chufangao/CTO huggingface dataset:
Clinical trial NCT03992846: Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
Official title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.
Sponsor: Kissei Pharmaceutical Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 486.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-13
Primary completion date: 2021-10-18
Completion date: 2022-04-01
Plan to share individual participant data: NO
Clinical trial NCT04668209: Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
Official title: Phase II, Randomized, Investigator Initiated Trial to Evaluate Safety and to Explore Clinical Benefit of Silmitasertib (CX-4945) in Patients With Severe Coronavirus Disease 2019 (COVID-19)
Acronym: CX4945
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-21
Primary completion date: 2022-06-30
Completion date: 2022-10-19
Limitations and caveats: After 15 months of active enrollment and a lack of qualifying hospitalized COVID-19 patients, the Sponsor-Investigator, Marilyn Csete Glassberg, MD, decided to terminate recruitment before meeting the stated enrollment objectives.
Plan to share individual participant data: NO
IPD sharing description: Study results will be published on clinicaltrials.gov.
Clinical trial NCT04147260: Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin
Official title: Partially-blind, Randomized, Parallel Group, Placebo and Active Comparator-controlled Phase I Clinical Trial to Evaluate the Photosensitivity Potential of BI 730357
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 85.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-11-06
Primary completion date: 2020-09-09
Completion date: 2020-09-09
Baseline population: Treated Set (TS): The TS included all subjects who were randomized and treated with at least 1 dose of investigational product (IP) (BI 730357, placebo, or Ciprofloxacin). The TS was used for safety analyses.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/
Clinical trial NCT02142738: Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)
Official title: A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 305.0 (ACTUAL)
Number of arms: 6.0
Start date: 2014-08-25
Primary completion date: 2016-05-09
Completion date: 2021-05-27
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03323151: A Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
Official title: A Phase I/II Study of Ixazomib and Ibrutinib in Relapsed/Refractory Mantle Cell Lymphoma
Acronym: PrE0404
Sponsor: PrECOG, LLC. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 43.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-08-13
Primary completion date: 2022-09-22
Completion date: 2023-09-07
Baseline population: Patients with mantle cell lymphoma (MCL) that has relapsed (come back) or refractory (progressed on treatment) will receive ixazomib and ibrutinib.~Ibrutinib has been approved by the Food and Drug Administration (FDA) as treatment for patients with mantle cell lymphoma who have received at least one prior therapy.~Ixazomib is in a class of medications called proteasome inhibitors. It may help to slow down the growth of cancer or may cause cancer cells to die.
Plan to share individual participant data: NO
IPD sharing description: Data is proprietary.
Clinical trial NCT05418777: Treatment of Pneumocystis in COPD (the TOPIC Study)
Official title: Treatment of Pneumocystis in COPD (the TOPIC Study)
Sponsor: William Beaumont Hospitals (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: lack of enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-28
Primary completion date: 2022-12-19
Completion date: 2022-12-19
Baseline population: No participants were enrolled and randomized to the placebo arm
Limitations and caveats: Study was terminated due to high screen failure rate leading to low enrollment
Clinical trial NCT04039503: A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Official title: Randomized, Phase 3, Double-blind Trial Comparing the Effect of the Addition of Tirzepatide Versus Placebo in Patients With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Acronym: SURPASS-5
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 475.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-30
Primary completion date: 2020-12-22
Completion date: 2021-01-13
Baseline population: All randomized participants.
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 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 NCT04908683: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
Acronym: EVERGREEN
Sponsor: Janssen Vaccines & Prevention B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 25236.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-21
Primary completion date: 2023-07-21
Completion date: 2023-07-21
Baseline population: Baseline characteristics data were analyzed on full analysis set (FAS) which included all participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
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 NCT04305236: Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer
Official title: A Phase II Open Label Trial of Neo-Adjuvant Abemaciclib With Fulvestrant in Patients Who Develop Localized Recurrence While on Adjuvant Endocrine Therapy With Molecular Evidence of Endocrine Resistance
Sponsor: University of California, Irvine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Halted due to study funding
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-23
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Limitations and caveats: Early study termination and depleted funding lead to the small number of patients enrolled onto the study. This also contributed to the inability to analyze the primary and secondary objectives.
Clinical trial NCT05286853: A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease
Official title: A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
Sponsor: Prokidney (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-07-17
Primary completion date: 2024-09-03
Completion date: 2024-09-03
Plan to share individual participant data: NO
Clinical trial NCT04591002: Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Official title: A Phase II, Open Label, Randomized Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) in Other Lobes After Curative Resection for Actionable EGFR Mutation-positive Stage I Lung Adenocarcinoma
Sponsor: Samsung Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Further consultation is required, we plan to submit it again as a new project and proceed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-07
Primary completion date: 2020-10-07
Completion date: 2020-10-30
Clinical trial NCT05118620: Pericapsular Nerve Group Block (PENG) for Hip Surgery
Official title: Pericapsular Nerve Group Block (PENG): A Randomized, Triple-Masked, Placebo-Controlled Clinical Trial
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of staff to enroll
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-09
Primary completion date: 2022-05-31
Completion date: 2022-05-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04530838: 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY UNBLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY JAPANESE INFANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 668.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-16
Primary completion date: 2022-04-02
Completion date: 2022-04-02
Baseline population: Safety population included all the participants who received at least 1 dose of the investigational product (IP) with safety follow up after any vaccination.
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 NCT03283046: Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma
Official title: Phase 1 Study of Lenalidomide/Dexamethasone With Nivolumab and Ipilimumab in Patients With Newly Diagnosed Multiple Myeloma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Similar to another study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-31
Primary completion date: 2020-10-31
Completion date: 2020-10-31
Clinical trial NCT05076877: A Study of Lazertinib (JNJ-73841937) in Healthy Participants
Official title: A Phase 1, Open-label, Study in Healthy Participants to Evaluate the Effect of Steady State Concentrations of Lazertinib (JNJ-73841937) on the Single-dose Pharmacokinetics of Probe Substrates (Midazolam, Rosuvastatin, and Metformin)
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-17
Primary completion date: 2022-02-10
Completion date: 2022-02-10
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 NCT03389685: Can PRP Reduce Pro-Inflammatory Biomarkers Following ACL Injury
Official title: Can Platelet Rich Plasma Reduce the Level of Pro-Inflammatory Synovial Fluid Biomarkers Following an Anterior Cruciate Ligament Tear
Sponsor: NYU Langone Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: COVID-19, Lack of Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-09
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Clinical trial NCT01004978: Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Official title: A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 235.0 (ACTUAL)
Number of arms: 2.0
Start date: 2009-10-28
Primary completion date: 2021-02-11
Completion date: 2022-12-21
Baseline population: All randomized patients
Clinical trial NCT05758818: A Study of Milademetan Administration on Cardiac Repolarization in Healthy Subjects
Official title: A Randomized, Positive and Placebo-Controlled Trial to Evaluate the Effects of Milademetan Administration on Cardiac Repolarization in Healthy Subjects
Sponsor: Rain Oncology Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: sponsor decision
Enrollment: 6.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-04-17
Primary completion date: 2023-06-08
Completion date: 2023-06-08
Plan to share individual participant data: NO
Clinical trial NCT02532257: Ibrutinib in Combination With Rituximab and Lenalidomide in Treating Patients With Previously Untreated, Stage II-IV Follicular Lymphoma or Marginal Zone Lymphoma
Official title: An Open Label, Phase 2 Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 48.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-04-11
Primary completion date: 2023-08-15
Completion date: 2023-08-15
Clinical trial NCT03671720: Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden
Official title: Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden
Sponsor: Capital Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-11
Primary completion date: 2021-12-30
Completion date: 2022-12-30
Plan to share individual participant data: NO
Clinical trial NCT02374424: Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients
Official title: Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Before High-Dose Chemotherapy BEAM With Autologous Stem Cell Transplantation (ASCT)
Acronym: GIOTTO
Sponsor: Fondazione Italiana Linfomi - ETS (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Interim analysis planned as per protocol didn't provide positive outcome therefore enrollment was not reopened. However, the enrolled patients concluded therapy and continued into the follow-up phase. The study was closed only after LVLP.
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2014-11-05
Primary completion date: 2018-02-28
Completion date: 2020-06-23
Plan to share individual participant data: NO
Clinical trial NCT04697290: CD19/CD20 Dual-CAR-T in B-cell Non-Hodgkin's Lymphoma Patients.
Official title: A Study of CD19/CD20 Dual CAR-T Cells in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma(B-NHL)
Sponsor: Beijing Tsinghua Chang Gung Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: SUSPENDED 
Why stopped: Plan adjustment
Enrollment: 12.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2022-03-10
Primary completion date: 2023-03-10
Completion date: 2023-06-10
Clinical trial NCT03508804: Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion
Official title: Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Lack of funding.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-31
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT05219604: Central Nervous System Effects Following Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Official title: The Magnitude and Duration of the Central Nervous System Effects Following Intravenous Infusion of Diphenhydramine Using Pharmacokinetic and Pharmacodynamic Modeling
Sponsor: Dent Neuroscience Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Institution decision
Enrollment: 3.0 (ACTUAL)
Start date: 2022-03-15
Primary completion date: 2022-10-04
Completion date: 2022-10-04
Clinical trial NCT03902938: Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Official title: Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Sponsor: Ascension South East Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The trial was stopped as the benefit was challenging to determine in the preliminary usage.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-02
Primary completion date: 2022-07-01
Completion date: 2022-07-01
Clinical trial NCT04070157: Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain
Acronym: TAPER
Sponsor: USWM, LLC (dba US WorldMeds) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: COVID pandemic and enrollment issues necessitating an adjustment to the study design.
Enrollment: 60.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2019-08-02
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT04306393: Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19
Official title: Nitric Oxide Gas Inhalation Therapy for Mechanically Ventilated Patients With Severe Acute Respiratory Syndrome Caused by SARS-CoV2: a Randomized Clinical Trial.
Acronym: NOSARSCOVID
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-21
Primary completion date: 2021-12-21
Completion date: 2022-06-15
Plan to share individual participant data: NO
Clinical trial NCT04402723: Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML
Official title: A Dose-escalated Phase Ⅰ Trial to Assess the Tolerance and Pharmacokinetics of Combination of Donafenib and Cytarabine/Daunorubicin in Relapsed AML Patient
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Corporate policy adjustments
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-06
Primary completion date: 2022-02-09
Completion date: 2022-02-09
Clinical trial NCT05568797: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above
Official title: A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of an RSVPreF3 OA Investigational Vaccine When Co-administered With FLU aQIV (Inactivated Influenza Vaccine - Adjuvanted) in Adults Aged 65 Years and Above
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1045.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-14
Primary completion date: 2023-02-17
Completion date: 2023-07-17
Plan to share individual participant data: YES
IPD sharing description: GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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 NCT03809234: Pgp Transporter and CNS Biodistribution of Ondansetron in Healthy Volunteers
Official title: Effects of Pgp Transporter Inhibition on CNS Biodistribution of Ondansetron in Healthy Volunteers
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Adverse effects related to study procedure (not study drug)
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-20
Primary completion date: 2020-11-30
Completion date: 2020-11-30