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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating treatment options for patients diagnosed with acute active clinically manifest cardiac sarcoidosis who have not yet received treatment. This phase 3 randomized controlled trial compares a low dose combination of Prednisone or Prednisolone and Methotrexate to standard dose Prednisone or Prednisolone. The study aims to assess whether the combination therapy is as effective as the standard dose while potentially offering better quality of life and fewer side effects. Participants will be randomly assigned to one of two groups. Outside Japan, one group receives Prednisone at 0.5 mgkgday for 6 months up to 30 mg daily, while the other gets Methotrexate once weekly starting at 15 mg, increasing to 20 mg if tolerated plus Folic Acid daily and Prednisone tapered over 3 months. In Japan, dosing regimens vary slightly but follow similar principles. Baseline tests include blood work, FDG-PET scans with myocardial perfusion imaging, ECG, echocardiogram, optional cardiac MRI, and quality of life questionnaires. Treatment lasts 6 months with scheduled visits at 4, 8 methotrexate group only, 12 weeks, and a final 6-month visit. During the study, participants undergo assessments for medication side effects, safety blood tests, and quality of life evaluations at multiple visits. At 6 months, comprehensive evaluations including imaging, biomarker analysis, device interrogation, muscle strength, skin and neuropsychiatric assessments will be completed. After this, further care is managed by the participants physician. The study measures heart function, medication effects, quality of life, and toxicity related to glucocorticoid use to understand the impact of these treatment strategies.

Age: 18Years +All GendersPhase 3
31 locations
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Actively Recruiting

This research aims to evaluate the rates of cervical cancer screening and endometrial sampling before gender-affirming hysterectomy in transgender and gender diverse TGD individuals. The study seeks to assess the need for these tests in this population and explore patient-centered options to improve care. By linking screening status with hysterectomy pathology, it provides preliminary data on current guideline adherence and informs future evidence-based guidelines. The study is observational and does not involve an intervention. It compares standard cancer screening methods with options like HPV self-testing to see how these choices may influence screening rates and patient experiences. Participants include those who have had or plan to have a hysterectomy, focusing on capturing real-world screening practices. Participants will be observed over a 36-month period, during which researchers will measure screening and sampling rates and effects of HPV self-testing options. The study collects patient experience data and evaluates whether offering self-testing changes screening behavior. All assessments are observational without treatment administration, with follow-up continuing through the study duration.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Scoliosis is a three-dimensional deformity that changes the spines shape and position. The most common type, adolescent idiopathic scoliosis AIS, affects mainly young adolescent females and can require bracing or surgery to prevent worsening. Researchers have developed a predictive model using 3D spinal measurements to better estimate curve progression in AIS. This study aims to refine and test this model in a larger group to help guide treatment decisions more accurately. The study uses a new low-dose biplanar X-ray system EOS to take stereo-radiographs and create 3D reconstructions of the spine and pelvis. These images help measure vertebrae, disks, and pelvic geometry in detail. Patients may receive usual treatments like bracing or surgery if needed, with bracing compliance monitored using special sensors. Surgical patients will have their data analyzed but leave the study after surgery. The goal is to validate the model by comparing the new 3D measurements with traditional methods over time. Participants will be followed for up to 24 months with visits ideally every 6 months, including physical exams, growth and maturity assessments, and X-rays without braces at least annually. The study collects detailed data at each visit to track scoliosis severity and curve changes using 3D spine reconstructions. Researchers will analyze these measurements to improve predictions of scoliosis progression and help identify which patients need early treatment to avoid surgery.

Age: 10Years - 15YearsAll Genders
9 locations