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Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are investigating the best way to assess the severity of intermediate narrowing in the left main coronary artery, which is linked to poor outcomes. The study compares three methods optical coherence tomography OCT derived minimal lumen area MLA, invasive fractional flow reserve FFR, and noninvasive computed tomography angiography-based FFR FFRCT. This research aims to find the optimal OCT-MLA cut-off and evaluate FFRCTs diagnostic accuracy against FFR as the reference standard. Participants undergo a multimodality assessment including OCT, invasive FFR, coronary computed tomography angiography CTA, and FFRCT. OCT is a newer imaging technique with higher resolution than IVUS, while FFR measures blood flow impact on lesions invasively. FFRCT uses computational fluid dynamics to predict blood flow noninvasively from CTA images. The study compares these methods specifically for intermediate left main stenosis to determine their accuracy and usefulness. During the procedure visit, participants receive OCT, FFR, CTA, and FFRCT assessments to measure coronary artery narrowing and blood flow. Researchers collect multiple measurements and compare the results. Clinical outcomes are also followed for one year. This includes monitoring symptoms, imaging, and other clinical endpoints to evaluate the diagnostic methods predictive value and safety. The total participation timeline includes baseline procedure assessments and a one-year follow-up period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are conducting a Phase III, multisite, randomized, double-blinded trial to compare pumitamig BNT327 combined with chemotherapy etoposide and carboplatin against atezolizumab combined with the same chemotherapy in participants with previously untreated extensive-stage small-cell lung cancer ES-SCLC. The study aims to evaluate treatment safety and effectiveness, including overall survival and progression-free survival. The study includes two stages Stage 1 has two treatment arms with different doses of pumitamig and one control arm receiving atezolizumab, while Stage 2 has one treatment arm with a different pumitamig dose and a control arm. Treatment involves intravenous infusions of the study drugs and chemotherapy. Participants may switch from carboplatin to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period, an induction and maintenance treatment period lasting up to 2 years or until disease progression or other endpoints, followed by a safety and survival follow-up phase. Participants undergo screening for eligibility before randomization. During the study, researchers monitor overall survival up to approximately 46 months, progression-free survival, response rates, adverse events, and quality of life through questionnaires. Safety follow-up visits occur after treatment ends. The total participation time may extend over several years, including treatment and follow-up assessments to evaluate long-term outcomes and safety.

Researchers are studying first-line treatment options for participants with non-small cell lung cancer NSCLC in this Phase 23, multisite, randomized, open-label trial. The study includes two substudies based on NSCLC histological subtypes, which have different chemotherapy standards. This design allows evaluation of pumitamig BNT327 combined with chemotherapy and other investigational agents in participants with advanced NSCLC who have not received prior systemic treatment. Participants are randomized to receive one of two dose levels of pumitamig plus chemotherapy during the Phase 2 part of each substudy. In Phase 3, an independent data monitoring committee and a blinded independent central review will oversee safety and tumor assessments. Treatments include pumitamig combined with carboplatin and either pemetrexed or paclitaxel, or pembrolizumab with the same chemotherapies as active comparators. All drugs are given by intravenous infusion. The study period for each participant may last up to 64 months. Throughout the study, participants undergo regular tumor assessments and safety monitoring, including evaluation of adverse events, response rates, progression-free survival, and quality of life using validated questionnaires. Data on dose adjustments and treatment discontinuations are collected. Follow-up continues up to five years to assess long-term outcomes and survival. Participants receive detailed evaluations to understand treatment effects and safety over time in this comprehensive lung cancer trial.