chufangao/CTO huggingface dataset:
Clinical trial NCT05068284: A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD
Acronym: AIM-CD
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 176.0 (ACTUAL)
Number of arms: 10.0
Start date: 2022-01-31
Primary completion date: 2023-07-20
Completion date: 2023-07-20
Baseline population: ITT1 population; all enrolled
Limitations and caveats: AbbVie has decided to discontinue further subject enrollment in the M20-371 (ABBV-154) study. This decision is not based on a safety or an efficacy signal; rather this decision was made because of a change in AbbVie's development.
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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT05574166: A Phase I Study to Evaluate Safety and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
Official title: A Phase I Single-Centre, Randomised, Double-Blind, Placebo-Controlled Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses and Multiple Doses of SP-8356
Sponsor: Shin Poong Pharmaceutical Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Only Part 1 was conducted but not Part 2. Due to the low exposures, definitive safety conclusions could not be made for the targeted exposure levels in the future.
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-03
Primary completion date: 2021-10-28
Completion date: 2021-10-29
Plan to share individual participant data: NO
Clinical trial NCT05064735: Research Study Looking at How Well Semaglutide Works in People Suffering From Obesity and Knee Osteoarthritis
Official title: Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 407.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-01
Primary completion date: 2023-07-24
Completion date: 2023-09-08
Baseline population: Full analysis set (FAS) included all randomized participants according to the intention-to-treat principle.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT01533727: CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-08-31
Primary completion date: 2017-12-31
Completion date: 2020-12-31
Clinical trial NCT02811744: 11C-Acetate PET/CT Imaging As a Biomarker of Amyloid-Induced Neuroinflammation
Official title: 11C-Acetate Position Emission Tomography/Computerized Tomography (PET/CT) Imaging As a Biomarker of Amyloid-Induced Neuroinflammation
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding issues.
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2022-02-28
Completion date: 2022-02-28
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04800315: A Study to Evaluate Safety and Effectiveness of Cendakimab (CC-93538) in Participants With Moderate to Severe Atopic Dermatitis
Official title: A Phase 2, Multicenter, Global, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Cendakimab (CC-93538) in Adult Subjects With Moderate to Severe Atopic Dermatitis
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 221.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-14
Primary completion date: 2022-07-20
Completion date: 2022-11-09
Baseline population: All Randomized
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link:~https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD time frame: See Plan Description
IPD access criteria: See Plan Description
Clinical trial NCT04348461: BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
Official title: Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19
Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: lack of financial support
Enrollment: 100.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-05-06
Primary completion date: 2020-09-15
Completion date: 2021-09-30
Clinical trial NCT04072575: A Study of Paliperidone Palmitate 6-Month Formulation
Official title: Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 178.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-19
Primary completion date: 2022-05-03
Completion date: 2022-05-03
Limitations and caveats: The sponsor identified that the study did not include a control arm reference group. The coronavirus disease-2019 (COVID-19) pandemic placed some restrictions on study face-to-face visits.
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 NCT01926587: Phase II Part 2 Expansion of Oral Rigosertib in Combination With Azacitidine
Official title: A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Sponsor: Traws Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-08-31
Primary completion date: 2020-12-08
Completion date: 2021-02-16
Clinical trial NCT05107427: Study of MRx0518 and Avelumab in Patients With Urothelial Carcinoma
Official title: A Phase 2 Switch Maintenance Study of MRx0518 and Avelumab in Patients With Unresectable Locally Advanced or Metastatic Urothelial Carcinoma Who Did Not Progress on First-Line Platinum-Containing Chemotherapy
Acronym: AVENU
Sponsor: 4D pharma plc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor unable to proceed
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-01
Primary completion date: 2023-04-30
Completion date: 2023-04-30
Plan to share individual participant data: NO
Clinical trial NCT03715465: The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Official title: The Clinical Utility of DLMO in the Treatment of Delayed Sleep-Wake Phase Disorder: A Randomized Trial
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-15
Primary completion date: 2021-11-05
Completion date: 2021-11-05
Plan to share individual participant data: NO
Clinical trial NCT05572476: Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
Official title: Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer
Acronym: LURBIMUNE
Sponsor: Institut Bergonié (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Recruitment difficulties, decline in the incidence of the studied pathology, active competitive clinical trials
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-10-31
Primary completion date: 2024-05-31
Completion date: 2024-05-31
Clinical trial NCT02724150: Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
Official title: Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
Sponsor: Damascus Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-01
Primary completion date: 2021-02-28
Completion date: 2021-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04774250: Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)
Official title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Acronym: PINIHL-AET
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-10
Primary completion date: 2022-12-23
Completion date: 2022-12-23
Plan to share individual participant data: NO
Clinical trial NCT04794088: Intravenous Imatinib in Mechanically Ventilated COVID-19 Patients
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of Intravenous Imatinib Mesylate (Impentri®) in Subjects With Acute Respiratory Distress Syndrome Induced by COVID-19
Acronym: INVENT COVID
Sponsor: Amsterdam UMC, location VUmc (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to the decline of COVID-19 patients on Dutch ICUs. A sample size reestimation based on blinded study data of 66 patients was furthermore favorable, indicating sufficient power to detect a difference in primary endpoint between groups.
Enrollment: 67.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-14
Primary completion date: 2022-03-16
Completion date: 2022-04-07
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03566511: Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide
Official title: Use of Functional MRI to Assess Functional Hypothalamic Activation in Response to Diazoxide
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Temporarily paused while the MR center develops newer study techniques. We might resume; this is not a suspension of IRB approval.
Enrollment: 24.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-06-12
Primary completion date: 2024-08-31
Completion date: 2024-08-31
Plan to share individual participant data: NO
Clinical trial NCT02789878: Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer
Official title: Phase II Study of Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for Patients With High-Risk Localized Prostate Cancer Prior to Radical Prostatectomy
Sponsor: Instituto do Cancer do Estado de São Paulo (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-24
Primary completion date: 2022-04-30
Completion date: 2022-08-01
Plan to share individual participant data: NO
Clinical trial NCT03971071: A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache
Official title: A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 620.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-10-07
Primary completion date: 2022-12-01
Completion date: 2023-06-13
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 NCT03098355: Interleukin-2 Following 4SCAR19/22 T Cells Targeting Refractory and/or Recurrent B Cell Malignancies
Official title: Anti-CD19/CD22 4th Generation CAR-T Cells (4SCAR19/22) Followed by Interleukin-2 Treating Pediatric Relapsed and Refractory B Cell Malignancies
Sponsor: Zhujiang Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The company did not offer the appropriate CART services.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-12-30
Primary completion date: 2022-12-15
Completion date: 2023-12-31
Plan to share individual participant data: NO
Clinical trial NCT04482712: Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS
Official title: Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of Acute Respiratory Distress Syndrome (RAPA-CARDS)
Acronym: RAPA-CARDS
Sponsor: The University of Texas Health Science Center at San Antonio (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The study was never submitted to IRB or approved, due to feasibility issues
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-30
Primary completion date: 2022-01-31
Completion date: 2023-01-31
Plan to share individual participant data: YES
IPD sharing description: All collected IPD, all IPD that underlie results in a publication will be shared.
IPD time frame: Data will become available at study completion at the time of journal publication.
Clinical trial NCT04666675: A Study of Oral Upadacitinib Tablets to Assess Change in Disease State in Participants Aged 12-75 Years With Moderate to Severe Atopic Dermatitis in Brazil
Official title: A Phase 3b Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis in Brazil
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Strategic considerations
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-12-24
Primary completion date: 2021-03-23
Completion date: 2021-03-23
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 NCT04664959: A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
Official title: A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Between SB16 (Proposed Denosumab Biosimilar) and Prolia® in Postmenopausal Women With Osteoporosis
Sponsor: Samsung Bioepis Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 457.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-26
Primary completion date: 2022-06-20
Completion date: 2022-12-19
Clinical trial NCT04995094: Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma
Official title: A Phase II, Neoadjuvant, Randomized, Multicenter Study of Imprime PGG Plus Pembrolizumab in Subjects With Stage III, Resectable Melanoma
Sponsor: HiberCell, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Enrollment challenges, study not feasible
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-15
Primary completion date: 2023-02-18
Completion date: 2023-05-18
Clinical trial NCT04328480: The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.
Official title: The ECLA PHRI COLCOVID Trial
Acronym: COLCOVID
Sponsor: Estudios Clínicos Latino América (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1279.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2021-04-25
Completion date: 2021-04-26
Plan to share individual participant data: NO
Clinical trial NCT01891643: PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Official title: A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-30
Primary completion date: 2020-06-25
Completion date: 2020-06-25
Clinical trial NCT04269551: A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Official title: A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-15
Primary completion date: 2022-01-06
Completion date: 2022-01-06
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 NCT03802227: A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.
Official title: A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using fMRI to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-22
Primary completion date: 2019-12-17
Completion date: 2020-01-03
Limitations and caveats: The study was originally planned for 24 patients. However enrollment was stopped due to the CDP being stopped at 8 and therefore limits the generalizability of this data.