chufangao/CTO huggingface dataset:
Clinical trial NCT04820621: Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment
Official title: Investigation of the Pharmacokinetics, Safety and Tolerability of Runcaciguat in Participants With Hepatic Impairment (Classified as Child Pugh A or B) and in a Control Group of Age-, Weight-, and Gender-matched Participants Following a Single Oral 15 mg Modified Release (MR) Tablet Dose in a Non-randomized, Non-controlled, Non-blinded, Observational Study With Group Stratification
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study is prematurely terminated due to changes in sponsor's overall development strategy. The decision of termination is not related to any safety concern of the compound.
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-07
Primary completion date: 2021-07-01
Completion date: 2021-07-01
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.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Clinical trial NCT03251144: Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Official title: In Vitro and in Vivo Studies of the Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Acronym: UCLACAREMITO
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-01
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Baseline population: Patients on TAF based vs TDF based ART
Plan to share individual participant data: NO
Clinical trial NCT04170543: A Phase 2b Diabetic Kidney Disease Study
Official title: A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 609.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-11-18
Primary completion date: 2023-05-16
Completion date: 2023-05-16
Limitations and caveats: 41 randomized participants were excluded from analysis populations in order to avoid heterogeneity in the data (bias, etc.) :~* 2 participants did not received any IP~* 24 participants were enrolled in phase 2a without having the possibility to be enrolled in phase 2b~* 15 participants were randomized in a site with GCP breach (inability to confirm the validity of the data reported)~These 41 participants are excluded from Baseline characteristics (558 participants).
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT04191382: Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Official title: Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer
Acronym: AMEERA-4
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: early discontinuation based on strategic sponsor decision not driven by any safety concerns
Enrollment: 105.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-02-04
Primary completion date: 2021-04-30
Completion date: 2021-05-28
Baseline population: Analysis was performed on intent-to-treat (ITT) population that included all enrolled participants for whom there was a confirmation of successful allocation of a randomization number by interactive response technology (IRT) and were analyzed according to the treatment arm assigned at randomization.
Limitations and caveats: The study recruitment discontinued early based on strategic sponsor decision that was not driven by any safety concerns. No inferential statistical analysis was performed due to early termination.
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 NCT06006416: Effect of Fenugreek Fibre on Gut Microbiome
Official title: Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial
Sponsor: RDC Clinical Pty Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The Sponsor decided not to conduct the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-01
Primary completion date: 2024-05-01
Completion date: 2024-09-01
Plan to share individual participant data: NO
Clinical trial NCT05867056: Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
Official title: An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Participants With Chronic HBV Infection Who Are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
Sponsor: Immunocore Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Enrollment into the phase 2 portion was never initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-12
Primary completion date: 2024-09-10
Completion date: 2024-12-15
Clinical trial NCT04444466: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
Official title: A First-In-Human, Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UCB8600 in Healthy Participants, Atopic Participants, and Chronic Spontaneous Urticaria Participants
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: internal company decision; not safety related
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-30
Primary completion date: 2021-08-02
Completion date: 2021-08-02
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT03669588: An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness
Acronym: ADAPT
Sponsor: argenx (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 167.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-22
Primary completion date: 2020-04-06
Completion date: 2020-04-06
Baseline population: All patients in the randomized population who received at least a partial dose of investigational medicinal product (IMP) were included in the baseline analysis.
Plan to share individual participant data: NO
Clinical trial NCT03638128: Open-label Extension of Study 20130173 of Denosumab in Children and Young Adults With Osteogenesis Imperfecta
Official title: Multicenter, Single-arm Open-label Extension Study to Assess Long-term Safety and Efficacy of Current or Prior Treatment With Denosumab in Children/Young Adults With Osteogenesis Imperfecta
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants
Enrollment: 75.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-26
Primary completion date: 2022-03-28
Completion date: 2022-03-28
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT04448119: Control of COVID-19 Outbreaks in Long Term Care
Official title: Control of COVID-19 Outbreaks in Long Term Care (CONTROL-COVID)
Sponsor: Appili Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment challenges
Enrollment: 67.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-16
Primary completion date: 2021-10-30
Completion date: 2021-10-30
Plan to share individual participant data: NO
Clinical trial NCT05049525: Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease
Official title: Evaluation of the Response of Itraconazole and Terbinafine Therapy in Subjects With Crohn's Disease Not Responding Adequately to Current Therapy
Acronym: CD-IT
Sponsor: Montreal Heart Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient patient enrollment
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-22
Primary completion date: 2024-02-28
Completion date: 2024-02-28
Plan to share individual participant data: NO
Clinical trial NCT04906382: Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer
Official title: Pilot Study of Tislelizumab (BGB-A317) in Recurrent Mismatch Repair Deficient Endometrial Cancer and the Effect on the Tumor Microenvironment
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Sponsor reorganization
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-01
Primary completion date: 2022-09-01
Completion date: 2022-09-01
Plan to share individual participant data: NO
Clinical trial NCT03304210: PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Official title: Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
Acronym: PIPAC-nabpac
Sponsor: University Hospital, Ghent (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-09-16
Primary completion date: 2020-05-06
Completion date: 2020-05-06
Clinical trial NCT01925378: A Phase II Single-arm Intervention Trial of Nelfinavir in Patients With Grade 2/3 or 3 Cervical Intraepithelial Neoplasia
Official title: A PHASE II SINGLE-ARM INTERVENTION TRIAL OF NELFINAVIR IN PATIENTS WITH GRADE 2/3 or 3 CERVICAL INTRAEPITHELIAL NEOPLASIA
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The study is going to open in a new site
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-07
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Clinical trial NCT03099486: Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC
Official title: A Pilot Phase II, Single Arm, Open Label, Investigator-initiated Clinical Trial of Regorafenib Plus 5-Fluorouracil/Leucovorin (5FU/LV) Beyond Progression on Regorafenib Monotherapy in Metastatic Colorectal Cancer (mCRC)
Sponsor: Fox Chase Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Administrative change
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-06
Primary completion date: 2020-06-02
Completion date: 2020-06-02
Plan to share individual participant data: NO
Clinical trial NCT04562298: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer
Sponsor: Shanghai East Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Both the sponsors and collaborator are considering terminating the study.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-21
Primary completion date: 2022-06-07
Completion date: 2022-06-07
Clinical trial NCT03946111: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
Official title: Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Did not enroll enough participants
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-07
Primary completion date: 2023-12-14
Completion date: 2023-12-14
Clinical trial NCT03303950: Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis
Official title: Busulfan, Fludarabine, Donor Stem Cell Transplant, and Cyclophosphamide in Treating Participants With Multiple Myeloma or Myelofibrosis
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-03-30
Primary completion date: 2019-05-14
Completion date: 2020-02-19
Clinical trial NCT03555149: A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
Official title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC)
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers.
Enrollment: 96.0 (ACTUAL)
Number of arms: 8.0
Start date: 2018-09-27
Primary completion date: 2022-09-26
Completion date: 2022-09-26
Baseline population: All participants who were randomized in the study, regardless of whether they actually received any study treatment.
Limitations and caveats: This study is not designed to make explicit power and Type I error considerations for a hypothesis test. Instead, this study is designed to obtain preliminary efficacy, safety, and PK data. No formal statistical hypothesis testing was performed in this study. Due to the limited sample size, the results need to be interpreted with caution. For the Atezo+Idasa and Atezo+LOAd703 groups, no meaningful conclusion could be drawn because these experimental arms have been terminated prematurely.
Clinical trial NCT01597518: Riluzole in Spinal Cord Injury Study
Official title: A Multi-Center, Randomized, Placebo Controlled, Double-Blinded, Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury
Acronym: RISCIS
Sponsor: AOSpine North America Research Network (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Enrollment challenges/ slow enrollment.
Enrollment: 193.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-10-31
Primary completion date: 2020-10-08
Completion date: 2020-10-08
Clinical trial NCT04548791: Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders
Official title: Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog Alfa (Activated) in Treatment of Episodic Bleeding in Subjects With Inherited Bleeding Disorders
Sponsor: Catalyst Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company decision (not a safety issue)
Enrollment: 19.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-17
Primary completion date: 2021-11-15
Completion date: 2021-12-03
Plan to share individual participant data: NO
Clinical trial NCT04843761: ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
Official title: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19
Acronym: TESICO
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 473.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-20
Primary completion date: 2022-08-22
Completion date: 2022-11-20
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05784129: A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection
Acronym: PROGRESS
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Janssen made an internal business decision to discontinue the PROGRESS study. This decision is not related to any efficacy or safety concerns.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-21
Primary completion date: 2023-09-29
Completion date: 2023-10-10
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03028571: Autonomic Blockade and Endogenous Glucose Production
Official title: Acute Sympathetic Blockade and Endogenous Glucose Production
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The investigators decided not to perform the study. No participants have been enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-17
Primary completion date: 2022-12-31
Completion date: 2024-12-31
Clinical trial NCT03110107: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Official title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Business Objectives have changed.
Enrollment: 512.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-05-04
Primary completion date: 2024-04-04
Completion date: 2024-04-04
Clinical trial NCT03550794: Thiamine as a Renal Protective Agent in Septic Shock
Official title: Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
Sponsor: Beth Israel Deaconess Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 95.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-04
Primary completion date: 2022-04-05
Completion date: 2022-04-05
Plan to share individual participant data: UNDECIDED