chufangao/CTO huggingface dataset:
Clinical trial NCT03422627: Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
Official title: A Phase 1b/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Efavaleukin Alfa in Adult Subjects With Steroid Refractory Chronic Graft Versus Host Disease
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-04-27
Primary completion date: 2022-10-13
Completion date: 2022-10-13
Baseline population: Measured in the safety analysis set, which included all participants who received at least 1 dose of efavaleukin alfa.
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT04365257: Prazosin to Prevent COVID-19 (PREVENT-COVID Trial)
Official title: Alpha-1 Adrenergic Receptor Antagonism to Prevent COVID-19 Cytokine Storm Syndrome and Acute Respiratory Distress Syndrome: A Randomized Study Comparing the Efficacy of Prazosin vs. Standard of Care for SARS-CoV-2 Infection
Acronym: PREVENT
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of recruitment
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-13
Primary completion date: 2022-03-31
Completion date: 2022-03-31
Plan to share individual participant data: NO
Clinical trial NCT03238742: The Efficacy of Xuebijing Injection on Sepsis
Official title: The Efficacy of Xuebijing Injection in Adult Patients With Sepsis
Sponsor: Southeast University, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 1817.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-20
Primary completion date: 2019-07-28
Completion date: 2020-01-08
Plan to share individual participant data: YES
IPD sharing description: Mortality
IPD time frame: Study published
IPD access criteria: Supplyment
Clinical trial NCT03303989: REduCing Immunogenicity to PegloticasE (RECIPE) Study
Official title: REduCing Immunogenicity to PegloticasE (RECIPE) Study
Acronym: RECIPE
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-14
Primary completion date: 2020-04-27
Completion date: 2021-03-31
Baseline population: 35 participants were randomized. Three participants withdrew after randomization, but prior to first pegloticase infusion. Baseline characteristics are of the 32 participants (22 in MMF+Peg, 10 in PBO+Peg)
Plan to share individual participant data: UNDECIDED
Clinical trial NCT01238120: The Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients
Official title: A Phase II Study of the Effects of Physical Activity and Low-Dose Ibuprofen on Cognitive Function in Cancer Patients Undergoing Chemotherapy
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 4.0
Start date: 2010-11-30
Primary completion date: 2019-12-31
Completion date: 2020-12-31
Plan to share individual participant data: NO
IPD sharing description: Overall study results will be presented to participants, faculty and staff at the University of Rochester Medical Center. tudy results will be presented at professional meetings and published
Clinical trial NCT05212025: Adavosertib and Gemcitabine in Advanced Pancreatic
Official title: Phase 2 Single Arm Trial Testing Adavosertib and Gemcitabine in Platinum-Resistant Advanced Pancreatic Adenocarcinoma
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: manufacturer choice
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-30
Primary completion date: 2023-06-01
Completion date: 2023-12-31
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Clinical trial NCT05323110: Study of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers
Official title: A Double-blind, Randomized, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single- and Multiple-ascending Doses of Intravenously Administered Anti-LIGHT Monoclonal Antibody CBS001 in Healthy Volunteers
Sponsor: Capella Bioscience Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Portfolio reprioritization
Enrollment: 56.0 (ACTUAL)
Number of arms: 11.0
Start date: 2022-04-14
Primary completion date: 2023-08-22
Completion date: 2023-08-22
Plan to share individual participant data: NO
Clinical trial NCT03141073: Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects
Official title: A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects
Sponsor: Hua Medicine Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 767.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-15
Primary completion date: 2021-02-28
Completion date: 2021-02-28
Plan to share individual participant data: NO
Clinical trial NCT05412706: Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy
Official title: Niraparib Maintenance Treatment in Metastatic Colorectal Cancer Patients With a Partial or Complete Response After Oxaliplatin-based Induction Therapy: Bohème Trial
Acronym: Bohème
Sponsor: Ospedale Policlinico San Martino (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The Principal Investigator has retired and has not been replaced has retired and a new one has not been identified Principal Investigator
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-09-04
Primary completion date: 2023-09-04
Completion date: 2023-09-04
Clinical trial NCT03968419: This Study Will Evaluate the Effect of Canakinumab or Pembrolizumab Given as Monotherapy or in Combination as Neo-adjuvant Treatment for Subjects With Early Stages NSCLC.
Official title: A Randomized, Open-label, Phase II Study of Canakinumab or Pembrolizumab as Monotherapy or in Combination as Neoadjuvant Therapy in Subjects With Resectable Non-small Cell Lung Cancer (CANOPY-N)
Acronym: CANOPY-N
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study early terminated due to low enrollment compared to the anticipated figures.
Enrollment: 88.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-05
Primary completion date: 2022-04-20
Completion date: 2022-08-15
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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT02698189: A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
Official title: A Phase IB Trial With MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Hematologic Malignancies
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated due to limited efficacy and not due to safety reasons
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-19
Primary completion date: 2018-01-18
Completion date: 2021-09-09
Baseline population: All enrolled participants
Limitations and caveats: Due to limited pharmacokinetics sampling for t1/2, caution must be exercised when interpreting the results of t1/2, CL/F, and AUC 0-∞ results.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05284812: A Phase Ⅱ Clinical Trial of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried (AEC/BC02)
Official title: A Phase Ⅱ Study on the Safety, Tolerability and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine Freeze-dried
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: It is planned to restart the clinical study after the completion of the clinical trial protocol modification.
Enrollment: 200.0 (ESTIMATED)
Number of arms: 7.0
Start date: 2022-02-10
Primary completion date: 2024-06-30
Completion date: 2024-12-31
Clinical trial NCT04203901: Dendritic Cell Immunotherapy Plus Standard Treatment of Advanced Renal Cell Carcinoma
Official title: A Phase 2b Randomized Trial of Autologous Dendritic Cell Immunotherapy (CMN-001) Plus Standard Treatment of Advanced Renal Cell Carcinoma
Sponsor: CoImmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Strategic corporate decision
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-22
Primary completion date: 2023-09-28
Completion date: 2023-09-28
Plan to share individual participant data: NO
Clinical trial NCT03870841: The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis
Official title: An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection
Sponsor: Pulmocide Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study is being terminated early as a result of the coronavirus (COVID-19) outbreak.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-03
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Clinical trial NCT05158153: Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Official title: Outpatient Recovery From Acute Kidney Injury Requiring Dialysis
Acronym: ORKID
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Inadequate recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-18
Primary completion date: 2022-04-19
Completion date: 2022-04-19
Plan to share individual participant data: NO
Clinical trial NCT03501056: Study of Activated Cytokine-induced Killer Armed With Bispecific Antibody for Advanced Lung Cancer
Official title: Phase II Randomized Comparison Clinical Trial of Target Activated CIK for Advanced Lung Cancer
Sponsor: Fuda Cancer Hospital, Guangzhou (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-27
Primary completion date: 2020-05-25
Completion date: 2020-07-27
Clinical trial NCT04598542: Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers
Official title: Open-Label, Parallel-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Corticosteroid Intra Articular Injection Given 7 Days Before or 7 Days After Lorecivivint Intra-articular Injection Into the Knee of Healthy Volunteers
Sponsor: Biosplice Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-13
Primary completion date: 2020-12-22
Completion date: 2020-12-22
Clinical trial NCT03244059: Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
Official title: Proof-of-concept Randomized, Double-blind, Phase IIa Study to Show Feasibility, Validate Assays and Approaches, and Explore Dosing and Safety of Belimumab in Pulmonary Emphysema Patients
Acronym: BOTEGA
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-09
Primary completion date: 2022-04-01
Completion date: 2022-04-01
Plan to share individual participant data: NO
Clinical trial NCT04472728: Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients
Official title: Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients
Acronym: COVA
Sponsor: Biophytis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Lack of eligible patients due to lower number of Covid-19 cases in all involved sites.
Enrollment: 238.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-26
Primary completion date: 2022-06-06
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT01244737: FLT-PET Imaging of Brain Tumors in Children
Official title: Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
Sponsor: Boston Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 50.0 (ACTUAL)
Number of arms: 3.0
Start date: 2010-10-31
Primary completion date: 2023-02-05
Completion date: 2023-02-05
Limitations and caveats: Arm 3: Despite much recruitment effort, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.
Plan to share individual participant data: NO
IPD sharing description: No current plans to share individual participant data
Clinical trial NCT04005170: Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer
Official title: A Phase II Trial of Combination of Toripalimab and Definitive Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-25
Primary completion date: 2020-12-31
Completion date: 2022-07-31
Plan to share individual participant data: NO
Clinical trial NCT04452643: Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to COVID-19 Infection in Healthcare Personnel
Official title: Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial on the Efficacy of BACMUNE (MV130) in the Prevention of Disease Due to SARS-CoV-2 Infection in Healthcare Personnel
Acronym: Bacmune
Sponsor: Inmunotek S.L. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Not authorized by Cofepris (Mexico Competent Regulatory Authority)
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04026568: A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma
Official title: A Single Dose Pharmaco-Diagnostic for Peripheral Nerve Continuity After Trauma
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Study investigator left Institution
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-17
Primary completion date: 2022-07-18
Completion date: 2022-07-18
Baseline population: Subject enrolled from Orthopaedic Trauma service for traumatic peripheral nerve injury.
Limitations and caveats: The study was terminated early due to lack of funding and the investigator and IND holder leaving the institution.
Plan to share individual participant data: NO
IPD sharing description: The results include both subjective and objective measures. Subjective measures will not be hidden from patients given the nature of measurements. Active discussion of objective measures will wait until final follow up at 20 weeks. Patients can use their subjective assessments in their standard-of-care treatment decisions and with their doctors. Investigators will not inform other physicians except at the consent of patients. Objective test results will not be discussed with treating physicians until 20 weeks. If a patient wants further surgical exploration of an injured peripheral nerve based on subjective return of function (or lack) with members of the study team, a patient conference will be arranged with ethicist and DSMB (Data Safety Monitoring Board). The patient's decision in conjunction with the treating surgeon (not on study team to avoid any conflicts) is to be paramount. Unblinding will also be discussed then with the DSMB.
Clinical trial NCT01770340: Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
Official title: Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
Sponsor: Kantonsspital Winterthur KSW (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-01-31
Primary completion date: 2017-04-30
Completion date: 2020-07-01
Clinical trial NCT03951649: Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Official title: Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-10
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT05674448: A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection
Official title: An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection
Sponsor: Huahui Health (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.
Enrollment: 9.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-11
Primary completion date: 2022-07-25
Completion date: 2023-01-04
Clinical trial NCT02494570: A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
Official title: A Phase 2 Multi-center Investigation of Efficacy of ABI-009 (Nab-sirolimus) in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (PEComa)
Acronym: AMPECT
Sponsor: Aadi Bioscience, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-10-31
Primary completion date: 2021-11-30
Completion date: 2022-04-30
Baseline population: Safety Analysis Set: patients treated with nab-sirolimus (N = 34)
Clinical trial NCT03244358: Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Official title: Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficulty accruing subjects the study accrual was closed
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-01
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Plan to share individual participant data: NO