Winfield

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment compared to no stimulation in people with treatment-resistant depression. This prospective, multi-center, randomized, controlled, blinded trial focuses on reducing depressive symptoms over 12 months using multiple depression rating scales. The study follows guidelines from the Centers for Medicare and Medicaid Services regarding evidence development for this treatment. Participants receive implantation of the VNS device, which delivers stimulation to the vagal nerve. After a minimum two-week period post-implantation, participants are randomly assigned to either active VNS treatment or no stimulation control, with outcomes observed for 12 months. Following this randomized phase, all participants enter an open-label extension where those in the control group receive active stimulation. Additional subjects may join this open-label study for up to five years to further assess long-term effects. Throughout the study, participants undergo regular assessments including the Montgomery Åsberg Depression Rating Scale (MADRS), WHO Disability Assessment Schedule, Health Outcome Scale, Clinical Global Impressions Scale, and Suicidality Tracking Scale. Researchers monitor response rates, remission times, duration of effects, and adverse events from implantation through 12 months. This comprehensive evaluation includes safety monitoring and functional outcome measures to understand the impact of VNS therapy on depression and related disabilities.

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 the effectiveness and safety of CREXONT, a combination of Carbidopa and Levodopa in extended-release capsules, in people with Parkinson's disease (PD) under real-world conditions. This Phase 4 study focuses on participants who have PD diagnosed according to specific criteria and experience motor fluctuations and "Off" periods despite stable treatment with oral Carbidopa-Levodopa. Participants will receive CREXONT ER capsules during the study. The study includes a treatment period lasting 42 days, during which participants continue their PD medication regimen while taking CREXONT. The study assesses changes in the amount of time participants spend in the "Good On" state, where motor symptoms are well controlled. Throughout the study, participants will complete Parkinson's Disease diaries, questionnaires, and attend study visits and phone calls. Researchers will monitor motor function using standardized rating scales and diary entries to evaluate changes in motor states from the start of the study to Day 42. Safety and adherence to treatment will also be assessed during this period.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the safety and effectiveness of apixaban compared with aspirin in patients who recently had an intracerebral hemorrhage (ICH) and also have atrial fibrillation (AF). The study aims to find out if apixaban is better than aspirin in preventing any type of stroke or death from any cause. It also looks at whether apixaban leads to better functional recovery measured by the modified Rankin Scale. This is a phase III, randomized, double-blinded trial enrolling 700 patients over 3.5 years. Participants will be randomly assigned to receive either apixaban, an oral blood thinner that inhibits Factor Xa, or aspirin, an oral antiplatelet medication. The study lasts from 12 months up to 36 months of follow-up after enrollment. Treatments are given orally, and patients will be monitored throughout the study period. Recruitment and coordination occur through NIH/NINDS StrokeNet sites. During the study, participants will undergo assessments including brain imaging (CT or MRI) to confirm diagnosis, functional outcome measurements using the modified Rankin Scale, and monitoring for any strokes or death. Safety will be closely observed, and patients will provide informed consent before joining. The primary outcome measured is stroke or death up to 3 years, and secondary outcomes include functional status changes. Participants are followed regularly to track these outcomes and overall health status.

Researchers are studying patients with newly diagnosed very low risk and low risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer. This phase III trial aims to keep excellent treatment results while reducing therapy burden for very low risk patients using 24 weeks of vincristine and dactinomycin (VA). It also evaluates how low risk patients respond to standard chemotherapy involving vincristine, dactinomycin, and cyclophosphamide (VAC) followed by VA, and examines the use of molecular risk testing and intensified therapy for patients with specific DNA mutations to improve outcomes. Participants are assigned to one of two main treatment plans based on their risk group. Very low risk patients receive vincristine and dactinomycin intravenously every 21 days for 8 cycles. Low risk patients receive vincristine, dactinomycin, and cyclophosphamide for 4 cycles, then vincristine and dactinomycin for 4 more cycles, also on a 21-day schedule. If DNA mutations in MYOD1 or TP53 are found, patients switch to an intensified treatment regimen (Regimen M) with vincristine, dactinomycin, and cyclophosphamide over 12 to 13 cycles. Radiation therapy may be added for some patients. Treatment continues unless the disease progresses or side effects are unacceptable. During the study, participants undergo scans including CT, MRI, bone scans, PET scans, and tumor biopsies. Blood and tissue samples are collected at various points for future research. Researchers measure how long patients remain free from disease progression, recurrence, or death up to 3 years. They also monitor overall survival and evaluate the feasibility of using central molecular testing for risk. The trial includes careful safety monitoring and aims to improve care for patients with this cancer type.

Inpatient falls cause serious physical harm and increase healthcare costs, affecting both patients and hospitals. The Centers for Medicare & Medicaid Services (CMS) classify falls with injury as "never events," meaning they are preventable errors that negatively impact hospital safety ratings and reimbursement. Despite evidence showing that fall prevention alarms are not effective, these alarms are still widely used in hospitals. This study aims to reduce the use of these alarms by applying tailored strategies based on education, audit and feedback, and opinion leaders, guided by the Choosing Wisely De-implementation Framework. It will compare different coaching intensities to find effective ways to reduce alarm use in hospital units. The study involves 30 medical or medical-surgical hospital units across the US. These units will be randomly assigned to receive either high-intensity or low-intensity coaching to implement the tailored strategies for reducing fall prevention alarm use. Coaches will train hospital staff in quality improvement and fall prevention practices, customizing their support to each site's needs. This approach may help future efforts to reduce low-value alarm use in other healthcare settings with high fall risks. Participants include stakeholders involved in fall prevention at the participating hospitals. The study will monitor the prevalence of fall prevention alarms and record patient falls monthly over 30 months. Researchers will assess how well the coaching strategies reduce alarm use and improve patient safety. The findings will inform best practices for de-implementing ineffective alarms and may guide broader quality improvement initiatives in healthcare.

Researchers are studying how Fitbit wearable devices can help detect infections early in children aged 3 to 18 years who have had surgery for complicated appendicitis. The study aims to develop and validate a machine learning algorithm that analyzes near-real-time Fitbit data such as heart rate, physical activity, and sleep to predict postoperative infection. This approach could improve clinician decisions, reduce delays in seeking care, and change healthcare use after surgery. Participants will wear a Fitbit device after their appendectomy surgery for complicated appendicitis. Data collected from the Fitbit will include heart rate, physical activity, and sleep patterns, which will be used to develop and test the infection-prediction algorithm. The study includes recruiting about 250 children for algorithm development and validation, and an additional group of 94 children will have their Fitbit data shared daily with their surgeons to assess the impact on clinical decision-making and healthcare utilization. During the study, Fitbit data will be collected for 30 days starting from enrollment to monitor recovery trends. Researchers will gather information on physical activity, heart rate, and sleep through Fitbit metrics and evaluate how these data influence clinician responses and patient outcomes. The study also involves surveys and daily reports sent to surgeons to assess when and how early infections are detected and treated. This research aims to transform pediatric surgery care by using wearable technology to detect complications sooner and reduce healthcare burden.

Researchers are comparing the psychological and physiological effects of walking in two different outdoor environments—urban/suburban commercial areas versus urban/suburban nature areas—in adults with prediabetes. The study aims to find out if stress, anxiety, and mood improve more in one type of environment compared to the other. This randomized crossover trial involves participants serving as their own controls to assess these effects. Participants will walk for 150 minutes per week over six weeks in each environment: a nature-based green urban setting and a built commercial gray urban setting. Each walking period lasts six weeks, separated by a five-week break during which participants return to their usual physical activity levels. The walking sessions involve three to five walks per week, each lasting 30 to 50 minutes at moderate intensity. During the study, participants visit the clinic four times, before and after each six-week walking phase, to measure anxiety, stress, mood, and restorativeness. Saliva samples are collected around these visits to assess physiological stress markers. Researchers monitor these outcomes at specific weeks (4, 7, 15, and 18) to evaluate changes associated with walking in each environment. The total involvement includes walking interventions, clinic visits, and a washout period between interventions.