Dover

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

This research aims to compare the effects of regional radiotherapy versus no regional radiotherapy in women with low-risk breast cancer who are receiving usual care. The study focuses on women with node-positive or T3N0 breast cancer who have undergone breast-conserving surgery or mastectomy, to see if avoiding regional radiotherapy works as well at preventing the cancer from returning. Participants receive either whole breast irradiation with or without regional radiotherapy to lymph nodes after surgery, or no regional radiotherapy following mastectomy or breast-conserving surgery. The study involves random assignment to these treatment groups and evaluates the impact of adding or omitting regional radiotherapy as part of their care. During the study, researchers will monitor breast cancer recurrence-free interval over 9.5 years, along with other outcomes such as invasive disease-free survival, mortality, overall survival, and quality of life. Patient-reported outcomes, arm mobility, adverse events, and cost-effectiveness are also assessed. Treatment adherence, follow-up visits, and collection of tumor tissue and blood samples are part of the participant's involvement throughout the trial.

Researchers are investigating how well standard systemic therapy, with or without additional definitive treatment such as prostate removal surgery or radiation therapy, works in treating men with prostate cancer that has spread to other parts of the body. This phase III trial aims to compare overall survival and progression outcomes between patients receiving systemic therapy alone and those receiving systemic therapy plus definitive treatment of the primary tumor. The study also examines quality of life factors, including urinary function, pain, and physical functioning. Participants first receive one of six acceptable forms of standard systemic therapy for 22 to 28 weeks, which may include hormonal therapies, oral medications, injections, or chemotherapy drugs like docetaxel. After this induction period, participants are randomly assigned to continue standard systemic therapy alone or to receive systemic therapy plus prostatectomy or radiation therapy within a specific timeframe. Following treatment, participants are monitored and followed up for up to eight years. During the study, participants undergo various assessments including physical exams, laboratory tests for prostate-specific antigen (PSA) and testosterone levels, and imaging scans to monitor disease progression. Patient-reported outcomes related to urinary symptoms, pain, and quality of life are collected at multiple time points up to three years. The main outcome measured is overall survival over an eight-year period. Researchers also bank tissue and blood samples for future studies and observe safety and disease progression throughout the follow-up period.