Bella Vista

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

Researchers are evaluating a new auto-adjusting positive airway pressure algorithm designed to treat obstructive sleep apnea (OSA). The study is a blind, randomized crossover or single-arm trial, conducted in two phases. Phase 1 focuses on confirming the algorithm's proper function and making minor software adjustments. Phase 2 expands the assessment to a broader group of participants, comparing objective data and subjective experiences between the new algorithm and a control algorithm. Participants will use two device algorithms: the investigational algorithm developed specifically for treating OSA and an established control algorithm. After randomization, participants will trial one algorithm at home, then switch to the other, completing questionnaires about their therapy experiences after each period. An optional extended trial is available for those satisfied with the investigational device. During the study, participants will provide consent, attend study visits, and may wear a commercial wellness wearable to collect sleep and activity data. Researchers will monitor treatment efficacy by comparing apnea-hypopnea index (AHI) data after 8 weeks. Participants return devices and complete questionnaires before study conclusion, with reimbursement provided. The study duration for each participant is approximately 8 weeks, with follow-up visits to review experiences and device performance.

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.