1)Implementation of an At-Home Collection Tool for Use in Inborn Errors of Acylcarnitine Metabolism (IEAM) and Application of a Machine Learning Disease Prediction Model
Lay Summary: Inborn errors of metabolism involving small molecules, such as acylcarnitines and amino acids, are a group of metabolic disorders that result from defects in the enzymes, or biologic machinery, necessary for the creation, transport, and/or breakdown of these compounds. Unrecognized imbalances in these compounds cause health crises in patients that lead to severe growth, intellectual, and developmental delays, or death. While these disorders can cause these imbalances directly, current therapy involves dietary restriction that further disrupts this balance and which may worsen morbidity and mortality without close monitoring. Due to the serious effect of these disruptions on health, organizations such as the Genetic Metabolic Dietitians International organization recommend frequent assessments of these compounds, however, they also site a lack of appropriate laboratories and technology as barriers to following their recommendations. Worse, for many patients, providing a sample is cost prohibitive due to the financial burdens involved. Prior to the development of our novel methodology, we were dependent on infrequent and non-representative sampling as frequent and longitudinal assessments were impossible. To rectify this technological gap, we developed a low-cost methodology for the analysis of greater than 30 acylcarnitines and have paired it with our novel filter paper pretreatment methodology. We now propose to leverage this technique to both increase monitoring and to assess for predictive biomarkers of these health crises. Our method will allow for longitudinal assessments in patients, provide data for research, and in the future it will increase access and improve patient health by reducing the time, difficulty, and cost of analysis.
Kirkland Wilson, MD
University Hospitals
2)Target Trial Emulation of Simultaneous Vaccine Effectiveness of Multiple Adult Seasonal Vaccines Utilizing National and Regional Electronic Health Records
Lay Summary: Annual vaccines for influenza, COVID-19, and RSV are recommended for older adults to prevent severe illness and reduce community spread. Currently, researchers measure vaccine success by tracking specific infections among those vaccinated and unvaccinated. While vaccines may not prevent every mild infection, their primary goal is to prevent hospitalization and death. This study aims to use anonymous health records to evaluate how effectively these shots protect your overall respiratory health.
Pauline Terebuh, MD, MPH
CWRU
3)Respiratory and Sleep Physiologic Analysis in the ICU (RESPITE-ICU): Leveraging ECG and Oximetry for Novel Sleep-Disordered Breathing Detection
Lay Summary: Sleep apnea is a common condition in which breathing repeatedly stops or becomes shallow during sleep. The most frequent form, obstructive sleep apnea (OSA), is treatable, but many people—especially those who are hospitalized—are never diagnosed. Missing the diagnosis matters because untreated moderate to severe OSA can worsen oxygen levels at night, disrupt sleep, and may contribute to complications that affect recovery and long-term health. In the intensive care unit (ICU), diagnosing OSA is particularly challenging because standard sleep studies are difficult to perform, expensive, and not routinely available. This pilot study will test a new approach that uses information already collected in the ICU. Nearly all ICU patients are continuously monitored with heart (ECG) and oxygen (SpO₂) signals. Our goal is to determine whether these routine signals can be used to accurately identify whether a patient has moderate to severe OSA. We will focus on a practical, real-world question: can we correctly sort patients into “likely moderate–severe OSA” versus “not moderate–severe OSA,” based on existing monitor data? To do this, we will enroll up to 25 adult ICU patients who can safely undergo sleep testing and who can provide consent. During an overnight period (8:00 PM to 8:00 AM), participants will have a portable sleep test performed at the bedside. A smaller subset (up to 15 patients) will also complete a full, attended sleep study when feasible. Importantly, the ICU monitor data and the sleep test data will be recorded simultaneously, allowing us to directly compare the algorithm’s outputs to results from the sleep test, which serves as the reference standard. A key challenge in the ICU is that signals can be noisy due to movement, sensor problems, procedures, or temporary disconnections. Therefore, we will develop “signal quality” measures that identify how much of the ECG and SpO₂ data are usable and when. These signal quality indices will help ensure the algorithm is built on reliable data and will also tell us how often the ICU environment provides enough usable signal for accurate screening. The main outcomes of this pilot will be (1) how accurate the monitoring-based approach is for detecting moderate to severe OSA, and (2) how feasible it is to collect enough high-quality data in the ICU to support this approach. We will also explore whether patients flagged by the algorithm have meaningful differences in clinical outcomes such as length of stay, readmission, discharge destination, and completion of follow-up sleep referral and testing after discharge. By generating early accuracy and feasibility data at relatively low cost, this project will provide essential pilot evidence to support larger studies. Future external funding will be sought to expand to multiple hospitals, improve and validate the algorithm across diverse patient populations, and integrate the approach into practical clinical workflows (such as automated referral pathways) to ensure that more patients with treatable OSA are identified and connected to care.
Zachary Strumpf, MD
University Hospitals
4)Fenofibrate Exposure and HPV-Related Cancers in People Living with HIV: Discovery, Validation, and Translational Insight
Lay Summary: People living with HIV are now living much longer lives due to effective antiretroviral therapy. However, as life expectancy has improved, long-term health conditions such as heart disease, metabolic disorders, and certain cancers have become increasingly important concerns for this population. One cancer of particular interest is human papillomavirus (HPV) associated cancer, which occurs more frequently in people living with HIV compared with the general population, even when HIV is well controlled. Fenofibrate is a medication commonly used to treat high triglyceride levels and other lipid abnormalities. In addition to its effects on cholesterol and triglycerides, laboratory and early clinical studies suggest that fenofibrate may influence biological pathways involved in inflammation, immune function, and cancer development. These findings raise an important question: could exposure to fenofibrate be associated with a lower risk of HPV-associated cancers in people living with HIV? The goal of this study is to examine whether people living with HIV who are treated with fenofibrate experience different rates of HPV-associated cancers compared with similar individuals who are not treated with this medication. Rather than testing a new drug in a clinical trial, this study will analyze existing clinical data collected during routine medical care. By using large, real-world health data sources, the study can evaluate patterns of medication use and cancer outcomes across a broad and diverse population of people living with HIV. This research will carefully compare individuals who have been exposed to fenofibrate with those who have not, while accounting for important health factors such as age, sex, HIV-related characteristics, and other medical conditions. The aim is to better understand whether fenofibrate exposure is associated with differences in HPV-related cancer outcomes in real-world clinical settings. If an association is observed, the findings could have important implications. Fenofibrate is an inexpensive, widely available medication with a long history of clinical use. Understanding whether it may also be linked to reduced cancer risk could help guide future clinical research and inform the design of prospective studies. Ultimately, this work could contribute to new strategies for reducing cancer burden among people living with HIV, a population that continues to face disproportionate cancer risk. By leveraging existing clinical data and focusing on a medication already used in routine care, this study aims to generate timely, patient-relevant evidence that can inform future prevention and treatment approaches. The results may help clinicians, researchers, and patients better understand how commonly used therapies could influence long-term health outcomes beyond their primary indications.
Aaron Fletcher, RDN, LD
CWRU
5) Rapid and Accurate Breast Cancer Screening with Magnetic Resonance Fingerprinting
Lay Summary: Breast cancer remains the most common cancer among women, and early detection is the best way to save lives. Unfortunately, today’s screening options have important drawbacks. Mammograms can miss cancers in women with dense breast tissue and expose women to radiation every year. MRI scans are more accurate but are expensive, time-consuming, and require an injection of contrast dye. These barriers prevent many women from accessing the best available screening tools. This project will test a new type of MRI called Magnetic Resonance Fingerprinting (MRF). Unlike traditional MRI, breast MRF takes only about 5 minutes, does not require any contrast injection, and provides precise, reproducible information about breast tissue. Early studies show that breast MRF can tell the difference between cancer and normal breast tissue, and even identify which cancers may respond to certain treatments. This makes it a promising new option for safer, faster, and more comfortable breast cancer screening. With this pilot grant support, we will study breast MRF in two ways. First, we will compare its ability to detect and classify breast cancers versus normal or benign findings in women undergoing MRI. Second, we will add breast MRF to screening MRI exams for 1000 women at University Hospitals Cleveland Medical Center and its regional sites. We expect breast MRF to be highly accurate at finding cancers, while reducing unnecessary biopsies and lowering costs. The impact of this work is significant. By eliminating the need for contrast injections, shortening exam time, and lowering costs, breast MRF could expand access to advanced screening for women who currently face barriers to care. If successful, this technology could change the standard of breast cancer screening, making it more accurate, more comfortable, and more equitable.
Faezeh Sodagari, MD
University Hospitals
6)VIBE: Ventilator Insights for Better Evaluation of Pediatric Respiratory Failure
Lay Summary: Over 75,000 US children receive mechanical ventilation in an ICU each year and respiratory failure is the most expensive diagnosis in pediatric care. Despite this, there have been very few clinical trials to guide clinicians, so they rely on observational research that of assesses ventilator parameters several times a day; however, a child will take over 25,000 breaths that day that are currently ignored. Modern clinical informatics systems enable the capture and analysis of these unexplored breaths. VIBE: Ventilator Insights for Better Evaluation of Pediatric Respiratory Failure acquires breath-by-breath measurements in children with respiratory failure and uses these breaths to identify factors associated with prolonged mechanical ventilation.
Joseph Kohne, MD MSC
University Hospitals
7) Towards understanding the clinical and systemwide benefits of Substance Use Navigator Specialists (SUNS) at University Hospitals and MetroHealth Emergency Departments (EDs)
Lay Summary: University Hospitals and MetroHealth are conducting a regional assessment of our emergency department’s (EDs) Substance Use Navigator Specialist (SUNS) programs. This is the first regional assessment of patients with substance use disorder (SUD) who engage with SUNS. We will evaluate clinical health outcomes (e.g. entry into treatment) and systemwide benefits (e.g. repeat hospital visits) in employing highly trained professionals with expertise in SUD care. This project will demonstrate the importance of regional collaboration to better serve this vulnerable population.
Kiran Faryar, MD, MPH
University Hospital