Clinical trials

The purpose of this study is to evaluate the efficacy and safety of a disposable noninvasive skin closure device in promoting postoperative wound healing and reducing surgical scar formation. Participants will receive the device on one half of the surgical incision, with the other half serving as a control. Wound healing and scar appearance will be assessed during follow-up visits after surgery.

Data about transgender medical care, especially the gender-affirming hormone therapy (GAHT) is extremely insufficient in China. Few evidence exists in the physical and psychological effects of the hormonal treatment in Chinese transgender population. CGAHT is designed to describe the social and mental condition of transgender people who are seeking for formal GAHT, and to investigate the physical and psychological effects of GAHT on this population in China.

Cardiovascular-Kidney-Metabolic (CKM) Syndrome is a continuous clinical disease spectrum integrating cardiovascular, renal, and metabolic disorders. Heart failure with preserved ejection fraction (HFpEF) is considered Stage 4 of CKM syndrome, characterized primarily by impairment of cardiac structure and function. Numerous studies have confirmed that exercise intervention is effective in improving metabolic profiles and inflammatory status in Stages 0-3 of CKM syndrome (e.g., obesity, metabolic syndrome, hypertension, and diabetes), and significantly improves clinical outcomes. However, for Stage 4 CKM syndrome, especially in patients with HFpEF, conventional exercise prescription faces significant challenges in balancing safety and efficacy. Moreover, traditional "one-size-fits-all" exercise rehabilitation strategies have failed to significantly improve clinical outcomes due to the lack of individualized precision approaches. To address this gap, this study proposes to adopt a multicenter, randomized, controlled design, enrolling patients with HFpEF at Stage 4 of CKM syndrome and randomly assigning them to either a personalized high-intensity interval training (HIIT) intervention group or a standard care control group. The \*\*primary endpoint\*\* of this study is the change in peak oxygen consumption (peak VO₂) from baseline after 24 weeks of intervention. In addition, a series of \*\*secondary endpoints\*\* have been established for comprehensive evaluation, including inflammatory biomarkers, cardiac structure and function, quality of life, and composite clinical events. These endpoints aim to comprehensively assess the intervention effects from the perspectives of cardiopulmonary function, metabolism and inflammation, quality of life, and clinical outcomes, as well as to explore the underlying mechanisms. This study is expected to validate the beneficial effects of personalized exercise on peak VO₂ and various secondary endpoints in patients with Stage 4 CKM syndrome. It will not only provide high-level evidence-based support for exercise therapy in HFpEF but also deepen the understanding of the role of exercise intervention in the full-course management of CKM syndrome, offering key scientific support for the development of precision prevention and treatment strategies across all stages.

Part 1: Neural Correlates of Motor Imagery in ACLR Patients This cross-sectional study aims to systematically compare differences in electroencephalographic (EEG) activity between patients who have returned to sport one year after anterior cruciate ligament reconstruction (ACLR) and healthy controls during functional tasks and associated motor imagery. We will collect EEG activity and behavioral performance data from both groups during task execution and imagination. The primary objective is to verify whether ACLR patients exhibit a specific deficit in motor imagery capability and to characterize the abnormal functional patterns within their central sensorimotor networks. By providing an objective, neurophysiological explanation for why patients struggle to return to sport, this study seeks to establish quantifiable baseline metrics for subsequent interventional research. Part 2: Effects and Cortical Plasticity Changes Following Motor Imagery-Enhanced Rehabilitation This randomized controlled trial (RCT) combines short-term intervention with long-term follow-up to systematically evaluate the efficacy and mechanisms of motor imagery therapy in ACLR patients. The specific objectives are threefold: First, to verify the immediate effects of the intervention on enhancing neuroplasticity and restoring motor function. Second, to assess the long-term impact on definitive clinical outcomes-specifically return-to-sport rates and time to return-through a 12-month follow-up. Third, to perform a longitudinal analysis determining whether early improvements in neurophysiological indicators can predict subsequent gains in motor performance and successful return-to-sport outcomes.

A Comparative Study of Traditional Rehabilitation and Remote Intelligent Rehabilitation: Exploring the Application Effectiveness of Intelligent Rehabilitation in Frozen Shoulder Rehabilitation

The present study is a prospective,single-center, single-arm, pre-post control clinical trial conducted at Peking University Third Hospital. 20 participants will be recruited into CCP group,Clinical outcomes will be evaluated at baseline, one week and two weeks after treatment and two weeks follow-up after treatment termination. The primary outcome measure is the Visual Analogue Scale (VAS) pain score before and after treatment. Secondary outcomes include Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Numerical Rating Scale (NRS), SF-36 Health Survey, Short-form McGill Pain Questionnaire (SF-MPQ), adverse event incidence rate, and analgesic medication use frequency.Adverse events will be assessed at every visit. Both the CRF and web-based electronic database, REDCap (edc.bjmu.edu.cn), will be used to manage individual participant data by two data entry personnel independently. SPSS V.25.0 statistical software was used for analysis. This report describes the study design of the clinical trial.

Systemic sclerosis (SSc) is an autoimmune disease primarily characterized by fibrosis of the skin and internal organs. In 2018, SSc was included in China's "First Batch of Rare Disease Catalog." Compared with the well-established large-scale SSc clinical cohorts in Europe, China's SSc cohort research is still in its infancy. Limited by the small number of SSc patients, complex and diverse clinical manifestations, uneven regional diagnostic and treatment capabilities, and dispersed research resources, there is currently a lack of in-depth research on the pathogenesis, disease characteristics, early intervention, precision treatment, and prognosis evaluation of SSc. Based on the preliminary research of the research group, this project will leverage the advantageous platforms of our hospital and SSc patient public welfare organizations to establish a scleroderma trial and research cohort, conduct clinical analysis, and screen for novel biological markers and drug targets, carry out large-scale epidemiological investigations, and cultivate specialized personnel, establish and improve China's SSc chronic disease management system, achieve balanced and equitable SSc diagnosis and treatment resources in China, and benefit the vast number of patients.

This multicenter, open-label, superiority randomized controlled trial will evaluate whether delaying planned induction from 40 weeks to 41 weeks improves delivery outcomes in women with A1 gestational diabetes mellitus (A1 GDM). The study is designed to enroll 1,500 eligible women (750 per group), all of whom are planned for vaginal delivery. Eligible participants are women aged 18-40 years with singleton pregnancy and who are primiparous. GDM will be diagnosed using OGTT at 24-28 weeks, and participants must meet criteria for A1 GDM, meaning blood glucose is controlled with diet and exercise only (no insulin or other glucose-lowering medications during pregnancy). After providing written informed consent, participants will be randomized 1:1 to one of two pre-specified induction strategies. Control group (planned induction at 40 weeks): Participants will have planned induction at 40+0 weeks (time window 39+6 to 40+0). If spontaneous labor occurs before or during the window, obstetric management will follow routine clinical practice. If labor has not started by the end of the window, induction will be performed according to the protocol. Intervention group (expectant management until 41 weeks): Participants will be managed expectantly until 41+0 weeks with planned induction in the 41+0 to 41+1 weeks window. If spontaneous labor occurs before or during the window, routine obstetric management will be used. If labor has not started by the end of the window, induction will be performed according to the protocol. Participants will be followed from randomization until delivery and hospital discharge, with selected outcomes followed up to postpartum day 42. The primary outcome is the cesarean delivery rate. Secondary outcomes include maternal outcomes such as postpartum hemorrhage and other obstetric complications, neonatal/perinatal outcomes including perinatal death, and need for respiratory support, as well as selected health-economic and patient-reported outcomes. All participating centers will apply standardized procedures for screening, monitoring, induction methods, and data collection. An independent Data and Safety Monitoring Board (DSMB) and a blinded Clinical Endpoint Committee will monitor safety and validate the primary outcome. The trial is expected to be completed within approximately 18 months after initiation of recruitment, and the results will provide high-quality evidence to inform timing of delivery for women with A1 GDM in China.

This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.

Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus（SLE）, Sjögren's syndrome (SS), systemic sclerosis (SSc), inflammatory myopathies (IM), ANCA-associated vasculitis (AAV), and antiphospholipid syndrome (APS). They affect the quality of life, while in severe cases, they can be life-threatening. Additionally, they impose a heavy economic burden on society. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Chimeric Antigen Receptor (CAR)-T cells targeting the B cell surface molecule CD19 have achieved significant clinical progress in acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma, with several CD19 CAR-T therapies approved for marketing worldwide. Increasingly, clinical studies are exploring the use of CD19 CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, the investigators used γδ T cells as carrier cells to investigate the safety and efficacy of universal CAR-γδ T cells in the treatment of autoimmune diseases.

Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.

This single-center randomized controlled trial evaluates whether budesonide nasal drops delivered in the Wu's position (Wu's 45° Head-Hanging Reclination Position) improve olfactory function more effectively than conventional budesonide nasal spray in adults with type 2 chronic rhinosinusitis (CRS)-related olfactory dysfunction. The study also evaluates patient-reported symptoms and quality of life, olfactory cleft structural abnormalities on sinus CT, computational fluid dynamics (CFD)-derived airflow parameters, safety, and whether baseline peripheral blood eosinophil count and clinical phenotype predict treatment response. The main questions this clinical trial aims to answer are: 1. Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients? 2. Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach? 3. Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?

The goal of this clinical study is to learn if using a special pillow placed behind the shoulder can help to reduce pain and improve sleep for patients after surgery to repair a torn rotator cuff. The main questions it aims to answer are: * Do patients who choose to use the posterior shoulder pillow have lower pain levels after surgery? * Do these patients report better sleep quality during recovery? * How safe and comfortable is the pillow for patients to use? Researchers will compare patients who use the pillow to those who do not use it to see if there is a difference in their recovery. Participants will: * Be asked about their willingness to use the pillow. Their treatment and recovery plan will be decided together with their doctor. * Be asked to rate their pain and sleep quality several times after surgery: at 1 week, 2 weeks, 4 weeks, and 6 weeks. * Have their shoulder function assessed by a clinician at 2, 4, and 6 weeks after surgery. * Receive a standard MRI scan before and 6 weeks after surgery as part of their regular medical care to check on healing.

This randomized, within-participant, contralateral-limb-controlled clinical trial will compare individually optimized compliant and rigid stiffness settings of a portable isokinetic knee training robot in children with spinal muscular atrophy. At least 13 children aged 6 to 12 years will be enrolled. For each participant, one leg will be randomly assigned to the compliant setting and the contralateral leg to the rigid setting using sequentially numbered, opaque, sealed envelopes. Both legs will receive the same training volume, number of repetitions, and angular velocity for up to 8 weeks. The primary outcome is the between-setting difference in the change from baseline in peak isokinetic knee-extension torque. Secondary outcomes include knee-extension range of motion, quadriceps cross-sectional area on magnetic resonance imaging, femoral nerve conduction measures, and sit-to-stand performance. Knee pain, suprapatellar skin temperature, fatigue, and other adverse events will be monitored throughout the study.

The goal of this clinical trial is to assess the effectiveness of isokinetic rehabilitation training under optimal stiffness in patients undergoing knee joint rehabilitation. The main questions it aims to answer are: * Does isokinetic training under optimal stiffness lead to greater force exertion compared to traditional bodyweight training? * What are the long-term (6-week) effects of isokinetic training under optimal stiffness on joint flexibility and muscle strength? Researchers will compare the effects of isokinetic training under optimal stiffness to traditional bodyweight training to see if isokinetic training produces superior improvements in muscle strength, flexibility, and overall functional recovery. Participants will: * Perform regular training sessions using a portable knee joint isokinetic trainer, customized to their optimal stiffness for maximum force exertion. * Engage in a 6-week rehabilitation program, with assessments at the beginning, and end of the study to evaluate changes in muscle strength, and functional recovery.

This is an observational, ambidirectional cohort study. Calcaneal fractures are the most common tarsal bone fractures, and most are intra-articular fractures involving the subtalar joint. Surgery with open reduction and internal fixation is the standard treatment for displaced intra-articular calcaneal fractures. During surgery, a sustentaculum tali screw is placed from the lateral wall of the calcaneus toward the medial side to support the reduced posterior articular surface. Depending on the screw tip position, fixation is classified as sustentaculum tali fixation (ST; screw fixed directly into the sustentaculum tali) or sustentaculum tali fragment fixation (STF; screw fixed into the larger medial fragment containing the sustentaculum tali). This study compares radiographic reduction quality, foot and ankle function, and complications between these two fixation groups. Approximately 92 participants with intra-articular calcaneal fractures will be enrolled, retrospectively from January 2015 to August 2026 and prospectively from September 2026. The fixation mode is determined on postoperative X-rays. Outcomes, including the Maryland Foot Score, the AOFAS ankle-hindfoot score, Böhler's angle, Gissane's angle, calcaneal height and width, and complications, will be compared between groups over at least 12 months of follow-up. No randomization is performed and no treatment is altered by this study.

This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.

This study is designed as a prospective, multicenter, parallel-group randomized controlled trial to evaluate the effectiveness of a "precision acupuncture + personalized lifestyle" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS). Compared with "conventional acupuncture + standard lifestyle intervention," the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment. The safety of the intervention, improvements in endocrine and metabolic profiles, menstrual and ovulatory outcomes, psychological status, quality of life, and health-economic outcomes will also be evaluated. The study aims to provide evidence for establishing an intelligent and individualized clinical management model for PCOS.

This study develops a multi-agent collaborative prediction model to forecast adverse drug reactions using real-world clinical medical records. It validates model performance via evidence-based data and compares decision outputs between the AI model and clinical physicians, aiming to improve early identification of drug adverse events. Only de-identified historical medical data will be analyzed; no new clinical interventions will be conducted, with no additional risks to participants.

The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg or 1×10\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.

This is an investigator initiated trial to assess the safety and efficacy of BCT301 cell Injection (CAR-iT cells derived from chemically induced pluripotent stem cells) in patients with refractory/recurrent IgG4-related disease.

This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.

The specific construction goals for this period include enrolling 100,000 individuals for dynamic follow-up, perfecting the biobank by collecting biological samples from 20,000 individuals, and gathering health questionnaire information from 30,000 people. The near-term goals emphasize the use of health check-up data combined with advanced artificial intelligence technologies to build disease prediction models and explore the association between retinal photographs and overall health status, which will assist in early screening and personalized interventions for high-risk populations. The medium- to long-term goals focus on biological age-related research, utilizing telomere length and multi-omics technologies to assess the differences between biological age and chronological age and analyze their key influencing factors. Data collection will be implemented through the health check-up centers of multiple campuses of PUTH.

This prospective, single-center, open-label exploratory diagnostic study aims to evaluate the safety, feasibility, and diagnostic performance of the novel Sortilin-targeted PET tracer 68Ga-SorB in patients with solid tumors. Eligible participants with confirmed or suspected melanoma, hepatocellular carcinoma, lung cancer, pancreatic cancer, breast cancer, or ovarian cancer will undergo 68Ga-SorB PET/CT imaging. The imaging findings will be compared with standard-of-care 18F-FDG PET/CT, using pathology results and/or clinical follow-up as the reference standard. The primary objectives are to evaluate the safety and tolerability of 68Ga-SorB, assess imaging feasibility, and characterize tumor uptake using quantitative PET parameters, including SUVmax and tumor-to-background ratio (TBR). Secondary exploratory objectives include comparing lesion detection between 68Ga-SorB PET/CT and 18F-FDG PET/CT, assessing diagnostic sensitivity and specificity, evaluating imaging characteristics across different tumor types, and exploring the correlation between Sortilin expression and tracer uptake. This study will provide preliminary clinical evidence supporting the development of Sortilin-targeted molecular imaging and future theranostic applications.

After heart bypass surgery, many patients develop a heart rhythm problem called postoperative atrial fibrillation, or POAF for short. This issue happens to 20%-40% of all bypass patients. Even with smaller, less invasive surgical cuts or robot-assisted heart bypass operations, between 4.8% and 18.4% of people still get POAF. When POAF occurs, patients usually stay in the hospital longer and face higher medical bills. It also raises chances of serious complications like stroke, heart failure and heart attacks, and lowers long-term survival rates. Stopping POAF early is therefore key to helping patients recover better after surgery. POAF comes from two main causes: personal health risks and stress from the surgery itself. Older age, high blood pressure, heart failure, lung disease, diabetes and overweight all make people more likely to develop irregular heart rhythms after an operation. Surgical trauma also plays a big role: cutting the breastbone, fluid building up around the heart, inflammation from heart-lung machines, pulling or stitching heart tissue, and unbalanced nerve signals during recovery can all spark POAF. Earlier studies have shown simple surgical adjustments can lower POAF risk safely, giving us a good basis to improve current surgery methods. The Ligament of Marshall is a fibrous bundle-like structure left over from heart development before birth. Its special tissue structure makes it easy to trigger chaotic heart beats. It holds muscle tissue that creates looping abnormal electrical signals, plus nerve clusters that overactivate the body's stress response after surgery - this is a major cause of POAF. Doctors who fix irregular heart rhythms with catheter burns already target this ligament to stop repeat atrial fibrillation. Major heart surgery for long-term irregular heartbeats also routinely cuts this ligament without adding extra surgical risks. Our study will collect real clinical data to deepen the understanding of POAF and partial denervation therapy. Cutting the Ligament of Marshall during minimally invasive cardiac surgery-coronary artery bypass grafting (MICS-CABG) is an easy, low-risk step with no extra risk of collateral injury. We hope this method can lower the chance of irregular heartbeats after surgery, reduce the need for rhythm-control drugs and their side effects, and help patients maintain stable heart function and better daily life right after surgery. For MICS-CABG, doctors do not need extra complicated steps to see and cut the Ligament of Marshall. We only make a small cut between the ribs on the left chest. After pericardial incision and suspension, this fibrous bundle-like structure is clearly visible and simple to operate on. Compared with traditional open-heart surgery that splits the whole breastbone, this small-cut approach avoids rough handling of the left heart and lessens overall surgical stress on patients.