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.

Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.

PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.

This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.

Systemic therapies for advanced gastric cancer (GC), including chemotherapy, targeted therapy and immunotherapy, have evolved significantly in the past few years. The combination of immune checkpoint inhibitors (ICIs) and chemotherapy has become the standard first-line (1L) treatment for advanced gastric or gastro-oesophageal junction (G/GEJ) cancer, although there remains a need for improvement in efficacy. Fruquintinib, an oral and highly selective vascular endothelial growth factor receptor inhibitor, has shown a synergistic antitumour effect when paired with ICI or chemotherapy. Moreover, it has demonstrated a tolerable safety profile and high potential for synergy with chemotherapy or immunotherapy, suggesting that a combination of fruquintinib, sintilimab and oxaliplatin+capecitabine (CAPEOX) can be a promising treatment for locally advanced G/GEJ cancer. This phase 1b/2 study aims to investigate the safety and efficacy of the combination of fruquintinib, sintilimab and CAPEOX regimen as a 1L combination therapy for unresectable advanced or metastatic G/GEJ cancer.

The FUNCTION trial (NCT06329973) is a single-arm, prospective, multicentre, phase Ib/II clinical trial that will consist of a dose escalation phase and an expansion phase. The study is planned to be conducted at 16 public hospitals. A total of 70 participants will be enrolled, comprising nine in the dose escalation phase and 61 in the expansion phase. The dosing regimen during the dose escalation phase will include three different doses of fruquintinib (3 mg, 4 mg and 5 mg, per oral, once per day days 1–14) + sintilimab, 200 mg, intravenous, day 1 +oxaliplatin 130 mg/m², day 1, intravenous, + capecitabine 800 mg/m², per oral, twice daily, days 1–14, every 21 days. The recommended phase 2 dose (RP2D) and maximum tolerated dose will be determined in the escalation phase, and the RP2D will be used in the expansion phase. The primary endpoints will be the maximum tolerated dose and objective response rate; the secondary endpoints will include OS, progression-free survival, disease control rate, duration of response, surgical conversion rate and adverse events and identification of molecular biomarkers for efficacy. The results from this study will provide evidence for expanding the clinical applications of fruquintinib plus sintilimab and CAPEOX as a 1L combination therapy in metastatic or non-resectable, locally advanced G/GEJ cancer and lay the foundation for future large-scale clinical investigations.

This study will be conducted in full compliance with the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH) GCP (Good Clinical Practice, GCP) guidelines, the rules of the Declaration of Helsinki and ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) Guidelines . The study protocol has received approval from the Henan Cancer Hospital ethical committee (Approval No. 2023-237-002). Written informed consent will be obtained from all patients prior to enrolment. For patients who have the mental capacity for informed consent, their consent for participation will be sought and will not be overridden by their family members. For patients who have impaired cognition, informed consent will be sought from their legally acceptable representative. On completion of the analyses, the study findings will be disseminated locally and internationally through manuscript publications in peer-reviewed journals and conference presentations.

NCT06329973.

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.

NCT06357806.

Urolithiasis represents a significant global health burden. Comparing incidence trends between countries with distinct socioeconomic profiles, such as the United States and China, is crucial for tailoring public health strategies. This study aimed to characterise and compare the temporal trends of urolithiasis incidence in the United States and China from 1992 to 2021, thereby providing insights for global disease management.

Data on urolithiasis incidence in the United States and China from 1992 to 2021 were extracted from the Global Burden of Disease (GBD) 2021 study. First, we utilised joinpoint regression analysis to quantify the magnitude and identify significant turning points in age-standardised incidence rate trends over the study period. Second, an age-period-cohort model (APC model) was applied to assess the independent influence of age, period and cohort effects on incidence. Finally, the Nordpred model was employed to project the incidence trends for the next decade.

From 1992 to 2021, the overall incidence of urolithiasis in the United States decreased, but has recently shown an increase; in China, there was a significant reduction. According to the APC model, the highest risk was observed among middle-aged and elderly individuals in these countries. The period and cohort effects in China showed a decline. In the United States, the period effect initially declined but has recently shown an increase; cohort effect peaked around 1930, then declined and also increased in recent years. Over the next decade, the incidence of urolithiasis in both countries was expected to increase.

This study analysed the temporal trends in urolithiasis incidence over the past 30 years in the United States and China. Both countries experienced notable advancements in the burden of urolithiasis; however, the risk of an increased incidence remained higher in the United States.

Intracranial atherosclerosis is the main cause of stroke globally, with acute large vessel occlusive (LVO) stroke being a predominant contributor to stroke-related mortality. In recent years, aspiration thrombectomy (AT) has emerged as a novel therapeutic method for treating acute LVO stroke. The purpose of this study aims to investigate the safety and efficacy of AT alone or combined with stent retriever thrombectomy (SRT) in the treatment of acute LVO stroke

This is a multicentre and observational real-world study involving patients diagnosed with acute LVO stroke. Participants will be treated with AT alone or combined with SRT. According to the actual annual number of embolectomy in the sub-centre and the research years, the sample size of this study is estimated to be 400 patients, of which 300 patients of anterior circulation lesions and 100 patients of posterior circulation lesions are planned to be recruited, being considered that the incidence of posterior circulation is about 20–25%. Clinical data, including baseline characteristics, intraoperative details, postoperative outcomes and follow-up results, will be systematically collected using an Electronic Data Capture system over a follow-up period of 3 months. The primary efficacy endpoint is the rate of excellent functional outcome (modified Rankin Scale score range 0–3) after 90 days, and the successful recanalisation confirmed by digital subtraction angiography. The primary safety outcome is symptomatic intracranial haemorrhage within 48 hours (National Institutes of Health Stroke Scale score increase ≥4). This study will provide us with powerful guidance for the treatment of acute LVO stroke with different aetiologies.

This study protocol was approved by the Ethics Committee on Human Experimentation at Shandong Provincial Hospital Affiliated to Shandong First Medical University (approval number: SWYX:2022–1025). All the participating sites have received the ethics approval. The outcomes will be disseminated through national and international presentations and peer-reviewed publications.

ChiCTR2200065172.

Frailty is a global health issue, particularly among older adults, and is strongly associated with adverse health outcomes. The intermediate stage of pre-frailty, which represents a transition from robust health to frailty, has garnered growing concern due to its potential reversibility. This systematic review and meta-analysis will aim to identify predictors associated with the progression from pre-frailty to frailty in older adults.

A comprehensive literature search will be conducted in PubMed, Web of Science, Embase, Cochrane Library, CINAHL, PsycINFO, CNKI, Wanfang Database, China Science and Technology Journal Database, and China Biomedical Literature Database from inception to the most recent search date. Eligible studies will report predictors of frailty progression among older adults with pre-frailty at baseline. Two reviewers will independently screen the studies, extract relevant data and assess methodological quality using the Newcastle Ottawa Scale. Meta-analysis and meta-regression will be performed to estimate pooled effect sizes and explore potential predictors. Subgroup analyses will be conducted to investigate possible sources of heterogeneity.

Ethical approval will not be required, as this study will not involve primary data collection. The findings will be submitted for publication in a peer-reviewed scientific journal.

CRD42024594175.

The visceral traction response (VTR) occurring during caesarean sections with neuraxial anaesthesia represents a common and significant complication that can greatly affect perioperative results and maternal contentment. Traditional methods for managing VTR frequently face limitations due to differences among individuals, highlighting the necessity for tailored approaches that incorporate personalised risk evaluations, cutting-edge monitoring techniques and enhanced treatment options. Despite the substantial potential of this emerging idea to tackle such an important clinical issue, there is a notable absence of a comprehensive review of the current evidence available.

This protocol for a scoping review outlines a methodical strategy to chart the existing research landscape related to precision management of VTR in the context of caesarean delivery performed under neuraxial anaesthesia. By developing a conceptual framework, assessing the combined benefits of cutting-edge technologies and summarising tailored intervention techniques, this review aims to pinpoint key attributes, critical areas and new research directions, ultimately contributing to the enhancement of clinical practices and the formulation of rigorous future studies.

This research will thoroughly follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. The eligibility criteria will be outlined using the population, concept, context framework. A comprehensive search across various international and Chinese databases (such as PubMed/MEDLINE, Embase, Cochrane Library, Web of Science, CINAHL, Scopus, Google Scholar, China National Knowledge Infrastructure, WanFang and VIP) will be performed for literature published until March 2025, with a final update conducted before submission. Two reviewers will independently assess the literature and extract data. The data will be synthesised in a narrative format, supplemented by tabular and graphical representations, including conceptual framework diagrams and technology application matrices.

As this is a secondary analysis of published literature, ethics approval is not required. Results will be disseminated through peer-reviewed publications and presentations at international conferences, establishing an evidence foundation for clinical pathways and guiding future research initiatives. The protocol is registered with the Open Science Framework (https://doi.org/10.17605/OSF.IO/VS94Y).

The objective of this study was to identify risk factors for enema reduction failure and to establish a combined model that integrates deep learning (DL) features and clinical features for predicting surgical intervention in intussusception in children younger than 8 months of age.

A retrospective study with a prospective validation cohort of intussusception.

The retrospective data were collected from two hospitals in south east China between January 2017 and December 2022. The prospective data were collected between January 2023 and July 2024.

A total of 415 intussusception cases in patients younger than 8 months were included in the study.

280 cases collected from Centre 1 were randomly divided into two groups at a 7:3 ratio: the training cohort (n=196) and the internal validation cohort (n=84). 85 cases collected from Centre 2 were designed as external validation cohort. Pretrained DL networks were used to extract deep transfer learning features, with least absolute shrinkage and selection operator regression selecting the non-zero coefficient features. The clinical features were screened by univariate and multivariate logistic regression analyses. We constructed a combined model that integrated the selected two types of features, along with individual clinical and DL models for comparison. Additionally, the combined model was validated in a prospective cohort (n=50) collected from Centre 1.

In the internal and external validation cohorts, the combined model (area under curve (AUC): 0.911 and 0.871, respectively) demonstrated better performance for predicting surgical intervention in intussusception in children younger than 8 months of age than the clinical model (AUC: 0.776 and 0.740, respectively) and the DL model (AUC: 0.828 and 0.793, respectively). In the prospective validation cohort, the combined model also demonstrated impressive performance with an AUC of 0.890.

The combined model, integrating DL and clinical features, demonstrated stable predictive accuracy, suggesting its potential for improving clinical therapeutic strategies for intussusception.

Non-suicidal self-injurious behaviour (NSSI) is defined as purposeful self-injury without the intention to die. NSSI has become an important threat to public health among teenagers globally, imposing considerable costs on individuals, families and society. It reflects poor emotional regulation and serves as an early warning sign for suicidal ideation and behaviour. The purpose of this study is to look at the prevalence of NSSI and the risk factors related to it in Beijing’s adolescent population.

Epidemiological surveys and qualitative interviews will both be used in this study. First, a cross-sectional epidemiological survey with stratified sampling will assess the prevalence, risk factors and variables associated with NSSI among adolescents in Beijing. The survey will include a sample size of at least 1415 adolescents. The significance of emotional control, social support and mental health in NSSI conduct will then be investigated through qualitative interviews. This part of the study will use a phenomenological qualitative research approach, with the sample size determined by data saturation, typically around 10 participants, but flexible due to the large sample from the epidemiological survey. In order to investigate the prevalence of NSSI, statistical analysis of correlation, descriptive statistics and regression analysis with multiple variables will be used to analyse the survey data using SPSS V.27.0 and Excel 2003. NVivo V.12 software will be used to code the qualitative data, and thematic analysis and word frequency will be used to find connections between the various NSSI experiences.

The Guang’anmen Hospital Ethics Committee of the China Academy of Chinese Medical Sciences has given its approval to the project (no. 2023-259-KY). Participants will provide both verbal and written informed consent prior to participation, with legal guardians signing for the qualitative part of the study. Participants will be informed of their right to withdraw from the study at any time without affecting their clinical care. Results will be shared through academic journals, conferences and public health platforms to raise awareness of NSSI and inform related policy development.

ChiCTR2400085968.

While transcatheter aortic valve replacement (TAVR) has become a well-established standard of care for patients with symptomatic severe aortic stenosis, the optimal antithrombotic strategy post-TAVR remains a subject of debate, particularly in patients without clear indications for anticoagulation or dual antiplatelet therapy. This study aims to investigate the safety and efficacy of rivaroxaban compared with antiplatelet monotherapy in this specific patient population.

This study is designed as a prospective, multicentre, open-label, randomised controlled trial. A total of 454 patients, who have successfully undergone TAVR and do not have indications for long-term anticoagulation or dual antiplatelet therapy, will be consecutively enrolled from seven centres across China. Participants will be randomly assigned to receive either anticoagulation with rivaroxaban (20/15 mg) or conventional antiplatelet therapy (aspirin or clopidogrel) for 1 month. Follow-up evaluations are scheduled at 1, 3, 6 and 12 months post-procedure. After the initial 1-month antithrombotic therapy, the regimen may be adjusted by the investigator based on the patient’s clinical and imaging follow-up results. The primary endpoint is a hierarchical composite of cardiovascular death, first occurrence of myocardial infarction or stroke, first occurrence of life-threatening, disabling or major bleeding, and grade 3 or higher hypo-attenuated leaflet thickening and reduced leaflet motion at 12 months post-TAVR. The win ratio method will be employed to analyse the primary endpoint.

This trial was approved by the Ethics Committee of the Beijing AnZhen Hospital. All relevant results will be disseminated through publications in peer-reviewed journals and presentations at conferences.

ChiCTR2400087453.