chufangao/CTO huggingface dataset:
Clinical trial NCT03642990: NR in Chemo-induced Peripheral Neuropathy
Official title: Nicotinamide Riboside (NR) in Paclitaxel-induced Peripheral Neuropathy
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Enrollment challenges
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-08
Primary completion date: 2021-08-18
Completion date: 2022-02-24
Limitations and caveats: This trial was limited to a non-curative population of women receiving taxane chemotherapy without added platinum-based agents. Difficulty in recruiting this small population led to eventual termination of the trial. Dose escalation to 1000 mg/day did not occur for any subject due to physician concerns that subjects were not tolerating the 300 mg dose well.
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data collected during the trial, after de-identification, will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. The IPD will be available to sharing immediately after publication and ending 5 years after article publication
IPD time frame: IPD will be available for sharing immediately after publication and ending 5 years after article publication.
IPD access criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
Clinical trial NCT03353220: Predictors of Lorcaserin-Induced Weight Loss
Official title: Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-03
Primary completion date: 2020-02-14
Completion date: 2020-02-14
Limitations and caveats: Study was stopped prematurely during Phase 2 due to lack of drug supply.
Plan to share individual participant data: NO
Clinical trial NCT03386721: Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
Official title: An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.
Enrollment: 256.0 (ACTUAL)
Number of arms: 17.0
Start date: 2018-02-19
Primary completion date: 2021-12-30
Completion date: 2021-12-30
Baseline population: Safety population included all participants who received at least one dose of study treatment, whether or not prematurely withdrawn from the study.
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 NCT04524858: Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)
Official title: A Phase 2a, Open-Label, Single-Arm Study to Investigate the Safety and Efficacy of ATI-450 for the Maintenance of Remission in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed With Anti-IL-1 Therapy
Sponsor: Aclaris Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to patient enrollment challenges stemming from the COVID-19 pandemic, Aclaris has decided to focus its efforts and resources on other immuno-inflammatory diseases.
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-23
Primary completion date: 2021-02-25
Completion date: 2021-02-25
Baseline population: Due to study termination and only 1 participant being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Clinical trial NCT02592824: Glutamate for Metabolic Intervention in Coronary Surgery II
Official title: Phase III Study of Metabolic Intervention With Glutamate in Coronary Surgery II
Acronym: GLUTAMICSII
Sponsor: University Hospital, Linkoeping (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 321.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-15
Primary completion date: 2020-10-30
Completion date: 2020-10-30
Limitations and caveats: The main limitations of the study are: (i) it relies on a surrogate marker for heart failure (ii) the proportion of patients with diabetes had almost doubled compared to the cohort used for the sample size estimation
Clinical trial NCT04284254: MT2018-18: Sleeping Beauty Transposon-Engineered Plasmablasts for Hurler Syndrome Post Allo HSCT
Official title: Sleeping Beauty Transposon-Engineered Plasmablasts for Expression and Delivery of Alpha-L-iduronidase in Patients With Hurler Syndrome That Have Previously Undergone Allogeneic Transplantation
Sponsor: Masonic Cancer Center, University of Minnesota (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Study went on hold because more pre-clinical work needs to be done per FDA feedback. However, the study never went off hold and the study team has decided to close this study without opening to enrollment.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-31
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Clinical trial NCT04101331: Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides
Official title: A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients With Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)
Acronym: REDIRECT
Sponsor: Affimed GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 108.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-13
Primary completion date: 2022-05-11
Completion date: 2024-01-11
Baseline population: Full analysis set (FAS): consist of all subjects who received at least one dose of AFM13.
Clinical trial NCT05954052: A Study of Glutathione in Children With Autism Spectrum Disorder
Official title: An Open-Label Study of Glutathione in Children With Autism Spectrum Disorder
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: lack of funding and difficulty with phlebotomy in children with Autism
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-01
Primary completion date: 2023-08-15
Completion date: 2023-08-15
Plan to share individual participant data: YES
IPD time frame: Following the completion of the trial and until 2 years from the publication of the trial outcome data.
Clinical trial NCT02470585: Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Acronym: VELIA
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business decision not related to patient safety
Enrollment: 1140.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-06-29
Primary completion date: 2019-05-03
Completion date: 2023-10-05
Baseline population: The intention-to-treat (ITT) population consisted of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03303105: Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Official title: A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Sponsor: Otsuka Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-07
Primary completion date: 2020-06-16
Completion date: 2020-06-16
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03573297: A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Official title: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in a Dose-reduction Paradigm in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 901.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-06-15
Primary completion date: 2022-09-05
Completion date: 2022-09-05
Baseline population: Safety Population: all participants who received at least 1 dose of study medication.
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 NCT03821038: Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients
Official title: International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis
Acronym: IRIS-7-C&D
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PK issue detected after bolus IV route administration
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-01
Primary completion date: 2021-10-06
Completion date: 2021-10-06
Plan to share individual participant data: NO
IPD sharing description: Study results will be published Individual data can't be shared and are protected by the new GDPR rule
Clinical trial NCT03637660: Phase 4 Comparative Trial of Benzathine Penicillin G for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Official title: A Phase 4 Comparative Trial of Benzathine Penicillin G 2.4 Million Units Administered as a Single Dose Versus Three Successive Weekly Doses for Treatment of Early Syphilis in Subjects With or Without HIV Infection
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 249.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-31
Primary completion date: 2022-09-07
Completion date: 2023-03-20
Clinical trial NCT03218384: Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Official title: Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Unable to complete enrollment as planned.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-07
Primary completion date: 2022-04-04
Completion date: 2022-04-04
Clinical trial NCT02255227: Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
Official title: Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
Acronym: PneumoMICI
Sponsor: Centre Hospitalier Universitaire de Saint Etienne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low inclusion rates
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-04-13
Primary completion date: 2019-08-06
Completion date: 2022-07-06
Clinical trial NCT05133635: High-Dose Corticosteroid or Tocilizumab for Clinical Worsening of COVID-19
Official title: Comparison of the Treatment Efficacy of High-Dose Corticosteroid and Tocilizumab During Clinical Worsening in Patients With COVID-19 Pneumonia
Sponsor: Marmara University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: A recent study suggested a new corticosteroid regime for intensive care unit patients.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-01
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Plan to share individual participant data: NO
Clinical trial NCT04454567: A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
Official title: A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
Sponsor: Assembly Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to a change in the Sponsor's overall development strategy from treatment of chronic disease to finite, curative treatments, and is based partially on the advice and feedback from experts and regulators.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-11
Primary completion date: 2021-04-08
Completion date: 2021-04-08
Limitations and caveats: Study ABI-H0731-205 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. At the time of early termination, only 2 participants were enrolled, both of which discontinued their assigned study treatment early due to the study being terminated early by the Sponsor. As a result, the primary outcome of number of participants with HBV DNA \<LLOQ at Week 48 could not be assessed.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03698227: OlaReDo - Olaratumab and Rechallenge With Doxorubicin in Soft Tissue Sarcoma Patients
Official title: Efficacy of Olaratumab and Rechallenge With Doxorubicin in Anthracycline Pretreated, Advanced Soft Tissue Sarcoma Patients. An Exploratory Phase-II Study
Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy on olaratumab
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-12
Primary completion date: 2020-06-25
Completion date: 2020-06-25
Plan to share individual participant data: NO
IPD sharing description: No IPD will be shared
Clinical trial NCT04891133: EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial
Official title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial
Acronym: Bari-SolidAct
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: The trial was stopped prematurely due to external evidence that arose during the study period showing that the IMP, baricitinib, was not effective in the primary study population.
Enrollment: 290.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-03
Primary completion date: 2022-12-15
Completion date: 2023-01-23
Plan to share individual participant data: YES
IPD sharing description: Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants. Anonymized data will be made publicly available using a data repository, including any programming code used to produce the trial results. De-identified data will be made available upon request and evaluation of the requestee's ability and willingness to maintain the integrity and privacy of the trial participants. Further details of data sharing will be given in a separate data sharing plan.
Clinical trial NCT02942056: The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Official title: The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Could not obtain appropriate funding or standardized manufacturing for cinnamon tablets
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Clinical trial NCT03354273: An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Official title: A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease
Sponsor: GE Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 730.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-05
Primary completion date: 2022-05-05
Completion date: 2022-05-05
Baseline population: The enrolled population consisted of all participants who signed informed consent.
Clinical trial NCT03686683: Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer
Official title: A Randomized Phase 3, Open-Label Trial of Sipuleucel-T Administered To Patients On Active Surveillance For Newly Diagnosed Prostate Cancer
Acronym: ProVent
Sponsor: Dendreon (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 532.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-18
Primary completion date: 2023-03-10
Completion date: 2023-03-10
Plan to share individual participant data: NO
Clinical trial NCT01665144: Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1651.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-12-20
Primary completion date: 2016-04-29
Completion date: 2023-03-31
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~Locations: central Contact Info Novartis.email@novartis.com
Clinical trial NCT03515824: Study of MK-1697 in Participants With Advanced Solid Tumors (MK-1697-001)
Official title: A Phase 1 Study of MK-1697 in Participants With Advanced Solid Tumors
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 22.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-08-13
Primary completion date: 2020-02-18
Completion date: 2020-02-18
Baseline population: No participants were enrolled in Part B since study was terminated at the completion of Part A.
Limitations and caveats: The study was terminated due to business reasons.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05275023: An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
Official title: A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients
Acronym: OCTOPUS-1
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 37.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-30
Primary completion date: 2023-12-12
Completion date: 2024-05-31
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