Xing Tai Shi

Researchers are evaluating the efficacy and safety of a drug called B007 compared to Cyclosporin in treating Primary Membranous Nephropathy, a kidney condition confirmed by biopsy. This study is a multicenter, randomized, controlled, open-label trial in phase II/III, focusing on patients aged 18 to 80 years with certain kidney function levels and proteinuria. Participants will receive either B007 via subcutaneous injections on days 1 and 15 or oral Cyclosporin capsules dosed at 3.5 mg per kg per day. The study includes screening to confirm eligibility, treatment administration, and monitoring for approximately two years to evaluate overall remission rates. Throughout the trial, participants will be monitored with laboratory tests to meet study standards and ensure safety. Researchers will assess kidney function, protein levels in urine, and remission rates over about two years. Safety will be followed closely, including checking for allergies, infections, and adherence to the treatment protocol.

Researchers are evaluating the safety and effectiveness of combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

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 the effectiveness and safety of BL-M07D1 with or without Pertuzumab compared to Taxane plus Trastuzumab and Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. This phase II/III, randomized, open, multicenter study involves women aged 18 to 75 years with confirmed HER2-positive invasive breast cancer at clinical stages II-III. The study aims to assess pathological complete response rates over approximately 48 months. Participants receive BL-M07D1 and Pertuzumab administered by intravenous infusion every three weeks. The study consists of a single-arm phase II segment and a randomized controlled phase III segment comparing the investigational treatments with standard therapy. Surgery, either mastectomy or breast-conserving, is planned after neoadjuvant therapy, with timing carefully coordinated with treatment completion. During the study, participants will undergo assessments including hormone receptor status confirmation, physical health evaluations, and organ function tests. Researchers will monitor treatment response, adverse events, and survival outcomes. Participants must use effective contraception if of childbearing potential. The study includes safety monitoring and follow-up over the course of treatment and up to 48 months post-treatment.

Researchers are evaluating the safety and effectiveness of a drug called GB491 combined with Letrozole compared to a placebo combined with Letrozole in treating patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. This study focuses on patients who have not received prior systemic antitumor therapy for this condition. It is a phase III randomized, double-blind, placebo-controlled trial designed to provide important information about treatment options for this group of breast cancer patients. Participants are randomly assigned to one of two groups: one receiving GB491 150 mg orally twice daily plus Letrozole 2.5 mg orally once daily, and the other receiving a placebo orally twice daily plus Letrozole 2.5 mg orally once daily. Treatment cycles last 28 days, starting from the first day of cycle 1. The study compares the combined treatment effects over time, focusing on progression-free survival and safety outcomes. Throughout the study, researchers will monitor participants for progression-free survival using established criteria for about 60 months. They will also assess safety and organ function, with required laboratory tests and clinical evaluations. Participants must meet specific eligibility criteria at the start and provide informed consent. The study aims to gather detailed data on how well the treatments work and their safety profiles over the extended follow-up period.

Researchers are evaluating the efficacy and safety of Lianxiaxiaopi Granules in treating adults with postprandial distress syndrome (a condition involving discomfort after eating). The study aims to determine if Lianxiaxiaopi Granules work better than a placebo in improving symptoms and to assess the safety of this treatment in people aged 18 to 65 years. Participants will be randomly assigned to take either Lianxiaxiaopi Granules or a placebo. Both groups will take one sachet orally three times a day for eight weeks. This phase III clinical trial uses a double-blind, placebo-controlled design to compare the treatment effects. During the study, researchers will monitor symptoms and response rates related to postprandial distress syndrome at the end of eight weeks. Participants will be evaluated through clinical assessments to measure symptom improvement and safety. The total participation time corresponds to the 8-week treatment period.

Researchers are evaluating the efficacy and safety of Antiwei granules for treating the common cold, specifically the wind-cold syndrome type. This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess how well Antiwei granules work and how safe they are for adults aged 18 to 65 who have had a recent onset of the common cold. Participants will be randomly assigned to receive either Antiwei granules or a placebo. Both groups will take oral doses of 1 sack (6g) three times daily for a total of 9 sacks over a 3-day treatment period. The study compares the effects of the active granules versus placebo on cold symptoms. During the trial, participants will be monitored closely with assessments focusing on the cure rate after 3 days of treatment. Researchers will track symptoms and safety throughout the short treatment period. The total study duration for each participant is about 3 days, during which the effectiveness and any side effects of the treatment will be recorded and analyzed.

Researchers are evaluating the safety and effectiveness of a carotid artery stent system in patients with carotid artery stenosis who have high-risk features for carotid endarterectomy. This prospective, multicenter, single-group study is being conducted at about 10 interventional neurology centers in China and involves using a stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. The primary goal is to monitor for stroke, heart attack, or death within 30 days after the procedure and ischemic stroke in the treated artery area between 31 and 365 days post-procedure. The study uses a carotid artery stent system made of a nitinol self-expanding stent delivered by a device designed to accommodate a guidewire. Eligible patients undergo the stenting procedure to treat narrowing in the carotid artery or its branches. There are no comparison groups, as this is a single-group study focusing on evaluating the device's performance in patients considered high-risk for traditional surgery. Participants will be closely followed for up to one year after their procedure. Researchers will assess outcomes such as stroke, heart attack, and death during this period. Evaluations include imaging studies like carotid ultrasound and angiography before and during the procedure. The study also involves regular safety monitoring and collecting data on any adverse events. Participants provide informed consent and agree to attend follow-up visits as scheduled.

Researchers are evaluating the effectiveness of treatments for acute traumatic brain injury (TBI) in multiple hospitals within the Beijing-Tianjin-Hebei region. This prospective, multicenter, observational cohort study aims to create a detailed database including hospital treatment capabilities and patient data such as neuroimaging, clinical progress, and rehabilitation outcomes. The study seeks to improve treatment strategies by comparing current outcomes and developing optimized clinical protocols to reduce mortality and disability among TBI patients. The study will enroll 2,000 patients aged 1 to 89 years with clinically confirmed traumatic brain injury verified by CT or MRI scans. The research is divided into two phases: the first phase surveys treatment outcomes and compares effectiveness across hospitals, while subsequent phases will implement and assess optimized treatment methods. Patients will undergo evaluations of neurological function using the Glasgow Coma Scale and Extended Glasgow Outcome Scale, as well as assessments of mental state, cognitive function, and quality of life through questionnaires like the Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9. Participants will have peripheral blood samples and hematoma-related tissues collected for analysis. Researchers will monitor patient progress for up to 12 months post-injury, measuring outcomes primarily by the Extended Glasgow Outcome Score. Secondary measures include assessments of anxiety, depression, post-concussion symptoms, PTSD, cognitive screening, and quality of life. This comprehensive follow-up aims to track clinical effectiveness, rehabilitation success, and long-term recovery in TBI patients.

Researchers are evaluating the effectiveness of drug-eluting stents combined with aggressive medical treatment compared to standard medical treatment alone in preventing stroke recurrence within one year for patients with symptomatic intracranial atherosclerotic disease. This prospective, multi-center, randomized trial focuses on patients who have experienced ischemic stroke related to severe narrowing of major intracranial arteries. The study aims to assess stroke and death rates within 30 days of enrollment or revascularization procedures, as well as ischemic strokes occurring up to one year after enrollment. Participants are randomly assigned to receive either a drug-eluting sirolimus stent implanted using a balloon-expandable system along with aggressive medical treatment or standard medical treatment alone. Aggressive treatment includes dual antiplatelet therapy with aspirin plus clopidogrel or ticagrelor for six months, while standard treatment involves similar medications for three months. Both groups receive risk factor management addressing hypertension, diabetes, lipid metabolism, smoking, and exercise. The stent system features a rapid exchange catheter with a semi-compliant balloon for intracranial artery treatment. During the study, participants undergo regular monitoring to track any strokes, death, or bleeding complications over 12 months. Key assessments include clinical evaluations and safety monitoring for bleeding severity using the GUSTO score. The trial measures the occurrence of stroke or death within the first 30 days after enrollment or revascularization and ischemic strokes in the treated artery territory from 31 days to one year. The total follow-up period lasts 12 months to evaluate the long-term outcomes of these treatments.