During pregnancy, physiological and psychological factors influence eating behaviour and food preferences. Food cravings are common in pregnancy and contribute to excessive gestational weight gain (GWG). Excessive GWG is present across all body mass index (BMI) categories and is associated with adverse outcomes. Outside of pregnancy, highly palatable food cues activate brain regions involved in reward and attention, which may influence eating behaviour and behavioural responses. However, brain and behavioural responses to food cues across pregnancy, and their association with psychological and metabolic factors, remain poorly understood. This study aims to investigate spatiotemporal brain responses to visual food cues across individuals with different BMI categories and their associations with behavioural, psychological and metabolic outcomes during pregnancy.

This is a prospective observational cohort study conducted at the Lausanne University Hospital, Switzerland. 94 pregnant individuals (47 healthy normal weight and 47 with overweight/obesity) will be assessed at 12–16 and 31–36 weeks of gestational age from November 2024 to September 2026. Data collected for the primary outcomes include electroencephalography-based brain responses to validated visual food cues varying in fat and carbohydrate content, behavioural responses to the same cues using a gamified smartphone Go/NoGo task. Secondary validated outcomes include heart rate variability (Actiheart), body composition (InBody S10), glycated haemoglobin (Afinion), cardiorespiratory fitness (The Chester step test), snack intake, eating behaviour (Intuitive Eating Scale-2, Three-Factor Eating Questionnaire-Revised), food cravings (Food Craving Questionnaire-state), mood and depressive symptoms (Edinburgh Postnatal Depression Scale). Statistical analyses include group comparisons, longitudinal analyses and regression models adjusted for potential sociodemographic/medical confounders.

All participants will provide written informed consent. The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (CER-VD 2023-01462). Findings will be disseminated through peer-reviewed publications, (inter)national conferences and shared with healthcare professionals and stakeholders to inform strategies for improving maternal health.

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [¹⁸F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

2024-512301-16-01

Walk-and-talk therapy integrates psychological support and physical activity conducted in outdoor environments, and has potential to better align with men’s preferences and masculine norms around emotional communication. Conventional indoor psychotherapy is effective for treating depression but can be less engaging for men, leading to less satisfaction and high rates of dropout. This trial aims to determine whether walk-and-talk therapy offers men with depressive symptoms clinically meaningful benefits over conventional indoor therapy.

This assessor-blinded, parallel group randomised controlled trial is comparing the efficacy of walk-and-talk therapy to conventional indoor therapy for men with depressive symptoms. After randomisation, all participants receive 10 fortnightly 1-hour individual psychotherapy sessions over 20 weeks as either: (1) conventional indoor therapy (sitting down indoors) or (2) walk-and-talk therapy (walking outdoors). Participants are assessed at ‘pre-intervention’ (baseline), ‘post-intervention’ (5 months post baseline) and ‘follow-up’ (12 months post baseline) time points. The primary outcome is change in overall psychological distress (21-item version of the Depression, Anxiety and Stress Scale (DASS-21)) at post-intervention. Secondary outcomes include male-type depression symptoms, mental well-being, suicidal ideation and quality of life. Costing data is being collected for cost-effectiveness analysis. Linear mixed models will be used to examine the impact of group (conventional indoor vs walk-and-talk), time (baseline, 5-month and 12-month) and the group-by-time interaction for primary and secondary outcomes.

This study is approved by the University of Newcastle Human Research Ethics Committee (H-2024-0090). Results will be published in an open access peer-reviewed journal and disseminated through conference presentations.

ACTRN12624000794505.

Sleep and circadian rhythm disturbances are proposed to be pathophysiological mechanisms underlying some cases of depressive and bipolar (mood) disorders. An unresolved clinical question is whether sleep and circadian-based therapies are effective antidepressants for young adults (18–30 years) with a mood disorder.

MELODY (Melatonin for Depression in Youth) is an investigator-initiated, single-centre, phase 3, randomised controlled trial with two blinded pharmacological arms (melatonin vs placebo) and one open-label digital intervention arm (digital cognitive behavioural therapy for insomnia (dCBT-I)). The trial is testing whether 12 weeks of adjunctive melatonin or dCBT-I are more effective than pill placebo at reducing depressive symptoms in 660 young people aged 18–30 years with a Structured Clinical Interview for (Diagnostic and Statistical Manual of Mental Disorders, fifth edition; SCID-5) diagnosis of Major Depressive Disorder or Bipolar Disorder type II, moderate to severe depressive symptoms and significant sleep or sleep-wake complaints. The week 12 primary outcome is depressive symptoms (Quick Inventory of Depressive Symptomatology, Adolescent version). Secondary outcomes include partial remission of the Major Depressive Episode (SCID-5) and change in other mental health symptoms, sleep, functioning or quality of life. A subset of participants will undergo in-home assessment of sleep physiology (Sleep Profiler) and in-lab assessment of circadian rhythms (dim-light melatonin onset) to examine biological changes. A 6-month follow-up will explore durability of treatment effects. Mediation analyses will test whether sleep or circadian rhythm changes play a causal role in antidepressant effects.

MELODY has been reviewed and approved by the Human Research Ethics Committee (HREC) of the Sydney Local Health District (HREC Approval Number: X23-0450, Protocol version: 1.4, 7/7/25). The findings of the MELODY trial will be disseminated into the scientific and clinical communities via refereed publications, talks and other professional and media outlets. The Brain and Mind Centre’s Lived Experience Working Group will contribute to dissemination of MELODY’s findings via youth-friendly methods (eg, social media videos, explainers).

ACTRN12624000017527.

Cardiovascular risk assessment and management in the paediatric population is a relatively uncharted territory. However, atherogenesis starts during childhood, making childhood and adolescence an important window of opportunity to prevent atherosclerotic cardiovascular disease (ASCVD) later in life. An emerging group at risk for early ASCVD are children with chronic conditions. This paper describes the rationale, design and methods for the Secondary Manifestations of ARTerial diseases in the Young with a chronic condition (SMART-Youth) study. This study aims to identify disease-associated and lifestyle-associated cardiovascular risk factors for preclinical atherosclerosis in children with a chronic condition. The results of this study may fuel development of tailored cardiovascular risk assessment and management strategies in children at-risk.

This is a prospective longitudinal cohort study including children aged 8–18 years with various chronic conditions (cystic fibrosis, juvenile idiopathic arthritis, systemic autoimmune disease, chronic kidney disease, primary immunodeficiency, autoinflammatory conditions, inflammatory bowel disease, congenital heart disease, premature birth, fetal growth restriction and children with persistent somatic symptoms) at the Wilhelmina Children’s Hospital of the University Medical Center Utrecht in The Netherlands. Assessment of cardiovascular risk factors includes blood pressure, body mass index, visceral and subcutaneous abdominal adipose tissue, nutrition, physical activity, stress, circulating lipids, HbA1c and C-reactive protein measurements. Preclinical atherosclerosis is measured by carotid intima-media thickness, carotid distension and carotid-femoral pulse wave velocity. These assessments are performed at baseline, 2-year follow-up and 17–18 years of age. Enrollment runs from August 2024 onwards, with a minimal study duration of 15 years and an estimated final sample of more than 2000 children. State-of-the-art regression-based methods will be used to examine the association of cardiovascular risk factors and preclinical atherosclerosis. Longitudinal data analysis methods will be used to model these associations over time.

Ethical approval was granted by the Medical Ethics Review Board of the University Medical Center Utrecht (NL84874.041.23). Written informed consent by participants and their parents is required for participation. Collected data will be made available to researchers upon reasonable request to the Steering Committee. Study findings will be disseminated through peer-reviewed publications, presentations at scientific meetings and meetings with patient organisations.

The primary aim of this scoping review was to synthesise published research priorities for back pain, neck pain and osteoarthritis. The secondary aim was to compare these research priorities to the priority areas identified in the Global Strategy to Improve Musculoskeletal Health.

Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews.

Literature searches were performed in MEDLINE, EMBASE and the James Lind Alliance Priority Setting Partnership database from inception to March 2025.

Peer-reviewed studies reporting the development of a prioritised ranking of research topics related to back pain, neck pain or osteoarthritis were included.

Included research priority sets were described. All research priorities for back pain, neck pain and osteoarthritis were presented. Research priorities were categorised according to priority areas identified in the Global Strategy to Improve Musculoskeletal Health.

15 studies from 3721 citations and three from the James Lind Alliance were included. Eight priority sets related to back and/or neck pain identified 155 research priorities. 15 priority sets related to osteoarthritis identified 206 research priorities. Most priority sets (69.6%) included patients in the development process, but only 17.4% included policymakers. Just three priority sets included participants from outside Europe, North America or Australia.

Most priorities were in the clinical and basic science research priority area (73.1%) followed by the health policy and systems research priority area (14.1%), health economics research priority area (4.7%), public health research priority area (4.4%), epidemiological and population health research priority area (1.9%) and the other priority area (1.7%).

The majority of published back pain, neck pain and osteoarthritis research priorities fall within clinical and basic science and were developed in high income countries. Given the known high population burden of musculoskeletal conditions, a broader approach to research beyond clinical and basic science is likely required to achieve population-level health benefits. Future initiatives should include all relevant members of the global musculoskeletal health community, including from low- and middle-income countries, to help ensure the development of broad-based research priorities that address all research domains required to improve back and neck pain and osteoarthritis health globally.

Pregestational diabetes is one of the most frequent medical conditions in pregnancy. Nutrition insecurity is a non-medical, health-related social need and affects glycaemic management and pregnancy outcomes for women with both type 1 and type 2 pregestational diabetes. Collaborative healthcare-community partnerships to enhance food access, facilitate culinary medicine, diabetes self-management education and support (DSMES) and address unmet social needs for pregnant women with pregestational diabetes remain to be evaluated.

In a two-arm randomised controlled trial, we will examine the combined effects of a tripartite NOURISH intervention ((1) produce home delivery, (2) culinary medicine with DSMES and (3) community health worker-led social needs assessment and support) versus the current standard of diabetes and prenatal care. We will recruit and enrol 174 pregnant women (87 NOURISH, 87 standard care) ≤22+6 weeks of gestation with pregestational diabetes, inadequate glycaemic management (haemoglobin A1c≥6.5%) and self-reported risk of food insecurity from a diabetes and prenatal care programme at a tertiary care academic health system located in the USA. We will measure the primary outcome of glycaemic management by delivery (haemoglobin A1c

The Institutional Review Board at The Ohio State University approved this study (IRB: STUDY20260307; date: 23 April 2026). We plan to submit results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.

NCT07560813.

This study aims to explore use trajectories of rehabilitation services among ageing Canadians (45–85 years) with osteoarthritis.

We will conduct a population-based cohort study using data from the Canadian Longitudinal Study on Aging (CLSA). We will describe rehabilitation use among respondents with osteoarthritis of the knee, hip or hand at baseline, 3-year and 6-year follow-up. Rehabilitation service use is measured via a single self-reported item capturing contact with a physiotherapist, occupational therapist or chiropractor in the past 12 months. We will use latent class growth analysis to identify 6-year trajectories of rehabilitation use, assigning participants to a single trajectory based on their highest probability of trajectory membership. All analyses will be stratified by income and within each income bracket by sex, gender and age. CLSA sampling weights will be applied to produce population estimates.

Ethics approval for this study was obtained from the Research Ethics Board of Western University (REB #128991), Ontario Tech University (REB #17980) and the Canadian Memorial Chiropractic College (REB# 242014). Informed consent was obtained from all CLSA participants at the time of recruitment. Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences, with relevance for researchers, clinicians and policymakers working to improve equitable access to rehabilitation for ageing Canadians.

Very preterm infants (

Australasian multicentre, two-arm, parallel-group, prospective, randomised, open, blinded-endpoint superiority trial in 868 infants born less than 32 weeks’ gestation. Infants are randomised to cycled environmental light and noise or routine care in a non-cycled hospital environment from soon after birth until discharge home. The intervention comprises wearing eye-masks and ear plugs from 20:00 to 6:00, followed by removal of these devices and exposure to normal environmental noise and 300-600 lux light from 6:00 to 20:00. The primary outcome is composite cognitive score on Bayley-4 developmental assessment at 2 years corrected postnatal age.

The trial is approved by the Child and Adolescent Health Service Human Research Ethics Committee under the National Mutual Acceptance Scheme in Australia. Infants are randomised to intervention or control group after informed parental consent is obtained. Results of the CIRCA DIEM Study will be disseminated widely via presentations at local, national and international conferences, publication in international peer-reviewed journals and inclusion on the study website. Information about trial findings will also be communicated directly to the parents/guardians of trial participants through the regular study newsletter. The trial investigators will seek opportunities to communicate study results to the lay public through media and social media avenues.

ANZCTRN12618000371291.

The Dutch guideline ‘Gallstone disease’ (2016) recommends performing a cholecystectomy within 72 hours following endoscopic retrograde cholangiopancreatography (ERCP) for common bile duct stones to prevent recurrent gallstone-related complications. Nevertheless, guideline adherence in the Netherlands remains low, and the time between ERCP and cholecystectomy often exceeds 72 hours. Our project aims to improve national guideline adherence to 85% or higher and thereby reduce the incidence of gallstone-related complications after ERCP.

The Dutch-TIMELINESS is a multicentre implementation project using a Multiphase Optimisation Strategy. The project includes 61 Dutch hospitals. In phase 1, all patients undergoing ERCP for choledocholithiasis from 1 January to 31 March 2023 will be analysed to serve as a benchmark. In phase 2, each hospital develops and implements its own tailored protocol in line with the guideline, guided by the benchmark data. In phase 3, from 1 December 2025 to 31 March 2026, the new protocols will be prospectively evaluated with real-time monitoring and refined as necessary. Statistical methods are predefined in the protocol.

The Medical Research Ethics Committees United reviewed the protocol and concluded it does not fall under the scope of the Medical Research Involving Human Subjects Act (WMO). Local institutional research departments and the board of directors reviewed and approved the protocol in all participating hospitals. Results will be published in international peer-reviewed scientific journals and presented at national conferences.

Learning health systems (LHS) aim to improve care through repeated cycles that link data, learning and action. These systems have a goal to uphold equity through purposefully including patients and other stakeholders in co-design and using real-world data to identify and respond to inequities. However, evidence shows that LHS do not automatically produce equitable outcomes, and a gap persists between stated equity goals and the practical mechanisms used to build equity into system design, measurement and decision-making. This scoping review examines how equity and related concepts, including antiracism and Indigenous self-determination, are operationalised within LHS.

We will conduct a scoping review using the Joanna Briggs Institute methodology and report the findings in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. To capture equity-oriented learning beyond formally labelled systems, we define LHS by function rather than name, focusing on systems that demonstrate linkages between data use, learning and action. We will search PubMed/MEDLINE, CINAHL, Embase, Scopus, Web of Science and PsycINFO, supplemented by hand searches of relevant journals for peer-reviewed articles published from 2015 to July 2026. Two reviewers will independently screen titles, abstracts and full texts. Using a structured extraction form, we will chart how equity is defined and operationalised within LHS, including governance and decision-making processes, data and measurement practices, learning activities and contextual factors that shape equity-oriented learning. We will synthesise findings descriptively and thematically to map where in the LHS cycle equity is operationalised, what equity dimensions are addressed and where reporting gaps remain. Findings will inform researchers, health system leaders and communities on how equity can be built into routine LHS processes.

Ethics approval is not required as this review synthesises published literature. Findings will be disseminated through peer-reviewed publications and conference presentations.

We aimed to examine existing and emerging master narratives on mental health and to capture the changing emphasis in these narratives over time. Making these shifts explicit can facilitate alignment of actors and practices that must collaborate to support those seeking help.

We gathered data via a scoping review, semistructured interviews and podcast episodes. Data analysis consisted of a thematic analysis to identify narratives and a content analysis to map shifts in emphasis over time.

Semistructured interviews and included podcast episodes were all Dutch. The scoping review included Dutch and English publications.

Semistructured interviews were performed with 11 participants working in medical education and mental health provision. The selected podcast featured interviews with 15 people who aim to change the Dutch mental healthcare system.

We extracted four master narratives and observed a shift in emphasis as well as a coexistence of narratives. The narratives we found were: (1) treating a classification, (2) understanding the patient’s problem, (3) recovering life-balance and (4) building collective resilience. We found increasing emphasis on ‘building collective resilience’ when discussing the future of mental health.

Our concretisation of narrative patterns underlying the perspectives and approaches in mental health is a first step in creating a collective understanding of the shifting master narratives, which enables working with it in practice. The shift has implications for mental health professionals, educators, policymakers and those seeking help. Future research should further examine these implications and explore the perspectives of individuals seeking mental health support and their network, both of which remain insufficiently addressed.

Phase 1 clinical trials fall at a critical intersection of translational research and drug development. With a high failure rate at this stage, only enterprises capable of substantial risk tolerance and heavy investment can step into translational medicine. Academic and public sector researchers in India often lack expertise in early-phase clinical trials. This, along with a lack of dedicated infrastructure, poses some unique challenges in the early-phase drug development process. In this paper, the authors explore public-private partnership (PPP) models of pharmaceutical innovation and propose the establishment of national clinical trial networks as a solution to derisk the industry by jointly undertaking translational research of innovations addressing public health priorities.

PPPs offer an alternative approach to overcome the challenges associated with early-phase clinical trials. By fostering collaboration between public and private entities, PPPs leverage the strengths of public institutions, which can provide infrastructure, funding and scientific expertise, while private companies contribute their experience in clinical trial management and commercialisation. This is of particular importance in the development of drugs of national health priority.

PPPs offer a promising strategy to expedite early-phase clinical trials in India by promoting collaboration, diversification and innovation. By acknowledging and mitigating the inherent risks, public and private stakeholders can work together to develop effective and accessible treatments for patients in need.

Intermediate-risk prostate cancer (PCa) is currently managed with radical whole-gland therapies, such as radical prostatectomy (RP) or radiotherapy (RT). While effective, these treatments can significantly impact quality of life (QoL), particularly in relation to urinary incontinence and erectile dysfunction. Focal therapy poses a promising alternative for whole-gland treatment in this specific patient population; however, current evidence has primarily been limited to phase I and II studies. Robust prospective evidence is needed to determine whether focal therapy can be considered a safe alternative for management of intermediate-risk PCa. The objective of this randomised controlled trial (RCT) is to evaluate the oncological effectiveness, QoL and cost-effectiveness of focal therapy compared with radical treatment as standard of care.

This ENFORCE focal study is designed as a multicentre RCT with six participating centres that perform focal therapy in the Netherlands. Patients are included after receiving informed consent and are thereafter 1:1 randomised between focal therapy, consisting of high-intensity focused ultrasound, irreversible electroporation or transurethral ultrasound ablation and radical treatment, consisting of RT or RP. A total of 356 patients will be enrolled. This study has two co-primary endpoints, oncological effectiveness at 36 months (non-inferiority) and QoL at 12 months (superiority) both of which must be met to demonstrate overall trial success. Follow-up will be at least 3 years, with a maximum of 5 years to gain information regarding long-term outcomes. The set follow-up visits are 6 weeks, 3 months, 6 months, 12 months and yearly thereafter. At the follow-up visits, clinical data will be collected, and questionnaires regarding QoL and costs will be administered. Furthermore, at 9 months and 18 months, prostate-specific antigen will be monitored in alignment with European guidelines on follow-up after RP and RT. Primary analyses will be conducted using intention-to-treat analyses.

Ethical approval has been obtained from the Medical Research Ethical Committee Oost-Nederland (NL83913.091.23, primary approval in December 2023; last approved version 10 July 2025). The results will be submitted for publication in peer-reviewed medical journals, and data will be accessible.

NCT06223295.

To characterise engagement across the diabetic retinopathy (DR) care continuum in the USA using a cascade-of-care framework and identify gaps contributing to preventable vision loss.

Systematic review.

From September to November 2025, with an updated search in March to April 2026 using the same eligibility criteria, we systematically searched Ovid MEDLINE and Ovid Embase supplemented by reviewing reference lists of relevant articles and opportunistic searches of the Centers for Disease Control and Prevention publications.

We included English-language US-based cross-sectional, cohort and case–control studies and systematic reviews containing US-based data published between 1 January 2018 and 31 December 2025 relevant to one of the defined DR cascade stages: (1) diagnosis of diabetes, (2) adherence to DR screening, (3) diagnosis of DR, (4) adherence to DR care and (5) DR-related blindness. We included systematic reviews only to inform DR-related blindness, where primary data were limited and excluded them from other stages to avoid double-counting. Exclusion criteria included studies not relevant to one of the defined DR cascade stages and editorial, perspective or commentary pieces.

Two reviewers independently screened studies, extracted data and assessed risk-of-bias using the Newcastle-Ottawa Scale and Risk of Bias in Systematic Reviews tool. We synthesised data narratively and organised via the DR treatment cascade framework.

Of 14 893 studies screened, 46 met the inclusion criteria. Cascade analysis revealed substantial losses in patient engagement at three stages: (1) only 15.5%–78.7% (median 59.4%, IQR 33.9%–74.0%) of individuals with diabetes obtain biennial DR screening; (2) a substantial 54.9%–88.5% (median 70.1%, IQR 62.5%–79.3%) of individuals with DR are unaware of their diagnosis; (3) only 30.9%–62.7% (median 52.0%, IQR 40.9%–59.1%) of individuals diagnosed with DR are initially linked to care and 55.3%–77.8% (median 70.3%, IQR 59.2%–77.7%) have a lapse in DR follow-up.

This review identifies major gaps in the DR care continuum, particularly in diagnosis awareness, linkage to care and follow-up adherence. The cascade framework highlights key points of disengagement and provides a basis for prioritising future research.

To examine the prevalence and sociodemographic factors associated with tobacco smoking, smokeless tobacco and dual use among adults in Ghana using the 2022 Demographic and Health Survey (GDHS).

Ghana, nationwide sample of males and females aged ≥15 years.

This was a cross-sectional secondary analysis of the 2022 GDHS.

A representative sample of 22 058 individuals (females, 15 014 aged 15–49; males, 7044 aged 15–59)

Current tobacco smoking, smokeless tobacco use and dual use.

Prevalence for smoking, smokeless tobacco and dual use was 4.7 (4.1–5.4), 1.6 (1.3–2.0) and 0.6 (0.4–0.9) among males and 1.0 (0.8–1.3), 0.08 (0.05–0.1) and 0.1 (0.05–0.1) among females, respectively. Among males, smoking was associated with higher age (30–44 years: AOR: 2.3, 95% CI 1.7 to 3.1; 45–59 years: AOR: 2.6, 95% CI 1.8 to 3.7). Higher education was protective for both sexes [(males: AOR: 0.4, 95% CI 0.2 to 0.8) and (females: AOR: 0.4, 95% CI 0.2 to 0.8)] compared with their counterparts who had no education. Males in the Coastal zone had higher odds of use (AOR: 1.8, 95% CI 1.3 to 2.3) compared with males in the Middle zone, while females in the Northern/Savanna zone had lower odds of tobacco use (AOR: 0.5, 95% CI 0.3 to 0.8) compared with the Middle zone. Being Christian was associated with lower odds of smoking among males (AOR: 0.3, 95% CI 0.2 to 0.5) compared with others, while being Mole-Dagbani ethnic is associated with higher odds of smoking among females (AOR: 3.0, 95% CI 1.7 to 5.4).

The study provides the first national analysis across Ghana’s 16 regions and investigates patterns of smoking, smokeless tobacco and dual tobacco use. While tobacco use in Ghana remains predominantly smoked and male-driven, the divergent patterns of use across educational, regional and ethnic groups, especially the emerging risk among females, represent a significant public health shift that demands focused gender-sensitive tobacco control interventions.

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a significant procedural adverse event (AE), occurring in 5–15% of cases and leading to substantial morbidity and mortality. Aggressive prolonged intravenous (IV) fluid regimens have demonstrated efficacy in reducing PEP in clinical trials. However, these regimens typically involve continuous infusion of IV fluids over 8–24 hours following ERCP, making them impractical for outpatient settings. Data on shorter hydration protocols are lacking. The STRIPE study aims to address this gap by evaluating short-term peri-procedural IV fluid regimens as a practical alternative for mitigating PEP.

This proof-of-concept, parallel-arm, randomised controlled trial will evaluate the impact of various short-term IV fluid regimens on post-ERCP serum amylase levels, a surrogate marker for PEP. Participants undergoing ERCP will be randomised into five groups, receiving 500 mL, 1000 mL, 1500 mL, 2000 mL or 2500 mL of IV Ringer’s lactate during the peri-procedural period. Patients, endoscopists and outcome assessors will be blinded to treatment allocation during the peri-procedural period. The primary outcome is the serum amylase level 24 hours post-ERCP. Secondary outcomes include PEP, 30-day AEs and unplanned healthcare encounters including those related to volume overload or cardiovascular AEs, duration of hospitalisation (for inpatients), death within 30 days and other relevant laboratory markers at 24 hours. A total of 505 participants (101 in each arm) will be enrolled to ensure adequate power after accounting for attrition and/or sample loss.

This trial was registered on clinicaltrials.gov on 7 February 2024. The study was approved by the University of Calgary Conjoint Health Research Ethics Board (REB23-0625). On study completion, data will be made available on reasonable request to the corresponding author after completion of the study. Study dissemination and knowledge translation is planned via presentations at scholarly meetings, publications in peer-reviewed journals and, ideally, via adoption of results into clinical practice guidelines.

NCT06260878.

Ageing is associated with declines in physical and cognitive function that increase the risk of disability and dependence. Intrinsic capacity (IC), proposed by the WHO, provides a multidimensional framework to assess health in older adults. This study aims to evaluate whether a multicomponent recreational exercise programme (Fun Exercise for Older Adults (FEXO)) improves IC, motivation and adherence compared with a conventional programme (OTAGO).

A randomised controlled trial with two groups (2:1 ratio) will be conducted among 120 community-dwelling older adults (≥60 years). Participants will be randomly assigned to FEXO (intervention) or OTAGO (control). Both programmes will consist of 3 weekly sessions for 14 weeks. Primary outcomes: IC, assessed through validated measures (Short Physical Performance Battery, Mini Nutritional Assessment, Mini-Mental State Examination, Cornell Scale for Depression in Dementia and sensory evaluation), motivation (BREQ-3) and adherence rate. Secondary outcomes include body composition, cardiovascular parameters, frailty, cognition and resilience (PRIFOR). Data will be analysed using two-way ANOVA (groupxtime) under an intention-to-treat approach. Effect sizes (p²) and 95% CIs will be reported. Additional analyses (correlation, regression, mediation and moderation) will explore associations and intervention effects.

Approved by the Ethics Committee of Universidad CEU Cardenal Herrera (Ref. CEEI23/487 and CEEI25/639). Results will be disseminated through peer-reviewed journals and scientific conferences. The findings of this study will contribute to improving evidence-based strategies for promoting healthy ageing and will support the development of more engaging and effective exercise interventions for older adults.

This study has been prospectively registered at ClinicalTrials.gov (identifier: NCT07133568).

Each year, suicide claims approximately 700 000 lives worldwide and generates a significant financial burden. Integrating genomic data, exposomic factors and digital phenotypes can enhance the development of short-term predictive models. Current knowledge and available tools provide the basis for designing personalised treatment strategies that incorporate real-time interventions to prevent suicide attempt recurrence cost-effectively. This study aims to develop a predictive algorithm for suicidal behaviour integrating psychiatric assessments, genetic risk markers, digital phenotypes and exposomic data.

This protocol describes a retrospective multicentre study that will recruit participants with a clinical history of suicide across 25 hospitals across Spain with a catchment area of 8.6 million people (17.8% of Spain’s population). Our sample target is over 5000 participants, aged over 12 years old, ensuring 93.5% statistical power for genetic analysis. Eligible participants must be over 12 years old. Data collection will include psychiatric assessments, biospecimen collections (DNA, RNA, plasma and serum), Google Takeout data for digital phenotyping, and a standardised set of administrative and clinical data registered for each patient. Genotyping will be performed with the Axiom Spanish array (>750 000 markers), and genome-wide association studies (GWAS) will be performed after genetic imputation in a whole sample of >10 000 individuals (5000 suicide attempters; 5000 controls). Prescription and clinical history will also be retrospectively integrated, and codified data statistics forms will periodically be sent to the Government. Statistical analyses will combine traditional regression models and AI-based algorithms to identify predictive behavioural, genomic profiles, and digital markers of suicidal behaviour. Cost-effectiveness analyses of pharmacogenomic markers for antidepressant response will also be conducted.

By successfully implementing this project, we aim to help reduce suicide reattempts and lessen the emotional and economic burden on families and the healthcare system.

This study has been approved by the Ethics Committee of the Fundación Jiménez Díaz (PIC301-24_FJD) and complies with the Declaration of Helsinki. It adheres to the GDPR (EU Regulation 2016/679), Spain’s Organic Law 3/2018 on Personal Data Protection and Digital Rights, and Law 41/2002 on patient autonomy. All required data protection measures will be implemented, including those under Real Decreto 1718/2010 on prescriptions and treatment adherence. Underaged participants will require parental consent for participation. The results will be disseminated through publication in peer-reviewed scientific journals and presentations at psychiatric conferences.

NCT07422090.

Primary progressive aphasia (PPA) is a neurodegenerative syndrome associated with Alzheimer’s disease and frontotemporal degeneration. Non-invasive brain stimulation (NIBS) is a promising treatment, especially associated with language therapy, but comparative efficacy and long-term effects between the different techniques (transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)) remain unknown. The present study aims to investigate the effects of non-invasive brain stimulation, alone or associated (tDCS/TMS/tDCS plus TMS) combined with language therapy delivered during a period of 6 months, in the progression of language impairment in PPA, compared with sham stimulation combined with language therapy.

The study is a randomised, double-blinded, parallel, sham-controlled clinical trial. Patients with PPA in early stages (global Clinical Dementia Rating equal to or less than 1) are eligible. They are to be randomised to one of the four treatment arms of the study (active tDCS-active TMS, active tDCS-sham TMS, sham tDCS-active TMS, sham tDCS-sham TMS). All patients will receive language therapy immediately after each session of NIBS, for 6 months. The primary outcome is the Mini-Linguistic State Examination. The secondary outcomes are naming of trained items, Addenbrooke’s Cognitive Examination, Interview for Deterioration in Daily Living Activities, Clinical Dementia Rating including behaviour and language domains, Neuropsychiatric Inventory and regional brain metabolism. Exploratory substudies will be conducted including blood biomarkers, quantitative electroencephalography and spontaneous speech assessment.

The study is registered (ClinicalTrials.gov: NCT07158216) and approved by the Ethics Committee of the Hospital Clinico San Carlos (code 25/309-IC_P_CE). Patients will be enrolled after signing an informed consent form. Study outcomes will be disseminated through presentations at scientific conferences, publications in peer-reviewed journals and other academic forums.

NCT07158216.