Long Yan Shi

Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Researchers are evaluating the use of pegmolesatide, a long-acting erythropoiesis-stimulating agent ESA, in patients with renal anemia who are currently treated with hypoxia-inducible factor prolyl hydroxylase inhibitors HIF-PHIs. This trial aims to explore the safety and effectiveness of switching from HIF-PHIs to pegmolesatide, addressing the current need for longer-acting and safe medications. The study is a multi-center, prospective, open-label, randomized parallel-controlled trial enrolling 96 dialysis chronic kidney disease patients with anemia. Participants are divided into two groups based on their current weekly Roxadustat dose a low-dose cohort 210 mg and a high-dose cohort >210 mg and 360 mg. Within each cohort, patients are randomly assigned to receive pegmolesatide at different initial doses 2 mg, 4 mg, or 6 mg administered subcutaneously once every 4 weeks. The dose may be adjusted according to the drugs instructions. The treatment period lasts 12 weeks, followed by a 16-week follow-up period. During the study, researchers will monitor hemoglobin levels and other blood parameters at various intervals to assess the effects of pegmolesatide. Patients will undergo assessments including hemoglobin tests, red blood cell counts, and safety monitoring for adverse events. The primary measurement is the change in mean hemoglobin levels from baseline to 12 and 16 weeks. The total participation time for each patient is 28 weeks, including treatment and follow-up.

People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.

Researchers are studying the safety and effectiveness of early use of tirofiban in patients who have acute ischemic stroke and are treated with tenecteplase. This study is exploring whether adding tirofiban soon after tenecteplase can reduce the risk of blood clot re-blockage in the brain, which happens in some patients after initial treatment. The study is a phase 3 trial aiming to improve stroke outcomes by preventing this reocclusion. Participants first receive tenecteplase intravenously for stroke treatment. Those who meet the study criteria are then randomly assigned to receive either tirofiban or a placebo. Tirofiban or placebo is given intravenously starting as soon as possible after randomization, initially as a higher dose for 30 minutes, followed by a continuous lower dose infusion for nearly 48 hours. After 24 hours, patients receive aspirin andor clopidogrel or their placebos, then after 44 hours, antiplatelet therapy with aspirin andor clopidogrel continues until the 90-day follow-up. During the study, participants undergo assessments including neurological exams and monitoring for bleeding or other adverse events. The main outcome measured is excellent functional recovery 90 days after randomization. Other outcomes include disability levels, neurological improvement, quality of life, bleeding events, and mortality. Safety and serious adverse events are tracked through the 90-day period to evaluate treatment effects and risks.

Researchers are studying the role of HPV integration in predicting the prognosis of young women aged 45 and below diagnosed with cervical intraepithelial neoplasia grade 2 CIN2, a precancerous cervical condition. The study aims to explore the correlation between HPV integration, vaginal flora changes, and cervical cytology results to better understand disease progression and outcomes. This multi-center cohort study includes 300 participants from hospitals in China, focusing on the natural course of CIN2 without surgical or medication treatment when appropriate. Participants will be followed at enrollment and then at 3, 6, 9, and 12 months. At these visits, HPV viral integration tests, HPV genotyping tests, cervical cytology, and sequencing of vaginal secretions will be performed. Colposcopies and biopsies will be conducted at 6 and 12 months to closely monitor cervical tissue changes. The study observes participants under regular clinical follow-up without intervention unless disease progression occurs. During the study, participants will provide cervical secretions and exfoliated cell samples for testing. Researchers will assess cervical histopathology, HPV integration status, cervical cytology, vaginal flora diversity, and HPV genotyping at multiple time points. Outcomes measured include cervical tissue changes and HPV-related markers to evaluate the diseases natural course. The study lasts 12 months with scheduled clinical visits and laboratory assessments to monitor participants cervical health and HPV status throughout this period.

Researchers are evaluating the traditional Chinese medicine Yufeng Ningxin for its potential to lower blood pressure in patients with hypertension. This randomized, double-blind, placebo-controlled trial aims to rigorously assess the effectiveness and safety of Yufeng Ningxin tablets in adults aged 18 to 65 years with newly diagnosed or treated hypertension. The study is led by Beijing Anzhen Hospital and will provide important data to better understand this treatment. Participants will be randomly assigned to receive either Yufeng Ningxin tablets or a placebo. Both groups will take 5 tablets per dose, three times daily, for 8 weeks. Yufeng Ningxin tablets contain 0.28 g per tablet. The study includes a comparison of these two groups over the treatment period to determine the effects on blood pressure and other health measures. During the trial, participants will have their blood pressure measured in the office and by 24-hour ambulatory monitoring at the start and after 8 weeks of treatment. Researchers will also assess headache impact, gut microbiota changes, blood lipid levels, blood sugar, and safety outcomes including hospitalizations and adverse events. The total participation time is about 8 weeks of treatment with monitoring throughout this period.

Researchers are studying the lot-to-lot consistency of immunogenicity and safety for a recombinant 9-valent human papillomavirus HPV vaccine made using Escherichia coli. This clinical trial focuses on females aged 18 to 30 years in China and aims to determine if immune responses are consistent across three commercial vaccine batches. The study supports international market access and meets World Health Organization Prequalification requirements. Participants receive three doses of the investigational 9-valent HPV vaccine at months 0, 1, and 6. The study includes visits at months 0, 1, 2, 6, and 7, with blood samples collected at months 0 and 7 to measure antibody levels. Participants keep diaries of adverse events for 30 days after each vaccination and report serious or special interest adverse events and pregnancies during the trial. During the study, participants undergo assessments of immune responses by measuring antibody concentrations one month after completing vaccination. Safety is monitored by documenting adverse events throughout the seven-month period. The trial evaluates geometric mean concentrations, seroconversion, and seropositivity rates of antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Overall participant involvement lasts about seven months, including vaccination and follow-up visits.