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.

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.

Poststroke cognitive impairment (PSCI) is a prevalent complication of stroke, characterised by deficits in one or more cognitive domains (eg, memory, attention, executive function). Beyond increasing mortality and disability risks, PSCI frequently co-occurs with motor dysfunction, which impairs activities of daily living and reduces quality of life. Due to the complexity of neural networks involved in PSCI, clinical practice currently lacks targeted therapeutic strategies; existing interventions (eg, pharmacotherapy, traditional cognitive training) are limited in scope and variable in efficacy. Here, we developed an innovative dynamic cognitive training system integrated with virtual reality (VR) technology, based on principles of neuroplasticity and multisensory integration. This study aimed to explore the intervention effects of this system on cognitive function in patients with PSCI while incorporating exploratory neuroimaging assessments to provide descriptive and hypothesis-generating information regarding brain functional changes associated with the intervention.

This single-centre, randomised controlled, evaluator-blinded clinical trial will assess the rehabilitative efficacy of VR-based cognitive training in patients with PSCI. A total of 60 patients who had a stroke will be enrolled and randomised to either a conventional rehabilitation group or a VR intervention group. The intervention will last 2 weeks, with five sessions of 60 min each training session per week. During the 60-minute training session, both groups will receive 30 min of conventional rehabilitation training. For the remaining 30 min, the control group will undergo traditional cognitive rehabilitation while the experimental group will be subjected to VR-based cognitive rehabilitation training. The primary outcome measure is the Montreal Cognitive Assessment; secondary outcomes include the Mini-Mental State Examination, Trail Making Test and Stroop Test. Assessments will be conducted at three time points: baseline (T0), immediately postintervention (T1) and 4 weeks after completing the intervention (T2). This study aims to evaluate the preliminary effectiveness of a VR-based intervention in improving multidimensional cognitive function, while incorporating exploratory neuroimaging outcomes to generate hypothesis-forming insights into potential neural correlates.

The trial was approved by the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2025–1933-273-02).

The results will be submitted to a peer review journal or at a conference.

ChiCTR2600116040.

Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, persisting despite advances in prophylactic regimens. Growth differentiation factor-15 (GDF-15) has been identified as a biomarker inversely associated with PONV risk and severity. As metformin is known to elevate circulating GDF-15 levels, we hypothesise that preoperative metformin use may be associated with a lower incidence of PONV. This study aims to evaluate the association between a history of preoperative metformin administration and the occurrence of PONV in adults undergoing general anaesthesia.

This is a single-centre, prospective, observational cohort study. We plan to enrol 909 adult patients scheduled for surgery under general anaesthesia with endotracheal intubation from December 2025 to December 2028. Participants will be divided into two groups based on their preoperative metformin exposure: an exposed group (n=303) with a documented history of metformin use and a non-exposed group (n=606) without such history, using a 1:2 ratio. The metformin regimen (choice of agent and daily dosage) will be determined by the attending physician as part of routine clinical care, independent of this study. The primary outcome is the incidence of PONV, defined as the occurrence of any nausea, retching or vomiting, within 120 hours post-surgery. Secondary outcomes include the incidence of PONV in the early (0–24 hours) and late (24–120 hours) postoperative phases; the severity of PONV symptoms and the requirement for rescue antiemetic medication during these intervals; the quality of recovery (assessed at 0–24, 24–48, 48–72, 72–96 and 96–120 hours); potential PONV risk factors in blood or urine and long-term survival rates at 1, 3 and 5 years.

This study protocol (version 04, dated 23 November 2025) was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University (Approval No. 2025ZSLYEC-689) prior to the initiation of participant recruitment. The first participant was enrolled under protocol version 04. A subsequent protocol amendment (version 05, dated 25 December 2025) was approved by the same Ethics Committee. This amendment added a quality of recovery assessment using the 15-item quality of recovery scoring system questionnaire at 30 days postoperatively. This amendment did not alter the primary or secondary outcomes, the sample size calculation, or any other key elements of the study design. The results of this study will be disseminated at scientific conferences and published in international peer-reviewed journals.

NCT07244575.

Postoperative depressive symptoms are common after breast cancer surgery and can adversely affect recovery and quality of life. This multicentre trial aims to determine whether a single intraoperative subanaesthetic dose of esketamine, as an adjunct to antidepressant therapy, improves postoperative depressive outcomes at postoperative day (POD) 30.

This multicentre, prospective, randomised, triple-blind, placebo-controlled trial will enrol 824 women aged 18–80 years with stage I–III breast cancer (American Society of Anesthesiologists physical status I–III) who are scheduled to undergo surgery. Participants will be randomised 1:1 to receive 0.2 mg/kg esketamine or an equivalent volume of normal saline after anaesthesia induction and before surgical incision. The primary outcome is the incidence of depressive symptoms at POD 30, assessed using the Hospital Anxiety and Depression Scale Depression (score ≥8). Secondary outcomes include acute and chronic pain, and anxious symptoms, etc. Primary analysis will use a generalised linear mixed model with a logit link on an intention-to-treat basis.

The study protocol has been formally approved by the institutional ethics committee of the National Cancer Center (Approval No.25/483-5429). Written informed consent will be obtained from all participants prior to enrolment. Results will be disseminated through peer-reviewed journals and international scientific conferences.

ChiCTR2600117573.

Individuals with cardiovascular disease are prone to frailty, while frailty accelerates disease progression and worsens outcomes. Exercise interventions are essential non-pharmacological treatments for frail elderly patients with cardiovascular disease; however adherence remains low and strategies are inconsistent. Telerehabilitation improves accessibility, allows continuous monitoring with timely clinical responses and helps overcome mobility and geographical barriers for frail older adults. Guided by the patient-centred approach, exercise telerehabilitation should consider both clinical effectiveness and patient preferences to enhance acceptance and adherence. However, patient preferences for web-based exercise telerehabilitation remain poorly understood.

This study is designed as a discrete choice experiment to elicit and quantify preferences for key features of web-based exercise telerehabilitation among frail older adults with cardiovascular disease. Candidate attributes and levels were developed through a systematic literature review, patient focus groups and expert consultation. An orthogonal fractional-factorial design will generate the choice sets. A questionnaire survey will recruit older adults with cardiovascular disease who are identified as frail based on validated frailty assessment scales. Participants will be recruited from a cardiovascular specialty hospital in Xiamen, China, with a planned sample size of 157. Final data will be analysed using mixed logit models to estimate attribute importance, quantify preference weights and identify preference heterogeneity.

This study has received ethical approval from the relevant institutional ethics committee (2025–46). All participants will provide informed consent. Findings will be disseminated to patient groups, clinicians and policymakers and published in peer-reviewed journals and presented at national and international conferences.

Long COVID is a complex, multisystem chronic condition that may persist or fluctuate for months to years after SARS-CoV-2 infection. Despite emerging international research, significant gaps remain in understanding the full breadth of long COVID’s impacts in Australia. No study has yet prospectively examined these multidimensional impacts using a culturally appropriate, user-validated toolkit. Our study aims to characterise symptom profiles, functional outcomes and psychological, social, financial and behavioural impacts of long COVID in Australian adults; identify factors associated with recovery trajectories; and validate a set of measures to support research and clinical care.

This national, multi-site, longitudinal prospective cohort study comprises three phases: (1) survey selection and user-testing; (2) psychometric validation; and (3) a longitudinal cohort study. Survey selection was informed by literature review, Australian parliament inquiry reports and international recommendations, and refined through iterative user-testing and expert review. A total of 1000 participants aged ≥18 years from diverse cultural backgrounds with ongoing symptoms following COVID-19 infection will be divided into three cohorts based on time since infection. Surveys will be administered at seven time points over 24 months, with optional follow-up to 36 months. Data linkage to state and national health datasets will enable an objective assessment of healthcare utilisation and associated costs. Psychometric properties of the tools will be evaluated using baseline responses from the initial 300 participants, including assessments of structural/construct validity, convergent validity, known-groups validity, cross-validity, internal reliability, responsiveness and test–retest reliability. Other data analyses will include descriptive statistics, repeated-measures analysis of variance, linear mixed-effects modelling and multivariable regression models.

Ethics approval was obtained from The St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) (112108/2024/PID00364) and RMIT University HREC (28124). Research findings will be disseminated at conferences and in peer-reviewed publications.

Australian New Zealand Clinical Trials Registry (ACTRN12625001415493).

Addition of bevacizumab and paclitaxel as induction therapy prior to standard atezolizumab and nab-paclitaxel in patients with programmed death-ligand 1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) may help to overcome vascular endothelial growth factor-associated resistance mechanisms that limit the immune-mediated antitumour efficacy of atezolizumab and nab-paclitaxel.

The Induction Therapy of PTX+BV Followed by Atezolizumab+Nab-PTX for PD-L1+TNBC (INDUCE) study is a multicentre, randomised, open-label, phase II trial designed to evaluate the efficacy and safety of two cycles of induction therapy with bevacizumab and paclitaxel followed by atezolizumab and nab-paclitaxel compared with standard atezolizumab and nab-paclitaxel in patients with PD-L1-positive mTNBC. The primary outcome of the study is progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumours, V.1.1. We have estimated that 89 PFS events are needed to allow a power of 80% to detect a difference between treatment groups at a one-sided significance level of 10% in this study. The target sample size is set to 106 patients to account for dropouts.

The study protocol and informed consent form have been approved by the Certified Research Review Board at the Nagoya University Graduate School of Medicine, Nagoya, Japan. Study results will be presented at international conferences and published in a peer-reviewed journal.

jRCTs041240039 NCT06793553.

To examine the associations between migration experiences during different life stages and long-term health outcomes among middle-aged and older adults.

A retrospective study based on data from the China Health and Retirement Longitudinal Study (CHARLS).

A nationally representative survey conducted in 150 county-level and 450 village-level administrative units across China.

A total of 14 753 Chinese adults aged 45 years or older who completed both the 2014 and 2020 waves of the CHARLS.

The primary outcome measures included self-rated health, depression, cognitive function and physical disability.

Participants were categorised into four groups based on migration timing: never experienced childhood and adulthood migration (NCMAM); childhood migration only, no adulthood migration; adulthood migration only, no childhood migration (PAMNCM) and both childhood and adulthood migration experiences (PCMAM). Compared with the NCMAM group, the PAMNCM group reported poorer self-rated health (OR=1.12, 95% CI (1.02 to 1.23), p

Migration experiences showed complex associations with health outcomes among middle-aged and older adults. Migration during both childhood and adulthood was linked to better mental health, whereas migration limited to adulthood was associated with slightly better cognitive function despite poorer self-rated health. Policies should account for the diversity of migration backgrounds and equitably address the distinct needs of all migration status groups.

Tobacco use is a major contributor to the burden of chronic obstructive pulmonary disease (COPD) and other non-communicable diseases in China. People at high risk for COPD who smoke, particularly those with pre-existing chronic conditions, often remain underserved by conventional smoking cessation programmes. Population medicine offers a promising framework for proactively identifying high-burden diseases, managing multimorbidity and prioritising interventions for vulnerable populations.

This protocol describes a stratified, two-arm cluster randomised controlled trial (Population Medicine Multimorbidity Intervention in Xishui County-Smoking) being conducted in Xishui County, a rural area of Guizhou Province, China. A total of 26 townships were stratified by population size and randomly assigned in a 1:1 ratio to receive either a multicomponent intervention or usual care. Eligible participants were individuals aged 35 years or older who smoked and were at high risk for COPD as identified by the COPD Screening Questionnaire. The intervention package integrates multiple components, including a digital smoking cessation programme, digital mental health support, community-based spirometry, tailored chronic disease management, health education and a performance-linked ‘pay-for-population’ scheme that aligns healthcare worker reimbursement with population health outcomes. Primary outcomes are smoking amount and nicotine dependence and secondary outcomes include COPD-related health outcomes, hypertension, diabetes, health risk behaviours, quality of life, healthcare utilisation and productivity loss. Follow-up occurs at 3, 6 and 12 months.

Ethical approval has been granted by the Peking Union Medical College Ethics Committee (CAMS&PUMC-IEC-2024-042). Informed consent was obtained from all participants prior to enrolment. Results will be shared through peer-reviewed publication and (inter)national conference presentations.

NCT06458205.

The use of new nicotine products (NNPs), particularly vapes, by pupils has been increasingly reported in schools. This paper reports the findings of a qualitative exploration of the impact of NNPs on schools by eliciting the views of 14–16-year-old pupils and school staff, as part of a wider study investigating the marketing and use of NNPs in Scotland.

Qualitative study using 16 focus groups with pupils conducted February–March 2025, and in-person and telephone interviews (nine individual and two paired) with school staff.

Four schools in Scotland based in areas of differing socioeconomic status and two levels of urbanity.

77 S3 (14–15 years) and S4 (15–16 years) pupils who vaped or were at risk of vaping. School staff (n=13) with a senior teaching or pastoral care/guidance role.

Focus groups with pupils and interviews with staff exploring perceptions of NNPs, particularly vapes, on schools, and what mitigating actions might be needed. The qualitative data underwent thematic analysis.

Pupils reported widespread use of vapes and to a lesser extent nicotine pouches, and described practices and behaviours, including truancy and missing classes as pupils sought other environments for their vaping, that were impacting on the life of the classroom and the wider school environment. The school staff outlined a number of approaches they had adopted to counteract disciplinary and other issues arising from vape use within schools, including instigating regular patrols, monitoring of toilet facilities and visiting neighbourhood shops, but acknowledged that they had little knowledge of nicotine pouches. They also perceived that they were not as knowledgeable as to the risks of NNPs and did not feel as comfortable addressing this issue within the classroom as they did compared with tobacco-related teaching.

Young people reported behaviours related to NNP use that were having a detrimental impact on the schools. Staff had developed various approaches to address these issues and were having to allocate significant time and resource, especially to vaping-related issues. Staff require knowledge and awareness training in relation to other NNPs, as well as specific guidance on the risks of vaping and nicotine use.

Patients undergoing thoracoscopic pulmonary resection are prone to moderate-to-severe acute postoperative pain, which not only increases the risk of pulmonary complications but may also lead to chronic postsurgical pain. While traditional opioids provide effective analgesia, they are associated with significant adverse effects. Intercostal nerve block (ICNB) can precisely relieve incisional pain but has a limited duration of action. Tegileridine is a novel biased μ-opioid receptor agonist, offering favourable analgesic efficacy with fewer adverse reactions. Currently, there is a lack of research on the combination of tegileridine and ICNB for analgesia following thoracoscopic pulmonary resection, warranting further clinical exploration.

This single-centre, randomised, double-blind, non-inferiority trial is designed to compare the postoperative analgesic efficacy of tegileridine-based patient-controlled intravenous analgesia (PCIA) combined with ICNB versus sufentanil-based PCIA combined with ICNB in patients undergoing thoracoscopic pulmonary resection. A total of 118 participants are enrolled and randomly assigned in a 1:1 ratio to either the tegileridine group or the sufentanil group. The primary outcome is the pain Visual Analogue Scale score during movement within 48 hours postoperatively, with non-inferiority determined using a margin of –1 point and 95% CIs. Secondary outcomes include the number of rescue analgesic interventions, PCIA-related parameters (total analgesic consumption, number of effective presses and total number of presses), incidence of opioid-related adverse events (respiratory depression, postoperative nausea and vomiting) and overall patient satisfaction.

The trial protocol was approved by the Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology on 14 February 2026 (Approval No. 2026-S010). The findings will be disseminated through publication in a peer-reviewed journal and on relevant institutional websites.

NCT07386626.

Postoperative delirium (POD) is a common complication following cardiac surgery and is closely associated with adverse clinical outcomes. The effect of perioperative dexmedetomidine on reducing POD remains controversial in the existing literature. In our previous meta-analysis, we obtained preliminary evidence suggesting that dexmedetomidine may reduce the incidence of POD by improving sleep quality, which may partly explain the heterogeneity reported in previous studies. Based on these findings, the present randomised controlled trial aims to test the hypothesis that preoperative intranasal administration of dexmedetomidine reduces the incidence of POD in patients undergoing cardiopulmonary bypass assisted cardiac surgery by enhancing preoperative sleep quality.

This trial is a single-centre, investigator-initiated, parallel, double-blind, randomised, placebo-controlled trial. Individuals aged 18 years or older who are scheduled for elective cardiopulmonary bypass—assisted cardiac surgery will be enrolled in the study. The planned sample size is 686. Participants will be randomly assigned to either the dexmedetomidine group receiving two doses of dexmedetomidine (1.5 µg/kg according to ideal body weight) administered between 21:00 and 21:30 on the night before surgery and 15 min before anaesthesia induction, or the placebo group, receiving an equivalent volume of normal saline at the same time points. The primary outcome is the incidence of delirium within 7 days after surgery. Secondary outcomes include the severity, subtypes and duration of delirium, length of postoperative hospital stay, in-hospital all-cause mortality, postoperative sleep assessed by the Numerical Rating Scale score, pain intensity, postoperative anxiety and depression scores. Mediation analyses will be conducted using the preoperative Sleep Quality Index to assess whether dexmedetomidine reduces POD by improving preoperative sleep quality. The Baron and Kenny causal steps framework in conjunction with bootstrap resampling will be employed to estimate the direct, indirect and total effects.

The study is approved by the Institutional Review Board of Xijing Hospital (KY20242259). Written informed consent will be obtained from all participants. The results will be submitted for publication in peer-reviewed journals.

NCT06619912.