Clinical trials

The aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life. The digital management cohort consists of: * At least 12 months of longitudinal monitoring of symptoms, environmental exposures, and health behaviors via a digital platform, supplemented by regular clinical assessments. * 3x embedded randomized controlled trials (RCTs) evaluating the clinical efficacy of non-pharmacological strategies: allergen avoidance (anti-mite bedding), physical activity (wearable-guided exercise), and dietary management (Mediterranean diet).

Obstructive sleep apnea (OSA) significantly increases the risk of cardiovascular events in patients with acute coronary syndrome (ACS), yet the underlying metabolic mechanisms remain unclear. This study aims to analyze the metabolic characteristics of ACS patients with OSA using metabolomics based on a prospective cohort. The study intends to construct an artificial intelligence-based risk stratification model to improve prognosis prediction and facilitate precision medicine for this population.

Low back pain (LBP) is a prevalent clinical condition characterized by pain localized between the lower edge of the 12th rib and the gluteal fold.The incidence of LBP has been escalating annually.An epidemiological survey encompassing 204 countries and territories globally projects a stark increase in the affected population, from an estimated 619 million in 2020 to a projected 843 million by 2050.LBP can affect individuals across all age groups, with a lifetime prevalence ranging from 60% to 80%, significantly impairing quality of life. Discogenic low back pain (DLBP), attributed to degenerative changes in the intervertebral discs, is the predominant subtype of LBP, comprising approximately 39% of all LBP cases. Disc degeneration typically initiates in early adulthood and progresses with age, potentially leading to DLBP.As the population ages, DLBP has emerged as a major contributor to disability worldwide, imposing a substantial burden on both individuals and society. Current international guidelines establish the foundation for surgical and pharmacological interventions for DLBP.However, considering the adverse effects and economic implications associated with surgical and medical treatments, there is a growing inclination towards recommending non-pharmacological therapies.These include physiotherapy, self-management, and psychotherapy, with a concurrent reduction in emphasis on pharmacological and surgical options. Acupuncture and moxibustion are integral components of traditional Chinese medicine, garnering global recognition for their role in restoring the equilibrium of yin and yang within the human body . Electroacupuncture, a modern derivation of traditional acupuncture, has been extensively applied worldwide for the management of various painful conditions, including headache, myofibromyalgia, neck pain, and cancer-related pain. Despite its broad application, a limited number of clinical efficacy and safety studies have been conducted on electroacupuncture for the treatment of discogenic low back pain (DLBP), thereby necessitating a scientific foundation for its therapeutic use . The present study aims to investigate the clinical efficacy and safety of electroacupuncture in the treatment of DLBP using an evidence-based medical approach. By employing a multicenter, randomized, and sham-controlled study design, this investigation seeks to provide a robust evidence-based medical foundation for the use of electroacupuncture in DLBP treatment. Participants will be randomly assigned to either the acupuncture group (experimental group) or the sham acupuncture group (control group) in a 1:1 ratio, akin to a lottery drawing. Following enrollment, participants will undergo a 4-week, 12-session intervention, followed by three follow-up visits at 4, 12, and 24 weeks post-treatment. The investigators will assess participants' low back pain, lumbar spine function, and quality of life through telephone communication or on-site questioning at these designated follow-up intervals. Needling may result in minor bleeding, pain, or hematoma at the needle site, and rare infections or allergic reactions may occur. Adverse reactions to needling, such as dizziness or nerve damage, are exceedingly rare. Participants in this study may confer direct medical benefits, such as remission of symptoms, or may not, with outcomes ranging from no remission to potential exacerbation of the condition . However, the knowledge gained from this study is anticipated to benefit future people with similar conditions . In addition to this study , participations may opt for treatment with modern rehabilitation medicine modalities or medications, including shortwave therapy, intermediate frequency therapy, or oral analgesics . This study would not impose any costs beyond the participants' regular medical treatment, and the investigators will cover all study-related medical expenses (including acupuncture treatment costs, needle costs, and scale evaluation costs) . The investigators are legally committed to maintaining the confidentiality of the participants' study records.

Thrombosis formation is the core mechanism for the occurrence of major adverse cardiovascular and cerebrovascular events in patients with coronary heart disease. Antithrombotic therapy is one of the most important treatment methods for secondary prevention of coronary heart disease. Antithrombotic drugs, while reducing ischemic events, often significantly increase the risk of bleeding. How to balance the risk of recurrent ischemic events and bleeding events in patients with coronary heart disease is a major challenge in the treatment of coronary heart disease. This project establishes a high-quality multicenter, prospective coronary heart disease cohort, with patients covering various clinical characteristics such as different regions, ages, and comorbidities. It verifies the ischemic risk and bleeding risk model developed in Project 1, compares the efficacy improvement of the new model with the traditional risk model, and verifies the effectiveness and stability of the model in different subgroups of the population, and assesses the generalizability of the model in real-world clinical practice, providing high-quality evidence-based basis for the formulation of individualized and precise antithrombotic strategies for coronary heart disease.

Mitral regurgitation (MR) is the most prevalent valvular heart disease in China. Transcatheter edge-to-edge repair (TEER) is currently the preferred treatment for patients with severe MR who face high surgical risks. However, existing preoperative assessment methods for TEER suffer from numerous limitations, including complex measurement parameters, high technical demands, and significant subjectivity. Vision Mamba, a cutting-edge technology in the visual domain, overcomes the limitations of common computational units in convolutional neural networks and Transformers through bidirectional state space models and positional encoding, demonstrating exceptional performance in visual tasks. To date, no studies have applied Vision Mamba to ultrasound videos for constructing TEER preoperative assessment models. Our team previously established a Transformer-based evaluation model using a small, single-center cohort. This study innovatively introduces a Vision Mamba-based visual foundation model. By integrating multi-faceted, multi-modal ultrasound videos from multiple centers, we develop a one-stop preoperative TEER assessment model for MR patients \[slice identification → video analysis → multi-modal information fusion → preoperative assessment recommendation (suitable/challenging/unsuitable)\]. This model will optimize surgical patient identification and accurately screen patients with contraindications. Furthermore, the one-stop model is fast and objective, significantly improving clinical efficiency. It holds promise for deployment at primary care levels to optimize healthcare resource allocation.

The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages.

Aiming at the problems of low image reading efficiency, crowded medical resources and fragmented cross-modal information of ophthalmic OCT and OCTA, a multimodal large model diagnostic framework for various diseases such as retinal diseases and optic nerve damage in glaucoma is constructed to fully explore the complementary information of various images such as SS-OCT structural images, SS-OCTA vascular images and optic nerve scans. Extract cross-modal joint features to improve the accuracy of automatic diagnosis.

The goal of this clinical trial is to evaluate the effects of probiotic combined with or without herbal powder on relieving constipation and improving the gut microbiota in community - dwelling people with a demand for improved bowel movements through human feeding trials, and to explore their potential mechanisms of action. The main research questions are as follows: Can the probiotic combined with or without herbal powder significantly increase the frequency of defecation in subjects, and at the same time improve fecal characteristics and defecation conditions? Can the the probiotic combined with or without herbal powder regulate the gut microbiota? What are the biological mechanisms by which the probiotic combined with or without herbal powder improve constipation and gut microbiota function? Researchers will compare experimental group 1 (taking the compound probiotic combined with herbal powder), experimental group 2 (taking probiotics alone) with the placebo control group (taking an identical - looking blank matrix powder) to observe their effects on defecation and the gut microbiota. The main tasks for participants include: Taking the compound probiotic combined with herbal powder (experimental group 1), probiotics alone (experimental group 2), or blank matrix powder (placebo control group) as required for 12 weeks. Recording daily defecation frequency, defecation conditions, fecal characteristics, and daily diet, and reporting any adverse reactions. Longitudinal monitoring employs serial assessments comprising: 1) physical examinations (mental status/vital signs); 2) laboratory diagnostics (hematology/urinalysis/fecal routine tests, hepatic-renal-metabolic panels); 3) ECG and abdominal ultrasonography; and 4) advanced analyses (gut microbiome sequencing and serum metabolomic profiling via LC/MS/MS).

Primary dysmenorrhea refers to menstrual pain not caused by pelvic organic lesions, commonly seen in young women, significantly affecting patients' quality of life. Dry needling therapy targeting myofascial trigger points for primary dysmenorrhea has been preliminarily applied in clinical settings. However, related research is limited with questionable quality, hindering its widespread clinical application. Furthermore, is there a connection between myofascial trigger points in dry needling and acupuncture acupoints in terms of selection and mechanism of action? Could this be a new interpretation of acupuncture theory? These are important questions that have garnered widespread attention. This study employs a randomized patient-blinded controlled design, enrolling primary dysmenorrhea patients aged 18 to 30 years. They are randomly divided into three groups: the trigger point dry needling group, traditional acupuncture treatment group, and trigger point sham needle (placebo) group. Changes in pain levels, quality of life scores, inflammatory factor levels, and local blood flow before and after treatment among the three groups are observed. The aim is to assess the therapeutic effects of dry needling trigger points and acupuncture treatments on primary dysmenorrhea and explore their potential mechanisms of action. By comparing the differences and similarities between dry needling trigger points and acupuncture treatments in terms of acupoint selection, treatment effects, and potential mechanisms of action, this study seeks to preliminarily explore the feasibility of integrating trigger point theory into the meridian 'acupoint' theory, laying the foundation for a modern interpretation of acupuncture

The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for the treatment of connective tissue disease-associated thrombocytopenia.

The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.

This study aims to establish a nationwide cohort and biobank of elderly patients with coronary heart disease (CHD) and to develop risk prediction models and clinical treatment optimization plans based on this data. The specific research content is as follows: The Study plan to continuously enroll hospitalized elderly CHD patients across 50 centers nationwide. Using networked electronic data collection technology, standardized methods and protocols will be used to gather demographic information (such as age, gender, education level, income, etc.), clinical information (medical history, past treatment records, current treatment plans, surgical records, medication use, etc.), lifestyle information (dietary habits, exercise frequency, smoking, drinking, etc.), biological information (such as inflammatory markers, etc.), and physical examination data (such as blood pressure, ECG, sleep monitoring, imaging examinations, etc.). These patients will be followed up long-term (1 month, 6 months, 1 year, and annually thereafter for up to 5 years) to establish a database that meets international standards. Centers meeting the criteria will also retain biological samples, creating a multicenter biobank for elderly CHD patients. Second, based on the established clinical cohort, a risk prediction model for elderly CHD patients will be developed, including mortality risk, ischemic risk, bleeding risk, etc. Additionally, optimized clinical diagnostic and treatment plans will be formulated to improve the treatment outcomes and quality of life for elderly CHD patients. This research is expected to provide scientific evidence and technical support for the prevention, diagnosis, and treatment of CHD in elderly patients.

Age-related macular degeneration (AMD) is one of the main causes of blindness in the elderly population. Intraocular injection of anti-VEGF drugs for neovascular AMD (nAMD) is the main treatment method at present. However, patients have different responses to anti-VEGF therapy, and some patients do not respond well to short - and long-term treatment. In this study, a retrospective study was adopted to collate and analyze the clinical data and imaging data of nAMD in the past, and to extract the imaging features from the multimodal modalities before and after treatment for deep learning, and to evaluate and quantify the clinical features, and to construct two multi-source feature models for predicting the short-term and long-term prognosis of nAMD patients. By verifying the accuracy of the model to predict the curative effect, the classification efficiency of the above characteristic models was compared, and the optimal model was selected. Its clinical application value was evaluated by calibration curve and decision curve. In addition, patients with poor treatment response in the study cohort were retrospectively analyzed, and the efficacy and safety of the combination of other treatment options in the actual clinic were analyzed. The purpose of this study is to provide scientific basis for early prediction, dynamic monitoring and optimization of overall treatment strategies for nAMD.

In this study, patients with chronic central serous chorioretinopathy who were treated by micropulse laser alone or micropulse laser combined with photodynamic therapy without drugs are retrospectively included. The visual acuity changes, subretinal fluid absorption and choroidal characteristics of the two groups are compared 1 to 6 months after treatment. We will also analyze baseline characteristics that influence post-treatment outcomes to identify potential predictors of poor treatment outcomes.

This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.

To compare the safety and efficacy of unmodified RAK cells and anti-TIM-3 blocked autologous RAK cells in preventing postoperative recurrence of HCC by postoperative TACE therapy combined with immune cell therapy.