Chen Zhou Shi

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the devices performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.

Researchers are evaluating the safety and performance of the Choydar flow-directed mesh stent in treating unruptured intracranial aneurysms, which are bulging blood vessels in the brain that have not burst. This observational study is conducted in a real-world setting to observe how well the device works without additional interventions. The study is sponsored by Johnson & Johnson Medical Shanghai Ltd. and focuses on participants with specific aneurysm types and sizes in certain brain arteries. Participants will receive the Choydar flow-directed mesh stent according to its approved instructions. No other treatments are part of this study. The procedure targets wide-neck saccular or fusiform aneurysms in the internal carotid or vertebral arteries, with parent artery diameters between 2.0 and 6.0 millimeters. The study observes participants through a 12-month follow-up period after the procedure to assess success and safety. During the study, participants will be assessed at several points including the day of the procedure and at 12 months afterward. Researchers will monitor outcomes such as aneurysm occlusion rates, technical success of the procedure, re-treatment rates, functional neurological status, and any major ischemic, hemorrhagic events, or deaths. The study involves imaging and clinical evaluations to measure these outcomes and ensure participant safety throughout the follow-up period.

Researchers are evaluating whether Extract of Ginkgo Biloba Leaves Tablets can improve memory and thinking skills in people aged 55 and older who have had an ischemic stroke caused by a blocked blood vessel in the brain. This study also looks at the safety of taking these tablets alongside usual post-stroke treatments. Participants must have had a stroke confirmed by MRI within 7 to 14 days before joining the study and have mild cognitive impairment after their stroke. Participants will be randomly assigned to one of two groups one group will take 240 mg of Extract of Ginkgo Biloba Leaves Tablets daily for 12 months in addition to their usual stroke care, while the other group will receive only their usual care without the tablets. The study will take place at hospitals across China and will last for 52 weeks for each participant. Throughout the study, participants will visit the clinic at 4, 26, and 52 weeks after starting treatment for checkups and tests, including brain scans, cognitive assessments such as the Montreal Cognitive Assessment and other neuropsychological tests, and evaluations of neurological function. Follow-up phone calls will occur at 12 and 38 weeks to monitor health and any new stroke events. Researchers will measure changes in thinking, memory, cognitive speed, verbal skills, and neurological status to understand the tablets effects and safety over time.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating the clinical effects and safety of Sodium Oligomannate GV-971 for treating mild to moderate Alzheimers Disease. This Phase 4 study aims to confirm how GV-971 works, monitor known side effects over long-term use, and identify any new adverse reactions to provide improved clinical guidance. Participants are randomly assigned to receive either GV-971 or a placebo, both given by mouth. The study lasts 36 weeks and uses a double-blind design where neither participants nor researchers know which treatment is given, ensuring unbiased results. The trial involves multiple centers and compares the two groups in parallel. During the study, participants will undergo assessments of cognitive and functional abilities using tools like ADAS-cog12 and ADCS-ADL23 at the start and after 36 weeks. Additional measures include MMSE, CIBIC-Plus, and NPI scores. Safety is monitored throughout, and the study tracks any adverse events. The total participation time is about 36 weeks from baseline.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating a standardized full-course extracorporeal membrane oxygenation ECMO management pathway for adults with moderate-to-severe acute respiratory distress syndrome ARDS in China. The study aims to address challenges in ECMO care, such as inconsistent clinical practices, low weaning success, and high complication rates. It focuses on creating a reproducible and evidence-based management strategy to improve the quality and outcomes of ECMO treatment nationwide. The study includes developing a multidisciplinary consensus-based ECMO management pathway covering all stages from assessment and initiation to maintenance, complication prevention, weaning, rehabilitation, and follow-up. Patients treated before pathway implementation receive usual care based on local protocols, while those treated after follow the standardized pathway with individualized adjustments allowed. The study uses a real-world, before-and-after design conducted across multiple centers. Participants undergo ECMO treatment as part of their care, with data recorded on key parameters and deviations from the pathway through an intelligent platform. Regular multidisciplinary reviews analyze outcomes, process barriers, and adverse events to enable continuous pathway improvement. The primary outcome measured is 90-day all-cause mortality after ECMO initiation. Secondary outcomes include mortality at 28 days, liberation from mechanical ventilation, ICU and hospital mortality and length of stay, respiratory support needs, and ECMO-related complications. The study runs from screening through treatment and follow-up with continuous data feedback until February 2030.

Researchers are investigating the use of lisaftoclax combined with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL who have previously been treated with BTK inhibitors. This global, open-label, phase III study aims to evaluate the effectiveness and safety of this combination compared to BTK inhibitor alone in patients who have been on BTK inhibitor monotherapy for at least 12 months. About 440 participants will be randomly assigned to one of two groups one will receive lisaftoclax together with a BTK inhibitor, and the other will receive only a BTK inhibitor. The study uses a parallel design where participants are allocated equally to each treatment arm to compare outcomes clearly. Both treatments are administered under medical supervision, and the study is open-label, meaning both the researchers and participants know which treatment is given. Participants will be assessed regularly over the course of the study, with evaluations including disease progression measured at 12 months and overall survival also tracked at 12 months. Eligibility screening includes assessments of performance status, bone marrow, kidney, and liver function, as well as consent to follow the study schedule. The research team monitors safety and treatment effects throughout the trial, which is expected to complete by late 2027.