Browsing by Subject "Pharmacy and Pharmaceutical Sciences"
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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 Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection(2004-11-01) Lemp, Jessie; Patricia Gwirtz; Walter McConathy; Richard EasomLemp, Jessie M. A Study of the Effectiveness and Tolerability of Weekly Rifapentine/Isoniazid for Three Months Versus Daily Isoniazid for Nine Months for the Treatment of Latent Tuberculosis Infection. Master of Science, November, 2004, 107 pp., 4 tables, 4 figures, references, 29 titles. The standard treatment for latent tuberculosis infection, nine months of daily isoniazid, is effective at preventing active tuberculosis; however, its full benefits are limited by non-adherence. A shorter intermittent regimen of rifapentine plus isoniazid once weekly for three months is equally effective as the standard regimen in animal models. This regimen facilitates the use of directly observed therapy, a method that significantly improves adherence. The Center for Disease Control is sponsoring Study 26 to test the effectiveness and tolerability the three-month rifapentine based regimen in latently infected persons with risk factors for progression to active tuberculosis. This thesis will describe the background rationale and methods for the clinical trial, and the internship experience.Item An Open-Label Pilot Study Evaluating the Effects of Travoprost on Eyebrow Regrowth Among Patients Undergoing Chemotherapy for Cancer(2005-12-01) Habib, Nausheen; Jamboor Vishwanatha; Harold J. Sheedlo; Michael W. MartinHabib, Nausheen. Master of Science, Biomedical Sciences, December 2005, An Open-Label Pilot Study Evaluating the Effects of Travoprost on Eyebrow Regrowth Among Patients Undergoing Chemotherapy for Cancer. The primary objective of this study is to determine the effect of eyebrow hair growth of a twice daily application of travoprost among patients undergoing chemotherapy or those who have already completed chemotherapy. Travoprost, used clinically in the treatment of glaucoma, is topically and unilaterally applied to a total of 15 patients to induce eyebrow hair growth. This is an ongoing pilot study in which the screening, treatment and follow-up visits are scheduled on day 0, week 4, week 8, week 12, and week 14. After an eight week treatment period, 69% of the patients demonstrated increased eyebrow density. This increase in eyebrow hair is consistent with travoprost’s ability to prolong the anagen or growing phase of the hair cycle.Item Analysis of the Clinical Research Methodologies Employed During a Phrase Three Efficacy Study for Ultracet as a Post-Herniorrhaphy Analgesic(2001-08-01) Aguilar-Zanatta, Jorge; Rustin Reeves; Don Peska; Della WeisThe history of pain management stems back many thousands of years. However, not until recent times have significant advancements in biochemistry and pharmacology allowed analgesics to be incorporated in clinical interventions and everyday life. Due to these advancement, attempts to refine pharmacological action on receptors in terms of specificity would render medications with fewer side effects. The technology is present, but the application and development of modern analgesics in post-surgical settings is substandard. According to C.L. Ireson and R.W. Schwartz, (2001), the outcomes of ailment interventions in the United States are “…no better and in numerous situations worse that those achieved in other countries,” even though the United States has the most expensive healthcare in the world. Furthermore, a study performed by Carr et al. (1998), has identified the United States as demonstrating consistent inadequacies in postoperative pain management. Several factors have been identified as being contributors of poor post-surgical pain control in America. Lack of awareness of the available strategies in acute pain control and its implementation in post surgical care are labeled as being problematic observations (Puid et al., 2001). In response to these conditions as well as the managed health care time and cost limitations, new and efficacious pharmaceuticals must be made available to a broad spectrum of socio-economic strata. Currently, there is a great debate over the use of laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic herniorrhaphy versus open tension free approaches. In terms of cost, the laparoscopic procedure is more expensive and yields less postoperative pain, however the open tension free approaches are less expensive and yield more postoperative pain (Sarli et al., 2001, Medical Research Council Laparoscopic Groin Hernia Trial Group, 2001, Parviz et al., 1995). There are advantages and disadvantages to both procedures. Assuming that efficacious postoperative analgesics were available, the open tension free repair would be more feasible in terms of cost and hernia recurrence rates (Sarli et al., 2001). In terms of pharmaceutical development, the laws and guidelines by the regulatory agencies such as the Food and Drug Administration, institutional review boards, and pharmaceutical sponsor protocols must be followed. Along with good clinical practice standards, interdisciplinary collaboration in pain studies produce results that are statistically and clinically salient. The patient’s well-being and comfort is the ultimate goal in clinical pain studies and in medicine in general, therefore postoperative pain should be aggressively managed.Item Analyzing the Scientific Debate of Coxibs and The Ethics Impact of Vioxx's Withdrawal on Drug Regulation and an Ongoing Phase III Clinical Trial with a New Cox-2 Inhibitor(2005-11-01) Fu, Jingwei; Gwirtz, Patricia A.; Rubin, Bernard R.; Jiminez-Williams, CynthiaOn September 30, 2004, Merck & Co. Inc announced voluntary withdrawal of its $25 billion blockbuster drug Vioxx from the market, five and a half years after Voixx received FDA approval. This is the largest prescription drug withdrawal in history. Merck made the decision based on the results of APPROVe (Adenomaous Polyp Prevention on Vioxx) clinical trial, which showed that Voixx had an increased risk of myocardial infarction and cerebral vascular stoke compared with placebo. The repercussions of Merck’s action were tremendous from both a financial aspect and an ethical aspect. The recalling of Vioxx has become an important public health issue and has placed drug regulation agencies in controversy. In April, 2005, Pfizer agreed to voluntarily suspend sales and marketing of its COX-2 inhibitor, Bextra in the United States as requested by the FDA. Vioxx and Bextra withdrawal has left a huge impact on the pharmaceutical industry. Debates are ongoing in the scientific community regarding the use of Cox-2 inhibitors and have caused much confusion in the medical community and in those who use these drugs for pain control for osteo- and rheumatoid arthritis disease. The goal of this report is to analyze the impact of Vioxx withdrawal and comment on how to apply this incident in guiding the industry with regards to drug development, drug regulation, and clinical practice in order to ensure the effectiveness in the drug development and safe usage of new pharmaceutical agents.Item Androgens and Cardiovascular Disease(1998-05-01) Dickerman, Rob D.; Walter J. McConathy; Thomas Yorio; Robert GracyDickerman, Rob D., Androgens and Cardiovascular Disease Doctor of Philosophy (Biomedical Sciences), May 1998; 111 pp; 10 tables, bibliography, 197 titles. Anabolic steroids are commonly used by many muscle and strength dependent athletes due to their ability to enhance the hypertrophic effects of resistance training. The use of anabolic steroids by bodybuilders appears to carry significant health risks, most commonly reported are sudden death, myocardial infarction and cardiomyopathy. To investigate the effects of anabolic steroids on cardiovascular risks, a study was designed to analyze the effects of androgens on lipoprotein levels and structure/function of the heart. For the study on lipid-related risk, twelve competitive bodybuilders were recruited for a comprehensive analysis of serum apolipoprotein A-I, B, total cholesterol, HDL-cholesterol, LDL-cholesterol, and testosterone. Serum total cholesterol, HDL- and LDL-cholesterol, apolipoproteins A-I and Be were significantly lower in androgen-users. Consistent with previous reports, androgens were associated with decreases in HDL-cholesterol and apolipoprotein A-I. However, androgens were also associated with reduced serum total cholesterol, LDL-cholesterol and apolipoprotein B. Despite the significantly higher total cholesterol/HDL-cholesterol ratio, the low levels of serum total cholesterol levels (percentile) in the androgen-users raises questions as to whether there is increased risk for cardiovascular disease and the exact role of androgens in cardiovascular risk. To investigate the effects of anabolic steroids in pathologic concentric left ventricular hypertrophy, the effects of androgens on left ventricular size and function were analyzed. Previous investigations conducted on left ventricular size and function have yielded inconclusive results. Problems existing in each of the previous investigations were small body mass, short length of myocardial exposure time to resistance training (years of training), significantly different body mass between steroid-users and steroid-free subjects and monitoring/reporting of steroid use. These problems may have contributed to the discrepancies between studies. Therefore, we selectively recruited eight competitive heavy weight drug-free bodybuilders and eight matched competitive weight bodybuilders on self-directed regimens of anabolic steroids for examination of left ventricular size and function via echocardiography. Increases in left ventricular posterior wall (LVPW) and ventricular septal thickness (VST) were apparent in the steroid-user group (p [less than] 0.05). Ratio of echocardiographic findings to body mass index (BMI) revealed a significantly smaller left ventricular and diastolic dimension (LVDEd/BMI, p [less than] 0.05) in the steroid-user. The smaller LVDEd in steroid-users is coupled with a significantly disproportionate septal and posterior wall thickness in steroid-users. There was no direct evidence of diastolic dysfunction. Thus it appears from these studies that androgens alter lipoproteins leading to a questionable increased risk for cardiovascular disease and may potentiate concentric left ventricular hypertrophy without affecting cardiac function.Item Cardiac Parasympathetic Dysfunction in Morphine Addiction(1997-12-01) Napier, Leslie D.; Caffrey, James L.; Raven, Peter B.; Gwirtz, Patricia A.Napier, Leslie D., Cardiac Parasympathetic Dysfunction in Morphine Addiction. Doctor of Philosophy (Biomedical Sciences), December, 1997, 137 pp., 9 tables, 22 figures, references, 163 titles. The effects of chronic morphine treatment on parasympathetic control of the heart and associated cellular mechanisms were examined using a canine model. Vagal bradycardia was significantly blunted in dogs treated for one week with subcutaneous morphine pellets. In a separate group of dogs, heart rate and high frequency fluctuations in heart rate declined during the first three hours of subcutaneous morphine infusion consistent with the vagatonic action of acute morphine. Heart rate remained below baseline on Day 2 of the morphine infusion but had returned to normal by Day 10. Ambient sympathetic tone was increased on Days 2 and 10, and plasma catecholamines were elevated on Day 2. The intrinsic heart rates on Days 2 (160 bpm) and 10 (162 bpm) of morphine treatment were lower than the pre-treatment rate (182 bpm). Suggested mechanisms include a fundamental change in sinoatrial nodal cell function or attenuated tachycardia induced by vasoactive intestinal peptide co-released with acetylcholine from post-ganglionic parasympathetic neurons. The time to 50% maximal bradycardia during vagal nerve stimulation was increased with chronic and acute morphine suggesting an effect on the rate of acetylcholine synthesis, release or degradation. Muscarinic receptor density in left ventricular and right atrial sarcolemmal membranes from dogs treated chronically with morphine were 34% and 17% higher, respectively, than in control animals. Chronic morphine had no effect on basal or MnCl2-stimulated cyclase activity in either region. Similarly, maximal β-adrenergic and muscarinic receptor/G-protein coupling to adenylate cyclase were not altered by chronic morphine. Atrial norepinephrine content was higher than that in the ventricles and was unaltered by morphine. Ventricular norepinephrine was decreased with chronic but not acute morphine treatment. Epinephrine was evenly distributed throughout the myocardium and was reduced in both the atria and the ventricles by either acute or chronic morphine. This pattern suggests that morphine may reduce extraneuronal uptake of catecholamines. Collectively these studies show that chronic morphine treatment and the accompanying persistent vagal activity may reduce parasympathetic function. This attenuated function, however, is short-lived since sympathetic systems adapt with compensatory responses masking, or perhaps reversing, initial parasympathetic deficits.Item Characterization of MRSA Infection at Childrens Medical Center, Dallas, January 2005-June 2005(2006-05-01) Okoro, Ngozi M.; Sandhu, Raghbir; Coggin, Claudia S.; Bae, SejongOkoro, Ngozi M., Characterization of MRSA infection at Childrens Medical Center, Dallas, January 2005-June 2005. Master of Public Health (Epidemiology), May 2006, 33p., 14 tables, 10 illustrations, bibliography, 13 titles. MRSA infection is increasingly emerging in patients without the established risk factors hence the term CAMRSA. This study is a descriptive secondary data analysis from an ongoing study at UTSM/CMCD and describes the CMCD patients with MRSA infection. Data analysis showed a consistent increase in the incidence rate of the infection with slight female preponderance. Race distribution showed that blacks were the majority. Most children were less than 2years, used Medicaid, had superficial infections and community-acquired infections. All (100%) isolates were susceptible to Vancomycin and Linezolid while many (92.2%) were resistant to Erythromycin. The increasing incidence in CAMRSA infection remains a challenge for public health professionals and the resistant pattern a potential problem to the pharmaceuticals.Item Characterization of Protein Kinase C in Cisplatin Sensitive and Resistant Human Cervical Cancer HeLa Cells(2000-12-01) Mohanty, Sanghamitra; Basu, Alakananda; Simecka, Jerry; Dimitrijevich, DanMohanty, S., Characterization of protein kinase C in cisplatin sensitive and resistant human cervical cancer HeLa cells. Master of Science (Microbiology and Immunology), December, 2000. 37 pp., 11 illustrations, bibliography, 27 titles. Signal transduction plays a crucial role in carcinogenesis. A defect in signaling, by evading cell death or promoting cell proliferation, may result in neoplastic transformation or protection of cells from the cytotoxicity of anticancer drugs. Therefore, in order to understand the complex mechanism of drug resistance, it is relevant to probe into the important signal transduction pathways. Protein kinase C, a key signal transducer, influences cisplatin sensitivity in many cell lines. We examined whether or not the PKC signal transduction pathway is affected during development of resistance to cisplatin by tumor cells. PKC activators increased cisplatin sensitivity in both parental and cisplatin-resistant cells. Western blot analysis showed a slight decrease in cPKCα and nPKCε, an evaluation in nPKCδ and no change in the abundance of PKCϚ in HeLa/CP cells compared to HeLa cells. Though TPA-induced translocation of PKC isoforms was identical in both cell lines, down regulation of PKCδ was defective in resistant cells. Therefore, a deregulation in PKCδ was associated with cisplatin resistance.Item Clinical Internship with the Clinical Glaucoma/Viability Group at Alcon Research, Ltd.: The Use of Prostaglandin Analogues in the Treatment of Patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)(2003-12-01) Hall, Magali G.; Robert Wordinger; Richard Easom; Victoria RudickHall, Magali. Master of Science, Biomedical Sciences, December 2003. The use of Prostaglandin Analogues (PGAs) in the Treatment of Patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT). Summary: Glaucoma is an ocular condition that causes damage to the optic nerve leading to a loss of visual function, and permanent blindness if left untreated. It is the leading cause of preventable blindness in the U.S. The main risk factor for glaucomatous optic neuropathy is elevated intraocular pressure (IOP), which can be controlled by pharmaceutical therapy, surgical therapy or both. Topical medication is usually recommended prior to surgical intervention. Objectives: This study had two main objectives. First, to determine the IOP lower safety and efficacy of three concentrations of a new prostaglandin analogues (PGA), and secondly to determine the incidence of ocular hyperemia with once-daily dosing of study medication compared to it’s vehicle and to latanoprost, a marketed PGA. Study Design: This was a Phase II, double-masked, dose-response study with five treatment arms (the three different concentrations of study drug), vehicle, and latanoprost. Study was conducted in fourteen days, with five study visits as follows: Screening and eligibility visit followed by three on-therapy visits scheduled on Day 1, Day 7, and Day 14. The primary efficacy variable was IOP measurements taken at four different time points on study visits. Results: Final data will not available in time to include in this paper.Item Clinical Internship with the Division of Gynecologic Oncology at UT Southwestern Medical Center: Carboplatin and Doxil for Gynecologic Cancers(2003-12-01) Epps, Camitria N.; Rudick, Victoria; Miller, David S.; Richardson, BarbaraEpps, Camitria N., Master of Science, Clinical Research Management, December 2003, Carboplatin and Doxil for Gynecologic Cancers, 107 Pages, 9 Tables, 42 titles in Bibliography. Objective: To examine the safety and efficacy of administering the drugs carboplatin and doxil in combination chemotherapy for the treatment of gynecologic cancers, mainly endometrial and ovarian cancer. Materials and Methods: Carboplatin and doxil were previously administered intravenously to 6 patients. Each patient received 3 to 8 cycles of chemotherapy. Doses of carboplatin ranged from 310 mg to 665 mg. The doses of doxil ranged from 54 mg to 80 mg. This is a retrospective study. The 6 patient’s medical charts were reviewed. Data was extracted and a spreadsheet formatted database was created. Results: Data were extracted and a spreadsheet formatted database was created. Results: Due to the small number of patients the results are not statistically significant. 2 patients showed tumor progression while receiving treatment. All patients tolerated doses very well and experienced minimal toxicities. Conclusion: Carboplatin plus doxil combination chemotherapy given intravenously has a potent effect on endometrial and ovarian cancers. Studies using this chemotherapy for the treatment of gynecologic cancers should be conducted on a wider scale to access the statistical significance of the treatment.Item Clinical Internship with the Pediatric Clinic's Clinical Research at the Patient Care Center of the University of North Texas Health Science Center/Texas College of Osteopathic Medicine: Literature Review of Meningococcal Meningitis(2002-07-01) Puckett, Fredric Clark; Harold Sheedlo; Robin Newman; John FlingEpidemic meningococcal meningitis and meningococcemia disease is caused by the bacterial pathogen Neisseria meningitidis. Once infected with meningococci, onset of the disease is rapid with a high rate or morbidity and mortality. Without medical intervention the mortality rate is over 50%. Medical treatment is over 50%. Medical treatment of an outbreak of the disease with antibiotics can reduce the death rate to 10-15%. However, 10-20% of survivors will suffer from neurological damage that may include loss of hearing, paralysis or mental retardation. Recent concerns have been noted regarding the emergence of Neisseria meningitidis strains resistant to antibiotics. Vaccines have been developed in an effort to reduce epidemic outbreaks of meningococcal meningitis and meningococcemia. The first generation polysaccharide vaccines have shown to be safe and possess some degree of effectiveness but have shortcomings of limited length of immune protection and evidence of hyporesponsiveness to subsequent vaccinations. The second generation conjugated polysaccharide vaccines have been able to overcome these problems and show great promise in reducing the sale of epidemic meningococcal outbreaks with implementation of effective mass vaccination campaigns. In addition, reducing the number of infections will limit the exposure of Neisseria meningitidis to antibiotics and, in theory, slow the development of resistance to antibiotics.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 Combined Chemo/Anti-Angiogenic Cancer Therapy in Lewis Lung Metastases(2002-05-01) Sinha-Datta, Anjuli; Goldfarb, Ronald H.; Agarwal, Neeraj; Mathew, Porunelloor A.Datta, Anjuli. Combined Chemo/Anti-Angiogenic Cancer Therapy in Lewis Lung Metastases. Master of Science (Microbiology and Immunology), May 2002. 41 pp., 17 illustrations, bibliography. The focus of my dissertation studies is an eight amino acid peptide (Å6) derived from the non-receptor binding region of urokinase plasminogen activator (uPA), which partially inhibits the binding of uPA to its receptor (uPAR). Å6 has been synthesized as a potential novel anti-cancer agent and kindly provided by Ångstrom Pharmaceuticals, Inc. (San Diego, CA). We further examined potential therapeutic properties of Å6 in vivo and in vitro. Å6 appeared to directly inhibit the invasion of Lewis lung carcinoma cells through Matrigel by approximately 40-45% compared to control. In addition, Å6 had a morphological effect resulting in thicker tubes on small vessel endothelial tube formation compared to no treatment. Interestingly, doxorubicin had similar effects when added to growing endothelial cells. Moreover, Å6 was administered alone and in combination with a standard clinically used chemotherapeutic agent, doxorubicin, in a Lewis lung carcinoma mouse model to test possible synergy between an anti-angiogenic compound (Å6) and a chemotherapeutic agent. This is the first observation that Å6 has the potential to display a direct anti-metastatic therapeutic effect for established pulmonary metastases in this model. Therefore, we believe that Å6 in combination with doxorubicin has the potential to provide better therapy to cancer patients with tumor metastases than potent chemotherapeutics agents alone, by increasing the dose of non-toxic Å6 and reducing the recommended dose of doxorubicin.Item Differences in Risk of Injury Between Stimulant-Treated and Untreated ADHD Patients(2006-08-01) Segars, Larry W.; Sandhu, Raghbir; Lykens, KristineSegars, Larry W., Differences in Risk of Injury between Stimulant-Treated and Untreated ADHD Patients. Doctor of Public Health (Epidemiology), August 2006, 63 pp, 7 tables, 0 illustrations, references, 78 titles. ADHD is a common psychiatric disorder of childhood and adolescence that also occurs in adults and spans the life of the patient. ADHD is characterized by lack of focus, distractibility, and poor concentration. Limited data have been generated focusing on ADHD patients and the association with an increased risk of injury. Unfortunately, no study has been published evaluating the effect of stimulant treatment for ADHD on the risk of injury requiring ambulatory medical care. This research utilized four concatenated years, specifically 1998-2001, of the National Ambulatory Medical Care Survey (NAMCS). This dissertation is comprised of five chapters beginning with a description of ADHD, its characteristics, diagnosis, and treatment. This overview chapter is followed by a complete review of the literature describing the publication’s which assessed the association between ADHD and the risk of injury. The next chapter is a thorough review of the NAMCS and its methodology. The concatenated dataset captured 889 office visits associated with a diagnosis of ADHD, 666 of which were also related to the prescription of a stimulant for the management of ADHD. Using NAMCS’s weight variable these values produced a national estimate of 21,223,391 office visits associated with the ADHD diagnosis and 15,604,329 office visits associated with the prescription of a stimulant for ADHD. This research determined that there was a borderline statistically significant increased association with the prescription of a stimulant for the treatment of ADHD and the risk of injury requiring treatment in an ambulatory medical care setting. Interestingly, compared to patient’s who recorded their race as Caucasian, patients who recorded their race as “Other”; representing the races of Asian, Native Hawaiian/Other Pacific Islander, or American Indian/Alaska Native, and individuals indicating more than one race, had a statistically significant increased risk of injury necessitating treatment in an ambulatory medical care setting. Potential theories for this unique finding, along with the limitations of this research, are provided in the final discussion chapter.Item Factors Associated with Multi-Drug Resistance among Patients with Streptoccus pneumoniae Ear Infections(2004-05-01) Mendoza, Belinda A.; Soto Mas, Francisco; Hsu, Chiehwen Ed; Rene, AntonioMendoza, Belinda A., Factors Associated with Multi-Drug Resistance among Patients with Streptoccus pneumoniae Ear Infections. Master of Public Health (Social and Behavioral Sciences), May 2004, 27 pp., 6 tables, 1 figure, references, 9 titles. Clinical trials play an important role in the development of new medical treatments. The purpose of this study is to describe patients participating in a clinical trial and at analyze the socio-demographic characteristics of patients with susceptible and multi-drug resistant Streptococcus pneumoniae ear infections. At the conclusion of this study, a socio-demographic description of clinical trial participants was obtained and the results were slightly younger than patients with susceptible S. pneumoniae ear infections and were more likely to attend day care.Item Gender Differences in Hemoglobin Level at the Onset of Symptoms of Cancer-Related Anemia(2003-12-01) Levar, Joshua M.; Victoria RudickLevar, Joshua M., Gender Differences in Hemoglobin Level at the Onset of Symptoms of Cancer-Related Anemia. Masters (Clinical Research Management), December, 2004, 39 pp., 2 tables, 5 illustrations, bibliography, 47 titles. The purpose of this study was to assess whether the previously demonstrated relationship between quality of life and anemia in cancer patients was influenced by gender. Two hundred and fifty one patients of various diagnoses completed the Functional Assessment of Cancer Therapy – Anemia (FACT-An) subscale to measure quality of life. Regression analysis revealed a significant positive correlation between hemoglobin and FACT-An subscale score, as well as a negative correlation between Eastern Cooperative Oncology Group (ECOG) performance status and FACT-An subscale score. Mean comparison demonstrated a significant difference in FACT-An score between patients currently and not currently receiving chemotherapy. An analysis of covariance, controlling for current therapy and ECOG performance status as confounders, found that men score more poorly on the FACT-An within the hemoglobin range of 10.-13.0 g/dL. In conclusion, the normalization of hemoglobin levels improves quality of life; however, gender differences should be taken into account when determining optimal hemoglobin levels.Item Horse Serum High Density Lipoproteins as Drug Transporters(2004-05-01) Johnson, Shemedia; Walter McConathyJohnson, Shemedia J., Horse Serum High Density Lipoproteins (HDL) as Drug Transporters. High-density lipoproteins (HDL) are complex particles composed of specific proteins and lipids that facilitate blood and tissue cholesterol homeostasis by transporting excess peripheral cholesterol to the liver. In association with cholesterol ester transfer protein (CETP) and the enzyme, lecithin: cholesterol acyltransferase (LCAT), HDL contributes to the transport of hydrophobic lipids, including cholesterol ester and triglycerides through the blood. The studies presented here involve the evaluation of horse serum HDL as a carrier of water insoluble drugs and an improved process to isolate and purify horse serum HDL utilizing hydrophobic affinity chromatography. Dilauryl fluorescein (DLF) has been chosen as a model compound for the study of horse HDL as a drug carrier. The prepared HDL/DLF particles have similar flotation densities and size properties to native horse serum HDL. The amount of DLF incorporated into HDL is 30μg/mg protein. Various cancer cell lines internalized DLF from horse HDL/DLF particles successfully. While human plasma contains cholesterol ester transfer protein (CETP), horse plasma does not. Horse plasma/serum can be supplemented by human plasma to study the role of CETP in drug transport and the stability of the horse HDL/drug complex.Item Impact of Intraocular Pressure Maintenance on Sight Preservation(2002-05-01) Ratliff, Marla D.; Brown, Susan; Lykens, Kristine A.; Coggin, Claudia S.Ratliff, Marla D., Impact of Intraocular Pressure Maintenance on Sight Preservation. Master of Public Health (Health Services Research), May 2002, 35 pp., 3 tables, 1 figure, 40 titles. Purpose: The objective of the study was to review diurnal IOP control and its impact on sight preservation. Methods: This is a retrospective study used in patients with elevated IOP. Patient IOPs were measured every 4 hours over a 24-hour period. Qualified patients provided open label TRAVATAN to dose once a day for 2 weeks. Following 2 weeks of dosing, IOP measurements were taken every 4 hours for 36 hours. Additional IOP measurements were taken at 60 and 84 hours after the last dose of TRAVATAN. Results: The IOP changes from baseline were statistically significant (p≤0.0001) at all time points out to 36 hours. Even without additional dosing, substantial IOP reductions (6mm Hg) were maintained out to 84 hours. Conclusions: Use of TRAVATAN may have less impact on IOP maintenance due to non-compliance and missed doses. This could help prevent glaucomatous loss and preserve sight.Item Lal, Harbans, Ph.D.(1994-02-08) Lal, Harbans; Hailey, BlakeDr. Lal, Professor and Chairman of Pharmacology, began his career with TCOM in 1980. He shares his early goals as faculty, his research, and his outlook on the school's future. Interviewed by Blake Hailey, February 8, 1994
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