Digital Commons Network^™

An Overview Of The Role Of Mathematical Models In Implementation Of Quality By Design Paradigm For Drug Development And Manufacture, Sharmista Chatterjee, Christine M.V. Moore, Moheb M. Nasr

United States Food and Drug Administration: Publications

A model is a representation of an underlying physical–chemical phenomenon. In the pharmaceutical industry, mathematical‐based models can be applied at all stages of development, starting with formulation design, continuing through process development and scale‐up, and extending into process monitoring and control of the commercial process. Implementation of models offers many benefits. These include, but are not limited to, (i) enhanced process understanding, (ii) reduction of experimentation cost, and (iii) improvement of productivity and product quality.

Models can be broadly categorized as either qualitative or quantitative. The focus of this chapter is quantitative models. These can be classified into three broad …

The Mechanism Of Cirp In Inhibition Of Keratinocytes Growth Arrest And Apoptosis Following Low Dose Uvb Radiation, Yi Liao, Jianguo Feng, Yi Zhang, Liling Tang, Shiyong Wu

United States Food and Drug Administration: Publications

UV induces CIRP expression and subsequent Stat3 activation, but the biological function and mechanism of CIRP and Stat3 in mediating UVB-induced skin carcinogenesis have not been fully elucidated. In this study, we demonstrate that CIRP is elevated in all tested melanoma and non-melanoma skin cancer cell lines; and the expression of CIRP is upregulated in keratinocytes after being irradiated with relatively low dose (<5 mJ/cm²), but not high dose (50 mJ/cm²), UVB acutely and chronically. The increased expression of CIRP, either induced by UVB or through overexpression, leads to resistance of keratinocytes to UVB-induced growth arrest and …

Monitoring Harm Perceptions Of Smokeless Tobacco Products Among U.S. Adults: Health Information National Trends Survey 2012, 2014, 2015, Shari P. Feirman, Elisabeth A. Donaldson, Mark Parascandola, Kimberly Snyder, Cindy Tworek

United States Food and Drug Administration: Publications

Introduction: Changes to the U.S. smokeless tobacco landscape in recent years include a change to health warnings on packages, the implementation of bans in some stadiums, and the launch of a federal youth pre- vention campaign. It is unclear whether such changes have impacted consumer beliefs about smokeless tobacco. This study examines relative harm perceptions of smokeless tobacco compared to cigarettes among adults and assesses changes in smokeless tobacco harm perceptions over time.

Methods: We analyzed data from three cycles (2012, 2014, 2015) of the Health Information National Trends Survey (HINTS). Using 2015 data, we assessed bivariate associations between smokeless …

Association Of Freestanding Dialysis Facility Size, Quality Incentive Program Scores And Patient Survival, Fozia Ajmal

Theses and Dissertations

Background

In 2011, The Centers for Medicare and Medicaid Services (CMS) has introduced a bundled payment reform along with a Quality Incentive Program (QIP) to bring efficiency in End stage renal disease (ESRD) care. The QIP rates facilities using clinical and reporting criteria, but misses out on patient outcomes. It penalizes facilities not achieving a target score by 0-2% of payments. The small facilities are expected to be impacted more by a reduction in payments. We determined the association between ESRD facility size and QIP scores and the association between QIP scores and patient survival.

Methods

We used the Medicare …

Early Life Factors And Health Outcomes In Children And Mothers, Olubunmi Olufunke Orekoya

Theses and Dissertations

This dissertation focused on early life exposures and their impact on children and mothers’ health. It consists of three distinct studies with an overarching goal of understanding how early life factors influence health outcomes among children and mothers. The broad aims are: 1) to examine the association between maternal gestational weight gain and offspring weight at 1 year, while assessing the mediating role of birth weight; 2) to determine the association between breastfeeding practices and development of allergic conditions (eczema/skin allergy, hay fever/respiratory allergy, and asthma); and 3) to examine the association between breastfeeding and postpartum weight retention at 12 …

Exploring Spatial Patterning And The Impact Of Obesogenic Built Environments For Youth Obesity, S. Morgan Hughey

Theses and Dissertations

Youth obesity is a major public health concern due to an array of physical, social, and psychological health consequences. Residential location, often referred to as ‘place’, has continued to emerge as a key health determinant with studies showing that where a child lives impacts their health. Environments where it is easy for individuals to have low levels of physical activity – either by discouraging active behavior or promoting sedentary behavior – and easy for individuals to consume unhealthful foods – either by the limited availability of healthful foods or increased availability of unhealthy foods – have been coined ‘obesogenic’. Additional …

Does Survival Vary For Breast Cancer Patients In The United States? A Study From Six Randomly Selected States, Hafiz Mohammad Rafiqullah Khan, Lisaann S. Gittner, Abhilash Perisetti, Anshul Saxena, Aamrin Rafiq, Kemesha Gabbidon, Sarah Mende, Maria Lyuksyutova

USF St. Petersburg Campus Faculty Publications

Background . Breast cancer is the most common cancer in women. Disparities in some characteristics of breast cancer patients and their survival data for six randomly selected states in the US were examined. Materials and Methods . A probability random sampling method was used to select the records of 2,000 patients from each of six randomly selected states. Demographic and disease characteristics were extracted from the Surveillance Epidemiology and End Results (SEER) database. To evaluate relationships between variables, we employed a Cox Proportional Regression to compare survival times in the different states. Results . Iowa had the highest mean age …

Comparison Of Environmental Supports To A Healthy Lifestyle On The Unh Campus With Student Behaviors, Mary Hammar

Honors Theses and Capstones

Background: Environmental factors play a large role in shaping diet and lifestyle behaviors. Creating a college campus environment conducive to healthy dietary choices and physical activity may promote student health.

Objective: The objective of this study was to explore and describe the availability of environmental supports for a healthy lifestyle on the UNH campus and student behaviors.

Design: The Healthy Campus Environmental Audit (HCEA), a comprehensive tool developed by a USDA multi-state research team led by Syracuse University, was implemented to measure the availability of healthy options in dining establishments (n=12) and the adequacy of recreation facilities (n=3) and walking/biking …

Filling The Gap In Obesity Prevention: Implementation Of The General’S Activity Program (Gap) In Carroll County, Kentucky, Brent Emerson

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

As obesity rates continue to rise, there is a significant need for public health programs that are able to effectively increase physical activity at the community level. Regular physical activity can help reduce the risk of negative health outcomes associated with obesity including cardiovascular disease, type 2 diabetes, and some forms of cancer while also strengthening muscles, improving mental health and mood, and increasing average life expectancy. Previous research has supported that one way to increase physical activity at the community level is through social marketing of state and local parks. Through the promotion of parks, community residents are able …

Physical Activity, Body Mass Index, And Clustered Metabolic Risk In U.S. Adolescents: 2007-2012 Nhanes., Bethany Dawn Williams

UNF Graduate Theses and Dissertations

Objectives: To examine variation in clustered metabolic risk (cMetS) in adolescents classified as not overweight/active (NOA), not overweight/not active (NONA), overweight/active (OA), and overweight/not active (ONA).

Background: While studies to date have shown that children and adolescents who meet the current physical activity (PA) recommendations and maintain a healthy body weight demonstrate significantly lower cardiometabolic risk, there are some studies that suggest the relationship between PA and metabolic risk may be mediated by adiposity.

Methods: The sample included adolescent participants (n=875; 12-17 years) of the 2007-2012 National Health and Nutrition Examination Survey (NHANES). The cMetS score included triglycerides, high-density lipoprotein …

Innovation And Collaboration: Creating A Transdisciplinary Childhood Obesity Prevention Graduate Certificate Program, Becky Jensen, Mindy Anderson-Knott, Mary Bowne, Linda Boeckner, Suzanne Stluka, Kendra Kattelmann, Jessica Meendering

Health and Nutritional Sciences Faculty Publications

Preparing future professionals to work in transdisciplinary settings with a skill set to effectively foster collaborations and sustainable change requires a thoughtful and concerted interprofessional educational approach. Through an inter-university partnership in 2010 with name of university and the name of university, a group of faculty convened to propose the Transdisciplinary Obesity Prevention (TOP) graduate certificate program. With funding supported by a United States (US) Department of Agriculture (USDA) National Institute of Food and Agriculture grant in 2011, a team of faculty from name of university and name of university representing various disciplines (exercise science, nutrition, dietetics, health promotion, public …

The Relationship Between Caring For Individuals Diagnosed With Prader-Willi Syndrome And Caregiver Stress, Michael Andrew Vice

Electronic Theses and Dissertations

Background/Purpose: Chronic stress is related to numerous health risks such as causing an individual to age more rapidly than an individual with less stress (Oliveira, et al., 2010; Bauer, 2009; McEwen, 2002). Other aging problems related to chronic stress are Alzheimer’s disease (Peterson et al., 2007) and premature death (Canizzo et al., 2011). Stress can lead to mental health issues such as depression (Wiegner, 2015; Hammen, 2005) and anxiety (Wiegner et al., 2015). Stress has also been linked to cardiovascular disease (Seldenrijk, 2015), asthma (Rod et al., 2012; Chen & Miller, 2007), obesity (McInnis et al., 2014), diabetes (Salpea, 2010), …

Respiratory Function And Associated Risk Factors In The Kentucky Women’S Health Registry, Negash Amsalu

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

From the University of Kentucky Women’s Health Registry Database (KWHRD) a total of 1838 women were voluntarily asked to undergo Spirometric respiratory function tests. These women came to the clinic for various reasons. Various independent variables (risk factors) were also recorded for these women. Among these risk factors were: age, BMI, smoking status, asthmatic status, educational status and ethnicity.

The purpose of the study was to investigate whether any of the risk factors had significant impacts on women’s respiratory health. Appropriate categorizations were tabulated for each risk factor so that comparisons would be possible and easier. The motivation of the …

Association Between Cerebrovascular Pathology And Anti-Hypertensive Treatment In Diabetics, Gary Owen

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

Background

Dementia is a growing public health concern as the population ages. Vascular dementia is the second most common type of dementia behind Alzheimer’s, and is caused by cerebrovascular damage, such as infarcts and hemorrhages. As in systemic cardiovascular disease, diabetes and hypertension are leading risk factors for cerebrovascular pathology. Anti-hypertensive treatment (AHT), therefore, may have a role in preventing cerebrovascular damage.

Methods

A case-control study design was utilized to evaluate any association between AHT during life and cerebrovascular pathology in autopsy in diabetic participants from the National Alzheimer’s Coordinating Centers (NACC). Pathology outcomes included infarcts of various sizes and …

Smart Moves Bright Bodies: A Rural Adaptation To Combat Obesity Among African-American Teenagers In Wilcox And Lowndes Counties, Alabama, Nicole D. Fields

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

Obesity is a significant problem in the United States; however, it is a burgeoning epidemic among youth in the United States. As of 2016, Alabama is the second-most obese state in the nation¹ and 16% of Alabama adolescents are obese². While obesity is a significant problem across all ethnic groups, minorities bear a disproportionate burden in Alabama: one in five African-American adolescents is obese². This disproportionate burden is demonstrated in two Alabama counties: Wilcox and Lowndes. Both counties are predominately African-American and rank in the bottom ten counties, statewide, for overall health outcomes^9,14. …

Revamp It: Utilization Of Socioecological Approach To Combat Adolescent Obesity In Knott County, Kentucky, Jonathan Wang

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

The Kentucky River District Health Department proposes the implementation of REVAMP IT in four selected elementary schools in Knott County, Kentucky to improve subjective attitudes towards various aspects of health knowledge, physical activity, social support, and screen-time, as well as reduce biometrically measured television time and increased step count. REVAMP IT is an evidence-based program that utilizes the socioecological model of Public Health to target aspects of the individual, relational, and community level to facilitate changes from multiple aspects. Screen-time and physical activity goals will be individually set by students, and Knott County Elementary School teachers will be responsible for …

A Population-Based Survival Analysis Of Mesothelioma And Smoking In Appalachian And Non-Appalachian Kentucky, Peter Van Wie

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

Mesothelioma is one of the most aggressive cancers in the United States and around the world, with a grim 5-year survival rate of only 8%. After diagnosis there is little that can be done to stop the progression of the disease. Smoking has been negatively associated with mesothelioma survival. This may be due to several factors including increased oxidative stress or sequestration of tobacco-related carcinogenic compounds by asbestos fibers trapped in the lung. This study investigated the association between smoking and mesothelioma survival in the Kentucky population. It examines the risk of living in the low socioeconomic region of Appalachian …

Implementing The Alive! Behavioral Intervention Program In Phillips County, Arkansas, Raeschell Williams

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

The Arkansas Department of Health proposes implementing the Alive! behavioral intervention program in Phillips County, Arkansas to decrease the prevalence of obesity in this community. Alive!, A Lifestyle Intervention Via Email, is an evidence-bases, email-derived, worksite intervention focused on reducing saturated fats, increasing fruit and vegetable intake, and increasing physical activity. As an email-based program, participants will receive weekly emails tailored to their individual goals with reminder emails delivered during the week with small-step goals to help the participant achieve their larger goal. As the country with the highest prevalence of obesity and second highest prevalence of obesity in 2014, …

Factors Associated With Large Vehicle Collision Fatalities From 2009-2015, An Assessment Of Factors Relevant To The 2014 Implementation Of The National Registry Of Certified Medical Examiners And Strategies For Driver Safety, Melinda L. Carol

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

OBJECTIVE: The Federal Motor Carrier Safety Administration (FMCSA) developed a National Registry of Certified Medical Examiners (NRCME) as a stride toward greater driver safety and public health. This retrospective, observational, cross-section study is intended to trend and analyze driver related factors that are pertinent to FMCSA certifying medical examination performed by NRCME providers in addition to driver behaviors and environmental factors from the years 2009 to 2015. The results of this study are intended to speculate the effectiveness of the NRCME and propose additional public health interventions aimed to reduce large vehicle fatalities.

METHODS: Data was extracted from …

Shaping Our Appalachian Region (Soar): Beginning To Now, Samantha Zarycki

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

Introduction

Appalachian Kentucky has been and is currently facing difficult times including low employment rates, low education rates and less-than-favorable healthcare and health status for the people of the region (Estep, 2014). There have been multiple government and non-government agencies who have implemented interventions with the purpose of lifting up the region. Shaping Our Appalachian Region, or SOAR, is a bipartisan organization which began in 2013, and was established for the purpose of caring for the region.

Methods

A qualitative data analysis using confidential interviews with six people involved with SOAR was used for this project. Using the deductive approach …

Hepatitis C Screening And Treatment Of Prisoners: Analysis Of Policy And Practice In Kentucky, Charity Faith Kranz

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

INTRODUCTION

The United States and the Commonwealth of Kentucky are currently overwhelmed by a triad of complex epidemics—incarceration, opioid overdose deaths secondary to substance use disorders, and hepatitis C. Research has suggested hepatitis C screening and treatment of prisoners may be a cost-effective strategy to address the hepatitis C epidemic. Since Kentucky has been particularly impacted by these interrelated health threats, further exploration of hepatitis C in Kentucky prison populations and their potential role in addressing these epidemics is warranted.

Primary Objective

The main goal of this research was to examine hepatitis C screening and treatment policy and practice within …

Influencing Food Choice: Effects Of Stress And Sleep Deprivation On Dietary Habits Of Young Adults, Amy L. Leiferman

The Journal of Undergraduate Research

Introduction: Lifelong dietary habits are shaped during young adulthood; hence, preventing poor food choice practices during this period is vital. Stress and sleep deprivation are two important lifestyle elements that affect eating habits. The purpose of this study was to evaluate stress and sleep deprivation as factors contributing to poor dietary choices of college-aged students. Methodology: During finals week, a survey inquiring about sleep duration, perceived stress, and dietary patterns throughout the semester (typical week vs. finals week), was administered to university students (n=83). Fifty-five participants (21 male) provided an ID number, which allowed university-collected demographic and food-purchasing …

Riding Through Life: A Lifespan Study Of The Attitudes, Behaviors, And Areas Of Educational Opportunity For Female Equestrians Toward Bra Use And Health Outcomes When Engaged In Equestrian Sports, Karin Pekarchik

Theses and Dissertations--Community & Leadership Development

Equestrian sport is a popular exercise choice for females of all ages, although the links between this exercise choice, health outcomes, and risk to health have not been thoroughly examined. These issues are of particular interest because the female equestrian has the opportunity to ride and/or compete for decades, from early to very late in life, covering almost the full sequence of the female lifespan. Equestrian sports provide physical activity through riding and caring for the horse, and promote positive mental outcomes through tangible practices, such as engaging in physical activity and hard work, goal-setting, acquisition of skills, and participation …

Connecting Self-Efficacy Of Dietary Choices And The Association With Dietary Intake Among Rural Adolescents In North Carolina And Kentucky, Rachel Gillespie

Theses and Dissertations--Nutrition and Food Systems

Determining the level of belief one has in themselves, or their self-efficacy, can be a key factor to improve certain dietary patterns and choices in the rural youth population. Sugar sweetened food and beverage consumption continues to rise and fruit and vegetable intake remains a struggle in rural areas; addressing both the food environment and adolescents’ self-efficacy could have a lasting impact on changing the nature of a generation of rural student’s food and beverage choices. This study measured self-efficacy levels of (n=425) adolescents in rural Kentucky and North Carolina using the Youth Impact Questionnaire and dietary intake using the …

Addressing Barriers To Hepatitis C Treatment Initiation In Kentucky Clinic, Moaz Abdelwadoud

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

Introduction. Hepatitis C virus (HCV) is the most prevalent blood borne infection in the United States and its chronic infection has a high burden on the American healthcare system. Since 2014, the all-oral Directly Acting Antiviral (DAA)-based therapy has been established as the standardized curative treatment for HCV with unprecedented high effectiveness and tolerability. Nevertheless, there is a significant gap between the promise from DAAs benefits and the treatment initiation rates in the United States and Kentucky.

Objectives. The goal of this study is to improve the access to the all-oral DAA-based treatment among HCV patients seeking outpatient …

Risk And Burden Of Adverse Intrapartum-Related Outcomes Associated With Non-Cephalic And Multiple Birth In Rural Nepal: A Prospective Cohort Study, Naoko Kozuki, Joanne Katz, Subarna Khatry, James M. Tielsch, Steven Leclerq, Luke C. Mullany

Global Health Faculty Publications

Objectives Intrapartum-related complications are the second leading cause of neonatal death worldwide. We estimate the community-level risk and burden of intrapartum-related fetal/neonatal mortality and morbidity associated with non-cephalic and multiple birth in rural Sarlahi District, Nepal.

Design Community-based prospective cohort study.

Setting Rural Sarlahi District, Nepal.

Participants Pregnant women residing in the study area.

Methods We collected data on maternal background characteristics, conditions during labour and delivery, fetal presentation and multiple birth during home visits. We ran log-binomial regression models to estimate the associations between non-cephalic/multiple births and fresh stillbirth, early neonatal mortality and signs of neonatal encephalopathy, respectively, and …

Complementary And Alternative Medicine (Cam) And Adolescent Body Mass Index (Bmi): A National Population-Based Study, Laura Y. Defrain Lpn

Williams Honors College, Honors Research Projects

COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) AND ADOLESCENT BODY MASS INDEX (BMI): A NATIONAL POPULATION-BASED STUDY

Abstract

Background

Childhood obesity rates in the United States have remained around 17% since the 1990s - this figure translates to an estimated 12.7 million obese children. Maintaining a healthy weight through adolescence may limit subsequent health risks in adulthood. Complementary and alternative medicine (CAM) encompasses a variety of non-pharmacological treatments and lifestyle choices that have been utilized in addition to or in place of typical Western medicine. The relationship between adolescent Body mass index (BMI) and the use of complementary and alternative medicine has …

Understanding The Lives Of Adolescents And Young Adults (Udaya): Uttar Pradesh, Population Council

Poverty, Gender, and Youth

This factsheet provides a comprehensive picture of adolescents’ situation and needs in Uttar Pradesh. Based on the “Understanding the lives of adolescents and young adults” (UDAYA) program of research conducted by the Population Council, the graphs and charts explore the situation and needs of younger (10−14 years) and older (15−19 years) adolescents; describe changes in their situation and needs over time; and assess factors that determine the quality of their transitions from adolescence to young adulthood. These graphs highlight findings on: education, employability and economic inclusion, agency, community and citizenship, entry into marriage and motherhood, health and nutrition, violence in …

Understanding The Lives Of Adolescents And Young Adults (Udaya) In Bihar, India, K.G. Santhya, Rajib Acharya, Neelanjana Pandey, Santosh Kumar Singh, Shilpi Rampal, A.J. Francis Zavier, Ashish Kumar Gupta

Poverty, Gender, and Youth

The goal of the “Understanding the lives of adolescents and young adults (UDAYA) in Bihar and Uttar Pradesh” program is to establish the levels, patterns, and trends in the situation of younger (10–14) and older (15–19) adolescents and to assess factors that influence the quality of transitions they make. The study is designed to provide robust insights on how investments in adolescents influence their life course by the time they reach young adulthood; enable evidence-based decisions on the types of programs worthy of scale-up; and furnish important baseline indicators against which the long-term impact of programs can be measured. This …

Adolescent Health: Priorities And Opportunities For Rashtriya Kishor Swasthya Karyakram (Rksk) In Uttar Pradesh, Sapna Desai

Poverty, Gender, and Youth

The Government of India in 2014 signaled its commitment to adolescent health through introduction of a national strategy, Rashtriya Kishor Swasthya Karyakram (RKSK). Targeting adolescents aged 10–14 and 15–19, the program aims to ensure universal coverage of health information and services for all adolescents—those in and out of school, married or unmarried, and in vulnerable groups. Envisaged as a paradigm shift to address adolescent health beyond sexual and reproductive health, RKSK spans six domains: nutrition, sexual and reproductive health, mental health, injuries and violence including gender-based violence, substance misuse, and non-communicable diseases. This policy brief presents evidence on adolescent health …