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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.
Actively Recruiting
Researchers are evaluating the impact of real-time audio-video telemedicine consultations with a neonatologist, called teleneonatology, on early health outcomes of at-risk newborns delivered in community hospitals. This study uses a stepped wedge cluster randomized design to compare early mortality, morbidity, and delivery room care between neonates receiving teleneonatology support and those receiving usual care. The trial is led by Mayo Clinic and focuses on newborns facing significant resuscitation needs shortly after birth. The study involves two groups one where at-risk neonates receive care from the community hospital team with telemedicine support from a neonatologist located at a regional neonatal intensive care unit, and a control group where neonates receive the hospitals usual care without telemedicine consultation. The telemedicine connection allows real-time, two-way audio and video communication during advanced neonatal resuscitations. The study includes neonates born preterm under 32 weeks or requiring advanced resuscitation interventions such as prolonged positive pressure ventilation, alternative airway placement, or chest compressions. Participants include clinicians attending newborn resuscitations and eligible neonates born at participating community hospitals. Researchers will monitor outcomes including mortality within 7 days, early neonatal morbidity, combined mortality and morbidity, and the highest level of resuscitation given in the delivery room within the first hour. The study tracks these outcomes to assess the effect of teleneonatology on newborn health during this critical early period. The total study duration extends through May 2029.