Brentwood

Researchers are evaluating the safety and effectiveness of the Vagus Nerve Stimulation VNS Therapy System as an additional treatment for people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, and blinded trial compares active VNS therapy to a no stimulation control group in reducing depressive symptoms over 12 months. The study follows guidelines aligned with Medicare and Medicaid coverage decisions for VNS in this condition. Participants receive an implant of the VNS device and are randomized at least two weeks after implantation to either have the device activated or remain without stimulation for the first 12 months. After this initial period, those in the control group can begin stimulation. Following the 12-month randomized phase, all participants enter an open-label, longitudinal study lasting about five years, including new enrollees after the initial trial phase. During the study, participants are monitored through various depression rating scales, including the Montgomery sberg Depression Rating Scale MADRS, to assess response and remission rates up to 12 months. Safety is tracked by recording adverse events from implantation through the first year. Additional assessments include disability and health outcome scales, as well as suicidality tracking. The study aims to gather long-term data on treatment effects and participant well-being.

Researchers are evaluating the real-world clinical impact of the Galleri4, a blood-based multi-cancer early detection MCED test, in a Medicare population aged 50 years and older. This multi-center prospective cohort study aims to assess the tests safety and performance alongside usual care, enrolling participants representative of Medicare beneficiaries. The study is observational and compares outcomes between those receiving the Galleri test plus usual care and those receiving usual care alone. Participants in the Galleri-tested arm will have blood collected for the MCED test with results returned to guide further evaluation. The comparator group consists of Medicare beneficiaries receiving usual care without the Galleri test. Both groups will be observed over a period of up to 3 years to evaluate cancer incidence and diagnostic outcomes. Throughout the study, researchers will monitor the incidence of stage IV cancers, the number and types of invasive procedures following test results, adherence to recommended cancer screening, and healthcare resource use related to cancer diagnostics. Safety and test performance will be tracked in the Galleri-tested group. Participation involves routine clinical visits and data collection for up to 3 years, with no interventions withheld for either group.

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.

This research evaluates the long-term safety and tolerability of zigakibart in adults with immunoglobulin A nephropathy IgAN. It is an open-label extension study for patients who have completed previous zigakibart trials. The study aims to determine whether zigakibart can be safely used over extended periods in people with this kidney condition. Participants will receive zigakibart as a subcutaneous injection at a dose of 600 mg every two weeks. This extension study follows earlier phase 12 and phase 3 trials and includes patients from these studies. The treatment period is designed to assess continued safety and effects over time during this open-label phase. During the study, participants will have regular assessments including monitoring for adverse events, laboratory tests measuring kidney function, immunoglobulin levels, and drug concentrations. Researchers will track safety lab results, vital signs, and antibody development. The study includes follow-up visits up to several years to evaluate long-term safety and kidney health outcomes such as proteinuria and estimated glomerular filtration rate eGFR.

Researchers are evaluating the pharmacokinetic profile, safety, efficacy, and immunogenicity of HLX13, an ipilimumab biosimilar, compared to the US-sourced YERVOY in adults with unresectable hepatocellular carcinoma HCC who have not previously received systemic therapy. This phase I, multicenter, randomized, double-blind study aims to understand how these treatments behave in the body and their effects on this advanced liver cancer. Participants will be randomly assigned to receive either HLX13 or US-sourced YERVOY at a dose of 3 mgkg on the first day of each 3-week cycle, for up to four cycles. Additionally, all subjects will receive EU-sourced OPDIVO nivolumab at 1 mgkg on the first day of each 3-week cycle for four cycles. Those who benefit from OPDIVO treatment may continue with local-sourced OPDIVO every 4 weeks for up to two years after randomization. During the study, participants will undergo blood tests to measure drug concentrations and immune response at multiple points up to 20 weeks after the first dose. Safety will be closely monitored through physical exams, vital signs, laboratory tests, and heart monitoring for up to 13 weeks after dosing. Researchers will also assess tumor response and record any adverse events during treatment and a 90-day safety follow-up period. Overall, participants may be involved in the study for several months, with continued treatment and monitoring as appropriate.

Researchers are investigating whether using a catheter-based endovascular device called the WATCHMAN to close off the left atrial appendage can help prevent ischemic stroke or systemic embolism in people with atrial fibrillation who remain at high risk of stroke despite ongoing treatment with oral blood thinners. This study is a multicenter, randomized controlled trial with an open-label design but with blinded assessment of results to ensure unbiased evaluation. Participants will be randomly assigned to either receive the left atrial appendage occlusion with the WATCHMAN device or continue their standard medical care without the device. Those in the device group will undergo the procedure to close off the left atrial appendage using the WATCHMAN device. Both groups will continue their oral anticoagulant treatment as prescribed. The study will continue until 265 primary events of ischemic stroke or systemic embolism occur, with an average follow-up estimated at about 4 years. Throughout the study, participants will be monitored for occurrences of ischemic stroke, systemic embolism, transient ischemic attacks, cognitive function using the Montreal Cognitive Assessment, cardiovascular and all-cause mortality, and new disabling ischemic strokes. Safety and effectiveness will be assessed during the event-driven study period. Participants will be followed for approximately 4 years on average to gather the necessary outcome data and ensure ongoing monitoring of their health status.

Researchers are studying Long COVID by analyzing specific blood RNA patterns to develop an algorithm that can identify and classify this condition among different patient groups. The goal is to distinguish Long COVID from normal health and other medical conditions that have similar symptoms. This interventional study aims to create a reliable diagnostic test for detecting the presence and severity of Long COVID. Participants provide two blood samples about 28 days apart and complete surveys about their ethnicity, medical history, and symptoms. Based on their responses, they are assigned to one of fourteen groups reflecting various types of Long COVID or control groups without infection or with other prior conditions. Blood samples are sent to the study sponsor, where an AI process will analyze RNA sequences to validate the Long COVID type and severity. During the study, participants complete surveys and undergo two blood draws. Researchers will measure RNA sequences to develop algorithms that classify Long COVID and its subtypes within 30 days. The study includes participants aged 18 and older, including healthy volunteers, and monitors safety through single masking. The full participation timeline includes initial screening and sample collection with follow-up assessments approximately one month apart.

This research investigates how stimulating a specific brain region influences craving and opioid use in people with opioid use disorder OUD. The study focuses on applying intermittent theta burst stimulation iTBS, a form of repetitive transcranial magnetic stimulation rTMS, to the left dorsolateral prefrontal cortex L DLPFC. The goal is to examine whether this brain stimulation can reduce craving and opioid use in individuals currently treated with buprenorphine. The study also explores brain changes using optional magnetic resonance imaging MRI. Participants will receive 8 weekly sessions of FDA-approved L DLPFC-targeted iTBS or sham stimulation, with two iTBS sessions per visit separated by 50 minutes. Before treatment, individuals are randomly assigned to active or sham groups, where sham involves flipping the coil to mimic the procedure without actual brain stimulation. Optional MRI scans are offered before the first iTBS session and after completion of the 8-week intervention to assess brain connectivity and activity. Follow-up visits occur at weeks 10, 12, and 20 to monitor outcomes. During the study, participants attend 12 visits over about 5 months, each lasting 1 to 2 hours. They complete interviews, questionnaires about opioid use and psychiatric symptoms, and urine toxicology tests. Optional MRI visits include cognitive tasks and brain imaging. Safety is monitored through medical history assessments and specific screening questionnaires. The main measurements focus on changes in craving using the Opioid Craving Scale and brain connectivity changes via MRI. Participants who initially receive sham stimulation are offered active iTBS after the study concludes.