Emerging evidence supports a role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in the pathogenesis of treatment-resistant major depressive disorder (TRD). However, interventional studies targeting IL-6 in this population remain scarce. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 signalling and is approved for the treatment of autoimmune conditions such as rheumatoid arthritis. The primary objective of this study is to examine whether IL-6 inhibition via tocilizumab can impact depressive symptoms, inflammation-related biomarkers and cognition in patients with TRD. A secondary objective is to compare the biological profiles of patients with TRD with elevated inflammation to those of healthy controls.

This is a proof-of-concept, randomised, parallel-group, triple-blind, placebo-controlled clinical trial. 22 adult outpatients diagnosed with TRD and evidence of low-grade inflammation (serum C reactive protein≥3 mg/L) will be randomised (1:1) to receive either one intravenous infusion of tocilizumab (8 mg/kg; maximum 800 mg) or normal saline, administered as an add-on to their ongoing treatment. Psychiatric, cognitive and biomarker assessments will be performed at baseline and at follow-up visits on days 7, 14 and 28 post-infusion. Additionally, 10 healthy controls with no psychiatric history will undergo the same baseline assessments for biomarker comparison.

The study has been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (Project number: 2025-0245, CAAE: 88904825.7.0000.5327). Findings will be disseminated through peer-reviewed publications, scientific meetings and, on request, lay summaries for participants.

NCT07052058.

An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

NCT06331195.

This study aimed to determine the associations between adherence to the 24-hour movement guidelines and symptoms of anxiety and depression among Colombian university students.

Cross-sectional study.

1125 individuals (mean age 20.2±2.5 years; 56.7% female).

Students sampled from a single public university.

Participants completed validated self-report instruments: the International Physical Activity Questionnaire-Short Form to assess physical activity (PA), sedentary behaviour (SB) and the Pittsburgh Sleep Quality Index to assess sleep duration. Symptoms of depression and anxiety were measured using the Hospital Anxiety and Depression Scale, with a score of ≥11 used to classify elevated symptoms. Binary logistic regression models were used to estimate associations between adherence to the 24-hour movement guidelines (meeting all three, two, one or none) and mental health outcomes, adjusting for potential confounders.

Only 15.5% of students met all three components of the 24-hour movement guidelines. Meeting a greater number of components was significantly associated with lower odds of depressive and anxiety symptoms. In fully adjusted analyses, students who met all three guidelines were less likely to report anxiety symptoms (OR=0.26; 95%CI 0.13 to 0.54) and depressive symptoms (OR=0.42; 95%CI 0.22 to 0.79) compared with those who met none. Among individual behaviours, sufficient PA and adequate sleep were independently associated with lower odds of both outcomes, whereas high SB was associated with higher odds of elevated symptoms.

In this cross-sectional study, adherence to a greater number of 24-hour movement guideline components was associated with lower levels of anxiety and depressive symptoms in a graded manner. However, the cross-sectional design precludes inference regarding directionality or causality, and bidirectional associations or residual confounding remain possible. Longitudinal and interventional studies are needed to determine whether integrated daily movement behaviours influence mental health outcomes in young adults, particularly in Latin American populations.

Despite implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), screening coverage for oral, breast and cervical cancers remains below 2%. Screening quality is inadequately addressed and delays in diagnosis and treatment initiation continue to persist. This multisite implementation research aims to improve district-level coverage and quality of screening, early diagnosis and timeliness of treatment initiation through a model co-developed within the NP-NCD context.

The study will be conducted in three phases across seven districts in diverse regions of India. In phase I (formative), the current status, barriers and facilitators of cancer screening, diagnosis and treatment initiation under NP-NCD will be assessed. In phase II (optimisation), a model (package of implementation strategies) will be co-developed and iteratively optimised with multistakeholder engagement at the subdistrict level to improve screening coverage and quality and strengthen the referral system for early diagnosis and treatment initiation. In phase III (scale-up and evaluation), the model will be implemented at the district level and evaluated for improvements in screening, early diagnosis and treatment initiation. A convergent mixed-methods design will be used, incorporating household surveys, facility assessments and stakeholder interviews. Implementation Research Logic Model will guide planning, execution and evaluation in the present study. Determinants of screening coverage and quality, early diagnosis and treatment initiation will be assessed using the Consolidated Framework for Implementation Research. Implementation strategies for the model will be finalised using the Expert Recommendations for Implementing Change framework. Implementation and service outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.

Ethical approval has been obtained from all study sites. The study findings will be disseminated at the state, national and global levels through meetings and conferences and submitted to a peer-reviewed journal for publication.

CTRI/2025/08/092672.

Ophthalmic complaints account for a substantial proportion of presentations to emergency and acute eye care services, yet initial assessment or referral is frequently performed by non-ophthalmologist healthcare professionals. Previous single-centre studies suggest that one-third of referrals are incorrectly diagnosed, potentially delaying appropriate management of vision-threatening conditions. However, the overall magnitude of diagnostic error and patterns of misdiagnosis across healthcare settings remain unclear. This study aims to systematically review and synthesise the evidence on the diagnostic concordance of ophthalmic referral diagnoses made by non-ophthalmologists in acute eye care.

A systematic review and meta-analysis will be conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols) guidance and registered with PROSPERO. MEDLINE (Ovid), Embase (Ovid) and the Cochrane CENTRAL database will be searched from inception to April 2025. Studies evaluating the diagnostic accuracy of referrals made by non-ophthalmologist healthcare professionals in emergency or acute eye care settings will be included. Two reviewers will independently screen studies, extract data and assess risk of bias using the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2) framework adapted for referral-diagnosis studies. The primary outcome will be diagnostic concordance between referral and final ophthalmologist diagnosis. Where appropriate, pooled concordance proportions will be synthesised using a random-effects meta-analysis. Condition-specific 2x2 diagnostic accuracy analyses will only be undertaken where valid binary target conditions and sufficient denominators are reported. Heterogeneity will be assessed using Cochran’s Q test and the I² statistic with subgroup analyses exploring differences by referring clinician type and anatomical location of ophthalmic pathology.

Ethical approval is not required for this study as it will synthesise data from previously published studies; findings will be disseminated through publication in a peer-reviewed journal and presentation at relevant academic conferences.

CRD420261352717.

The DREAMSPHEN study (Dose REduction of Antipsychotics vs. Maintenance treatment in schizophrenia after Stratification based on psychotic PHENotype) aims to compare the benefits and risks of a hyperbolic tapering method for antipsychotics to the maintenance of antipsychotics in a sample of clinically stabilised patients with schizophrenia spectrum disorder.

A sample of 288 patients will be recruited from 12 centres in France. Inclusion criteria are: diagnosis of schizophrenia spectrum disorder (according to the 5th version of the Diagnostic and Statistical Manual of mental disorders, DSM-5), minimum of 3 months remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine and long-acting antipsychotic injection). First, the psychotic phenotype of the patients (cycloid psychosis vs other psychotic phenotype) will be assessed. Then, patients will be randomised either to the maintenance of treatment (MT) or to the antipsychotics dose reduction (DR) arm. DR will follow a hyperbolic schema according to Horowitz protocol. Patients will be assessed at baseline, and every 2 months until 24 months follow-up regarding social functioning, psychotic and negative symptoms, side effects of antipsychotic medication, cognitive functioning, patient satisfaction, substance and alcohol use, and quality of life. The primary outcome will be a good social functioning after 24 months defined as a score at the Personal and Social Performance Scale >70. Secondary outcome measures will include: psychotic and negative symptoms, hospitalisation for psychotic episode, antipsychotic dose, antipsychotic side effects, withdrawal symptoms, cognitive functioning, patient’s well-being and quality of life. Safety measures will include death, admissions to psychiatric hospital, psychotic relapses and severe self-harm.

The DREAMSPHEN trial aims to better identify patients with psychotic disorders who are most likely to benefit from antipsychotic tapering with an aim to inform future clinical treatment guidelines for antipsychotic treatment. DREAMSPHEN V2.0 of the 14 May 2025 has received ethical approval from Comité de protection des personnes Ile de France IV (N° 2023-509558-80-00) on 17 July 2025.

EU Clinical Trials Register – EudraCT no. 2023-509558-80-00. Clinical trials: NCT07152184. Registered on 9 August 2025.

Neoadjuvant chemotherapy (NAC) followed by definitive treatment consisting of either radical radiotherapy or radical cystectomy is the recommended treatment for patients with organ-confined muscle-invasive bladder cancer (OC-MIBC). A randomised controlled trial (RCT) aimed to compare the effectiveness of radical radiotherapy and radical cystectomy but failed to recruit. Radical radiotherapy is non-invasive and organ-preserving, and observational studies have suggested this treatment may be associated with similar outcomes compared with radical cystectomy. However, in these observational studies, the risk of confounding was high, and they did not consider the receipt of NAC. The surgery or radiotherapy (SORT) for the early-stage cancer study will assess the comparative effectiveness and cost-effectiveness of either radical cystectomy or radical radiotherapy, both after NAC for OC-MIBC. We will use a target trial emulation approach to reduce the risk of bias when assessing comparative effectiveness from observational data.

The SORT study will use UK’s National Cancer Registry to identify individuals diagnosed with urothelial OC-MIBC (T2-4aN0M0) between 1 January 2015 and 31 December 2021 who received either radical radiotherapy or radical cystectomy after NAC. The data will be linked to Hospital Episode Statistics (HES), National Radiotherapy Data Set (RTDS) and Systemic Anti-Cancer Therapy (SACT) data sets to gather information on clinical, tumour and socio-demographic characteristics and receipt of treatment. Using the target trial emulation framework, we will define the eligibility criteria and radical radiotherapy and radical cystectomy receipt. To reduce the risk of confounding, we will use advanced statistical approaches to allow for differences in measured baseline characteristics between the comparison groups.

The primary outcome is 3-year all-cause mortality after radical treatment receipt. Secondary outcomes will include all-cause and bladder-cancer-associated mortality at 3 and 5 years, time to death, incremental costs and incremental cost-effectiveness reported according to net health benefits.

The study was approved by the London School of Hygiene and Tropical Medicine Ethics Committee (Reference number 29717 - 1). Results will be communicated in open-access journals and conferences to clinicians, researchers, patients and policymakers.

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

Genitourinary syndrome of menopause (GSM) is a chronic, oestrogen-deficient condition that is frequently underdiagnosed and undertreated. Although low-dose vaginal estriol improves epithelial trophism and microbial balance, a substantial proportion of women report persistent symptoms. High-quality randomised evidence evaluating combined therapeutic strategies remains scarce. Energy-based modalities, including the erbium:YAG (Er:YAG) laser (=2940 nm), have been proposed as adjunctive treatments. This trial aims to assess the efficacy of Er:YAG laser therapy combined with vaginal estriol compared with estriol alone in postmenopausal women with GSM.

This is a single-centre, randomised, double-blind, controlled clinical trial. Postmenopausal women aged 45–70 years with vaginal pH ≥5.0 and at least one moderate GSM symptom (Visual Analogue Scale ≥4) will be eligible. Exclusion criteria include current systemic or local hormone therapy, previous vaginal energy-based treatment, abnormal cervical cytology and body mass index ≥35 kg/m². All participants will receive vaginal estriol cream (0.5 mg per dose) daily for 14 days, followed by twice-weekly administration for 16 weeks. Participants will be randomised (1:1) to receive either estriol plus sham Er:YAG laser or estriol plus active Er:YAG laser. Three laser sessions will be delivered at approximately 4-week intervals. Assessments will occur at baseline, monthly during treatment and 4 months after the final session. The primary outcome is the Vulvovaginal Health Index, with the primary endpoint defined as the change from baseline to 4 months post-treatment, reflecting sustained effect. Secondary outcomes include GSM symptom severity, vaginal microbiome composition (16S rRNA sequencing), quality of life (Menopause Rating Scale) and sexual function (Female Sexual Function Index). Data will be analysed using repeated-measures analysis of variance or appropriate non-parametric tests, with significance set at p

Ethical approval has been obtained from the Human Research Ethics Committee of UNINOVE. Written informed consent will be obtained. Findings will be disseminated via peer-reviewed journals and scientific meetings.

NCT06873971.

Organ preservation strategies for rectal cancer following neoadjuvant treatment require intensive endoscopic monitoring to detect early luminal recurrence. This is termed 'Watch and Wait' (WAW). Standard protocols commonly mandate flexible sigmoidoscopy every 3–4 months for 2 years. Digital proctoscopy with the LumenEye device has been shown to be a safe alternative that can be performed in an outpatient setting without the need for sedation and with less staffing requirements. The study objective is to evaluate the economic implications of using digital proctoscopy compared with flexible sigmoidoscopy for patients with rectal cancer managed under a WAW protocol.

The study was conducted in a secondary care National Health Service (NHS) setting. A cost comparison analysis was performed over a 2 year time horizon (seven procedures per patient). 177 procedures on rectal cancer patients undergoing WAW with digital proctoscopy between August 2023 and November 2024 were included. The control group, that is, flexible sigmoidoscopy was modelled. The base case was flexible sigmoidoscopy without sedation. Scenarios using sedation were also evaluated. Costs were categorised into fixed and variable costs. A one-way sensitivity analysis, probabilistic sensitivity analysis and What-If scenarios were also performed.

The primary outcome was the minimum cost difference between the two procedures. The secondary outcome measure was the robustness of the cost differences. Over 2 years, the total cost per patient was £768.92 (95% CI £656.6 to £900.7) for digital proctoscopy compared with £1,588.15 (95% CI £1458.1 to £1725.2) for flexible sigmoidoscopy without sedation. The absolute minimum cost saving per patient is £820.23 (95% CI £648.7 to £985.1). Cost savings increased to £848.94 (95% CI £677.20 to £1013.83) to £935.62 (95% CI £761.02 to £1103.08) when sedation was used in flexible sigmoidoscopy procedures. Personnel costs during the procedure and recovery phase were the dominant cost drivers for flexible sigmoidoscopy. Probabilistic sensitivity analysis and What-If scenarios confirmed the robustness of the findings, with flexible sigmoidoscopy remaining more costly.

Digital proctoscopy with the LumenEye device is a cost-saving alternative to flexible sigmoidoscopy for patients with rectal cancer on a WAW protocol. Our findings support the integration of digital proctoscopy into WAW pathways as a cost-efficient alternative within resource-constrained healthcare systems. Endoscopy service pressures are also likely to be alleviated.

This study explored the lived experiences, challenges and coping strategies of Arab male patients with spinal cord injury (SCI) who rely on intermittent catheterisation (IC) to manage neurogenic bladder.

A descriptive qualitative approach was employed, with data analysed using a phenomenological framework.

Rehabilitation Hospital, King Fahad Medical City, Riyadh, Saudi Arabia.

Male patients with SCI undergoing rehabilitation and performing IC were included in the study. Although both male and female patients were approached to participate, all eligible female patients declined participation. During the recruitment process, some female patients informally expressed privacy concerns and discomfort related to discussing bladder management issues and genital care, which may have contributed to their decision to decline participation.

10 male participants with SCI were recruited after eligible female patients declined participation. Three main themes, each with associated subthemes, emerged to reflect the participants’ experiences. Theme 1: Frequent use of IC in daily life, comprised four subthemes: (1) frequency of practice, (2) environmental and health-related challenges, (3) privacy during IC and (4) fluid intake and output. Theme 2: Cleanliness and general care included two subthemes: (1) catheter cleaning and (2) incontinence. Theme 3 focused on body image and sexuality. Cultural and social norms, including privacy concerns and sensitivities surrounding intimate care in the local context, played a significant role in shaping participants’ experiences and coping strategies.

IC was associated with challenges affecting multiple aspects of daily life among patients with SCI, including social interactions and body image. Participants described various coping strategies used to manage the physical and psychological demands associated with IC. These experiences appeared to be influenced by cultural considerations, including privacy, modesty and sensitivity surrounding urinary care within the local Saudi context.

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (² p

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

NCT04610515.

In current practice, fluid volumes administered to children following kidney transplant vary widely. Up to 52% of children experience fluid overload-related complications. Current fluid guidelines are not evidence-based and the optimal amount of fluid for children after transplant is not known. The aim of Randomised multiple centre trial of conservative versus LIberal fluid adMInisTration for children receiving a kidney tranSplant (LIMITS) is to determine whether relative limitation of fluid volume administered to children receiving kidney transplants is superior to liberal fluid volume administration.

LIMITS is a pragmatic, open-label, UK-based, multicentre randomised controlled trial, with an internal pilot phase and integrated economic evaluation. A total of 140 children receiving kidney transplants will be randomised to receive either conservative postoperative fluid administration (maximum of 150 mL/m²/hour for no longer than 18 hours, followed by a fixed daily target of maximum 1.5 L/m²/day thereafter) versus the comparator of liberal postoperative fluid administration (fluid volume administered to replace urine output and insensible losses for at least 48 hours with target urine output >2 mL/kg/hour). The primary outcome is mean days at home in the first 30 days after kidney transplant. The primary outcome will be analysed using a mixed linear regression model adjusted for donor type (living vs deceased donor) and participant weight (

The trial received Health Research Authority approval on 20 August 2025 (REC reference: 25/EE/0161, IRAS project ID: 354370). Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain.

ISRCTN21516608.

Irrational prescribing is a major global health concern, contributing significantly to increased morbidity, mortality and antimicrobial resistance (AMR). Despite existing knowledge and awareness, irrational antibiotic use remains prevalent among healthcare professionals.

This qualitative study aimed to explore the contributing factors to irrational antibiotic prescribing, understand healthcare professionals’ perceptions, identify barriers to rational use and gather suggestions for improving rational antibiotic use.

A qualitative study using semi-structured interviews was conducted with participants. A total of 60 healthcare professionals (20 physicians, 20 pharmacists and 20 nurses) participated after providing verbal consent.

Semi-structured interviews were conducted with healthcare professionals across various clinical settings in Pakistan until data saturation was reached. The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was used to ensure transparent reporting. An inductive thematic analysis approach was employed and themes and subthemes were developed from the data.

The findings revealed a generally good understanding of irrational prescribing. Contributing factors included prescriber-related issues, patient expectations, weak regulatory oversight and underutilisation of pharmacists. Key barriers identified were financial constraints, lack of awareness and insufficient resources. Suggestions for improvement included regular audits, public awareness campaigns, an integrated healthcare system, interprofessional collaboration, drug utilisation reviews, adverse drug reaction reporting, standardising hospital policies and strengthening regulatory frameworks.

This study highlights critical factors and barriers contributing to irrational antibiotic prescribing and presents practical suggestions to improve rational use. Implementing evidence-based approaches, updating clinical guidelines, and promoting awareness among healthcare professionals are essential steps toward improving prescribing practices and combating AMR.

To analyse the completeness of the COVID-19 vaccination schedule and identify factors associated with vaccine uptake.

Cross-sectional study.

Data were collected through face-to-face interviews conducted in all 26 Brazilian state capitals and the Federal District between 2022 and 2023, using a sequential sampling approach.

A total of 1392 individuals aged 18 years or older experiencing homelessness for at least 6 months were included.

The primary outcome was the completeness of the COVID-19 vaccination schedule (complete vs incomplete), based on self-reported vaccination status. Secondary analyses examined sociodemographic, institutional and behavioural factors associated with vaccine uptake using binary logistic regression.

Completion of the vaccination schedule was positively associated with receiving government aid (OR: 1.58; 95% CI 1.09 to 2.30), visits from street clinic health agents (OR: 3.19; 95% CI 1.95 to 5.36), prior COVID-19 diagnosis (OR: 5.77; 95% CI 3.17 to 11.15), support for mandatory vaccination (OR: 3.76; 95% CI 2.48 to 5.76), trust in vaccine efficacy (OR: 3.92; 95% CI 2.63 to 5.89), seeking information from community sources (OR: 1.91; 95% CI 1.01 to 3.88) and trust in federal authorities (OR: 1.57; 95% CI 1.06 to 2.31).

This study identified structural, social and individual factors associated with complete COVID-19 vaccination among people experiencing homelessness in Brazil. Although overall coverage was substantial, gaps in vaccination completeness persisted. Social support, healthcare outreach and trust in vaccines were associated with higher uptake, highlighting important barriers and facilitators to vaccination in socially vulnerable populations.

Despite progress in primary care, access to oral health remains limited in India. Integrating oral health into primary care can improve oral health outcomes for communities, especially in rural areas. This study aims to develop an implementation model for integrating dental healthcare into primary healthcare systems in Chamarajanagar and Mysuru districts of Karnataka.

A mixed-methods implementation research approach will be adopted for this study, comprising three phases: formative, pilot and implementation and evaluation.

A mixed-methods study at the district level will be conducted to capture diverse perspectives and characterise inequalities in oral healthcare access and literacy levels across urban, rural and tribal areas. Oral health literacy surveys, facility preparedness checklists and in-depth interviews will be conducted. With a consultative approach involving stakeholders, we ensure their input in the design and pilot the integrated interventions to build a replicable model for integrating dental health services into primary healthcare.

Through this structured approach, the study seeks to improve overall oral health outcomes and achieve sustainable improvements in oral health at both community and system levels.

This study has been approved by the Institutional Ethics Committee at the Institute of Public Health Bengaluru (IPH/23-24/E/374). Findings will be disseminated through workshops, presentations and publications in peer-reviewed journals.

The incidence of depression among children and adolescents has been increasing in recent years, posing significant challenges to public health and clinical care. A variety of treatments, including pharmacotherapy, psychotherapy and physical interventions, are widely used in clinical practice. However, a comprehensive synthesis of the evidence on the efficacy and acceptability of all these treatment modalities is currently lacking. This study aims to use network meta-analysis (NMA) to compare the efficacy and acceptability of all available treatments for depression in children and adolescents, offering valuable insights to inform clinical decision-making and guide future research in this critical area.

We will include randomised controlled trials evaluating active interventions for depressive disorders in children and adolescents. Seven electronic databases (PubMed, Embase, the Cochrane Library, Web of Science, PsycINFO, Scopus and ClinicalTrials.gov) were searched from inception to 2 July 2024 and updated on 2 November 2025. Two of four investigators will independently screen studies, extract data from eligible articles and assess the risk of bias using the Cochrane Risk of Bias 2.0 tool. The primary outcome will be the change in depressive symptoms. Secondary outcomes will include acceptability (all-cause discontinuation), response rate, remission rate and overall functioning. Pairwise and Bayesian NMA will be conducted. Small-study effects and publication bias will be assessed. The certainty of the evidence will be evaluated according to the Confidence in Network Meta-Analysis approach.

As this review involves secondary analysis of previously published studies, ethical approval is not required. The findings will be disseminated through publication in peer-reviewed journals.

PROSPERO-ID CRD42024557384.

Pregnancy in women with pre-existing type 1 or type 2 diabetes (T1D, T2D) is associated with increased risk of complications, largely driven by maternal glucose control. Hormonal changes during pregnancy make glucose management more challenging. Physical activity (PA) may improve glucose control and reduce complications; however, little is known about PA patterns in this population and no pregnancy-specific PA guidance exists for women with pre-existing diabetes. Understanding the behaviours and experiences of both pregnant women and the healthcare professionals (HCPs) who support them is needed to inform evidence-based guidance.

This mixed-methods study comprises three sub-studies. The first will recruit 175 pregnant women (75 with T1D and 100 with T2D) who will complete three 7-day monitoring periods, one per trimester. PA will be assessed using wrist-worn accelerometers and exercise diaries, dietary intake via remote food photography, and corresponding continuous glucose monitor and diabetes-related well-being data will be collected.

The second involves a subsample of ~16 women participating in focus groups to explore experiences of being physically active during pregnancy.

The third invites ~100 HCPs involved in diabetes in pregnancy care to complete an online survey, ~10 HCPS will take part in an optional interview about their experiences of providing PA guidance.

The primary outcome is the change in PA across pregnancy. Secondary outcomes include associations between PA, glucose metrics, diet and diabetes-related well-being, and qualitative themes relating to experiences of women and HCP. Quantitative data will be analysed using multilevel modelling and regression analysis, and qualitative data using reflexive thematic analysis.

Ethical approval was granted by the East Midlands Nottingham 1 Research Ethics Committee (25/EM/0190) and University of Exeter Public Health and Sport Sciences ethics committee. Findings will be disseminated through peer-reviewed publications and conference presentations.

This study aimed to evaluate the prevalence and metabolic, hormonal and clinical characteristics of metabolic syndrome among women with polycystic ovary syndrome (PCOS) in the Oran region (western Algeria).

Cross-sectional study.

Outpatient endocrinology and gynaecology services in the Oran region, western Algeria.

A total of 313 women aged 16–45 years diagnosed with PCOS according to the Rotterdam 2004 criteria.

Prevalence of metabolic syndrome and differences in anthropometric (body mass index (BMI)), metabolic (fasting glucose and lipid profile), hormonal (gonadotropins, androgens, anti-Müllerian hormone (AMH), progesterone, vitamin D) and clinical features (hyperandrogenism, menstrual irregularity, infertility) between women with and without metabolic syndrome.

Of the 313 participants, 181 (57.9%) met the criteria for metabolic syndrome. These women had significantly higher BMI (26.70±5.93 vs 25.06±6.47 kg/m²; p=0.004), elevated fasting glucose (133.43±28.52 vs 105.41±28.54 mg/dL; p

More than half of women with PCOS exhibited metabolic syndrome, characterised by obesity, dyslipidaemia, insulin resistance and vitamin D deficiency. These findings highlight the need for early metabolic screening and holistic management in women with PCOS to reduce long-term cardiovascular and reproductive risks.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects around 35%–50% of men during their lifetime. The efficacy of current oral medication for CP/CPPS remains limited. Recent studies demonstrated that vagus nerve stimulation may improve chronic pelvic and abdominal pain. Accordingly, transcutaneous auricular vagus nerve stimulation (taVNS) might represent a promising, non-invasive therapeutic approach for the clinical management of CP/CPPS.

The trial of Transcutaneous Auricular vagus nerve Stimulation for moderate to severe Chronic Prostatitis/CPPS is a prospective, randomised, sham-controlled trial with a 1:1 allocation ratio. Participants will be assigned randomly to either the taVNS group or the sham-taVNS group. The intervention period will consist of a 4-week treatment (a total of 40 sessions), followed by an 8-week follow-up period. The primary outcome is the change from baseline in the National Institutes of Health Chronic Prostatitis Symptom Score Index total score at week 4. Secondary outcomes include the International Prostate Symptom Score Scale, European Quality of Life 5-Dimensions-5-Levels questionnaire, Self-Rating Anxiety Scale and Self-Rating Depression Scale. Safety assessments will be conducted throughout the entire study period.

This study protocol and informed consent documents were reviewed and approved by the Institutional Review Board of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval number: 2023-250 KY). Written informed consent will be obtained from all participants and/or their legal guardians prior to trial participation. The findings will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences. The research data will be made available on reasonable request.

NCT06287970.