Tai Zhou Shi

Radiation pneumonitis is a significant side effect of thoracic radiotherapy that can impact patients' quality of life, survival, and the effectiveness of tumor treatment. This study aims to identify biomarkers such as serum proteins, gene expression, genetic changes, and epigenetic modifications that may predict radiation pneumonitis. It also explores the relationship between radiation pneumonitis and other radiotherapy-induced toxicities and seeks to build a predictive model for radiation pneumonitis while evaluating patient survival and treatment outcomes. The study collects clinical data, CT images, and blood samples from lung cancer patients treated with thoracic radiotherapy at three hospitals. Blood samples are taken before, during, and after radiotherapy to analyze biomarkers. Patients are followed during treatment, one month after, every three months for the first year, and every six months thereafter. At each follow-up, chest CT scans and clinical information are collected. Radiation pneumonitis and other toxicities are graded by radiation oncologists using standard criteria. The study uses advanced analysis methods to identify biomarkers and build predictive models using clinical data, imaging, and biomarkers. Participants will undergo regular imaging and clinical assessments to monitor radiation pneumonitis and other side effects. Researchers will analyze survival status, symptoms, and treatment outcomes over time, with primary outcomes measured at 12 months for radiation pneumonitis and at 5 years for overall survival. The study also investigates the impact of radiation pneumonitis on patient survival and cancer treatment effectiveness, aiming to improve understanding and prediction of this condition in lung cancer patients receiving thoracic radiotherapy.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.

Researchers are evaluating the efficacy and safety of orelabrutinib in adults with systemic lupus erythematosus (SLE) who are already receiving standard care treatments. This phase IIb, randomized, double-blind, placebo-controlled, multicenter study aims to better understand how different doses of orelabrutinib work in managing SLE symptoms and improving patient outcomes. Participants will be randomly assigned to receive either a low dose or a high dose of orelabrutinib, or a placebo, all taken orally once daily along with their standard of care therapy. The study compares these different treatment groups to assess the effects of the drug over time while maintaining current SLE treatments. The treatment phase includes ongoing oral administration of the assigned intervention combined with standard care. During the study, participants will undergo various assessments including measurement of the SLE Responder Index (SRI) at week 48 to evaluate treatment response. Researchers will monitor safety and efficacy through clinical evaluations and laboratory tests. The total participation period includes screening, treatment, and follow-up, allowing detailed observation of the drug's impact and participant health over several months.

Researchers are evaluating the long-term safety, effectiveness, and immune response of two doses of TQH2722 injection in adults with severe chronic sinusitis, with or without nasal polyps. This multicenter, randomized Phase II expansion trial focuses on people aged 18 to 75 who have previously participated in a related TQH2722 study. The study aims to better understand how TQH2722, a fully human monoclonal antibody that affects certain cell signals, may help manage chronic sinusitis over extended periods. Participants receive either 300mg or 600mg doses of TQH2722 injection. The trial continues from prior treatment phases, allowing participants who completed earlier parts of the study or withdrew for reasons other than side effects related to TQH2722 to enroll. During the study, participants maintain stable doses of nasal glucocorticoids, specifically Mometasone furoate nasal spray, if they had been using other nasal steroids before screening. The study includes careful monitoring of safety and treatment effects over a long-term period. Throughout the study, participants undergo assessments for adverse events and treatment effects up to 32 weeks. Safety is closely monitored, including laboratory tests and clinical evaluations. Researchers track any new or worsening symptoms and measure immune response to TQH2722. Participants agree to use effective contraception during the study and avoid family planning for six months from consent through the last dose. This comprehensive approach helps ensure participant safety while collecting important data on long-term treatment with TQH2722.

Researchers are evaluating a smartwatch-based, multi-faceted cardiovascular health intervention for overweight or obese adults with prehypertension, prediabetes, or borderline dyslipidemia. This trial aims to provide practical guidance for preventing and managing cardiovascular risks in this population by comparing a comprehensive behavioral intervention model to usual care. The study uses a prospective, multicenter, cluster randomized controlled design involving about 1,400 participants from urban and rural clusters across three regions. Participants in the intervention group receive a 6-month intensive phase using smartwatches and a WeChat mini-program to support exercise, diet, and health monitoring, along with face-to-face health education. This is followed by a 6-month maintenance phase with self-management support via smart devices and continued face-to-face education. The control group receives face-to-face health education only throughout the study. Follow-up visits occur at 3, 6, and 12 months from baseline. During the trial, participants undergo assessments of cardiovascular health factors including diet, physical activity, smoking, sleep, body measurements, blood lipids, glucose, and blood pressure. The primary outcome is the change in Life's Essential 8 risk score after 6 months. Secondary outcomes include changes at 12 months and improvements in each risk factor. Health education manuals, data collection, and personalized interventions are provided, with ongoing monitoring and support from healthcare providers to help manage cardiovascular risk.

Disease recurrence and spread are common after curative treatment for esophageal cancer. Identifying risk factors that predict recurrence and metastasis is important. Pleural lavage cytology (PLC) has been linked to recurrence and survival in lung cancer, but its role in esophageal cancer is unclear. This study aims to evaluate the frequency of positive PLC, its association with patient survival, and the effectiveness of postoperative treatment in esophageal cancer patients. PLC will be performed twice: once before the tumor is removed and once after esophageal resection surgery. The study will determine how often PLC is positive and assess its value for patients with resectable esophageal cancer. The focus is on patients who are eligible for surgery with the goal of complete tumor removal (R0 resection). Participants will undergo pleural lavage cytology before and after surgery. Researchers will track the number of patients with positive PLC results from July 2022 to July 2023. The study will monitor survival outcomes and the impact of postoperative treatments. This observational approach helps understand PLC's role in managing esophageal cancer over the study period.