South Charleston

Researchers are evaluating ALTO-207 compared to a placebo in adults with treatment-resistant depression TRD to measure changes in depressive symptoms. This phase 2 trial aims to better understand the effects of ALTO-207 on depression severity in participants who have not responded well to previous antidepressant treatments. Participants will be randomly assigned to receive either ALTO-207 twice daily or a matching placebo. The study is double-blind and placebo-controlled, ensuring that neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 8 weeks, during which changes in depressive symptoms will be closely monitored. During the study, participants will undergo assessments including the Montgomery-sberg Depression Rating Scale MADRS to track changes in depression severity from the start through 8 weeks. Additional evaluations include response rates and clinical global impressions of severity over time. Safety and symptom monitoring will occur throughout, and participation may last up to 8 weeks based on treatment and follow-up visits.

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 the use of BrainsWay Deep Transcranial Magnetic Stimulation Deep TMS to treat individuals diagnosed with moderate to severe Alcohol Use Disorder AUD. The trial is a prospective, double-blind, randomized, controlled, multi-center study involving outpatients aged 18 to 86 years. It aims to compare alcohol use outcomes between a group receiving active Deep TMS treatment and a group receiving sham inactive treatment. This study includes subjects seeking treatment to reduce or stop heavy drinking. Participants are randomly assigned to either the Deep TMS group or the sham group in a 11 ratio. The acute treatment phase involves 15 visits over 3 to 5 weeks, with each visit including two treatment sessions spaced 30 minutes apart, each lasting about 20 minutes. Following this, the maintenance and follow-up phase includes one treatment session per week until the six-month follow-up visit. Before each treatment session, participants are exposed to alcohol-related cues, then receive either active or sham Deep TMS stimulation. Throughout the study, participants will have their alcohol use monitored using the percent of heavy drinking days during months 2 to 4 based on self-reported timelines and supportive lab results. Researchers will also use several assessment scales to evaluate alcohol use and craving. Safety is closely monitored by tracking adverse events, vital signs, and physical and neurological examinations. The entire study participation lasts up to six months, including treatment and follow-up phases.