Broadmeadow

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating efruxifermin (EFX) in adults aged 18 to 80 who have compensated cirrhosis caused by nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of EFX in improving liver health and delaying disease progression in this population. The study focuses on subjects with advanced liver fibrosis (stage 4) but without liver decompensation. Participants are randomly assigned to receive either efruxifermin or a placebo, both administered by subcutaneous injection. The study includes two cohorts: Cohort 1 requires biopsy confirmation of liver fibrosis and specific metabolic features, while Cohort 2 allows biopsy or non-invasive diagnosis. Treatment and observation continue over an extended period to evaluate changes in liver fibrosis and clinical events. During the study, researchers will monitor the time until significant clinical events such as disease progression or liver decompensation occur, with a follow-up of up to five years. For Cohort 1, the proportion of participants showing improvement in fibrosis without worsening steatohepatitis will be assessed at 96 weeks. Participants will undergo regular evaluations including clinical assessments and laboratory tests to track liver function and safety throughout the study period.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are conducting a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 3 study to assess the effectiveness, safety, and tolerability of a single intra-articular injection of PTP-001 (MOTYS) in adults aged 40 to 80 years with knee osteoarthritis. The study focuses on participants with mild to moderate radiographic knee OA and symptomatic knee pain, aiming to compare PTP-001 against a placebo over a 52-week period. Participants will be randomly assigned in equal numbers to receive either a single dose of PTP-001 or a placebo saline injection into the target knee on Day 1. The study includes a screening period up to 28 days before treatment, a one-day treatment phase, and a 12-month follow-up phase. A total of at least 260 participants are planned, with 130 in each treatment group. During the study, participants will undergo evaluations to measure improvements in knee function and pain at 6 months. Researchers will monitor symptoms using pain scales and collect safety data throughout the year. Participants are expected to adhere to study visit schedules, use acetaminophen as needed for knee pain, and avoid other unauthorized medications during the trial.

Researchers are evaluating VIA Disc NP, a minimally processed human nucleus pulposus tissue allograft, as a supplement for degenerated intervertebral discs in participants with symptomatic lumbar disc degeneration lasting more than 6 months and unresponsive to at least 3 months of conservative treatment. This Phase 2 randomized, double-blind, sham-controlled, multi-center study aims to assess the safety and effectiveness of VIA Disc NP compared to a sham procedure. Participants will be randomly assigned in a 1:1 ratio to receive either a single intradiscal injection of 100 mg of VIA Disc NP mixed with sterile saline at one or two affected levels (L1-S1) or a sham procedure where a needle is inserted through the skin and muscle but does not penetrate the disc annulus. The treatment is delivered once, targeting 1 or 2 lumbar disc levels. During the study, participants will be monitored for treatment effectiveness and safety up to 26 weeks. Effectiveness is measured by the proportion achieving a meaningful improvement in pain scores from baseline to 26 weeks, and safety by reported treatment-related adverse events up to 12 weeks. Assessments include pain severity (VAS), disability scores (ODI), neurologic exams, and patient-reported outcomes. The total participation age range is 22 to 85 years old.

Researchers are evaluating a new method of delivering Evoke Compound Action Potentials (ECAP)-controlled closed-loop spinal cord stimulation (SCS) using updated software and/or hardware features for people living with chronic pain in the trunk and/or limbs. This feasibility study aims to test and assess the novel treatment delivery with the Evoke SCS System to better understand its potential use for managing chronic pain. Participants will receive the Evoke Spinal Cord Stimulation System, which is a device that provides ECAP-controlled, closed-loop spinal cord stimulation. The study is single-arm and multicenter, focusing on patients who have already undergone or are planning to undergo implantation of the Evoke System within its approved use. The study does not include a comparison group. During the study, researchers will monitor changes in Evoke Compound Action Potentials (ECAPs) using the Evoke SCS System. Participants will be followed for up to two years to assess this primary outcome. Throughout participation, individuals will be asked to comply with study requirements and provide informed consent, with ongoing evaluation to understand the treatment's impact on chronic pain.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are conducting a global, multi-center, prospective post-market study to observe the long-term effectiveness of Boston Scientific neurostimulation systems in managing pain. The study aims to gather real-world clinical outcomes, economic value, and technical performance data of these commercially approved neurostimulation devices when used in routine clinical practice. The treatment involves an initial trial period using a Boston Scientific neurostimulation device for pain relief. Participants who experience a positive response during the trial may proceed to receive a permanent implant of the neurostimulation system. The therapy is tailored individually based on the investigator's judgment and standard care practices at each study site, following specific inclusion and exclusion criteria. Participants will be monitored throughout the trial and permanent implant phases to assess pain relief and overall treatment effectiveness. Assessments may include patient evaluations of pain and ability to complete study requirements. The study focuses on capturing comprehensive data to evaluate both clinical outcomes and device performance during regular use. Total participation duration depends on individual treatment progression from trial to permanent implant.

Researchers are evaluating the safety and tolerability of a drug called C-1101 compared to sterile saline in adults who have chronic painful lumbosacral radiculopathy, a condition causing pain radiating to or below the knee known as sciatica. This is a Phase 1 study designed to assess how well patients tolerate a single dose of C-1101 administered through a transforaminal epidural injection. Participants will receive either C-1101 or a placebo (sterile saline) in a single dose given as a transforaminal epidural injection. The study includes a dose escalation design to evaluate safety and tolerability over a 24-week period following administration. This approach helps understand the effects of the drug compared to placebo in a controlled setting. During the study, participants will be monitored for any treatment-emergent adverse events and adverse events of special interest from Day 1 up to Week 24. Researchers will assess the severity and incidence of such events to determine safety. The total participation duration includes screening, treatment, and follow-up over 24 weeks to carefully track any side effects or reactions.

Researchers are evaluating the ShiraTronics Migraine Therapy System in a pilot study to assess its preliminary safety and effectiveness in preventing chronic migraines for patients who have not responded well to other treatments. The study focuses on adults aged 22 years and older who experience frequent headaches and have a history of migraines lasting at least one year. This research aims to provide new options for those with refractory chronic migraine who have limited success with existing therapies. Participants will use the ShiraTronics Migraine Therapy System, a neurostimulator device designed to relieve, interrupt, and prevent chronic migraine attacks. The study does not specify multiple groups or comparators but emphasizes the evaluation of this device’s impact on migraine symptoms over a set period. The treatment will be monitored closely for safety and efficacy throughout the study. During the study, participants will be assessed based on the number of headache days they experience during 12 weeks of treatment. Researchers will track migraine frequency, safety outcomes, and overall response to the neurostimulator. Participants must maintain stable use of any migraine medication they are currently taking and will be monitored for any changes or side effects. The total duration and detailed procedures beyond the primary outcome measure are not specified but focus on observing the device’s effect on chronic migraine frequency and patient safety.