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Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are conducting an observational study to assess patient satisfaction, effectiveness, and safety of subcutaneous Atezolizumab treatment in people with certain types of lung cancer and hepatocellular carcinoma. The study focuses on participants treated for approved indications in routine clinical practice across multiple countries and centers. It collects primary data on patient-reported outcomes and clinical effectiveness in real-world settings. Participants receive Atezolizumab as prescribed by their doctors for conditions including early-stage non-small cell lung cancer NSCLC after surgery and chemotherapy, metastatic NSCLC, extensive-stage small cell lung cancer ES-SCLC, and advanced or unresectable hepatocellular carcinoma HCC. Atezolizumab administration is at the physicians discretion and is independent of study participation. The study includes several cohorts based on cancer type and stage. During the study, participants report treatment satisfaction using the Therapy Administration Satisfaction Questionnaire Subcutaneous TASQ-SC at cycles 2 and 3, each lasting 3 weeks. Researchers also evaluate overall survival up to about 3.5 years, quality of life with the EORTC QLQ-C30 questionnaire, and record adverse events during the same period. The study aims to monitor patient experience, clinical outcomes, and safety over the long term, with participation lasting several years.

The WILLEM study is a multicenter observational trial focusing on high-risk cardiac patients with arrhythmias or abnormal ECG patterns. It aims to validate a cloud-based AI-powered ECG analysis platform called Willem173, which is designed to detect and predict cardiac abnormalities. The study compares the AI diagnoses with cardiologists evaluations and assesses the platforms ability to delay or avoid severe cardiac events such as sudden death. Participants include patients with relevant cardiac arrhythmias or diseases and at least one ECG record with over one year of follow-up data. Participants are divided into two groups a training group to develop new AI methodologies and a test group to evaluate the AIs performance and avoid overfitting. The AI platform analyzes cardiac electrical signals lasting 10 seconds or more, collected from various devices including hospital ECG machines, Holter monitors, wearable ECG patches, and telemedicine interfaces. Cardiology experts review all data to label arrhythmias and patterns. Both retrospective and prospective patient data are used. During the study, participants provide ECG data and clinical information for analysis. Researchers monitor primary outcomes such as real-time detection of cardiac arrhythmias within minutes of ECG recording. Secondary outcomes include survival, major cardiovascular events, rehospitalization, and quality of life measured one year after the initial ECG or enrollment. Informed consent is obtained from patients or authorized relatives if patients cannot consent themselves. The study is conducted until November 2026, with ongoing data collection and evaluation.

Researchers are evaluating a new approach to prevent heart and blood vessel problems in patients with inflammatory rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and systemic lupus erythematosus. These patients have a 50% higher chance of cardiovascular events compared to the general population, and current risk scores often underestimate their true risk. This phase IV clinical trial aims to test if using carotid ultrasound to detect early artery disease can better identify patients at high risk and improve prevention. Participants aged 50 years and older with inflammatory rheumatic diseases and low-to-moderate cardiovascular risk will be randomly assigned to either receive a carotid ultrasound or follow standard care based on current guidelines. Those in the ultrasound group found to have carotid plaques will be classified as very high risk and started on high-intensity statin therapy to lower LDL cholesterol below 55 mgdL. Patients without plaques and those in the control group will receive care according to the European Society of Cardiology 2021 recommendations. The study will last 48 months with ongoing monitoring. Throughout the study, patients will have regular visits to track their health and treatment effects. Those needing lipid-lowering therapy will have monthly visits during treatment adjustment, then every six months until the study ends. All patients will be monitored for major cardiovascular events such as heart attacks, strokes, and hospitalizations over four years. Safety and side effects will also be evaluated, aiming to see if the ultrasound-based strategy better prevents heart problems compared to standard care.

Researchers are evaluating whether adding Hyperthermic Intraperitoneal Chemotherapy HIPEC with Mitomycin C after complete surgical removal of peritoneal metastases in patients with colon cancer affects the chance of cancer returning in the abdomen. This phase IV clinical trial addresses uncertainties from prior research by focusing on the time patients remain free from peritoneal recurrence rather than overall survival. It excludes rectal cancers and patients with extensive peritoneal disease or incomplete surgery to better understand HIPECs role in this setting. Participants are randomly assigned to one of two groups one receiving complete cytoreductive surgery plus HIPEC with Mitomycin C delivered at 35 mgm2 in a heated peritoneal dialysis solution for 90 minutes with dose fractionation, and the other receiving surgery alone without HIPEC. The study corrects previous trial shortcomings by increasing HIPEC infusion time and limiting patient selection based on cancer spread and surgery completeness. During the trial, participants will be monitored for peritoneal recurrence over three years, with assessments including imaging and disease-free survival measures. Researchers will also track postoperative complications within 90 days after surgery and evaluate quality of life at multiple points before surgery, after chemotherapy, and at one and two years. The trial aims to provide detailed information on recurrence patterns, survival, and patient well-being over three years following treatment.

Researchers are conducting a multicenter, double-blind, placebo-controlled Phase III clinical trial to evaluate inhaled aprotinin in adults with moderate or severe acute respiratory distress syndrome ARDS. ARDS is a serious lung condition causing inflammation, fluid buildup, and severe breathing failure. Despite current supportive care, no specific drug treatment has shown clear benefit, so this study aims to assess if inhaled aprotinin can improve patient outcomes. In this trial, 156 critically ill patients in intensive care units will be randomly assigned to receive either inhaled aprotinin or a placebo, alongside standard supportive treatments. Aprotinin will be given by nebulization through breathing tubes, four times daily at a dose of 500 KIU every six hours for six days. The placebo group will follow an identical schedule. The study uses a double-blind design to keep participants and researchers unaware of group assignments. Participants will be closely monitored during their ICU and hospital stay with regular assessments of breathing, organ function, and inflammation markers. The main measurement is the number of days patients are free from mechanical ventilation within 28 days after treatment starts. Secondary outcomes include survival rates, time spent in ICU or hospital, kidney and heart support needs, and biomarker levels. Safety will be overseen by an independent committee, and follow-up will continue up to 180 days after treatment.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are conducting an international, multicenter, prospective, non-randomized post-market clinical follow-up PMCF study to confirm and support the clinical safety and performance of the Coroflex4 ISAR NEO coronary stent system, which is a sirolimus-eluting stent. This study includes all consecutive patients treated with this stent in a real-world, non-selected population under daily clinical practice to meet EU Medical Device Regulation requirements. Participants receive treatment with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer during their standard care for coronary artery disease or ischemic heart disease. The study observes patients treated with this device without randomization or control groups, focusing on its use in routine medical settings. During the study, participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after the procedure. Additional safety measures during percutaneous coronary intervention PCI will be tracked, such as avoiding stent dislodgement, balloon rupture, hypotube rupture, coronary perforation, coronary dissection, no reflow, and coronary thrombosis. The study involves informed consent and follows patients outcomes under normal clinical conditions until study completion.

Researchers are conducting an observational, multicenter study to collect and analyze medical information from patients diagnosed with advanced metastatic or unresectable melanoma. The study focuses on understanding the characteristics of these patients at their first diagnosis, either as initial metastatic or unresectable disease or as the first metastatic relapse after previous treatment for localized melanoma. This research aims to provide important insights into melanoma progression and treatment patterns in Spain. The study observes patients receiving usual clinical care without assigning any specific treatment or intervention. Treatment decisions are made independently by the patients healthcare providers as part of routine medical practice. Patients included have been diagnosed with stage III, metastatic, or unresectable melanoma since January 8, 2018, and their medical records will be reviewed to gather relevant data. Participants involvement primarily involves the collection of information from their medical records, with no additional diagnostic or follow-up procedures beyond standard care. Researchers will review baseline sample characteristics to understand patient profiles at diagnosis. The study does not involve any direct intervention or changes to treatment and focuses on long-term data collection to support melanoma research and patient care improvements.

Researchers are evaluating the effectiveness and safety of subcutaneous immunotherapy in patients aged 12 to 65 who have mild to moderate rhinitis or rhinoconjunctivitis, with or without mild to moderate asthma, caused by sensitivity to grass and olive pollen. This randomized, double-blind, placebo-controlled phase 3 trial aims to study allergy treatments to improve symptoms and reduce medication use over one year. Participants are randomly assigned to one of three groups one receiving 10,000 TUmL MG01 plus 10,000 TUmL T517, another receiving 30,000 TUmL MG01 plus 10,000 TUmL T517, and a placebo group receiving the same solution without active ingredients. The allergen extracts come from a mixture of grasses and olive pollen, administered through subcutaneous injections. Treatment lasts for one year, evaluating different doses compared to placebo. During the study, participants will regularly record symptoms and medication use using a smartphone app. Researchers will monitor combined symptoms and medication scores as the primary outcome, along with medication-free days, symptom-free days, asthma exacerbations, quality of life tests for rhinitis and asthma, and immune response measures. Safety is closely followed through adverse reaction monitoring and immunological and security parameters over the 12-month treatment period.