Chi Zhou Shi

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Researchers are establishing a standardized clinical information database for liver cancer patients through a collaborative effort led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China (USTC). This database aims to support high-quality real-world clinical studies and research on hepatocellular carcinoma and related liver cancers. Participants may receive routine treatments such as surgical operations including resection, ablation, transarterial chemoembolization (TACE), and hepatic arterial infusion chemotherapy (HAIC). They might also be treated with various anti-tumor drugs including immunologic, targeted, and chemotherapy medications. Treatments and clinical data are collected to enrich the database for future research. During the study, participants will provide blood samples and postoperative pathology residual samples and will be followed over time to monitor their health and treatment outcomes. The primary outcome measured is overall survival over 10 years. Participants must be willing to comply with follow-up visits and provide informed consent, ensuring comprehensive data collection for long-term analysis.

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 evaluating how a vaccine chatbot affects parents' awareness, knowledge, willingness, and vaccination status regarding HPV vaccines for their middle school daughters in China. This study is a cluster randomized trial involving female students in junior middle school and their parents. It aims to assess whether the chatbot improves HPV vaccine awareness and vaccination rates compared to no chatbot use. The study also examines how well the chatbot is accepted and explores factors that help or hinder its promotion. The intervention involves inviting parents in the intervention group to use an HPV vaccine chatbot online via WeChat or web browsers for two weeks. They can ask any HPV vaccine-related questions and receive immediate validated answers from a database based on official and expert sources. Invitations to use the chatbot are sent every four days during the two-week period. The control group does not use the chatbot. The study includes about 1,800 parents divided equally between intervention and control groups across multiple cities and schools. Participants complete a baseline survey before the intervention, followed by a two-week intervention period for the chatbot group. A follow-up survey occurs two weeks after baseline, and HPV vaccination status of the female students is collected four months after baseline. Researchers use statistical methods to analyze the chatbot's effect, and they also evaluate its cost-effectiveness, adoption, and implementation in real-world settings using both quantitative and qualitative approaches.

Researchers are investigating whether managing body temperature during surgery can reduce the risk of delirium and improve long-term survival in older adults undergoing major cancer surgery. Intraoperative hypothermia, or lowered body temperature during surgery, is common and linked to complications such as postoperative delirium, immune suppression, and potentially increased cancer recurrence. This study focuses on patients aged 65 and older undergoing major cancer operations lasting two or more hours under general anesthesia. The study compares two approaches to temperature management during surgery. One group receives routine care where warming devices are only used if body temperature drops below 35.56C. The other group gets targeted temperature management, including pre-warming with forced-air covers and heated blankets before anesthesia and active warming throughout surgery to maintain a temperature near 36.86C. Intravenous fluids are warmed, and multiple warming devices may be used to keep patients comfortably warm. Participants will be monitored for delirium during the first four days after surgery and for progression-free survival up to three years following surgery. Researchers will assess thermal comfort, shivering, emergence delirium, and blood transfusion rates. The study includes regular temperature checks, cognitive assessments, and long-term follow-up to gather data on recovery quality, complications, and cancer outcomes.

Researchers are evaluating the safety, effectiveness, and how the body processes a single oral dose of GP681 in patients aged 12 and older who have influenza and are at high risk for influenza complications. This Phase III clinical trial compares GP681 tablets to placebo tablets to better understand their impact on influenza symptoms in this vulnerable population. Participants will receive either two 20mg GP681 tablets or matching placebo tablets as a single oral dose. The study specifically focuses on patients diagnosed with influenza within 48 hours of symptom onset who meet criteria for being at high risk of complications due to conditions such as asthma, diabetes, heart disease, or age 65 and older. The treatments are administered once, and the trial is conducted under a randomized, double-blind, placebo-controlled design. During the study, participants will be monitored for the time it takes for their influenza symptoms to improve, up to 15 days after dosing. Researchers will assess symptom severity, fever, and other influenza-related signs while participants maintain a health diary. Safety evaluations and other clinical assessments will ensure monitoring of any adverse effects. The total participation duration covers the treatment and follow-up period needed to evaluate outcomes and safety.