Higashiagatsuma

Researchers are conducting a survey to study patients who have received Ondexxya Intravenous Injection 200 mg to neutralize the anticoagulant effects of Factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. This observational study aims to monitor safety specifications such as thrombotic events, infusion reactions, and re-bleeding, while also understanding the drugs safety and effectiveness under real-world use. The survey collects information about the occurrence of unknown adverse drug reactions, the incidence of adverse reactions during routine use, and factors that might influence the drugs safety or effectiveness. There are no specific treatments or interventions administered as part of the study since it observes patients receiving routine care with Ondexxya. Participants will be monitored for 30 days to document adverse drug reactions and safety-related events, including how patient background factors may affect outcomes. Data collection involves safety and effectiveness information gathered during this period, with no additional procedures or visits beyond standard clinical care. The study is sponsored by AstraZeneca and will continue until October 2026.

Researchers are evaluating the effectiveness and safety of a Software as a Medical Device for treating patients with Post-Traumatic Stress Disorder PTSD. This study involves participants aged 18 to 65 who have been diagnosed with PTSD based on the DSM-5 criteria and who experienced their trauma between 1 and 20 years ago. The trial is designed as a multicenter, randomized, double-blind, parallel-group study to compare different versions of the software device. Participants will be randomly assigned to use one of the two versions of the Software as a Medical Device. The treatment involves interacting with this device over a period that may last up to 21 weeks. The primary focus is to assess changes in PTSD symptoms using a clinician-administered scale specific to PTSD, conducted both at the start of the study and after the intervention period. During the study, participants will undergo evaluations including the Clinician-Administered PTSD Scale for DSM-5 to monitor their symptoms. The researchers will carefully observe safety and how well participants tolerate the device. The study is sponsored by Otsuka Medical Devices Co., Ltd. Japan and is planned to continue until January 2028, with ongoing monitoring throughout the treatment and follow-up periods.