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Global gaps in how we assess undergraduate medical students mental health: a scoping review protocol

Por: Michaloud · F. · Olie · E. · Deruelle · P. · De Jong · A. · Visier · L. · Costa · D. · Lognos · B. · Celi · L. A. · Teisserenc · B. · Schaefer · M. S. · Jaber · S. · Pensier · J. · Chanques · G.
Introduction

Mental health problems among undergraduate medical students are a major global public health concern that emerge early during training and are shaped by demanding educational environments, emotional stressors and organisational pressures. Although research has expanded rapidly, the literature remains fragmented across themes, regions and methods. This scoping review aims to map the global quantitative literature on medical students’ mental health and identify gaps in scope, geography, methodology and equity.

Methods and analysis

This scoping review will be conducted in accordance with the Joanna Briggs Institute methodological guidance and reported in accordance with PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. We will include quantitative studies assessing mental health among undergraduate medical students. MEDLINE (Ovid), Web of Science (Clarivate), the Cochrane Library (Wiley) and PsycINFO (Ovid) will be searched without date or language restrictions using a keyword-based search strategy. Two reviewers will independently screen titles, abstracts and full texts and extract data using a standardised form. Data will include publication year, country, study design, sample size, mental health measures, thematic domains and patterns of collaboration. Mental health domains will be classified using an a priori thematic framework encompassing psychological symptoms and distress, psychological resources, academic environment, social support and physical health and lifestyle factors. Equity-related variables (sex, gender identity, sexual orientation, race/ethnicity, socioeconomic status) will be operationalised based on analytical use. Results will be synthesised descriptively using tables and visualisations.

Ethics and dissemination

Ethical approval is not required. Findings will be disseminated through publication and presentations. The dataset and code will be openly available on publication.

Trial registration details

Protocol registration will be made available online via the Open Science Framework (doi:10.17605/OSF.IO/2EHNU).

Daytime circadian patterns of exhaled volatile organic compounds in adults without and with type 1 and type 2 diabetes: protocol for an exploratory observational study

Por: Nicolier · C. · Rothenbühler · M. · Balmer · M. L. · Witthauer · L.
Introduction

Circadian regulation modulates metabolic and hormonal processes throughout the day, yet it remains unclear whether these diurnal fluctuations are reflected in exhaled volatile organic compound (VOC) profiles and whether such temporal patterns differ between individuals with and without diabetes. Previous breath analysis studies in diabetes have shown heterogeneous results, which may reflect differences in analytical approaches and the lack of standardised sampling times.

Methods and analysis

This prospective, single-centre observational study examines daytime VOC dynamics from 08:00 to 16:00 among adults without diabetes, and individuals with type 1 diabetes or type 2 diabetes. 60 participants will complete one in-person visit with repeated breath measurements using a BreathSpec® gas chromatography–ion mobility spectrometry system (GC-IMS) device, capillary glucose testing, body composition assessment, questionnaires, and oral and stool microbiota sampling. A standardised breakfast is provided; subsequent meals follow structured timing but are not standardised. The primary outcome is temporal variation in VOC intensities. Secondary outcomes include between-group differences and associations with glucose levels, body composition and microbiota composition. Analyses will use established GC–IMS tools and exploratory multivariate approaches.

Ethics and dissemination

Ethics approval was granted by the Ethics Committee of the Canton of Bern (BASEC 2023-01143). Results will be shared via peer-reviewed publications, conferences and lay summaries.

Trial registration number

NCT05984979.

Doravirine versus dolutegravir-based regimen in antiretroviral treatment-naive people living with HIV-1 (ANRS0392s ELDORADO): protocol for an international, open-label, randomised, non-inferiority, phase III trial

Por: Lhostellier · A. · Kouanfack · C. · Chazallon · C. · Wagner-Cardoso · S. · Eholie · S. P. · Banze · N. · Halue · G. · Capeau · J. · Delaugerre · C. · Moh · R. · Bonnet · F. · Mfeukeu Kuate · L. · Jaquet · A. · Perazzo · H. · Bernard · C. · Bastard · J.-P. · Goldwirt · L. · Vilquin · P. · N
Introduction

Increasing evidence suggests that dolutegravir (DTG), endorsed by the WHO since 2018 for first-line antiretroviral therapy (ART), is associated with significant weight gain and potentially also with cardiometabolic disorders. In an effort to expand therapeutic options for people living with HIV (PLHIV), the EvaLuating the non-inferiority of DORAvirine vs DOlutegravir trial aims to compare the virologic efficacy of doravirine (DOR) and DTG-based regimens and to assess their safety, including a focus on cardiometabolic effects.

Methods and analysis

This is an international, phase III, multicentre, open-label, non-inferiority, randomised trial that will enrol 610 ART-naïve PLHIV (HIV RNA≥1000 copies/mL at screening) across six countries (Brazil, Cameroon, France, Côte d’Ivoire, Mozambique and Thailand) spanning four continents. Key inclusion criteria include age ≥18 years, confirmed HIV-1 infection with plasma RNA levels ≥1000 copies/mL, indication for ART initiation and no prior ART exposure. Participants will be randomised in a 1:1 ratio to receive either DOR 100 mg once daily in combination with tenofovir disoproxil fumarate (TDF) (300 mg daily) plus lamivudine (3TC) (300 mg daily) or DTG (50 mg daily) in combination with TDF (300 mg once daily) plus either emtricitabine (FTC) (200 mg daily) or 3TC (300 mg daily). Randomisation will be stratified by screening HIV-1 RNA load (≤100 000 or >100 000 copies/mL) and by country. The primary outcome is virological efficacy, defined as the proportion of participants achieving HIV-1 RNA

Ethics and dissemination

Primary outcome results (week 48) are expected in early 2028. The project was submitted to and approved by national ethics committees and pharmaceutical regulatory authorities in all participating countries: Brazil (CEP INI FIOCRUZ (21.040-900)/CEP HGNI (26.030-380)); Cameroon (CNERSH (2024/09/1717/CE/CNERSH/SP)/Ministry of Public Health (D30-1464/AAR/MINSANTE/SG/DROS/CRC); Côte d'Ivoire: (CNESVS (0018224/MSHPCMU/CNESVS-km)/AIRP (1329/AIRP/DISMP/Om/kbaag); France (CTIS CPP/ANSM (2023-508626-10-00)); Mozambique (CNBS (20/CNBS/25)/ANARME (4635/380/ANARME)); Thailand: (IHRP (08/1944)/Thai FDA: ongoing on 19 January 2026). The trial received authorisation from the French National Commission for Data Protection and Liberties (CNIL) under approval number 924 302. Written informed consent is obtained from all participants prior to any study-specific procedures and trial enrolment, in accordance with the Declaration of Helsinki and applicable national regulations. Study findings will be disseminated through publication in peer-reviewed journals and presentations at national and international scientific conferences. Results will also be communicated to policymakers, healthcare professionals, community stakeholders and study participants through appropriate dissemination activities, including policy briefs, stakeholder meetings and lay summaries on dedicated and easily accessible platforms.

Trial registration numbers

NCT06203132; EU-CT, 2023-508626-10-00.

Intelligent monitoring to predict atrial fibrillation (NOTE-AF): clinical study 1 for the 'Health virtual twins for the personalised management of stroke related to atrial fibrillation (TARGET) project - a protocol for a prospective cohort analysis

Por: Essa · H. · Johnston · B. · Lip · G. Y. H. · Ortega-Martorell · S. · Williams · K. · Welters · I. D. · TARGET Consortium · Ortega-Martorell · Olier · Mistry · Knowles · Bellfield · Aikodon · Lotto · Jones · Dawson · Thijssen · Maganaris · Baltzopoulos · McDowell · Smith · Ohlsson
Introduction

Atrial Fibrillation (AF) is the most common arrhythmia worldwide affecting an estimated 5% of people over the age of 65 and is a leading cause of stroke and heart failure. Identification of patients at risk allows preventative measures and treatment before these complications occur. Conventional risk prediction models are static, do not have flexibility to incorporate dynamic risk factors and possess only modest predictive value. Artificial intelligence and machine learning-powered health virtual twin technology offer transformative methods for risk prediction and guiding clinical decisions.

Methods and analysis

In this prospective observational study, 1200 patients will be recruited in two tertiary centres. Patients hospitalised with acute illnesses (sepsis, heart failure, respiratory failure, stroke or critical illness) and patients having undergone high-risk surgery (major vascular surgery, upper gastrointestinal surgery and emergency surgery) will be monitored with a patch-based remote wireless monitoring system for up to 14 days. Clinical and electrocardiographic data will be used for modelling the risk of new-onset AF. The primary outcome is episodes of AF >30 s and will be described as ratio of episodes/patient and as percentage of patients having episodes of AF. Secondary outcomes include 30-day and 90-day readmission rates and complications of AF.

The aim of this study is to generate data for the development and validation of health virtual twins predicting onset of AF in an at-risk population. The intelligent monitoring to predict atrial fibrillation (NOTE-AF) study is part of the TARGET project, a Horizon Europe funded programme which includes risk prediction, diagnosis and management of AF-related stroke (https://target-horizon.eu/).

Ethics and dissemination

The study has received approval by the Health Research Authority and the National Research Ethics Service (REC reference 24/NW/0170, IRAS project ID: 342528) in the UK and has been registered on clinicaltrials.gov (NCT06600620). Results will be disseminated as outlined in the TARGET protocol to communicate project ideas, activities and results to diverse audiences.

Trial registration number

NCT06600620.

Effectiveness of antihypertensive drugs for secondary prevention of ischaemic stroke: a nationwide historic cohort study

Por: Perrier · J. · Gabet · A. · Olie · V. · Pariente · A. · Tzourio · C. · Bezin · J.
Objectives

To evaluate the impact of various antihypertensive drugs on secondary stroke prevention in a real-life setting.

Design

Nationwide historic cohort study.

Setting

French healthcare system data (SNDS).

Participants

Adults hospitalised for ischaemic stroke between 2014 and 2015 were followed up until December 2021 and stratified based on the presence of atrial fibrillation (AF).

Outcome measures

Risk of stroke recurrence was assessed using a time-dependent Cox cause-specific model accounting for changes in drug exposure. We also investigated the risk of major adverse cardiovascular events (MACE) or all-cause death. Models were adjusted on stroke characteristics, coprescriptions and co-morbidities, at inclusion and across follow-up.

Results

Among 54 764 patients without AF (median age 71; 46% women) and 17 960 with AF (median age 79; 51% women), stroke recurrence occurred in 11% and 13%, respectively. In non-AF patients, reduced recurrence risk was associated only with use of calcium channel blockers (adjusted HR (aHR) 0.91, 95% CI 0.86 to 0.97), thiazide diuretics (aHR 0.90, 95% CI 0. 83 to 0.97), loop diuretics (aHR 0.86, 95% CI 0.77 to 0.95) and potassium-sparing agents (aHR 0.83, 95% CI 0.70 to 0.98). In AF patients, only potassium-sparing agents (aHR 0.82, 95% CI 0.69 to 0.99) were associated with reduced recurrence risk. All antihypertensive drugs, apart from loop diuretics, were associated with a reduced risk of MACE or all-cause death.

Conclusions

In this large cohort, only diuretics and calcium channel blockers were associated with a reduced risk of recurrent stroke. Most antihypertensive drugs, however, may be more effective in overall cardiovascular prevention.

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