chufangao/CTO huggingface dataset:
Clinical trial NCT02947269: Prucalopride in Postoperative Ileus
Official title: A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery
Sponsor: University of Auckland, New Zealand (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 150.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-25
Primary completion date: 2020-08-30
Completion date: 2020-08-30
Clinical trial NCT02237638: Phase I Study on VEGF Vaccination in Metastatic Solid Tumors
Official title: A Phase I Open-label Clinical Trial, Evaluating the Therapeutic Vaccine hVEGF26-104/RFASE in Patients With Advanced Solid Tumors
Sponsor: Amsterdam UMC, location VUmc (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-04-30
Primary completion date: 2020-01-31
Completion date: 2020-01-01
Clinical trial NCT02052882: Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Official title: An Open Label Phase II Study of Romiplostim for Chemotherapy Induced Thrombocytopenia
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-01-30
Primary completion date: 2023-11-13
Completion date: 2023-11-13
Clinical trial NCT04420585: Desmopressin for Bedwetting in Children With SCD
Official title: Desmopressin as a Therapy for Nocturnal Enuresis in Pediatric Patients With Sickle Cell Disease
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Study was not able to meet recruitment after 9 years of trying to enroll patients on different versions of the protocol and changing recruitment strategies.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-07
Primary completion date: 2023-06-12
Completion date: 2023-06-12
Plan to share individual participant data: NO
Clinical trial NCT04794205: Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary
Official title: Acute Changes In Thermal Pain Response Following Single Oral Dose of Beta-Cary
Acronym: BCP-Pain
Sponsor: Hartford Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Delayed project onset; PI determined pilot data could be collected at a later date.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-09-30
Primary completion date: 2022-04-30
Completion date: 2022-04-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05520970: Safety and Immunogenicity of COVID-19 Vaccine, AdCLD-CoV19-1
Official title: A Phase IIb, Multicenter, Observer-Blinded, Randomized, Placebo-Controlled Trial to Evaluate the Immunogenicity and Safety of the AdCLD-CoV19-1 in Healthy Adults Aged 19 Years Old and Above
Sponsor: Cellid Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study early terminated based on the sponsor(manufacture)'s decision
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-08-19
Primary completion date: 2022-11-08
Completion date: 2022-11-08
Plan to share individual participant data: NO
Clinical trial NCT03409107: Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)
Official title: A 28-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center, Study in Recombinant Human Erythropoietin (rhEPO) naïve Non-dialysis Participants With Anemia Associated With Chronic Kidney Disease to Evaluate the Efficacy, Safety and Effects on Quality of Life of Daprodustat Compared to Placebo
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 614.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-05
Primary completion date: 2020-10-07
Completion date: 2020-10-07
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Clinical trial NCT04662528: Safety and Efficacy of MAT9001(Omega-3-pentaenoic Acid) in Subjects With Triglycerides ≥500 mg/dL and <2000 mg/dL
Official title: A Phase 3, Placebo-Controlled, Randomized, Double-blind, Parallel-arm Trial to Assess the Safety and Efficacy of MAT9001 in Subjects With Severe Hypertriglyceridemia: The AMPLIFY Trial
Acronym: AMPLIFY
Sponsor: Matinas Biopharma, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: suspended
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-30
Primary completion date: 2022-08-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT02948959: Evaluation of Dupilumab in Children With Uncontrolled Asthma
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age With Uncontrolled Persistent Asthma
Acronym: VOYAGE
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 408.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-21
Primary completion date: 2020-08-26
Completion date: 2020-08-26
Baseline population: Analysis was performed on intent to treat population which included all randomized participants.
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 NCT03207542: Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Official title: An Open-label Phase 2 Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI request
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-07-31
Primary completion date: 2020-07-31
Completion date: 2021-07-31
Clinical trial NCT06137651: Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis
Official title: A Phase I/Ib Trial of Trotabresib (BMS-986378), an Oral BET Inhibitor) in Combination With Vinorelbine and Radiation Therapy in HER2+ Breast Cancer Patients With Central Nervous System Metastasis and Leptomeningeal Disease (CA076-1008)
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study terminated by the sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-12-31
Primary completion date: 2024-03-27
Completion date: 2024-03-27
Clinical trial NCT05977127: Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly
Official title: Intradermal Administration of a COVID-19 mRNA Vaccine in Elderly
Acronym: HVaNa
Sponsor: Radboud University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment rate dropped because of national COVID-19 vaccination campaign taking place parallel to this study.
Enrollment: 48.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-09-26
Primary completion date: 2024-03-21
Completion date: 2024-03-21
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04743804: Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment Challenges
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-29
Primary completion date: 2022-12-22
Completion date: 2022-12-22
Baseline population: The Modified Intent-to-Treat Analysis Set included all randomized participants, excluding participants who enrolled prior to availability of ST-HUS and ADAMTS13 central laboratory results and were subsequently found to be ineligible after randomization.
Limitations and caveats: Due to continued enrollment challenges, Alexion decided to terminate this study prematurely. There were no safety or efficacy concerns throughout the course of study. The planned interim analysis for sample size re-estimation and the planned primary analysis as specified in Protocol Amendment 2 were not conducted due to early termination of the study. No hypothesis testing or inferential statistical analysis for the purpose of treatment comparisons was performed due to small sample size.
Plan to share individual participant data: NO
Clinical trial NCT03021954: Platelet Rich Plasma in Levator Ani Muscle Trauma
Official title: The Role of Platelet Rich Plasma in Supporting the Recovery of Post-partum Levator Ani Muscle Trauma
Sponsor: Dr Cipto Mangunkusumo General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-30
Primary completion date: 2019-01-31
Completion date: 2020-01-31
Plan to share individual participant data: NO
Clinical trial NCT02822573: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Official title: A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment
Acronym: Remember
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 276.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-30
Primary completion date: 2022-07-29
Completion date: 2022-07-29
Baseline population: All participants that were enrolled and randomized completed baseline assessments.
Limitations and caveats: Our mainly non-Hispanic, white sample of breast cancer survivors, while geographically diverse, is not representative of all survivors. A lack of validated alternate forms of most of our tests may have contributed to a practice effect. We did not collect estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2) status.
Plan to share individual participant data: YES
IPD sharing description: Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base is committed to following the NIH Statement on Sharing Research Data. As of July 2018, the Wake Forest (WF) NCORP Research Base (RB) signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
IPD time frame: See NIH Policy
IPD access criteria: request using link below
Clinical trial NCT04844918: A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Official title: Efficacy and Safety of Once-Weekly Tirzepatide in Participants With Obesity Disease: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-J)
Acronym: SURMOUNT-J
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 267.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-10
Primary completion date: 2023-06-24
Completion date: 2023-06-24
Baseline population: All participants, excluding the GCP compliance investigative site, who received at least one dose of study drug.
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT03496766: Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS
Official title: An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer With HRAS Mutations
Sponsor: Spanish Lung Cancer Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The recruitment was closed prematurely to due to slow recruitment.
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-05-07
Primary completion date: 2022-10-30
Completion date: 2022-11-09
Limitations and caveats: The recruitment was closed prematurely to due to slow recruitment, so there are no consistent data to achieve any relevant conclusion at this point.
Plan to share individual participant data: NO
Clinical trial NCT04912141: Prevention of Acute Kidney Injury in Patients With NSTEMI
Official title: Conestat Alfa (a Recombinant Human C1 Esterase Inhibitor) for the Prevention of Acute Kidney Injury After Non-ST Elevation Myocardial Infarction: a Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2, Dose-finding Study
Acronym: AKI
Sponsor: Pharming Technologies B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lower than expected study enrolment rate. New strategic considerations.
Enrollment: 29.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-21
Primary completion date: 2023-04-28
Completion date: 2023-04-28
Plan to share individual participant data: NO
Clinical trial NCT02418273: Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders
Official title: Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: was not funded
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-01
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Clinical trial NCT05097014: CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD
Official title: A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Acronym: TRIFORCE
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 106.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-10-28
Primary completion date: 2023-02-24
Completion date: 2023-02-24
Plan to share individual participant data: YES
IPD sharing description: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.~Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD access criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
Clinical trial NCT04379076: InterLeukin-7 (CYT107) to Improve Clinical Outcomes in Lymphopenic pAtients With COVID-19 Infection UK Cohort
Official title: A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in UK
Acronym: ILIAD-7-UK
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: POOR ACCRUAL
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-14
Primary completion date: 2022-02-28
Completion date: 2022-03-30
Plan to share individual participant data: NO
IPD sharing description: publication
Clinical trial NCT04964414: Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19
Official title: Prospective Randomized Study of the Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Slow recruitment
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2023-01-13
Completion date: 2023-03-29
Limitations and caveats: Early termination and significant loss to follow-up leading to small numbers of subjects analyzed.
Plan to share individual participant data: YES
IPD sharing description: Individual participant data (IPD) may be shared, after de-identification, with researchers who provide a methodologically sound proposal. IPD to be shared will include that necessary to achieve the aims in the approved proposal.
IPD time frame: Beginning 1 year after publication of summary data. Ending 5 years after publication.
IPD access criteria: Proposals should be directed to shafferad@upmc.edu. To gain access, data requestors will need to sign data access agreement.
Clinical trial NCT02118337: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies
Official title: A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Subjects With Select Advanced Malignancies
Sponsor: MedImmune LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 9.0
Start date: 2014-05-19
Primary completion date: 2020-03-17
Completion date: 2020-03-17
Baseline population: As-treated population included those participants who received any study drug (MEDI0680, durvalumab, or nivolumab) and grouped according to actual treatment received.
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.
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 NCT03153137: Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Official title: Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects
Acronym: RUBATO
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 142.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-14
Primary completion date: 2021-06-30
Completion date: 2021-07-26
Plan to share individual participant data: NO
Clinical trial NCT03098420: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section
Official title: Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Low enrollment; recruitment challenges due to competing studies in women and infant center
Enrollment: 29.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-07-31
Primary completion date: 2021-05-20
Completion date: 2021-05-20
Limitations and caveats: Early termination leading to small numbers of subjects analyzed, due to recruitment challenges related to competing studies in the women and infants center
Plan to share individual participant data: NO
Clinical trial NCT03172026: Maraviroc to Augment Rehabilitation Outcomes After Stroke
Official title: Maraviroc to Augment Rehabilitation Outcomes After Stroke
Acronym: MAROS
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Poor recruitment for each site, partly related to Covid epidemic.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-01
Primary completion date: 2020-10-01
Completion date: 2020-10-01
Baseline population: Only 2 participants were enrolled and began study activities before the study was halted prematurely due to recruitment difficulty.