Medicine and Health Sciences Commons^™

A Brief Review Of Fda’S Novel Tools For Ensuring Pharmaceutical Quality In The Human Drug Supply Chain, Heather R. Campbell, Robert A. Lodder

Pharmaceutical Sciences Faculty Publications

Purpose

Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid pharmaceutical manufacturing oversight. This paper briefly reviews these tools.

Methods

Current inspection approaches employed by the FDA are identified by searching the FDA’s guidances, the Code of Federal Regulations, public reports and other online resources.

Outcomes

Industry

A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows …

Zilpaterol And Ractopamine: Reaching Consensus On Trace-Level Transfers To Racehorses, Jacob Machin, Kimberly Brewer, Clara K. Fenger, Sarah White-Springer, Abelardo Morales-Briceno, Thomas Tobin

Maxwell H. Gluck Equine Research Center Faculty Publications

In this article, we review the investigation of trace amounts of b-2 adrenergic agonists, a drug class that possess significant risk to the integrity of horse racing whether intentionally used or through the inadvertent contamination of feed.

Predicting Tomorrow: Optimizing The Early Detection Of Disease And Disease Recovery In Dairy Calves Using Precision Technologies, Melissa Cantor

Theses and Dissertations--Animal and Food Sciences

The leading causes of morbidity and mortality in preweaned dairy calves are diarrhea and bovine respiratory disease complex (BRD). The delayed detection of these diseases in calves can also delay intervention and disease recovery. The overarching objective of this dissertation was to follow a cohort of calves daily for the first 90 days of life for naturally occurring clinical BRD bouts and diarrheal bouts. The objective answered if feeding behaviors and activity levels were different in at-risk calves during BRD development and BRD recovery from an antimicrobial intervention. Furthermore, the potential of colostrum replacer as a feeding intervention strategy to …

Death, Discipline, And The Dead: Biopolitical Rhetoric In Early Modern English Texts, Leslie Raybuck Malland

Theses and Dissertations--English

Death, Discipline, and the Dead: Biopolitical Rhetoric in Early Modern English Texts locates allusions to the biopolitical culture of Early Modern England within popular English texts. Through my examination of the period’s fascination with death—public executions, newly-authorized anatomies—and the ways in which death, as well as the treatment of the dead, was authorized by and supported the ideological aims of the state, my research identifies how those themes carry over into the most popular works of the day, reviewing instances of both verbal and nonverbal rhetoric across genres to find allusions to biopower — or, state control of the biological. …

Development And Clinical Validation Of Knowledge-Based Planning Models For Stereotactic Body Radiotherapy Of Early-Stage Non-Small-Cell Lung Cancer Patients, Justin David Visak

Theses and Dissertations--Radiation Medicine

Lung stereotactic body radiotherapy (SBRT) is a viable alternative to surgical intervention for the treatment of early-stage non-small-cell lung cancer (NSCLC) patients. This therapy achieves strong local control rates by delivering ultra-high, conformal radioablative doses in typically one to five fractions. Historically, lung SBRT plans are manually generated using 3D conformal radiation therapy, dynamic conformal arcs (DCA), intensity-modulated radiation therapy, and more recently via volumetric modulated arc therapy (VMAT) on a C-arm linear accelerator (linac). Manually planned VMAT is an advanced technique to deliver high-quality lung SBRT due to its dosimetric capabilities and utilization of flattening-filter free beams to improve …

Exploring The Relationships Between Cultural Values And Diet Patterns Among Mexican And Cuban Immigrants In Kentucky, Nasreen Omran

Theses and Dissertations--Nutrition and Food Systems

The number of Latinx in the U.S. is expected to grow to about 28 percent of the population by the year 2060. As the number of Latinx increases in the U.S. it is important to understand how cultural beliefs influence dietary behaviors as Latinx are disproportionately affected by diet related disease such as diabetes mellitus, cancer, and cardiovascular disease. The aim of this secondary data analysis is to examine the relationship between family values, gender roles, and religious values on diet patterns in adult Mexican and Cuban immigrants in Kentucky utilizing the Mexican American Cultural Values Scale. The study findings …

A Novel Role For Neurotensin In Regulation Of Stem Cell Function In The Small Intestine, Stephanie Rock

Theses and Dissertations--Toxicology and Cancer Biology

Neurotensin (NT) is a nutrient-regulated gut hormone that plays important roles in lipid absorption, obesity, metabolic disorders, and normal and neoplastic growth in the intestine. In this study, we 1) elucidate the mechanisms regulating NT release from endocrine cells, 2) examine the role of NT on proliferation and stem cell function in the small intestine and 3) define the effects of NT on colorectal cancer stem cells. We report that NT release from endocrine cells is enhanced by the MAPK scaffold protein Kinase Suppressor of Ras 1 (KSR1) and the exocyst complex component 70 (Exo70). Moreover, free fatty acid stimulated …

Effects Of Season And Nutrition On Insulinemic Responses In Insulin Dysregulated Horses, Erica Lyn Macon

Theses and Dissertations--Veterinary Science

Insulin dysregulation (ID) is the main risk factor for the development of hyperinsulinemia-associated laminitis (HAL). ID in the equid has been extensively researched; however, recommendations for diagnosing and managing ID horses have originated from work completed in other models, such as the ID pony and healthy horse. Therefore, our overall objective was to improve current diagnostic tools and nutritional management strategies by investigating the effect of season, the fed and fasted state on the oral sugar test (OST) and dietary nutrient content on insulinemic responses in the ID horse. To address this, four main objectives with three specific aims were …

Evaluating The Incidence Of Melanoma And Lung Cancer Of Current And Former Active-Duty U.S. Military Who Were Deployed In Support Of Operation Enduring Freedom And Operation Iraqi Freedom, Brian Kovacic

Theses and Dissertations--Epidemiology and Biostatistics

The incidence of melanoma and lung cancer has been gradually increasing in the United States over the past three decades with the reputed causes due to etiological and environmental exposures, and tobacco usage. There has been concern that melanoma and lung cancer incidence among military personnel may be associated with deployment to environments with intense sun exposure and increased smoking rates due to post-traumatic stress disorder. The aim of this study was to examine associations between deployment in support of Operation Enduring Freedom (OEF) or Operation Iraqi Freedom (OIF), from 2001 through 2015, with subsequent melanoma and lung cancer incidence. …

Sexual Behaviors Associated With Online Partner-Seeking Among Men Who Have Sex With Men From Small/Midsized Towns Or Rural Areas In Kentucky, Vira Pravosud

Theses and Dissertations--Epidemiology and Biostatistics

The HIV epidemic remains one of the most significant public health issues in the United States, particularly among men who have sex with men (MSM). New avenues for partner-seeking have emerged over the past three decades, including through the Internet, social media, and geosocial networking applications. Consisting of three cross-sectional studies, this dissertation research aimed to determine associations between the use of various online tools for partner-seeking (hereafter collectively referred to as “apps”) and HIV-related sexual behaviors among 252 young adult MSM residing in small/midsized towns or rural areas in Central Kentucky, a group that has been under-represented in the …

Teeka Tehreek: Increasing Epi Vaccinations In Khyber Pakhtunkhwa, Pakistan, Narjis Fatima Hussain

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Abstract

Globally, Pakistan ranks third among countries with the most unvaccinated and under-vaccinated children. Within the country, there are huge regional disparities, and the Khyber Pakhtunkhwa region (KPK FATA) has one of the lowest vaccination rates in the country. Low vaccination rates contribute to the high burden of childhood infectious diseases in Pakistan that cause 70% of childhood deaths. Addressing the issue requires an understanding of the barriers towards vaccinations; 30% of refusals are due to religious reasons and other misconceptions that are compounded by low literacy rates. Since religion has a critical authority in shaping the population’s beliefs, attitudes, …

Nurse Home Visitation Program In Hamilton County, Oh To Increase Maternal And Child Health Outcomes, Hannah Widner

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Hamilton County Ohio currently has poor outcomes related to maternal and infant health, specifically among African Americans. Compared to the Healthy People 2020 goals, Hamilton County has higher rates of infant mortality, preterm birth, neonatal infant mortality, and conception within 18 months of previous pregnancies. These rates are disproportionate among African Americans. For instance, African American babies born in Ohio have higher infant mortality rate (14.3 per 1,000) prematurity as a cause of death (4 per 1,000) and neonatal mortality rate (9.2 per 1,000). These are compared to White babies in Ohio with infant mortality rate (5.1 per 1,000), prematurity …

Implementing The Mothers And Babies Program To Reduce Preterm And Low Birth Weight Deliveries, Tan Frison

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Georgia ranks fourth (4th) in the nation for the highest low birth weight rate at 10%, and sixth (6th) in the nation for preterm birth rate at 11.7%, among the states. Based on statistical data Bulloch county has maintained an average low birth weight statistic of 10% for over a decade. In 2019, there were 107 preterm and 79 low weight births in Bulloch county, Georgia. These numbers confirm there is a need for more preventive resources for mothers and children within this community. To address this burden, the Bulloch County health department has decided to implement the Mothers and …

Farmer Suicide: Rates, Trends, And Associations To Commodity Production Among States Reporting Violent Deaths, 2003-2017, Paul Norrod

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Occupational studies show that farmers are at higher risk for suicide with rates at least two-fold those of the U.S. population.2-4 Therefore, the purpose of this study was to (1) determine age- and sex-specific farmer suicide rates, (2) evaluate rate trends, and (3) assess the relationship between commodity production and farmer suicide using the National Violent Death Reporting System (NVDRS) and quinquennial Census of Agriculture. We identified 1,652 farmer suicide cases from the NVDRS. Age-specific rates showed the highest rates among male farmers over 64 at 14.03 per 100,000. Annual rates for the 15-year study period peaked during 2013 at …

Recovery Housing In The United States And The Importance Of Data Collection, Maanasa Manchikanti

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Substance use disorder (SUD) has been a prevalent issue in both the clinical and public health sectors for some time. Substance use disorder can be defined as a disease that affects an individual’s brain and behavior, causing them to develop an inability to control the use of legal or illegal drugs and substances (Mayo Clinic, 2021). Substances include but are not limited to alcohol, marijuana, opioids, and other controlled substances (Mayo Clinic, 2021). Substance misuse is a large topic of focus in public health because it not only deteriorates the quality of health in individuals and society, but also comes …

Rates Of Diabetes Screening In Kentucky Before And After Implementation Of The Affordable Care Act (Aca), Cory Reinert

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Diabetes mellitus, commonly referred to as “diabetes”, is currently at epidemic proportions in the United States as its prevalence has drastically increased over the past several decades. The percentage of Americans with diagnosed diabetes has risen from 0.93 percent of the population in 1958 to 10.5 percent in 2018 (ADA, 2021). Diabetes also impacts record numbers of Kentucky residents.

Regular screening for those considered at-risk can encourage patients to implement lifestyle modifications, pharmacological therapy, or other interventions earlier in the course of disease. This can help prevent or delay onset of T2D and can reduce diabetes-related complications in those who …

Implementing The Textme Cardiovascular Mobile Health Intervention In Detroit, Michingan, Melissa Horton

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Cardiovascular disease is currently the leading cause of death in the United States. One of the cities with the highest rates of cardiovascular disease is Detroit, Michigan. Those diagnosed with cardiovascular disease are encouraged to make lifestyle modifications to improve their health. However, if cardiovascular disease is not managed, it can lead to serious health outcomes such as stroke, heart disease, and death. The TEXTMe program is designed to send randomized text messages to participants to encourage lifestyle changes around diet, exercise, and smoking cessation. Participants in the program will be recruited from three health clinics located in the city …

Cognitive-Motor Interactions In Gait And Postural Control And Cortical Network Neurocorrelates, Nathan Morelli

Theses and Dissertations--Rehabilitation Sciences

The ability to mitigate performance decrements during the concurrent completion of cognitive and motor tasks (i.e., dual task (DT)) deteriorates in patients with mild Traumatic Brain Injury (mTBI). It is theorized that the long-term sequelae of mTBI are due to the return to full activity prior to neurophysiologic healing. To mitigate the negative outcomes associated with mTBIs, translational clinical research of neurophysiologic recovery is of paramount importance for both athletic and non-athletic populations. Despite the well-known health consequences, clinical decisions regarding neurophysiologic recovery and return to activity remain problematic for clinicians. Return to activity decisions are currently based on normalization …

Evaluation Of The Effectiveness Of A Pain Neuroscience Education Curriculum For Patients Who Experience Chronic Musculoskeletal Pain With Concurrent Opioid Dependence, Nicole D. Windsor

Theses and Dissertations--Rehabilitation Sciences

Background: Chronic musculoskeletal pain (CMP) is estimated to affect over 100 million adults annually and is targeted as an instigator of opioid dependence (OpD). Opioid medications are often the first response for patients suffering from CMP, but over 10 million people annually admit to misusing opioids. With the opioid epidemic, the healthcare system now has a population of patients who experience CMP with concurrent OpD. This persistent problem creates a perfect storm of fear of movement, low self-efficacy, and physical dysfunction. A critical component to chronic pain management is understanding how patients view their pain experience. Education may be one …

Beyond The Treatment Protocol: Active Ingredients For Precision Voice Rehabilitation, Maria H. Bane

Theses and Dissertations--Rehabilitation Sciences

Despite the growing body of research demonstrating voice therapy efficacy, only 12 of 100 people referred to a speech-language pathologist (SLP) for a voice evaluation will successfully complete therapy. One possible reason for this discrepancy is that clinical laboratory and clinical outcomes studies have focused on if voice therapy works while failing to explain how voice therapy works. While the if question is important, the yes or no response this question generates is of limited utility when those referred for voice therapy fail to complete. Consequently, the how question, which concentrates on the mechanisms and processes underlying effective voice therapy, …

Epidemiology Of Upper Extremity Injuries In High School Sports, Autumn Ruthe Whitson

Theses and Dissertations--Rehabilitation Sciences

Participation in high school sports has seen a steady increase over the past four decades. With nearly eight million student-athletes participating, careful monitoring of injuries related to their participation is imperative. Injury surveillance efforts through national databases have produced a multitude of studies detailing injuries that occur in specific sports, specific body parts, or particular diagnoses. The lower extremity tends to be injured more frequently than the upper extremity resulting in various comprehensive analyses on that particular body area. Currently, there are no comprehensive reports on the epidemiology of injury to the upper extremity in student-athletes participating in high school …

The Influence Of Physical Health, Emotional Health, And Socioeconomic Factors On The Musculoskeletal Pain Experience In Patients Attending A Pro Bono Physical Therapy Clinic, Garrett Naze

Theses and Dissertations--Rehabilitation Sciences

Non-communicable, chronic diseases are highly prevalent in the United States, reducing the quality of life for those affected and contributing to the majority of the nation’s healthcare expenditure. These conditions include, among others, cardiovascular disease, diabetes, and musculoskeletal disease. Musculoskeletal disease is particularly of interest for the field of physical therapy as the vast majority of patients seeking care in the outpatient setting present with musculoskeletal pain complaints, resulting in limitations in function, participation, and quality of life for the patient.

The factors influencing health outcomes are diverse and include a person’s physical environment, social and economic factors, access to …

The Use Of Mechanotherapy To Promote The Recovery From Disuse Atrophy In Aging Rat Skeletal Muscle, Zachary Hettinger

Theses and Dissertations--Rehabilitation Sciences

The combination of age and disuse-related skeletal muscle atrophy predisposes older adults to reduced mobility, loss of independence, and poor quality of life. Poor health outcomes resulting from periods of disuse in older adults are exacerbated by an inability to fully recover, ultimately accelerating geriatric populations towards further functional decline. Aged-related changes to skeletal muscle viscoelastic properties, specifically of muscle extracellular matrix (ECM) stiffness, may not only impact how muscle responds during recovery, but also to interventions intended to augment recovery. Remodeling of muscle ECM in the aged may therefore benefit muscle mass recovery, yet therapies focused on ECM remodeling …

Development Of A Field Expedient Screening Tool For The Coach To Identify Musculoskeletal Risk Factors In Baseball Players, Kyle Andrew Matsel

Theses and Dissertations--Rehabilitation Sciences

Identification of musculoskeletal (MSK) injury risk factors in baseball players can be challenging particularly for youth and high school coaches. Many baseball coaches lack a sports medicine and/or strength and conditioning staff to assist with injury prevention initiatives. Given the extensive responsibilities in managing the team and preparing the players for athletic competition, little time remains to focus on injury prevention and arm care programs. Furthermore, assessment, diagnosis, and management of MSK impairments is outside the scope of practice and expertise of baseball coaches. However, educating and empowering the coach to efficiently screen their players for potentially injury producing MSK …

Changing The Perspective In Management Of A Progressive Neurological Disorder: Developing Interventions To Target Multifactorial Components Of Parkinson’S Disease With Emphasis On Improving Clinical Meaningful Outcomes, Jordana Christine Lockwich

Theses and Dissertations--Rehabilitation Sciences

Neurological disorders are currently the leading source of disability in the United States with Parkinson’s disease (PD) having the fastest growing incidence rate (Abate et al., 2017). PD is the second most common degenerative disease in older adults above 60 years old (Tysnes & Storstein, 2017) and epidemiology reports predict that the number of PD cases has doubled to 6 million since 1990 (Dorsey, Sherer, et al., 2018) It is estimated that PD prevalence will continue to rise with a projected 60,000 new cases in the United States by 2030 (Dorsey, Elbaz, et al., 2018) and has the potential to …

New Evidence For P-Gp-Mediated Export Of Amyloid-Β Peptides In Molecular, Blood-Brain Barrier And Neuronal Models, Amanda B. Chai, Anika M. S. Hartz, Xuexin Gao, Alryel Yang, Richard Callaghan, Ingrid C. Gelissen

Sanders-Brown Center on Aging Faculty Publications

Defective clearance mechanisms lead to the accumulation of amyloid-beta (Aβ) peptides in the Alzheimer’s brain. Though predominantly generated in neurons, little is known about how these hydrophobic, aggregation-prone, and tightly membrane-associated peptides exit into the extracellular space where they deposit and propagate neurotoxicity. The ability for P-glycoprotein (P-gp), an ATP-binding cassette (ABC) transporter, to export Aβ across the blood-brain barrier (BBB) has previously been reported. However, controversies surrounding the P-gp–Aβ interaction persist. Here, molecular data affirm that both Aβ₄₀ and Aβ₄₂ peptide isoforms directly interact with and are substrates of P-gp. This was reinforced ex vivo by the …

The Impact Of The 2018 Kentucky Cigarettes Taxes On Tobacco Use Among Youth, Claire W. Mampunza

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Introduction: In the Commonwealth of Kentucky, cigarette smoking results in 1.92 billion dollars spent every year on medical costs, the death of approximately 9,000 Kentuckians, and 34 percent of all cancer cases. In 2017, 14.3 percent of high school students in Kentucky declared being current cigarette smokers, compared to 8.8 percent nationally. Tobacco use among youth is a public health concern because 88 percent of adult smokers initiate smoking before age 18. Youth nicotine use can damage the growing brain, which continues to develop until 25 years of age. In July 2018, the excise tax on cigarettes increased from …

Covid Mitigation Strategies And Safety Perceptions Among Workers During Spring 2020 Shutdown, William Mciver

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

A novel coronavirus pandemic radically shifted the working environment of the population in the United States in the spring of 2020. Studies have examined the difference between healthcare workers and the general population, but there exists a gap when looking at mitigation strategies between healthcare workers and other workers that continued working outside the home. This study surveyed workers and asked about employment status, employment field, COVID safety precautions taken in the workplace, and feelings of safety. This study examined that and found statistically significant differences in the mitigation strategies used by healthcare workplaces and all other non-healthcare workplaces. This …

Educational Intervention To Change Knowledge And Attitudes Regarding Sexual Behaviors To Reduce Rates Of Sexually Transmitted Infections Among University Of Kentucky’S Sorority Life Students., Julianna Maita

Theses and Dissertations--Public Health (M.P.H. & Dr.P.H.)

Sexually transmitted infections disproportionally affect young adults. Within this age group, women are at an increased risk for contracting and STI and face more severe long-term adverse consequences than men. College aged individuals are at an increased risk for contracting an STI due to risky sexual behaviors such as unprotected sex with multiple partners. College students involved in Greek Life have been found to engage in risker sexual behaviors than non-Greek life students. These individuals perceive themselves to be at a higher risk for contracting an STI and have an increased number of unprotected sexual encounters under the influence of …

Adverse Childhood Experience And Undergraduate Student Success: A Longitudinal Investigation Into The Relationship Between Childhood Stress And Success In Higher Education, Sarah E. Cprek

Theses and Dissertations--Educational Policy Studies and Evaluation

Institutions of higher education have long worked to understand factors that influence or predict student success and degree completion. Childhood experiences including potential exposure to toxic stress have been found to impact student success in K-12 schools yet have rarely been evaluated among undergraduates. Therefore, the purpose of this study is to investigate the relationship between Adverse Childhood Experiences (ACEs) and undergraduate degree completion among a random sample of 1,894 students at a state-funded university in the US. Participants completed a web-based survey assessing ACEs in spring 2015. Results from the survey were linked to student academic records for each …