chufangao/CTO huggingface dataset:
Clinical trial NCT04423718: Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
Official title: Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Acronym: PULSAR
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1011.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-11
Primary completion date: 2022-07-27
Completion date: 2024-08-07
Baseline population: Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA Principles for responsible clinical trial data sharing. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.~Interested researchers can use www.vivli.org 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 member section of the portal.
Clinical trial NCT03532542: An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy
Official title: Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen
Sponsor: Sarepta Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The trial was stopped to reduce the clinical trial burden on participants while ensuring continued treatment via a post-trial access program with commercially available casimersen and golodirsen. Study was not terminated due to safety concerns.
Enrollment: 171.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-02
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Baseline population: Safety Analysis Set: All enrolled participants who received at least 1 dose of study drug (golodirsen or casimersen).
Limitations and caveats: This study was terminated before all participants had reached the last protocol-defined end-of-study visit. Study termination resulted in participants either being transitioned to a post-trial access program, to another study, or they declined further treatment.
Clinical trial NCT04913610: Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection
Official title: A Phase-II, Randomised, Double-blind, Parallel-group, Proof-of-concept Trial to Investigate ABBV-4083 Given for 7 or 14 Days or in Combination With Albendazole in Subjects With Onchocerca Volvulus Infection, Comprising: Part 1 to Investigate Safety, Tolerability, Efficacy for Dose-Ranging and Pharmacokinetics; Part 2 to Investigate Efficacy of Selected Doses, Safety, Tolerability and Pharmacokinetics
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 153.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-05-22
Primary completion date: 2023-08-29
Completion date: 2023-08-29
Baseline population: Intention-to-Treat (ITT) population includes all randomized participants who received at least one dose of study drug
Plan to share individual participant data: NO
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.
Clinical trial NCT05289492: Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma
Official title: Study of EOS884448 Alone, and in Combination with Iberdomide with or Without Dexamethasone, in Participants with Relapsed or Refractory Multiple Myeloma
Sponsor: iTeos Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company operational decision. Decision to stop study is not due to safety or efficacy concerns
Enrollment: 16.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-05-01
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Clinical trial NCT04418024: Efficacy and Safety of AG10 in Subjects with Transthyretin Amyloid Polyneurophathy
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)
Acronym: ATTRibute-PN
Sponsor: Eidos Therapeutics, a BridgeBio company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: After a careful review of the currently available treatments worldwide for patients with ATTR-polyneuropathy, Eidos has made the decision to halt the current study design.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-21
Primary completion date: 2024-03-31
Completion date: 2024-04-30
Clinical trial NCT05280717: Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC)
Official title: A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years
Acronym: COSMIC
Sponsor: Vir Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Part C cohort 1 was discontinued early in the context of evolving variants with increased fold changes in the in vitro half maximal inhibitory concentration (IC50) and uncertainty in the clinical relevance of these changes.
Enrollment: 316.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-03-28
Primary completion date: 2023-04-05
Completion date: 2023-11-06
Baseline population: Part B was not initiated in alignment with the strategic direction of the sotrovimab program and Part C Cohort-2 was not conducted as Part C Cohort-1 was stopped for programmatic reasons given the evolving Corona virus disease-19 (COVID-19) variant landscape. Hence, no participants were enrolled in Part B and Part C (Cohort-2). Baseline Characteristic data are reported for Safety Population.
Clinical trial NCT03796273: Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases
Official title: tGLI1 as a Therapeutic Target in Brain Metastases: A Window of Opportunity Study in Breast Cancer Brain Metastases and Primary Gliomas
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Low accruals
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-13
Primary completion date: 2022-10-23
Completion date: 2022-10-23
Clinical trial NCT04943744: Gastrointestinal STRING Test With Oral Immunotherapy
Official title: Monitoring Gastrointestinal Responses In Food Oral Immunotherapy Using the Esophageal STRING Test
Acronym: STRING
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Parent study closed to enrollment
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-17
Primary completion date: 2024-05-17
Completion date: 2024-05-17
Plan to share individual participant data: NO
Clinical trial NCT04327206: BCG Vaccination to Protect Healthcare Workers Against COVID-19
Official title: BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial
Acronym: BRACE
Sponsor: Murdoch Childrens Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 6828.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-30
Primary completion date: 2021-11-10
Completion date: 2022-05-27
Plan to share individual participant data: YES
IPD sharing description: Under the terms of the funding agreement with the Bill and Melinda Gates foundation, the BRACE trial has a data sharing agreement in place.~An anonymised Individual Participant Data (IPD) dataset and a data dictionary will be provided to Vivli (https://vivli.org/) under the terms of the agreements with the Bill and Melinda Gates foundation grant and Vivli.~After database lock, the following may be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions, under a collaborator agreement, for accessing:~* Individual participant data that underlie the results reported in our articles after deidentification (text, tables, figures and appendices)~* Study protocol, Statistical Analysis Plan, PICF
IPD time frame: After database lock, a 12-month embargo period will be in place, to allow adequate time for analyses and publication outputs. Data transfer to Vivli should occur during the embargo period.
IPD access criteria: Researchers from a recognised research institution can approach MCRI for access of data.~The researcher will need to provide evidence that the proposed use of the data has been ethically reviewed and approved by an Institutional Review Board (IRB)/ Human Research Ethics Committee(HREC), and accept MCRI's conditions, under a collaborator agreement.
Clinical trial NCT04218240: Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
Official title: Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone?
Acronym: PGB-LOF
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-17
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Baseline population: males and females who are 18+ years of age, opioid use disorder
Plan to share individual participant data: NO
IPD sharing description: Not at this time
Clinical trial NCT01666249: Clinical Efficacy of Postpartum Immunization of Rh and Coombs Negative Women With Sensitization Risk.
Official title: Evaluation of the Clinic Efficacy of Immunoglobulin Anti-RhD KamRho-D® (Panamerican) in Postpartum Immunization of Rh and Coombs Negative Women at Sensitization Risk.
Sponsor: Azidus Brasil (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Suspended for indetermined period.
Enrollment: 347.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2014-04-30
Primary completion date: 2014-11-30
Completion date: 2020-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05238675: A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 322.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-03-21
Primary completion date: 2024-05-01
Completion date: 2024-05-30
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 http://trials.boehringeringelheim.com/ 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 NCT04949191: The Purpose of the Study is to Continue to Provide Pemigatinib to Patients With Advanced Malignancies.
Official title: An Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Pemigatinib
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A business decision due to availability of commercial drug and other options for accessing study drug treatment.
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-07-08
Primary completion date: 2024-04-11
Completion date: 2024-04-11
Baseline population: The 6 mg (n=2) and 13.5 mg (n=2) monotherapy groups have been combined into a single arm retain participant privacy and reduce the risk of participant re-identification.
Plan to share individual participant data: NO
Clinical trial NCT03562195: A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma
Official title: A Randomized, Double Blind, Parallel Group Study of the Efficacy and Safety of Mepolizumab as Adjunctive Therapy in Patients With Severe Asthma With Eosinophilic Inflammation
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-29
Primary completion date: 2022-09-07
Completion date: 2022-09-07
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Clinical trial NCT04090203: Boiled Peanut Oral Immunotherapy
Official title: Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients
Acronym: BPOIT
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-05
Primary completion date: 2021-05-20
Completion date: 2021-05-20
Limitations and caveats: Enrollment was paused due to institutional IRB regulations during the COVID-19 pandemic. After resumption of enrollment, the study proceeded as planned.
Plan to share individual participant data: NO
Clinical trial NCT04984616: Atorvastatin on Inflammation and Cardiac Function in Chronic Chagas Disease
Official title: Effect of Statins (Atorvastatin) on Inflammation and Cardiac Function in Patients with Chronic Chagas Disease: Pathophysiological Studies in a Multicenter Proof-of-concept
Acronym: ATOCHA
Sponsor: University of Chile (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The recruitment rate in all centers was extremely low. The number of participants failed to reach a statistically significant minimum.
Enrollment: 300.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-12
Primary completion date: 2024-03-31
Completion date: 2024-04-01
Plan to share individual participant data: UNDECIDED
IPD sharing description: The study protocol and the Clinical Study Report will be available as supporting information alongside all publications derived from this study.~By incorporating the Individual Participant Data on a repository after an embargo period of one year after the last patient is recruited
Clinical trial NCT05131204: Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: A Randomized, Open-Label, Eculizumab and Ravulizumab Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Currently Treated With Eculizumab or Ravulizumab
Acronym: ACCESS 2
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision not related to efficacy or safety.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-06
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Limitations and caveats: 20Dec2022 - Due to feasibility challenges related to enrollment and not due to efficacy or safety concerns, the sponsor terminated the study early and discontinued participant enrollment.
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: 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 made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT04182516: Study of NMS-03305293 in Pts with Selected Advanced/Metastatic Solid Tumors
Official title: A Phase I Dose Escalation Study of NMS-03305293 in Adult Patients with Selected Advanced/Metastatic Solid Tumors
Sponsor: Nerviano Medical Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study closure is related to sponsor decision to shift towards the clinical development of NMS-03305293 in combination in a broader range of indication and not based on emerging safety or efficacy concerns.
Enrollment: 52.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-11-25
Primary completion date: 2023-03-31
Completion date: 2024-05-16
Clinical trial NCT04028713: Dose Tapering Study of Adalimumab in Psoriasis
Official title: A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
Sponsor: University Hospital, Ghent (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Too slow inclusion rate.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-16
Primary completion date: 2022-03-22
Completion date: 2022-03-22
Plan to share individual participant data: NO
Clinical trial NCT04261439: A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
Official title: A Phase I/Ib Study of Subcutaneous Recombinant Human NIZ985 ((hetIL-15) (IL-15/sIL-15Rα)) in Combination With Spartalizumab in Patients With Check Point Inhibitor (CPI) Relapsed Advanced Solid Tumors and Lymphoma
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor's decision and not due to any safety concerns
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-27
Primary completion date: 2023-12-27
Completion date: 2023-12-27
Plan to share individual participant data: NO
Clinical trial NCT05097079: Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Treatment Efficacy and Safety Study of MYOBLOC® for the Treatment of Chronic Sialorrhea in Pediatric Subjects
Sponsor: Supernus Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Company/sponsor business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-30
Primary completion date: 2023-05-31
Completion date: 2023-05-31
Clinical trial NCT03884829: A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
Official title: A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
Sponsor: Cyclacel Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Switch to oral formulation of CYC140 (plogosertib)
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-25
Primary completion date: 2021-11-29
Completion date: 2023-10-19
Plan to share individual participant data: NO
Clinical trial NCT05005182: Luspatercept With or Without Hydroxyurea for the Treatment of Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis or Unclassifiable With Ring Sideroblasts
Official title: Phase II Study to Determine the Efficacy and Safety of Luspatercept (ACE-536) in Patients With Myelodysplastic/Myeloproliferative Neoplasms With Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T) and Myelodysplastic/Myeloproliferative Neoplasms, Unclassifiable With Ring Sideroblasts (MDS/MPN-U With RS)
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-20
Primary completion date: 2023-04-17
Completion date: 2023-06-17
Baseline population: All patients have been combined in order to maintain patient privacy
Clinical trial NCT06009653: Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
Official title: Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
Acronym: TRZ
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Administrative Reasons
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-09-13
Primary completion date: 2024-05-29
Completion date: 2024-05-29