Long Yan Shi

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating pegmolesatide, a long-acting erythropoiesis-stimulating agent (ESA), in patients with renal anemia who are undergoing dialysis and have been treated with hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). Pegmolesatide was recently approved by the National Medical Products Administration in June 2023. While previous studies showed its safety and effectiveness in dialysis patients previously treated with recombinant human erythropoietin, this trial aims to assess the safety and efficacy of switching from HIF-PHIs to pegmolesatide, as well as to establish dose conversion standards. The study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial enrolling 96 patients. Participants are divided into low-dose and high-dose Roxadustat cohorts based on their prior weekly Roxadustat dose. Each cohort is further split by hemoglobin levels and then randomized to receive different initial doses of pegmolesatide (2 mg, 4 mg, or 6 mg) administered subcutaneously every four weeks. Treatment lasts for 12 weeks, followed by a 16-week follow-up period. During the study, patients receive regular doses of pegmolesatide with dose adjustments as needed per drug instructions. Researchers will monitor hemoglobin levels from baseline to 12 and 16 weeks to evaluate treatment effects. Throughout the trial, patients undergo assessments to ensure safety and treatment adherence, with overall involvement lasting 28 weeks from the start of treatment to the end of follow-up.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Researchers are evaluating the safety and effectiveness of giving tirofiban early to patients who have received tenecteplase for acute ischemic stroke. This phase 3 study addresses the problem of reocclusion that happens in 14-34% of patients after thrombolysis, likely due to platelet activation. The goal is to see if adding tirofiban soon after tenecteplase can reduce this risk and improve patient outcomes. Participants will be randomly assigned to receive either a continuous intravenous infusion of tirofiban or a placebo. The infusion starts at 0.3 micrograms per kilogram per minute for 30 minutes, followed by 0.075 micrograms per kilogram per minute for 47.5 hours, beginning within 4 to 24 hours after tenecteplase treatment. Aspirin and/or clopidogrel placebos are given orally 24 hours after tenecteplase, with actual antiplatelet therapy starting at 44 hours and continuing until 90 days after randomization. During the study, participants are monitored for neurological function changes and safety. The main outcome measured is excellent functional recovery 90 days after randomization. The study includes neurological assessments, imaging tests, and laboratory evaluations. Participants are followed for 90 days to observe treatment effects and any adverse events.

Cervical precancerous lesions, specifically Cervical Intraepithelial Neoplasia grade 2 (CIN2), pose significant risks to the health and fertility of young women. This research evaluates how the integration of Human Papillomavirus (HPV) DNA affects the progression and prognosis of CIN2 in women aged 45 and below. The study also explores the relationship between HPV integration status, vaginal flora diversity, and cervical cytology findings to improve understanding of disease outcomes. The study follows 300 women diagnosed with CIN2 confirmed by biopsy, recruiting them from multiple hospitals in China. Participants undergo comprehensive testing, including HPV viral integration tests, HPV genotyping, cervical cytology (ThinPrep tests), and vaginal secretion analysis at baseline and at 3, 6, 9, and 12 months. Colposcopy and biopsies are performed at the 6- and 12-month visits to assess lesion progression. No surgical or medication treatments are given unless the disease progresses during the 12-month observation. Participants will attend scheduled visits for sample collection and testing throughout the year-long follow-up. Researchers will perform various laboratory analyses, including HPV integration and genotyping, cervical cytology, and 16SrRNA sequencing of vaginal secretions. These assessments aim to monitor disease progression, understand HPV's role in CIN2 outcomes, and evaluate changes in vaginal flora. The study's comprehensive data collection supports a detailed evaluation of prognostic factors and disease management in young women with CIN2.