chufangao/CTO huggingface dataset:
Clinical trial NCT04531462: A Study to Test How Well Empagliflozin Works in Japanese People With Type 2 Diabetes Who Are Older Than 65 Years
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, 52 Weeks Phase IV Trial to Evaluate Efficacy and Safety of Oral, Once Daily Empagliflozin in Elderly Japanese Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 129.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-05
Primary completion date: 2022-08-19
Completion date: 2022-08-26
Baseline population: Full Analysis Set (FAS): This set included all patients randomised, treated with at least one dose of trial medication, and with a baseline and at least one on-treatment glycated haemoglobin (HbA1c) value.
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 NCT05279235: Efficacy and Safety of JT001 (VV116) Compared With Favipiravir
Official title: A Multi-center, Double-blinded, Randomized, Phase III Study to Evaluate the Efficacy and Safety of JT001 (VV116) Compared With Favipiravir in Participants With Moderate to Severe Coronavirus Disease 2019 (COVID-19)
Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Development strategy adjustment
Enrollment: 290.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-14
Primary completion date: 2022-12-15
Completion date: 2022-12-15
Plan to share individual participant data: UNDECIDED
IPD sharing description: Undecided
Clinical trial NCT03489512: Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia
Official title: Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study
Sponsor: Instituto de Investigacion Sanitaria La Fe (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Administrative issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-01
Primary completion date: 2020-10-01
Completion date: 2021-04-01
Clinical trial NCT03463915: Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Official title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome
Sponsor: University of Louisville (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-25
Primary completion date: 2020-10-23
Completion date: 2020-10-23
Plan to share individual participant data: YES
IPD sharing description: De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.
IPD time frame: Data will be available beginning 1 month and ending 24 months following article publication.
IPD access criteria: Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.
Clinical trial NCT03087097: Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition
Official title: Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema (THRIVE) for Patients in the Rehabilitative Phase of Malnutrition: A Pilot Study Evaluating Microbial Engraftment, Safety and Nutritional Outcomes
Acronym: THRIVE
Sponsor: Microbiome Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: COVID-19 pandemic and resource constraints
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-11
Primary completion date: 2020-07-21
Completion date: 2020-07-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05624320: Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses
Official title: Improved Near Vision and Intermediate Without Loss of Binocular Distance Vision Using AGN-190584 in Subjects Utilizing Single -Use Daily, Contact Lenses for Distance Vision Correction in Both Eyes
Sponsor: Gordon Schanzlin New Vision (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of interest
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-01
Primary completion date: 2023-05-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT04528927: Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia
Official title: Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia Multicentric Randomized Comparative Study
Acronym: THINC
Sponsor: Abderrahmane Mami Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: - Interest in the use of HCQ is controversial.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-15
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Plan to share individual participant data: NO
Clinical trial NCT02613169: Infant TB Infection Prevention Study
Official title: Preventing Mycobacterium Tuberculosis Infection in HIV-Exposed Infants
Acronym: iTIPS
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-08-31
Primary completion date: 2019-10-31
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03327064: A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
Official title: A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: COVID-19 pandemic, unable to enroll participants
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Plan to share individual participant data: NO
Clinical trial NCT03363763: Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex
Official title: Phase 2 Multi Center Prospective Rand. Double Blind Placebo Cont. Parallel Design Study to Evaluate Safety & Efficacy of Topical Sirolimus for Cutaneous Angiofibromas in Subjects W/ Tuberous Sclerosis Complex Followed by Opt. Open Label
Sponsor: Aucta Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated (The clinical trial has ended prematurely due to low patient recruitment)
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-04-12
Primary completion date: 2023-03-24
Completion date: 2023-03-24
Plan to share individual participant data: NO
Clinical trial NCT04183738: Inflammation and Co-Infections in D²EFT
Official title: The Impact of Co-infections on Inflammation in Patients Commencing Second-line Antiretroviral Therapy. A Sub-study of D²EFT (Dolutegravir and Darunavir Evaluation in Adults Failing Therapy)
Acronym: i2-D²EFT
Sponsor: Kirby Institute (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: In the context of COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-02-01
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Plan to share individual participant data: NO
Clinical trial NCT04943692: Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
Official title: Efficacy and Safety of Metformin Glycinate Compared to Metformin Hydrochloride on the Progression of Type 2 Diabetes
Acronym: COMETII
Sponsor: Laboratorios Silanes S.A. de C.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Administrative decision of the investigation direction
Enrollment: 500.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-08-31
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT04223635: Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
Official title: An Open-label, Single-dose Study to Assess the Pharmacokinetics of Pexidartinib in Subjects With Moderate Hepatic Impairment Compared to Healthy Subjects
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-07
Primary completion date: 2020-10-02
Completion date: 2020-10-02
Baseline population: Baseline characteristics were assessed using the Safety Analysis Set.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT03545997: Montelukast for Patients With Obstructive Sleep Apnea Syndrome
Official title: Impact of Blocked Cysteinyl Leukotriene Pathway on Endothelial Function in Patients With Obstructive Sleep Apnea Syndrome: Multicenter Randomized Placebo Controlled Crossover Trial
Acronym: MONTSAS
Sponsor: University Hospital, Grenoble (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: lack of recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-29
Primary completion date: 2020-03-20
Completion date: 2020-03-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02519777: Integrase and Maraviroc Intensification in Neurocognitive Dysfunction (InMIND)
Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification With Maraviroc and Dolutegravir With No Intensification or Intensification With Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 191.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-21
Primary completion date: 2019-12-02
Completion date: 2021-01-05
Baseline population: All participants were included in the analysis.
Clinical trial NCT03937908: Pharmacokinetics Centella Asiatica Product (CAP) in Mild Cognitive Impairment
Official title: A Pharmacokinetic Study of Centella Asiatica Product (CAP) in Elderly Participants With Mild Cognitive Impairment Receiving Cholinesterase Inhibitor Therapy
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Participant study visits not possible during COVID-19 pandemic. Funder not able to support a continuation at some future date.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2020-12-21
Completion date: 2020-12-21
Limitations and caveats: Study was discontinued before the target number of participants were enrolled due to pandemic-related restrictions.
Plan to share individual participant data: YES
IPD sharing description: ALL IPD that underlie results in a publication will be shared via a published journal article.
IPD time frame: Immediately after publication and for a period of 3 years following publication.
IPD access criteria: Anyone who wishes access to the data, for any reason. Requests should be directed to Dr. Amala Soumyanath at soumyana@ohsu.edu
Clinical trial NCT03502616: Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 270.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-07
Primary completion date: 2019-12-19
Completion date: 2020-08-20
Baseline population: Safety analysis set: included all participants who were randomized and received at least one dose of the investigational product (that is \[i.e.\], tofacitinib or placebo).
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 NCT06061523: A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants
Official title: A Phase I, Open-label, Randomized Crossover Study to Evaluate the Relative Bioavailability and the Effect of Food for Sotorasib Tablets in Healthy Participants
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: FDA and EMA agreed existing data are appropriate for approval and no further BE studies are required.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-15
Primary completion date: 2024-09-09
Completion date: 2024-09-09
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04216693: Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH)
Official title: Efficacy and Safety of Digoxin in the Treatment of Adults Patients With Non-alcoholic Steatohepatitis: a Multi-center, Randomized, Placebo-controlled Trial
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Administrative decision to terminate.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-01
Primary completion date: 2022-12-01
Completion date: 2023-06-01
Plan to share individual participant data: NO
Clinical trial NCT04860518: Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With COVID-19
Official title: A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection
Acronym: HIBISCUS
Sponsor: Faron Pharmaceuticals Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The decision is based on changes in the pandemic and further weakening of the recruitment that will not enable a completion of the study in any reasonable time
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-23
Primary completion date: 2022-04-04
Completion date: 2022-04-04
Limitations and caveats: No formal statistical hypotheses were analysed due the early termination of the study with only 5 dosed subjects.
Clinical trial NCT05579769: A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
Official title: A Phase II Pediatric Study of a Graft-VS.-Host Disease (GVHD) Prophylaxis Regimen With no Calcineurin Inhibitors After Day +60 Post First Allogeneic Hematopoietic Cell Transplant for Hematological Malignancies
Sponsor: St. Jude Children's Research Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Principal Investigator left institution
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-14
Primary completion date: 2024-05-08
Completion date: 2024-05-08
Plan to share individual participant data: YES
IPD sharing description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
IPD time frame: Data will be made available at the time of article publication.
IPD access criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Clinical trial NCT04170829: A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine (MERS002)
Official title: A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers
Sponsor: King Abdullah International Medical Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-17
Primary completion date: 2020-11-26
Completion date: 2020-11-26
Plan to share individual participant data: NO
Clinical trial NCT04305249: Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies
Official title: A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Patients With Advanced Solid Tumors and Hematological Malignancies
Acronym: ERASER
Sponsor: Antengene Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-15
Primary completion date: 2024-04-11
Completion date: 2024-05-24
Plan to share individual participant data: NO
Clinical trial NCT04032535: Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6523 After Single or Multiple Ascending Doses in Healthy Subjects, Followed by a Placebo Controlled Repeated Dose 2-way Crossover in COPD Subjects
Acronym: CHF6523
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-24
Primary completion date: 2022-12-05
Completion date: 2022-12-05
Plan to share individual participant data: NO
Clinical trial NCT03800641: A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation
Official title: A Study of Dexmedetomidine Pharmacokinetics for Preoperative Sedation With Administration of Oral, Intravenous and Nasal Drops
Sponsor: Eye & ENT Hospital of Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-11
Primary completion date: 2019-03-29
Completion date: 2020-01-23