chufangao/CTO huggingface dataset:
Clinical trial NCT03958630: PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel Translocator Protein (TSPO) Radioligand
Official title: PET Imaging of Neuroinflammation in Neurodegenerative Diseases Via a Novel TSPO Radioligand
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: PI closed the protocol due to low recruitment
Enrollment: 13.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-03
Primary completion date: 2021-05-27
Completion date: 2023-12-04
Limitations and caveats: Secondary outcomes were not analyzed because:~* No data for the disease specific uptake across neurodegenerative diseases~* No longitudinal data was collected because the protocol was terminated due to low recruitment
Clinical trial NCT04633226: Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
Official title: A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.
Acronym: PNEU-PED-KOR
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 58.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-10
Primary completion date: 2022-11-04
Completion date: 2022-11-04
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT02939209: Pre-emptive Opioid Treatment to Prevent Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block
Official title: Preventing Rebound Pain After Arthroscopic Rotator Cuff Repair and/or Acromioplasty Under General Anesthesia and Interscalene Block: A Randomized Controlled Trial of Pre-emptive Opioid Treatment Compared to Placebo
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 73.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-20
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Clinical trial NCT04382170: Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy
Official title: Dexmedetomidine Sublingual Film for the Management of Agitation in Delirium: Safety and Preliminary Efficacy
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study sponsor decided not to perform this study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Plan to share individual participant data: NO
Clinical trial NCT05897372: Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study
Official title: Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study
Acronym: WP3
Sponsor: Herlev Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-08-01
Primary completion date: 2024-09-23
Completion date: 2024-09-23
Plan to share individual participant data: NO
Clinical trial NCT03118817: Expansion Study to Evaluate the Efficacy and Safety of HM95573 in BRAF, KRAS or NRAS Mutant Solid Cancers
Official title: A Single-arm, Open-label, Multi-center, Phase I Expansion Study Evaluating the Efficacy and Safety of HM95573 Monotherapy in Patients With BRAF, KRAS or NRAS Mutation-positive Solid Cancers
Sponsor: Hanmi Pharmaceutical Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 65.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-19
Primary completion date: 2020-02-04
Completion date: 2020-02-04
Clinical trial NCT00556374: Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3420.0 (ACTUAL)
Number of arms: 4.0
Start date: 2006-12-18
Primary completion date: 2014-10-07
Completion date: 2022-07-26
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT04878055: Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.
Official title: A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia
Sponsor: Dompé Farmaceutici S.p.A (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 287.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-14
Primary completion date: 2021-09-30
Completion date: 2021-10-31
Baseline population: FAS Full Analysis Set: set which consisted of all randomized subjects who received at least one dose of the IMP. The FAS population was analyzed according to the intent-to-treat (ITT) principle, i.e. by treatment allocation regardless the occurrence of intercurrent events (treatment policy strategy).
Clinical trial NCT04020419: Natural Berry Extract Treatment of Hemangiomas
Official title: Natural Berry Extract Treatment of Hemangiomas
Acronym: Pediaberry
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Study ending early due to program transferring to another site.
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-01
Primary completion date: 2023-05-24
Completion date: 2023-05-24
Plan to share individual participant data: NO
Clinical trial NCT03790852: Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
Official title: A Phase 1/1b Open Label, Multi-center Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: All patients past planned primary endpoint; decision by Sponsor to wind down open-label follow-up activities.
Enrollment: 121.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-26
Primary completion date: 2021-06-02
Completion date: 2022-06-09
Clinical trial NCT04683796: Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease
Official title: Comparison of Treatment Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Moderate to Severe Dry Eye Disease: A Randomized Controlled Trial Protocol
Sponsor: Mahidol University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-01
Primary completion date: 2023-02-28
Completion date: 2023-03-30
Plan to share individual participant data: NO
IPD sharing description: Data will be available upon the specific request.
Clinical trial NCT03837457: PRISM: Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Mycosis Fungoides Who Have Completed the SOLAR Study
Official title: PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study
Acronym: PRISM
Sponsor: miRagen Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study no longer needed because eligible subjects may receive treatment with cobomarsen in a crossover arm of the SOLAR clinical trial (NCT03713320)
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-01
Primary completion date: 2020-07-24
Completion date: 2020-07-27
Plan to share individual participant data: NO
Clinical trial NCT04086121: A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
Official title: An Open Label Extension Study to Assess the Long Term Safety of Treatment With BI 655130 Administered Subcutaneously in Adult Patients With Moderate to Severe Atopic Dermatitis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-24
Primary completion date: 2021-04-28
Completion date: 2022-02-23
Baseline population: Safety analysis set (SAF): This patient set includes all randomized patients who received at least one dose of study drug.
Limitations and caveats: The study was terminated due to sponsor decision. The planned treatment period of 4 years was not reached.
Plan to share individual participant data: YES
IPD sharing description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement. Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.~The data shared are the raw clinical study data sets.
IPD time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Clinical trial NCT01610336: A Safety and Efficacy Study of INC280 and Gefitinib in Patients With EGFR Mutated, c-MET-amplified NSCLC Who Have Progressed After EGFRi Treatment
Official title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 161.0 (ACTUAL)
Number of arms: 11.0
Start date: 2012-04-05
Primary completion date: 2016-06-10
Completion date: 2020-05-27
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 NCT04066491: Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L BTC
Official title: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Based on a review of data conducted by the Independent Data Monitoring Committee (IDMC), Sponsor decided to discontinue this study as the study was unlikely to achieve the primary objective of overall survival.
Enrollment: 309.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-20
Primary completion date: 2021-05-20
Completion date: 2022-11-10
Limitations and caveats: Data collection and analysis of Pharmacokinetics and Immunogenicity were omitted and not conducted due to business reason.
Plan to share individual participant data: YES
IPD sharing description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
IPD time frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union.
IPD access criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Clinical trial NCT04939701: Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
Official title: A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Known to Express NY-ESO-1
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The comprehensive assessment of other studies indicated the lack of significant monotherapy activity, therefore, team decided to terminate the study.
Enrollment: 16.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-23
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Baseline population: Safety Analysis Set (SAF). All participants who took at least 1 dose of the investigational product (IP).
Plan to share individual participant data: NO
IPD sharing description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under Sponsor Specific Details for Astellas.
Clinical trial NCT04893551: A Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Participants
Official title: Phase 1b, Multicentre, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Patients
Sponsor: BerGenBio ASA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: After completion of all planned dose levels in the dose escalation phase, the sponsor decision was not to continue with expanding the cohorts of any of the dose levels, using the existing study design.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-25
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in the article, after deidentification \[text, tables, figures and appendices\].
IPD time frame: Beginning 3 months and ending 5 years following article publication
IPD access criteria: Proposal should be directed to HYPERLINK mailto:clinical@bergenbio.com clinical@bergenbio.com. To gain access, data requestors will need to sign a data access agreement.
Clinical trial NCT04602494: Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
Official title: Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents
Acronym: Pilot
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The pilot study used apo-varenicline under temp FDA authorization. When varenicline was available an IND exemption was granted to enroll children, IRB approved a trial of varenicline in participants ages 16-25 June 27, 2022, the pilot was terminated
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-12-18
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@mgh.harvard.edu. To gain access, data requestors will need to sign a data access agreement.
IPD time frame: Beginning 3 months and ending 5 years following article publication.
IPD access criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.
Clinical trial NCT02999893: A Study of APR-246 in Oesophageal Cancer
Official title: A phase1b/2 Study Evaluating the Efficacy of APR-246, a First-in-class Agent Targeting Mutant p53 in the Treatment of Platinum Resistant Advanced and Metastatic Oesophageal or Gastro-oesophageal Junction Cancers
Acronym: APROC
Sponsor: Peter MacCallum Cancer Centre, Australia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding ceased
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-11
Primary completion date: 2020-10-16
Completion date: 2021-02-07
Clinical trial NCT04026750: Insulin Tolerance Test Study in Patients With Type 1 Diabetes
Official title: A Randomized, Double-Blind, Placebo-Controlled Insulin Tolerance Test Study to Assess the Safety, Tolerability, and Pharmacodynamics OF Pitolisant in Patients With Type 1 Diabetes
Sponsor: High Point Clinical Trials Center (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on scientific data collected during the trial and high screen fail rate.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-15
Primary completion date: 2020-02-16
Completion date: 2020-02-16
Plan to share individual participant data: NO
Clinical trial NCT03461458: Autologous, Culture-Expanded Mesenchymal Stromal Cells for Degenerative Disc Disease
Official title: A Phase I Study Evaluating the Safety and Feasibility of Autologous, Culture-Expanded Adipose-Derived Mesenchymal Stromal Cells in Subjects With Painful Degenerative Disc Disease
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Principal Investigator transition
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-17
Primary completion date: 2021-02-06
Completion date: 2021-02-06
Clinical trial NCT03662711: Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease
Official title: Comparison of 1-year Treatment With Inhaled Long Acting Bronchodilators (LABD) Plus Inhaled Glucocorticosteroids (ICS) Versus LABD Without ICS on Re-hospitalizations and/or Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) Recently Hospitalized Because of an Acute Exacerbation of COPD (ICS-Life Study).
Sponsor: Università degli Studi di Ferrara (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Contract terminated between AIFA and the Sponsor (University of Ferrara)
Enrollment: 843.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-11
Primary completion date: 2022-10-26
Completion date: 2022-10-26
Clinical trial NCT04712110: A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Official title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-019 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-12
Primary completion date: 2022-03-28
Completion date: 2022-03-28
Baseline population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.