chufangao/CTO huggingface dataset:
Clinical trial NCT02167945: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official title: An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-II)
Acronym: TOPAZ-II
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 615.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-06-12
Primary completion date: 2021-05-13
Completion date: 2021-05-13
Baseline population: Safety population: All participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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 and 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, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03634800: Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M)
Official title: Radiotherapy With Immunotherapy for Systemic Effect in Myeloma (RISE-M)
Acronym: RISE-M
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of patient accruals.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-23
Primary completion date: 2020-01-09
Completion date: 2020-01-16
Baseline population: 6 patients enrolled but 1 patient withdrew consent prior to starting treatment. 5 patients that enrolled and started treatment will be a part of the analysis population.
Clinical trial NCT03175549: Medication Development in Alcoholism: Apremilast Versus Placebo
Official title: Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo
Sponsor: The Scripps Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-01
Primary completion date: 2020-04-01
Completion date: 2020-04-01
Plan to share individual participant data: NO
Clinical trial NCT04682431: A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Official title: A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Sponsor: Ikena Oncology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor business decision.
Enrollment: 127.0 (ACTUAL)
Number of arms: 18.0
Start date: 2020-11-10
Primary completion date: 2023-08-25
Completion date: 2023-08-31
Plan to share individual participant data: NO
Clinical trial NCT03618108: Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease
Official title: Phase IIa Prospective Study to Evaluate the Safety and Measure Efficacy of Anti-chlamydophila Antibiotic Combination (ACAC) Therapy Comprising 100mg Doxycycline, 500mg Azithromycin and 300mg Rifabutin in the Treatment of Patients With Coronary Heart Disease (CHD)
Acronym: ACAC-CHD
Sponsor: Cadrock Pty. Ltd. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-04
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04230954: Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Official title: A Phase II Study of Cabozantinib (XL184) Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer
Sponsor: University of South Alabama (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI left institution
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-16
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Plan to share individual participant data: NO
Clinical trial NCT01247324: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 821.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-08-31
Primary completion date: 2015-04-02
Completion date: 2022-12-31
Baseline population: Intent-to-treat (ITT) population included all randomized participants in the study.
Clinical trial NCT05098041: A Study of Soticlestat and Rifampin in Healthy Adults
Official title: A Phase 1 Open-Label Study to Evaluate the Drug-Drug Interaction of Rifampin as a Strong CYP3A Inducer on Soticlestat Pharmacokinetics in Healthy Adult Participants
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-22
Primary completion date: 2022-02-16
Completion date: 2022-03-03
Baseline population: The safety set included all participants who received at least one dose of the study drug(s).
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03845894: Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
Official title: Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: feasibility
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-03
Primary completion date: 2022-06-25
Completion date: 2022-06-25
Plan to share individual participant data: YES
IPD sharing description: Will be shared upon request: raw data and statistical calculations
IPD time frame: Available after study conclusion, for up to 3 years afterward.
Clinical trial NCT06120725: Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke
Official title: Ticagrelor Versus Clopidogrel in Large Vessel Ischemic Stroke, a Randomized Controlled Trial
Sponsor: Kafrelsheikh University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 580.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2023-09-01
Completion date: 2023-11-01
Plan to share individual participant data: UNDECIDED
IPD sharing description: All the data that support the findings of this research will be available from the corresponding author M. Zeinhom upon reasonable request.
Clinical trial NCT04539275: VA CoronavirUs Research and Efficacy Studies-1
Official title: VA CoronavirUs Research and Efficacy Studies-1 (VA CURES-1)
Acronym: VACURES-1
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: DMC recommended early termination of enrollment
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-16
Primary completion date: 2021-06-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT03971110: A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
Official title: A Multi-centre, Single-arm, Prospective Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy Using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients With Advanced Prostate Cancer Undergoing Radical Prostatectomy.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to the limited potential patients pool, the enrollment goal could not be achieved. After review and communication, the decision to teminate study was made.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-28
Primary completion date: 2022-11-09
Completion date: 2022-11-09
Plan to share individual participant data: NO
Clinical trial NCT04126733: Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)
Official title: An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC)
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-14
Primary completion date: 2020-11-11
Completion date: 2022-03-28
Limitations and caveats: Preliminary efficacy assessment suggested that the study would not meet its primary efficacy endpoint, therefore the study was stopped.
Plan to share individual participant data: UNDECIDED
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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Clinical trial NCT04088734: Gene Transfer Study of ABO-102 in Patients With Middle and Advanced Phases of MPS IIIA Disease
Official title: A Phase I/II Open Label, Single-dose, Gene Transfer Study of scAAV9.U1a.hSGSH (ABO-102) in Patients With Middle and Advanced Phases of MPS IIIA Disease
Sponsor: Ultragenyx Pharmaceutical Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Terminated due to lack of efficacy seen in patients with advanced MPS IIIA disease. The patients will be followed up annually for safety until five years post dosing
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-18
Primary completion date: 2022-03-10
Completion date: 2022-03-10
Plan to share individual participant data: NO
Clinical trial NCT03890289: Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma
Official title: Idelalisib Plus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: a Phase 2, Single-arm, Multicentric Study
Acronym: GAUDEALIS
Sponsor: Fondazione Italiana Linfomi - ETS (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was halted prematurely due to safety, since tocity stopping rules have been met
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-18
Primary completion date: 2021-04-29
Completion date: 2023-05-10
Plan to share individual participant data: NO
Clinical trial NCT02562716: S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official title: A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma
Sponsor: SWOG Cancer Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 147.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-06
Primary completion date: 2020-05-31
Completion date: 2022-09-26
Baseline population: 147 participants were randomized, but 43 were found to be ineligible per central radiology review, and 1 was found to be ineligible due to incorrect primary tumor. One patient withdrew study consent prior to any therapy and was not evaluable. Therefore 102 were deemed eligible and analyzable for the primary analysis.
Clinical trial NCT04557384: A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer
Official title: A Phase 1, Nonrandomized, Open-Label Investigation of Subcutaneous Ramucirumab Administration in Participants With Advanced Solid Tumors
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to inadequate PK profile associated with the subcutaneous formulation.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-23
Primary completion date: 2021-05-25
Completion date: 2021-05-25
Baseline population: All participants who received at least one dose of study drug.
Limitations and caveats: Study was terminated due to low likelihood of achieving a relevant therapeutic exposure.
Plan to share individual participant data: NO
Clinical trial NCT04556266: A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies
Official title: A Phase I Trial Evaluating the Safety of Consolidative Infusions of CD19-Specific Chimeric Antigen Receptor (CAR) T Cells Following T-cell Depleted Allogeneic Transplantation for High Risk B-cell Malignancies
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: No patients were enrolled to this study since being open to enrollment. Due to changes in available therapies, there aren't enough people who will be eligible for the study. Therefore, the study was closed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-07-01
Primary completion date: 2022-03-01
Completion date: 2022-03-01
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT02535247: Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
Official title: A Phase I/II Study to Determine Feasibility and Safety MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma
Sponsor: Fox Chase Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Merck no longer providing drug for study
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-05
Primary completion date: 2020-02-25
Completion date: 2020-02-25
Baseline population: Study did not progress to portion with combination of pembrolizumab and copanlisib
Clinical trial NCT00116142: Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Official title: Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2005-06-30
Primary completion date: 2020-06-29
Completion date: 2020-06-29
Plan to share individual participant data: NO
Clinical trial NCT04745351: Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Official title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19
Acronym: REDPINE
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.
Enrollment: 249.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-31
Primary completion date: 2022-04-20
Completion date: 2022-05-24
Baseline population: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/
IPD time frame: 18 months after study completion
IPD access criteria: A secured external environment with username, password, and RSA code.
Clinical trial NCT04506983: GPC3-CAR-T Cells for the Hepatocellular Carcinoma
Official title: The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
Sponsor: Beijing Tsinghua Chang Gung Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Adjust the plan
Enrollment: 12.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2022-06-10
Primary completion date: 2023-06-10
Completion date: 2023-10-10
Clinical trial NCT03434379: A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Acronym: IMbrave150
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 558.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-15
Primary completion date: 2020-08-31
Completion date: 2022-11-17
Baseline population: The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT03629483: Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block
Official title: Impact of Dexmedetomidine Combined With Ropivacaine for Postoperative Continuous Femoral Nerve Block on Postoperative Delirium and Long-term Oucomes in Elderly Patients After Single Knee Arthroplasty
Sponsor: Peking University First Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Trial stopped by the sponsor because of no funding.
Enrollment: 736.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2018-12-10
Primary completion date: 2018-12-11
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT05181995: Safety and Efficacy of 50 mg NYX-783 QD vs. Placebo in PTSD
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 50 mg NYX-783 Once Daily Compared to Placebo in Participants With Post-Traumatic Stress Disorder (PTSD)
Sponsor: Aptinyx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: company decision
Enrollment: 121.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-13
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Plan to share individual participant data: NO
Clinical trial NCT03579888: CD19-Specific T Cells Post AlloSCT
Official title: Donor-Derived Very-Rapid Manufactured CD19-Specific T Cells for Lymphoid Malignancies After Allogeneic Hematopoietic Stem-Cell Transplantation
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study halted prematurely
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-26
Primary completion date: 2021-05-27
Completion date: 2021-05-27