Huai Nan Shi

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating the clinical effects and safety of Sodium Oligomannate GV-971 for treating mild to moderate Alzheimers Disease. This Phase 4 study aims to confirm how GV-971 works, monitor known side effects over long-term use, and identify any new adverse reactions to provide improved clinical guidance. Participants are randomly assigned to receive either GV-971 or a placebo, both given by mouth. The study lasts 36 weeks and uses a double-blind design where neither participants nor researchers know which treatment is given, ensuring unbiased results. The trial involves multiple centers and compares the two groups in parallel. During the study, participants will undergo assessments of cognitive and functional abilities using tools like ADAS-cog12 and ADCS-ADL23 at the start and after 36 weeks. Additional measures include MMSE, CIBIC-Plus, and NPI scores. Safety is monitored throughout, and the study tracks any adverse events. The total participation time is about 36 weeks from baseline.

Researchers are establishing a standardized clinical database for patients with liver cancer, including hepatocellular carcinoma and related types, to support high-quality real-world clinical studies. This observational study is led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China USTC in collaboration with multiple centers nationwide. The purpose is to collect detailed clinical information to better understand liver cancer outcomes over time. Participants will receive routine clinical treatments for liver cancer, such as surgical resection, ablation, transarterial chemoembolization TACE, hepatic arterial infusion chemotherapy HAIC, and various anti-tumor drugs including immunologic, targeted, and chemotherapy agents. The study observes and records these standard treatments without assigning interventions. The research will track these patients in a cohort database to monitor their treatment and progression. During the study, participants will be followed for up to 10 years to assess overall survival, recurrence-free survival, and survival time after cancer recurrence. Researchers will collect blood and surgical tissue samples and perform regular follow-up visits to gather clinical data and pathology results. This long-term monitoring aims to provide comprehensive insights into liver cancer progression and treatment outcomes.

Researchers are evaluating and comparing the effects of total intravenous anesthesia using remimazolam versus propofol in patients at moderate to high risk undergoing major elective noncardiac surgery under general anesthesia. This randomized controlled trial aims to determine if remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery. The study is conducted by Nanfang Hospital, Southern Medical University and is classified as a phase 4 trial. Participants receive either remimazolam or propofol as anesthesia. Remimazolam is given intravenously at 6-12 mgkgh for induction and 1.0-2.0 mgkgh for maintenance, adjusted to keep the Bispectral Index between 40 and 60. Propofol is administered intravenously at 1.5-2.5 mgkg for induction and 4-12 mgkgh for maintenance, also titrated to maintain the same Bispectral Index range. These dosing strategies help monitor and control anesthesia depth during surgery. During the study, participants will be closely monitored for outcomes including days alive and out of hospital at 30 days after randomization, all-cause mortality within 30 days, length of hospital stay, unplanned re-hospitalizations, postoperative complications, and quality of recovery on the first day after surgery. The trial involves double-blind randomization and includes follow-up assessments at 30 days to gather comprehensive data on recovery and safety.

Researchers are investigating whether adding endovascular therapy EVT to best medical management benefits patients with minor acute ischemic stroke who experience early neurological deterioration END due to large vascular occlusion LVO in the anterior circulation. The study focuses on patients presenting more than 24 hours after stroke onset, a late treatment window, where the effectiveness of EVT is not well known. The goal is to assess the safety and efficacy of EVT in this specific group of patients. The study randomly assigns approximately 272 patients aged 18 years and older with minor stroke and LVO to one of two groups. One group receives best medical management alone, which includes standard therapies like monitoring vital signs, managing blood pressure, glucose, lipids, and antithrombotic treatment as appropriate. The other group receives best medical management plus EVT, which may include mechanical or aspiration thrombectomy, intra-arterial thrombolysis, angioplasty, or stenting, chosen by local interventionalists. Treatment is given after randomization, which occurs more than 24 hours after stroke onset. Participants will have seven study visits, including at randomization, 24, 48, and 72 hours after, at 7 days or discharge, and at 30 and 90 days post-randomization. Data collected include demographics, symptoms, lab tests, neuroimaging, and neurological function scales. The main outcome measures are the proportion of patients achieving a good clinical outcome at 90 days, assessed by the modified Rankin Scale, along with safety outcomes like intracranial hemorrhage and mortality. A Data and Safety Monitoring Board oversees participant safety throughout the trial.

Researchers are evaluating the safety and effectiveness of atorvastatin in adults aged 18 to 80 years who have experienced spontaneous intracerebral hemorrhage ICH within 3 to 24 hours of symptom onset. This multicenter, prospective, randomized, open-label, blinded end-point PROBE study aims to determine if atorvastatin improves clinical outcomes compared to best medical treatment alone. The study focuses on patients with hematomas located in the supratentorial region and uses the modified Rankin Scale mRS to measure functional outcomes at 90 days. Participants will be randomly assigned to one of two groups one group will receive atorvastatin 20 mg once daily for 21 days along with best medical treatment BMT following current guidelines for ICH, while the other group will receive only BMT. The treatment period lasts for 21 days starting within 48 hours of symptom onset or last known well time. The study will monitor changes in hematoma and perihematomal edema volumes at specific time points during the first week after hemorrhage. During the trial, participants will undergo assessments including computed tomography CT scans to confirm ICH diagnosis and measure hematoma size, as well as evaluations using the Glasgow Coma Scale and mRS. Researchers will track functional independence and neurological outcomes at 90 7 days. Safety and adverse events will be monitored throughout the study. The total follow-up includes primary and secondary outcome measurements up to three months after treatment to evaluate the impact of atorvastatin on recovery.

Researchers are evaluating whether adding zilebesiran to standard antihypertensive treatment can reduce major cardiovascular events in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to determine if zilebesiran lowers the risk of cardiovascular death, heart attacks, strokes, or heart failure events compared to placebo. The study will continue until a targeted number of these events have occurred, which may take up to about 5 years. Participants will be randomly assigned to receive either 300 mg of zilebesiran or a placebo, both given as subcutaneous injections every 6 months, alongside their usual blood pressure medications. The study uses a parallel design and includes careful monitoring of blood pressure and cardiovascular events over time. Both groups will continue their standard antihypertensive therapies, including at least two medications where one must be a diuretic. During the study, participants will be regularly assessed for cardiovascular events such as heart attacks, strokes, heart failure hospitalizations, and cardiovascular death. Blood pressure measurements will be taken at baseline and at 6 months, among other times. The primary outcome is the time until the first occurrence of a major cardiovascular event, with secondary outcomes including changes in blood pressure and other cardiovascular events. Participants will be followed for up to approximately 5 years to monitor these outcomes and overall survival.