chufangao/CTO huggingface dataset:
Clinical trial NCT00033293: Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Official title: A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2004-03-15
Primary completion date: 2013-12-10
Completion date: 2022-12-31
Clinical trial NCT04308395: Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
Official title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
Sponsor: Sol-Gel Technologies, Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%.
Enrollment: 108.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-03
Primary completion date: 2021-07-14
Completion date: 2021-07-14
Clinical trial NCT01045382: MSC and HSC Coinfusion in Mismatched Minitransplants
Official title: Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study
Sponsor: University of Liege (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: recruitment too slow
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-07-31
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Clinical trial NCT04493502: A Study of LY3041658 in Adults With Hidradenitis Suppurativa
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-26
Primary completion date: 2022-03-15
Completion date: 2022-10-13
Baseline population: All randomized participants who received at least one dose of 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 NCT04080752: A Study of JNJ-61393215 in the Treatment of Depression
Official title: Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults With Major Depressive Disorder With Anxious Distress With Suboptimal Response to Standard Antidepressants
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 222.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-17
Primary completion date: 2021-09-02
Completion date: 2021-09-02
Baseline population: The safety analysis set included all randomized participants who received at least 1 dose of study agent.
Limitations and caveats: The study was limited to a single dose level. During the study, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic emerged. Public health measures required progressive restriction of movement of participants, site staff, and sponsor staff. The recruitment and enrollment were halted on 17 March 2020. All ongoing participants were permitted to continue the study if they were able to attend the on-site scheduled visits.
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 Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03054038: Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung Cancer
Official title: Phase I Trial of Combination Afatinib and Necitumumab in EGFR Mutation Positive NSCLC With Acquired Resistance to First or Third Generation EGFR TKIs
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-07-20
Primary completion date: 2022-03-23
Completion date: 2022-03-23
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03193359: Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Official title: A Multicenter, Open-label, Safety, Tolerability and Efficacy Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Corporate Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-15
Primary completion date: 2021-09-09
Completion date: 2021-09-09
Clinical trial NCT04770064: Targeting Senescence to Reduce Osteoarthritis Pain and cartilagE Breakdown (ROPE)
Official title: Targeting Senescence to Reduce Osteoarthritis Pain and cartilagE Breakdown (ROPE)
Acronym: ROPE
Sponsor: University of Kentucky (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Funding was not awarded
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-06-30
Primary completion date: 2024-05-31
Completion date: 2024-05-31
Plan to share individual participant data: NO
IPD sharing description: Individual participant data (IDP) will not be made available to other researchers.
Clinical trial NCT04626089: Metformin Glycinate in Patients With MS or DM2 , Hospitalized With COVID-19 and SARS Secondary to SARS-CoV-2
Official title: Adaptive Study for Efficacy and Safety of Metformin Glycinate for the Treatment of Patients With MS and DM2, Hospitalized With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2. Randomized, Double-Blind, Phase IIIb.
Acronym: DMMETCOV19
Sponsor: Laboratorios Silanes S.A. de C.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Administrative decision of the company
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-28
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT04028050: A Study of Atezolizumab in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Official title: A Phase IIIB, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) in Combination With Carboplatin Plus Etoposide to Investigate Safety and Efficacy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer - MAURIS
Acronym: MAURIS
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 155.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-08-12
Primary completion date: 2023-07-13
Completion date: 2023-07-13
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT03678506: Apixaban for Extended Anticoagulation (APIDULCIS)
Official title: APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer
Acronym: APIDULCIS
Sponsor: Arianna Anticoagulazione Foundation (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval \[CI\], 4.5-11.2)
Enrollment: 800.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-16
Primary completion date: 2021-09-01
Completion date: 2023-01-31
Plan to share individual participant data: YES
IPD sharing description: All collected data will be shared
IPD time frame: The data will be available after the publication of global results of the study or after 18 months from the enrollment of the last patients
IPD access criteria: Data access requests will be reviewed by the Scientific board of the study.
Clinical trial NCT02681302: Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence
Official title: Phase Ib-IIA Study of Combined Check Point Inhibition After Autologous Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence
Acronym: CPIT001
Sponsor: Hackensack Meridian Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Lack of Accrual
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-06-07
Primary completion date: 2024-05-10
Completion date: 2024-05-10
Clinical trial NCT03775200: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Official title: The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression
Acronym: P-TRD
Sponsor: COMPASS Pathways (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 233.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-01
Primary completion date: 2021-07-30
Completion date: 2021-09-27
Baseline population: The Safety Analysis Set included all randomised participants who received study drug.
Clinical trial NCT04963413: RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.
Official title: RENEW: Pilot Study of Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.
Sponsor: University of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated by mutual agreement by sponsor and institution.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-13
Primary completion date: 2023-09-28
Completion date: 2023-09-28
Plan to share individual participant data: NO
Clinical trial NCT03938545: ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
Official title: ASCEND GO-2: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for the Treatment of Patients With Active, Moderate to Severe Graves' Ophthalmopathy
Sponsor: Immunovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision based on premature unblinding of treatment allocations necessitated by program-wide review
Enrollment: 65.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-23
Primary completion date: 2021-02-02
Completion date: 2021-04-15
Limitations and caveats: The study was terminated early due to a safety finding (hypercholesterolemia).
Clinical trial NCT03656510: Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
Official title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Janssen made the strategic decision to discontinue the CROCuS study. This decision is not based on any safety concerns.
Enrollment: 246.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-29
Primary completion date: 2022-04-18
Completion date: 2022-04-18
Clinical trial NCT04050540: Doxycycline PEP for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV PrEP
Official title: PrEP and dPEP: Doxycycline Post-exposure Prophylaxis for Prevention of Sexually Transmitted Infections Among Kenyan Women Using HIV Pre-exposure Prophylaxis
Acronym: dPEP-KE
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 449.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-05
Primary completion date: 2022-10-30
Completion date: 2022-10-30
Plan to share individual participant data: NO
Clinical trial NCT03645395: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)
Official title: A Phase 2a Open-label Study to Investigate Safety and Tolerability (Including the Maximum Tolerated Dose), Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in Combination With Lenalidomide in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Sponsor: Molecular Templates, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 9.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-04-08
Primary completion date: 2021-03-10
Completion date: 2021-03-10
Baseline population: Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Plan to share individual participant data: NO
Clinical trial NCT03713242: A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
Official title: A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
Sponsor: Idorsia Pharmaceuticals Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-02-26
Primary completion date: 2020-02-27
Completion date: 2020-02-27
Plan to share individual participant data: NO
Clinical trial NCT05035368: Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes
Official title: Ladarixin 400 mg Twice a Day as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Overweight Insulin-resistant Type 1 Diabetic Patients
Sponsor: Dompé Farmaceutici S.p.A (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Dompé decided to withdraw LDX0121 following an internal re-planning and an extensive review of the study design.~At the time of withdrawal, no site had been activated and the drug had not been sent to investigators. No patients had been enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Plan to share individual participant data: NO
Clinical trial NCT03988634: Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
Official title: A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
Acronym: PARAGLIDE-HF
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 467.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-29
Primary completion date: 2022-12-14
Completion date: 2022-12-14
Baseline population: Demographic and baseline characteristics are based on the full analysis set (FAS), as primary and secondary analysis are based on the FAS.~The FAS consisted of all patients to whom study treatment was assigned by randomization and at least 1 dose of study treatment received.
Limitations and caveats: No efficacy analyses include OPEN LABEL' data. After Protocol Amendment 01, the open-label option was removed from the study, only the 233 patients randomized in the Double-blind Phase Sacubitril+ Valsartan (LCZ696) and the 233 patients randomized in the Double-blind Phase Valsartan arms were included in the efficacy analysis.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of the patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT02907307: Efficacy, Safety LactiSal 1% Gel, LactSal 50 mg, Clotrimazole 100 mg Tablet in Treatment Vulvovaginal Candidiasis
Official title: Comparative Study of the Efficacy and Safety of LactiSal 1% Vaginal Gel and LactSal 50 mg Vaginal Tablet Versus Clotrimazole 100 mg Vaginal Tablet in the Treatment of Vulvovaginal Candidiasis (VVC)
Sponsor: Medinova AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Development project stopped
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-31
Primary completion date: 2019-12-31
Completion date: 2020-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03770494: A Study of LY3405105 in Participants With Advanced Cancer
Official title: A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated for lack of sufficient efficacy.
Enrollment: 54.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-31
Primary completion date: 2021-02-04
Completion date: 2021-02-04
Plan to share individual participant data: NO
Clinical trial NCT02980731: A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
Official title: Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)
Acronym: VENICE II
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 210.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-13
Primary completion date: 2021-12-29
Completion date: 2021-12-29
Baseline population: All enrolled participants who received at least one dose of venetoclax
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 and 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 NCT01958021: Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Official title: A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Acronym: MONALEESA-2
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 668.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-12-17
Primary completion date: 2016-01-29
Completion date: 2023-03-16
Baseline population: The Full Analysis Set (FAS-population) consisted of all randomized patients.
Limitations and caveats: Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment and so are not part of the Safety Set.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.