Datong

Researchers are evaluating the safety, tolerability, pharmacokinetics, and immune response of a drug called B1344 in patients with Nonalcoholic Fatty Liver Disease NAFLD. This randomized, double-blind, placebo-controlled trial also observes early signs of how B1344 might work as a treatment for Nonalcoholic Steatohepatitis NASH. The study is conducted across multiple centers and is led by Tasly Biopharmaceuticals Co., Ltd. Participants receive multiple subcutaneous injections of B1344 at varying doses 30 mg and 45 mg weekly, or 60 mg and 90 mg every two weeks. There is also a placebo group receiving injections on the same schedule. The trial is designed with escalating doses to assess different treatment levels safely. During the study, participants will have regular assessments including laboratory tests, MRI scans to measure liver fat, blood tests for liver enzymes and blood sugar control, and monitoring of any side effects. The main outcome measured is the frequency and severity of adverse events over 113 days. Secondary outcomes include drug concentration in the blood, changes in liver fat, triglycerides, body weight, and other metabolic markers, with total participation lasting about 90 to 113 days.

Obese patients often face complex health issues and varied responses to treatment, making long-term management difficult. Bariatric surgery is currently the most effective weight-loss method, but challenges like weight regain and metabolic decline after surgery remain. Glucagon-like peptide-1 receptor agonists GLP-1RA, such as semaglutide, have shown promise in improving weight and metabolism, and combining these with surgery may offer added benefits. This multicenter study aims to evaluate the combined effectiveness of bariatric surgery plus GLP-1RA in diverse regional populations across China. Participants will undergo laparoscopic sleeve gastrectomy and receive nutritional counseling postoperatively. One group will receive weekly subcutaneous semaglutide injections starting one month after surgery, with doses beginning at 0.25 mg and increasing up to 2.4 mg weekly, continuing for six months. The comparison group will have surgery plus basic nutritional recommendations without the drug treatment. Nutritional plans evolve from very low-calorie to calorie-restricted diets over time for all participants. During the study, participants will be monitored at multiple time points including immediately after surgery and at 1, 3, 6, and 12 months postoperatively. Assessments include weight, waist circumference, blood tests for glucose, cholesterol, liver and kidney function, and blood pressure. The main outcome is the percentage of weight loss at one year. Safety and metabolic changes will also be tracked to understand the combined treatments real-world effectiveness over the study period.

Researchers are evaluating the effectiveness and safety of the KPCXM18 injection at different doses for treating acute ischemic stroke. This phase 2 clinical trial uses a multicenter, randomized, double-blind, parallel, placebo-controlled design to compare treatments. The goal is to provide evidence for future studies and understand how the drug behaves in the body through population pharmacokinetic analysis. Participants are assigned to one of three groups a low-dose KPCXM18 injection group receiving 60 mg twice daily, a high-dose group receiving 100 mg twice daily, or a placebo group. All treatments are given by intravenous infusion every 12 hours for about 12 days. Researchers will observe and compare the effects of these doses against placebo to assess benefits and safety. During the study, participants will be monitored closely with assessments including the Modified Rankin Scale to measure disability at days 12, 30, and 90. Additional evaluations include stroke severity using the NIH Stroke Scale and daily functioning by the Barthel Index. The trial spans about three months of follow-up after treatment, with safety and effectiveness tracked throughout. Participants will be involved in regular visits to measure their recovery progress and any side effects.

Researchers are evaluating the safety, tolerability, and early effects of JS207 in adults with advanced non-small cell lung cancer NSCLC who have experienced disease progression after receiving platinum-based chemotherapy and immunotherapy. This phase II trial aims to assess how well JS207 works alone or combined with other treatments in this setting. Participants receive one of three treatments JS207 with docetaxel chemotherapy every three weeks, JS207 with JS004 antibody every three weeks, or JS207 alone at 10mgkg or another dose. These groups allow comparison of different combinations to explore potential benefits and safety profiles. During the study, participants will be monitored for tumor response, disease control, duration of response, progression-free survival, overall survival, and any adverse effects or laboratory abnormalities. These outcomes will be assessed over periods ranging from 1.5 to 2 years to gather comprehensive information about treatment effects and safety.

Researchers are evaluating the efficacy and safety of JS107 compared to investigator-selected therapies as second-line or later treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma. The trial focuses on patients whose tumors are positive for CLDN18.2 and negative for HER2, who have already received at least one prior systemic therapy including fluorouracil and platinum. This is a randomized, controlled, open-label Phase III study enrolling about 560 participants. Participants are randomly assigned in equal numbers to either receive JS107 intravenously at 3 mgkg every 21 days or one of three chemotherapy regimens chosen by investigators irinotecan, paclitaxel, or docetaxel. These chemotherapy drugs are administered according to standard doses and schedules over 21- or 28-day cycles, with premedications given as needed. Treatment continues until disease progression, death, withdrawal, or study termination. During the study, participants will be monitored through imaging assessments to measure progression-free survival and overall survival, with other evaluations including response rates and safety outcomes up to two years or more. Tumor tissue testing for CLDN18.2 positivity is required before enrollment. The study also tracks drug concentrations and immune responses to JS107. Participation may last several years, with follow-up visits to assess treatment effects and adverse events under medical supervision.

Obesity greatly increases the risk of heart failure, and current treatments like caloric restriction, exercise, medications, or surgery may not be suitable for obese patients with heart failure. This research aims to study whether a combined approach using a diet management app and an intelligent weight scale can help obese patients with heart failure and reduced ejection fraction lose weight and improve their heart condition. The trial compares the effectiveness of a fully functional app and scale versus a limited-function version to assess their impact on heart failure outcomes and overall quality of life. Participants are randomly assigned to two groups one using a fully featured diet management app and intelligent weight scale with various monitoring tools and health metrics, and the other using a limited version of both. The full app tracks food intake, exercise, weight, and provides dietary analysis and recommendations, while the full scale measures body composition and vital signs. The limited versions offer fewer features. Participants use the app at every meal and weigh themselves daily for 12 months. During the study, participants will visit the clinic at 12 months for checkups. Researchers will evaluate outcomes such as a composite of death and heart failure hospitalizations over one year, changes in quality of life related to heart failure, and weight change. The trial includes monitoring of heart failure frailty and quality of life assessments at baseline, 3 months, and 1 year, with ongoing safety and condition tracking throughout the study period.

This research aims to validate a previously developed risk prediction model for multidrug-resistant Gram-negative bacterial MDRGNB infections in adult patients admitted to intensive care units ICUs. The multicenter prospective study includes adult ICU patients from 11 different research centers, focusing on predicting MDRGNB infection risk shortly after ICU admission using commonly available clinical data. The study enrolls patients consecutively and generates infection risk predictions within 24 hours of ICU admission without influencing clinical decisions. The prediction models performance is assessed in real-world settings by evaluating its discrimination, calibration, and clinical net benefit using a predefined risk threshold. The study is observational and does not involve any investigational treatments or interventions. Participants undergo routine clinical monitoring, including collecting clinical microbiological specimens within 48 hours of ICU admission. Researchers track the primary outcome of MDRGNB infection occurring within 48 hours after admission. Secondary outcomes include 28-day mortality, organ failure assessment scores at 48 hours, and any antibiotic-related adverse events within 28 days. The study follows patients over this period to assess outcomes without altering standard care.