Clinical trials

This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans. The primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.

Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.

This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions: * Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD? * What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?

The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system. The main questions it aims to answer are: * Does the Agent-assisted workflow yield better structured admission diagnosis and management planning scores than standalone LLM assistance? * Does the Agent-assisted workflow outperform the traditional workflow without AI tools? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the Agent tool can improve diagnostic accuracy and efficiency. Participants will: * Be recruited from 15 hospitals in China and participate remotely under video proctoring * Be randomly assigned to one of the three fixed workflows, with randomization stratified by hospital tier, specialty and seniority * Complete 6 anonymized simulated HIS admission cases within one hour * Submit structured answers for each case covering principal diagnosis, secondary diagnoses, differential diagnoses, diagnostic justification, next diagnostic or therapeutic steps, consultation and referral decisions, and diagnostic confidence * Have their operation logs and time consumption recorded automatically by the study platform

This multicenter observational study aims to develop and validate an artificial intelligence-based precision transfusion prediction model for critically ill patients. The study will collect clinical characteristics, laboratory parameters, transfusion-related information, physiological data, and clinical outcomes from critically ill patients admitted to intensive care units. An AI model will be developed using retrospective data and further evaluated using prospective observational data. The primary objective is to investigate factors associated with multiple organ dysfunction syndrome (MODS) and establish a predictive model to support individualized transfusion management in critically ill patients.

The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are: Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it? Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study. Participants will: Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.

The ACCURATE-PRO study is an investigator-initiated, prospective, multicenter, observational, real-world cohort study. The core objective in managing chronic coronary syndrome (CCS) is to identify clinically significant myocardial ischemia to guide treatment decisions and improve long-term prognosis. While coronary computed tomography angiography (CCTA) is a crucial non-invasive anatomical imaging tool, it has limitations in determining the functional significance of coronary stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) provides this functional assessment non-invasively based on CCTA images. However, there is a lack of systematic, prospective, multicenter evidence regarding its clinical value in risk stratification, treatment decision support, and prognostic evaluation for a continuous, real-world spectrum of CCS patients in China. This study aims to evaluate the relationship between abnormal CT-FFR results and the risk of 1-year major adverse clinical events in CCS patients undergoing CCTA and CT-FFR. The study hypothesizes that abnormal CT-FFR is associated with a higher risk of 12-month major adverse clinical events, and that CT-FFR results are significantly correlated with subsequent treatment strategies, providing important value in risk stratification and mid-to-long-term prognosis. The trial plans to consecutively enroll approximately 3,000 patients across multiple clinical centers in China. Eligible participants must be 18 years or older, have a clinical diagnosis of CCS, and have successfully obtained CT-FFR results following a CCTA examination. Patients will be excluded if they have acute coronary syndrome (such as STEMI, NSTEMI, or acute unstable angina), unanalyzable CT-FFR results/image quality, or non-cardiac conditions limiting their life expectancy to less than one year. Since this is an observational study, it will not alter routine clinical care pathways or assign interventions. The primary exposure factor analyzed will be the lowest CT-FFR result per patient, comparing an abnormal CT-FFR group (≤ 0.80) to a normal CT-FFR group (\> 0.80). Participants will be followed up via telephone, outpatient visits, or hospitalization at 6, 12, 24, and 60 months after enrollment. The primary endpoint is a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 1 year after enrollment. Key secondary endpoints include the occurrence of the primary endpoint at 24 and 60 months, target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization), stroke, health economics analysis, and the association between CT plaque characteristics and clinical outcomes.

The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.

The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.

This single-center, prospective, single-blind randomized controlled pilot trial aims to explore whether oral ezetimibe can reduce the 6-month recurrence rate of atrial tachyarrhythmia after catheter ablation in patients with persistent atrial fibrillation. A total of 120 eligible patients will be randomized at a 1:1 ratio into the ezetimibe group and the control group within 24 hours after ablation. Stratified randomization based on body mass index (BMI) and left atrial diameter will be performed via an interactive web response system (IWRS). This study adopts a single-blind design: patients and investigators are unblinded to group allocation, whereas an independent Endpoint Adjudication Committee consisting of three electrophysiologists will blindly review all ECG data to determine arrhythmia recurrence. The intervention group will receive 10 mg oral ezetimibe once daily for six months following ablation, and the use of hobimibe is prohibited in this group. The control group will refrain from the use of both ezetimibe and hobimibe, with standardized postoperative management maintained consistently across the two groups. The primary endpoint is the recurrence of atrial tachyarrhythmia lasting ≥30 seconds after the blanking period within six months post-ablation. Secondary endpoints include early atrial tachyarrhythmia recurrence, atrial fibrillation burden, changes in left atrial diameter, quality of life scores, and composite cardiovascular events. Safety outcomes encompass hepatic and muscular adverse reactions as well as serious adverse events. This prospective pilot study will provide preliminary clinical evidence for optimizing rhythm control strategies after atrial fibrillation catheter ablation.

The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction

Through the research of this project, we expect to validate the clinical utility of the TuFEst-LN model in assessing axillary lymph node status in breast cancer patients. Specifically, we aim to prospectively validate its ability to identify pathologically node-negative patients among clinically and radiologically assessed cN0 patients undergoing upfront surgery ，and explore the predictive value of the TuFEst-LN model combined with preoperative MRI for ypN status assessment in initially node-positive patients following neoadjuvant therapy.

The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.

To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.

The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.

Vestibular migraine is a common condition that causes repeated episodes of dizziness or vertigo, often with migraine headaches, sensitivity to light and sound, and nausea. It affects 1% to 2.7% of the general population and is one of the most frequent diagnoses in dizziness clinics. Despite its prevalence, there is very little high-quality evidence to guide preventive treatment. This study compares two preventive treatments for vestibular migraine: rimegepant (a newer medication that blocks a protein called CGRP involved in migraine attacks) and flunarizine (a medication commonly used for vestibular migraine prevention in some countries). The study hypothesis is that rimegepant is not inferior to flunarizine in reducing the number of days with moderate-to-severe vestibular symptoms. Approximately 400 adults aged 18 to 75 with definite vestibular migraine will be enrolled across multiple countries (China, Italy, Spain, and the United Kingdom). Participants will be randomly assigned in a 1:1 ratio to receive either rimegepant 75 mg once daily or flunarizine 10 mg once nightly for 12 weeks. The total study participation is 20 weeks, including a 4-week observation period, a 12-week treatment period, and a 4-week safety follow-up period. Participants will complete daily electronic diaries to record their symptoms throughout the study. The primary outcome is the change in the number of moderate-to-severe vestibular symptom days from the observation period to weeks 13-16, comparing the two treatment groups. Secondary outcomes include treatment completion rates, changes in monthly migraine days, adverse events, and patient-reported outcomes including dizziness-related disability, anxiety, depression, and global impression of change.

Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes device delivery, and may even lead to device failure. Moreover, stent underexpansion further elevates the risks of cardiac death, myocardial infarction, target vessel revascularization, and in-stent thrombosis. Rotational atherectomy (RA) is an effective modality for treating severely calcified coronary lesions, as it adequately modifies calcific plaques, facilitates luminal enlargement, and improves device deliverability. However, RA fragments calcific plaques into microparticles that are subsequently cleared by the reticuloendothelial system in the distal microvasculature, potentially inducing microvascular dysfunction. In recent years, intravascular lithotripsy (IVL) has emerged as an innovative calcium-modification technique in clinical practice. This technology employs acoustic pressure waves to selectively disrupt deep-seated calcific plaques, inducing fractures within the calcium while sparing the soft tissue of the vessel wall from substantial injury. IVL is performed with low-pressure balloon inflation (4-6 atm), which helps to minimize the risk of vascular injury; its mechanism of action does not produce macroscopic debris, theoretically obviating distal embolization and associated microcirculatory disturbances. Recently published prospective observational studies-the REPLICA-EPIC18 and BENELUX-IVL registries-have demonstrated that IVL is feasible and safe in "real-world" severely calcified lesions, effectively facilitating stent implantation. Although both RA and IVL are important tools for managing severe calcific lesions, there remains a paucity of high-level, head-to-head evidence directly comparing post-procedural minimal stent area between the two modalities. Clarifying this issue is of significant clinical importance for guiding clinicians in selecting optimal revascularization strategies tailored to distinct pathological characteristics and patient profiles, thereby improving procedural safety and patient outcomes. To this end, we plan to conduct a prospective, multicenter, randomized clinical trial (RCT) aimed at comparing the minimal stent area between intravascular lithotripsy and rotational atherectomy in patients with severely calcified lesions.

This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.

The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid. The main questions this study aims to answer are: What medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment? Participants will: Receive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week. Continue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor. Have cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment. Have tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology. Have imaging tests, including enhanced MRI, about every 3 months to check the disease. Be followed by clinic visits and/or telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.