Athens

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating how effective, safe, and tolerable a vaccine for Clostridioides difficile (C. difficile) infection is in adults aged 65 years and older. The study focuses on reducing the number of C. difficile infections, which can cause diarrhea, in this older adult population. This is a Phase 3, placebo-controlled, double-blinded, randomized trial involving participants who are at risk because of recent or planned contact with healthcare systems or recent antibiotic use. Participants will receive either the C. difficile vaccine or a saline placebo. Both are given by injection into the upper arm muscle. The study includes 3 planned clinic visits and 3 phone visits initially, followed by yearly clinic visits until the study ends. Participants will remain in the study until enough infection events have occurred—this period may last up to about three and a half years, but could be shorter or longer depending on how quickly events happen or if the study stops early due to clear results. Throughout the study, participants will report any side effects such as local reactions and systemic events for 7 days after each vaccination, and adverse events for up to one month. Serious adverse events are monitored for up to 18 months after the last dose. If participants experience 3 or more loose stools within 24 hours during the study, they must save the next stool and contact the study team for infection testing. This ongoing monitoring helps assess the vaccine's impact on preventing medically attended C. difficile infections over time.

The trial investigates the use of Amnio-Maxx as an additional treatment for patients with diabetic foot ulcers (DFUs) that have not responded to standard care alone. It focuses on patients with Wagner grade 1 and 2 chronic ulcers, mostly including individuals aged 65 years or older. The study aims to assess how well Amnio-Maxx helps heal these ulcers compared to standard care, measuring wound closure and reduction in ulcer size over 12 weeks. Participants will first undergo a 2-week run-in period before being randomly assigned to receive either Amnio-Maxx combined with standard care or standard care alone. The Amnio-Maxx patch is processed using special aseptic techniques and dehydrated with saline. Patients will be monitored weekly for 12 weeks, with additional visits if needed for dressing changes. The study collects data on wound healing progress, pain levels, and safety. Throughout the study, participants will attend weekly visits for assessments including wound size measurements, safety checks, and pain evaluations. Healing will be verified independently at 12 weeks. Participants must follow offloading protocols for the ulcer site and provide informed consent. The trial tracks healing outcomes and monitors for adverse events, aiming to understand the effectiveness and safety of Amnio-Maxx in managing diabetic foot ulcers.

Researchers are evaluating the use of Derm-Maxx, an acellular human dermis graft, as an additional treatment for patients with diabetic foot ulcers that have not healed with standard care alone. This multicenter randomized open-label trial focuses on patients with Wagner grade 1 and 2 diabetic foot ulcers. The study aims to assess healing rates and wound closure over a 12-week treatment period, with at least half of the participants being 65 years or older. Participants will undergo a 2-week run-in period before being randomly assigned to receive either Derm-Maxx plus standard of care or standard of care alone. During the 12-week treatment phase, patients will have weekly visits to monitor ulcer healing, with additional dressing changes recorded as needed. Derm-Maxx is applied to ulcers that have been properly prepared and offloaded using a specific device. The study also evaluates pain and safety alongside healing outcomes. Throughout the study, participants will be closely monitored with assessments of ulcer size, wound closure, and circulation to the affected foot. Researchers will collect data through physical exams, wound measurements, and adherence to offloading protocols. Safety and pain levels will be tracked to ensure participant well-being. The total duration of participation includes screening, run-in, treatment, and follow-up visits over at least 12 weeks.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating ways to improve advance care planning (ACP) among underserved communities, who often receive lower quality end-of-life care and unwanted, costly treatments. This study compares two conversation-based tools designed to encourage discussions about end-of-life wishes and motivate ACP behaviors. The goal is to increase high-quality end-of-life care, reduce health disparities, and lessen unnecessary suffering for patients and families. The study is a cluster randomized controlled trial involving 75 underserved communities across the US. It compares a serious conversation game called Hello, the widely used Conversation Project (CP) Starter Kit, and usual care where only an advance directive is distributed. The Hello game has 32 questions prompting sharing of values and beliefs about end-of-life issues, while the CP Starter Kit is a workbook with prompts and resources to facilitate conversations. The third group receives a general conversation game called Table Topics. Participants include adults from underserved populations who have not completed an advance directive in the past 5 years. Researchers will assess completion of a visually verified advance directive six months after the intervention. Other ACP behaviors will also be measured. The study involves community events, follow-up, and data collection to understand which tools best engage underserved groups in ACP and improve end-of-life care outcomes.