chufangao/CTO huggingface dataset:
Clinical trial NCT04462757: SCIL-1Ra in COVID-19 Feasibility & PK/PD
Official title: Subcutaneous and Intravenous IL-1Ra (Anakinra) in COVID-19 Infection - Feasibility & Pharmacokinetics/Pharmacodynamics Study
Acronym: SCIL_COV19
Sponsor: University of Manchester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of patients in the trial population from which to recruit and lack of funding
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-28
Primary completion date: 2020-08-31
Completion date: 2020-12-23
Plan to share individual participant data: NO
Clinical trial NCT02331095: Statin Use in Patients With Acute VTE
Official title: A Pilot Study of Using Statins in Patients With Acute Venous Thromboembolism (VTE)
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Low recruitment
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2017-10-27
Completion date: 2020-05-20
Limitations and caveats: Our study was limited by the small sample size, early termination due to low recruitment rate and lack of funding. The protocol was amended to include patients on rivaroxaban (initially only warfarin). Lost to follow up is also significant.
Clinical trial NCT03398434: Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
Official title: A Multicenter, Randomized, Open-label, Active-controlled, Dose-range Finding Study to Assess the Pharmacodynamic Parameters, Safety and Tolerability of MAA868 and Its Effect on Thrombogenesis Biomarkers Compared to Apixaban in Patients With Atrial Fibrillation
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Trial cancelled before First Patient First Visit (no patient enrolled)
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-10-16
Primary completion date: 2019-11-28
Completion date: 2020-01-30
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 NCT05027516: Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea
Official title: An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome
Acronym: ResistAZM
Sponsor: Institute of Tropical Medicine, Belgium (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-17
Primary completion date: 2022-05-09
Completion date: 2022-05-09
Plan to share individual participant data: NO
Clinical trial NCT05125562: Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19
Official title: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Mild-to-Moderate COVID-19: A Phase II Clinical Trial
Sponsor: Direct Biologics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor has withdrawn/closed the IND with the FDA. A letter dated 21NOV2022 was submitted to the FDA.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-12-07
Primary completion date: 2023-03-07
Completion date: 2023-03-07
Plan to share individual participant data: NO
Clinical trial NCT02702401: Study of Pembrolizumab (MK-3475) vs. Best Supportive Care in Participants With Previously Systemically Treated Advanced Hepatocellular Carcinoma (MK-3475-240/KEYNOTE-240)
Official title: A Phase III Study of Pembrolizumab (MK-3475) vs. Best Supportive Care as Second-Line Therapy in Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-240)
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 413.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-26
Primary completion date: 2019-01-02
Completion date: 2021-09-22
Baseline population: The baseline characteristics population includes all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04003818: Efficacy and Safety of Teicoplanin in CDAD
Official title: Prospective, Interventional, Phase IV Study, Evaluating the Efficacy and Safety of Teicoplanin (100-200 mg, Administered Orally Twice a Day) in Patients With Clostridium Difficile Infection-associated Diarrhea and Colitis
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to COVID-19 and great challenges during patient enrolment period, current status of this study is far behind the plan. The study cannot be completed according to the plan. Sanofi decides to terminate the study upon comprehensive assessment.
Enrollment: 50.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-15
Primary completion date: 2021-01-21
Completion date: 2021-03-10
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03812588: Contact: Developing New Clinical Management Strategies
Official title: Developing New Clinical Management Strategies for Antidepressant Treatments
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-30
Primary completion date: 2020-05-27
Completion date: 2021-08-01
Limitations and caveats: Due to challenges associated with the pandemic, the study was completed with a smaller sample size than originally intended.
Clinical trial NCT04627142: A Study to Test Different Doses of BI 1701963 in Combination With Irinotecan in People With Advanced Bowel Cancer With Kirsten Rat Sarcoma Viral Oncogene Homologue (KRAS) Mutation
Official title: A Phase 1 Open-label Dose Escalation Trial of BI 1701963 in Combination With Irinotecan in KRAS Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-23
Primary completion date: 2022-01-18
Completion date: 2022-01-18
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT02659020: A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
Official title: A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma
Acronym: ANNOUNCE 2
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 310.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-03-01
Primary completion date: 2020-07-28
Completion date: 2021-04-27
Baseline population: All participants from phase 1b/2.
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 NCT04117477: Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients
Official title: Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration
Sponsor: Children's Hospital Medical Center, Cincinnati (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A new multisite study was opened in place of this study.
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-27
Primary completion date: 2021-03-20
Completion date: 2021-03-20
Clinical trial NCT03589885: Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis
Official title: Multicenter, rAndomized, Double-blind, Placebo-conTrolled, 52-week stUdy to demonstRatE the Efficacy, Safety and Tolerability of Secukinumab Injections With 2 mL Auto-injectors (300 mg) in Adult Subjects With Plaque Psoriasis
Acronym: MATURE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 122.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-12-19
Primary completion date: 2019-11-19
Completion date: 2020-08-05
Baseline population: Full Analysis set (FAS) consisted of 122 subjects and used for efficacy analyses.
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 NCT04681729: Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of Dupilumab in Patients With Chronic Inducible Cold Urticaria Who Remain Symptomatic Despite the Use of H1-antihistamine Treatment
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-10
Primary completion date: 2023-02-02
Completion date: 2023-04-20
Baseline population: Randomized population consisted of all participants from the screened population who had been allocated to randomized intervention by interactive response technology regardless of whether the treatment kit was used or not.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04534842: Efficacy and Safety of SYNB1618 and SYNB1934 in Adult Patients With Phenylketonuria
Official title: An Open-label Study of the Efficacy and Safety of SYNB1618 and SYNB1934 in Patients With Phenylketonuria (SynPheny-1)
Acronym: SynPheny-1
Sponsor: Synlogic (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-25
Primary completion date: 2022-10-07
Completion date: 2022-10-07
Clinical trial NCT03563742: A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Official title: Open-Label Study With Rilpivirine in Treatment-naïve Indian Subjects With HIV-1 Infection to Determine Safety and Efficacy
Acronym: RISE
Sponsor: Johnson & Johnson Pte Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: High SF rate (less treatment-naïve subjects \& subjects with viral load \<100000). Reevaluation in scientific position in India after internal discussion.
Enrollment: 58.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-24
Primary completion date: 2021-06-28
Completion date: 2021-06-28
Clinical trial NCT05611086: N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia
Official title: N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia: A Single Blind, Randomized Controlled Trial
Sponsor: Dr Cipto Mangunkusumo General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study stopped because the study period already ended
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-29
Primary completion date: 2020-12-03
Completion date: 2020-12-03
Plan to share individual participant data: NO
Clinical trial NCT04809805: A Study to Learn How Safe BAY2666605 is, How it Affects the Body, How it Moves Into, Through and Out of the Body, the Maximum Amount That Can be Given and Its Action Against Tumors in Adult Participants With Skin Cancer That Has Spread to Other Parts of the Body and Other Types of Advanced Cancer
Official title: An Open Label, Phase 1, First-in-human, Study to Evaluate Safety, Tolerability, Maximum Tolerated or Administered Dose, Pharmacokinetics, Pharmacodynamics and Tumor Response Profile of Schlafen12 Complex Inducer (SLFN12 ci) BAY 2666605 in Participants With Metastatic Melanoma and Other Advanced Solid Tumors.
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to the high probability of not achieving a therapeutic window and lack of evidence of sufficient clinical benefit.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-15
Primary completion date: 2022-11-09
Completion date: 2023-04-27
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 NCT03022045: A Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Official title: A Phase 3, Randomized, Open-Label Study to Assess Efficacy and Safety of Two Different Dose Regimens of Risankizumab Administered Subcutaneously in Japanese Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-26
Primary completion date: 2017-09-17
Completion date: 2020-11-19
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 NCT03566238: This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study to Demonstrate Efficacy and Safety of A4250 in Children With Progressive Familial Intrahepatic Cholestasis Types 1 and 2 (PEDFIC 1)
Acronym: PEDFIC 1
Sponsor: AlbireoPharma (UNKNOWN)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-05-16
Primary completion date: 2020-07-27
Completion date: 2020-07-28
Clinical trial NCT03386578: Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum
Official title: Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention During Pregnancy and Postpartum in Adolescents and Young Women and Their Infants
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 390.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-03
Primary completion date: 2023-10-25
Completion date: 2024-02-24
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie results in the publication, after deidentification.
IPD time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.~* For what types of analyses?~  * To achieve aims in the proposal approved by the IMPAACT Network.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the IMPAACT Data Request form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
Clinical trial NCT03437330: Empagliflozin Effect on Glucose Toxicity
Official title: Empagliflozin Effect on Glucose Toxicity in Type 2 Diabetes Patients - a Randomized, Open-label, Controlled, Parallel Group, Exploratory Study
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: poor recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-27
Primary completion date: 2023-05-03
Completion date: 2023-05-03
Plan to share individual participant data: NO
Clinical trial NCT02351869: Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder
Official title: Nitrous Oxide as a Putative Novel Dual-Mechanism Treatment for Bipolar Disorder
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was terminated due to COVID-19 pandemic-related halting of recruitment in the context of an upcoming replacement of the study MRI scanner.
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2020-02-01
Completion date: 2020-06-07
Clinical trial NCT04126343: A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
Official title: A Single-Center, Randomized, Placebo-Controlled, 3 Treatment Period Crossover Study to Assess the Effect of Padsevonil on Cardiac Repolarization (QTc Interval) (Using Moxifloxacin as a Positive Control) in Healthy Study Participants
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrollment: 54.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-10-23
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Baseline population: Baseline Characteristics refer to the Safety Set which consisted of all study participants who received at least 1 dose of study medication.
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT03734016: A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
Official title: A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Acronym: ALPINE
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 652.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-01
Primary completion date: 2022-08-08
Completion date: 2024-02-28
Baseline population: Intent-to-Treat (ITT) Analysis Set includes all randomized participants
Plan to share individual participant data: YES