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Safety of Empagliflozin: An Individual Participant-Level Data Meta-Analysis from Four Large Trials
IntroductionEmpagliflozin is a sodium-glucose co-transporter-2 inhibitor used to treat type 2 diabetes (T2D) to improve glycemic control, reduce risk...
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Efficacy and safety of the orthopaedic manipulation techniques of the Lin School of Lingnan Region in the treatment of adolescent idiopathic scoliosis: protocol of a participant-and-assessor-blinded randomized controlled study
BackgroundAdolescent idiopathic scoliosis (AIS) is the most common developmental spine disorder among children. It is characterized by a lateral...
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Centring participant experience: a realist evaluation of a menstruator-friendly facility design project in a refugee settlement, Lebanon
IntroductionMenstrual health in humanitarian contexts is a neglected topic. Its taboo nature presents difficulties for participants in menstrual...
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Influence of Participant Perceptions of Adherence-Related Interactions with Study/Study Team on Drug Levels: HPTN069 Analysis of Self-Reported Adherence Experiences While on Study
Adherence to HIV pre-exposure prophylaxis (PrEP) study drug is critical for safety, tolerability, and efficacy trials, and may be affected by how...
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Impact of Participant Characteristics on Clinical Outcomes with iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of SPARTA Japan
IntroductionThe real-world SPARTA Japan study confirmed the effectiveness and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus...
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Overlap** research efforts in a global pandemic: a rapid systematic review of COVID-19-related individual participant data meta-analyses
BackgroundIndividual participant data meta-analyses (IPD-MAs), which involve harmonising and analysing participant-level data from related studies,...
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Patient Experiences Completing Patient Reported Outcome Measures in Behavioral Health Within a Health Safety-Net Setting
Measurement based care (MBC), a practice that uses patient reported outcome measures (PROMs), is not widely used in behavioral health settings and...
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Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool
BackgroundPatient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and...
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Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion
Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical...
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The optimal second-line therapy for older adults with type 2 diabetes mellitus: protocol for a systematic review and network meta-analysis using individual participant data (IPD)
BackgroundDue to increasing life expectancy, almost half of people with type 2 diabetes are aged 65 years or over worldwide. When metformin alone...
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Intravenous nicardipine for Japanese patients with acute intracerebral hemorrhage: an individual participant data analysis
The effects of acute systolic blood pressure levels achieved with continuous intravenous administration of nicardipine for Japanese patients with...
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Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols
BackgroundRetaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure...
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Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis
BackgroundThe factors which influence participant retention in paediatric randomised controlled trials are under-researched. Retention may be more...
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How do study design features and participant characteristics influence willingness to participate in clinical trials? Results from a choice experiment
BackgroundResearch about the decision to participate in a clinical study has tended to be limited to single indications and has focused on narrow...
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The Cure SMA Clinical Trial Experience Survey: A Study of Trial Participant Perspectives on Clinical Trial Management and Patient-Centric Management Practices
IntroductionUnderstanding clinical trial experiences can illuminate opportunities to optimize trial design and management, with potential benefits...
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Effect of Renal Impairment on Pharmacokinetics and Safety of Ensitrelvir, a SARS-CoV-2 3CL Protease Inhibitor
IntroductionEnsitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2, shows efficacy and safety in participants with mild to moderate...
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Laparoscopic versus open gastrectomy for nonmetastatic T4a gastric cancer: a meta-analysis of reconstructed individual participant data from propensity score-matched studies
BackgroundThe applicability of laparoscopy to nonmetastatic T4a patients with gastric cancer remains unclear due to the lack of high-quality...
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Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN study
BackgroundThe SCHUMANN study evaluated the efficacy and safety of the selective P2 × 3 antagonist eliapixant in patients with...
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Characteristics Associated with Participant Attrition and Retention in a Perinatal Home Visiting Program
Using data from the Florida Maternal, Infant, and Early Childhood Home Visiting (MIECHV) funded programs, we examined program- and participant-level...
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Assessing the safety of physical rehabilitation in critically ill patients: a Delphi study
BackgroundPhysical rehabilitation of critically ill patients is implemented to improve physical outcomes from an intensive care stay. However, before...