Yu Lin 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 the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are conducting a Phase 1b clinical trial to study anisodine hydrobromide in patients who have acute ischemic stroke and are undergoing endovascular therapy. The main goals are to assess the safety and tolerability of the drug and to find the appropriate dose for future studies. This open-label, non-randomized trial uses a dose-escalation design to identify the maximum tolerated dose and recommended dose for Phase II trials. Participants receive anisodine hydrobromide intravenously at one of four dose levels 1.0 mg, 1.5 mg, 2.0 mg, or 2.5 mg twice daily for seven consecutive days alongside standard endovascular therapy. The first dose is given before vascular recanalization but must not delay the endovascular procedure. The drug is diluted in sodium chloride solution and infused over about 60 minutes. All participants also receive standard care for stroke, including mechanical thrombectomy and other procedures as needed. Throughout the study, participants are closely monitored for safety and neurological outcomes. Researchers will measure safety events within eight days of the first dose, neurological changes within 24 hours, stroke infarct volume at day 8, and functional recovery at day 90 using the modified Rankin Scale. Additional assessments include brain hemorrhage events and all-cause mortality within 90 days. The total participation duration extends to approximately three months to capture these outcomes and ensure safety monitoring.

Researchers are evaluating vascular closure techniques for patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement TAVR. The study compares the use of a single versus double Perclose Proglide device to manage the access site, which is crucial to reduce vascular complications that can lead to serious outcomes such as bleeding, transfusions, and kidney failure. This randomized controlled trial aims to determine if using a single device offers clinical benefits alongside reduced procedural cost and time. Participants will be randomly assigned to receive either a single or double Perclose Proglide device during their TAVR procedure for large bore arteriotomy site closure. The Perclose system uses a preclosure technique where sutures are placed before expanding the arterial access site to secure closure after valve delivery. The study is open-label and conducted across multiple centers with oversight by an independent data coordinating center. During the study, patients will be monitored in the hospital and followed for 30 days to assess vascular complications and related outcomes, including bleeding, need for additional procedures, device failure, and mortality. Researchers will evaluate the time to achieve hemostasis and length of hospital stay. Participants will have planned follow-up evaluations, and data on safety and efficacy outcomes will be collected throughout the trial period.

Researchers are evaluating the progression-free survival of D-1553 Tablet compared to Docetaxel Injection in patients with KRAS G12C mutation-positive locally advanced or metastatic non-small cell lung cancer NSCLC who have not responded to prior standard therapy. This phase III, randomized, controlled, double-blind study aims to assess progression-free survival as the primary endpoint, with other outcomes measured over up to three years. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will receive either the experimental D-1553 Tablet or the active comparator Docetaxel Injection, each administered in 21-day treatment cycles. D-1553 is a KRAS inhibitor, while Docetaxel is an anti-tumor drug that works by affecting microtubule dynamics. The study design includes a quadruple masking and random allocation to ensure unbiased results. During the study, participants will undergo evaluations of progression-free survival, overall survival, response rates, disease control, and patient-reported outcomes over a period of up to three years. Safety assessments include monitoring adverse events and laboratory tests from consent through 30 days after the last dose. Pharmacokinetic parameters such as time to maximum plasma concentration and half-life will be measured during specific cycles. The total participation duration depends on individual treatment response and follow-up.

Researchers are comparing two sizing strategies for transcatheter aortic valve replacement TAVR in patients with severe bicuspid aortic stenosis type 0. This study aims to evaluate the down sizing strategy versus the standard annular sizing strategy using self-expanding valves. Bicuspid aortic valve patients undergoing TAVR face higher risks such as perivalvular leakage and device failure, especially with heavily calcified valve leaflets common in this group. The study involves two groups an experimental group using a balloon-based down sizing approach where the valve size is smaller than the annular sizing recommendation, and a control group using the traditional annular sizing method. Both groups use Evolut PRO self-expanding valves with pre-dilation balloon sizing just below the annular size. The implant depth target is 0-3 mm for both groups. Balloon sizing assists in determining the presence of a waist sign to guide valve size selection in the experimental group. Participants will undergo TAVR procedures with detailed follow-up assessments including clinical event rates of device success, pacemaker implantation, and new left bundle branch block occurrence measured at 1 month after the procedure. Safety and device performance are monitored closely with evaluations of valve function and complications. The trial is randomized, double-blind, and will continue until June 2030, with all visits and outcomes carefully recorded.

This research aims to assess whether immunonutrition can reduce oral mucositis compared with standard nutrition in patients with locally advanced nasopharyngeal carcinoma receiving chemoradiotherapy. Oral mucositis is a common and severe side effect in these patients, causing pain, difficulty swallowing, and malnutrition, which can disrupt treatment and worsen quality of life and prognosis. Nutritional interventions like immunonutrition may help improve immune response, reduce inflammation, and enhance treatment tolerance and outcomes. Participants receive induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy with intensity-modulated radiotherapy and cisplatin. They are randomly assigned to one of two groups one group receives enteral immunonutrition Oral Impact twice daily starting 5 days before radiotherapy until treatment ends, while the other group receives a standard enteral nutrition formula ENSURE three times daily over the same period. During the study, participants are monitored for the incidence, timing, and duration of severe oral mucositis over 7 weeks. Researchers also assess immune status, inflammatory markers, nutritional and physical function, quality of life, and survival rates up to 2 years after randomization. Safety and adverse events are recorded throughout the study. Participants are expected to follow scheduled visits, laboratory tests, and questionnaires.

This research aims to evaluate the safety and effectiveness of TQA2225AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis NASH. It is a randomized, double-blind, placebo-controlled Phase II study designed to assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.