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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating two different treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study aims to compare axillary radiotherapy ART with axillary lymph node dissection ALND to see which approach results in less risk of lymphedema and how each affects recurrence and overall survival. This trial is a prospective, randomized, open-label, parallel-assigned, multicenter study involving 820 patients over 5 years, including those treated with chemotherapy and hormone therapy. Participants are randomly assigned to one of two groups. One group receives axillary radiotherapy targeting levels I and II plus level III and supraclavicular areas, with or without the internal mammary chain, but without lymphadenectomy. The other group undergoes axillary lymph node dissection along with radiotherapy to level III and supraclavicular areas, with or without the internal mammary chain. The study includes a pilot phase with the first 200 patients and plans interim analysis to assess progress. During the trial, participants will be monitored for disease-free survival, overall survival, and the incidence of lymphedema for up to 5 years, with lymphedema tracked for up to 3 years after surgery. Researchers will evaluate outcomes related to recurrence and quality of life. The study involves regular assessments including imaging to evaluate axillary response and follow-up visits to monitor health and side effects. Participants are followed closely to understand the long-term impact of the treatments.

Age: 18Years +All GendersPhase Not Applicable
60 locations
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Actively Recruiting

Researchers are evaluating an interdisciplinary, community-based program called Reforat designed to reduce 30-day hospital readmissions and improve functional outcomes in patients aged 65 or older with chronic heart, lung, or mixed conditions after hospital discharge. The study aims to see if Reforat can lower readmission rates to 25% compared to standard care and improve medication adherence, quality of life, and survival. Patients will be compared between those receiving Reforat and those under usual care to assess health outcomes and cost-effectiveness. The intervention includes a full-scale program with interdisciplinary care, home follow-ups, therapeutic optimization, functional rehabilitation, health education, and psychosocial support. The trial also includes a feasibility phase and long-term follow-up. The intervention group receives presential follow-up by a multidisciplinary team, while the control group receives standard hospital-at-home care. Follow-up assessments occur at 3, 6, 9, and 12 months after discharge to monitor hospital readmissions, survival, nursing home admissions, and overall well-being. Participants will undergo assessments before and after the intervention, with a post-discharge evaluation at 30 days and continued monitoring up to 12 months. Researchers will collect data on readmissions, mortality, functional decline, medication adherence, risk of falls, social isolation, emotional well-being, and caregiver burden. Patient satisfaction and smoking cessation rates are also measured. This comprehensive evaluation aims to determine the programs impact on health outcomes and quality of life in older adults with chronic cardiorespiratory conditions.

Age: 65Years +All GendersPhase Not Applicable
1 location