Jie Yang Shi

This research aims to better understand patients diagnosed with aortic valve disease, including aortic insufficiency and aortic valve stenosis, during hospitalization. The study is a multicenter cohort study focused on evaluating risk factors that affect patient outcomes. Researchers will use this information to develop a model that can help guide clinical decisions for people with these heart valve conditions. Participants diagnosed with aortic valve disease will be followed over time to observe their health outcomes. The study will monitor events such as all-cause death and cardiovascular complications, including whether patients undergo aortic valve replacement. No specific treatments or interventions are assigned, as this is an observational study. During the study, participants will be observed from baseline until death or the end of the follow-up period. Researchers will collect data on mortality and cardiovascular events to analyze prognostic risk factors. The primary outcome is all-cause mortality, while secondary outcomes include cardiovascular death and valve replacement. This ongoing observation will help improve understanding of the disease progression and patient prognosis.

People with end stage kidney disease ESKD who require dialysis face a much higher risk of cardiovascular disease compared to the general population, with cardiac issues causing 58% of deaths in this group. However, while aspirin is known to reduce cardiovascular problems in the general population, there is limited evidence about its effects in dialysis patients. The ASPIrin to Reduce Event in Dialysis ASPIRED trial aims to study whether taking low-dose aspirin can safely improve cardiovascular outcomes in people with ESKD receiving dialysis. This study is a multi-center, double-blind, randomized controlled trial that will compare daily low-dose aspirin 100 mg to a placebo pill in patients undergoing dialysis. The trial uses an existing dialysis registry platform to screen, recruit, and collect data during routine clinical care, minimizing participant burden and study costs. Randomization is managed through a secure web-based system, and follow-up visits occur every six months as part of regular clinic visits. The trial is expected to last approximately five years and includes oversight by an independent safety and monitoring board. Participants will be involved in regular six-monthly clinic visits where their health will be monitored as part of their usual dialysis care. Researchers will track the occurrence of major cardiovascular events, including heart attacks, strokes, vascular complications, and deaths, throughout the study period. Data will be collected from routine clinical procedures and the dialysis registry to evaluate outcomes. Safety and efficacy will be closely monitored, and the study will follow participants for up to five years to assess the long-term effects of aspirin use in this population.

This research aims to improve the evaluation of radiation oropharyngeal mucositis, a painful side effect experienced by patients undergoing radiotherapy for head and neck tumors. The study compares a new four-type classification system based on histopathological changes with traditional grading methods. It also explores changes in blood markers related to different types of mucositis by using residual blood samples from patients. The study is observational and does not require any extra visits or tests beyond routine clinical care. It is divided into three parts first, comparing the consistency of different mucositis assessment methods among doctors second, evaluating the stability of these assessments across multiple doctors and third, comparing doctor assessments using the new classification with patients self-assessments. Patients are assessed every 1 to 2 weeks during radiotherapy. Participants will provide consent for data collection, including routine diagnosis and treatment information. Researchers will measure the consistency between doctors evaluations and between doctors and patients over up to three years. Patient and doctor satisfaction with the assessment methods will also be recorded. The main outcome is inter-rater consistency among doctors, with monitoring continuing throughout the study period.

Researchers are evaluating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for treating pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive ERhuman epidermal growth factor 2 negative HER2- breast cancer who have an ESR1 mutation and have previously been treated with ribociclib or palbociclib. The study aims to compare the effectiveness, safety, and tolerability of these two treatment combinations. Participants are randomly assigned to one of two groups one receives 5 mg daily oral lasofoxifene plus oral abemaciclib 150 mg twice a day the other receives fulvestrant 500 mg via intramuscular injections on Days 1, 15, and 29 and then monthly thereafter, combined with oral abemaciclib 150 mg twice a day. This open-label study assesses these treatments over approximately three years. During the trial, participants will be monitored through regular assessments including tumor measurements, survival tracking, quality of life questionnaires, and evaluation of adverse events. Researchers will measure progression-free survival as the primary outcome and also track response rates, overall survival, treatment duration, and time to chemotherapy. Brain metastases patients meeting specific criteria are allowed, and safety is closely observed throughout the study period which may last up to about three years.

Rheumatoid arthritis RA is a leading cause of disability, especially among Chinese women, and early treatment is crucial to improving outcomes. This research focuses on patients with a specific type of RA called synovial myeloid stromal type, which is linked to more severe disease and poorer response to standard treatment. The study aims to evaluate whether early intensified treatment can improve disease control in these patients by using a new synovial pathology classification to guide therapy. The study compares two treatment approaches for adults with moderate to severe active RA of the synovial myeloid stromal type. One group receives methotrexate combined with tofacitinib, while the other group receives methotrexate alone. Methotrexate is taken orally once a week at doses of 10-15 mg, and tofacitinib is taken orally twice a day at 5 mg. The treatment period lasts 12 weeks, followed by a 48-week follow-up phase. This randomized, open-label study is conducted across multiple centers. Participants will undergo assessments of disease activity, joint function, and safety at various points throughout the study, including weeks 4, 8, 12, 24, 36, and 48. Researchers will measure the proportion of patients achieving at least 20% improvement in RA symptoms at 12 weeks, along with changes in disease activity scores and joint damage progression at 48 weeks. The study also explores serum biomarkers to develop a precise diagnostic system. Overall participation lasts about 60 weeks from treatment start through follow-up.

Researchers are conducting a prospective cohort study to evaluate the reliability of plasma and tissue SAA1 levels as a marker to predict hyperprogression in cancer patients undergoing immunotherapy. Hyperprogression is a rapid tumor growth occurring in some patients early in immunotherapy, leading to poor prognosis and reduced quality of life. Identifying high-risk groups early is crucial, as no effective treatments or biomarkers currently exist for this condition. This observational study involves patients diagnosed with various malignant tumors, including nasopharyngeal carcinoma, head and neck tumors, lung, breast, stomach, colorectal, glioma, esophageal, liver, bile duct, cervical, prostate, and bladder cancers. Participants will all be treated with immune checkpoint inhibitors. The study will collect clinical tissue and blood samples for sequencing, proteomics, and metabolomics analysis to measure SAA1 levels. Participants will be monitored over a period of up to three years to assess outcomes such as incidence of hyperprogression within two years, as well as event-free survival, progression-free survival, and overall survival over three years. The study includes evaluations of patient performance status and treatment adherence. Researchers will track these measures to better understand the predictive value of SAA1 for hyperprogression in pan-cancer patients receiving immunotherapy.

Head and neck squamous cell carcinoma SCC is a common cancer worldwide, causing many new cases and deaths each year. Radiotherapy is important to control the recurrence of these tumors, but it often causes acute inflammation such as radiotherapy-induced oral mucositis RIOM, which can affect patients quality of life and treatment effectiveness. Researchers are studying plasma levels of Serum amyloid A1 SAA1, a protein linked to inflammation, to see if it can help predict the onset and severity of RIOM early in patients receiving radiotherapy for nasopharyngeal carcinoma or other head and neck tumors. This is a prospective, multicenter, observational study where participants with nasopharyngeal carcinoma or head and neck tumors who need radiotherapy will be followed. Plasma SAA1 levels will be measured to explore their ability to predict radiotherapy-induced oral mucositis. The study will track the development, start time, duration, and severity of oral mucositis along with other side effects of radiotherapy and tumor response over a period of up to three years. Participants will be monitored throughout radiotherapy and afterward for up to three years to assess different grades of oral mucositis and other side effects. The study will collect clinical data, observe tumor response, and evaluate plasma SAA1 levels as a biomarker. This long-term observation aims to improve early screening and prevention strategies for radiotherapy-induced oral mucositis, enhancing patient care during and after radiotherapy.

Researchers are conducting a multicenter study involving patients diagnosed with tricuspid regurgitation during hospitalization. The study aims to evaluate the risk factors that affect the prognosis of these patients and to develop models that predict outcomes. The main focus is to understand all-cause death as the primary outcome, alongside cardiovascular events as secondary outcomes. This observational study follows patients over an average of five years to monitor their health outcomes. There are no specific treatment interventions, as the study observes patients health status and events as they occur naturally without assigning any experimental therapies or procedures. Participants will be followed through regular observation during the study period, during which researchers will collect data on mortality, cardiovascular deaths, and hospitalizations for heart failure. The study involves continuous follow-up to track these events and analyze their relationships with risk factors. Total participation may last about five years, allowing detailed long-term monitoring of patient outcomes.