chufangao/CTO huggingface dataset:
Clinical trial NCT04436744: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
Official title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase II, Neoadjuvant Study Evaluating the Efficacy, Safety, and Pharmacokinetics of GDC-9545 Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 221.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-04
Primary completion date: 2021-07-06
Completion date: 2021-11-24
Baseline population: Intent-to-Treat (ITT) population included all randomized participants.
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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT02906020: A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
Official title: Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant
Acronym: MOVES-PD
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The topline results of the 52-week double-blind placebo-controlled period were analyzed. The study did not meet the primary or secondary endpoints. Based on these results, the decision was made to halt the long-term follow-up period of the study
Enrollment: 273.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-15
Primary completion date: 2020-12-18
Completion date: 2021-05-27
Baseline population: Analysis was performed on all randomized unique participants (N=250) only.
Limitations and caveats: This study did not achieve its primary or secondary endpoints at the time of the analysis of the double-blind 52-week treatment period of Part 2 and was terminated early.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT02693093: A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
Official title: A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic Pancreatitis
Acronym: Tactic
Sponsor: Kangen Pharmaceuticals, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 264.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-24
Primary completion date: 2021-09-30
Completion date: 2021-12-30
Plan to share individual participant data: NO
Clinical trial NCT04688931: A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Official title: A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC)
Acronym: ATLAS
Sponsor: UroGen Pharma Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Alternate approach pursued
Enrollment: 282.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-19
Primary completion date: 2023-03-17
Completion date: 2023-03-17
Clinical trial NCT04791423: Study of GRAd-COV2 for the Prevention of COVID-19 in Adults
Official title: A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older
Acronym: COVITAR
Sponsor: ReiThera Srl (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 10300.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-15
Primary completion date: 2021-06-04
Completion date: 2022-05-13
Clinical trial NCT05678283: A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors
Official title: A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Business Objectives have changed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-09
Primary completion date: 2024-04-29
Completion date: 2024-04-29
Plan to share individual participant data: NO
IPD sharing description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.
Clinical trial NCT03177720: Evaluation of Innovative Tools in Development of Antibiotics
Official title: Determination of Single-dose Intrapulmonary Pharmacokinetics of Ciprofloxacin and Imipenem in Healthy Subjects and Intubated Patients Suffering From Pneumonia Using Bronchoalveolar Lavage
Sponsor: Medical University of Vienna (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-29
Primary completion date: 2021-07-31
Completion date: 2021-07-31
Clinical trial NCT05282121: A Study to Test Whether BI 685509 Alone or in Combination With Empagliflozin Helps People With Liver Cirrhosis Caused by Viral Hepatitis or Non-alcoholic Steatohepatitis (NASH) Who Have High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver)
Official title: Randomised, Open-label and Parallel Group Trial to Investigate the Effects of Oral BI 685509 Alone or in Combination With Empagliflozin on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 90.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-26
Primary completion date: 2024-04-23
Completion date: 2024-06-17
Plan to share individual participant data: YES
IPD sharing description: Once the criteria in section Time frame are fulfilled, researchers can use the 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.~Furthermore, researchers can 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.
IPD time frame: After structured results have been posted, 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 the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Clinical trial NCT05256134: A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)
Official title: A Phase III, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease
Acronym: SKYLINE
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Decision to terminate development of gantenerumab for treatment of people at risk for or at earliest stages of Alzheimer disease (AD) following results of a pre-planned analysis of safety \& efficacy of gantenerumab in Graduate I\&II (WN29922/WN39658).
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-19
Primary completion date: 2023-03-13
Completion date: 2023-03-13
Baseline population: Intent-to-treat (ITT) Population included all participants randomly assigned to study treatment. Participants were grouped into the two arms (placebo or gantenerumab) according to the treatment assigned at randomization.
Limitations and caveats: SKYLINE study was terminated early \& limited data could be collected \& analyzed. Hence, no conclusions can be made on effectiveness of gantenerumab in treatment of people at risk for or at earliest stages of AD.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data 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/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT03151746: Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
Official title: Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-14
Primary completion date: 2021-12-02
Completion date: 2021-12-02
Limitations and caveats: The limitation to this study is that enrollment was affected by COVID 19 protocols within the hospital enrollment. This is why the project was terminated early .
Plan to share individual participant data: NO
Clinical trial NCT04853992: Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Official title: Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Sponsor: JW Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-10
Primary completion date: 2022-07-08
Completion date: 2022-07-11
Plan to share individual participant data: YES
IPD access criteria: De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT04679389: Acetazolamide Efficacy in Ataxia in PMM2-CDG
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating Acetazolamide Efficacy in Ataxia in PMM2-CDG
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lack of funding
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-17
Primary completion date: 2024-01-24
Completion date: 2024-01-24
Plan to share individual participant data: NO
IPD sharing description: De-identified data may be shared amongst member of the consortium FCDGC and with the NIH.
Clinical trial NCT03003949: The Menopause Transition: Estrogen Variability, Stress Reactivity and Mood
Official title: The Menopause Transition: Estrogen Variability, HPA Axis and Affective Symptoms
Acronym: Changes
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: In-person visit restrictions due to COVID-19
Enrollment: 82.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-24
Primary completion date: 2020-05-10
Completion date: 2020-05-10
Plan to share individual participant data: YES
IPD sharing description: The investigators will submit data to the Research Domain Criteria Database (RDoCdb) and/or the National Database for Clinical Trials Related to Mental Illness (NDCT). The investigators will work with RDoCdb and NDCT staff to define data structures for any data being collected as part of the study. Descriptive data will be submitted two times per year and provide supporting documentation as necessary for others to more fully understand the manner in which data were collected. The investigators will submit cumulative data each submission cycle and will review data for any personally identifiable information and ensure that data are loaded correctly. The investigators will share data within 4 months after submission and submit experimental data within 12 months after study completion. Study data for each publication will be created and submit a link to the RDoCdb study along with any publications so readers of articles can link back to the data used in RDoCdb and NDCT.
Clinical trial NCT04408599: A Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC410 in Subjects With Advanced or Metastatic Solid Tumors
Sponsor: NextCure, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Upon completion of the Phase 1 portion of the NC410 monotherapy trial, NextCure focused efforts on a combination trial of NC410 in solid tumors.
Enrollment: 46.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-06-10
Primary completion date: 2023-07-06
Completion date: 2023-07-06
Plan to share individual participant data: NO
Clinical trial NCT02878694: Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft
Official title: Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft
Acronym: TTT-PT-DOP
Sponsor: University Hospital, Caen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: insufficient recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-14
Primary completion date: 2020-10-09
Completion date: 2020-10-09
Plan to share individual participant data: NO
Clinical trial NCT03792347: Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Official title: A Phase Ib Study of Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Acronym: PALACE-1
Sponsor: Ruijin Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-21
Primary completion date: 2020-03-17
Completion date: 2020-06-17
Limitations and caveats: This was a single arm study. The sample size was small. Patients were highly selected and from a single center. These may strict the generalizability of the results.
Plan to share individual participant data: NO
Clinical trial NCT01988506: Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
Official title: Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach
Acronym: TRANSREG
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 81.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-01-06
Primary completion date: 2019-10-16
Completion date: 2021-04-01
Plan to share individual participant data: NO
Clinical trial NCT05329168: ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
Official title: An Open-Label, Multiple-Ascending Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LSVT-1701 as an Add-on to Standard of Care Antibiotics for the Treatment of Complicated Methicillin-Sensitive and -Resistant Staphylococcus Aureus Bacteremia Including Left- and Right-sided Infective Endocarditis
Acronym: ERASE
Sponsor: Lysovant (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: business decision before FPFV; not related to any safety concerns
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-01
Primary completion date: 2023-08-17
Completion date: 2023-11-01
Plan to share individual participant data: NO
Clinical trial NCT00497952: Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis
Official title: Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis
Sponsor: Talaris Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: all clinical development programs terminated by sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2007-07-31
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02706951: A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 648.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-03-23
Primary completion date: 2017-10-02
Completion date: 2022-08-10
Baseline population: The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04455503: Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1
Official title: A Phase 1/2, Study of Adjuvant Immunotherapy With EVX-02 and Anti-PD-1 After Complete Resection of Stage IIIB/IIIC/IIID or Stage IV Melanoma in Patients at High Risk for Recurrence
Sponsor: Evaxion Biotech A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Based on the promising interim results of study part 1, it was decided to further accelerate the development of the 2nd generation DNA plasmid immunotherapy. Therefore enrolment of patients was completed after study part 1
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-13
Primary completion date: 2023-02-28
Completion date: 2023-03-28
Clinical trial NCT04815603: Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging
Official title: A Phase 2a, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging
Sponsor: BioAge Labs, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-22
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Plan to share individual participant data: NO
Clinical trial NCT05013554: Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Official title: A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors.
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor's decision. Termination decision unrelated to safety profile
Enrollment: 44.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-08-16
Primary completion date: 2024-01-15
Completion date: 2024-01-15
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03406715: Combination Immunotherapy-Ipilimumab-Nivolumab-Dendritic Cell p53 Vac - Patients With Small Cell Lung Cancer (SCLC)
Official title: Combination Immunotherapy With Ipilimumab and Nivolumab Plus a Dendritic Cell Based p53 Vaccine (Ad.p53-DC) in Patients With Relapsed Small Cell Lung Cancer (SCLC)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor closed study
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-15
Primary completion date: 2022-03-23
Completion date: 2022-05-16