Sui Zhou Shi

Researchers are studying the effects of different doses of colchicine, a drug recently recommended by the U.S. FDA for treating coronary heart disease (CHD), in Chinese patients who have undergone percutaneous coronary intervention (PCI). Since colchicine is not yet approved for CHD treatment in China and the standard dose may not suit the lower body weight typical in East Asian populations, this Phase 3, multicenter, randomized, double-blind study aims to assess the drug's efficacy and safety in reducing cardiovascular events in this group. Participants will be randomly assigned to one of three groups receiving either colchicine 0.5 mg daily, colchicine 0.375 mg daily, or a placebo pill once a day. The study includes follow-up visits at 1, 6, 12, 18, and 24 months after randomization, with additional phone assessments every three months. All participants will continue standard medical care for heart disease as per national guidelines, and safety and effectiveness will be carefully monitored throughout the study. During the study, researchers will track cardiovascular events such as heart-related death, heart attack, stroke, and procedures to restore blood flow, over an estimated period of 2 to 4 years. Safety and adverse events will be assessed regularly every three months. A Clinical Event Committee blinded to treatment assignment will review all suspected cardiovascular outcomes, while an independent Data and Safety Monitoring Board will oversee safety data, including an interim analysis when half of the expected events have occurred.

Researchers are evaluating an artificial intelligence-based multimodal cognitive screening system designed to identify mild cognitive impairment related to type 2 diabetes mellitus (T2DM) early on. This observational study focuses on patients aged 40 to 75 years who have memory complaints and aims to determine how well the AI system can detect cognitive changes over a 3 to 5 year follow-up period. The study also examines the relationship between diabetic metabolic indicators, such as glycemic variability and HbA1c levels, and changes in cognitive function to assess the value of early detection and intervention in these patients. Participants will undergo follow-up observation for 3 to 5 years without additional interventions. Cognitive status data will be collected at the start of the study and at the end of the follow-up period to monitor changes over time. No medications or treatments will be administered as part of the study; the focus is solely on observing cognitive function and diabetes-related metabolic factors. During the study, participants' cognitive abilities will be regularly assessed using the AI screening system. Researchers will collect data on cognitive deterioration rates and the accuracy of early identification by the AI tool. The study includes monitoring participants' ability to perform daily activities and tracking memory-specific deficits, with follow-up lasting up to five years to capture long-term cognitive outcomes and safety.

Nausea and vomiting during pregnancy (NVP) is a common and challenging problem in the first trimester that significantly affects the quality of life of pregnant women. Current treatments are limited due to concerns about drug safety for the embryo and discomfort associated with traditional acupuncture methods. This study evaluates the clinical efficacy and safety of thumbtack needle (TN), a type of shallow puncture intradermal needle, as a treatment for moderate to severe NVP. The trial is a multi-center, large-sample, randomized, controlled, and blinded clinical study designed to provide high-quality evidence on TN's effects on nausea, vomiting, quality of life, anxiety, depression, and various pregnancy and neonatal outcomes. Participants receive either real thumbtack needle treatment or a sham thumbtack needle that looks similar but lacks the needle body and stimulation. The TN is applied to specific acupoints and retained for 3 days before removal and reapplication by a doctor, with a total of five treatments over 15 days. The sham treatment group follows the same schedule and procedures without the needle effect. This approach aims to compare the effects of continuous and stable stimulation by TN against a placebo-like control. During the study, participants are assessed for changes in nausea and vomiting using the Pregnancy Unique Quantification of Emesis (PUQE) scale from baseline to day 15. Researchers also monitor weight changes, anxiety and depression levels, blood electrolyte levels, liver and kidney function, thyroid function, use of intravenous fluids and additional drugs, hospital admissions, pregnancy complications, and both pregnancy and neonatal outcomes. Safety and adherence are closely observed throughout the 15-day treatment period.