chufangao/CTO huggingface dataset:
Clinical trial NCT03660059: A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)
Official title: A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX
Sponsor: Astellas Pharma Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 385.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-09-27
Primary completion date: 2021-04-01
Completion date: 2021-11-02
Plan to share individual participant data: YES
IPD sharing description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Clinical trial NCT02004691: Efficacy, Safety, Pharmacodynamic, and Pharmacokinetics Study of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
Official title: A Phase 2/3, Multicenter, Randomized, Double-blinded, Placebo-controlled, Repeat-dose Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Olipudase Alfa in Patients With Acid Sphingomyelinase Deficiency
Acronym: ASCEND
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-18
Primary completion date: 2021-03-15
Completion date: 2023-10-19
Baseline population: Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who had received at least 1 infusion (partial or total) and were analyzed according to the treatment arm allocated by randomization.
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 NCT05428215: Comparison of PKs of 17-Beta-Estradiol Via Sublingual Placement Versus Swallowing in Male-to-Female Transgender Patients
Official title: Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients
Sponsor: MaineHealth (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Inability to adequately recruit participants, need for additional study participants based on preliminary data collection
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-12-29
Primary completion date: 2023-07-20
Completion date: 2023-07-20
Plan to share individual participant data: NO
Clinical trial NCT03785756: Efficacy of 300 mg Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Official title: A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multiple-Dose, Active and Placebo-Controlled Efficacy Study of Ibuprofen Prolonged-Release Tablets for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Sponsor: Reckitt Benckiser Healthcare (UK) Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 280.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-29
Primary completion date: 2020-02-20
Completion date: 2020-02-28
Baseline population: One subject in the placebo group withdrew from the study before receiving the allocation intervention.
Plan to share individual participant data: NO
Clinical trial NCT04464148: Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
Official title: Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Feasibility study was not initiated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04131517: A Study to Test the Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Official title: An Open-Label, Randomized, Two-Way Crossover Study to Investigate the Potential Pharmacokinetic Interaction of Padsevonil With Oral Contraceptives in Healthy Female Participants
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on available data, UCB has decided to stop development of padsevonil as adjunctive treatment of focal-onset seizures
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-23
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Baseline population: Baseline Characteristics refer to Safety Set which included study participants who received at least 1 dose of study medication (PSL or OC). No study participants started Part 2 due to the COVID-19 pandemic. Later, the program developing PSL in focal-onset seizures was stopped and the study was terminated.
Limitations and caveats: The study was terminated on 22 May 2020 because the program developing padsevonil in focal-onset seizures was stopped.
Plan to share individual participant data: NO
IPD sharing description: Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Clinical trial NCT03553563: A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
Official title: An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-24
Primary completion date: 2022-12-27
Completion date: 2022-12-27
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 NCT03444298: A Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults
Official title: A Phase II Randomized, Double Blinded, Placebo-controlled Study of Gamma Tocopherol-enriched Supplement on Lower Airway Responses to Inhaled Wood Smoke in Healthy Adults
Acronym: SmokeyT
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-08
Primary completion date: 2023-03-02
Completion date: 2023-03-06
Plan to share individual participant data: NO
Clinical trial NCT02618109: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
Official title: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
Acronym: LABMI
Sponsor: University Hospital, Angers (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: recruitment difficulties
Enrollment: 119.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Clinical trial NCT01906073: Nasal Fentanyl for Chronic Cancer Pain
Official title: An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids
Acronym: NFCP-2
Sponsor: Norwegian University of Science and Technology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT04995497: Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery
Official title: IV vs. Erector Spinae Plane Blocks-Cardiac Surgery
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-15
Primary completion date: 2023-04-07
Completion date: 2023-04-30
Baseline population: Its the same
Limitations and caveats: Ours is a single center trial. This likely should be investigated at multiple institutions with different surgical anesthesia groups for proper validation.
Plan to share individual participant data: NO
Clinical trial NCT05264506: Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
Official title: A Phase 3, Open-label, Multi-center, Single-arm Study to Assess Contraceptive Efficacy and Safety of the Nomegestrol Acetate + 17β-estradiol Combined Oral Contraceptive (OG-8175A) in Premenopausal Females Aged 14 to 35 Years (Inclusive)
Sponsor: Organon and Co (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision to stop the study early and complete all required study close-out activities. This decision was made for business reasons unrelated to safety. None of the pre-specified efficacy endpoints were analyzed.
Enrollment: 2007.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-02-17
Primary completion date: 2024-01-12
Completion date: 2024-01-26
Clinical trial NCT04184609: Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes
Official title: Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes
Sponsor: Ohio State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding ran out before participants were enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-07-01
Primary completion date: 2023-11-03
Completion date: 2023-11-03
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share all of the individual participant data collected during the trial.
Clinical trial NCT03769090: A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
Official title: A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older With Asthma
Acronym: MANDALA
Sponsor: Bond Avillion 2 Development LP (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3132.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-12-13
Primary completion date: 2021-08-19
Completion date: 2022-02-07
Baseline population: Of the 3,132 participants randomized, the full analysis set across all ages comprises 3,127 participants as one participant was randomized and did not receive randomized study treatment, and four participants were randomized in error and did not receive randomized study treatment. These five participants have therefore been excluded from the summaries of baseline characteristics, efficacy and safety.
Plan to share individual participant data: NO
Clinical trial NCT03152409: Salicylic Augmentation in Depression
Official title: Salicylic Augmentation in Depression
Acronym: SAD
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inadequate resources to complete the study
Enrollment: 32.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-15
Primary completion date: 2021-02-16
Completion date: 2021-02-16
Limitations and caveats: In Mar. 2020 study placed on prolonged pause due to the pandemic. Research activities resumed with limitations later that year. The last study participant was screened in Feb. 2021. However, personnel departure affected study activities, so study was again paused, with plans to resume once adequate personnel were hired. However no additional support was provided. In Dec. 2022, it was decided to terminate the study when it became clear that resources would be insufficient to complete the trial.
Plan to share individual participant data: NO
Clinical trial NCT04715230: Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Official title: Meth-OD: A Phase 2a Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Acronym: Meth-OD
Sponsor: InterveXion Therapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision based on slower than anticipated enrollment leading to fund exhaustion.
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-30
Primary completion date: 2022-10-05
Completion date: 2022-11-14
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: YES
IPD sharing description: Final datasets are expected to contain IXT-m200 and METH concentration data, ACES scores over time, and safety data. No individually identifiable private information will be distributes.
IPD time frame: These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.
IPD access criteria: These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com
Clinical trial NCT04351230: T-DM1 With or Without Abemaciclib for the Treatment of HER2-Positive Metastatic Breast Cancer
Official title: Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: There are no patients enrolled on this study and all efforts are being discontinued
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-11
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Clinical trial NCT02683213: Efficacy of Fluoxetine - a Trial in Stroke
Official title: Establishing the Effect(s) and Safety of Fluoxetine Initiated in the Acute Phase of Stroke
Acronym: EFFECTS
Sponsor: Karolinska Institutet (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1500.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-20
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: YES
IPD sharing description: Three trial investigator teams have collaboratively developed a core protocol for Fluoxetine after stroke. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients.
Clinical trial NCT04225897: A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
Official title: A Phase 2 Open-Label Study in Infants With REspiratory Syncytial VIRus Lower RespirAtory Tract Infection, Followed by a DoubLe-blind, Placebocontrolled Part, to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Effect of RV521 (REVIRAL 1)
Acronym: REVIRAL 1
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Part A and Part B were completed but Pfizer terminated Part C due to strategic consideration. There were no safety concerns in the decision to stop Part C and no changes to the risk-benefit for participants who received RV521 in the study.
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-11-13
Primary completion date: 2022-12-05
Completion date: 2022-12-05
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04854096: Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis
Official title: A Phase 2b, Open-label, Multicenter, Randomized, Controlled, 2-Arm Study to Assess the Efficacy and Safety of Orally Administered NS-018 Versus Best Available Therapy in Subjects With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)
Sponsor: NS Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was stopped due to a business decision.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-31
Primary completion date: 2024-05-16
Completion date: 2024-05-16
Plan to share individual participant data: NO
IPD sharing description: Submission to the FDA
Clinical trial NCT03696342: Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
Official title: Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
Acronym: PRO-157
Sponsor: Laboratorios Sophia S.A de C.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor's convenience
Enrollment: 46.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-01
Primary completion date: 2020-03-24
Completion date: 2020-03-24
Limitations and caveats: This trial was terminated early due to the sponsor's convenience in the pipeline followed by the studied product. A small sample renders this results as merely descriptive.
Clinical trial NCT02410772: TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
Official title: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial. TBTC Study 31, ACTG Study A5349
Acronym: S31/A5349
Sponsor: Centers for Disease Control and Prevention (FED)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2516.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-01-25
Primary completion date: 2020-07-31
Completion date: 2021-05-31
Baseline population: Baseline Population Description: The population is the Microbiologically eligible population that included the randomized participants excluding the ones with no evidence of cultures positive for M. tuberculosis, or with resistance to one or more of isoniazid, rifampin or fluoroquinolones, or are enrolled in violation of eligibility criteria
Limitations and caveats: A study limitation is that placebos were not used, and therefore neither participants nor site staff were blinded to treatment assignment. Another limitation is that only 8% of participants were HIV-coinfected, limiting the power to compare regimens in this important population
Plan to share individual participant data: YES
IPD sharing description: Data being collected in CDISC format.
Clinical trial NCT03059147: Phase 1 Study of SF1126 in Combination With Nivolumab in Patients With Advanced Hepatocellular Carcinoma
Official title: A Phase I Study of SF1126, a Dual PI3 Kinase and Bromodomain Inhibitor, in Combination With Nivolumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A-B7 Cirrhosis
Sponsor: SignalRX Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of recruitment and sponsor's priority changes
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-27
Primary completion date: 2019-04-22
Completion date: 2020-06-29
Plan to share individual participant data: NO
Clinical trial NCT05053035: A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in C9orf72-Associated Amyotrophic Lateral Sclerosis
Sponsor: Alector Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor is considering a subsequent study in ALS, potentially with different inclusion/exclusion criteria.
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-02
Primary completion date: 2022-10-28
Completion date: 2022-10-28