Shang Rao 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 a drug called GB491 combined with Letrozole compared to a placebo combined with Letrozole in treating patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. This study focuses on patients who have not received prior systemic antitumor therapy for this condition. It is a phase III randomized, double-blind, placebo-controlled trial designed to provide important information about treatment options for this group of breast cancer patients. Participants are randomly assigned to one of two groups: one receiving GB491 150 mg orally twice daily plus Letrozole 2.5 mg orally once daily, and the other receiving a placebo orally twice daily plus Letrozole 2.5 mg orally once daily. Treatment cycles last 28 days, starting from the first day of cycle 1. The study compares the combined treatment effects over time, focusing on progression-free survival and safety outcomes. Throughout the study, researchers will monitor participants for progression-free survival using established criteria for about 60 months. They will also assess safety and organ function, with required laboratory tests and clinical evaluations. Participants must meet specific eligibility criteria at the start and provide informed consent. The study aims to gather detailed data on how well the treatments work and their safety profiles over the extended follow-up period.

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 conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of WS016 for treating hyperkalemia, a condition characterized by high potassium levels in the blood. The trial includes adults aged 18 years and older with serum potassium levels between 5.0 and 6.5 mmol/L. The study consists of two parts: Part A is a randomized, double-blind, placebo-controlled trial, and Part B is an open-label extension for eligible participants from Part A. In Part A, participants are first randomly assigned in a 5:1 ratio to receive either oral WS016 at a 12g dose or a placebo three times a day for 48 hours, totaling six doses. Following this corrective phase, those with normal potassium levels are re-randomized into one of four groups to receive WS016 at 6g, 12g, or 18g, or placebo once daily for 28 days. Participants who finish or discontinue Part A due to potassium level changes and meet eligibility criteria can join Part B, receiving WS016 once daily for 11 months. The dose in Part B starts at 12g and may be adjusted based on ongoing potassium monitoring. Throughout the study, researchers measure serum potassium levels, focusing on average levels during the 28-day maintenance phase. Participants will undergo regular blood tests and health assessments to monitor potassium and overall safety. The study also includes tracking any side effects and adjusting treatment as needed. The total duration for participants entering Part B may extend up to nearly a year, including the initial phases and the long-term extension.

Researchers are evaluating the effectiveness and safety of TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. The study focuses on adults aged 18 to 75 years with chronic rhinosinusitis and nasal polyps (CRSwNP), a condition involving persistent nasal symptoms and polyps in both nostrils. This is a Phase III clinical trial designed to assess improvements in nasal polyp size and nasal congestion over 24 weeks. Participants will be randomly assigned to receive either TQC2731 injection or a placebo. The study involves monitoring the nasal polyp score (NPS) and nasal congestion score (NCS) from baseline through 24 weeks to evaluate changes. Both groups will continue using a stable dose of intranasal corticosteroids during the study. The trial is double-blind and placebo-controlled, ensuring that neither participants nor researchers know which treatment is given. During the study, participants will undergo nasal endoscopy to assess polyp size and daily or weekly symptom scoring for nasal congestion. Researchers will track adherence to nasal spray use and symptom recording through electronic diaries. Safety will be monitored throughout, and participants will be followed for 24 weeks to measure changes in nasal polyp and congestion scores as primary outcome measures.

This research focuses on adults with bronchiectasis who are affected by Pseudomonas aeruginosa (PA) infections. The ERASE II study follows up on an earlier trial that tested the safety and effectiveness of Tobramycin Inhalation Solution to eradicate PA. The goal is to see how successfully removing PA impacts the long-term health outcomes of these patients, including quality of life and lung function. The study includes an initial 9-month period from the original ERASE trial, followed by an additional 27 months of observation, totaling 36 months. During this extended follow-up, no new interventions are given; instead, patients are monitored to track their health status, including any recurrence of PA infection and related complications. Participants will have their lung function, quality of life, number of lung flare-ups, hospital stays, and treatment costs regularly assessed. Researchers will also monitor sputum samples at multiple points up to 15 months to check for PA eradication. This comprehensive monitoring aims to understand the lasting effects of PA removal on bronchiectasis progression and patient well-being over three years.

Researchers are studying the effects of normobaric oxygen (NBO) therapy on patients who have experienced an acute ischemic stroke (AIS) and are transferred for endovascular thrombectomy (EVT). The goal is to assess the safety and effectiveness of NBO in improving functional outcomes three months after stroke. Stroke is a major cause of death and disability worldwide, and while treatments like mechanical thrombectomy can improve blood flow, less than half of patients with large vessel occlusion achieve good recovery. NBO offers potential brain protection by improving oxygen delivery to affected areas and reducing damage through multiple mechanisms. Participants will receive either inhaled 100% oxygen (NBO) or best medical care without NBO. The study focuses on patients transferred for EVT who meet specific stroke severity and imaging criteria. NBO treatment is delivered through oxygen inhalation, aiming to increase oxygen availability to the brain before reperfusion. The study is conducted in a Phase 3 setting and compares outcomes between those receiving NBO and those receiving standard care. During the study, participants will be monitored for disability levels using the modified Rankin scale at 90 days and one year after treatment. Assessments include neurological exams and imaging to confirm stroke details and severity. Researchers will also track safety and functional outcomes to evaluate the impact of NBO therapy. Participants are followed for at least three months after randomization to observe recovery and potential benefits.