Dobson, North Carolina

Inspiring Seniors Towards Exercise Promotion to Protect Cognition

The Role of the Time of Day in the Effects of Exercise on Memory in Heathy Young Adults

Cumulative evidence indicates that a single bout of exercise has beneficial impacts on short- and long-term memory in young adults. From a physiological perspective, acute exercise leads to changes of heart rate variability (HRV), which is associated with memory retrieval process. From a psychological perspective, acute exercise increases the arousal level and thus facilitates cognitive processing including memory storage and retrieval. Such HRV- and/or arousal-based effects of exercise on memory could be differed by the time of day in young adults based on their circadian rhythms of HRV; sleep-wake transition led to rapid changes of HRV. Moreover, young adults prefer afternoon or evening to morning, showing less wakefulness and lower memory performance in the morning relative to afternoon. Based on the potential physiological and/or psychological mechanisms, exercise could impact young adults' memory differently by the time of day. Few studies, however, tested the effects of exercise on memory based on the time of day; rather, a recent study found null effects of exercise-induced arousal on implicit and explicit memory performance in college students in the morning. The investigators here aim to 1) determine the extent to which the time of day moderates how moderate-intensity cardiovascular exercise impacts verbal-auditory and visuo-spatial short- and long-term memory in young adults, and 2) consider potential physiological and psychological markers that may mediate exercise's effects on cognitive performance. Specifically, the investigators will conduct a mixed-design randomized experiment to compare the effects of a single session of moderate-intensity cardiovascular exercise on cognitive performance at two times of day - in the morning (7 - 9 AM) and late afternoon (3 - 5 PM). Participants in each of two groups (morning versus afternoon) will complete two sessions of cognitive tests - at baseline without exercise and after an exercise intervention, while their emotional states, arousal levels, and heart rate (HR) will be measured at baseline, before, during, and after the exercise and memory sessions. The hypotheses are 1) acute exercise in the morning will be more beneficial for short- and long-term memory than an equal volume of exercise in the afternoon; 2) resting HRV and changes in perceived arousal and emotional states will be associated with memory performance following the exercise intervention. The rationale for the hypotheses is that cognitive benefits of exercise can differ by the preference for the time of day, so it is important to investigate such interactions to inform recommendations of the timing of exercise for young adults in academic settings. Moreover, exploring the role of psychophysiological markers in mediating exercise effects on cognition help to further understanding of the benefits of exercise for brain health.

Nature IDEAS Study: an RCT to Increase Time Spent in Nature Among University Students

America faces a syndemic of youth 'nature deficit disorder' and poor mental health. These conditions can be improved by nature contact, but the outdoors is not equally accessible, particularly for students of color. This study leverages the NatureDose™ app to identify racial/ethnic inequities in nature opportunities, belonging, and benefits and conduct an RCT to improve mental health and address disparities by getting university students outdoors into nature. The investigators will test 3 over-arching questions: 1. Are there differences in nature opportunities and/or belongingness for White versus students of color? 2. Does more time in nature correlate with greater feelings of nature connectedness, belongingness, and better mental health? 3. Is a nature-based intervention that leverages NatureDoseTM a cost-effective way to improve mental health, particularly for students of color? This project has two stages. 1) We will determine nature opportunities at each institution using park and sports field mapping, remote sensing, and tree canopy assessment within 30 miles of campuses to identify disparities. 2) As Fall semester starts, we will recruit 160 students/site for a randomized controlled trial (N=1,440 total, giving 80% power to detect effects down to Cohen's d=0.2 even with attrition). Students will complete baseline surveys on nature connectedness (NR-6), nature belongingness (validated scale for university students), mental health (distress, worry, positive/negative affect), and demographics. Next, students will download the NatureDose™ app, which uses 30+ datasets and machine learning models to quantify nature. The app calculates how much nature is near users whenever they are outdoors, and weekly minutes in nature. App data will be collected over a 2-week baseline period, after which students will be randomized to receive 1) standard information about the health benefits of nature (50%) (Active Control) or 2) standard health information, a request to increase weekly minutes in nature, eligibility for a prize, and peer performance comparison. After 2 weeks, students will repeat baseline surveys.

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF). Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed. Estimated duration of participation: Up to 3 years.

A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)

AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

Objective This prospective study benchmarks the accuracy of CorEFS AI software in estimating ejection fraction (EF) severity categories using continuous ECG waveforms from the FDA-cleared Peerbridge Cor® ECG device, calibrated to the American Society of Echocardiography (ASE) scale. Background Heart failure (HF) remains a significant public health issue, particularly in older adults (75+), with high morbidity and mortality rates. Half of HF cases involve reduced EF (HFrEF), a condition associated with a 75% five-year mortality rate. Despite advancements in HF management, accessible, low-cost EF monitoring is lacking. Echocardiography (Echo) is the gold standard for EF measurement but is limited in ambulatory and home settings. Continuous ECG wearables like the Peerbridge Cor® offer a promising alternative, providing high diagnostic yield, low wear burden, and real-time EF estimation. Previous studies (References 1-11) demonstrate the potential of AI-enabled ECG analysis in EF prediction, with accuracies up to 91.4% and AUCs of 0.94 in estimating EF severity. Successful demonstration of the proposed endpoints to clinically acceptable statistical thresholds will provide a new and alternative capability for EF severity assessments compared to ultrasound, MRI, and other imaging modalities where access is limited. Hypothesis Specific ECG changes may identify left ventricular dysfunction (LVSD) and predict EF severity, enabling low-burden, cost-effective EF monitoring in high-risk populations. Study Design Participant Enrollment and Setup Participants will receive the Peerbridge Cor® wearable, with data collection occurring through: In-clinic setup: Study staff apply and initiate device use. Patient Home Setup (PHS): Telehealth guidance for independent device application (20% of participants). Subprotocols A: 30 minutes of Cor® ECG recording; 15 minutes analyzed. B: Up to 7 days of Cor® device use with periodic 15-minute sitting sessions. EF Reference Standard EF severity will be determined via FDA-cleared transthoracic echocardiography (TTE), using the Simpson's Bi-Plane Method. Data Collection Peerbridge Cor® ECG Data: 30 minutes recorded; 15 minutes analyzed in 5-minute segments. Echo Study: Conducted before or during Cor® recording. 12-Lead ECG: Simultaneous recording with the Cor® device. Participants log sessions using the Cor® device's Event button. De-identified medical histories will support subgroup analyses. Endpoints Agreement between Cor® ECG-derived EF severity and Echo results will be assessed across ASE-defined categories (Normal, Mild, Moderate, Severe). Positive predictive value (PPV) adjusted for prevalence will be calculated. This streamlined protocol validates CorEFS software for reliable, cost-effective EF monitoring and clinical decision support.

A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK

Clinical Utility of Management of Patients With Pulmonary Nodules Using the Percepta Nasal Swab Classifier

This is a prospective, multicenter, randomized study to evaluate the clinical utility of the Percepta® Nasal Swab classifier in managing patients with pulmonary nodules identified incidentally or by lung cancer screening. Patients will be randomized to either the test group, where the test result will be returned to the physician to incorporate into decision-making on how to manage the patient's nodule, or the control group which will represent the standard of care where the result will not be returned to the physician. The study will observe and evaluate how the addition of the Percepta Nasal Swab classifier result impacts current management of newly identified lung nodules. The study will enroll approximately 2400 participants meeting eligibility criteria at up to 100 centers in the US. Enrollment is expected to take approximately 24 months and participants will be followed for 24 to 30 months or until a diagnosis of lung cancer.

Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System

This study is being conducted to demonstrate the safety and effectiveness of the AquaPass System in reducing fluid overload in patients with decompensated heart failure and chronic kidney disease stage 2-3 who are not responding adequately or resistant to current medical treatment. The study checks if patients' fluid loss as a result of taking diuretics medications is improved when using AquaPass in parallel to this treatment. The evaluation of success is done by comparing participants' weight before and after the use of the AquaPass system, to evaluate if the system effectively removes excess fluids. Patients will also have blood and urine tests every morning to check how well their kidneys and heart are functioning. The first visit will be observation only, without using AquaPass. This will serve as the baseline data. The investigators will compare the data of the AquaPass treatments with this baseline to measure the effectiveness of the system in removing access fluids.

Precision Nudging for Hypertension Management: Observational Study