Browsing by Subject "UNTHSC"
Now showing 1 - 20 of 62
- Results Per Page
- Sort Options
Item Clinical Internship in the Surgery Department at the University of North Texas Health Science Center: Assessment of Human Antibody Response to Urokinase Part A: Specimin Acquisition Trial for the Assessment of Human Antibody Response to Urokinase in Subjects Treated for Acute Lower-Extremity Ischemia(2003-12-01) Hughes, Telicia A.; Rustin E. ReevesSignificance and Specific Aim of the Study. Significance. FDA has informed Abbott Laboratories of additional concerns related to manufacturing deficiencies for urokinase (Abbokinase). Until these problems are corrected, further distribution of Abbokinase would violate federal laws designed to assure the safety of drugs for patient use. FDA’s concerns about the product relate to serious deficiencies in the manufacturing processes, the testing of the product, and the screening and testing of the donors of the kidney cells used to make Abbokinase. Abbokinase is derived from cultures of human kidney cells from newborns who have died of natural causes, and is approved in the United States to dissolve blood clots in the lungs and heart arteries. It is also approved to help clear intravenous catheters. During inspections of Abbott Laboratories and of BioWittaker, Inc. Abbott’s supplier of human kidney cells, FDA identified numerous significant deviations from current good manufacturing practice (CGMP) regulations designed to assure product safety. Compliance with CGMP is important because products manufactured from human sources have the potential to transmit infectious agents. CGMP for products such as Abbokinase requires important, overlapping safeguards in the production process, including adequate –screening of donors and testing of cells, -controls for proper harvesting, storage, and handling of materials used in all stages of manufacturing, and –processes to remove or inactivate infectious agents from the product. Over the past several months, the firm has reported to FDA that a number of in-process lots of Abbokinase was contained with microorganisms. Six such lots were found to contain various strains of reovirus, a virus that usually results in no symptoms or causes minor respiratory or gastrointestinal symptoms. Association of reovirus infection with other human diseases have been reported, although a causal link has not been established. Another in-process lot was contaminated with mycoplasma, a microorganism that can cause respiratory infections, and, on rare occasions, other infections that may be serious. Abbott has assured FDA that none of these in-process lots were manufactured into final product or distributed. These recent findings of contamination and Abbott’s inability to locate the source of the problem have raised further concerns at FDA about Abbott’s entire manufacturing process for Abbokinase. Abbot’s deviations from CGMP could significantly impact the safety of the product. One FDA concern is that deficiencies in manufacturing practices could also lead to the product being contaminated with microorganisms that have not yet been detected. FDA also obtained additional information regarding the inadequacy of the screening and testing of the mothers and donors of the human kidney cells used to produce Abbokinase. Information was also obtained regarding the seven instances of in-process lots of product being contaminated with reovirus and mycoplasma. In the letter to Abbott, the agency has detailed the steps Abbott needs to take to correct the serious and significant manufacturing deviations. These include: -completing a thorough and adequate investigation of the reovirus and mycoplasma contamination, including the source of the contamination, -manufacturing Abbokinase using human kidney cells that have been obtained, processed, and tested through adequate methods, and –assuring that fully validated methods are used in the manufacturing process to test for infectious agents and remove them. Abbott submitted a supplemental new drug application providing for changes in procurement and processing of neonatal kidney cells, improvements in the manufacture and testing of the drug substance and drug product, revised release specifications for the drug substance and drug product, revised release specifications for the drug substance and drug product, a revised CBER lot release protocol, withdrawal of the “Open-Cath” dosage strengths, and revised labeling. Labeling revisions include updated information regarding product source and adverse reactions, as well as withdrawal of the coronary artery thrombosis and catheter clearance indication. The Department of Health and Human Services completed the review of that supplemental application, as amended, and it was approved based on Abbott’s written commitments, one of which is –To conduct a study to assess the immunogenicity of Urokinase after primary dosing. Urokinase is indicated in adults for the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments for the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures. Therefore, it is important to complete this study, to meet federal requirements, so that Urokinase could be fully marketed and help to improve the quality of life. Specific Aim. 1. To access the human antibody response to Urokinase, a thrombolytic agent in subjects treated for lower extremity ischemia. A.) Technique: All subjects will receive an intra-arterial infusion of a minimum of 240,000 IU of Urokinase (UK). In part A of this study we will obtain serum specimens from subjects receiving UK. These blood specimens will be used in part B of this study for the qualitative/quantitative assessment of antibody response to Urokinase, specifically IgM, IgE, IgG. Antibody directed against the UK drug substance, API, and the inactive peptides/protein in the formulation.Item Development of the Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): Preliminary Results(2002-05-01) Russo, David P.Russo, David P., Development of the Attitudes Toward Osteopathic Principles and Practice Scale (ATOPPS): Preliminary Results. Master of Public Health, May 2002, 11 pp., 2 tables, bibliography, 19 titles. Little is known about how student attitudes toward osteopathic principles and practice (OPP) develop and evolve over the course of their osteopathic medical education. Interviews were conducted with osteopathic medical students, osteopathic manipulative medicine (OMM) residents, fellows, and physician specialists. These interviews were summarized in a 39-item instrument administered to 127 students at the completion of their core OMM rotation at UNTHSC-TCOM. Factor analysis of student responses to the 39 candidate items yielded two interpretable factors. 14 of the original 39 statements were eliminated and the smaller second factor was dropped. Factor 1 contained items reflecting both positive and negative attitudes toward the application OPP in patient care, medical education, and professional distinctiveness. Two internal consistency estimates of reliability were computer for the revised 25-item ATOPPS. Estimates for the split-half coefficients for part 1 were .89, for part 2 was .87; the Spearman-Brown coefficient alpha was .93Item Does Osteopathic Manipulative Treatment Improve Dyspnea and Exercise Tolerance Subjects with Stable Chronic Obstructive Pulmonary Disease?(2006-05-01) Pickett, Carolyn M.; Stoll, Scott; Cruser, des Anges; Licciardone, John C.Pickett, Carolyn M., D.O., M.S. Does Osteopathic Manipulative Treatment Improve Dyspnea and Exercise Tolerance in Subjects with Stable Chronic Obstructive Pulmonary Disease? Master of Science (Clinical Research and Education – OMM), May 2006, 54 pages, 10 tables, 4 figures, references 48 titles. Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death globally and is projected to increase. This highly prevalent and costly disease causes reduced physical and social functioning, and none of the existing medications for COPD seem to modify long-term decline in lung function. COPD patients with the severe dyspnea have more deficits in the health status and energy. Reduced functional status has been significantly correlated with health related quality of life. Osteopathic Manipulative Treatment (OMT) has been suggested for treatment of COPD as early as 1902, some research indicates that OMT may improve dyspnea and exercise tolerance, yet there are few published studies on OMT and COPD. Study goals were to increase scientific knowledge about how OMT may immediately improve dyspnea and exercise tolerance in stable COPD following exertion. This RCT was approved by the Institutional Review Board at the University of North Texas Health Science Center (UNTHSC) in Fort Worth and funded by the Osteopathic Research Center (ORC) at UNTHSC. –Hypothesis 1: A single intervention of OMT will improve dyspnea in a stable COPD subject, as measured by response to the Borg scale with exertion, when compared to no treatment. –Hypothesis: a single intervention of OMT will improve exercise tolerance in a stable COPD subject, as measured by distance walked during the six-minute walk test, when compared to no treatment. Twenty-one subjects completed the trial, 10 in the OMT group and 11 in the no-treatment group. No significant differences were found in the Borg scale or 6MWT following OMT. This study is limited by a small sample size and single OMT intervention design; however, it does demonstrate the feasibility of this research at this institution and may lead to a larger, more definitive and funded clinical trial.Item Medical Students' Knowledge of and Attitudes About Complementary and Alternative Medicine Before and After an Integrated Clinical Experience Learning Module(2003-05-01) Stupski, Bernard A.; Scott Stoll; Muriel Marshall; Russell GamberStupski, Bernard A., Medical Students’ Knowledge of and Attitudes about Complementary and Alternative Medicine before and after an Integrated Clinical Experience Learning Module, Master of Science, May 2003, 2 pp., 2 tables, bibliography, 13 titles. Background: Complementary and Alternative Medicine (CAM) is an important health care trend that is drawing increasing attention from medical schools. An educational program, the Integrated Clinical Experience (ICE), was instituted at the Texas College of Osteopathic Medicine to address CAM for second year medical students. Methods: A thirty-five question survey developed to measure the students’ knowledge of and attitudes about CAM was given at the beginning and end of the ICE week. Results: Students had significantly more knowledge about CAM prevalence following the ICE week. Students perceived greater efficacy and relevance in education for certain CAM modalities and felt more likely to incorporate CAM into their clinical practice and use CAM for self care.Item Novel Methods for Processing Biological Samples Stored Onto FTA® Paper(2003-05-01) Aranda, Xavier G.; Arthur J. Eisenberg; Rafael Alvarez; John PlanzAranda, Xavier G., Novel Methods for Processing Samples Stored Onto FTA® Paper. Masters of Science (Biomedical Sciences), May, 2003, 76 pp., 10 tables, 17 illustrations, bibliography, 30 titles. The goal was to develop methodologies to facilitate the processing of samples stored on FTA® paper for paternity and forensic testing. The research was divided into three major areas. The first was an evaluation of the stability of the different FTA® matrices, and the development of a process which would maximize the amount of genetic information that could be obtained from a single 1.2 mm FTA® punch. The second was the development of a process for the efficient elution of the DNA trapped within the FTA® matrix. This would facilitate the use of FTA® technology with high throughput robotic processing systems. The third was the development of methodologies which would allow the integration of FTA® technology with a non-invasive buccal swab collection process. The methods developed from these studies are now used in the DNA Identity Laboratory at UNTHSC and many other laboratories throughout the world for routine casework analysis.Item Physician Assistant Studies Catalog 1998-1999(1998-01-01)Item Physician Assistant Studies Catalog 1999-2000(1999-01-01)Item Physiologic and Anatomic Changes in Carpal Tunnel Syndrome: Is Osteopathic Manipulative Treatment an Effective Non-Surgical Alternative Therapy?(2005-05-01) White, Heath D.; Williams, Stuart; Cruser, des Anges; Stoll, ScottWhite, Heath D., D.O., M.S. Physiologic and Anatomic Changes in Carpal Tunnel Syndrome: Is Osteopathic Manipulative Treatment an Effective Non-surgical Alternative Therapy? Master of Science (Clinical Research and Education – OMM), May 2005, 110 pp., 4 tables, 5 figures, references, 46 titles. Objective: Carpal tunnel syndrome (CTS), caused by compression of the median nerve within the carpal tunnel, has a prevalence that ranges between 0.53 and 16.3 with medical costs exceeding $2 billion annually. The goal of this clinical trial was to assess for physiologic and anatomic changes in CTS in response to OMT. Physiologic changes were measured with nerve conduction studies (NCS). Anatomic changes were measured with magnetic resonance imaging. Methods: This prospective, randomized, controlled, blinded clinical trial phased to evaluate 50 subjects randomized between two treatment groups, OMT and placebo sub-therapeutic ultrasound. Eligibility criteria included adults between 21 and 70 with a clinical diagnosis of CTS and increased conduction latency of the median nerve. Outcome measures were median motor and sensory conduction distal latencies. Subjects received six treatments. NCS were conducted at entry to the study (baseline), midpoint, and endpoint. Results: Thirty-seven of a planned 50 subjects were randomized to groups. Thirty-one subjects were included in the final data analysis. Preliminary analysis found no significant difference in NCS values over the three testing intervals. Evaluation for effect(s) of multiple treatment providers by analyzing the single treatment provider with the greatest number of subjects found significant improvement in some NCS values for the OMT group. This study was funded by the Osteopathic Research Center, and approved by the UNTHSC Institutional Review Board. Conclusions: The results of this preliminary analysis indicate the possibility for improvement of CTS with OMT, but no conclusive statements about the efficacy of OMT can be made. This preliminary study enabled us to identify multiple areas in the research design and methodology that may be improved, and provides the framework for future studies.Item Safety and Efficacy of a Novel Xanthine Oxidase/Xanthine Dehydrogenase Inhibitor in the Treatment of Gout(2003-12-01) Brooks, Molly; Rudick, Victoria; Forman, Mitchell; Jimenez-Williams, CynthiaSummary: The internship report is based on the activities completed during the Internship Practicum at the Department of Internal Medicine, Division of Rheumatology, at the University of North Texas Health Science Center at Fort Worth and at the Rheumatology Clinic at John Peter Smith Hospital. This internship serves as partial training in the area of Clinical Research Management and focuses on studies involving rheumatic diseases, with specific emphasis on Gout. Specific Aims/Hypothesis: Ongoing clinical trials in the Department of Internal Medicine Rheumatology clinic are the bases for the project which focuses on the treatment of gout and a proprietary study on the uses of a novel xanthine oxidase/ xanthine dehydrogenase inhibitor (XOD/XDH inhibitor) to relieve the symptoms of gout. The particular research is a phase three study to assess the safety and efficacy of a novel xanthine oxidase/ xanthine dehydrogenase inhibitor compared to a placebo and an established xanthine oxidase/ xanthine dehydrogenase inhibitor, allopurinol. The hypothesis of the study is that the new XOD/XDH inhibitor will be more effective at lowering uric acid levels and thus will reduce the frequency of gout more effectively and with fewer side effects than traditional treatment or a placebo. Under the direction of the Department of Internal Medicine, subjects who met inclusion/exclusion criteria of the study were randomly assigned to be treated with colchicine in addition to either allopurinol, or the novel compound, which hereafter will be referred to as the novel XOD/XDH inhibitor, or to a placebo. The safety and efficacy of the novel XOD/XDH inhibitor will be compared to the traditional drug of choice allopurinol, a uric acid lowering agent, and to a placebo. The placebo is an inactive pill that is designed to look and taste like either allopurinol or the novel XOD/XDH inhibitor. While the period of the internship is not long enough to complete the study and thereby assess the reliability of the hypothesis, the internship and this report have two specific aims: (1) to perform a literature search of gout and related topics and (2) to understand and perform activities of a clinical research coordinator as they relate to the novel XOD/XDH inhibitor study and to other clinical trials in rheumatology. The literature search focuses on specific areas concerned with details about gout: history, epidemiology, forms, causes, signs and symptoms, clinical diagnosis, differential diagnosis, complications, therapeutics (past, present, and future), prevention, associations, cellular mechanisms involved in hyperuricemia, as well as inflammation. The project also provides a description of the activities involved in clinical research, and discusses specifically the roles of the various personnel: Clinical Trials Coordinator, Principle Investigator, Sub-investigator, Institutional Review Board, and Clinical Trials Monitor as they have been involved in the novel XOD/XDH inhibitor study and other studies in rheumatology. Significance: Finding a new treatment for gout is of significant importance for several reasons. In countries with a high standard of living, such as the United States, prevalence of gout has increased and is probably the second most common form of inflammatory arthritis. Gout can result in significant short-term disability, occupational limitations, and increased utilization of medical services therefore making the disease a significant public health problem. New treatment options could greatly improve the prognosis for patients and in addition reduce the cost of the disease by preventing loss of wages due to patient absence from work, for example. Furthermore, new treatments for gout could provide patients with safer therapeutics alternatives than the traditional treatments.