Culpeper

This research aims to evaluate the safety and performance of the Enhanced Lithotripsy System ELS for treating urinary stones in adults. The study focuses on patients aged 21 or older who have a single urinary stone in the ureter. The purpose is to assess how well the ELS can break stones into small fragments that can pass more easily, potentially reducing discomfort. Participants will receive the ELS procedure, which uses low pressure ultrasound combined with microbubbles to pit and fragment the urinary stones. All participants undergo this experimental procedure, and no placebo or comparison group is involved. The study includes follow-up evaluations at 30 days and, if necessary, at 60 days to check for remaining stone fragments via CT scans. During the study, participants will be monitored for stone presence using CT imaging and assessed for changes in pain levels, quality of life, and return to normal daily activities and work. Safety and effectiveness will be evaluated up to 30 days after treatment, with an additional assessment at 60 days if stones remain. The total study duration extends from the procedure through these follow-up periods.

This trial studies women aged 65 and older with early-stage estrogen receptor positive ER breast cancer. It evaluates whether a 90-day period of pre-operative endocrine therapy pre-ET can help inform decisions about the use of radiation therapy after breast conserving surgery BCS. The study builds on previous findings suggesting that pre-ET can influence patient and physician choices regarding adjuvant treatment. Participants are randomly assigned to one of two groups the intervention group receives 90 days of pre-ET using tamoxifen or an aromatase inhibitor before surgery, while the control group proceeds directly to BCS without pre-ET. After surgery, decisions about radiation therapy and additional endocrine therapy AET are made by patients and their doctors. Treatment adherence to AET is monitored for two years. Throughout the study, participants complete patient-reported outcome surveys to assess tolerance and compliance with endocrine therapy. Researchers track treatment adherence, decision conflict and regret, quality of life, side effects, and long-term cancer outcomes including recurrence and survival over five years. The total participation spans multiple years to capture these long-term effects.