Clinical trials

The goal of this clinical trial is to learn if allogeneic human bone marrow-derived mesenchymal stem cells (CG-BM1) are safe and show preliminary efficacy in treating patients with ankylosing spondylitis (AS). It will also explore the appropriate dose of CG-BM1. The main questions it aims to answer are: What medical problems (adverse events) do participants have when taking CG-BM1? (Safety and tolerability) Does CG-BM1 improve disease activity, pain, and function in patients with AS? (Preliminary efficacy) Researchers will compare CG-BM1 to a placebo (an inactive substance that looks like CG-BM1) in the second phase of the study to see if CG-BM1 works for AS. This study has two phases: Phase 1 (dose-escalation): Open-label, single-arm. Participants will receive one of three escalating doses of CG-BM1 weekly for 4 weeks. Phase 2 (dose-expansion): Randomized, double-blind, placebo-controlled. Participants will receive either the recommended dose of CG-BM1 or a placebo weekly for 4 weeks, in addition to standard background therapy (celecoxib). Participants will: Receive CG-BM1 or placebo via intravenous infusion once a week for 4 weeks Visit the clinic for follow-up assessments at Week 1, 4, 8, 12, and 24 after the first infusion Undergo physical exams, laboratory tests (blood and urine), and complete questionnaires about disease activity, pain, and function (e.g., BASDAI, VAS, ASAS response criteria)

Investigation of the efficacy of fecal microbiota transplantation added to calorie-restricted diet and semaglutide versus calorie-restricted diet and semaglutide alone for weight loss and metabolic improvement in patients with moderate to severe obesity and type 2 diabetes mellitus.

This is a single-center clinical trial started by the study team. The goal is to compare two surgeries for people who have a varus knee alignment and a tear at the back attachment of the medial meniscus. Researchers want to learn how the newer bone-cut procedure with arthroscopic meniscus repair compares to the standard bone-cut procedure with arthroscopic meniscus repair. Researchers will also track safety and hospital-related costs. Main questions the study aims to answer: * At 12 months after surgery, how does the improvement in knee function compare between the newer-surgery group and the standard-surgery group? The study will evaluate preliminary trends in clinical efficacy using the Lysholm knee function score. * Do the two groups differ in pain relief, imaging findings, meniscus healing, complications, and hospital stay and preliminary cost-effectiveness? The study plans to enroll about 20 participants at Sun Yat-sen University Eighth Affiliated Hospital (Shenzhen Futian). Participants will be assigned by chance, like drawing lots, in a one-to-one ratio. This is an pilot study with a PROBE (Prospective Randomized Open-label Blinded-Endpoint) design. While participants and surgeons will know which surgery is performed, the research assistant responsible for collecting patient-reported outcomes will be blinded to group allocation to minimize observer bias. Study groups: * Experimental group: hemi-tibial plateau osteotomy plus arthroscopic meniscus repair. * Control group: high tibial osteotomy plus arthroscopic meniscus repair. Who may join: * Age 35 to 65 years, with no restriction on sex; * Diagnosed with a medial meniscus posterior root tear; * Presence of varus knee deformity; * Imaging findings support the diagnosis (e.g., knee MRI); * Failure of conservative treatment: no meaningful improvement after more than 1 month of non-surgical management (e.g., rest, medication, or physical therapy); * Varus alignment angle less than 10 degrees; * The deformity is predominantly tibial in origin; * Knee radiographs do not show the most severe osteoarthritis (Kellgren-Lawrence grade other than IV). Who cannot join: * A knee that is chronically "locked," meaning it cannot bend or straighten normally. * The most severe level of knee arthritis on knee X-ray. * Severe arthritis in the hip or ankle that could affect knee function testing. * Inflammatory or infectious conditions that can affect the knee, or abnormal inflammation blood tests that make participation unsafe. * Knee instability or poorly functioning prior ligament reconstruction, based on the study doctor's judgment. * Any prior surgery on the target knee, or on other joints of the same-side lower limb. * Serious heart, liver, or kidney disease, cancer, bleeding disorders, immune deficiency, or severe mental health conditions that make participation unsafe. * Body mass index of 30 or higher. * Pregnancy or breastfeeding, or not willing to use birth control during the study. * Participation in another clinical study within the past 3 months (except registry studies). * Any other reason the study doctor believes makes participation unsafe or not appropriate. What participants will do: * Complete screening and baseline assessments within about 30 days before surgery and sign informed consent. * Receive the assigned surgery during the hospital stay. * Return for follow-up visits at 3 months, 6 months, and 12 months after surgery. * Complete knee function and symptom questionnaires and rate pain at each follow-up visit. * Have standing knee X-rays and full-length leg X-rays at 3, 6, and 12 months. * Have an MRI of the operated knee at 3, 6, and 12 months to assess meniscus healing and meniscus extrusion. Outcomes: * Primary outcome: change from baseline to 12 months in the Lysholm knee function score. * Secondary outcomes: changes in the Lysholm score at 3 and 6 months; changes in the WOMAC knee arthritis symptom score at 3, 6, and 12 months; changes in pain rating on a standard pain scale at 3, 6, and 12 months; imaging measures and bone healing on X-rays; meniscus healing and extrusion on MRI; surgery time and blood loss; complications during and after surgery; length of hospital stay and hospital costs; and quality of life utility value from a standard health questionnaire.

Nontuberculous Mycobacterial lung disease (NTM-LD) is a significant infectious challenge. The precise causes remain unclear, diagnosis can be complex, treatment outcomes are often unsatisfactory, and the disease can severely affect a patient's quality of life. Environmental factors, such as the warm and humid climate in South China, may contribute to unique characteristics of NTM in this region, but systematic research is currently lacking. This study aims to improve the understanding of NTM-LD in South China. It consists of two complementary parts: 1. The first part is a retrospective review of medical records from approximately 1,500 NTM patients across multiple hospitals in South China. This analysis seeks to identify common patterns in symptoms, diagnostic findings, and treatment responses within this population. 2. The second part is a prospective study involving about 106 current NTM-LD patients. Blood and lung fluid samples will be collected to analyze, using advanced laboratory techniques, how the patient's immune system responds to the infection. This investigation aims to uncover clues about why some cases are difficult to treat. The overall goal of this research is to generate evidence that can aid healthcare providers in South China in diagnosing and managing NTM-LD more effectively. Please note that this is an observational study; no new drugs or experimental treatments are being tested.

Diabetic kidney disease (DKD) is one of the main complications of diabetes and a leading cause of end-stage kidney disease. Blood glucose variability is closely associated with disease progression in individuals with DKD. Recent evidence suggests that gut bacteria and their circulating metabolites may play important roles in regulating blood glucose variability and clinical outcomes. However, it remains unclear whether gut bacteria and blood metabolites influence DKD progression through effects on blood glucose variability. This study aims to (1) characterize gut bacteria and blood metabolites in individuals with DKD at different stages and levels of disease severity, and evaluate their value in predicting adverse outcomes; (2) assess the relationships among gut bacteria, blood metabolites, and blood glucose variability; and (3) determine whether gut bacteria and blood metabolites affect clinical outcomes by modulating blood glucose variability. A total of 270 individuals with DKD will be enrolled in a prospective observational cohort. The investigators will conduct continuous glucose monitoring and collect stool and blood samples for advanced analyses of gut microbiota and blood metabolites. The objective is to clarify how gut bacteria and circulating metabolites relate to blood glucose variability and disease prognosis, and to develop tools to identify high-risk individuals at an early stage. Ultimately, the findings may provide new insights and strategies to improve clinical care and quality of life for individuals with DKD.

Eradication of HP can significantly improve and reduce HP-related diseases. A 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 85%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. High-dose proton pump inhibitors (PPI) combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. However, the acid inhibition effect of PPI mainly depends on the degree of individual metabolism of proton pump,which might influence the eradication effect. Keverprazan, a new competitive potassium acid blocker(P-CAB), is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with PPIs. This study aimed to evaluate two different doses of therapy (1 g b.i.d. vs. 1.0 g t.i.d.) and two different durations of therapy (14 vs.10 days) to gain insights of the effectiveness of Keverprazan-amoxicillin dual therapy .

Post-stroke patients were required to complete a session of robot-assisted training, which involved nine repetitions of 5-meter overground walking (three trials for each of the three controllers) in a rectangular hospital corridor.