Clinical trials

The goal of this clinical trial is to determine the appropriate Bispectral Index (BIS) range and propofol effect-site concentration required to maintain adequate anesthesia depth during total intravenous anesthesia (TIVA) combined with midazolam, dexmedetomidine, or esketamine in patients undergoing unilateral knee replacement surgery. The main questions it aims to answer are: 1. What are the appropriate BIS range and propofol effect-site concentration for maintaining adequate anesthesia depth when combined with each of the three medications (midazolam, dexmedetomidine, or esketamine) during TIVA? 2. How these combination regimens affect the quality of recovery and postoperative pain in patients？ Participants will: 1. Receive one of four anesthesia regimens during surgery: propofol alone, propofol combined with midazolam, dexmedetomidine, or esketamine. 2. Undergo a stepwise reduction of propofol effect-site concentration towards the end of surgery. 3. Have their consciousness assessed using the isolated forearm technique, while BIS, EEG signals, and vital signs are continuously monitored throughout the procedure. 4. Have their recovery quality and postoperative pain assessed after surgery.

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with single therapies. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration require attention. GLP-1 RAs offer distinct advantages for weight and metabolic improvement, and their combined application with surgery may yield synergistic benefits. Given the lack of multi-regional validation in China's diverse population, this multicenter study aims to confirm the real-world effectiveness and generalizability of bariatric surgery plus GLP-1RA across distinct regional cohorts.

The goal of this clinical trial is to evaluate whether Shouhui Tongbian Capsule can improve postoperative constipation in adults aged 18 to 75 years after surgery for benign anorectal diseases, including hemorrhoids and anal fistula. The clinical trial will also evaluate the safety of Shouhui Tongbian Capsule and explore associations between treatment effects and changes in gut microbiota, metabolic profiles, and inflammatory indicators. The main questions are: Does Shouhui Tongbian Capsule improve constipation symptoms after benign anorectal surgery? Does Shouhui Tongbian Capsule reduce postoperative and defecation-related pain? Does Shouhui Tongbian Capsule improve quality of life and anorectal function? What adverse events occur during treatment? Are clinical improvements associated with changes in gut microbiota, metabolic profiles, or inflammatory indicators? Researchers will compare Shouhui Tongbian Capsule with lactulose to evaluate differences in efficacy and safety for postoperative constipation. Participants will: Receive either Shouhui Tongbian Capsule three times daily or lactulose once daily for 14 days Complete assessments of constipation symptoms, pain, quality of life, and anorectal function Provide stool and blood samples before treatment and on Day 14 Attend assessments during treatment and approximately 1 month after surgery Report adverse events and other medical problems during participation

This prospective, single-center, randomized interventional study aims to investigate the effects of commonly used adjunct anesthetic drugs on the Bispectral Index (BIS) and electroencephalographic (EEG) activity during total intravenous anesthesia. BIS monitoring is widely used to estimate the depth of anesthesia. However, previous studies suggest that certain anesthetic drugs, particularly dexmedetomidine and esketamine, may alter BIS values independently of the patient's actual level of consciousness. As a result, BIS readings may not always accurately reflect anesthetic depth when multiple drugs are administered together. Adult patients undergoing elective laparoscopic cholecystectomy under standardized propofol-remifentanil anesthesia will be randomly assigned to receive one of the following adjunct drugs: midazolam, dexmedetomidine, esketamine, or no additional study drug (control group). Continuous BIS values and raw EEG signals will be recorded throughout the study period. The primary objective is to compare changes in BIS values among different adjunct anesthetic drugs under otherwise similar anesthetic conditions. The study will also explore corresponding EEG characteristics associated with these changes. The findings are expected to improve understanding of drug-related differences in processed EEG monitoring and provide data for future development of more accurate anesthesia depth assessment methods.

The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.

The goal of this clinical trial is to investigate whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve exercise capacity in patients with COPD. The main questions it aims to answer are: • whether an astaxanthin-based dietary supplement combined with a pulmonary rehabilitation training program could improve 6MWD in patients with COPD. The drug administration group will receive: * Two capsules of astaxanthin formula supplement daily for 8 weeks. * Pulmonary rehabilitation training: a total of 8 weeks, 2-3 times a week. The control group will receive a total of 8-week pulmonary rehabilitation training, 2-3 times a week. The investigators will compare the drug administration group and the control group to see if the difference between the 2 groups reaches a minimal clinically important difference.

Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes. This study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly). The primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.

Medical thoracoscopy (rigid and semirigid) is an effective, safe method for diagnosing and managing pleural diseases. Rigid thoracoscopy demonstrates superior overall diagnostic yield compared to semirigid techniques (flexible forceps/cryobiopsy) due to its ability to obtain larger, deeper biopsies with rigid forceps. However, diagnostic rates become similar when biopsies are successfully obtained. Limitations of rigid thoracoscopy include restricted maneuverability (especially in posterior/mediastinal areas), increased procedural pain from leveraging against ribs and larger trocars, higher sedation requirements, and a steep learning curve for pulmonologists. To address these issues, a novel dual-function semirigid thoracoscope (UE FET-680, China) was developed. Its straight working channel accommodates standard rigid biopsy forceps, potentially matching rigid thoracoscopy's diagnostic yield while improving usability. This randomized trial will compare the efficacy and safety of this new device versus conventional rigid thoracoscopy in undiagnosed exudative pleural effusions.

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor agonist therapy for Chinese patients with obesity.

This study is a prospective investigation comparing the efficacy and safety of Janus kinase inhibitors versus calcineurin inhibitors as initial therapy for interstitial lung disease associated with antisynthetase syndrome. The goal is to determine which treatment is more effective at improving lung function and preventing disease progression, while comparing their safety profiles. The findings will help provide clearer treatment guidance for doctors and patients.

This study employs a randomized controlled trial methodology to systematically evaluate the efficacy and safety of a modified acupotomy technique in the treatment of ankylosing spondylitis. Through ultrasound-guided localization, the operative sites are assessed to clarify the improvement effect of the modified acupotomy on disease activity in AS patients. The aim is to enhance the clinical outcomes of AS, provide evidence-based medical support for acupotomy treatment of AS, and improve the diagnosis and treatment standards for the condition.

Intraoperative hypoxemia is a common and serious complication during monitored anesthesia care for elective endoscopic retrograde cholangiopancreatography (ERCP), especially in older adults. Frail patients have reduced physiologic reserve and are at increased risk of life-threatening events including unplanned intubation, hemodynamic collapse, and hypoxic brain injury. However, the independent relationship between frailty and intraoperative hypoxemia during sedated ERCP remains poorly defined, and no validated risk prediction model exists for this high-risk population. This single-center, dual-cohort study will be conducted at China-Japan Friendship Hospital to evaluate whether preoperative frailty can predict intraoperative hypoxemia in patients aged 65 years and older undergoing elective ERCP. Frailty will be assessed primarily using the Frailty Index (FI), with secondary screening by the Modified Frailty Index-11 (mFI-11), Edmonton Frail Scale (EFS), Clinical Frailty Scale (CFS), FRAIL scale, and Fried phenotype. The primary outcome is intraoperative hypoxemia, defined as SpO₂ \< 90% for 5 seconds or longer. In the retrospective phase (n = 313), investigators will identify risk factors and develop a preliminary prediction model. In the prospective phase (n = 388), the model will be validated, refined, and internally tested for discrimination, calibration, and clinical utility. This study aims to establish frailty as a reliable preoperative risk marker and provide a clinically practical prediction tool to support risk stratification, personalized sedation strategies, and perioperative safety in elderly patients undergoing ERCP.

This study is a multicenter, prospective cohort study designed to systematically evaluate the clinical efficacy of integrated Traditional Chinese and Western Medicine on short-term functional improvement in patients with ankylosing spondylitis, with the Bath Ankylosing Spondylitis Functional Index (BASFI) at 6 months of treatment as the primary outcome measure.

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with single therapies. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration require attention. GLP-1 RAs offer distinct advantages for weight and metabolic improvement, and their combined application with surgery may yield synergistic benefits. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.

A prospective multicenter randomized controlled trial was conducted to evaluate the efficacy and safety of thoracoscopic biopsy guided by confocal optical real-time microscopic imaging (nCLE) in the diagnosis of fibrinal pleurisy of unknown etiology. Patients with fibrinous pleurisy of unknown etiology who were to undergo thoracoscopic pleural biopsy were enrolled and informed consent was signed. Subjects were randomized to either the nCLE guided biopsy Group (Group A) or the visual biopsy group (Group B) according to the randomization table (1:1 ratio). nCLE was used to probe the benign and malignant status of pleural lesions, compare the consistency of random pathological biopsy or nCLE guided biopsy with histopathological results, compare whether nCLE guided biopsy can reduce the number of thoracoscopic biopsies, and follow up short-term postoperative complications to evaluate its safety.

An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.

This study is a multicentre, ambidirectional, observational cohort study. The ambidirectional design incorporates both the collection of retrospective data from the three years prior to enrolment, and a prospective follow-up period of up to two years. The study is designed to evaluate the long-term effects of Integrated Medicine on radiographic progression in patients diagnosed with Ankylosing spondylitis (AS).

The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are: 1. Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)? 2. Does it improve their body composition, muscle strength, balance, and flexibility? 3. Does it reduce their daily sitting time? Researchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes. Participants will: 1. Be randomly assigned to one of the two groups. 2. If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks. 3. Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires.

The goal of this clinical trial is to compare the diagnostic efficacy and safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy (EBUS-TBMC) versus standard EBUS-guided Transbronchial Needle Aspiration (EBUS-TBNA) in adult patients with suspected mediastinal lymph node tuberculosis. The main questions it aims to answer are: Does EBUS-TBMC provide a superior diagnostic yield for detecting granulomatous inflammation compared to EBUS-TBNA in the same target lymph node? Does the cryopreservation process affect the viability of Mycobacterium tuberculosis for culture, and does the larger tissue sample obtained via EBUS-TBMC enhance the sensitivity of molecular tests such as Xpert MTB/RIF? Is the safety profile of EBUS-TBMC, particularly regarding bleeding complications, comparable to that of EBUS-TBNA in this patient population? Researchers will compare the two biopsy techniques using a paired design within the same patient to see if EBUS-TBMC results in higher rates of positive pathology, microbiology, and molecular diagnoses. Participants will: Undergo both EBUS-TBNA and EBUS-TBMC procedures on the same mediastinal lymph node during a single bronchoscopy session, with the order of procedures randomized. Provide blood and tissue samples for comprehensive testing, including histology, mycobacterial culture, and Xpert MTB/RIF assay. Complete short-term (within 2 hours post-procedure) and 7-day follow-up assessments to monitor for any adverse events. Participate in a 6-month clinical follow-up to establish a final diagnosis, which will serve as the reference standard for evaluating the diagnostic tests.

Spirometry is the gold-standard tool for diagnosing Chronic Obstructive Pulmonary Disease (COPD). However, its implementation in primary care is often limited by a shortage of qualified technicians and inconsistent testing quality. This study will use Augmented Reality (AR) glasses to provide real-time interaction and guidance to participants during spirometry. It will be designed as a two-phase study to evaluate the technical validity and clinical effectiveness of AR-assisted spirometry (AR-SPIRO) system.

Brief Summary The goal of this clinical trial is to determine whether an initial diagnostic approach using ultrasound elastography-guided pleural biopsy (UEPB) is non-inferior to immediate medical thoracoscopic pleural biopsy in terms of diagnostic yield for obtaining a definitive histopathological diagnosis in patients with exudative pleural effusion of unclear etiology. The main questions it aims to answer are: Is the step-up strategy (UEPB first, reserving thoracoscopy for non-diagnostic cases) non-inferior to immediate medical thoracoscopy in diagnostic yield? Does the step-up strategy provide advantages in safety, patient tolerance, hospital stay, and cost-effectiveness compared to immediate thoracoscopy? Researchers will compare a step-up strategy (initial UEPB, followed by medical thoracoscopy if UEPB is non-diagnostic) versus immediate medical thoracoscopic pleural biopsy to see if the step-up approach achieves comparable diagnostic accuracy while potentially reducing procedure-related burden and healthcare resource use. Participants will: Be randomly assigned in a 1:1 ratio to either the step-up strategy arm or the immediate medical thoracoscopy arm. If assigned to the step-up arm: undergo UEPB under local anesthesia; if the biopsy is non-diagnostic, proceed to semi-rigid medical thoracoscopy. If assigned to the immediate thoracoscopy arm: undergo semi-rigid medical thoracoscopic pleural biopsy as the initial and sole diagnostic procedure. Provide tissue samples for histopathological, immunohistochemical, and molecular analyses as clinically indicated. Complete short-term follow-up at 7 days post-procedure (by telephone or clinic visit) to monitor adverse events and symptom recovery. If initially diagnosed with non-specific benign disease or remain undiagnosed, complete a long-term follow-up at 12 months to establish a final diagnosis.

The goal of this clinical trial is to learn if a Ventilation-Perfusion Discrepancy Index (VQDI)-guided strategy for selecting the target lung lobe can improve outcomes compared to the standard strategy in patients with severe emphysema undergoing bronchoscopic lung volume reduction with endobronchial valves (EBVs). The main question it aims to answer is: · Does selecting the target lobe based on the lowest VQDI (indicating the worst functional mismatch) lead to a higher rate of successful treatment response at 6 months compared to selecting the lobe based on the worst destruction on CT scan? If there is a comparison group: Researchers will compare the VQDI-guided selection group to the conventional CT/Chartis-guided selection group to see which strategy results in more patients achieving significant improvement in both lung function and reduction in the size of the treated lobe. Participants will: * Undergo standard clinical assessments (lung function tests, CT scan, exercise test) and an additional V/Q SPECT/CT scan to calculate the VQDI. * Have their collateral ventilation status checked using the Chartis system during bronchoscopy. * Be randomly assigned to one of the two target lobe selection strategies. * Receive EBV placement in the selected lobe. * Attend follow-up visits at 1, 3, 6, and 12 months after the procedure for check-ups, repeated lung function tests, questionnaires, and CT scans to assess their response to treatment.

Angina with non-obstructive coronary arteries (ANOCA) is highly prevalent, impairing quality of life and independently associated with cardiovascular events, yet effective treatments are lacking. The endothelin-1 (ET-1)-endothelin receptor (ETR) system is pivotal in ANOCA pathogenesis. Preclinical studies show that ETR blockade or pericyte-specific knockout of ETA receptor improves coronary microcirculatory function in models of myocardial ischemia-reperfusion and diabetes. Clinical evidence indicates ETR antagonists can enhance microvascular endothelial function and myocardial perfusion in ANOCA patients. However, prior studies diagnosed ANOCA based only on symptoms and angiography without precise microvascular functional assessment. Early ETR antagonists also showed frequent adverse effects (e.g., edema, headache), reducing treatment satisfaction. To address this, the investigators will conduct an open-label, single-center, single-arm trial using invasive coronary microcirculatory function testing to accurately phenotype ANOCA and assess microvascular changes. Patients on standard therapy will receive macitentan-a novel ETR antagonist with improved vasodilatory efficacy and safety-to evaluate its effects on coronary microcirculatory function, angina symptoms, and adverse events. Additionally, the investigators will perform multi-omics profiling (proteomics, transcriptomics, metabolomics) on patient blood samples to identify molecular signatures linked to ANOCA subtypes and treatment response, providing evidence for precision intervention strategies in ANOCA.

The goal of this clinical trial is to evaluate the clinical efficacy and safety of YiWei Jiaohuang Ointment in treating gastrointestinal bleeding associated with oral antithrombotic therapy. The main question it aims to answer is: Does Yiwei JiaoHuang Ointment accelerate the conversion to negative results in fecal occult blood tests among patients with gastrointestinal bleeding associated with antithrombotic therapy? Researchers will compare use rabeprazole alone as routine therapy to see if Yiwei JiaoHuang Ointment can accelerate the conversion to negative results in fecal occult blood tests. Participants will ： Take Yiwei JiaoHuang Ointment every day for 2 weeks. Return to the hospital for a fecal occult blood test after 3 days, 1 week, and 2 weeks of medication.

This study aims to obtain short-term clinical results on the safety and efficacy of single-port robot-assisted metabolic weight loss surgery, and to provide further evidence for the clinical promotion of single-port robot systems.