chufangao/CTO huggingface dataset:
Clinical trial NCT04385849: Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19
Official title: Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-22
Primary completion date: 2020-07-25
Completion date: 2020-07-25
Baseline population: No subjects were enrolled in the Placebo arm.
Limitations and caveats: The study is terminated early due to low enrollment. Effect of the study drug on efficacy was not analyzed.
Plan to share individual participant data: NO
Clinical trial NCT04049578: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children With Autism Spectrum Disorder
Official title: A Phase Ib, Multicenter, Open-Label, 6-Week Study With a 48-Week Extension to Investigate the Pharmacokinetics, Safety, and Tolerability of Balovaptan in Children Ages 2-4 Years With Autism Spectrum Disorder
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Recent analysis of Phase II balovaptan data in paediatric ASD did not support the continuation of this study. No new safety concerns were identified.
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-19
Primary completion date: 2020-04-23
Completion date: 2020-05-06
Limitations and caveats: Study was terminated with 2 participants enrolled. Due to low enrollment number patient analysis are not provided to protect participant confidentiality.
Plan to share individual participant data: NO
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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 NCT03191526: A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)
Official title: A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)
Sponsor: Kyowa Kirin Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to not achieving the primary outcome.
Enrollment: 66.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-22
Primary completion date: 2019-06-06
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT04327999: Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
Official title: Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma
Sponsor: Vanderbilt-Ingram Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Funding ended
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-05
Primary completion date: 2023-09-25
Completion date: 2023-09-25
Clinical trial NCT04794790: Buprenorphine Induction for Fentanyl Dependent Opioid Users
Official title: Pilot Study to Look at Feasibility of Testing and Treatment of Combination Fentanyl and Opioid Dependent Individuals With Different Buprenorphine Induction Methods
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Unable to enroll--patients uninterested in trying buprenorphine.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-05-09
Primary completion date: 2024-02-22
Completion date: 2024-06-22
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05126927: A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors
Official title: A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.
Sponsor: SmartNuclide Biopharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-02
Primary completion date: 2022-01-19
Completion date: 2022-08-01
Plan to share individual participant data: NO
Clinical trial NCT04422210: A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Official title: A Phase Ib Dose-Escalation and Dose-Expansion Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Patients With Untreated Extensive-Stage Small Cell Lung Cancer.
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the GO41864 study.
Enrollment: 2.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-09-22
Primary completion date: 2020-11-06
Completion date: 2020-11-06
Baseline population: The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Limitations and caveats: The study was terminated by the Sponsor. Only 2 participants were enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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 NCT03917719: An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
Official title: An Open-Label Extension Study of Edasalonexent in Pediatric Patients With Duchenne Muscular Dystrophy
Acronym: GalaxyDMD
Sponsor: Catabasis Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Phase 3 PolarisDMD trial did not meet the primary endpoint. As a result, activities related to the development of edasalonexent have stopped including the CAT-1004-302 Open-Label Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
Enrollment: 130.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-14
Primary completion date: 2020-10-26
Completion date: 2020-10-26
Clinical trial NCT01996098: Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation
Official title: A Multicenter, Randomized, Phase III Trial of Chemotherapy Followed by 6-month or 12-month Icotinib Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA Non-small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutation
Acronym: ICTAN
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Slow accural.
Enrollment: 251.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-01-01
Primary completion date: 2021-12-31
Completion date: 2024-02-15
Clinical trial NCT05610254: The Cold Fluids Study
Official title: Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-24
Primary completion date: 2022-12-03
Completion date: 2022-12-03
Plan to share individual participant data: NO
Clinical trial NCT05653427: A Study of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
Official title: A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Amivantamab Monotherapy in Participants With Previously Treated Advanced Hepatocellular Carcinoma
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: N\~15 subjects data analysis did not meet statistical consideration of ORR and study primary/secondary objectives were not met. Enrollment was terminated for futility
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-12-08
Primary completion date: 2023-10-10
Completion date: 2023-10-10
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT03419806: Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease
Official title: Levodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa
Acronym: IPO-001
Sponsor: Vastra Gotaland Region (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-02-16
Primary completion date: 2020-03-27
Completion date: 2020-04-20
Plan to share individual participant data: NO
Clinical trial NCT03739476: Clinical Trial With Quetiapine Prophylaxis Postoperative Delirium in High Risk Surgical Patients
Official title: Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine
Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.
Enrollment: 50.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-13
Primary completion date: 2020-04-02
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT03979638: A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)
Acronym: RELIEF
Sponsor: Bellus Health Inc. - a GSK company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial was terminated due to the impact of the COVID-19 on trial activities. 68 patients with refractory chronic cough were enrolled with 52 completing treatment
Enrollment: 68.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-10
Primary completion date: 2020-04-23
Completion date: 2020-04-23
Baseline population: The baseline analysis population consisted of all randomized participants who have received at least 1 dose of study drug.
Clinical trial NCT03871517: INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
Official title: INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
Sponsor: Beijing Tiantan Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 5438.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-03
Primary completion date: 2022-03-01
Completion date: 2022-12-01
Plan to share individual participant data: NO
Clinical trial NCT03745196: The Effect of PC945 on Aspergillus or Candida Lung Infections in Patients With Asthma or Chronic Respiratory Diseases
Official title: A Double-blind, Placebo-controlled Study to Assess the Effects of Inhaled PC945 in the Treatment of Culture-positive Aspergillus or Candida Fungal Bronchitis in Subjects With Moderate to Severe Asthma or Other Chronic Respiratory Diseases.
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: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-15
Primary completion date: 2020-06-01
Completion date: 2020-06-01
Clinical trial NCT03436433: Seizure Prophylaxis in Patients With Glioma or Brain Metastasis
Official title: Phase II Trial of Seizure Prophylaxis in Brain Tumor Patients Undergoing Neurosurgical Procedure
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Did not enroll as planned
Enrollment: 4.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-31
Primary completion date: 2020-12-04
Completion date: 2020-12-04
Limitations and caveats: This study was limited by the small sample size, and a dataset with a larger sample size should be used to further evaluate the impact of LCM, LEV, and no antiepileptic drugs on adverse events, ED visits and hospital readmissions in the future.
Plan to share individual participant data: NO
Clinical trial NCT05120960: A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors
Official title: A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: 0 participant accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-02-27
Primary completion date: 2024-04-12
Completion date: 2024-04-12
Clinical trial NCT03712371: Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
Official title: Phase 1b/2 Study of Chitosan for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients
Sponsor: Medical University of South Carolina (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Interim study results were not favorable to continue with further enrollment.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-16
Primary completion date: 2020-07-02
Completion date: 2021-09-07
Plan to share individual participant data: NO
Clinical trial NCT03911336: Harnessing Chronomodulation to Enhance Osteogenesis
Official title: Harnessing Chronomodulation to Enhance Osteogenesis - A Pilot Randomized Controlled Trial -
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Decided not to proceed
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-01-01
Primary completion date: 2023-01-01
Completion date: 2023-01-01
Plan to share individual participant data: NO
Clinical trial NCT04736602: Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
Official title: An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 3-month Formulation in Chinese Children With Central Precocious Puberty
Sponsor: Ipsen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-27
Primary completion date: 2022-02-09
Completion date: 2022-09-03
Baseline population: Intention-To-Treat (ITT) population consisted of all participants who received at least 1 dose of study medication.
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, annotated 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 study participants.~Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
IPD time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
IPD access criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Clinical trial NCT05744115: Ga-68-PSMA-11 in Men With Prostate Cancer
Official title: Utility of Ga-68-PSMA-11 in Management of Prostate Cancer
Acronym: Ga68-PSMA-11
Sponsor: Harry S. Truman Memorial Veterans' Hospital (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The investigational product was approved by the FDA (12/20/2021) and is now commercially available
Enrollment: 38.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-27
Primary completion date: 2022-04-14
Completion date: 2022-04-14
Plan to share individual participant data: YES
IPD sharing description: A de-identified, anonymized dataset will be prepared to share with other VA investigators upon request
Clinical trial NCT04148105: Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Official title: Efficacy and Safety of Cilostazol-Nimodipine Combined Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
Sponsor: Ascension South East Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Insufficient recruitment
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-01
Primary completion date: 2023-05-21
Completion date: 2023-05-26
Plan to share individual participant data: YES
IPD sharing description: All of the individual participant data collected during the trial, after deidentification will be made available following publication upon request at the discretion of the principal investigator.
Clinical trial NCT04253236: To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
Official title: A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for the Treatment of Patients With Warm Autoimmune Hemolytic Anemia
Acronym: ASCEND-WAIHA
Sponsor: Immunovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-11
Primary completion date: 2021-04-01
Completion date: 2021-04-01
Baseline population: Safety Population: all participants who received at least one dose of study treatment. Only data for Cohort 1 is presented as study was terminated early prior to completion of dosing all participants in Cohort 1 and and Cohort 2 was not initiated.
Clinical trial NCT04944901: 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
Official title: Randomized, Double-blind, Placebo-controlled, 28-Day Daily-dose Crossover Study of the Safety and Tolerability of SB-121 (Lactobacillus Reuteri With Sephadex® and Maltose) in Subjects, Ages 15 to 45 Years, Diagnosed With Autistic Disorder
Sponsor: Scioto Biosciences, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-02
Primary completion date: 2022-03-03
Completion date: 2022-03-03
Plan to share individual participant data: NO
Clinical trial NCT01742338: Dose of Corticosteroids in COPD
Official title: Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study
Acronym: DOSE
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of research staff to recruit participants
Enrollment: 89.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-05-03
Primary completion date: 2020-03-15
Completion date: 2020-03-15
Clinical trial NCT03663283: Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty
Official title: Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2020-02-14
Completion date: 2020-02-14
Clinical trial NCT03437200: Combination of Chemoradiation With Immunotherapy in Inoperable œsophageal Cancer
Official title: Phase II Trial in Inoperable œsophageal Cancer Evaluating the Feasibility of the Combination of Definitive Chemoradiation With the Immune Checkpoint Blockers Nivolumab +/- Ipilimumab
Acronym: CRUCIAL
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-17
Primary completion date: 2022-10-07
Completion date: 2022-10-07