Sui Zhou Shi

Researchers are evaluating the effects of different doses of colchicine on cardiovascular health in Chinese patients with coronary heart disease CHD who have undergone percutaneous coronary intervention PCI. This phase 3, multicenter, prospective, randomized, controlled, double-blind study aims to determine whether long-term colchicine treatment reduces cardiovascular events and to assess the safety of these doses in this population. The study addresses the uncertainty about the standard colchicine doses suitability for Chinese patients due to differences in body weight and lack of large-scale evidence in China. Participants will be randomly assigned to one of three groups colchicine 0.5 mg daily, colchicine 0.375 mg daily, or placebo, each taken as one oral pill per day. The study includes follow-up visits at months 1, 6, 12, 18, 24, and continuing every six months thereafter, with phone assessments alternating every three months. All participants will also receive standard treatments for CHD such as antiplatelets and management of related conditions according to national guidelines. Cardiovascular events and safety data will be regularly monitored by independent committees, with an interim analysis planned once about half of the primary endpoints have occurred. Participants will be involved in scheduled visits and phone calls to monitor health status and collect information on cardiovascular events and adverse effects for an estimated 2 to 4 years. The main outcome measured is a combination of cardiovascular death, nonfatal heart attack, stroke, and ischemia-driven revascularization. Secondary outcomes include various cardiovascular events and overall mortality. Safety will be overseen by a Data and Safety Monitoring Board, and all suspected cardiovascular events will be reviewed by a blinded Clinical Event Committee to ensure accurate assessment throughout the study period.

Researchers are evaluating an artificial intelligence-based multimodal cognitive screening system to identify mild cognitive impairment MCI related to diabetes early in patients with type 2 diabetes mellitus T2DM. This observational study follows participants for 3 to 5 years to assess the systems accuracy and feasibility. The study also explores how diabetic metabolic indicators, such as glycemic variability and HbA1c levels, relate to changes in cognitive function, aiming to improve early detection and intervention for cognitive decline in T2DM patients. Participants are observed without additional interventions over the 3 to 5 years of follow-up. The study includes groups of participants with normal cognition and those with mild cognitive impairment. Cognitive status data are collected at the beginning and end of the study period, with no study drug or treatment administered. During the study, participants undergo cognitive assessments and monitoring of diabetic metabolic factors. Researchers measure the accuracy of the AI screening system in early detection and track the rate of cognitive decline over the follow-up period. The study also evaluates the predictive value of combining multiple types of data. Participants remain under observation with regular assessments, helping to understand the relationship between diabetes and cognitive changes over time.

Nausea and vomiting in pregnancy NVP is a common and challenging problem during the first trimester, affecting the quality of life for many pregnant women. This research aims to evaluate the clinical effectiveness and safety of thumbtack needle TN therapy, a type of acupuncture, for treating NVP. The study is a multi-center, large-sample, randomized, controlled, and triple-blinded clinical trial designed to provide high-quality evidence on this treatment. The trial compares thumbtack needle therapy with a sham thumbtack needle treatment. TN involves applying small intradermal needles to specific acupuncture points, which are kept in place for 3 days with patients pressing the needles multiple times daily. Treatments occur every 3 days for a total of 5 sessions over 15 days. The sham treatment mimics the procedure without actual needle penetration and without pressing during retention. Participants will be closely monitored throughout the study with assessments including nausea and vomiting severity, quality of life, anxiety, depression, sleep quality, weight changes, blood tests for electrolytes, liver and kidney function, thyroid hormones, and pregnancy and neonatal outcomes. Safety and patient satisfaction will also be evaluated. The primary outcome is the change in nausea and vomiting severity measured by the PUQE scale from baseline to day 15. Follow-up continues up to 42 days postpartum to observe pregnancy complications and neonatal health.