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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of two different inhaled oxygen concentrations on lung function in older patients undergoing laparoscopic gastrointestinal surgery under general anesthesia. This multicenter, prospective, randomized controlled clinical study involves patients aged 65 years and older at 19 centers in China. The aim is to compare low oxygen concentration (40%) versus high oxygen concentration (80%) during surgery using a lung-protective ventilation strategy. Participants will be randomly assigned in a 1:1 ratio to receive either 40% or 80% fraction of inspired oxygen (FiO2) during surgery. The total gas flow rate will be set at 2 liters per minute. All patients will have ventilation managed with tidal volumes of 6-8 ml/kg, positive end-expiratory pressure (PEEP) of 6-8 cmH2O, and a respiratory rate adjusted to maintain carbon dioxide levels between 35-45 mmHg. Lung recruitment maneuvers will be performed after intubation and before extubation. Patients are expected to be extubated in the operating room. During the study, researchers will assess the oxygenation index 48 hours after surgery as the primary outcome. Secondary outcomes include pulmonary complications within seven days after surgery and mortality rates within 30 days. The study plans to enroll 1098 patients. Safety and lung function will be closely monitored through these measures during the postoperative period.
Actively Recruiting
Researchers are conducting a Phase IIIb extension trial to study long-term treatment with hydronidone capsules in patients with chronic viral hepatitis B who have liver fibrosis. Liver fibrosis currently lacks effective chemical or biological treatments, and the study aims to evaluate the safety and effectiveness of hydronidone capsules in reducing fibrosis severity and preventing clinical endpoint events such as cirrhosis, liver cancer, or liver-related complications. This trial follows a previous Phase III randomized, double-blind, placebo-controlled study. Participants receive either hydronidone capsules or placebo capsules three times daily, each dose containing 3 capsules, for a total daily dose of 270 mg of hydronidone in the treatment group. Both groups also receive entecavir antiviral therapy once daily at 0.5 mg, or an alternative antiviral as decided by the investigator if entecavir is unsuitable. Medications are taken half an hour before meals. Treatment and observation continue for 5 years to assess long-term outcomes. During the study, participants undergo clinical laboratory tests including routine ALT and AST every 6 months or as appropriate, HBV DNA testing, hepatitis B assessments, and transient elastography to monitor liver status. The frequency and types of examinations may be adjusted to improve adherence but will not be reduced more than once per year. The main outcome measure is the cumulative incidence of clinical endpoint events over 5 years. Safety and treatment effects will be closely monitored throughout the extended treatment period.