Baden

Researchers are evaluating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early and locally advanced estrogen receptor-positive (ER+), HER2-negative breast cancer who show no detectable circulating tumor DNA (ctDNA) in their blood and have a low Ki-67 value after initial therapy. This phase II, prospective, randomized, controlled, open-label study focuses on participants whose tumors respond to endocrine therapy, aiming to compare treatment effectiveness and quality of life outcomes between the two approaches. Participants first undergo a 4-week Run-in phase taking aromatase inhibitors (or tamoxifen if aromatase inhibitors are not tolerated) while providing blood and tumor samples for ctDNA assessment and Ki-67 analysis. Based on these results, they are assigned to one of three treatment arms: neoadjuvant endocrine therapy (aromatase inhibitors or tamoxifen), neoadjuvant chemotherapy, or chemotherapy if ctDNA is detected or Ki-67 is high. The main treatment phase lasts 6 to 8 months, followed by surgery. Throughout the study, participants attend clinic visits before treatment, during the Run-in phase, before the main treatment, mid-treatment, after completing therapy, at surgery and post-surgery, and annually for five years. They provide blood samples for ctDNA analysis, undergo biopsies, and complete questionnaires about quality of life, symptoms, and sexual health. The primary outcome measured is the modified Preoperative Endocrine Prognostic Index (PEPI) score from randomization to surgery.

Researchers are evaluating the use of percutaneous auricular Vagus Nerve Stimulation (pVNS) combined with standard rehabilitation training for patients with chronic musculoskeletal or myofascial back pain. This pilot study is designed to assess the feasibility, effectiveness, and safety of pVNS using the VIVO4 wearable medical device during a 3-week inpatient rehabilitation period. The study aims to compare personalized pVNS therapy plus standard care to standard care alone in improving functional outcomes for chronic back pain sufferers. Participants will be randomly assigned to one of two groups: one receiving the VIVO4 device pVNS therapy alongside standard rehabilitation, and the other receiving standard rehabilitation alone. The VIVO4 device allows adjustment of electrical stimulation amplitude to create a comfortable tingling sensation without pain. Both the investigator and the patient can personalize the stimulation settings during the treatment. The study includes a 3-week treatment phase with optional follow-up assessments at 3 and 6 months to evaluate longer-term effects. During the study, participants will undergo various assessments including the Oswestry Disability Index to measure changes in disability from baseline to the end of treatment. All medications and therapies used alongside the study interventions will be recorded and considered in the final analysis. The study monitors safety and effectiveness, with the total participation time including treatment and follow-up periods. This approach aims to provide detailed information on the impact of pVNS combined with rehabilitation on chronic back pain management.