Industrial Engineering Commons^™

Safety And Efficacy Results Of Switch From Imiglucerase To Velaglucerase Alfa Treatment In Patients With Type 1 Gaucher Disease, Deborah Elstein, Atul Mehta, Derralynn A. Hughes, Pilar Giraldo, Joel Charrow, Laurie Smith, Suma P. Shankar, Thomas N. Hangartner, Yune Kunes, Nan Wang, Eric Crombez, Ari Zimran

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Gaucher disease (GD) is a lysosomal storage disorder; symptomatic patients with type 1 GD need long-term disease-specific therapy of which the standard of care has been enzyme replacement therapy (ERT). Thirty-eight of 40 patients (aged 9–71 years) clinically stable on ERT with imiglucerase, safely switched to a comparable dose of velaglucerase alfa (units/kg) during TKT034, a 12-month, open-label clinical study, and for 10–50 months in an extension study. The most common adverse events (AEs) judged to be drug-related in the extension were fatigue and bone pain. No drug-related serious AEs were reported. No AEs led to study withdrawal. At 24 …

Velaglucerase Alfa (Vpriv) Enzyme Replacement Therapy In Patients With Gaucher Disease: Long-Term Data From Phase Iii Clinical Trials, Derralynn A. Hughes, Derlis Gonzalez, Elena A. Lukina, Atul Mehta, Madhulika Kabra, Deborah Elstein, Isaac Kisinovsky, Pilar Giraldo, Ashish Bavdekar, Thomas N. Hangartner, Nan Wang, Eric Crombez, Ari Zimran

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Type 1 Gaucher disease is an inherited lysosomal enzyme deficiency with variable age of symptom onset. Common presenting signs include thrombocytopenia, anemia, hepatosplenomegaly, bone abnormalities, and, additionally in children, growth failure. Fifty-seven patients aged 3–62 years at the baseline of two phase III trials for velaglucerase alfa treatment were enrolled in the single extension study. In the extension, they received every-other-week velaglucerase alfa intravenous infusions for 1.2–4.8 years at 60 U/kg, although 10 patients experienced dose reduction. No patient experienced a drug-related serious adverse event or withdrew due to an adverse event. One patient died following a convulsion that was …

Toe Joint Replacement Models, Tarun Goswami, Allison L. Van Horn, Alexander O. Sheets

Biomedical, Industrial & Human Factors Engineering Faculty Publications

In various embodiments, provided are implantable devices for replacing all or a portion of a metatarsophalangeal joint, comprising (i) a metatarsal component comprising a Substan tially convex bearing Surface; or (ii) a phalanx component comprising a Substantially concave bearing Surface; or (iii) both. In various embodiments, also provided are methods of treating hallux Valgus by replacing all or a portion of a meta tarsophalangeal joint with one or more of the provided implantable devices.

Oculomotor Neurocircuitry, A Structural Connectivity Study Of Infantile Nystagmus Syndrome, Nasser H. Kashou, Angelica R. Zampini

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Infantile Nystagmus Syndrome (INS) is one of the leading causes of significant vision loss in children and affects about 1 in 1000 to 6000 births. In the present study, we are the first to investigate the structural pathways of patients and controls using diffusion tensor imaging (DTI). Specifically, three female INS patients from the same family were scanned, two sisters and a mother. Six regions of interest (ROIs) were created manually to analyze the number of tracks. Additionally, three ROI masks were analyzed using TBSS (Tract-Based Spatial Statistics). The number of fiber tracks was reduced in INS subjects, compared to …

A Probabilistic Fracture Assessment Of Vertebral Cortical Bone, Tarun Goswami, Isaac Mabe

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Cortical bone is a material with a porous structure. The presence of pores creates local stress concentrations and the likelihood of premature failure. Assuming that pores are present in all bone, vertebral endplates, for example, can subside. Subsidence has taken place at rates as high as 77 percent. A computational probabilistic assessment of the pore size distribution and their contribution to the fracture toughness has been presented in this paper. A Monte Carlo simulation was used to develop and assign random pores. Also the model compared crack sizes to the thickness of the cortical bone present as a limiting case. …

Wear Characteristics Of Wright State University Total Ankle Replacement Under Shear And Torsion Loads, Tarun Goswami, Dinesh Gundapaneni

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Introduction: Total ankle replacement (TAR) involves replacement of the damaged bone with prosthetic components and is usually performed in patients suffering with arthritis to relieve pain and maintain motion. There are several different factors that contribute to failure of TARs but aseptic loosening is the primary method of failure in total ankle replacements. Because of its superior mechanical properties UHMWPE is used as a liner material in TARs. Wear generated from the liner due to high contact stresses during gait causes osteolysis resulting in early loosening of the prostheses.

Most of the earlier studies have focused on wear due to …

Effect Of Anthropometric Adjustments On Bmd And Bmc Z-Scores In A Population Of Prader-Willi Syndrome Pediatric Patients, Amanda E. Marker, David F. Short, Talia Eldar-Geva, Harry J. Hirsch, Varda Gross-Tsur, Maayan Tiomkin, Ari Zimran, Thomas N. Hangartner

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Two adjustment models were applied to a dataset of bone-mineral density (BMD) and bone-mineral content (BMC) from dual-energy x-ray absorptiometry (DXA) measurements of pediatric patients with Prader-Willi Syndrome (PWS). One model used weight, height and % body fat (WHF) in the calculation of Z-scores in addition to race, sex and age already included in the standard model. As percent body fat is not always available, a second model with only weight and height was also examined (WH).

2d Wireform Process Improvement, Katy Conlin, Carlo Ebora, Jordan Gamble

Mechanical Engineering

The body of this work has been created for Edwards Lifesciences in conjunction with senior project requirements. As such, the information produced and contained within is under a non‐disclosure agreement. As per request by sponsor, the body of the work will not be submitted to any outside parties, and the title page will serve as proof of completion.

A Practical Guide To An Fmri Experiment, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Functional Magnetic Resonance Imaging (fMRI) has been around for two decades and research in this field has been exponentially rising. Much of this research has been dominated by basic science. Recent trends have brought the clinical realm into play in which valuable contributions can still be made. Helping the clinician understand the basic concepts behind an fMRI experiment is crucial to further developing and evaluating functional paradigms and research. Critical to designing an fMRI experiment is understanding the related physics and how fine tuning scanning parameters affects the image quality, which in turn affect the findings of an fMRI study. …

Automated Localization And Segmentation Of Pelvic Floor Structures On Mri To Predict Pelvic Organ Prolapse, Sinan Onal

USF Tampa Graduate Theses and Dissertations

Pelvic organ prolapse (POP) is a major health problem that affects women. POP is a herniation of the female pelvic floor organs (bladder, uterus, small bowel, and rectum) into the vagina. This condition can cause significant problems such as urinary and fecal incontinence, bothersome vaginal bulge, incomplete bowel and bladder emptying, and pain/discomfort. POP is normally diagnosed through clinical examination since there are few associated symptoms. However, clinical examination has been found to be inadequate and in disagreement with surgical findings. This makes POP a common but poorly understood condition. Dynamic magnetic resonance imaging (MRI) of the pelvic floor has …

Interpolation-Based Super-Resolution Reconstruction: Effects Of Slice Thickness, Amir Pasha Mahmoudzadeh, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Standard clinical magnetic resonance imaging (MRI) is acquired in two-dimensions where the in-plane resolution is higher than the slice select direction. These acquisitions include axial, coronal, and sagittal planes. To date, there have been few attempts to combine the information of these three orthogonal orientations. This paper aims to take advantage of the different in-plane resolution acquired from each plane orientation and combine them into one volume in order to attain a higher resolution image. This combination of MRI data will allow the detection of smaller areas that would otherwise be missed using only one slice orientation. A comparison of …

Rheological Model Of Force Transmission Through The Helmet And Concussion Sensitivity, Isiah Kendall, Anthony Vicini, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

In contact sports, head-to-head collisions can lead to concussions, which pose serious health risks to players. This research aims to understand the force transfer from the helmet to the brain that causes concussions in collisions using a rheological model. Experimental data was gathered from players in the National Football League and testing of one type of helmet and padding. The rheological model was verified with published data and good correlation was achieved. Further sensitivity analysis of concussion risk was performed with respect to force, body weight, mass, and impact duration fit to normal and Weibull distributions using Monte Carlo simulations …

Evaluation Of Interpolation Effects On Upsampling And Accuracy Of Cost Functions-Based Optimized Automatic Image Registration, Amir Pasha Mahmoudzadeh, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Interpolation has become a default operation in image processing and medical imaging and is one of the important factors in the success of an intensity-based registration method. Interpolation is needed if the fractional unit of motion is not matched and located on the high resolution (HR) grid. The purpose of this work is to present a systematic evaluation of eight standard interpolation techniques (trilinear, nearest neighbor, cubic Lagrangian, quintic Lagrangian, hepatic Lagrangian, windowed Sinc, B-spline 3rd order, and B-spline 4th order) and to compare the effect of cost functions (least squares (LS), normalized mutual information (NMI), normalized cross correlation (NCC), …

Toe Brace Designs, Tarun Goswami, Allison L. Van Horn, Alexander O. Sheets

Biomedical, Industrial & Human Factors Engineering Faculty Publications

In various embodiments, provided are braces for use in supporting the metatarophalangeal joint, reducing or maintaining the intermetatarsal angle, enhancing or maintaining alignment of the hallux, or combinations thereof in a subject having hallux valgus.

Current Trends Of Fmri In Vision Science: A Review, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Studying brain functional activities is an area that is experiencing rapid interest in the field of neuroimaging. Functional magnetic resonance imaging (fMRI) has provided vision science researchers a powerful and noninvasive tool to understand eye function and correlate it with brain activities. In this chapter, we focus on the physiological aspects followed by a literature review. More specifically, to motivate and appreciate the complexity of the visual system, we will begin with a description of specific stages the visual pathway, beginning from the distal stimulus and ending in the visual cortex. More importantly, the development of ascending visual pathway will …

Improving Health Care Quality And Safety: The Development And Assessment Of Laparoscopic Surgery Instrumentation, Practices And Procedures, Bernadette Mccrory

Department of Mechanical and Materials Engineering: Dissertations, Theses, and Student Research

Adverse events due to medical errors are a leading cause of death in the United States exceeding the mortality rates of motor vehicle accidents, breast cancer and AIDS. Improvements can and should be made to reduce the rates of preventable surgical errors since they account for nearly half of all adverse events within hospitals. Although minimally invasive surgery has proven patient benefits such as reduced postoperative pain and hospital stay, its operative environment imposes substantial physical and cognitive strain on the surgeon increasing the risk of error. In order to mitigate errors and protect patients, a multidisciplinary approach was taken …

Safety, Ergonomics And Human Factors Engineering On Biomedical Devices Design, Alejandra Sandoval Vazquez^, Noe Vargas Hernandez*

COURI Symposium Abstracts, Spring 2012

No abstract provided.

New Window On Optical Brain Imaging; Medical Development, Simulations And Applications, Chemseddine Mansouri, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

In this chapter we hope to give a technological review of near-infrared light and systems, discuss optode design considerations including background on the fiber design as it relates to this field and finally touch on current trends and applications. For the latter, we will focus on diffusion theory and simulation of photon propagation using a head model. We will follow this with concluding remarks.

Revised Reference Curves For Bone Mineral Content And Areal Bone Mineral Density According To Age And Sex For Black And Non-Black Children: Results Of The Bone Mineral Density In Childhood Study, Babette S. Zemel, Heidi J. Kalkwarf, Vicente Gilsanz, Joan M. Lappe, Sharon Oberfield, John A. Shepherd, Margaret M. Frederick, Xangke Huang, Ming Lu, Soroosh Mahboubi, Thomas N. Hangartner, Karen K. Winer

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Context: Deficits in bone acquisition during growth may increase fracture risk. Assessment of bone health during childhood requires appropriate reference values relative to age, sex, and population ancestry to identify bone deficits.

Objective: The objective of this study was to provide revised and extended reference curves for bone mineral content (BMC) and areal bone mineral density (aBMD) in children.

Design: The Bone Mineral Density in Childhood Study was a multicenter longitudinal study with annual assessments for up to 7 yr.

Setting: The study was conducted at five clinical centers in the United States.

Participants: Two thousand fourteen healthy children (992 …

Reducing Selection Bias In Case-Control Studies From Rare Disease Registries, J. Alexander Cole, John S. Taylor, Thomas N. Hangartner, Neal J. Weinreb, Pramod K. Mistry, Aneal Khan

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Background: In clinical research of rare diseases, where small patient numbers and disease heterogeneity limit study design options, registries are a valuable resource for demographic and outcome information. However, in contrast to prospective, randomized clinical trials, the observational design of registries is prone to introduce selection bias and negatively impact the validity of data analyses. The objective of the study was to demonstrate the utility of case-control matching and the risk-set method in order to control bias in data from a rare disease registry. Data from the International Collaborative Gaucher Group (ICGG) Gaucher Registry were used as an example.

Methods: …

Recording Of Elevated Temperature Fatigue Crack Growth Data By Dcpd System, N. Ramachandran, N. Arakere, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

The growth of "long" fatigue cracks, in α-β titanium alloy forging, subjected to cyclic stresses, is studied in this paper. The fatigue crack growth rate (FCGR) data were recorded at room temperature, 350, 450, 550 and 650°F using the Direct Current Potential Difference (DCPD) technique. The DCPD method, used in this investigation, was found to record and correlate the potential difference in terms of crack growth rate (da/dN) and Mode I stress intensity factor range satisfactorily. Various factors related to error minimization and calibration equations for compact tension specimens have been elaborated. Also discussed were the means to enhance the …

Tracking Of Bone Mass And Density During Childhood And Adolescence, Heidi J. Kalkwarf, Vicente Gilsanz, Joan M. Lappe, Sharon Oberfield, John A. Shepherd, Thomas N. Hangartner, Xangke Huang, Margaret M. Frederick, Karen K. Winer, Babette S. Zemel

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Context: Whether a child with low bone mineral density (BMD) at one point in time will continue to have low BMD, despite continued growth and maturation, is important clinically. The stability of a characteristic during growth is referred to as “tracking.”

Objective: We examined the degree of tracking in bone mineral content (BMC) and BMD during childhood and adolescence and investigated whether tracking varied according to age, sexual maturation, and changes in growth status.

Design: We conducted a longitudinal study with measurements at baseline and annually for 3 yr.

Setting: The Bone Mineral Density in Childhood Study was conducted at …

Height Adjustment In Assessing Dual Energy X-Ray Absorptiometry Measurements Of Bone Mass And Density In Children, Babette S. Zemel, Mary B. Leonard, Andrea Kelly, Joan M. Lappe, Vicente Gilsanz, Sharon Oberfield, Soroosh Mahboubi, John A. Shepherd, Thomas N. Hangartner, Margaret M. Frederick, Karen K. Winer, Heidi J. Kalkwarf

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Context: In children, bone mineral content (BMC) and bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) are affected by height status. No consensus exists on how to adjust BMC or BMD (BMC/BMD) measurements for short or tall stature.

Objective: The aim of this study was to compare various methods to adjust BMC/BMD for height in healthy children.

Design: Data from the Bone Mineral Density in Childhood Study (BMDCS) were used to develop adjustment methods that were validated using an independent cross-sectional sample of healthy children from the Reference Data Project (RDP).

Setting: We conducted the study in five …

Digital Human Models Of People With Disabilities, Ron Hamameh

Wayne State University Theses

The current state-of-the-art in Digital Human Modeling (DHM) allows for full simulation and analysis of any task a person is required to perform at home, at work, in the military, in space, in sports, etc. The problem is that the software is missing a very important population: people with physical disabilities. What modifications and enhancements must be made to existing, commercially available DHM software to include this population?

Distribution Tridimensionnelle De La Lumière Dans Une Strucutre De Tête D’Adulte Dérivée D’Un Acte Irm: Approche Par La Méthode De Monte Carlo, Chemseddine Mansouri, Jean-Pierre L'Huillier, Nasser H. Kashou

Biomedical, Industrial & Human Factors Engineering Faculty Publications

No abstract provided.

Detection Of Aortic Calcification During Vertebral Fracture Assessment (Vfa) Compared To Digital Radiography, John T. Schousboe, Kevin E. Wilson, Thomas N. Hangartner

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Background: Cardiovascular disease is the most common cause of mortality among post-menopausal women. Our objective was to determine whether or not lateral spine images obtained on a bone densitometer to detect prevalent vertebral fracture can also accurately detect radiographic abdominal aortic calcification (AAC), an important risk factor for cardiovascular disease independent of clinical risk factors.

Methodology/Principal Findings: One hundred seventy four postmenopausal women had bone densitometry, lateral spine densitometry imaging (called vertebral fracture assessment, or VFA), and lateral spine digital radiographs. Radiographs and VFA images were scored for AAC using a previously validated 24 point scale and a simplified, …

Overview Of Metal-On-Polyethylene, Metal-On-Metal, And Ceramic Hip Wear Mechanisms, A. Buford, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

Premature failure of orthopaedic hip implants caused by multiple wear mechanisms is the primary failure mode of prosthetic hips. Wearing of the implants may lead to aseptic loosening, biological incompatibilities, and mechanical failure of the implant. In order to prevent or restrict the effects of the wear mechanisms, multiple laboratory studies are being conducted in order to determine each mechanism and its contribution to increased wear rates. This paper combines previous laboratory studies related to the wear of metal-onpolyethylene, metal-on-metal, and ceramic materials. The bulk quantity materials discussed include cobalt chromium alloys, stainless steels, zirconium oxide ceramics, and polyethylene materials …

Wear Mechanisms In Ceramic Hip Implants, M. Slonaker

Biomedical, Industrial & Human Factors Engineering Faculty Publications

The wear in hip implants is one of the main causes for premature hip replacements. The wear affects the potential life of the prosthesis and subsequent removals of in-vivo implants. Therefore, the objective of this article is to review various joints that show lower wear rates and consequently higher life. Ceramics are used in hip implants and have been found to produce lower wear rates. This article discusses the advantages and disadvantages of ceramics compared to other implant materials. Different types of ceramics that are being used are reviewed in terms of the wear characteristics, debris released, and their size …

Wear Mechanisms In Ceramic Hip Implants, M. Slonaker, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

The wear in hip implants is one of the main causes for premature hip replacements. The wear affects the potential life of the prosthesis and subsequent removals of in-vivo implants. Therefore, the objective of this article is to review various joints that show lower wear rates and consequently higher life. Ceramics are used in hip implants and have been found to produce lower wear rates. This article discusses the advantages and disadvantages of ceramics compared to other implant materials. Different types of ceramics that are being used are reviewed in terms of the wear characteristics, debris released, and their size …

General Creep-Fatigue Life Prediction Models, J. Toland, Tarun Goswami

Biomedical, Industrial & Human Factors Engineering Faculty Publications

This paper presents a data bank that was compiled from published and unpublished sources. Using these data, low cycle fatigue curves were generated under a range of test conditions showing the effect of test parameters on the Coffin-Manson behavior of steel alloys. Generic equations have been developed in this paper to predict the creep-fatigue life of high temperature materials. Several new multivariate equations were developed to predict the creep-fatigue life of following alloy groups; I) Cr-Mo steels, 2) stainless steels and 3) generic materials involving the materials from the following alloy groups, solder, copper, steels, titanium, tantalum, and nickel based …