Ageo

Crohn's disease is a chronic inflammatory condition affecting the digestive tract that currently has no cure. This research aims to evaluate the safety and effectiveness of upadacitinib in treating moderate to severe active Crohn's disease in a real-world setting in Japan. The study will monitor any adverse events and changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their doctors following local approved guidelines. Around 240 participants will be enrolled, and treatment will be according to each participant's usual clinical care. The study is observational and non-interventional, meaning no additional treatments or procedures beyond standard care will be required. Participants will be followed for up to 64 weeks, with study visits conducted either in person or virtually according to standard care practices. Researchers will assess safety by tracking serious infections related to the drug and monitor disease activity throughout the study period. There is expected to be no extra burden on participants beyond their routine care and assessments.

Significant narrowing of the left main coronary artery is linked to a poor outlook, making accurate assessment of its importance critical for improving patient outcomes. Fractional flow reserve (FFR) is widely used and recommended to evaluate the functional impact of intermediate coronary narrowing in stable angina patients. Optical coherence tomography (OCT) is a newer imaging method with higher resolution and faster image capture than intravascular ultrasound, but its minimal lumen area measurement has not yet been validated against FFR. Coronary computed tomography angiography (CTA) is a noninvasive alternative with good negative predictive value, while computational fluid dynamics allows noninvasive calculation of FFR from CTA images (FFRCT). However, no data currently compare FFRCT accuracy with FFR and OCT measurements for left main stenosis. This study compares OCT-derived minimal lumen area, invasive FFR, and FFRCT in patients with intermediate left main stenosis. Participants with 30% to 80% narrowing of the unprotected left main artery will undergo these diagnostic tests. The study aims to find the best OCT minimal lumen area cutoff and evaluate how well FFRCT identifies significant stenosis compared to the reference FFR value of 0.8 or less. During the study, participants will have multimodal imaging and functional tests including OCT, FFR, CTA, and FFRCT. Researchers will measure and compare these results at the procedure or baseline visit. The study includes adults aged 18 and older who can provide consent. Safety and diagnostic accuracy will be monitored, with a focus on correlations between imaging and functional measurements to improve assessment methods for left main coronary stenosis.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.