chufangao/CTO huggingface dataset:
Clinical trial NCT04722666: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Official title: A Double-blind, Placebo-controlled, Randomized Dose-ranging Trial to Investigate Efficacy and Safety of Intravenous MIJ821 Infusion in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated by Novartis
Enrollment: 200.0 (ACTUAL)
Number of arms: 7.0
Start date: 2021-07-20
Primary completion date: 2023-09-26
Completion date: 2023-09-26
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 patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/
Clinical trial NCT03502577: BCMA-Specific CAR T-Cells Combined With a Gamma Secretase Inhibitor (JSMD194) to Treat Relapsed or Persistent Multiple Myeloma
Official title: A Phase I Study of B-Cell Maturation Antigen (BCMA)-Specific Chimeric Antigen Receptor T Cells in Combination With JSMD194, a Small Molecule Inhibitor of Gamma Secretase, in Patients With Relapsed or Persistent Multiple Myeloma
Sponsor: Fred Hutchinson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed per SRC Low Accrual Policy
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-23
Primary completion date: 2022-04-20
Completion date: 2022-04-20
Plan to share individual participant data: NO
Clinical trial NCT01788280: Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab
Official title: Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Unable to get materials from GE, study not proceeding and never opened to accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-31
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Clinical trial NCT04442490: A Study to Evaluate the Efficacy of Sage-217 in the Treatment of Adult Participants With Major Depressive Disorder (MDD)
Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Subjects With Major Depressive Disorder
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 543.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-12
Primary completion date: 2021-03-26
Completion date: 2021-04-21
Baseline population: Safety Set included all participants who were administered IP.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT02067741: CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer
Official title: A Stratified, Multicenter Phase II Trial of Transdermal CR1447 (4-OH-testosterone) in Endocrine Responsive-HER2 Negative and Triple Negative-androgen Receptor Positive Metastatic or Locally Advanced Breast Cancer
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The SAKK board decided to prematurely end the life-long follow-up of the trial SAKK 21/12, as 90% of the patients have died.
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-14
Primary completion date: 2018-08-02
Completion date: 2022-10-24
Plan to share individual participant data: NO
Clinical trial NCT03220009: Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Official title: A Randomized Phase II Trial of Adjuvant Nivolumab or Expectant Observation Following Neoadjuvant Ipilimumab Plus Nivolumab and Surgical Resection of High-Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study was never approved by CTEP neither was it ever activated
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-03
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Clinical trial NCT03035630: Sunitinib Followed by Avelumab or the Reverse for Metastatic Renal Cell Carcinoma
Official title: Randomized Phase II Trial Comparing Sequential First-line Sunitinib and Second-line Avelumab vs First-line Avelumab and Second-line Sunitinib for Metastatic Renal Cell Carcinoma: SUAVE Trial. Hoosier Cancer Research Network GU15-223
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Principal investigator left lead institution and efforts to open the protocol at another institution were not successful.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-23
Primary completion date: 2018-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT04193202: Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)
Official title: A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 419.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-21
Primary completion date: 2021-10-19
Completion date: 2021-11-03
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03693573: A Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma
Official title: An Open Label, Phase IIIB, Single Arm, Multicenter Safety Study of Atezolizumab in Combination With Bevacizumab in Untreated Locally Advanced or Metastatic Clear Cell or Non-Clear Cell Renal Cell Carcinoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: In the context of the ongoing evaluation of our data, we have determined that there is no need to generate additional safety data at this time in the 1L mRCC pa
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-11
Primary completion date: 2021-08-14
Completion date: 2024-01-31
Clinical trial NCT03283670: Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Official title: Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies
Acronym: NARSAD
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 24.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-11-22
Primary completion date: 2020-02-18
Completion date: 2020-02-18
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share IPD.
Clinical trial NCT03061812: Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
Official title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Acronym: TAHOE
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 444.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-11
Primary completion date: 2020-02-12
Completion date: 2020-02-12
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: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04946162: The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Official title: The Use of Tadalafil in Confirmed COVID-19 Pneumonia.
Sponsor: Santa Barbara Cottage Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The investigators never completed the IRB application due to decrease in need to conduct the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-20
Primary completion date: 2020-04-20
Completion date: 2020-04-20
Plan to share individual participant data: NO
Clinical trial NCT01709981: Anti-inflammatory Effects of Colchicine in PCI
Official title: Anti-inflammatory Effects of Colchicine in Patients Undergoing Percutaneous Coronary Intervention: Inflammatory Marker Substudy of the Colchicine-PCI Trial
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 280.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-05-30
Primary completion date: 2019-08-30
Completion date: 2021-12-13
Clinical trial NCT03416816: A Study of DSP-0337 in Patients With Advanced Solid Tumors to Determine the Safety and the Pharmacokinetic Profile
Official title: A First-in-Human Phase I Trial to Determine the Safety and the Pharmacokinetic Profile of DSP-0337 in Patients With Advanced Solid Tumors
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Alternate development strategy
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-15
Primary completion date: 2020-06-15
Completion date: 2020-06-15
Clinical trial NCT04260191: Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Official title: A Global Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of the Half-life Extended Bispecific T-cell Engager AMG 910 in Subjects With Claudin 18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Decision
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-29
Primary completion date: 2022-06-02
Completion date: 2022-06-02
Baseline population: Safety Analysis Set: All participants that were enrolled and received at least 1 dose of AMG 910.
Limitations and caveats: The study was discontinued due to a strategic decision to end clinical development for AMG 910 that was unrelated to safety.
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 specifications. Further details are available at the URL below.
Clinical trial NCT06045624: A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects
Official title: A Phase 1, First in Human, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose and Open Label Food Effect Study to Evaluate Safety, Tolerability, and Pharmacokinetics of OR-101 Administered Orally in Healthy Subjects
Sponsor: Ornovi, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The study was cancelled as the sponsor decided to reformulate the IP
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-10-17
Primary completion date: 2024-02-06
Completion date: 2024-02-06
Plan to share individual participant data: NO
Clinical trial NCT02898753: VAL-1221 Delivered Intravenously in Ambulatory and Ventilator-free Participants With Late-Onset Pompe Disease
Official title: A Three-Month, Open-Label, Randomized, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of VAL-1221 Versus Myozyme®/Lumizyme® in Patients With Late-Onset GSD-II (Pompe Disease) Followed by Open-Label Treatment With VAL-1221 in All Patients
Sponsor: Valerion Therapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company closure due to lack of funding
Enrollment: 12.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-06-21
Primary completion date: 2020-03-25
Completion date: 2020-03-25
Plan to share individual participant data: NO
Clinical trial NCT03865953: Oral LAT8881 in Neuropathic Pain
Official title: A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain
Sponsor: Lateral Pharma Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 53.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-09
Primary completion date: 2020-04-19
Completion date: 2020-05-03
Plan to share individual participant data: NO
IPD sharing description: This is an Early Proof of Concept study
Clinical trial NCT04203017: Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis
Official title: Allogeneic Fecal Microbiota Transplantation as a Consolidation Treatment After Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Sclerosis
Sponsor: St. Petersburg State Pavlov Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: the bio-samples are corrupted for technical reasons
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-01
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Clinical trial NCT04919863: Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
Official title: A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
Sponsor: ATXA Therapeutics Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 79.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-24
Primary completion date: 2022-01-20
Completion date: 2022-01-20
Clinical trial NCT02471144: Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis
Official title: A Randomized, Double-blind, Placebo- and Active Controlled Multicenter Trial to Demonstrate Efficacy of Subcutaneous Secukinumab Compared to Placebo and Etanercept (in a Single-blinded Arm) After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, and Long-term Efficacy in Subjects From 6 to Less Than 18 Years of Age With Severe Chronic Plaque Psoriasis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 162.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-09-29
Primary completion date: 2018-12-13
Completion date: 2023-03-30
Baseline population: The randomized set was defined as all patients who were randomized. Mis-randomized patients were excluded from the randomized set. If patients were re screened and successfully randomized, they were included in the randomized set according to the treatment assigned in the last randomization.
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 patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Clinical trial NCT02910843: Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer
Official title: Neoadjuvant Treatment With Regorafenib and Capecitabine Combined With Radiotherapy in Locally Advanced Rectal Cancer. A Multicenter Phase Ib Trial (RECAP)
Acronym: RECAP
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: due to structural financial deficit of SAKK
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-22
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT03535675: Muscadine Plus (MPX) In Men With Prostate Cancer
Official title: A Randomized Double-Blind, Placebo-Controlled Study Of The Effects Of MPX Capsules On Rising Prostate-Specific Antigen Levels In Alanine/Alanine SOD2 Genotype Men Following Initial Therapy For Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated by DSMB due to futility.
Enrollment: 59.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-30
Primary completion date: 2022-07-06
Completion date: 2022-11-03
Plan to share individual participant data: NO
Clinical trial NCT03380026: Mechlorethamine Induced Contact Dermatitis Avoidance Study
Official title: Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study)
Acronym: MIDAS
Sponsor: Rochester Skin Lymphoma Medical Group, PLLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-13
Primary completion date: 2020-08-03
Completion date: 2020-12-13
Plan to share individual participant data: YES
IPD sharing description: Data will be embargoed until the study site has fully examined it. Expected embargo would be one year from study completion.~Study data that is de-identified will be maintained at the study site. As this field is rapidly changing, if a database is available for safe, public upload at the end of study embargo, it will be uploaded to a national database. Otherwise requests for use of the study data will be accepted at the study site and shared with investigators whose proposed use of data has been approved by an independent institutional review board. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.
IPD time frame: Expected embargo would be one year from study completion. De-identified data will be maintained at the study site for 2 years after the study ends. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.
IPD access criteria: Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.
Clinical trial NCT03055234: Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD)
Official title: A Phase 3, Multicenter, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Sickle Cell Disease
Sponsor: United Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Business decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-30
Primary completion date: 2021-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO