Loneliness and social isolation are critical public health issues linked to significant adverse health outcomes and increased healthcare utilisation, including visits to the emergency department (ED). The ED often serves as a primary societal safety net, providing care for vulnerable populations who may be disproportionately affected by these conditions. In fact, loneliness and social isolation might be the underlying reasons they presented to the ED in the first place either consciously or not. For such individuals, the ED encounter may represent a rare point of human contact, yet the stressful and depersonalising nature of the ED environment may paradoxically exacerbate their sense of isolation. Furthermore, ED staff may lack the training and awareness of the scope of the problem to properly screen for loneliness and address it. Yet, the compounded impact of the ED experience on lonely or socially isolated patients and the relationship between loneliness and healthcare utilisation remains poorly understood. This paper presents a protocol for a scoping review designed to systematically map the existing evidence on the experiences of these patients and the perspectives of the clinicians who care for them.

This scoping review will be conducted following the Arksey and O’Malley methodological framework in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The findings will be reported according to the Extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (PRISMA-S; see ). A comprehensive search will be performed across five electronic databases (PubMed, Embase, Scopus, Web of Science, CNKI) and grey literature sources. Studies published in English or Chinese that address loneliness or social isolation in the ED context, from the perspective of adult or paediatric patients or clinical staff, will be included. A novel, artificial intelligence (AI)-assisted screening process will be utilised for initial relevance assessment, followed by full manual screening and data extraction by two independent reviewers to ensure rigour and mitigate bias. Findings will be synthesised using a narrative approach and thematic analysis to identify key concepts, themes and existing gaps in the literature.

As this study synthesises data from previously published literature, it does not require formal ethical approval. The findings will be disseminated through a manuscript submitted to a peer-reviewed, open-access journal. The aim is to provide an evidence-based roadmap to guide future research, inform policy and support the development of interventions designed to improve care and outcomes for this vulnerable population within the acute care setting.

The review has been registered at Open Science Framework, DOI 10.17605/OSF.IO/MBVSR.

Acute febrile illness is a major cause of morbidity and healthcare seeking in sub-Saharan Africa, including Mozambique. However, few studies have explored the perceptions and practices related to clinical management of acute febrile illness. Our aim was to understand the perceptions, knowledge and practices of healthcare professionals and community members regarding the management of acute febrile illness.

A qualitative study was conducted using a thematic analysis approach. Eight focus group discussions (FGDs) and three in-depth interviews (IDIs) were conducted in two Mozambican provinces across four healthcare facilities. Purposive sampling was used to select participants, comprising both healthcare professionals and community members. Data were analysed thematically through manual coding, applying inductive and deductive approaches, in line with established qualitative analytical frameworks.

The study included a total of 60 participants, 28 healthcare professionals who participated in FGDs (25) and IDIs (3) and 32 community members who participated in FGDs. Major causes of fever, according to healthcare professionals, were upper and lower respiratory infections, malaria, diarrhoeal diseases and COVID-19. The diagnostic approach for febrile patients primarily included screening, malaria testing and other non-specific investigations depending on availability at health facilities. Antibiotics and antipyretics were the most commonly prescribed treatments. The healthcare professionals reported a decrease in prescribing antimalarials due to extensive training on malaria case management. In contrast, community members reported relying primarily on home-based and traditional practices to treat acute febrile illness before seeking care at health facilities. These practices are related to sociocultural habits, such as the use of traditional medicine and self-medication. The main barriers to seeking care at health facilities were the perception of poor quality of care, long waiting times, cultural beliefs and lack of medicines.

Proper management of non-malarial febrile illness remains a major challenge for both healthcare professionals and communities. Training, adherence to case management protocols and efforts to change behaviours to mitigate harmful sociocultural practices are urgently necessary to improve febrile illness management.

Scaling and root planing (SRP) combined with adjunctive antibiotic therapy is widely adopted in the management of periodontitis in patients with type 2 diabetes mellitus (T2DM), with the aims of ameliorating glycaemic control, alleviating local inflammation and facilitating periodontal tissue regeneration. As a topically administered adjunctive antibiotic for periodontal treatment, minocycline hydrochloride (MH) ointment has shown favourable clinical efficacy in systemically healthy patients with periodontitis. However, robust evidence supporting its clinical efficacy and potential glycaemic-improving effects in patients with periodontitis complicated by T2DM remains limited. The present study is designed to test the null hypothesis that no significant differences in clinical outcomes exist between SRP combined with MH and SRP alone in the management of periodontitis among patients with T2DM, with its primary objective to investigate whether MH as an SRP adjunct confers superior clinical benefits to SRP alone.

We will conduct a randomised, single-blind, placebo-controlled clinical trial. 56 patients with T2DM-associated stage III/IV periodontitis will be recruited from the Department of Periodontology, Peking University School and Hospital of Stomatology, Beijing, China. Eligible participants will be randomised into two groups: the experimental group will undergo SRP combined with topically administered MH ointment and the control group will undergo SRP with a matched placebo. The primary outcomes will include probing depth (PD) changes at periodontal pocket sites with a baseline PD ≥6 mm at 6 months post-baseline, with a specific focus on the percentage of such sites with PD reduced to ≤5 mm. The secondary outcomes will comprise PD changes at pocket sites with a baseline PD ≥5 mm at 6 months post-baseline, as well as clinical attachment loss, the plaque index, bleeding index, the levels of IL-1β, IL-17, calprotectin and insulin levels in gingival crevicular fluid and serum, complete blood count, blood biochemistry, including glycated haemoglobin levels, and the composition of subgingival plaques at baseline, and 2 and 6 months post-baseline.

This study was approved by the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-2024102139b). Results will be published in a peer-reviewed scientific journal.

ChiCTR2400092305.

V.3.1 (date: 6 January 2026).

Delayed post-polypectomy bleeding (DPPB) remains a significant complication of endoscopic resection, contributing to morbidity and increased healthcare costs. Although prophylactic clipping is widely practised to mitigate this risk, evidence from recent randomised controlled trials (RCTs) regarding its efficacy is inconsistent. This protocol outlines a systematic review and meta-analysis to evaluate the effectiveness of prophylactic clips following thermal resection.

We will conduct a comprehensive search of MEDLINE, EMBASE and the Cochrane Library from inception to 10 February 2026, to identify RCTs comparing prophylactic clips vs no clips in patients undergoing thermal endoscopic resection of non-pedunculated polyps. The primary outcome is DPPB within 30 days, defined as overt bleeding requiring medical intervention or a haemoglobin decrease ≥2 g/dL. Secondary outcomes include DPPB in proximal large (≥20 mm) lesions, perforation, post-polypectomy syndrome and procedure time. Data synthesis will use a random-effects model. Methodological quality will be assessed using the Cochrane Risk of Bias 2 tool. Publication bias will be visualised using funnel plots. We will quantify the effect of potential effect modifiers by meta-regression if appropriate. The quality of evidence will be evaluated according to the Grading of Recommendations Assessment, Development and Evaluation framework.

This study will not use primary data, and therefore formal ethical approval is not required. The findings will be disseminated through peer-reviewed journals and committee conferences.

CRD420251246840.

This study aimed to investigate the association of the triglyceride-glucose (TyG) index with the risk of acute myocardial infarction (AMI) and all-cause mortality in patients with coronary artery disease (CAD), and to inspect whether AMI mediates the relationship between TyG index and mortality.

A large-scale, retrospective cohort study.

This single-centre study was conducted at a tertiary academic hospital in South China. The association between the TyG index and AMI was assessed using multivariable logistic regression, with progressive adjustment for demographic and clinical covariates. Cox proportional hazards models were used to estimate the HRs for all-cause mortality associated with TyG index. Restricted cubic splines and mediation analysis were employed to examine non-linear relationships and the mediating role of AMI.

A total of 20 125 patients diagnosed with CAD during hospitalisation between January 2020 and February 2025 were initially enrolled. After applying exclusion criteria (insufficient data), 18 245 participants were included in the final analysis.

We examined the association of the TyG index with the risk of AMI, as well as its association with all-cause mortality across different CAD subgroups.

The association between the TyG index and all-cause mortality was significantly modified by AMI status (P for interaction

An elevated TyG index independently predicts the risk of AMI in patients with CAD. Its prognostic value for mortality, however, is critically dependent on the presence of AMI: while a higher TyG index is associated with increased mortality in patients with AMI, moderately elevated TyG levels (Q2–Q3) are associated with lower mortality, whereas the highest quartile shows no significant association. Mediation analysis further reveals that AMI significantly mediates the association between TyG index and mortality, highlighting the importance of AMI prevention in mitigating the adverse prognostic impact of insulin resistance in the CAD population. These findings warrant validation in prospective studies.

To explore the impact of acute worsening events (AWEs), defined as clinically relevant deteriorations in peak expiratory flow, reliever use and/or symptoms, on patients’ daily lives and identify behaviours linked to their recognition and management.

A qualitative international substudy was conducted in the Netherlands, Spain, the USA, Canada and the UK (2023–2024).

19 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from a randomised clinical trial participated. Interviews, triggered by AWEs and repeated 6 weeks later, were audio-recorded, transcribed and analysed.

Patients varied in identifying bad days, reporting inability to perform physical activities, symptom worsening or the need for add-on treatment. Recognition of AWEs depended on their duration: shorter events (

AWEs significantly impact daily life but vary widely in recognition and thresholds for seeking care. Limited awareness of daily disease variations may contribute to both under-reporting of worsening events to healthcare providers and suboptimal self-management in COPD.

NCT05492877.

A good limb position (GLP) plays an important role in the rehabilitation process of patients who have had a stroke with hemiplegia. However, there remains a lack of effective assessment tools for clinical nurses to evaluate their GLP management practices.

This study aimed to develop and test the psychometric properties of the Good Limb Position Management Scale for Stroke Patients with Hemiplegia by Nurses (GLPMSSPHN).

A quantitative and cross-sectional design.

89 hospitals in 16 cities of China.

A total of 516 participants completed the questionnaire and were finally used for the analyses.

An initial scale was developed based on the Capability, Opportunity and Motivation-Behaviour model combined with a comprehensive literature review, semi-structured interviews, Delphi expert consultations and a pilot test. A field survey was then performed using the initial scale to test the reliability and validity of the scale. Reliability analysis was conducted by calculating Cronbach’s α coefficients and test–retest reliability. The results of exploratory factor analysis and confirmatory factor analysis were used as the validity index to further verify the model structure of the scale and develop a formal scale.

The GLPMSSPHN was formulated with 4 dimensions and 35 items. Exploratory factor analysis extracted four factors, with a cumulative variance contribution rate of 81.842%, and confirmatory factor analysis indicated that the scale had good construct validity. The Cronbach’s α coefficient of the scale was 0.978, and the test–retest reliability was 0.863.

The GLPMSSPHN has ideal reliability and validity and provides a valid and reliable tool for clinical nurses to identify and assess the management level of GLP in patients who have had a stroke with hemiplegia.

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.

Information anxiety (IA) describes the distress caused by the gap between the information individuals have and what they feel they should possess. In the current digital environment—marked by volatility, uncertainty, complexity and ambiguity—IA has expanded beyond traditional academic and workplace contexts to become a pervasive concern across populations. Mapping the empirical evidence on IA is critical to understanding its prevalence, determinants, impacts and coping strategies.

This protocol outlines a scoping review guided by the Joanna Briggs Institute methodology and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR). We will systematically search EBSCOhost, Scopus and Web of Science for peer-reviewed empirical studies published from 1 January 2000 to the planned end date of 5 November 2025. Two reviewers will independently screen records, with a third resolving discrepancies. Data extraction will be conducted using a customised tool, and results will be synthesised narratively and visually, structured around bibliometric characteristics, the Population, Concept, Context framework and a Stimulus-Organism-Response model. Subgroup analyses will be conducted across populations, disciplines and regions.

As this study is based on secondary analysis of published data, ethical approval is not required. Findings will be disseminated through peer-reviewed journals and academic conferences.

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.

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.

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.

Referrals to speech and language pathology are infrequent for people with Parkinson’s disease (PD), despite speech and communication being often affected and greatly impacting their quality of life. This study investigated the knowledge, self-competence and challenges faced by speech and language pathologists (SLPs) in Malaysia when managing PD cases.

Participants self-administered an online-survey in a cross-sectional study design. The survey consisted of 14 questions on current practices of SLPs with their patients with PD, self-perceived competence when assessing and managing PD and perceived barriers for catering to patients with PD. Inferential statistics were run on self-perceived competence across domains and their relationship with demographic/current practice factors. Descriptive statistics were used to analyse perceived barriers.

The survey was administered in English through Google Forms.

54 Malaysian SLPs with at least one active case of PD in their caseload were invited via email and WhatsApp Messenger. These contacts were obtained from the Speech-Language Therapists Association of Malaysia (SPEAK), and snowball sampling was encouraged to recruit additional SLPs through other social networks.

To quantify Malaysian SLPs’ self-perceived competence levels (assessed on 5-point Likert scales) in assessing and managing five key domains in patients with PD: speech, language, oro-motor skills, cognition and swallowing; and to identify the frequency and types of barriers encountered in clinical practice with patients with PD through structured multiple-choice questions. Secondary outcomes included quantifying current service delivery patterns (frequency of PD referrals, stage at referral, caseload size), multidisciplinary consultation patterns and confidence levels in managing rehabilitation risks associated with PD, all measured through structured survey items with categorical or ordinal response options.

Most participants had 1–5 patients with PD in their active caseload, referred at a middle or advanced stage of the disease. The majority of participants felt competent in assessing and managing motor speech and language in patients with PD. Conversely, most of them did not feel competent in assessing and managing cognition in these patients, regardless of demographic factors or current practices. This difference was significant. Most participants also reported facing barriers such as health conditions or comorbidities, family expectations on the therapy outcome and the unavailability of a multidisciplinary approach.

The study reveals that SLPs working in Malaysia feel competent in working with motor speech and language in individuals with PD. However, it highlights a need for additional training to address cognitive assessment and management as a crucial tool to boost functional communication in people with PD. The study also reveals a need for promoting a multidisciplinary approach.

In kidney transplantation, immunosuppressive therapy is essential to control alloimmune reactions, prevent graft rejection and improve patient survival rates. However, commonly used drugs like tacrolimus (TAC) and mycophenolate mofetil (MMF) have a narrow therapeutic window and exhibit significant inter- and intra-individual variability in pharmacokinetics (PK) and dose-response relationships. Recent pilot studies suggest that the gut microbiome may influence this variability.

ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiome modulations After kidney transplantation (ENIGMA) is a prospective, low-interventional, naturalistic longitudinal trial designed to identify biomarkers of TAC and MMF PK variability by examining gut microbiome changes and modulations after kidney transplantation and their link with TAC and MMF PK. Biological samples from 50 patients will be collected at nine specific timepoints pre- and post-transplantation using a rich PK and biological sampling strategy. This approach will enable the derivation of PK parameters for the investigated drugs and the creation of a biobank for future hypothesis testing.

The ENIGMA trial has received ethical approval from the European Medicines Agency (EMA). The reference number of our project is R&D/1325226 and is registered on the Clinical Trial Information System (CTIS) platform with European Union Clinical Trial number 2023–5 08 335-31-00. Results of the trial will be published in scientific journals and presented at different (inter)national conferences.

2023–5 08 335-31-00 EMA.

Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a promising respiratory support method for avoiding invasive mechanical ventilation in neonatal intensive care units (NICUs). However, its effectiveness and safety have not been widely established through clinical evidence. In this study, we aim to evaluate the feasibility of NIV-NAVA as a primary respiratory support method after birth and its effects on short-term clinical outcomes and long-term neurodevelopment in preterm infants.

In this prospective multicentre observational study, 230 preterm infants will be recruited after birth. This study will include preterm infants born between 27⁺⁰ and 31⁺⁶ weeks of gestation who require respiratory support within the first 48 hours after birth. NIV-NAVA will be initiated as primary respiratory support either immediately after birth or during the early NICU stay, with settings adjusted according to each infant’s clinical condition. Discontinuation of NIV-NAVA or transition to continuous positive airway pressure or high-flow nasal cannula will be performed based on clinical stability. A less invasive surfactant administration method will be used for infants with respiratory distress syndrome to avoid intubation whenever possible. Infants intubated at birth will be extubated to NIV-NAVA as early as is clinically feasible. Invasive ventilation may be applied if clinical deterioration occurs. The rate of NIV-NAVA failure, duration of non-invasive and invasive ventilation, rate of bronchopulmonary dysplasia and clinical outcomes, such as air leak, patent ductus arteriosus, intraventricular haemorrhage and retinopathy of prematurity, will be measured. The neurodevelopmental outcomes of infants will be assessed for up to 3 years.

The Institutional Review Board (IRB) of Korea University Anam Hospital (2024AN0554) and Seoul National University Bundang Hospital (IRB No. B-2507-984-304) approved this study. The results will be disseminated through scientific conferences and publications.

NCT06786039 registered on 14 January 2025.

Semirigid thoracoscopy plays an important role in the diagnosis of pleural diseases. However, its diagnostic performance remains unsatisfactory particularly in terms of the negative likelihood ratio. Therefore, more effective supplementary diagnostic tools are required. Probe-based confocal laser endomicroscopy (pCLE), which allows live tissue imaging at the cellular level, can discriminate between malignant and benign pleura during medical thoracoscopy. However, the clinical relevance of pCLE in pleural disease remains unclear. This protocol describes a randomised controlled trial that evaluates the additional diagnostic value of pCLE in diagnosing pleural diseases using semirigid thoracoscopy.

This study is a multicentre, parallel-group, randomised controlled trial that will be conducted at ten sites in China. A total of 158 adult patients with undiagnosed exudative pleural effusions will be enrolled and randomly allocated (1:1) to undergo either a conventional pleural biopsy (control group) or a pCLE-guided pleural biopsy (intervention group) via semirigid thoracoscopy. In the intervention group, a pCLE system will be applied during thoracoscopy to identify suspicious pleural areas for targeted biopsy. The primary outcome is the diagnostic yield of the procedure in patients with unknown causes of pleural effusion. Secondary outcomes include negative likelihood ratio, diagnostic sensitivity in specific diseases, procedural time, rate of adequate specimens for achieving molecular diagnosis and complications.

Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2025-KY-018). Written informed consent will be obtained from all the participants. The findings will be disseminated through journal publications and conference presentations.

NCT06741839.

Although several systematic reviews and meta-analyses have demonstrated the benefits of exercise interventions in older adults with frailty, the potential harm associated with these interventions has not been systematically synthesised. This systematic review aims to examine the adverse events reported in exercise intervention trials involving older adults with frailty and to compare the risk of adverse events between the intervention and control groups.

Searches will be performed in four electronic databases (PubMed, Cochrane Library, Web of Science and SPORTDiscus) for published trials. Eligible studies will be randomised controlled trials of exercise interventions, including older adults with frailty aged ≥60 years, with frailty identified using a validated method. Five reviewers and three referees, all with expertise in exercise interventions, will be assigned to three independent review teams to ensure efficient screening. Reviewers will independently screen titles, abstracts and full texts using Rayyan, and then extract trial and adverse event data into an Excel spreadsheet. The risk of bias in eligible trials will be assessed using the Cochrane Risk of Bias 2 (RoB-2) tool. The referees will resolve any disagreements between the two reviewers throughout the screening, data extraction and risk-of-bias assessment processes. The primary outcome is adverse events, defined as any unfavourable, unintended signs, symptoms or disease that occurred during the study period. An independent biostatistician will perform a random-effects meta-analysis using a generalised linear mixed model with a binomial likelihood and a logit link to estimate the pooled risk ratios (RRs) for adverse events in the intervention group relative to the control group. Publication bias will be evaluated using funnel plots and Egger’s regression test. Depending on the number of available studies, subgroup analyses will be conducted to examine differences in RRs according to the study quality, duration of intervention, exercise frequency, setting and supervision.

Ethical approval was not required because we did not use specific patient data. The findings of the systematic review and meta-analysis will be disseminated through publication in a peer-reviewed journal and presentation at appropriate conferences.

CRD420251180645.

To examine whether the use of a venous access-site closure device is associated with the occurrence of postoperative nausea and vomiting (PONV) after atrial fibrillation (AF) ablation under propofol sedation.

Observational study.

A single-centre retrospective observational study in Okayama, Japan.

We retrospectively analysed consecutive patients who underwent AF ablation under deep propofol sedation with adaptive servo-ventilation. A total of 686 patients were included. Patients were managed using a standardised sedation protocol with or without low-dose pentazocine. Patients treated with conventional manual compression for haemostasis (n=383) were compared with those treated using a venous access-site closure device (n=303).

Postprocedural bed rest duration and the incidence and timing of PONV were compared between groups. Associations between closure device use and PONV were evaluated using logistic regression analysis.

The primary outcome was the occurrence of PONV following AF ablation.

All procedures were completed under propofol sedation without conversion to general anaesthesia. The duration of postprocedural bed rest was shorter in the device group than in the conventional-compression group (mean difference –14.7 hours, 95% CI –15.2 to –14.0).

PONV occurred in 6/303 patients (2.0%) in the device group and 20/383 patients (5.2%) in the conventional-compression group, corresponding to a relative risk of 0.38 (95% CI 0.15 to 0.93), an OR 0.25 (95% CI 0.10 to 0.62) and a risk difference of –3.2% (95% CI –6.0% to –0.5%).

In multivariable analysis, use of a venous closure device was associated with a lower likelihood of PONV.

In this single-centre observational study, use of a venous access-site closure device was associated with a lower occurrence of PONV after AF ablation under propofol sedation. These findings suggest that postprocedural management strategies enabling earlier mobilisation may be associated with improved patient comfort; however, causal inference is limited by the observational design.

The Tianjin Health and Chronic Disease Study (THCDS) is a longitudinal dynamic cohort study established in 2022, aiming to investigate risk factors and intervention targets of common non-communicable diseases (NCDs) in Tianjin, China.

A total of 14 324 participants (average age: 53.48, 34.8% females) were recruited for the baseline survey from July 2022 to November 2023. All participants underwent routine medical examination, including anthropometric (height, weight and blood pressure), ECG, colour Doppler ultrasound (thyroid, carotid artery, heart, abdominal and reproductive system), chest imaging measurements (X-ray or computerised tomographic scanning), and plasma, urine and faeces sample test and a standardised questionnaire, including demographic information, lifestyle factors (smoking, alcohol consumption, diet, sleep factors, physical activity, cognitive activity and social activity) and self-reported history of common chronic diseases. Participants older than 60 were also invited to perform cognitive function tests using the Montreal Cognitive Assessment scale. Follow-ups were tracked annually through routine medical examinations and standardised questionnaires to detect their health status.

Key baseline findings revealed sex disparities in disease prevalence and clinical characteristics, with males showing higher rates of hypertension (46.60% vs 34.23%), type 2 diabetes (17.39% vs 9.54%) and gout (33.47% vs 15.59%), while females had higher prevalence of hyperlipidaemia (15.47% vs 18.26%), insomnia (5.42% vs 10.00%) and cancer (1.75% vs 3.23%) (all p

THCDS is an ongoing prospective cohort with long-term follow-up (at least 15 years). Ongoing follow-ups will be used to investigate longitudinal trajectories of risk factors and chronic diseases and to identify modifiable determinants to inform NCD prevention strategies.

ChiCTR2400083075; pre-result.