Brentwood

Researchers are studying the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for people with treatment-resistant depression. The study aims to find out if active VNS therapy can reduce the severity of depression symptoms compared to no stimulation over a 12-month period. This is a randomized, controlled, and blinded trial involving subjects implanted with the VNS device. Participants are randomly assigned to one of two groups: one group will have the VNS device activated two weeks after implantation, while the other group will have the device implanted but not activated for the first 12 months. After 12 months, those in the control group may receive stimulation. After completing the 12-month randomized portion, all subjects can join an open-label, longer-term study lasting about 5 years to continue monitoring. During the study, participants will undergo assessments using several depression rating scales at regular intervals, including the Montgomery Åsberg Depression Rating Scale (MADRS), with evaluation of response, remission, and duration of effects. Additional measures include assessments of disability, health outcomes, clinical global impressions, and suicidality tracking. Safety and adverse events are also monitored from implantation through 12 months.

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 test's 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 evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are studying the long-term safety and tolerability of zigakibart in adults with primary immunoglobulin A nephropathy (IgAN), a kidney disease. This open-label extension phase 3 study includes patients who previously participated in earlier zigakibart studies, aiming to understand how well the drug works and how safe it is over an extended period. Participants in this study will receive zigakibart as a solution for subcutaneous injection, given at a dose of 600 mg every two weeks. This trial follows patients who completed previous zigakibart studies, providing ongoing treatment and monitoring their response and safety over time. During the study, participants will have regular visits for safety checks, laboratory tests, and measurements of kidney function and protein levels in urine. Researchers will monitor adverse events, serious side effects, drug levels in the blood, antibody formation, and changes in immunoglobulin levels. The study may last up to approximately five years, with follow-up assessments continuing 24 weeks after the last dose to ensure safety and evaluate long-term effects.

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 mg/kg 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 mg/kg 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 evaluating the FlowTriever System combined with anticoagulation medication compared to anticoagulation medication alone in treating intermediate-risk acute pulmonary embolism (PE). This multicenter, randomized controlled trial aims to better understand the clinical outcomes of these treatment approaches in adults with PE who have specific heart and lung risk factors. Participants receive either mechanical thrombectomy using the FlowTriever System or anticoagulation drugs such as Heparin Sodium, Coumadin, Rivaroxaban, or Apixaban. The study compares these two methods to see how they affect recovery and complications. Treatments are given as per standard practice, with patients randomized to one of the two groups. During the study, participants will be monitored for clinical outcomes including breathing difficulty 48 hours after treatment, mortality, hospital readmission, bleeding events, and quality of life up to three months. Various assessments such as 6-minute walk tests, heart imaging, and questionnaires on symptoms and health quality are performed. The study tracks these results through discharge and follow-up visits to 90 days, with total participation lasting several months.

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.

Researchers are studying how stimulating a specific brain region affects craving and opioid use in people with opioid use disorder (OUD). The study focuses on individuals taking buprenorphine, a common medication for OUD, and aims to test whether intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (L DLPFC) can reduce craving and opioid use. This randomized, sham-controlled trial will help understand if brain stimulation can improve inhibitory control and lower relapse risk in OUD. Participants will receive 8 weekly sessions of FDA-approved iTBS targeting the L DLPFC, with each session consisting of 2 stimulation periods separated by a 50-minute break. Some will receive active iTBS, while others will receive sham stimulation that mimics the experience but does not deliver actual stimulation. Optional brain imaging (MRI) scans will be offered before and after the treatment period to study brain changes. After the 8 weeks of treatment, follow-up visits will occur at weeks 10, 12, and 20, with participants who received sham stimulation offered open-label active iTBS afterward. Participants will attend a total of 12 visits over about 5 months involving interviews, questionnaires, computer tasks, and brain stimulation sessions. Assessments will include measures of opioid craving using self-reports and brain imaging tasks, urine toxicology tests, and evaluations of psychiatric symptoms. Safety will be monitored closely, including screening for seizure risk and potential side effects. Data confidentiality is ensured through secure storage and coded data. The study aims to provide detailed information on changes in craving and opioid use following brain stimulation.