chufangao/CTO huggingface dataset:
Clinical trial NCT03461952: Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe)
Official title: A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination With Ipilimumab for the Treatment of Patients With Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay
Acronym: NIMBLe
Sponsor: Canadian Cancer Trials Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: cfDNA screening data found that the prevalence of POLE/POLD1 mutations was lower than expected. It was determined that there are no feasible options to amend this study in a fashion that would not be duplicative of other currently accruing trials.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-11
Primary completion date: 2021-06-01
Completion date: 2022-02-09
Plan to share individual participant data: NO
Clinical trial NCT03978637: Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
Official title: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business Decision
Enrollment: 23.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-04
Primary completion date: 2023-10-13
Completion date: 2023-10-13
Plan to share individual participant data: NO
Clinical trial NCT03664674: Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Official title: A Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Sponsor: Otonomy, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 148.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-27
Primary completion date: 2020-12-22
Completion date: 2020-12-22
Baseline population: This population is designated as the Safety Analysis Set, which is comprised of all subjects that were randomized and received study drug. They are grouped based on what they received, not what they were randomized to receive.
Plan to share individual participant data: NO
Clinical trial NCT02933801: ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
Official title: ODM-201 Maintenance Therapy in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Previously Treated With Novel Hormonal Agents and Non-progressive Disease After Subsequent Treatment With a Taxane: A Multicenter Randomized Double-blind Placebo-controlled Phase II Trial.
Sponsor: Swiss Group for Clinical Cancer Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Decision Board no further financial support after 3 years of follow-up as remaining patients in follow-up phase would not relevantly change the endpoints.
Enrollment: 92.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-31
Primary completion date: 2021-06-28
Completion date: 2023-11-15
Plan to share individual participant data: NO
Clinical trial NCT04274452: A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Official title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP)
Acronym: ADVANCE2
Sponsor: argenx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The ARGX-113-1908 study will be replaced by a similar design with a subcutaneous formulation (ARGX-113-2004)
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-29
Primary completion date: 2021-09-01
Completion date: 2021-09-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04707469: Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Official title: Efficacy and Safety of Once-daily Oral Semaglutide 25 mg and 50 mg Compared With 14 mg in Subjects With Type 2 Diabetes
Acronym: PIONEER PLUS
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1606.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-01-15
Primary completion date: 2023-03-07
Completion date: 2023-03-08
Baseline population: Full analysis set (FAS) included all randomised participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT02909335: De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study
Official title: De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study
Acronym: FOREVER
Sponsor: Rennes University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2021-11-30
Completion date: 2021-11-30
Plan to share individual participant data: NO
Clinical trial NCT03325816: Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
Official title: Phase I/II Trial of Anti-PD-1 Checkpoint Inhibitor Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor: Georgetown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 9.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-11-20
Primary completion date: 2019-03-28
Completion date: 2020-08-11
Plan to share individual participant data: NO
Clinical trial NCT03933410: UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder
Official title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects With A Urea Cycle Disorder With Inadequate Control on Standard of Care
Acronym: UNLOCKED
Sponsor: Kaleido Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Kaleido Biosciences, Inc. closed the K020-218 trial due to business reasons, and not due to any safety concerns.
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-17
Primary completion date: 2021-02-02
Completion date: 2021-03-02
Clinical trial NCT04097821: Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Official title: A Randomized, Open-label, Phase I/II Open Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Myelofibrosis Patients
Acronym: ADORE
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 14.0
Start date: 2019-09-26
Primary completion date: 2023-05-03
Completion date: 2024-08-28
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.
Clinical trial NCT04236440: Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration
Official title: Proof-of-mechanism Single-center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate Pharmacodynamics, Safety, Tolerability and Exposure of BAY 2586116 (Part A) and an Open-label Comparison of Different Application Modes for Single Nasal/Pharyngeal Dose Administrations (Part B and Part C) in 12 Participants With Obstructive Sleep Apnea
Acronym: KOALA
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-04
Primary completion date: 2021-05-06
Completion date: 2021-06-24
Plan to share individual participant data: NO
IPD sharing description: Availability of this study's data will be later 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Clinical trial NCT04648189: Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC
Official title: Are Anti-EGFR Monoclonal Antibodies the Magic Bullets That Remove Circulating EGFR+EpCAM+ Tumor Cells in Patients With Non-small Cell Lung Cancer
Sponsor: The Netherlands Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: One of the participating specialties has decided to no longer cooperate in this research
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-01
Primary completion date: 2022-09-19
Completion date: 2022-09-19
Plan to share individual participant data: UNDECIDED
IPD sharing description: to be decided
Clinical trial NCT03347279: Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
Official title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
Acronym: NAVIGATOR
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1061.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-23
Primary completion date: 2020-09-08
Completion date: 2020-11-12
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:~https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT03803007: Acute Ischemic Stroke Interventional Study
Official title: Randomized, Double Blind, Multi Center, Multinational, Placebo Controlled, Single Parallel Escalating Dose Safety and Efficacy Study of ACT017 Used as an Add on Therapy on Top of Standard of Care of Acute Ischemic Stroke
Acronym: ACTIMIS
Sponsor: Acticor Biotech (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-06
Primary completion date: 2021-09-27
Completion date: 2021-09-27
Plan to share individual participant data: NO
Clinical trial NCT04042623: Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
Official title: An Open-Label Phase 2a Study to Evaluate the Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy
Sponsor: Aravive, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business reasons
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-27
Primary completion date: 2020-08-01
Completion date: 2020-08-01
Limitations and caveats: After enrollment of one subject, the study was paused due to the COVID-19 pandemic. Subsequently, the sponsor terminated the study due to a change in sponsor priorities.
Plan to share individual participant data: NO
Clinical trial NCT04478695: Study of AMG 330 in Combination With Pembrolizumab in Adult With Relapsed or Refractory Acute Myeloid Leukemia
Official title: A Phase 1b Study Assessing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 330 cIV in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen Decision
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-29
Primary completion date: 2020-10-23
Completion date: 2020-10-23
Baseline population: The study was terminated with only 1 participant enrolled into Cohort 1 (0 participants were enrolled into Cohort 2). No data are reported here to maintain participant confidentiality.
Limitations and caveats: This study was early terminated, leading to a small number of participants enrolled and analyzed.
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 NCT05189977: A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Official title: A Phase 1, Open-label, Fixed-sequence, Cross-over Trial to Assess the Effects of a Single Dose of Prazosin or Propranolol in the Presence of Brexpiprazole/Sertraline at Steady-state on Blood Pressure
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision to terminate the trial early was not based on safety concerns. The trial was terminated early due to some implausible blood pressure values being captured, which was the primary endpoint of the study.
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-07
Primary completion date: 2023-08-03
Completion date: 2023-08-03
Clinical trial NCT01556776: A Study of Lenalidomide Maintenance for High-risk Patients With CLL Following First-line Therapy
Official title: CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy
Sponsor: German CLL Study Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-07-20
Primary completion date: 2016-03-31
Completion date: 2021-01-14
Plan to share individual participant data: NO
Clinical trial NCT02725593: Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Official title: A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial With a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients Aged 10-24 Years
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-22
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04556721: A Pharmacokinetic Study of Sugammadex in Dialysis Patients
Official title: Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Difficulty and lack of recruitment of the patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-10
Primary completion date: 2021-09-10
Completion date: 2021-09-10
Plan to share individual participant data: NO
Clinical trial NCT04909502: Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis
Official title: A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
Sponsor: Emerald Health Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Temporary recruitment pause to re-assess the protocol design, specifically the eligibility criteria
Enrollment: 50.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2021-10-19
Primary completion date: 2023-12-31
Completion date: 2024-04-30
Clinical trial NCT04139577: FMT In High-Risk Acute GVHD After ALLO HCT
Official title: Fecal Microbiota Transplantation (FMT) in for the Treatment of High-Risk Acute Graft-Versus-Host Disease (GVHD) After Allogeneic Hematopoietic Cell Transplantation (HCT)
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-18
Primary completion date: 2022-08-03
Completion date: 2023-01-05
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT03371862: Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)
Official title: Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.
Acronym: SLIPS
Sponsor: Imperial College London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants recruited. Not able to recruit due to COVID 19.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-20
Primary completion date: 2020-08-06
Completion date: 2020-09-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02647892: Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
Official title: Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted
Enrollment: 70.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-01-08
Primary completion date: 2021-11-05
Completion date: 2021-11-05
Plan to share individual participant data: NO