Browsing by Subject "methodology"
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Item Overview of Study Start Up Activities for a Clinical Trial at an Investigative Site(2012-11-01) Chaudhari, Prianka S.; Dr. Patricia GwirtzPracticum site, ACRC Trials is a Site Management Organization (SMO) which provides services to the sponsors and Contract Research Organizations (CROs). The main aim of the internship practicum was to describe, analyze and comprehend the study start up activities for a clinical trial at the practicum site. The aim was accomplished by administering survey questionnaire to the staff members, reading study start up Standard Operating Procedures (SOPs) and checklists. If an investigative site optimizes and develops the Standard Operating Procedures (SOPs) for a clinical trial irrespective of type and length of the study then significant time and money can be saved. Saved resources can be used to make an investigative site more efficient in conducting and managing multiple trials.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.