Chi Zhou Shi

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating 9MW1911 in adults aged 40 to 75 who have been diagnosed with Chronic Obstructive Pulmonary Disease COPD for at least one year. This Phase II clinical trial is designed to assess how well 9MW1911 works and how safe it is for treating COPD. The study compares two different doses of 9MW1911 given intravenously with a placebo, and aims to better understand treatment effects on COPD flare-ups and lung function. Participants receive intravenous infusions of either 9MW1911 in one of two dose levels or a placebo every 28 days. Each treatment group includes 120 patients, all receiving stable standard care for COPD. The study lasts for 52 weeks of treatment, followed by safety and immune response monitoring up to 60 weeks. Researchers measure lung function, COPD exacerbations, quality of life, and other health markers during this period. During the study, participants will have regular visits for lung function tests, questionnaires about COPD symptoms and quality of life, blood tests, and safety assessments. These assessments occur at multiple time points, such as weeks 0, 4, 8, 12, 24, 36, and 52. The main outcome is the rate of moderate to severe COPD exacerbations over one year. Additional measures include lung function changes, time to first exacerbation, and biological markers. Safety and tolerability are followed for up to 60 weeks to ensure participant well-being throughout the trial.

Researchers are evaluating the efficacy and safety of two inhalers, BDA MDI budesonide and albuterol and AS MDI albuterol sulfate, in reducing severe asthma attacks among symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter study involves about 1000 participants who have been diagnosed with asthma and continue to experience symptoms despite maintenance therapy. Participants will be randomly assigned to receive either BDA MDI 160180 mcg two puffs of 8090 mcg or AS MDI 180 mcg two puffs of 90 mcg as needed to relieve asthma symptoms or before exercise. The study includes a screening period lasting 14 to 28 days, followed by a treatment period of at least 24 weeks and up to 52 weeks, and concludes with a safety follow-up about two weeks after the last treatment visit. During the trial, participants will attend regular visits to monitor their asthma control and lung function. Researchers will assess the time to the first severe asthma exacerbation, the rate of exacerbations, steroid use, and responses to asthma control questionnaires. Safety will be carefully followed during and after treatment, with the total participation lasting up to approximately one year.

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

Researchers are studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are establishing a standardized clinical database for patients with liver cancer, including hepatocellular carcinoma and related types, to support high-quality real-world clinical studies. This observational study is led by the Department of Hepatobiliary Surgery at the First Affiliated Hospital of the University of Science and Technology of China USTC in collaboration with multiple centers nationwide. The purpose is to collect detailed clinical information to better understand liver cancer outcomes over time. Participants will receive routine clinical treatments for liver cancer, such as surgical resection, ablation, transarterial chemoembolization TACE, hepatic arterial infusion chemotherapy HAIC, and various anti-tumor drugs including immunologic, targeted, and chemotherapy agents. The study observes and records these standard treatments without assigning interventions. The research will track these patients in a cohort database to monitor their treatment and progression. During the study, participants will be followed for up to 10 years to assess overall survival, recurrence-free survival, and survival time after cancer recurrence. Researchers will collect blood and surgical tissue samples and perform regular follow-up visits to gather clinical data and pathology results. This long-term monitoring aims to provide comprehensive insights into liver cancer progression and treatment outcomes.

Researchers are investigating the effects of amlodipine alone versus amlodipine combined with folic acid in Chinese adults aged 45 to 74 years who have H-type hypertension, specific MTHFR 677 genotypes CC or CT, elevated plasma homocysteine levels, and low serum folate. This large, multi-center, randomized, double-blind, double-dummy clinical trial aims to evaluate which treatment better reduces the risk of first ischemic stroke over five years. Participants are first screened and then enter a 2 to 4 week run-in period where they take amlodipine to assess tolerance and compliance. Afterward, eligible participants are randomized by genotype into two groups one receiving amlodipine 5mg daily with a placebo, and the other receiving amlodipine 5mg combined with 0.8mg folic acid daily with a placebo. Other blood pressure medications may be added as needed to reach target blood pressure goals. Follow-up visits occur every three months during the five-year treatment period with medication provided at each visit. Throughout the study, participants undergo interviews, clinical evaluations, and laboratory tests including genetic and blood analyses. Researchers monitor adherence, blood pressure, and cardiovascular health. The main outcome measured is the occurrence of first ischemic stroke by the end of five years. Secondary outcomes include other cardiovascular events and kidney function. Two interim analyses will be conducted during the study to assess progress and safety.

Researchers are evaluating the effects of different amlodipine-based treatments on the risk of first ischemic stroke in Chinese adults aged 45 to 74 years with hypertension and the MTHFR 677 TT genotype. This large, multi-center, randomized, double-blind, triple-dummy controlled trial aims to compare amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate over a 5-year period. The study focuses on preventing ischemic stroke as the primary outcome. Participants first undergo a screening period to confirm eligibility through interviews, clinical evaluations, and lab tests. Those who qualify enter a 2 to 4 week run-in phase with daily amlodipine to check treatment tolerance and compliance. Eligible participants are then randomly assigned to one of three daily oral treatment groups amlodipine alone, amlodipine folic acid, or amlodipine folic acid plus 5-MTHF. Additional antihypertensive medications may be added as needed to control blood pressure. Participants are followed every 3 months for drug distribution and monitoring. Throughout the study, participants will have regular clinical visits, interviews, and biological sample collections to monitor health and treatment effects. Researchers will track the incidence of first ischemic stroke and other cardiovascular and kidney outcomes over five years. Safety and treatment adherence are carefully observed, with two planned interim analyses during the trial. Total participation spans from initial screening through five years of treatment and follow-up.

Researchers are studying the effects of managing body temperature during major cancer surgery in older patients aged 65 and above. The trial focuses on whether keeping patients at normal body temperature during surgery can reduce the chance of postoperative deliriuma condition with sudden confusion and attention problems that can worsen recovery and long-term health. The study also looks at whether temperature management can improve long-term cancer outcomes by possibly reducing cancer recurrence and related complications. Participants are randomly assigned to one of two groups. One group receives routine thermal management with warming measures activated only if body temperature drops below 35.5C during surgery. The other group undergoes targeted temperature management, involving pre-warming before anesthesia with forced-air covers and heated blankets, continuous warming during surgery, and warmed intravenous fluids to maintain a target temperature near 36.8C. Both approaches aim to keep patients warm but differ in timing and intensity of warming measures. During the study, participants are monitored for delirium occurrence within 4 days after surgery as the primary outcome. Researchers also assess thermal comfort, shivering intensity, emergence delirium shortly after surgery, and blood transfusion needs. The trial includes follow-up to evaluate progression-free survival over the long term. The study involves regular temperature monitoring and clinical assessments in the perioperative period, with total participation spanning surgery and postoperative recovery phases.

Researchers are evaluating the safety, effectiveness, and how the body processes a single oral dose of GP681 compared to a placebo in people aged 12 and older who have influenza and are at high risk for complications. This Phase III clinical trial aims to better understand the impact of GP681 on influenza symptoms and viral activity in this vulnerable population. Participants will be randomly assigned to receive either a 40mg oral dose of GP681 tablets or a matching placebo tablet. This is a double-blind, placebo-controlled study, meaning neither the participants nor the researchers know who receives the actual drug or placebo. The study will measure outcomes such as the time it takes for influenza symptoms to improve and changes in viral RNA levels over a 15-day period. During the study, participants will be monitored closely with symptom evaluations, virus testing at multiple time points, and assessments of fever resolution and influenza-related complications. They will keep health diaries and attend study visits for up to 15 days to track their recovery and any side effects. Safety and efficacy data will be collected throughout this period to assess the impact of GP681 compared with placebo.