Bollington

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating the safety and performance of the ConvaVAC13 Ag Negative Pressure Wound Therapy System in treating chronic wounds, specifically focusing on Venous Leg Ulcers VLUs. Chronic wounds are those that heal slowly or not at all, causing pain and affecting daily life. VLUs are the most common chronic leg wounds, affecting about 1 in 100 people, and current treatments include wound cleaning, special dressings, compression therapy, and antimicrobial creams or dressings. This study aims to see if the ConvaVAC13 Ag system can improve healing outcomes for VLUs effectively and safely. The ConvaVAC13 Ag system is a device that uses negative pressure wound therapy NPWT combined with silver ions, which have antimicrobial properties. NPWT involves applying a sealed dressing connected to a vacuum pump that removes excess fluid, promotes tissue growth, and reduces bacteria in the wound. The study involves participants receiving treatment with this device on their VLUs. The system aims to support wound healing by removing harmful biofilms and promoting tissue repair. Participants will be involved in the study for at least 14 days, during which the main measurement is the percentage reduction in wound size at day 14. Researchers will monitor wound healing progress and safety throughout the treatment period. The study helps assess how well the device performs in managing VLUs, with evaluations of wound condition and patient outcomes. The total participation time may vary depending on individual wound response and healing progress.

This research aims to understand the real-world clinical outcomes and treatment patterns of adults with obstructive hypertrophic cardiomyopathy oHCM who are treated with mavacamten. It also explores the experiences of both patients and physicians using mavacamten in community-based practices across the US. The study is observational and focuses on gathering comprehensive data from actual clinical settings. Participants with obstructive HCM who have been prescribed mavacamten will be included. The study involves retrospective chart reviews of patients treated with mavacamten from April 2022 to December 2024, and a patient survey requiring English proficiency and access to a computer or smartphone. Physicians treating these patients will also provide feedback about treatment preferences and implementation. The treatment follows the product label for mavacamten use. Participants will have their medical records reviewed for various baseline and follow-up clinical data, including blood pressure, diagnosis date, genetic testing, family history, comorbidities, prior surgeries, and heart function class. Data on mavacamten treatment duration, dose changes, reasons for dose adjustments or discontinuation, and heart function recovery are collected at baseline and at weeks 4, 8, 12, and 24. Structured interviews with physicians gather perspectives on treatment eligibility and experience. The study duration and assessments occur up to 24 weeks from baseline.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.