Anacortes

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are investigating how real-time audio-video telemedicine consultations with a neonatologist, called teleneonatology, affect early health outcomes of at-risk newborns delivered in community hospitals. This multicenter study uses a stepped wedge cluster randomized design to assess the impact of teleneonatology on early mortality, morbidity, and delivery room care in these newborns. The study involves connecting a neonatologist in a regional neonatal intensive care unit (NICU) with physicians in community hospitals through a live, two-way audio-video telemedicine system. This connection allows neonatologists to provide advanced support during neonatal resuscitations remotely. The study focuses on neonates born at less than 32 weeks gestation or those needing advanced resuscitation such as prolonged positive pressure ventilation, alternative airway placement, or chest compressions. Participants will include both community hospital clinicians attending newborn resuscitations and the at-risk neonates meeting the inclusion criteria. Researchers will measure outcomes such as the 7-day mortality rate to evaluate the effect of teleneonatology. The study excludes neonates with severe congenital anomalies requiring early intensive care or surgery, those receiving comfort care only, and cases where an in-person neonatologist or transport team is present at birth.

Researchers are evaluating the effects of several targeted drugs—vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib—on patients with progressive meningiomas that have specific genetic mutations. This phase II trial focuses on tumors that are growing, spreading, or worsening despite prior treatment. The study aims to measure how well these drugs work in slowing tumor progression and improving response rates, especially in patients whose tumors have mutations in SMO, PTCH1, NF2, AKT1, PIK3CA, PTEN, and CDK-related pathways. Patients are assigned to one of four treatment groups based on their tumor's genetic mutation profile. Those with SMO or PTCH1 mutations receive vismodegib daily by mouth, those with NF2 mutations receive the FAK inhibitor GSK2256098 twice daily, patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily for four days each week, and those with CDK pathway alterations receive abemaciclib every 12 hours. Each treatment cycle is 28 days, continuing unless the disease worsens or side effects become unacceptable. After treatment ends, patients are followed every six months for up to five years. Participants undergo various assessments including imaging scans and genetic testing to confirm eligibility and monitor tumor status. Researchers track progression-free survival at six months and response rates up to two years. Safety is monitored through adverse event reporting and lab tests. The study also collects data on overall survival and treatment tolerability. Patients are carefully evaluated before and during treatment to ensure safety and measure the drugs' effects on tumor growth and patient health over time.