Yi Chun Shi

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

This research aims to develop a screening and diagnostic pathway that integrates digital cognitive tools and blood biomarkers for early detection of Alzheimer's disease (AD)-related cognitive impairment in community populations. Alzheimer's disease accounts for 60-80% of dementia cases worldwide, with a growing global burden, especially in aging populations and low- to middle-income countries. Early detection during the long preclinical phase presents opportunities for timely intervention, and new screening methods are needed to improve accuracy, efficiency, and scalability in community settings. The study proposes a two-step screening approach. The first step involves rapid digital pre-screening including the SCD-9 questionnaire to capture subjective cognitive complaints, a digital cognitive test called PCAT, and a predictive model estimating future dementia risk in cognitively normal individuals. The second step confirms AD pathology using multiple blood-based biomarkers such as p-tau217, p-tau181, and A2/40, measured by various assay platforms. This nationwide, multicenter study will take place in six regions across China and include a total of 6,000 participants aged 50 and above. Participants will undergo cognitive assessments, questionnaires, and blood tests to evaluate cognitive function and AD pathology. The study will measure the sensitivity and specificity of the screening and diagnosis program, along with completion rates, time to completion, community feasibility, compliance, and health-economic outcomes. Clinical Dementia Rating by qualified physicians and amyloid PET scans serve as gold standards for cognitive impairment and AD pathology, respectively. Data analysis will follow established statistical and health economics methods to assess program effectiveness and feasibility.

Researchers are evaluating the safety and effectiveness of giving tirofiban early to patients who have received tenecteplase for acute ischemic stroke. This phase 3 study addresses the problem of reocclusion that happens in 14-34% of patients after thrombolysis, likely due to platelet activation. The goal is to see if adding tirofiban soon after tenecteplase can reduce this risk and improve patient outcomes. Participants will be randomly assigned to receive either a continuous intravenous infusion of tirofiban or a placebo. The infusion starts at 0.3 micrograms per kilogram per minute for 30 minutes, followed by 0.075 micrograms per kilogram per minute for 47.5 hours, beginning within 4 to 24 hours after tenecteplase treatment. Aspirin and/or clopidogrel placebos are given orally 24 hours after tenecteplase, with actual antiplatelet therapy starting at 44 hours and continuing until 90 days after randomization. During the study, participants are monitored for neurological function changes and safety. The main outcome measured is excellent functional recovery 90 days after randomization. The study includes neurological assessments, imaging tests, and laboratory evaluations. Participants are followed for 90 days to observe treatment effects and any adverse events.

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.