Katsushika City

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating the safety and effectiveness of the Double-effect kissing balloon technique W-KBT using Perfusion balloon PB and Drug coated balloon DCB in patients with left main coronary artery disease LMD who have left circumflex artery LCx ostium stenosis. This prospective, observational, multi-center study focuses on patients with stable angina, non-ST-elevation myocardial infarction, or unstable angina who require percutaneous coronary intervention PCI. Patients who meet the selection criteria will receive PCI with W-KBT following crossover stenting for LMT-LAD direction, proximal optimization technique POT, and conventional kissing balloon technique C-KBT as part of usual care. Approximately 280 participants aged 18 and older will be enrolled across 17 sites in Japan. The study will monitor patients through hospital discharge and for 12 months afterward during routine clinical practice. Participants will be followed to assess procedure success during PCI and major adverse cardiovascular events MACE within 12 months. Additional measures include time to ST-change from DCB inflation, total DCB inflation time, changes in blood pressure and heart rate, use of vasopressors or mechanical support after W-KBT, and incidence of ischemia-driven revascularization at the LCx ostium. Data will be collected to evaluate the efficacy and safety of this treatment approach over the year following the procedure.

Researchers are evaluating two different approaches to antithrombotic therapy after Left Atrial Appendage Closure LAAC in people with non-valvular atrial fibrillation who have a high risk of bleeding. The study compares Non-Antithrombotic Therapy NAPT followed by oral anticoagulants OAC monotherapy for 45 days against Single Antiplatelet Therapy SAPT with aspirin. This Phase 4 trial aims to determine if the NAPT approach is not worse than SAPT over an observation period of up to 4 years, focusing on a combination of serious events including death, heart attack, stroke, embolism, and bleeding complications. Participants are randomly assigned to one of two groups the SAPT arm or the NAPT arm, with equal chance of assignment. Both groups start with oral anticoagulants for 45 days after LAAC. After this period, the SAPT group continues with low-dose aspirin, while the NAPT group does not receive further antithrombotic medication for the remainder of the study. The study includes visits at 45 days, 1 year, and 2 years after enrollment, along with telephone follow-ups up to 4 years. During their participation, subjects will undergo clinical evaluations to monitor safety and effectiveness, including imaging tests to check for device-related thrombus at specific intervals. Researchers will track major health events such as mortality, heart attacks, strokes, embolism, and bleeding incidents throughout the study. The study includes regular hospital visits, phone assessments, and ongoing observation, lasting up to 4 years per participant to thoroughly assess long-term outcomes.

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.