chufangao/CTO huggingface dataset:
Clinical trial NCT03632642: Penicillin Against Flucloxacillin Treatment Evaluation
Official title: Pilot Randomised Controlled Trial of Penicillin Versus Flucloxacillin for Definitive Treatment of Invasive Penicillin Susceptible Staphylococcus Aureus
Acronym: PANFLUTE
Sponsor: The University of Queensland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study never commenced
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-01
Primary completion date: 2019-12-31
Completion date: 2020-07-31
Plan to share individual participant data: UNDECIDED
IPD sharing description: As this study is a feasibility pilot study of a planned definitive RCT, it is likely that IPD will be made available to future potential collaborators on a definitive study in order to determine the feasibility, calculate an appropriate sample size and determine if any changes are required to the study protocol and SAP in particular.
Clinical trial NCT02684487: Vitamin D Status in Patients With Severe Sepsis
Official title: Vitamin D Status in Patients With Severe Sepsis: A Randomized Clinical Trial
Acronym: ViDISS
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: PI left institution. Protocol not submitted to IRB, contract not executed, and study was not done.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-31
Primary completion date: 2022-07-31
Completion date: 2022-12-31
Plan to share individual participant data: YES
Clinical trial NCT05442775: A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
Official title: A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
Sponsor: Cytokinetics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The DMC recommended the trial be discontinued due to futility following a planned second interim analysis of the parent trial (CY 5031).
Enrollment: 71.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-04
Primary completion date: 2023-06-07
Completion date: 2023-06-07
Baseline population: Full Analysis Set
Limitations and caveats: Based on interim analysis results of the Phase 3 parent trial CY 5031 which met the criteria for futility in participants with ALS, CY 5032 was prematurely terminated on 31 March 2023.
Clinical trial NCT05082831: Human ECM Implanted Within Microfracture Interstices & the Cartilage Defect in the Knee to Regenerate Hyaline Cartilage
Official title: A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Human Extracellular Matrix Implanted in the Bone Interstices & the Cartilage Defect Following Arthroscopic Microfracture Surgery in the Knee,in Comparison to Microfracture Surgery Alone
Acronym: hECM;HST003
Sponsor: Histogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Difficulty in enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-11-15
Primary completion date: 2022-12-16
Completion date: 2023-01-16
Plan to share individual participant data: NO
Clinical trial NCT03248843: A Study of PD-L1 Antibody KN035 in Japanese Subjects With Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I, Open Label, Dose Escalation Study of The Safety and Pharmacokinetics of Anti-PD-L1 Monoclonal Antibody KN035 Administered in Subcutaneous Injection as A Single Agent to Japanese Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor: 3D Medicines (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-09-15
Primary completion date: 2020-03-31
Completion date: 2020-03-31
Plan to share individual participant data: NO
Clinical trial NCT04152382: A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis
Official title: A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated due to liver findings
Enrollment: 30.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-11-20
Primary completion date: 2022-02-09
Completion date: 2022-02-09
Plan to share individual participant data: NO
Clinical trial NCT02180672: Steroids for Pediatric Apnea Research in Kids
Official title: Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
Acronym: SPARK
Sponsor: Children's Hospital of Philadelphia (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 211.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-09-30
Primary completion date: 2019-12-30
Completion date: 2021-10-30
Clinical trial NCT05413330: Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
Official title: Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial
Sponsor: Damascus University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 73.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-12
Primary completion date: 2022-01-05
Completion date: 2022-03-29
Plan to share individual participant data: NO
Clinical trial NCT04704843: A Study of Guselkumab in Adult Participants With Celiac Disease
Official title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Response of Guselkumab in Adult Participants With Celiac Disease
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study terminated. Sponsor decision.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-17
Primary completion date: 2021-09-13
Completion date: 2021-09-13
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 NCT04843852: TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
Official title: Augmentation of Humoral Immunity Using Toll-Like Receptor (TLR) 9 Adjuvanted HBV Surface Antigen to Enhance Anti-HBSAg Response
Acronym: BOOST-9
Sponsor: University of Maryland, Baltimore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study not implemented
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-31
Primary completion date: 2023-12-31
Completion date: 2024-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02808650: Prexasertib in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors
Official title: A Phase 1 Study of LY2606368 (Prexasertib Mesylate Monohydrate) a CHK1/2 Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-27
Primary completion date: 2019-12-31
Completion date: 2021-03-31
Clinical trial NCT04856891: A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies
Acronym: EoDyssey
Sponsor: Allakos Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 94.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-20
Primary completion date: 2022-06-14
Completion date: 2023-01-09
Plan to share individual participant data: NO
Clinical trial NCT02673229: Comparison of Collagenase With Antibiotic Ointment of Minor Partial Thickness Burns
Official title: Comparison of Collagenase Santyl Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns
Sponsor: University of Kansas Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: slow enrollment due to cost of medication and conflict of interest enrolling uninsured patients
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-09-30
Primary completion date: 2018-12-27
Completion date: 2020-03-30
Baseline population: This is descriptive statistics on the demographic information for each group, the bacitracin group and the santyl group.
Clinical trial NCT03416374: A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy
Official title: An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-02-18
Primary completion date: 2021-05-28
Completion date: 2021-05-28
Baseline population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03660345: PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
Official title: Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema
Sponsor: Rush Eye Associates (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-04
Primary completion date: 2021-05-04
Completion date: 2021-05-04
Plan to share individual participant data: NO
Clinical trial NCT03161093: A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Official title: A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Acronym: FACT OA1
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3307.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-08-17
Primary completion date: 2019-09-09
Completion date: 2021-08-27
Clinical trial NCT04907851: A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)
Official title: A Modular, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy and Safety of RXC004, in Patients With Advanced Solid Tumours That Have Progressed Following Therapy With Current Standard of Care
Acronym: KEYNOTE-E86
Sponsor: Redx Pharma Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 45.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-10
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: NO
Clinical trial NCT02160782: Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
Official title: Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001 (Maralixibat), an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome
Acronym: ICONIC
Sponsor: Mirum Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-10-28
Primary completion date: 2020-05-28
Completion date: 2020-05-28
Limitations and caveats: Limitations of the trial such as small numbers of subjects analyzed or technical problems leading to unreliable data.
Plan to share individual participant data: NO
Clinical trial NCT05933070: A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML
Official title: A Phase I Open-Label Dose Escalation Study Of Intravenous INKmune In Patients With Myelodysplastic Syndrome With Excess Blasts (MDS-EB-1/2 - MDS-CMML 1/2) Or Acute Myeloid Leukaemia (AML)
Acronym: LAUREL
Sponsor: Inmune Bio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow/low Enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-15
Primary completion date: 2024-03-28
Completion date: 2024-04-26
Plan to share individual participant data: NO
Clinical trial NCT04780581: Glucocorticoid Therapy in Coronavirus Disease COVID-19 Patients
Official title: MP3-pulses-COVID-19. Methylprednisolone Pulses Versus Dexamethasone According RECOVERY Protocol in Patients With Pneumonia Due to SARS-COV-2 Coronavirus Infection
Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Impossibility of reaching the sample size established by protocol
Enrollment: 127.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-01
Primary completion date: 2021-11-09
Completion date: 2021-11-09
Plan to share individual participant data: NO
Clinical trial NCT03198143: Effect of Ghrelin on Decision-Making
Official title: Effect of Ghrelin on Nutritional and Financial Decision-Making
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI leaving institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-31
Primary completion date: 2021-02-28
Completion date: 2022-02-28
Plan to share individual participant data: NO
Clinical trial NCT04343651: Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate COVID-19
Official title: A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
Sponsor: CytoDyn, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 86.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-01
Primary completion date: 2020-07-21
Completion date: 2021-09-20
Baseline population: The Modified Intent-to-Treat (mITT) population is defined as the set of subjects who have received at least one dose of leronlimab or placebo and is population used for the analysis of efficacy parameters or measurements.~The Safety Population includes all subjects who received at least one dose of leronlimab or placebo. This population was used for the analysis of safety parameters or measurements. There were 84 subjects in the MITT and Safety Population.
Plan to share individual participant data: NO
Clinical trial NCT03367871: Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
Official title: Phase II Single Arm Study of Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Recurrent, Persistent, or Metastatic Cervical Cancer
Sponsor: University of Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator left institution
Enrollment: 17.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-09-06
Primary completion date: 2023-01-30
Completion date: 2023-01-30
Plan to share individual participant data: NO
Clinical trial NCT03048461: The Effect of Platelet-rich Plasma in Subjects With Androgenetic Alopecia
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Investigating the Effect of Autologous Platelet-rich Plasma in Subjects With Androgenetic Alopecia.
Sponsor: Northwestern University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Did not want to enroll and proceed with this study concept.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-30
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT03109795: Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System
Official title: Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System
Acronym: ATLAS
Sponsor: University of Iowa (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding ended
Enrollment: 35.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-10
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Baseline population: Study was terminated before any participants were randomized
Limitations and caveats: Study was terminated before any participants were randomized because of lack of funding.
Plan to share individual participant data: NO
Clinical trial NCT04531592: Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients
Official title: Evaluation of Valproic Acid (VPA) as Adjunctive Therapy for Liver Transplant Patients With Moderate to Severe Hemorrhage at Risk of Ischemia Reperfusion (I/R) Injury
Sponsor: Westat (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study terminated by the Sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-31
Primary completion date: 2023-06-30
Completion date: 2023-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05011396: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
Official title: A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)
Acronym: Palisade-2
Sponsor: VistaGen Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study stopped by the sponsor for business reasons and not due to any safety concerns with PH94B
Enrollment: 324.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-30
Primary completion date: 2022-08-16
Completion date: 2022-08-16
Clinical trial NCT03809897: Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
Official title: An Effectiveness and Safety Study of Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders
Sponsor: Hospital Universitari Vall d'Hebron Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Budget not sufficient to cover the study scope proposed and recruitment rates expected to be no sufficient.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-31
Primary completion date: 2020-04-30
Completion date: 2020-04-30
Clinical trial NCT03452839: Bolus Versus Continuous Infusion of Meropenem
Official title: Continuous Infusion Versus Intermittent Administration of Meropenem in Critically Ill Patients: A Multicenter Randomized Double Blind Trial
Acronym: MERCY
Sponsor: Università Vita-Salute San Raffaele (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 607.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-05
Primary completion date: 2022-10-01
Completion date: 2022-12-01
Clinical trial NCT02319369: Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
Official title: A Phase 1 Study of Milademetan (DS 3032b), an Oral MDM2 Inhibitor, In Dose Escalation as a Single Agent and In Dose Escalation/Expansion In Combination With 5 Azacitidine In Subjects With Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated based on a business decision by the Sponsor.
Enrollment: 74.0 (ACTUAL)
Number of arms: 5.0
Start date: 2014-11-25
Primary completion date: 2020-08-21
Completion date: 2020-08-21
Baseline population: Baseline demographics were assessed in the Enrolled Analysis Set.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.