Jie Yang Shi

Researchers are evaluating patients diagnosed with aortic valve disease, including aortic insufficiency and aortic valve stenosis, during hospitalization. The study aims to identify risk factors linked to prognosis and develop a model to help guide clinical decisions. The main focus is on all-cause death, with cardiovascular events as a secondary outcome. This multicenter cohort study involves observing patients over time without specific treatments or interventions assigned. It mainly tracks health outcomes and risk factors related to aortic valve disease to build a prognosis model. Participants will be followed up to observe their health outcomes, especially mortality and cardiovascular events. Researchers will collect data to evaluate risk factors and create a prognostic model that could assist future clinical decision-making. The total follow-up duration is not specified, but the study observes patients from diagnosis through to death or the end of the study period.

People with end stage kidney disease (ESKD) who require dialysis have a much higher risk of developing cardiovascular disease compared to the general population, with heart problems causing over half of the deaths in this group. This trial is studying whether taking low dose aspirin daily can safely reduce cardiovascular events in these dialysis patients. The study is a Phase 4, multi-center, randomized controlled trial designed to provide clear evidence about aspirin's benefits and risks in this specific population, where existing data is limited. Participants will be randomly assigned to receive either a daily 100 mg aspirin tablet or a matching placebo. The trial uses the Chinese peritoneal dialysis and hemodialysis registry to efficiently screen and recruit patients and collect data during routine dialysis care. Follow-up visits occur every six months as part of regular clinical care, and the study will continue until enough cardiovascular events have occurred, expected to take about five years. During the study, participants will have their health monitored through routine clinic visits every six months, with data collected on cardiovascular events and safety. The main outcome measured is the number of participants experiencing major cardiovascular events over the study period. An independent board will oversee safety and study progress. The trial uses intention-to-treat analysis and aims to minimize participant burden by integrating study procedures into usual care.

Radiation oropharyngeal mucositis is a painful side effect experienced by patients undergoing radiotherapy for head and neck tumors. The study aims to evaluate and compare the consistency of different doctors in assessing this condition using a new classification system based on four stages of acute radiation injury versus traditional grading methods. The research also explores changes in blood markers related to the different types of mucositis using leftover clinical blood samples. This is an observational study with no extra visits or tests beyond routine clinical care. Patients' clinical diagnosis and treatment information will be collected after they provide informed consent. The study has three parts: comparing assessment consistency among different grading methods, determining internal consistency among doctors for each method, and comparing the new classification method's results with patients' self-assessments. Patients may be assessed every 1-2 weeks during their radiotherapy treatment. Participants will be involved in routine clinical evaluations during radiotherapy, with doctors assessing mucositis multiple times at the same stage to measure agreement between assessments. Researchers will analyze the consistency of grading results among methods and doctors, and compare doctor assessments to patient self-assessments. The primary outcome is inter-rater consistency among doctors throughout the study, which may last up to 3 years.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

Rheumatoid arthritis (RA) is a common cause of disability, especially among Chinese women. This trial focuses on a specific type of RA called synovial myeloid stromal RA, which tends to be more severe and have worse outcomes. Researchers aim to evaluate whether early intensified treatment based on synovial pathology classification can improve treatment outcomes compared to standard treatment. The study is a randomized, controlled, open-label, multicenter clinical trial involving adult patients with moderate to severe active RA who have this synovial type. Participants are randomly assigned to one of two groups. The intensive treatment group receives methotrexate combined with tofacitinib, a Janus kinase inhibitor, while the conventional treatment group receives methotrexate alone. The intervention period lasts 12 weeks, followed by a 48-week follow-up to monitor long-term effects. This design allows comparison of early combination therapy against standard methotrexate monotherapy for controlling disease activity and preventing joint damage. Throughout the study, patients will undergo assessments of disease activity, joint function, and safety at multiple time points. The main measure is the proportion of patients achieving at least 20% improvement in RA symptoms (ACR20) after 12 weeks. Secondary measures include changes in disease activity, joint function, safety evaluations, and the rate of joint destruction progression after 48 weeks. Researchers will also explore blood biomarkers through proteomics to support precise diagnosis. Participants are closely monitored for side effects and treatment adherence during the entire study period.

Researchers are investigating the safety and effectiveness of QLG2198 in adult Chinese patients undergoing hemodialysis who experience moderate-to-severe uremic pruritus, a condition characterized by intense itching. This phase 3, multicenter study aims to compare QLG2198 to a placebo in reducing itch intensity. Participants must have chronic kidney disease and be on hemodialysis three times a week for at least 12 weeks before joining the study. The study lasts approximately 31 to 32 weeks for each participant, beginning with a 4-week screening period. Following screening, there is a 12-week double-blind phase where participants receive either QLG2198 (0.5 micrograms per kilogram of dry body weight) or placebo intravenously three times a week at the end of each dialysis session. After this, a 14-week open-label extension phase follows, during which all participants receive QLG2198 under the same dosing schedule. The study concludes with a 1-week follow-up period. Participants will be monitored regularly throughout the study, including assessments of itch severity using the Worst Itch Numeric Rating Scale at week 4 of the double-blind phase. Researchers will also evaluate safety and collect data on treatment adherence. The study includes thorough screening and follow-up to ensure participant well-being and to measure changes in itch intensity accurately over the course of treatment.

Immune checkpoint inhibitors have brought important advances in cancer treatment by improving patient survival. However, some patients experience rapid tumor growth early in immunotherapy, known as hyperprogression, which severely worsens quality of life and lacks effective treatment options. Early detection of patients at high risk for hyperprogression is crucial, but there are currently no reliable biomarkers for this purpose. Researchers found that the protein SAA1 was significantly increased in patients with hyperprogression across various cancers and may serve as an effective predictive marker. This study is a multicenter, prospective cohort trial designed to confirm if plasma and tissue levels of SAA1 can reliably predict hyperprogression in patients undergoing immunotherapy for different types of cancer. Eligible participants are adults diagnosed with certain cancers and planned to receive immune checkpoint inhibitors. There are no interventions or treatments assigned by the study; rather, researchers will observe and analyze SAA1 levels in clinical tissue and blood samples. Participants will be monitored over two years to assess the occurrence of hyperprogression. Researchers will collect and analyze clinical samples and data to evaluate the relationship between SAA1 levels and tumor growth acceleration. The study aims to improve early identification of high-risk patients to better guide future treatment strategies and improve patient outcomes.

Researchers are investigating the role of plasma Serum Amyloid A1 (SAA1) levels in predicting radiotherapy-induced oral mucositis (RIOM) among patients with head and neck squamous cell carcinoma (SCC) and nasopharyngeal carcinoma. Head and neck SCC is a common cancer worldwide with high incidence and mortality. Radiotherapy is a key treatment but often causes acute inflammatory reactions like oral mucositis, which negatively impacts patients' quality of life and treatment effectiveness. Previous studies suggested that SAA1, an inflammation-related protein, may serve as a biomarker for early radiation damage. This is a prospective, multicenter, observational study focusing on plasma SAA1 levels in patients undergoing radiotherapy for head and neck cancers. The study aims to explore the predictive power of SAA1 for the development of RIOM to enable early screening and prevention. Participants will be monitored throughout their radiotherapy treatment and followed for up to 3 years to assess the severity of oral mucositis using different grading scales. Participants will be adults diagnosed with nasopharyngeal carcinoma or other head and neck tumors requiring radiotherapy, with good performance status (ECOG 0 or 1). They will undergo regular assessments of oral mucositis severity during and after radiotherapy. Researchers will measure plasma SAA1 levels as a biomarker and track outcomes up to 3 years after study enrollment. The study focuses on safety, adherence, and long-term monitoring of radiotherapy side effects.

This research focuses on patients diagnosed with tricuspid regurgitation during hospitalization. It is a multicenter cohort study aiming to evaluate risk factors that affect prognosis and to develop prognostic models for this condition. The main goal is to study all causes of death, with cardiovascular events as a secondary focus. The study does not involve specific treatments or interventions but follows patients over time to observe their health outcomes. Participants diagnosed with tricuspid regurgitation will be tracked through follow-up observations to gather data on their condition and related health events. Participants will be monitored for an average of 5 years to assess all-cause mortality and cardiovascular events. Researchers will collect information over this period to understand risk factors and build models predicting prognosis. The study ensures ongoing observation to support these objectives.