chufangao/CTO huggingface dataset:
Clinical trial NCT04962022: Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants
Official title: COVID-19: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF PF-07321332/RITONAVIR IN HEALTHY PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-20
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Baseline population: The baseline analysis population included all participants enrolled in the study.
Plan to share individual participant data: NO
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 NCT05484011: A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Official title: P1b, Open-Label, Safety, Tolerability, Efficacy Study of a Soluble Beta-glucan Odetiglucan in Combination w/ a CD40 Agonist (CDX-1140) in Patients w/ Metastatic Pancreatic Adenocarcinoma Whose Disease Did Not Progress During 1st-Line Chemo
Sponsor: HiberCell, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-15
Primary completion date: 2024-03-04
Completion date: 2024-03-04
Plan to share individual participant data: NO
Clinical trial NCT03178201: TGR1202 in Relapsed and Refractory Follicular Lymphoma
Official title: Study of the Phosphoinositide-3-Kinase-Delta Inhibitor TGR-1202 in Patients With Relapsed or Refractory Follicular Lymphoma
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI left institution
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-20
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT04942054: A Study in Patients With Advanced Breast Cancer
Official title: A Phase 1 Study to Determine Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive, HER-2 Negative Advanced Breast Cancer Patients
Sponsor: Sun Pharma Advanced Research Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to close is due commercial reasons only
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-20
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Plan to share individual participant data: NO
Clinical trial NCT02586623: Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension
Official title: RESTORE: A Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa Therapy
Acronym: RESTORE
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 453.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-11
Primary completion date: 2022-07-21
Completion date: 2022-09-09
Baseline population: The Safety Set (open-label droxidopa) included all participants who received at least one dose of Investigational Medicinal Product (IMP). The Full Analysis Set (double-blind droxidopa, double-blind placebo) included all randomized patients who took at least one dose of IMP in the double-blind period.
Clinical trial NCT03924323: A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Official title: A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 273.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-30
Primary completion date: 2021-09-20
Completion date: 2021-09-20
Baseline population: The Safety Population consisted of all subjects in the Randomized Population who took at least 1 dose of study medication.
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 NCT02256696: Assessing PA-824 for Tuberculosis (the APT Trial)
Official title: A Phase 2 Randomized, Open-Label Trial of PA-824-Containing Regimens Versus Standard Treatment for Drug-Sensitive Sputum Smear-Positive Pulmonary Tuberculosis
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-04-29
Primary completion date: 2022-05-01
Completion date: 2022-05-01
Plan to share individual participant data: YES
IPD sharing description: This plan is in process, to be finalized prior to the end of recruitment.
IPD time frame: Within one year of reaching recruitment goals.
IPD access criteria: This plan is in process, to be finalized prior to the end of recruitment.
Clinical trial NCT03335774: Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in the Treatment of Symptomatic Internal Hemorrhoids.
Sponsor: Nivagen Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 103.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-12
Primary completion date: 2021-03-05
Completion date: 2021-03-05
Plan to share individual participant data: NO
Clinical trial NCT04270461: NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors
Official title: A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors
Sponsor: Jiujiang University Affiliated Hospital (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study is withdrawn because of administrative reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-17
Primary completion date: 2020-10-17
Completion date: 2020-10-17
Plan to share individual participant data: NO
Clinical trial NCT03852719: Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
Official title: A Multicenter, Open-label, Randomized Phase 3 Clinical Study to Assess Efficacy and Safety of Bulevirtide in Patients With Chronic Hepatitis Delta
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-17
Primary completion date: 2020-11-26
Completion date: 2024-08-08
Baseline population: The Full Analysis Set (FAS) includes all participants who were randomized to Bulevirtide (BLV) and took at least 1 dose of BLV or randomized to delayed treatment group.
Plan to share individual participant data: NO
Clinical trial NCT04339816: Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial
Official title: Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial
Acronym: AZIQUINE-ICU
Sponsor: Charles University, Czech Republic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Steering Committee decision in accordance with stopping rule 1: Emergence of new data
Enrollment: 3.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-13
Primary completion date: 2020-11-04
Completion date: 2020-11-04
Plan to share individual participant data: YES
IPD sharing description: Deidentified record-level data will be shared in a public database
IPD time frame: within 6 months of study completion
Clinical trial NCT04449588: Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS
Official title: A Multi-center, Open-label, Randomized Parallel Controlled Evaluation on the Efficacy and Safety of BDB-001 Injection in the Treatment of Progressive Severe COVID-19 in Phase II/III
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
Enrollment: 369.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-23
Primary completion date: 2024-03-26
Completion date: 2024-03-26
Plan to share individual participant data: NO
Clinical trial NCT03758729: Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
Official title: Phase II Study of Nivolumab in Combination With Radiation Therapy as Definitive Treatment for Patients With Locally Advanced, Unresectable Head and Neck Mucosal Melanoma.
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Internal Issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-31
Primary completion date: 2020-05-31
Completion date: 2020-05-11
Clinical trial NCT02509403: An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel
Official title: An Open-label Trial to Evaluate the Safety of an Essential Oil Infused Perineal Towel - WIPEAWAY
Acronym: WIPEAWAY
Sponsor: University of Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The company responsible for funding has filed for bankruptcy
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Clinical trial NCT04871425: Ketamine Versus Fentanyl for Surgical Abortions
Official title: Ketamine Versus Fentanyl for Surgical Abortions: A Randomized Controlled Noninferiority Trial
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-27
Primary completion date: 2021-10-14
Completion date: 2021-10-14
Baseline population: We recruited and randomized 110 participants. After randomization, five participants in the ketamine group were excluded due to two participants receiving the wrong medication, one participant not achieving IV access, one not having transportation, and one being hypertensive. Thus, 52 participants received ketamine and 53 participants received fentanyl.
Plan to share individual participant data: NO
Clinical trial NCT05412004: Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
Official title: A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial
Acronym: SURMOUNT-OSA
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 469.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-21
Primary completion date: 2024-03-12
Completion date: 2024-03-29
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 European Union (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 NCT04854486: Impact of GSE and Xylitol (Xlear) on COVID-19 Symptoms and Time to PCR Negativisation in COVID-19 Patients
Official title: Impact of GSE and Xylitol (Xlear) in Symptoms and Time to PCR Negativisation of Patients With Acute COVID-19 Infection
Sponsor: Larkin Community Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Study Period Ended / Not Completed
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-16
Primary completion date: 2022-03-30
Completion date: 2022-11-16
Plan to share individual participant data: NO
Clinical trial NCT03582137: A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's Disease
Official title: A Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's Disease
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 74.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-05
Primary completion date: 2022-01-04
Completion date: 2022-01-04
Plan to share individual participant data: YES
IPD sharing description: Anonymized data not published within this article will be made available by request from qualified investigators who provide a valid research question, for 20 months after the trial is electronically published.
IPD time frame: 20 months after the trial is electronically published.
IPD access criteria: by request from qualified investigators who provide a valid research question; as approved by Principal Investigator
Clinical trial NCT06187376: Chinese Herbal Medicine for Gynecologic Patients
Official title: Evaluating the Safety and Acceptability of Using Chinese Herbal Medicine in Patients With Primary Dysmenorrhea: A Randomized-controlled Trial
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study withdrawn due to inability to determine path forward regarding study design between sponsor and institutional staff.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-31
Primary completion date: 2024-07-16
Completion date: 2024-07-16
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data collected during the trial, after deidentification.
IPD time frame: Immediately following publication. No end date.
IPD access criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.~To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata.
Clinical trial NCT02655692: CAP-Ketamine for Antidepressant Resistant PTSD
Official title: CAP-Ketamine for Antidepressant Resistant PTSD
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 163.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-18
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Baseline population: All available data was utilized in the analysis using raw means and SDs
Plan to share individual participant data: NO
Clinical trial NCT04880213: Study of M5049 in Healthy Japanese and Caucasian Participants
Official title: A Phase I, Open-label, Single-dose, Sequential Dose Group Study of Orally Administered M5049 Tablet Formulation in Healthy Japanese and Caucasian Participants to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-05-06
Primary completion date: 2021-11-23
Completion date: 2021-11-23
Plan to share individual participant data: NO
IPD sharing description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
Clinical trial NCT05310084: Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
Official title: A PHASE 3, RANDOMIZED, OBSERVER-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF BNT162b2 WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE (SIIV) IN ADULTS 18 THROUGH 64 YEARS OF AGE
Sponsor: BioNTech SE (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1134.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-20
Primary completion date: 2022-10-05
Completion date: 2022-10-05
Baseline population: Safety population included all participants who received any of the study intervention.
Plan to share individual participant data: NO
Clinical trial NCT04496674: Bispecific PSMAxCD3 Antibody CC-1 in Patients With Squamous Cell Carcinoma of the Lung
Official title: PPhase-I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 as Single Agent and Combined With Checkpoint Blockade in Patients With Squamous Cell Carcinoma of the Lung
Sponsor: German Cancer Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: premature termination of the trial due to bad recruitment
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-02
Primary completion date: 2023-05-03
Completion date: 2023-05-03
Clinical trial NCT02724020: MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma
Official title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of Single-Agent MLN0128 and the Combination of MLN0128+MLN1117 Compared With Everolimus in the Treatment of Adult Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma That Has Progressed on Vascular Endothelial Growth Factor-Targeted Therapy
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-06-30
Primary completion date: 2020-02-03
Completion date: 2020-10-13
Baseline population: Full Analysis Set included all randomized participants.
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 NCT03548935: STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Official title: Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Acronym: STEP 1
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1961.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-04
Primary completion date: 2020-03-30
Completion date: 2021-03-05
Baseline population: Full analysis set (FAS) included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03746704: Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Adult Participants With Advanced PD-L1 Positive Malignancies
Official title: A Phase 1, First-in-Human Study of ImmunoPET Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504, an Anti-PD-L1 Tracer for Positron Emission Tomography in Patients With Advanced PD-L1 Positive Malignancies
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-04
Primary completion date: 2021-07-08
Completion date: 2021-07-08
Plan to share individual participant data: YES
IPD sharing description: All individual patient data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).