Shintoku

Researchers are evaluating the safety and effectiveness of ONO-2020 in adults aged 55 to 90 years with agitation linked to Alzheimers Disease dementia. This phase 2a, randomized, placebo-controlled study is conducted across multiple centers in Japan and aims to better understand how ONO-2020 affects agitation symptoms in this population. Participants will be randomly assigned to receive either two ONO-2020 tablets or two placebo tablets once daily. The treatment period lasts up to 12 weeks, during which patients are hospitalized from 21 days before treatment starts through the treatment phase. The study is designed as a double-blind, parallel-group trial to compare ONO-2020 against placebo. Throughout the study, researchers will monitor changes in agitation using the Cohen-Mansfield Agitation Inventory CMAI and assess safety through vital signs, ECG measurements, laboratory tests, and the Columbia-Suicide Severity Rating Scale. Additional assessments include cognitive function tests and daily living activity scores. The study will continue safety monitoring up to 16 weeks, with the primary evaluation of agitation changes by week 12.

Researchers are comparing overall survival in patients with advanced biliary tract cancer receiving different treatment combinations. This phase 3 international study evaluates Futibatinib and Zimberelimab combined with Gemcitabine plus Cisplatin against Durvalumab or Pembrolizumab combined with Gemcitabine plus Cisplatin as first-line therapy for these patients. The study aims to assess which treatment approach may provide better outcomes for this advanced cancer type. Participants will be assigned to one of two groups one receiving Futibatinib orally once daily together with Zimberelimab by intravenous infusion every three weeks, plus Gemcitabine and Cisplatin given intravenously on Days 1 and 8 of each three-week cycle the other group will receive either Durvalumab or Pembrolizumab by intravenous infusion every three weeks alongside Gemcitabine and Cisplatin on the same schedule. Treatments continue with these cycles as per study protocol. During the study, participants will be regularly assessed for overall survival up to approximately 45 months. Additional evaluations include progression-free survival, tumor response rates, duration of response, and monitoring of adverse events. These assessments will be conducted through imaging, biomarker analysis, and clinical examinations to understand treatment effects and safety over time.

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.