chufangao/CTO huggingface dataset:
Clinical trial NCT04408924: Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
Official title: CYCLONE 1: A Phase 2 Study of Abemaciclib in Metastatic Castration-Resistant Prostate Cancer Patients Previously Treated With a Novel Hormonal Agent and Taxane-based Chemotherapy
Acronym: CYCLONE 1
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-01-20
Primary completion date: 2022-04-27
Completion date: 2023-06-02
Baseline population: All participants who received at least one dose of the study drug.
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 NCT04840927: A Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release (TR) Tablets Compared to an E7386 Immediate Release (IR) Tablet in Healthy Adult Participants
Official title: An Open-Label, Single Center, Randomized, Pharmacoscintigraphic Study to Evaluate the Relative Bioavailability of E7386 Following Oral Administration of Targeted Release Tablets Compared to an E7386 Immediate Release Tablet in Healthy Adult Subjects
Sponsor: Eisai Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Delay in availability of IMP
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-09
Primary completion date: 2023-05-17
Completion date: 2023-05-17
Plan to share individual participant data: YES
IPD sharing description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Clinical trial NCT04204096: Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)
Official title: A Phase III, Multicenter, Observer Blind, Randomized, Controlled Study to Evaluate Immune Equivalence of Multi-dose Formulation Against Single-dose Formulation of Vi-DT Typhoid Conjugate Vaccine and Safety in Healthy Filipino......
Sponsor: International Vaccine Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1800.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-04
Primary completion date: 2020-09-11
Completion date: 2021-01-29
Plan to share individual participant data: NO
Clinical trial NCT05093166: Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure
Official title: Prospective, Open-label, Uncontrolled Pilot Clinical Trial to Assess the Safety and Efficacy of Autologous Cultured Oral Mucosa Grafts for Urethral Reconstruction in Patients Due to Hypospadias Treatment Failure
Acronym: HOLOUR
Sponsor: Holostem Terapie Avanzate s.r.l. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Due to the current re-organization at the Sponsor site
Enrollment: 8.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2021-11-26
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
Clinical trial NCT03234907: Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 215.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-08-03
Primary completion date: 2020-08-14
Completion date: 2020-08-14
Baseline population: FAS for the induction phase study included all randomized participants who received any amount of blinded study drug during the Induction Phase.
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 NCT03950622: Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-AGE)
Acronym: PNEU-AGE
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1205.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-13
Primary completion date: 2020-03-30
Completion date: 2020-03-30
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04824872: Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Official title: A Double-Blind, Placebo-Controlled, Cross-over Trial, Evaluating Efficacy and Safety of Dasiglucagon for Treatment of Post-bariatric Hypoglycemia in Roux-en-Y Gastric Bypass (RYGB) Operated Adults
Sponsor: Zealand Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2023-02-28
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Clinical trial NCT02214160: Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Extension Study for Subjects Previously Enrolled in Triheptanoin Studies
Official title: An Open-label Long-Term Safety and Efficacy Extension Study in Subjects With Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Previously Enrolled in UX007 or Triheptanoin Studies
Sponsor: Ultragenyx Pharmaceutical Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 94.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-12-09
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Clinical trial NCT05093621: Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
Official title: Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
Acronym: TFO
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-08
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT03409198: Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Breast Cancer
Official title: A Randomized Phase IIb Study Evaluating Immunogenic Chemotherapy Combined with Ipilimumab and Nivolumab in Patients with Metastatic Hormone Reseptor Positive Breast Cancer
Acronym: ICON
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-21
Primary completion date: 2022-05-11
Completion date: 2022-05-11
Plan to share individual participant data: NO
Clinical trial NCT01826877: Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer
Official title: A Phase I, Open Label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With Ad-GMCAIX in Patients With Metastatic Renal Cell Carcinoma
Sponsor: Jonsson Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-01-14
Primary completion date: 2018-07-03
Completion date: 2021-05-27
Clinical trial NCT04553406: Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
Official title: A Randomized, Partially Blinded, Placebo- and Comparator-Controlled, Multicenter, Phase 2a, Dose Ranging, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SPR720 as Compared With Placebo or Standard of Care for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
Sponsor: Spero Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business decision pending resolution of clinical hold with FDA
Enrollment: 2.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-03
Primary completion date: 2021-01-28
Completion date: 2021-01-28
Plan to share individual participant data: NO
Clinical trial NCT03438344: Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Reducing CMV Related Complications in Patients With Blood Cancer Undergoing Donor Stem Cell Transplant
Official title: A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of a Haploidentical Hematopoietic Stem Cell Transplant
Sponsor: City of Hope Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI Withdrawal
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT03840902: M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
Official title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Based on recommendations by an external Independent data Monitoring Committee (IDMC), Sponsor decided to discontinue this clinical study due to a low likelihood of achieving superiority in the efficacy endpoints versus standard of care.
Enrollment: 153.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-16
Primary completion date: 2023-02-17
Completion date: 2023-02-17
Baseline population: Full Analysis Set (FAS) included all participants who were randomized to study treatment.
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports 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 bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT02786537: Study of Oral Treatments for Hepatitis C
Official title: THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders
Acronym: PRIORITIZE
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 1275.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-06-30
Primary completion date: 2019-06-13
Completion date: 2020-09-02
Baseline population: Study participants as randomized to HCV treatment
Limitations and caveats: This pragmatic trial allowed patients who were randomized to SOF/LDV but unable to obtain SOF/LDV (due to limitations in access from insurance, etc.) to be treated with the accessible, alternative DAA regimens. This contributed to the variance from 'as randomized' population to the 'as treated' population. Rapidly changing HCV landscape led to discontinuation of PrOD treatment regimen and modification of initial analysis plan including reduction of original sample size.
Plan to share individual participant data: NO
Clinical trial NCT02714205: Flushing Reduction Associated With Nitrates
Official title: Flushing Reduction Associated With Nitrates
Acronym: FRAN
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 141.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-24
Primary completion date: 2022-03-08
Completion date: 2022-04-05
Plan to share individual participant data: NO
Clinical trial NCT04366271: Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19
Official title: Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19
Acronym: MESCEL-COVID19
Sponsor: Hospital Infantil Universitario Niño Jesús, Madrid, Spain (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-07
Primary completion date: 2020-07-31
Completion date: 2021-05-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04342156: Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19
Official title: Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
Acronym: SHARP COVID-19
Sponsor: Tan Tock Seng Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The number of patients with COVID-19 in Singapore was coming down for the community and the concerns about the potential side effects particularly when the baseline ECG and serum electrolytes was not proposed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-30
Primary completion date: 2020-08-31
Completion date: 2020-10-31
Plan to share individual participant data: NO
Clinical trial NCT03795194: Antibiotic Duration in Post-appendectomy Abscess
Official title: A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess
Sponsor: Phoenix Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to low enrollment.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2021-12-15
Completion date: 2021-12-15
Limitations and caveats: Low enrollment. Early termination leading to small number of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT03859869: A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Official title: Creon (Pancrelipase) Therapy for Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Pancreatic Cancer: A Double-blind, Randomized, Parallel Design With 2 Dose Cohorts of Pancrelipase in Resected Pancreatic Cancer Subjects and an Open-label Single Dose Cohort in Non-resected Pancreatic Cancer Subjects
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Business Considerations (difficulty with enrollment)
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-25
Primary completion date: 2022-03-23
Completion date: 2022-03-23
Baseline population: Full Analysis Set: all randomized participants who received at least 1 dose of study drug
Limitations and caveats: This study was terminated due to low enrollment rates. The decision to terminate the study was not based on any safety or efficacy data.
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 NCT04723394: Phase III Study of AZD7442 for Treatment of COVID-19 in Outpatient Adults
Official title: A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults
Acronym: TACKLE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 910.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-28
Primary completion date: 2021-08-21
Completion date: 2022-10-19
Baseline population: Full Analysis Set - All participants randomized and dosed with IMP
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 request 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.
Clinical trial NCT04820686: A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection
Official title: A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects With Chronic Hepatitis B Virus Infection
Sponsor: Assembly Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 65.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-07
Primary completion date: 2023-03-30
Completion date: 2023-03-30
Limitations and caveats: Study ABI-H0731-204 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. As a result, not all subjects completed Week 96 and some outcome measures were impacted.
Plan to share individual participant data: NO
Clinical trial NCT03714815: A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Official title: A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Acronym: SERENADE OL
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: the absence of a positive trend in all efficacy parameters indicates that macitentan 10 mg does not have a beneficial effect in patients with HFpEF and PVD.
Enrollment: 91.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-07
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Limitations and caveats: Limited number of efficacy parameters were assessed in an exploratory manner. Study was stopped prematurely as main double-blind study did not meet the primary efficacy outcome measure.
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04201093: Fixed-Dose Trial in Early Parkinson's Disease (PD)
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)
Acronym: TEMPO-1
Sponsor: Cerevel Therapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 522.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-13
Primary completion date: 2024-06-28
Completion date: 2024-06-28
Plan to share individual participant data: NO