Clinical trials

Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal reactions, and other adverse effects.

This study intends to randomly divide the SAT patients admitted to the ICU into the ropivacaine N01 treatment group and the recombinant human thrombopoietin control group. By measuring the platelet count of the SAT patients, the therapeutic effect of ropivacaine N01 will be evaluated. Moreover, through the APACHE II score of the patients, the improvement of platelet technology, the 28-day mortality rate, the incidence of adverse reactions, the length of ICU stay and the hospitalization cost, the advantages and social value of ropivacaine N01 in treating SAT will be explored.

This study is a prospective, multicenter, integrated trial designed to evaluate, from the perspectives of diagnostic performance and clinical utility, whether a diagnostic and treatment strategy based on the NuRapid-CRISPR rapid pathogen detection technology can reduce the 28-day all-cause mortality rate in patients with sepsis or septic shock in the ICU, compared to traditional pathogen culture. The study consists of two parts: 1. Diagnostic Accuracy Study: For all enrolled sepsis patients, microbiological specimens will undergo concurrent blinded testing, with NuRapid-CRISPR serving as the test of interest and traditional pathogen culture as the reference standard. A prospective comparison will evaluate differences between the two methods in key metrics such as pathogen detection rate, sensitivity, specificity, and turnaround time. 2. Clinical Utility Cohort Study: All patients will undergo NuRapid-CRISPR testing as part of routine clinical care. Based on whether the rapid results are adopted clinically to guide early antimicrobial therapy decisions, the cohort will naturally form an exposure group (early treatment adjustments based on NuRapid-CRISPR results) and a control group (treatment primarily based on traditional culture results or empirical therapy). The study will prospectively compare the two groups in terms of the time to optimize antimicrobial therapy, coverage of the initial treatment spectrum, and infection-related clinical outcomes.

The goal of this single arm ,non-interventional, prospective, descriptive study is to evaluate the efficacy of guselkumab treatment in preventing endoscopic recurrence of Crohn's Disease in adult participants who have a documented diagnosis of moderate to severe CD and have undergone an ileocolonic surgical resection. The primary endpoint is Endoscopic recurrence rate at week24.

This clinical trial evaluates the efficacy and safety of adding fecal microbiota transplantation (FMT) to first-line standard of care for patients with initially unresectable colorectal cancer (CRC). FMT is an established procedure designed to restore intestinal microbiome homeostasis by transferring processed fecal microbiota from a rigorously screened healthy donor into the patient's gastrointestinal tract. The standard first-line treatment regimen typically consists of chemotherapy, with or without targeted therapy. Approximately 220 patients across 13 participating centers will be randomly assigned to receive either standard therapy alone or standard therapy combined with FMT. The primary endpoint is the objective response rate (ORR). Secondary endpoints include the conversion to resectability rate, progression-free survival (PFS), safety and adverse events, quality of life (QoL), anxiety and depression scales, as well as dynamic changes in the gut microbiome and circulating biomarkers. The ultimate goal of this trial is to determine whether microbiome modulation via FMT can synergistically enhance the antitumor efficacy of standard first-line therapies and mitigate treatment-related toxicities in this patient population.

To validate the prognostic importance of the burden of new-onset atrial fibrillation (NOAF) complicating acute myocardial infarction (AMI) in a prospectively designed hospital-based registry. To characterize those factors that contribute to the progression of post-MI NOAF burden. To establish a prediction model for the risk stratification of patients with NOAF complicating AMI. To explore the clinical usefulness of NOAF burden in guiding the anticoagulation therapy among patients with post-MI NOAF.

The investigators collected clinical data and serum samples of patients with polycystic ovary syndrome (PCOS) in this study, used statistical software such as SPSS for date analysis, and used experimental techniques such as ELISA and flow cytometry to detect serum samples, aiming to explore the relationship between the body anthropometry, skin conditions, psychosomatic status, diet, sleep, exercise, glucose and lipid metabolism, gonadal hormones, and body fat distribution in patients with polycystic ovary syndrome, and to discovery new biomarkers. Multidisciplinary exploration of the mechanisms of disease occurrence and development, the establishment of a PCOS multicenter, multidisciplinary and multidimensional clinical research database, combined with the established statistical analysis strategy for big data and analysis, to promote the realization of more accurate personalized medicine.

According to estimates by the World Health Organization, approximately half of the global adult population currently suffers from varying degrees of myopia. In urban areas of China, the myopia rate among primary school students has reached about 40%, and can exceed 80% in high school students. The proportion of patients with high myopia (refractive error greater than 600 degrees) is also increasing year by year. This group is more prone to severe visual problems, including an increased risk of complications such as cataracts, glaucoma, and macular degeneration. Pathological myopia is the main risk factor for vision loss caused by high myopia. In such patients, the elongation of the ocular axis leads to local thinning and protrusion of the posterior pole of the eyeball, forming a posterior scleral staphyloma. Posterior scleral staphyloma is the most representative pathological feature of pathological myopia. Local dilation of the choroid leads to thinning and stretching of the retina, which may ultimately cause problems such as macular retinal schisis, seriously affecting vision and even leading to blindness. This project aims to develop a multimodal intelligent screening system by combining the excellent imaging technology and advanced artificial intelligence (AI) of the Optos non-mydriatic ultra-wide-angle laser scanning ophthalmoscope, B-scan ultrasonography ophthalmic diagnostic instrument, and optical coherence tomography (OCT). The system is designed to achieve precise identification and assessment of ocular fundus diseases, especially pathological myopia, and particularly the core condition of posterior scleral staphyloma (PSS). Simultaneously, a vision prediction model will be constructed to assist doctors in formulating personalized diagnosis and treatment strategies, predicting the trend of vision deterioration, and enhancing the effectiveness of early intervention. This system is expected to significantly improve the prevention and control of pathological myopia, reduce the risk of blindness, and play a pivotal role in telemedicine services, benefiting people in remote areas and promoting public health equity and service quality.

This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes in mean 24-hour ambulatory diastolic blood pressure over a 6-month follow-up period. The study is expected to provide evidence for the use of RDN as a treatment for IDH.

Emerging evidence identifies vascular aging independently predicting cardiovascular events, yet effective clinical interventions remain lacking. Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor whose levels decline with age, and preclinical studies suggest that boosting NAD+ can improve vascular function and structure. Preliminary clinical studies in healthy older adults indicate that supplementation with NAD+ precursors, such as nicotinamide riboside(NR) or nicotinamide mononucleotide (NMN), can reduce arterial stiffness as measured by pulse wave velocity (PWV). However, whether NAD+ supplementation can improve vascular endothelial function and exert anti-stiffening effects in patients who have already developed measurable arterial stiffness remains unknown. Based on this evidence, the investigator hypothesize that the Coenzyme I for Injection will reverse vascular aging in older adults with established arterial stiffening.

We plan to enroll 20-29 patients with advanced bladder cancer to undergo T-cell therapy. Each treatment cycle consists of three T-cell infusions, with two cycles planned per patient. Each cycle will include imaging studies, laboratory tests, and vital sign monitoring to evaluate quality of life and treatment efficacy. Through real-world clinical data, we aim to scientifically determine whether this novel T-cell therapy can significantly alter the pathological progression of tumors and improve patient outcomes. Ultimately, we seek to benefit a broader patient population by achieving long-term tumor-bearing or tumor-free survival, transforming cancer management into a chronic disease model and improving patients' quality of life.

Due to factors such as disease status, gastrointestinal conditions, commonly used medications (e.g., vasopressors), and cardiac output, the plasma concentration of isavuconazole in critically ill patients may differ from that in healthy individuals, exhibiting significant variability. This study aims to explore the variability of isavuconazole plasma concentrations in critically ill patients and its correlation with efficacy and adverse effects. The research includes: 1. The distribution and variability of isavuconazole plasma concentrations in critically ill patients; 2. Clinical outcomes; 3. Adverse effects.

Cataract is a major cause of blindness due to eye diseases. Methods for evaluating the degree of lens opacification in cataracts are divided into subjective and objective methods. The commonly used subjective method is the Lens Opacification Classification System (LOCS Ⅲ), while the objective methods mainly include the Dysfunctional Lens Index (DLI) of the Ray Tracing aberration analysis system, the PNS score of the Pentacam anterior segment analysis system, etc. Subjective diagnosis may lead to certain misjudgments, which have affected clinical diagnosis and treatment. There is an urgent need to add objective diagnostic measures to assist clinical work. The Scanning Source Optical Coherence Tomography (SS - OCT) biometer - IOL Master 700 forms an OCT imaging of the eye based on the swept - source optical coherence tomography (OCT) biometric technology. It can visually show the longitudinal section of the entire lens, and the clear display of the patient's lens tomographic OCT image is obtained through image visualization measurement. The main purpose of this study is to analyze the lens images obtained by the IOLmaster 700. Based on the current mainstream algorithm models such as ResNet - 34 and XGBoost, develop a heterogeneous accelerated artificial intelligence algorithm according to our research needs to accurately calculate the degree of lens opacification. And write image analysis software by ourselves to automatically calculate the required indicators and output them. Establish a heterogeneous accelerated artificial intelligence - assisted lens opacification grading and prediction system, supporting software for biometer equipment, and a cataract lens image database. The software provides online service functions, and all researchers can use the image analysis function of the software after logging in, truly realizing the sharing of large instrument supporting software operations. Thereby improving the accuracy and efficiency of clinical diagnosis and treatment, the prognostic prediction level of patients after cataract surgery, guiding clinical diagnosis and treatment more accurately, and at the same time, it can be used as a tool for community screening.

Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI. While drug-eluting stents (DES) remain the standard treatment, their long-term efficacy in diabetic patients is suboptimal. Drug-coated balloons (DCBs) offer a "leave nothing behind" strategy by delivering anti-proliferative drugs without permanent implants, potentially reducing restenosis and adverse events. Although DCBs have shown promise in selected lesion types, evidence in T2DM patients is limited, particularly from prospective, randomized trials. This study aims to evaluate the efficacy and safety of DCB angioplasty compared to conventional strategies in patients with CAD and T2DM, focusing on angiographic outcomes, symptom relief, and major adverse cardiovascular events.

Perioperative neurocognitive disorder (PND) is one of the most common postoperative complications among elderly patients. However, the mechanism and targeted intervention of PND remains unclear. Our previous clinical studies demonstrated the association between olfactory impairment and PND. Moreover, our translational studies showed that anesthesia/surgery induced olfactory impairment and caused cognitive impairment in mice and olfactory enrichment could prevent the anesthesia/surgery-induced cognitive impairment. However, there was no clinical investigation to determine whether olfactory enrichment can mitigate PND in elderly patients. Therefore, we propose determining whether olfactory enrichment can prevent and/or treat PND in elderly patients.

The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China

Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.

The aim of this study is to establish a shared database of acute myocardial infarction patients with periodontitis, to clarify the clinical benefits of periodontitis intervention on acute myocardial infarction patients through simulated RCT study, and to establish a high-level database of acute myocardial infarction patients with periodontitis, so as to promote the application of oral health intervention in clinical practice.

Cardiac rehabilitation is an important link in cardiovascular disease. This study mainly explores the effectiveness of new cardiac rehabilitation therapy (early respiratory rehabilitation, phase I rehabilitation, exercise therapy, external counterpulsation, extracorporeal shock wave, etc.) on patients with ischemic heart disease such as coronary heart disease and heart failure, and the compliance of home rehabilitation compared with traditional cardiac rehabilitation therapy (traditional exercise rehabilitation, rehabilitation education, etc.).

To explore whether a ReDS-guided strategy for AMI patients with cardiac insufficiency following coronary flow reperfusion is superior to routine care for improving outcomes.

In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.

Recently a new clinical dementia subgroup based on brain imaging, called "diabetes related dementia (DrD)". DrD, unlike Alzheimer's disease and vascular dementia, is considered a "controllable" or "modifiable" form of dementia. However, there is currently a lack of corresponding treatment measures. Ginkgo biloba ketone ester tablets are extracts of Ginkgo biloba leaves. Previous studies have shown that they can increase cerebral blood flow, reduce cerebrovascular resistance, improve cerebral circulation, and are beneficial for the treatment of cognitive impairment. This project intends to explore the role of ginkgo ketoester tablets in diabetes related dementia through a multicenter randomized double-blind controlled clinical study.

One-stop procedure combining catheter ablation (CA) and left atrial appendage closure (LAAC) has been a feasible treatment for patients with atrial fibrillation at high risk of stroke and/or bleeding. Although it could achieve considerable rhythm control and stroke prophylaxis, a number of patients has experienced progressive heart failure after the procedure. Notably, previous studies indicate that both pulmonary vein isolation by CA and LAAC could significantly increase left atrial pressure, while currently no study has investigated left atrial pressure change in patients underwent combined procedure. The investigators hypothesise that combined procedure would significantly increase left atrial pressure and subsequently deteriorate cardiac function. Therefore, the investigators aim to measure the left and right atrial pressure change before and after CA and LAAC in combined procedure, and investigate the influence of the pressure change on clinical outcomes.

To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events. To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.

This study aims to evaluate the concept of closed-loop treatment of atrial fibrillation for the optimization of the treatment strategy.