Clinical trials

This is an interventional clinical study. A total of 90 subjects aged 18 to 40 years are planned to be recruited. The subjects have low back pain that affects daily work and life, resulting in reduced exercise tolerance or aggravated pain after exercise, while retaining basic living ability and being capable of performing partial activities; their VAS scores range from 4 to 6. At baseline, the duration of subjects' low back pain and disability index will be recorded, along with muscle stiffness and electroencephalogram findings. Afterwards, electronic moxibustion treatment will be administered for 4 weeks. Subjects will be randomly divided into a treatment group and a control group with equal numbers of participants. The treatment group will use a Wenyang instrument with a rated frequency of 50 Hz, with the temperature set between 40℃ and 60℃ based on subjects' comfort level. Each treatment session lasts 30 to 60 minutes, 5 times per week for 4 weeks. The Wenyang instrument is used by subjects at home, with researchers providing remote guidance and supervision via voice or video. Subjects will check in and upload records after each use of electronic moxibustion, which will be documented by researchers. If subjects suffer from unbearable low back pain during the study, they may take oral ibuprofen or celecoxib for pain relief. The dosage and administration time will be recorded, and check-in and upload will be completed after each dose of analgesics for researchers' documentation. Subjects in the control group will take oral ibuprofen or celecoxib for pain relief as needed (i.e., when they feel pain). The dosage and administration time will be recorded with check-in and upload. After 4 weeks of intervention, the two groups will be compared in terms of the number of days of analgesic use or total consumed dosage, as well as changes in VAS scores, disability index, muscle stiffness and electroencephalogram findings.

This observational study aims to investigate the associations between multidimensional human phenotypic characteristics and growth and developmental features. A total of 500 participants aged 6 to 60 years are planned to be enrolled. Multidimensional phenotypic characteristics will be assessed using non-invasive methods, including fingerprint imaging, foot morphology assessment, facial and tongue feature acquisition, anthropometric measurements, and musculoskeletal examinations. Development-related musculoskeletal characteristics, including plantar arch morphology, lower-limb alignment, joint range of motion, and generalized joint mobility, will also be assessed. The collected data will be analyzed to explore associations between external phenotypic characteristics and musculoskeletal growth and developmental features.

To establish a multidimensional assessment system for college students' motor function and construct a quantitative model. Kinematic and physiological parameters will be collected using a wrist-worn wearable device, combined with active movement task testing, anthropometric measurements, and other relevant health information, to comprehensively assess college students' motor function characteristics, including balance, coordination, endurance, and explosive power.Secondary Objective: To explore the combined effects of motor ability, lifestyle, and traditional Chinese medicine constitution.

The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and are eligible to stop therapy. It will also learn about the safety of this gradual reduction approach. The main questions it aims to answer are: Does the dose-reduction strategy lead to a higher 2-year molecular relapse-free survival rate (maintaining major molecular response, BCR-ABL1 ≤0.1%) compared with immediate TKI discontinuation? What medical problems (adverse events) do participants experience during and after dose reduction, and how do they differ from those in the direct-stop group? Researchers will compare the dose-reduction group (reduced daily TKI for 12 months, then 1-year follow-up) with the direct-discontinuation group (immediate stop, 2-year follow-up) to see whether gradual reduction is superior in preserving molecular remission. In addition, they will compare the changes in T-cell subsets between the two groups to explore immune mechanisms that may influence treatment-free remission. Participants will: Be randomly assigned to either dose reduction or immediate discontinuation; Take reduced TKI (or no drug) daily for 1 year, followed by 1-year observation (total 24 months); Visit the clinic every 2 months for the first 6 months, then every 3 months thereafter, for physical exams, blood tests, molecular monitoring (BCR-ABL1 PCR), and ECG; Have T-cell subsets measured by flow cytometry at months 3, 6, 12, and 24; Complete quality-of-life questionnaires (EORTC QLQ-CML24) at baseline and at months 3, 6, 12, and 24; Report all adverse events; if MMR is lost, they must restart full-dose TKI and be monitored monthly until remission is regained;

This multicenter, prospective, observational cohort study aims to evaluate a previously developed dynamic risk prediction model for severe treatment-related myelosuppression in patients with nasopharyngeal carcinoma receiving systemic therapy. The model is designed to estimate the risk of grade 3 or higher anemia, thrombocytopenia, and leukopenia or neutropenia during treatment. Eligible adult patients with histologically confirmed nasopharyngeal carcinoma will be consecutively enrolled at participating centers. Before each cycle of systemic therapy, routinely available clinical and laboratory data will be collected and used to generate updated risk predictions. Patients will be followed throughout systemic therapy and for 28 days after the last treatment. This is an observational study. Treatment and supportive care will be determined by treating physicians according to routine clinical practice. Model predictions will be used only for research evaluation and will not be used to guide or modify patient treatment. The study will evaluate the predictive performance and clinical applicability of the model across multiple centers.

This study will examine how different short-term exercise and vibration conditions affect lower-limb muscle activity in young adults with flat feet and young adults with normal feet. Participants will complete several conditions, including whole-body vibration, whole-body vibration combined with plantar stimulation under different areas of the foot, and a Baduanjin heel-raise exercise. Surface electromyography sensors will be placed on the skin over selected lower-limb muscles to record muscle activity before and during each condition. Each participant will complete all study conditions in a balanced order. This study does not aim to treat flat feet or evaluate long-term clinical benefits. The purpose is to collect preliminary information on immediate muscle activation and foot discomfort, which may help design future studies on foot-related exercise, plantar stimulation, and rehabilitation training.

Diabetic foot ulcer (DFU) is a leading cause of hospitalization, disability, and mortality among diabetic patients, imposing a substantial burden on both patients and national healthcare resources. Despite the availability of comprehensive multidisciplinary treatment approaches, the wound healing rate for DFU remains only approximately 50%. Therefore, the development of novel technologies for DFU wound management represents an urgent scientific priority.Our team has been dedicated to the DFU field for over 22 years and has established a well-maintained DFU follow-up cohort and a comprehensive biospecimen repository. In our preliminary work, we employed multi-omics approaches to analyze the microbial community structure and metabolite profiles of DFU wounds. Furthermore, we investigated the mechanisms of turmeric-derived nanoparticle aerogel (TAG) in DFU wound infection and tissue repair based on the wound microenvironment. These findings were published in Advanced Science in 2024.Building upon this foundation and utilizing a turmeric-derived hydrogel formulation, we plan to conduct a randomized, multi-center, parallel-controlled, prospective clinical study (N=54). This trial aims to evaluate the efficacy of TAG as an adjunct to standard care in promoting target ulcer healing and reducing recurrent infections in patients with Wagner grade 1 to 3 DFU, with the goal of optimizing clinical practice in DFU wound management.

Oral mucositis is one of the most common and debilitating complications in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Severe oral mucositis can lead to pain, nutritional impairment, infection, prolonged hospitalization, and increased healthcare costs. This randomized controlled trial aims to evaluate whether a standardized oral care program consisting of caregiver education, supervised tooth brushing, sodium bicarbonate mouth rinsing, oral moisturizing, and compliance monitoring can reduce the incidence and severity of oral mucositis compared with routine oral care. A total of 126 pediatric HSCT recipients will be randomly assigned in a 1:1 ratio to the intervention or control group. Clinical outcomes, oral pain, inflammatory biomarkers, oral microbiota, and metabolomic profiles will be evaluated throughout the transplantation period.

This randomized controlled trial evaluates a "Hospital-to-Home" self-management support model for Acute Coronary Syndrome (ACS) patients, which is based on the integrated COM-B and HAPA theories. Participants are randomly assigned to either an intervention group receiving a structured self-management program or a control group receiving standard education. The study compares self-management behaviors and health outcomes between the two groups to assess the model's effectiveness.

IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.

This multicenter observational study will evaluate the safety and effectiveness of immune checkpoint inhibitor rechallenge in adults with lung cancer who developed checkpoint inhibitor pneumonitis. The study will use both retrospective medical records and prospective follow-up data. Participants will not be assigned to any treatment by the study protocol. All treatment decisions will be made by the treating physicians as part of routine clinical care. Participants will be classified into three groups according to their subsequent treatment: rechallenge with a PD-L1 inhibitor, rechallenge with a PD-1 inhibitor, or no immune checkpoint inhibitor rechallenge. The primary outcome is the recurrence of checkpoint inhibitor pneumonitis after rechallenge. Secondary outcomes include immune-related adverse events, progression-free survival, overall survival, objective response rate, and disease control rate at 24 weeks. Approximately 150 participants will be included across multiple study centers in China.

This multicenter, prospective, randomized, non-inferiority trial aimed to compare the efficacy and safety of cold snare endoscopic mucosal resection (CS-EMR) and hot snare endoscopic mucosal resection (HS-EMR) for resection of intermediate-size (10-20 mm) flat nonpedunculated colorectal polyps.

To evaluate the utility of DCR-derived parameters for identifying dynamic functional imaging phenotypes, assessing disease severity, and predicting the risk of disease progression in COPD.

Invasive fungal disease (IFD) refers to an infectious disease caused by fungi invading the human body, growing and reproducing in tissues, organs, or blood, and leading to inflammatory responses and tissue damage. Due to the suppression of immune system function during the disease and its treatment process, patients with hematological malignancies are prone to opportunistic infections, including IFD, with the lungs being the most common site of infection. In patients with hematological malignancies, IFD is often difficult to diagnose and progresses rapidly. Some patients become critically ill, which severely affects their prognosis. With the rapid development of molecular biology techniques, metagenomic next-generation sequencing (mNGS) of pathogenic microorganisms-as a broad-coverage, highly sensitive diagnostic tool with a short reporting cycle-has been widely applied in the etiological diagnosis of clinical infectious diseases. However, its clinical value in the diagnosis of IFD remains to be explored. This study is a single-center, single-arm, open-label clinical study to to explore the clinical performance of peripheral blood mNGS in the diagnosis and treatment of IFD in patients with hematological malignancies.

Underwater endoscopic mucosal resection (UEMR) and endoscopic submucosal dissection (ESD) have both been reported to be two effective treatment methods for small rectal neuroendocrine tumor (NET). However, there is no consensus on the best method for the endoscopic resection of rectal NET. Therefore, we aimed to compare the efficacy and safety of UEMR and ESD for the treatment of small rectal NET.

This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.

This multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.

This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).

This retrospective observational cohort study will evaluate whether perioperative antibiotic use is associated with long-term surgical scar outcomes. The study will include adult patients who underwent body surface surgery at Nanfang Hospital between January 1, 2005 and January 1, 2025 and have available surgical, medication, and scar-related clinical records. The study will not assign participants to any treatment. Researchers will review existing medical records, perioperative antibiotic exposure, surgical characteristics, complications, and scar assessments or photographs. Scar outcomes will be assessed using modified visual analogue scale scores, scar width, scar type, and scar-related complications.

The goal of this clinical trial is to learn if adding rituximab to the ATG-based Protocol can prevent Epstein-Barr virus (EBV) from reactivating in children who have received an allogeneic haploidentical hematopoietic stem cell transplant. It will also learn about the safety of adding rituximab. The main questions it aims to answer are: Does giving rituximab twice during the conditioning regimen lower the number of children who have EBV reactivation after transplant? What medical problems or side effects do children experience when they receive rituximab in addition to the ATG-based Protocol? Researchers will compare the group that receives rituximab (two doses before transplant) with a control group that receives no rituximab, to see if the addition of rituximab effectively prevents EBV reactivation. Participants will: Receive either rituximab (two doses during the preconditioning phase) or no extra treatment (control group), depending on which group they are assigned to Have regular follow-up visits for blood tests to monitor their EBV-DNA levels Keep a record of any symptoms or health changes they notice between visits

The prevalence of chronic obstructive pulmonary disease (COPD) is on the rise, leading to an increasing economic and social burden. Currently, the diagnosis and staging of COPD heavily rely on pulmonary function testing. However, limitations such as patient cooperation and comorbidities can hinder accurate diagnosis. In situations like a respiratory pandemic, pulmonary function testing may not be feasible. Dynamic chest radiography has emerged as a promising area of research due to its quick procedure, high patient cooperation, low risk, minimal radiation exposure, and reduced direct contact. Recent clinical studies have started to explore the relationship between dynamic chest X-ray measurements and lung function parameters. However, there is a noticeable scarcity of research focusing on the use of dynamic chest X-ray in aiding the diagnosis of COPD, particularly in Chinese populations where cohort data is lacking. Consequently, there is a pressing need to investigate the correlation between various dynamic chest radiograph parameters and lung function indicators, as well as their potential diagnostic value in COPD.

Brief Summary： The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are: * Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter? * What medical problems do participants experience during and after each treatment? * What are the imaging cure and stability rates at 1, 2, and 5 years after treatment? Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes. Participants will: * Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling * Undergo the assigned endovascular procedure * Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)

The purpose of this single-center, randomized, double-blind, controlled trial is to clarify the clinical efficacy and safety of Getong Tongluo Capsule in patients with ischemic stroke. Combined with gut microbiome and metabolomics techniques, investigators will explore whether this medicine exerts neuroprotective effects via the gut-brain axis. Investigators will further verify its pharmacological mechanism through animal experiments to provide evidence for its clinical application.

The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life. The main questions it aims to answer are: Does early combined surgery reduce the need for long-term glaucoma medications? Does early combined surgery improve ocular surface health compared with cataract surgery followed by guideline-based glaucoma eye drops? Does early combined surgery improve vision-related quality of life and anxiety compared with the medication-based treatment strategy? What medical problems or complications do participants have after treatment? Researchers will compare phacoemulsification combined with gonioscopy-assisted trabeculotomy to phacoemulsification followed by guideline-based topical eye pressure-lowering medications. Participants will: Undergo cataract surgery with or without gonioscopy-assisted trabeculotomy Attend follow-up visits for 24 months after treatment Have eye pressure, visual acuity, OCT, AS-OCT, visual field, ocular surface, and safety examinations at scheduled visits Complete quality-of-life and anxiety questionnaires at scheduled visits Provide tear samples at selected visits for biomarker testing where applicable

How to promote the prognosis and outcome of RTOM, restore oral function, and improve quality of life are key issues for improving the long-term outcomes of head and neck malignant tumor radiotherapy, and are also integral parts of the patient-centered Traditional Chinese Medicine "prevention-treatment-rehabilitation" system for RTOM. This project aims to thoroughly evaluate the efficacy and safety of Chinese herbal compounds in the rehabilitation phase of RTOM, targeting the long-term rehabilitation outcomes of RTOM, and to conduct a phase II clinical trial. In this project, Sancai Fengsui Decoction will be used as an oral medication to improve the rehabilitation status of RTOM, and will be compared with a placebo group. The efficacy of the oral medication will be evaluated by comparing outcome measures including the 2-week pain relief rate in the oral cavity/oropharynx, the RTOG grade remission rate for RTOM, and the relief rate of xerostomia. As an important extension of TCM prevention and treatment for RTOM, this project can provide a high-level evidence-based TCM protocol for the long-term rehabilitation of RTOM.