Browsing by Subject "Laboratory and Basic Science Research"
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Item Cell line authentication and contamination assessment for human cell cultures(2015-05-01) Ormos, Andrea; Arthur J. Eisenberg; Rhonda Roby; John V. PlanzCell line authentication is an essential step in ensuring the integrity and reproducibility of biomedical research. The major contaminants in cell cultures are fungi, viruses, bacteria and contamination from other cell lines of the same or different species. Contaminants alter the physiology and properties of cells, compromising the results of experiments. In this study, an improved multiplex assay was developed, detecting mycoplasma and mouse cell line contamination, while performing DNA typing. The assay was tested on cell cultures, the reproducibility of the assay was verified, sample collection and procedures were optimized and limit of detection for contaminants were determined. A survey was conducted to assess the interest in an in-house cell line authentication and contamination assessment service.Item Clinical Research Patient Recruitment and Retention(2008-01-01) Chandler, Jessica; Michael Smith; John R. Burk; Kathy KwaakThe internship practicum requirement for my Masters degree was completed at Texas Pulmonary and Critical Care Consultants P.A., Research. I worked under the direction of John Burk, M.D., and Kathy Kwaak, RN CCRN. These were the principal investigator and study coordinator respectively. While at TPCCC, I learned about both the administrative and clinical aspects of clinical research. I also gained a great understanding of patient recruitment and retention. Along with the knowledge, I used current study data to complete my research project. The primary focus of my practicum was to evaluate different aspects of patient compliance and retention as a result of the form of patient recruitment. Forms of recruitment in this study include TPCCC database and central advertising. I evaluated five studies. I collected information regarding the number of individuals contacted, enrolled, consented, screened, and early terminations for each study. Furthermore, I determined the most effective form of recruitment at TPCCC. I also acquired data, via a questionnaire, regarding patients’ feelings toward research.Item Clinical Research: Drug Studies and Device Trials, Theory and Approach(2002-07-01) McCormick, Timothy Chad; Rustin Reeves; Don Pesca; Dellas WeisA clinical trial is composed of four different phases. Each of these phases serve a purpose such as testing safety, efficacy, and dosage. These phases are essential to provide the best possible model for mass use of a drug or a new device. Drug studies differ from device studies in their design and their delivery. In this case, a post-operative pain medication was tested, as well as a differential study between two types of cutting devices used in laparoscopic cholecystectomy. The post-operative pain study is a phase III study that is testing the efficacy, safety, and the pharmacokinetics of a proposed drug. The device study is considered a phase IV study because it is evaluating two commonly used techniques for laparoscopic cholecystectomy. Both of these techniques have previously been approved by the FDA and are mass marketed. These two studies were followed for six weeks and evaluated for protocol design, differences and similarities, and for hands on experience in the clinical research arena. Upon completion of the six week opportunity, it is evident that clinical research is a viable piece of medicine today. Following these two studies allowed for an understanding of the differences and similarities encountered when executing a drug study, as well as a device study. The complexities of the two studies were evaluated, and without doubt, the drug study included much more paper work, patient testing, inclusion/exclusion criteria, study evaluation, and most of all, man hours. All in all, this was a very rewarding experience that allowed for a greater understanding of the implementation and value of today’s clinical research.Item Corticotropin-Releasing Factor and Corticosterone Modulate the Anxiogenic-Like Effects of mCPP(1998-06-01) Jenkins, Jennifer A.; Michael Forster; Robert Luedtke; Patricia GwirtzJenkins, Jennifer A., Corticotropin-Releasing Factor and Corticosterone Modulate the Anxiogenic-Like Effects of mCPP. Doctor of Philosophy (Pharmacology), June 1998, 119 pp., 2 tables, 29 figures, bibliography, 100 titles. The administration of PTZ or mCPP produces anxiety-like behavior as measured by an increase in the percentage of entries into the open arms and the time spent on the open arms of the elevated plus maze (Prunell et al., 1994). Reportedly, PTZ and mCPP substitute for each other in the drug discrimination paradigm (Wallis and Laz, 1998). It is therefore suggested that commonality exists among anxiogenic drugs as perceived by trained animals. Andrews and Stephen (1990) suggested that this overall parallelism is an indication that anxiogenic agents may possess similar properties. Therefore, the question posed is as follows: Is there a common denominator anxiety? The global hypothesis is that the core component of anxiety produced by anxiogenic agents or processes involves stimulation of the HPA axis to release CRF, ACTH and/or CORT. Long Evans rats were trained to discriminate either mCPP (1.4 mg/kg) or PTZ (16mg/kg) from saline in a two-lever choice procedure (FR10) which is food reinforced. Animals were pretreated with CRF, α-helical CRF (a CRF antagonist), two steroid synthesis inhibitors (ketoconazole, KETZ and aminoglutethimide, AMG), CORT or underwent an adrenalectomy prior to behavioral testing in order to test the hypothesis that the release of CRF and/or CORT are components of the discriminate stimulus of the mCPP and/or PTZ. Pretreatment with CRF, KETZ, AMG and an adrenalectomy facilitated mCPP level selection. However in the absence of mCPP neither drug nor adrenalectomy produced drug lever selection. In addition CORT did not alter the mCPP dose response curve. However, CORT replacement therapy returned the does response curve to baseline in adrenalectomized animals. Alpha-helical CRF did not block mCPP discrimination. Unlike mCPP-trained animals, KETZ and AMG decreased PTZ-lever selection in PTZ-trained animals. In addition, CORT enhanced and partially substituted for the discriminative stimulus of PTZ. However, adrenalectomy completely abolished drug lever selection in PTZ animals. To compare the discriminative stimulus effects of mCPP and PTZ, PTZ-trained animals were injected with cumulative doses of mCPP. mCPP-trained animals were injected with cumulative doses of PTZ. mCPP and PTZ minimally substituted for each other. The results suggested that neither CRF nor CORT are components of the discriminative stimulus of mCCP and that the role of the HPA axis in mCPP discrimination maybe be a modulator of the stress response. However, CORT is a component of the discriminative stimulus of PTZ such that CORT is necessary for drug lever selection in PTZ trained animals.Item Detection of Androgen Receptors by Flow Cytometry(2008-05-01) Dutta, Mayurika; McClain, Robert; Singh, Meharvan; Hall, StanDutta, Mayurika, ‘Detection of androgen receptors by Flow Cytometry’. Internship Practicum report, Biotechnology, May 2008, 80 pp., 1 table, 18 figures. The use of androgen therapy is expanding given the documented potential benefits like increasing bone mineral density, muscle mass and strength. Androgen therapy also has potential risks including increasing the likelihood of prostate cancer and cardiovascular disease. So, we need a way to differentiate those who are likely to be benefitted by the therapy and those that are not. Data from Dr. Meharvan Singh’s lab has shown that activation of intracellular androgen receptors triggers cell survival pathways, while activation of the membrane androgen receptor suppresses cytoprotective pathways, and thus promotes cell death. We propose to develop a diagnostic kit that measures the relative ratio of intracellular androgen receptors and membrane androgen receptors, which is predicted to gauge relative risks or benefits associated with androgen therapy.Item Developing a Strategic Approach to Drive Training Excellence for Clinical Research Professionals(2009-05-01) Ali, Asif J.; Dr. Patricia GwirtzPurpose: To evaluate and assess the current training models in relation to the core knowledge and skills requirements for clinical professionals specifically of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). Hypothesis: Current training of CRAs and CRCs is inadequate due to a number of reasons. Teaching core necessary research skills is a basic foundation for the development of specific training models for CRAs and CRCs. Design: Study modules and training presentations were created for the purpose of teaching the company’s standard operating procedures (SOP) to MedTrials Employees. Research journal articles were searched for roles of CRAs and CRCs. The data gathered helped identify and analyze training gap seen between research professionals. Results: Roles of CRCs proved to be multiple and varied between sites and trials. CRAs tasks were more stable and mainly involved having expertise in the overall process of clinical trials. However, both positions showed a necessity to improve their current model of training.Item Developmental and Internal Validation of a Mitochondrial DNA Direct Amplification Kit for Forensic Reference Samples(2015-05-01) Alicea-Centeno, Alessandra; Arthur J. Eisenberg; Rhonda Roby; Dixie L. PetersEvaluation of the control region of the mitochondrial genome is a common practice for forensic casework and research purposes. Since no kit is currently commercially available for the amplification of mitochondrial DNA (mtDNA), its sequencing procedure is time-consuming and laborious. Six steps are generally followed: DNA extraction, quantification and normalization, amplification of two regions (hypervariable regions 1 and 2), cycle sequencing, capillary electrophoresis and data analysis. This project evaluated a mtDNA direct amplification kit by performing developmental and internal validations. The studies performed included sensitivity, stability, reproducibility, case- type samples, mixtures and accuracy. The mtDNA direct amplification kit successfully amplified reference samples used in each study without the need of extraction and quantification steps. In addition, mtDNA profiles were obtained from the sequenced amplification products. Using the validated direct amplification procedure in the laboratory will improve workflow, decrease operational cost and reduce the possibility of error by minimizing sample handling.Item Ergonomic Efficiency Field Evaluation of the C-03-35 Intraocular Lens Delivery System(2004-05-01) Kajtoch, Michael; Gwirtz, Patricia A.; Bens, Annita V.; Hileman, KendraObjective: The purpose of this post-market clinical investigation is to validate the ergonomic efficiency of the C-03-35 Intraocular Delivery System following cataract removal by phacoemulsification. The C-O-35 Delivery System is a newly approved device developed by Alcon Laboratories, Inc, which allows the delivery of the ACRYSOF Model SA60AS soft acrylic intraocular lens in a sterile, single-use and disposable unit that combines the hand piece plus the ACRYSOF intraocular lens-contained cartridge in an integrated system. This system is somewhat different from the predecessor MONARCH II Delivery System, which requires the surgeon to correctly insert the ACRYSOF intraocular lens into a cartridge and then assemble the cartridge into a reusable hand piece. The C-03-35 Delivery System eliminates these steps; therefore, it should decrease the risk of damage that may occur to the optic or the haptic as well as reducing surgery time. Materials and Methods: This study is an open label ergonomic assessment of the C-03-35 Delivery System that will be completed after the operative visit (performed on one eye only) of 120 patients by up to twelve investigators. The investigators will enroll patients requiring cataract extraction with intraocular lens implantation into the study that meet predetermined inclusion/exclusion criteria. Data Collection and Analysis: Upon concluding the surgical procedure, the investigator will complete a series of Case Report Forms consisting of questions assessing the ergonomic efficiency of the C-03-35 Delivery System. The Case Report Forms will comprise of questions regarding the optic and haptic placement, ease of use, as well as any adverse events that might have occurred. In addition, the investigator will complete an Exit Case Report Form once the patient concludes the study, is discontinued from the study, or if the patient fails to attend the follow-up visits. The required C-03-35 Case Report Form examination schedule is included in Appendix C. The information obtained from the Case Report Forms will then be entered into a clinical database. The safety information will be analyzed by the Biostatics Department by comparing the safety data obtained from the field evaluation to the Federal Food and Drug Administration’s standards called the FDA Grid of Historical Controls. The FDA Historical Grid provides pharmaceutical companies with performance guidelines by which the investigational test article is measured. In the case of intraocular lenses, the FDA Historical Grid provides standards for overall visual acuity (%20/40), best-case visual acuity (%20/40), and adverse events. Only adverse events will be compared to the FDA Historical Grid and analyzed for this field evaluation. The visual acuity parameters of the intraocular lens will not be analyzed in this study, since the C-03-35 Delivery System uses a FDA approved ACRYSOF Model SA60AS lens with established performance. In addition, the ergonomic efficiency questions such as ease of use will be summarized into a table. Although not currently on the protocol of the study, this information may also be further compared against the MONARCH II Delivery System analysis results, since safety as well as ergonomic efficiency data were also collected during that study. The FDA Grid of Historical Controls is included in Appendix D.Item Evaluating Noise and the Implications of Methodology in the Analytical Threshold Designation for Forensic Genetic Analysis(2015-08-01) Malone, Ashley N.; Joseph E. Warren; John V. Planz; Raghu R. KrishnamoorthyIt is common in the forensic science community to have standardization and uniformity in all laboratory processes. The method for the determination of a minimum detection threshold or synonymously an analytical threshold for genetic analysis is not uniform across forensic labs. Variation amongst the methods in DNA testing by forensic laboratories leads to variations in the results of the DNA testing. The results of this study show a method using DNA sample types versus non-DNA sample types will better reflect the effects of baseline noise that may be encountered in forensic casework samples. In addition, there is a need for a calculation method to be designated as an appropriate tool in determining analytical thresholds. More studies on baseline noise and methods in distinguishing analytical thresholds will help in the determination of the most appropriate calculation method to be used across all forensic laboratories.Item Evaluation of the Systematic Clinical Trials Protocol Approval Process at a Matrix Cancer Center(2007-11-01) Bloomer, Tyler; Patricia Gwirtz; Rusty Reeves; Lynn BakerThe National Cancer Institute (NCI) estimates that approximately 555,550 people die of cancer each year in the United States. This is an average of a little more than 1,500 people per days and ranks cancer as the second leading cause of death behind heart disease. In 2007, an astonishing 1,444,920 new cancer cases are anticipated to be diagnosed. It is through scientific research and the necessary employment of clinical trials that advanced are made to fight this dreadful disease. A breakthrough or advancement made in the treatment of cancer begins with basic research of cells and tissues in the laboratory. Once a particular treatment or technique is developed, and proven to be successful in animal models, it can then be evaluated in people through clinical trials. Clinical trials follow a rigorous scientific process to answer specific questions relating to the new newly developed therapy or technique. A clinical trial is the only mechanism to determine the true effectiveness of a promising new therapeutic being investigated. Thus, any unnecessary delays in approving a clinical trial protocol increases the time before that trial can begin enrolling patients and therefore gain approval for new treatment options. The International Conference of Harmonization Good Clinical Practice (ICH GCP) guidance document defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.” The ICH GCP further goes on to describe that the protocol gives the rationale and background for a trial. The World Health Organization’s (WHO) Handbook for Good Clinical Research Practice states that “the study protocol is the core document communicating trial requirements to all parties who have responsibility to all parties who have responsibility for approval, conduct, oversight, and analysis of the research.” Thus, before any trial can begin accruing patients, its protocol, along with a study’s informed consent, must be thoroughly reviewed and approved by a network of entities to ensure that a study’s protocol outlines a trial that is safe and effective. A recent study conducted at the Vanderbilt-Ingram Cancer Center (VICC) and at a VICC Affiliate Network (VICCAN) sites indicated that two particular processes took longer than all others involved in their clinical trial protocol approval process. These two particular processes were the Scientific Review Committee review process and the Contracts and Grants approval process. This was contrary to what the authors expected, in that, they believed the IRB review and approval process would take the longest. Many of the challenges reported by the authors of the study at the VICC parallel those encountered in the protocol approval process at UT Southwestern. A closer examination of these parameters is needed. The Harold C. Simmons Comprehensive Cancer Center (SCCC) at UT Southwestern Medical Center is a matrix cancer center and relies upon the interactions between other institutions and departments to conduct all phases of its cancer research. Thus, the process involved in approving a clinical trial protocol also rely upon the interactions between other institutions and departments. This is where many challenges and various institutional administrative barriers arise. Therefore, it is the goal of this practicum report to formally evaluate and document the protocol approval process at the SCCC at UT Southwestern. The report will also identify unwarranted time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in approving a study protocol are consistent with approval processes encountered at other institutions and academic health center settings like the Vanderbilt-Ingram Cancer Center and the Simmons Comprehensive Cancer Center.Item Gaining New Insights on Improving the Current System of Institutional Review Boards Research Site Interaction: A Novel Approach(2008-05-01) Bangalore, Kiran; Harold SheedloThe debate on the flaws and challenges faced by the Institutional Review Board (IRB) has been going on from its inception. The Office of Inspector General (OIG) in the department of Health and Human Services along with the FDA have reported on the current situation calling upon experts to find solutions to the laborious and inefficient human subject protection protocol review system. In spite of the emergence of thousands of IRB' s and newer proposed models of review systems, the current system still remains inefficient. This is a problem faced in all countries and there is an overwhelming need for an efficient, ethically equipped, and standard system to review, regulate and monitor clinical research. A national standardized clinical research review board (CRRB) would enable in safely securing research and its subjects and advance science and ethics.Item HIPAA's Effect on Patient Enrollment in Clinical Trials(2002-08-01) Ommani, Sophia J.; Kaman, Robert; Arredondo, LaChelle; Bens, Annita V.Ommani, Sophia J., HIPAA’s Effect on Patient Enrollment in Clinical Trials. Master of Medical Science, August, 2002, pp. 88, 10 tables, 11 figures, references, 34 titles. The new regulation disseminated under the Health Insurance Portability and Accountability Act may impose serious restrictions as to how medical information can be used and disclosed. The law’s basic provisions began to take effect in 1997 with three principles: 1) to make it possible for people to get coverage even when they have past or present medical conditions/health factors, 2) to help people maintain the coverage needed when changing insurance or jobs, and 3) to make insurance more accessible for those who work in small businesses. A separate provision in the law imposes strict regulations on the privacy and security or patient health information. This provision has created the need to conduct research on the impact that this will have on a variety of health care issues. While some clinical practice research may be conducted without information linked to medical records, other research relies on personal identifiers to track treatment of an individual over time or link multiple sources of patient information. A randomized study was conducted to test the hypothesis that HIPAA would effect patient enrollment in clinical trials, and results supported the hypothesis. A lack of 1) willingness to authorize release of medical information and 2) a lack of understanding of the informed consent with the HIPAA language were the two predominant reasons given for refusing to sign.Item Identifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center(2008-12-01) Hatfield, ElishaOver the decades, clinical research has grown and evolved into what one would consider now as the cornerstone of medical advancement. Through the use of clinical trials, new and improved prevention and treatments continue to be discovered. These trials are not only an essential part of the process of drug discovery and development, but are required for drug approval. Conducting these clinical trials takes diligent cooperation between the pharmaceutical industry, government agencies, investigators, and academic medical centers (AMC’s). With the implementation of new regulations as well as continual changes to policies and procedures overseeing clinical research, management of such trials has become a very meticulous and a lengthy process. Additionally, escalating costs of drug development and an increased need for new treatments in the market at faster rates have made the need for more effective and productive means of conducting clinical trials a priority for competitive research sites. With the landscape of clinical research constantly evolving, adaptation of study management and procedures is a continuous hurdle that clinical research sites must overcome. Changes in regulations, limitations of funds and the need for more effective subject recruitment methods are all barriers that most AMC’s are facing today. Finding ways to overcome these obstacles is an essential part of conducting effective and productive clinical trials. In order to keep up with this change and maintain a high quality of research, continual review and audit of current research standards and procedures has become a necessity. Review of standard operating procedures and study documentation can help identify barriers which inhibit the process and initiate appropriate modifications in order to maintain efficient and effective study trials. As such, for this Internship Practicum Project, the intern reviewed the standard procedures and monitored clinical studies with the Gastrointestinal Disease Oriented Team (GI DOT) in an attempt to identify barriers affecting the overall productivity and efficiency of the team. Once these barriers had been outlined, recommendations for changes in standard procedures were made in order to help improve the functionality of the GI DOT and, subsequently, enhance the success of GI protocols within the Simmons Cancer Center Clinical Research Office.Item Identifying barriers to enrollment and strategies to increase enrollment at a community-based cancer treatment center(2014-05-01) Gokul, Sheila R.; Ladislav DoryAlthough clinical trials are essential for the development of cancer treatments, only approximately 3% of cancer patients in the U.S. participate in them. While 55% of these patients are enrolled in cancer clinical trials through community-based practices and around 80% of all cancer patients are seen at this type of practice, there is a lack of knowledge about the enrollment barriers at these sites. This study evaluates enrollment barriers at a community-based cancer clinic at the levels of the investigative site, healthcare provider, and patient. Barriers to enrollment and strategies to increase enrollment are evaluated through historical data analyses and results from a survey assessing the opinions of healthcare providers on enrollment and research practices.Item Inhibitory Rib-Raising and Microneurographic Measurement of Sympathetic Nervous System Activity(2007-05-01) Kinzler, Damien W.; Michael Smith; Russell Gamber; Hollis KingThe clinical effectiveness of osteopathic manipulative therapy (OMT) techniques that are designed to address the autonomic nervous system (ANS) are untested to current research standards. As the concept of “autonomic imbalance” is frequently ascribed as the etiology of various pathologic conditions, it is paramount to undertake basic research into not only efficacy but also possible mechanistic actions and origins. Osteopathic physicians often utilize treatment regimens and techniques for which the given mechanism of action is simply attributed to “balancing the autonomics”. This intuitive concept may finally be at the threshold where enough basic science exists to justify clinical investigations. Osteopathic manual manipulative techniques have shown effectiveness in the treatment of various musculoskeletal conditions and have been shown to lower perceived pain; supporting the use of manual therapy as an effective treatment modality. A brief review yields the following within just the last four years: Eisenhart showed positive range-of-motion outcomes after ankle sprain in the emergency department. Biondi reviews the usefulness of cervical manipulation for tension headache and McReynolds demonstrated an equivalent decrease in acute neck with OMT versus intramuscular ketolac in an emergency department setting, although the dosing was not maximal. German researchers have shown effectiveness in chronic epicondylopathia humeri radialis and research has led to the demonstration of lowered post-operative pain in hip or knee arthroplasty. There has also been decreased post-operative pain medication reported in hysterectomy when compared with a control group. OMT has demonstrated a decrease in fibromyalgia symptoms when used with standard care over standard care alone. Low back pain, perhaps the most extensively studied diagnosis in which OMT has been evaluated, has reported numerous positive outcomes including lower levels of narcotic use and decreased pain in both double-blinded and meta-analysis studies, although there is still considerable debate within this area. There has also been favorable outcomes associated with the management of gain in Parkinson’s disease and preliminary work has shown the efficacy in treatment of carpal tunnel syndrome. Most of the aforementioned musculoskeletal conditions are not amenable to traditional therapies and have a high-cost burden on the economy. Traditional treatments generally have a “wait and see” approach combined with analgesics which may not cause harm, but hampers quality of life and income in the interim. The cost effectiveness of OMT is still in the preliminary stages, but there is evidence supporting a superior cost benefit ratio when compared to standard care and since many of these conditions have no other proven treatment modality available patients will often try anything over nothing. The evaluation of OMT addressing clear autonomic dysfunction is limited. This study closes a small part of that gap by examining the proposed physiologic mechanism of OMT and its’ interaction with the ANS. Small studies have documented changes, namely heart rate variability, in autonomic processes in healthy individuals while other, older studies have found benefit in clinical variables. With few exceptions however, most of these studies lacked a particular technique protocol. Operators were free to use whatever intervention that they chose and most of these studies were not performed under rigorous testing methods with a randomized design. The technique that was evaluated (inhibitory rib-raising) has a documented history from the origins of osteopathic medicine in the United States, and is currently taught to students in osteopathic medical schools as part of their medical education curriculum. Rib-raising is most often taught to enhance the mechanical motion of the ribs, but other paradigms utilize this technique to either enhance or inhibit sympathetic nervous system (SNS) activity. The evaluation of inhibitory rib-raising or its’ proposed mechanism of action has never been rigorously scrutinized to modern scientific standards. The current study was designed to address that gap with both direct and indirect measurement of SNS variable in healthy individuals with the hypothesis that there would be a time-dependent, graded reduction in measured sympathetic nervous system activity (MSNA) in healthy individuals undergoing cold-pressor stimulus.Item Medicare 2005 Demonstration Project: Patient Reporting of Nausea Symptoms and Its Impact on Improving Quality of Patient Care(2006-01-01) Mueller, Brett H.; Rustin Reeves; Ray Page; Walter McConathyFor the completion of the requirements for my Masters degree in clinical research management, I interned under the mentorship of Ray Page, D.O., Ph.D., at the Center for Cancer and Blood Disorders. While at this site, I worked on completing my retrospective chart review research project while also gaining clinical exposure in medical and radiation oncology, observing different aspects of running and managing a medical practice, and learning how to run and manage clinical trials as a future principal investigator. The focus of my internship practicum was to analyze the effectiveness of the 2005 Oncology Demonstration Project. One-hundred thirty three patient charts were identified for this study because as some point during the 2005 year, the patient reported serious symptoms of nausea and vomiting. Over 5,000 patient notes that were documented during the 2005 year were reviewed for the one-hundred and thirty three patient population. Substantial data was collected regarding the ability of the clinicians’ and nurses’ effectiveness in administering nausea and vomiting care with, and without, the 2005 Oncology Demonstration Project. Additional activities during this internship includes shadowing DR. Page, shadowing and learning from the clinical coordinators at the Center, assisting the clinical manager with regulatory binder filling, protocol review, creating a study budget, and participating in, and helping in many other facets of clinical research carried out at the Center for Cancer and Blood Disorders.Item Physical and Biochemical Factors Affecting the Recovery and Analysis of DNA from Human Skeletal Remains(2014-12-01) Combs, Laura Gaydosh; Joseph E. Warren; Rhonda Roby; Teresa D. GoldenThere are approximately 4,400 sets of unidentified human remains recovered each year, nearly a quarter of which are not identified within the year following recovery. Obtaining genetic information through DNA testing of bone samples has become a critical element to identifying missing persons and recovered human remains. DNA is preserved within the structure of bone for vast amounts of time, surviving environmental and microbial insults, yet bone is one the most challenging sample types encountered by forensic scientists. This is due to the resilient structure of bone and the prevalence and variety of materials which co-isolate with DNA during extraction and function as inhibitors of the polymerase chain reaction (PCR). Bone-associated PCR inhibitors include native components and environmental materials, acquired as a consequence of the porous composition of bone. Quality assurance requirements governing DNA testing laboratories do not mandate direct evaluation of the product of the DNA extraction process; coupled with poor characterization of PCR inhibitors, the forensic community has not adequately demonstrated the efficiency of methods used to extract DNA from bone samples. The primary hypothesis is failure of PCR-based testing of DNA from skeletal remains is frequently encountered due to inefficient extraction methods and PCR inhibition. This dissertation project has: 1) demonstrated an approach for identifying and characterizing putative PCR inhibitors, emphasizing those originating from the mineral contents of bone; and, 2) assessed the efficiency of current methods used for extracting DNA from bone samples, in terms of quality and quantity of the recovered template. Control genomic DNA, bone samples from adjudicated forensic cases obtained from the University of North Texas Center for Human Identification, and cadaver bone samples obtained from the Willed Body Program at University of North Texas Health Science Center were used for experiments. Laboratory experiments included: DNA extraction, analysis of DNA fragmentation, quantification of DNA, amplification of short tandem repeat (STR) forensic loci, genetic analysis, and elemental analyses that were conducted in collaboration with the University of North Texas Department of Chemistry and Forensic Science Program.Item Presentation of a Sample Case Studies from a Phase 4 Clinical Trial, "Communit-Based Research Assessment Investigating Clobetasol Proplonate 0.05% Spray for the Treatment of Chronic Plaque Psorias - The COBRA Trial"(2008-03-01) Kulkarni, Gopal; Gwritz, Patricia A.; Colon, Luz E.; Johnson, Lori A.Internship Project. Title of the Project. Presentation of Sample Case Studies from phase 4 clinical trial, “Community-Based Research Assessment Investigating Clobetasol Propionate 0.05% Spray for the Treatment of Chronic Plaque Psoriasis- the COBRA trial” Specific Aims. The specific aims of the practicum were to: 1) Select 50 subjects who had photographs available from the Data Listing (database) of the COBRA trial subjects; 2) Collect data for each case from the database provided; 3) Classify the collected data into efficacy, safety, subject satisfaction, compliance and quality of life evaluations; 4) Generate a presentation (slide kit) of the selected case studies for educational and training purposes. Signficance. Case study presentations are a tool to demonstrate the performance of a drug used in a clinical trial. Due to the large scale of the COBRA trial, there was to a need to generate a reference presentation using data belonging to a sample of subjects from the trial. This reference presentation may be useful for educational and training purposes. This chapter describes the process of development of these case study presentations from the data obtained in the COBRA trial.Item Project Management in View of Increasing Sponsor Demands(2006-04-01) Kurschner, Jill Elizabeth; Bens, Annita V.; Kaman, Robert; Arredondo, LaChelleKurschner, Jill E., Project Management in View of Increasing Sponsor Demands. Masters of Clinical Research Management (Biomedical Sciences), April, 2006, 190 pp., 24 tables, bibliography, 27 titles. In an ever increasing environment of Sponsor demands, it is imperative that Contract Research Organizations (CROs) like Company A, provide a niche in which they deliver a clinical trial-related service which is faster, less expensive, and more ingenious than their competitors while still in compliance with federal regulations. Successful project management practices, specifically trial progress tracking tools, are the avenue by which this goal can be achieved. As part of the internship practicum project, two company-wide questionnaires were disseminated to 34 applicable clinical operations employees at Company A. Questionnaire #1 was developed to assess employees’ global views of clinical trial progress tracking. Questionnaire #2 was designed based on the results received from Questionnaire #1. This questionnaire surveyed employees’ ideas and opinions regarding standardization of 5 specific trial progress tracking tools at Company A. Information gathered from the questionnaires will potentially Company A with the implementation of additional standardized trial progress tracking tools.Item Regulation of Carotid Baroreflex Resetting During Arm Exercise(1999-06-01) Querry, Ross G.; Peter B. Raven; Patricia Gwirtz; Michael SmithQuerry, Ross G., Regulation of Carotid Baroreflex Resetting during Arm Exercise. Doctor of Philosophy (Biomedical Sciences), June 1999, 100 pp., 4 tables, 12 figures, bibliography, 56 titles. Cardiovascular responses to exercise are modulated by the integration of the central nervous system and afferent information from arterial baroreflexes and working skeletal muscle. Investigations have shown that during exercise, the carotid baroreflex (CBR) is reset in proportion to the exercise intensity. The role of the central nervous system contribution to the CBR resetting has not been elucidated. Investigations of CBR function in the animal model consistently report CBR variables such as maximal gain that are different than those reported in humans. These discrepancies may be due in part to methodological limitations in the neck pressure/neck suction (NP-NS) technique used to investigate the isolated CBR function in humans. To accurately examine the internal stimulus from the NP-NS maneuver, subjects were instrumented with a percutaneous catheter to record tissue pressure at the carotid sinus during five-second and rapid pulse NP-NS protocols. Carotid baroreflex function curves were analyzed with and without transmission correction of the carotid sinus pressure (CSP). Results indicated that positive pressure was more fully transmitted (~83%) than negative pressure (~65%) during the five-second-pulse, but not the rapid pulse protocol. Correction of the CSP in either protocol resulted in significant increases in CBR maximal gain and threshold and a reduced saturation pressure. These methodological refinements were then utilized to investigate the role of central command on CBR function during exercise. Subjects performed static and rhythmic handgrip exercise before and after regional anesthesia. Carotid baroreflex curves were analyzed at rest and during exercise before and after blockade at the same absolute workload. Muscle weakness from the blockade required an increased effort to maintain control tension. Heart rate, arterial pressure and perceived exertion during exercise were increased following blockade. During control exercise the CBR function curves were reset upward and rightward compared to rest with a further parallel shift during exercise with blockade. The operating point of the CBR was reset along with the centering point, but did not show the divergence toward the threshold pressure that had been previously described during dynamic exercise. The results support the proposal that central command was a primary mechanism for the resetting of the carotid baroreflex during exercise, but may not be the primary mechanism in the resetting of the operating point of the reflex.