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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating the risk of serious heart-related problems in older men with advanced prostate cancer who have been treated with the medicines darolutamide or enzalutamide. Prostate cancer is a common and serious illness in men, and while these medicines help control the disease, they may also increase the chance of heart attacks, strokes, or death from heart and blood vessel disease. The study aims to compare how often these serious heart events occur between the two treatments and to identify which patients may be at higher risk. This observational study uses existing healthcare data from men aged 55 years and older in the United States who have already received either darolutamide or enzalutamide as part of their routine care for advanced prostate cancer. Participants are grouped based on their treatment and diagnosis of metastatic hormone-sensitive prostate cancer or non-metastatic castrate resistant prostate cancer. Since this is a retrospective database study, no new treatments, extra visits, blood tests, or health check-ups are required. Participants are not required to attend any study visits as the research analyzes past medical records. Researchers will measure the rates of major cardiovascular events such as heart attacks and strokes, and assess risk factors for these events using data collected from August 2018 through December 2025 or the most recent available. The study is supported by Bayer and aims to improve understanding of heart-related risks associated with these prostate cancer treatments.
Actively Recruiting
Researchers are studying people in Asia and the United States who have chronic kidney disease CKD along with type 2 diabetes T2D to understand more about the use, safety, and effectiveness of the treatment finerenone in real-world settings. CKD is a long-term condition where the kidneys progressively lose function, and T2D is a condition where the body does not produce or use insulin properly, leading to high blood sugar that can damage the kidneys. Finerenone blocks certain proteins called mineralocorticoid receptors, which may help protect the kidneys, heart, and blood vessels. It was recently approved for use in the US, and this observational study aims to collect information on people receiving finerenone as part of their regular care. The study uses data from commercial electronic health records and national claims databases in Asia and the US, covering the period from July 1, 2021, to the most recent available data. Participants are adults with CKD and T2D who have started finerenone treatment prescribed by their doctors. Since this is an observational study, no new treatments or interventions are given by the researchers. Instead, the study collects existing data on participants, including their kidney function, heart health, other medical conditions, and medications used while on finerenone. Participants are not required to attend any study visits or tests specifically for this research. The researchers use already available health records to analyze participant characteristics, comorbidities, and medication use before and after starting finerenone. They also monitor outcomes such as kidney failure, cardiovascular events, and medication dosing over time. The study will continue until September 30, 2026, gathering long-term real-world information about finerenone use and safety in people with CKD and T2D.
Actively Recruiting
This research investigates the use of focused extracorporeal shockwave therapy f-ESWT as a treatment for subchondral bone marrow lesions BMLs in people with knee osteoarthritis OA. BMLs are closely linked to knee pain, structural damage, and disease progression in knee OA, often leading to long-term disability and increased risk of knee replacement surgery. The study aims to explore the efficacy and safety of f-ESWT compared to standard care such as analgesics and protected weight bearing in patients with persistent BMLs despite conservative treatment. Participants will receive four sessions of high-energy f-ESWT over four consecutive weeks, targeting the subchondral bone area with BMLs identified by MRI. The therapy involves focused shockwaves delivered by a device at energy levels between 0.28-0.60 mJmm. The study will monitor changes in pain and knee function, with MRI scans performed before treatment, and at 3 and 6 months post-treatment. This pilot, randomized-controlled study includes 30 subjects who have confirmed BMLs and knee pain lasting more than 2 months. During the study, participants will be assessed at baseline, 1, 2, 3, and 6 months after treatment using an 11-point numerical rating scale for knee pain and the Knee injury and Osteoarthritis Outcome Score KOOS to measure knee function and quality of life. MRI imaging will evaluate the area and condition of BMLs at specified intervals. Researchers will also monitor for any adverse events throughout the trial. The total participation duration spans at least 6 months with multiple follow-up assessments to evaluate treatment outcomes and safety.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate a mobile health mindfulness therapy intervention for older adults with serious illness and their caregivers. Many older adults with serious illness experience anxiety and have limited access to effective non-drug treatments. Caregivers also face high levels of stress and anxiety due to the mutual impact of patient and caregiver distress. This study focuses on reducing anxiety in this patient-caregiver dyad using a scalable, evidence-based approach. The study compares two mobile apps Mindfulness Coach, a Veterans Affairs-based mindfulness training app with 14 levels of guided meditations, exercises, and assessments, and an active control app, WebMD, which provides general health content. Both groups are instructed to use their assigned app four times a week, with orientation and booster sessions. Mindfulness Coach includes increasing training durations and mindfulness education, while the control offers general health information. Participants will be assessed for anxiety and depression using the Hospital Anxiety and Depression Scale at 8 weeks and 6 months, along with perceived stress at 8 weeks. Researchers will monitor how acceptable and feasible the mindfulness app is for users and evaluate its preliminary effectiveness. The study involves randomized assignment to groups, double masking, and a focus on older adults and their caregivers who meet specific inclusion criteria related to anxiety levels and caregiving roles.