Anshan

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

Researchers are conducting the China Cognition and Aging Study China COAST to understand dementia and its subtypes in China, including mild cognitive impairment MCI, sporadic and familial Alzheimers disease SAD and FAD, vascular dementia VaD, and other types. This large, national, multi-center, longitudinal observational study aims to build a comprehensive database to improve diagnosis, study the causes and genetic features, monitor disease progression, and evaluate prevention and treatment strategies, including non-drug interventions. The study also focuses on education, stigma, and management of dementia in the Chinese population. Participants include individuals with MCI, SAD, FAD, VaD, normal cognitive function, and other dementias recruited from both community and hospital populations. Researchers collect detailed demographic, clinical, genetic, imaging, and biological sample data. Study procedures include clinical evaluations, neuropsychological tests, imaging such as PETMR scans, and fluid biomarker analysis. The study follows participants through repeated assessments every 2 to 3 years, tracking changes from normal cognition to MCI and dementia, and exploring risk and protective factors. Participants engage in baseline and follow-up visits involving cognitive and mental health assessments using standardized scales like MMSE, MoCA, and CDR. Genetic analyses and biomarker measurements support diagnosis and disease understanding. The study also conducts randomized controlled trials of non-pharmacological treatments and education programs aimed at improving dementia awareness and care. Safety monitoring and informed consent are carefully managed, with ongoing follow-up to track disease progression and effects of interventions over time.

Researchers are conducting a large observational study called the China HeadAche Disorders Registry CHAIRS to better understand primary headaches and medication-overuse headaches MOH in patients aged 12 years and older. The study aims to collect detailed information including biomarkers, brain imaging, cognitive and genetic data, as well as social, demographic, medical, and treatment-related data. Long-term follow-up is planned to observe outcomes related to headache disorders over many years. Participants include those with various types of primary headaches such as migraine, tension-type headache, new daily persistent headache, and MOH. The study includes behavioral follow-up visits at multiple time points monthly for the first 18 months, then at 24 months, and annually thereafter. Some participants are observed during routine clinical use of treatments like Yangxue Qingnao Granules, Erenumab, and Eptinezumab, with treatment decisions made by their physicians and outcomes tracked over 12 weeks or longer. Throughout the study, participants undergo periodic assessments including MRI scans, cognitive tests like the Montreal Cognitive Assessment MoCA and Mini-Mental State Exam MMSE, and questionnaires evaluating headache impact, anxiety, depression, quality of life, sleep quality, and fatigue. Data on headache frequency, severity, medication use, and biological samples are collected. Follow-up can extend up to 10 years, allowing researchers to monitor long-term changes and outcomes related to headache disorders and treatments.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

This research aims to evaluate whether combining cold atmospheric plasma CAP therapy with endovascular intervention can speed up wound healing and improve safety in adults aged 18 to 80 with diabetic foot ulcers DFUs complicated by lower extremity arterial blockage. The study compares CAP treatment plus standard care to placebo sham CAP plus standard care to investigate if CAP leads to greater ulcer area reduction and fewer adverse local symptoms. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. Participants receive either active CAP therapy or sham CAP therapy once daily for 10 days following successful balloon angioplasty of infrapopliteal arteries. CAP treatment involves applying CAP-activated gas for 25 minutes per session using a specialized device. Sham CAP uses identical equipment without plasma activation to maintain blinding. All participants continue to receive guideline-based standard diabetic foot ulcer care throughout the study. During the study, participants undergo daily wound assessments to measure ulcer size, infection signs, and pain levels. Quality of life questionnaires EQ-5D and SF-12 are completed at the start and at Week 4. The main outcome measured is the change in ulcer area from baseline through Day 10 and Week 4. Researchers also monitor pain scores, time to early healing, quality of life changes, and local adverse events. The study follow-up period is 4 weeks after randomization to evaluate efficacy and safety outcomes.

Critical limb ischemia is a severe form of peripheral arterial disease often seen in patients with diabetes, leading to painful ulcers, tissue damage, and sometimes amputation. This study investigates the use of cold atmospheric plasma CAP combined with endovascular intervention to treat diabetic foot ulcers complicated by lower extremity arterial occlusion. The study aims to assess whether this combination can improve healing outcomes and provide safer, more effective care for patients facing high risks from current therapies. Participants will receive successful infrapopliteal angioplasty to restore blood flow in affected arteries. They will then be randomly assigned to receive either CAP therapy or a sham procedure. CAP treatment involves daily sessions for the first five days, followed by every other day for a total of 13 sessions, each lasting about 25 minutes. The CAP device delivers ozone-rich plasma followed by nitric oxide-rich plasma to promote disinfection and healing. The sham procedure mimics the treatment sounds without producing plasma, ensuring blinding. Throughout the 21-day study period, researchers will monitor ulcer size, time to reduction, infection signs, pain levels, and quality of life using questionnaires. Safety will be tracked by recording skin irritation, bleeding, and burning sensations. Assessments include vascular imaging and clinical evaluations to measure treatment effects on wound healing and blood flow, with the goal of gathering evidence for CAPs role alongside endovascular techniques in diabetic foot care.

Researchers are evaluating the safety and effectiveness of a renal artery radiofrequency ablation system guided by a three-dimensional cardiac electrophysiological mapping system for treating essential hypertension. This prospective, multi-center, randomized controlled trial includes both drug-control and sham-control studies to provide evidence for product registration, marketing, and clinical use. The study involves adults aged 18 to 70 with uncontrolled essential hypertension despite medication. Participants are assigned to different groups one receives percutaneous renal denervation using the FlashPoint radio-frequency ablation system guided by the Columbus 3D mapping system, while another undergoes a sham procedure consisting of renal artery angiography followed by continued antihypertensive medication. Drug-control research includes 65 subjects divided into renal artery ablation with drug treatment and drug treatment only groups. Sham-control research includes 180 subjects randomized 21 to renal artery ablation with drug treatment or sham procedure with drug treatment. Throughout the study, patients will have blood pressure measurements and medication assessments at 1, 2, 3, 4, 5, 6, and 12 months after the procedure. Urine samples will be collected for drug testing to check medication compliance. Researchers will monitor 24-hour ambulatory mean systolic blood pressure reduction and the incidence of major adverse events up to 6 months and 1 month respectively, along with various secondary outcomes related to blood pressure, drug burden, and safety events.

Researchers are evaluating Huaier granules to prevent the return and spread of colorectal cancer in patients who have undergone radical surgery. This open-label, real-world study aims to assess both the effectiveness and safety of Huaier granules in this patient group. The study is conducted at multiple sites and sponsored by Xi Shan Wang. Participants will be observed in one of three groups those receiving radiotherapy or chemotherapy alone, those receiving Huaier granules combined with radiotherapy or chemotherapy, and those receiving Huaier granules alone. The study follows patients after their surgery to monitor how these different approaches impact cancer recurrence and metastasis. During the 36-month study period, participants will undergo regular assessments to measure disease-free survival, overall survival, local recurrence-free survival, and distant metastasis-free survival. Researchers will also collect data on quality of life changes, adverse events, and immune function. Participants will be monitored closely to track their health and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients aged 70 and older who have experienced an acute ischemic stroke. This multicenter, randomized controlled trial focuses on treatment within 4.5 hours of stroke onset to assess how this therapy may improve neurological outcomes compared to a standard dose. Participants are randomly assigned to receive either a low dose 0.175 mgkg, up to 17.5 mg or a standard dose 0.25 mgkg, up to 25 mg of tenecteplase given intravenously. The study is designed as a parallel-group trial comparing these two dosing regimens to understand which may be more beneficial and safe for elderly stroke patients. Participants will be monitored for recovery and safety through neurological assessments using scales such as the Modified Rankin Scale and the National Institutes of Health Stroke Scale up to 90 days after treatment. Outcomes like neurological improvement, functional independence, quality of life, and any bleeding events will be closely measured. The trial will continue until December 2028, with follow-up visits planned to evaluate participants progress and overall health.