Huang Gang Shi

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 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.

Researchers are investigating whether switching to liquefied petroleum gas (LPG) and improving kitchen ventilation can reduce household air pollution from solid fuel use and improve heart and lung health. The study also examines if combining both interventions works better than either alone, their cost-effectiveness, sustainability, and impact on reducing cardiopulmonary events. This is a multi-center, randomized controlled trial involving adults aged 18 to 75 years living in specific village settings. Participants are divided into four groups: one continues using solid fuels without ventilation; one uses LPG without ventilation; another uses solid fuels with ventilation facilities; and the last group uses both LPG and ventilation. During the 12-month intervention, LPG stoves and ventilation equipment are provided as appropriate, along with regular supplies like LPG fuel and electricity cost compensation. After 12 months, the group without initial intervention receives free LPG stoves and ventilation equipment. Participants will be monitored over one year, with follow-up assessments at 6, 12, 24, and 36 months. Researchers will measure changes in ultrafine particles, fine particulate matter (PM2.5), heart rate variability through ECG, and lung function tests such as forced vital capacity and forced expiratory volume. The study includes regular health education and tracks adherence to cooking practices and ventilation use to assess cardiopulmonary health outcomes and air pollution exposure.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients who have experienced an acute ischemic stroke. This prospective, multicenter, randomized controlled Phase 4 trial focuses on patients aged 70 years and older who receive treatment within 4.5 hours of stroke onset. The study aims to compare low-dose tenecteplase with the standard dose to understand its impact on stroke recovery in aging patients. Participants are randomly assigned to one of two groups: a low-dose group receiving tenecteplase at 0.175 mg/kg (up to 17.5 mg per patient) or a standard-dose group receiving tenecteplase at 0.25 mg/kg (up to 25 mg per patient). Treatment is administered intravenously as thrombolysis. The trial monitors patients closely to assess how these dosing strategies affect recovery and safety. During the study, researchers will evaluate neurological function using the Modified Rankin Scale 90 days after treatment, measuring the percentage of participants who achieve a score of 0 or 1, indicating no symptoms or no significant disability. Patients will undergo neurological assessments and safety monitoring throughout the trial. The study ensures informed consent and collects relevant clinical data to support its findings on tenecteplase use in elderly stroke patients.

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 studying the effects of normobaric oxygen (NBO) therapy on patients who have experienced an acute ischemic stroke (AIS) and are transferred for endovascular thrombectomy (EVT). The goal is to assess the safety and effectiveness of NBO in improving functional outcomes three months after stroke. Stroke is a major cause of death and disability worldwide, and while treatments like mechanical thrombectomy can improve blood flow, less than half of patients with large vessel occlusion achieve good recovery. NBO offers potential brain protection by improving oxygen delivery to affected areas and reducing damage through multiple mechanisms. Participants will receive either inhaled 100% oxygen (NBO) or best medical care without NBO. The study focuses on patients transferred for EVT who meet specific stroke severity and imaging criteria. NBO treatment is delivered through oxygen inhalation, aiming to increase oxygen availability to the brain before reperfusion. The study is conducted in a Phase 3 setting and compares outcomes between those receiving NBO and those receiving standard care. During the study, participants will be monitored for disability levels using the modified Rankin scale at 90 days and one year after treatment. Assessments include neurological exams and imaging to confirm stroke details and severity. Researchers will also track safety and functional outcomes to evaluate the impact of NBO therapy. Participants are followed for at least three months after randomization to observe recovery and potential benefits.

Researchers are investigating the safety and effectiveness of remote ischemic conditioning (RIC) in patients with acute ischemic stroke caused by large vessel blockage in the brain. While endovascular thrombectomy is effective in reopening blocked vessels, many patients still suffer poor outcomes due to brain tissue damage during and after the procedure. The study aims to see if RIC, a noninvasive therapy involving brief cycles of arm blood flow restriction, can protect the brain and improve recovery in these patients. The study compares two durations of remote ischemic conditioning: one lasting 14 days and another lasting 30 days after mechanical thrombectomy. RIC is performed using an automatic device that inflates and deflates a cuff on the upper arm, with five cycles of 5-minute inflation and 5-minute deflation. This procedure is done once before thrombectomy and then twice daily during the assigned post-thrombectomy period. All patients also receive best medical management according to guidelines. Mechanical thrombectomy is done following standard practices to reopen blocked vessels safely. Participants will be monitored for 90 days after their stroke to assess recovery and safety. The main measure is the proportion of patients who achieve a good functional outcome, defined as a modified Rankin Scale score of 0 to 2 at 90 days. Throughout the study, medical evaluations, imaging, and clinical assessments will be conducted to track progress and any side effects. The study also explores how the length of RIC treatment affects patient outcomes, aiming to find the best approach to protect the brain after stroke treatment.

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.

Researchers are studying the effects of Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment on patients with decompensated liver cirrhosis. Traditionally, cirrhosis was thought to progress only toward worsening liver function, but recent findings suggest that some liver recovery, called "recompensation," is possible after removing the cause of liver damage. This study aims to understand if patients undergoing TIPS can achieve recompensation and how this affects their risk of liver cancer and survival. The study involves patients between 18 and 80 years old diagnosed with decompensated liver cirrhosis due to treatable causes like hepatitis B, hepatitis C, or alcoholic liver disease. Participants must have indications for TIPS, such as bleeding varices resistant to endoscopic treatment or refractory ascites. The study observes these patients after TIPS treatment to assess their liver function and progression. Participants will be monitored for at least one year to measure the rate of liver recompensation following TIPS. Researchers will track liver-related complications, survival, and the development of liver cancer. Assessments will include clinical symptoms, lab tests, imaging, and liver function evaluations. Safety and treatment effects will be closely observed throughout the study period.