chufangao/CTO huggingface dataset:
Clinical trial NCT02977689: Trial of IDH305 in IDH1 Mutant Grade II or III Glioma
Official title: Phase 2 Study of IDH305 in Subjects With IDH1 Mutant Grade II or III Glioma That Has Progressed After Observation or Radiation Therapy
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Novartis paused all study start-up activities due to safety evaluation of IDH305 compound.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-30
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Clinical trial NCT00630032: Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
Official title: Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.
Acronym: TavIx
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 762.0 (ACTUAL)
Number of arms: 2.0
Start date: 2007-09-30
Primary completion date: 2017-06-30
Completion date: 2020-09-03
Plan to share individual participant data: YES
IPD sharing description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
IPD time frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
IPD access criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Clinical trial NCT03190239: Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer Patients
Official title: Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed After First - Line Induction Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer: A Prospective, Open, Single Arm Clinical Study
Acronym: XQonc-007
Sponsor: Xinqiao Hospital of Chongqing (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: abandon
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-15
Primary completion date: 2020-07-30
Completion date: 2020-07-30
Clinical trial NCT03740009: Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause
Official title: Effects of a Tissue Selective Estrogen Complex (TESC) on Depression and the Neural Reward System in the Perimenopause
Acronym: Duavee
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-02
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Plan to share individual participant data: NO
Clinical trial NCT01875250: Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
Official title: A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-07-22
Primary completion date: 2019-09-01
Completion date: 2020-02-28
Plan to share individual participant data: NO
Clinical trial NCT03701074: Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Official title: Single Center, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
Sponsor: University of South Alabama (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: very slow enrollment. Only one patient enrolled. Termination by PI
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-15
Primary completion date: 2020-10-30
Completion date: 2020-12-02
Baseline population: Overall only one infant was enrolled into the study. Hence, control arm had no patient enrolled
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04478266: Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Official title: A Randomized, Multicenter, Double-blind Phase 3 Study of Amcenestrant (SAR439859) Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease
Acronym: AMEERA-5
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data. No new safety signals were observed.
Enrollment: 1068.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-14
Primary completion date: 2022-06-28
Completion date: 2023-05-26
Baseline population: Analysis was performed on safety population which included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention, analyzed according to the treatment arm they actually received.
Limitations and caveats: The study was terminated based on the review by an independent data monitoring committee of the prespecified interim analysis of the Phase 3 AMEERA-5 efficacy data.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT02758626: Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome
Official title: A Phase 2 Randomized, Double-Masked Placebo-Controlled Crossover Safety and Tolerability Study of Ataluren for Drug Resistant Epilepsy in Patients With Nonsense Mutation CDKL5 or Dravet Syndrome
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2021-02-27
Completion date: 2021-02-27
Plan to share individual participant data: NO
Clinical trial NCT03649711: Chronic Kidney Disease (CKD) Platelet Study
Official title: A Mechanistic Study in Patients With Non-Dialysis Chronic Kidney Disease to Investigate Altered Platelet Response to Antiplatelet Therapy (CKD-Platelet Study)
Sponsor: University of Arkansas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 76.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-01
Primary completion date: 2021-09-02
Completion date: 2021-09-02
Plan to share individual participant data: YES
IPD sharing description: De-identified data for all primary and secondary outcome measures will be uploaded on clinicaltrials.gov website.
IPD time frame: 2 years after study closure indefinitely
Clinical trial NCT03050814: Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in People With Previously Untreated Metastatic Colorectal Cancer QUILT-2.004
Official title: A Randomized Phase II Trial of Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in Patients With Previously Untreated Metastatic or Unresectable Colorectal Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated after an unplanned interim efficacy analysis.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-05
Primary completion date: 2021-08-25
Completion date: 2021-08-25
Baseline population: 4 participants that were enrolled but not assigned to a treatment arm had baseline data collected and it is reported in this table. These participants were screen failures who were not treated.
Plan to share individual participant data: NO
Clinical trial NCT04515394: Study of Tepotinib Combined With Cetuximab in Participants With Left-Sided RAS/BRAF Wild Type Metastatic Colorectal Cancer (PERSPECTIVE)
Official title: A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early due to operational challenges identifying suitable participants for screening in the study.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-28
Primary completion date: 2022-03-14
Completion date: 2022-03-31
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT04363866: Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)
Official title: A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: discontinued in favor of more promising directions that may benefit patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2021-03-31
Completion date: 2021-09-30
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after the identification
IPD time frame: Beginning 3 months and ending 5 years following article publication
IPD access criteria: Anyone who wishes to access the data for any purpose. Data may be obtained by contacting the corresponding author of the relevant publication
Clinical trial NCT03977155: Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BOS-589 in the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Sponsor: Boston Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-04
Primary completion date: 2020-05-06
Completion date: 2020-05-06
Plan to share individual participant data: NO
Clinical trial NCT04561817: To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
Official title: An Open Label Phase II Study to Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Evolving data with Ipatasertib that changes the known risk / benefit background in pursuing future studies.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2022-10-01
Completion date: 2023-10-01
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data collected during the trial, after deidentification.
IPD time frame: Beginning 3 months and ending 5 years following article publication.
IPD access criteria: Investigators whose proposed use of the data has been approved by an independent review committee (%8Dlearned intermediary%8E) identified for this purpose.To achieve aims in the approved proposal.information on Availability of data will be provided later
Clinical trial NCT03877549: Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
Official title: Dexamethasone Administered Via the Epidural Catheter as an Adjunct in Patients Undergoing Cesarean Delivery
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI left Henry Ford Health before completion.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-24
Primary completion date: 2022-06-15
Completion date: 2022-06-15
Clinical trial NCT01889238: Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
Official title: A PHASE 2, SINGLE-ARM, OPEN-LABEL, MULTICENTER STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ENZALUTAMIDE IN PATIENTS WITH ADVANCED, ANDROGEN RECEPTOR-POSITIVE, TRIPLE-NEGATIVE BREAST CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 118.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-06-12
Primary completion date: 2015-03-01
Completion date: 2024-01-10
Baseline population: Intent-to-treat (ITT) population included all enrolled participants who had positive androgen receptor (AR+) breast cancer as assessed by central review and received at least 1 dose of study drug.
Limitations and caveats: As per change in planned analysis, AR low population (all enrolled participants who had AR nuclear staining \> 0%, \< 10% assessed centrally) was not analyzed for efficacy and duration of response, time to response were not analyzed for any population
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05199142: A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
Official title: A Phase 1b, Exploratory, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline
Sponsor: Syndesi Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Development plan changed
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-23
Primary completion date: 2022-03-11
Completion date: 2022-03-11
Clinical trial NCT04252586: A Long-term Safety Study of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
Official title: An Open-label Extension Trial to Investigate the Long-term Safety of Cannabidiol Oral Solution (GWP42003-P, CBD-OS) in Patients With Rett Syndrome
Sponsor: Jazz Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated due to COVID-19 pandemic and recruitment challenges in the parent study (GWND18064 - NCT03848832).
Enrollment: 21.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-28
Primary completion date: 2021-06-09
Completion date: 2021-06-09
Baseline population: Baseline characteristics were assessed in the Safety Analysis Set which was defined as all participants who received at least one dose of GWP42003-P in the study.
Limitations and caveats: This trial was terminated due to enrollment challenges and the COVID-19 pandemic. Due to early termination and participants withdrawal, the number of participants was small and the length of treatment was reduced.
Plan to share individual participant data: NO
Clinical trial NCT03878953: A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
Official title: A Phase 3, Open-label Clinical Study of rhPTH(1-84) Treatment in Japanese Subjects With Chronic Hypoparathyroidism
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-31
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Plan to share individual participant data: NO
IPD sharing description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).
Clinical trial NCT05344365: A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
Official title: An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP)
Sponsor: Vanda Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was terminated for business reasons; not due to safety or efficacy concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Clinical trial NCT04362254: A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials
Official title: An Open Label, Long Term Safety Trial of Spesolimab Treatment in Patients With Crohn's Disease Who Have Completed Previous Spesolimab Trials
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: BI's decision to terminate the development of spesolimab in fistulising and fibrostenotic Crohn's disease.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-15
Primary completion date: 2022-05-14
Completion date: 2022-09-23
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT04333355: Safety in Convalescent Plasma Transfusion to COVID-19
Official title: Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Sponsor: Hospital San Jose Tec de Monterrey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Other clinical trails probed that the use of convalescent plasma for patients with COVID-19 is safe .
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-08
Primary completion date: 2020-08-20
Completion date: 2020-08-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04184882: A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)
Official title: A Randomized, Double Blind, Placebo-Controlled Phase 1b Study With Open-Label Extension to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Patients With Duchenne Muscular Dystrophy (DMD)
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Operational Reasons
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-24
Primary completion date: 2022-09-04
Completion date: 2022-09-04
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT04162899: A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind and Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SHR0302 in Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsor: Reistone Biopharma Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 105.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-06
Primary completion date: 2020-08-21
Completion date: 2020-08-31