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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating two treatments for breast cancer patients who have a positive sentinel lymph node after receiving neoadjuvant systemic therapy. The study focuses on comparing axillary radiotherapy (ART) without lymphadenectomy to axillary lymph node dissection (ALND) to see which approach lowers the risk of lymphedema while monitoring cancer recurrence and overall survival. The trial includes patients treated with either neoadjuvant chemotherapy or hormone therapy and aims to assess quality of life alongside clinical outcomes. This is a prospective, randomized, open-label, multicenter study involving about 820 patients divided evenly between chemotherapy and hormone therapy groups. Participants will receive either ART targeting axillary levels I and II plus level III, supraclavicular, and possibly the internal mammary chain, or undergo ALND followed by radiotherapy to level III, supraclavicular, and possibly the internal mammary chain. A pilot phase with the first 200 patients has been completed, and an interim analysis will be conducted on this group. During the study, researchers will track disease-free survival over up to five years from diagnosis, noting any recurrence or death. Patients will undergo imaging assessments such as ultrasound or MRI to evaluate axillary response after treatment. Quality of life and side effects like lymphedema will also be measured. Follow-up will include monitoring overall survival and recurrence, ensuring comprehensive evaluation of both treatment safety and effectiveness.
Actively Recruiting
Researchers are evaluating whether an interdisciplinary, community-based program called Reforça't can reduce hospital readmissions within 30 days and improve functional outcomes for patients aged 65 or older with chronic cardiac, respiratory, or mixed conditions after hospital discharge. This randomized clinical trial also aims to see if Reforça't improves medication adherence, quality of life, and reduces mortality compared to standard care. The study includes several phases: an initial feasibility phase to test the program's implementation from January 7 to 11, 2025, with 10-15 patients; a comprehensive intervention phase from January 12 to June 30, 2025, involving 200 patients receiving interdisciplinary care including home visits, therapy optimization, rehabilitation, health education, and psychosocial support; and a long-term follow-up phase from April 7, 2025, to June 30, 2026, with assessments at 3, 6, 9, and 12 months after intervention. Participants will undergo assessments before and 30 days after the intervention. Researchers will monitor hospital readmissions, survival, nursing home admissions, and overall well-being for 12 months post-discharge. The main outcomes measured are the reduction in 30-day readmission rates and decreases in mortality, readmissions, and nursing home admissions over the year following hospital discharge.