Lou Di 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 evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are investigating the safety and effectiveness of RC1416 injection in adults aged 40 to 85 years with moderate to severe chronic obstructive pulmonary disease (COPD). This phase II, multicenter, randomized, double-blind, placebo-controlled study focuses on patients who have experienced COPD for at least 12 months and meet specific lung function criteria. The goal is to assess how the treatment affects the rate of moderate or severe COPD flare-ups and lung function over one year. Participants will receive either RC1416 or a placebo by subcutaneous injection every two weeks for a total of 52 weeks. Two different doses of the study drug are being evaluated. Throughout the treatment period, researchers will also monitor changes in inflammation markers such as FeNO, total IgE, eosinophil count, and TARC levels. During the study, participants will undergo regular assessments to measure lung function, frequency and severity of COPD exacerbations, and blood tests to track immune and inflammation markers. The primary outcomes include the annual rate of moderate or severe COPD exacerbations and changes in forced expiratory volume in 1 second (FEV1) from baseline over the 52 weeks. Safety and tolerability of the treatment will also be closely observed throughout the trial.

Researchers are evaluating the efficacy and safety of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 660 participants aged 18 to 75 years. The study focuses on those who have had asthma diagnosed for at least a year and have experienced multiple asthma exacerbations in the past year despite using high-dose inhaled corticosteroids and other asthma medications. Participants are randomly assigned in equal numbers to receive either TQC2731 injection at a dose of 420 mg every four weeks or a placebo injection with no active drug. Both treatments are given by subcutaneous injection. The study treatment lasts for 52 weeks, during which the effects of blocking the Thymic Stromal Lymphopoietin (TSLP) protein by TQC2731 are assessed. Throughout the study, participants will be monitored for asthma exacerbations and other health outcomes. Researchers will regularly evaluate safety and treatment effects over the full 52-week period. The primary outcome measured is the annual rate of asthma exacerbations from the first day of dosing through completion. Participants' medication use, symptom control, and adverse events will also be tracked to assess treatment impact and safety.