En Shi Tu Jia Zu Miao Zu Zi Zhi Zhou

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 the effectiveness, safety, and pharmacokinetics of roflumilast cream 0.3% for treating plaque psoriasis in Chinese individuals aged 6 years and older. This is a phase III, multicenter, randomized, double-blind study comparing roflumilast cream to a vehicle cream. Participants must have a clinical diagnosis of plaque psoriasis with a certain severity and stable disease for a defined period. Participants will be randomly assigned to receive either roflumilast cream 0.3% or vehicle cream. The treatment duration is 8 weeks, during which participants will apply the assigned cream as directed. The study excludes those who have recently used certain systemic or topical psoriasis treatments or biologics, and those with other skin conditions that could interfere with the assessment. During the study, participants will undergo assessments including clinical evaluations of psoriasis severity using Investigator Global Assessment (IGA) scores and Psoriasis Area and Severity Index (PASI) scores. Safety will be monitored through medical history, physical exams, laboratory tests, and pregnancy tests for females of childbearing potential. The primary outcome is the proportion of participants achieving treatment success based on IGA scores after 8 weeks. Participants will be followed throughout the study to monitor treatment effects and safety.

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.

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.