Shao Xing Shi

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

This research observes patients who have received Siltartoxatug Injection, a drug used for preventing tetanus after injuries. The study aims to document wound conditions and evaluate the clinical outcomes of tetanus prevention in a large real-world setting. It also focuses on monitoring safety by recording any side effects or serious adverse reactions from the treatment. Participants receive Siltartoxatug Injection following their injury as part of routine care. The study collects detailed information about their injury and wound status at enrollment. There is no comparison group; all participants are observed after receiving this treatment. Participants are followed for 90 days after receiving the injection. During this time, researchers assess whether tetanus develops and track any adverse events. The study uses selective safety data collection to monitor reactions to the drug. This follow-up period helps determine both the effectiveness and safety of the tetanus prevention approach using Siltartoxatug.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating whether troxerutin can help prevent blood clots in adults with mild or severe COVID-19. This Phase 1 trial compares troxerutin to a placebo to understand if it reduces thrombotic events and to assess its safety in this patient group. The study focuses on patients who have tested positive for COVID-19 and experience symptoms ranging from mild to severe pneumonia signs. Participants will receive either oral troxerutin tablets or matching placebo tablets, each taken as 3 tablets (60 mg each) twice daily for 7 days. Some groups will also receive low molecular weight heparin (2000 IU once daily) alongside the tablets. The study includes multiple treatment arms: troxerutin alone, placebo alone, troxerutin plus heparin, and placebo plus heparin. The treatment period lasts 7 days. During the study, participants will visit the clinic on days 1, 4, 7, and 28 for checkups and testing. They will keep a diary to record their symptoms, occurrences of thrombotic events, bleeding events, and type II heparin-induced thrombocytopenia-related issues. The main outcome measured is the number of patients in a prothrombotic state over the 7-day treatment period. Safety and medical problems during treatment will also be closely monitored.

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 studying patients with acute ischemic stroke (AIS) to see if an intelligent navigation system can reduce delays before hospital treatment and improve outcomes after reperfusion therapy. The study addresses the low treatment rates in China due to long delays before and during hospital care. This system is designed specifically for patients who arrive at the hospital on their own, a group that makes up about two-thirds of emergency stroke patients, and who have been less studied in pre-hospital care efforts. The intervention is an intelligent navigation applet integrated into Ali Pay, a widely used platform in China with over 1.1 billion users. This applet includes three main functions: stroke education delivered regularly to users, tools for stroke recognition using questionnaires, voice, and facial recognition, and a hospital recommendation feature that uses real-time traffic and hospital delay data to guide patients to the best stroke center for reperfusion therapy. Participants will be patients diagnosed with AIS who receive reperfusion therapy within 24 hours of stroke onset. Researchers will assess outcomes including functional status measured by the modified Rankin Scale (mRS) 90 days after treatment. The study aims to determine if the applet can shorten pre-hospital delays and improve patient recovery after stroke. Patients transported by emergency medical services or with in-hospital strokes are not included in this study.

Atopic dermatitis is a skin condition that causes rash and itching due to skin inflammation. This research evaluates the real-world use of the drug upadacitinib in adolescents and adults with moderate to severe atopic dermatitis in China. About 1000 participants who have been prescribed upadacitinib by their doctors will take part in this study. Participants will take oral upadacitinib tablets as directed by their doctors following routine clinical practice and local guidelines. The study will not require additional treatments or procedures beyond usual care. Participants will be followed up for about 12 months to monitor their treatment. During the study, participants will attend regular visits at hospitals or clinics according to their usual care schedule. Researchers will collect data on dose changes, drug compliance, and any interruptions or permanent discontinuations of upadacitinib. Patient-reported data will also be gathered through electronic diaries and apps to assess treatment experience and outcomes over the 12-month period.

Researchers are evaluating the combination of anlotinib hydrochloride capsules and penpulimab injection as adjuvant therapy for patients with hepatocellular carcinoma (HCC) at high risk of recurrence after radical surgery or ablation. This phase 3, randomized, double-blind, placebo-controlled study aims to compare this combination treatment against a placebo to assess its effect on recurrence-free survival (RFS). Participants will receive either anlotinib hydrochloride capsules combined with penpulimab injection or matching placebos. The study focuses on patients who have undergone radical excision or ablation (radio frequency or microwave) within 4 to 12 weeks before randomization and have high risk factors for recurrence. The investigational drugs target multiple pathways: anlotinib hydrochloride as a multitargeted receptor tyrosine kinase inhibitor and penpulimab as an antibody targeting PD-1. Throughout the study, participants will be monitored for recurrence-free survival up to 3 years from baseline. Eligibility assessments ensure participants have no extrahepatic metastasis or vascular invasion and have recovered from surgery or ablation. The study includes careful tracking of disease status and safety, with follow-up visits to evaluate the treatment's impact on preventing cancer recurrence over time.

Researchers are evaluating the safety and effectiveness of a pulsed electric field ablation system for treating symptoms of chronic bronchitis in adults with moderate to severe chronic obstructive pulmonary disease (COPD). This prospective, randomized, parallel-group, sham-controlled, multicenter trial plans to enroll 210 patients. Participants will be randomized in a 2:1 ratio to either the treatment group receiving the active device or a sham procedure group. The treatment involves bronchial rheoplasty, a staged procedure where pulsed electric fields are applied first to the right lung and then about one month later to the left lung. The sham group undergoes the same catheter insertion steps without delivery of energy. Both groups receive these staged interventions approximately one month apart. During the study, participants will be monitored over six months, with evaluations including the COPD Assessment Test (CAT) score as the primary outcome. Researchers will assess patient responses through clinical follow-ups and measure changes in symptoms. The study also includes safety monitoring and requires participants to adhere to scheduled bronchoscopies and assessments throughout the trial period.