School of Biomedical Sciences
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Item 17 Beta-Estradiol, Integrins, and Synaptic Proteins(2009-05-01) Chandra, Manjari; Simpkins, James W.Item 17Beta-Estradiol Suppresses Hydrogen Peroxide-Induced Nuclear Factor Kappa B Activation in HT22 Cells(2008-05-01) Kim, Pil J.; Simpkins; Singh; Yang, ShaohuaKim, Pil J., 17beta-estradiol suppresses hydrogen peroxide-induced nuclear factor κappa B activation in HT22 cells. Master of Science (Biomedical Sciences), May, 2008, 78pp., 20 illustrations, 66 titles. Reactive oxygen species (ROS) are natural byproducts of normal cellular reactions. They are oxygen ions, free (non)radicals, and peroxides that are highly reactive with normal macromolecules, such as lipids, DNA, and proteins. Cells are normally able to defend against the damages of ROS via enzymes that neutralize them into water. However, when cells are not able to cope with the accumulation of ROS, distributions in signaling pathways and gene transcription will occur, which will ultimately lead to cell death. It is now widely accepted that increased oxidative stress-induced damage in the brain is a major cause of neurodegenerative diseases, such as Alzheimer’s disease (AD). Nuclear factor κappa-B (NFκB) is not only a ubiquitously expressed transcription factor but also a signaling protein that is activated by ROS-induced oxidative stress. Our laboratory has demonstrated the neuroprotective effects of 17β-estradiol (E2) are elicited via an anti-oxidant effect. The purpose of this project was to determine the role of NFκB activation in E2-mediated neuroprotection against hydrogen peroxide (H2O2)-induced oxidative stress. HT-22, a murine immortalized hippocampal neuronal cell line, was utilized to determine whether NFκB is activated by hydrogen peroxide-induced oxidative stress and whether E2 suppresses H2O2-induced NFκB activation. We observed that H2O2 activated NFκB by phosphorylation of IκBα (pIκBα), one of the NFκB inhibitor proteins, reduction of total IκBα, and induction of NFκB (p65) nuclear translocation. In contrast, E2 suppressed H2O2-induced NFκB activation by dramatic reducing pIκBα, increasing total IκBα, and inhibiting p65 nuclear translocation. Our results show that one of the mechanisms by which estrogens are neuroprotective against oxidative stress is through the attenuation of H2O2-induced NFκB activation.Item [3H] Ethynylbicycloorthobenzoate ([3H] EBOB) Binding in Native and Recombinant GABAA Receptors(2000-05-01) Yagle, Monica A.; Dillon, Glenn; Martin, Michael; de Fiebre, ChristopherYagle, Monica A., [3H] Ethynylbicycloorthobenzoate ([3H] EBOB) Binding in Native and Recombinant GABAA Receptors. Master of Science (Pharmacology), May 2000, 59 pp., 3 tables, 7 illustrations, bibliography, 75 titles. Modulation of the GABAA receptor has been studied with noncompetitive convulsant ligands such as tert-butylbicyclophosphorothionate (TBPS) and picrotoxin (PTX). EBOB is a more recently developed ligand that appears to bind in the same region of the channel at TBPS, but with a higher affinity. While only a few studies have examined the binding of EBOB to vertebrate brain tissue and insect preparations, none have examined potential subunit-dependent binding of EBOB. We have thus examined [3H] EBOB binding in rat cerebellum and HEK293 cells stably expressing human α1β2γ2, human α2β2γ2, and rat α6β2γ2 GABAA receptors. For comparison, [35S] TBPS binding was also examined in α1β2γ2 receptors. Saturation and Scatchard analyses revealed saturable [3H] EBOB binding at one site in all tissue preparations with Kd values ranging from 3 to 9nM. [3H] EBOB binding, like [35S] TBPS binding was inhibited by the CNS convulsants dieldrin, lindane, tert-butylbicyclophosphorothionate (TBOB), PTX, TBPS, and pentylenetetrazole (PTZ) at one site in a concentration dependent fashion. Affinities were in the high nM to low μM range for all compounds except PTZ (low mM range). GABA modulated [3H] EBOB binding in a biphasic manner in α1β2γ2 receptors with a 100-fold difference between stimulatory and inhibitory affinities. Inhibition of GABA-mediated current by TBOB in α1β2γ2 receptors resulted in a functional IC50 of 0.2 μM, in agreement with binding study results. Differences seen in binding between the different receptor subtypes examined suggest that some characteristics of EBOB binding are subunit dependent. In addition, we have shown that [3H] EBOB is a useful ligand in the study of recombinant GABAA receptors and that results obtained with [3H] EBOB are comparable to those obtained with [35S] TBPS.Item A Bone and Buccal Sensitivity Study Comparison and Stability Study using the PowerPlex[R] Fusion 6C System(2018-05) McDaniel, Ethan L.; Warren, Joseph E.; Planz, John V.; Krishnamoorthy, Raghu R.; Gaydosh-Combs, LauraA validation study, a bone sensitivity study and a stability study were performed using the PowerPlex[R] Fusion 6C System. These studies were performed on a 7500 Real-Time PCR System, 9700 GeneAmp Thermocycler and 3500xL Genetic Analyzer. Buccal DNA was used to develop a method to analyze the DNA profiles gathered during the bone sensitivity study and stability study. DNA profiles for specific concentrations of DNA in solution were obtained during the bone sensitivity study. The stability study showed profiles exhibiting the effects of metal PCR inhibitors being introduced to the DNA extract solutions. Full profiles were obtained for calcium concentrations less than 7.35 mM, while the instrument was fully inhibited for copper concentrations between 0mM and 7.35 mM. Based on the limited data, the PowerPlex Fusion 6C System cannot tolerate copper when present in DNA solutions; whereas, calcium may be tolerated as an inhibitor up to 7.35mM.Item A Cadaveric Investigation of the Dorsal Scapular Nerve(2016-12-01) Nguyen, Vuvi H.; Reeves, Rustin E.; Liu, Hao; Rosales, Armando A.Dorsal scapular nerve (DSN) syndrome is often associated with sharp, dull, or aching pain in the upper extremity and back. The primary cause of pain is the entrapment of this nerve at the middle scalene muscle. Even though there is clinical evidence that DSN syndrome exists, it is often overlooked during clinical diagnosis. The purpose of this study is to locate the surface projection of the DSN relative to the middle scalene muscle while using the laryngeal prominence as a reference point. From 20 embalmed adult cadavers, 23 DSN were dissected and documented regarding its spinal root origins, anatomical route, and muscular innervations. A transverse plane through the laryngeal prominence was established to measure the distance of the DSN as it enters, crosses, and exits the middle scalene muscle. Approximately 70% of the DSNs originated from C5, 22% branched from C4, and 8% from C6. In regards to the route of the DSN in relation to the middle scalene muscle, 74% of the DSNs pierced this muscle, 13% crossed this muscle anteriorly, and 13% traveled posterior to this muscle. About 48% of the DSNs supplied the levator scapulae muscle only and 52% innervated the levator scapulae and both the rhomboid muscles. The average distances from a transverse plane of the laryngeal prominence to where the DSN entered, crossed, and exited the middle scalene muscle were 1.50 cm (±0.88 cm), 1.79cm (±0.89 cm), and 2.08 cm (±0.96 cm) respectively. Injection studies were performed on 10 un-dissected embalmed cadavers to verify the accuracy of our surface projection measurements of the DSN relative to the middle scalene muscle. These injections were performed at approximately 2.08 cm (~1 thumb interphalangeal joint width) from the transverse plane of the laryngeal prominence. Dissections at these injection sites revealed that the scalene muscles were consistently located. The middle scalene muscle was accurately located in approximately 50% of the injections. The goal of this research is to understand the variability in DSN's anatomy as well as introduce a method that will assist clinicians to efficiently pinpoint and therefore treat patients with DSN entrapment.Item A Calcium-Dependent Nuclear Signaling Pathway Transcriptionally Silences Atrial Natriuretic Factor Gene Expression(1995-08-01) Zeng, Hong; Stephen R. Grant; Walter McConathy; Richard EasomZeng, Hong, A Calcium-Dependent Nuclear Signaling Pathway Transcriptionally Silences Atrial Natriuretic Factor Gene Expression. Master of Science (Biomedical Science), August, 1995, 85 pp., 2 tables, 20 illustrations, bibliography, 90 titles. A cultured myocardial cell model was used to examine a potential role of calcium-dependent protein kinases and phosphatases in regulating the induction of the atrial natriuretic factor (ANF) gene mediated through adrenoreceptor signaling. In primary culture, rat neonate cardiomyocytes supplemented with phenylephrine (PE) following transfection (24 h) with a full length ANF promoter-reporter construct, showed elevated levels of promoter activity when compared to transfected cardiomyocytes cultured in the absence of PE. Prazosin, a dedicated α1-antagonist, completely blocked the transcriptional induction mediated through PE stimulation. Two different calcium mobilizing agents, BAY K8644 and gramicidin D, significantly reduced PE-stimulated ANF promoter activity. The over-expression of co-transfected exogenous CaM kinase II isoforms resulted in transcriptional silencing of PE-induced promoter activity for cardiac ANF. Transfection of a constitutively active, mutant form of the calcium-dependent phosphatase 2B, calcineurin, gene also transcriptionally silenced ANF gene expression. Exposure of PE-induced cardiomyocytes to either FK-506-treated cells in the absence of PE exposure suggesting that transcriptional silencing may be mediated through a transcriptional repression mechanism. Taken together, these results suggest that the activation of a Ca2+-dependent nuclear signaling pathway mediated through either CaM kinase II or calcineurin leads to complete transcriptional silencing of the embryonic ANF gene expression.Item A Clinical Research Study Involving the Use of Erythropoietin in Perioperative Patients Undergoing Surgery for Gynecologic Cancer(2002-07-01) Larson, Sharon Beth; Richardson, Barbara; Martin, MichaelThe purpose of this internship practicum report is to analyze the pathophysiology and impact of anemia in low-income gynecologic cancer patients. The report also assesses the impact of erythropoietin on hemoglobin levels prior to gynecologic cancer surgery. This report is based on a clinical research study to determine whether or not erythropoietin will mitigate the suppression of bone marrow inherent to the gynecologic cancer population and alleviate some of the symptoms and side effects of the anemia.Item A Comparative Analysis of Recruitment Methods used in Randomized Controlled Clinical Drug Trials(2019-05) Garud, Ashwini A.; Mathew, Stephen O.; Goulopoulou, Styliani; Anderson, Jessica; Maynard, BrianClinical trials are a crucial part of any drug development process. The reliability and validity of clinical trials depend on the successful recruitment of subjects. The overall goal of this project was to evaluate the effectiveness of subject recruitment methods used in Randomized Controlled Trials (RCTs) focusing on Major Depressive Disorder (MDD) and Postpartum Depression (PPD) studies. Recruitment methods (on-site and off-site) utilized in these trials were examined for their cost-effectiveness, recruitment return, including the number of subjects enrolled and the number of subjects randomized in the trial and subject demographics. Regarding cost effectiveness, on-site methods were found to be more effective in terms of recruitment return and less costly than off-site for both studies. There was a significant difference in race and gender when subjects were recruited from on-site versus off-site recruitment. For MDD study, a comparatively large number of enrolled and randomized participants were recruited from on-site recruitment methods as compared to off-site, this may be due to the number of physician referrals, indicating that physicians play a major role in subject recruitment. For the Postpartum Depression study, the number of enrolled and randomized subjects from off-site recruitment method was higher than those of on-site methods. Monitoring recruitment strategies implemented in the study and assessing their effectiveness would be helpful in employing strategies for future trials.Item A Comparative Review of Screening, Consent, and Trial Visits and Follow-up Practices in Cardiovascular Dual Antiplatelet Therapy Drug, Device, and Registry Studies at Legacy Heart Center and The Heart Hospital Baylor Plano(2014-12-01) Mohiuddin, Ismail S.; Patricia A. Gwirtz; Rustin E. ReevesCoronary artery disease (CAD) is the number one cause of death in the United States and a large amount of research has been conducted to find the best treatment strategy to treat and prevent it. The PEGASUS-TIMI 54 study, a drug trial, the PzF SHIELD study, a device trial, and the TIGRIS study, a registry trial, build off of that research and are seeking novel strategies to improve patient outcomes There are significant differences between drug, device, and registry clinical research trials. Comparing these three dual antiplatelet research studies on the basis of screening, consent, and trial visits and follow-up practices gives insight into the distinct features of each kind of clinical research trial.Item A Comparative Study of Three Methods to Enhance the Collection of DNA from Plant Material(2013-05-01) Ausmer, Alea D.; Warren, JosephThe Botanical Research Institute of Texas is using two methods of DNA extraction from plants, an automated method called Bullet Blender® and a manual method of grinding. A third method, using an instrument called the Fast Prep-24™, was evaluated and the DNA yield obtained was compared to the other methods. Eight plant species were chosen and two sample preparation methods, wet and dry, were evaluated. DNA yield gels were run in order to compare DNA quality and UV spectroscopy was used to evaluate quantity. Independent Student t-tests were performed to compare means variation between the DNA yield on the wet and dry samples and one-way ANOVA was used to compare variation between the three extraction methods. No significant difference was found between the wet and dry samples for DNA concentrations, but a significant difference was observed between the Fast Prep-24™ instrument and the other two methods.Item A Cross-Sectional Study on Factors Affecting Maternal Trust in Texas Government to Make Good Decisions About Newborn Screening and Dried Bloodspot Storage(2015-12-01) Nguyen, Huy David Dang; Robert T. Mallet; Peter B. RavenNewborn screening (NBS) results in a surplus of blood samples in the form of dried bloodspots (DBS). Texas’s “opt-in” policy requires mothers’ permission for the state to store DBS samples for research. A cross-sectional study was performed on post-partum mothers in North Texas to determine the effect of the mothers’ demographics, knowledge, attitudes, and decisions about NBS and DBS storage on trust in Texas’ ability to make good decisions regarding bloodspot research. The aforementioned trust in the Texas government was strongly associated with trust in Texas to keep the babies’ information private, belief that using DBS for public health was beneficial, and trust in Texas to de-identify their babies’ DBS. Medicaid coverage also showed a slight association with this trust. Overall, mothers who are supportive of public health research using de-identified specimens such as DBS are more confident in the Texas’s ability to make the right choices regarding DBS storage.Item A DNA-Based Multiplex Screening Tool for Separation of Fragmented and Commingled Skeletal Remains(2007-12-01) Ambers, Angie; Joseph Warren; John Planz; Arthur EisenbergAmbers, Angie, A DNA-based Multiplex Screening Tool for Separation of Fragmented and Commingled Skeletal Remains. Master of Science (Forensic Genetics), December, 2007, 63 pages, 13 tables, 19 figures, references, 38 titles. In mass death scenarios, human remains are often fragmented, scattered, and commingled. Ascertaining the number of victims and determining the victims’ identities in such scenarios is a challenging task. A DNA-based screening tool used early in the investigation of mass disasters or mass graves would provide a relatively quick way to initially assess casualty numbers and separate remains for further analysis. Such a tool would promote the most efficient allocation of resources and speed the identification process. The multiplex designed here incorporates a few genetic loci that show high variability in the human population, giving it sufficient discriminatory power for separation of commingled remains. Specifically, the multiplex includes the amelogenin sex-determining locus, D3S1358, and a 3’ (CA)n dinucleotide repeat in the mitochondrial D-loop. Further optimization/validation studies need to be conducted, and a fourth locus (D5S818) may need to be considered to increase the tool’s power of discrimination.Item A guanidine dietary supplement influences pH sensitivity and NSAID activity in acid-sensing ion channels(2015-12-01) Agharkar, Amruta S.; Gonzales, Eric B.; Singh, Meharvan; Luedtke, Robert R.The acid-sensing ion channels (ASICs) are proton sensitive, sodium channels that belong to the epithelial sodium channel/ Degenerin family of ligand-gated ion channels. Activation of the ASIC1a subtype in the central nervous system increases neurodegeneration after ischemic stroke while ASIC3 subtype in the peripheral nervous system is involved in perception of pain. They are emerging targets for ischemic stroke, pain and inflammation. However, we lack selective ligands to target ASICs. In order to gain a better understanding of the channel and to develop selective ligands we must first determine how ASICs are modulated by synthetic as well as endogenous guanidine compounds. This study investigates whether a guanidine dietary supplement, creatine, modulates ASICs. Creatine has been shown to protect from ischemia and benefits patients suffering from muscular dystrophy, osteoarthritis, and fibromyalgia. Furthermore, pain medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit ASICs. Since supplements and NSAIDs are available over-the-counter, the significant amount of the population would consume them simultaneously.However, the interactions of combination of creatine and NSAIDs on ASICs still remain elusive. Here we sought to determine if creatine would modulate ASIC1a and ASIC3 proton sensitivity and if the combination of creatine and NSAIDs would inhibit ASIC3. Our results indicate that, creatine reduces human ASIC1a (hASIC1a) steady-state desensitization and increases their recovery from desensitization. Creatine also slows down the open-state desensitization of hASIC1a. The efficacy of hASIC1a is increased by creatine at higher concentrations. This indicates that, creatine increases channel's reactivation from desensitization by stabilizing the closed conformation of hASIC1a. Creatine's effect on rat ASIC3 (rASIC3) was calcium dependent. Creatine reduced proton sensitivity of rASIC3 in the nominal calcium environment. As previously reported, NSAIDs inhibited steady-state current of rASIC3 which is involved in pain perception. However, creatine reduced NSAIDs efficacy on rASIC3. To summarize, the creatine's effect depends on the desensitized state of hASIC1a and creatine increases the availability of channels for opening. While in rASIC3, creatine reduces proton sensitivity in nominal Ca2+ and antagonizes NSAIDs inhibitory effect. Thus, the use of creatine should be monitored in diseased states and when it is consumed along with NSAIDs.Item A Look at Diabetes Mellitus and the Effects of a Study Drug on Diabetic Nephropathy(2002-08-01) Schlueter, Cynthia K.; Debbie Lewis; Clifton Cage; Rustin ReevesDuring my internship, I assisted with a twenty-four week, phase 2, double blinded, placebo controlled trial for a drug being developed to slow, if not prevent, the development of ESRD from overt neuropathy in patients with both type 1 and type 2 diabetes. This drug is a naturally occurring component of vitamin B6 and is an AGE-inhibitor. The AGE-inhibitory effect of the study drug was discovered by isolating Amadori products in the pathway to AGE formation. Once the intermediates were isolated, the sponsor’s scientists searched for compounds that could specifically block the conversion of these Amadori products into AGEs. The study drug was found to be a strong inhibitor of this pathway. In comparison, the common AGE inhibitor, aminoguanidine was found to be ineffective in blocking the post-Amadori foundation AGEs. Therefore, it must block AGE formation at one of the less clinically relevant pathways, and should be less effective in treating nephropathy according to the sponsor’s scientists. This study included type 1 and type 2 patients with clinically diagnosed diabetic retinopathy and a urinary albumin excretion rate (UAE) of greater than 300 mg/24h. Other inclusion and exclusion criteria were applied for the safety of the subjects and greater viability of the data.Item A Novel Approach to Inquiry-Based Learning Models in the Sciences: Utilization of Case Presentations and Patient Encounter Workshops in High School Life Science Classrooms(2004-07-01) Whitaker, Lekeisha R.; Rustin E. Reeves; Victoria Rudick; Rouel RoqueA Novel Approach to Inquiry-Based Learning Models in the Sciences: Utilization of Case Presentations and Patient Encounter Workshops in High School Life Science Classrooms. Lekeisha R. Whitaker. Abstract. A novel approach to inquiry-based learning models is needed in a curriculum that reflects changing demographics, societal demands, and diverse cultural background. The proposed module which is designed to teach the urinary system to Fort Worth Independent District high school biology students as outlined in the Texas Essential Knowledge and Skills (TEKS) guide, represents application of this novel tool in the classroom. It is designed to be implemented in inquiry-based learning classrooms that function to encourage the natural process of inquiry throughout grade levels. The proposed module takes advantage of media resources, introductory case reports, and patient encounter workshops that outline diet, disease, and health disparities as a way to capture student interest in content relevant material, engage students in the daily lessons, and invoke long-term retention of basic life science concepts. Through future research and testing of module design and effectiveness in the classroom, the proposed approach to inquiry-based learning may serve to optimize student understanding of fundamental science concepts and diet and disease as it relates to normal body function, with implications that may affect change in lifestyle. Furthermore, the proposed learning module, if effective, may also serve as a template to be used to teach other life science subjects.Item A Novel Curriculum: Integrating Anatomy, Osteopathic Principles and Practice, and Clinical skills.(2011-05-01) Colston, John S.; Cruser, des AngesThe purpose of this project was to create and test a novel curricular model integrating anatomy, osteopathic principles and practice, and clinical skills. The curricular model was created through collaborative effort with a multi-discipline advisory group. The model’s effectiveness was assessed in two separate learning events involving medical students and pre-medical students. Knowledge assessments and opinion surveys distributed pre and post-learning event demonstrated a positive trend toward knowledge acquisition and support of the curricular model. Implementation of the novel curriculum was successful, producing desired learning outcomes and demonstrating the value of integrating clinical context with basic sciences. Further research and implementation of a more complete version of the model is warranted.Item A Novel Multiplex Assay for an Ancestry-Informative Marker (AIM) Panel of INDELs(2016-05-01) Sturm, Sarah A.; Bobby L. LaRue; Bruce Budowle; Raghu R. KrishnamoorthyThe current standard for forensic laboratories in criminal casework is to use Short Tandem Repeat (STR) markers to develop an evidentiary profile. Commercially available STR amplification kits yield amplicons 100 to 500 base pairs (bp) in length. Commonly, forensic DNA samples are highly degraded to approximately 180-200 bps in length, resulting in incomplete STR profiles. Therefore, markers that can be generated with smaller amplicons may be better suited for degraded DNA samples. Additionally, there are cases where no STR match was obtained through a DNA database search and thus no investigative lead is obtained. The bioancestry of a sample donor could aid law enforcement in such cases. A class of markers that could provide investigative value from degraded DNA samples is Ancestry-Informative Marker (AIM) Insertion/Deletions (INDELs). INDELs are polymorphisms that can be amplified from degraded samples due to their smaller amplicon size. AIMs have the ability provide bioancestry information. This project tested the hypothesis that a multiplex PCR-based assay of INDELs can be developed, and subsequently be analyzed by capillary electrophoresis for population identity testing applications. The use of this assay would require no additional tools or machinery than what already is in standard forensic laboratories. To test this hypothesis, a previously developed panel of AIM-INDEL markers was used to develop this multiplex assay.Item A Novel sRNA Member of the Carbon Storage Regulatory System of Escherichia Coli(2002-12-01) Weilbacher, Thomas; Jerry SimeckaWeilbacher, Thomas S., A Novel sRNA Member of the Carbon Storage Regulatory System of Escherichi coli. Master of Science (Microbiology & Immunology), December, 2002, 57 pp., 2 tables, 12 illustrations, bibliography, 44 titles. Small untranslated RNAs (sRNAs) perform a variety of important functions in bacterial systems. The 245 nt sRNA of Escherichia coli K-12, CsrC, was uncovered using a genetic screen for genes that regulate glycogen biosynthesis. CsrC RNA binds multiple copies of CsrA, a protein that post-transcriptionally regulates central carbon flux, biofilm formation, and motility in E. coli. CsrC antagonizes the regulatory effects of CsrA, presumably by sequestering this protein. The discovery of CsrC is intriguing, in that a similar sRNA, CsrB, performs essentially the same function. Both of these sRNAs possess similar imperfect repeat sequences (18 in CsrB, 9 in CsrC), primarily localized in the loops of predicted hairpins, which may serve as CsrA binding elements. Transcription of csrC increases as the culture approaches the stationary phase of growth and is activated by CsrA and the response regulator UvrY. Complementation and in vitro transcription-translation experiments reveal that CsrA effects on csrC are mediated indirectly, through UvrY. Because CsrB and CsrC antagonize the activity of CsrA and are dependent on CsrA for their synthesis, a csrB null mutation causes a modest compensatory increase in CsrC levels and vice versa. An updated model for the signaling circuitry of the Csr system is discussed.Item A Phase II Clinical Study to Evaluate the Efficacy and Safety of rhThrombin in Subjects Undergoing Arterial Bypass Surgery and AV Graft Formation for Hemodialysis(2004-12-01) Plascencia, Xochitl; Rustin E. Reeves; Della Weis; Don PeskaThe Association of American Medical Colleges Task Force on Clinical Research defines clinical research as a component of medical and health research intended to produce knowledge essential for understanding human disease, preventing and treating illness, and promoting health (Friedman, 1998). A clinical trial is defined as a research study conducted in humans which is designed to answer specific questions using scientifically controlled conditions with specified methodologies and endpoints (Gallin, 2002). Clinical research trials are essential in determining whether or not a drug is safe and effective. There are four phases that investigational drugs go through before they are allowed to be out in the market. Before beginning phase I of a study, there is usually a pre-clinical research and development phase. During this time the initial synthesis of study drug is accomplished and animal testing takes place. Phase I is the initial introduction of an investigational new study drug into humans. Phase I is usually conducted in healthy individuals and the primary goal is to determine the safety profile of the drug. Phase II trials tend to evaluate safety and initial efficacy. Subjects enrolled in this phase tend to have the disease necessary for use of study drug. Phase III studies are conducted to gather additional information about the effectiveness and safety of the drug and to determine the overall benefit-risk relationship of the drug. Finally, phase IV studies are usually referred to as post-marketing studies. During this phase, additional safety information is identified and the drug’s safety during routine use is evaluated. Each phase can range from two to ten years depending on the complexity of the clinical trial (Gallin, 2002). A phase II, randomized, double blind study of the safety and efficacy of topical recombinant human thrombin in patients undergoing peripheral arterial bypass surgery and arterio-venous graft formation for hemodialysis is the focus of the prospective drug study to be carried out in the surgery department at The University of North Texas Health Science Center. The primary objective of this study is to evaluate the safety and efficacy of recombinant human thrombin when used in different types of surgeries. Prior to signing an informed consent, subjects will have to meet inclusion and exclusion criteria set by study protocol. Study specific assessments and procedures will be performed after the informed consent is signed and dated. If bleeding at the anastomosis is found to necessitate intervention, a single application of either rhThrombin or placebo in combination with an absorbable hemostatic sponge to each anastomosis requiring hemostasis will be applied by the surgeon. The safety and efficacy of rhThrombin will be determined by measuring the incidence and severity of adverse events and of laboratory abnormalities. Occurrence of hemostasis within 600 seconds of application of the study drug at the anastomotic surgical site, incidence of anti-rhThrombin product antibodies, and time to hemostasis will also be measured.Item A Pilot Study into the Impact of Remote Monitoring on the Trial Site(2017-12-01) Paulman, Brendan; Stephen O. Mathew; Scott MadduxRemote monitoring as the primary method of clinical trial oversight is increasingly common due to advancements in technology which allow SDV to be performed without site visits. However, remote monitoring often changes the workflow of the clinical trial site staff. This study aims to determine how remote monitoring affects the time allocation of site staff toward duties related to monitoring visits, and to identify which tasks are most affected when the sponsor uses a remote monitoring strategy. A survey was sent out to clinical research staff within BSWRI. Research staff tended to spend less time toward remote monitoring duties than on-site monitoring duties. Submitting source documents, regulatory, and AE documentation were identified as more time-consuming for remote monitoring, while preparing for visits and assisting the monitor while on-site were identified as more time-consuming for on-site monitoring. This study identified potential targets for improvements in the workflow of clinical trial sites.