chufangao/CTO huggingface dataset:
Clinical trial NCT03458728: Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
Official title: A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: no anticipated benefit over available standard therapies
Enrollment: 31.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-04-30
Primary completion date: 2023-02-01
Completion date: 2023-02-01
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Clinical trial NCT01436227: Pazopanib Hydrochloride in Treating Patients With Von Hippel-Lindau Syndrome
Official title: A Phase II Trial of Pazopanib in Von Hippel-Lindau Syndrome
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-01-17
Primary completion date: 2024-03-13
Completion date: 2024-03-13
Clinical trial NCT05470933: A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors
Official title: A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors
Sponsor: Suzhou Junjing BioSciences Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-23
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Plan to share individual participant data: NO
Clinical trial NCT03289039: Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer
Official title: A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-25
Primary completion date: 2021-07-20
Completion date: 2021-07-20
Baseline population: The analysis population is only including treated patients.
Plan to share individual participant data: NO
Clinical trial NCT01721746: A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Official title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 405.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-12-21
Primary completion date: 2016-02-16
Completion date: 2020-12-29
Baseline population: All randomized participants
Clinical trial NCT04687930: Genicular Nerve Block in Juvenile Idiopathic Arthritis
Official title: Genicular Nerve Block in Juvenile Idiopathic Arthritis
Sponsor: Sohag University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2021-02-15
Completion date: 2021-02-15
Clinical trial NCT02535078: Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma
Official title: A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination With Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients With Advanced Melanoma
Sponsor: Immunocore Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-11-30
Primary completion date: 2023-06-19
Completion date: 2023-09-06
Clinical trial NCT04400760: The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.
Official title: The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts: The EDGE Study.
Acronym: EDGE
Sponsor: The University of The West Indies (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-01
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Clinical trial NCT04894474: A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for Post-exposure Prevention of SARS-CoV-2 Infection in Household Contacts to a Confirmed SARS-CoV-2 Infected Individual
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: project terminated
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-06-17
Primary completion date: 2022-05-23
Completion date: 2022-07-24
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT04390152: Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19
Official title: Safety and Efficacy of Intravenous Infusion of Wharton's Jelly Derived Mesenchymal Stem Cell Plus Standard Therapy for the Treatment of Patients With Acute Respiratory Distress Syndrome Diagnosis Due to COVID 19: A Randomized Controlled Trial
Sponsor: BioXcellerator (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Stopped by the IP, because the first 6 patients recruited had died and it was unknown if it represented any safety risk or if the sample was insufficient to evaluate the study hypotesis.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-13
Primary completion date: 2022-03-03
Completion date: 2022-03-03
Plan to share individual participant data: NO
IPD sharing description: Individual data won't be shared.
Clinical trial NCT05132569: Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG)
Acronym: URSA
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: For strategic reasons the Tolebrutinib MG study has been terminated
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-03
Primary completion date: 2023-02-21
Completion date: 2023-02-21
Baseline population: Analysis was performed on all randomized participants. Based on the low enrolment number and in order to protect and maintain participant privacy/confidentiality, data were reported under a single arm.
Limitations and caveats: The study was prematurely terminated by the Sponsor due to strategic reasons and was not based on any safety issues. Hence, several planned efficacy analysis were not conducted for the study.
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 NCT05261490: Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer
Official title: A Phase Ⅰ/Ⅱ Study of TTI-622 in Combination With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: A business decision was made by Pfizer to terminate and remove the Phase 2 expansion of this study for administrative reasons. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-01
Primary completion date: 2024-02-15
Completion date: 2024-02-15
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 NCT03136055: Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
Official title: A Pilot Study of Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-20
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Plan to share individual participant data: NO
Clinical trial NCT04509674: EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)
Official title: EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 6522.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-16
Primary completion date: 2023-11-05
Completion date: 2023-11-05
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 NCT04430283: Evaluation of FDY-5301 in Major Trauma Patients in ICU
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Intravenous FDY-5301 for the Prevention and Treatment of ICU Acquired Weakness in Major Trauma Patients.
Sponsor: Faraday Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated because of difficulty identifying patients that met the inclusion criteria, as well as logistical difficulties in opening clinical ICU study sites.
Enrollment: 8.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-20
Primary completion date: 2022-03-04
Completion date: 2022-03-04
Clinical trial NCT04955938: A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms
Official title: A Phase Ib Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: unable to accrue
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-29
Primary completion date: 2023-06-07
Completion date: 2023-06-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03779841: Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
Official title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A (AGN-151607) Injections Into the Epicardial Fat Pads to Prevent Post-Operative Atrial Fibrillation in Patients Undergoing Open-Chest Cardiac Surgery
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 323.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-01
Primary completion date: 2022-03-24
Completion date: 2023-03-06
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT05780216: Mindfulness and Psychedelics
Official title: Mindfulness and Psychedelics: A Combined Neurophenomenological and Pharmacological Approach to the Characterization of Mindfulness States in Experienced Meditators
Sponsor: Psychiatric University Hospital, Zurich (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-20
Primary completion date: 2023-08-05
Completion date: 2023-09-15
Plan to share individual participant data: NO
IPD sharing description: Only anonymized, quantitative neurophysiological and behavioral data can be shared upon publication according to the FAIR data principles. Qualitative interview data are sensitive and cannot be shared due to confidentiality reasons.
Clinical trial NCT01983462: Vascular Dysfunction in Human Obesity Hypertension
Official title: Vascular Dysfunction in Human Obesity Hypertension: Integrative Role of Sympathetic and Renin-Angiotensin Systems
Acronym: VANISH
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding expired
Enrollment: 33.0 (ACTUAL)
Number of arms: 3.0
Start date: 2013-10-31
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT04442737: A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain
Official title: A Phase 4, Randomized, Active-Controlled, Open-label Study to Evaluate the Safety and Tolerability of Switching to Once-Daily Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Regimen in Virologically-suppressed Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Experiencing Rapid Weight Gain With an INI + TAF/FTC ARV Regimen
Acronym: DEFINE
Sponsor: Janssen Scientific Affairs, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 103.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-01
Primary completion date: 2023-08-07
Completion date: 2023-08-30
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT01338987: Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation
Official title: Multi-Institutional Prospective Pilot Study of Lupron to Enhance Lymphocyte Immune Reconstitution Following Allogeneic Bone Marrow Transplantation in Post-Pubertal Children and Adults With Molecular Imaging Evaluation
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 76.0 (ACTUAL)
Number of arms: 5.0
Start date: 2011-04-19
Primary completion date: 2017-12-01
Completion date: 2020-11-19
Plan to share individual participant data: NO
Clinical trial NCT02940548: Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness
Official title: A Comparative Study for the Effects of Nifedipine GITS and Amlodipine Besylate on Recovery of Blood Pressure Rhythm and Arterial Stiffness in the Young and Middle-aged Subjects With Non-dipper Hypertension
Acronym: NARRAS
Sponsor: Peking University People's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The patient recruitment and follow-ups were influenced with the pandemic of COVID-19
Enrollment: 99.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05251233: Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Official title: Evaluation of the Role of Proton Pump Inhibitors on the Postoperative Course Following Pancreaticoduodenectomy
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator and study team chose to end study early.
Enrollment: 56.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-21
Primary completion date: 2024-06-27
Completion date: 2024-06-27
Plan to share individual participant data: NO
Clinical trial NCT05578508: Stem Cells for the Treatment of Pouchitis
Official title: A Phase I Study of Bone Marrow Derived Mesenchymal Stem Cells (MSCs) for the Treatment of Medically Refractory Pouchitis
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI decision not to move forward with study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-04-30
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT02647359: Study of Ataluren in Participants With Nonsense Mutation Aniridia
Official title: A Phase 2, Multicenter, Randomized, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Ataluren (PTC124) for the Treatment of Nonsense Mutation Aniridia
Acronym: STAR
Sponsor: PTC Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2021-01-22
Completion date: 2021-01-22
Baseline population: The safety population included all randomized participants who received at least 1 dose of study drug.