Su Qian Shi

Hepatitis B virus (HBV) infection is a major global health concern, with chronic infection increasing the risk of liver cirrhosis, liver cancer, and death. Researchers aim to better understand which factors influence the long-term outcomes of chronic HBV infection in a broad group of Chinese patients. This study is an observational cohort designed to collect detailed data on epidemiology, clinical status, biology, virology, immune response, and treatments to identify these important factors. Participants with chronic HBV infection, defined by positive hepatitis B surface antigen (HBsAg) for at least 6 months, will be included in this real-life cohort. There are no specific treatment interventions or experimental therapies involved, as the study focuses on observing and collecting comprehensive patient data over time. During the study, researchers will track patient health outcomes for up to 20 years, including loss of viral antigens (HBeAg and HBsAg), development of liver cirrhosis, liver failure, liver cancer (hepatocellular carcinoma), and mortality. The long-term follow-up will involve monitoring clinical and laboratory parameters to understand disease progression and outcomes in this patient population.

Acute Aortic Syndrome (AAS) is a serious and life-threatening condition where inflammation significantly affects its development and progression, leading to high rates of death and complications. This research focuses on understanding how inflammation and anti-inflammatory treatments impact patients with AAS, particularly those undergoing surgery. The study is a large, long-term observational registry involving 20 cardiovascular centers in China, enrolling adult patients from 2016 through 2040 to investigate early and late outcomes related to inflammation. Participants in the study have undergone various treatments for AAS, including medical therapy, open surgery, endovascular repair, or hybrid procedures. The research collects detailed clinical data using specially designed forms and statistical analysis software to explore the role of inflammation and anti-inflammatory strategies alongside surgical repair. The registry also includes patients who had additional cardiac surgeries like coronary artery bypass or carotid artery replacement during their AAS treatment. During the study, researchers assess patients for severe inflammatory responses and organ function within the first week after surgery, and track outcomes such as mortality within 30 days, stroke, kidney injury, infections, bleeding, blood transfusions, and time spent in intensive care. The study aims to provide insights over 15 years on how inflammation affects recovery and long-term prognosis in AAS patients, helping to guide improved treatment strategies and reduce residual cardiovascular risks.

Chronic hepatitis B virus (HBV) infection is a widespread health concern globally. This research focuses on HBeAg-negative chronic hepatitis B patients who fall into an indeterminate phase, meaning their blood test results do not clearly fit established disease phases. The study aims to understand the clinical outcomes of these patients, as their prognosis remains unclear despite existing guidelines for other HBV phases. Participants will either be observed every 6 months without treatment or receive first-line antiviral therapies such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide, or peginterferon. The study is a multi-center, prospective, observational cohort, allowing researchers to monitor the natural course or treatment effects in this specific patient group. During the study, participants will undergo regular monitoring, including liver assessments and blood tests, over a period extending up to 240 weeks. Researchers will measure outcomes such as the rate of hepatocellular carcinoma development and hepatitis B surface antigen clearance by the end of the study. Safety and disease progression will be carefully followed to improve understanding of this indeterminate phase in chronic hepatitis B.

This research evaluates whether giving a half-dose bolus of recombinant staphylokinase (r-SAK) before primary percutaneous coronary intervention (PCI) improves outcomes in patients experiencing acute ST-segment elevation myocardial infarction (STEMI). STEMI is a serious heart condition caused by blocked coronary arteries leading to heart muscle damage. Early reperfusion treatment can reduce heart damage and improve prognosis, but it is unclear if adding thrombolytic therapy immediately before PCI within 120 minutes benefits patients. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial comparing r-SAK to placebo in patients undergoing PCI within 120 minutes. Participants are randomly assigned to receive either an intravenous half-dose bolus of r-SAK or placebo within 10 minutes after STEMI diagnosis. The study focuses on facilitating PCI by potentially improving blood flow in blocked arteries through r-SAK's clot-dissolving action. The trial addresses challenges such as delays in transferring patients to PCI-capable hospitals and the risk of complications from high thrombus burden during stent placement. During the study, researchers will monitor participants for major adverse cardiovascular events (MACE) within 90 days. Assessments include clinical evaluations, ECGs, and safety monitoring to observe heart function and adverse effects. The total participation involves initial treatment and follow-up visits to track health status and treatment impact over three months.

Researchers are evaluating the efficacy and safety of Yangxinshi tablets in patients with coronary heart disease complicated by cardiac dysfunction. This Phase 4 randomized controlled trial aims to determine whether adding Yangxinshi tablets to conventional treatment can reduce ischemic or heart failure-related clinical events, improve exercise tolerance, and enhance quality of life and mental health in these patients. The study includes 2708 patients aged 40 to 80 years with specific heart conditions and symptoms. Participants are randomly divided into two groups: one group receives conventional treatment plus Yangxinshi tablets (3 tablets, three times daily), while the control group receives only conventional treatment without additional tablets. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others aimed at improving outcomes and relieving symptoms. The treatment continues until the expected number of endpoint events occurs or the study ends. During the study, participants are monitored for ischemic events or heart failure-related clinical events, including death, stroke, myocardial infarction, and hospital readmissions. The average follow-up period is about three years. Researchers assess exercise tolerance, quality of life, and mental health, while monitoring safety and overall health status throughout the study.

Researchers are conducting a large study called the IDEAL study to evaluate the use of an artificial intelligence (AI) model in detecting intracranial aneurysms using head CT angiography (CTA) scans. The study will enroll over 6450 adult patients scheduled for head CTA across 21 hospitals in more than 10 provinces in China. The main goal is to compare how well the AI-assisted diagnosis detects aneurysms compared to a control group, focusing on sensitivity and specificity. The study will also examine patient prognosis and outcomes related to aneurysm detection and treatment. Participants will be randomly assigned to one of two groups: the True-AI group using a deep-learning AI model with high sensitivity and specificity for aneurysm detection, or the Sham-AI group which uses a similar system but with very low sensitivity and comparable specificity. Neither patients nor radiologists will know which group they are in. The study includes follow-up procedures such as repeat imaging at 12 months and tracks clinical outcomes, hospitalizations, treatments, and quality of life. Cost-effectiveness and workload impact of the AI system will also be evaluated. During the study, patients will undergo head CTA scans as part of routine clinical care. Researchers will collect and analyze diagnostic accuracy data, resource use, and clinical follow-up information. They will monitor aneurysm-related events, repeat imaging results, and patient quality of life. The study aims to assess both short- and long-term effects of integrating AI into routine aneurysm diagnosis, with a total monitoring period of at least 12 months post-imaging.

Researchers are studying acute pancreatitis (AP), an inflammation of the pancreas that can cause other organs to malfunction. The condition arises from activated pancreatic enzymes triggered by various causes, with inflammatory factors playing a central role. While non-steroidal anti-inflammatory drugs (NSAIDs) like indomethacin are commonly used to treat inflammation and have shown promise in preventing post-ERCP pancreatitis, there is limited high-quality evidence regarding their effectiveness as a treatment for AP itself. This phase 4 trial aims to clarify the effects of indomethacin on AP through a randomized controlled study. Participants will receive either indomethacin sustained release (SR) at 50 mg every 12 hours or placebo suppositories of similar shape and size, starting from admission day 1 through day 7. The study is double-blinded and placebo-controlled, conducted across multiple centers. This intervention period is designed to assess the ability of indomethacin to reduce inflammation and potential organ dysfunction associated with AP. During the trial, researchers will monitor participants for the occurrence of organ dysfunction caused by acute pancreatitis over one week. Patients will undergo clinical evaluations, laboratory tests, and imaging as needed to track disease progression and treatment effects. Safety and adverse events will be closely observed, with the entire participation lasting at least one week to capture early outcomes related to organ function and complications.

Researchers are evaluating the use of oral Lactobacillus reuteri as an additional therapy for people with Inflammatory Bowel Disease (IBD). This study focuses on patients diagnosed with IBD for at least 3 months but not more than 3 years. The goal is to observe the effects of this probiotic on intestinal inflammation and the progression of the disease over a 12-month period. Participants will take either the probiotic Lactobacillus reuteri or a maltodextrin supplement for 8 weeks. During this experimental phase, patients will have four visits scheduled in January, March, June, and December. Endoscopic examinations will be performed at 1, 3, 6, and 12 months after starting treatment to assess inflammation and collect intestinal fluid for gut microbiota analysis. Throughout the study, researchers will monitor changes in inflammation through blood tests and measure fecal calprotectin levels to evaluate disease progression. Outcome measures include improvement of intestinal inflammation using endoscopic scoring over 12 months. Patients will be observed and assessed at multiple time points to track treatment effects and safety.

Researchers are evaluating whether starting intravenous tirofiban within 48 hours of stroke onset, followed by dual antiplatelet therapy (DAPT), can increase the chances of excellent recovery in patients with mild ischemic stroke compared to standard DAPT alone. Mild stroke patients often face early neurological worsening and poor outcomes, and while DAPT reduces stroke recurrence, its effectiveness in mild cases is limited. Tirofiban, a medication that inhibits platelet aggregation, has shown promise for mild-to-moderate stroke but needs further study specifically in mild stroke. The study compares two treatment approaches: one group receives a loading dose of tirofiban intravenously (0.4 mcg/kg/min for 30 minutes) followed by a continuous infusion (0.1 mcg/kg/min for 47.5 hours), then oral aspirin and clopidogrel daily; the other group receives standard oral aspirin and clopidogrel therapy only. Treatment is initiated within 48 hours of stroke symptom onset. This is a phase 4, multicenter, open-label trial with blinded evaluation of outcomes. Participants will be monitored for 90 days to assess functional recovery using the modified Rankin Scale, focusing on the proportion achieving excellent outcomes (scores 0-1). Researchers will also evaluate safety and any adverse events. The study involves clinical assessments, imaging to rule out hemorrhage, blood tests, and close follow-up during and after treatment to ensure adherence and monitor effectiveness and safety.