Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.

POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.

The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

NCT06100978.

Rheumatoid arthritis (RA) and spondyloarthritis (SpA) are chronic inflammatory rheumatic diseases characterised by pain, fatigue, mood disturbances, sleep problems and reduced quality of life. These symptoms are highly variable both between individuals and within individuals across days, reflecting the fluctuating nature of disease activity and daily functioning. Although physical activity is known to alleviate many of these symptoms, individuals with RA and SpA often encounter barriers that limit regular engagement. Capturing the dynamic interplay between symptoms and physical activity therefore requires methods that account for day-to-day and moment-to-moment variability. Ecological momentary assessment (EMA), especially when combined with actigraphy, enables real-time, context-sensitive monitoring of symptoms and physical activity in daily life. However, little is known about the feasibility and acceptability of such protocols in individuals with RA and SpA, for whom participant burden and adherence may represent significant challenges. This pilot study therefore aims to assess the feasibility and acceptability of a 14-day EMA protocol and to explore factors associated with objectively measured physical activity in individuals with RA and SpA.

50 adults diagnosed with RA or SpA will be recruited through rheumatology clinics or via advertisement. Eligible participants must be smartphone users without cognitive or physical impairments affecting participation. After providing consent, participants will complete baseline questionnaires regarding disease activity, quality of life, sleep, pain, fatigue, affective states and will attend a remote session with a member of the research team to learn how to use the mobile app. They will then complete a 14-day EMA protocol, during which data on patient-related outcomes (PROs), including pain, fatigue, sleep quality and affective states (i.e. positive and negative affects) will be assessed four times daily: upon awakening, 11:00, 15:00 and 20:30. Physical activity and sleep will be continuously monitored using both a wrist-worn and a thigh-worn device. Feasibility will be evaluated based on adherence to EMA prompts and actigraphy wear time. Acceptability will be assessed via a study-specific questionnaire and qualitative interviews conducted at the end of the protocol. Exploratory analyses will examine real-time, temporal and lagged relationships between PROs (pain, fatigue affective states), sleep and physical activity levels.

This study was approved by the French national ethics committee [Comité de protection des personnes Nord Ouest I, 2025-A01349-40] on 24/07/2025. The results will be disseminated in peer-reviewed journals and at international conferences.

NCT07167784.

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.

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

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.

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

Current evidence is unclear due to methodological limitations. We bridge critical knowledge gaps by quantifying the longitudinal changes in movement behaviours and their correlates from early childhood through adolescence.

Longitudinal observational cohort study.

General healthy child and adolescent sample in Singapore.

Growing Up in Singapore Towards healthy Outcomes study participants.

We used wrist-worn accelerometry and proxy-reported data to examine movement behaviours (sleep, inactivity, light physical activity (PA; LPA) and moderate-to-vigorous PA (MVPA) and screen-viewing) at ages 5.5, 8, 10 and 12 years and the sociodemographic and maternal lifestyle-related correlates using linear regression models with generalised estimating equations.

Among 837 children, sleep, LPA and MVPA declined by 3% (from 9.1 to 8.8 hours/day), 24% (from 5.8 to 4.4 hours/day) and 44% (from 71.3 to 40.1 min/day), respectively, while inactivity and screen viewing increased by 26% (from 8.0 to 10.1 hours/day) and 155% (from 1.8 to 4.6 hours/day), respectively, from ages 5.5 to 12 years. The greatest annual increase in inactivity (0.6 hour/annum) and screen-viewing (0.8 hour/annum) and decrease in LPA (0.3 hour/annum) and MVPA (10.4 min/annum) occurred from ages 8 to 10 years. Girls of Malay ethnicity and lower socioeconomic status, and whose mothers had less favourable movement behaviours, had significantly less sleep, higher inactivity and screen-viewing and/or lower PA. Maternal PA levels and/or sitting time were associated with children’s sleep, inactivity and MVPA up to age 8 years, while maternal sitting and screen-viewing behaviours were associated with children’s screen-viewing at all ages.

Using contemporaneous datasets relevant to the present day, we confirmed that children become less physically active and have longer screen-viewing as they transition into adolescence and highlighted characteristics to be prioritised in future interventions.

Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.

INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.

The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.

NCT06456658.

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

NCT06952907.

To describe the sociodemographic characteristics of mothers of Haitian origin and the obstetric and neonatal outcomes of their newborns born in French Guiana between 2013 and 2021 in order to identify specific vulnerabilities within this population.

A descriptive, population-based study using data from a comprehensive birth cohort including all deliveries in French Guiana from 2013 to 2021.

All maternity units in French Guiana, a French overseas territory located in South America.

A total of 66 485 live births were recorded during the study period, including 14 065 (21.2%) births to mothers of Haitian origin.

Sociodemographic characteristics, antenatal care indicators and neonatal outcomes were compared between mothers of Haitian origin and mothers of other origins. Adjusted odds ratios (aOR) and 95% CI were calculated for key outcomes.

Compared with mothers of other origins, Haitian mothers had higher odds of delivering a newborn small for gestational age (aOR=1.41, 95% CI 1.32 to 1.50), neonatal hospitalisation at birth (aOR=1.19, 95% CI 1.11 to 1.28), having an insufficient number of antenatal visits (aOR=1.32, 95% CI 1.26 to 1.38) and lacking health insurance coverage (aOR=2.83, 95% CI 2.52 to 3.17). Conversely, they had a lower risk of adolescent pregnancy (

Mothers of Haitian origin in French Guiana experience distinct social and perinatal vulnerabilities. Strengthening equitable access to healthcare and implementing targeted community-based interventions are essential to improve maternal and neonatal health outcomes in this population.

Heart failure (HF), chronic kidney disease (CKD) and atherosclerotic cardiovascular disease (ASCVD) are highly prevalent conditions that often coexist. Using electronic health records (EHRs), we evaluated the 1-year risk of all-cause death, major cardiovascular and kidney events in patients with HF, CKD, ASCVD and with combinations of these conditions, compared with an unselected control population aged ≥75 years.

Retrospective cohort study based on EHR data.

Integrated primary and secondary health unit located in the North of Portugal. Eligible adult patients were identified using EHRs from 2008 to June 2022.

Eight cohorts were defined: (1) control: patients with ≥75 years; (2) ASCVD alone; (3) HF alone; (4) CKD alone; (5) cardiorenal syndrome (CRS): combined HF+CKD; (6) atherosclerotic HF: combined ASCVD+HF without CKD; (7) atherosclerotic CKD: combined ASCVD+CKD without HF and (8) combined ASCVD+CRS. The risk of these conditions was compared with controls using propensity score age-sex matching. We identified 19 129 patients with ASCVD alone, 13 640 patients with HF alone, 40 545 with CKD alone and 10 499 with CRS. The control group comprised 36 532 patients aged 75 years or older.

The primary outcome was all-cause mortality. The main secondary outcomes were cardiovascular death, HF hospitalisations and end-stage renal disease.

The 1-year mortality rate was 0.65% in the control cohort, 5.6% for patients with ASCVD alone, 6.05% for patients with HF alone and 3.53% for patients with CKD alone. Adjusted risk of all-cause death was significantly increased in the ASCVD-alone (HR: 8.42, 95% CI 7.12 to 9.95), HF-alone (HR: 9.19, 95% CI 7.75 to 10.9) and CKD-alone (HR: 5.35, 95% CI 4.62 to 6.19) cohorts, compared with control population; however, patients with the combination of all three conditions (ie, ASCVD+CRS) had the highest mortality risk (HR: 14.18, 95% CI 11.62 to 17.3). A similar association pattern was observed for cardiovascular death, HF events and end-stage renal disease.

Our results support the concept of an atherosclerotic cardiorenal phenotype, with a very high risk of mortality, cardiovascular and renal adverse events. Implementation strategies are required to target these conditions simultaneously.

The only supportive therapy for patients with severe acute kidney injury (AKI), a common complication among the critically ill, is dialysis. Based on the literature and current guidelines, continuous renal replacement therapy (CRRT) with a total effluent dose of 20–25 mL/kg/hour and adjustments to ensure such dose is delivered despite down time (eg, due to surgical procedures) is recommended. However, experimental and clinical studies suggest that azotaemia, which can be induced by lowering the effluent dose, may accelerate renal recovery. This clinical study investigates whether a lower effluent dose (10–15 mL/kg/hour) for a maximum of 7 days or until successful (>24 hours) liberation of CRRT in critically ill patients with a dialysis-dependent AKI accelerates renal recovery and reduces time on CRRT compared with guideline-directed standard dose (25–30 mL/kg/hour).

The Ketzerei trial is an international, multicentre randomised, controlled trial, designed to investigate if a lower effluent dose (10–15 mL/kg/hour) accelerates renal recovery and reduces the time on CRRT compared with the guideline directed standard effluent dose (25–30 mL/kg/hour). The study aims to enrol 150 critically ill patients with a dialysis-dependent AKI. Eligible patients will be randomised to receive either a standard effluent dose (control group, 25–30 mL/kg/hour) or lower effluent dose (interventional group, 10–15 mL/kg/hour). The primary endpoint is the number of days free from CRRT and alive (from randomisation through day 28). Key secondary endpoints include the number of (serious) adverse events due to potential uremia, the duration of RRT and intensive care unit survival.

The Ketzerei trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe (2023–343 f-s), the University of Muenster and subsequently by the corresponding Ethics Committee of the participating sites. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

clinicaltrials.gov (NCT06021288).

To determine the proportion of Aboriginal and/or Torres Strait Islander Peoples with diabetes who were monitored according to recommended national guidelines and had their clinical parameters within recommended targets. We also examined trends over time (2013–2022) and compared urban and rural areas.

A repeated cross-sectional study using data from a national general practice database (MedicineInsight, 2013–2022).

De-identified electronic health records (EHR) of people attending 427 mainstream general practices across Australia.

This study included all Aboriginal and/or Torres Strait Islander adults (18+ years) diagnosed with diabetes mellitus who were regular patients (attended at least once a year in three consecutive years) within the MedicineInsight database.

Outcomes measured were (i) monitoring of blood glucose, lipids, blood pressure (BP), renal function and Body Mass Index (BMI)/waist circumference (WC) and (ii) achieving recommended targets: glycosylated haemoglobin (HbA1c) ≤7.0%, fasting glucose 4–7 mmol/L, random glucose 5–10 mmol/L, total cholesterol ≤4.0 mmol/L, low-density lipoprotein 60 mL/min/1.73 m², urine albumin-creatinine ratio (uACR) 2, WC

Between 70% and 90% of individuals were monitored for the clinical parameters above, except for BMI/WC (55%–75%). Trends in monitoring over time were similar across remoteness areas, increasing slightly in 2013–2014 and declining from 2019. Among those monitored, 53%–86% achieved targets for blood glucose, lipids and renal function; 32%–42% for BP; and

The risk of diabetes complications among Aboriginal and/or Torres Strait Islander Peoples could be reduced by improving management of blood pressure and overweight/obesity in all areas, and blood glucose and lipids in rural areas.