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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the protective effects, safety, and immune response of an 11-valent recombinant human papillomavirus (HPV) vaccine called Hansenulapolymorpha in Chinese women aged 18 to 45 years. This Phase III randomized, blinded, placebo-controlled trial involves 13,500 women divided into three age groups: 18-26, 27-35, and 35-45 years. The study aims to assess the incidence of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) associated with various HPV types after vaccination. Participants receive either the 11-valent HPV vaccine or a placebo through intramuscular injections in the upper arm deltoid muscle. The vaccination schedule includes three doses given at 0, 2, and 6 months. The trial compares the vaccine's effects against placebo across the different age groups, following strict immunization timing. During the study, women attend follow-up visits and provide information through diary cards and contact forms. Researchers monitor safety, immune responses, and HPV-related cervical changes, including CIN2+ occurrences one month after the third dose. The trial also includes pregnancy testing before vaccination and requires effective contraception during the study. Total participation includes vaccination and follow-up over approximately six years to evaluate long-term outcomes.
Actively Recruiting
Researchers are studying the effects of normobaric oxygen (NBO) therapy on patients who have experienced an acute ischemic stroke (AIS) and are transferred for endovascular thrombectomy (EVT). The goal is to assess the safety and effectiveness of NBO in improving functional outcomes three months after stroke. Stroke is a major cause of death and disability worldwide, and while treatments like mechanical thrombectomy can improve blood flow, less than half of patients with large vessel occlusion achieve good recovery. NBO offers potential brain protection by improving oxygen delivery to affected areas and reducing damage through multiple mechanisms. Participants will receive either inhaled 100% oxygen (NBO) or best medical care without NBO. The study focuses on patients transferred for EVT who meet specific stroke severity and imaging criteria. NBO treatment is delivered through oxygen inhalation, aiming to increase oxygen availability to the brain before reperfusion. The study is conducted in a Phase 3 setting and compares outcomes between those receiving NBO and those receiving standard care. During the study, participants will be monitored for disability levels using the modified Rankin scale at 90 days and one year after treatment. Assessments include neurological exams and imaging to confirm stroke details and severity. Researchers will also track safety and functional outcomes to evaluate the impact of NBO therapy. Participants are followed for at least three months after randomization to observe recovery and potential benefits.