Browsing by Subject "death"
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Item A Six-Year Analysis of the Distribution of Time to Death Among Colorectal Cancer Patients in the State of Texas(2000-05-01) Williams, Vanessa P.; Antonio A. Rene; Thomas J. Fairchild; Sally BlakleyWilliams, Vanessa P., A Six-Year Analysis of the Distribution of Time to Death Among Colorectal Cancer Patients in the State of Texas. Master of Public Health (Epidemiology), May 2000, 55 pp., 11 tables, 9 figures, references, 52 titles. The cancer experience of Texans differs substantially by race/ethnicity. Among Caucasian, African American, and Hispanic men and women, colon cancer is either the second or third leading type of cancers among Texans. The distribution of time to death over a six-year period were assessed from a cohort of African American, Hispanic, and Caucasian men and women diagnosed with colon cancer in 1992. The purpose of this study is to determine if there is a difference in the overall death time distribution and tumor histology among African Americans, Hispanics, and Caucasian men and women who were diagnosed with colon cancer in 1992 in the state of Texas. Analysis results indicated that Hispanic females (65.59%) and Caucasian males (65.52%) had higher survival times among the race/ethnic groups. African American males (53.85%) and females (56.40%) experienced lower survival time for the cohort. For overall distribution of time to death among deceased subjects, African American males and Hispanic females experienced the lowest distribution times among the subjects. The overall distribution of time to death for all histology types were the same for each type.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 The Immedicate Effect of OMT on a COPD Population: A Pilot Study(2006-05-01) Som, Mousumi; Kimberly Fulda; John LicciardoneSom, Mousumi, M.S. The Immediate Effect of OMT on a COPD Population: A Pilot Study. Master of Science (Clinical Research and Education OMM), May 2006, 81 pages, 3 figures, references 45 titles. Objective: Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of morbidity and mortality in the United States costing approximately 32 billion dollars yearly. COPD cannot be cured, and existing modalities are limited. This study explored the use of Osteopathic Manipulative Treatment (OMT) on pulmonary function and alveolar ventilation. Methods: this prospective, randomized single blinded pilot study included 21 subjects with two interventions: OMT and no intervention. Subjects were 40 to 80 years of age with a clinical diagnosis of COPD. Primary outcome measures included pulmonary function values: FVC, FEV1, FEV1/FVC, RV, TLC. Secondary outcome measures included alveolar ventilation measured by pulse oximetry. Results: No statistically significant results were observed. Clinically relevant trends indicated a potential impact of OMT on COPD subjects. This study was funded by the Osteopathic Research Center (ORC) and approved by the UNTHSC Institutional Review Board. Conclusions: This study demonstrated the feasibility of conducting research on COPD subjects by the ORC. Because of the small sample size, no conclusive statements can be made determining the efficacy of OMT on pulmonary function and alveolar ventilation.