chufangao/CTO huggingface dataset:
Clinical trial NCT02683239: Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip
Official title: A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Acronym: FACT LTS & OA
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 5331.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-02-17
Primary completion date: 2020-12-01
Completion date: 2021-06-15
Baseline population: The full analysis set for the evaluation of long-term safety (FAS-LTS) included all randomized participants in the study.
Clinical trial NCT02888067: Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation With Moderate vs. Deep Neuromuscular Block
Official title: Surgical Conditions During Vocal Cord Surgery Requiring Jet Ventilation in Patients With Moderate vs. Deep Neuromuscular Block
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-01
Primary completion date: 2022-07-20
Completion date: 2022-07-20
Plan to share individual participant data: NO
Clinical trial NCT04013880: ASTX727 and FT-2102 in Treating IDH1-Mutated Recurrent/Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia
Official title: A Phase IB/II Study to Evaluate the Safety, Tolerability, and Efficacy of ASTX727 and FT-2102 in IDH1-Mutated Myelodysplastic Syndrome or Acute Myeloid Leukemia
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Loss of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-27
Primary completion date: 2021-03-31
Completion date: 2022-03-31
Clinical trial NCT05284019: Real World Effectiveness of Eptinezumab in Participants With Migraine
Official title: An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States
Acronym: EVEC
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was terminated due to enrolment challenges.
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-04
Primary completion date: 2023-02-17
Completion date: 2023-04-14
Baseline population: All randomized participants.
Limitations and caveats: The study was terminated early due to enrolment challenges.
Clinical trial NCT04304508: Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
Official title: Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Acronym: PACIFIC-STROKE
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1808.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-15
Primary completion date: 2022-02-18
Completion date: 2022-02-18
Baseline population: Full analysis set (FAS)
Plan to share individual participant data: UNDECIDED
IPD sharing description: Availability of this study's data will 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 NCT02047539: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
Official title: Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Clinical trial NCT04808570: A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Official title: A Single-arm, Open-label, Multi-center Phase Ib/II Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL)
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor terminated the study due to the R\&D strategy change.
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-05
Primary completion date: 2023-11-22
Completion date: 2023-11-22
Clinical trial NCT04040075: Testing the Safety and Efficacy of Commercial Drug Biktarvy in Subjects Known to Have the 184 Resistance Mutation to a Component in Biktarvy
Official title: Open-label Switch Study From a Regimen of Elvitegravir/Tenofovir Alafenamide/Emtricitabine/Cobicistat and Darunavir, to a FDC of Bictegravir/Tenofovir Alafenamide/Emtricitabine in Virologically Suppressed HIV-l Subjects Known to Have an 184 V/I Mutation
Sponsor: Southampton Healthcare, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Unable to complete enrollment goals due to unanticipated factors of screen failures, covid pandemic, and continued staffing and enrollment difficulties
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-01
Primary completion date: 2022-06-14
Completion date: 2022-07-08
Plan to share individual participant data: NO
Clinical trial NCT04305275: A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor
Official title: A Phase 2, Double-Blind, Placebo-controlled, Randomized Study Evaluating the Efficacy, Safety, and Tolerability of Sage-324 in the Treatment of Individuals With Essential Tremor
Sponsor: Sage Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-19
Primary completion date: 2021-02-01
Completion date: 2021-02-15
Baseline population: Safety Set included all participants who were administered SAGE-324 or placebo.
Plan to share individual participant data: NO
IPD sharing description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Clinical trial NCT04406272: VB-111 in Surgically Accessible Recurrent/Progressive GBM
Official title: A Randomized, Controlled Phase II Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the Viral Cancer Therapy Ofranergene Obadenovec (VB-111) in Patients With Surgically Accessible Recurrent/Progressive Glioblastoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial stopped at request of VBL Therapeutics, as they are no longer pursuing their VB-111 development program.
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-01
Primary completion date: 2024-08-01
Completion date: 2024-08-01
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT03364309: A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
Official title: A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 438.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-04-26
Primary completion date: 2020-06-04
Completion date: 2020-06-04
Baseline population: All randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT02019875: CYP3A4 Activity and Mineral Homeostasis
Official title: Effect of Modulating CYP3A4 Activity on Mineral Homeostasis
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 92.0 (ACTUAL)
Number of arms: 6.0
Start date: 2014-06-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Limitations and caveats: None noted
Clinical trial NCT02663622: Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002)
Official title: A Phase II Trial of CD24Fc for Prevention of Acute Graft-versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplant
Sponsor: Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-09-19
Primary completion date: 2020-06-08
Completion date: 2021-05-18
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT01877187: Lipiodol as an Imaging Biomarker in Patients With Primary and Metastatic Liver Cancer
Official title: Lipiodol as an Imaging Biomarker of Tumor Necrosis After Transcatheter Chemoembolization Therapy in Patients With Primary and Metastatic Liver Cancer
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-04-30
Primary completion date: 2020-02-29
Completion date: 2020-02-29
Clinical trial NCT04771273: A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Official title: Multicenter, Double-blind, Parallel-group, Randomized, 48 Weeks, Dose-ranging, Placebo-controlled Phase II Trial to Evaluate Efficacy, Safety and Tolerability of Multiple Subcutaneous (s.c.) Doses of BI 456906 in Patients With Non-alcoholic Steatohepatitis (NASH) and Fibrosis.
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 295.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-27
Primary completion date: 2023-11-09
Completion date: 2023-12-21
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 NCT03906565: Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer
Official title: Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Colorectal Cancer After Failure or Intolerability to Second-line Standard Treatment
Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: The efficacy evaluation (based on current data) deviated too much from results of previous clinical trials. It's assumed that high dropout rate of subjects, mainly due to covid-19 epidemic in China in the past 3 years, is the main reason.
Enrollment: 30.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2019-04-12
Primary completion date: 2023-12-31
Completion date: 2024-12-31
Clinical trial NCT04983979: The ORTIZ Study: Optimising RASi Therapy With SZC
Official title: A Multi Site, Placebo Controlled, Double Blind Randomised Clinical Trial Evaluating the Effectiveness of Sodium Zirconium Cyclosilicate Versus Placebo to Enable Safe Optimisation of RASi Therapy in Patients With Diabetic Kidney Disease.
Acronym: ORTIZ
Sponsor: Barts & The London NHS Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of recruitment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-17
Primary completion date: 2023-03-16
Completion date: 2023-05-16
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04880785: Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine
Official title: Virologic Outcomes of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine.
Acronym: VOLVER
Sponsor: Fundacion SEIMC-GESIDA (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 121.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-28
Primary completion date: 2023-06-12
Completion date: 2024-04-09
Clinical trial NCT04676724: Study of Sequential GSK3228836 and Peginterferon Treatment in Participants With Chronic Hepatitis B (CHB)
Official title: A Phase IIb Multi-Center, Randomised, Open Label Study to Assess the Efficacy and Safety of Sequential Treatment With GSK3228836 Followed by Pegylated Interferon Alpha 2a in Participants With Chronic Hepatitis B Virus (B-Together)
Acronym: B-Together
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-28
Primary completion date: 2023-02-17
Completion date: 2023-02-17
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT03381859: Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4
Official title: A Single-site, Open-label, Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve, EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis, With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir (50mg)/Grazoprevir (100 mg)
Acronym: CLEAR-C4
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: HCV treatment expansion occurred in Egypt
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-01
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Plan to share individual participant data: NO
Clinical trial NCT04077749: Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Official title: A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Sponsor: Lahey Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The study never started. It was withdrawn from the IRB.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-01
Primary completion date: 2021-06-30
Completion date: 2021-09-15
Plan to share individual participant data: NO
Clinical trial NCT05289570: Voxelotor for Improving Oxygen Saturation in Adults
Official title: A Phase 2b Open-Label, Single Arm Study to Evaluate the Efficacy of Voxelotor for Improving Oxygen Saturation and Reducing Ventilatory Support Requirements in Adult Patients With New or Increased Oxygen Requirement
Acronym: Voxelotor
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated by new sponsor due to funding issues.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-03
Primary completion date: 2023-06-28
Completion date: 2023-07-04
Plan to share individual participant data: NO
Clinical trial NCT05162027: Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)
Official title: Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders (TMD)
Acronym: TMD CARE
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrollment rate
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-26
Primary completion date: 2023-01-03
Completion date: 2023-01-03
Baseline population: Enrollees who completed baseline period and randomization
Limitations and caveats: Early termination due to low enrollment rate.
Clinical trial NCT04492722: A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
Official title: A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor decided to terminate the study early due to lack of efficacy. There were no safety concerns related to the study.
Enrollment: 613.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-10-01
Primary completion date: 2022-09-06
Completion date: 2022-09-06
Baseline population: All participants who were randomised and received any study treatment were included in the Full Analysis Set (FAS).
Limitations and caveats: Following study termination and reduced scope of the analysis, the PK analysis has not been performed.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.