To better inform dementia management, it is important to understand how individuals experience, interpret and respond to dementia policy in real life. This study aimed to explore key stakeholders’ perspectives on the critical determinants of effective implementation of the first dementia policy in Macao, and the impact of policy implementation on dementia care.
Semi-structured individual interviews were conducted in person with key stakeholders identified in earlier phases of the research. The participants were encouraged to share their opinions on the significance and objectives of the dementia policy, the changes in dementia care related to the launch of the policy, and how to better implement the policy for continuous improvement.
Interviews were conducted face-to-face at the participants’ office or at a location of their choice.
Individuals involved in the planning, establishing, leading, managing, operating, implementing, participating in, using and/or advocating for dementia policies and/or comprehensive dementia care models.
All participants perceived the Macao Dementia Policy as a landmark initiative that raised public awareness, fostered inter-professional collaboration and established a foundational service network. At the service level, they reported improvements in the accessibility of diagnostic pathways and greater attention to caregiver support. Nevertheless, implementation challenges remained, including fragmented service information, inadequate non-pharmacological treatment options and limited service capacity. Participants recommended that future actions should focus on optimising long-term policy planning and resource allocation, strengthening the direct support network for caregivers, and enhancing public education and research-informed innovation.
Macao’s experience suggests that the successful implementation of a dementia policy requires not only the establishment of formal service structures but also a concerted focus on optimising resource allocation and strengthening caregiver support. To further enhance the policy’s effectiveness, future efforts should prioritise designing and assessing targeted interventions.
Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.
This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.
The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.
Body image dissatisfaction (BID) is relatively common in Chinese female undergraduates. This study aims to explore the reasons for BID among female undergraduates to develop effective early intervention strategies.
A qualitative research approach was used through semi-structured interviews, allowing for an in-depth understanding of the experiences of participants.
The study was conducted from April 2024 to November 2024 at Yibin University in Sichuan province, China.
The study involved 25 female undergraduates with an average age of 19.8±1.3 years. These participants were selected to provide rich qualitative data about their experiences and views regarding BID.
The participants showed a high level of BID, and the thematic analysis revealed five overarching themes regarding the causes of BID among female undergraduates: (1) individual factors; (2) media factors; (3) family factors; (4) peer factors; and (5) overall societal impact.
The thematic analysis revealed that dissatisfaction with body image among female undergraduates is a multidimensional issue influenced by various factors, including individual and sociocultural elements. The conclusion emphasises the necessity of strengthening comprehensive intervention measures to address these influencing factors.
Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.
A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.
In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.
This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.
ANZCTR 386960
The prevalence of pulmonary nodules (PNs) has been rising in China, but PN patients’ perceptions towards the management remain underexplored. This study aimed to investigate the knowledge, attitudes and behaviours (KAB) regarding PN management among Chinese patients.
A cross-sectional study was conducted to evaluate the KAB scores using a self-designed questionnaire.
The study included 519 PN patients (275 males, aged 41.07±19.47) diagnosed at Wenzhou Hospital of Traditional Chinese Medicine Affiliated to Zhejiang Chinese Medicine University between November 2022 and January 2023. Participants completed a self-designed questionnaire assessing their KAB regarding PN management.
The primary outcomes included mean scores for KAB, with secondary outcomes examining correlations and associations with demographic factors.
The mean KAB scores were 4.24±2.93 (range: 0–10), 17.97±4.88 (range: 0–32) and 31.30±11.98 (range: 0–52). Pearson’s correlation analysis revealed a weakly positive correlation between knowledge and behaviour (r=0.248, p
PN patients demonstrate insufficient knowledge and moderate attitudes and behaviours regarding PN management. These findings highlight the need for targeted educational interventions to improve understanding among PN patients.
The retention of a critical mass of human resources is currently an urgent priority for China’s older adults’ care sector. This study investigated the relationship between social support and turnover intention among employees in older adults caring social organisations (SOs) and focused on studying the mediating role of job satisfaction.
Cross-sectional study.
Older adults caring for SOs in Anhui, Chongqing and Shanghai, China.
A hybrid sampling method was applied to this study, which encompassed multistage stratified sampling and targeted sampling. Questionnaires were administered to 1433 employees of SOs caring for the elderly from November 2019 to August 2023.
A generalised linear model was employed to examine factors associated with turnover intention. Spearman correlation analysis was used to investigate the relationships between key variables. Finally, the mediating effects among the study variables were examined using structural equation modelling.
The overall median scores (IQR) for employees’ turnover intention and social support were 10.00 (6.00) and 72.00 (14.00), respectively. The total effect on turnover intention comprised the direct effect of social support on turnover intention (β =–0.165, SE =0.040, 95% CI =–0.243 to –0.087) and the indirect effect of social support on turnover intention through job satisfaction (β =–0.079, SE =0.016, 95% CI =-0.111 to –0.049).
The study elucidated the indirect influence of social support on turnover intention among employees in older adults caring SOs, mediated by job satisfaction.
Colonoscopy is an essential procedure for the early diagnosis of colorectal conditions; however, over 60% of patients undergoing non-sedated colonoscopy report moderate to severe pain. This study aims to investigate the central analgesic mechanisms of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA). A multimodal approach combining electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to assess pain-related brain activity, with artificial intelligence applied to model the relationship between objective neurophysiological signals and subjective pain experience.
This is a single-centre, randomised, double-blind, controlled trial involving 60 patients undergoing colonoscopy without anaesthesia. Participants will be randomly allocated (1:1) to either an electrical stimulation group receiving TENS-WAA or a sham stimulation group. EEG and fNIRS data will be acquired before, during and after the procedure. The primary outcome is the analysis of EEG-fNIRS signals to characterise cerebral responses associated with pain modulation. Secondary outcomes include patient-reported pain using the Visual Analogue Scale (VAS), total colonoscopy duration and the correlation between EEG-fNIRS indicators and VAS scores. A deep learning framework will be used to enhance pain prediction accuracy.
This study has received ethical approval from the Ethics Committee of Changhai Hospital, Shanghai (approval reference CHEC2025-006), and has been registered at ClinicalTrials.gov. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed academic journals and at relevant scientific conferences, regardless of outcome, contributing to evidence-based, non-pharmacological pain management strategies.
ClinicalTrials.gov, NCT06813703.
Chronic venous disease, particularly lower extremity varicose veins (VVs) and incompetent perforating veins (IPVs), is a prevalent condition associated with significant morbidity, including venous ulcers and post-surgical recurrence. Current diagnostic modalities for IPVs—such as digital subtraction angiography, CT venography, magnetic resonance venography and conventional ultrasound—are limited by ionising radiation, operator dependency or inadequate spatial resolution. Ultrasound tomography (UT), an emerging automated 3D imaging technology, offers comparable resolution, wider field of view and reduced operator bias compared with conventional ultrasound. Preliminary studies suggest UT improves IPV detection rates, yet its diagnostic accuracy and clinical utility remain unvalidated in large-scale trials. This study aims to evaluate UT’s diagnostic performance and its impact on surgical outcomes in a paired-design and randomised controlled trial (RCT), addressing a critical gap in non-invasive venous assessment.
This study combines a paired diagnostic trial and a prospective, triple-blind RCT. In the paired trial (n=84), patients with VVs (Clinical-Etiological-Anatomical-Pathophysiological C2–C5) receive both conventional ultrasound and UT combined with Doppler examination to compare IPV detection sensitivity against surgical findings. The RCT (n=264) randomises patients to conventional ultrasound group (control group) or conventional ultrasound+UT group (intervention group). After examination, all patients undergo standardised treatment (radiofrequency ablation with sclerotherapy and selective IPV ligation), with follow-up extending to 5 years. The primary endpoint is 1-year recurrence rates and secondary endpoints, including 3-month, 3-year and 5-year recurrence rates, as well as Venous Clinical Severity Scores, quality of life and Aberdeen Varicose Vein Questionnaire scores.
The study has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital (approval number: 2024-132). Written informed consent will be obtained from each participant, and final results will be published in peer-reviewed journals.
The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier: ChiCTR2500097289.
To investigate the educational value of combining intraoperative explanations with laparoscopic surgical video reviews for teaching the local anatomy of the stomach.
Thirty resident physicians undergoing standardised training in our hospital, including undergraduate resident physicians and clinical-type postgraduates in surgery who had not participated in radical gastrectomy for gastric cancer, were selected as study subjects. They were randomly divided into an experimental group and a control group, with 15 participants in each group. The experimental group received instruction through intraoperative explanations combined with laparoscopic surgical video reviews, while the control group participated in surgery without additional instructional methods. After the teaching sessions, both groups underwent clinical practice assessments, theoretical examinations and evaluations of teaching satisfaction. The distribution of the data was assessed using the Shapiro-Wilk normality test along with Quantile-Quantile plots. Two-way analysis of variance was employed to evaluate the main effects and interaction effects of clinical practice scores across different groups and student types. Statistical power was examined through post hoc power analysis.
The clinical practice assessment results, theoretical examination scores and teaching satisfaction ratings of the experimental group were significantly higher than those of the control group, with all differences reaching statistical significance (p
Combining intraoperative explanations with laparoscopic surgical video reviews for teaching local anatomy during distal gastrectomy is more effective than participation in surgery alone. This approach allows students to review surgical videos at their convenience, enhancing their understanding and mastery of local anatomical structures and significantly improving the quality of local anatomy education for resident physicians.
Eye injury poses a significant challenge to the global burden of blindness. Using the Global Burden of Disease (GBD) database, this study aims to comprehensively assess the latest global burden of eye injury and examine its relationship with the Socio-Demographic Index (SDI).
Observational study.
Population-based data on eye injury from the GBD 2021 database, covering the period 1990–2021.
Primary outcomes included incidence, prevalence and years lived with disability (YLDs) due to eye injury. Secondary outcomes included temporal trends analysed using joinpoint regression, age-period-cohort effects, health inequality indices (Slope Index of Inequality (SII) and Concentration Index) and decomposition analysis of contributing factors.
From 1990 to 2021, global eye injury incidence (in thousands) increased from 33 702.80 (95% uncertainty interval (UI): 27 271.41 to 44 086.12) to 39 996.91 cases (95% UI: 32 341.74 to 52 215.74), while age-standardised incidence rates (ASIR) declined from 622.73 to 503.26 per 100 000 population (average annual percent change (AAPC): –0.63, 95% confidence interval (CI) –0.81 to –0.46, p75 years). Health inequality between SDI regions narrowed (SII decreased from 3.10 to 2.21 per 100 000), with population growth contributing 207.93% to increased incidence.
The burden of eye injury exhibits distinct patterns across development levels, requiring tailored interventions: occupational safety for young adults in developing regions and fall prevention for the elderly in developed areas. Prevention strategies should align with regional economic development stages, emphasising workplace safety in industrialising regions while maintaining robust healthcare accessibility.
Mediastinal and/or hilar lymphadenopathy (MHL) is increasingly identified owing to various underlying conditions. Minimally invasive biopsy techniques, including endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), transbronchial mediastinal cryobiopsy (TBMC) and transbronchial forceps biopsy (TBFB), are common diagnosis tools. However, their safety and diagnostic efficiency remain unclear. This trial aims to compare the diagnostic yield and safety of these three techniques.
This study is a three-arm, parallel-design, randomised controlled trial involving 972 adult patients with MHL recruited from multiple medical centres. Participants will be randomly assigned to the EBUS-TBNA, TBMC via a tunnel or TBFB via a tunnel group. The primary outcome is diagnostic yield, and the secondary outcomes include diagnostic sensitivity, sample quality and procedure-related complications. Statistical analyses will be conducted using the appropriate methods. An independent sample ² test will be used to test the differences in the diagnostic yield and incidence of procedure-related complications.
Ethics approval was obtained from the China-Japan Friendship Hospital Ethics Committee (2022-KY-194).
Written informed consent will be obtained from all patients or their guardians before their enrolment in the study. This study will be conducted per the principles established in the Declaration of Helsinki and the International Council for Harmonisation Guidelines for Good Clinical Practice.
Postoperative arrhythmias are common and clinically significant complications. They are a cause of increased morbidity and mortality rates in surgical patients. Although various pharmacological and procedural strategies have been explored for preventing postoperative arrhythmia, evidence regarding their effectiveness remains inconsistent. The stellate ganglion block (SGB) has emerged as a promising alternative to reduce the occurrence of postoperative arrhythmias. By summarising the existing evidence, this meta-analysis aims to assess the effectiveness of SGB in preventing postoperative arrhythmias.
We will review literature from January 1970 to April 2025 using MEDLINE, Cochrane CENTRAL and Embase. Studies eligible for inclusion will be randomised controlled trials and observational studies reporting postoperative arrhythmia incidence in surgical patients who received preoperative or intraoperative SGB. We will include articles in the following languages: English, Spanish, Chinese or Portuguese. Secondary outcomes are SGB-related complications. The risk of bias will be determined by Rob-2 and ROBINS-I tools. Meta-analyses, reporting relative risks or ORs with 95% confidence intervals will be performed when at least three studies report the same outcome under comparable conditions. Quality of evidence will be evaluated using GRADE guidelines.
We will use information from previously published manuscripts found in reputable databases, and ethical approval is not necessary.
CRD420251029643.
This study aims to examine the prevalence of elevated blood pressure (BP) among adolescents aged 13–17 years in Shiyan city, Hubei province, China. Additionally, it analyses the distribution characteristics and potential factors influencing elevated BP, providing a scientific foundation for the prevention and management of hypertension in adolescents.
Cross-sectional study.
A total of 11 schools in central China.
From October 2023 to January 2024, a cross-sectional study involving 8534 students aged 13–17 years from 11 schools in central China was conducted. Convenience sampling was used to select participants, and data were collected through questionnaires and medical physical examinations.
This study used physiological measurement to assess BP levels, while questionnaire surveys and anthropometric measurements were employed to identify associated factors.
The overall detection rate of elevated BP was 22.7% (20.2% for boys and 25.6% for girls). Increased body mass index (BMI) (OR: 1.026, 95% CI: 1.003 to 1.048), neck circumference (OR: 1.099, 95% CI: 1.073 to 1.126) and chest circumference (OR: 1.015, 95% CI: 1.007 to 1.023) were associated with an increased risk of elevated BP. Conversely, longer screen time was linked to a lower risk of elevated BP (OR: 0.961, 95% CI: 0.942 to 0.98). Girls (OR: 1.592, 95% CI: 1.419 to 1.787) were at higher risk than boys. Additionally, not consuming meat or poultry (OR: 2.029, 95% CI: 1.171 to 3.514) was identified as a risk factor for elevated BP.
The distribution of elevated BP among adolescents exhibited population heterogeneity. Elevated BP was found to be associated with higher BMI, neck circumference and chest circumference, as well as the absence of meat consumption. Additionally, targeted attention to girls is essential for preventing elevated BP.
The functional cure of chronic hepatitis B (CHB) is an ideal goal of therapy, as it is associated with improved long-term outcomes. Patients with low levels of HBsAg have higher rates of functional cure by pegylated interferon α (PEG-IFNα) therapy, and similar results have been observed in patients treated with PD-1 antibody. However, the combination therapy of PD-1 antibody and PEG-IFNα for promoting functional cure has not been studied. This study protocol aims to evaluate the efficacy and safety of a novel combined strategy, PD-1 antibody combined with PEG-IFNα therapy, in nucleos(t)ide analogues (NAs)-treated CHB patients.
This is a prospective, multicentre, open-label, randomised controlled study. Virologically suppressed CHB patients by NAs therapy will be recruited and randomised into PEG-IFNα group, PD-1 antibody group or PD-1 antibody combined PEG-IFNα group. PD-1 antibody will be injected intravenously once per 3 weeks for 24 weeks, and PEG-IFNα will be injected subcutaneously once a week for 48 weeks. The primary outcomes are the rate of HBsAg loss at 24 weeks. For safety analysis, adverse events in different groups will be compared.
This study has been approved by the Ethics Committee of the Fifth Medical Center of the Chinese PLA General Hospital (KY-2023-12-86-3). All results of the study will be submitted to a peer-reviewed journal.
Acute decompensated heart failure (ADHF), characterised by rapid deterioration of cardiac function, imposes substantial clinical and economic burdens due to high mortality (10%), frequent rehospitalisations (30% within 3 months) and impaired health-related quality of life. While exercise-based cardiac rehabilitation (ExCR) is a guideline-recommended intervention for stable heart failure, its utilisation remains critically low (11%) in ADHF populations, particularly during the vulnerable period spanning 90 days post-discharge—a high-risk phase marked by elevated mortality and morbidity. Current evidence gaps persist regarding optimal ExCR timing, dosage and efficacy during this critical window. This randomised controlled trial investigates the feasibility and impact of early ExCR initiation in the ADHF vulnerable period, evaluating outcomes in physical capacity, cardiac function and quality of life to inform evidence-based exercise protocols for this high-risk population.
This prospective, non-inferiority, randomised controlled trial will recruit 88 patients with ADHF. Participants will be randomised 1:1 to a 12-week personalised ExCR group or a traditional health education-based CR control group. Assessments will occur at baseline and 1, 2 and 3 months. The primary outcome is the change in 6 min walk distance post-intervention. Secondary outcomes include changes in grip strength, New York Heart Association Classification(NYHA class), brain natriuretic peptide, left ventricular ejection fraction, hospital stay, Short Physical Performance Battery score, Activities of Daily Living, Minnesota Living with Heart Failure Questionnaire score, and frailty status. Safety measures include all-cause readmission and mortality within 3 months post-discharge, as well as adverse events during the trial.
The study protocol was approved by the Peking University First Hospital Ethics Committee (Approval No. 2024yan180-002) in accordance with the Declaration of Helsinki. All participants will provide written informed consent prior to enrolment. The findings will be disseminated via peer-reviewed publications and conference presentations.
This study protocol was registered at ClinicalTrials.gov (Identifier: NCT06795737,
Given the global trend toward population ageing, chronic obstructive pulmonary disease (COPD) has emerged as an increasingly common health concern. As a chronic pulmonary disorder frequently encountered in clinical settings, COPD typically involves multiple organ-system impairments. Among these impairments, dysphagia is a significant complication in elderly patients with COPD. Dysphagia profoundly compromises the patients’ quality of life and increases risks such as malnutrition and aspiration pneumonia, thereby exacerbating the overall disease burden. Although systematic reviews evaluating dysphagia prevalence in COPD populations, the quantitative synthesis of associated risk factors has been hindered by inadequate reporting in the original studies. At present, no systematic reviews or meta-analyses specifically address the risk factors associated with dysphagia among elderly patients with COPD. Therefore, this systematic review aims to identify and systematically analyse these risk factors, ultimately providing reliable evidence to facilitate early identification and improve clinical management strategies.
The literature will be meticulously searched through a variety of electronic databases, including Web of Science, PubMed, Embase, Cochrane Library, China Biomedical Literature Service System (CBM), Chinese Scientific Journal Database (VIP), Wan Fang Database and China National Knowledge Infrastructure (CNKI). We will conduct a thorough investigation of the literature focusing on risk factors associated with dysphagia in elderly individuals diagnosed with COPD, spanning from the inception of each database up to October 2025. Two investigators will independently review the literature, evaluate the quality of studies and extract data based on clearly defined inclusion and exclusion criteria to maintain rigour and consistency. The analysis will employ Stata V.14.0 software for the purposes of data merging and assessment of potential biases. OR along with 95% CI will serve as integrated statistical metrics. Statistical heterogeneity will be assessed using the I2 statistic.
Since this study involves an analysis of previously published literature without direct patient participation, obtaining ethical approval is not required. The outcomes of the current investigation will be disseminated through academic journals following a stringent peer-review process.
CRD420251006411.
Ultrasound-guided serratus anterior plane block (SAPB) is commonly used for postoperative pain management in video-assisted thoracoscopic surgery (VATS). However, the choice of local anaesthetics for SAPB remains controversial. This study aims to compare the efficacy and safety of liposomal bupivacaine versus ropivacaine combined with two local anaesthetic adjuncts (dexamethasone and dexmedetomidine) for postoperative pain relief in VATS patients.
This is a single-centre, double-blinded, randomised controlled trial conducted at the Hangzhou First People’s Hospital Affiliated to Westlake University School of Medicine in Hangzhou, China. A total of 120 adult patients scheduled for VATS will be randomly assigned in a 1:1:1 ratio to one of the following three groups: liposomal bupivacaine (group L), ropivacaine combined with dexamethasone (group D) and ropivacaine combined with dexmedetomidine (group R). The primary outcome is the Numeric Rating Scale pain score at rest at 24, 48 and 72 hours postoperatively. Secondary outcomes include opioid consumption, adverse events, Quality of Recovery-15 scores, patient satisfaction and length of hospital stay.
The study was approved by the Ethics Committee of the Hangzhou First People’s Hospital Affiliated to Westlake University School of Medicine (approval number IIT-2024405-01) on 6 November 2024. The protocol was registered in the Chinese Clinical Trial Registry on 9 January 2025. The planned study period is from 1 January 2025 to 31 December 2027, with participant recruitment scheduled from 1 March 2025 to 31 December 2026. Recruitment has not yet started. All participants will provide written informed consent. The results will be disseminated through peer-reviewed journals and academic conferences.
ChiCTR2500095609.
Stroke causes neurological deficits and respiratory dysfunction, with prolonged bed rest exacerbating secondary pulmonary injury. This study evaluated the efficacy of pressure biofeedback training combined with Liuzijue Qigong (LQG) in improving functional outcomes and respiratory function in patients with tracheostomised stroke.
This will be a parallel, single-centre randomised controlled trial involving 66 patients. Eligible patients will be randomly allocated to receive pressure biofeedback therapy combined with LQG training or simple pressure biofeedback training only. The primary outcomes will be the Chelsea Critical Care Physical Assessment Tool score and the findings of diaphragm ultrasound imaging. The secondary outcomes will include the National Institutes of Health Stroke Scale score, pulmonary function test score, maximum phonation time, SpO2 and arterial blood gas results. Outcome analyses will be conducted on both intention-to-treat and per-protocol populations. A preliminary analysis will test whether pressure biofeedback therapy combined with LQG training leads to statistically better outcomes. This trial will provide evidence of the effectiveness of pressure biofeedback training combined with LQG training on respiratory function in patients with stroke after tracheal occlusion.
This study protocol was approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Centre (reference number: Yangzhi2024-137). All study participants will be required to provide written informed consent. The findings of this study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences.
ChiCTR2500097509.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, significantly affecting patients’ quality of life (QoL) and increasing the risk of complications such as heart failure, stroke and dementia. In addition to the physical burden, psychological distress, including depression and anxiety, is prevalent among patients with AF and can exacerbate clinical symptoms and worsen overall well-being. While radiofrequency ablation (RFA) is widely used for rhythm control in AF, its long-term effects on both physical and psychological outcomes, including symptom severity, anxiety, depression and QoL, remain underexplored. This study aims to investigate the long-term impact of RFA on both physical and psychological health in patients with AF, using network analysis to explore symptom interrelationships and their collective influence on QoL.
This longitudinal observational study will investigate the evolution of symptom severity, depression, anxiety and QoL in patients with AF undergoing RFA. Data will be collected at four time points: preprocedure (T0), 3 months (T1), 6 months (T2) and 12 months (T3) postprocedure. The study will employ network analysis to examine the dynamic interactions between physical and psychological symptoms, focusing on core symptoms and their impact on patient outcomes. To assess symptom severity, depression, anxiety and QoL, the following standardised tools will be used: the Atrial Fibrillation Severity Scale, Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 and WHO Quality of Life—Brief Version, respectively. Statistical analyses will include network analysis with R software to explore the interrelationships between symptoms, as well as repeated measures multivariate analysis of variance (MANOVA) to assess changes over time and interactions among variables.
The study was approved by the Ethics Committee of the Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU, No 20250128) and will be conducted in accordance with the Helsinki Declaration and its amendments. Results will be published in peer-reviewed journals, presented at scientific conferences and shared through various popular science forums and patient organisations.
Diabetes is a significant modifiable risk factor for cognitive dysfunction. There are currently no effective treatments that delay or reverse the progression of cognitive dysfunction. Accumulating evidence demonstrates that specific antidiabetes medications hold promise in improving cognitive function. However, the comparative effects of various antidiabetic drug classes on cognitive protection remain to be fully elucidated. This study aims to investigate and compare the cognitive benefits of liraglutide, empagliflozin and linagliptin on achieving mild cognitive impairment (MCI) remission in individuals with type 2 diabetes (T2D).
The LIGHT-MCI trial is an investigator-initiated, multicentre, open-label, parallel-group, randomised, superiority trial involving T2D patients with MCI, consisting of a 48-week core study followed by an extension phase through to 76 weeks. A total of 396 participants will be randomly allocated 1:1:1 to receive liraglutide, empagliflozin or linagliptin treatment. The primary outcome measure is the efficacy difference of liraglutide, empagliflozin and linagliptin in achieving MCI remission in individuals with T2D. The key secondary outcome measures include changes in scores of general cognition and various cognitive subdomains (including processing speed, executive function, immediate memory, visuospatial construction ability, language, attention and delayed memory), basic and instrumental daily living ability, MRI-derived normalised measures of total brain volume, cerebral microstructures, cortical and nuclear volume, white matter hyperintensity, volume, white matter microstructural integrity, odour-induced brain activation and resting-state functional connectivity, olfactory function and metabolic parameters.
The LIGHT-MCI trial has received approval from the Ethics Committees of the Drum Tower Hospital Affiliated to Nanjing University Medical School (2022-092-02) and other participating centres in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation for Good Clinical Practice (ICH GCP E6). Informed consent is required for participation. Findings from this trial are disseminated through peer-reviewed publications, conference presentations, newsletters and social media.