chufangao/CTO huggingface dataset:
Clinical trial NCT05030584: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
Official title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 52 Weeks in Postmenopausal Women
Acronym: OASIS-3
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 628.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-27
Primary completion date: 2023-03-29
Completion date: 2024-02-12
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 NCT05478252: A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes
Official title: Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 388.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-03
Primary completion date: 2023-08-09
Completion date: 2023-09-18
Baseline population: Full analysis set (FAS) included all randomized participants
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT02808429: Efficacy and Safety of Atacicept in IgA Nephropathy
Official title: A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
Sponsor: EMD Serono (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was terminated early as per sponsor decision due to unexpectedly slow enrollment.
Enrollment: 16.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-01-31
Primary completion date: 2020-02-07
Completion date: 2020-02-07
Baseline population: The modified intent-to-treat (mITT) population included all randomized participants who had received at least 1 dose of the Investigational Medicinal Product (IMP).
Limitations and caveats: The study was prematurely terminated due to poor enrollment and Part B was not conducted as per Sponsor decision. This decision was not related to any safety or efficacy findings regarding Atacicept.
Plan to share individual participant data: YES
IPD sharing description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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.
Clinical trial NCT02230189: Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics
Official title: Mechanistic Study of Epithelial miRNAs and T-cell Recruitment Dynamics That Occur After Allergen Challenge in Patients With Asthma.
Acronym: ACE
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-03-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Clinical trial NCT04849377: RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC
Official title: RBD-HPV: Risk-Based De-Intensification for HPV+ HNSCC
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: lack of eligible participants due to change in study criterias
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-06-14
Primary completion date: 2022-06-14
Completion date: 2022-06-14
Plan to share individual participant data: NO
IPD sharing description: All of the individual participant data collected during the trial, after deidentification.
Clinical trial NCT06178367: Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
Official title: Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin
Sponsor: Indonesia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-08-26
Primary completion date: 2023-09-30
Completion date: 2023-09-30
Plan to share individual participant data: NO
Clinical trial NCT04446299: Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Official title: A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Sponsor: Braintree Laboratories (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 519.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-13
Primary completion date: 2020-12-22
Completion date: 2021-01-22
Plan to share individual participant data: NO
Clinical trial NCT02793583: Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma
Official title: A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
Acronym: UNITY-NHL
Sponsor: TG Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Strategic/Business Decision
Enrollment: 710.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-25
Primary completion date: 2022-05-31
Completion date: 2022-07-04
Plan to share individual participant data: YES
IPD sharing description: Data will be shared once the last patient visit has been completed
Clinical trial NCT04927481: A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer
Official title: A Multicenter, Open-label, Single-arm, Phase II Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced HER2 Negative Breast Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The sponsor has adjusted its R\&D strategy.
Enrollment: 28.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-11
Primary completion date: 2023-01-17
Completion date: 2023-01-17
Clinical trial NCT03496168: Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER
Official title: An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)
Acronym: PIONEER-OLE
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-26
Primary completion date: 2023-11-09
Completion date: 2023-11-09
Clinical trial NCT04971187: Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer
Official title: A Single-Arm Phase 2 Study to Investigate Bintrafusp Alfa With Platinum-Pemetrexed for TKI-Resistant EGFR-Mutant NSCLC
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI Request
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-30
Primary completion date: 2022-02-21
Completion date: 2022-02-21
Baseline population: 3 participants were registered, 2 participants were not treated, not eligible or inevaluable 1 participant received treatment.
Limitations and caveats: The study was terminated early due to the drug company no longer producing the drug.
Clinical trial NCT03387215: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure
Official title: Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
Sponsor: Intra-Cellular Therapies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-10
Primary completion date: 2020-03-16
Completion date: 2020-03-16
Clinical trial NCT04153929: A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Official title: A Phase II, Randomized, Parallel Group, Dose-finding Study of Subcutaneously Administered BI 456906 for 16 Weeks, Compared With Placebo and Open-label Semaglutide in Patients With Type 2 Diabetes Mellitus.
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 413.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-04-30
Primary completion date: 2021-10-08
Completion date: 2021-11-04
Baseline population: Treated set (TS): TS included all patients who were randomized and received at least one dose of study drug.
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 NCT06017479: Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention
Official title: Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination
Sponsor: Indonesia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-30
Primary completion date: 2024-03-25
Completion date: 2024-03-25
Baseline population: Besides the required samples are 126 samples to complete the study. There are 59 samples that didn't meet the inclusion criteria of the study, which are because of there are 8 samples who refuse to participate, 14 samples that are under 18 years old, 7 samples that have history of antibiotics consumption in 1 month prior to the study, 19 samples that are UTI proved through urinalysis, 11 samples that use of urinary catheter prior to the study.
Limitations and caveats: The limitation of the study is that many of the patients with UTIs refuse to undergo urine culture tests due to several reasons.
Plan to share individual participant data: YES
IPD sharing description: These are the study protocol used in this study
IPD time frame: Immediately following publication. No end date
IPD access criteria: Anyone who wishes to access the data
Clinical trial NCT03751969: A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
Official title: A Study Evaluating the Mass Balance of Micro-dose [14C]HSK3486 Emulsion Injection in Healthy Chinese Male Adults
Sponsor: Haisco Pharmaceutical Group Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: study canceled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-30
Primary completion date: 2020-11-01
Completion date: 2020-12-01
Clinical trial NCT04445688: Crossover Trial of AD036 in Obstructive Sleep Apnea
Official title: Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine
Sponsor: Apnimed (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-15
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Clinical trial NCT02656888: Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Official title: Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2020-06-30
Completion date: 2020-09-30
Clinical trial NCT04005352: Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
Official title: A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)
Acronym: TALON
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 734.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-25
Primary completion date: 2022-09-09
Completion date: 2022-09-09
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 NCT04289558: Nitrite Infusion in Children With Malaria
Official title: Safety, Feasibility, and Endothelial Effects of Sodium Nitrite Infusion in Children With Falciparum Malaria
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: current grant expiration in May, insufficient funds remaining, travel restrictions, COVID-19 restrictions in Tanzania, etc.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-01
Primary completion date: 2021-10-01
Completion date: 2021-10-01
Plan to share individual participant data: NO
Clinical trial NCT03787095: Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART
Official title: Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART: A Phase I/II, Double-blind, Placebo-controlled, Ascending Multiple Dose Study
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Stopped by monitoring committee recommendation due to adverse events
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-13
Primary completion date: 2020-08-18
Completion date: 2020-08-18
Baseline population: All participants
Limitations and caveats: The study was terminated early due to adverse events and was not able to fully evaluate the efficacy outcomes due to the small number of accrued participants.
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 AIDS Clinical Trials Group by NIH.
IPD access criteria: * With whom?~  * Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group.~* For what types of analyses?~  * To achieve aims in the proposal approved by the AIDS Clinical Trials Group.~* By what mechanism will data be made available?~  * Researchers may submit a request for access to data using the AIDS Clinical Trials Group Data Request form at:https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
Clinical trial NCT06181227: A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema
Official title: A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema
Sponsor: Aviceda Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of Efficacy
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-11-30
Primary completion date: 2024-04-05
Completion date: 2024-04-05
Clinical trial NCT03706040: A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Risankizumab in Adult and Adolescent Subjects With Moderate to Severe Atopic Dermatitis
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 172.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-27
Primary completion date: 2020-10-28
Completion date: 2021-04-26
Baseline population: The intent-to-treat population includes all randomized participants
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: For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04348071: Safety and Efficacy of Ruxolitinib for COVID-19
Official title: Safety and Efficacy of Ruxolitinib for COVID-19
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Could not make FDA required changes
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-31
Primary completion date: 2021-08-31
Completion date: 2021-10-31
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data will be made available for all primary outcome measures.
IPD time frame: Data will be made available upon publication in a peer-reviewed journal.
IPD access criteria: Data access requests will be reviewed by the sponsor-investigator and collaborators.
Clinical trial NCT04409483: Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Official title: Evaluation of Additional Treatments for COVID-19: a Randomized Trial in Niger
Acronym: TRASCOV
Sponsor: Epicentre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Epidemic dynamics
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-01
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Plan to share individual participant data: YES
IPD sharing description: De-identified patient data will be shared with local and international authorities.
IPD time frame: Data will become fully accessible after primary publication of results.
Clinical trial NCT04428333: Study of GSK3359609 With Pembrolizumab and 5-fluorouracil (5-FU)-Platinum Chemotherapy in Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Official title: A Randomized, Double-Blind, Adaptive, Phase II/III Study of GSK3359609 in Combination With Pembrolizumab and 5FU-Platinum Chemotherapy Versus Placebo in Combination With Pembrolizumab Plus 5FU-Platinum Chemotherapy for First-Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Acronym: INDUCE-4
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The trial was stopped by the sponsor based on assessment of the clinical data
Enrollment: 117.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-12
Primary completion date: 2021-04-27
Completion date: 2023-09-19
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.