Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.

DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m², and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.

This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.

NCT06890143.

Cognitive impairment is a common consequence after stroke. Intermittent theta burst stimulation (iTBS) has emerged as a promising cognitive therapy. However, traditional iTBS typically employs lower doses and one-size-fits-all stimulation targets, which may not fully capitalise on the potential of this therapy and warrants further evaluation for both efficacy and safety. This study aims to evaluate the efficacy and safety of high-dose iTBS targeting the individualised frontoparietal cognitive network (FCN) identified by precision functional neuroimaging for post-stroke cognitive impairment (PSCI).

This is a prospective, double-blind, sham-controlled, parallel-group randomised controlled trial. 60 eligible participants with PSCI will be randomly assigned (1:1) to an active iTBS or a sham-controlled group. The active group will receive high-dose iTBS (3600 pulses/day) at 80% resting motor threshold targeting the left individualised FCN, guided by a real-time neuronavigation system. The sham group will follow identical procedures using a sham coil. Both groups will also undergo conventional computerised cognitive training. The intervention will be administered on workdays over a period of 3 weeks, totalling 15 workdays. The primary outcome is the change in Montreal Cognitive Assessment scores from baseline to immediately post-treatment. Secondary outcomes include long-term change in global cognition, activities of daily living and specific cognitive domains (assessed by a comprehensive neuropsychological battery covering memory, attention, executive function and language), as well as mood. Assessments occur at baseline, post-treatment and 3-month follow-up. Safety outcomes, specifically the number of adverse events related to iTBS, will be monitored and recorded throughout the trial.

This study has been approved by the Medical Ethics Committee of the China Rehabilitation Research Center. The results of this study will be published in peer-reviewed scientific journals and disseminated at academic conferences.

NCT05953415.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

China has continued to improve tuberculosis (TB) control in the past decade; however, the sudden outbreak of COVID-19 hindered this progress. As a province with a large population and frequent international exchanges, Guangdong has been seriously affected by COVID-19. This study aimed to understand the effect of COVID-19 on TB detection in Guangdong based on the autoregressive integrated moving average (ARIMA) model.

Time-series study.

Guangdong, China.

We used the ARIMA model to quantify the effect of COVID-19 by comparing reported cases during the COVID-19 pandemic with predicted cases under a counterfactual scenario of no COVID-19 pandemic. After model evaluation, we chose ARIMA (0,1,2)(0,1,1)₁₂ as the prediction model. We also highlighted that there were three emergency response periods in which the responses and public responses to COVID-19 varied.

During the pandemic period, the average annual TB notification rate was 57.95/100 000, which decreased by 27.97% compared with the pre-pandemic period. Although it decreased by 6.17% on average annually in the pre-pandemic period, it decreased by 14.92% in 2020 as compared with 2019, but only decreased by 0.34% in 2021 as compared with 2020. The results of the ARIMA model showed that the number of reported cases in 2020 decreased by 6.62% compared with that of the predicted cases, but this decreased by 0.42% only in 2021. The most seriously affected period was the second-level emergency response period in 2020, when the relative difference between reported and predicted cases reached the peak (–16.43%). The least affected period was the third-level emergency response period of 2021, the reported cases recovered and exceeded the predicted cases, with a gap of 0.77%.

TB detection in Guangdong had generally declined during the COVID-19 pandemic, which might be related to the movement restrictions, diverted resources and patients’ concerns. This decline would lead to the delay or even interruption of diagnosis and treatment, which would cause the regression of TB control. To improve TB detection, it is important for stakeholders to take consorted effort during public health emergencies.

Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.

This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.

The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.

ChiCTR2400090542.

To identify enablers and barriers for scaling up non-communicable disease (NCD) interventions across diverse global contexts and to map these factors to the WHO’s health system building blocks.

A multi-method qualitative study applying the Consolidated Framework for Implementation Research to analyse data from multiple projects nearing or completing scale-up.

Global Alliance for Chronic Diseases-funded implementation research projects conducted across 18 low- and middle-income countries and high-income settings.

Data was derived from documents (n=77) including peer-reviewed publications, policy briefs, and reports and interviews with stakeholders (n=18) (eg, principal investigators, medical professionals, public health workers).

Various context-specific interventions targeting sustainable scale-up of NCD (eg, diabetes, hypertension, cardiovascular disease) interventions at the community, primary care or policy levels.

The primary outcome was identifying contextual enablers and barriers to intervention scale-up. Secondary outcomes included exploring how these factors aligned with health system building blocks (eg, leadership/governance, healthcare workforce).

Twenty enablers (eg, intervention adaptability, strong stakeholder engagement, local empowerment) and 25 barriers (eg, resource limitations, intervention complexity, stakeholder burnout) were identified. Contextual alignment, supportive governance and capacity building were critical for sustainability, while cultural misalignment and socio-political instability frequently hampered scaling efforts.

Tailoring interventions to local health systems, ensuring stakeholder co-ownership and incorporating strategies to mitigate stakeholder burn-out are essential to achieving sustainable, scalable NCD solutions. Future research should focus on integrating systematic cultural adaptation, sustainable financing and workforce capacity building into scale-up planning.

First-degree relatives of colorectal cancer (CRC) patients have a twofold to fourfold increased risk of CRC. Tailored communication interventions have shown efficacy in improving their risk awareness and screening participation. While computer-based tailoring systems offer convenience, they often overlook the integration of healthcare professionals’ verbal input, potentially limiting effectiveness and long-term impact. To address this gap, we developed ScreenTalk, an intelligent voice-interactive tailored communication system that employs intelligent speech interaction to automate the tailoring process, enhance message credibility and improve scalability within CRC screening workflows.

This study is a two-arm, cluster-randomised controlled trial with a hybrid type I design involving 314 participants across three tertiary general hospitals in Guangzhou, China. Participants in both groups will receive usual care. Additionally, the intervention group will receive a 1-month tailored intelligent voice-interactive intervention, whereas the control group will receive unrelated health education to control for attention. Screening uptake (primary outcomes) and health beliefs (secondary outcomes) are measured at baseline and at 3 months, 6 months, 9 months and 12 month post the intervention. Implementation outcomes including reach, implementation, adoption and maintenance will be assessed through questionnaire, qualitative interviews and tailored system record.

The trial has been approved by the Ethics Committee of the Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Information on the purpose and process of this study will be provided to the participants before recruitment, and written signatures will be collected from all participants to ensure their voluntary participation and protection of their rights and privacy.

NCT06710860 on ClinicalTrials.gov. Registered 26 November 2024. Date and version: 3.0, 14 July 2025.

To gain an in-depth understanding of the experience of elderly joint replacement patients in making surgical decisions and to identify the needs of patients in the decision-making process.

A qualitative study, semistructured interviews were used and analysed by Colaizzi’s seven-step method.

This study was conducted in the orthopaedics department of a tertiary hospital in Wuhan.

Eligible participants were aged 60 years or older, scheduled for elective joint replacement surgery, cognitively intact and voluntarily consented to participate in the study.

We conducted interviews with a total of 25 elderly patients who underwent joint replacement surgery. This study reveals three themes and eight subthemes regarding the surgical decision-making experiences of elderly patients undergoing joint replacement. The three themes summarise three stages of the decision-making experience, respectively, trade-offs before decisions, feelings during decision-making and expectations after the decision. In the first stage, three subthemes were identified: (1) weighing the surgical risks and benefits, (2) assessment of medical proficiency and (3) low patient involvement in decision-making. In the second stage, three subthemes emerged: (1) internal fear, (2) self-doubt and (3) a heavy burden. In the third stage, two subthemes were identified: (1) a recovery process filled with confidence and (2) a desire for improved quality of life.

This study delves deep into the experiences of elderly patients undergoing joint replacement surgery during the surgical decision-making process. It provides a theoretical basis for decision-making assistance for elderly joint replacement patients, which is conducive to reducing patients’ decision-making conflicts and enhancing their decision-making capabilities.

Hypertension and depression frequently co-occur, complicating patient management and worsening outcomes. This scoping review aims to systematically map non-pharmacological interventions for managing comorbid hypertension and depression, providing insights into current practices and guiding future research.

Following the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews standards, a comprehensive search was conducted across multiple databases, including PUBMED, Embase, PsycINFO, CINAHL, Cochrane Library, Chinese Biomedical Literature Database and Chinese National Knowledge Infrastructure, covering the literature from January 2004 to December 2023. Studies were selected based on predefined inclusion criteria focusing on non-pharmacological or complex interventions. Data extraction was performed using the Template for Intervention Description and Replication checklist to ensure detailed and structured summaries of each intervention.

Fifteen quantitative studies were included, most of which were pilot randomised control trials, pre-post studies and with generally small sample sizes (20 to 2365). Interventions were categorised into integrated and coordinated care, behavioural and psychological interventions and physical and lifestyle interventions. Delivery methods varied, with most interventions being face-to-face, while a few used digital platforms such as mobile apps and telephone support. Disease-level and patient-level outcomes were mainly reported, while only three examined system-level outcomes. 13 of 15 included studies showed positive results in managing comorbidity. The variability in follow-up periods (ranging from 1 week to 12 months) and measurement instruments across studies limited the ability to draw consistent long-term conclusions.

This scoping review highlights the role of psychosocial and non-pharmacological interventions, particularly collaborative/integrated care and behavioural therapies, in managing comorbid hypertension and depression. These interventions consistently improve depressive symptoms, with mixed effects on blood pressure control. Further research is needed to standardise core outcomes and evaluate the long-term effectiveness and scalability of these interventions.

Proximal humeral fractures are increasingly common, particularly among older people, whereas the prognosis of surgical treatments for these fractures remains substantially uncertain. In China, where the ageing population is rapidly growing, high-quality prospective data on surgical outcomes, complications and cost-effectiveness are lacking. To address this gap, we propose to initiate a prospective, multicentre cohort study on surgical treatment for proximal humeral fractures in China—Cohort of Acute Shoulder Trauma (CAST) study.

The CAST is a multicentre, prospective cohort study enrolling patients with acute proximal humeral fractures undergoing surgical treatments at eight hospitals in China between May 2024 and December 2029. Patients can receive any of the surgical treatment methods which include percutaneous Kirschner wire fixation, external fixation, open reduction and internal fixation using locking plates or intramedullary nails, suture anchors and shoulder arthroplasty. We will collect patient-reported outcome measures (Quick Disabilities of the Arm, Shoulder and Hand), Constant-Murley, American Shoulder and Elbow Surgeons, EuroQol 5-Dimension and Visual Analogue Scale), physical examination results, imaging assessments (based on X-rays, ultrasound, CT and MRI scans), laboratory tests (including inflammatory cytokines) and data on medical costs. We will follow patients at 1 day, and at 1 month, 3 months, 6 months, 12 months and 24 months postoperatively. The planned sample size is 1500 patients.

The study protocol has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University (Approval No. 2024-ky-104(K)). Written informed consent will be obtained from all participants. Findings from the CAST study will be disseminated through peer-reviewed journals and academic conferences.

ChiCTR2500109651.

Perioperative sleep disturbance (PSD) can adversely affect immunological and cognitive functions, can prolong hospital stays and have long-lasting effects on quality of life, ultimately increasing mortality rates. Unfortunately, PSD is common among surgical patients and can manifest at any stage during surgical care with a high incidence. Owing to the high incidence and severe adverse outcomes of PSD, effective management of PSD is imperative in clinical practice. Intranasal administration of dexmedetomidine is a safe and effective strategy for improving perioperative sleep quality. It is characterised by high bioavailability, a low incidence of adverse events and the avoidance of pain from venipuncture and intramuscular injection. However, this clinical evidence is insufficient due to the limited sample size, diverse outcome observation indicators and inconsistent research quality. Consequently, we will conduct a protocol for a systematic review and meta-analysis to offer clinical evidence on whether intranasal dexmedetomidine can be opted as an effective treatment for PSD.

English databases (PubMed, Web of Science, Ovid Medline, Embase and Cochrane Library), Chinese electronic databases (Wanfang database, VIP Database and China National Knowledge Infrastructure) and clinical trial registry platforms will be screened from their inception up to October 2025 to detect randomised controlled trials of intranasal dexmedetomidine for the management of PSD. We will compute the mean differences (MDs) or standardised MDs along with 95% CIs for continuous data, and the risk ratio with 95% CIs for dichotomous data using Review Manager V.5.4. Either the fixed-effects or random-effects model will be employed depending on the heterogeneity assessed by Cochran’s Q test and the I² statistic. Risk of bias will be assessed by Cochrane risk-of-bias tool V.2, while evidence quality will be evaluated by the Grading of Recommendations Assessment, Development and Evaluation approach. The conclusiveness of evidence will be evaluated via trial sequential analysis. Moreover, publication bias will be assessed via funnel plot analysis supplemented with Egger’s regression test.

Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.

CRD420251002119.

Gastric cancer (GC) remains a leading cause of cancer-related mortality worldwide, with most Chinese patients diagnosed at a locally advanced stage. Neoadjuvant chemotherapy (NAC) is increasingly used to improve resectability and survival. Laparoscopy-assisted distal gastrectomy (LADG) provides short-term recovery benefits compared with open distal gastrectomy (ODG), but its safety and oncologic efficacy following NAC remain uncertain. This trial aims to determine whether LADG is non-inferior to ODG in terms of long-term survival outcomes in patients with locally advanced distal gastric cancer (LAGC) after NAC.

This is a multicentre, randomised, controlled, non-inferiority trial conducted at high-volume GC centres in China. Eligible patients (aged 18–75 years; cT3–4a, N0/+, M0) with histologically confirmed distal gastric adenocarcinoma who have completed standard NAC will be randomised 1:1 to LADG or ODG with D2 lymphadenectomy. Surgical quality will be standardised through operative manuals, intraoperative video recording and central auditing. The primary endpoint is 3-year disease-free survival. Secondary endpoints are 3- and 5-year overall survival. A total of 998 patients (499 per arm) will be enrolled, providing 80% power to test non-inferiority with an absolute 8% margin, accounting for 15% attrition. Analyses will follow the intention-to-treat principle, with Cox models used for survival comparisons and subgroup analyses according to nodal status, tumour size and pathological response.

This trial has been reviewed and approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University (Approval No. 2025 (865), 16 July 2025). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals and international conferences, providing high-level evidence to guide the surgical management of LAGC after NAC.

Chinese Clinical Trial Registry, ChiCTR2500109677; registered on 23 September 2025. Protocol V.2.1, dated 29 June 2025.