Medicine and Health Sciences Commons^™

Detection Of Allergen Markers In Food: Analytical Methods, Girdhari M. Sharma, Sefat E. Khuda, Christine H. Parker, Anne C. Eischeid, Marion Pereira

United States Food and Drug Administration: Publications

Food allergens are proteins that are well tolerated by most, but can cause severe reactions in sensitive individuals. Since there is no cure for food allergy, strict adherence to an allergen-free diet is the only safe choice currently available for allergic consumers. Accurate food labeling can help consumers avoid foods containing an allergenic ingredient. Regulatory agencies have mandated the labeling of major food allergens on packaged foods to help with safe food choices. However, the inadvertent presence of an allergen in food due to cross-contact and labeling error can jeopardize consumer health. Analytical methods are developed for allergen detection and …

Current Analytical Techniques For Food Lipids, Cynthia T. Srigley, Magdi M. Mossoba

United States Food and Drug Administration: Publications

Thee analysis of food lipids presents significant challenges due to the wide variety of sample matrices, large range of total fat contents, and complex compositions of fatty acids. This is chapter reviews conventional analytical techniques for the quantification of total fat and fatty acids in foods and food ingredients, including the gravimetric determination of total fat, the calculation of fat and fatty acids using gas chromatography (GC), and the analysis of proximates content (i.e., fat, protein, carbohydrate, moisture, and ash) by Fourier transform infrared (FTIR) spectroscopy. Current official methods of analysis are evaluated and the use of certified reference materials …

Multiple Imputation To Evaluate The Impact Of An Assay Change In National Surveys, Maya Sternberg

United States Food and Drug Administration: Publications

National health surveys, such as the National Health and Nutrition Examination Survey, are used to monitor trends of nutritional biomarkers. These surveys try to maintain the same biomarker assay over time, but there are a variety of reasons why the assay may change. In these cases, it is important to evaluate the potential impact of a change so that any observed fluctuations in concentrations over time are not confounded by changes in the assay. To this end, a subset of stored specimens previously analyzed with the old assay is retested using the new assay. These paired data are used to …

Rapid Testing Of Food Matrices For Bacillus Cereus Enterotoxins, Sandra M. Tallent, Jennifer M. Hait, Ann M. Knolhoff, Reginald W. Bennett, Thomas S. Hammack, Timothy R. Croley

United States Food and Drug Administration: Publications

Nine different food products frequently associated with Bacillus cereus outbreaks were chosen as representative matrices to be evaluated with end-point polymerase chain reaction (PCR), enzyme linked immunosorbent assay, lateral flow device and mass spectrometry for detection of enterotoxins associated with human illness. Testing was performed on food portions inoculated with a bacterial strain and incubated at 30C for either 5 h or 24 h. A screening end-point multiplex PCR targeting enterotoxin genes including the emetic toxin and three diarrheal toxins, hemolytic hemolysin BL (Hbl), nonhemoltyic enterotoxin (Nhe), and cytolysin K. Commercially available kits were used to determine the presence/absence of …

Antiemetic Use Among Pregnant Women In The United States: The Escalating Use Of Ondansetron, Lockwood G. Taylor, Steven T. Bird, Leyla Sahin, Melissa S. Tassinari, Patty Greene, Marsha E. Reichman, Susan E. Andrade, Katherine Haffenreffer, Sengwee Toh

United States Food and Drug Administration: Publications

Purpose To examine ondansetron use in pregnancy in the context of other antiemetic use among a large insured United States population of women delivering live births.

Methods We assessed ondansetron and other antiemetic use among pregnant women delivering live births between 2001 and 2015 in 15 data partners contributing data to the Mini-Sentinel Distributed Database. We identified live birth pregnancies using a validated algorithm, and all forms of ondansetron and other available antiemetics were identified using National Drug Codes or procedure codes. We assessed the prevalence of antiemetic use by trimester, calendar year, and formulation.

Results In over 2.3 million …

Food Safety Traceability, Yimin Wei, Boli Guo, Hongyan Liu, Shuai Wei, Jianrong Zhang

United States Food and Drug Administration: Publications

With globalized economics, it is becoming more frequent to trade food across country and regional borders, which leads to expanding and spreading of all kinds of food safety incidents and hazards. Mad cow disease, foot and mouth disease, avian flu and other zoonotic diseases pose a grave threat to food safety and human health, causing serious economic losses for food industries and causing social panic at the same time. In order to reduce the losses caused by such serious zoonotic diseases, as well as to ensure food safety, many countries have started to implement food safety traceability systems. The European …

Quality By Design: Process Trajectory Development For A Dynamic Pharmaceutical Coprecipitation Process Based On An Integrated Real‐Time Process Monitoring Strategy, Huiquan Wu, Mansoor A. Khan

United States Food and Drug Administration: Publications

Increasing prevalence of poorly water‐soluble drugs in pharmaceutical development provides notable risks of new products demonstrating low and erratic bioavailability. This dissolution‐limited bioavailability may have consequences for safety and efficacy, particularly for drugs delivered by the oral route of administration. Several novel drug delivery technologies have been developed to improve drug solubility, dissolution rates, and bioavailability. Among those are solid dispersion, nanotechnology, supercritical fluid technology, lipid‐based technology, and crystal engineering. Although these strategies are available for enhancing the bioavailability of drugs with low aqueous solubility, the success of these approaches is not yet guaranteed and is greatly dependent on the …

The Impact Of The Boxed Warning On The Duration Of Use For Depot Medroxprogesterone Acetate, Efe Eworuke, Joo-Yeon Lee, Lisa Soule, Vaishali Popat, David G. Moeny

United States Food and Drug Administration: Publications

Objective The objective of this study was to examine the impact of the Food and Drug Administration’s boxed warning on the utilization of depot medroxyprogesterone (DMPA).

Methods From the IMS Lifelink data (2001–2009), we identified DMPA and oral combined hormonal contraceptive (CHC) users without a prescription claim 6 months before and after the first and last claim. Episodes were defined as all contiguous claims with no more than 90- day DMPA or 30-day CHC between claims. Days’ supply (CHC) and 90-day duration (DMPA) was used to determine episodes. We used interrupted time series to evaluate changes in the mean episode …

Modeling And Statistical Issues Related To Salmonella In Low Water Activity Foods, Sofia M. Santillana Farakos, Michelle Danyluk, Donald Schaffner, Régis Pouillot, Linda J. Harris, Bradley P. Marks

United States Food and Drug Administration: Publications

The presence and survival of Salmonella in low water activity (a_w) foods continues to pose a challenge for the food industry. Peer‐reviewed literature data on prevalence and levels of contamination of Salmonella in low water activity foods in the United States are limited. Available published data include those on: Salmonella contamination on nuts and peanuts (Calhoun et al., 2013), almonds (Danyluk et al., 2007; Bansal et al., 2010), pecans (Brar, Strawn, and Danyluk, 2016), and walnuts (Davidson et al., 2015); prevalence and levels of Salmonella on spices (Van Doren et al., 2013); as …

Disparities In Hypertension And Cardiovascular Disease In Blacks: The Critical Role Of Medication Adherence, Keith C. Ferdinand, Kapil Yadav, Samar A. Nasser, Helene D. Clayton-Jeter, John Lewin, Dennis R. Cryer, Fortunato Fred Senatore

United States Food and Drug Administration: Publications

Blacks are two to three times as likely as whites to die of preventable heart disease and stroke. Declines in mortality from heart disease have not eliminated racial disparities. Control and effective treatment of hypertension, a leading cause of cardiovascular disease, among blacks is less than in whites and remains a challenge. One of the driving forces behind this racial/ethnic disparity is medication nonadherence whose cause is embedded in social determinants. Eight practical approaches to addressing medication adherence with the potential to attenuate disparities were identified and include: (1) patient engagement strategies, (2) consumer-directed health care, (3) patient portals, (4) …

Current Practices In Corrosion, Surface Characterization, And Nickel Leach Testing Of Cardiovascular Metallic Implants, Srinidhi Nagaraja, Matthew Di Prima, David Saylor, Erica Takai

United States Food and Drug Administration: Publications

In an effort to better understand current test practices and improve nonclinical testing of cardiovascular metallic implants, the Food and Drug Administration (FDA) held a public workshop on Cardiovascular Metallic Implants: corrosion, surface characterization, and nickel leaching. The following topics were discussed: (1) methods used for corrosion assessments, surface characterization techniques, and nickel leach testing of metallic cardiovascular implant devices, (2) the limitations of each of these in vitro tests in predicting in vivo performance, (3) the need, utility, and circumstances when each test should be considered, and (4) the potential testing paradigms, including acceptance criteria for each test. In …

High Throughput Quantification Of Apolipoproteins A-I And B-100 By Isotope Dilution Ms Targeting Fast Trypsin Releasable Peptides Without Reduction And Alkylation, Bryan A. Parks, David M. Schieltz, Michael L. Andrews, Michael S. Gardner, John C. Rees, Christopher A. Toth, Jeffrey I. Jones, Lisa G. Mcwilliams, Zsuzsanna Kuklenyik, James L. Pirkle, John R. Barr

United States Food and Drug Administration: Publications

Purpose: Apolipoprotein A-I (ApoA-I) and apolipoprotein B-100 (ApoB-100) are amphipathic proteins that are strong predictors of cardiovascular disease risk. The traceable calibration of apolipoprotein assays is a persistent challenge, especially for ApoB-100, which cannot be solubilized in purified form.

Experimental design: A simultaneous quantitation method for ApoA-I and ApoB-100 was developed using tryptic digestion without predigestion reduction and alkylation, followed by LC separation coupled with isotope dilution MS analysis. The accuracy of the method was assured by selecting structurally exposed signature peptides, optimal choice of detergent, protein: enzyme ratio, and incubation time. Peptide calibrators were value assigned by isobaric tagging …

Whose Preferences Matter? A Patient-Centered Approach For Eliciting Treatment Goals, Nananda F. Col, Andrew J. Solomon, Vicky Springman, Calvin P. Garbin, Carolina Ionete, Lori Pbert, Enrique Alvarez, Brenda Tierman, Ashli Hopson, Christen Kutz, Idanis Berrios Morales, Carolyn Griffin, Glenn Phillips, Long H. Ngo

Department of Psychology: Faculty Publications

Background. Patients facing a high-stakes clinical decision are often confronted with an overwhelming array of options. High-quality decisions about treatment should reflect patients’ preferences as well as their clinical characteristics. Preference-assessment instruments typically focus on pre-selected clinical outcomes and attributes chosen by the investigator. Objective. We sought to develop a patient-centered approach to elicit and compare the treatment goals of patients with multiple sclerosis (MS) and healthcare providers (HCPs). Methods. We conducted five nominal group technique (NGT) meetings to elicit and prioritize treatment goals from patients and HCPs. Five to nine participants in each group responded silently to one question …

Microbial Ecology Of Fresh Vegetables, J. Zheng, A. De Jesus, S. Sahu, A. E. Hayford, Y. Luo, A. R. Datta, E. W. Brown, R. Bell

United States Food and Drug Administration: Publications

The total consumption of fresh and processed vegetables has exceeded 123 kg per capita in the United States and 118 kg per capita in the European Union (http://www.helgilibrary.com/ indicators/index/vegetable‐consumption‐percapita) in 2009. Changes in lifestyles and consumption trends have prompted the sustained growth of fresh‐cut or minimally processed vegetables that are fresh and ready‐to‐eat (RTE). In 2011, for example, total US fresh‐cut produce sales through both food service and retail channels were estimated to surpass $27 billion (Cook et al., 2012).

The Neuropsychology Of Sport And Performance, Arthur C. Maerlender

Center for Brain, Biology, and Behavior: Faculty Publications

Neuropsychological theory has been a mainstay for understanding pathology within the brain-behavior context. However, our theories for predicting superior behavior are not as well developed. Sport neuropsychology was developed on the presumption that athletes represent a population in a relatively well-controlled environment for studying brain pathology due to injury. This study of pathology within a high-performance environment has been responsible for identifying the effects of mild traumatic brain injury (mTBI) on individual functioning. Far less attention has been paid to the other end of the performance continuum, and yet, viable brain-behavior hypotheses should hold true across the spectrum of function …

Validity And Reliability Of Baseline Testing In A Standardized Environment, Kathryn L. Higgins, Todd Caze, Arthur C. Maerlender

Center for Brain, Biology, and Behavior: Faculty Publications

Objective — The Immediate Postconcussion Assessment and Cognitive Testing (ImPACT) is a computerized neuropsychological test battery commonly used to determine cognitive recovery from concussion based on comparing post-injury scores to baseline scores. This model is based on the premise that ImPACT baseline test scores are a valid and reliable measure of optimal cognitive function at baseline. Growing evidence suggests that this premise may not be accurate and a large contributor to invalid and unreliable baseline test scores may be the protocol and environment in which baseline tests are administered. This study examined the effects of a standardized environment and administration …

Measurement Of Cortisol In Saliva: A Comparison Of Measurement Error Within And Between International Academic‑Research Laboratories, Jessica L. Calvi, Frances R. Chen, Victoria Brann Benson, Eleanor Brindle, Matt Bristow, Alpana De, Sonja Entringer, Helen Findlay, Christine Heim, Eric A. Hodges, Heiko Klawitter, Sonia Lupien, Holly M. Rus, Jitske Tiemensma, Silvanna Verlezza, Claire-Dominique Walker, Douglas A. Granger

Center for Brain, Biology, and Behavior: Faculty Publications

Objective: Hundreds of scientific publications are produced annually that involve the measurement of cortisol in saliva. Intra- and inter-laboratory variation in salivary cortisol results has the potential to contribute to crossstudy inconsistencies in findings, and the perception that salivary cortisol results are unreliable. This study rigorously estimates sources of measurement variability in the assay of salivary cortisol within and between established international academic-based laboratories that specialize in saliva analyses. One hundred young adults (Mean age: 23.10 years; 62 females) donated 2 mL of whole saliva by passive drool. Each sample was split into multiple- 100 μL aliquots and …

Patterns Of Referral In High School Concussion Management Programs: A Pilot Study Of Consultants From Different Disciplines, Jonathan Lichtenstein, Kate S. Linnea, Arthur C. Maerlender

Center for Brain, Biology, and Behavior: Faculty Publications

School-based concussion management programs cover thousands of young athletes, yet there is little in the way of research to assess program processes or outcomes. This study examined the referral patterns of consultants working with ten high school concussion management programs. In addition to the number of referrals made to specialists, other potential outcome variables were explored. The sample included over 5,000 athlete-seasons and 298 concussions managed directly by certified athletic trainers. All programs used computerized neuropsychological testing (both baseline and post injury). Two groups were compared: five programs used a clinical neuropsychologist (NP) as the testing consultant and five used …

Attention Is Associated With Postural Control In Those With Chronic Ankle Instability, Adam B. Rosen, Nicholas T. Than, William Z. Smith, Jennifer M. Yentes, Melanie L. Mcgrath, Mukul Mukherjee, Sarah A. Myers, Arthur C. Maerlender

Center for Brain, Biology, and Behavior: Faculty Publications

Chronic ankle instability (CAI) is often debilitating and may be affected by a number of intrinsic and environmental factors. Alterations in neurocognitive function and attention may contribute to repetitive injury in those with CAI and influence postural control strategies. Thus, the purpose of this study was to determine if there was a difference in attentional functioning and static postural control among groups of Comparison, Coper and CAI participants and assess the relationship between them within each of the groups. Recruited participants performed single-limb balance trials and completed the CNS Vital Signs (CNSVS) computer-based assessment to assess their attentional function. Center …

Sandbagging On The Immediate Post-Concussion Assessment And Cognitive Testing (Impact) In A High School Athlete Population, Kathryn L. Higgins, Robert L. Denny, Arthur C. Maerlender

Center for Brain, Biology, and Behavior: Faculty Publications

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) is a computerized neuropsychological test battery commonly used to assess cognitive functioning after a concussion. It is recommended that application of ImPACT utilizes a baseline administration so athletes have an individualized baseline with which to compare post-injury results should they sustain a concussion. It has been suggested that athletes may provide suboptimal effort, called “sandbagging,” in order to return to their baseline cognitive scores, and thus to play, more quickly. This research examines ImPACT baseline scores when high school athletes were asked to attempt to “sandbag,” and compares those scores with scores …

Psychological And Neural Contributions To Appetite Self-Regulation, Luke E. Stoeckel, Leann L. Birch, Todd Heatherton, Traci Mann, Christine Hunter, Susan Czajkowski, Lisa Onken, Paige K. Berger, Cary R. Savage

Center for Brain, Biology, and Behavior: Faculty Publications

Objective: This paper reviews the state of the science on psychological and neural contributions to appetite self-regulation in the context of obesity. Methods: Three content areas (neural systems and cognitive functions; parenting and early childhood development; and goal setting and goal striving) served to illustrate different perspectives on the psychological and neural factors that contribute to appetite dysregulation in the context of obesity. Talks were initially delivered at an NIH workshop consisting of experts in these three content areas, and then content areas were further developed through a review of the literature. Results: Self-regulation of appetite involves a complex interaction …

Pilot Study Of Endurance Runners And Brain Responses Associated With Delay Discounting, Laura E. Martin, Jason-Flor V. Sisante, David R. Wilson, Angela A. Moody, Cary R. Savage, Sandra A. Billinger

Center for Brain, Biology, and Behavior: Faculty Publications

High levels of endurance training have been associated with potentially negative health outcomes and addictive-like symptoms such as exercise in the presence of injury and higher levels of impulsivity. This pilot study examined the relationships among self-report measures of addictive symptoms related to exercise and behavioral and neural measures of impulsivity in endurance runners. We hypothesized endurance runners would have increased preference for immediate rewards and greater activation of cognitive control regions when making decisions involving delayed rewards. Twenty endurance runners (at least 20 miles/week) were recruited to undergo measures of self-report exercise addiction symptoms, impulsive decision-making (delay discounting) and …

Lateral Hypothalamic Activity Indicates Hunger And Satiety States In Humans, Omid Talakoub, Raquel R. Paiva, Matija Milosevic, Marcelo Q. Hoexter, Ruth Franco, Eduardo Alho, Jessie Navarro, Jose F. Pereira Jr., Milos R. Popovic, Cary Savage, Antonio C. Lopes, Pedro Alvarenga, Durval Damiani, Manoel J. Teixeira, Euripides C. Miguel, Erich T. Fonoff, Marcelo C. Batistuzzo, Clement Hamani

Center for Brain, Biology, and Behavior: Faculty Publications

Lateral hypothalamic area (LHA) local field potentials (LFPs) were recorded in a Prader–Willi patient undergoing deep brain stimulation (DBS) for obesity. During hunger, exposure to food-related cues induced an increase in beta/ low-gamma activity. In contrast, recordings during satiety were marked by prominent alpha rhythms. Based on these findings, we have delivered alphafrequency DBS prior to and during food intake. Despite reporting an early sensation of fullness, the patient continued to crave food. This suggests that the pattern of activity in LHA may indicate hunger/satiety states in humans but attest to the complexity of conducting neuromodulation studies in obesity.

Stress: Effects And Management, Breanna Buscher

Nebraska College Preparatory Academy: Senior Capstone Projects

Stress is how the body reacts to any change in a person's life, as well as how it reacts in life or death situations. It is important everyone knows how to manage stress and what will happen if they do not. While there are an abundance of terrifying things that can happen when stress goes unmanaged, there are also plenty of easy ways everyone can keep their stress in check.

Stress can feel overwhelming and often cause health problems if gone unmanaged but luckily there are a plethora of ways to manage it.

Future Research: I would like to research …

An Ableist Society: What Does Disability Look Like?, Maricela Paramo

Nebraska College Preparatory Academy: Senior Capstone Projects

One out of every five adults in the United States has a disability. That is about 63.976 million people, yet, ableism is a common type of discrimination. This paper is an attempt to create awareness of ableism and its negative effects by providing testimonies and methods that will help people with disabilities live a life without prejudice.

The United States is nowhere close to being an ableist free society and it will remain this way until people stop using ableist language as an insult or to mock someone, until mocking the disabled is not a media entertainment, until public figures …

Steroids: A Growing Dilemma In Athletics, Seara Ontiveros

Nebraska College Preparatory Academy: Senior Capstone Projects

A comprehensive and straight forward description of what exactly steroids are and what they do to the body is described by Gary Wadler, a health major at the New York University School of Medicine, he comments: “When the receptor sites in their bodies, which don’t have much testosterone in them, suddenly are presented with a lot of testosterone, they get activated…The unbalance of hormones increases the red blood cell formations... They’ll get more muscular, more defined. They’ll lose some fat, and increase their lean body mass, [they’ll] get stronger”. Although anabolic steroids and other hormones are consumed by many athletes …

Assessment With Children Who Need Augmentative And Alternative Communication (Aac): Clinical Decisions Of Aac Specialists, Shelley Lund, Wendy Quach, Kristy S. E. Weissling, Miechelle L. Mckelvey, Aimee R. Dietz

Department of Special Education and Communication Disorders: Faculty Publications

Purpose

The purpose of this study was to explore how speech-language pathologists (SLPs) who are augmentative and alternative communication (AAC) specialists approach the assessment process for 2 case studies, 1 child with cerebral palsy and 1 with autism spectrum disorder. The aim of the study was to answer the following questions: (a) How do clinicians with expertise approach the AAC assessment process for children with developmental disabilities? (b) Can any initial hypothesis be drawn about how SLPs approach the assessment of children with motor versus social interactive deficits?

Method

This study used a phenomenological qualitative design. The researchers conducted 2 …

Toward Solving The Etiological Mystery Of Primary Biliary Cholangitis, Atsushi Tanaka, Patrick S.C. Leung, Howard A. Young, M. Eric Gershwin

United States Public Health Resources

Primary biliary cholangitis (PBC) is considered a model autoimmune disease due to its signature anti-mitochondrial antibody (AMA) autoantibody, female predominance, and relatively specific portal infiltration and cholestasis. The identification and cloning of the major mitochondrial autoantigens recognized by AMA have served as an immunologic platform to identify the earliest events involved in loss of tolerance. Despite the relatively high concordance rate in identical twins, genome-wide association studies have not proven clinically useful and have led to suggestions of epigenetic events. To understand the natural history and etiology of PBC, several murine models have been developed, including spontaneous models, models induced …

Relationship Between Dietary Total Digestible Nutrients And Digestible Organic Matter In Beef Cattle Finishing And Growing Diets With Or Without Distillers Grains, Hannah C. Hamilton, Jana L. Gramkow, Jim C. Macdonald Donald, Galen E. Erickson, Andrea K. Watson, Terry J. Klopfenstein

Nebraska Beef Cattle Reports

The relationship between organic matter digestibility and total digestible nutrients is unestablished for diets containing distillers grains. Three cattle digestion studies were used to evaluate the relationship between total digestible nutrients and digestible organic matter. Results suggest digestible organic matter is consistent relative to total digestible nutrients content for traditional, corn based diets. In finishing and growing diets containing distillers grains additional digestible energy supplied by distillers grains is not accounted for when evaluating only digestible organic matter. Measuring digestible energy content of diets used in digestion trials is essential.

Evaluation Of The Value Of Fiber In Distillers Grains Plus Solubles On Performance Of Finishing Cattle, Jordan E. Burhoop, Liesel J. Schneider, Curtis J. Bittner Bittner, F. Henry Hilscher, Jim C. Macdonald, Rodney A. Moxley, David R. Smith, Galen E. Erickson

Nebraska Beef Cattle Reports

A finishing study was conducted to determine the value of the fiber in distillers grains plus solubles on cattle performance. Five treatments were evaluated: a corn control diet, 20 or 40% modified distillers grains plus solubles, plus two diets containing corn germ meal and corn bran balanced to equal the fiber content of the two modified distillers grains plus solubles diets. Th ere was a significant improvement in ADG and F:G for cattle fed modified distillers grains plus solubles compared to control. Cattle fed the corn germ meal and bran diets had increased DMI, slightly lower ADG, and poorer F:G …