chufangao/CTO huggingface dataset:
Clinical trial NCT01930123: Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance Biomarkers in Nonalcoholic Fatty Liver Disease
Official title: Impact of Fructose on Metabolism, Energy Homeostasis and Magnetic Resonance (MR) Biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD)
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient enrollment.
Enrollment: 118.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-10-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Baseline population: Participants who completed the study.
Clinical trial NCT04183335: Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Official title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 151.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-12
Primary completion date: 2021-11-12
Completion date: 2022-02-03
Baseline population: Analysis was performed on randomized population.
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 NCT03047005: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-28
Primary completion date: 2021-12-16
Completion date: 2022-12-16
Clinical trial NCT03795350: Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
Official title: Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
Acronym: STORM
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-14
Primary completion date: 2020-04-03
Completion date: 2020-04-03
Plan to share individual participant data: NO
Clinical trial NCT04853329: Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
Official title: Phase 1/2, Multicenter, First-In-Human, Dose Escalation and Dose Expansion Study of CPO107 Administered Intravenously to Patients With Advanced CD20-positive Non-Hodgkins Lymphoma
Sponsor: Conjupro Biotherapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Business reasons
Enrollment: 7.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-13
Primary completion date: 2024-12-31
Completion date: 2024-12-31
Plan to share individual participant data: NO
IPD sharing description: Undecided
Clinical trial NCT04178590: Effect of Injectable Platelet-Rich Fibrin (i-PRF) in Initial Treatment of Chronic Periodontitis
Official title: Effects of Application Injectable Platelet-Rich Fibrin (i-PRF) as Adjunct Therapy in the Initial Treatment of Periodontitis
Acronym: EIPRFITCP
Sponsor: University of Belgrade (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-02
Primary completion date: 2020-06-29
Completion date: 2020-07-09
Baseline population: 32 participants
Clinical trial NCT05231603: Ivermectin for Post Exposure Prophylaxis of Covid-19
Official title: Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts
Acronym: I-CPEP
Sponsor: Clinical Research Centre, Malaysia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Poor response
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-16
Primary completion date: 2022-05-31
Completion date: 2022-10-11
Plan to share individual participant data: NO
Clinical trial NCT04366960: Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients
Official title: Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients: Comparison of 40 mg o.d. Versus 40 mg b.i.d. A Randomized Clinical Trial
Acronym: X-Covid 19
Sponsor: Niguarda Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 189.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-14
Primary completion date: 2021-05-25
Completion date: 2021-05-25
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02709655: Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Active-reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years, With Major Depressive Disorder (MDD)
Sponsor: H. Lundbeck A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 683.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-05-18
Primary completion date: 2022-01-21
Completion date: 2022-01-21
Baseline population: All-patients-treated set Phase A (APTS_A) included all participants enrolled to the 4-week Single-blind period (Phase A) who received at least 1 dose of study drug.
Clinical trial NCT03419403: UNITE Study: Understanding New Interventions With GBM ThErapy
Official title: Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated because clinical development of depatuxizumab mafodotin in glioblastoma was stopped due to lack of survival benefit.
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-07-30
Primary completion date: 2019-09-05
Completion date: 2020-03-03
Baseline population: Safety population: All randomized participants who received at least 1 dose of depatuxizumab mafodotin
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 NCT04180969: rTMS of Limbic Circuitry in Stress Modulation in Healthy Volunteers
Official title: Impact of Repetitive Transcranial Magnetic Stimulation (rTMS) of Limbic Brain Circuitry in Stress Modulation in a Healthy Population
Acronym: TSM-1
Sponsor: Wayne State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2023-04-10
Primary completion date: 2023-04-10
Completion date: 2023-04-10
Plan to share individual participant data: YES
IPD sharing description: Full sharing plan is being developed.
IPD time frame: Materials will only become available after the study is completed and the first manuscript from this project is published.
IPD access criteria: Qualified investigators may apply in writing to Dr. Greenwald
Clinical trial NCT03828539: Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Official title: Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting
Acronym: HER-MES
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 777.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-22
Primary completion date: 2020-07-29
Completion date: 2020-07-29
Baseline population: Demographic variables and other baseline characteristics were summarized for each randomized treatment group and for all patients (total) using the Full Analysis set (FAS)
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 NCT04692155: Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
Official title: Phase Ib/II Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)
Acronym: CHOP U2
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: FDA hold
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-31
Primary completion date: 2022-06-30
Completion date: 2022-06-30
Clinical trial NCT04015557: Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria
Official title: Functional Consequences and Therapeutic Intervention in Hampered Production of Cysteine, Glutathione and Taurine in Classical Homocystinuria
Sponsor: Hospital de Clinicas de Porto Alegre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Study was interrupted due to COVID-19 pandemic
Enrollment: 10.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2022-02-11
Primary completion date: 2022-06-30
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT03113617: 68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
Official title: 68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-10
Primary completion date: 2021-12-19
Completion date: 2021-12-19
Plan to share individual participant data: NO
Clinical trial NCT05447507: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation
Official title: Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block
Sponsor: Seoul National University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-08
Primary completion date: 2022-10-26
Completion date: 2022-10-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03385564: An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Official title: An Exploratory Maintenance Trial Evaluating the Effect of BI 655064 in Lupus Nephritis Patients Who Have Achieved a Meaningful Response Either at the End of 1293.10 or After an Induction Treatment Outside of 1293.10
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-09
Primary completion date: 2021-05-25
Completion date: 2021-07-27
Baseline population: Treated set (TS): this patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
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 NCT03780543: A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Official title: A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Sponsor: Assembly Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 92.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-20
Primary completion date: 2021-04-26
Completion date: 2021-04-26
Plan to share individual participant data: NO
Clinical trial NCT04510584: Maintenance Treatment With Bevacizumab and Atezolizumab for Ovarian Cancer
Official title: Halting Early Advancement of Residual Disease by Treatment With Bevacizumab and Atezolizumab in Ovarian Cancer
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: 19 patients screenfailed, stopping recruitment before first patient enrollment to analyze pilot results from screening samples.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-16
Primary completion date: 2023-02-22
Completion date: 2023-02-22
Plan to share individual participant data: NO
Clinical trial NCT03138889: Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Acronym: PROPEL
Sponsor: Nektar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 162.0 (ACTUAL)
Number of arms: 6.0
Start date: 2017-06-09
Primary completion date: 2022-07-05
Completion date: 2022-08-24
Baseline population: * Safety population: all patients who received at least one dose (or partial dose) of study treatment~* Dose-limiting toxicity (DLT) Population: all patients who completed at least the DLT observation period or discontinued from the study treatment due to DLT~* Response evaluable population: subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least one post-baseline assessment of tumor response.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04876716: Azole-echinocandin Combination Therapy for Invasive Aspergillosis
Official title: Azole-echinocandin Combination Therapy for Invasive Aspergillosis A Randomized Pragmatic Superiority Trial
Acronym: IA-DUET
Sponsor: Erasmus Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: futility
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-11
Primary completion date: 2024-05-01
Completion date: 2024-05-01
Clinical trial NCT04191278: Mobile Health Interventions for Medication Adherence Among PLWH
Official title: Mobile Health Interventions for Varenicline Adherence Among HIV-positive Smokers
Acronym: HIVSMART
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: COVID prevented study initiation
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-11-30
Primary completion date: 2022-07-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT02743221: A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy
Official title: An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).
Acronym: TASCO1
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 154.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-29
Primary completion date: 2018-01-15
Completion date: 2020-09-01
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT05154890: A Multiple Ascending Dose Study of ACN00177 (Pegtarviliase) in Subjects With CBS Deficiency
Official title: A Phase 1/2 Multiple Ascending-Dose Study in Subjects With Homocystinuria Due to Cystathionine β-Synthase (CBS) Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of ACN00177
Sponsor: Aeglea Biotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 13.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-05-13
Primary completion date: 2023-04-21
Completion date: 2023-04-21
Clinical trial NCT03887650: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Official title: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus
Sponsor: Hartford Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-11
Primary completion date: 2022-01-11
Completion date: 2022-03-08
Limitations and caveats: Opioid consumption was subjected to patient recall and reporting bias. Patients were advised by surgery clinics to limit opioid intake postoperatively, which might indirectly limit opioid use and made it more difficult to show a difference. The study was double-blinded, the anesthesiologists who performed the block, were unblinded due to the difference in the physical appearance of the study drugs.
Plan to share individual participant data: NO
Clinical trial NCT00729118: Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
Official title: Vorinostat (SAHA) and Lenalidomide After Autologous Transplant for Patients With Multiple Myeloma
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2008-09-26
Primary completion date: 2019-12-26
Completion date: 2020-05-04
Plan to share individual participant data: NO
Clinical trial NCT04377620: Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated by sponsor
Enrollment: 211.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-05-24
Primary completion date: 2021-02-26
Completion date: 2021-02-26
Baseline population: Intent-to-treat (ITT) population included all participants who were randomized to the study.
Plan to share individual participant data: UNDECIDED