Ri Zhao Shi

Researchers are evaluating the use of albumin combined with endovascular therapy in patients who have suffered an acute ischemic stroke in the anterior circulation. This prospective, multicenter, open-label, randomized controlled trial aims to verify the effectiveness and safety of adding albumin to the current standard endovascular treatment for this type of stroke. The study is sponsored by Capital Medical University and focuses on patients aged 18 to 80 years with specific stroke characteristics. Participants are randomly assigned to one of two groups one receiving albumin combined with endovascular treatment and the other receiving endovascular treatment alone. Albumin is given intravenously at a dose of 0.5 gkg up to 37.5 g on the first day and then daily on the second, third, and fourth days. Both groups receive acute stroke care and secondary prevention according to American stroke guidelines. Initial assessments include CT or MRI scans to locate the stroke and rule out bleeding, along with neurological and functional scoring. Throughout the study, patients undergo various evaluations such as the National Institutes of Health Stroke Scale NIHSS, Modified Rankin Scale mRS, Alberta Stroke Program Early CT Score ASPECTS, and quality of life assessments using standardized questionnaires. Vital signs and laboratory tests are monitored at baseline, with a 90-day follow-up conducted by telephone to assess recovery and outcomes. The primary measure is the proportion of patients achieving good functional recovery at 90 days after treatment.

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 conducting a multicenter, prospective observational study across 200 hospitals in China to examine current treatment patterns for chronic hepatitis B CHB. The study aims to compare patient outcomes under different treatment regimens to provide evidence-based data that can improve CHB treatment strategies and follow-up care, ultimately advancing efforts toward a functional cure for chronic hepatitis B. Participants include those receiving or planned to receive treatments such as entecavir ETV, tenofovir disoproxil fumarate TDF, tenofovir alafenamide fumarate TAF, tenofovir amibufenamide TMF, or peginterferon alpha-2b injection. The study observes real-world clinical practice without assigning treatments, capturing data on these therapies over an extended period. During the study, researchers will monitor outcomes including the percentage of patients developing HBsAg-associated hepatocellular carcinoma HCC, incidence of HCC, rates of HBsAg seroclearance and seroconversion, changes in HBsAg levels, HBV DNA levels, liver fibrosis improvement, and liver-related complications. Data collection spans from week 4 up to week 240, with continuous follow-up to assess treatment effects and patient status over time.

Researchers are evaluating the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in treating stenosis of arteriovenous fistulas used for hemodialysis. This prospective, multi-center, single-arm clinical study plans to enroll 328 participants who have mature arteriovenous fistulas or grafts with significant narrowing. The study aims to measure how well the treated blood vessel remains open, focusing on the primary patency of the target lesion six months after the procedure. Participants will receive treatment using the Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter during a surgical procedure. After treatment, participants will have follow-up visits within 5 days, then at 1 month, 6 months, and later at 12, 18, and 24 months to monitor the treated area. The primary goal is to assess the blood vessels openness at 6 months, with additional checks extending up to two years to evaluate longer-term outcomes. During the study, participants will undergo various assessments including Doppler ultrasound to measure blood flow and detect restenosis, evaluations of clinical success shortly after the procedure, and checks for the need for further revascularization treatments. Safety and technical success of the device will also be monitored immediately after the intervention. The total participation time spans up to 24 months, allowing detailed observation of the devices performance and the participants vascular health over time.

Researchers are evaluating the use of recombinant human coagulation factor VIII-Fc fusion protein FRSW107 as an on-demand treatment for males aged 12 to 65 years with severe hemophilia A, a condition marked by a congenital deficiency of factor VIII causing bleeding. The study aims to assess the effectiveness, safety, and immune response related to FRSW107 treatment, as well as its pharmacokinetic profile and potential exposure-response relationship in previously treated patients. Participants will receive FRSW107 as needed, within a recommended dose range of 20-50 IUkg, for a treatment period lasting up to 6 months. This single-group study involves administering the drug to control bleeding episodes when they occur, without a comparator group. The treatment is given through infusion, and dosing is based on the occurrence of bleeding events during the study period. Throughout the study, participants will undergo various assessments including measurement of haemostatic effectiveness over 6 months, evaluation of factor VIII activity, joint health scores, and monitoring for adverse events, inhibitor development, and immune responses. Researchers will collect data on the number of infusions and dosing required per bleeding episode. Safety and efficacy will be closely monitored, with follow-up and data collection continuing for the full six months of treatment.