Trials

The terms personalized, individualized and precision medicine are increasingly used to describe health interventions, yet their operational meaning in clinical research remains unclear. Despite extensive conceptual discussion, there is limited empirical evidence on how these labels are applied in randomized controlled trials (RCTs) and whether such trials meet standards of transparency and methodological rigor. We systematically examined 262 RCTs published between 2020 and 2022 that used the ter...

BackgroundClinical research coordinators play a crucial role in ensuring the scientific rigor, regulatory compliance, and operational integrity of clinical trials. However, in Africa, they often lack access to structured, competency-based training, especially in operational, regulatory, and trial management domains. This study evaluated the effectiveness of a comprehensive training intervention designed to standardize and enhance core competencies of clinical trial coordinators. MethodsWe condu...

BackgroundThe FACE-Q Skin Cancer Module is a condition-specific patient-reported outcome measure for facial skin cancer. While its psychometric properties have been established, normative reference values that enable score interpretation in clinical practice and research are lacking. ObjectiveTo establish normative reference values for the FACE-Q Skin Cancer Module using preoperative patient data and to validate these values by comparison with a demographically matched cohort of healthy partner...

BackgroundAdapted dance is a promising rehabilitation intervention for physical and psychosocial impairments in people with chronic stroke. However, in-person attendance is hindered by limited community ambulation, transportation, and schedule conflicts. At-home participation with a live-streamed dance program could address these issues, but psychosocial benefits may be diminished because of reduced social interactions. The primary objective of this study was to assess the feasibility and safety...

BackgroundMedical students represent a critical population for photoprotection education, as future physicians responsible for skin cancer prevention counseling. However, no previous studies have characterized knowledge, attitudes, and practices (KAP) regarding photoprotection among medical students in Central America or the Caribbean. ObjectiveTo assess KAP related to photoprotection and identify associated factors among medical students at a Nicaraguan university. MethodsA cross-sectional st...

Aims/hypothesisTo investigate the feasibility and preliminary efficacy of a 12-week remotely-delivered exercise snacks (ES) intervention in adults with type 2 diabetes. MethodsInsufficiently active adults with type 2 diabetes (N=69; 46 females; mean age {+/-} SD: 58{+/-}11 years) were randomized to an ES or mobility/stretching comparator group (CON), which involved 4 x 1-min bouts of either vigorous or low intensity exercise, respectively, on [≥]5 days/week. The primary outcome was feasibili...

Frequent blood testing is a routine but burdensome reality for many children, particularly those with chronic, rare, or medically complex conditions. Repeated clinic, hospital, and laboratory visits can disrupt family life, increase stress for children and caregivers, and limit access to timely monitoring and research participation. Despite advances in pediatric care, blood collection has remained largely tethered to in-person clinical settings. This study validates a new model: safe, effective,...

ObjectivesTo estimate potential launch prices of generic semaglutide following patent expiry from 2026 and to quantify the global obesity and type 2 diabetes (T2DM) burden in countries where generic access may become possible. MethodsWe used World Bank population data and World Obesity and Diabetes Atlas prevalence estimates to calculate obesity and T2DM burden in countries where semaglutide patents expire in 2026 or were not filed. Patent status was identified using MedsPaL and cross-checked w...

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhase 3 of...

BackgroundBiomedical Large Language Models (LLMs) combined with prompt engineering offer domain-specific reasoning, yet their application to individual-level causality assessment remains unexplored. This study evaluated five combinations of biomedical LLMs, prompting strategies, and causality algorithms by comparing their agreement with two human expert evaluators. Research design and methodsA total of 150 Individual Case Safety Reports (ICSRs) were analyzed: 140 reports from Food and Drug Admi...

ObjectiveDespite substantial variability in the severity of post-anoxic encephalopathy, all comatose patients after cardiac arrest are usually treated according to the same standardized intensive care protocol, including sedation, mechanical ventilation, and targeted temperature management (TTM). We hypothesize that patients with a favourable EEG pattern (continuous EEG within 12 hours after cardiac arrest) may not benefit from prolonged sedation and TTM. We studied the feasibility and safety of...

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhase 4 of...

Cryopreservation, or cryonics, is an experimental procedure that preserves individuals at cryogenic temperatures after legal death in the hope of future revival. Although Switzerland hosts Schengen Areas first dedicated cryopreservation facility, public sentiment toward the practice has remained largely unexamined. This exploratory survey of 249 Swiss adults assessed awareness, ethical views, and openness to cryopreservation. Results show broad support for individual autonomy, with most responde...

BackgroundHelmet use is a proven safety measure that reduces the risk of head injury among cyclists and e-scooter riders. Despite legal requirements for pedal bikes and e-bikes in Australia, compliance varies, particularly among users of electric vehicles. The growing popularity of e-bikes and e-scooters in urban areas presents new public health challenges, yet observational data on helmet use, behavioural determinants, and the effectiveness of safety interventions remain limited. AimPhases 1 a...

BackgroundHypertension is a major modifiable risk factor for cardiovascular disease, yet blood pressure (BP) control remain suboptimal, particularly in socially disadvantaged communities. Guidelines recommend initiating single-pill combination (SPC) therapy to improve adherence and BP control, but uptake in primary care is limited. ObjectivesTo evaluate the SOLO care improvement project, promoting SPC initiation among general practitioners (GPs) in Amsterdam Zuidoost, a disadvantaged, multi-eth...

Artificial intelligence (AI), particularly large language models (LLMs), is increasingly explored in healthcare, yet its real-world usability and safety in high-risk clinical pharmacy tasks remain uncertain. Vancomycin therapeutic drug monitoring (TDM), which requires precise pharmacokinetic calculations and context-sensitive interpretation within a narrow therapeutic window, provides a stringent test case for AI-assisted decision support. This proof-of-concept study developed and evaluated a hy...

BackgroundThe NHS-Galleri trial reported a substantial reduction in Stage IV cancer diagnoses and a four-fold increase in cancer detection rates, but did not meet its primary endpoint of reducing combined Stage III+IV diagnoses in a prespecified group of 12 cancers. We hypothesize that stage slip-- progression of cancers from Stage I/II to Stage III during diagnostic workup--is the primary mechanism behind this statistical masking. MethodsWe developed a Monte Carlo simulation of 142,000 partici...

Exercise training is a cornerstone of Cardiovascular Rehabilitation (CR) and, as of now, moderate-to-vigorous continuous exercise training (MICT) is the standard. New exercise modalities in the context of CR are constantly being explored to improve patient outcomes. These Canadian Association of Cardiovascular Prevention and Rehabilitation (CACPR) exercise training recommendations provide a synthesis of evidence-informed recommendations from existing documents, including recommendations around H...

GLP-1 receptor agonists (GLP-1 RAs) are effective in delaying progression of chronic kidney disease in individuals with type 2 diabetes mellitus (T2DM). We evaluated whether GLP-1 RA prescription is associated with reduced nephrotoxicity in adults receiving long-term lithium therapy. We conducted a retrospective, propensity score-matched cohort study using electronic health records from the TriNetX global network, which includes de-identified data from over 127 million patients across 109 health...

PurposeWhile genomic testing is integral to pediatric inborn errors of immunity (IEI) care, few studies have examined strategies to support its optimal delivery. This study aimed to characterize a pediatric IEI cohort and assess the impact of implementing a mainstream model-of-care (MoC). Materials/MethodsComprehensive chart audit was conducted for patients ([≤]18y) who received IEI genomic testing in Queensland, Australia, from 2017-2025. Descriptive analyses captured demographic and clinic...