Xianning

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

Researchers are conducting a Phase 2 clinical trial to evaluate the safety and immune response of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd. This study involves children aged between 2 months (minimum 42 days) and 5 years in China. The trial is randomized, double-blind, and uses a positive control vaccine, Prevenar13®, made by Pfizer, to compare outcomes. Participants will be randomly assigned to receive either the Sinovac PCV24 vaccine or the control vaccine Prevnar®, both given as a 0.5 mL injection into the muscle following different immunization schedules. The study plans to enroll at least 420 children who meet the age requirements and will be divided equally between the two groups. During the study, researchers will monitor the participants’ immune response by measuring specific antibody levels 30 days after vaccination. They will also track any adverse reactions occurring within 30 days after vaccination to assess safety. Guardians will provide consent and keep in contact with researchers throughout the study period to support follow-up and data collection.

Researchers are studying the effects of different doses of colchicine, a drug recently recommended by the U.S. FDA for treating coronary heart disease (CHD), in Chinese patients who have undergone percutaneous coronary intervention (PCI). Since colchicine is not yet approved for CHD treatment in China and the standard dose may not suit the lower body weight typical in East Asian populations, this Phase 3, multicenter, randomized, double-blind study aims to assess the drug's efficacy and safety in reducing cardiovascular events in this group. Participants will be randomly assigned to one of three groups receiving either colchicine 0.5 mg daily, colchicine 0.375 mg daily, or a placebo pill once a day. The study includes follow-up visits at 1, 6, 12, 18, and 24 months after randomization, with additional phone assessments every three months. All participants will continue standard medical care for heart disease as per national guidelines, and safety and effectiveness will be carefully monitored throughout the study. During the study, researchers will track cardiovascular events such as heart-related death, heart attack, stroke, and procedures to restore blood flow, over an estimated period of 2 to 4 years. Safety and adverse events will be assessed regularly every three months. A Clinical Event Committee blinded to treatment assignment will review all suspected cardiovascular outcomes, while an independent Data and Safety Monitoring Board will oversee safety data, including an interim analysis when half of the expected events have occurred.

Researchers are evaluating a new treatment regimen called MA+AZA, which combines mitoxantrone hydrochloride liposomes with cytarabine and azacitidine, for patients newly diagnosed with acute myeloid leukemia (AML). This Phase 3, prospective, multicenter, randomized controlled study compares the MA+AZA regimen to the traditional DA+AZA chemotherapy regimen to determine which provides better induction treatment for primary AML. The goal is to observe the effectiveness and safety of the new combination and gather high-quality clinical evidence to improve treatment outcomes and prognosis for AML patients. Participants are randomly assigned to receive either the MA+AZA regimen or the DA+AZA regimen. The MA+AZA group receives mitoxantrone hydrochloride liposome 24 mg/m2 intravenously on day 1 every 4 weeks, cytarabine 100 mg/m2 intravenously every 12 hours from days 1 to 7, and azacitidine 100 mg subcutaneously once daily from days 1 to 7. The DA+AZA group receives daunorubicin 60 mg/m2 intravenously once daily from days 1 to 3, cytarabine 100 mg/m2 intravenously every 12 hours from days 1 to 7, and azacitidine 100 mg subcutaneously once daily from days 1 to 7. During the study, participants are monitored to evaluate the complete remission rate 2 to 3 weeks after the first 28-day treatment cycle. Researchers assess treatment efficacy and safety through clinical evaluations and laboratory tests. The study includes patients aged 18 to 75 years with confirmed AML and adequate liver, kidney, and heart function, with performance status scores between 0 and 2. Informed consent is obtained from all participants or their families before enrollment.

Researchers are evaluating an artificial intelligence-based multimodal cognitive screening system designed to identify mild cognitive impairment related to type 2 diabetes mellitus (T2DM) early on. This observational study focuses on patients aged 40 to 75 years who have memory complaints and aims to determine how well the AI system can detect cognitive changes over a 3 to 5 year follow-up period. The study also examines the relationship between diabetic metabolic indicators, such as glycemic variability and HbA1c levels, and changes in cognitive function to assess the value of early detection and intervention in these patients. Participants will undergo follow-up observation for 3 to 5 years without additional interventions. Cognitive status data will be collected at the start of the study and at the end of the follow-up period to monitor changes over time. No medications or treatments will be administered as part of the study; the focus is solely on observing cognitive function and diabetes-related metabolic factors. During the study, participants' cognitive abilities will be regularly assessed using the AI screening system. Researchers will collect data on cognitive deterioration rates and the accuracy of early identification by the AI tool. The study includes monitoring participants' ability to perform daily activities and tracking memory-specific deficits, with follow-up lasting up to five years to capture long-term cognitive outcomes and safety.