Clinical trials

The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen. The main questions it aims to answer are: * Does Anruikefen injection improve sleep quality better than oral nalfurafine? * Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus. Participants will: * Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily). * Continue treatment for 4 weeks, followed by a 1-week safety follow-up. * Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.

The goal of this observational cohort study is to delineate the five-year dynamic trajectories of metabolic phenotypes in Chinese adults with overweight or obesity, with or without type 2 diabetes, focusing on transition rates from metabolically healthy overweight/obesity to unhealthy overweight/obesity or to type 2 diabetes, as well as the incidence and progression of diabetic complications and cardiovascular events in those with type 2 diabetes and overweight/obesity. Researchers will compare three phenotype groups, namely metabolically healthy overweight/obesity, metabolically unhealthy overweight/obesity, and type 2 diabetes with overweight/obesity, to assess differences in metabolic parameter changes, complication rates, and cardiovascular risk. Participants will use a digital health management platform for data upload and lifestyle support, and will complete comprehensive health assessments at baseline, at 2.5 years, and at 5 years, along with annual light follow-ups.

In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.

The goal of this clinical trial is to understand whether Lactobacillus rhamnosus LR607 can enhance neoadjuvant chemoimmunotherapy for adult patients with non-small cell lung cancer. It will also evaluate the safety of LR607. The main questions it aims to answer include: Can LR607 improve the major pathological response of neoadjuvant chemoimmunotherapy? What is the relationship between LR607 combined with neoadjuvant chemoimmunotherapy and treatment-related adverse reactions? What changes occur in the gut microbiota composition at the species level and gut metabolites of subjects after LR607 treatment? Participants will: Take LR607 daily for 3 months Visit the hospital for check-ups and examinations every month Record their pathological response, tumor recurrence, and treatment-related adverse reactions

The goal of this clinical trial is to learn if a new type of brain stimulation called theta-burst patterned temporal interference stimulation (tTIs) works to improve awareness in people with disorders of consciousness (DoC). The main questions it aims to answer are: 1. Does tTIs help people with disorders of consciousness show more signs of awareness? 2. Does tTIs improve the brain's ability to process information and connect different brain areas? Is tTIs safe and easy for people with disorders of consciousness to tolerate? Researchers will compare a group receiving active tTIs to a group receiving a "sham" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better. Participants will:Receive either active tTIs or sham stimulation twice a day for 5 consecutive days (total of 10 sessions). Undergo brain activity tests (EEG) and physical exams to check their level of awareness before and after the 5 days of treatment. Have their progress followed by researchers through phone calls at 1, 3, and 6 months after the treatment ends.

This is a single-center, randomized, open-label, parallel-controlled clinical trial designed to investigate the anticoagulation efficacy and safety of different initial doses of Nafamostat Mesilate (NM) in ICU patients undergoing Continuous Renal Replacement Therapy (CRRT). Researchers will screen patients admitted to the Department of Critical Care Medicine at Zhujiang Hospital, Southern Medical University, to identify eligible participants based on inclusion and exclusion criteria. After obtaining informed consent, participants will be randomized into two groups. On the basis of standardized CRRT treatment, the Low-Dose Group (Group A) will receive a continuous infusion of Nafamostat Mesilate at an initial dose of 20 mg/h, while the High-Dose Group (Group B) will receive an initial dose of 50 mg/h. The drug will be continuously infused pre-filter into the CRRT circuit. Dosage adjustments will be made for both groups to maintain target anticoagulation levels while ensuring that pre-filter safety limits are not exceeded. The primary outcome measure is filter lifespan, along with other secondary outcomes.

Consciousness disorders following severe brain injury refer to a series of disturbances in arousal and cognition secondary to organic brain diseases, including Unresponsive Wakefulness Syndrome (UWS) (also termed Vegetative State, VS) and Minimally Conscious State (MCS). Disorders of consciousness(DoC) is listed in the International Statistical Classification of Diseases and Related Health Problems, though it is not currently recognized as an independent and consistent diagnostic category. According to epidemiological surveys, conservative estimates suggest that 70,000 to 100,000 new cases of DoC are reported annually in China, posing significant challenges for clinical diagnosis and treatment. Accurately assessing DoC, understanding its neurobiological underpinnings, and developing effective rehabilitation strategies remain subjects requiring further investigation through both clinical and basic neuroscience research. Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is a non-invasive brain stimulation technique that delivers electrical impulses to the auricular branch of the vagus nerve. Substantial evidence indicates that taVNS serves as a therapeutic intervention for various neurological and psychiatric disorders, such as epilepsy, treatment-resistant depression, migraines, and cognitive impairments. As an emerging neurostimulation technique, taVNS has been investigated for its potential to promote the recovery of awareness in patients with DoC. However, clinical evidence remains limited, underscoring the need for further trials to substantiate its efficacy. Developed from traditional implanted Vagus Nerve Stimulation(VNS), taVNS offers high safety and minimal to negligible side effects, presenting a promising therapeutic avenue for patients with severe traumatic brain injury and disorders of consciousness. Methods: This study is a single-arm trial. A total of 20 patients are planned to be enrolled. Each patient will receive taVNS twice daily over a period of 10 consecutive days, totaling 20 sessions. Primary and secondary outcome measures will be assessed at baseline and after the completion of taVNS treatment. The primary efficacy endpoint will be the change in behavioral responses as evaluated by the Coma Recovery Scale-Revised (CRS-R). Additionally, resting-state high-density electroencephalography (EEG) and combined transcranial magnetic stimulation with EEG (TMS-EEG) recordings will be utilized to investigate the neurophysiological correlates of taVNS intervention. Discussion: This study will provide valuable insights to inform the selection of treatment approaches for patients with disorders of consciousness. By employing a pre-post within-subject comparison design, it aims to validate the therapeutic role of Closed-Loop Transcutaneous Auricular Vagus Nerve Stimulation (CL-taVNS) in this patient population.

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

To investigate the association between lactate-mediated alterations in the gut microbiota and disease progression in patients with liver cirrhosis; and to examine the correlations of lactate levels among serum, fecal, and tissue samples in patients with liver cirrhosis.

Investigating the association between intestinal Ruminococcus gnavus and its derived biogenic amines with metabolic dysfunction-associated fatty liver disease

Neoadjuvant immunochemotherapy (NAIC) has demonstrated promising pathological and survival outcomes in patients with resectable locally advanced oral and oropharyngeal squamous cell carcinoma (LA-OSCC/OPSCC). However, the optimal postoperative management strategy following NAIC and radical surgery remains undefined, particularly regarding the necessity of postoperative radiotherapy and the potential role of PD-1 inhibitor maintenance therapy. This single-center, ambispective cohort study aims to compare event-free survival, pathological response, survival outcomes, failure patterns, treatment-related toxicities, and functional outcomes among three postoperative strategies: postoperative radiotherapy, postoperative PD-1 inhibitor maintenance, and observation alone. The study seeks to provide real-world evidence to support risk-adapted, individualized postoperative decision-making after NAIC

This research project aims to collect images from patients with chronic glomerulonephritis. For each subject, the images obtained from renal biopsy will undergo evaluation by both the diagnostic model and the 'gold standard' diagnosis by pathologists. The researchers will test the subjects using the diagnostic model and compare the results with the known 'gold standard' diagnosis, in order to evaluate the AUC, specificity, and sensitivity of the diagnostic model.

This is a single-center, single-arm, prospective exploratory study designed to evaluate the safety and efficacy of luspatercept for the treatment of anemia following allogeneic hematopoietic stem cell transplantation in patients with acute leukemia. A total of 46 eligible subjects are planned to be enrolled. The primary efficacy endpoint is the proportion of patients achieving a hemoglobin increase of ≥1.5 g/dL at 8 weeks post-transplantation (without transfusion support) compared to baseline (the average of 3 days prior to the first dose). Secondary endpoints include assessing the impact of luspatercept on time to hematopoietic engraftment (neutrophil and platelet) and recording safety indicators such as adverse events, graft-versus-host disease, and infections. Subjects will receive subcutaneous luspatercept at 1 mg/kg on day +7 and day +28 post-transplantation.

The purpose of this clinical trial is to tolerability and safety of humanized CD19 CAR-T therapy with TLR2 in adult patients with acute B lymphoblastic leukemia/lymphoma who cannot tolerate intense chemotherapy at initial treatment. Participants will receive a single infusion of CD19 CAR-T and complete follow-ups over the next three years.

This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Each tDCS and rTMS treatment lasted for 20 minutes.Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.

Evaluation of the Safety and Preliminary Efficacy of Intranasal Administration of Human Umbilical Cord Mesenchymal Stem Cell-Derived Small Extracellular Vesicles (hUC-MSC-sEV-001) in Patients for Ischemic Stroke

Investigating the Relationship Between Oral Microbiome Alterations and Tumor Markers in Locally Advanced Oral Squamous Cell Carcinoma (LA-OSCC) After Neoadjuvant Chemoimmunotherapy: Implications for Therapeutic Efficacy, Chemoresistance, and Prognostic Assessment

To assess 1-year recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who are at high risk of Inguinal orchiectomy recurrence usingTACE combined with icaritin

The goal of this clinical research study is to learn if azacitidine combined with Chidamide will help to control the disease in patients with high-risk AML after an allogeneic stem cell transplant. The safety of this combination will also be studied.

With the development of modern medicine, targeted and immunotherapies have been widely adopted in clinical practice. Beyond conventional chemotherapy combination regimens, the integration of radiotherapy into multimodal treatment strategies has also expanded significantly. While robust evidence supports the use of romiplostim for managing chemotherapy-induced thrombocytopenia (CIT), there is currently no clinical research evaluating its efficacy in treating thrombocytopenia associated with radiotherapy-combined treatment regimens in solid tumors. To address this unmet clinical need, this study aims to evaluate the safety and efficacy of romiplostim N01 for injection in the treatment of radiotherapy-combined regimen-induced thrombocytopenia in solid tumor patients. The findings will establish evidence-based management strategies to optimize clinical decision-making in this context.

A prospective collection of 35 cases was conducted at Zhujiang Hospital of Southern Medical University. Patients diagnosed with locally advanced oral squamous cell carcinoma (LA-OSCC) or locally advanced oropharyngeal squamous cell carcinoma (LA-OPSCC) from April 2023 onward, who received two cycles of neoadjuvant immunochemotherapy (tislelizumab + paclitaxel + cisplatin/carboplatin) at our institution, were included. The study analyzed treatment safety, efficacy, tumor regression patterns, 2-year progression-free survival (PFS), and 5-year overall survival (OS) rates.

This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.

IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.

CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or medium vessel occlusion.

This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.