Tuberculosis (TB) remains a globally concerning infectious disease, and significant challenges persist in attaining the 2030 targets set by the WHO. With the rapid advancements in computer-aided detection (CAD) technology, CAD-assisted Chest X-Ray (CAD-CXR) has been applied in TB patients triaging, but the practical application value of the CAD-CXR system in real-world primary healthcare settings in China for TB prevention and control has not been fully elucidated. This protocol reports a design of a cluster randomised controlled trial (CRCT), which aims to evaluate the effectiveness and clinical pathway of CAD-CXR in enhancing TB diagnostic yield in primary healthcare settings, thereby contributing to global TB elimination strategies.

Scheduled for September 2025, this CRCT will recruit 22 townships in Yichang of Hubei Province, China. These townships will be randomly allocated at a 1:1 ratio to either the CAD-CXR system intervention group or the control group. In the intervention group, healthcare providers will use the CAD-CXR analysis system to assist in TB screening, whereas the control group will rely solely on conventional CXR interpretation by radiologists. The primary outcome of the study is the TB diagnostic yield; the secondary outcomes include diagnostic delay duration and the accuracy of the CAD-CXR system. These metrics will be comprehensively evaluated to assess the effectiveness of the CAD-CXR intervention. Findings from this study are anticipated to offer evidence-based recommendations regarding the optimal application scenarios and implementation pathways for CAD-CXR.

This study was approved by the Ethics Committee of the Peking Union Medical College (CAMS&PUMC-IEC-2025-044). Findings of this study will be disseminated through traditional academic pathways, including peer-reviewed publications and conference presentations.

NCT06963606.

Intraventricular haemorrhage (IVH) remains a major contributor to mortality and long-term neurodevelopmental impairment among preterm infants, particularly those born extremely preterm or extremely low birth weight. Although extensive research has investigated various facets of IVH, including prevention, therapeutic interventions, underlying pathophysiology and long-term outcomes, the heterogeneity in selection, measurement and reporting across studies significantly impairs data synthesis through meta-analysis and limits the translation of evidence into clinical practice. To address this issue, we propose the development of a Core Outcome Set (COS) for IVH research in preterm infants.

This study will follow established guidance from the Core Outcome Measures in Effectiveness Trials Initiative and COS-Standards for Development. The sequential phases include: (1) a systematic review to comprehensively identify outcomes previously reported in IVH research involving preterm infants; (2) qualitative interviews with diverse stakeholders (clinicians, researchers and caregivers) to explore perspectives and identify additional relevant outcomes; (3) a multiround Delphi survey to achieve consensus on core outcomes; and (4) a consensus meeting to finalise the COS.

The entire project has been approved by the Ethics Committee of West China Second University Hospital (No. 2022-069). Written informed consent will be obtained from all participants prior to participation. Study findings will be disseminated through conferences and publications in peer-reviewed journals.

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 explore the suffering experiences of patients with nasopharyngeal carcinoma (NPC) in China.

This qualitative study employed a descriptive phenomenological approach. Data were collected through semistructured interviews and analysed using Colaizzi’s seven-step method. The study was conducted at a university-affiliated cancer centre in Southwest China. A total of 20 patients diagnosed with NPC were recruited through purposive sampling between January and April 2024.

‘Disruption to reinvention’ emerged as a unifying thread that integrated three main themes (and nine subthemes): (1) beginning of suffering: plunged into a world of illness (denial and fear, significant concern and life in chaos); (2) struggle for adjustment: a rollercoaster experience (suffering trajectory, aggravating factors and alleviating factors) and (3) beyond suffering: living with illness (perceived benefits, new normal in life and personal growth).

The suffering experiences of patients with NPC represent a complex and dynamic process. People with NPC frequently experience multiple sufferings, disrupting their lives. Notably, most patients progressed from disruption to reinvention, reflecting the possibility that suffering can be transcended. The findings of this study can assist healthcare professionals in better identifying the suffering of patients and its influencing factors, allowing for the tailoring of interventions to alleviate their suffering.

Chronic low back pain (CLBP) is characterised by multifaceted pathophysiology involving both central sensitisation and peripheral dysfunction. Conventional therapies often fail to address this complexity due to their unidimensional targets. Paired associative stimulation (PAS), a dual-target neuromodulatory approach that combines central and peripheral interventions, has demonstrated efficacy in enhancing motor recovery post-stroke by synchronously inducing corticospinal plasticity and peripheral neuromuscular adaptation. Building on this paradigm, we propose a novel combined primary motor cortex (M1) and multifidus muscle stimulation protocol. The intervention pairs transcranial magnetic stimulation over M1 with peripheral magnetic stimulation targeting the multifidus muscle, hypothesising that temporally coordinated central and peripheral stimulation will synergistically enhance the corticospinal drive to the lumbar spine and restore multifidus neuromuscular control, thereby alleviating pain and improving functional capacity in CLBP.

This study will enrol 82 individuals diagnosed with CLBP between 18 and 65 years of age. Study participants will undergo randomisation into two parallel groups: the experimental arm receiving active PAS therapy (n=41) and the control arm receiving sham PAS treatment (n=41). The intervention protocol consists of 20 treatment sessions delivered across a 4-week timeframe, with participants attending five sessions weekly. Assessment time points are scheduled at study entry (baseline) and 4, 8 and 12 weeks following intervention initiation. The study’s primary outcome is the Oswestry Disability Index (ODI). Secondary outcomes encompass the Visual Analog Scale (VAS), Short-form McGill Pain Questionnaire (SF-MPQ), Short Form 36 Health Survey (SF-36), Pain Catastrophizing Scale (PCS), and functional magnetic resonance imaging (fMRI). Data analysis will adhere to the intention-to-treat methodology. Between-group comparisons across temporal measurement points will employ mixed-effects modelling approaches.

Ethical approval for the research protocol was obtained from the Ethics Committee of Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (approval number: 2025-K-45), with trial registration completed in the China Clinical Trial Registry on 27 April 2025. On study completion, findings will be prepared for submission to peer-reviewed academic publications.

ChiCTR2500101574.

Most mental health disorders are first experienced during childhood. There are evidence-based treatments, but it is difficult to reach all children in need. Schools have long been recognised as an ideal setting to provide mental health interventions and services for children. There is growing evidence of the effectiveness of school-based digital mental health interventions. Emotion regulation (ER) is central to psychopathology across childhood and adolescence. Cultivating ER can help build resilience and foster long-term well-being. We developed an app (‘CoaCH Effective Emotion Regulation’, CHEER) designed to promote ER, eventually aiming to reduce broader mental health disorders in children. The aim of the proposed study is to investigate the feasibility and preliminary effectiveness of the CHEER.

A feasibility cluster randomised controlled trial with two parallel arms (intervention vs usual care), including students recruited across three sites in Anhui province, will be conducted. Schools are randomly assigned to the intervention or usual care control condition. Participants complete measures at three timepoints: baseline, postintervention and 1-month follow-up. The primary outcomes are the ER abilities and strategies of children. The secondary outcomes are well-being, depressive symptoms and anxiety symptoms. The APP feasibility will be assessed by analysing children’s objective engagement parameters alongside their subjective experience.

Ethical approval for the study has been granted by the Medical Ethics Committee of Anhui Medical University (Project Number: 82240119). The results of the study will be disseminated through publications in scientific articles and presentations at relevant conferences and/or public events.

ChiCTR2400091728 (chictr.org.cn).

An increasing number of randomised controlled trials (RCTs) have compared the analgesic effects of erector spinae plane block with those of intercostal nerve block for postoperative analgesia in various surgeries, but the results have been inconsistent. This protocol of a systematic review and meta-analysis aims to evaluate whether the analgesic effects of erector spinae plane block are superior to those of intercostal nerve block.

A comprehensive search will be conducted by two authors via PubMed, EMBASE, the Cochrane Library and Web of Science from inception to 25 December 2025. No search language restrictions will be set. We will include RCTs that compared the analgesic effects of erector spinae plane block with those of intercostal nerve block after surgery. Total opioid consumption over 24 hours postoperatively will be the primary outcome. The duration of analgesia, pain intensity and incidence of adverse effects will be the secondary outcomes. RevMan V.5.4 software will be used to conduct the statistical analysis. The Cochrane Collaboration’s tool will be used to assess the risk of bias. The I² test will be used to assess heterogeneity. Subgroup analysis and meta-regression will be performed to explore the source of heterogeneity. Sensitivity analysis will be used to examine the reliability of the pooled data. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to recommend evidence quality. Publication bias will be evaluated via Egger’s test.

Ethical approval is not applicable. The results will be publicly published on completion.

CRD420251073023.

Thyroid-associated ophthalmopathy (TAO), the most common orbital disease in adults, is an autoimmune disease of the orbital and periorbital tissues. Typical ocular symptoms of TAO include periorbital oedema, conjunctival congestion and oedema, eyelid retraction, exophthalmos, restrictive strabismus, etc. Hypercholesterolaemia is considered one of the modifiable risk factors of TAO. However, it is unclear whether lipid levels are related to TAO activity and severity and the intravenous glucocorticoids (GC) therapeutic effect. The study aims to evaluate the association between initial lipid and lipoprotein levels, the clinical features of TAO and the efficacy of intravenous methylprednisolone in patients with moderate-to-severe TAO, as well as to explore the oxidative stress-related mechanisms involved.

This real-world prospective cohort study will recruit 178 patients with moderate-to-severe TAO who receive two intravenous methylprednisolone regimens, respectively. The primary outcome is the improvement in the composite index at 3 months after baseline treatment, with secondary outcomes including other ocular features, changes in serological characteristics and major adverse events.

The study protocol was approved by the ethics committees of Xiangya Third Hospital of Central South University (Kuai241012) on 29 November 2024. The study will be conducted according to the guidelines of the Declaration of Helsinki. Participants will be informed of the purpose and content of the study and will complete a written informed consent form before being recruited. The findings will be published in peer-reviewed journals as well as in reports of relevant conferences.

Chinese Clinical Trial Registry (ChiCTR2400094094). Registered on 17 December 2024.

Although caesarean sections (CSs) are essential for the management of obstructed labour and other obstetric complications, postoperative pain, delayed recovery and complication risks continue to be significant challenges in perioperative management. Improvements in traditional medications and surgical techniques have helped, yet issues, including medication side effects and extended recovery times, persist. Therefore, it is particularly important to seek non-pharmacological interventions, such as acupoint stimulation, to optimise the perioperative management of CS. The aim of this systematic review protocol is to synthesise the available evidence and assess the effect of acupoint stimulation in the perioperative period of CS.

We plan to search PubMed, Web of Science, EMBASE, Scopus, the Cochrane Library and China National Knowledge Infrastructure, from their inception to August 2025. Primary outcome indicators will include pain, time to first defecation, time to first bowel movement and time to return of bowel sounds. Secondary outcome indicators will include postoperative complications, such as nausea and vomiting, bloating, anxiety and depression, as well as length of hospital stay and morphine consumption. Subgroup analyses, meta-regression and sensitivity analyses will be used to investigate the potential sources of heterogeneity and to test the stability of the results. Trial sequential analysis will be introduced to enhance the reliability of the evidence.

No ethical approval is required as this study synthesises the existing published data. Results will be disseminated through peer-reviewed publications and conference presentations. Any protocol amendments will be documented in PROSPERO and detailed in the final publication.

CRD42024558572.

Thyroid-associated antibodies are crucial in the occurrence and development of thyroid-associated ophthalmopathy (TAO). Protein A immunoadsorption is a more specific and plasma-independent antibody removal technology, which has been used in a variety of autoimmune diseases, such as systemic lupus erythematosus and antineutrophil cytoplasmic antibodies associated vasculitis (ANCA-associated vasculitis). This study protocol aims to verify the efficacy and safety of the application of protein A immunoadsorption in TAO to provide a new method for the treatment of this pressing disease.

This clinical trial is a single-centre, prospective, non-randomised controlled trial in China. 174 screened patients with moderate to severe active TAO will be divided into three groups: protein A immunoadsorption treatment group, methylprednisolone hormone pulse group and tocilizumab injection group, with 58 patients in each group. They will undergo 1-year treatment and follow-up. The primary outcomes include: (1) improvement of eyelid retraction greater than 2 mm; (2) a reduction of the Clinical Activity Score (CAS) by ≥1 point; (3) the exophthalmos retreats to ≥2 mm. The secondary outcomes include: (1) Improvement of Graves’ Ophthalmopathy Quality of Life (GO-QOL) questionnaire score after 6 months of treatment; (2) reduction of thyroid-associated antibody titre. Treatment is considered effective if two or more primary outcomes are met or if one primary outcome and two secondary outcomes are met. Otherwise, the treatment is ineffective. The evaluation of the results is based on the most severely affected eye, and the efficacy is evaluated by the outcome of this eye at the end point.

Ethical approval has been obtained from the Institutional Review Board (IRB) of Third Xiangya Hospital, Central South University. Findings will be reported to (1) participating patients; (2) funding bodies, institutes and the hospital; (3) presented at local, national and international conferences and (4) disseminated by peer-review publications.

ChiCTR 2500095461. Registered on 7 January 2025; https://www.chictr.org.cn/.

Recurrence of hypertriglyceridaemia-associated acute pancreatitis (HTG-AP) is common. Uncontrolled HTG after hospital discharge is an important risk factor for recurrence. However, the optimal triglyceride (TG) goal of lipid-lowering therapy for outpatients remains unclear. The efficacy and safety of intensive TG-lowering therapy on reducing recurrence of HTG-AP trial aims to determine whether intensive TG-lowering therapy (with a TG goal of

This is an investigator-initiated, multicentre, open-label, parallel, superiority, randomised, controlled trial. Adult patients who have been successfully treated and discharged from their index episode of HTG-AP will be screened for eligibility after a 4-week to 3-month run-in period in the outpatient setting, and then patients with the fasting serum TG levels ≥150 mg/dL at baseline are eligible. During the study period, a total of 256 study participants will be randomised to receive either intensive TG-lowering therapy or usual care. In the intensive TG-lowering therapy group, the goal of TG levels is lower than 150 mg/dL, which will be monitored at 1 month, 3 months, 6 months, 12 months and 18 months after randomisation. In the usual care group, the goal of TG levels is lower than 500 mg/dL according to the current guidelines. Lifestyle suggestions and TG-lowering agents are the main strategies to manage the lipid level. The primary endpoint is the incidence of recurrent episodes of HTG-AP at 18 months after randomisation.

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2023101–3). Ethics approval of each participating centre is required before initiation of enrolment. The results of this study will be published in peer-reviewed journals and reported at international conferences.

ChiCTR2300073483 (Chinese Clinical Trial Registry)

V.4.0 (2024).