sabacho@bgu.ac.il"}, "investigator": {"last_name": "Ron Dagan, MD", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01363726', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u'Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel', 'org_study_id': u'sor415005ctil', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Israel: Ethics Commission", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction", "time_frame": "7 years", "safety_issue": "No", "description": "To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "pediatric infectious diseases unit,", "organization": "Soroka U Medical center"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.", "time_frame": "7 years", "safety_issue": "No", "description": "To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations."}}]', 'source': u'Soroka University Medical Center', 'sponsors': '[{"lead_sponsor": {"agency": "Soroka University Medical Center", "agency_class": "Other"}}]', 'start_date': u'October 2005', 'study_design': u'Observational Model: Ecologic or Community, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01363726', 'verification_date': u'October 2005', 'why_stopped': ''} 2015-10-09 20:52:41 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00313053?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=61&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:52:41 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:41 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:41 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00313053?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=61&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This is a phase I trial in patients with relapsed or refractory leukemia of a human\n monoclonal antibody that kills B cell acute lymphoblastic leukemia. The trial will study the\n safety, pharmacokinetics, and anti-tumor activity of the antibody given as a single agent\n and with vincristine.\n ', 'brief_title': u'Study of mAb 216 With Chemotherapy for Treatment of Pediatric Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia', 'clinical_results': '{}', 'completion_date': u'July 2008', 'condition_browse': '{"condition_browse": {"mesh_term": ["Leukemia", "Leukemia, Lymphoid", "Precursor Cell Lymphoblastic Leukemia-Lymphoma"]}}', 'conditions': '[{"condition": "Leukemia, Lymphocytic, Acute"}, {"condition": "Leukemia"}, {"condition": "Acute Lymphoid Leukemia (ALL)"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:- Patients must be > than 12 months at the time of study entry.\\n\\n - Patients must have had histologic verification of B-lineage ALL with bone marrow\\n relapse or refractory disease that is unresponsive to traditional chemotherapy.\\n\\n - For patients WITHOUT prior allogeneic bone marrow transplant (BMT):\\n\\n - Second or subsequent bone marrow relapse\\n\\n - Primary refractory marrow disease\\n\\n - M3 marrow (> 25% blasts)\\n\\n - For patients WITH prior allogeneic BMT:\\n\\n - First or subsequent bone marrow relapse post-BMT\\n\\n - M3 marrow or M2 (> 5% and < 25% blasts) if cytogenetic or variable number tandem\\n repeat (VNTR) confirmation\\n\\n - Confirmation of antibody reactivity\\n\\n - Patient\'s leukemic blasts (peripheral blood or marrow) must be documented to bind mAb\\n 216 in vitro (Teng lab).\\n\\n - Patient\'s red blood cell (RBC) documented to NOT express fetal \\"i\\" antigen and RBC\\n shown to NOT bind mAb 216 in vitro (Teng lab)\\n\\n - Patient must not be eligible for therapies of higher priority\\n\\n - Performance level Karnofsky 50% for patients > 10 years of age and Lansky >= 50 for\\n patients <= 10 years of age.\\n\\n - Life expectancy must be at least 8 weeks.\\n\\n - Patients must have fully recovered from the acute toxic effects of all prior\\n chemotherapy, immunotherapy, or radiotherapy prior to entering this study:\\n\\n - Myelosuppressive chemotherapy: must not have been received within 2 weeks of\\n entry onto this study.\\n\\n - Biologic: at least 7 days since the completion of therapy with a biologic agent.\\n\\n - No hematologic criteria for white blood cell (WBC), hemoglobin (Hgb), or platelets\\n\\n - Patients with thrombocytopenia should be responsive to platelet transfusions and must\\n not have uncontrolled bleeding.\\n\\n - Adequate renal function defined as: a serum creatinine that is less than or equal to\\n 1.5 x normal for age\\n\\n - Adequate liver function defined as: total bilirubin <= 1.5 x upper limit of normal\\n (ULN) for age, and SGPT (ALT) <= 5 x upper limit of normal (ULN) for age\\n\\n - Adequate cardiac function defined as: shortening fraction of >= 27% by\\n echocardiogram, or ejection fraction of >= 50% by gated radionuclide study.\\n\\n - All patients and/or their parents or legal guardians must sign a written informed\\n consent/assent.\\n\\n - All Institutional Review Board (IRB) and Food and Drug Administration (FDA)\\n requirements for human studies must be met.\\n\\n Exclusion Criteria:- Central nervous system (CNS) 3 or refractory CNS leukemia\\n\\n - Isolated extramedullary relapse\\n\\n - Uncontrolled infection\\n\\n - Lack of mAb 216 binding to patient\'s leukemic blasts in vitro\\n\\n - Binding of mAb 216 to the\\"i\\" antigen on patient\'s erythrocytes\\n\\n - Prior treatment with rituximab"}, "gender": "Both", "minimum_age": "12 Months", "maximum_age": "18 Years", "healthy_volunteers": "No"}}', 'enrollment': u'20', 'firstreceived_date': u'April 7, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Human mAb 216"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Vincristine"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Stanford University School of Medicine", "address": {"city": "Stanford", "state": "California", "zip": "94305", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00313053', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'A Phase I Study of mAb 216 With Chemotherapy for the Treatment of Pediatric Patients With Relapsed or Refractory B-progenitor Acute Lymphoblastic Leukemia', 'org_study_id': u'PEDSMAB216', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Clare J. Twist M.D.", "role": "Principal Investigator", "affiliation": "Stanford University"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["United States: Food and Drug Administration", "United States: Institutional Review Board"]}}', 'phase': u'Phase 1', 'primary_completion_date': u'April 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "Maximum tolerable dose without toxicity", "time_frame": "not known", "safety_issue": "Yes"}}, {"primary_outcome": {"measure": "Safety", "time_frame": "unknown", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Clare J. Twist M.D.", "organization": "Stanford University School of Medicine"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "95343"}, {"secondary_id": "CA85199-01"}, {"secondary_id": "PEDSMAB216"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Decrease in leukemic blasts", "time_frame": "unknown", "safety_issue": "No"}}]', 'source': u'Stanford University', 'sponsors': '[{"lead_sponsor": {"agency": "Stanford University", "agency_class": "Other"}}, {"collaborator": {"agency": "National Institutes of Health (NIH)", "agency_class": "NIH"}}]', 'start_date': u'September 2004', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00313053', 'verification_date': u'October 2010', 'why_stopped': ''} 2015-10-09 20:52:42 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00110084?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=68&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:52:43 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:43 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:43 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00110084?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=68&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Nab-paclitaxel/Gemcitabine", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin\n Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor\n cells, either by killing the cells or by stopping them from dividing. Giving more than one\n drug (combination chemotherapy) may kill more tumor cells.\n\n PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine\n works in treating women with metastatic breast cancer.\n ', 'brief_title': u'ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer', 'clinical_results': '{"clinical_results": {"participant_flow": {"recruitment_details": "Participants were recruited from 22 medical clinics in the United States between November 2005 to May 2006", "group_list": {"group": {"@group_id": "P1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "50"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "22"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "28"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Adverse Event", "participants_list": {"participants": {"@group_id": "P1", "@count": "9"}}}, {"title": "Death", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Patient Refusal", "participants_list": {"participants": {"@group_id": "P1", "@count": "10"}}}, {"title": "Alternate Therapy", "participants_list": {"participants": {"@group_id": "P1", "@count": "5"}}}, {"title": "Intercurrent Illness", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Other", "participants_list": {"participants": {"@group_id": "P1", "@count": "2"}}}]}}}}, "baseline": {"group_list": {"group": {"@group_id": "B1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "50"}}}}}, {"title": "Age", "units": "years", "param": "Median", "dispersion": "Full Range", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "56", "@lower_limit": "29", "@upper_limit": "86"}}}}}, {"title": "Gender, Customized", "units": "participants", "param": "Number", "category_list": {"category": {"sub_title": "Female", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "50"}}}}}, {"title": "Region of Enrollment", "units": "participants", "param": "Number", "category_list": {"category": {"sub_title": "United States", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "50"}}}}}, {"title": "Dominant disease site", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Soft tissue", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "5"}}}, {"sub_title": "Osseous", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "4"}}}, {"sub_title": "Visceral", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "41"}}}]}}, {"title": "Estrogen receptor status", "description": "Using IHC (Immunohistochemistry): categorization is determined by individual institution standards.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Positive", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "34"}}}, {"sub_title": "Negative", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "14"}}}, {"sub_title": "Unknown", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "2"}}}]}}, {"title": "HER2 (human epidermal growth factor receptor 2) status", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Positive", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "1"}}}, {"sub_title": "Negative", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "49"}}}]}}, {"title": "Number of metastatic sites", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "1", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "5"}}}, {"sub_title": "2", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "15"}}}, {"sub_title": "3+", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "30"}}}]}}, {"title": "Performance Score", "description": "Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "0 - Fully Active", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "23"}}}, {"sub_title": "1 - Ambulatory, restricted strenuous activity", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "27"}}}]}}, {"title": "Progesterone receptor status", "description": "Using IHC (Immunohistochemistry): categorization is determined by individual institution standards.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Positive", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "28"}}}, {"sub_title": "Negative", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "20"}}}, {"sub_title": "Unknown", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "2"}}}]}}]}}, "outcome_list": {"outcome": [{"type": "Primary", "title": "Proportion of Patients With Confirmed Responses", "description": "Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.\\nConfirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.", "time_frame": "Two consecutive evaluations at least 6 weeks apart", "safety_issue": "No", "population": "per protocol", "group_list": {"group": {"@group_id": "O1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "50"}}}}}, {"title": "Proportion of Patients With Confirmed Responses", "description": "Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.\\nConfirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Confirmed response", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "25"}}}, {"sub_title": "Assessable", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "50"}}}]}}]}, "analysis_list": {"analysis": {"group_id_list": {"group_id": "O1"}, "groups_desc": "Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.", "non_inferiority": "No", "param_type": "Proportion of confirmed responses (%)", "param_value": "50", "ci_percent": "95", "ci_n_sides": "2-Sided", "ci_lower_limit": "36", "ci_upper_limit": "64", "estimate_desc": "95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution."}}}, {"type": "Secondary", "title": "Progression-free Survival", "description": "Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.", "time_frame": "Time from registration to progression or death (up to 5 years)", "safety_issue": "No", "group_list": {"group": {"@group_id": "O1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "50"}}}}}, {"title": "Progression-free Survival", "description": "Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.", "units": "months", "param": "Median", "dispersion": "95% Confidence Interval", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "7.9", "@lower_limit": "5.4", "@upper_limit": "10"}}}}}]}}, {"type": "Secondary", "title": "Overall Survival", "description": "Overall survival time was defined as the number of days from registration to the date of death or last follow-up", "time_frame": "Death or last follow-up (up to 5 years)", "safety_issue": "No", "population": "Median survival time from Kaplan-meir estimate has not been attained.", "group_list": {"group": {"@group_id": "O1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}}}, {"title": "Overall Survival", "description": "Overall survival time was defined as the number of days from registration to the date of death or last follow-up", "units": "months", "param": "Median", "dispersion": "95% Confidence Interval", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1"}}}}}]}}, {"type": "Secondary", "title": "Adverse Event", "description": "Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0", "time_frame": "Every 6 weeks", "safety_issue": "Yes", "group_list": {"group": {"@group_id": "O1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "50"}}}}}, {"title": "Adverse Event", "description": "Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Neutropenia", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "27"}}}, {"sub_title": "Fatigue", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "14"}}}, {"sub_title": "Anemia", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "7"}}}, {"sub_title": "Dyspnea", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "7"}}}, {"sub_title": "Thrombocytopenia", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "6"}}}, {"sub_title": "Arthralgia", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "4"}}}, {"sub_title": "Vomiting", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "4"}}}, {"sub_title": "Neuropathy", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}, {"sub_title": "Myalgia", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}, {"sub_title": "Nausea", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}, {"sub_title": "Pain-abdominal", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}, {"sub_title": "Aspartate aminotransferase (AST)", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}]}}]}}]}, "reported_events": {"group_list": {"group": {"@group_id": "E1", "title": "Nab-paclitaxel/Gemcitabine", "description": "Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle"}}, "serious_events": {"default_vocab": "MedDRA 6", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, serious adverse events", "counts": {"@group_id": "E1", "@subjects_affected": "11", "@subjects_at_risk": "50"}}}}, {"title": "Blood and lymphatic system disorders", "event_list": {"event": [{"sub_title": "Anemia", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Febrile neutropenia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Cardiac disorders", "event_list": {"event": {"sub_title": "Arrythmia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Ileus", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Nausea", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"su b_title": "Pain-Abdominal", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Vomiting", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Bronchial infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Sepsis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Investigations", "event_list": {"event": [{"sub_title": "Neutropenia", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Platelet count decreased", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": {"sub_title": "Dehydration", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": [{"sub_title": "Arthralgia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Muscle Weakness", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Myalgia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Nervous system disorders", "event_list": {"event": {"sub_title": "Dizziness", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Dyspnea", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Pulmonary", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Skin and subcutaneous tissue disorders", "event_list": {"event": {"sub_title": "Erythema multiforme", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Vascular disorders", "event_list": {"event": {"sub_title": "Hypotension", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}]}}, "other_events": {"frequency_threshold": "0", "default_vocab": "MedDRA 6", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, other adverse events", "counts": {"@group_id": "E1", "@subjects_affected": "50", "@subjects_at_risk": "50"}}}}, {"title": "Blood and lymphatic system disorders", "event_list": {"event": {"sub_title": "Anemia", "counts": {"@group_id": "E1", "@events": "302", "@subjects_affected": "47", "@subjects_at_risk": "50"}}}}, {"title": "Cardiac disorders", "event_list": {"event": [{"sub_title": "Atrial fibrillation", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Supraventricular tachycardia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Eye disorders", "event_list": {"event": {"sub_title": "Vision-Blurred", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Constipation", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Diarrhea-No Colostom", "counts": {"@group_id": "E1", "@events": "33", "@subjects_affected": "18", "@subjects_at_risk": "50"}}, {"sub_title": "Nausea", "counts": {"@group_id": "E1", "@events": "101", "@subjects_affected": "30", "@subjects_at_risk": "50"}}, {"sub_title": "Oral cavity Mucositis/stomatitis (clinical exam)", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Oral cavity Mucositis/stomatitis (functional/symptomatic)", "counts": {"@group_id": "E1", "@events": "35", "@subjects_affected": "18", "@subjects_at_risk": "50"}}, {"sub_title": "Pain-Abdominal", "counts": {"@group_id": "E1", "@events": "7", "@subjects_affected": "4", "@subjects_at_risk": "50"}}, {"sub_title": "Pain-Stomach", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Vomiting", "counts": {"@group_id": "E1", "@events": "34", "@subjects_affected": "18", "@subjects_at_risk": "50"}}]}}, {"title": "General disorders", "event_list": {"event": [{"sub_title": "Edema: Head/Neck", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Edema: Limb", "counts": {"@group_id": "E1", "@events": "14", "@subjects_affected": "8", "@subjects_at_risk": "50"}}, {"sub_title": "Edema: trunk/genital", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Fatigue", "counts": {"@group_id": "E1", "@events": "269", "@subjects_affected": "48", "@subjects_at_risk": "50"}}, {"sub_title": "Fever-No ANC", "counts": {"@group_id": "E1", "@events": "26", "@subjects_affected": "16", "@subjects_at_risk": "50"}}, {"sub_title": "Pain", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}]}}, {"title": "Immune system disorders", "event_list": {"event": {"sub_title": "Hypersensitivity", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Bladder infection", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Bronchial infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Catheter related infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Infection", "counts": {"@group_id": "E1", "@events": "5", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Lung (pneumonia) infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Pleural infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Sepsis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Sinus infection", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Skin (cellulites) infection", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Skin infection", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Urinary tract infection", "counts": {"@group_id": "E1", "@events": "4", "@subjects_affected": "3", "@subjects_at_risk": "50"}}]}}, {"title": "Investigations", "event_list": {"event": [{"sub_title": "Alanine aminotransferase increased", "counts": {"@group_id": "E1", "@events": "14", "@subjects_affected": "7", "@subjects_at_risk": "50"}}, {"sub_title": "Alkaline phosphatase", "counts": {"@group_id": "E1", "@events": "5", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Amylase", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Aspartate aminotransferase increased", "counts": {"@group_id": "E1", "@events": "12", "@subjects_affected": "7", "@subjects_at_risk": "50"}}, {"sub_title": "Blood bilirubin increased", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Leukopenia", "counts": {"@group_id": "E1", "@events": "16", "@subjects_affected": "10", "@subjects_at_risk": "50"}}, {"sub_title": "Lipase increased", "counts": {"@group_id": "E1", "@events": "5", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Lymphopenia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Metabolic/Lab", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Neutropenia", "counts": {"@group_id": "E1", "@events": "194", "@subjects_affected": "44", "@subjects_at_risk": "50"}}, {"sub_title": "Platelet count decreased", "counts": {"@group_id": "E1", "@events": "121", "@subjects_affected": "40", "@subjects_at_risk": "50"}}, {"sub_title": "Weight gain", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Weight loss", "counts": {"@group_id": "E1", "@events": "6", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": [{"sub_title": "Anorexia", "counts": {"@group_id": "E1", "@events": "9", "@subjects_affected": "5", "@subjects_at_risk": "50"}}, {"sub_title": "Dehydration", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Hyperglycemia", "counts": {"@group_id": "E1", "@events": "6", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Hypoalbuminemia", "counts": {"@group_id": "E1", "@events": "21", "@subjects_affected": "4", "@subjects_at_risk": "50"}}, {"sub_title": "Hypocalcemia", "counts": {"@group_id": "E1", "@events": "5", "@subjects_affected": "4", "@subjects_at_risk": "50"}}, {"sub_title": "Hypokalemia", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "50"}}]}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": [{"sub_title": "Arthralgia", "counts": {"@group_id": "E1", "@events": "117", "@subjects_affected": "30", "@subjects_at_risk": "50"}}, {"sub_title": "Back pain", "counts": {"@group_id": "E1", "@events": "5", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Bone pain", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Chest wall pain", "counts": {"@group_id": "E1", "@events": "4", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Extremity-lower weakness", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Muscle Weakness", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Myalgia", "counts": {"@group_id": "E1", "@events": "94", "@subjects_affected": "29", "@subjects_at_risk": "50"}}]}}, {"title": "Nervous system disorders", "event_list": {"event": [{"sub_title": "Ataxia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Dizziness", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Dysgeusia", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Headache", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Peripheral motor neuropathy", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Peripheral sensory neuropathy", "counts": {"@group_id": "E1", "@events": "145", "@subjects_affected": "26", "@subjects_at_risk": "50"}}, {"sub_title": "Syncope", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Psychiatric disorders", "event_list": {"event": {"sub_title": "Depression", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Renal and urinary disorders", "event_list": {"event": {"sub_title": "Proteinuria", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Cough", "counts": {"@group_id": "E1", "@events": "4", "@subjects_affected": "3", "@subjects_at_risk": "50"}}, {"sub_title": "Dyspnea", "counts": {"@group_id": "E1", "@events": "115", "@subjects_affected": "30", "@subjects_at_risk": "50"}}, {"sub_title": "Hypoxia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Pharynx Mucositis/stomatitis (functional/symptomatic)", "counts": {"@group_id": "E1", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Pleural effusion", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Pneumonitis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Skin and subcutaneous tissue disorders", "event_list": {"event": [{"sub_title": "Alopecia", "counts": {"@group_id": "E1", "@events": "304", "@subjects_affected": "45", "@subjects_at_risk": "50"}}, {"sub_title": "Dry skin", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Hand-foot skin reaction", "counts": {"@group_id": "E1", "@events": "16", "@subjects_affected": "5", "@subjects_at_risk": "50"}}, {"sub_title": "Pruritus", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "2", "@subjects_at_risk": "50"}}, {"sub_title": "Rash/Desquamation", "counts": {"@group_id": "E1", "@events": "7", "@subjects_affected": "4", "@subjects_at_risk": "50"}}, {"sub_title": "Skin Irritation", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}, {"title": "Vascular disorders", "event_list": {"event": [{"sub_title": "Flushing", "counts": {"@group_id": "E1", "@events": "3", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Phlebitis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}, {"sub_title": "Thrombosis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "50"}}]}}]}}}, "certain_agreements": {"pi_employee": "All Principal Investigators ARE employed by the organization sponsoring the study.", "restrictive_agreement": "There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI\'s rights to discuss or publish trial results after the trial is completed."}, "point_of_contact": {"name_or_title": "Dr. Vivek Roy", "organization": "Mayo Clinic", "phone": "507-284-1159", "email": "roy.vivek@mayo.edu"}}}', 'completion_date': u'August 2010', 'condition_browse': '{"condition_browse": {"mesh_term": "Breast Neoplasms"}}', 'conditions': '[{"condition": "Breast Cancer"}]', 'detailed_description': u'\n OBJECTIVES:\n\n Primary\n\n - Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate\n in women with metastatic breast cancer.\n\n - Determine the toxicity profile of this regimen, in terms of incidence and severity of\n observed toxic effects, in these patients.\n\n Secondary\n\n * Determine the time to disease progression and survival of patients treated with this\n regimen.\n\n OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and\n gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence\n of disease progression or unacceptable toxicity.\n\n After completion of study treatment, patients are followed every 3 months for up to 5 years.\n\n PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "DISEASE CHARACTERISTICS:\\n\\n - Histologically or cytologically confirmed invasive breast cancer\\n\\n - Clinical evidence of metastatic disease\\n\\n + No bone metastases or other non-measurable disease as the only evidence of\\n metastasis\\n\\n - Measurable disease, defined as at least 1 measurable lesion\\n\\n - The following are considered non-measurable disease:\\n\\n - Small lesions (< 2 cm)\\n\\n - Bone lesions\\n\\n - Leptomeningeal disease\\n\\n - Ascites\\n\\n - Pleural or pericardial effusions\\n\\n - Inflammatory breast disease\\n\\n - Lymphangitis cutis or pulmonis\\n\\n - Abdominal masses that are not confirmed and followed by imaging techniques\\n\\n - Cystic lesions\\n\\n - HER2(human epidermal growth factor receptor 2)-positive disease allowed provided\\n patient has received prior treatment with trastuzumab\\n\\n - No evidence of active brain metastasis, including leptomeningeal involvement\\n\\n - Hormone receptor status:\\n\\n - Not specified\\n\\n PATIENT CHARACTERISTICS:\\n\\n Age\\n\\n - 18 and over Sex\\n\\n - Female Menopausal status\\n\\n - Not specified Performance status\\n\\n - ECOG 0-1 Life expectancy\\n\\n - At least 12 weeks Hematopoietic\\n\\n - Absolute neutrophil count \\u2265 1,500/mm^3\\n\\n - Platelet count \\u2265 100,000/mm^3\\n\\n - Hemoglobin \\u2265 9 g/dL Hepatic\\n\\n - AST and ALT \\u2264 2.5 times upper limit of normal (ULN)\\n\\n - Bilirubin \\u2264 1.5 times ULN Renal\\n\\n - Creatinine \\u2264 1.5 mg/dL Other\\n\\n - Not pregnant or nursing\\n\\n - Negative pregnancy test\\n\\n - Fertile patients must use effective contraception during and for 30 days after\\n completion of study treatment\\n\\n - No pre-existing peripheral neuropathy > grade 1\\n\\n - No other clinically significant illness or significant medical condition that would\\n preclude study participation\\n\\n - No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an\\n injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or\\n agents that are chemically similar to study drugs\\n\\n - No serious medical risk factors involving any of the major organ systems that would\\n preclude study participation\\n\\n - No active stage III or IV invasive non-breast malignancy within the past 5 years\\n\\n PRIOR CONCURRENT THERAPY:\\n\\n Biologic therapy\\n\\n - See Disease Characteristics Chemotherapy\\n\\n - No more than 1 prior adjuvant chemotherapy regimen\\n\\n - No prior chemotherapy for metastatic disease\\n\\n - At least 6 months since prior adjuvant or neoadjuvant taxane\\n\\n - More than 2 weeks since prior cytotoxic chemotherapy\\n\\n - Prior neoadjuvant chemotherapy allowed\\n\\n - No other concurrent chemotherapy Endocrine therapy\\n\\n - Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed\\n Radiotherapy\\n\\n - Prior radiotherapy to target lesion allowed provided there is evidence of disease\\n progression after completion of treatment\\n\\n - More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target\\n lesion only or single-dose palliative radiotherapy\\n\\n - No concurrent radiotherapy Surgery\\n\\n - Not specified Other\\n\\n - More than 2 weeks since prior investigational drugs\\n\\n - No concurrent participation in another clinical trial that is studying\\n investigational procedures or therapies\\n\\n - Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation\\n of pain or lytic lesions from breast cancer"}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'50', 'firstreceived_date': u'May 3, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Gemcitabine", "Paclitaxel"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Gemcitabine", "description": "1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle", "arm_group_label": "Nab-paclitaxel/Gemcitabine", "other_name": "Gemzar"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Paclitaxel protein-bound particles for injectable suspension (albumin-bound)", "description": "125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle", "arm_group_label": "Nab-paclitaxel/Gemcitabine", "other_name": "nab (nanoparticle albumin-bound)-Paclitaxel, Abraxane"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "recurrent breast cancer"}, {"keyword": "stage IV breast cancer"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "http://cancer.gov/clinicaltrials/NCCTG-N0531", "description": "Clinical trial summary from the National Cancer Institute\'s PDQ\\u00ae database"}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Mobile Infirmary Medical Center", "address": {"city": "Mobile", "state": "Alabama", "zip": "36652-2144", "country": "United States"}}}}, {"location": {"facility": {"name": "Mayo Clinic in Arizona", "address": {"city": "Scottsdale", "state": "Arizona", "zip": "85259", "country": "United States"}}}}, {"location": {"facility": {"name": "Aurora Presbyterian Hospital", "address": {"city": "Aurora", "state": "Colorado", "zip": "80012", "country": "United States"}}}}, {"location": {"facility": {"name": "Boulder Community Hospital", "address": {"city": "Boulder", "state": "Colorado", "zip": "80301-9019", "country": "United States"}}}}, {"location": {"facility": {"name": "Penrose Cancer Center at Penrose Hospital", "address": {"city": "Colorado Springs", "state": "Colorado", "zip": "80933", "country": "United States"}}}}, {"location": {"facility": {"name": "CCOP - 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Rike Cancer Center at Miami Valley Hospital", "address": {"city": "Dayton", "state": "Ohio", "zip": "45409", "country": "United States"}}}}, {"location": {"facility": {"name": "Good Samaritan Hospital", "address": {"city": "Dayton", "state": "Ohio", "zip": "45406", "country": "United States"}}}}, {"location": {"facility": {"name": "Grandview Hospital", "address": {"city": "Dayton", "state": "Ohio", "zip": "45405", "country": "United States"}}}}, {"location": {"facility": {"name": "Samaritan North Cancer Care Center", "address": {"city": "Dayton", "state": "Ohio", "zip": "45415", "country": "United States"}}}}, {"location": {"facility": {"name": "Veterans Affairs Medical Center - Dayton", "address": {"city": "Dayton", "state": "Ohio", "zip": "45428", "country": "United States"}}}}, {"location": {"facility": {"name": "Blanchard Valley Medical Associates", "address": {"city": "Findlay", "state": "Ohio", "zip": "45840", "country": "United States"}}}}, {"location": {"facility": {"name": "Fremont Memorial Hospital", "address": {"city": "Fremont", "state": "Ohio", "zip": "43420", "country": "United States"}}}}, {"location": {"facility": {"name": "Kenton Oncology, Incorporated", "address": {"city": "Kenton", "state": "Ohio", "zip": "43326", "country": "United States"}}}}, {"location": {"facility": {"name": "Charles F. Kettering Memorial Hospital", "address": {"city": "Kettering", "state": "Ohio", "zip": "45429", "country": "United States"}}}}, {"location": {"facility": {"name": "Lima Memorial Hospital", "address": {"city": "Lima", "state": "Ohio", "zip": "45804", "country": "United States"}}}}, {"location": {"facility": {"name": "Northwest Ohio Oncology Center", "address": {"city": "Maumee", "state": "Ohio", "zip": "43537", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Luke\'s Hospital", "address": {"city": "Maumee", "state": "Ohio", "zip": "43537", "country": "United States"}}}}, {"location": {"facility": {"name": "Middletown Regional Hospital", "address": {"city": "Middletown", "state": "Ohio", "zip": "45044", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Charles Mercy Hospital", "address": {"city": "Oregon", "state": "Ohio", "zip": "43616", "country": "United States"}}}}, {"location": {"facility": {"name": "Toledo Clinic - Oregon", "address": {"city": "Oregon", "state": "Ohio", "zip": "43616", "country": "United States"}}}}, {"location": {"facility": {"name": "Firelands Regional Medical Center", "address": {"city": "Sandusky", "state": "Ohio", "zip": "44870", "country": "United States"}}}}, {"location": {"facility": {"name": "North Coast Cancer Care, Incorporated", "address": {"city": "Sandusky", "state": "Ohio", "zip": "44870", "country": "United States"}}}}, {"location": {"facility": {"name": "Promedica Cancer Center at Flower Hospital", "address": {"city": "Sylvania", "state": "Ohio", "zip": "43560", "country": "United States"}}}}, {"location": {"facility": {"name": "Mercy Hospital of Tiffin", "address": {"city": "Tiffin", "state": "Ohio", "zip": "44883", "country": "United States"}}}}, {"location": {"facility": {"name": "CCOP - Toledo Community Hospital", "address": {"city": "Toledo", "state": "Ohio", "zip": "43623", "country": "United States"}}}}, {"location": {"facility": {"name": "Medical University of Ohio Cancer Center", "address": {"city": "Toledo", "state": "Ohio", "zip": "43614", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Vincent Mercy Medical Center", "address": {"city": "Toledo", "state": "Ohio", "zip": "43608", "country": "United States"}}}}, {"location": {"facility": {"name": "Toledo Clinic, Incorporated - Main Clinic", "address": {"city": "Toledo", "state": "Ohio", "zip": "43623", "country": "United States"}}}}, {"location": {"facility": {"name": "Toledo Hospital", "address": {"city": "Toledo", "state": "Ohio", "zip": "43606", "country": "United States"}}}}, {"location": {"facility": {"name": "Toledo Surgical Specialists", "address": {"city": "Toledo", "state": "Ohio", "zip": "43623", "country": "United States"}}}}, {"location": {"facility": {"name": "UVMC Cancer Care Center at Upper Valley Medical Center", "address": {"city": "Troy", "state": "Ohio", "zip": "45373-1300", "country": "United States"}}}}, {"location": {"facility": {"name": "Fulton County Health Center", "address": {"city": "Wauseon", "state": "Ohio", "zip": "43567", "country": "United States"}}}}, {"location": {"facility": {"name": "United States Air Force Medical Center Wright-Patterson", "address": {"city": "Wright-Patterson Afb", "state": "Ohio", "zip": "45433-5529", "country": "United States"}}}}, {"location": {"facility": {"name": "Ruth G. McMillan Cancer Center at Greene Memorial Hospital", "address": {"city": "Xenia", "state": "Ohio", "zip": "45385", "country": "United States"}}}}, {"location": {"facility": {"name": "Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest", "address": {"city": "Allentown", "state": "Pennsylvania", "zip": "18105", "country": "United States"}}}}, {"location": {"facility": {"name": "Geisinger Medical Center", "address": {"city": "Danville", "state": "Pennsylvania", "zip": "17822-0001", "country": "United States"}}}}, {"location": {"facility": {"name": "Geisinger Medical Group", "address": {"city": "State College", "state": "Pennsylvania", "zip": "16801", "country": "United States"}}}}, {"location": {"facility": {"name": "Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center", "address": {"city": "Wilkes-Barre", "state": "Pennsylvania", "zip": "18711", "country": "United States"}}}}, {"location": {"facility": {"name": "Rose Ramer Cancer Clinic at Anderson Area Medical Center", "address": {"city": "Anderson", "state": "South Carolina", "zip": "29621", "country": "United States"}}}}, {"location": {"facility": {"name": "CCOP - Upstate Carolina", "address": {"city": "Spartanburg", "state": "South Carolina", "zip": "29303", "country": "United States"}}}}, {"location": {"facility": {"name": "Gibbs Regional Cancer Center at Spartanburg Regional Medical Center", "address": {"city": "Spartanburg", "state": "South Carolina", "zip": "29303", "country": "United States"}}}}, {"location": {"facility": {"name": "Rapid City Regional Hospital", "address": {"city": "Rapid City", "state": "South Dakota", "zip": "57701", "country": "United States"}}}}, {"location": {"facility": {"name": "Avera Cancer Institute", "address": {"city": "Sioux Falls", "state": "South Dakota", "zip": "57105", "country": "United States"}}}}, {"location": {"facility": {"name": "Medical X-Ray Center, PC", "address": {"city": "Sioux Falls", "state": "South Dakota", "zip": "57105", "country": "United States"}}}}, {"location": {"facility": {"name": "Sioux Valley Hospital and University of South Dakota Medical Center", "address": {"city": "Sioux Falls", "state": "South Dakota", "zip": "57117-5039", "country": "United States"}}}}, {"location": {"facility": {"name": "Green Bay Oncology, Limited at St. Mary\'s Hospital", "address": {"city": "Green Bay", "state": "Wisconsin", "zip": "54303", "country": "United States"}}}}, {"location": {"facility": {"name": "Green Bay Oncology, Limited at St. Vincent Hospital", "address": {"city": "Green Bay", "state": "Wisconsin", "zip": "54301-3526", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Mary\'s Hospital Medical Center - Green Bay", "address": {"city": "Green Bay", "state": "Wisconsin", "zip": "54303", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Vincent Hospital Regional Cancer Center", "address": {"city": "Green Bay", "state": "Wisconsin", "zip": "54307-3508", "country": "United States"}}}}, {"location": {"facility": {"name": "Bay Area Cancer Care Center at Bay Area Medical Center", "address": {"city": "Marinette", "state": "Wisconsin", "zip": "54143", "country": "United States"}}}}, {"location": {"facility": {"name": "Green Bay Oncology, Limited - Oconto Falls", "address": {"city": "Oconto Falls", "state": "Wisconsin", "zip": "54154", "country": "United States"}}}}, {"location": {"facility": {"name": "Green Bay Oncology, Limited - Sturgeon Bay", "address": {"city": "Sturgeon Bay", "state": "Wisconsin", "zip": "54235", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00110084', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane\xae) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer', 'org_study_id': u'CDR0000423195', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Vivek Roy, MD, FACP", "role": "Study Chair", "affiliation": "Mayo Clinic"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 2', 'primary_completion_date': u'May 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Proportion of Patients With Confirmed Responses", "time_frame": "Two consecutive evaluations at least 6 weeks apart", "safety_issue": "No", "description": "Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart.\\nConfirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Vivek Roy, M.D.", "organization": "Mayo Clinic Cancer Center"}}', 'results_reference': '[{"results_reference": {"citation": "Roy V, LaPlant BR, Gross GG, Bane CL, Palmieri FM; North Central Cancer Treatment Group. Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531). Ann Oncol. 2009 Mar;20(3):449-53. doi: 10.1093/annonc/mdn661. Epub 2008 Dec 15.", "PMID": "19087987"}}, {"results_reference": {"citation": "Roy V, LaPlant BR, Gross GG, et al.: NCCTG phase II trial N0531of weekly nab-paclitaxel (nab-p) in combination with gemcitabine (gem) in patients with metastatic breast cancer (MBC). [Abstract] J Clin Oncol 25 (Suppl 18): A-1048, 2007."}}, {"results_reference": {"citation": "Moreno-Aspitia A, Perez EA. North Central Cancer Treatment Group N0531: Phase II Trial of weekly albumin-bound paclitaxel (ABI-007; Abraxane) in combination with gemcitabine in patients with metastatic breast cancer. Clin Breast Cancer. 2005 Oct;6(4):361-4.", "PMID": "16277889"}}]', 'secondary_ids': '[{"secondary_id": "U10CA025224"}, {"secondary_id": "N0531"}, {"secondary_id": "855-05"}, {"secondary_id": "N0433"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Progression-free Survival", "time_frame": "Time from registration to progression or death (up to 5 years)", "safety_issue": "No", "description": "Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation."}}, {"secondary_outcome": {"measure": "Overall Survival", "time_frame": "Death or last follow-up (up to 5 years)", "safety_issue": "No", "description": "Overall survival time was defined as the number of days from registration to the date of death or last follow-up"}}, {"secondary_outcome": {"measure": "Adverse Event", "time_frame": "Every 6 weeks", "safety_issue": "Yes", "description": "Number of patients that experienced adverse events (grade 3 or more occurring in >5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0"}}]', 'source': u'Mayo Clinic', 'sponsors': '[{"lead_sponsor": {"agency": "Mayo Clinic", "agency_class": "Other"}}, {"collaborator": {"agency": "National Cancer Institute (NCI)", "agency_class": "NIH"}}]', 'start_date': u'August 2005', 'study_design': u'Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00110084', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:44 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00823108?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=40&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:44 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:44 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:44 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:44 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00823108?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=40&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "arm_group_type": "Experimental", "description": "Glucose-insulin-potassium"}}, {"arm_group": {"arm_group_label": "2", "arm_group_type": "No Intervention", "description": "Control"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can\n be safely administered to patients with septic shock. GIK has been used in thousands of\n critically ill patients in research studies with very few safety concerns. However, there is\n a lack of data in regards to patients with septic shock. There are many reasons to believe\n that GIK would be beneficial in sepsis, including improving heart function and decreasing\n inflammation. This study will administer intravenous GIK for 12 hours continuously and\n monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive\n the same monitoring but will not receive GIK.\n ', 'brief_title': u'Rapid Administration of Insulin in Sepsis', 'clinical_results': '{}', 'completion_date': u'October 2010', 'condition_browse': '{"condition_browse": {"mesh_term": "Shock, Septic"}}', 'conditions': '[{"condition": "Septic Shock"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n 1. Suspected or confirmed infection;\\n\\n 2. Any two of four criteria of systemic inflammatory response:\\n\\n - Temperature > 100.4\\u00b0 or < 96.8\\u00b0 F\\n\\n - Heart rate > 90 beats/minute\\n\\n - Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg\\n\\n - WBC >12,000 or < 4000 cells/\\u00b5L or > 10% bands\\n\\n 3. Initiation of quantitative resuscitation protocol in the ED;\\n\\n 4. Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4)\\n to treat shock\\n\\n Exclusion Criteria:\\n\\n 1. Age <18 years;\\n\\n 2. Pregnancy;\\n\\n 3. Any primary diagnosis other than sepsis;\\n\\n 4. Established Do Not Resuscitate status or advanced directives restricting aggressive\\n care or treating physician deems aggressive care unsuitable;\\n\\n 5. Known hyperkalemia (serum potassium >5.5);\\n\\n 6. Dialysis-dependent renal failure;\\n\\n 7. Anticipated requirement for immediate surgery (within 24 hours);\\n\\n 8. Active participation in another interventional study;\\n\\n 9. Transferred from another hospital setting with sepsis therapy initiated;\\n\\n 10. Inability to obtain informed consent;\\n\\n 11. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to\\n enrollment;\\n\\n 12. Active malignancy currently under treatment (chemo- or radiation therapy);\\n\\n 13. Known systemic allergy to insulin;\\n\\n 14. History of periodic paralysis associated with carbohydrate loading;\\n\\n 15. R eceiving continuous intravenous inotropic support (including dobutamine, milrinone,\\n amrinone, and levosimendan)."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'20', 'firstreceived_date': u'January 14, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Insulin"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "GIK", "description": "12 hour infusion of GIK solution", "arm_group_label": "1"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "GIK, septic shock, sepsis"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Carolinas Medical Center", "address": {"city": "Charlotte", "state": "North Carolina", "zip": "28203", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00823108', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Rapid Administration of Insulin in Sepsis: A Pilot Study', 'org_study_id': u'12-08-23B', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Alan E Jones, MD", "role": "Study Director", "affiliation": "Carolinas Medical Center"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 1', 'primary_completion_date': u'October 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Absolute safety endpoint (explicit definitions)", "time_frame": "During infusion", "safety_issue": "Yes"}}, {"primary_outcome": {"measure": "Change in SOFA score, microcirculatory flow", "time_frame": "During infusion", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Alan E. Jones, MD", "organization": "Carolinas Medical Center"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Carolinas Healthcare System', 'sponsors': '[{"lead_sponsor": {"agency": "Carolinas Healthcare System", "agency_class": "Other"}}]', 'start_date': u'March 2009', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00823108', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:44 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00823576?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=39&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:45 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:45 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00823576?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=39&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "arm_group_type": "Active Comparator", "description": "Group witness: one receiving a single bolus of analgesic\\nSeepage simple person the end of intervention of 200mg of ropivaca\\u00efne 0,5 % at the level of zones it"}}, {"arm_group": {"arm_group_label": "2", "arm_group_type": "Active Comparator", "description": "Group catheter: receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Because local anesthetic infiltration has not been comparated to continuous infusion after\n spine fusion surgery, the investigators designed this study to determine whether this\n technique could enhance analgesia and improve patient outcome after posterior lumbar\n arthrodesis.\n\n The Main Objective of the study is to compare the evolution of the postoperative levels of\n pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving\n an infiltration "single shot" of local analgesic (Ropivaca\xefne), one receiving a single shot\n infiltration and a continuous infiltration of Ropivacaine during 48 hours.\n\n In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,\n and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.\n\n The secondary outcomes are the consumption of morphine,the rate of the nausea and the\n postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration\n of hospital stay and the persistence of residual pain.\n ', 'brief_title': u'Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery', 'clinical_results': '{}', 'completion_date': u'March 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Pain, Postoperative"}}', 'conditions': '[{"condition": "Postoperative Pain"}]', 'detailed_description': u'\n Postoperative pain after posterior lumbar stabilization surgery is related to soft tissue\n and muscle dissection and to manipulations and removal at the operation site. Most patients\n complain of severe pain at rest during the first 24 h after surgery. This pain increases\n considerably with mobilization because of the reflex spasm of paraspinal muscles that is\n triggered by the primary wound pain. During the following 48-72 h, postoperative back pain\n is generally moderate at rest, whereas it remains severe on movement and produces discomfort\n that can interfere with patient mobilization and, possibly, with discharge time. Despite the\n favourable effects of analgesia in the early postoperative period, this drug association may\n produce a number of well-known side effects, such as nausea, vomiting, respiratory\n depression, sedation, renal abnormality, and upper gastrointestinal and operative site\n bleeding. Local anesthetic infiltration of the surgical wound is a useful method in the\n treatment of postoperative pain after various surgical procedures. Ropivacaine is an\n interesting molecule for infiltration because of its vasoconstrictive properties and\n decreased neuro- and cardiotoxicity compared with bupivacaine.\n\n The Main Objective of the study is to compare the evolution of the postoperative levels of\n pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving\n an infiltration "single shot" of local analgesic (Ropivaca\xefne), one receiving a single shot\n infiltration and a continuous infiltration of Ropivacaine during 48 hours.\n\n After we obtained approval from the ethics committee and informed, written consent from\n patients, patients older than 18 years old , heavier than 50 kg, without psychological\n disorders, benefiting from of arthrodesis scheduled by a rachis lumbar posterior way were\n enrolled.\n\n Patients were randomized to one of the two following postoperative analgesia groups after a\n presealed envelope was opened.\n\n Post operative pain management is standardised with paracetamol, profenid and ACP morphine\n for each patient.\n\n In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,\n and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.\n\n The Main Objective of the study is to compare the pain between 2 groups by means of the EVA\n (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16,\n H24, H48.\n\n The secondary outcomes are:\n\n - The consumption of morphine 24 H and 48 H after surgery - The rate of the nausea and\n the postoperative vomits defined as the number of patients presenting the symptom on\n the number of patients in the group. - Delay up to the first rise\n\n - Delay will be estimated in hours enter the end of the intervention surgery and the\n first one night\n\n - The quality of the sleep estimated every morning with an analogical visual scale from 0\n (very bad quality of sleep) to 10 (excellent quality of sleep)\n\n - The duration of stay: calculated in days as the delay between the end of the\n intervention and the capacity at the exit.\n\n - Recall of the patients in 3 and 6 months after the surgery to estimate the persistence\n of residual pains and if they still consume opioid. We shall ask to the patient to\n clarify the presence or the absence of pain The amount of analgesics required and the\n local and systemic adverse events were recorded for each patient.\n\n Discharge was decided by the surgeons according to the following discharge criteria:1)\n satisfactory pain control for self-mobility; 2) uncomplicated wound-healing process 3) no\n impairments in haemoglobin 4) normothermie 5) normal transit, no nausea and vomit.\n\n Sample-size calculation was based on an expected difference of 20 mm in VAS measurements for\n pain between groups. We calculate we need 64 patients for our main outcome. Each patient\n will be monitored during 6 month after the surgery.\n\n The length of the study is 2 years.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients benefiting from of arthrodesis scheduled by a rachis lumbar posterior way\\n\\n - Older than 18 years old\\n\\n - Heavier than 50 kg\\n\\n - Patients in the state health scheme\\n\\n - Patients having signed consent\\n\\n Exclusion Criteria:\\n\\n - Surgery linked to an infectious, tumoral or traumatological cause\\n\\n - Patients suffering of chronic pain define as patients consuming stage 3 analgesic\\n since more than 3 months.- Patients receiving isoptine or fl\\u00e9ca\\u00efne before surgery\\n\\n - Arthrodesis on more than 3 stages\\n\\n - Impossibility of cooperate with the patient\\n\\n - Contra-indication for the maintain or the installation of a catheter diffusing\\n analgesic\\n\\n - Contra-indication of using local analgesic"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'64', 'firstreceived_date': u'January 14, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Ropivacaine"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Ropivacaine", "description": "Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours.", "arm_group_label": ["1", "2"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Arthodeses rachis lombar"}, {"keyword": "Spinal Surgery"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "CHU de Nice - 4 avenue Reine Victoria - H\\u00f4pital de Cimiez", "address": {"city": "Nice", "state": "Alpes-Maritimes", "zip": "06001", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00823576', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Efficacy of Ropivacaine Continuous Wound Instillation Versus Single Shot After Spine Fusion Surgery', 'org_study_id': u'08-CIR-03', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "LITRICO LS St\\u00e9phane, PH", "role": "Principal Investigator", "affiliation": "CHU de Nice - H\\u00f4pital Pasteur - 30 ave de la Voie Romaine - 06100 Nice"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)", "has_dmc": "No"}}', 'phase': u'Phase 4', 'primary_completion_date': u'December 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Primary end points Principal: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48.", "time_frame": "2 days", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "CAILLON Cynthia", "organization": "CHU de Nice"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "The consumption of morphine mg-The rate of the nausea and the postoperative vomits defined-Delay up to the first rise-Delay will be estimated in hours enter the end of the intervention surgery and the first one night", "time_frame": "2 days", "safety_issue": "No"}}]', 'source': u'Centre Hospitalier Universitaire de Nice', 'sponsors': '[{"lead_sponsor": {"agency": "Centre Hospitalier Universitaire de Nice", "agency_class": "Other"}}]', 'start_date': u'December 2008', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00823576', 'verification_date': u'January 2009', 'why_stopped': ''} 2015-10-09 20:52:45 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00831818?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=38&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:45 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:45 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:45 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00831818?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=38&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "description": "Mothers of healthy infants who breastfeed on demand"}}, {"arm_group": {"arm_group_label": "2", "description": "Mothers of healthy infants who do not breastfeed"}}]', 'biospec_descr': u'\n ', 'biospec_retention': u'Samples With DNA', 'brief_summary': u'\n Weight retention after pregnancy contributes to increasing rates of obesity. There is\n evidence that breastfeeding is accompanied from changes in fat mobilisation and fat mass,\n nevertheless there are no data on the effects of breastfeeding on appetite-regulation. This\n study aims to investigate the direct effect of breastfeeding on the systemic levels of\n appetite-regulating hormones: ghrelin and PYY. Blood samples will be obtained at five time\n points (before, during and after breastfeeding) in ten mothers of healthy infants who\n breastfeed on demand and in ten mothers of healthy infants who do not breastfeed. All\n mothers will be fasting since 4 hours. The results will bring information on a possible\n direct effect of breastfeeding on appetite-regulatory hormones.\n ', 'brief_title': u'Effects of Breastfeeding on Maternal Plasma Ghrelin and Peptide Tyrosine Tyrosine (PYY) Levels', 'clinical_results': '{}', 'completion_date': u'November 2010', 'condition_browse': '{}', 'conditions': '[{"condition": "Breastfeeding"}]', 'detailed_description': u'\n The gut-brain axis is one of the main regulators of appetite (Cummings et Overduin).\n Responsible for this interaction are among others the appetite-controlling gut peptides:\n ghrelin and PYY. Ghrelin is produced primarily in the endocrine cells of the oxyntic mucosa\n of the gastric fundus and was originally described as a potent endogenous GH stimulating\n factor (Kojima et al, Date et al). It induces short-term food intake and long-term adiposity\n by acting at the hypothalamus (Tschop et al, Nakazato et al). Ghrelin is highly conserved\n throughout the evolution and responsible for many central and peripheral endocrine and\n non-endocrine effects (van der Lely et al, Ghigo et al). Peptide YY or PYY is mainly\n produced in the terminal ileum and colon and characterized as an agent inhibiting\n gastrointestinal motility and appetite PYY(3-36) has been shown only recently in humans\n (Lundberg et al, Batterham et al. 2002). Upon infusion of PYY(3-36) subsequent food\n consumption was reduced in both lean and obese subjects (Batterham et al. 2003).\n\n While the physiological and pathological control of appetite has attracted much attention in\n these times of increasing prevalence of obesity, nothing is known on the regulation of gut\n peptides during breastfeeding. Concerns that long-term weight retention after pregnancy\n contributes to increasing rates of obesity underscore the importance of understanding\n postpartum energy utilization (Mokdad et al). The 6 months following delivery of the baby\n are associated with a significant decrease of maternal fat mass. Fat mobilisation appears to\n be physiologic and gradual, even when food is readily available. Trunk fat and thigh fat are\n the primary energy depots mobilized to support lactation (Butte et Hopkinson). Several\n studies have revealed that breastfeeding facilitates post-partum weight loss (8,10).\n Nevertheless, it was shown that lactating women loose central and peripheral fat less\n rapidly then nonlactating women (Wosje et Kalkwarf). Prolonged breastfeeding has been shown\n to reduce the risk of developing obesity in the offspring (Cripps et al), and ghrelin has\n been suggested as a hormonal link between the duration of breastfeeding and body weight\n development (Fak et al).\n\n The endocrinology of lactating women consists in increased amounts of prolactin and\n oxytocin, needed for milk production and release respectively. Very little is known on the\n relationship between these hormones and the appetite-modulating gut peptides. Intravenous\n ghrelin activates the hypothalamic-hypophysis-adrenal axis in humans and also increases\n prolactin release in healthy humans (Aimaretti et al). Intraventricular ghrelin\n administration increases intrahypothalamic oxytocin production in rats (Olszewski et al).\n\n We recently found that continuous intravenous injection of Oxytocin decreases plasma ghrelin\n concentrations in healthy men (own recent and not yet published data). It is thought that\n increased circulating Prolactin stimulates appetite in lactating women, but there are no\n data on the effects of Prolactin on appetite-modulating gut hormones (Grattan). With the\n proposed study we aim to check the relevance of these findings in normal physiology and to\n study the breastfeeding-induced changes in circulating ghrelin and PYY concentrations in\n lactating mothers.\n\n Setting Clinical Trial Unit of the Division of Endocrinology and Metabolism, Department of\n Internal Medicine III, AKH, Waehringer G\xfcrtel 18-20, A-1090, Vienna.\n\n Study Subjects Study group: Ten mothers of healthy infants who breastfeed on demand. Control\n group: Ten mothers of healthy infants who do not breastfeed.\n\n Study Protocol\n\n Breastfeeding group:\n\n The study will start at ca. 10h00-12h00 and the women will be fasting since ca. 4 hours.\n There will be no restriction of water-intake before and throughout the study. An intravenous\n cannula will be inserted in the antecubital vein of one arm for blood withdrawal. The arm\n not needed for carrying the baby during breastfeeding will be used (e.g. if the baby is due\n to drink on the right breast, the intravenous cannula will be put on the left arm, und vice\n versa). In any case, a support cushion will be used for breastfeeding. The subjects will\n rest for ca. 30 minutes. Then, a basal blood withdrawal will be performed.\n\n When the mother decides to breastfeed the baby on demand, blood will be withdrawn\n immediately before breastfeeding (time 0) and then at time points 15, 30 and 60 minutes. The\n duration of breastfeeding will be noted. 9 ml blood will be withdrawn in an EDTA-containing\n vacutainer at each timepoint (total 45 ml during the whole study). Ca 100\xb5l will be\n separated into a cap for the online measuring of glucose, while the rest will be immediately\n cooled on ice and centrifuged within 30 minutes. Plasma will be aliquoted in 3 cryotubes, 2\n of which will be frozen in -80\xb0C and the third in -20\xb0C.\n\n Control Group:\n\n The study will start at ca. 10h00-12h00 and the women will be fasting since ca. 4 hours.\n There will be no restriction of water-intake before and throughout the study. An intravenous\n cannula will be inserted in the antecubital vein of one arm for blood withdrawal. The\n subjects will rest for ca. 30 minutes. Then, a basal blood withdrawal will be performed,\n thereafter 4 times halfhourly.\n\n Statistical analysis The sample number (10 breast-feeding and 10 not-breastfeeding mothers)\n can detect with 80% power a difference of 18% between ghrelin values after breastfeeding\n (\u03b1=0.05, \u03b2=0.2). Statistics will be performed using the SPSS release 12.0.1 software.\n Changes in hormone concentrations will be compared with repeated measures ANOVA. A possible\n association between parameters will be tested using linear regression analysis.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Mothers of healthy infants (babies aged 3-6 months)."}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n Group 1:\\n\\n - healthy mothers (with normal BMI) fully breastfeeding their infants (aged 3 to 6\\n months) on demand\\n\\n - past normal pregnancy\\n\\n Group 2:\\n\\n - healthy mothers (with normal BMI) that do not breastfeed their infants (aged 3 to 6\\n months)\\n\\n - past normal pregnancy\\n\\n Exclusion Criteria (for both groups):\\n\\n - current endocrine and metabolic disease of the mother\\n\\n - cardiocirculatory, kidney or liver disease of the mother\\n\\n - infants having growth problems or any other current disease"}, "gender": "Female", "minimum_age": "20 Years", "maximum_age": "40 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'20', 'firstreceived_date': u'January 28, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "breastfeeding"}, {"keyword": "ghrelin"}, {"keyword": "PYY"}, {"keyword": "appetite-regulation"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Austria"}]', 'locations': '[{"location": {"facility": {"name": "AKH, Medical University of Vienna", "address": {"city": "Vienna", "zip": "A-1090", "country": "Austria"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00831818', 'number_of_arms': '', 'number_of_groups': u'2', 'official_title': u'Effects of Breastfeeding on Maternal Plasma Ghrelin and PYY Levels', 'org_study_id': u'Breastfeeding_01', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Martin Clodi, MD", "role": "Principal Investigator", "affiliation": "Division of Endocrinology and Metabolism, Medical University of Vienna"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Austria: Ethikkommission", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "ghrelin, PYY", "time_frame": "60 minutes", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Prof. Dr. Martin Clodi", "organization": "Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "insulin, C-peptide, oxytocin, prolactin", "time_frame": "60 minutes", "safety_issue": "No"}}]', 'source': u'Medical University of Vienna', 'sponsors': '[{"lead_sponsor": {"agency": "Medical University of Vienna", "agency_class": "Other"}}]', 'start_date': u'July 2008', 'study_design': u'Observational Model: Case Control, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00831818', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:46 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00853463?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=37&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:47 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:47 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:47 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:47 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:47 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00853463?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=37&resultsxml=true> {'acronym': u'Discharge', 'arm_groups': '[{"arm_group": {"arm_group_label": "No Alert", "arm_group_type": "No Intervention", "description": "The responsible physician of a patient randomized to the control arm will not be contacted regarding the increased VTE risk of the patient."}}, {"arm_group": {"arm_group_label": "Alert", "arm_group_type": "Other", "description": "The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other\n hospitals that focuses on whether physician notification prior to discharge of high risk VTE\n patients will reduce the incidence of VTE after hospital discharge.\n ", 'brief_title': u'Discharge ALERT: Quality Improvement Initiative', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Embolism", "Pulmonary Embolism", "Thromboembolism", "Thrombosis", "Venous Thromboembolism", "Venous Thrombosis"]}}', 'conditions': '[{"condition": "Pulmonary Embolism"}, {"condition": "Deep Vein Thrombosis"}, {"condition": "Prophylaxis"}, {"condition": "Venous Thromboembolism"}, {"condition": "Prevention"}]', 'detailed_description': u'\n BACKGROUND INFORMATION AND RATIONALE FOR THE STUDY\n\n Venous thromboembolism (VTE) is often avoidable in hospitalized patients because proven\n prevention strategies have been established for patients at risk (1). North American and\n European prophylaxis guidelines have been widely disseminated. However, despite focus on\n strategies for the prevention of VTE in hospitalized patients at the time of admission to\n the hospital, there has been little focus on prevention of VTE at the time of discharge from\n the hospital (2,3).\n\n At Brigham and Women\'s Hospital, we undertook a previous Quality Improvement Initiative (BWH\n protocol # 2000P000328) aimed at increasing the frequency of VTE prophylaxis in high risk\n patients. This novel strategy required: 1) devising a risk score that reliably and quickly\n identified patients at high risk of VTE, and 2) randomizing high-risk patients without\n prophylaxis into an intervention group or control group. The intervention group\'s physicians\n received a single electronic, computerized alert explaining that the patient was at high\n risk, was not receiving prophylaxis, and suggesting that prophylaxis be ordered from a\n template of available pharmacological and mechanical options. In contrast, the control\n group\'s physicians received no alert (4).\n\n Each of 8 common risk factors was weighted according to a point scale. To be labeled as\n "high-risk" for VTE, the point score must equal or exceed 4 points.\n\n There were 2,506 patients in the Quality Improvement Initiative: 1,255 in the intervention\n group and 1,251 in the control group. The incidence of symptomatic VTE at 90 days was high:\n 8.2% in the control group and 4.9% in the intervention group (4).\n\n Currently, an investigator initiated Quality Improvement Initiative (BWH protocol #\n 2005-P-002527) of human alerts rather than electronic, computerized alerts, has been\n undertaken in high risk patients not receiving prophylaxis. Enrollment of 2,500 patients at\n 25 centers located throughout the United States was completed in November 2007 with a\n follow-up rate that exceeded 99%. Analysis of the data is currently being conducted.\n\n Limited research focus has been placed on high-risk VTE subjects in the community, outside\n of the hospital setting. Since most VTE prophylaxis has focused upon protection of high-risk\n patients at the time of hospital admission, there is a need to focus on VTE prophylaxis\n within 48 hours of hospital discharge. It is clear that as preparations are being made for\n hospital discharge, many patients remain at high risk for DVT and acute pulmonary embolism.\n After discharge, some patients will have an even higher risk than during hospitalization\n because of prolonged immobilization and bed rest at home (5).\n\n The Discharge Alert Quality Improvement Initiative will determine whether alerting\n physicians about the importance of continued VTE prophylaxis just prior to the time of\n planned hospital discharge will lower the incidence of outpatient VTE. This new strategy is\n unproven and might not be effective, but this Quality Improvement Initiative should provide\n a definitive answer.\n\n We will also implement as part of our Discharge Alert Trial an in-hospital Quality\n Improvement Initiative of intensive patient education at Brigham and Women\'s Hospital to\n improve patient adherence to physician-ordered pharmacological venous thromboembolism (VTE)\n prophylaxis. We hypothe size that after implementation of this education program, fewer\n patients will decline physician-ordered doses of enoxaparin or unfractionated heparin (UFH)\n compared with a recent cohort of patients at risk for VTE who did not receive specialized\n education about VTE.\n\n METHODOLOGY\n\n Identification of Patients at Risk for Venous Thromboembolism (VTE)\n\n Hospitalized patients awaiting planned discharge within 48 hours will be evaluated with a\n previously validated (BWH protocol # 2000P000328) VTE risk profile. The VTE risk profile\n will be computed for each patient awaiting discharge using 8 common risk factors. Each risk\n factor is weighted according to a point score. To be labeled as "high risk" for VTE, the\n point score must equal or exceed 4 points.\n\n Minor (Low) Risk Factors (1 POINT each):\n\n - Advanced Age (> 70 years of age)\n\n - Obesity (BMI > 29, or the presence of the word "obesity" in admission exam notes)\n\n - Bed rest / Immobility (not related to surgery)\n\n - Female Hormone Replacement Therapy or Oral Contraceptives\n\n Intermediate Risk Factor (2 POINTS each):\n\n - Major Surgery (> 60 minutes, during this admission)\n\n Major (High) Risk Factors (3 POINTS each):\n\n - Cancer (active)\n\n - Prior VTE\n\n - Hypercoagulability\n\n Screening for Venous Thromboembolism Prophylaxis\n\n If the cumulative VTE risk score is at least 4, orders are reviewed to detect ongoing\n mechanical or pharmacological prophylactic measures. Mechanical prophylactic measures\n include graduated compression stockings and intermittent pneumatic compression devices.\n Pharmacological prophylactic measures include unfractionated heparin, enoxaparin,\n dalteparin, fondaparinux, tinzaparin, and warfarin.\n\n At Brigham and Women\'s Hospital, we will also identify all new orders for pharmacological\n VTE prophylaxis with enoxaparin and UFH using the BWH computerized order entry system as\n part of an additional component of the Quality Improvement Initiative. For this component of\n the Quality Improvement Initiative, eligibility is defined as having a DVT Risk Score of 3\n or higher and having electronically entered physician\'s orders for appropriate pharmacologic\n VTE thromboprophylaxis.\n\n Quality Improvement Intervention\n\n The intervention will take place within 48 hours of planned hospital discharge. If\n randomized to the alert, the responsible physician will be notified that: 1) his or her\n patient is at high risk for VTE, and 2) VTE prophylaxis should be considered in the\n Discharge orders. If randomized to no alert (control patients), the responsible physician\n will not be contacted.\n\n At Brigham and Women\'s Hospital, we will also provide 500 eligible patients in a prospective\n cohort with one-on-one education using a scripted dialog to describe the rationale and\n importance of pharmacological VTE prophylaxis.\n\n Prophylaxis Guidelines at Discharge\n\n "Consider Venous Thromboembolism prophylaxis at the time of hospital discharge in patients\n with congestive heart failure or respiratory disease or prolonged immobility."\n\n "For those without contraindication, consider pharmacological prophylaxis with low-molecular\n weight heparin, unfractionated heparin, or fondaparinux."\n\n "For those at high risk of bleeding, consider mechanical prophylaxis with intermittent\n pneumatic compression devices or graduated compression stockings."\n\n Follow Up\n\n A 90-day follow-up will be performed for all study patients. If patient outcomes cannot be\n determined by medical record review alone, then study representatives may contact the\n subject\'s Primary Care Physician (PCP) for necessary information. IRB approval must be\n obtained at each participating hospital prior to any contact with subjects\' PCPs.\n\n Data Collection and Study Endpoints\n\n The primary endpoint is clinically diagnosed DVT or PE at 90 days. Safety endpoints include\n total mortality and hemorrhagic events at 90 and 30 days, respectively. These are the same\n endpoints utilized in our prior Quality Improvement Initiative (BWH protocol # 2000P000328).\n\n Hemorrhagic events will be classified according to the Global Utilization of Streptokinase\n and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial criteria.\n Bleeding events will be classified as severe or life-threatening if they are intracerebral\n or if they result in substantial hemodynamic compromise requiring treatment. Moderate\n bleeding is defined by the need for transfusion. Minor events refer to bleeding not\n requiring transfusion or causing hemodynamic compromise. We will report rates of "major\n bleeding" which will be defined as GUSTO severe/life-threatening or moderate bleeding.\n\n For the additional component of the Quality Improvement Initiative at Brigham and Women\'s\n Hospital, we will also assess improvement of medication adherence with enoxaparin and UFH\n following an intensive and individualized patient education program compared with our\n recently completed cohort study in which no uniform education program was targeted at VTE\n prophylaxis.\n\n Statistical Analysis\n\n The initial sample size (power 80%, two-sided alpha 5%) has been calculated at 2,500\n patients based on an estimated 7% rate of the primary end point in the control group, and an\n odds ratio of 0.59 for the primary endpoint in intervention group patients. This yields a\n sample size requirement of 2,138 patients, plus an estimated 362 patients who will withdraw\n from the study.\n\n We will use Wilcoxon rank-sum tests for comparisons in the distributions of continuous\n variables between groups, and chi-square tests or Fisher\'s exact test for comparisons of\n categorical variables. The primary analysis is the difference in the Kaplan-Meier estimator\n for freedom from VTE at day 90 between intervention and control patients. The log-rank test\n will estimate the cumulative probability of the primary endpoint in the intervention and\n control groups. We will use the proportional-hazards model for estimation of the relative\n hazard of clinical endpoints associated with the physician alert. All p-values reported are\n two-sided.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients > 18 years of age\\n\\n - Planned discharge within 48 hours\\n\\n - Cumulative VTE risk score at least 4\\n\\n - Patients from Medical Services\\n\\n Exclusion Criteria:\\n\\n - VTE risk score <4\\n\\n - Patients <18 years of age\\n\\n - Full anticoagulation therapy planned upon discharge, i.e., atrial fibrillation,\\n mechanical heart valve, venous thromboembolism treatment, etc.\\n\\n - Patient is admitted to a non-medical service, i.e., surgical service, orthopedics,\\n obstetrics/gynecology, neurology, psychiatry, or other non-medical service"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'2515', 'firstreceived_date': u'February 26, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "Alert", "description": "The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders", "arm_group_label": "Alert", "other_name": "\\"Alert\\""}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Pulmonary Embolism"}, {"keyword": "Deep Vein Thrombosis"}, {"keyword": "Prophylaxis"}, {"keyword": "Venous thromboembolism"}, {"keyword": "Prevention"}, {"keyword": "Medical patients"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Long Beach VA Healthcare System", "address": {"city": "Long Beach", "state": "California", "zip": "90822", "country": "United States"}}}}, {"location": {"facility": {"name": "UC Irvine", "address": {"city": "Orange", "state": "California", "zip": "92868", "country": "United States"}}}}, {"location": {"facility": {"name": "UC Davis", "address": {"city": "Sacramento", "state": "California", "zip": "95817", "country": "United States"}}}}, {"location": {"facility": {"name": "Denver VA Medical Center", "address": {"city": "Denver", "state": "Colorado", "zip": "80262", "country": "United States"}}}}, {"location": {"facility": {"name": "William Backus Hospital", "address": {"city": "Norwich", "state": "Connecticut", "zip": "06360", "country": "United States"}}}}, {"location": {"facility": {"name": "Medstar Research Frankin Square Hospital", "address": {"city": "Baltimore", "state": "Maryland", "zip": "21237", "country": "United States"}}}}, {"location": {"facility": {"name": "Washington County Hospital", "address": {"city": "Hagerstown", "state": "Maryland", "zip": "21740", "country": "United States"}}}}, {"location": {"facility": {"name": "Brigham and Women\'s Hospital", "address": {"city": "Boston", "state": "Massachusetts", "zip": "02115", "country": "United States"}}}}, {"location": {"facility": {"name": "North Shore Medical Center", "address": {"city": "Salem", "state": "Massachusetts", "zip": "01970", "country": "United States"}}}}, {"location": {"facility": {"name": "St. Joseph Mercy Hospital", "address": {"city": "Ypsilanti", "state": "Michigan", "zip": "48197", "country": "United States"}}}}, {"location": {"facility": {"name": "University of Missouri- Columbia", "address": {"city": "Columbia", "state": "Missouri", "zip": "65212", "country": "United States"}}}}, {"location": {"facility": {"name": "St. John\'s Mercy Medical Center", "address": {"city": "St. Louis", "state": "Missouri", "zip": "63141", "country": "United States"}}}}, {"location": {"facility": {"name": "Lovelace Medical Center", "address": {"city": "Albuquerque", "state": "New Mexico", "zip": "87102", "country": "United States"}}}}, {"location": {"facility": {"name": "Albany Medical Center", "address": {"city": "Albany", "state": "New York", "zip": "12208", "country": "United States"}}}}, {"location": {"facility": {"name": "North Shore University Hospital", "address": {"city": "Manhasset", "state": "New York", "zip": "11030", "country": "United States"}}}}, {"location": {"facility": {"name": "Duke University Medical Center", "address": {"city": "Durham", "state": "North Carolina", "zip": "27705", "country": "United States"}}}}, {"location": {"facility": {"name": "Indiana Regional Medical Center", "address": {"city": "Indiana", "state": "Pennsylvania", "zip": "15701", "country": "United States"}}}}, {"location": {"facility": {"name": "Thomas Jefferson Hospital", "address": {"city": "Philadelphia", "state": "Pennsylvania", "zip": "19107", "country": "United States"}}}}, {"location": {"facility": {"name": "Washington Hospital", "address": {"city": "Washington", "state": "Pennsylvania", "zip": "15301", "country": "United States"}}}}, {"location": {"facility": {"name": "Presbyterian Hospital Texas Health", "address": {"city": "Dallas", "state": "Texas", "zip": "75231", "country": "United States"}}}}, {"location": {"facility": {"name": "Intermountain Medical Center", "address": {"city": "Salt Lake City", "state": "Utah", "zip": "84143", "country": "United States"}}}}, {"location": {"facility": {"name": "University of Utah Hospital Medical Center", "address": {"city": "Salt Lake City", "state": "Utah", "zip": "84132", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00853463', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Multi-centered Discharge Alert to Prevent DVT and PE at Hospital Discharge', 'org_study_id': u'2008-P-001083', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Samuel Z Goldhaber, MD", "role": "Principal Investigator", "affiliation": "Brigham and Women\'s Hospital"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'March 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Clinically diagnosed DVT and/or PE", "time_frame": "90 days after discharge", "safety_issue": "No"}}]', 'reference': '[{"reference": {"citation": "Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. Review.", "PMID": "15630031"}}, {"reference": {"citation": "Goldhaber SZ, Dunn K, MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women\'s Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest. 2000 Dec;118(6):1680-4.", "PMID": "11115458"}}, {"reference": {"citation": "Goldhaber SZ, Tapson VF; DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol. 2004 Jan 15;93(2):259-62.", "PMID": "14715365"}}, {"reference": {"citation": "Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77.", "PMID": "15758007"}}, {"reference": {"citation": "Spencer FA, Lessard D, Emery C, Reed G, Goldberg RJ. Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007 Jul 23;167(14):1471-5.", "PMID": "17646600"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Samuel Goldhaber, MD", "organization": "Brigham and Women\'s Hospital"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Mortality", "time_frame": "30 and 90 days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Hemorrhagic events", "time_frame": "30 and 90 days", "safety_issue": "No"}}]', 'source': u"Brigham and Women's Hospital", 'sponsors': '[{"lead_sponsor": {"agency": "Brigham and Women\'s Hospital", "agency_class": "Other"}}, {"collaborator": {"agency": "Sanofi", "agency_class": "Industry"}}]', 'start_date': u'April 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00853463', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:48 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00902681?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=36&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:48 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:48 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:48 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:48 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00902681?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=36&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Reference", "arm_group_type": "Other", "description": "a single dose of 8 mg fesoterodine (Toviaz\\u2122 8 mg) tablet manufactured at Zwickau"}}, {"arm_group": {"arm_group_label": "Test", "arm_group_type": "Other", "description": "a single dose of 8 mg fesoterodine (Toviaz\\u2122 8 mg) tablet manufactured at Vega Baja (Test)"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended\n releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.\n ', 'brief_title': u'A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz\u2122) In Healthy Subjects', 'clinical_results': '{}', 'completion_date': u'August 2009', 'condition_browse': '{"condition_browse": {"mesh_term": "Urinary Bladder, Overactive"}}', 'conditions': '[{"condition": "Treatment of Overactive Bladder"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy male and/or female subjects\\n\\n - Body Mass Index (BMI) of 17.5 to 30.5 kg/m2\\n\\n Exclusion Criteria:\\n\\n - Subjects with evidence or history of clinically significant urologic diseases\\n\\n - A positive urine drug screen\\n\\n - Pregnant or nursing females; females of childbearing potential who are unwilling or\\n unable to use an acceptable method"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "55 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'36', 'firstreceived_date': u'May 14, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Fesoterodine"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Fesoterodine", "description": "A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg", "arm_group_label": "Reference", "other_name": "Toviaz 8 mg"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Fesoterodine", "description": "A fesoterodine extended-release tablet (ER) formulation once daily administration of 8 mg", "arm_group_label": "Test", "other_name": "Toviaz 8 mg"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "Bioequivalence, Pharmacokinetics"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221082&StudyName=A%20Bioequivalence%20Study%20Of%208%20Mg%20Fesoterodine%20Extended-Release%20Tablets%20%28Toviaz%u2122%29%20In%20Healthy%20Subjects", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06511", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00902681', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'An Open-Label, Randomized, Single-Dose, Two-Way Crossover Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz\u2122), Manufactured At Zwickau Versus Vega Baja, In Healthy Subjects.', 'org_study_id': u'A0221082', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'August 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "AUCinf, AUClast, and Cmax of 5-HMT", "time_frame": "6 weeks", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Tmax and half-life of 5-HMT as data permit.", "time_frame": "6 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Safety laboratory tests and adverse events", "time_frame": "6 weeks", "safety_issue": "No"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'June 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00902681', 'verification_date': u'May 2011', 'why_stopped': ''} Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. 2015-10-09 20:52:50 [twisted] CRITICAL: Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. From cffi callback <function infoCallback at 0x7f5a960f6398>: Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1059, in infoCallback connection.get_app_data().failVerification(f) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1589, in get_app_data return self._app_data File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1148, in __getattr__ return getattr(self._socket, name) AttributeError: 'NoneType' object has no attribute '_app_data' 2015-10-09 20:52:50 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00911235?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=35&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:50 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:50 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:50 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:50 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00911235?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=35&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Fesoterodine Alone", "arm_group_type": "Experimental", "description": "Reference treatment"}}, {"arm_group": {"arm_group_label": "fesoterodine plus fluconazole", "arm_group_type": "Other", "description": "Test treatment"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a\n moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine\n in healthy adult subjects.\n ', 'brief_title': u'The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects', 'clinical_results': '{}', 'completion_date': u'July 2009', 'condition_browse': '{"condition_browse": {"mesh_term": ["Urinary Bladder, Overactive", "Urinary Incontinence", "Urinary Incontinence, Urge"]}}', 'conditions': '[{"condition": "Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy subjects between the ages of 18 and 55 years\\n\\n Exclusion Criteria:\\n\\n - Not healthy subjects. subjects with acute or chronic medical or psychiatric condition\\n or laboratory abnormality"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "55 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'28', 'firstreceived_date': u'May 28, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Fesoterodine", "Fluconazole"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Fesoterodine", "description": "Single 8 mg oral dose of fesoterodine", "arm_group_label": "Fesoterodine Alone"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "fesoterodine plus fluconazole", "description": "On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)", "arm_group_label": "fesoterodine plus fluconazole"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221080&StudyName=The%20Effect%20Of%20Fluconazole%20On%20Pharmacokinetics%20Of%20Fesoterodine%20In%20Healthy%20Subjects", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06511", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00911235', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.', 'org_study_id': u'A0221080', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'July 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "AUCinf and Cmax of 5-HMT", "time_frame": "3 days per period", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "AUClast, Tmax and half-life of 5-HMT as data permit.", "time_frame": "3 days per period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.", "time_frame": "3 days per period", "safety_issue": "No"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'May 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00911235', 'verification_date': u'May 2011', 'why_stopped': ''} Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/ app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. 2015-10-09 20:52:51 [twisted] CRITICAL: Error during info_callback Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 415, in dataReceived self._write(bytes) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/protocols/tls.py", line 554, in _write sent = self._tlsConnection.send(toSend) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1270, in send result = _lib.SSL_write(self._ssl, buf, len(buf)) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) --- <exception caught here> --- File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1055, in infoCallback return wrapped(connection, where, ret) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1154, in _identityVerifyingInfoCallback verifyHostname(connection, self._hostnameASCII) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 29, in verify_hostname cert_patterns=extract_ids(connection.get_peer_certificate()), File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/pyopenssl.py", line 58, in extract_ids ids.append(DNSPattern(n.getComponent().asOctets())) File "/app/.heroku/python/lib/python2.7/site-packages/service_identity/_common.py", line 154, in __init__ "Invalid DNS pattern {0!r}.".format(pattern) service_identity.exceptions.CertificateError: Invalid DNS pattern '130.14.81.50'. From cffi callback <function infoCallback at 0x7f5a95429578>: Traceback (most recent call last): File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 926, in wrapper callback(Connection._reverse_mapping[ssl], where, return_code) File "/app/.heroku/python/lib/python2.7/site-packages/twisted/internet/_sslverify.py", line 1059, in infoCallback connection.get_app_data().failVerification(f) File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1589, in get_app_data return self._app_data File "/app/.heroku/python/lib/python2.7/site-packages/OpenSSL/SSL.py", line 1148, in __getattr__ return getattr(self._socket, name) AttributeError: 'NoneType' object has no attribute '_app_data' 2015-10-09 20:52:51 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00914667?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=34&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:51 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:51 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:51 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:51 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00914667?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=34&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Warfarin Alone", "arm_group_type": "Experimental", "description": "Reference treatment"}}, {"arm_group": {"arm_group_label": "Warfarin Concomitantly With Fesoterodine", "arm_group_type": "Experimental", "description": "Test treatment"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This is an open-label, randomized, two-way crossover study to evaluate the steady-state\n effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single\n supratherapeutic dose of warfarin (25 mg) in healthy subjects.\n ', 'brief_title': u'The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects', 'clinical_results': '{}', 'completion_date': u'August 2009', 'condition_browse': '{"condition_browse": {"mesh_term": "Urinary Bladder, Overactive"}}', 'conditions': '[{"condition": "Urinary Bladder, Overactive"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy male and/or female subjects between the ages of 18 and 55 years\\n\\n Exclusion Criteria:\\n\\n - Not healthy subjects--subjects with acute or chronic medical or psychiatric\\n conditions or laboratory abnormality"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "55 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'14', 'firstreceived_date': u'June 3, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Fesoterodine", "Warfarin"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "warfarin", "description": "Single Dose Warfarin 25 mg on Day 1", "arm_group_label": "Warfarin Alone"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Warfarin plus Fesoterodine", "description": "Fesoterodine 8 mg ER tablets QD for 9 Days and Single Dose Warfarin 25 mg on Day 3", "arm_group_label": "Warfarin Concomitantly With Fesoterodine"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "Overactive Bladder Urgency Frequency"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221079&StudyName=The%20Effect%20Of%20Fesoterodine%20On%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20Warfarin%20In%20Healthy%20Subjects", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06511", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00914667', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Fesoterodine On The Pharmacokinetics And Pharmacodynamics Of A Single Supratherapeutic Dose Of Warfarin In Healthy Subjects.', 'org_study_id': u'A0221079', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'August 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "Cmax and AUCinf for both S- and R-warfarin", "time_frame": "8 days per period", "safety_issue": "No"}}, {"primary_outcome": {"measure": "AUC_INR and INRmax", "time_frame": "8 days per period", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "AUClast, Tmax and t\\u00bd for both S- and R-warfarin", "time_frame": "8 days per period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "AUC_PT and PTmax", "time_frame": "8 days per period", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Safety will be assessed by subjective symptoms/objective findings including physical examinations, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.", "time_frame": "8 days per period", "safety_issue": "No"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'July 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00914667', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:52 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00959153?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=33&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:52 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:52:52 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:52 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:52 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:52 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:52 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00959153?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=33&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Kidney stones", "arm_group_type": "Experimental", "description": "Kidney stones"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be\n treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects\n will be followed for 14 days. If at the 14 day follow-up visit the subject continues to\n present with a stone size 4 mm or greater will have an option of retreatment or other\n intervention. If the subject consents to be retreated at this time, this subject will be\n followed up for another 14 days.\n ', 'brief_title': u'Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney', 'clinical_results': '{}', 'completion_date': u'August 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Calculi", "Kidney Calculi", "Nephrolithiasis", "Urinary Calculi"]}}', 'conditions': '[{"condition": "Kidney Stones"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter\\n\\n - Presence of one stone greater than 4 mm and less than 12 mm\\n\\n Exclusion Criteria:\\n\\n - Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis,\\n pancreatitis or obstruction of the biliary duct system\\n\\n - Impaction of stone to be treated\\n\\n - Staghorn stones\\n\\n - Failed or inadequate lithotripsy procedure within 3 months prior to study\\n\\n - Coagulation abnormalities or anticoagulation therapy\\n\\n - Pregnant or females of child-bearing potential General, spinal or epidural anesthesia\\n is contraindicated\\n\\n - Can not be positioned correctly for fluoroscopic imaging"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'20', 'firstreceived_date': u'August 11, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Device", "intervention_name": "LithoSpace Extracorporeal Shockwave Lithotripter", "description": "Shockwave therapy to break up kidney stones", "arm_group_label": "Kidney stones"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "Fragmenting of kidney stones"}, {"keyword": "extracorporeal shockwave lithotripsy"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Metropolitan Lithotriptor Associates", "address": {"city": "Garden City", "state": "New York", "zip": "11530", "country": "United States"}}}}, {"location": {"facility": {"name": "Allied Urological Services, LLC", "address": {"city": "New York", "state": "New York", "zip": "10016", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00959153', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)', 'org_study_id': u'G080108', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Active, not recruiting', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 3', 'primary_completion_date': u'August 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "stone fragmentation", "time_frame": "14 days", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Hugo Stephan", "organization": "AST"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Advance Shockwave Technology GmbH', 'sponsors': '[{"lead_sponsor": {"agency": "Advance Shockwave Technology GmbH", "agency_class": "Industry"}}]', 'start_date': u'June 2010', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00959153', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:53 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01020058?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=32&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:53 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:53 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:53 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:54 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01020058?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=32&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Lichtenstein in local anesthesia", "arm_group_type": "Active Comparator", "description": "Patient operated in local anesthesia, with a mesh repair ad modum Lichtenstein"}}, {"arm_group": {"arm_group_label": "TEP", "arm_group_type": "Active Comparator", "description": "Patient receives a totally extraperitoneal laparoscopic repair"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to compare the frequency of long-term post operative pain after\n an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an\n totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The\n investigators will also be assessing the cost for the procedures and hospital care as well\n as the cost for sick-leave depending on procedure performed. The study hypothesis is that\n the laparoscopic approach will be associated with less long term post operative pain.\n ', 'brief_title': u'Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia', 'clinical_results': '{}', 'completion_date': u'December 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Hernia", "Hernia, Inguinal"]}}', 'conditions': '[{"condition": "Hernia, Inguinal"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Unilateral inguinal hernia\\n\\n - suitable for open mesh repair in local anesthesia as well as laparoscopic repair\\n\\n - ASA score I-III\\n\\n - informed consent\\n\\n Exclusion Criteria:\\n\\n - ASA score IV (not suitable for TEP)\\n\\n - bilateral hernias (laparoscopic repair preferable)\\n\\n - recurrent hernia (primary repair affects preferable treatment)\\n\\n - large scrotal hernias (not suitable for local anesthesia)\\n\\n - earlier open lower abdominal surgery, aside from appendectomy (scarring may be a\\n hindrance for TEP)"}, "gender": "Male", "minimum_age": "20 Years", "maximum_age": "80 Years", "healthy_volunteers": "No"}}', 'enrollment': u'400', 'firstreceived_date': u'November 24, 2009', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Anesthetics"}}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Mesh repair for primary inguinal hernia", "description": "Open Lichtenstein repair in local anesthesia using a polypropylene mesh compared to totally extra-peritoneal laparoscopic repair using a polypropylene mesh", "arm_group_label": ["Lichtenstein in local anesthesia", "TEP"], "other_name": ["Lichtenstein", "TEP"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Sweden"}]', 'locations': '[{"location": {"facility": {"name": "Enk\\u00f6ping Hospital", "address": {"city": "Enkoping", "zip": "75436", "country": "Sweden"}}}}, {"location": {"facility": {"name": "Uppsala University Hospital", "address": {"city": "Uppsala", "zip": "751 85", "country": "Sweden"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01020058', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia', 'org_study_id': u'2004:M-360', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Staffan Wollert, MD, PhD", "role": "Study Director", "affiliation": "Uppsala University Hospital"}}', 'overall_status': u'Active, not recruiting', 'oversight_info': '{"oversight_info": {"authority": "Sweden: Regional Ethical Review Board", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'December 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "long-term post operative pain", "time_frame": "6 wks, 1 year", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Staffan Wollert", "organization": "Uppsala University Hospital"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "cost-effectiveness of the separate procedures", "time_frame": "6wks, 1year", "safety_issue": "No"}}]', 'source': u'Uppsala University Hospital', 'sponsors': '[{"lead_sponsor": {"agency": "Uppsala University Hospital", "agency_class": "Other"}}, {"collaborator": {"agency": "Uppsala County Council, Sweden", "agency_class": "Other"}}]', 'start_date': u'April 2006', 'study_design': u'Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01020058', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:55 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01058460?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=31&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:55 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:55 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:55 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:55 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01058460?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=31&resultsxml=true> {'acronym': u'COCY', 'arm_groups': '[{"arm_group": {"arm_group_label": "cytology", "arm_group_type": "No Intervention", "description": "Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice."}}, {"arm_group": {"arm_group_label": "HPV-cytology", "arm_group_type": "Experimental", "description": "Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n To compare the effects of conventional cytology testing with concommitant HPV-cytology\n testing for the detection of high grade cervical lesions in primary cervical cancer\n screening in Hong Kong\n\n Hypotheses:\n\n 1. There is a significant difference in the number of CIN2+ cases detected between the\n cytology testing group and the cytology-HPV co-testing group at baseline.\n\n 2. Significantly more CIN2+ cases will be detected at the second round of screening among\n participants with normal cytology result in the control arm than those with normal\n cytology and negative HPV results in the intervention arm.\n ', 'brief_title': u'HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN', 'clinical_results': '{}', 'completion_date': u'June 2017', 'condition_browse': '{"condition_browse": {"mesh_term": ["Carcinoma in Situ", "Cervical Intraepithelial Neoplasia", "Neoplasms", "Uterine Cervical Neoplasms"]}}', 'conditions': '[{"condition": "Cervical Cancer"}, {"condition": "Cervical Intraepithelial Neoplasia"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Ethnic Chinese women aged 30 to 60 years who have completed a written consent\\n\\n - Women who have not attended screening for the past 3 years or more will be given\\n priority\\n\\n Exclusion Criteria:\\n\\n - Currently pregnant\\n\\n - Without a cervix\\n\\n - Congenital abnormalities of the lower genital tract\\n\\n - Previous history of invasive cervical cancer\\n\\n - Who has been followed-up or treated for an abnormal cytology result in the past 12\\n months\\n\\n - Who are unable to provide consent"}, "gender": "Female", "minimum_age": "30 Years", "maximum_age": "60 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'12000', 'firstreceived_date': u'January 27, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "HPV-cytology co-testing", "description": "Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.", "arm_group_label": "HPV-cytology"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Cervical Intraepithelial Neoplasia, Grade III"}, {"keyword": "Cervical Intraepithelial Neoplasia, Grade II"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "China"}]', 'locations': '[{"location": {"facility": {"name": "Department of Obstetrics & Gynaecology, The University of Hong Kong", "address": {"city": "Hong Kong SAR", "country": "China"}}, "status": "Recruiting", "investigator": {"last_name": "Hextan YS Ngan, MD, MBBS", "role": "Principal Investigator"}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01058460', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong', 'org_study_id': u'UW09-377', 'other_outcomes': '[]', 'overall_contact': '{"overall_contact": {"last_name": "Hextan YS Ngan, MD, MBBS", "phone": "852-2255-4684", "email": "hysngan@hkusua.hku.hk"}}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Hextan YS Ngan, MD, MBBS", "role": "Principal Investigator", "affiliation": "Department of Obstetrics & Gynaecology, The University of Hong Kong"}}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "Hong Kong: Ethics Committee"}}', 'phase': u'N/A', 'primary_completion_date': u'June 2017', 'primary_outcomes': '[{"primary_outcome": {"measure": "Histological CIN2, CIN3 and cervical carcinoma", "time_frame": "At baseline and each subsequent follow-up", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Professor Hextan Y.S. Ngan", "organization": "Department of Obstetrics & Gynaecology, The University of Hong Kong"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Clearance of mild cervical abnormalities among HPV negative subjects", "time_frame": "At baseline and 1-year after", "safety_issue": "No"}}]', 'source': u'The University of Hong Kong', 'sponsors': '[{"lead_sponsor": {"agency": "The University of Hong Kong", "agency_class": "Other"}}, {"collaborator": {"agency": "The Family Planning Association of Hong Kong", "agency_class": "Other"}}]', 'start_date': u'June 2010', 'study_design': u'Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01058460', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:56 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01069445?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=30&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:56 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:56 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:56 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:56 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:52:56 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:56 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01069445?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=30&resultsxml=true> {'acronym': u'RISTOMED', 'arm_groups': '[{"arm_group": {"arm_group_label": "Diet advices", "arm_group_type": "Active Comparator", "description": "will receive the Optimal Diet for Elderly"}}, {"arm_group": {"arm_group_label": "Diet advices + VSL-3", "arm_group_type": "Experimental", "description": "will receive the Optimal Diet for Elderly + VSL#3\\u00ae probiotic blend"}}, {"arm_group": {"arm_group_label": "Diet advices + 5203-L", "arm_group_type": "Experimental", "description": "will receive the Optimal Diet for Elderly + AISA-5203-L fruit extracted terpene"}}, {"arm_group": {"arm_group_label": "Diet advices + Argan oil", "arm_group_type": "Experimental", "description": "will receive the Optimal Diet for Elderly + Argan oil"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Ageing of the population is a major event in the world. Gerontological/geriatric literature\n unanimously indicate that physical exercise and diet are at present the two available\n fundamental approaches to contrast/prevent most of the age associated alterations. In the\n elderly the inflammageing, the oxidative stress and the alteration of the intestinal\n microbiota can be influenced by nutritional status and possibly corrected by an appropriate\n dietetic intervention:\n\n Nowadays the nutraceutical food supplements become an opportunity for the consumer to\n improve the quality of individual diet for specific needs This study will focus on the\n development of a specific dietary approach through an E-Health dietary service, associated\n or not to nutraceutical food supplements intake, to modulate the oxidative stress,\n inflammageing and gut microflora in the elderly people.\n ', 'brief_title': u'Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene', 'clinical_results': '{}', 'completion_date': u'April 2011', 'condition_browse': '{}', 'conditions': '[{"condition": "Healthy Elderly People"}]', 'detailed_description': u'\n Ageing of the population is a major event in the world. Gerontological/geriatric literature\n unanimously indicate that physical exercise and diet are at present the two available\n fundamental approaches to contrast/prevent most of the age associated alterations. In the\n elderly the inflammageing, the oxidative stress and the alteration of the intestinal\n microbiota can be influenced by nutritional status and possibly corrected by an appropriate\n dietetic intervention:\n\n Nowadays the nutraceutical food supplements become an opportunity for the consumer to\n improve the quality of individual diet for specific needs\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Age: from 65 to 85 years\\n\\n - Body Mass Index: 22-30 kg/m2\\n\\n - ECOG Performance status: WHO performance score 0 to 2\\n\\n - Absence of known diseases and/or abnormalities of haematological parameters\\n (haematological, inflammatory, metabolic, hepatic and renal diseases)\\n\\n - The subjects must be able to comply with management of nutraceutical products and\\n with scheduled follow-up\\n\\n - The subjects must be able to use the computer and to access to the web, by themselves\\n or with the help of a caregiver\\n\\n Exclusion Criteria:\\n\\n - History of significant neurologic or psychiatric disorders including dementia,\\n seizures, bipolar disorder\\n\\n - Geriatric anorexia [less than 2 full meals per day and /or less than one serving of\\n dairy products (milk, cheese, yogurt) per day or two or more servings of legumes or\\n eggs per week or one serving of meat, fish or poultry every day]\\n\\n - Weight loss > 5% in the last month\\n\\n - Previous antibiotic treatment within 4 months\\n\\n - Active infection requiring per OS or IV antibiotics, including active tuberculosis,\\n known and declared HIV, HCV\\n\\n - Constipation and/or abdominal pain/discomfort that require dietary supplements or\\n medical therapy\\n\\n - Gastric disease that requires medical therapy (e.g. gastric secretion inhibitory\\n drugs)\\n\\n - Chronic inflammatory bowel disease (Crohn\'s disease or ulcerative colitis,\\n diverticulosis, diverticulitis)\\n\\n - Diabetes mellitus\\n\\n - Dislipidemia and/or any metabolic disease that requires medical or dietetic treatment\\n\\n - Myocardial infarction within 6 months prior to study entry, congestive heart disease,\\n uncontrolled cardiac insufficiency, and any current grade 3 or 4 cardio-vascular\\n disorder despite treatment\\n\\n - Current history of neoplasm except for curatively treated non melanoma skin cancer or\\n in situ carcinoma of the cervix and except for other cancer curatively treated and\\n with no evidence of disease for at least 5 years\\n\\n - Other sever underlying medical conditions, which could impair the ability of the\\n patient to participate in the study\\n\\n - Chronic anti-inflammatory therapy with FANS or previous therapy within 20 days from\\n the beginning of the study. The occasional use of anti-inflammatory therapy is not an\\n exclusion criteria, but the use is not allowed within 3 days before the analysis and\\n for more than 8 days/2 months during the study\\n\\n - Previous (within 15 days) or concomitant treatment that modifies intestinal\\n absorption (e.g. metformine, acarbose in diabetic treatment\\u2026)\\n\\n - Probiotics, prebiotics or simbiotics (yogurt or another functional foods) intake in\\n the last 3 weeks\\n\\n - Use of food supplements or functional foods such as probiotics, prebiotics,\\n simbiotics, vitamins and minerals different than whose established in this study, is\\n not allowed during the study period or previously within 1 week (except for vitamin\\n D, calcium, vitamin B12)\\n\\n - Total parenteral nutrition within 4 months\\n\\n - History of allergy to one of the excipients present in the products under evaluation\\n\\n - Concomitant or within 4 week period administration of any experimental drug, food\\n supplements or nutraceuticals under investigation\\n\\n - Subjects clearly intending to withdraw from the study if not randomised in a given\\n arm, or subjects who cannot be regularly followed up for psychological, social,\\n familial or geographic reasons\\n\\n - Subjects with expected non-compliance to protocol guidelines"}, "gender": "Both", "minimum_age": "65 Years", "maximum_age": "85 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'48', 'firstreceived_date': u'February 15, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "VSL#3\\u00ae probiotic blend", "description": "Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water", "arm_group_label": "Diet advices + VSL-3"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "AISA-5203-L fruit extracted terpene", "description": "Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water", "arm_group_label": "Diet advices + 5203-L"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Argan oil", "description": "Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad \\u2026) and a large glass of water", "arm_group_label": "Diet advices + Argan oil"}}, {"intervention": {"intervention_type": "Behavioral", "intervention_name": "Optimal Diet", "description": "a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.", "arm_group_label": "Diet advices"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "diet"}, {"keyword": "probiotics"}, {"keyword": "inflammaging"}, {"keyword": "oxidative stress"}, {"keyword": "gut microbiota"}, {"keyword": "food complements"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "P\\u00f4le de gerontology Clinique H\\u00f4pital Xavier Arnozan , University Hospital, Bordeaux", "address": {"city": "Pessac", "zip": "33600", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01069445', 'number_of_arms': u'4', 'number_of_groups': '', 'official_title': u'Open Label, Randomized Study of the Impact of Diet on Gut Microbiota, Inflammageing and Oxidative Stress in Elderly People. Potential Benefits of Dietary Advices Alone or Associated to Nutraceutical Food Supplements Argan Oil, VSL#3 Probiotic Blend, 5203-L Fruit Extract Terpene. French Part of a Multicentric European Study', 'org_study_id': u'CHUBX 2009/08', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Isabelle BOURDEL-MARCHASSON, Professor", "role": "Principal Investigator", "affiliation": "University Hospital, Bordeaux"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'April 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "The primary beneficial effect parameter is hsPCR (high-sensitivity C-reactive protein)", "time_frame": "2 months", "safety_issue": "No"}}]', 'reference': '[{"reference": {"citation": "Franceschi C, Valensin S, Bonaf\\u00e8 M, Paolisso G, Yashin AI, Monti D, De Benedictis G. The network and the remodeling theories of aging: historical background and new perspectives. Exp Gerontol. 2000 Sep;35(6-7):879-96. Review.", "PMID": "11053678"}}, {"reference": {"citation": "Wener MH, Daum PR, McQuillan GM. The influence of age, sex, and race on the upper reference limit of serum C-reactive protein concentration. J Rheumatol. 2000 Oct;27(10):2351-9.", "PMID": "11036829"}}, {"reference": {"citation": "Mendall MA, Patel P, Ballam L, Strachan D, Northfield TC. C reactive protein and its relation to cardiovascular risk factors: a population based cross sectional study. BMJ. 1996 Apr 27;312(7038):1061-5.", "PMID": "8616412"}}, {"reference": {"citation": "Devaraj S, O\'Keefe G, Jialal I. Defining the proinflammatory phenotype using high sensitive C-reactive protein levels as the biomarker. J Clin Endocrinol Metab. 2005 Aug;90(8):4549-54. Epub 2005 May 17.", "PMID": "15899961"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Jean-Pierre LEROY / Clinical Research and Innovation Director", "organization": "University Hospital, Bordeaux"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Inflammageing status: WBC, hemoglobin, ERS, fibrinogen, total cholesterol, triglycerides, insulin, glucose, (and HOMA Index), interleukin-6, TNF\\u03b1, IL-10, TGF1, IGF-1, adiponectin, lectin, Homocysteine, folic acid and vitamin B12, calprotectin", "time_frame": "2 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Oxidative stress: plasma total antioxidant capacity by TEAA (Trolox Equivalent Antioxidant Activity), glutathione level, the superoxide dismutase, the glutathione peroxidase, the glutathione reductase and the catalase activities", "time_frame": "2 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Gut microbiota: expression of 16S ribosomal RNA in bacterial groups from faeces. Ratio between lactobacilli and clostridia bacteria. Real time PCR and PCR DGGE", "time_frame": "2 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Quality of life: SF-36, GHQ, and daily VAS, ECOG performance status, IADL, Speilbeger Anxiety Scale, CES-D scale", "time_frame": "2 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Physical performance status (SPPB), muscle function (hand-grip dynamometry), and physical activity level (IPAQ)", "time_frame": "2 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Compliance to the web diet advices and to the nutraceutical supplement intake (daily VAS)", "time_frame": "2 months", "safety_issue": "No"}}]', 'source': u'University Hospital, Bordeaux', 'sponsors': '[{"lead_sponsor": {"agency": "University Hospital, Bordeaux", "agency_class": "Other"}}]', 'start_date': u'March 2010', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01069445', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:57 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01087853?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=29&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:57 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:57 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:57 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:57 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:57 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01087853?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=29&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Phase A1: Plasmalyte", "arm_group_type": "Active Comparator", "description": "Plasmalyte"}}, {"arm_group": {"arm_group_label": "Phase A2: 0.9% Saline", "arm_group_type": "Active Comparator", "description": "0.9% Saline"}}, {"arm_group": {"arm_group_label": "Phase B1: PlasmaVolume", "arm_group_type": "Active Comparator", "description": "PlasmaVolume"}}, {"arm_group": {"arm_group_label": "Phase B2: Voluven", "arm_group_type": "Active Comparator", "description": "Voluven"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n Patients often require fluid replacement during and after an operation. This is usually\n given through veins in the arm using an intravenous cannula and doctors have traditionally\n used fluid containing sodium chloride (saline). However accumulating evidence suggests that\n large infusions of saline are associated with adverse physiological effects including\n acidification of the blood and a rise in potassium and chloride levels. Studies in animals\n have shown that high levels of chloride in the blood and excess saline can cause blood\n vessels in the kidney to constrict leading possibly to a decrease in kidney function.\n Improvement in acid-base balance and kidney function may be observed with balanced solutions\n containing constituents that are more closely matched to the body's own fluid composition.\n However, little is known about the physiological effects of these solutions as they have\n only recently been developed.\n\n Magnetic resonance imaging (MRI) is a radiological modality which can now assess blood flow\n and supply of the kidney noninvasively without the need for the injection of radiological\n dyes known as contrast agents. This is now of major importance due to the possible adverse\n effects of MRI contrast agents leading to Nephrogenic Systemic Fibrosis (NSF), a progressive\n disease which has been observed in some kidney patients after receiving 'gadolinium based'\n contrast agents. This has therefore led to increased interest and demand for noncontrast\n based imaging methods. In this study we aim to compare the effects of balanced versus\n unbalanced fluid infusions in healthy human volunteers:\n\n We will aim to measure:\n\n 1. Blood biochemical composition and acidity\n\n 2. Kidney function and supply as measured by dynamic MRI\n ", 'brief_title': u'The Effect of Crystalloids and Colloids on Visceral Blood Flow', 'clinical_results': '{}', 'completion_date': u'March 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Acid-Base Imbalance", "Water-Electrolyte Imbalance"]}}', 'conditions': '[{"condition": "Fluid Overload"}, {"condition": "Water Electrolyte Imbalance"}, {"condition": "Acid Base Imbalance"}]', 'detailed_description': u'\n Type of Study: Two phase double blind, randomised crossover study. In phase A (crystalloid),\n we will compare the effects of Plasmalyte 148 with 0.9% saline and in phase B (colloid) we\n will compare the effects of PVR with Voluven.\n\n Participants will either be involved in phase A or phase B not both. In each phase\n participants will receive a randomly assigned fluid and then the comparator fluid 1 week\n later.\n\n Subject selection: 24 healthy, male volunteers, (12 for each phase) between the age of 18\n and 40, and weighing between 65 and 80 kg will be recruited for of the study. Informed\n consent will be obtained before entering volunteers into the study.\n\n Study Protocol: Volunteers will report for the study at 09.00 hours after a fast from\n midnight and having abstained from alcohol, nicotine, tea and coffee for at least 24 hours.\n After voiding of the bladder, height will recorded to the nearest 0.01 m, weight measured to\n the nearest 0.1 kg using Avery 3306ABV scales (Avery Berkel, Royston, UK), and body mass\n index calculated.\n\n Any urine passed over a 24 hour period from the start of the infusion will be collected for\n measurement of creatinine clearance, osmolality and electrolytes. Two venous cannulae will\n be inserted, one in each forearm and blood will be sampled for full blood count,\n haemoglobin, electrolytes, creatinine, albumin and osmolality. A venous blood gas sample\n will also be obtained to calculate base excess. Serum and urinary osmolality will be\n measured on a Fiske 2400 Osmometer (Vitech Scientific Ltd., Partridge Green, West Sussex,\n UK) using a freezing point depression method which has a coefficient of variance (CV) of\n 1.2%. A Vitros 950 analyser (Ortho Clinical Diagnostics, Amersham, UK) will be used to\n measure serum sodium (CV 0.6%), potassium (CV 1.0%), magnesium, chloride (CV 1.1%),\n bicarbonate, (CV 4.0%), urea (CV 2.0%) and albumin (CV 1.6%). Strong ion difference will be\n calculated by subtracting the serum chloride concentration from the sum of the serum\n concentrations of sodium and potassium.28 Urinary sodium (CV 1.5%) and potassium (CV 1.5%)\n will be assayed on a Vitros 250 analyser (Ortho Clinical Diagnostics, Amersham, UK).\n Haematological parameters will be measured on a Sysmex SE 9500 Analyser (Sysmex UK Ltd.,\n Milton Keynes, UK) using direct current hydrodynamic focusing and cumulative pulse height\n detection. The CV for haemoglobin and packed cell volume estimation is 11.5%.\n\n In Phase A, 12 subjects will receive 2 litres of 0.9% saline BP (Baxter Health Care,\n Thetford, UK) or Plasmalyte\xae (Baxter Health Care, Thetford, UK). The assignment of the\n initial infused solution will be random followed by the alternate solution at crossover. The\n crystalloid solution will be infused in the supine position over 60 minutes.\n\n In Phase B, 12 subjects will receive 1 litre of PlasmaVolume\xae (Baxter Health Care, Thetford,\n UK) or Voluven\xae (Fresenius Kabi, Bad Homburg, Germany). The initial infused solution will be\n randomly assigned and the subject will receive the alternate solution at the crossover\n timepoint. The starch solution will be infused in the supine position over 30 minutes. A\n nurse who will not be involved in the study will mask all labels and administration sets on\n the infusion bags with opaque tape and also perform the randomisation. Randomisation will\n performed using sequentially numbered paired sealed opaque envelopes. The aforementioned\n blood tests will be repeated at 30/60 minute intervals for 4 hours. Subjects will be\n encouraged to void urine as the need arises, and on completion of the study. In addition to\n laboratory data, time to first void and void volume will be recorded. Postinfusion urine\n will be pooled and analysed for osmolality, pH and concentrations of electrolytes and NGAL.\n The crossover experiment will be repeated with the alternate infusion not used in the first\n study, 7-10 days later. Participation in the crossover phase will be postponed one week if\n the baseline laboratory work shows continued effect of hemodilution or phlebotomy with a\n hematocrit decrease of 3% or greater from the first infusion baseline.\n\n Monitoring of volunteers: Pulse oximetry will be performed continuously during the infusion.\n Blood pressure will be measured every 15 min for the first two hours and then every 30 min\n until the end of the study. Infusions will be stopped if there is any evidence of\n hypersensitivity or anaphylactic reactions or for the following:\n\n The pulse rate rises above 110/minute or falls below 50/minute. The SaO2 falls below 92% The\n blood pressure rises above 140 mm Hg systolic or 95 mm Hg diastolic The blood pressure falls\n below 90 mm Hg systolic or 55 mm Hg diastolic The volunteer expresses the desire to have the\n infusion stopped.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy\\n\\n - Male\\n\\n - Aged between 18 and 40 years\\n\\n - Weight between 65 and 80 kilograms\\n\\n - Able to give informed consent\\n\\n Exclusion Criteria:\\n\\n - Chronic medical conditions\\n\\n - Use of any regular medications\\n\\n - History of substance abuse\\n\\n - Known hypersensitivity to study infusion fluids\\n\\n - Contraindications to MRI scanning"}, "gender": "Male", "minimum_age": "18 Years", "maximum_age": "40 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'25', 'firstreceived_date': u'March 15, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Crystalloid", "description": "2 litres intravenous infusion in 60 minutes", "arm_group_label": ["Phase A1: Plasmalyte", "Phase A2: 0.9% Saline"]}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Colloid", "description": "1 litre intravenous infusion over 30 minutes", "arm_group_label": ["Phase B1: PlasmaVolume", "Phase B2: Voluven"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Fluid Therapy"}, {"keyword": "Water Electrolyte Imbalance"}, {"keyword": "Acid Base Imbalance"}, {"keyword": "Renal Circulation"}, {"keyword": "Magnetic Resonance Imaging"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United Kingdom"}]', 'locations': '[{"location": {"facility": {"name": "Brain and Body MRI Centre, University of Nottingham", "address": {"city": "Nottingham", "state": "Nottinghamshire", "zip": "NG7 2RD", "country": "United Kingdom"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01087853', 'number_of_arms': u'4', 'number_of_groups': '', 'official_title': u'The Effects of Balanced and Unbalanced Crystalloids and Colloids on Serum Biochemistry and Visceral Blood Flow: A Two Phase, Double Blind, Randomised Crossover Study', 'org_study_id': u'09063', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Dileep Lobo, MBBS MD FRCS", "role": "Principal Investigator", "affiliation": "University of Nottingham"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["United States: Institutional Review Board", "United Kingdom: Medicines and Healthcare Products Regulatory Agency"], "has_dmc": "No"}}', 'phase': u'Phase 1/Phase 2', 'primary_completion_date': u'March 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "The primary end point of each phase of this study will be a 6 mmol difference in serum chloride concentration after infusion of the balanced and unbalanced crystalloids and colloids.", "time_frame": "Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dileep Lobo", "organization": "University of Nottingham"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "2009-014774-18"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Changes in blood volume, renal and superior mesenteric arterial blood flow and vessel diameter.", "time_frame": "Phase A: Times 0, 60, 90, 120, 180 and 240 min and Phase B: Times 0, 30, 60, 120, 180 and 240 min", "safety_issue": "No"}}]', 'source': u'University of Nottingham', 'sponsors': '[{"lead_sponsor": {"agency": "University of Nottingham", "agency_class": "Other"}}]', 'start_date': u'March 2010', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01087853', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:52:58 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01143311?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=28&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:52:58 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:52:58 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:52:58 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:52:58 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:52:59 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01143311?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=28&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "ARM A", "arm_group_type": "Other", "description": "4 distinct biopsies will be taken\\nin a non UV-exposed area (inner arm)\\nin a UV-exposed area (external surface of the forearm)\\nin a pretumoral region (actinic keratosis)\\ninside the tumor"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The aim of this study is to analyze the differential expression of the miR transcriptome in\n the distinctive stages of the development of cutaneous squamous cell carcinoma (C-SCC). In\n this aim the investigators plan to recruit a cohort of 20 patients suffering of C-SCC and to\n collect from each of them, biopsies corresponding to i) non UV-exposed areas ii) UV-exposed\n areas, iii) actinic keratosis and iv) tumoral regions. Total RNAs will be prepared from each\n biopsy and the miRNA profiles will be characterized using a dedicated miR array.\n ', 'brief_title': u'Role of microRNA in the Development of Cutaneous Squamous Cell Carcinoma', 'clinical_results': '{}', 'completion_date': u'April 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Skin Neoplasms"}}', 'conditions': '[{"condition": "Cancer of the Skin"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - patient older than 40th, suffering of a C-SCC\\n\\n - letter of consent signed by the patient\\n\\n - to be registered to social security\\n\\n Exclusion Criteria:\\n\\n - Pregnant women or breastfeeding.\\n\\n - Small C-SCC (size < 6mm)\\n\\n - Allergy to Xylocaine\\n\\n - All vulnerable (minor, adult guardianship\\u2026)"}, "gender": "Both", "minimum_age": "40 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'20', 'firstreceived_date': u'April 19, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Genetic", "intervention_name": "Arm A", "description": "4 distinct biopsies will be taken\\nin a non UV-exposed area (inner arm)\\nin a UV-exposed area (external surface of the forearm)\\nin a pretumoral region (actinic keratosis)\\ninside the tumor", "arm_group_label": "ARM A"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "CHU de Nice - 4 avenue Reine Victoria - H\\u00f4pital de Cimiez", "address": {"city": "Nice", "state": "Alpes-Maritimes", "zip": "06001", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01143311', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': '', 'org_study_id': u'09-PP-05', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Thierry Passeron, PhD", "role": "Principal Investigator", "affiliation": "CHU de Nice - Service de Dermatologie - H\\u00f4pital de l\'Archet - 151 Route de saint-antoine de ginesti\\u00e8re 06200 Nice"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "France: Ministry of Health", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'June 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "miRNAs", "time_frame": "1 year", "safety_issue": "No", "description": "We will select the miRNAs differently expressed between biopsies obtained respectively from areas of normal, pretumoral and tumoral areas (candidate miRs = miRs potentially involved in tumor transformation of epidermal keratinocytes). This will be assessed by analyzing in each of the biopsies from each patient, the expression of different miRs that are known to date, using a dedicated microarray, then by checking the data obtained by quantitative PCR."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "CAILLON Cynthia", "organization": "DRCI du CHU de Nice"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Centre Hospitalier Universitaire de Nice', 'sponsors': '[{"lead_sponsor": {"agency": "Centre Hospitalier Universitaire de Nice", "agency_class": "Other"}}]', 'start_date': u'June 2010', 'study_design': u'Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01143311', 'verification_date': u'June 2010', 'why_stopped': ''} 2015-10-09 20:53:00 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01143350?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=27&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:00 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:00 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:00 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:00 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:00 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01143350?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=27&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "EHPAD Training and Stimulation", "arm_group_type": "Experimental", "description": "EHPAD of the group of Training / Stimulation will benefit:\\nafter a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l \'ensemble of l \'\\u00e9quipe of l \'EHPAD by a training officer.\\nof a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD."}}, {"arm_group": {"arm_group_label": "2- EHPAD control", "arm_group_type": "Placebo Comparator", "description": "EHPAD of the reference group, will have their habitual functioning"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The STIM-EHPAD study (for stimulation in nursing home) aims to evaluate the short and medium\n term effectiveness of staff education as a non-pharmacological intervention to manage apathy\n in older people with a diagnosis of dementia.\n\n - Primary efficacy criteria: Apathy Inventory clinician score changes\n\n - Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes,\n Observation scale changes, frequency and severity of the other BPSD using the NPI,\n qualitative analysis of the nursing home staff behavioural changes\n ', 'brief_title': u"Non Pharmacological Treatment in Alzheimer's Disease and Associated Disorders", 'clinical_results': '{}', 'completion_date': u'March 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Alzheimer Disease"}}', 'conditions': '[{"condition": "Alzheimer\'s Disease"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients older than 65 years\\n\\n - A diagnosis of dementia according to the ICD 10 criteria\\n\\n - MMSE score \\u2264 24\\n\\n - Presenting the diagnostic criteria of apathy (cf page ??)\\n\\n - An Apathy Inventory clinician total score >3 (with at least a score higher than 1 at\\n one of the 3 dimensions; lack of initiative, lack of interest, emotional blunting)\\n\\n Exclusion Criteria:\\n\\n - Patients more than 65 years\\n\\n - MMSE score > 24"}, "gender": "Both", "minimum_age": "65 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'300', 'firstreceived_date': u'February 25, 2010', 'has_expanded_access': u'N o', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Other", "intervention_name": "Bras A (EHPAD Training and stimulation)", "description": "EHPAD of the group of Training / Stimulation will benefit:\\nafter a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l \'ensemble of l \'\\u00e9quipe of l \'EHPAD by a training officer.\\nof a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD.", "arm_group_label": "EHPAD Training and Stimulation"}}, {"intervention": {"intervention_type": "Other", "intervention_name": "EHPAD Control", "description": "EHPAD of the reference group, will have their habitual functioning", "arm_group_label": "2- EHPAD control"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "Robert", "address": {"city": "Nice", "state": "Alpes-Maritimes", "zip": "06001", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01143350', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': '', 'org_study_id': u'09-PP-09', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Philippe Ph ROBERT, PhD", "role": "Principal Investigator", "affiliation": "CHU de Nice - CM2R - H\\u00f4pital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)"}}', 'phase': u'N/A', 'primary_completion_date': u'March 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus.", "time_frame": "1 year", "safety_issue": "No", "description": "Identification of yet unknown enzymes involved in the processing of Ab, especially on those responsible for the exoproteasic truncation of Ab at its N-terminus."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "CAILLON Cynthia", "organization": "DRCI du CHU de Nice"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Secondary efficacy criteria: Apathy Inventory patient and caregiver version changes, Observation scale changes, frequency and severity of the other BPSD using the NPI, qualitative analysis of the nursing home staff behavioural changes", "time_frame": "1 year", "safety_issue": "No"}}]', 'source': u'Centre Hospitalier Universitaire de Nice', 'sponsors': '[{"lead_sponsor": {"agency": "Centre Hospitalier Universitaire de Nice", "agency_class": "Other"}}]', 'start_date': u'March 2010', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01143350', 'verification_date': u'March 2010', 'why_stopped': ''} 2015-10-09 20:53:00 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01173757?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=26&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:01 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:01 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:01 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:01 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:01 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:01 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01173757?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=26&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "PF-04995274", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to evaluate the relationship between plasma drug levels and\n receptor binding in brain using PET; and to evaluate safety and tolerability after a single\n administration of PF-04995274 in healthy volunteers.\n ', 'brief_title': u'To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers', 'clinical_results': '{}', 'completion_date': u'November 2010', 'condition_browse': '{}', 'conditions': '[{"condition": "Healthy"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - healthy male and/or female subjects of nonchildbearing potential between the ages of\\n 18 and 55 years, inclusive\\n\\n Exclusion Criteria:\\n\\n - Evidence or history of clinically significant hematological, renal, endocrine,\\n pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or\\n allergic disease.\\n\\n - History of regular alcohol consumption exceeding 7 drinks/week for females or 14\\n drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of\\n beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening\\n\\n - Fulfillment of any of the MRI contraindications on the standard radiography screening\\n questionnaire"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "55 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'8', 'firstreceived_date': u'July 29, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "PF-04995274", "description": "Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1", "arm_group_label": "PF-04995274"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "Healthy Volunteers"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1661002&StudyName=To%20Evaluate%20The%20Relationship%20Between%20Plasma%20Drug%20Levels%20And%20Receptor%20Binding%20In%20Brain%20Using%20PET%20%28Positron%20Emission%20Tomography%29%20In%20He", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06511", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06519", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New Haven", "state": "Connecticut", "zip": "06520", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01173757', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.', 'org_study_id': u'B1661002', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'November 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Exposure response of overall 5HT4 receptor occupancy of PF-04995274", "time_frame": "up to 3 days", "safety_issue": "No"}}, {"primary_outcome": {"measure": "5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain", "time_frame": "up to 3 days", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Adverse events", "time_frame": "up to 3 days", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "change from baseline in vital signs", "time_frame": "up to 3 days", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Singlet ECG post-dose", "time_frame": "up to 3 days", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Clinical safety laboratory endpoints", "time_frame": "up to 3 days", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Clinical examinations", "time_frame": "up to 3 days", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma", "time_frame": "up to 3 days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma", "time_frame": "up to 3 days", "safety_issue": "No"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'August 2010', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01173757', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:02 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01193426?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=25&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:02 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:02 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:02 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:02 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01193426?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=25&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Cirrhosis patient", "description": "All consecutive patients with cirrhosis admitted to the five participating center Patients were hospitalized or treated in an ambulatory setting for treatment of ascites or complications of cirrhosis. Ascitic fluid was obtained by paracentesis according to the usual clinical management for these patients."}}]', 'biospec_descr': u'\n ', 'biospec_retention': u'Samples Without DNA', 'brief_summary': u'\n Spontaneous bacterial peritonitis (SBP), an infection of ascitic fluid in the absence of\n localized intra-abdominal infection, is one of the main potentially fatal complications of\n cirrhosis. In the case of SBP, early diagnosis and rapid therapeutic care can improve\n patient survival (Garcia-Tsao, 2001).\n\n The diagnosis of SBP is based on the detection of a polymorphonuclear neutrophils count\n equal to or greater than 250 /mm3 in the ascitic fluid (method of reference). However,\n obtaining an ascitic cell count is sometimes difficult because it can not always be\n performed in emergency especially outside the opening hours of the laboratory of\n Bacteriology. This raises the necessity of developing quick and easy alternative approaches\n of diagnosis.\n\n Few groups have proposed the use of urinary reagent strip for rapid diagnosis of SBP.\n Nevertheless, the investigators clinical teams have shown that the sensitivity of this test\n was low in a large national multicenter prospective study involving more than a thousand\n patients (Nousbaum et al., 2007). The use of Multistix strips test is thus not recommended\n for the routine application of diagnosis of SBP due to its lack of sensitivity.\n\n Although performed on small groups of patients, several studies have reported that IL-8 or\n IL-6 might be used as markers of ascitic fluid infections. Based on these data and confirmed\n by the investigators preliminary results the investigators propose to study on a broad\n recruitment of patients estimated to about 500 inclusions (about 45 infected patients) the\n interest of using IL-8 and IL-6 as predictive markers of SBP. The investigators propose to\n use an ELISA method, standardized, rapid and automated, applicable in the context of\n emergency (7 days a week and 24 hours a day) as previously described in the work conducted\n to exclude the urinary tract infection (Oregioni et al., 2005).\n\n During the preliminary experiments conducted for this project, the investigators also found\n systematic variation of another marker, leptin. This is a protein hormone involved in the\n inflammatory and immune responses (Otero et al., 2005). It appears necessary to include the\n study of this marker in the analysis of differential protein response between patients\n suffering or not suffering from SBP.\n\n The investigators therefore propose a diagnostic study, non-interventional, prospective,\n multicenter trial conducted over 2 years.\n\n - The main objective is to establish the diagnostic performance (sensitivity,\n specificity, positive predictive value and negative) of IL-8 and IL-6, assayed in the\n ascites fluid by an automated ELISA in the early diagnosis of SBP.\n\n - The secondary objectives are to confirm the interest of the measurement of leptin in\n the SBP and to establish the diagnostic performance of IL-8 and IL-6 or leptin\n according to different clinical features in patients (score Child-Pugh classification\n and history of SBP, ascitic fluid infection with positive bacterial culture).\n ', 'brief_title': u'Diagnostic of Spontaneous Bacterial Peritonitis', 'clinical_results': '{}', 'completion_date': u'November 2013', 'condition_browse': '{"condition_browse": {"mesh_term": "Peritonitis"}}', 'conditions': '[{"condition": "Spontaneous Bacterial Peritonitis"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "All consecutive patients with cirrhosis admitted to the five participating center Patients\\n were hospitalized or treated in an ambulatory setting for treatment of ascites or\\n complications of cirrhosis."}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - Age > 18 years old\\n\\n - Patient with social insurance\\n\\n - Signature of informed consent\\n\\n - Patient admitted for treatment of ascites or complications of cirrhosis. Diagnosis of\\n cirrhosis relied on clinical, biological and morphological criteria (portal\\n hypertention, hepatic biopsy\\u2026).\\n\\n Exclusion Criteria:\\n\\n - Patient who have received abdominal surgery within the last month.\\n\\n - Patient with chylous ascites or ascites not related to portal hypertention\\n (pancreatic ascites, hemoperitoneum, ascites observed during acute heart failure,\\n peritoneal tuberculosis, hepatocellular carcinome\\u2026)\\n\\n - Patient with obesity severe (IMC \\u2265 \\u00e0 35 kg/m2)"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'500', 'firstreceived_date': u'August 31, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Other", "intervention_name": "Ascite liquid puncture", "description": "Ascitic fluid obtained by paracentesis", "arm_group_label": "Cirrhosis patient"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Hepatic"}, {"keyword": "cirrhosis"}, {"keyword": "IL-6"}, {"keyword": "IL-8"}, {"keyword": "Leptine"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "Hepato-gastro-enterology and bacteriology department", "address": {"city": "Brest", "zip": "29609", "country": "France"}}, "status": "Recruiting", "contact": {"last_name": "NOUSBAUM Jean Baptiste, PU PH", "phone": "0033 2 98 34 71 48", "email": "jean-baptiste.nousbaum@chu-brest.fr"}, "investigator": [{"last_name": "NOUSBAUM Jean Baptiste, PU PH", "role": "Principal Investigator"}, {"last_name": "PAYAN Christopher, PU PH", "role": "Principal Investigator"}]}}, {"location": {"facility": {"name": "Hepato-gastro-enterology and Bacteriology department", "address": {"city": "Creil", "country": "France"}}, "status": "Recruiting", "contact": {"last_name": "CADRANEL Jean Fran\\u00e7ois, PhD", "phone": "0033 3 44 61 64 43", "email": "jfrancois.cadranel@ch-creil.fr"}, "investigator": {"last_name": "CADRANEL Jean Fran\\u00e7ois, PhD", "role": "Principal Investigator"}}}, {"location": {"facility": {"name": "Hepato-gastro-enterology and Bacteriology department", "address": {"city": "Hy\\u00e8res", "zip": "83400", "country": "France"}}, "status": "Recruiting", "contact": {"last_name": "RENOU Christophe, PhD", "phone": "0033 4 94 00 27 08", "email": "crenou@ch-hyeres.fr"}, "investigator": [{"last_name": "RENOU Christophe, PhD", "role": "Principal Investigator"}, {"last_name": "RAOULT Annie, PhD", "role": "Principal Investigator"}]}}, {"location": {"facility": {"name": "Hepato-gastro-enterology and Bacteriology department", "address": {"city": "Montpellier", "zip": "34295", "country": "France"}}, "status": "Recruiting", "contact": {"last_name": "PAGEAUX Georges, PU PH", "phone": "0033 4 67 33 70 81", "email": "gp-pageaux@chu-montpellier.fr"}, "investigator": [{"last_name": "PAGEAUX Georges, PU PH", "role": "Principal Investigator"}, {"last_name": "VANDE PERRE Philippe, PU PH", "role": "Principal Investigator"}]}}, {"location": {"facility": {"name": "Hepato-gastro-enterology and Bacteriology department", "address": {"city": "Nice", "zip": "06000", "country": "France"}}, "status": "Recruiting", "contact": {"last_name": "LANDRAUD Luce, MD,PhD", "phone": "0033 4 92 03 62 14", "email": "landraud.l@chu-nice.fr"}, "investigator": [{"last_name": "LANDRAUD Luce, MD, PhD", "role": "Principal Investigator"}, {"last_name": "TRAN Albert, PU PH", "role": "Sub-Investigator"}]}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01193426', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': u'Evaluation of IL-6 and IL-8 Interleukin Rates to Diagnose Spontaneous Bacterial Peritonitis', 'org_study_id': u'10-API-01', 'other_outcomes': '[]', 'overall_contact': '{"overall_contact": {"last_name": "LANDRAUD Luce, MD, PhD", "phone": "0033 4 92 03 62 14", "email": "landraud.l@chu-nice.fr"}}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "LANDRAUD Luce, MD, PhD", "role": "Study Director", "affiliation": "CHU de Nice"}}', 'overall_status': u'Recruiting', 'oversight_info': '{"oversight_info": {"authority": "France: National Consultative Ethics Committee for Health and Life Sciences", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'September 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Interleukin-8 rate", "time_frame": "Every 6 months during 3 years", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Interleukin-6 rate", "time_frame": "Every 6 months during 3 years", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dr. Luce LANDRAUD", "organization": "Bacteriology department"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "leptin rate", "time_frame": "Every 6 months during 3 years", "safety_issue": "No"}}]', 'source': u'Centre Hospitalier Universitaire de Nice', 'sponsors': '[{"lead_sponsor": {"agency": "Centre Hospitalier Universitaire de Nice", "agency_class": "Other"}}]', 'start_date': u'September 2010', 'study_design': u'Observational Model: Cohort, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01193426', 'verification_date': u'August 2010', 'why_stopped': ''} 2015-10-09 20:53:02 [scrapy] INFO: Crawled 42 pages (at 42 pages/min), scraped 38 items (at 38 items/min) 2015-10-09 20:53:03 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01201577?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=24&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:03 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:03 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:03 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:03 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:03 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01201577?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=24&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Placebo/Probiotic", "arm_group_type": "Active Comparator"}}, {"arm_group": {"arm_group_label": "Placebo/Prebiotic", "arm_group_type": "Active Comparator"}}, {"arm_group": {"arm_group_label": "Prebiotic/Probiotic", "arm_group_type": "Active Comparator"}}, {"arm_group": {"arm_group_label": "Placebo/Placebo", "arm_group_type": "Placebo Comparator"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n It has recently been discovered that bacteria are able to communicate using specialised\n molecules known as Quorum Sensing Signalling Molecules (QSSMs). An accumulation of QSSMs in\n their surrounding environment allow for the bacteria to quantify the size of colonies. At\n specific colony sizes the concentration of QSSMs reaches a critical threshold leading to the\n activation of genes that cause an infection. It is by this mechanism that bacteria within a\n colony coordinate behaviour to activate infectivity when colony sizes are large enough to\n withstand defensive measures from the host's immune system. A disruption of quorum sensing\n may reduce the severity of infection and this has led to the development of inhibitors of\n quorum sensing as a new strategy in antibacterial therapy.\n\n QSSMs are also thought to facilitate infection by other mechanisms and are able to influence\n the number and function of a specific type of immune cell known as an 'antigen presenting\n cell'. These cells are pivotal in allowing the immune system to recognise components of\n bacteria as foreign and thereby mount the appropriate response. It was found that large\n numbers of these types of cells underwent programmed cell death (cell suicide) in the\n presence of QSSMs compared to when QSSMs were absent. This mirrors the situation in blood\n sampled from patients with severe infections where there is a greater proportion of cell\n deaths among antigen presenting cells than other types of immune cell.\n\n This study aims to establish in healthy volunteers, the mechanisms by which QSSMs affect\n immune cells and facilitate the spread of infection. Antibiotic administration in humans can\n alter the environment of the intestine and can lead to an overgrowth of harmful bacteria to\n potentially cause an infection. Probiotics supplements can prevent bacterial overgrowth and\n potentially reduce infective complications. The mechanism, which we aim to clarify, may\n involve changes in both the production of QSSMs and the function of immune cells.\n\n Hypothesis\n\n 1. Antibiotic use alters gut flora, leading to the appearance in the systemic circulation\n of bacterial QSSMs and changes in immune function of the host.\n\n 2. Probiotics and/or prebiotics have beneficial effects by preserving the normal resident\n gut flora, thereby, modulating bacterial QSSMs and preserving the immune function of\n the host.\n\n Aims\n\n The aims of our study are 2 fold:\n\n 1. Firstly, to study the effect of orally administered antibiotic on QSSMs (in faeces and\n blood) and on innate and adaptive immunity in healthy humans.\n\n 2. Secondly, to study the effect of orally administered combinations of prebiotic,\n probiotic and antibiotic on QSSMs (in faeces and blood) and on innate and adaptive\n immunity in healthy humans.\n ", 'brief_title': u'Biological Modulation of Bacterial QSSMs, Innate and Adaptive Immunity by Antibiotics, Probiotics and Prebiotics in Healthy Individuals', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{}', 'conditions': '[{"condition": "Quorum Sensing"}, {"condition": "Prebiotics"}, {"condition": "Probiotics"}, {"condition": "Sepsis"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Male volunteers\\n\\n - Age 18-55 years\\n\\n - Willing to participate and able to give informed consent\\n\\n - Alcohol abstinence during study\\n\\n Exclusion Criteria:\\n\\n - Smokers/substance abusers\\n\\n - Individuals with diabetes mellitus\\n\\n - Oral/Intravenous steroids\\n\\n - Allergy to azithromycin\\n\\n - Individuals already taking regular medications/probiotics/nutritional supplements\\n\\n - Individuals with chronic disease or currently under investigation\\n\\n - Individuals with \\u22643 bowel movements/week\\n\\n - Individuals with \\u22652 bowel movements/day"}, "gender": "Male", "minimum_age": "18 Years", "maximum_age": "75 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'40', 'firstreceived_date': u'September 13, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Sulfalene"}}', 'interventions': '[{"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Bifidobacterium longum BB536", "description": "2 capsules od", "arm_group_label": "Placebo/Probiotic"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Active hexose correlated compound (AHCC)", "description": "One capsule tds", "arm_group_label": "Placebo/Prebiotic"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Bifidobacterium longum BB536 and Active hexose correlated compound (AHCC)", "description": "One capsule tds (prebiotic) and two capsules od (probiotic)", "arm_group_label": "Prebiotic/Probiotic"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Corn starch placebo capsule", "description": "One capsule tds and two capsules od", "arm_group_label": "Placebo/Placebo"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Azithromycin", "description": "250mg od", "arm_group_label": ["Placebo/Probiotic", "Placebo/Prebiotic", "Prebiotic/Probiotic", "Placebo/Placebo"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Quorum sensing"}, {"keyword": "Prebiotics"}, {"keyword": "Probiotics"}, {"keyword": "Sepsis"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United Kingdom"}]', 'locations': '[{"location": {"facility": {"name": "University of Nottingham", "address": {"city": "Nottingham", "state": "Nottinghamshire", "zip": "NG7 2UH", "country": "United Kingdom"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01201577', 'number_of_arms': u'4', 'number_of_groups': '', 'official_title': u'Biological Modulation of Bacterial QSSMs, Innate and Adaptive Immunity by Antibiotics, Probiotics and Prebiotics in Healthy Individuals', 'org_study_id': u'09GA014', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Abeed Chowdhury, MB ChB BSc MRCS", "role": "Principal Investigator", "affiliation": "University of Nottingham"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United Kingdom: National Institute for Health Research", "has_dmc": "No"}}', 'phase': u'Phase 1', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Serum QSSM level", "time_frame": "14 days", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dileep Lobob", "organization": "University of Nottingham"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "T cell Th1/Th2 ratio", "time_frame": "14 days", "safety_issue": "No"}}]', 'source': u'University of Nottingham', 'sponsors': '[{"lead_sponsor": {"agency": "University of Nottingham", "agency_class": "Other"}}]', 'start_date': u'October 2009', 'study_design': u'Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01201577', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:03 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01214226?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=23&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:03 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:03 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:03 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:03 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01214226?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=23&resultsxml=true> {'acronym': u'CorpentoxHAA', 'arm_groups': '[{"arm_group": {"arm_group_label": "Pentoxifylline + Prednisolone", "arm_group_type": "Active Comparator", "description": "Pentoxifylline 400 mg prolonged-released tablets 3 time a day [1200 mg/day]\\n+ Prednisolone 2 ORODISPERSIBLE TABLETS OF 20 MG 1 TIME PER DAY [40 mg/day]"}}, {"arm_group": {"arm_group_label": "Placebo + Prednisolone", "arm_group_type": "Placebo Comparator", "description": "Placebo prolonged-release tabled 3 time a day\\n+ Prednisolone 2 ORODISPERSIBLE TABLETS OF 20 MG 1 TIME PER DAY [40 mg/day]"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The treatment of severe forms of alcoholic hepatitis (AH) constitutes a major challenge for\n clinicians involved in the management of severe alcoholic liver disease. In patients with\n Maddrey function higher than 32, compelling evidence from data has shown that\n corticosteroids improve short-term survival. However, novel strategies or molecules are\n required in light of the fact that approximately 40 % of patients continue to die at 6\n months. A double-blinded randomized controlled trial of 101 patients has showed that\n Pentoxifylline improves survival of patients with severe AH, as compared to placebo. In\n terms of mechanisms, the effect of pentoxifylline is related to prevention of hepatorenal\n function whereas corticosteroids induce an early improvement in liver function. When\n considering these differences of mechanisms, many clinicians suggest that the addition of\n pentoxyfilline to corticosteroids is an attractive option that needs to be tested in\n patients with severe AH.\n ', 'brief_title': u'Double-blind Randomized Controlled Trial in Severe Alcoholic Hepatitis', 'clinical_results': '{}', 'completion_date': u'January 2011', 'condition_browse': '{"condition_browse": {"mesh_term": ["Hepatitis", "Hepatitis A", "Hepatitis, Alcoholic", "Liver Diseases", "Liver Diseases, Alcoholic"]}}', 'conditions': '[{"condition": "Alcoholic Hepatitis"}, {"condition": "Alcoholic Liver Disease"}]', 'detailed_description': u'\n The aim of the present study is to determine whether or not the adjunction of Pentoxifylline\n to corticosteroids would improve 6-month survival of patients with severe alcoholic\n hepatitis. This multicenter, randomized, double-blinded, controlled, phase 3 trial was\n conducted in 24 centers located in France and Belgium. Alcoholic hepatitis was\n biopsy-proven. All eligible patients were randomly assigned in a 1:1 ratio to receive\n corticosteroids + Pentoxifylline or corticosteroids + Placebo. The primary outcome of the\n study was 6-month survival. Assuming a two-sided type I error of 0.05, a randomization ratio\n of 1:1 between the 2 groups, 6-month survival of 64% in the Placebo and Corticosteroids\n group and of 78 % in the Pentoxifylline and Corticosteroids group, we estimated that with\n 268 randomized patients (134 in each group), the study would have a power of 80% to detect\n this increase in 6-month survival in the Pentoxifylline and Corticosteroid group.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Alcohol consumption more than 40 gram/day for women and 50 gram/day for men\\n\\n - Maddrey discriminant function higher than 32\\n\\n - Onset of jaundice within the 3 previous months\\n\\n - Biopsy-proven alcoholic hepatitis\\n\\n Exclusion Criteria:\\n\\n - Hypersensitivity to pentoxifylline\\n\\n - Any severe disease that may potential affect survival such as cardiac failure,\\n ischemic cardiopathy, respiratory failure\\n\\n - Any neoplasm that occurred within the 2 previous years\\n\\n - Hepatocellular carcinoma or any previous diagnosis of hepatocellular carcinoma\\n\\n - Portal thrombosis\\n\\n - Severe gastrointestinal bleeding\\n\\n - Uncontrolled sepsis within the 7 previous days\\n\\n - Hepatorenal syndrome type I\\n\\n - Viral and fungal infection\\n\\n - Acute pancreatitis\\n\\n - Any tuberculosis that occurred within the 5 previous years\\n\\n - Psychiatric disorders that contraindicate the use of corticosteroids\\n\\n - Infection related to virus of the hepatites B or C\\n\\n - HIV infection (Human immunodeficiency virus)\\n\\n - Any treatment with corticosteroids, immunosuppressive agents, budesonide, thalidomide\\n or pentoxifylline that was given within the previous year\\n\\n - Pregnancy or breast feeding"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "70 Years", "healthy_volunteers": "No"}}', 'enrollment': u'278', 'firstreceived_date': u'October 1, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Methylprednisolone", "Methylprednisolone Hemisuccinate", "Methylprednisolone acetate", "Pentoxifylline", "Prednisolone", "Prednisolone acetate", "Prednisolone hemisuccinate", "Prednisolone phosphate"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Pentoxifylline", "description": "400 mg prolonged-released tablets 3 time per day for 1 month.", "arm_group_label": "Placebo + Prednisolone", "other_name": "TORENTAL 400MG"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "placebo", "description": "prolonged-release tablets 3 time per day for 1 month", "arm_group_label": "Pentoxifylline + Prednisolone"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Belgium"}, {"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "University hospital", "address": {"city": "Brussel", "zip": "1070", "country": "Belgium"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Angers", "zip": "49933", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Jean Verdier (AH-HP)", "address": {"city": "Bondy", "zip": "93143", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Bordeaux", "zip": "33000", "country": "France"}}}}, {"location": {"facility": {"name": "Centre hospitalier", "address": {"city": "B\\u00e9thune", "zip": "62408", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Caen", "zip": "14000", "country": "France"}}}}, {"location": {"facility": {"name": "Hospital Antoine B\\u00e9cl\\u00e8re (Assistance Publique des H\\u00f4piaux de Paris)", "address": {"city": "Clamart", "zip": "92141", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Beaujon (AH-HP)", "address": {"city": "Clichy", "zip": "92118", "country": "France"}}}}, {"location": {"facility": {"name": "Centre Hospitalier", "address": {"city": "Creil", "zip": "60100", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Henri Mondor (AP-HP)", "address": {"city": "Cr\\u00e9teil", "zip": "94000", "country": "France"}}}}, {"location": {"facility": {"name": "Centre hospitalier", "address": {"city": "Dunkerque", "zip": "59240", "country": "France"}}}}, {"location": {"facility": {"name": "Centre Hospitalier", "address": {"city": "Lens", "zip": "62300", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Lille", "zip": "59037", "country": "France"}}}}, {"location": {"facility": {"name": "Centre hospitalier Sambre en avesnois", "address": {"city": "Maubeuge", "zip": "59600", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Montpellier", "zip": "34295", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Nantes", "zip": "45000", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Nice", "zip": "06202", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Cochin (AH-HP)", "address": {"city": "Paris", "zip": "75014", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital de la Piti\\u00e9-Salp\\u00e9tri\\u00e8re (AP-HP)", "address": {"city": "Paris", "zip": "75013", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Saint Antoine (AP-HP)", "address": {"city": "Paris", "zip": "75012", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Poitiers", "zip": "49000", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital", "address": {"city": "Rennes", "zip": "35033", "country": "France"}}}}, {"location": {"facility": {"name": "Centre Hospitalier Victor Provo", "address": {"city": "Roubaix", "zip": "59100", "country": "France"}}}}, {"location": {"facility": {"name": "University Hospital", "address": {"city": "Strasbourg", "zip": "67100", "country": "France"}}}}, {"location": {"facility": {"name": "Centre Hospitalier", "address": {"city": "Tourcoing", "zip": "59208", "country": "France"}}}}, {"location": {"facility": {"name": "Centre Hospitalier", "address": {"city": "Valenciennes", "zip": "59300", "country": "France"}}}}, {"location": {"facility": {"name": "University hospital, Nancy", "address": {"city": "Vandoeuvre les nancy", "zip": "54511", "country": "France"}}}}, {"location": {"facility": {"name": "H\\u00f4pital Paul Brousse (AH-HP)", "address": {"city": "Villejuif", "zip": "94000", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01214226', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Evaluation of the Survival Benefit of the Adjunction of Pentoxifylline to Corticosteroids in Patients Suffering From Severe Alcoholic Hepatitis', 'org_study_id': u'2006-006944-78', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Philippe MATHURIN, MD PhD", "role": "Principal Investigator", "affiliation": "University Hospital, Lille"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)", "has_dmc": "No"}}', 'phase': u'Phase 3', 'primary_completion_date': u'December 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Overall Survival", "time_frame": "6 months", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Service des Maladies de l\'Appareil Digestif, H\\u00f4pital Huriez,", "organization": "CHRU Lille, France (Pr Philippe Mathurin / MD, PhD)"}}', 'results_reference': '[{"results_reference": {"citation": "Lucey MR, Mathurin P, Morgan TR. Alcoholic hepatitis. N Engl J Med. 2009 Jun 25;360(26):2758-69. doi: 10.1056/NEJMra0805786. Review.", "PMID": "19553649"}}, {"results_reference": {"citation": "Louvet A, Wartel F, Castel H, Dharancy S, Hollebecque A, Canva-Delcambre V, Deltenre P, Mathurin P. Infection in patients with severe alcoholic hepatitis treated with steroids: early response to therapy is the key factor. Gastroenterology. 2009 Aug;137(2):541-8. doi: 10.1053/j.gastro.2009.04.062. Epub 2009 May 13.", "PMID": "19445945"}}, {"results_reference": {"citation": "Louvet A, Naveau S, Abdelnour M, Ramond MJ, Diaz E, Fartoux L, Dharancy S, Texier F, Hollebecque A, Serfaty L, Boleslawski E, Deltenre P, Canva V, Pruvot FR, Mathurin P. The Lille model: a new tool for therapeutic strategy in patients with severe alcoholic hepatitis treated with steroids. Hepatology. 2007 Jun;45(6):1348-54.", "PMID": "17518367"}}, {"results_reference": {"citation": "Mathurin P. Corticosteroids for alcoholic hepatitis--what\'s next? J Hepatol. 2005 Sep;43(3):526-33. Review.", "PMID": "16026887"}}, {"results_reference": {"citation": "Naveau S, Chollet-Martin S, Dharancy S, Mathurin P, Jouet P, Piquet MA, Davion T, Oberti F, Bro\\u00ebt P, Emilie D; Foie-Alcool group of the Association Fran\\u00e7aise pour l\'Etude du Foie. A double-blind randomized controlled trial of infliximab associated with prednisolone in acute alcoholic hepatitis. Hepatology. 2004 May;39(5):1390-7.", "PMID": "15122768"}}, {"results_reference": {"citation": "Mathurin P, Abdelnour M, Ramond MJ, Carbonell N, Fartoux L, Serfaty L, Valla D, Poupon R, Chaput JC, Naveau S. Early change in bilirubin levels is an important prognostic factor in severe alcoholic hepatitis treated with prednisolone. Hepatology. 2003 Dec;38(6):1363-9.", "PMID": "14647046"}}, {"results_reference": {"citation": "Mathurin P, Mendenhall CL, Carithers RL Jr, Ramond MJ, Maddrey WC, Garstide P, Rueff B, Naveau S, Chaput JC, Poynard T. Corticosteroids improve short-term survival in patients with severe alcoholic hepatitis (AH): individual data analysis of the last three randomized placebo controlled double blind trials of corticosteroids in severe AH. J Hepatol. 2002 Apr;36(4):480-7.", "PMID": "11943418"}}, {"results_reference": {"citation": "Mathurin P, Duchatelle V, Ramond MJ, Degott C, Bedossa P, Erlinger S, Benhamou JP, Chaput JC, Rueff B, Poynard T. Survival and prognostic factors in patients with severe alcoholic hepatitis treated with prednisolone. Gastroenterology. 1996 Jun;110(6):1847-53.", "PMID": "8964410"}}, {"results_reference": {"citation": "Ramond MJ, Poynard T, Rueff B, Mathurin P, Th\\u00e9odore C, Chaput JC, Benhamou JP. A randomized trial of prednisolone in patients with severe alcoholic hepatitis. N Engl J Med. 1992 Feb 20;326(8):507-12.", "PMID": "1531090"}}]', 'secondary_ids': '[{"secondary_id": "PROM 2006/0636"}, {"secondary_id": "2006-006944-78"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Hepatorenal syndrome", "time_frame": "6 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Score of Lille model", "time_frame": "Seven days", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Percentage of Meld score (Model for End-stage Liver Disease) higher than 17", "time_frame": "6 months", "safety_issue": "No"}}]', 'source': u'University Hospital, Lille', 'sponsors': '[{"lead_sponsor": {"agency": "University Hospital, Lille", "agency_class": "Other"}}, {"collaborator": {"agency": "Ministry of Health, France", "agency_class": "Other"}}]', 'start_date': u'December 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01214226', 'verification_date': u'September 2010', 'why_stopped': ''} 2015-10-09 20:53:05 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01245946?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=22&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:05 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:05 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:05 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:05 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01245946?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=22&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Photodynamic therapy", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "Conventional therapy", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n - Acne vulgaris is a common inflammatory skin disease that affects more than 85% of teens\n and some people may continue throughout adulthood.\n\n - Topical retinoids related to oral antibiotics are considered first-line treatment of\n moderate inflammatory acne.\n\n - Recently, photodynamic therapy (PDT) with a photosensitizer, 5-aminolevulinic acid\n (ALA) or methyl aminolevulinate (MAL), has proven useful in the management of\n inflammatory acne. Although progress has been made in the study of photodynamic therapy\n for acne, to date, no study has compared PDT with standard and well-validated\n pharmaceutical treatments and with the current recommended therapy for most types of\n acne combination therapy with a topical retinoid plus one or more antimicrobial agents.\n\n Hypothesis\n\n - PDT with the photosensitizer ALA will be effective and safe for the treatment of\n moderate facial inflammatory acne.\n\n - The ALA-PDT is more effective than conventional therapy with oral antibiotics and\n topical retinoids in the treatment of moderate inflammatory acne with faster action at\n 12 weeks of follow-up.\n ', 'brief_title': u'Photodynamic Therapy Compared to Adapalene 0.1% Gel Plus Doxycycline in the Treatment of Acne Vulgaris', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Acne Vulgaris"}}', 'conditions': '[{"condition": "Acne"}]', 'detailed_description': u'\n - There will be a randomized, controlled, single blind comparison study of PDT with\n 5-aminolevulinic acid (ALA) 20% versus conventional therapy consisting of topical 0.1%\n adapalene plus doxycycline 100 mg/day orally in patients with moderate inflammatory\n acne.\n\n - Be sought from all patients written informed consent prior to study entry.\n\n - For sample size calculation, we assumed that the correlation is the same in both groups\n and is relatively low (0.01), the number of lesions per subject is equal in both groups\n with a mean of 100 and low variance, which take 1 control per case and that. Whereas\n the percentage of improvement in the control group is 0.6 and expected in the treatment\n group is 0.7 yields a sample size of 23 patients in the treatment group and 23 new\n controls.\n\n Interventions:\n\n Patients will be randomized to receive:\n\n 1. ALA-PDT: In 23 patients applied 20% ALA solution in the affected area for 1.5 hours.\n Subsequently irradiated with noncoherent red light (lamp Waldmann PDT 1200; wavelength\n 590-700 nm) with irradiance of 70 mW/cm2 and total dose or fluence of 37 J/cm2 for 7-9\n minutes. From the sixth week will begin nightly topical adapalene 0.1% gel.\n\n 2. Standard therapy:\n\n In 23 patients applied topical adapalene 0.1% gel at night for 12 weeks plus doxycycline 100\n mg / day for 6 weeks.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Men and women between 18 and 30 years of age with moderate inflammatory acne\\n\\n Exclusion Criteria:\\n\\n - Those who have received any treatment for acne either topic in the last 3 months\\n before and systemic (including ACO started) in the last 6 months of the study.\\n\\n - Patients who are pregnant or breastfeeding.\\n\\n - Patients with history of photosensitivity or autoimmune disease.\\n\\n - Patients with a history or active TB disease or HIV.\\n\\n - Patient refusal to participate in the study."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "30 Years", "healthy_volunteers": "No"}}', 'enrollment': u'46', 'firstreceived_date': u'November 22, 2010', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Adapalene", "Doxycycline"]}}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Photodynamic therapy", "description": "Photodynamic therapy: 2 sessions separated by 2 weeks of TDF with topical ALA20% for 1.5 hrs, then irradiated with red light (Waldmann lamp) at a fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin adapalene 0.1% gel until 12 weeks", "arm_group_label": "Photodynamic therapy", "other_name": "PDT"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Conventional therapy", "description": "Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.", "arm_group_label": "Conventional therapy", "other_name": "Adapalene plus doxycycline"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Acne moderate"}, {"keyword": "Photodynamic Therapy"}, {"keyword": "Topical retinoids"}, {"keyword": "Antimicrobial agents"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Chile"}]', 'locations': '[{"location": {"facility": {"name": "Departamento de dermatolog\\u00eda, Centro M\\u00e9dico San Joaqu\\u00edn, Pontificia Universidad Cat\\u00f3lica de Chile", "address": {"city": "Santiago", "state": "San Joaqu\\u00edn", "zip": "1234", "country": "Chile"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT01245946', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Efficacy Comparison Study of Topical Aminolaevulinic Acid-Photodynamic Therapy Versus Adapalene Gel 0.1% Plus Doxycycline for Treatment of Moderate Acne Vulgaris. Randomized, Simple Blind, Controlled Trial.', 'org_study_id': u'10-146', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Ariel Hasson, MD", "role": "Study Chair", "affiliation": "Dermatology department, Pontificia Universidad Cat\\u00f3lica de Chile"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Chile: Pontificia Universidad Cat\\u00f3lica de Chile", "has_dmc": "Yes"}}', 'phase': u'Phase 2', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Lesion counts", "time_frame": "Twelve weeks", "safety_issue": "No", "description": "Be conducted by an investigator blinded to the interventions, count of inflammatory and non-inflammatory acne lesions at the start of treatment and controls at the sixth and twelfth week."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Claudia Nicklas D, Department of Dermatology, Pontificia Universidad Cat\\u00f3lica de Chile", "organization": "Pontificia Universidad Cat\\u00f3lica de Chile"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Photographic scores, quality of life, adherence to treatment and global severity of acne", "time_frame": "Twelve weeks", "safety_issue": "No", "description": "The researchers will make assessment of the quality of life, adherence to treatment, global severity of acne and scars and blemishes record at the beginning and end of the study (12 weeks)."}}]', 'source': u'Pontificia Universidad Catolica de Chile', 'sponsors': '[{"lead_sponsor": {"agency": "Pontificia Universidad Catolica de Chile", "agency_class": "Other"}}]', 'start_date': u'October 2010', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01245946', 'verification_date': u'November 2010', 'why_stopped': ''} 2015-10-09 20:53:06 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT01284400?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=21&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=2) 2015-10-09 20:53:06 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:06 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:06 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:06 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:06 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT01284400?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=21&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Disease management", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "Usual treatment and care", "arm_group_type": "No Intervention"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Although many studies have demonstrated the efficacy of disease management programs on\n mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure\n (HF), no study has focused on psychological status as an outcome of disease management in\n patients with HF. Disease management could lead to the reduction of psychological distress,\n thus improving the self-care ability and adherence of patients with HF. In addition, very\n little information is available on the effectiveness of disease management programs in areas\n other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and\n Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the\n efficacy of home-based disease management programs compared with usual care in improving\n psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.\n ', 'brief_title': u'Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Heart Failure"}}', 'conditions': '[{"condition": "Heart Failure"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion criteria\\n\\n 1. Age \\u2265 18 years\\n\\n Exclusion criteria\\n\\n 1. End-stage HF defined as requiring mechanical support or continues intravenous\\n inotropic support\\n\\n 2. A serious life-threatening illness with a life-expectancy of <6 months Within the\\n past 3 months\\n\\n 3. Cognitive dysfunction\\n\\n 4. Substance abuse or psychotic disorder\\n\\n 5. Managed by visiting nursing\\n\\n 6. Long distance between patients\' home and hospital"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'156', 'firstreceived_date': u'January 25, 2011', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Other", "intervention_name": "Home-based disease management", "description": "Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses", "arm_group_label": "Disease management"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "heart failure"}, {"keyword": "disease management"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[]', 'locations': '[]', 'nct_aliases': '[]', 'nct_id': u'NCT01284400', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)', 'org_study_id': u'J-HOMECARE', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Hiroyuki Tsutsui, MD, PhD", "role": "Study Chair", "affiliation": "Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Japan: Ministry of Health, Labor and Welfare", "has_dmc": "Yes"}}', 'phase': u'Phase 3', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Psychosocial status (depression, anxiety)", "time_frame": "up to 12 months", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Hiroyuki Tsutsui", "organization": "Department of Cardiovascular Medicine, Hokkaido University Graduate School of Medicine"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "UMIN000000565"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Death", "time_frame": "up to 12 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Readmission due to heart failure", "time_frame": "up to 12 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Hospital admission", "time_frame": "up to 12 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Quality of life", "time_frame": "up to 12 months", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Physical activity", "time_frame": "up to 12 months", "safety_issue": "No"}}]', 'source': u'Japanese Heart Failure Outpatient Disease Management Evaluation Investigators', 'sponsors': '[{"lead_sponsor": {"agency": "Japanese Heart Failure Outpatient Disease Management Evaluation Investigators", "agency_class": "Other"}}]', 'start_date': u'January 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT01284400', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:07 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00122057?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=67&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:07 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:07 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:07 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:07 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00122057?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=67&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The aim of this study is to determine whether antibiotic treatment could reduce mechanical\n ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical\n ventilation.\n ', 'brief_title': u'Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis', 'clinical_results': '{}', 'completion_date': u'June 2007', 'condition_browse': '{"condition_browse": {"mesh_term": ["Cross Infection", "Respiratory Tract Diseases"]}}', 'conditions': '[{"condition": "Respiratory Tract Diseases"}, {"condition": "Nosocomial Infections"}]', 'detailed_description': u'\n Rationale:\n\n Ventilator-associated tracheobronchitis (VAT) is common in intensive care unit (ICU)\n patients, rates of 2.7%-10.6% are reported in the literature. This nosocomial infection is\n associated with weaning difficulties resulting in prolonged duration of mechanical\n ventilation (MV) and ICU stay. A case-control study performed in chronic obstructive\n pulmonary disease (COPD) patients with VAT found antibiotic treatment to be significantly\n associated with reduced duration of MV. Another case control-study, performed in VAT\n pati ents without chronic respiratory failure, found no significant difference in duration of\n MV between patients who received adequate antibiotic treatment and those who received\n inadequate antibiotic treatment. In addition, antibiotic use is known to be associated with\n subsequent multidrug-resistant bacteria (MRB), longer duration of MV, and mortality rates.\n Therefore, a randomized controlled study is necessary to determine the impact of antibiotic\n treatment on outcome in VAT patients.\n\n Patients and methods:\n\n 390 patients will be included in this prospective randomized open multicenter study.\n Inclusion of 390 patients is required to demonstrate a significant reduction of MV duration\n of 5 days (\u03b1 = 0.025, \u03b2 = 0.10). An intermediate analysis will be performed. All patients\n intubated and ventilated > 48h who developed a first episode of VAT are eligible. Primary\n endpoint is the duration of MV. Secondary end points are ICU length of stay, mortality,\n ventilator-associated pneumonia, ICU-acquired infection, MRB, and yeast rates.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients with tracheobronchitis diagnosed after 48h of invasive mechanical\\n ventilation\\n\\n Exclusion Criteria:\\n\\n - Immunodepressed patients\\n\\n - Patients with tracheostomy at ICU admission\\n\\n - Patients who developed ventilator-associated pneumonia before ventilator-associated\\n tracheobronchitis"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'58', 'firstreceived_date': u'July 14, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Anti-Bacterial Agents", "Antibiotics, Antitubercular"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "antibiotic treatment"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "ventilator-associated tracheobronchitis"}, {"keyword": "nosocomial tracheobronchitis"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "12 ICUs in north of France", "address": {"city": "Lille", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00122057', 'number_of_arms': '', 'number_of_groups': '', 'official_title': '', 'org_study_id': u'2005/0506', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Saad Nseir, MD", "role": "Principal Investigator", "affiliation": "University Hospital of Lille"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "France: Ministry of Health"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2007', 'primary_outcomes': '[{"primary_outcome": {"measure": "duration of mechanical ventilation"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "University Hospital, Lille", "organization": "University Hospital, Lille"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "length of intensive care unit (ICU) stay"}}, {"secondary_outcome": {"measure": "mortality rate"}}, {"secondary_outcome": {"measure": "ventilator-associated pneumonia rate"}}]', 'source': u'University Hospital, Lille', 'sponsors': '[{"lead_sponsor": {"agency": "University Hospital, Lille", "agency_class": "Other"}}]', 'start_date': u'June 2005', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00122057', 'verification_date': u'September 2006', 'why_stopped': ''} 2015-10-09 20:53:09 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00141128?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=66&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:09 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:09 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:09 [spiders.trials] DEBUG: responsible_party: must be string or read-only buffer, not None 2015-10-09 20:53:09 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:09 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:09 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00141128?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=66&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel\n methodology\n ', 'brief_title': u'Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.', 'clinical_results': '{}', 'completion_date': u'June 2006', 'condition_browse': '{"condition_browse": {"mesh_term": ["Urinary Incontinence", "Urinary Incontinence, Stress"]}}', 'conditions': '[{"condition": "Urinary Incontinence, Stress"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Female\\n\\n - Stress urinary incontinence\\n\\n Exclusion Criteria:\\n\\n - Bladder outflow obstruction\\n\\n - Neurological disease"}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "65 Years", "healthy_volunteers": "No"}}', 'enrollment': u'18', 'firstreceived_date': u'August 29, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "SS-RBX"}}]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061024&StudyName=Evaluation+Of+A+Novel+Methodology+In+The+Assessment+Of+Urethral+Function+Using+SS%2DRBX%2E", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Denmark"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Glostrup", "zip": "2600", "country": "Denmark"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00141128', 'number_of_arms': '', 'number_of_groups': '', 'official_title': u'Measurement Of Urethral Function In Women With Stress Urinary Incontinence - Evaluation Of The Sensitivity Of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine To Detect Pharmacological Augmentation Of Urethral Pressure.', 'org_study_id': u'A6061024', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Denmark: Danish Medicines Agency"}}', 'phase': u'Phase 2', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI."}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'December 2005', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00141128', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:10 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00146315?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=65&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:10 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:10 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:10 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:10 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:10 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00146315?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=65&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Control", "arm_group_type": "Active Comparator", "description": "Secondary prevention program for coronary heart disease"}}, {"arm_group": {"arm_group_label": "Supervised exercise", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n In Spain, family physician are currently recommended to prescribe an unsupervised walking\n program to their coronary heart disease (CHD) patients as a part of their cardiac\n rehabilitation program. However, there are a few family physicians who provide their CHD\n patients with supervised exercise (30 minutes of pedaling on an stationary bicycle at 60-85%\n of the peak heart rate (HR) attained at the maximal or symptom limited treadmill test, 3\n times a week) at their primary care health centers, thinking that these patients improve\n their functional capacity, quality of life, and the control of cardiovascular risk factors,\n more than walking because they can not achieve the ideal exercise intensity for maximal\n benefits by walking. This study has been designed to investigate if CHD patients get more\n health benefits with the supervised exercise program at the health center than with the\n unsupervised walking program.\n ', 'brief_title': u'ESCAP: Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting', 'clinical_results': '{}', 'completion_date': u'June 2010', 'condition_browse': '{"condition_browse": {"mesh_term": ["Coronary Artery Disease", "Coronary Disease", "Heart Diseases", "Myocardial Ischemia"]}}', 'conditions': '[{"condition": "Coronary Heart Disease"}]', 'detailed_description': u'\n In order to obtain the maximal health benefits, CHD patients have to attain an exercise\n intensity between 60 and 85% of the maximal or symptom-limited heart rate (HR). This is not\n currently attained by the patients who are prescribed an unsupervised walking program.\n\n The OBJECTIVE of this randomized clinical trial is to investigate if CHD patients improve\n their functional capacity and quality of life more, and control their cardiovascular risk\n factors better, by coming to their health centers to pedal during 30 minutes on an\n stationary bicycle , 3 or more times a week, with a HR monitor which makes sure that they\n attain HRs within the prescribed interval, and supervised by health personal, than by\n walking without supervision. For that purpose, low risk CHD patients from 11 Spanish health\n centers will be randomly assigned to a supervised exercise group (ESCAP) or to another\n unsupervised walking group (control). Both groups will be also provided with health\n education and the corresponding treatment for cardiovascular risk factor control and\n complication prevention by their family physicians. The average changes observed in the two\n groups will be compared, on the basis of intention to treat through analysis of covariance.\n We will use mixed-effect models to take into account intra-patients and intra-center\n correlation.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Coronary heart disease low risk patients\\n\\n - Under 80 years old\\n\\n Exclusion Criteria:\\n\\n - 80 years of age and over\\n\\n - Patients included in cardiac rehabilitation programs\\n\\n - Moderate and high risk patients\\n\\n - Patients with handicaps for exercising\\n\\n - Patients unable to attend the supervised exercise sessions\\n\\n - Unstable angina\\n\\n - Uncontrolled atrial ventricular arrhythmias\\n\\n - Third degree AV block (without pacemaker)\\n\\n - Uncompensated congestive heart failure\\n\\n - Severe aortic stenosis\\n\\n - Suspected or known dissecting aneurysm\\n\\n - Active myocarditis or pericarditis\\n\\n - Thrombophlebitis\\n\\n - Recent embolism\\n\\n - Acute systemic illness or fever\\n\\n - Significant emotional distress (psychosis)\\n\\n - Orthostatic blood pressure drop of >20 mm Hg with symptoms\\n\\n - Uncontrolled sinus tachycardia\\n\\n - Resting ST segment displacement (>2 mm)\\n\\n - Uncontrolled diabetes (resting blood glucose >400 mg/dl)\\n\\n - Other metabolic problems such as acute thyroiditis, hypo or hyperkalemia,\\n hypovolemia, etc.\\n\\n - Resting SBP>200 mm Hg or resting DBP>110 mm Hg"}, "gender": "Both", "minimum_age": "20 Years", "maximum_age": "79 Years", "healthy_volunteers": "No"}}', 'enrollment': u'97', 'firstreceived_date': u'September 6, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "Supervised exercise on a stationary bicycle, 3-5 days a week", "description": "Supervised exercise on a stationary bicycle, 3-5 days a week, plus a secondary prevention program for coronary heart disease", "arm_group_label": "Supervised exercise"}}, {"intervention": {"intervention_type": "Behavioral", "intervention_name": "Secondary prevention program for coronary heart disease", "description": "Secondary prevention program for coronary heart disease", "arm_group_label": "Control"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Primary Health Care"}, {"keyword": "Family Practice"}, {"keyword": "Family Physician"}, {"keyword": "Exercise"}, {"keyword": "Coronary Heart Disease"}, {"keyword": "Randomized Controlled Trials"}, {"keyword": "Multicenter Studies"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "http://uiapb.rediapp.net/", "description": "Primary Care Research Unit of Bizkaia (Basque Health Service)"}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Spain"}]', 'locations': '[{"location": {"facility": {"name": "Primary Care Research Unit of Bizkaia (Basque Health Service)", "address": {"city": "Bilbao", "state": "Bizkaia", "zip": "48014", "country": "Spain"}}}}, {"location": {"facility": {"name": "Santa Barbara primary care center (Castilla La Mancha Health Service)", "address": {"city": "Toledo", "zip": "45007", "country": "Spain"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00146315', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Effectiveness of the Supervised Exercise for Patients With Coronary Heart Disease in the Primary Care Setting (ESCAP): a Randomized Clinical Trial', 'org_study_id': u'ESCAP-G03/170-200311075', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Ricardo Ortega, Dr.", "role": "Principal Investigator", "affiliation": "Santa Barbara primary care center (Castilla La Mancha Health Service)"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Spain: Ministry of Health", "has_dmc": "No"}}', 'phase': u'Phase 3', 'primary_completion_date': u'June 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Functional capacity (exercise treadmill test)", "time_frame": "6 months follow-up", "safety_issue": "No"}}]', 'reference': '[{"reference": {"citation": "Ortega S\\u00e1nchez-Pinilla R. [Differences in intensity of effort between supervised and non-supervised exercise of patients with ischaemic cardiopathy]. Aten Primaria. 2004 Sep 30;34(5):265-6. Spanish.", "PMID": "15456577"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Ricardo Ortega", "organization": "Castilla La Mancha Health Service"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Health Related Quality of life (SF-36)", "time_frame": "6 months follow-up", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Cardiovascular risk factor control", "time_frame": "6 months follow-up", "safety_issue": "Yes"}}]', 'source': u'Basque Health Service', 'sponsors': '[{"lead_sponsor": {"agency": "Basque Health Service", "agency_class": "Other"}}, {"collaborator": {"agency": "Preventive Services and Health Promotion Research Network", "agency_class": "Other"}}, {"collaborator": {"agency": "Santa B\\u00e1rbara and Cuenca primary care centers(Castilla La Mancha Health Service)", "agency_class": "Other"}}, {"collaborator": {"agency": "Castilla-Le\\u00f3n Health Service", "agency_class": "Other"}}, {"collaborator": {"agency": "Dalt Sant Joan primary care center (Balears Islans Health Service)", "agency_class": "Other"}}, {"collaborator": {"agency": "Public Health Service of Catalu\\u00f1a", "agency_class": "Other"}}, {"collaborator": {"agency": "Public Health Service of Madrid", "agency_class": "Other"}}, {"collaborator": {"agency": "Public Health Service of Galicia", "agency_class": "Other"}}, {"collaborator": {"agency": "Cantabria Health Service", "agency_class": "Other"}}]', 'start_date': u'January 2005', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00146315', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:11 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00186472?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=64&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:11 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:11 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:11 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:11 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:11 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00186472?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=64&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n Infants born premature face numerous medical problems, causing significant anxiety for their\n parents. Parents experience a range of negative emotions including concern for the health\n and well being of their fragile infant, guilt, and disappointment. Research has indicated\n that having an infant in the Neonatal Intensive Care Unit (NICU) is highly stressful for\n parents and multiple studies have demonstrated that parents can develop significant\n psychological reactions to this experience. Specifically, many parents develop clinically\n significant anxiety disorders such as acute stress disorder (ASD) and posttraumatic stress\n disorder (PTSD). This not only impacts the mental well-being of the parents, but also can\n lead to problems with the parent-infant relationship, and, in turn, negatively impact the\n infant and the family as a whole. Despite the reported negative effects parents experience\n due to the stress of having an infant on the NICU, surprisingly little research has examined\n how to reduce parents' symptoms of anxiety. Because parents play an essential role in the\n care of their infant after discharge from the NICU, treating the parent's emotional distress\n is highly important. The purpose of this study is to examine the efficacy of a\n cognitive-behaviorally based intervention in reducing parents' symptoms of anxiety\n associated with having an infant on the NICU. This treatment is modeled after treatments\n that have proven effective with parents of children with other types of medical problems,\n for example, parents of children with cancer. It is the hope of the investigators that this\n intervention will effectively reduce symptoms of anxiety of NICU parents as well as the\n likelihood of developing subsequent psychological disorders.\n ", 'brief_title': u'Intervention to Decrease Anxiety in Parents of Infants in the Neonatal Intensive Care Unit (NICU)', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": ["Stress Disorders, Post-Traumatic", "Stress Disorders, Traumatic", "Stress Disorders, Traumatic, Acute"]}}', 'conditions': '[{"condition": "Anxiety"}, {"condition": "Acute Stress Disorder"}, {"condition": "Posttraumatic Stress Disorder"}, {"condition": "Depression"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n 1. 18 years of age or older;\\n\\n 2. Participants speak either English or Spanish;\\n\\n 3. The participant\'s infant is expected to live;\\n\\n 4. The participant\'s infant was born at Lucile Packard Children\'s Hospital or\\n transferred to the hospital within 72 hours;\\n\\n 5. Participant\'s infant is over 1000 grams\\n\\n Exclusion Criteria:\\n\\n 1. Individuals under 18 years of age;\\n\\n 2. Individuals who do not speak either English or Spanish;\\n\\n 3. Individuals whose infant was not born at or transferred to (within 72 hours of The\\n infant\'s birth) Lucile Packard Children\'s Hospital;\\n\\n 4. Individuals whose infant has a life threatening condition and is not expected to\\n survive;\\n\\n 5. Current drug abuse/dependence"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A"}}', 'enrollment': '', 'firstreceived_date': u'September 13, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "Brief Cognitive Behavioral Treatment"}}]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Stanford University", "address": {"city": "Stanford", "state": "California", "zip": "94305", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00186472', 'number_of_arms': '', 'number_of_groups': '', 'official_title': '', 'org_study_id': u'NIH 5 T 32 MH19908-7', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Rebecca S Bernard, Ph.D.", "role": "Principal Investigator", "affiliation": "Stanford University"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Richard Shaw, M.D.", "organization": "Stanford University School of Medicine"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Stanford University', 'sponsors': '[{"lead_sponsor": {"agency": "Stanford University", "agency_class": "Other"}}]', 'start_date': '', 'study_design': u'Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00186472', 'verification_date': u'December 2006', 'why_stopped': ''} 2015-10-09 20:53:13 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00259636?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=63&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:13 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:13 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00259636?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=63&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Patients with fibromyalgia & migraine are randomized to receive zonisamide or placebo.\n ', 'brief_title': u'Zonisamide for Fibromyalgia & Migraine', 'clinical_results': '{}', 'completion_date': u'January 2008', 'condition_browse': '{"condition_browse": {"mesh_term": ["Fibromyalgia", "Migraine Disorders", "Myofascial Pain Syndromes"]}}', 'conditions': '[{"condition": "Fibromyalgia"}, {"condition": "Migraine"}]', 'detailed_description': u'\n Study was not conducted due to logistical problems\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - 18-65 with fibromyalgia & migraine\\n\\n Exclusion Criteria:\\n\\n - allergy sulfa, liver or kidney disease, pregnant or not using contraception"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "65 Years", "healthy_volunteers": "No"}}', 'enrollment': u'0', 'firstreceived_date': u'November 26, 2005', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Zonisamide"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "zonisamide", "description": "zonisamide 100 mg -300 mg daily vs placebo"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "University of Pittsburgh", "address": {"city": "Pittsburgh", "state": "Pennsylvania", "zip": "15206", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00259636', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Zonisamide for Fibromyalgia & Migraine', 'org_study_id': u'EISAI 51-345-749', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Dawn Marcus, MD", "role": "Principal Investigator", "affiliation": "University of Pittsburgh"}}', 'overall_status': u'Withdrawn', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 4', 'primary_completion_date': u'January 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "Visual analogue score", "time_frame": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment", "safety_issue": "No", "description": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment"}}, {"primary_outcome": {"measure": "Tender point count", "time_frame": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment", "safety_issue": "No", "description": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment"}}, {"primary_outcome": {"measure": "Headache index", "time_frame": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment", "safety_issue": "No", "description": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dawn Marcus", "organization": "University of Pittsburgh"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Sleep efficiency", "time_frame": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment", "safety_issue": "No", "description": "assessment measures at study enrollment (pre-treatment), and after 2, 4, and 8 weeks of treatment"}}]', 'source': u'University of Pittsburgh', 'sponsors': '[{"lead_sponsor": {"agency": "University of Pittsburgh", "agency_class": "Other"}}, {"collaborator": {"agency": "Eisai Inc.", "agency_class": "Industry"}}]', 'start_date': u'August 2004', 'study_design': u'Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00259636', 'verification_date': u'May 2011', 'why_stopped': u'\n Logistical problems prevented enrollment\n '} 2015-10-09 20:53:13 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00272753?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=62&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:13 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: responsible_party: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:13 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:13 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00272753?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=62&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The aim is to study whether the bude sonide component within the budesonide/ formoterol\n combination inhaler has additive value in a model of "slow onset acute asthma" , namely\n three AMP provocation tests performed on one day\n ', 'brief_title': u'Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations', 'clinical_results': '{}', 'completion_date': u'November 2005', 'condition_browse': '{}', 'conditions': '[{"condition": "Asthma"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - asthma diagnosis according to ATS criteria,\\n\\n - lung function (FEV1) above 60% of predicted,\\n\\n - AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation\\n test\\n\\n Exclusion Criteria:\\n\\n - having smoked > 10 Pack-years,\\n\\n - hypersensitivity to one of the study drugs,\\n\\n - significant co-morbidity, pregnancy or lactating"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "55 Years", "healthy_volunteers": "No"}}', 'enrollment': u'20', 'firstreceived_date': u'January 4, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Albuterol", "Budesonide", "Formoterol", "Symbicort"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "budesonide/formoterol Turbuhaler", "other_name": "Symbicort"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "formoterol Turbuhaler"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "salbutamol"}}]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Netherlands"}]', 'locations': '[{"location": {"facility": {"name": "Research Site", "address": {"city": "Amsterdam", "country": "Netherlands"}}}}, {"location": {"facility": {"name": "Research Site", "address": {"city": "Groningen", "country": "Netherlands"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00272753', 'number_of_arms': '', 'number_of_groups': '', 'official_title': u'A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma', 'org_study_id': u'BN-00S-0022', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "AstraZeneca Netherlands Medical Director, MD", "role": "Study Director", "affiliation": "AstraZeneca"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)", "has_dmc": "No"}}', 'phase': u'Phase 4', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "The decrease in lung function (FEV1) after the third AMP provocation test."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Decrease in lung function (FEV1) after the second AMP provocation test,"}}, {"secondary_outcome": {"measure": "lung function and Borg Score over the test day,"}}, {"secondary_outcome": {"measure": "increase in FEV1 at three minutes after study drug inhalation,"}}, {"secondary_outcome": {"measure": "time course of recovery from the AMP-induced decrease in lung function"}}]', 'source': u'AstraZeneca', 'sponsors': '[{"lead_sponsor": {"agency": "AstraZeneca", "agency_class": "Industry"}}]', 'start_date': u'April 2004', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00272753', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:15 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:16 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=1> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=4) 2015-10-09 20:53:17 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00642603?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=47&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:17 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:17 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:17 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00642603?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=47&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "XELOX + bevacizumab (Q2W)", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "XELIRI + bevacizumab (Q2W)", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of\n Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12\n cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were\n randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and\n oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to\n receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment\n was until disease progression, and the target sample size was 100-500 individuals.\n ', 'brief_title': u'A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer', 'clinical_results': '{"clinical_results": {"participant_flow": {"group_list": {"group": [{"@group_id": "P1", "title": "XELOX + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}, {"@group_id": "P2", "title": "XELIRI + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}]}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "21"}, {"@group_id": "P2", "@count": "20"}]}}, {"title": "Safety Population", "participants_list": {"participants": [{"@group_id": "P1", "@count": "19"}, {"@group_id": "P2", "@count": "20"}]}}, {"title": "COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "0"}, {"@group_id": "P2", "@count": "2"}]}}, {"title": "NOT COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "21"}, {"@group_id": "P2", "@count": "18"}]}}]}}}}, "baseline": {"group_list": {"group": [{"@group_id": "B1", "title": "XELOX + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}, {"@group_id": "B2", "title": "XELIRI + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}, {"@group_id": "B3", "title": "Total", "description": "Total of all reporting groups"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "21"}, {"@group_id": "B2", "@value": "20"}, {"@group_id": "B3", "@value": "41"}]}}}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "63.9", "@spread": "12.06"}, {"@group_id": "B2", "@value": "60.6", "@spread": "9.89"}, {"@group_id": "B3", "@value": "62.3", "@spread": "11.04"}]}}}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "8"}, {"@group_id": "B2", "@value": "7"}, {"@group_id": "B3", "@value": "15"}]}}, {"sub_title": "Male", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "13"}, {"@group_id": "B2", "@value": "13"}, {"@group_id": "B3", "@value": "26"}]}}]}}]}}, "outcome_list": {"outcome": {"type": "Primary", "title": "Progression-free Survival (PFS) in U.S. Patients Only", "description": "PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.", "time_frame": "From first patient enrolled up to approximately 48 months", "safety_issue": "No", "population": "This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.", "group_list": {"group": [{"@group_id": "O1", "title": "XELOX + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}, {"@group_id": "O2", "title": "XELIRI + Bevacizumab (Q2W)", "description": "Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "0"}, {"@group_id": "O2", "@value": "0"}]}}}}, {"title": "Progression-free Survival (PFS) in U.S. Patients Only", "description": "PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.", "units": "months", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1"}, {"@group_id": "O2"}]}}}}]}}}, "reported_events": {"desc": "Safety analysis population = received at least one dose of study medication. 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"event_list": {"event": {"sub_title": "Rhabdomyolysis", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}}}, {"title": "Nervous system disorders", "event_list": {"event": {"sub_title": "Lacunar Infarction", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": {"sub_title": "Pulmonary Embolism", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}}}, {"title": "Skin and subcutaneous tissue disorders", "event_list": {"event": {"sub_title": "Angioedema", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", 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"@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Abscess Intestinal", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Clostridial Infection", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Clostridium Bacteraemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Escherichia Bacteraemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Gastrointestinal Infection", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Urinary Tract Infection", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Viral Infection", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Vulvovaginal Mycotic Infection", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}, {"title": "Investigations", "event_list": {"event": [{"sub_title": "Weight Decreased", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Blood Creatinine Increased", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Sputum Abnormal", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "X-ray Abnormal", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": [{"sub_title": "Dehydration", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "4", "@subjects_at_risk": "20"}]}, {"sub_title": "Anorexia", "counts": [{"@group_id": "E1", "@subjects_affected": "5", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Hypokalaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "3", "@subjects_at_risk": "20"}]}, {"sub_title": "Decreased Appetite", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Hyponatraemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Hypoalbuminaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Food Intolerance", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Hyperglycaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Hypoglycaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Hypomagnesaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}]}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": [{"sub_title": "Arthralgia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Musculoskeletal Pain", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Back Pain", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Muscle Spasms", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Musculoskeletal Stiffness", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Neck Pain", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Pain In Extremity", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": 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"@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}]}}, {"title": "Psychiatric disorders", "event_list": {"event": [{"sub_title": "Depression", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Insomnia", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Anxiety", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}, {"title": "Renal and urinary disorders", "event_list": {"event": [{"sub_title": "Haematuria", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Proteinuria", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}]}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Epistaxis", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "3", "@subjects_at_risk": "20"}]}, {"sub_title": "Cough", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Dyspnoea", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Dyspnoea Exertional", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Hiccups", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Dysaesthesia Pharynx", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Nasal Congestion", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Oropharyngeal Pain", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Respiratory Tract Congestion", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}, {"title": "Skin and subcutaneous tissue disorders", "event_list": {"event": [{"sub_title": "Palmar-Plantar Erythrodysaesthesia Syndrome", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Rash", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}, {"sub_title": "Alopecia", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Pruritus", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Dry Skin", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Livedo Reticularis", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Nail Disorder", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Night Sweats", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}, {"sub_title": "Urticaria", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}, {"title": "Surgical and medical procedures", "event_list": {"event": {"sub_title": "Tooth Extraction", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "20"}]}}}, {"title": "Vascular disorders", "event_list": {"event": [{"sub_title": "Hypertension", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "20"}]}, {"sub_title": "Flushing", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "19"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "20"}]}]}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor\'s intellectual property rights."}, "limitations_and_caveats": "This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.", "point_of_contact": {"name_or_title": "Medical Communications", "organization": "Genentech, Inc.", "phone": "800-821-8590"}}}', 'completion_date': u'September 2012', 'condition_browse': '{"condition_browse": {"mesh_term": "Colorectal Neoplasms"}}', 'conditions': '[{"condition": "Colorectal Cancer"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Adult patients, \\u226518 years of age\\n\\n - Histologically confirmed adenocarcinoma of colon or rectum, with unresectable\\n metastatic or locally advanced disease\\n\\n - \\u22651 measurable target lesion\\n\\n - Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of\\n \\u22641\\n\\n Exclusion Criteria:\\n\\n - Prior systemic therapy for advanced or metastatic disease\\n\\n - History of another malignancy within last 5 years, except cured basal cell cancer of\\n skin or cured cancer in situ of the cervix\\n\\n - Clinically significant cardiovascular disease\\n\\n - Current or recent use of full dose oral warfarin or full dose parenteral\\n anticoagulants or thrombolytic agents\\n\\n - Chronic daily treatment with >325 mg/day aspirin"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'41', 'firstreceived_date': u'March 19, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Bevacizumab", "Capecitabine", "Fluorouracil", "Irinotecan", "Oxaliplatin"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "capecitabine [Xeloda]", "description": "1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle", "arm_group_label": "XELOX + bevacizumab (Q2W)"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "capecitabine [Xeloda]", 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{"facility": {"address": {"city": "Round Rock", "state": "Texas", "zip": "78681", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "San Antonio", "state": "Texas", "zip": "78229", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Southlake", "state": "Texas", "zip": "76092", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Sugarland", "state": "Texas", "zip": "77479", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Waco", "state": "Texas", "zip": "76712", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Webster", "state": "Texas", "zip": "77598-4420", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Salt Lake City", "state": "Utah", "zip": "84106", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Christiansburg", "state": "Virginia", "zip": "24073", "country": "United 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{"measure": "Progression-free Survival (PFS) in U.S. Patients Only", "time_frame": "From first patient enrolled up to approximately 48 months", "safety_issue": "No", "description": "PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause."}}]', 'reference': '[]', 'removed_countries': '[{"country": "Canada"}]', 'responsible_party': '{"responsible_party": {"name_title": "Disclosures Group", "organization": "Hoffmann-La Roche"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Hoffmann-La Roche', 'sponsors': '[{"lead_sponsor": {"agency": "Hoffmann-La Roche", "agency_class": "Industry"}}]', 'start_date': u'May 2008', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00642603', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:18 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00700804?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=46&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:18 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:18 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:18 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:18 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00700804?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=46&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "High Calcium Diet", "arm_group_type": "Experimental"}}, {"arm_group": {"arm_group_label": "Low Calcium Diet", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The primary objective is to determine whether meat interacts positively with calcium to\n improve calcium retention. The secondary objective is to determine whether any interaction\n between dietary protein and calcium affects biomarkers of bone metabolism.\n ', 'brief_title': u'Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?', 'clinical_results': '{"clinical_results": {"participant_flow": {"recruitment_details": "Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks", "pre_assignment_details": "Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.", "group_list": {"group": [{"@group_id": "P1", "title": "High Calcium Diet", "description": "Women consumed diets containing 1500 milligrams of calcium daily"}, {"@group_id": "P2", "title": "Low Calcium Diet", "description": "Women consumed diets containing 600 milligrams of calcium daily"}]}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "17"}, {"@group_id": "P2", "@count": "17"}]}}, {"title": "COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "14"}, {"@group_id": "P2", "@count": "13"}]}}, {"title": "NOT COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "3"}, {"@group_id": "P2", "@count": "4"}]}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Withdrawal by Subject", "participants_list": {"participants": [{"@group_id": "P1", "@count": "1"}, {"@group_id": "P2", "@count": "2"}]}}, {"title": "Protocol Violation", "participants_list": {"participants": [{"@group_id": "P1", "@count": "1"}, {"@group_id": "P2", "@count": "1"}]}}, {"title": "Loose Stools", "participants_list": {"participants": [{"@group_id": "P1", "@count": "1"}, {"@group_id": "P2", "@count": "1"}]}}]}}}}, "baseline": {"group_list": {"group": [{"@group_id": "B1", "title": "High Calcium Diet", "description": "Women consumed diets containing 1500 milligrams of calcium daily"}, {"@group_id": "B2", "title": "Low Calcium Diet", "description": "Women consumed diets containing 600 milligrams of calcium daily"}, {"@group_id": "B3", "title": "Total", "description": "Total of all reporting groups"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "17"}, {"@group_id": "B2", "@value": "17"}, {"@group_id": "B3", "@value": "34"}]}}}}, {"title": "Age", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "<=18 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "0"}, {"@group_id": "B2", "@value": "0"}, {"@group_id": "B3", "@value": "0.0"}]}}, {"sub_title": "Between 18 and 65 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "16"}, {"@group_id": "B2", "@value": "14"}, {"@group_id": "B3", "@value": "30.0"}]}}, {"sub_title": ">=65 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "1"}, {"@group_id": "B2", "@value": "3"}, {"@group_id": "B3", "@value": "4.0"}]}}]}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "57", "@spread": "5"}, {"@group_id": "B2", "@value": "58", "@spread": "6"}, {"@group_id": "B3", "@value": "57", "@spread": "5"}]}}}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "17"}, {"@group_id": "B2", "@value": "17"}, {"@group_id": "B3", "@value": "34.0"}]}}, {"sub_title": "Male", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "0"}, {"@group_id": "B2", "@value": "0"}, {"@group_id": "B3", "@value": "0.0"}]}}]}}]}}, "outcome_list": {"outcome": [{"type": "Secondary", "title": "Serum Insulin-like Growth Factor 1 (IGF-1)", "time_frame": "7 weeks", "safety_issue": "No", "group_list": {"group": [{"@group_id": "O1", "title": "High Calcium Diet", "description": "Women consumed diets containing 1500 milligrams of calcium daily"}, {"@group_id": "O2", "title": "Low Calcium Diet", "description": "Women consumed diets containing 600 milligrams of calcium daily"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "14"}, {"@group_id": "O2", "@value": "13"}]}}}}, {"title": "Serum Insulin-like Growth Factor 1 (IGF-1)", "units": "nanomoles per liter (nmols/L)", "param": "Geometric Mean", "dispersion": "Standard Error", "category_list": {"category": [{"sub_title": "High Protein Diet", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "5.23", "@spread": "0.12"}, {"@group_id": "O2", "@value": "5.07", "@spread": "0.12"}]}}, {"sub_title": "Low Protein Diet", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "4.96", "@spread": "0.12"}, {"@group_id": "O2", "@value": "4.87", "@spread": "0.12"}]}}]}}]}}, {"type": "Primary", "title": "Calcium Absorption", "description": "Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time", "time_frame": "17 weeks", "safety_issue": "No", "population": "Only participants which completed both protein diet periods were included in the statistical analysis", "group_list": {"group": [{"@group_id": "O1", "title": "High Calcium Diet", "description": "Women consumed diets containing 1500 milligrams of calcium daily"}, {"@group_id": "O2", "title": "Low Calcium Diet", "description": "Women consumed diets containing 600 milligrams of calcium daily"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "14"}, {"@group_id": "O2", "@value": "13"}]}}}}, {"title": "Calcium Absorption", "description": "Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time", "units": "percentage of Calcium absorbed", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": [{"sub_title": "High Protein Diet", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "18.1", "@spread": "2.5"}, {"@group_id": "O2", "@value": "29.5", "@spread": "2.5"}]}}, {"sub_title": "Low Protein Diet", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "18.0", "@spread": "2.5"}, {"@group_id": "O2", "@value": "26", "@spread": "2.5"}]}}]}}]}, "analysis_list": {"analysis": {"group_id_list": {"group_id": ["O1", "O2"]}, "non_inferiority": "No", "p_value": "0.05", "method": "Mixed Models Analysis", "method_desc": "Effects of calcium (Ca), protein & their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)", "param_type": "Mean Difference (Final Values)", "param_value": "9.7", "dispersion_type": "Standard Deviation", "dispersion_value": "2.5", "estimate_desc": "Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant."}}}]}, "certain_agreements": {"pi_employee": "All Principal Investigators ARE employed by the organization sponsoring the study.", "restrictive_agreement": "There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI\'s rights to discuss or publish trial results after the trial is completed."}, "point_of_contact": {"name_or_title": "Janet Hunt, PhD", "organization": "United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center", "phone": "701-795-8353", "email": "janetrhunt@gmail.com"}}}', 'completion_date': u'January 2005', 'condition_browse': '{}', 'conditions': '[{"condition": "Dietary Proteins"}]', 'detailed_description': u'\n This study tests the effects of dietary protein and calcium on calcium retention and indices\n of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2\n Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass\n Index (weight in kilograms divided by height in meters squared)and randomly assigned to a\n high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group,\n and consume both low protein (LP,10% protein) and high protein (HP, 2 0% protein) diets for 7\n weeks each. There is a 3-week "washout" between dietary periods, during which the subjects\n consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating\n menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for\n 28 days by whole body scintillation counting. In addition to Calcium retention, other\n endpoints include urinary indices of acid excretion and urine serum indices of bone\n resorption.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - at least 3 years since last menses\\n\\n - bone mineral density equal to or greater than 2.5 standard deviations from average\\n bone mineral density for young adults,\\n\\n - body mass index equal to or less than 35 kilograms/meter squared\\n\\n Exclusion Criteria:\\n\\n - taking prescription medication other than hormone replacement therapy"}, "gender": "Female", "minimum_age": "50 Years", "maximum_age": "80 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'34', 'firstreceived_date': u'June 18, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Calcium, Dietary"}}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "High Protein Diet", "description": "High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm", "arm_group_label": "High Calcium Diet"}}, {"intervention": {"intervention_type": "Behavioral", "intervention_name": "Low Protein Diet", "description": "High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm", "arm_group_label": "Low Calcium Diet"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "Calcium retention"}, {"keyword": "dietary protein"}, {"keyword": "dietary calcium"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center", "address": {"city": "Grand Forks", "state": "North Dakota", "zip": "58202", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00700804', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?', 'org_study_id': u'GFHNRC064', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Janet R Hunt, PhD", "role": "Principal Investigator", "affiliation": "USDA Grand Forks Human Nutrition Research Center"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["United States: Federal Government", "United States: Institutional Review Board", "United States: Food and Drug Administration"], "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'July 2004', 'primary_outcomes': '[{"primary_outcome": {"measure": "Calcium Absorption", "time_frame": "17 weeks", "safety_issue": "No", "description": "Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Janet R Hunt, PhD, Research Nutritionist", "organization": "United States Department of Agriculture (USDA) Grand Forks Human Nutriton Research Center"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "IRB-200307-010"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Serum Insulin-like Growth Factor 1 (IGF-1)", "time_frame": "7 weeks", "safety_issue": "No"}}]', 'source': u'USDA Grand Forks Human Nutrition Research Center', 'sponsors': '[{"lead_sponsor": {"agency": "USDA Beltsville Human Nutrition Research Center", "agency_class": "U.S. Fed"}}, {"collaborator": {"agency": "National Cattlemen\'s Beef Association", "agency_class": "Other"}}]', 'start_date': u'June 2003', 'study_design': u'Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00700804', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:18 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00709839?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=45&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:19 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:19 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:19 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:19 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:19 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00709839?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=45&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to investigate the effect of hydrocortisone on glucose-induced\n insulin secretion and sensitivity, by means of an intravenous glucose tolerance test with\n frequent sampling (FSIGT) followed by minimal model analysis. In a randomized single-blind\n cross-over design, the subjects will receive either hydrocortisone or placebo 4 minutes\n before an intravenous glucose load.\n ', 'brief_title': u'Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans', 'clinical_results': '{}', 'completion_date': u'December 2008', 'condition_browse': '{}', 'conditions': '[{"condition": "Healthy"}]', 'detailed_description': u'\n Glucocorticoids (mainly cortisol in men and corticosterone in rodents) are secreted in the\n adrenal cortex under the control of the hypothalamic-pituitary-adrenal (HPA) axis. They are\n known for and named after their combined actions on glucose metabolism: suppression of\n insulin secretion, inhibition of glucose uptake in peripheral tissues, and promotion of\n gluconeogenesis in the liver. As a result, glucose intolerance accompanies syndromes of\n cortisol excess, while recurrent hypoglycemia, especially in response to stress, is a\n typical feature of isolated familial glucocorticoid deficiency. Almost any acute severe\n challenge to homeostasis or stress will activate the hypothalamic-pituitary-adrenal (HPA)\n axis and cause a rise in plasma glucocorticoid levels, which is essential for survival.\n Thanks to their immunosuppressive and antiinflammatory actions, glucocorticoids are\n widely-used therapeuticals with important adverse effects.\n\n The need to optimize the benefit-risk ratio of glucocorticoid therapy has lead to a recent\n focus of research in the pathways mediating their effects. Glucocorticoids act rapidly and\n within minutes, exerting effects which contradict the classical genomic signalling pathway.\n Little is known on the clinical rapid effects of glucocorticoids on carbohydrate metabolism.\n Corticosterone acutely lowers insulin plasma concentrations and their response to\n hyperglycemia in rodents in vivo. Intraperitoneally administered hydrocortisone suppresses\n the insulin levels stimulated by intravenous glucose in mice. Although subject to numerous\n studies, the metabolic effects of glucocorticoids have been generally tested after giving\n dexamethasone for a few days.\n\n To our knowledge, there are no data on rapid effects of glucocorticoids on insulin secretion\n and sensitivity in humans. Despite the increased interest in rapid effects of steroids in\n the last decade, the immediate effects of glucocorticoids on carbohydrate metabolism have\n not yet been studied. This question is not easy to address in vivo because of the multiple\n (also compensatory) influences that can impact the endocrine pancreas. Therefore, we propose\n to use a rapid approach, studying the effect of a bolus of hydrocortisone on the response to\n an intravenous glucose tolerance test with frequent sampling (FSIGT).\n\n The FSIGT consists in giving intravenously a glucose bolus and taking frequently blood\n samples afterwards for determining glucose, insulin and C-peptide. The glucose and insulin\n data analysed with the minimal model technique allow the calculation of the acute insulin\n response, glucose effectiveness and the insulin sensitivity index. The data on C-peptide\n will be used to evaluate the beta cell function.\n\n The effects of Hydrocortisone on glucose-induced insulin secretion and sensitivity will be\n investigated by means of an FSIGT followed by minimal model analysis. The subjects will\n receive in a randomized single-blind cross-over design:\n\n 1. 0.6 mg/kg body wt Hydrocortisone + 330 mg/kg body wt glucose\n\n 2. Placebo + 330 mg/kg body wt glucose\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy subjects\\n\\n - No concomitant medication\\n\\n - BMI < 25 kg/m2\\n\\n - Age: 18-60 years old\\n\\n Exclusion Criteria:\\n\\n - Impaired glucose tolerance or diabetes mellitus\\n\\n - Hyperthyroidism, hypothyroidism\\n\\n - Hepatic, renal or cardiovascular diseases\\n\\n - Malignancies\\n\\n - History of medical therapy within 3 weeks prior to enrolment into the study"}, "gender": "Male", "minimum_age": "18 Years", "maximum_age": "60 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'10', 'firstreceived_date': u'July 1, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Cortisol succinate", "Hydrocortisone", "Hydrocortisone 17-butyrate 21-propionate", "Hydrocortisone acetate", "Hydrocortisone-17-butyrate"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Hydrocortisone", "description": "0.6 mg/kg body weight, intravenous bolus given at time-point minus 4\'"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Glucose 33%", "description": "1ml/kg body weight, intravenous bolus given at time-point 0\'"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "glucocorticoid"}, {"keyword": "hydrocortisone"}, {"keyword": "carbohydrate metabolism"}, {"keyword": "appetite-regulatory hormones"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Austria"}]', 'locations': '[{"location": {"facility": {"name": "Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna", "address": {"city": "Vienna", "zip": "A-1090", "country": "Austria"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00709839', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Rapid Effects of Hydrocortisone on Glucose-induced Insulin Secretion in Healthy Humans', 'org_study_id': u'FSIGT_Hydrocortisone_01', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Anton Luger, MD", "role": "Principal Investigator", "affiliation": "Medical University of Vienna"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Austria: Ethikkommission", "has_dmc": "No"}}', 'phase': u'Phase 4', 'primary_completion_date': u'October 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "Plasma insulin, glucose and C-peptide", "time_frame": "Minutes: -10, -5, 0, 3, 4, 5, 6, 8, 10, 15, 20, 30, 40, 60, 80, 100, 120, 150, 180", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Prof. Dr. Anton Luger", "organization": "Department of Medicine III, Medical University of Vienna"}}', 'results_reference': '[{"results_reference": {"citation": "Vila G, Krebs M, Riedl M, Baumgartner-Parzer SM, Clodi M, Maier C, Pacini G, Luger A. Acute effects of hydrocortisone on the metabolic response to a glucose load: increase in the first-phase insulin secretion. Eur J Endocrinol. 2010 Aug;163(2):225-31. doi: 10.1530/EJE-10-0282. Epub 2010 May 18.", "PMID": "20484150"}}]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Plasma levels of appetite-regulatory hormones: ghrelin, PYY and nesfatin-1.", "time_frame": "Minutes: -10, 0, 30, 60, 120, 180", "safety_issue": "No"}}]', 'source': u'Medical University of Vienna', 'sponsors': '[{"lead_sponsor": {"agency": "Medical University of Vienna", "agency_class": "Other"}}]', 'start_date': u'June 2008', 'study_design': u'Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00709839', 'verification_date': u'January 2009', 'why_stopped': ''} 2015-10-09 20:53:20 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00754221?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=44&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:20 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:20 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:20 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:20 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00754221?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=44&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "arm_group_type": "Experimental"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in\n relieving the symptoms of Fibromyalgia in patients.\n ', 'brief_title': u'Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia', 'clinical_results': '{}', 'completion_date': u'May 2009', 'condition_browse': '{"condition_browse": {"mesh_term": ["Fibromyalgia", "Myofascial Pain Syndromes"]}}', 'conditions': '[{"condition": "Fibromyalgia"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Male or female of any race, at least 18 years of age\\n\\n - Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for\\n at least 3 months, and pain in at least 11 of 18 specific tender point sites)\\n\\n - Completed preceding double-blind randomized, controlled trial\\n\\n Exclusion Criteria:\\n\\n - Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic\\n Neuralgia) that may confound assessment or self evaluation of the pain associated\\n with fibromyalgia\\n\\n - Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other\\n than fibromyalgia), active infection, or untreated endocrine disorder\\n\\n - A current or recent diagnosis (last 6 months) or episode of major depressive\\n disorder, dysthymia and/or uncontrolled depression\\n\\n - History of mania, hypomania, other psychotic disorder, or current mood disorder with\\n psychotic features"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'390', 'firstreceived_date': u'September 16, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Reboxetine"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "[S,S]-Reboxetine", "description": "Once a day, oral treatment, of 4, 6, 8 or 10 mg", "arm_group_label": "1"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "Phase 3, safety study, [S,S]-Reboxetine, Fibromyalgia"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061053&StudyName=Open%20label%20extension%20study%20of%20%5BS%2CS%5D-Reboxetine%20in%20patients%20with%20fibromyalgia", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Canada"}, {"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Birmingham", "state": "Alabama", "zip": "35242", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Phoenix", "state": "Arizona", "zip": "85023", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Tucson", "state": "Arizona", "zip": "85741", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Elk Grove", "state": "California", "zip": "95758", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Fullerton", "state": "California", "zip": "92835", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Lafayette", "state": "California", "zip": "94549", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Northridge", "state": "California", "zip": "91325", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Oceanside", "state": "California", "zip": "92056", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Roseville", "state": "California", "zip": "95661", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Sacramento", "state": "California", "zip": "95816", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "San Jose", "state": "California", "zip": "95124", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Santa Ana", "state": "California", "zip": "92705", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "New London", "state": "Connecticut", "zip": "06320", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Brooksville", "state": "Florida", "zip": "34613", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Jacksonville", "state": "Florida", "zip": "32223", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Jacksonville", "state": "Florida", "zip": "32216", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Ocala", "state": "Florida", "zip": "34471", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Ocala", "state": "Florida", "zip": "34474", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "St. Petersburg", "state": "Florida", "zip": "33709", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Sunrise", "state": "Florida", "zip": "33351", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Tampa", "state": "Florida", "zip": "33614", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Tampa", "state": "Florida", "zip": "33606", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "West Palm Beach", "state": "Florida", "zip": "33407", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Winter Haven", "state": "Florida", "zip": "33880", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Atlanta", "state": "Georgia", "zip": "30328", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Gurnee", "state": "Illinois", "zip": "60031", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Moline", "state": "Illinois", "zip": "61265", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Oak Brook", "state": "Illinois", "zip": "60523", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Indianapolis", "state": "Indiana", "zip": "46250", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Indianapolis", "state": "Indiana", "zip": "46260", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Overland Park", "state": "Kansas", "zip": "66215", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Overland Park", "state": "Kansas", "zip": "66212", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Pratt", "state": "Kansas", "zip": "67124", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Louisville", "state": "Kentucky", "zip": "40213", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Madisonville", "state": "Kentucky", "zip": "42431", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Mount Sterling", "state": "Kentucky", "zip": "40353", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Mt. Sterling", "state": "Kentucky", "zip": "40353", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Baton Rouge", "state": "Louisiana", "zip": "70809", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Wheaton", "state": "Maryland", "zip": "20902", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Boston", "state": "Massachusetts", "zip": "02135", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Brockton", "state": "Massachusetts", "zip": "02301", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Fall River", "state": "Massachusetts", "zip": "02720", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "N. 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Director", "affiliation": "Pfizer"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 3', 'primary_completion_date': u'May 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "Vital Signs", "time_frame": "66 weeks", "safety_issue": "Yes"}}, {"primary_outcome": {"measure": "12-Lead ECG", "time_frame": "66 weeks", "safety_issue": "Yes"}}, {"primary_outcome": {"measure": "Hematology & Biochemistry Laboratory Parameters", "time_frame": "66 weeks", "safety_issue": "Yes"}}, {"primary_outcome": {"measure": "Adverse Events", "time_frame": "66 weeks", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Short-Form 36 Health Survey", "time_frame": "66 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Sheehan Disability Scale", "time_frame": "66 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Pain Visual Analogue Scale", "time_frame": "66 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Multidimensional Assessment of Fatigue", "time_frame": "66 weeks", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Fibromyalgia Impact Questionaire", "time_frame": "66 weeks", "safety_issue": "No"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'May 2008', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00754221', 'verification_date': u'May 2011', 'why_stopped': u'\n This study has been terminated early as the esreboxetine development program is being\n discontinued. There are no safety or efficacy concerns.\n '} 2015-10-09 20:53:21 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00754390?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=43&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:21 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:21 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:21 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:21 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00754390?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=43&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Overall Study", "arm_group_type": "Experimental", "description": "Participants consumed 4 experimental diets for 4 weeks each in randomized order"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This study is determine the effects of dietary calcium and phytate on zinc absorption.\n ', 'brief_title': u'Effects of Calcium and Phytate on Zinc Absorption', 'clinical_results': '{"clinical_results": {"participant_flow": {"recruitment_details": "Women were recruited by the United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center to participate in an out-patient feeding study in Grand Forks, North Dakota", "pre_assignment_details": "205 participants applied, 157 were eligible, 27 accepted invitation to attend an information meeting, 10 started study, 7 of the alternates joined study as original participants withdrew or were discharged.", "group_list": {"group": {"@group_id": "P1", "title": "Calcium and Phytate Interactions", "description": "Subjects consumed 4 test meals (Moderate Calcium (Ca),Low Phytate; Moderate Ca,High Phytate; High Ca,Low Phytate; High Ca,High Phytate) in random order"}}, "period_list": {"period": [{"title": "Ca/Phytate Test Meal 1 (Randomized)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "17"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "12"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "5"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Withdrawal by Subject", "participants_list": {"participants": {"@group_id": "P1", "@count": "3"}}}, {"title": "Protocol Violation", "participants_list": {"participants": {"@group_id": "P1", "@count": "2"}}}]}}, {"title": "Ca/Phytate Test Meal 2 (Randomized)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "12"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "12"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "0"}}}]}}, {"title": "Ca/Phytate Test Meal 3 (Randomized)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "12"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "11"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": {"title": "Protocol Violation", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}}}, {"title": "Ca/Phytate Test Meal 4 (Randomized)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "11"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "10"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": {"title": "Protocol Violation", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}}}]}}, "baseline": {"group_list": {"group": {"@group_id": "B1", "title": "Entire Study Population", "description": "Includes all subjects randomized to the 4 treatments. Treatments were assigned in randomized order so the number of subjects starting the study does not equal the starting number for a given treatment"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "17"}}}}}, {"title": "Age", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "<=18 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "0"}}}, {"sub_title": "Between 18 and 65 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "17"}}}, {"sub_title": ">=65 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "0"}}}]}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "32.7", "@spread": "9.5"}}}}}, {"title": "Gender", "units": "Participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "17"}}}, {"sub_title": "Male", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "0"}}}]}}]}}, "outcome_list": {"outcome": {"type": "Primary", "title": "Zinc Absorption", "description": "Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time", "time_frame": "16 weeks", "safety_issue": "No", "population": "Analysis restricted to women who completed all 4 treatment periods", "group_list": {"group": [{"@group_id": "O1", "title": "Moderate Calcium, Low Phytate Diet", "description": "Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 440 milligrams of phytate per day"}, {"@group_id": "O2", "title": "Moderate Calcium, High Phytate Diet", "description": "Two days of radiolabelled diet containing 700 milligrams of Calcium per day and 1800 milligrams of phytate per day"}, {"@group_id": "O3", "title": "High Calcium, Low Phytate Diet", "description": "Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 440 milligrams of phytate per day"}, {"@group_id": "O4", "title": "High Calcium, High Phytate Diet", "description": "Two days of radiolabelled diet containing 1900 milligrams of Calcium per day and 1800 milligrams of phytate per day"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "10"}, {"@group_id": "O2", "@value": "10"}, {"@group_id": "O3", "@value": "10"}, {"@group_id": "O4", "@value": "10"}]}}}}, {"title": "Zinc Absorption", "description": "Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. 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Null Hypothesis: Dietary calcium does not affect zinc absorption", "non_inferiority": "No", "p_value": "0.17", "method": "Mixed Models Analysis"}, {"group_id_list": {"group_id": ["O1", "O2", "O3", "O4"]}, "groups_desc": "Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption", "non_inferiority": "No", "p_value": "0.0002", "method": "Mixed Models Analysis"}, {"group_id_list": {"group_id": ["O1", "O2", "O3", "O4"]}, "groups_desc": "Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.", "non_inferiority": "No", "p_value": "0.09", "method": "Mixed Models Analysis"}]}}}, "certain_agreements": {"pi_employee": "All Principal Investigators ARE employed by the organization sponsoring the study.", "restrictive_agreement": "There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI\'s rights to discuss or publish trial results after the trial is completed."}, "point_of_contact": {"name_or_title": "Brenda Ling", "organization": "United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center", "phone": "701-795-8300", "email": "brenda.ling@ars.usda.gov"}}}', 'completion_date': u'May 2006', 'condition_browse': '{}', 'conditions': '[{"condition": "Dietary Zinc Absorption"}]', 'detailed_description': u'\n Zinc absorption is tested from 2 days of consuming each of four diets with zinc-65 isotope,\n followed by retention monitoring in a whole body scintillation counter for 4 weeks. All four\n 4 experimental diets are tested with each subject, in randomized order, for a total of 16\n weeks.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Average weight for height\\n\\n Exclusion Criteria:\\n\\n - Medications other than birth control pills or hormone replacement therapy,\\n\\n - Pregnancy within last 6 months"}, "gender": "Female", "minimum_age": "21 Years", "maximum_age": "50 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'17', 'firstreceived_date': u'September 16, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Calcium, Dietary"}}', 'interventions': '[{"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Moderate Calcium, Low phytate Diet", "description": "Participants consumed diet containing 700 milligrams calcium and 440 milligrams of phytate for 4 weeks", "arm_group_label": "Overall Study"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "Moderate Calcium, High Phytate Diet", "description": "Participants consumed diet containing 700 milligrams calcium and 1800 milligrams of phytate for 4 weeks", "arm_group_label": "Overall Study"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "High Calcium, Low Phytate Diet", "description": "Participants consumed diet containing 1900 milligrams calcium and 440 milligrams of phytate for 4 weeks", "arm_group_label": "Overall Study"}}, {"intervention": {"intervention_type": "Dietary Supplement", "intervention_name": "High Calcium, High Phytate Diet", "description": "Participants consumed diet containing 1900 milligrams calcium and 1800 milligrams of phytate for 4 weeks", "arm_group_label": "Overall Study"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "dietary zinc absorption"}, {"keyword": "dietary phytic acid"}, {"keyword": "dietary calcium"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "United States Department of Agriculture Grand Forks Human Nutrition Research Center", "address": {"city": "Grand Forks", "state": "North Dakota", "zip": "58202", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00754390', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Effects of Calcium and Phytate on Zinc Absorption', 'org_study_id': u'GFHNRC042', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Janet R Hunt", "role": "Principal Investigator", "affiliation": "USDA Grand Forks Human Nutrition Research Center"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Federal Government", "has_dmc": "No"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2006', 'primary_outcomes': '[{"primary_outcome": {"measure": "Zinc Absorption", "time_frame": "16 weeks", "safety_issue": "No", "description": "Retention of Zinc-65 was monitored for 28 days by whole body scintillation counting. The percentage of Zinc-65 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Zinc-65 retained versus time"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Janet R Hunt, Research Nutritiontist", "organization": "United States Department of Agriculture Grand Forks Human Nutrition Research Center"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'USDA Grand Forks Human Nutrition Research Center', 'sponsors': '[{"lead_sponsor": {"agency": "USDA Beltsville Human Nutrition Research Center", "agency_class": "U.S. Fed"}}]', 'start_date': u'November 2005', 'study_design': u'Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00754390', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:22 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00777816?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=42&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:22 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:22 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:22 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:22 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:22 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00777816?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=42&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "arm_group_type": "Active Comparator"}}, {"arm_group": {"arm_group_label": "2", "arm_group_type": "Placebo Comparator"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to\n patients with active, stable, moderate to severe rheumatoid arthritis (RA).\n\n It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control\n in subjects with RA.\n ', 'brief_title': u'Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": ["Arthritis", "Arthritis, Rheumatoid"]}}', 'conditions': '[{"condition": "Rheumatoid Arthritis"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - American College of Rheumatology (ACR) diagnostic criteria for RA\\n\\n - Moderate to severe disease, defined as follows - At least six tender and six swollen\\n joints (28 joint count) AND ESR > 28 mm/hr or CRP > 1.0 mg/dL\\n\\n - Current duration of RA at Screening \\u2265 6 months and \\u2264 20 years\\n\\n - RA and other medical conditions must be stable.\\n\\n - Age \\u2265 18 and \\u2264 75 at Screening\\n\\n - Weight \\u2265 80 lbs (36.3 kg) and \\u2264 275 lbs (125.0 kg)\\n\\n - For females with child-bearing potential, a negative serum pregnancy test\\n\\n Exclusion Criteria:\\n\\n - Major surgery within 28 days prior to Day 0\\n\\n - Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery\\n planned within 9 months following Day 0\\n\\n - Known HIV antibody, or hepatitis B surface antigen\\n\\n - History of malignancy within 5 years prior to Screening other than carcinoma in situ\\n of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma\\n of the skin\\n\\n - Immunodeficiency\\n\\n - History or symptoms of a demyelinating disease\\n\\n - History of severe allergic or anaphylactic reactions to humanized or murine\\n monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 <\\n 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or\\n hypotension may be signs of anaphylaxis.\\n\\n - History of tuberculosis, positive PPD test, active atopic disease requiring\\n medication, or asthma. A subject who has had a positive PPD test but has completed a\\n course of treatment for tuberculosis, had a documented vaccination against\\n tuberculosis, or had a negative QuantiFERON -TB test result is eligible.\\n\\n - Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease\\n requiring more therapy than using one inhaler 4\\u00d7 daily\\n\\n - Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary\\n fibrosis)\\n\\n - Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the\\n diagnosis of liver disease was based on positive Hep C serology due to prior\\n vaccination, the subject is eligible.\\n\\n - Pregnant or planning to become pregnant during the course of the study, or\\n breast-feeding"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "75 Years", "healthy_volunteers": "No"}}', 'enrollment': u'18', 'firstreceived_date': u'October 17, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "XOMA 052", "description": "A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.", "arm_group_label": "1"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Placebo", "description": "A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.", "arm_group_label": "2"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "Rheumatoid"}, {"keyword": "Arthritis"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"address": {"city": "Clearwater", "state": "Florida", "zip": "33765", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Middleburg Heights", "state": "Ohio", "zip": "44130", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00777816', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis', 'org_study_id': u'X052070', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Alan Solinger, M.D.", "role": "Study Director", "affiliation": "XOMA (US) LLC"}}', 'overall_status': u'Suspended', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "No"}}', 'phase': u'Phase 2', 'primary_completion_date': u'October 2014', 'primary_outcomes': '[{"primary_outcome": {"measure": "Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.", "time_frame": "Day 0 pre-dose through Day 56", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Alan M. Solinger, M.D. / Medical Monitor; V.P. Clinical Immunology", "organization": "XOMA (US) LLC"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.", "time_frame": "Day 0 Pre-dose through Day 56", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.", "time_frame": "Day 0 pre-dose through Day 56", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.", "time_frame": "Day 0 pre-dose through Day 56", "safety_issue": "No"}}]', 'source': u'XOMA (US) LLC', 'sponsors': '[{"lead_sponsor": {"agency": "XOMA (US) LLC", "agency_class": "Industry"}}]', 'start_date': u'February 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00777816', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:23 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00810641?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=41&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:24 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:53:24 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:24 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:24 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:24 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00810641?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=41&resultsxml=true> {'acronym': u'BPPV-HC', 'arm_groups': '[{"arm_group": {"arm_group_label": "Gufoni maneuver", "arm_group_type": "Active Comparator", "description": "Gufoni maneuver for apogeotropic HC-BPPV"}}, {"arm_group": {"arm_group_label": "Headshaking maneuver", "arm_group_type": "Active Comparator", "description": "headshaking maneuver for apogeotropic HC BPPV"}}, {"arm_group": {"arm_group_label": "sham maneuver", "arm_group_type": "Sham Comparator", "description": "sham maneuver for apogeotropic HC BPPV"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study was to compare the immediate efficacies of each treatment\n maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo\n (HC-BPPV).\n ', 'brief_title': u'Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo', 'clinical_results': '{"clinical_results": {"participant_flow": {"recruitment_details": "Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.", "pre_assignment_details": "We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.", "group_list": {"group": [{"@group_id": "P1", "title": "Gufoni Maneuver", "description": "Gufoni maneuver for apogeotropic HC-BPPV"}, {"@group_id": "P2", "title": "Headshaking Maneuver", "description": "headshaking maneuver for apogeotropic HC BPPV"}, {"@group_id": "P3", "title": "Sham Maneuver", "description": "sham maneuver for apogeotropci HC BPPV"}]}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "par ticipants_list": {"participants": [{"@group_id": "P1", "@count": "52"}, {"@group_id": "P2", "@count": "54"}, {"@group_id": "P3", "@count": "51"}]}}, {"title": "COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "52"}, {"@group_id": "P2", "@count": "53"}, {"@group_id": "P3", "@count": "49"}]}}, {"title": "NOT COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "0"}, {"@group_id": "P2", "@count": "1"}, {"@group_id": "P3", "@count": "2"}]}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": {"title": "Withdrawal by Subject", "participants_list": {"participants": [{"@group_id": "P1", "@count": "0"}, {"@group_id": "P2", "@count": "1"}, {"@group_id": "P3", "@count": "2"}]}}}}}}, "baseline": {"group_list": {"group": [{"@group_id": "B1", "title": "Gufoni Maneuver", "description": "Gufoni maneuver for apogeotropic HC-BPPV"}, {"@group_id": "B2", "title": "Headshaking Maneuver", "description": "headshaking maneuver for apogeotropic HC BPPV"}, {"@group_id": "B3", "title": "Sham Maneuver", "description": "sham maneuver for apogeotropci HC BPPV"}, {"@group_id": "B4", "title": "Total", "description": "Total of all reporting groups"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "52"}, {"@group_id": "B2", "@value": "54"}, {"@group_id": "B3", "@value": "51"}, {"@group_id": "B4", "@value": "157"}]}}}}, {"title": "Age", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "<=18 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "1"}, {"@group_id": "B2", "@value": "0"}, {"@group_id": "B3", "@value": "0"}, {"@group_id": "B4", "@value": "1"}]}}, {"sub_title": "Between 18 and 65 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "32"}, {"@group_id": "B2", "@value": "30"}, {"@group_id": "B3", "@value": "27"}, {"@group_id": "B4", "@value": "89"}]}}, {"sub_title": ">=65 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "19"}, {"@group_id": "B2", "@value": "24"}, {"@group_id": "B3", "@value": "24"}, {"@group_id": "B4", "@value": "67"}]}}]}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "57.8", "@spread": "13.5"}, {"@group_id": "B2", "@value": "60.5", "@spread": "12.4"}, {"@group_id": "B3", "@value": "61.5", "@spread": "14.9"}, {"@group_id": "B4", "@value": "59.9", "@spread": "13.6"}]}}}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "39"}, {"@group_id": "B2", "@value": "30"}, {"@group_id": "B3", "@value": "28"}, {"@group_id": "B4", "@value": "97"}]}}, {"sub_title": "Male", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "13"}, {"@group_id": "B2", "@value": "24"}, {"@group_id": "B3", "@value": "23"}, {"@group_id": "B4", "@value": "60"}]}}]}}, {"title": "Region of Enrollment", "units": "participants", "param": "Number", "category_list": {"category": {"sub_title": "Korea, Republic of", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "52"}, {"@group_id": "B2", "@value": "54"}, {"@group_id": "B3", "@value": "51"}, {"@group_id": "B4", "@value": "157"}]}}}}]}}, "outcome_list": {"outcome": {"type": "Primary", "title": "Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial", "description": "The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.", "time_frame": "one hour", "safety_issue": "No", "population": "Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.", "group_list": {"group": [{"@group_id": "O1", "title": "Gufoni Maneuver", "description": "Gufoni maneuver for apogeotropic HC-BPPV"}, {"@group_id": "O2", "title": "Headshaking Maneuver", "description": "headshaking maneuver for apogeotropic HC BPPV"}, {"@group_id": "O3", "title": "Sham Maneuver", "description": "sham maneuver for apogeotropci HC BPPV"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "52"}, {"@group_id": "O2", "@value": "53"}, {"@group_id": "O3", "@value": "49"}]}}}}, {"title": "Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial", "description": "The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.", "units": "participants", "param": "Number", "dispersion": "95% Confidence Interval", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "38", "@lower_limit": "2.48", "@upper_limit": "13.78"}, {"@group_id": "O2", "@value": "33", "@lower_limit": "1.42", "@upper_limit": "7.17"}, {"@group_id": "O3", "@value": "17", "@lower_limit": "1.78", "@upper_limit": "9.85"}]}}}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI\'s rights to discuss or publish trial results after the trial is completed."}, "limitations_and_caveats": "In this study, resolution of BPPV was determined using a telephone interview during the follow-ups after one week.", "point_of_contact": {"name_or_title": "Treatment of apogeotropic HC BPPV", "organization": "KONOS", "phone": "82 10 5538 6565", "email": "ohsun@jbnu.ac.kr"}}}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Vertigo"}}', 'conditions': '[{"condition": "HC-BPPV"}]', 'detailed_description': u'\n A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of\n HC-BPPV were randomized to one of each three treatment groups at their first clinic visit.\n These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in\n apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning\n maneuver immediately after each treatment method based on resolves of vertigo and positional\n nystagmus.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - a history of brief episodes of positional vertigo,\\n\\n - direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic\\n nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning\\n positions,\\n\\n - no spontaneous nystagmus during upright sitting position, and\\n\\n - absence of identifiable central nervous system disorders that could explain the\\n positional vertigo and nystagmus.\\n\\n Exclusion Criteria:\\n\\n - central positional nystagmus with identifiable CNS lesions that could explain the\\n positional nystagmus"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "80 Years", "healthy_volunteers": "No"}}', 'enrollment': u'157', 'firstreceived_date': u'December 17, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "Gufoni maneuver", "description": "For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).", "arm_group_label": "Gufoni maneuver"}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "Head-shaking maneuver", "description": "For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.", "arm_group_label": "Headshaking maneuver"}}, {"intervention": {"intervention_type": "Procedure", "intervention_name": "sham maneuver", "description": "For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.", "arm_group_label": "sham maneuver"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "BPPV(benign paroxysmal positional vertigo)"}, {"keyword": "HC-BPPV(BPPV involving the horizontal semicircular canal)"}, {"keyword": "Nystagmus"}, {"keyword": "Treatment outcome"}, {"keyword": "Horizontal Canal Benign Paroxysmal Positional Vertigo"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Korea, Republic of"}]', 'locations': '[{"location": {"facility": {"name": "Chonbuk National University Hospital", "address": {"city": "Jeonju", "state": "Cholabuk-do", "zip": "560-712", "country": "Korea, Republic of"}}}}, {"location": {"facility": {"name": "Seoul National University Bundang Hospital", "address": {"city": "Seongnam", "state": "Kyoungki-do", "country": "Korea, Republic of"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00810641', 'number_of_arms': u'3', 'number_of_groups': '', 'official_title': u'Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo', 'org_study_id': u'KONOS', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Korea: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 3', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial", "time_frame": "one hour", "safety_issue": "No", "description": "The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "KONOS", "organization": "Korean neuro-ophthalmology and neuro-otology society"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Chonbuk National University', 'sponsors': '[{"lead_sponsor": {"agency": "Chonbuk National University", "agency_class": "Other"}}, {"collaborator": {"agency": "Seoul National University Bundang Hospital", "agency_class": "Other"}}]', 'start_date': u'January 2009', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00810641', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:25 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00330668?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=60&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:25 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:25 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:25 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:25 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00330668?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=60&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect\n long term safety and efficacy data on the continued use of recombinant human insulin-like\n growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency\n (IGFD). The secondary objective is to use the data collected to learn more about the\n relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.\n ', 'brief_title': u'Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency', 'clinical_results': '{"clinical_results": {"participant_flow": {"recruitment_details": "Study Initiation Date: 21 OCT 2005. Study completion Date: 19 JAN 2010. 44 investigators enrolled 114 subjects.\\nPatients who completed a prior Tercica study, MS301 (NCT00125164).", "pre_assignment_details": "Patients initially received either mecasermin 80 or 120 \\u00b5g/kg twice daily. Patients who received 80 \\u00b5g/kg then switched to receive 120 \\u00b5g/kg. During the once daily period, all patients were first switched to receive mecasermin 160 \\u00b5g/kg, followed by individual dose-escalation to a targeted maximum dose of 240 \\u00b5g/kg.", "group_list": {"group": {"@group_id": "P1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "114"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "0"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "114"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Adverse Event", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Lost to Follow-up", "participants_list": {"participants": {"@group_id": "P1", "@count": "9"}}}, {"title": "Non-Compliance", "participants_list": {"participants": {"@group_id": "P1", "@count": "5"}}}, {"title": "Withdrawal by Subject", "participants_list": {"participants": {"@group_id": "P1", "@count": "20"}}}, {"title": "Sponsor\'s decision", "participants_list": {"participants": {"@group_id": "P1", "@count": "76"}}}, {"title": "Lack of Efficacy", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Use of exclusionary medication", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Patient started Lupron", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}]}}}}, "baseline": {"group_list": {"group": {"@group_id": "B1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "114"}}}}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "8.5", "@spread": "2.4"}}}}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "32"}}}, {"sub_title": "Male", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "82"}}}]}}, {"title": "Race/Ethnicity, Customized", "units": "Participants", "param": "Number", "category_list": {"category": [{"sub_title": "Hispanic", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "6"}}}, {"sub_title": "White", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "100"}}}, {"sub_title": "Black", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "1"}}}, {"sub_title": "Asian", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "4"}}}, {"sub_title": "Native Hawaiian", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "1"}}}, {"sub_title": "Other", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "2"}}}]}}, {"title": "Region of Enrollment", "units": "participants", "param": "Number", "category_list": {"category": {"sub_title": "United States", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "114"}}}}}, {"title": "Height Standard Deviation (SD) Score", "description": "Please note that SD is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.", "units": "SD score", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "-2.4", "@spread": "0.7"}}}}}, {"title": "IGF-1 Standard Deviation (SD) Score", "description": "Please note that SD is a standard term used in growth studies and represents Standard Deviations calculated as the patient value minus the mean divided by the standard deviation. Standard Deviation Scores vary depending on the age and sex of the child.", "units": "SD score", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "-0.9", "@spread": "1.4"}}}}}, {"title": "Maximum Stimulated Growth Hormone", "description": "Growth Hormone Stimulation Test results expressed in ng/mL.", "units": "ng/mL", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "19.2", "@spread": "12.9"}}}}}, {"title": "Weight", "units": "Kg", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "21.8", "@spread": "6.2"}}}}}]}}, "outcome_list": {"outcome": [{"type": "Primary", "title": "Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.", "time_frame": "after one year of treatment", "safety_issue": "No", "group_list": {"group": {"@group_id": "O1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}}}, {"title": "Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.", "units": "cm/year", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1"}}}}}]}}, {"type": "Secondary", "title": "Height Velocities During Subsequent Years of rh IGF-1 Treatment", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.", "time_frame": "after 2, 3 and 5 years of treatment", "safety_issue": "No", "group_list": {"group": {"@group_id": "O1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}}}, {"title": "Height Velocities During Subsequent Years of rh IGF-1 Treatment", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.", "units": "cm/year", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1"}}}}}]}}, {"type": "Secondary", "title": "Height Velocity Standard Deviation (SD) Score", "time_frame": "during the course of the study", "safety_issue": "No", "group_list": {"group": {"@group_id": "O1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}}}, {"title": "Height Velocity Standard Deviation (SD) Score", "units": "SD score", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1"}}}}}]}}, {"type": "Secondary", "title": "Height SD Score", "time_frame": "during the course of the study", "safety_issue": "No", "group_list": {"group": {"@group_id": "O1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}}}, {"title": "Height SD Score", "units": "SD score", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1"}}}}}]}}]}, "reported_events": {"time_frame": "Approximately 4.25 years.", "group_list": {"group": {"@group_id": "E1", "title": "rhIGF-1 Injection", "description": "All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily."}}, "serious_events": {"default_vocab": "MedDRA (11.0)", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, serious adverse events", "counts": {"@group_id": "E1", "@subjects_affected": "6", "@subjects_at_risk": "114"}}}}, {"title": "Hepatobiliary disorders", "event_list": {"event": {"sub_title": "Cholelithiasis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Appendicitis", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}, {"sub_title": "Otitis Externa", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}, {"sub_title": "Pneumonia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}]}}, {"title": "Injury, poisoning and procedural complications", "event_list": {"event": {"sub_title": "Forearm Fracture", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": {"sub_title": "Hypoglycaemia", "counts": {"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "114"}}}}]}}, "other_events": {"frequency_threshold": "5", "default_vocab": "MedDRA (11.0)", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, other adverse events", "counts": {"@group_id": "E1", "@subjects_affected": "107", "@subjects_at_risk": "114"}}}}, {"title": "Blood and lymphatic system disorders", "event_list": {"event": {"sub_title": "Lymphadenopathy", "counts": {"@group_id": "E1", "@events": "8", "@subjects_affected": "8", "@subjects_at_risk": "114"}}}}, {"title": "Ear and labyrinth disorders", "event_list": {"event": {"sub_title": "Ear Pain", "counts": {"@group_id": "E1", "@events": "9", "@subjects_affected": "7", "@subjects_at_risk": "114"}}}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Abdominal Pain Upper", "counts": {"@group_id": "E1", "@events": "27", "@subjects_affected": "20", "@subjects_at_risk": "114"}}, {"sub_title": "Diarrhoea", "counts": {"@group_id": "E1", "@events": "13", "@subjects_affected": "13", "@subjects_at_risk": "114"}}, {"sub_title": "Vomiting", "counts": {"@group_id": "E1", "@events": "44", "@subjects_affected": "23", "@subjects_at_risk": "114"}}]}}, {"title": "General disorders", "event_list": {"event": [{"sub_title": "Influenza Like Illness", "counts": {"@group_id": "E1", "@events": "18", "@subjects_affected": "9", "@subjects_at_risk": "114"}}, {"sub_title": "Injection Site Bruising", "counts": {"@group_id": "E1", "@events": "10", "@subjects_affected": "9", "@subjects_at_risk": "114"}}, {"sub_title": "Injection Site Hypertrophy", "counts": {"@group_id": "E1", "@events": "30", "@subjects_affected": "16", "@subjects_at_risk": "114"}}, {"sub_title": "Pyrexia", "counts": {"@group_id": "E1", "@events": "43", "@subjects_affected": "28", "@subjects_at_risk": "114"}}]}}, {"title": "Immune system disorders", "event_list": {"event": {"sub_title": "Seasonal Allergy", "counts": {"@group_id": "E1", "@events": "6", "@subjects_affected": "6", "@subjects_at_risk": "114"}}}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Bronchitis", "counts": {"@group_id": "E1", "@events": "9", "@subjects_affected": "8", "@subjects_at_risk": "114"}}, {"sub_title": "Ear Infection", "counts": {"@group_id": "E1", "@events": "13", "@subjects_affected": "10", "@subjects_at_risk": "114"}}, {"sub_title": "Gastroenteritis", "counts": {"@group_id": "E1", "@events": "14", "@subjects_affected": "9", "@subjects_at_risk": "114"}}, {"sub_title": "Gastroenteritis Viral", "counts": {"@group_id": "E1", "@events": "23", "@subjects_affected": "20", "@subjects_at_risk": "114"}}, {"sub_title": "Influenza", "counts": {"@group_id": "E1", "@events": "31", "@subjects_affected": "22", "@subjects_at_risk": "114"}}, {"sub_title": "Molluscum Contagiosum", "counts": {"@group_id": "E1", "@events": "7", "@subjects_affected": "7", "@subjects_at_risk": "114"}}, {"sub_title": "Nasopharyngitis", "counts": {"@group_id": "E1", "@events": "34", "@subjects_affected": "22", "@subjects_at_risk": "114"}}, {"sub_title": "Otitis Externa", "counts": {"@group_id": "E1", "@events": "16", "@subjects_affected": "11", "@subjects_at_risk": "114"}}, {"sub_title": "Otitis Media", "counts": {"@group_id": "E1", "@events": "28", "@subjects_affected": "20", "@subjects_at_risk": "114"}}, {"sub_title": "Pharyngitis Streptococcal", "counts": {"@group_id": "E1", "@events": "32", "@subjects_affected": "23", "@subjects_at_risk": "114"}}, {"sub_title": "Sinusitis", "counts": {"@group_id": "E1", "@events": "24", "@subjects_affected": "12", "@subjects_at_risk": "114"}}, {"sub_title": "Upper Respiratory Tract Infection", "counts": {"@group_id": "E1", "@events": "79", "@subjects_affected": "38", "@subjects_at_risk": "114"}}, {"sub_title": "Viral Upper Respiratory Tract Infection", "counts": {"@group_id": "E1", "@events": "10", "@subjects_affected": "8", "@subjects_at_risk": "114"}}]}}, {"title": "Injury, poisoning and procedural complications", "event_list": {"event": {"sub_title": "Arthropod Bite", "counts": {"@group_id": "E1", "@events": "7", "@subjects_affected": "7", "@subjects_at_risk": "114"}}}}, {"title": "Investigations", "event_list": {"event": {"sub_title": "Blood Glucose Decreased", "counts": {"@group_id": "E1", "@events": "8", "@subjects_affected": "7", "@subjects_at_risk": "114"}}}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": {"sub_title": "Hypoglycaemia", "counts": {"@group_id": "E1", "@events": "72", "@subjects_affected": "46", "@subjects_at_risk": "114"}}}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": [{"sub_title": "Arthralgia", "counts": {"@group_id": "E1", "@events": "15", "@subjects_affected": "9", "@subjects_at_risk": "114"}}, {"sub_title": "Pain In Extremity", "counts": {"@group_id": "E1", "@events": "13", "@subjects_affected": "10", "@subjects_at_risk": "114"}}]}}, {"title": "Nervous system disorders", "event_list": {"event": [{"sub_title": "Dizziness", "counts": {"@group_id": "E1", "@events": "7", "@subjects_affected": "6", "@subjects_at_risk": "114"}}, {"sub_title": "Headache", "counts": {"@group_id": "E1", "@events": "86", "@subjects_affected": "35", "@subjects_at_risk": "114"}}]}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Cough", "counts": {"@group_id": "E1", "@events": "27", "@subjects_affected": "21", "@subjects_at_risk": "114"}}, {"sub_title": "Nasal Congestion", "counts": {"@group_id": "E1", "@events": "13", "@subjects_affected": "7", "@subjects_at_risk": "114"}}, {"sub_title": "Pharyngolaryngeal Pain", "counts": {"@group_id": "E1", "@events": "21", "@subjects_affected": "14", "@subjects_at_risk": "114"}}, {"sub_title": "Rhinitis Allergic", "counts": {"@group_id": "E1", "@events": "6", "@subjects_affected": "6", "@subjects_at_risk": "114"}}, {"sub_title": "Tonsillar Hypertrophy", "counts": {"@group_id": "E1", "@events": "11", "@subjects_affected": "8", "@subjects_at_risk": "114"}}]}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "Each investigator may publish or report data from their own subjects. The trial data in aggregate are the property of Tercica, Inc. and may not be published without permission of Tercica, Inc. Tercica, Inc. will be the final arbitrator of issues relating to the publication or presentation of the aggregate data."}, "limitat ions_and_caveats": "The study was terminated by the sponsor on identification of an unacceptable frequency of hypoglycemia which was reported at doses of \\u2265200 mcg/kg once daily. Only safety results are presented as efficacy data were not analyzed according to protocol.", "point_of_contact": {"name_or_title": "Sr Vice President, Clinical Development and Medical Affairs", "organization": "Ipsen, US", "phone": "clinical.trials@ipsen.com", "email": "clinical.trials@ipsen.com"}}}', 'completion_date': u'March 2010', 'condition_browse': '{"condition_browse": {"mesh_term": ["Failure to Thrive", "Growth Disorders"]}}', 'conditions': '[{"condition": "Growth Disorders"}]', 'detailed_description': u'\n Primary IGFD is a term that has been used to describe patients with intrinsic cellular\n defects in GH action. In this protocol, subjects that have completed one year of mecasermin\n treatment on Tercica protocol MS301 (NCT00125164) will be allowed to enroll in this\n extension study. All subjects were planned to receive treatment.\n\n This is a Phase IIIb open-label, multi-center, parallel dose, extension study conducted in\n approximately 40 centers across the United States.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Parents or legally authorized representatives must give signed informed consent\\n before any trial related activities are conducted\\n\\n - Where required, assent of the subject will be appropriately documented prior to any\\n study related activities\\n\\n - Completion of assessments at Visit 9 (Month 120 of Study MS301 [NCT00125164])\\n\\n Exclusion Criteria:\\n\\n - Incomplete participation in MS301 (NCT00125164)\\n\\n - Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1\\n injection) or its formulation\\n\\n - Development or presence of a chronic condition except as approved by the Medical\\n Monitor\\n\\n - Pregnancy\\n\\n - Any social or medical condition that, in the opinion of the investigator, would be\\n detrimental to either the subject or the study"}, "gender": "Both", "minimum_age": "4 Years", "maximum_age": "15 Years", "healthy_volunteers": "No"}}', 'enrollment': u'114', 'firstreceived_date': u'May 26, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "rh IGF-1 (mecasermin)", "description": "Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 \\u00b5g/kg, escalated to a targeted maximum dose of 240 \\u00b5g/kg.", "other_name": "Increlex"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "Insulin-like Growth Factor Deficiency"}, {"keyword": "IGF-1"}, {"keyword": "Short Stature"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "Ipsen", "address": {"city": "Paris", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00330668', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'Recombinant Human Insulin-Like Growth Factor-1 (IGF-1) Treatment of Children With Growth Failure Associated With Primary IGF-1 Deficiency: An Open-Label, Multi-Center, Extension Study', 'org_study_id': u'MS306', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Sr Vice President, Clinical Development and Medical Affairs", "role": "Study Director", "affiliation": "Ipsen (formerly Tercica, Inc.)"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration", "has_dmc": "Yes"}}', 'phase': u'Phase 3', 'primary_completion_date': u'February 2010', 'primary_outcomes': '[{"primary_outcome": {"measure": "Height Velocity in Modified Intent-to-Treat Population (ITT Patients Randomized to 120 Mcg/kg Twice Daily)", "time_frame": "after one year of treatment", "safety_issue": "No", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement."}}]', 'reference': '[]', 'removed_countries': '[{"country": "United States"}]', 'responsible_party': '{"responsible_party": {"name_title": "Senior Vice President, Clinical Development and Medical Affairs", "organization": "Ipsen"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Height Velocities During Subsequent Years of rh IGF-1 Treatment", "time_frame": "after 2, 3 and 5 years of treatment", "safety_issue": "No", "description": "Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement."}}, {"secondary_outcome": {"measure": "Height Velocity Standard Deviation (SD) Score", "time_frame": "during the course of the study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Height SD Score", "time_frame": "during the course of the study", "safety_issue": "No"}}]', 'source': u'Ipsen', 'sponsors': '[{"lead_sponsor": {"agency": "Ipsen", "agency_class": "Industry"}}]', 'start_date': u'November 2005', 'study_design': u'Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00330668', 'verification_date': u'May 2011', 'why_stopped': u'\n Unacceptable frequency of hypoglycemia observed at and above 200 ug/kg/day\n '} 2015-10-09 20:53:26 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00335569?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=59&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:26 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:26 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:26 [spiders.trials] DEBUG: responsible_party: must be string or read-only buffer, not None 2015-10-09 20:53:26 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:26 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00335569?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=59&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of the study is to evaluate the clinical equivalence and the general\n tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle,\n Serono) when administered to patients undergoing IVF.\n ', 'brief_title': u'Clinical Tolerance and Equivalence of hCG-IBSA vs Recombinant Human Chorionic Gonadotrophin in Women Undergoing In Vitro Fertilisation', 'clinical_results': '{}', 'completion_date': u'December 2008', 'condition_browse': '{"condition_browse": {"mesh_term": "Infertility"}}', 'conditions': '[{"condition": "Infertility"}]', 'detailed_description': u'\n This is a prospective, multicenter, randomized, investigator blind, parallel group, active\n control, phase III clinical trial. Patients meeting the eligibility requirements of the\n study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the\n reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to\n have any contact with the study medications (supplied in boxes labeled in a manner that does\n not reveal the content of the boxes), and requesting that patients do not make any\n statements to the investigator that might indicate the treatment to which they were\n assigned. Equivalence testing with regard to the primary outcome variable will establish\n whether the two treatments are indeed similarly effective.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - >/=18 and < 40 years old;\\n\\n - BMI between 18 and 30 kg/m2;\\n\\n - less than 3 previous completed cycles;\\n\\n - both ovaries present;\\n\\n - regular menstrual cycle of 25-35 days;\\n\\n - infertility attributable to a tubal factor, American Fertility Society grade I or II\\n endometriosis, male factor or unexplained factor.\\n\\n - within 12 months of the beginning of the study, uterine cavity consistent with\\n expected normal function as assessed through hysterosalpingogram, sonohystrogram or\\n hysteroscopic examination;\\n\\n - basal FSH level less than 10 IU/L;\\n\\n - criteria for hCG administration fulfilled (at least 2 follicles with a diameter of 16\\n mm or more, with acceptable serum E2 concentration).\\n\\n - a male partner with semen analysis within the past 6 months showing acceptable values\\n of seminal parameters, defined as > 3x10 exp 6 spermatozoa/ml;\\n\\n - qualified to receive 150 - 300 IU FSH as starting dose.\\n\\n Exclusion Criteria:\\n\\n - age < 18 and > o = 40 years;\\n\\n - primary ovarian failure or women known as poor responders (i.e. requiring more than\\n 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3\\n oocytes retrieved, or with an E2 serum concentration < 3\'000 pmol/L);\\n\\n - ovarian cysts > 20 mm, or enlargement not due to polycystic ovarian syndrome;\\n\\n - patients affected by pathologies associated with any contraindication of being\\n pregnant;\\n\\n - hypersensitivity to the study medication;\\n\\n - any bleeding since stimulation;\\n\\n - uncontrolled thyroid or adrenal dysfunction;\\n\\n - neoplasias;\\n\\n - severe impairment of the renal and/or hepatic functions;\\n\\n - use of concomitant medication that might interfere with study evaluations (e.g.\\n nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents);\\n\\n - more than 18 days of FSH stimulation."}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "40 Years", "healthy_volunteers": "No"}}', 'enrollment': u'144', 'firstreceived_date': u'June 9, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Chorionic Gonadotropin"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "hCG-IBSA"}}]', 'is_fda_regulated': '', 'is_section_801': '', 'keywords': '[{"keyword": "Infertility, sterility, hCG, IVF"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Switzerland"}]', 'locations': '[{"location": {"facility": {"name": "Department of Gynecology and Obstetrics Universit\\u00e4tfrauenklinik", "address": {"city": "Basel", "zip": "4031", "country": "Switzerland"}}}}, {"location": {"facility": {"name": "4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102", "address": {"city": "Bern", "zip": "3010", "country": "Switzerland"}}}}, {"location": {"facility": {"name": "Department of Gynecology and ObstetricsUniversity Hospital", "address": {"city": "Geneve", "zip": "1211", "country": "Switzerland"}}}}, {"location": {"facility": {"name": "3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois", "address": {"city": "Lausanne", "zip": "1011", "country": "Switzerland"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00335569', 'number_of_arms': '', 'number_of_groups': '', 'official_title': u'A Prospective, Randomized, Controlled Clinical Study on the Assessment of Tolerance and Clinical Equivalence of hCG- IBSA (IBSA) Versus Ovitrelle (Serono), Both Administered Sub-cutaneously in Women Undergoing in Vitro Fertilization (IVF).', 'org_study_id': u'04CH/HCG02', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Dominique de Ziegler, Prof.", "role": "Principal Investigator", "affiliation": "D\\u00e9partements de Gyn\\u00e9cologie/Obst\\u00e9trique et de P\\u00e9diatrie"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Switzerland: Swissmedic", "has_dmc": "No"}}', 'phase': u'Phase 3', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "Total number of oocytes retrieved per patient who received hCG"}}]', 'reference': '[{"reference": {"citation": "Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981;50:465-95. Review.", "PMID": "6267989"}}, {"reference": {"citation": "Johnsen SG. A study of human testicular function by the use of human menopausal gonadotrophin and of human chorionic gonadotrophin in male hypogonadotrophic eunuchoidism and infantilism. Acta Endocrinol (Copenh). 1966 Oct;53(2):315-41.", "PMID": "6012569"}}, {"reference": {"citation": "Forest MG, David M, Lecoq A, Jeune M, Bertrans J. Kinetics of the HCG-induced steroidogenic response of the human testis. III. Studies in children of the plasma levels of testosterone and HCG: rationale for testicular stimulation test. Pediatr Res. 1980 Jun;14(6):819-24.", "PMID": "6105640"}}, {"reference": {"citation": "GEMZELL C. INDUCTION OF OVULATION WITH HUMAN GONADOTROPINS. Recent Prog Horm Res. 1965;21:179-204. Review.", "PMID": "14321057"}}, {"reference": {"citation": "Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. Review.", "PMID": "1868645"}}, {"reference": {"citation": "Vermesh M, Kletzky OA. Follicle-stimulating hormone is the main determinant of follicular recruitment and development in ovulation induction with human menopausal gonadotropin. Am J Obstet Gynecol. 1987 Dec;157(6):1397-402.", "PMID": "3122575"}}, {"reference": {"citation": "Brown JB, Evans JH, Adey FD, Taft HP, Townsend L. Factors involved in the induction of fertile ovulation with human gonadotrophins. J Obstet Gynaecol Br Commonw. 1969 Apr;76(4):289-307.", "PMID": "5778792"}}, {"reference": {"citation": "Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11.", "PMID": "6419189"}}, {"reference": {"citation": "Abdalla HI, Ah-Moye M, Brinsden P, Howe DL, Okonofua F, Craft I. The effect of the dose of human chorionic gonadotropin and the type of gonadotropin stimulation on oocyte recovery rates in an in vitro fertilization program. Fertil Steril. 1987 Dec;48(6):958-63.", "PMID": "3119376"}}, {"reference": {"citation": "Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. Review.", "PMID": "2660037"}}, {"reference": {"citation": "Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med. 1999 Jan 15;18(1):93-105.", "PMID": "9990695"}}]', 'removed_countries': '[]', 'responsible_party': '{}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes,"}}, {"secondary_outcome": {"measure": "2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG;"}}, {"secondary_outcome": {"measure": "Implantation rate;Pregnancy rate."}}, {"secondary_outcome": {"measure": "Adverse Events", "time_frame": "from day 1 to 35 +/- 7 days after oocytes retrieval", "safety_issue": "Yes", "description": "Adverse events were monitored and collected during all the study period"}}, {"secondary_outcome": {"measure": "Incidence of moderate or severe OHSS", "time_frame": "From the day of hCG injection until 35 +/- 7 days after oocyte retrieval", "safety_issue": "Yes", "description": "The incidence moderate or severe of OHSS will be assessed in both treatment groups"}}]', 'source': u'IBSA Institut Biochimique SA', 'sponsors': '[{"lead_sponsor": {"agency": "IBSA Institut Biochimique SA", "agency_class": "Industry"}}]', 'start_date': u'August 2005', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00335569', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:27 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00348894?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=58&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:27 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:27 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:27 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:27 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00348894?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=58&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Open Treatment", "arm_group_type": "Experimental", "description": "[S,S]-reboxetine"}}, {"arm_group": {"arm_group_label": "Standard Care", "arm_group_type": "Other", "description": "Standard Care"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to assess the long-term safety and tolerability of\n [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy\n ', 'brief_title': u'[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.', 'clinical_results': '{}', 'completion_date': u'October 2007', 'condition_browse': '{"condition_browse": {"mesh_term": ["Diabetic Neuropathies", "Peripheral Nervous System Diseases"]}}', 'conditions': '[{"condition": "Pain"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical,\\n sensorimotor polyneuropathy\\n\\n - Patients at screening must have a score >/=40 mm on the pain visual analogue scale\\n\\n Exclusion Criteria:\\n\\n - Patients with significant hepatic impairment\\n\\n - Patients with other severe pain, that may impair the self-assessment of the pain due\\n to DPN"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'136', 'firstreceived_date': u'July 4, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Reboxetine"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "[S,S]-Reboxetine", "description": "[S,S]-reboxetine", "arm_group_label": "Open Treatment"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Any", "description": "Any standard of care treatment for DPN", "arm_group_label": "Standard Care"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061031&StudyName=%5BS%2CS%5D-Reboxetine%20Long%20Term%20Safety%20Study%20In%20Chronic%20Painful%20Diabetic%20Peripheral%20Neuropathy.%0A", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Argentina"}, {"country": "Canada"}, {"country": "Croatia"}, {"country": "Estonia"}, {"country": "Finland"}, {"country": "Germany"}, {"country": "India"}, {"country": "Poland"}, {"country": "Russian Federation"}, {"country": "South Africa"}, {"country": "Sweden"}, {"country": "Ukraine"}, {"country": "United Kingdom"}, {"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Birmingham", "state": "Alabama", "zip": "35233", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Birmingham", "state": "Alabama", "zip": "35294", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Phoenix", "state": "Arizona", "zip": "85050", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Scottsdale", "state": "Arizona", "zip": "85254", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Jonesboro", "state": "Arkansas", "zip": "72401", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Auburn", "state": "California", "zip": "95602", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Huntington Beach", "state": "California", "zip": "92648", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Orangevale", "state": "California", "zip": "95662", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Naples", "state": "Florida", "zip": "34102", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Winter Park", "state": "Florida", "zip": "32789", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Honululu", "state": "Hawaii", "zip": "96814", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Chicago", "state": "Illinois", "zip": "60610", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Columbia", "state": "Missouri", "zip": "65212", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Jefferson City", "state": "Missouri", "zip": "65109", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "St Louis", "state": "Missouri", "zip": "63141", "country": "United States"}}}}, {"location": {"facility": {"name": "Pfizer Investigational 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'[{"primary_outcome": {"measure": "Vital signs", "time_frame": "duration of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Physical examination", "time_frame": "duration of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "12-lead ECG", "time_frame": "duration of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Hematology/Biochemistry", "time_frame": "duration of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Adverse events", "time_frame": "duration of study", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer Inc"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Pain Visual Analogue Scale", "time_frame": "duration of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Neuropathic Pain Symptom 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Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00348894', 'verification_date': u'May 2011', 'why_stopped': u'\n - Study was terminated due to insufficient clinical efficacy observed in previous studies\n conducted in postherpetic neuralgia.\n '} 2015-10-09 20:53:28 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00394797?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=57&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:28 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:28 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:28 [spiders.trials] DEBUG: responsible_party: must be string or read-only buffer, not None 2015-10-09 20:53:28 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:28 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:28 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00394797?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=57&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to try and determine whether repair of moderate ischemic mitral\n regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on\n survival.We will compare patients undergoing CABG + mitral repair or CABG only groups.\n Primary endpoints include late survival. Secondary endpoints include event free survival,\n symptoms, and echocardiographic outcomes.\n ', 'brief_title': u'Surgical Correction of Moderate Ischemic Mitral Regurgitation', 'clinical_results': '{}', 'completion_date': '', 'condition_browse': '{"condition_browse": {"mesh_term": "Mitral Valve Insufficiency"}}', 'conditions': '[{"condition": "Moderate Ischemic Mitral Regurgitation"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR"}, "sampling_method": "Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - patients undergoing coronary bypass surgery who have moderate degree of ischemic MR\\n\\n Exclusion Criteria:\\n\\n - etiology of mitral regurgitation other than ischemic, degree of regurgitation other\\n than moderate."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A"}}', 'enrollment': '', 'firstreceived_date': u'October 31, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "mitral valve annuloplasty"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Israel"}]', 'locations': '[{"location": {"facility": {"name": "Shaare Zedek Medical Center", "address": {"city": "Jerusalem", "zip": "91031", "country": "Israel"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00394797', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': '', 'org_study_id': u'IMR001', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Shuli Silberman, MD", "role": "Principal Investigator", "affiliation": "Shaare Zedek Medical Center"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Israel: Ministry of Health"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "survival at 1,5 and 10 years"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "event free survival"}}, {"secondary_outcome": {"measure": "symptoms"}}, {"secondary_outcome": {"measure": "echocardiographic parameters"}}]', 'source': u'Shaare Zedek Medical Center', 'sponsors': '[{"lead_sponsor": {"agency": "Shaare Zedek Medical Center", "agency_class": "Other"}}]', 'start_date': '', 'study_design': u'Observational Model: Cohort, Time Perspective: Retrospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00394797', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:30 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00398372?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=56&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:30 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:30 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:30 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:30 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:30 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00398372?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=56&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism\n of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.\n ', 'brief_title': u"Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment", 'clinical_results': '{}', 'completion_date': u'September 2009', 'condition_browse': '{"condition_browse": {"mesh_term": ["Lymphoma", "Lymphoma, Non-Hodgkin"]}}', 'conditions': '[{"condition": "Lymphoma, Non-Hodgkin"}, {"condition": "Lymphomas: Non-Hodgkin"}, {"condition": "Lymphomas: Non-Hodgkin Cutaneous Lymphoma"}, {"condition": "Lymphomas: Non-Hodgkin Diffuse Large B-Cell"}, {"condition": "Lymphomas: Non-Hodgkin Follicular / Indolent B-Cell"}, {"condition": "Lymphomas: Non-Hodgkin Mantle Cell"}, {"condition": "Lymphomas: Non-Hodgkin Marginal Zone"}, {"condition": "Lymphomas: Non-Hodgkin Peripheral T-Cell"}, {"condition": "Lymphomas: Non-Hodgkin Waldenstr Macroglobulinemia"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:Non-Hodgkin\'s Lymphoma Patients Receiving Antibody Treatment"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'500', 'firstreceived_date': u'November 9, 2006', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Rituximab"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Epratuzumab"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Stanford University School of Medicine", "address": {"city": "Stanford", "state": "California", "zip": "94305", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00398372', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u"Le20: Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment", 'org_study_id': u'LYMNHL0031', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Wen-Kai Weng", "role": "Principal Investigator", "affiliation": "Stanford University"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board"}}', 'phase': u'N/A', 'primary_completion_date': u'June 2007', 'primary_outcomes': '[{"primary_outcome": {"measure": "To characterize the molecular and cell biology of the tumor cells in lymphoma.", "time_frame": "6 months", "safety_issue": "No"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Wen-Kai Weng", "organization": "Stanford University School of Medicine"}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "200114861"}, {"secondary_id": "77550"}, {"secondary_id": "CA09287"}, {"secondary_id": "CA111827"}, {"secondary_id": "LYMNHL0031"}]', 'secondary_outcomes': '[]', 'source': u'Stanford University', 'sponsors': '[{"lead_sponsor": {"agency": "Stanford University", "agency_class": "Other"}}, {"collaborator": {"agency": "Amgen", "agency_class": "Industry"}}, {"collaborator": {"agency": "National Institutes of Health (NIH)", "agency_class": "NIH"}}]', 'start_date': u'November 2000', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00398372', 'verification_date': u'July 2010', 'why_stopped': ''} 2015-10-09 20:53:31 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00423098?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=55&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:31 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:31 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:31 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00423098?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=55&resultsxml=true> {'acronym': '', 'arm_groups': '[{"arm_group": {"arm_group_label": "Standard dose", "arm_group_type": "Experimental", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}}, {"arm_group": {"arm_group_label": "Low dose", "arm_group_type": "Active Comparator", "description": "Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in\n combination with two different corticosteroid (CS) regimes for the induction of remission of\n a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group\n I) or to a reduced dose CS regimen (group II)\n ', 'brief_title': u'Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare', 'clinical_results': '{"clinical_results": {"participant_flow": {"group_list": {"group": [{"@group_id": "P1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "P2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "period_list": {"period": {"title": "Overall Study", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "42", "#text": "Total number of patients screened was 90, but the total number of randomized patients was 81."}, {"@group_id": "P2", "@count": "39"}]}}, {"title": "COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "39", "#text": "Completed 24 weeks of study medication."}, {"@group_id": "P2", "@count": "35"}]}}, {"title": "NOT COMPLETED", "participants_list": {"participants": [{"@group_id": "P1", "@count": "3"}, {"@group_id": "P2", "@count": "4"}]}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Adverse Event", "participants_list": {"participants": [{"@group_id": "P1", "@count": "1"}, {"@group_id": "P2", "@count": "2"}]}}, {"title": "Unsatisfactory therapeutic effect", "participants_list": {"participants": [{"@group_id": "P1", "@count": "0"}, {"@group_id": "P2", "@count": "1"}]}}, {"title": "Administrative problems", "participants_list": {"participants": [{"@group_id": "P1", "@count": "0"}, {"@group_id": "P2", "@count": "1"}]}}, {"title": "Death", "participants_list": {"participants": [{"@group_id": "P1", "@count": "2"}, {"@group_id": "P2", "@count": "0"}]}}]}}}}, "baseline": {"group_list": {"group": [{"@group_id": "B1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "B2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "B3", "title": "Total", "description": "Total of all reporting groups"}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "42"}, {"@group_id": "B2", "@value": "39"}, {"@group_id": "B3", "@value": "81"}]}}}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "B1", "@value": "32.2", "@spread": "8.53"}, {"@group_id": "B2", "@value": "34.2", "@spread": "10.74"}, {"@group_id": "B3", "@value": "33.1", "@spread": "9.65"}]}}}}, {"title": "Age, Customized", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "18-29 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "20"}, {"@group_id": "B2", "@value": "18"}, {"@group_id": "B3", "@value": "38"}]}}, {"sub_title": "30-39 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "16"}, {"@group_id": "B2", "@value": "10"}, {"@group_id": "B3", "@value": "26"}]}}, {"sub_title": "40-49 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "4"}, {"@group_id": "B2", "@value": "6"}, {"@group_id": "B3", "@value": "10"}]}}, {"sub_title": "50-59 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "2"}, {"@group_id": "B2", "@value": "4"}, {"@group_id": "B3", "@value": "6"}]}}, {"sub_title": ">=60 years", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "0"}, {"@group_id": "B2", "@value": "1"}, {"@group_id": "B3", "@value": "1"}]}}]}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "37"}, {"@group_id": "B2", "@value": "29"}, {"@group_id": "B3", "@value": "66"}]}}, {"sub_title": "Male", "measurement_list": {"measurement": [{"@group_id": "B1", "@value": "5"}, {"@group_id": "B2", "@value": "10"}, {"@group_id": "B3", "@value": "15"}]}}]}}]}}, "outcome_list": {"outcome": [{"type": "Primary", "title": "Number of Patients With Complete Remission", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.", "time_frame": "24 Weeks", "safety_issue": "No", "population": "Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Complete Remission", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab.", "units": "Participants", "param": "Number", "category_list": {"category": [{"sub_title": "Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "8"}, {"@group_id": "O2", "@value": "8"}]}}, {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "34"}, {"@group_id": "O2", "@value": "31"}]}}]}}]}}, {"type": "Secondary", "title": "Number of Patients With Complete Remission", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.", "time_frame": "12 Weeks", "safety_issue": "No", "population": "Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Complete Remission", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "9"}, {"@group_id": "O2", "@value": "5"}]}}, {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "33"}, {"@group_id": "O2", "@value": "34"}]}}]}}]}}, {"type": "Secondary", "title": "Number of Patients With Partial Remission", "description": "Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.", "time_frame": "Baseline to 12 and 24 weeks", "safety_issue": "No", "population": "Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Partial Remission", "description": "Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved.", "units": "Participants", "param": "Number", "category_list": {"category": [{"sub_title": "At 12 weeks - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "16"}, {"@group_id": "O2", "@value": "11"}]}}, {"sub_title": "At 12 weeks - No", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "26"}, {"@group_id": "O2", "@value": "28"}]}}, {"sub_title": "At 24 weeks - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "20"}, {"@group_id": "O2", "@value": "14"}]}}, {"sub_title": "At 24 weeks - No", "measurement_ list": {"measurement": [{"@group_id": "O1", "@value": "22"}, {"@group_id": "O2", "@value": "25"}]}}]}}]}}, {"type": "Secondary", "title": "Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)", "description": "Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.", "time_frame": "12 Weeks and 24 Weeks", "safety_issue": "No", "population": "Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)", "description": "Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks.", "units": "mg/kg", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": [{"sub_title": "Week 12", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "106.1", "@spread": "13.55"}, {"@group_id": "O2", "@value": "68.2", "@spread": "16.41"}]}}, {"sub_title": "Week 24", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "114.2", "@spread": "15.01"}, {"@group_id": "O2", "@value": "73.0", "@spread": "17.76"}]}}]}}]}}, {"type": "Secondary", "title": "Number of Patients With Moderate to Severe Flares", "description": "A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)", "time_frame": "12 and 24 weeks", "safety_issue": "No", "population": "Intention to treat (ITT) population: All randomized patients who received at least one dose of study drug.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Moderate to Severe Flares", "description": "A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "At week 12 - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "0"}, {"@group_id": "O2", "@value": "0"}]}}, {"sub_title": "At week 12 - No", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}, {"sub_title": "At week 24 - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "1"}, {"@group_id": "O2", "@value": "0"}]}}, {"sub_title": "At week 24 - No", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "41"}, {"@group_id": "O2", "@value": "39"}]}}]}}]}}, {"type": "Secondary", "title": "Duration of Exposure to Study Medication", "description": "The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.", "time_frame": "24 weeks", "safety_issue": "No", "population": "Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Duration of Exposure to Study Medication", "description": "The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1.", "units": "days", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "164.5", "@spread": "24.87"}, {"@group_id": "O2", "@value": "157.7", "@spread": "41.15"}]}}}}]}}, {"type": "Secondary", "title": "Number of Patients With Adverse Events and Infections", "description": "Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.", "time_frame": "24 weeks", "safety_issue": "No", "population": "Safety population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Adverse Events and Infections", "description": "Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "At least one adverse event", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "35", "@spread": "5.63"}, {"@group_id": "O2", "@value": "30", "@spread": "6.62"}]}}, {"sub_title": "Any severe adverse event", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "7", "@spread": "7.08"}, {"@group_id": "O2", "@value": "3", "@spread": "8.31"}]}}, {"sub_title": "Any drug related adverse event", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "18", "@spread": "7.32"}, {"@group_id": "O2", "@value": "16", "@spread": "8.35"}]}}, {"sub_title": "Any serious adverse event", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "8"}, {"@group_id": "O2", "@value": "4"}]}}, {"sub_title": "Any infection", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "25"}, {"@group_id": "O2", "@value": "17"}]}}, {"sub_title": "Any severe infection", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "3"}, {"@group_id": "O2", "@value": "1"}]}}, {"sub_title": "Any drug related infection", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "10"}, {"@group_id": "O2", "@value": "6"}]}}, {"sub_title": "Any serious infection", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "4"}, {"@group_id": "O2", "@value": "1"}]}}]}}]}}, {"type": "Secondary", "title": "Number of Patients With Treatment Failure", "description": "Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.", "time_frame": "12 Weeks and 24 Weeks", "safety_issue": "Yes", "population": "Safety Population: All patients who received at least one dose of study drug and had at least one post-baseline safety assessment.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Number of Patients With Treatment Failure", "description": "Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "At 12 weeks - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "23"}, {"@group_id": "O2", "@value": "25"}]}}, {"sub_title": "At 12 weeks - No", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "19"}, {"@group_id": "O2", "@value": "14"}]}}, {"sub_title": "At 24 weeks - Yes", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "21"}, {"@group_id": "O2", "@value": "22"}]}}, {"sub_title": "At 24 weeks - No", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "21"}, {"@group_id": "O2", "@value": "17"}]}}]}}]}}, {"type": "Secondary", "title": "Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)", "description": "SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.", "time_frame": "From Baseline to week 4, week 12 and week 24", "safety_issue": "No", "population": "Intent-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)", "description": "SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common.", "units": "Units on a scale", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": [{"sub_title": "Change from Baseline to Week 4: (N= 39, 37)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-7.4", "@spread": "5.63"}, {"@group_id": "O2", "@value": "-7.7", "@spread": "6.62"}]}}, {"sub_title": "Change from Baseline to Week 12: (N= 41, 35)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-9.7", "@spread": "7.08"}, {"@group_id": "O2", "@value": "-10.3", "@spread": "8.31"}]}}, {"sub_title": "Change from Baseline to Week 24: (N= 39, 34)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-10.3", "@spread": "7.32"}, {"@group_id": "O2", "@value": "-9.8", "@spread": "8.35"}]}}]}}]}}, {"type": "Secondary", "title": "Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)", "description": "BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician\'s intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].", "time_frame": "From Baseline to week 4, week 12 and week 24", "safety_issue": "No", "population": "Intent-to-treat (ITT) populationincluded all randomized patients who received at least one dose of study drug. Only patients with assessments at both baseline and post-baseline visits are summarized.", "group_list": {"group": [{"@group_id": "O1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "O2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": [{"@group_id": "O1", "@value": "42"}, {"@group_id": "O2", "@value": "39"}]}}}}, {"title": "Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)", "description": "BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician\'s intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72].", "units": "Units on a scale", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": [{"sub_title": "Change from baseline Week 4: (N= 40, 37)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-4.8", "@spread": "5.34"}, {"@group_id": "O2", "@value": "-5.5", "@spread": "6.50"}]}}, {"sub_title": "Change from baseline Week 12: (N= 41, 35)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-8.6", "@spread": "6.76"}, {"@group_id": "O2", "@value": "-8.7", "@spread": "6.19"}]}}, {"sub_title": "Change from baseline Week 24: (N= 40, 34)", "measurement_list": {"measurement": [{"@group_id": "O1", "@value": "-8.6", "@spread": "5.79"}, {"@group_id": "O2", "@value": "-9.4", "@spread": "5.52"}]}}]}}]}}]}, "reported_events": {"group_list": {"group": [{"@group_id": "E1", "title": "Standard Dose", "description": "Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}, {"@group_id": "E2", "title": "Low Dose", "description": "Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient\'s weight. The planned treatment duration was 24 weeks."}]}, "serious_events": {"default_vocab": "MedDRA", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, serious adverse events", "counts": [{"@group_id": "E1", "@subjects_affected": "8", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "4", "@subjects_at_risk": "39"}]}}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Diarrhoea", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Pancreatitis acute", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Vomiting", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}]}}, {"title": "General disorders", "event_list": {"event": [{"sub_title": "Death", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Mucosal inflammation", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Multi-organ failure", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Oedema peripheral", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}]}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Cytomegalovirus infection", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Epstein-barr virus infection", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Gastroenteritis", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Herpes zoster", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Sinusitis", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}]}}, {"title": "Injury, poisoning and procedural complications", "event_list": {"event": [{"sub_title": "Fall", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Tendon rupture", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}]}}, {"title": "Nervous system disorders", "event_list": {"event": [{"sub_title": "Headache", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Syncope", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}]}}, {"title": "Renal and urinary disorders", "event_list": {"event": {"sub_title": "Renal failure acute", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": {"sub_title": "Dysphonia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}}}, {"title": "Vascular disorders", "event_list": {"event": {"sub_title": "Hypertension", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}}}]}}, "other_events": {"frequency_threshold": "5", "default_vocab": "MedDRA", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, other adverse events", "counts": [{"@group_id": "E1", "@subjects_affected": "28", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "18", "@subjects_at_risk": "39"}]}}}, {"title": "Blood and lymphatic system disorders", "event_list": {"event": {"sub_title": "Anaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "3", "@subjects_at_risk": "39"}]}}}, {"title": "Cardiac disorders", "event_list": {"event": {"sub_title": "Tachycardia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Abdominal pain upper", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "3", "@subjects_at_risk": "39"}]}, {"sub_title": "Constipation", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Diarrhoea", "counts": [{"@group_id": "E1", "@subjects_affected": "9", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "8", "@subjects_at_risk": "39"}]}, {"sub_title": "Gastritis", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}, {"sub_title": "Nausea", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Vomiting", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "4", "@subjects_at_risk": "39"}]}]}}, {"title": "General disorders", "event_list": {"event": {"sub_title": "Oedema peripheral", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "5", "@subjects_at_risk": "39"}]}}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Folliculitis", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}, {"sub_title": "Herpes zoster", "counts": [{"@group_id": "E1", "@subjects_affected": "6", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "39"}]}, {"sub_title": "Nasopharyngitis", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Upper respiratory tract infection", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}]}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": [{"sub_title": "Arthralgia", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "5", "@subjects_at_risk": "39"}]}, {"sub_title": "Muscle spasms", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@su bjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "39"}]}, {"sub_title": "Musculoskeletal stiffness", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}]}}, {"title": "Psychiatric disorders", "event_list": {"event": {"sub_title": "Insomnia", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "4", "@subjects_at_risk": "39"}]}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": {"sub_title": "Cough", "counts": [{"@group_id": "E1", "@subjects_affected": "3", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}}}, {"title": "Vascular disorders", "event_list": {"event": {"sub_title": "Hypertension", "counts": [{"@group_id": "E1", "@subjects_affected": "2", "@subjects_at_risk": "42"}, {"@group_id": "E2", "@subjects_affected": "2", "@subjects_at_risk": "39"}]}}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "The terms and conditions of Novartis\' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial."}, "point_of_contact": {"name_or_title": "Study Director", "organization": "Novartis Pharmaceuticals", "phone": "862-778-8300"}}}', 'completion_date': u'November 2009', 'condition_browse': '{"condition_browse": {"mesh_term": ["Lupus Nephritis", "Nephritis"]}}', 'conditions': '[{"condition": "Lupus Nephritis"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion criteria\\n\\n - Male or female patients with systemic lupus erythematosus (SLE)(at least 4\\n classification criteria)\\n\\n - Aged \\u226518 years,\\n\\n - Proliferative lupus nephritis classified as ISN/RPS class III or IV\\n\\n - Renal biopsy within the last 24-month preceding the study entry\\n\\n - Proteinuria defined as >0.5 gram urine protein per gram urine creatinine at screening\\n and baseline\\n\\n - Clinical activity defined by one or more of the following changes in renal function:\\n Serum creatinine >1.0 mg/dl (88.4 \\u03bcmol/l)\\n\\n - Microscopic hematuria defined as >5 red cells per high power field\\n\\n - Presence of cellular casts\\n\\n Exclusion criteria\\n\\n - Patients with calculated creatinine clearance <30 ml/min (using the Cockcroft-Gault\\n formula)\\n\\n - Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3\\n months,\\n\\n - Patients having received oral or i.v. cyclophosphamide during the last 3 month\\n\\n - Patients having received mycophenolate mofetil (MMF) within the preceding 3 months\\n\\n - Use of any antibody therapy within the past 6 months\\n\\n - Pregnant or nursing (lactating) women or women of child-bearing potential who are\\n planning to become pregnant, or are not willing to use effective means of\\n contraception throughout the study and during one month after the end of the study.\\n\\n - Use of other investigational drugs within 1 month of enrollment (except for\\n antibodies: within 6 months of enrollment\\n\\n - History of hypersensitivity to any of the study drugs or to drugs with similar\\n chemical structures,\\n\\n - History of malignancy of any organ system, treated or untreated, within the past 5\\n years whether or not there is evidence of local recurrence or metastases, with the\\n exception of localized basal cell carcinoma of the skin.\\n\\n Other protocol-defined inclusion/exclusion criteria may apply."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'81', 'firstreceived_date': u'January 16, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["Methylprednisolone", "Methylprednisolone Hemisuccinate", "Methylprednisolone acetate", "Mycophenolate mofetil", "Mycophenolic Acid", "Prednisolone", "Prednisolone acetate", "Prednisolone hemisuccinate", "Prednisolone phosphate", "Prednisone"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "Mycophenolate sodium", "description": "Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.", "arm_group_label": ["Standard dose", "Low dose"], "other_name": "Myfortic"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Prednisone", "description": "Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient\'s weight.", "arm_group_label": ["Standard dose", "Low dose"]}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "Methylprednisolone", "description": "All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.", "arm_group_label": ["Standard dose", "Low dose"]}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Lupus Nephritis"}, {"keyword": "enteric-coated mycophenolate sodium"}, {"keyword": "EC-MPS"}, {"keyword": "Myfortic"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Colombia"}, {"country": "France"}, {"country": "Germany"}, {"country": "Greece"}, {"country": "Hungary"}, {"country": "Italy"}, {"country": "Spain"}, {"country": "Taiwan"}, {"country": "United Kingdom"}]', 'locations': '[{"location": {"facility": {"name": "Novartis", "address": {"city": "Bogota", "country": "Colombia"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Creteil", "country": "France"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Nantes", "country": "France"}}}}, {"location": {"facility": {"name": "Novartis Investigative Site", "address": {"city": "Paris", "country": "France"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Berlin", "country": "Germany"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Tubingen", "country": "Germany"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Athens", "country": "Greece"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Budapest", "country": "Hungary"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Debrecen", "country": "Hungary"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Brescia", "country": "Italy"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Ferrara", "country": "Italy"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Milano", "country": "Italy"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Padova", "country": "Italy"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Barcelona", "country": "Spain"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Madrid", "country": "Spain"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Taichung", "country": "Taiwan"}}}}, {"location": {"facility": {"name": "Novartis", "address": {"city": "Cambridge", "country": "United Kingdom"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00423098', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare', 'org_study_id': u'CERL080A2420', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Novartis Pharmaceuticals", "role": "Study Director", "affiliation": "Novartis Pharmaceuticals"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)"}}', 'phase': u'Phase 2', 'primary_completion_date': u'November 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "Number of Patients With Complete Remission", "time_frame": "24 Weeks", "safety_issue": "No", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal range according to local lab."}}]', 'reference': '[]', 'removed_countries': '[{"country": "United States"}]', 'responsible_party': '{"responsible_party": {"name_title": "External Affairs", "organization": "Novartis Pharmaceuticals"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Number of Patients With Complete Remission", "time_frame": "12 Weeks", "safety_issue": "No", "description": "Complete remission was defined as urine protein/urine creatinine ratio < 0.5 gram urine protein per gram urine creatinine, urine sediment normalized (no cellular casts, < 5 red cells per high power field), and serum creatinine within 10% of normal value."}}, {"secondary_outcome": {"measure": "Number of Patients With Partial Remission", "time_frame": "Baseline to 12 and 24 weeks", "safety_issue": "No", "description": "Partial remission was defined as urine protein/creatinine ratio reduced by at least 50% from baseline and stable serum creatinine within 10% of baseline value) or improved."}}, {"secondary_outcome": {"measure": "Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)", "time_frame": "12 Weeks and 24 Weeks", "safety_issue": "No", "description": "Corticosteroid use was measured as cumulative dose until 12 and 24 weeks of treatment as well as daily doses at baseline, 12 and 24 weeks."}}, {"secondary_outcome": {"measure": "Number of Patients With Moderate to Severe Flares", "time_frame": "12 and 24 weeks", "safety_issue": "No", "description": "A moderate to severe flare was defined as the occurrence of increased lupus activity after partial or complete remission, based on the presence of 1 BILAG A score or >=3 BILAG B scores. British Isles Lupus Assessment Group (BILAG) index divides lupus activity in 8 organs/systems which are each given a score of A to E. A=disease sufficiently active to need disease modifying treatment; B=problems requiring symptomatic treatment; C=mild stable disease; D=previously affected but currently inactive system; E=the system or organ has never been involved. BILAG score: A=9, B=3, C=1, D/E=0; range(0-72)"}}, {"secondary_outcome": {"measure": "Duration of Exposure to Study Medication", "time_frame": "24 weeks", "safety_issue": "No", "description": "The duration of exposure was calculated as the date of the last Mycophenolate sodium dose minus the date of the last Mycophenolate sodium dose +1."}}, {"secondary_outcome": {"measure": "Number of Patients With Adverse Events and Infections", "time_frame": "24 weeks", "safety_issue": "No", "description": "Safety assessments included collecting all adverse events (AEs), serious adverse events (SAEs), with their severity and relationship to study drug. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening ( NIH criteria Grade 4), causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above."}}, {"secondary_outcome": {"measure": "Number of Patients With Treatment Failure", "time_frame": "12 Weeks and 24 Weeks", "safety_issue": "Yes", "description": "Treatment failure was defined as no therapeutic response (without complete or partial remission) or premature discontinuation during the first 24 weeks from study medication or the study for any reason except complete or partial remission."}}, {"secondary_outcome": {"measure": "Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)", "time_frame": "From Baseline to week 4, week 12 and week 24", "safety_issue": "No", "description": "SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index and was a well established global score index based on assessment of 24 items measuring a disease activity in the 10-day period prior to the assessment. SLEDAI item weights range from 1 for fever to 8 for seizures. A maximum theoretical score is 105. Total score range from 1 to 105. A flare has been defined as a SLEDAI score increase of 3 or more to a level of 8 or higher. During flares SLEDAI scores of 25 to 30 are common."}}, {"secondary_outcome": {"measure": "Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)", "time_frame": "From Baseline to week 4, week 12 and week 24", "safety_issue": "No", "description": "BILAG (British Isles Lupus Assessment Group) index divides lupus activity into 8 organs/systems and was based on the principle of the physician\'s intention to treat, assessing activity in the previous one month. Each organ or system was given a score of A to E, where A = disease that is sufficiently active to require disease modifying treatment; a B = problems requiring symptomatic treatment; C = stable mild disease; D = previously affected but currently inactive system; and E = the system or organ has never been involved. [A=9, B=3, C=1, D/E=0 the score range for each patient will be 0-72]."}}]', 'source': u'Novartis', 'sponsors': '[{"lead_sponsor": {"agency": "Novartis Pharmaceuticals", "agency_class": "Industry"}}]', 'start_date': u'February 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00423098', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:31 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00444548?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=54&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:31 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:31 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:31 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:31 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:31 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00444548?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=54&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n [S,S]-Reboxetine will be used to evaluate pharmacodynamic changes in urethral function in\n healthy volunteers using a novel methodology\n ', 'brief_title': u'Evaluation of A Novel Methodology in the Assessment of Urethral Function Using [S,S]-Reboxetine in Healthy Volunteers', 'clinical_results': '{}', 'completion_date': u'July 2007', 'condition_browse': '{}', 'conditions': '[{"condition": "Healthy"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Healthy female subjects, aged 18-65 years.\\n\\n - Subjects must be non-pregnant and non-lactating, and be either post menopausal\\n (greater than 1 year without menses), surgically sterilized, or using another\\n acceptable form of contraception.\\n\\n - Subjects of child bearing potential must have confirmed negative pregnancy tests at\\n screening and prior to commencing all study periods.\\n\\n Exclusion Criteria:\\n\\n - Evidence or history of clinically significant disease (including drug allergies, but\\n excluding untreated, asymptomatic,seasonal allergies at time of dosing).\\n\\n - Subjects with any clinically significant abnormality following review of laboratory\\n data, urinalysis and physical examination."}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "65 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'12', 'firstreceived_date': u'March 6, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Reboxetine"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "[S,S]-Reboxetine"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "Equipment"}, {"keyword": "Supplies"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6061028&StudyName=Evaluation%20of%20A%20Novel%20Methodology%20in%20the%20Assessment%20of%20Urethral%20Function%20Using%20%5BS%2CS%5D-Reboxetine%20in%20healthy%20volunteers", "description": "To obtain contact information for a study center near you, click here."}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Denmark"}]', 'locations': '[{"location": {"facility": {"name": "Pfizer Investigational Site", "address": {"city": "Hellerup", "zip": "2900", "country": "Denmark"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00444548', 'number_of_arms': '', 'number_of_groups': '', 'official_title': u'Measurement Of Urethral Function In Healthy Female Volunteers - Evaluation Of The Sensitivity of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine.', 'org_study_id': u'A6061028', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Pfizer CT.gov Call Center", "role": "Study Director", "affiliation": "Pfizer"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "Danish Dataprotection Agency, Danish Medicines Agency and Ethics Committee Denmark:"}}', 'phase': u'N/A', 'primary_completion_date': '', 'primary_outcomes': '[{"primary_outcome": {"measure": "Reflectometry measurements at visit 2, 3, 4 , 5, 6 and 7."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Director, Clinical Trial Disclosure Group", "organization": "Pfizer, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Urethral pressure profile measurements at visit 2, 3, 4, 5, 6 and 7"}}]', 'source': u'Pfizer', 'sponsors': '[{"lead_sponsor": {"agency": "Pfizer", "agency_class": "Industry"}}]', 'start_date': u'May 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00444548', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:33 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00458029?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=53&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:33 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:33 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:33 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:33 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:33 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00458029?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=53&resultsxml=true> {'acronym': u'HEALTHY', 'arm_groups': '[{"arm_group": {"arm_group_label": "1", "arm_group_type": "Experimental", "description": "integration of activities, events, and programs affecting total school food service environment, physical education class, behavior change, promotion, and communications"}}, {"arm_group": {"arm_group_label": "2", "arm_group_type": "No Intervention", "description": "observational control"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n HEALTHY was a primary prevention trial conducted in 42 middle schools at 7 locations across\n the US to impact risk factors for type 2 diabetes in adolescents. Students were recruited at\n start of 6th grade (fall 2006) and followed to end of 8th grade (spring 2009). Half of the\n schools were randomized to receive an intervention that integrated four components: the\n school nutrition environment, physical education class activities, behavior change\n initiatives, and educational and promotional communications activities.\n ', 'brief_title': u'Middle-School Based Primary Prevention Trial of Type 2 Diabetes', 'clinical_results': '{}', 'completion_date': u'February 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Diabetes Mellitus, Type 2"}}', 'conditions': '[{"condition": "Type 2 Diabetes"}]', 'detailed_description': u'\n In response to increases in incident cases of type 2 diabetes in American children and\n youth, NIDDK funded a multi-site primary prevention trial designed to moderate risk for type\n 2 diabetes in middle school aged children. In pilot studies, it was found that an indicator\n of adiposity, a body mass index greater than the 85th percentile for gender and age, was the\n most prevalent, modifiable risk factor for diabetes in this age group. In addition,\n indicators of insulin resistance and dysglycemia, elevated mean fasting insulin and glucose\n levels, were assessed to determine if the intervention was capable of reducing these risk\n factors for diabetes in middle school aged children.\n\n The trial was conducted at 7 field centers in 42 middle schools randomly assigned to\n intervention or control. Following student recruitment and baseline data collection in the\n first semester of 6th grade (2006), the intervention was implemented in the second semester\n of 6th grade (2007) and continued throughout 7th (school year 2007-2008) and 8th (school\n year 2008-2009) grades. All students were exposed to components of the intervention, which\n were implemented school-wide or grade-wide; however, only students who provided appropriate\n informed consent and assent participated in data collection and evaluation. The primary\n objective of the trial was to determine if, at the end of the 8th grade, the intervention\n significantly impacted the risk for developing type 2 diabetes compared to control.\n\n Six pilot studies were performed to collect data to guide the development of an\n intervention. The prior studies focused on:\n\n - Establishing the feasibility of recruiting students and obtaining physical and\n physiological measurements, including fasting and 2-hour post glucose load blood draws\n (early 2003).\n\n - Evaluating a physical education (PE) class program designed to increase\n moderate-to-vigorous physical activity (late 2003).\n\n - Testing the ability of a nutrition intervention to change food and beverage offerings\n in school food service and vending (early 2004).\n\n - Implementing a program that integrated the PE class and food service nutrition\n interventions with a communications and awareness campaign (fall 2004).\n\n - Determining the feasibility of a behavior change intervention, delivered through\n in-class and other school settings and family outreach, to accomplish self monitoring\n and goal setting (fall 2005).\n\n - Evaluating PE class activities targeting 7th and 8th graders and a training and support\n program to motivate PE teacher buy-in and adherence (fall 2005).\n\n Formative research was conducted to inform the creation of all intervention components.\n\n Based on a comprehensive review of the literature and the pilot study results, a robust\n multi-component intervention was developed to impact the environment and lifestyle choices\n of middle school children. The intervention consisted of the following integrated\n components:\n\n - changes in the nutritional quality of food and beverage offerings throughout the total\n school food environment, including cafeteria meals and programs, a la carte, and\n vending machines;\n\n - changes in the physical education (PE) program, equipment, and teacher training to\n increase both participation and number of minutes spent in moderate-to-vigorous\n physical activity when implemented by PE teachers in PE class;\n\n - brief classroom activities designed to increase knowledge, enhance decision making\n skills, promote peer involvement and interaction, and enhance social influence;\n\n - individual and group behavior change initiatives aimed at promoting healthier behaviors\n through self monitoring, goal setting, and problem solving;\n\n - family outreach to involve parents/guardians and family members by providing\n information and strategies to support youth in accomplishing behavioral goals; and\n\n - school-wide communications to enhance and promote changes in nutrition, activity, and\n behavior.\n\n In addition to the primary objective of affecting risk for T2D, major secondary objectives\n were to: further understand and characterize the etiology of risk of T2D in this age group;\n evaluate the ability of the intervention to influence lifestyle changes and choices both in\n and out of school; determine the cost-effectiveness of the intervention; compare academic\n performance, attendance, and comportment in intervention versus control schools; and\n describe the influence of non-study changes in the school environment that affect student\n nutrition and physical activity. Finally, data were collected to evaluate the degree to\n which the components of the intervention were delivered and administered as planned.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Middle school student body is at least 50% minority (defined as African American,\\n Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or\\n reduced lunch.\\n\\n - Middle school annual school-wide attrition from all causes is <= 25% (estimate\\n determined from data provided by the school).\\n\\n - Middle school expected cohort size at end of study is at least 50 per school\\n determined by applying 50% anticipated enrollment rate and annual school-wide\\n attrition rate over 3 years.\\n\\n - Student able to participate in the school\'s standard PE program.\\n\\n - Student\'s parent/guardian has provided informed consent for the child to participate\\n in data collection and evaluation procedures.\\n\\n - Student has provided informed assent to participate in data collection and evaluation\\n procedures.\\n\\n Exclusion Criteria: (none specified)"}, "gender": "Both", "minimum_age": "10 Years", "maximum_age": "16 Years", "healthy_volunteers": "Accepts Healthy Volunteers"}}', 'enrollment': u'4603', 'firstreceived_date': u'April 5, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Behavioral", "intervention_name": "integrated program of nutrition, activity, behavior, and promotion", "description": "implemented across 5 half-year periods: winter/spring 2007, fall 2007, winter/spring 2007, fall 2008, winter/spring 2008", "arm_group_label": "1"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "type 2 diabetes risk factors"}, {"keyword": "obesity"}, {"keyword": "prevention"}, {"keyword": "adolescence"}, {"keyword": "school based"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "http://www.healthystudy.org", "description": "public access to HEALTHY intervention program materials"}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "University of California at Irvine", "address": {"city": "Irvine", "state": "California", "zip": "92868", "country": "United States"}}}}, {"location": {"facility": {"name": "George Washington University Biostatistics Center", "address": {"city": "Rockville", "state": "Maryland", "zip": "20852", "country": "United States"}}}}, {"location": {"facility": {"name": "University of North Carolina at Chapel Hill", "address": {"city": "Chapell Hill", "state": "North Carolina", "zip": "27599", "country": "United States"}}}}, {"location": {"facility": {"name": "Oregon Health & Science University", "address": {"city": "Portland", "state": "Oregon", "zip": "97239", "country": "United States"}}}}, {"location": {"facility": {"name": "Temple University", "address": {"city": "Philadelphia", "state": "Pennsylvania", "zip": "19140", "country": "United States"}}}}, {"location": {"facility": {"name": "University of Pittsburgh", "address": {"city": "Pittsburgh", "state": "Pennsylvania", "zip": "15213", "country": "United States"}}}}, {"location": {"facility": {"name": "Baylor College of Medicine", "address": {"city": "Houston", "state": "Texas", "zip": "77030", "country": "United States"}}}}, {"location": {"facility": {"name": "University of Texas Health Science Center", "address": {"city": "San Antonio", "state": "Texas", "zip": "78210", "country": "United States"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00458029', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Middle-School Based Primary Prevention Trial (HEALTHY)', 'org_study_id': u'IND - DK61230-HEALTHY', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Gary D Foster, PhD", "role": "Principal Investigator", "affiliation": "Temple University"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Federal Government", "has_dmc": "Yes"}}', 'phase': u'Phase 3', 'primary_completion_date': u'June 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "Body mass index (BMI) >= 85th percentile, adjusted for gender and age", "time_frame": "baseline, end of 7th grade, end of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Fasting glucose (mg/dL)", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"primary_outcome": {"measure": "Fasting insulin (mU/mL)", "time_frame": "baseline, end of study", "safety_issue": "No"}}]', 'reference': '[{"reference": {"citation": "HEALTHY Study Group, Hirst K, Baranowski T, DeBar L, Foster GD, Kaufman F, Kennel P, Linder B, Schneider M, Venditti EM, Yin Z. HEALTHY study rationale, design and methods: moderating risk of type 2 diabetes in multi-ethnic middle school students. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S4-20. doi: 10.1038/ijo.2009.112.", "PMID": "19623188"}}, {"reference": {"citation": "Drews KL, Harrell JS, Thompson D, Mazzuto SL, Ford EG, Carter M, Ford DA, Yin Z, Jessup AN, Roullet JB; HEALTHY Study Group. Recruitment and retention strategies and methods in the HEALTHY study. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S21-8. doi: 10.1038/ijo.2009.113.", "PMID": "19623184"}}, {"reference": {"citation": "Gillis B, Mobley C, Stadler DD, Hartstein J, Virus A, Volpe SL, El ghormli L, Staten MA, Bridgman J, McCormick S; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study nutrition intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S29-36. doi: 10.1038/ijo.2009.114.", "PMID": "19623185"}}, {"reference": {"citation": "McMurray RG, Bassin S, Jago R, Bruecker S, Moe EL, Murray T, Mazzuto SL, Volpe SL; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study physical education intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S37-43. doi: 10.1038/ijo.2009.115.", "PMID": "19623187"}}, {"reference": {"citation": "Venditti EM, Elliot DL, Faith MS, Firrell LS, Giles CM, Goldberg L, Marcus MD, Schneider M, Solomon S, Thompson D, Yin Z; HEALTHY Study Group. Rationale, design and methods of the HEALTHY study behavior intervention component. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S44-51. doi: 10.1038/ijo.2009.116.", "PMID": "19623189"}}, {"reference": {"citation": "DeBar LL, Schneider M, Ford EG, Hernandez AE, Showell B, Drews KL, Moe EL, Gillis B, Jessup AN, Stadler DD, White M; HEALTHY Study Group. Social marketing-based communications to integrate and support the HEALTHY study intervention. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S52-9. doi: 10.1038/ijo.2009.117.", "PMID": "19623190"}}, {"reference": {"citation": "Schneider M, Hall WJ, Hernandez AE, Hindes K, Montez G, Pham T, Rosen L, Sleigh A, Thompson D, Volpe SL, Zeveloff A, Steckler A; HEALTHY Study Group. Rationale, design and methods for process evaluation in the HEALTHY study. Int J Obes (Lond). 2009 Aug;33 Suppl 4:S60-7. doi: 10.1038/ijo.2009.118.", "PMID": "19623191"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Kathryn Hirst/Coordinating Center Principal Investigator", "organization": "George Washington University Biostatistics Center"}}', 'results_reference': '[{"results_reference": {"citation": "Baranowski T, Cooper DM, Harrell J, Hirst K, Kaufman FR, Goran M, Resnicow K; STOPP-T2D Prevention Study Group. Presence of diabetes risk factors in a large U.S. eighth-grade cohort. Diabetes Care. 2006 Feb;29(2):212-7.", "PMID": "16443862"}}, {"results_reference": {"citation": "Jago R, Harrell JS, McMurray RG, Edelstein S, El Ghormli L, Bassin S. Prevalence of abnormal lipid and blood pressure values among an ethnically diverse population of eighth-grade adolescents and screening implications. Pediatrics. 2006 Jun;117(6):2065-73.", "PMID": "16740849"}}, {"results_reference": {"citation": "Cullen KW, Hartstein J, Reynolds KD, Vu M, Resnicow K, Greene N, White MA; Studies to Treat or Prevent Pediatric Type 2 Diabetes Prevention Study Group. Improving the school food environment: results from a pilot study in middle schools. J Am Diet Assoc. 2007 Mar;107(3):484-9.", "PMID": "17324667"}}, {"results_reference": {"citation": "Hartstein J, Cullen KW, Reynolds KD, Harrell J, Resnicow K, Kennel P; STOPP T2D Prevention Study Group. Impact of portion-size control for school a la carte items: changes in kilocalories and macronutrients purchased by middle school students. J Am Diet Assoc. 2008 Jan;108(1):140-4.", "PMID": "18156001"}}, {"results_reference": {"citation": "Studies to Treat or Prevent Pediatric Type 2 Diabetes Prevention Study Group. Prevalence of the metabolic syndrome among a racially/ethnically diverse group of U.S. eighth-grade adolescents and associations with fasting insulin and homeostasis model assessment of insulin resistance levels. Diabetes Care. 2008 Oct;31(10):2020-5. doi: 10.2337/dc08-0411. Epub 2008 Jun 30.", "PMID": "18591405"}}, {"results_reference": {"citation": "Jago R, Baranowski T, Watson K, Bachman C, Baranowski JC, Thompson D, Hern\\u00e1ndez AE, Venditti E, Blackshear T, Moe E. Development of new physical activity and sedentary behavior change self-efficacy questionnaires using item response modeling. Int J Behav Nutr Phys Act. 2009 Mar 31;6:20. doi: 10.1186/1479-5868-6-20.", "PMID": "19335875"}}, {"results_reference": {"citation": "Jago R, McMurray RG, Bassin S, Pyle L, Bruecker S, Jakicic JM, Moe E, Murray T, Volpe SL. Modifying middle school physical education: piloting strategies to increase physical activity. Pediatr Exerc Sci. 2009 May;21(2):171-85.", "PMID": "19556623"}}, {"results_reference": {"citation": "HEALTHY Study Group, Kaufman FR, Hirst K, Linder B, Baranowski T, Cooper DM, Foster GD, Goldberg L, Harrell JS, Marcus MD, Trevi\\u00f1o RP. Risk factors for type 2 diabetes in a sixth- grade multiracial cohort: the HEALTHY study. Diabetes Care. 2009 May;32(5):953-5. doi: 10.2337/dc08-1774. Epub 2009 Feb 5.", "PMID": "19196888"}}, {"results_reference": {"citation": "Baranowski T, Watson KB, Bachman C, Baranowski JC, Cullen KW, Thompson D, Siega Riz AM. Self efficacy for fruit, vegetable and water intakes: Expanded and abbreviated scales from item response modeling analyses. Int J Behav Nutr Phys Act. 2010 Mar 29;7:25. doi: 10.1186/1479-5868-7-25.", "PMID": "20350316"}}, {"results_reference": {"citation": "HEALTHY Study Group, Foster GD, Linder B, Baranowski T, Cooper DM, Goldberg L, Harrell JS, Kaufman F, Marcus MD, Trevi\\u00f1o RP, Hirst K. A school-based intervention for diabetes risk reduction. N Engl J Med. 2010 Jul 29;363(5):443-53. doi: 10.1056/NEJMoa1001933. Epub 2010 Jun 27.", "PMID": "20581420"}}, {"results_reference": {"citation": "Jago R, Drews KL, McMurray RG, Thompson D, Volpe SL, Moe EL, Jakicic JM, Pham TH, Bruecker S, Blackshear TB, Yin Z. Fatness, fitness, and cardiometabolic risk factors among sixth-grade youth. Med Sci Sports Exerc. 2010 Aug;42(8):1502-10. doi: 10.1249/MSS.0b013e3181d322c4.", "PMID": "20139783"}}, {"results_reference": {"citation": "Marcus MD, Baranowski T, DeBar LL, Edelstein S, Kaufman FR, Schneider M, Siega-Riz AM, Staten MA, Virus A, Yin Z. Severe obesity and selected risk factors in a sixth grade multiracial cohort: the HEALTHY study. J Adolesc Health. 2010 Dec;47(6):604-7. doi: 10.1016/j.jadohealth.2010.04.017. Epub 2010 Jun 29.", "PMID": "21094439"}}, {"results_reference": {"citation": "Siega-Riz AM, El Ghormli L, Mobley C, Gillis B, Stadler D, Hartstein J, Volpe SL, Virus A, Bridgman J; HEALTHY Study Group. The effects of the HEALTHY study intervention on middle school student dietary intakes. Int J Behav Nutr Phys Act. 2011 Feb 4;8:7. doi: 10.1186/1479-5868-8-7.", "PMID": "21294869"}}]', 'secondary_ids': '[{"secondary_id": "DK61223, DK61231, DK61249"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Lipids (total cholesterol, HDL, LDL, triglycerides)", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Other laboratory indicators of diabetes and obesity risk, such as HbA1c", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Blood pressure", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Waist circumference", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Physical activity", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Sedentary behavior", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Fitness", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Daily nutritional intake", "time_frame": "baseline, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "PE class activity level (MVPA by heart rate monitor)", "time_frame": "baseline, end of 7th grade, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Quality-adjusted life years saved (QALYS)", "time_frame": "baseline, end of 7th grade, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Total school food environment amounts and nutrients", "time_frame": "baseline, end of 7th grade, end of study", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Grade and school level state standardized test score pass rates", "time_frame": "end of 6th, 7th, 8th grades", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Grade and school level attendance rates", "time_frame": "end of 6th, 7th, 8th grades", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Grade and school level comportment rates (i.e., referral to administrative offices for disciplinary action)", "time_frame": "end of 6th, 7th, 8th grades", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Costs associated with intervention delivery and administration", "time_frame": "once per intervention semester (5 x)", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Decisions, policies, and activities at the school, local, state, or federal level that influence the school environment for nutrition and physical activity", "time_frame": "once per year (3 x)", "safety_issue": "No"}}]', 'source': u'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'sponsors': '[{"lead_sponsor": {"agency": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "agency_class": "NIH"}}]', 'start_date': u'August 2006', 'study_design': u'Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00458029', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:34 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00465712?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=52&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:34 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:34 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:34 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:34 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:34 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00465712?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=52&resultsxml=true> {'acronym': u'AMNIO', 'arm_groups': '[{"arm_group": {"arm_group_label": "A", "arm_group_type": "Experimental", "description": "Transabdominal amnioinfusion performed before external cephalic version"}}, {"arm_group": {"arm_group_label": "V", "arm_group_type": "No Intervention", "description": "Without transabdominal amnioinfusion"}}]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u"\n The aim of the study is to evaluate the effect of transabdominal amnioinfusion before second\n external cephalic version after initial failure.Patient with a single foetus, at term, in\n breech presentation and after a first cephalic version are included. The randomisation\n determines whether the patient is included in the group with amnioinfusion before second\n cephalic version or with usual second cephalic version only; The efficacy's evaluation is\n based on rate of cephalic presentation at birth.Success rate of cephalic version with or\n without transabdominal amnioinfusion, rates of cesarian section in the two groups,maternal\n and fetal morbidity, time between second cephalic version and birth will be studied.\n\n Prospective interventional randomized sequential comparative multicentric study. A maximum\n of 240 patients will be included (120 in each group). As the study is sequential it will be\n over as soon as a significative difference is shown.\n ", 'brief_title': u'Effect of Amnioinfusion on External Cephalic Version Successful Rate', 'clinical_results': '{}', 'completion_date': u'May 2011', 'condition_browse': '{"condition_browse": {"mesh_term": "Breech Presentation"}}', 'conditions': '[{"condition": "Breech Presentation"}]', 'detailed_description': u"\n The purpose of the study is to evaluate the effect of transabdominal amnioinfusion before a\n second external cephalic version after initial failure. In case of success it could be an\n alternative to cesarian section. Without any other technique the foetus is in cephalic\n presentation after a first external cephalic version in 50%.\n\n Patients with a single fetus, at term, in breech presentation are proposed to participate.\n The randomization is done at the inclusion and determines whether the patient is included in\n the group with amnioinfusion before second cephalic version or usual second cephalic version\n only. The only difference between the two groups is the realisation of an amnioinfusion, the\n cephalic version's technique is the same.\n\n Efficacy's evaluation is based on rate of cephalic presentation at birth. Success rate of\n cephalic version, rates of cesarian section, maternal and fetal morbidity in the two groups,\n time between second cephalic version and birth will be studied.\n ", 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - single fetal pregnancy\\n\\n - breech presentation\\n\\n - at term\\n\\n - initial failure of external cephalic version\\n\\n - structurally normal foetus\\n\\n Exclusion Criteria:\\n\\n - polyhydramnios\\n\\n - anhydramnios\\n\\n - abnormality of the fetal heart rhythm\\n\\n - uterine congenital malformation\\n\\n - cesarian section for a previous birth\\n\\n - unability to understand study"}, "gender": "Female", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'240', 'firstreceived_date': u'April 24, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[{"intervention": {"intervention_type": "Procedure", "intervention_name": "transabdominal amnioinfusion", "description": "transabdominal amnioinfusion performed 4 to 24 hours before the second trial of external cephalic version", "arm_group_label": "A"}}]', 'is_fda_regulated': u'No', 'is_section_801': '', 'keywords': '[{"keyword": "transabdominal amnioinfusion"}, {"keyword": "external cephalic version"}, {"keyword": "breech presentation"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "France"}]', 'locations': '[{"location": {"facility": {"name": "Mother Child University Hospital", "address": {"city": "Nantes", "zip": "44000", "country": "France"}}}}, {"location": {"facility": {"name": "Olympe de Gouges Women Health Centre, Bretonneau University Hospital", "address": {"city": "Tours", "zip": "37000", "country": "France"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00465712', 'number_of_arms': u'2', 'number_of_groups': '', 'official_title': u'Effect of Amnioinfusion on External Cephalic Version After Initial Failure a Prospective Multicentric Randomized Study', 'org_study_id': u'PHRN05-FP/AMNIO2006', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Franck Perrotin, MD-PhD", "role": "Principal Investigator", "affiliation": "Tours University Hospital"}}', 'overall_status': u'Terminated', 'oversight_info': '{"oversight_info": {"authority": "France: Afssaps - Agence fran\\u00e7aise de s\\u00e9curit\\u00e9 sanitaire des produits de sant\\u00e9 (Saint-Denis)", "has_dmc": "Yes"}}', 'phase': u'N/A', 'primary_completion_date': u'May 2011', 'primary_outcomes': '[{"primary_outcome": {"measure": "cephalic presentation at birth", "time_frame": "at birth", "safety_issue": "No"}}]', 'reference': '[{"reference": {"citation": "Benifla JL, Goffinet F, Darai E, Madelenat P. Antepartum transabdominal amnioinfusion to facilitate external cephalic version after initial failure. Obstet Gynecol. 1994 Dec;84(6):1041-2.", "PMID": "7970462"}}, {"reference": {"citation": "B\\u00e9nifla JL, Goffinet F, Bascou V, Darai E, Proust A, Madelenat P. [Transabdominal amnio-infusion facilitates external version maneuver after initial failure. Six successful attempts]. J Gynecol Obstet Biol Reprod (Paris). 1995;24(3):319-22. French.", "PMID": "7622781"}}, {"reference": {"citation": "Boucher M, Bujold E, Marquette GP, Vezina Y. The relationship between amniotic fluid index and successful external cephalic version: a 14-year experience. Am J Obstet Gynecol. 2003 Sep;189(3):751-4.", "PMID": "14526307"}}, {"reference": {"citation": "Cheng M, Hannah M. Breech delivery at term: a critical review of the literature. Obstet Gynecol. 1993 Oct;82(4 Pt 1):605-18. Review.", "PMID": "8377990"}}, {"reference": {"citation": "Collaris RJ, Oei SG. External cephalic version: a safe procedure? A systematic review of version-related risks. Acta Obstet Gynecol Scand. 2004 Jun;83(6):511-8. Review.", "PMID": "15144330"}}, {"reference": {"citation": "Collea JV, Chein C, Quilligan EJ. The randomized management of term frank breech presentation: a study of 208 cases. Am J Obstet Gynecol. 1980 May 15;137(2):235-44.", "PMID": "7377243"}}, {"reference": {"citation": "Fernandez CO, Bloom SL, Smulian JC, Ananth CV, Wendel GD Jr. A randomized placebo-controlled evaluation of terbutaline for external cephalic version. Obstet Gynecol. 1997 Nov;90(5):775-9.", "PMID": "9351763"}}, {"reference": {"citation": "Fischer R. Breech Presentation. 2004. http://www.emedicine.com/med/topic3272.htm"}}, {"reference": {"citation": "Fisk NM, Ronderos-Dumit D, Soliani A, Nicolini U, Vaughan J, Rodeck CH. Diagnostic and therapeutic transabdominal amnioinfusion in oligohydramnios. Obstet Gynecol. 1991 Aug;78(2):270-8.", "PMID": "2067774"}}, {"reference": {"citation": "Flamm BL, Fried MW, Lonky NM, Giles WS. External cephalic version after previous cesarean section. Am J Obstet Gynecol. 1991 Aug;165(2):370-2.", "PMID": "1872341"}}, {"reference": {"citation": "Gembruch U, Hansmann M. Artificial instillation of amniotic fluid as a new technique for the diagnostic evaluation of cases of oligohydramnios. Prenat Diagn. 1988 Jan;8(1):33-45.", "PMID": "3278306"}}, {"reference": {"citation": "Gimovsky ML, Wallace RL, Schifrin BS, Paul RH. Randomized management of the nonfrank breech presentation at term: a preliminary report. Am J Obstet Gynecol. 1983 May 1;146(1):34-40.", "PMID": "6342396"}}, {"reference": {"citation": "Gramellini D, Fieni S, Kaihura C, Faiola S, Vadora E. Transabdominal antepartum amnioinfusion. Int J Gynaecol Obstet. 2003 Nov;83(2):171-8.", "PMID": "14550592"}}, {"reference": {"citation": "Gramellini D, Fieni S, Kaihura C, Piantelli G, Verrotti C. Antepartum amnioinfusion: a review. J Matern Fetal Neonatal Med. 2003 Nov;14(5):291-6. Review.", "PMID": "14986801"}}, {"reference": {"citation": "Gramellini D, Fieni S, Piantelli G, Faiola S, Kaihura C, Verrotti C, Cavallotti D, Viola P, Bacchini G, Vadora E. [Amnioinfusion: techniques, indications, and controlled retrospective study of 55 cases]. Acta Biomed Ateneo Parmense. 2000;71 Suppl 1:325-9. Italian.", "PMID": "11424764"}}, {"reference": {"citation": "Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83.", "PMID": "11052579"}}, {"reference": {"citation": "Hellstr\\u00f6m AC, Nilsson B, St\\u00e5nge L, Nylund L. When does external cephalic version succeed? Acta Obstet Gynecol Scand. 1990;69(4):281-5.", "PMID": "2244457"}}, {"reference": {"citation": "Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2004;(1):CD000184. Review. Update in: Cochrane Database Syst Rev. 2012;1:CD000184.", "PMID": "14973948"}}, {"reference": {"citation": "Hofmeyr GJ, Hannah ME. Planned caesarean section for term breech delivery (Cochrane Review). In: The Cochrane Library, Issue 3, 2004b. Chichester, UK: John Wiley & Sons, Ltd"}}, {"reference": {"citation": "Hofmeyr GJ, Kulier R. Cephalic version by postural management for breech presentation (Cochrane Review). In: The Cochrane Library, Issue 3, 2004c. Chichester, UK: John Wiley & Sons, Ltd."}}, {"reference": {"citation": "Hofmeyr GJ, Kulier R. External cephalic version for breech presentation at term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004d. Chichester, UK: John Wiley & Sons, Ltd"}}, {"reference": {"citation": "Hofmeyr GJ. External cephalic version facilitation for breech presentation at term. Cochrane Database Syst Rev. 2000;(2):CD000184. Review. Update in: Cochrane Database Syst Rev. 2001;(4):CD000184.", "PMID": "10796176"}}, {"reference": {"citation": "Hofmeyr GJ. External cephalic version for breech presentation before term (Cochrane Review). In: The Cochrane Library, Issue 3, 2004e. Chichester, UK: John Wiley & Sons, Ltd."}}, {"reference": {"citation": "Hutton EK, Kaufman K, Hodnett E, Amankwah K, Hewson SA, McKay D, Szalai JP, Hannah ME. External cephalic version beginning at 34 weeks\' gestation versus 37 weeks\' gestation: a randomized multicenter trial. Am J Obstet Gynecol. 2003 Jul;189(1):245-54.", "PMID": "12861170"}}, {"reference": {"citation": "Kotaska A. Inappropriate use of randomised trials to evaluate complex phenomena: case study of vaginal breech delivery. BMJ. 2004 Oct 30;329(7473):1039-42. Review. Erratum in: BMJ. 2004 Dec 11;329(7479):1385.", "PMID": "15514356"}}, {"reference": {"citation": "Lansac J, Body G, Perrotin F, Marret H. Pratique de l\'accouchement. Paris: Masson ; 2001, p. 365-369."}}, {"reference": {"citation": "Le Bret T, Grang\\u00e9 G, Goffinet F, Cabrol D. [External cephalic version: experience about 237 versions at Port-Royal maternity]. J Gynecol Obstet Biol Reprod (Paris). 2004 Jun;33(4):297-303. French.", "PMID": "15170425"}}, {"reference": {"citation": "Lilford RJ, van Coeverden de Groot HA, Moore PJ, Bingham P. The relative risks of caesarean section (intrapartum and elective) and vaginal delivery: a detailed analysis to exclude the effects of medical disorders and other acute pre-existing physiological disturbances. Br J Obstet Gynaecol. 1990 Oct;97(10):883-92.", "PMID": "2223678"}}, {"reference": {"citation": "Newman RB, Peacock BS, VanDorsten JP, Hunt HH. Predicting success of external cephalic version. Am J Obstet Gynecol. 1993 Aug;169(2 Pt 1):245-9; discussion 249-50.", "PMID": "8362933"}}, {"reference": {"citation": "Novakov-Miki\\u0107 A, Stoji\\u0107 S, Bogavac M, Mandi\\u0107 A. [Amnionic infusion therapy in conditions with low amnionic fluid levels]. Med Pregl. 2003 Jan-Feb;56(1-2):33-7. Croatian.", "PMID": "12793184"}}, {"reference": {"citation": "Perrotin F, Sauget S, Laffont M, Lansac J, Body G. Version par man\\u0153uvre externe: nouveaux apports techniques. In: Coll\\u00e8ge National des Gyn\\u00e9cologues Obst\\u00e9triciens Fran\\u00e7ais. Mises \\u00e0 jour en Gyn\\u00e9cologie Obst\\u00e9trique - VIGOT Ed. - Paris, 2003;25:5-23"}}, {"reference": {"citation": "Pritchard JA, MacDonald PC. Dystocia caused by abnormalities in presentation, position, or development of the fetus. Williams Obstetrics. Norwalk, CT: Appleton-Century-Crofts; 1980, p. 787-796."}}, {"reference": {"citation": "Rietberg CC, Elferink-Stinkens PM, Brand R, van Loon AJ, Van Hemel OJ, Visser GH. Term breech presentation in The Netherlands from 1995 to 1999: mortality and morbidity in relation to the mode of delivery of 33824 infants. BJOG. 2003 Jun;110(6):604-9.", "PMID": "12798480"}}, {"reference": {"citation": "Royal College of Obstetricians and Gynaecologists Clinical Audit Unit. Effective procedures in maternity care suitable for audit. London: RCOG Press; 1997;4(7). Breech presentation at term, p. 32."}}, {"reference": {"citation": "Royal College of Obstetricians and Gynaecologists The management of breech presentation. 2001"}}, {"reference": {"citation": "Lee D, Contreras M, Robson SC, Rodeck CH, Whittle MJ. Recommendations for the use of anti-D immunoglobulin for Rh prophylaxis. British Blood Transfusion Society and the Royal College of Obstetricians and Gynaecologists. Transfus Med. 1999 Mar;9(1):93-7.", "PMID": "10216910"}}, {"reference": {"citation": "Shalev E, Battino S, Giladi Y, Edelstein S. External cephalic version at term--using tocolysis. Acta Obstet Gynecol Scand. 1993 Aug;72(6):455-7.", "PMID": "8394624"}}, {"reference": {"citation": "Stuart IP. Term breech trial. Lancet. 2001 Jan 20;357(9251):228.", "PMID": "11213120"}}, {"reference": {"citation": "Wagner A, Potin J, Himily V, Arbeille P, Perrotin F. The \\"Loss Of Resistance\\" Syringe: a useful tool for difficult amnioinfusion. Fetal Diagn Ther (submitted)."}}, {"reference": {"citation": "Mousa HA. Re: L\\u00e9d\\u00e9e et al. Management in intractable obstetric haemorrhage: an audit study on 61 cases. Eur J Obstet Gynecol Reprod Biol 2001;94:189-96. Eur J Obstet Gynecol Reprod Biol. 2001 Dec 10;100(1):116-7.", "PMID": "11728673"}}, {"reference": {"citation": "Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12. Review.", "PMID": "8336883"}}]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Pr Franck Perrotin", "organization": "CHRU de Tours"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'University Hospital, Tours', 'sponsors': '[{"lead_sponsor": {"agency": "University Hospital, Tours", "agency_class": "Other"}}]', 'start_date': u'July 2006', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00465712', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:35 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00487214?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=51&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:35 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:35 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:35 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:35 [spiders.trials] DEBUG: intervention_browse: must be string or read-only buffer, not None 2015-10-09 20:53:35 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00487214?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=51&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients\n starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction\n with bimatoprost in "real-world" settings\n ', 'brief_title': u'Internet-based, Naturalistic Evaluation of Tolerability and Individual Patient Target Pressures With Bimatoprost 0.03% in Glaucoma', 'clinical_results': '{}', 'completion_date': u'February 2003', 'condition_browse': '{"condition_browse": {"mesh_term": ["Glaucoma", "Glaucoma, Open-Angle"]}}', 'conditions': '[{"condition": "Glaucoma, Open-Angle"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"study_pop": {"textblock": "Patients with either open-angle glaucoma or ocular hypertension at 41 centers in the\\n United States"}, "sampling_method": "Non-Probability Sample", "criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients with either open-angle glaucoma or ocular hypertension were eligible if they\\n needed bilateral IOP reduction beyond what was achieved with their current\\n medication, or if they were intolerant of other IOP-lowering medications."}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'361', 'firstreceived_date': u'June 13, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{}', 'interventions': '[]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[]', 'lastchanged_date': u'May 31, 2011', 'link': '[{"link": {"url": "http://www.allerganclinicaltrials.com", "description": "(Link to Clinical Trial Results)"}}]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[]', 'locations': '[]', 'nct_aliases': '[]', 'nct_id': u'NCT00487214', 'number_of_arms': '', 'number_of_groups': u'1', 'official_title': '', 'org_study_id': u'MEDNET2001', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Medical Affairs", "role": "Study Director", "affiliation": "Allergan"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Institutional Review Board"}}', 'phase': u'N/A', 'primary_completion_date': u'February 2003', 'primary_outcomes': '[]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Therapeutic Area Head", "organization": "Allergan, Inc"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[]', 'source': u'Allergan', 'sponsors': '[{"lead_sponsor": {"agency": "Allergan", "agency_class": "Industry"}}]', 'start_date': u'June 2002', 'study_design': u'Observational Model: Cohort, Time Perspective: Prospective', 'study_type': u'Observational', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00487214', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:37 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00492284?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=50&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:37 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:37 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:37 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00492284?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=50&resultsxml=true> {'acronym': u'RADICAL', 'arm_groups': '[{"arm_group": {"arm_group_label": "1/4 Fluence Triple Therapy", "arm_group_type": "Experimental", "description": "Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter"}}, {"arm_group": {"arm_group_label": "1/2 Fluence Triple Therapy", "arm_group_type": "Experimental", "description": "Reduced-fluence Visudyne followed by intravitreal 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"@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "41"}]}, {"sub_title": "Kidney function abnormal", "counts": [{"@group_id": "E1", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "41"}]}, {"sub_title": "Prostatic disorder", "counts": [{"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "3", "@subjects_affected": "2", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "41"}]}]}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Bronchitis", "counts": [{"@group_id": "E1", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "4", "@subjects_affected": "4", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "41"}]}, {"sub_title": "Cough increased", "counts": [{"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "6", "@subjects_affected": "6", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "41"}]}, {"sub_title": "Pneumonia", "counts": [{"@group_id": "E1", "@events": "2", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "3", "@subjects_affected": "3", "@subjects_at_risk": "41"}]}, {"sub_title": "Dyspnea", "counts": [{"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "41"}]}, {"sub_title": "Lung disorder", "counts": [{"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "4", "@subjects_affected": "4", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "41"}]}]}}, {"title": "Skin and subcutaneous tissue disorders", "event_list": {"event": [{"sub_title": "Rash", "counts": [{"@group_id": "E1", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "41"}]}, {"sub_title": "Skin carcinoma", "counts": [{"@group_id": "E1", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "1", "@subjects_affected": "1", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "41"}]}, {"sub_title": "Skin disorder", "counts": [{"@group_id": "E1", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "39"}, {"@group_id": "E2", "@events": "0", "@subjects_affected": "0", "@subjects_at_risk": "39"}, {"@group_id": "E3", "@events": "2", "@subjects_affected": "2", "@subjects_at_risk": "43"}, {"@group_id": "E4", "@events": "4", "@subjects_affected": "3", "@subjects_at_risk": "41"}]}]}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "Publication materials will be reviewed and commented on by the Sponsor prior to submission for publication; Names of all Investigators and Sponsor representatives responsible for study design and analysis of results will be disclosed in the publication."}, "limitations_and_caveats": "Retreatment and vision analysis limitations, sample size, lack of standard monotherapy regimen used in practice, no treatment regimen approved by regulatory authorities, potential for bias in FA assessment, no central reading center, single-masked", "point_of_contact": {"name_or_title": "Medical Information Department", "organization": "QLT Inc.", "phone": "1-800-663-5486", "email": "medaff@qltinc.com"}}}', 'completion_date': u'May 2010', 'condition_browse': '{"condition_browse": {"mesh_term": ["Choroidal Neovascularization", "Macular Degeneration", "Neovascularization, Pathologic"]}}', 'conditions': '[{"condition": "Choroidal Neovascularization"}, {"condition": "Macular Degeneration"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Treatment naive for choroidal neovascularization (CNV) secondary to age-related\\n macular degeneration (AMD) in the study eye except for laser treatment outside the\\n subfoveal area\\n\\n - Subfoveal CNV due to AMD\\n\\n - CNV must be = or >50 % of the entire lesion\\n\\n - All lesion composition types with a lesion greatest linear dimension (GLD) < 5400\\n microns (approximately = or <9 disc areas [DA])\\n\\n - Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA\\n score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320),\\n inclusive\\n\\n Exclusion Criteria:\\n\\n - Subfoveal geographic atrophy or subfoveal fibrosis of the study eye\\n\\n - Intraocular surgery within 3 months of enrollment\\n\\n - Inability to attend the protocol-required visits\\n\\n - Known allergies or hypersensitivity to any of the study treatments.\\n\\n - Other systemic diseases or active uncontrolled infections that would make subject a\\n poor medical risk\\n\\n - Uncontrolled glaucoma, defined as (1)subject is on >1 glaucoma medication (includes\\n combination treatments) or (2)subject has glaucoma that could lead to progressive\\n visual field deterioration\\n\\n - If subject has had a stroke within the last year"}, "gender": "Both", "minimum_age": "50 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'162', 'firstreceived_date': u'June 25, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": ["BB 1101", "Dexamethasone", "Dexamethasone 21-phosphate", "Dexamethasone acetate", "Verteporfin"]}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "verteporfin", "description": "Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)", "arm_group_label": ["1/2 Fluence Triple Therapy", "1/2 Fluence Double Therapy"], "other_name": ["Visudyne", "photodynamic therapy"]}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "verteporfin", "description": "Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)", "arm_group_label": "1/4 Fluence Triple Therapy", "other_name": ["Visudyne", "photodynamic therapy"]}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "ranibizumab", "description": "0.5 mg intravitreal injection", "arm_group_label": ["1/4 Fluence Triple Therapy", "1/2 Fluence Triple Therapy", "1/2 Fluence Double Therapy", "Ranibizumab"], "other_name": "Lucentis"}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "dexamethasone", "description": "0.5 mg intravitreal injection", "arm_group_label": ["1/4 Fluence Triple Therapy", "1/2 Fluence Triple Therapy"]}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "Macular Degeneration"}, {"keyword": "AMD"}, {"keyword": "CNV"}, {"keyword": "Choroidal neovascularization"}, {"keyword": "Photodynamic therapy"}, {"keyword": "CNV Secondary to Age Related Macular Degeneration"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Canada"}, {"country": "United States"}]', 'locations': '[{"location": {"facility": {"address": {"city": "Mobile", "state": "Alabama", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Phoenix", "state": "Arizona", "country": "United States"}}}}, {"location": {"facility": {"name": "Retina Centers, PC", "address": {"city": "Tucson", "state": "Arizona", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Beverly Hills", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Campbell", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Los Angeles", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Poway", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Sacramento", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Torrance", "state": "California", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Fort Myers", "state": "Florida", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Indianapolis", "state": "Indiana", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Davenport", "state": "Iowa", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Missoula", "state": "Montana", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Omaha", "state": "Nebraska", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Portsmouth", "state": "New Hampshire", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Portland", "state": "Oregon", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Philadelphia", "state": "Pennsylvania", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "West Mifflin", "state": "Pennsylvania", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Arlington", "state": "Texas", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Temple", "state": "Texas", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Seattle", "state": "Washington", "country": "United States"}}}}, {"location": {"facility": {"address": {"city": "Calgary", "state": "Alberta", "country": "Canada"}}}}, {"location": {"facility": {"address": {"city": "Vancouver", "state": "British Columbia", "country": "Canada"}}}}, {"location": {"facility": {"address": {"city": "Halifax", "state": "Nova Scotia", "country": "Canada"}}}}, {"location": {"facility": {"address": {"city": "London", "state": "Ontario", "country": "Canada"}}}}, {"location": {"facility": {"address": {"city": "Toronto", "state": "Ontario", "country": "Canada"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00492284', 'number_of_arms': u'4', 'number_of_groups': '', 'official_title': u'A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne\xae-Lucentis\xae Combination Therapies and Lucentis\xae Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.', 'org_study_id': u'BPD OCR 022', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Henry Hudson, MD", "role": "Principal Investigator", "affiliation": "Retina Centers, PC"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["United States: Food and Drug Administration", "Canada: Health Canada"], "has_dmc": "Yes"}}', 'phase': u'Phase 2', 'primary_completion_date': u'May 2009', 'primary_outcomes': '[{"primary_outcome": {"measure": "Mean Number of Retreatments (Day 0 Excluded)", "time_frame": "Month 1 to Month 12", "safety_issue": "No", "description": "Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment."}}, {"primary_outcome": {"measure": "Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)", "time_frame": "Baseline to Month 12", "safety_issue": "No", "description": "Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Dr. Oscar Cuzzani", "organization": "QLT Inc."}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Mean Number of Retreatments (Day 0 Excluded)", "time_frame": "Month 1 to Month 24", "safety_issue": "No", "description": "Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment."}}, {"secondary_outcome": {"measure": "Mean Change From Baseline in Study Eye Best-Corrected VA Score", "time_frame": "Baseline to Month 24", "safety_issue": "No", "description": "Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100"}}, {"secondary_outcome": {"measure": "Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline", "time_frame": "Baseline to Month 12, Baseline to Month 24", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline", "time_frame": "Baseline to Month 12, Baseline to Month 24", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline", "time_frame": "Baseline to Month 12, Baseline to Month 24", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Mean Change From Baseline in Central Retinal Thickness", "time_frame": "Baseline to Month 12, Baseline to Month 24", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Mean Change From Baseline in Lesion Size", "time_frame": "Baseline to Month 12, Baseline to Month 24", "safety_issue": "No", "description": "Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion"}}]', 'source': u'QLT Inc.', 'sponsors': '[{"lead_sponsor": {"agency": "QLT Inc.", "agency_class": "Industry"}}]', 'start_date': u'July 2007', 'study_design': u'Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00492284', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:38 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00500539?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=49&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:38 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:38 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:38 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00500539?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=49&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n The primary objective of this study is to assess the immunogenic potential of the liquid\n formulation of omalizumab administered over a period of 6 months in moderate to severe\n persistent allergic asthma patients 12 years of age or older, with no previous exposure to\n the drug (omalizumab na\xefve patients). The secondary objective of this study is to assess the\n safety of the liquid formulation of omalizumab in the same patients.\n ', 'brief_title': u'Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.', 'clinical_results': '{"clinical_results": {"participant_flow": {"group_list": {"group": {"@group_id": "P1", "title": "Omalizumab", "description": "The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used."}}, "period_list": {"period": [{"title": "Treatment Period (24 Weeks)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "155"}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "140"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "15"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Adverse Event", "participants_list": {"participants": {"@group_id": "P1", "@count": "4"}}}, {"title": "Unsatisfactory therapeutic effect", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Subject withdrew consent", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Lost to Follow-up", "participants_list": {"participants": {"@group_id": "P1", "@count": "2"}}}, {"title": "Administrative problems", "participants_list": {"participants": {"@group_id": "P1", "@count": "2"}}}, {"title": "Protocol Deviation", "participants_list": {"participants": {"@group_id": "P1", "@count": "5"}}}]}}, {"title": "Follow-up Period (16 Weeks)", "milestone_list": {"milestone": [{"title": "STARTED", "participants_list": {"participants": {"@group_id": "P1", "@count": "148", "#text": "Participants could discontinue study drug and still enter the follow-up period."}}}, {"title": "COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "136"}}}, {"title": "NOT COMPLETED", "participants_list": {"participants": {"@group_id": "P1", "@count": "12"}}}]}, "drop_withdraw_reason_list": {"drop_withdraw_reason": [{"title": "Adverse Event", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Subject withdrew consent", "participants_list": {"participants": {"@group_id": "P1", "@count": "2"}}}, {"title": "Lost to Follow-up", "participants_list": {"participants": {"@group_id": "P1", "@count": "3"}}}, {"title": "Administrative problems", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Death", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Protocol Deviation", "participants_list": {"participants": {"@group_id": "P1", "@count": "1"}}}, {"title": "Missing", "participants_list": {"participants": {"@group_id": "P1", "@count": "3"}}}]}}]}}, "baseline": {"group_list": {"group": {"@group_id": "B1", "title": "Omalizumab", "description": "The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "155"}}}}}, {"title": "Age", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "<=18 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "13"}}}, {"sub_title": "Between 18 and 65 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "135"}}}, {"sub_title": ">=65 years", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "7"}}}]}}, {"title": "Age", "units": "years", "param": "Mean", "dispersion": "Standard Deviation", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "B1", "@value": "42.7", "@spread": "14.32"}}}}}, {"title": "Gender", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Female", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "95"}}}, {"sub_title": "Male", "measurement_list": {"measurement": {"@group_id": "B1", "@value": "60"}}}]}}]}}, "outcome_list": {"outcome": [{"type": "Primary", "title": "The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period", "description": "An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.", "time_frame": "16 weeks after last dose", "safety_issue": "Yes", "population": "The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken.", "group_list": {"group": {"@group_id": "O1", "title": "Follow-up Period", "description": "Participants were evaluated at 16 weeks after the last dose of study drug."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "136"}}}}}, {"title": "The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period", "description": "An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Fab HAHA Positive - Negative at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fab HAHA Positive - Positive at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fab HAHA Positive - Missing at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fc HAHA Positive - Negative at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fc HAHA Positive - Positive at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fc HAHA Positive - Missing at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Fab and/or Fc HAHA Positive - Fab and Fc HAHA -Ve", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Missing at baseline", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}]}}]}}, {"type": "Secondary", "title": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.", "time_frame": "24 weeks treatment period + 4 weeks for following up participants", "safety_issue": "Yes", "population": "The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.", "group_list": {"group": {"@group_id": "O1", "title": "Treatment Period", "description": "The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used."}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "155"}}}}}, {"title": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks.", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Participants with AEs during the treatment period", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "124"}}}, {"sub_title": "Mild AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "25"}}}, {"sub_title": "Moderate AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "76"}}}, {"sub_title": "Severe AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "23"}}}, {"sub_title": "AEs suspected to be related to study drug", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "22"}}}, {"sub_title": "AEs not suspected to be related to study drug", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "102"}}}, {"sub_title": "Deaths", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "1"}}}, {"sub_title": "Serious Adverse Events (SAEs)", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "14"}}}, {"sub_title": "Discontinued due to Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "4"}}}, {"sub_title": "Discontinued due to Serious Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "2"}}}, {"sub_title": "Discontinued due to non-serious Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "2"}}}]}}]}}, {"type": "Secondary", "title": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).", "time_frame": "Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE rep orting)", "safety_issue": "Yes", "population": "The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.", "group_list": {"group": {"@group_id": "O1", "title": "Follow-up Period", "description": "Participants were assessed at 16 weeks after the last dose of study drug"}}, "measure_list": {"measure": [{"title": "Number of Participants", "units": "participants", "param": "Number", "category_list": {"category": {"measurement_list": {"measurement": {"@group_id": "O1", "@value": "148"}}}}}, {"title": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period).", "units": "participants", "param": "Number", "category_list": {"category": [{"sub_title": "Participants with AEs during the follow-up period", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "51"}}}, {"sub_title": "Mild AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "11"}}}, {"sub_title": "Moderate AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "37"}}}, {"sub_title": "Severe AEs", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "3"}}}, {"sub_title": "AEs suspected to be related to study drug", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "AEs not suspected to be related to study drug", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "51"}}}, {"sub_title": "Deaths", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Serious adverse events (SAEs)", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "1"}}}, {"sub_title": "Discontinued due to Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "1"}}}, {"sub_title": "Discontinued due to Serious Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "0"}}}, {"sub_title": "Discontinued due to non-serious Adverse Events", "measurement_list": {"measurement": {"@group_id": "O1", "@value": "1"}}}]}}]}}]}, "reported_events": {"time_frame": "Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total).", "desc": "The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not.", "group_list": {"group": [{"@group_id": "E1", "title": "Omalizumab Treatment Period", "description": "The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used."}, {"@group_id": "E2", "title": "Omalizumab Follow up Period", "description": "Participants were assessed at 16 weeks after the last dose of study drug"}]}, "serious_events": {"default_vocab": "MedDRA", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, serious adverse events", "counts": [{"@group_id": "E1", "@subjects_affected": "14", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "148"}]}}}, {"title": "Blood and lymphatic system disorders", "event_list": {"event": {"sub_title": "Anaemia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}}}, {"title": "Cardiac disorders", "event_list": {"event": [{"sub_title": "Angina unstable", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Cardiac arrest", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}]}}, {"title": "Gastrointestinal disorders", "event_list": {"event": [{"sub_title": "Enteritis", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Gastric ulcer", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}]}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Bronchiectasis", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Pneumonia", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}]}}, {"title": "Injury, poisoning and procedural complications", "event_list": {"event": [{"sub_title": "Cartilage injury", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Post procedural swelling", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}]}}, {"title": "Metabolism and nutrition disorders", "event_list": {"event": {"sub_title": "Dehydration", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}}}, {"title": "Musculoskeletal and connective tissue disorders", "event_list": {"event": {"sub_title": "Intervertebral disc protrusion", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}}}, {"title": "Nervous system disorders", "event_list": {"event": {"sub_title": "Epilepsy", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}}}, {"title": "Pregnancy, puerperium and perinatal conditions", "event_list": {"event": {"sub_title": "Abortion spontaneous", "counts": [{"@group_id": "E1", "@subjects_affected": "0", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "148"}]}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Asthma", "counts": [{"@group_id": "E1", "@subjects_affected": "4", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Laryngeal inflammation", "counts": [{"@group_id": "E1", "@subjects_affected": "1", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}]}}]}}, "other_events": {"frequency_threshold": "5", "default_vocab": "MedDRA", "default_assessment": "Systematic Assessment", "category_list": {"category": [{"title": "Total", "event_list": {"event": {"sub_title": "Total, other adverse events", "counts": [{"@group_id": "E1", "@subjects_affected": "74", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "34", "@subjects_at_risk": "148"}]}}}, {"title": "Infections and infestations", "event_list": {"event": [{"sub_title": "Gastroenteritis viral", "counts": [{"@group_id": "E1", "@subjects_affected": "8", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "0", "@subjects_at_risk": "148"}]}, {"sub_title": "Nasopharyngitis", "counts": [{"@group_id": "E1", "@subjects_affected": "15", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "3", "@subjects_at_risk": "148"}]}, {"sub_title": "Sinusitis", "counts": [{"@group_id": "E1", "@subjects_affected": "27", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "12", "@subjects_at_risk": "148"}]}, {"sub_title": "Upper respiratory tract infection", "counts": [{"@group_id": "E1", "@subjects_affected": "18", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "6", "@subjects_at_risk": "148"}]}]}}, {"title": "Nervous system disorders", "event_list": {"event": {"sub_title": "Headache", "counts": [{"@group_id": "E1", "@subjects_affected": "13", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "148"}]}}}, {"title": "Respiratory, thoracic and mediastinal disorders", "event_list": {"event": [{"sub_title": "Asthma", "counts": [{"@group_id": "E1", "@subjects_affected": "24", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "16", "@subjects_at_risk": "148"}]}, {"sub_title": "Cough", "counts": [{"@group_id": "E1", "@subjects_affected": "9", "@subjects_at_risk": "155"}, {"@group_id": "E2", "@subjects_affected": "1", "@subjects_at_risk": "148"}]}]}}]}}}, "certain_agreements": {"pi_employee": "Principal Investigators are NOT employed by the organization sponsoring the study.", "restrictive_agreement": "The terms and conditions of Novartis\' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety."}, "point_of_contact": {"name_or_title": "Study Director", "organization": "Novartis Pharmaceuticals", "phone": "862-778-8300"}}}', 'completion_date': u'September 2008', 'condition_browse': '{"condition_browse": {"mesh_term": "Asthma"}}', 'conditions': '[{"condition": "Asthma"}]', 'detailed_description': '', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "Inclusion Criteria:\\n\\n - Patients 12 years old or above with moderate to severe allergic asthma\\n\\n - Body weight greater than 30kg and less than 150 kg and total serum IgE level greater\\n than 30 to less than 700 IU/ml\\n\\n - Diagnosis of allergic asthma greater than 1 year duration, according to the American\\n Thoracic Society criteria (14) and at screening, a history consistent with clinical\\n features of moderate to severe persistent asthma.\\n\\n - Positive skin prick test (diameter of wheel is greater than 3mm) to at least one\\n perennial allergen within the previous one year to visit 1, to which the patient will\\n be exposed on a regular basis (most days) for the duration of the study.\\n\\n - No clinically significant asthma exacerbations that required treatment with systemic\\n corticosteroids during the four weeks immediately prior to screening visit (Visit 1)\\n and during screening period (between Visit 1 and 2)\\n\\n - Demonstrated evidence of inadequate asthma symptom control, despite treatment with\\n ICS according to clinical features of moderate to severe persistent asthma.\\n\\n Exclusion Criteria:\\n\\n - Previous exposure to omalizumab\\n\\n - Previous exposure to other humanized proteins or monoclonal antibodies\\n\\n - Known HAHA to other monoclonal antibodies\\n\\n - History of hypersensitivity to any of the study drugs or to drugs with similar\\n chemical structures\\n\\n - Known hypersensitivity to any ingredients, including excipients of the study\\n medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal\\n gamma globulin)\\n\\n - Active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)\\n\\n - Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections,\\n hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary\\n aspergillosis)"}, "gender": "Both", "minimum_age": "12 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'155', 'firstreceived_date': u'July 11, 2007', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Omalizumab"}}', 'interventions': '[{"intervention": {"intervention_type": "Drug", "intervention_name": "omalizumab", "description": "The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe."}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'Yes', 'keywords': '[{"keyword": "Asthma"}, {"keyword": "omalizumab"}, {"keyword": "safety"}, {"keyword": "allergic asthma"}, {"keyword": "adolescents"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "Argentina"}, {"country": "Germany"}, {"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Allergy & Immunology Associates, Ltd", "address": {"city": "Scottsdale,", "state": "Arizona", "zip": "AZ 85251", "country": "United States"}}}}, {"location": {"facility": {"name": "California Allergy and Asthma Medical Group", "address": {"city": "Palmdale", "state": "California", "zip": "CA 93551", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy Associates Medical Group, Inc,", "address": {"city": "San Diego", "state": "California", "zip": "CA 92120", "country": "United States"}}}}, {"location": {"facility": {"name": "Bensch Research Associates", "address": {"city": "Stockton", "state": "California", "zip": "CA 95207", "country": "United States"}}}}, {"location": {"facility": {"name": "1st Allergy and Clinical Research Center", "address": {"city": "Centennial", "state": "Colorado", "zip": "CO 80112", "country": "United States"}}}}, {"location": {"facility": {"name": "Innovative Research of West Florida, Inc.", "address": {"city": "Largo", "state": "Florida", "zip": "FL 33770", "country": "United States"}}}}, {"location": {"facility": {"name": "Georgia Pollen", "address": {"city": "Albany", "state": "Georgia", "zip": "GA 31707", "country": "United States"}}}}, {"location": {"facility": {"name": "Kansas City Allergy & Asthma", "address": {"city": "Overland Park", "state": "Kansas", "zip": "66210", "country": "United States"}}}}, {"location": {"facility": {"name": "Asthma and Allergy Specialists, PA", "address": {"city": "Minneapolis", "state": "Minnesota", "zip": "MN 55402", "country": "United States"}}}}, {"location": {"facility": {"name": ": The Clinical Research Center, LLC", "address": {"city": "St. Louis", "state": "Missouri", "zip": "MO 63141", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy, Asthma and Clinical Immunology", "address": {"city": "Brick", "state": "New Jersey", "zip": "NJ 08724", "country": "United States"}}}}, {"location": {"facility": {"name": "Asthma & Allergy Research of NJ, Inc.", "address": {"city": "Mt. Laurel", "state": "New Jersey", "zip": "NJ 08054", "country": "United States"}}}}, {"location": {"facility": {"name": "Nassau Chest Pysicians, PC", "address": {"city": "Massapequa", "state": "New York", "zip": "NY 11758", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy and Asthma Center of NC, PA", "address": {"city": "High Point", "state": "North Carolina", "zip": "NC 27262", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy Center at Brookstone", "address": {"city": "Columbus", "state": "Ohio", "zip": "OH 31904", "country": "United States"}}}}, {"location": {"facility": {"name": "Toledo Center for Clinical Research", "address": {"city": "Sylvania", "state": "Ohio", "zip": "OH 43650", "country": "United States"}}}}, {"location": {"facility": {"name": "Asthma and Allergy Center", "address": {"city": "Toledo", "state": "Ohio", "zip": "OH 43617", "country": "United States"}}}}, {"location": {"facility": {"name": "The Corvallis Clinic, PC", "address": {"city": "Corvallis", "state": "Oregon", "zip": "OR 97330", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy, Asthma & Dermatology Research Center", "address": {"city": "Lake Oswego", "state": "Oregon", "zip": "OR97037", "country": "United States"}}}}, {"location": {"facility": {"name": "Clinical Research Institute of Southern Oregon, PC", "address": {"city": "Medford", "state": "Oregon", "zip": "OR 97504", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy & Asthma Specialists, PC", "address": {"city": "Blue Bell", "state": "Pennsylvania", "zip": "PA 19422", "country": "United States"}}}}, {"location": {"facility": {"name": "Asthma Allergy & Pulmonary Associates, PC", "address": {"city": "Philadelphia", "state": "Pennsylvania", "zip": "PA 19107", "country": "United States"}}}}, {"location": {"facility": {"name": "AAPRI Clinical Research Institute", "address": {"city": "Providence,", "state": "Rhode Island", "zip": "RI 02906", "country": "United States"}}}}, {"location": {"facility": {"name": "North Texas Institute for Clinical Trials", "address": {"city": "Fort Worth", "state": "Texas", "zip": "TX 76132", "country": "United States"}}}}, {"location": {"facility": {"name": "Allergy and Asthma Associates", "address": {"city": "Houston,", "state": "Texas", "zip": "TX 77054", "country": "United States"}}}}, {"location": {"facility": {"name": "Clinical Trials of North Houston", "address": {"city": "Houston", "state": "Texas", "zip": "TX 77070", "country": "United States"}}}}, {"location": {"facility": {"name": "Novartis Investigative Site,", "address": {"city": "Buenos Aires,", "country": "Argentina"}}}}, {"location": {"facility": {"name": "Novartis Investigative Site", "address": {"city": "Buenos Aires", "country": "Argentina"}}}}, {"location": {"facility": {"name": "Novartis Investigative Site,", "address": {"city": "Corrientes,", "country": "Argentina"}}}}, {"location": {"facility": {"name": "Novartis Investigative Site,", "address": {"city": "Mendoza", "country": "Argentina"}}}}, {"location": {"facility": {"name": "Novartis Investigator site", "address": {"city": "Nuremberg", "country": "Germany"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00500539', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'An Open Label, Single Arm Study to Assess the Safety and Immunogenicity of Omalizumab Liquid Administered Subcutaneously to Male and Female Adolescents and Adults With Persistent Allergic Asthma', 'org_study_id': u'CIGE025C2303', 'other_outcomes': '[]', 'overall_contact': '{}', 'overall_contact_backup': '{}', 'overall_official': '{"overall_official": {"last_name": "Jose Bardelas, MD", "role": "Principal Investigator", "affiliation": "Allergy and Asthma center of North Carolina, PA, High Point, NC 27262"}}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": ["United States: Food and Drug Administration", "Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica", "Germany: Paul-Ehrlich-Institut", "Spain: Spanish Agency of Medicines"]}}', 'phase': u'Phase 3', 'primary_completion_date': u'September 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period", "time_frame": "16 weeks after last dose", "safety_issue": "Yes", "description": "An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive."}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "external affairs", "organization": "Novartis"}}', 'results_reference': '[]', 'secondary_ids': '[]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period", "time_frame": "24 weeks treatment period + 4 weeks for following up participants", "safety_issue": "Yes", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks."}}, {"secondary_outcome": {"measure": "Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period", "time_frame": "Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting)", "safety_issue": "Yes", "description": "The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period)."}}]', 'source': u'Novartis', 'sponsors': '[{"lead_sponsor": {"agency": "Novartis", "agency_class": "Industry"}}, {"collaborator": {"agency": "Genentech, Inc.", "agency_class": "Industry"}}, {"collaborator": {"agency": "Tanox", "agency_class": "Industry"}}]', 'start_date': u'July 2007', 'study_design': u'Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00500539', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:40 [scrapy] DEBUG: Crawled (200) <GET https://www.clinicaltrials.gov/ct2/show/NCT00616213?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=48&resultsxml=true> (referer: https://www.clinicaltrials.gov/ct2/results?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&pg=3) 2015-10-09 20:53:40 [spiders.trials] DEBUG: overall_official: must be string or read-only buffer, not None 2015-10-09 20:53:40 [spiders.trials] DEBUG: overall_contact: must be string or read-only buffer, not None 2015-10-09 20:53:40 [spiders.trials] DEBUG: overall_contact_backup: must be string or read-only buffer, not None 2015-10-09 20:53:40 [spiders.trials] DEBUG: clinical_results: must be string or read-only buffer, not None 2015-10-09 20:53:40 [spiders.trials] DEBUG: condition_browse: must be string or read-only buffer, not None 2015-10-09 20:53:40 [scrapy] DEBUG: Scraped from <200 https://www.clinicaltrials.gov/ct2/show/NCT00616213?lup_e=05%2F31%2F2011&lup_s=05%2F31%2F2011&rank=48&resultsxml=true> {'acronym': '', 'arm_groups': '[]', 'biospec_descr': '', 'biospec_retention': '', 'brief_summary': u'\n RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the\n growth of tumor cells, either by killing the cells or by stopping them from dividing.\n Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in\n bone marrow or peripheral blood and may help the immune system recover from the side effects\n of chemotherapy. Giving PR-104 together with G-CSF may kill more tumor cells.\n\n PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 when given\n together with G-CSF in treating patients with solid tumors.\n ', 'brief_title': u'PR104 and G-CSF in Treating Patients With Solid Tumors', 'clinical_results': '{}', 'completion_date': u'June 2009', 'condition_browse': '{}', 'conditions': '[{"condition": "Unspecified Adult Solid Tumor, Protocol Specific"}]', 'detailed_description': u'\n OBJECTIVES:\n\n Primary\n\n - Determine the maximum tolerated dose of PR-104 in combination with filgrastim (G-CSF)\n in patients with solid tumors.\n\n Secondary\n\n - Characterize the safety of this regimen in these patients.\n\n - Evaluate the pharmacokinetics of PR-104 and its alcohol metabolite.\n\n - Evaluate the rate of hypoxia in various solid tumors using F-MISO PET\n (18F-fluoromisonidazole positron emission tomography) imaging.\n\n - Assess for antitumor toxicity in these patients.\n\n - Collect plasma samples for the assessment of potential biomarkers of tumor hypoxia.\n\n OUTLINE: This is a multicenter, dose-escalation study of PR-104.\n\n Patients receive PR-104 IV over 1 hour on day 1 and filgrastim (G-CSF) on day 2. Courses\n repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n Patients also undergo 18F-fluoromisonidazole PET scans at baseline and prior to course 3 to\n assess tumor hypoxia.\n\n Patients undergo blood sample collection periodically during course 1. Samples are analyzed\n for the pharmacokinetics of PR-104 and for identification of biomarkers for tumor hypoxia.\n\n After completion of study treatment, patients are followed at 30 days.\n ', 'download_date': u'ClinicalTrials.gov processed this data on October 09, 2015', 'eligibility': '{"eligibility": {"criteria": {"textblock": "DISEASE CHARACTERISTICS:\\n\\n - Histologically or cytologically confirmed solid tumors\\n\\n - Measurable or evaluable disease\\n\\n PATIENT CHARACTERISTICS:\\n\\n Inclusion criteria:\\n\\n - ECOG performance status 0-1\\n\\n - Absolute neutrophil count \\u2265 1.5 x 10^9/L\\n\\n - Platelet count \\u2265 100 x 10^9/L\\n\\n - Hemoglobin \\u2265 9 g/dL (no red blood cell transfusions allowed)\\n\\n - Serum bilirubin \\u2264 1.5 times upper limit of normal (ULN)\\n\\n - PTT \\u2264 1.5 times normal\\n\\n - Serum creatinine \\u2264 1.5 times ULN\\n\\n - ALT or AST \\u2264 2 times ULN (\\u2264 5 times ULN if liver metastases are present)\\n\\n - Not pregnant or nursing\\n\\n - Fertile patients must use effective contraception during and for 30 days after\\n completion of study therapy\\n\\n - Able to read, understand, and provide written informed consent\\n\\n Exclusion criteria:\\n\\n - Evidence of a significant medical disorder or laboratory finding that, in the opinion\\n of the investigator, compromises the patient\'s safety during study participation,\\n including any of the following:\\n\\n - Uncontrolled infection or infection requiring a concomitant parenteral\\n antibiotic\\n\\n - Uncontrolled diabetes\\n\\n - Congestive heart failure\\n\\n - Myocardial infarction within the past 6 months\\n\\n - Chronic renal disease\\n\\n - Coagulopathy (excluding prophylactic anticoagulation)\\n\\n - Known HIV positivity\\n\\n - Hepatitis B sAg-positive or known to be hepatitis C-positive with abnormal liver\\n function tests\\n\\n PRIOR CONCURRENT THERAPY:\\n\\n - No more than 3 prior myelosuppressive chemotherapy regimens\\n\\n - Patients who have received more than 3 prior myelosuppressive regimens may be\\n eligible, if considered to have adequate marrow, based on prior exposure to 1 of\\n the following regimens:\\n\\n - Minimally myelosuppressive regimens\\n\\n - Limited courses of myelosuppressive regimens\\n\\n - More than 4 weeks since prior and no other concurrent licensed or investigational\\n anticancer treatment (6 weeks for nitrosoureas or mitomycin C)\\n\\n - More than 24 hours since any prior radiotherapy and no likelihood of toxicity from\\n this therapy\\n\\n - More than 4 weeks since major surgery\\n\\n - No prior radiotherapy to > 20% of bone marrow\\n\\n - No prior high-dose chemotherapy (including either myeloablative or non-myeloablative\\n transplantations)\\n\\n - Prior and concurrent androgen deprivation therapy allowed\\n\\n - Concurrent systemic steroids allowed, provided the patient has been on a stable dose\\n for at least 2 weeks prior to first dose of PR-104\\n\\n - No concurrent irradiation therapy (palliative or therapeutic), unless given in the\\n absence of tumor progression"}, "gender": "Both", "minimum_age": "18 Years", "maximum_age": "N/A", "healthy_volunteers": "No"}}', 'enrollment': u'5', 'firstreceived_date': u'February 14, 2008', 'has_expanded_access': u'No', 'intervention_browse': '{"intervention_browse": {"mesh_term": "Fluoromisonidazole"}}', 'interventions': '[{"intervention": {"intervention_type": "Biological", "intervention_name": "filgrastim", "description": "filgrastim will be administered at a standard dose and schedule", "other_name": ["Neupogen", "G-CSF"]}}, {"intervention": {"intervention_type": "Drug", "intervention_name": "PR104", "description": "PR104 is administered intravenously once every 21 days", "other_name": "PR-104"}}, {"intervention": {"intervention_type": "Other", "intervention_name": "F-18-fluoromisonidazole", "description": "F-18-fluoromisonidazole is administered intravenously prior to performance of PET scan", "other_name": "FMISO"}}]', 'is_fda_regulated': u'Yes', 'is_section_801': u'No', 'keywords': '[{"keyword": "unspecified adult solid tumor, protocol specific"}]', 'lastchanged_date': u'May 31, 2011', 'link': '[]', 'link_text': u'Link to the current ClinicalTrials.gov record.', 'location_countries': '[{"country": "New Zealand"}, {"country": "United States"}]', 'locations': '[{"location": {"facility": {"name": "Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea", "address": {"city": "Scottsdale", "state": "Arizona", "zip": "85258-4512", "country": "United States"}}}}, {"location": {"facility": {"name": "South Texas Accelerated Research Therapeutics", "address": {"city": "San Antonio", "state": "Texas", "zip": "78229", "country": "United States"}}}}, {"location": {"facility": {"name": "Waikato Hospital", "address": {"city": "Hamilton", "zip": "2020", "country": "New Zealand"}}}}]', 'nct_aliases': '[]', 'nct_id': u'NCT00616213', 'number_of_arms': u'1', 'number_of_groups': '', 'official_title': u'A Phase I, Multi-Center, Open-Label, Dose Escalation Trial of the Safety and Pharmacokinetics of Intravenous PR104 Given With Prophylactic G-CSF in Subjects With Solid Tumors', 'org_study_id': u'PR104-1004', 'other_outcomes': '[]', 'overall_contact': '{}', 'over all_contact_backup': '{}', 'overall_official': '{}', 'overall_status': u'Completed', 'oversight_info': '{"oversight_info": {"authority": "United States: Food and Drug Administration"}}', 'phase': u'Phase 1', 'primary_completion_date': u'September 2008', 'primary_outcomes': '[{"primary_outcome": {"measure": "Maximum tolerated dose of PR-104", "time_frame": "3 weeks (cycle 1)", "safety_issue": "Yes"}}]', 'reference': '[]', 'removed_countries': '[]', 'responsible_party': '{"responsible_party": {"name_title": "Brenda Gibson, Assoc. Director", "organization": "Proacta, Inc."}}', 'results_reference': '[]', 'secondary_ids': '[{"secondary_id": "PROACTA-PR-104-1004"}]', 'secondary_outcomes': '[{"secondary_outcome": {"measure": "Safety profile using CTCAE v3 criteria", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Dose-limiting toxicity of PR-104", "safety_issue": "Yes"}}, {"secondary_outcome": {"measure": "Pharmacokinetics of PR-104 and its alcohol metabolite in blood", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Anti-tumor activity", "safety_issue": "No"}}, {"secondary_outcome": {"measure": "Biomarkers of tumor hypoxia", "safety_issue": "No"}}]', 'source': u'Proacta, Incorporated', 'sponsors': '[{"lead_sponsor": {"agency": "Proacta, Incorporated", "agency_class": "Industry"}}]', 'start_date': u'February 2008', 'study_design': u'Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment', 'study_type': u'Interventional', 'target_duration': '', 'url': u'https://clinicaltrials.gov/show/NCT00616213', 'verification_date': u'May 2011', 'why_stopped': ''} 2015-10-09 20:53:40 [scrapy] INFO: Closing spider (finished) 2015-10-09 20:53:40 [scrapy] INFO: Dumping Scrapy stats: {'downloader/request_bytes': 33511, 'downloader/request_count': 74, 'downloader/request_method_count/GET': 74, 'downloader/response_bytes': 330046, 'downloader/response_count': 74, 'downloader/response_status_count/200': 74, 'dupefilter/filtered': 55, 'finish_reason': 'finished', 'finish_time': datetime.datetime(2015, 10, 9, 20, 53, 40, 229167), 'item_scraped_count': 68, 'log_count/CRITICAL': 3, 'log_count/DEBUG': 398, 'log_count/INFO': 8, 'request_depth_max': 3, 'response_received_count': 74, 'scheduler/dequeued': 74, 'scheduler/dequeued/memory': 74, 'scheduler/enqueued': 74, 'scheduler/enqueued/memory': 74, 'start_time': datetime.datetime(2015, 10, 9, 20, 52, 2, 742227)} 2015-10-09 20:53:40 [scrapy] INFO: Spider closed (finished)