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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are studying vasomotor symptoms (VMS) related to menopause in women who participated in previous OASIS studies. These women experienced hot flashes caused by hormonal changes during menopause, which is the time when menstrual cycles stop. The research aims to understand the burden of VMS and how treatments were used before and after their participation in the OASIS clinical trials, which tested the drug elizanetant against a placebo. This observational study does not involve giving any new treatments. Instead, it collects data from women who had already received standard care for VMS during and after their involvement in OASIS 1, 2, or 3 studies. The study has two parts: Part A invites participants to complete an online survey about treatments used in the year before their OASIS trial, including prescription and over-the-counter medications, adherence, and reasons for stopping treatments. Part B uses anonymized medical records to track treatments taken in the six months following the end of the OASIS study. Participants will complete the survey between March and June 2025, while medical record data will be collected from April to May 2025. No visits, tests, or new procedures are required for this study, which is conducted entirely electronically. Researchers will analyze medication use, adherence, discontinuation reasons, and healthcare resource use to better understand real-world treatment patterns for menopausal VMS.
Actively Recruiting
Subchondral bone marrow lesions (BMLs) in knee osteoarthritis (OA) are linked to knee pain, worsening joint structure, disease progression, and higher chances of knee replacement surgery. These lesions may improve or disappear within 30 months, but often persist, causing long-term disability. Various treatments like rest, weight-bearing protection, bisphosphonates, subchondroplasty, and orthobiologic injections have been proposed, but conservative methods take long to work and invasive treatments have mixed results with side effects. Focused extracorporeal shockwave therapy (f-ESWT) is a non-invasive and safe approach used in bone disorders with similar features to BMLs, and this pilot study explores its effectiveness and safety compared to standard care in people with knee OA and BMLs. Participants with knee OA and confirmed subchondral BMLs on MRI who have knee pain at rest and walking despite at least 4 weeks of conservative treatment will receive four weekly sessions of high-energy f-ESWT targeting the affected bone area. The treatment energy ranges from 0.28 to 0.60 mJ/mm² and is focused on the lesion site identified by MRI. This study evaluates f-ESWT as an alternative to standard care involving analgesics and protected weight bearing. Participants will be monitored for adverse events and changes in knee pain using an 11-point numerical rating scale and knee function using the Knee injury and Osteoarthritis Outcome Score (KOOS). Assessments occur at baseline, and at 1, 2, 3, and 6 months post-treatment. MRI scans of the affected knee will be done before treatment and at 3 and 6 months after treatment to observe lesion changes. The main outcome measured at 12 weeks is the change in knee pain scores. The study includes adults aged 30 to 80 years with knee OA and BMLs.
Actively Recruiting
Healthy Volunteer
Older adults with serious illnesses and their caregivers often face high levels of anxiety but have limited access to effective non-drug treatments. This research aims to test a mobile health mindfulness therapy app called Mindfulness Coach, designed to reduce anxiety symptoms in these patients and their family caregivers. The study focuses on a scalable and sustainable approach to improve mental health support within primary care settings for this population. Participants will use the Mindfulness Coach app, which offers a structured mindfulness training program with 14 levels that include guided meditations, educational content, and assessments. Users progress by engaging with all elements of each level. The control group will use a general health and wellness app, WebMD, providing daily health content with similar access frequency and support sessions to match the intervention group's experience. During the study, researchers will assess anxiety levels using the Hospital Anxiety and Depression Scale over 8 weeks and 6 months. Participants will be monitored for engagement with the apps, and their feedback on usability and acceptability will be collected. The study also evaluates the potential benefits for both patients and caregivers in managing anxiety without adding medication or extra appointments.