Yu Lin Shi

This research aims to verify the accuracy, stability, and clinical usefulness of artificial intelligence (AI) algorithms for measuring heart function through echocardiography. The study involves collaboration with multiple medical centers and focuses on comparing AI measurements with those done manually by physicians of different experience levels. It also explores whether AI can reduce the time needed for echocardiogram analysis and improve clinical workflows, while assessing AI's performance in complex heart conditions such as cardiomyopathy and valve disease. The study collects echocardiographic data using Mindray ultrasonic machines, with AI and physicians at each center measuring key heart parameters including left and right ventricular size and function. AI and intermediate doctors complete measurements within one day of data collection, while senior physicians at the main research unit finalize their assessments within one month. The goal is to establish a standardized reference system for AI in ultrasound measurement and promote its use across various medical institutions. Participants aged 18 to 80 years with specific heart conditions or normal hearts are involved. Researchers measure heart chamber sizes and functions through echocardiography, comparing AI and physician results for consistency and accuracy. The study also monitors how AI-assisted measurements could optimize diagnosis time and medical resource use. The total duration of participant involvement depends on data collection and measurement timelines, with ongoing analysis to support AI's clinical application in cardiovascular care.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating the effectiveness and safety of BGB-16673 compared to the investigator's choice of treatment (either bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors. CLL and SLL are blood cancers that cause enlarged lymph nodes, spleen, or liver and symptoms such as night sweats, weight loss, and fever, leading to a shorter life expectancy. Participants will be randomly assigned to receive either oral BGB-16673 or the investigator's choice of intravenous bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. About 150 participants in Mainland China and Taiwan will take part in this Phase 3, open-label, randomized study. During the study, researchers will measure how long participants live without their disease worsening, known as progression-free survival, over approximately 23 months. Participant health and disease status will be monitored through imaging, laboratory tests, and clinical assessments to evaluate treatment effects and safety.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the use of single versus double Perclose Proglide devices for closing the access site during transfemoral transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis. TAVR is a minimally invasive treatment option for these patients and has shown safety and effectiveness across various risk groups. Proper closure of the vascular access site is crucial because vascular complications can lead to serious adverse outcomes such as bleeding, kidney failure, and increased mortality. The study aims to compare the clinical outcomes and potential benefits of using a single closure device versus the commonly used double device technique. This is a prospective, multicenter, randomized controlled trial involving patients scheduled for transfemoral TAVR who meet specific criteria. Participants are randomized to receive vascular closure using either a single Perclose Proglide device or a double device technique. The Perclose system works by deploying sutures before dilating the artery to allow closure of the large access site after valve delivery. The study evaluates the access site closure during the initial hospital stay and includes follow-up assessments. During the study, participants undergo planned evaluations including monitoring for vascular complications defined by established criteria. The primary outcome is the rate of major and minor vascular complications at the access site during hospitalization. Secondary outcomes include complication rates at 30 days, bleeding events, need for additional interventions, device failure, time to hemostasis, and length of hospital stay. Safety and adherence to the protocol are closely monitored throughout the study period.

Researchers are evaluating the progression-free survival of D-1553 Tablet compared to Docetaxel Injection in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have a KRAS G12C mutation and have not responded to prior standard therapies. This phase III, randomized, controlled, double-blind study uses progression-free survival as the main outcome, assessed by an Independent Review Committee based on RECIST 1.1 criteria. The goal is to understand how these treatments perform in this specific patient group after prior therapy failure. Participants will be randomly assigned to receive either D-1553, a KRAS inhibitor taken as a tablet, or Docetaxel, an anti-tumor drug given as an injection that affects microtubules in cancer cells. The treatments are delivered according to the study protocol, with the study being conducted at multiple centers. The study compares the effects of these two treatments in managing NSCLC with the KRAS G12C mutation. During the study, participants will undergo regular assessments including tumor evaluations based on RECIST 1.1 to monitor disease progression. The primary outcome measure is progression-free survival from baseline up to three years. Safety and overall health will be monitored throughout the study to track any side effects or changes. Participants are expected to comply with the study requirements and provide necessary samples for mutation confirmation and ongoing monitoring over the study period.

Researchers are evaluating two sizing strategies for transcatheter aortic valve replacement (TAVR) in patients with severe bicuspid aortic stenosis (AS) of Type 0. This randomized superiority trial compares a "down sizing" technique, which uses a smaller device than standard recommendations, against the traditional annular sizing method. Bicuspid aortic valves present complex anatomical challenges, and patients often face higher risks of complications such as perivalvular leakage and device failure compared to those with tricuspid valves. The study aims to assess whether the down sizing strategy improves device success and reduces complications. The trial involves two groups: one receiving TAVR with the down sizing strategy using self-expanding valves on the Evolut Pro platform, and the other receiving TAVR with the traditional annular sizing strategy on the same platform. Both strategies use self-expanding valves designed to fit the aortic valve area, with patients selected based on specific valve and anatomical criteria. The study focuses on patients with Type 0 bicuspid aortic stenosis undergoing transfemoral TAVR, with precise measurements of the annulus perimeter guiding device selection. Participants will be monitored for device success, including freedom from pacemaker implantation and new onset left bundle branch block one month after the procedure. The primary outcome is a composite clinical event rate evaluated at one month post-TAVR. Throughout the study, patients undergo detailed imaging and clinical assessments to confirm valve type, measure valve function, and evaluate complications. The trial includes informed consent and continuous safety monitoring to ensure patient well-being during and after the intervention.

Researchers are evaluating the effects of immunonutrition compared to standard nutrition on reducing oral mucositis in patients with locally advanced nasopharyngeal carcinoma undergoing chemoradiotherapy. Oral mucositis is a common and often severe side effect causing pain, swallowing difficulties, and malnutrition, which can delay treatment and worsen patients' quality of life and prognosis. This study aims to determine whether immunonutritional therapy can improve outcomes and reduce the severity of oral mucositis in these patients. Participants are randomly assigned to receive either enteral immunonutrition or standard enteral nutrition. The immunonutrition group receives Oral Impact®, 250 ml twice daily starting 5 days before radiotherapy and continuing until the end of radiotherapy. The standard nutrition group is given ENSURE®, 250 ml three times daily prepared by mixing powder with water. Both nutritional supplements are designed to provide calories, with immunonutrition also targeting immune regulation and anti-inflammatory effects. Throughout the 7-week study period, researchers will monitor the incidence of severe oral mucositis as the primary outcome. Participants undergo clinical evaluations including laboratory tests to assess organ function and nutritional status. The study also tracks patients' adherence to the nutrition plans and collects data on treatment tolerance, quality of life, and any adverse effects to evaluate the safety and effectiveness of immunonutrition compared to standard care.

This trial investigates the effects of TQA2225/AP025, 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 evaluate the safety and effectiveness of two different doses (25mg and 50mg) of this drug compared to a placebo. Participants have a confirmed diagnosis of NASH based on liver biopsy and imaging, and the study aims to assess changes in liver health over time. Participants receive either 25mg or 50mg of TQA2225/AP025 or a matching placebo, and the treatment is administered during the study period. The trial compares the impact of these doses on liver fibrosis and inflammation, as measured by liver biopsy scores and imaging results. The study includes a treatment duration of 48 weeks, during which the drug's effect on liver tissue is closely monitored. During the study, participants undergo liver biopsies at baseline and after 48 weeks to evaluate liver changes. Additional assessments include MRI scans to measure liver fat content, laboratory tests to monitor liver enzymes and kidney function, and safety evaluations. Researchers will track participants' adherence to the treatment and monitor any side effects or changes in health status throughout the 48-week period.