Browsing by Subject "safety"
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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 AWARENESS OF AED SAFETY AMONG EMPLOYEES AT UNTHSC(2013-04-12) Adamson, AaronPurpose: Cardiovascular Disease is the number cause of death in America and is the leading cause of death in adults over the age of forty. Cardiac arrest is the primary cause of sudden death in individuals who are not admitted into the hospital, and the majority of these deaths are due to Ventricular fibrillation (VF). Automated External Defibrillators (AEDs) are portable machines typically located in public areas that diagnose VF and treat with defibrillation. The American Heart Association introduced AEDs through community public access defibrillator programs and helped pass laws throughout the United States to ensure that AEDs are available in public facilities. In the past year, the campus of UNTHSC has increased 1) the awareness of AED safety and use, and 2) the implementation of CPR and AED training. Methods: A survey was conducted to evaluate awareness on the safety of AED use and the presence of AEDs on campus among non-clinical employees. Results: The increased training was accompanied by a small increase in knowledge of the "location of the nearest AED" (45% to 52%), and the "fear of misuse" decreased from 56% to 47%. Moreover, the "fear of a lawsuit" was reduced from 47% to 29%. Conclusions: Although these findings suggest that the general awareness has improved, the data suggest that a greater effort is needed to better inform the general public of the safety of AED use.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 Generating a Future Vision of Patient Safety: A Pilot Program to Test the Integration of Certified Professional in Patient Safety Curriculum into Undergraduate Medical Education(Sage Publications, 2021-07-28) Gelinas, Lillee S.; Reynolds, Conner D.; Lindsley, Joshua; Lieto, JanetPreventable healthcare-associated harm results in significant morbidity and mortality in the United States, costing nearly 400 000 patient lives annually. The Institute for Healthcare Improvement provides high-quality educational resources tailored for working healthcare professionals. One such resource is the Certified Professional in Patient Safety (CPPS) review course, which equips professionals with advanced proficiency in 5 core patient safety domains. The CPPS certification is the only interprofessional, patient safety science credential recognized worldwide. In 2010, the Lucian Leape Institute at the National Patient Safety Foundation described the critical need for medical students to participate in patient safety solutions as well. However, equivalent patient safety credentialing remains challenging for students in the preclinical and clinical stages of training to obtain. To address this growing dilemma, the Texas College of Osteopathic Medicine (TCOM) piloted the first-of-its-kind CPPS course with 10 medical students to test a novel, academic-level approach to patient safety curriculum. Medical students showed large gains in performance on the post-test (83.18% +/- 26.12%) compared to the pre-test (46.46% +/- 27.18%) (P < .001, eta(2) p = .368), representing increased knowledge across all learning domains. On the national certification examination, students had a 90% first-time pass rate, exceeding the current national average of 70% for first-time examinees. In satisfaction surveys, students expressed the value of pilot curriculum for their medical training, the importance of similar Patient Safety Education and CPPS certification for all medical students, their confidence as future healthcare change agents. Content analysis of open response questions revealed 3 key areas of strength and opportunity for guiding future iterations of the course. This pilot generates a future vision of patient safety, equipping students with critical knowledge to systematically improve healthcare quality.Item Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System--Issues Involving Patient Enrollment(2005-05-01) Hiraki, Stephanie J.; Harold Sheedlo; Don Peska; John AschenbrennerHiraki, Stephanie J., Implementation of a Pain Management Protocol in Abdominal Surgery Patients Involving an Investigational Fentanyl Patient-Controlled Transdermal System-Issues Involving Patient Enrollment. Master of Science (Clinical Research Management), May 2005, 112 pp., 2 tables, 6 illustrations, bibliography, 42 titles. An open label, randomized, comparative, parallel, phase III multicenter study will be the main focus in the surgery department at the University of North Texas Health Science Center Patient Care Center. The study will evaluate the safety and efficacy of the fentanyl patient-controlled transdermal system (PCTS) versus an intravenous patient controlled anesthesia morphine pump (PCA pump) for abdominal surgery postoperative pain management. Patient enrollment is essential. Slow patient enrollment in clinical trials will lead to a delay in the sponsor’s submission of the investigational product for review and approval from the FDA. The barriers and facilitators to the accrual and retention of patients in this study will be covered.Item Review of the Current Treatment Options for a Prostate Cancer, Evolution of Radiosurgery, and Initiation of a Cyberknife Prostate Cancer Trial(2007-03-01) Camarena, Julieanna Angel; Oglesby, Michael; Gwirtz, Patricia A.; Aschenbrenner, JohnCamarena, Julieanna, Angel. Review of the Current Treatment Options for Prostate Cancer, Evolution of Radiosurgery, and Initiation of Cyberknife Prostate Cancer Trial. Master of Science (Clinical Research Management), May 2008, 141 pp., 3 tables, 4 illustrations, bibliography, 73 titles. Prostate cancer is the uncontrolled growth of the prostate gland cells. It is the most common cancer found in American men other than non-melanoma skin cancer. This disease will affect 1 in 6 men during their lifetime. With early diagnosis and treatment, prostate cancer has a cure rate of 90%. Currently there are several treatment options available for prostate cancer. The most common forms of treatment for early and intermediate state prostate cancers are surgery, radiation therapy, hormone deprivation therapy, and active surveillance. New treatment modalities including CyberKnife radiosurgery are currently being tested to gather data on safety and efficacy. Although the CyberKnife system gained clearance from the Food and Drug Administration in 2001 to treat tumors anywhere in the body where radiation treatment is indicated, long term data has not accrued on this device to assess its safety and efficacy. Investigational new treatments such as the CyberKnife must undergo clinical trials even after it is approved to determine long term effects of the procedure. As an intern with a CyberKnife, prostate cancer clinical trial, the author assisted in initiating the clinical trial at a major institution and observed the many aspects of clinical research with a focus on the role of a clinical research coordinator. Through this experience, the author researched the key components in a protocol and the background information necessary to compose a clinical trial protocol in the area of prostate cancer.Item Review of the History of Coronary Stenting, Role and Evolution of Adjunctive Pharmacotherapy and Experience with an Ongoing Drug-Eluting Stent Trial(2005-12-01) Kang, Mi Jung; Bens, Annita V.; Ratka, Anna; Oglesby, MichaelKang, Mi Jung. Review of the History of Coronary Stenting, Role and Evolution of Adjunctive Pharmacotherapy and Experience with an Ongoing Drug-Eluting Stent Trial. Master of Science (Clinical Research Management), December 2005, 116 pp., 6 tables, 12 figures, bibliography, 61 titles. The history of stent development with regard to the use of coating materials and eluting drugs, with special emphasis on mechanism of release and duration of action of drugs used in drug-eluting stents, was summarized. The general safety profile of currently used adjunctive pharmacotherapy to coronary stenting, with special emphasis on the clinical trials providing the scientific assessments of the effectiveness and safety of the regimens was reviewed. The enrollment process and the critical role of the Clinical Research Coordinator (CDC) in the process of the implementation of a clinical study with a new drug-eluting stent were described.Item Safety and Efficacy of Alefacept, Efalizumab, Etanercept, and Infliximab in Treating Moderate to Severe Psoriasis: A Meta-Analysis of Randomized Controlled Trials(2007-05-03) Brimhall, Angela K.; John Licciardone; Roberto Cardarelli; Richard VirgilioBrimhall, Angela K., Master of Science, Clinical Research and Academic Medicine, May 19, 2007, Safety and Efficacy of Alefacept, Efalizumab, Etanercept, and Infliximab in Treating Moderate to Severe Plaque Psoriasis: A Meta-Analysis of Randomized Controlled Trials. Pages=41, Tables=3, Figures=9, Bibliography=61 titles. To evaluate and compare efficacy and safety of biological agents in the treatment of plaque psoriasis, data was identified through four parallel systematic reviews. Randomized, controlled, double-blind, monotherapy trials of alefacept, efalizumab, etanercept and infliximab were selected. Sixteen studies comprising 7,931 patients met inclusion criteria. Efficacy was measured by pooled relative risk (RR) and number needed to treat (NNT) of PASI 75 achievement as compared to placebo. Each biological agent was efficacious (P [less than] .001); however, there was a graded response for achievement of PASI 75. The risk of one or more adverse event was increased in the alefacept, efalizumab, and infliximab groups compared to placebo.Item The Effect of Self Administered Workers' Compensation on Employee Safety Programs(1997-12-01) Smitha, Matt W.Smitha, Matt W., The Effect of Self Administered Workers’ Compensation on Employee Safety Programs. Master of Public Health, December 1997, 72 pp., three tables, seven figures, reference list, 28 titles. In Texas nonsubscribers to workers’ compensation have been under ongoing attack as powerful interest groups such as casualty insurance carriers have lobbied for an end to the elective system. Seventy-two nonsubscribing Texas companies were surveyed. Logistic regression with an alpha level of p=0.05 found the safety program qualitative score, Wald (1)=10.1992, p=0.0014 to be a significant predictor of increased management attention to safety while the other variables of total losses, frequency rate, and severity rate together in the same model were found to not be significant predictors of the same dependent response. Eighty-one percent of organizations surveyed reported that management attention to safety had increased after the company became a nonsubscriber.