Su Qian Shi

Chronic hepatitis B virus HBV infection is a major global health issue that can lead to serious liver problems such as cirrhosis, liver cancer, and death. This observational study aims to gather detailed information from a broad group of Chinese patients with chronic HBV infection to better understand the factors that influence disease outcomes. The study involves creating a comprehensive database of clinical, epidemiological, biological, virological, immunologic, and treatment-related data from patients with chronic HBV infection. There are no drug interventions instead, participants are monitored as part of this long-term cohort. Participants will be followed over many years, with researchers tracking outcomes like loss of hepatitis B antigens, development of cirrhosis, liver failure, liver cancer, and mortality. Regular assessments will collect relevant health information to help identify the factors linked to disease progression. The study is planned to continue until 2030, providing extensive long-term data on chronic HBV infection.

Researchers are investigating acute aortic syndrome AAS, a serious and life-threatening heart condition where inflammation plays a significant role in its development and progression. This large observational study involves 20 cardiovascular centers in China collaborating to understand inflammatory responses and anti-inflammatory treatments in patients undergoing surgery for AAS. The study aims to assess how inflammation and anti-inflammatory strategies affect patient outcomes after surgery, including complications and survival. The study enrolls adult patients who have undergone surgery for AAS, which includes various types of aortic injuries such as dissection, penetrating ulcers, or hematomas. Participants may have received medical therapy, open surgery, endovascular repair, or hybrid procedures, sometimes combined with other cardiac surgeries. Data about their inflammatory responses and clinical results are collected through designed forms and analyzed using statistical software. This observational study began in 2016 and will continue enrolling patients until 2040. Participants will be followed over time to evaluate key outcomes like severe inflammatory reactions within 7 days after surgery and operative mortality within 30 days. Researchers will also monitor other complications such as organ dysfunction, stroke, kidney injury, infections, bleeding, and length of intensive care stay. The study gathers detailed information through clinical data collection and monitors these outcomes to better understand and improve management for patients with AAS over the long term.

Chronic hepatitis B virus HBV infection is a significant global health concern. Researchers are investigating the clinical outcomes of patients with chronic hepatitis B CHB who are negative for hepatitis B e antigen HBeAg and fall into an indeterminate phase, meaning their blood test results do not clearly fit into the usual CHB phases. This study aims to understand the health progression of these patients, whose outcomes are not well known, which can help improve individual patient management. Participants are divided into two groups one group will be observed with regular monitoring every six months, and the other group will receive first-line antiviral treatments such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide, or peginterferon. The study is a prospective, observational cohort design conducted across multiple centers, aiming to follow patients over a long period. During the study, participants will have regular assessments to track key outcomes including the occurrence of liver cancer hepatocellular carcinoma and the clearance rate of hepatitis B surface antigen HBsAg over 240 weeks about 4.5 years. Researchers will monitor liver health, viral levels, and other clinical markers to understand disease progression. The study is led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and will continue until May 2028.

Researchers are evaluating whether adding a half-dose bolus of recombinant staphylokinase r-SAK, a clot-dissolving drug, immediately before primary percutaneous coronary intervention PCI can improve outcomes in patients with acute ST-segment elevation myocardial infarction STEMI treated within 120 minutes. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of r-SAK in reducing major adverse cardiovascular events within 90 days after treatment. Participants are randomly assigned to receive either a single intravenous bolus of 5 mg r-SAK over 3 minutes or a placebo injection within 10 minutes after STEMI diagnosis. Following this, all patients undergo primary PCI within 30 to 120 minutes. The study is conducted across multiple centers and compares the effects of r-SAK versus placebo as adjunctive therapy before PCI. During the study, participants will be monitored for major adverse cardiovascular events up to 90 days, with additional assessments including cardiac and cerebrovascular events, blood biomarkers NT-proBNP, cardiac imaging by echocardiogram and cardiac magnetic resonance imaging CMR, and blood flow in coronary arteries immediately before and after PCI. Safety and efficacy will also be tracked up to one year. The total participation duration includes follow-up visits at days 7, 90, and 360 after treatment.

Researchers are evaluating the safety and effectiveness of Yangxinshi tablets in patients with coronary heart disease combined with cardiac dysfunction. This study aims to determine if adding Yangxinshi tablets to standard treatment can reduce heart-related events, enhance exercise capacity, and improve quality of life and mental health. The trial includes 2708 patients and is a Phase 4 randomized controlled study sponsored by SPH Qingdao Growful Pharmaceutical Co., Ltd. Participants are randomly assigned to one of two groups one group receives conventional treatment plus Yangxinshi tablets 3 tablets taken orally three times a day, while the control group receives conventional treatment alone. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others for symptom relief and improving heart outcomes. The treatment continues until a set number of heart-related events occur or the study ends. Throughout the study, participants undergo regular assessments including measurements of heart events, exercise tolerance, heart function tests, blood markers, and mental health questionnaires over an average of three years. Additional evaluations at 24 and 48 weeks include depression and anxiety scales, echocardiography, and exercise testing. The research team closely monitors safety, quality of life, and heart function throughout the study period.

Researchers are conducting the IDEAL study, a large, multicenter, prospective, double-blind randomized controlled trial, to evaluate the impact of an artificial intelligence AI model on diagnosing intracranial aneurysms using head CT angiography CTA. The study aims to compare the diagnostic sensitivity and specificity of this AI-assisted approach against a sham AI method, while also assessing patient prognosis and various clinical outcomes. Over 6450 patients scheduled for head CTA will be enrolled across 21 hospitals in China. Participants will be randomly assigned to one of two groups the True-AI group, where radiologists use a deep-learning AI model with high sensitivity to assist in diagnosing intracranial aneurysms, and the Sham-AI group, where radiologists use a similar AI model with very low sensitivity but comparable specificity. Both groups will undergo their usual head CTA scans and diagnoses. The study includes a 12-month follow-up to monitor repeat imaging, clinical follow-up, treatment, and patient outcomes. During the study, patients will have their head CTA images interpreted with either the True-AI or Sham-AI assistance, without knowledge of group assignment by patients or radiologists. Researchers will assess diagnostic accuracy, detection rates of intracranial lesions, workload of CTA interpretation, resource use, hospitalization rates, quality of life measures, functional outcomes, and safety indicators at 3, 6, and 12 months. The primary outcomes focus on diagnostic sensitivity and specificity at 6 months, with secondary outcomes covering broader clinical and patient-centered measures over the follow-up period.

This trial focuses on patients aged 70 years or older with resectable stage IIA-IIIB non-small cell lung cancer NSCLC who do not have certain genetic alterations EGFR, ALK, ROS1. Researchers are evaluating a combination of oral paclitaxel solution, immune checkpoint inhibitors, and stereotactic body radiotherapy SBRT as a neoadjuvant treatment before surgery. The study aims to assess safety, tolerability, and preliminary effectiveness of this approach in older adults who may have higher risks from standard therapies. During Phase I, participants receive escalating doses of oral paclitaxel solution 80, 120, 160 mgm on Days 1 and 8 of each cycle, divided into morning and evening doses, combined with an anti-PD-1 or anti-PD-L1 monoclonal antibody and SBRT delivered as 8 Gy per fraction for 3 fractions. Phase II enrolls more participants at the recommended dose to further assess antitumor activity. Participants suitable for surgery after neoadjuvant therapy may undergo radical lung cancer surgery, while others receive definitive radiotherapy. Participants will undergo tumor response assessments through pathology and imaging, surgical evaluation if operable, and long-term follow-up for event-free and overall survival. Researchers will monitor treatment-related adverse events, pathologic complete response, and biomarker changes including immune cells, circulating tumor DNA, and PD-L1 expression. The study duration extends through treatment and follow-up until 2028, with careful safety and efficacy evaluations at multiple timepoints.

Researchers are evaluating the use of indomethacin, a non-steroidal anti-inflammatory drug NSAID, as an early treatment for acute pancreatitis AP, a condition where the pancreas becomes inflamed due to enzyme activation. The study aims to clarify the effects of NSAIDs on AP treatment, as previous animal studies suggested potential benefits but clinical evidence has been inconsistent. This Phase 4, multi-center, double-blinded, placebo-controlled trial seeks to provide high-quality data on this topic. Participants will be randomly assigned to receive either indomethacin SR 50 mg suppositories every 12 hours from admission day 1 to day 7 alongside standard AP treatments or similar placebo suppositories on the same schedule with standard care. Standard treatment includes adequate intravenous fluids, pain relief, and early enteral nutrition if possible. The study compares these two groups to assess the impact of indomethacin on AP outcomes. During the study, participants will be monitored for organ dysfunction related to AP over one week, which is the primary outcome. Secondary outcomes include rates of pancreatic necrosis, ICU admission, and mortality within one month. Assessments will involve clinical evaluations and imaging. The study runs from admission through at least one month, with close safety monitoring and follow-up to understand treatment effects and patient health outcomes over time.

This research aims to study the use of oral Lactobacillus reuteri as an additional therapy for people with Inflammatory Bowel Disease IBD. The study evaluates changes in intestinal inflammation and gut microbiota over a period of 12 months, with a focus on understanding disease progression and inflammatory changes using blood and stool tests. The study is sponsored by Wecare Probiotics Co., Ltd and involves randomized assignment to treatment groups. Participants will receive either a daily probiotic intervention with Limosilactobacillus reuteri LR08 10 billion CFU, 2 grams or a placebo of maltodextrin 3 grams for 8 weeks. Both interventions are stored in a cool, dry place. The study includes scheduled visits at 1 month, 3 months, 6 months, and 12 months after starting the treatment to conduct endoscopic observations and collect intestinal fluid for 16S RNA analysis. During the study, participants will undergo endoscopic examinations to assess intestinal inflammation using an endoscopic scoring system. Blood tests will measure inflammatory markers, and stool samples will be analyzed for calprotectin levels to monitor disease progression. The Crohns Disease Activity Index CDAI will also be used to evaluate disease severity. The total follow-up period extends to 12 months to capture longer-term effects and safety.

Researchers are evaluating whether starting intravenous tirofiban within 48 hours after mild ischemic stroke symptoms begin, followed by dual antiplatelet therapy DAPT, can improve functional recovery compared to standard DAPT alone. This study focuses on patients with mild stroke symptoms NIHSS score 5 or less who often face risks of early neurological decline and poor outcomes despite current treatments. The trial aims to provide more evidence on tirofibans potential benefits in this group. Participants are randomly assigned to one of two groups one receiving an initial intravenous tirofiban infusion for 48 hours with a specific dosing schedule, then switching to oral dual antiplatelet therapy aspirin and clopidogrel, and the other receiving standard oral dual antiplatelet therapy alone. The trial is open-label with blinded outcome assessment and compares the treatments over the early period following stroke onset. Throughout the study, participants will be monitored for functional outcomes using the modified Rankin Scale at 90 days. Additional assessments include neurological status changes within the first 7 days, stroke recurrence, bleeding events, and cardiovascular outcomes. The trial lasts through 90 days after treatment start, with careful safety and effectiveness evaluations to understand the impact of the treatment approach.