Browsing by Subject "efficacy"
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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.; Victoria Rudick; David S. Miller; Barbara RichardsonEpps, 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 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.