Embryo aneuploidy increases substantially with maternal age, contributing to implantation failure and miscarriage. Conventional morphological assessment cannot determine euploidy. Non-invasive preimplantation genetic testing (ni-PGT) evaluates cell-free DNA in spent embryo culture medium, potentially improving embryo selection without trophectoderm biopsy. Robust evidence of clinical benefit in women aged 35–42 years remains limited.

This is a multicentre, open-label, parallel-group randomised controlled trial conducted in three centres in China. Infertile women aged 35–42 years undergoing their first intracytoplasmic sperm injection cycle and having ≥2 good-quality days 5–6 blastocysts (Gardner grade ≥4BC,defined as an expansion grade of at least 4, with an inner cell mass grade of B or better and a trophectoderm grade of C or better) will be randomised 1:1 to ni-PGT-guided embryo selection or conventional morphology-based selection. Randomisation will be stratified by study centre using variable permuted block sizes of 4 and 6 and implemented through a unified centralised randomisation system. After a multicentre set-up period for investigator training and harmonisation of spent culture-medium sampling procedures, during which no participant was enrolled or randomised, recruitment and randomisation commenced on 14 February 2025 at the lead site; additional sites started recruitment after local ethics approval and site initiation. A freeze-all strategy will be applied; frozen-thawed single blastocyst transfer will start from the second menstrual cycle after oocyte retrieval.

For the primary endpoint, embryo transfers using embryos from the index retrieval cycle that occur within 12 months after randomisation and within the first three frozen-thawed single embryo transfer attempts will contribute to the cumulative outcome, whichever occurs first. Clinical care will not be restricted beyond this prespecified analysis range. The primary outcome is the cumulative ongoing pregnancy rate within 12 months after randomisation, defined as the proportion of participants achieving at least one ongoing pregnancy (clinical pregnancy continuing to ≥12 weeks’ gestation) following a qualifying embryo transfer within the prespecified analysis range. Key secondary outcomes include early miscarriage rate (

The trial will be conducted according to the Declaration of Helsinki. Ethics approval has been obtained from all participating centres before participant recruitment at each site. Written informed consent will be obtained from all participants. Results will be disseminated through peer-reviewed publication and conference presentations.

ChiCTR2400088283

Atosiban may confer therapeutic benefits to specific subpopulations in assisted reproductive technology. The Phase I Atosiban study indicated potential improvements in live birth rates among women with previous implantation failure undergoing frozen-thawed blastocyst transfer who exhibited abnormal uterine contractions, although these findings did not reach statistical significance. Therefore, further investigations are warranted to thoroughly elucidate the efficacy of atosiban and to evaluate whether uterine contractions can serve as a reliable biomarker for its targeted application.

This is a single-centre, randomised, triple-blind, placebo-controlled trial aiming to enrol 792 infertile women aged 20–40 years with a history of at least one previous embryo implantation failure and abnormal uterine contractions prior to single blastocyst-stage embryo transfer. Eligible participants will be randomly assigned in a 1:1 ratio to receive either intravenous atosiban or a placebo before embryo transfer. The primary outcome is live birth rate, with secondary outcomes encompassing various pregnancy and perinatal parameters. Randomisation will be stratified by age and transfer type. Intention-to-treat analysis will be performed using generalised linear models. The trial will be monitored by an independent data and safety monitoring committee, including one interim analysis.

This study has been approved by the Institutional Ethics Committee of Northwest Women’s and Children’s Hospital (No. 2025-058-02). Written informed consent will be obtained from all participants. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

NCT07185230.

Postoperative neurocognitive disorders, including delirium and longer-term cognitive decline, are among the most common and costly complications of surgery in older adults, yet effective preventive strategies remain limited. Insomnia and sleep–circadian disruption are highly prevalent in this population, affecting up to one-third of older adults undergoing elective surgery and represent potentially modifiable risk factors that are rarely addressed in perioperative care. Cognitive Behavioural Therapy for Insomnia (CBT-I) is the first-line, evidence-based treatment for insomnia; however, its feasibility and efficacy have not been systematically evaluated for perioperative implementation. This protocol describes a pilot randomised controlled trial designed to evaluate the feasibility and acceptability of a condensed CBT-I intervention in the perioperative setting. The study will also explore its potential effects on insomnia and postoperative outcomes.

The SLEEP-BOOST study is a single-site, randomised controlled pilot trial conducted at Massachusetts General Hospital. The study will enrol 50 older adults (≥65 years) undergoing elective orthopaedic surgery with insomnia symptoms (Insomnia Severity Index≥10). Participants will be randomised 1:1 to either a condensed CBT-I intervention or a patient contact-matched Sleep Hygiene Education control group. All participants will complete 3 weeks of preoperative actigraphy and daily sleep diaries, with follow-up assessments at 2 weeks, 1 month and 3 months after surgery. The primary outcome is feasibility, assessed through adherence metrics, protocol engagement and acceptability. Secondary outcomes will be treated as exploratory including insomnia severity, sleep quality, actigraphy-derived sleep and circadian metrics, cognitive trajectories, postoperative pain, mood, functional status and incidence of postoperative neurocognitive disorders.

This protocol has received ethics approval from Massachusetts General Hospital Institutional Review Board (Protocol #2024P000780). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant sleep treatment organisations. Participants will receive a summary of the study results.

NCT06375265.

To investigate the impact of non-pharmaceutical interventions (NPIs) on COVID-19 transmission in different pandemic stages across 12 Asian countries.

This was an ecological study of publicly available data. This study used the Stringency Index from the Oxford COVID-19 Government Response Tracker (OxCGRT) as a composite measure of implementation strictness of non-pharmaceutical interventions.

Data were obtained from Our World in Data and OxCGRT (January 2021 to September 2022).

12 countries were included in the study: Azerbaijan, Turkey, Bahrain, Israel, Lebanon, Japan, South Korea, Singapore, Malaysia, Thailand, Cambodia, and Indonesia.

The instantaneous reproduction number (Rt). Rt is defined as the expected number of secondary infections occurring at time t, divided by the number of infected individuals, each scaled by their relative infectiousness at time t (an individual’s relative infectiousness is based on the generation interval and time).

Three different pandemic development patterns were identified: Cluster 1 countries (marked by distinct fluctuation), Cluster 2 countries (characterised by smaller fluctuation) and Cluster 3 countries (featuring a peak between July and September). An increase in the Stringency Index was associated with a significant decrease in Rt during warmer seasons in both Cluster 1 and 2 (both p values

This study demonstrates that the effectiveness of NPIs varies with seasonal changes and pandemic patterns. Therefore, to improve the efficiency of public health responses, policymakers should tailor NPI strategies based on seasonal variations and local socio-structural factors. The findings provide new insights for future research on the impact of NPI implementation during pandemics, which plays a critical role in pandemic management.

Pemphigus vulgaris is a rare autoimmune blistering disease characterised by recurrent mucocutaneous erosions, high symptom burden and unpredictable relapse. Current management relies mainly on pharmacological therapy and hospital-based follow-up, with limited real-time monitoring and individualised support in home-based disease management. To address these challenges, this trial aims to evaluate the effectiveness of an Intelligent Multimodal Symptom Assessment and Response System, integrating patient-reported outcomes, wearable physiological data and image-based lesion assessments, to improve symptom management and quality of life in pemphigus vulgaris patients. Primary objective is to evaluate the effectiveness of the Intelligent Multimodal Symptom Assessment and Response System in improving symptom alerting and symptom management outcomes in patients with pemphigus vulgaris. Secondary objectives are to enhance patients’ self-management ability in symptom monitoring and control, to improve treatment adherence throughout the follow-up period, to promote health-related quality of life among pemphigus vulgaris patients, to assess the usability and acceptability of the system from the patients’ perspective.

This is a multicentre, parallel-group, randomised controlled trial. 160 participants will be randomly assigned to either the intervention group (receiving the Intelligent Multimodal Symptom Assessment and Response System) or the control group (receiving standard care). Eligible participants will be adults aged 18 years or older with a confirmed diagnosis of pemphigus vulgaris and active skin or mucosal lesions, who are able to use digital devices and provide written informed consent. Individuals with severe comorbidities, concurrent participation in other clinical trials or cognitive impairments that may interfere with study adherence will be excluded. The intervention will be delivered via a digital platform, integrating electronic patient-reported outcomes, wearable physiological data and lesion images over a 12-week follow-up period.

Ethical approval was obtained from the Institutional Review Board of the School of Nursing, Fudan University (IRB 2025-07-13), the Medical Ethics Committee of the Institute of Dermatology, Chinese Academy of Medical Sciences (2025-KY-034) and the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (2025-452). Approvals were granted on 10 September, 18 July and 23 July 2025, respectively. This protocol is based on V1.0, 13 July 2025 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences.

ChiCTR2500109711.

Adequate sedation is essential for paediatric patients undergoing invasive haematologic-oncologic procedures. The combination of propofol and remifentanil is commonly used yet is associated with respiratory depression. Esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less respiratory depression than other sedatives. This study aims to assess esketamine versus remifentanil in combination with propofol for invasive haematological-oncological procedures for paediatric patients.

This prospective, randomised, double-blind, two-period crossover trial will include 80 paediatric patients aged 6–12 years, with American Society of Anesthesiologists Physical Status II to III, who are scheduled to undergo repeated invasive procedures including bone marrow aspirates and lumbar punctures under sedation. Participants will be randomised to two sequences: AB or BA. In sequence AB, children will receive propofol (3 mg/kg) and esketamine (0.5 mg/kg) in period 1 and propofol (3 mg/kg) and remifentanil (1 µg/kg) in period 2. In sequence BA, the order is reversed. The primary endpoint of this trial is the incidence of desaturation events, defined as SpO₂

The trial was approved by the Ethics Committee of the Children’s Hospital of Soochow University (Approval No. 2025008). The results of this trial will be submitted for peer review and publication in a scientific journal.

ChiCTR2500098533.

Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is the hepatic manifestation of the metabolic syndrome. When it co-occurs with type 2 diabetes (T2DM), it presents a significant therapeutic challenge due to a higher risk of fibrosis progression and adverse outcomes. While new treatments for MASH are emerging, their efficacy in the T2DM subpopulation remains an unmet need. Chiglitazar is a novel peroxisome proliferator-activated receptor pan-agonist that regulates key pathways in lipid metabolism, glucose homeostasis and inflammation. This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.

This is a prospective, multicentre, randomised, double-blind, placebo-controlled study. This trial will enrol 300 adult patients aged 18–75 years with biopsy-confirmed MASH and fibrosis stage F1 or higher. Participants will be randomised (1:1) to receive either chiglitazar 48 mg daily or a matching placebo. All participants will also receive background therapy consisting of vitamin E (100 mg three times a day) and polyene phosphatidyl choline (456 mg three times a day). The treatment duration is 78 weeks. The primary efficacy endpoint is resolution of steatohepatitis with no worsening of liver fibrosis. Key secondary endpoints include improvement in liver fibrosis by at least one stage and changes in metabolic and liver safety biomarkers.

Ethical approval has been obtained from the Shanghai Punan Hospital of Pudong New District Ethics Committee (Punan Branch of Renji Hospital Ethics Committee, Shanghai Jiaotong University School of Medicine). KY2025-066. The findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.

NCT07303803.

Midwives/nurse midwives are the healthcare professionals most often present on the birth scene. However, they have been the professionals who are most justified to defend their legally established position by arguing their competence and autonomy. Thus, it is important to show their reality through experiences, particularly when autonomy does not

align with regulations. This meta-synthesis aims to bring together scientific evidence regarding midwife/nurse midwife’s autonomy experience in caring for labouring women in health facilities.

The meta-aggregation will be used to conduct a systematic review of qualitative studies. In January 2025, a search was carried out in scientific databases: EBSCOhost (CINAHL Ultimate, MEDLINE Ultimate and Academic Search Complete), LILACS, PubMed, Wiley Online Library, Scopus and Web of Science. The articles will be independently reviewed by two authors who will assess data quality, extraction and synthesis. Studies will be assessed for rigour using critical appraisal tools provided by the Joanna Briggs Institute. Data extraction and synthesis will be carried out using software, and results will be presented in tables. The results of the qualitative research will, where possible, be grouped according to the meta-aggregation approach proposed by the Joanna Briggs Institute.

Ethical approval to analyse secondary data is not required. The results will be published in peer-reviewed journals and presented at international and national conferences.

CRD42024572542

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.

Guided by Straussian Grounded Theory, this study aimed to explore patients’ dynamic trade-off processes in evaluating bariatric surgery outcomes and to construct a patient-centred theoretical framework to inform clinical assessment and intervention.

Qualitative study using Straussian Grounded Theory, semi-structured, in-depth interviews were conducted. Data were analysed using open, axial and selective coding. Reporting followed the Standards for Reporting Qualitative Research guidelines.

This study was conducted at a tertiary hospital in China between June 2023 and August 2023.

A total of 11 patients who had undergone bariatric surgery were enrolled, aged 21–54 years, with postoperative follow-up durations ranging from 1 to 10 years.

A core category—Dynamic Trade-off Evaluation of Bariatric Surgery Outcomes—was identified, characterised by dynamism, trade-off and subjectivity. The framework comprises four inter-related components: trade-off basis, trade-off moderation, trade-off process and comprehensive evaluation. Outcome evaluation emerged as a non-linear process progressing through four stages: burden-dominant, contradiction-coexistence, contradiction-persistence and meaning-reconstruction stages. Individual goal orientation and psychological resilience served as key moderating factors shaping evaluative trajectories.

This study proposes a novel theoretical framework elucidating how patients dynamically evaluate bariatric surgery outcomes. By revealing stage-specific mechanisms and moderating factors, the framework provides a theoretical basis for improving preoperative expectation management and postoperative support.

Chronic postsurgical pain (CPSP) after hip arthroplasty is a major complication that affects patients’ long-term quality of life. However, reliable tools for the individualised prediction of CPSP risk after hip arthroplasty are lacking. This study aims to develop and validate a nomogram model to predict CPSP risk in patients undergoing hip arthroplasty.

This prospective observational cohort study will consecutively recruit 300 patients undergoing primary hip arthroplasty at the Department of Orthopaedics and Joints, Nanping First Hospital Affiliated with Fujian Medical University. The primary outcome is CPSP assessed at 3 months postoperatively (Visual Analogue Scale score ≥4). Candidate predictor variables have been identified based on literature review and clinical expertise, and include demographics, comorbidities, preoperative pain, psychological status and surgical and perioperative management. The dataset will be randomly split into development and internal validation sets in a 7:3 ratio. We will employ Least Absolute Shrinkage and Selection Operator regression to select variables and will use multivariable logistic regression to build the final prediction model. Internal validation will be performed using bootstrap resampling (1000 repetitions). The model’s discrimination, calibration and clinical utility will be assessed using the C-statistic (area under the curve), calibration plots and decision curve analysis, respectively. The final model will be presented as a nomogram.

The study protocol has been approved by the Ethics Committee of Nanping First Hospital (Approval No: NPSY202412034). All participants will provide written informed consent. The results will be submitted for publication in a peer-reviewed academic journal.

ChiCTR2500107193; https://www.chictr.org.cn/showproj.html?proj=282634.