chufangao/CTO huggingface dataset:
Clinical trial NCT03919175: Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma
Official title: A Phase 2 Study of Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Umbralisib development terminated; closed to accrual 8/29/2022
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-01
Primary completion date: 2024-05-05
Completion date: 2024-05-05
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: \[contact information for Sponsor Investigator or designee\]. 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: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT02979093: Oxytocin and Brain Responses in Maternal Addiction
Official title: Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to recruit proposed study sample size due to COVID restrictions.
Enrollment: 73.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-05
Primary completion date: 2021-05-17
Completion date: 2021-05-17
Plan to share individual participant data: NO
IPD sharing description: The University of Iowa and Yale will compile data from both sites for data analysis purposes only. There is no plan to make individual participant data available.
Clinical trial NCT02899728: Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer
Official title: A Phase II Study of Olaparib Plus Cediranib in Combination With Standard Therapy for Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inadequate accrual rate
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-30
Primary completion date: 2020-03-17
Completion date: 2020-03-17
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02885649: Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
Official title: Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Funding unavailable
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-05
Primary completion date: 2020-03-02
Completion date: 2020-03-02
Clinical trial NCT04147195: Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH)
Official title: NASH EXploratory Single and COmbination Treatment (NEXSCOT): An Open Label, Multicenter, Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Various Single and Combination Treatments in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) Who Manifest a Non-alcoholic Steatohepatitis (NASH)-Like Biomarker Phenotype
Acronym: NEXSCOT
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 41.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-04
Primary completion date: 2022-01-06
Completion date: 2022-01-06
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 NCT03438396: A Trial of Tisotumab Vedotin in Cervical Cancer
Official title: A Single Arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 102.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-12
Primary completion date: 2020-02-06
Completion date: 2022-08-02
Baseline population: Full analysis set (FAS) included all participants who received at least 1 dose of tisotumab vedotin.
Plan to share individual participant data: NO
Clinical trial NCT04397445: Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Official title: Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration
Sponsor: Food and Drug Administration (FDA) (FED)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-08
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Plan to share individual participant data: YES
IPD sharing description: Plan is to make data from the study publicly available as part of a manuscript publication. In addition, the protocol and statistical analysis plan will be made available online at this site as well as with any eventual publications.
Clinical trial NCT05026801: Azithromycin Plus Hydroxychloroquine for COVID-19 Infection
Official title: A Randomized, Double-blinded Phase 3 Multi-center Study of the Clinical and Microbiologic Efficacy of a Combination of Azithromycin and Hydroxychloroquine for Treatment of COVID-19 Infection
Sponsor: Iterum Therapeutics, International Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Inadequate support to carry out study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-08
Primary completion date: 2021-08-26
Completion date: 2021-08-26
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual participant data for all primary and secondary outcome measures will be made available.
IPD time frame: Data will be available within 30 days of study completion.
IPD access criteria: Data access requests will be reviewed on a case by case basis. Requestors will be required to sign a Data Access Agreement.
Clinical trial NCT04393311: Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety and Efficacy of Ulinastatin for the Treatment of COVID-19 in Hospitalized Patients
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Discontinuation of drug candidates
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-28
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
IPD sharing description: No plan to share data.
Clinical trial NCT04638309: APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)
Official title: Phase 1 Study to Evaluate Safety and Efficacy of APR-548 in Combination With Azacitidine for the Treatment of TP53-Mutant Myelodysplastic Syndromes
Sponsor: Aprea Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-20
Primary completion date: 2022-04-25
Completion date: 2022-04-25
Plan to share individual participant data: NO
Clinical trial NCT03343613: A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
Official title: A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to strategic business decision by Eli Lilly and Company.
Enrollment: 60.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-11-17
Primary completion date: 2020-02-07
Completion date: 2020-05-04
Clinical trial NCT05223673: Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Official title: A Randomised, Open-label, Multi-centre, Two-arm Phase 3 Study Comparing Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil to Trifluridine/Tipiracil Single Agent With a Safety Lead-In Part in Participants With KRAS/NRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy
Acronym: COLSTAR
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decided to discontinue the study during the Lead-In part and the Phase III part was not started due to strategic reasons.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-21
Primary completion date: 2023-06-21
Completion date: 2023-06-21
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT05228821: Voxelotor Brain Oxygenation and Neurocognitive Study
Official title: An Open Label, Single Arm, Multicenter Study to Evaluate the Effect of Voxelotor on Cerebral Blood Flow and Neurocognitive Function in Adolescents and Adults With Sickle Cell Disease
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The study has been stopped due to Sponsor's business reasons. The termination is not a result of any safety concerns or change in the benefit-risk ratio.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-08-09
Primary completion date: 2023-08-23
Completion date: 2023-08-23
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04915729: A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
Official title: A Phase III Multi-centre, Prospective, Randomised, Open Label, Blinded Endpoint (PROBE), Active-controlled Parallel Group Trial to Assess Efficacy and Safety of Tenecteplase Versus Alteplase in Chinese Patients With Acute Ischaemic Stroke Within 4.5 Hours After Stroke Onset
Acronym: ORIGINAL
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1490.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-22
Primary completion date: 2023-10-08
Completion date: 2023-10-08
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 NCT03127124: QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer
Official title: An Open-label, Multicenter, Single-arm, Phase 1b/2 Study of NANT-008 in Combination With 5-fluorouracil, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma.
Sponsor: NantPharma, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: This study was withdrawn due to no enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-27
Primary completion date: 2023-12-06
Completion date: 2023-12-06
Plan to share individual participant data: NO
Clinical trial NCT03970837: Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)
Official title: A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
Acronym: contRAst 2
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Only Asia cohort is early terminated.Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.
Enrollment: 1764.0 (ACTUAL)
Number of arms: 12.0
Start date: 2019-06-05
Primary completion date: 2021-10-29
Completion date: 2023-01-18
Baseline population: Intent-To-Treat (ITT) Population (All randomized participants who received at least 1 dose of study treatment) was used for Global cohort and ITT-Supplementary Asia Cohort (Participants randomized on or after 07-August-2021 who received at least one dose of study treatment) was used for Asia cohort. One participant from the GSK3196165 150mg + csDMARD (Asia Cohort) arm was randomized but not treated so is excluded from the ITT-Asia cohort population.
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04632992: A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Official title: MyTACTIC: An Open-Label Phase II Study Evaluating Targeted Therapies in Patients Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
Acronym: MyTACTIC
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 252.0 (ACTUAL)
Number of arms: 15.0
Start date: 2021-01-13
Primary completion date: 2023-12-04
Completion date: 2024-02-27
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).~For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical-trials/data-sharing/).
Clinical trial NCT04650698: TXA in Revision Total Shoulder Arthroplasty
Official title: The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Enrollment rate was slower than anticipated.
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-07
Primary completion date: 2023-03-12
Completion date: 2023-03-12
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) will be shared upon reasonable request.
IPD time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD access criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Uchenna.Umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Clinical trial NCT03752242: Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Official title: An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Acne Vulgaris.
Sponsor: BioMimetix JV, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment stopped for chemistry work on investigational product.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-03
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Limitations and caveats: The clinical trial was stopped after enrollment of 2 subjects for re-formulation of investigational product. Therefore, due to the small sample size data is uninterpretable.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04964089: A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
Acronym: DAYLIGHT
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 557.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-23
Primary completion date: 2023-03-28
Completion date: 2023-04-06
Baseline population: All randomized subjects who received at least one active study treatment (KSI-301 or aflibercept)
Plan to share individual participant data: NO
Clinical trial NCT04483479: Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)
Official title: A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week Period
Acronym: Rollover
Sponsor: Enterin Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor recruitment/retention due to the pandemic. Data was not analyzed due to early termination.
Enrollment: 27.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-30
Primary completion date: 2022-02-17
Completion date: 2022-02-17
Limitations and caveats: Study was terminated early due to poor recruitment/retention due to the pandemic.
Plan to share individual participant data: NO
Clinical trial NCT04972253: Phase I BLASST-3 Trial
Official title: Biomarker-directed Neoadjuvant Therapy for Cisplatin-ineligible or Cisplatin-refusing Muscle-invasive Bladder Cancer: Phase I Bladder Cancer Signal Seeking Trial
Acronym: (BLASST)-3
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Low Accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-23
Primary completion date: 2022-12-31
Completion date: 2023-12-31
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 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 Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu