En Shi Tu Jia Zu Miao Zu Zi Zhi Zhou

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 two different neoadjuvant treatment strategies for adults with muscle-invasive bladder cancer MIBC that expresses the HER2 protein. The study aims to compare disitamab vedotin RC48 combined with gemcitabine versus disitamab vedotin combined with toripalimab before surgery, focusing on the rate of complete tumor removal confirmed by pathology. This is a Phase 3 trial designed to assess if the two treatment approaches are similarly effective in this setting. Participants will be randomly assigned to one of two groups one receives disitamab vedotin plus gemcitabine, and the other receives disitamab vedotin plus toripalimab. Both treatments are given intravenously every two weeks for 3 to 6 cycles, depending on tumor response seen in imaging after the initial 3 cycles. After completing neoadjuvant therapy, all patients undergo radical cystectomy with pelvic lymph node dissection within four weeks. Those eligible will then receive additional adjuvant therapy with disitamab vedotin plus toripalimab for 6 cycles, followed by up to one year of toripalimab maintenance therapy. During the study, participants will have regular imaging scans of the abdomen, pelvis, and chest every 3 to 6 months after surgery, or cystoscopy and imaging if bladder-sparing treatment is chosen. Study staff will contact participants every 3 months to track imaging results and symptoms such as hematuria or respiratory issues, and to document any cancer recurrence or progression. The primary outcome is the pathological complete response rate measured shortly after surgery. Safety is monitored through tracking treatment-related adverse events during neoadjuvant therapy. The total study duration is up to 3 years from start to completion.

Researchers are evaluating normobaric hyperoxia NBO as a treatment for patients who have experienced an acute ischemic stroke and are transferred for endovascular thrombectomy EVT. The study aims to assess the effectiveness and safety of NBO in improving functional outcomes at 3 months after stroke. Stroke is a leading cause of death and disability, and although reperfusion treatments like thrombectomy improve blood flow, less than half of patients achieve favorable recovery. NBO is thought to protect the brain by rescuing hypoxic tissue and reducing damage processes, with advantages such as low cost and easy use. Participants will be randomly assigned to receive either NBO, which involves inhaling 100% oxygen alongside the best medical care, or best medical care alone. The study compares these two groups to see if NBO provides additional benefits. The treatment is given during the acute phase before or during transfer for EVT. The study includes a single-blind design and follows patients for outcomes over time. During the study, participants will have their disability level measured using the modified Rankin Scale at 90 days and one year after randomization. Other assessments include neurological function scores, imaging scans, infarct volume changes, and quality of life questionnaires at various time points. Safety and recovery progress are closely monitored throughout, with follow-up visits to track long-term effects. The total participation duration includes initial treatment and follow-up through one year.

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.

Researchers are evaluating the safety and effectiveness of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III clinical trial where 660 participants with asthma are randomly assigned to receive either TQC2731 or a placebo. The study aims to see if TQC2731 can reduce asthma worsening episodes over one year compared to placebo. Participants receive either the TQC2731 injection or placebo every four weeks for up to 48 weeks through subcutaneous injection. The treatment cycles repeat monthly from the start until Week 48. The study compares these two groups to assess the impact on asthma symptoms and lung function. Throughout the trial, participants will have regular assessments including lung function tests, asthma symptom diaries, quality of life questionnaires, and blood tests for inflammation markers and immune response. Researchers track the number of asthma exacerbations during the 52 weeks of treatment and up to 64 weeks for some outcomes. Safety and immune reactions are monitored carefully. The total study duration for each participant is about one year of treatment plus follow-up.