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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.
Actively Recruiting
Researchers are working to develop a decision support system that helps emergency medical service (EMS) personnel assess patients who have chest pain before they reach the hospital. The study focuses on evaluating a machine learning model that aims to improve decision making for these patients by identifying time-sensitive conditions like heart attacks and strokes. Prehospital care is evolving to ensure patients receive the right level of care quickly, balancing the need for urgent hospital treatment against safe alternatives like primary care or self-care advice. Participants will be monitored using routine data collected at the scene, including responses to questions about medical history and pain characteristics. In addition, one blood sample will be taken to measure troponin and glucose levels, either from a capillary sample or a venous sample if a catheter is already in place. The blood tests are analyzed immediately, and results are recorded in the clinical report form. The study does not change the standard care patients receive, which typically involves transport to the emergency department for further evaluation. During the study, participants will respond to questions asked by ambulance nurses and consent to data collection from medical records and blood testing. Researchers will monitor patient outcomes, including serious events and death, from the time EMS is contacted through follow-up periods ranging from one day up to 100 days. The study aims to validate and improve the decision support model to enhance patient safety and optimize care pathways for people experiencing chest pain.
Actively Recruiting
Researchers are evaluating the effects and mechanisms of different patient education methods for individuals aged 50 years and older diagnosed with osteoporosis or osteopenia. The study aims to compare three types of educational interventions to see how they influence osteoporosis-specific self-care, quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain. This randomized clinical trial includes three groups to understand which education approach may best support patients in managing their condition. Participants are assigned to one of three groups: a control group receiving general osteoporosis information from healthcare services via an open website; a face-to-face education group attending three two-hour sessions led by physiotherapists and a physician or nurse over 3 to 5 weeks; and a digital education group accessing an internet-based program with nine modules available over a year. The digital program includes text, images, videos, exercises, quizzes, and checklists, with adherence monitored through module access and session attendance. During the study, participants complete questionnaires and physical assessments at the start, then again at 3 and 12 months. Some participants also wear accelerometers to objectively measure physical activity and sedentary behavior at these times. The main outcome measured is osteoporosis-specific self-care using the OsCare Questionnaire from baseline to 12 months. The study tracks adherence, health outcomes, and safety over one year to better understand how patient education impacts osteoporosis management.
Actively Recruiting
Suicide is the leading cause of death among 10-18-year-olds in Sweden, with suicide attempts being the strongest predictor of later suicide death. These attempts often result in inpatient care and significant societal costs. There is currently no evidence-based treatment targeting suicidal behavior across diagnoses, so the Safe Alternatives for Teens and Youths (SAFETY) program was developed as a family-based cognitive-behavioral suicide prevention intervention that shows promise but requires further study. This research evaluates the SAFETY intervention's effectiveness, durability, and cost-effectiveness compared to Enhanced Treatment As Usual (E-TAU), which includes safety planning, in a single-blind randomized controlled trial. The intervention is offered immediately following a youth suicide attempt. The study measures outcomes at multiple time points, including pre-treatment, immediately post-treatment, and at 3, 12, 24, and 60 months after treatment. Participants will be assessed for suicide attempts using the Columbia-Suicide Severity Rating Scale and electronic medical records at these intervals. Secondary outcomes include nonsuicidal self-injury, global functioning, anxiety, depression, and hopelessness, with evaluations of treatment predictors, moderators, and mediators. Long-term follow-up data will also include psychiatric disorders, health care use, medication prescriptions, employment, and academic performance from registries.