Wright-Patterson Air Force Base

Adjustment disorders AjDs are common mental health diagnoses in the US military, characterized by difficulty adapting to stressors, which can impair function and readiness. Diagnosing AjDs is challenging due to overlaps with other disorders and unclear criteria. This research evaluates the Adjustment Disorder New Module for Military ADNM-20-Mil, a recently adapted diagnostic tool designed specifically for the military population. The study also pilots the use of the audio-visual stimulation device SANA to explore its potential as an adjunctive treatment. The trial randomly assigns participants to either standard care alone or standard care plus the SANA device, which delivers coordinated light and sound pulses to promote relaxation through neuromodulation. Those in the SANA group use the device twice daily for 22 minutes each session over 28 days while all participants wear the Empatica monitoring bracelet daily during this period. The study follows participants over multiple time points to assess changes in symptoms and device feasibility. Participants complete assessments at baseline, immediately after the 28-day device use, at 3 months, and at 6 months. These include diagnostic interviews, symptom scales, and well-being questionnaires to measure adjustment disorder symptoms, PTSD symptoms, anxiety, depression, and overall clinical impression. The study monitors participants adherence to device use and collects continuous physiological data from the bracelet. Total participation spans approximately 6 months, allowing evaluation of the ADNM-20-Mils sensitivity to change and the SANA devices impact in this context.

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.

Researchers are evaluating early versus delayed treatment with venetoclax and obinutuzumab in patients newly diagnosed with high-risk chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. This phase III trial aims to determine if starting treatment before symptoms appear improves overall survival and other outcomes compared to starting treatment after symptoms develop. Venetoclax blocks a protein important for cancer cell survival, while obinutuzumab is an immunotherapy antibody that may help the immune system attack cancer cells. Participants are randomly assigned to receive either early or delayed treatment with venetoclax and obinutuzumab. Both groups receive obinutuzumab intravenously on specific days during six cycles and venetoclax orally daily for up to 12 cycles, each cycle lasting 28 days. Treatment continues unless disease progression or unacceptable side effects occur. During and after treatment, patients undergo CT scans, blood sample collection, and bone marrow biopsies. Throughout the study, participants are closely monitored with various assessments including laboratory tests, imaging, and quality of life questionnaires. Researchers measure overall survival, response rates, progression-free survival, and patient-reported outcomes over up to 10 years. Safety, tolerability, and disease markers such as measurable residual disease are also evaluated. Follow-up continues for 10 years after treatment completion to observe long-term outcomes.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.