chufangao/CTO huggingface dataset:
Clinical trial NCT03552029: Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)
Official title: A Phase 1 Study of Milademetan in Combination With Quizartinib in Subjects With FLT3-ITD Mutant Acute Myeloid Leukemia That Are Relapsed/Refractory, or Newly Diagnosed and Unfit for Intensive Chemotherapy
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated based on a business decision by the Sponsor.
Enrollment: 10.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-12
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Baseline population: Demographics and baseline characteristics were assessed in the Enrolled Analysis Set.
Limitations and caveats: This study was terminated based on a business decision by the Sponsor and was not due to a safety concern.
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 NCT02790736: Brief Intervention to Reduce Fear of Public Speaking
Official title: Brief Intervention to Reduce Fear of Public Speaking
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: COVID-19 restrictions
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2020-10-30
Completion date: 2020-10-30
Limitations and caveats: Early termination of this pilot study leading to small numbers of subjects evaluated
Plan to share individual participant data: NO
Clinical trial NCT03446651: Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Official title: Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-12
Primary completion date: 2022-09-07
Completion date: 2022-09-07
Limitations and caveats: This is preliminary data analysis conducted solely for the purpose of complying with clinicaltrials.gov timelines
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05070728: Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI)
Official title: A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
Sponsor: EyePoint Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: No longer pursuing indication
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-17
Primary completion date: 2022-10-17
Completion date: 2023-04-12
Clinical trial NCT04208412: A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
Official title: A Randomized, Double-blind, Placebo-controlled, Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900, an Oral Plasma Kallikrein Inhibitor, in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
Sponsor: KalVista Pharmaceuticals, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-02
Primary completion date: 2020-12-08
Completion date: 2020-12-08
Clinical trial NCT04442269: Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2023-07-27
Completion date: 2024-02-09
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).
Clinical trial NCT03128528: Analysing the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
Official title: Randomized, Double-blind, Placebo Controlled, Parallel-group, Prospective Clinical Study to Analyse the Effect of Empagliflozin on Reduction of Tissue Sodium Content in Patients With Chronic Heart Failure
Acronym: ELSI
Sponsor: University of Erlangen-Nürnberg Medical School (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 84.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-01
Primary completion date: 2020-01-31
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT03919162: A Trial to Evaluate the Efficacy and Safety of PQ912 in Patients With Early AD
Official title: A Phase 2A Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Varoglutamstat (PQ912) in Patients With Early Alzheimer's Disease With a Stage-Gate to Phase 2B (VIVA-MIND)
Acronym: VIVA-MIND
Sponsor: Vivoryon Therapeutics N.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: It has been made the strategic decision to terminate the study. This decision to terminate the study early is not being made for safety reasons.
Enrollment: 112.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-15
Primary completion date: 2024-07-12
Completion date: 2024-08-12
Plan to share individual participant data: YES
Clinical trial NCT03840967: A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
Official title: A Phase II Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Homologous Recombination (HR) Defective or Loss of Heterozygosity (LOH) High Metastatic Esophageal/Gastroesophageal Junction/Proximal Gastric Adenocarcinoma
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to slow accruals
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-09
Primary completion date: 2022-11-17
Completion date: 2023-02-22
Plan to share individual participant data: NO
Clinical trial NCT04120987: Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra
Official title: The Incidence of Ocular Inflammation as Defined by the Inflammadry Assay in 250 Consecutive Cataract Patients and Their Response to Treatment With Xiidra
Sponsor: Bucci Laser Vision Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Administrative
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-31
Primary completion date: 2022-06-25
Completion date: 2022-06-25
Clinical trial NCT04317001: Treatment for Cognitive Impairment in Depression
Official title: Developing Improved Treatment for Cognitive Impairment in Depression
Acronym: T-CID
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Researcher leading the study moved institutions study not feasible
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-01
Primary completion date: 2022-11-30
Completion date: 2024-11-30
Plan to share individual participant data: NO
Clinical trial NCT05549908: Vaccine Prevention of Rabies Adopts 4-shot Immunization Method
Official title: Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
Sponsor: Changchun Zhuoyi Biological Co., Ltd (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1800.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-22
Primary completion date: 2021-10-31
Completion date: 2023-04-20
Plan to share individual participant data: YES
IPD sharing description: all results.
IPD time frame: before December 2023.
IPD access criteria: public for all.
Clinical trial NCT01988571: Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
Official title: Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 279.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-02-01
Primary completion date: 2020-09-24
Completion date: 2020-09-24
Clinical trial NCT05259397: PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Official title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-07225570 EITHER ALONE OR IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY, IN PARTICIPANTS WITH RECURRENT NON-MUSCLE INVASIVE BLADDER CANCER
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Pfizer has decided to terminate Study C4661001 due to strategic considerations. This decision is not due to any specific safety reasons or requests from any regulatory authorities. No participants have been enrolled in this study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-03-24
Primary completion date: 2022-09-19
Completion date: 2022-09-19
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 NCT04157075: Intra-operative Uterosacral Ligament Bupivacaine Injection During Minimally Invasive Hysterectomy
Official title: The Effect of Intra-operative Uterosacral Bupivacaine Injection on Post-operative Pain in Patients Undergoing Minimally Invasive Hysterectomy
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 180.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-15
Primary completion date: 2022-10-15
Completion date: 2022-10-15
Plan to share individual participant data: NO
Clinical trial NCT03860207: Study of the Safety and Efficacy of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma and Other Solid Tumor Cancers
Official title: Phase I/II Study of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients With Relapsed/Refractory Neuroblastoma, Osteosarcoma, and Other GD2(+) Solid Tumors
Sponsor: Y-mAbs Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: study terminated due to business priorities
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-22
Primary completion date: 2021-10-20
Completion date: 2021-10-20
Baseline population: Safety Analysis Set.~In Protocol version 1.0 to 5.0 patients ≥ 1 year were eligible. In Protocol version 6.0 to 10.0 patients between ≥ 1 year and \< 18 years were eligible.
Limitations and caveats: The study was terminated after 11 subjects due to a business strategy decision. At this point the maximum tolerated dose was not established.
Clinical trial NCT03311269: A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Official title: A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux
Acronym: VICARES
Sponsor: Vascular Insights, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated for administrative reasons
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-22
Primary completion date: 2018-05-15
Completion date: 2020-03-27
Limitations and caveats: A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.
Plan to share individual participant data: NO
Clinical trial NCT02989857: Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Acronym: ClarIDHy
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 187.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-02-20
Primary completion date: 2019-01-31
Completion date: 2021-05-17
Baseline population: Intent-To-Treat (ITT) Set included all participants who were randomized, with the treatment group designated according to the randomization.
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT02448381: FLASH [Fluorescent Light Activated Synthetic Hypericin] Clinical Study: Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides)
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Determine the Efficacy of Topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma
Sponsor: Soligenix (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 169.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-31
Primary completion date: 2020-06-30
Completion date: 2020-11-30
Baseline population: The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX301 or Placebo)
Clinical trial NCT04830878: Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
Official title: A Phase I, Multicenter, Uncontrolled, Open Label Study Assessing the Efficacy and Safety of a Combination of Systemic and Intravitreal Injections of Methotrexate for the Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients With RheGmatogenous Retinal DetacHmenT (the SIGHT Study)
Acronym: SIGHT
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-30
Primary completion date: 2023-04-30
Completion date: 2024-04-30
Clinical trial NCT04096326: AGN-151586 Dose-Ranging Study for Treatment of Glabellar Lines
Official title: A Phase 2b Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of AGN-151586 in Participants With Moderate to Severe Glabellar Lines
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 198.0 (ACTUAL)
Number of arms: 10.0
Start date: 2019-09-26
Primary completion date: 2020-09-09
Completion date: 2020-09-09
Baseline population: Modified intent-to-treat (mITT) population included all randomized participants who received the study intervention and who had at least one postintervention investigator-rated facial wrinkle scale with photonumeric guide (FWS) measurement at maximum frown.
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 NCT04680637: Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus
Official title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The trial was terminated prematurely as it met pre-defined criteria for futility at IA3.
Enrollment: 168.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-06
Primary completion date: 2023-05-22
Completion date: 2023-05-22
Baseline population: Full Analysis Set: Included all participants randomized in the study.
Limitations and caveats: This study was discontinued early due to meeting predefined futility criteria at its third interim analysis.
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. Further details are available at the URL below.