Colton

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are evaluating adaptive interventions to improve long-term use of buprenorphine in adults with probable opioid use disorder (OUD) who come to the emergency department (ED). The study uses a two-stage, sequential multiple assignment randomized trial (SMART) design to develop an effective treatment strategy. The trial aims to increase buprenorphine use and reduce overdose, self-harm, or death, especially for those with a history of overdose or co-occurring depression or PTSD. The trial has two first-stage treatments: the CA Bridge Model with Substance Use Navigator (SUN) support to start treatment and link to care, or SUN plus immediate telehealth connection to an outpatient provider (SUN+TeleBridge). Non-responders, defined by lack of buprenorphine prescription filling or return to the ED with OUD-related events within 90 days, are randomly assigned to second-stage treatments: ongoing buprenorphine care by an ED-based interim treatment team (ED-ITT) alone or ED-ITT combined with behavioral health support (ED-ITT+BHS). First-stage responders receive no further intervention unless they return to the ED or report stopping buprenorphine. Participants will be monitored for six months after enrollment to track the number of days they fill buprenorphine prescriptions. The study involves regular caseload reviews, patient outreach, monitoring adherence, and mental health assessments. Researchers will measure buprenorphine use days and time to adverse events like overdose or self-harm, aiming to identify the most effective adaptive treatment strategy for sustaining buprenorphine use.

Researchers are evaluating the safety and effectiveness of apixaban compared with aspirin in patients who recently had an intracerebral hemorrhage (ICH) and also have atrial fibrillation (AF). The study aims to find out if apixaban is better than aspirin in preventing any type of stroke or death from any cause. It also looks at whether apixaban leads to better functional recovery measured by the modified Rankin Scale. This is a phase III, randomized, double-blinded trial enrolling 700 patients over 3.5 years. Participants will be randomly assigned to receive either apixaban, an oral blood thinner that inhibits Factor Xa, or aspirin, an oral antiplatelet medication. The study lasts from 12 months up to 36 months of follow-up after enrollment. Treatments are given orally, and patients will be monitored throughout the study period. Recruitment and coordination occur through NIH/NINDS StrokeNet sites. During the study, participants will undergo assessments including brain imaging (CT or MRI) to confirm diagnosis, functional outcome measurements using the modified Rankin Scale, and monitoring for any strokes or death. Safety will be closely observed, and patients will provide informed consent before joining. The primary outcome measured is stroke or death up to 3 years, and secondary outcomes include functional status changes. Participants are followed regularly to track these outcomes and overall health status.

This research aims to evaluate whether giving 2 grams of oral azithromycin before the start of labor induction can reduce infections in pregnant women and their newborns. The study focuses on women in their third trimester who are undergoing induction of labor. It addresses common risks associated with induction, such as maternal infections including chorioamnionitis and endometritis, and neonatal infections. The trial is a phase 1, double-blinded, randomized controlled study conducted at a single institution to assess the potential preventive role of azithromycin against infections during and after labor induction. Participants will be randomly assigned to receive either 2 grams of azithromycin or a placebo of 4 magnesium oxide tablets before labor induction begins. The medication is taken orally and given prior to starting the induction process. The study compares the effects of the antibiotic versus placebo on rates of infection in mothers and their newborns. Azithromycin is chosen due to its long action, affordability, good tolerance, and previous evidence supporting its use in preventing infections related to cesarean deliveries and spontaneous labor. During the study, participants will be monitored from delivery through 6 weeks postpartum to track infections. Researchers will assess and compare infection rates between the treatment and placebo groups. The study includes regular evaluations and checks to ensure safety and effectiveness, including fetal heart rate monitoring before enrollment. The total involvement includes consent, medication administration prior to induction, and follow-up after delivery to measure infection outcomes and overall maternal and neonatal health.

Researchers are evaluating the performance of the FebriDx4 test in distinguishing bacterial from non-bacterial causes among children aged 2 to 11 years who have a fever and suspected acute respiratory tract infection. This study is prospective, multi-center, observational, and blinded, focusing on pediatric patients presenting to emergency departments, urgent care centers, or primary care offices. The goal is to assess the test's ability to detect a bacterial-associated immune response compared to a clinical reference algorithm determined by pediatric experts. The study involves the use of the FebriDx4 device, a rapid lateral flow immunoassay that detects elevated levels of host response proteins Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) from a fingerstick blood sample. Children with suspected acute respiratory infections will undergo testing with this device during their visit. No other interventions or treatment groups are described. Participants will be assessed for clinical signs, symptoms, and immune response indicators through the FebriDx4 test and standard pathogen detection methods such as bacterial culture and multiplex PCR. The primary outcome is how well the FebriDx4 test performs in identifying bacterial infection on the day of testing. The study requires informed consent and includes follow-up procedures and expert adjudication of infection status. The total participation duration includes the testing day and a 7-day follow-up period.

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 evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the safety and tolerability of lumateperone in children and adolescents aged 5 to 17 years with schizophrenia, bipolar disorder, or autism spectrum disorder. This global, multicenter, open-label Phase 3 study includes both new patients and those rolling over from previous lumateperone studies or lead-in efficacy studies. The conditions studied are confirmed using standardized diagnostic tools, and participants must generally be outpatients expected to remain so during the study. Participants will receive lumateperone once daily in doses ranging from 5 mg to 42 mg, provided as capsules or orally disintegrating tablets, adjusted by age and condition. The study includes a screening period of up to two weeks to determine eligibility, followed by a 26-week open-label treatment phase where all patients receive lumateperone. After treatment, there is a two-week safety follow-up period to monitor any lasting effects or adverse events. During the study, participants will be monitored for common adverse events up to six months. The study involves regular assessments to ensure safety and tolerability, including evaluation for suicidal risk and maintenance of outpatient status. Parents or guardians provide consent while participants provide assent. The total participation lasts approximately 30 weeks, including screening, treatment, and follow-up.