Browsing by Subject "Other Medical Sciences"
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Item Establishing Metrics for Evaluating Performance and Quality in Clinical Trial Management(2012-12-01) Vandermause, Matthew C.; Rustin ReevesPurpose: To identify performance metrics for use in clinical trial management, identify different levels of understanding of and experience with performance metrics among clinical research professional, and to establish performance metrics within the clinical research organization MedTrials, Inc. Hypothesis: There is a significant gap in knowledge and disconnect between clinical research professionals regarding performance metrics and how and when to use them. Design: A survey was designed to test the understanding and knowledge of clinical research professionals regarding performance metrics. This study survey was also designed to gather opinions of clinical research professionals regarding the usefulness of performance metrics and when and where to appropriately use performance metrics. Results: There is a deficiency in the understanding of performance metrics among clinical research professionals, as well as some disconnect regarding how to appropriately use performance metrics.Item Histamine Induced Changes in Phospholipase C Activity, Calcium Mobilization, and Contractility in Human Ciliary Muscle Cells(1996-06-01) Markwardt, Kerry L.; Michael W. Martin; Thomas Yorio; Eugene QuistMarkwardt, Kerry L., Histamine induced changes in phospholipase C activity, calcium mobilization, and contractility in human ciliary muscle cells. Doctor of Philosophy (Biomedical Sciences), June, 1996. Histamine has long been known to be an important mediator of inflammation and autocoid throughout the body. It has been shown to cause the contraction of many types of smooth muscle. Due to its known presence in many ocular structures and aqueous humor especially during inflammatory states, it was hypothesized that histamine could have an effect on intraocular pressure (IOP). This could occur if histamine triggered events which ultimately lead to contraction of the ciliary muscle, since it is established that contraction of the ciliary muscle affects aqueous humor outflow. Therefore, it was hypothesized in this study, the histamine causes increases in inositol phosphate production and intracellular calcium in human ciliary muscle cells which ultimately leads to contraction. To test this hypothesis, human ciliary muscle (CM) cells were cultured and used in various experiments to determine the effect of histamine on inositol phosphate production, intracellular calcium mobilization, and contractility. This study, for the first time in CM cells, showed that histamine, via an H1 receptor subtype, caused dose dependent increases in both inositol phosphates and intracellular calcium. Furthermore, it was shown that these histamine-induced events ultimately lead to contraction of the CM cells. Combining the results from all our studies, the data indicate that in human CM cells, histamine via an H1 receptor, activates phospholipase C which generates inositol phosphates such as inositol triphosphate (IP3). IP3 binds to an IP3 sensitive receptor on the endoplasmic reticulum causing the initial release of calcium which is sufficient to cause contraction of the CM cells. The intracellular release of calcium is also involved in activating a calcium channel which allows the influx of extracellular calcium into the cell. The results of these studies suggest that histamine could potentially have an IOP lowering effect in the eye due to contraction of the ciliary muscle. Overall, these studies contribute to a better understanding of the effect of histamine on a key IOP regulating tissue in the eye.Item Identifying barriers to enrollment and strategies to increase enrollment at a community-based cancer treatment center(2014-05-01) Gokul, Sheila R.; Ladislav DoryAlthough clinical trials are essential for the development of cancer treatments, only approximately 3% of cancer patients in the U.S. participate in them. While 55% of these patients are enrolled in cancer clinical trials through community-based practices and around 80% of all cancer patients are seen at this type of practice, there is a lack of knowledge about the enrollment barriers at these sites. This study evaluates enrollment barriers at a community-based cancer clinic at the levels of the investigative site, healthcare provider, and patient. Barriers to enrollment and strategies to increase enrollment are evaluated through historical data analyses and results from a survey assessing the opinions of healthcare providers on enrollment and research practices.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 Synergy 2007: Annual Research Report(2007-01-01)Item Targeted Nanoparticles for the Treatment of Neuroblastoma(2011-05-01) Pratap, Suraj; Lacko, Andras G.Neuroblastoma (NB) is one of the most frequently diagnosed tumors in infants and children. However, the mechanism by which it is initiated and subsequently develops on the molecular and cellular level is yet to be fully elucidated. Its wide spectrum of clinical presentation has baffled physicians and biomedical scientists alike. The variant called high risk neuroblastoma (HRNB) is extremely resistant to the currently available drug regimes. Despite the recent advances in anti-cancer agents and the use of multi-modality therapy for the treatment of HRNB the morbidity and mortality in this group of patients continues to remain high. The purpose of our project was to find novel alternative therapeutic approaches by encapsulating known anti-NB agents in a lipoprotein based formulation to achieve selected, targeted delivery of these drugs to HRNB tumors. We wanted to enhance the therapeutic efficacy of these drugs that have shown encouraging results in pre-clinical trials but have so far exhibited an adverse pharmacokinetic profile precluding their systemic application. Our laboratory has been working for the last several years on a novel drug delivery platform by encapsulating drugs into the core of high density lipoprotein (HDL) type nano-particles. Using this strategy, we encapsulated all-trans retinoic acid (ATRA), fenretinide (FR) and valrubicin into reconstituted HDL (rHDL) nanoparticles and subsequently evaluated some of their physical and chemical properties and their anti-NB potential. Further, we tested the efficiency of an apolipoprotein mimetic peptide called 5-A peptide as a component of rHDL particles and compared its efficiency with apolipoprotein A-1 (Apo-A1). The 5-A peptide offers numerous advantages over the Apo-A-1 both in terms of cost of production as well as manufacturing time. After successfully encapsulating the drugs, we characterized them and tested their cytotoxic potential on various cancerous cell lines. We also conducted cell uptake studies to test our hypothesis of tissue targeting and selective uptake of rHDL nano-particles mediated by the scavenger receptor type B1 (SR-B1). We conducted a pilot study on nude mice in which we administered rHDL containing fluorescent dye intravenously in mice xenografted with NB tumors and took subsequent images to track its distribution in the body. Our results demonstrate that it is possible to encapsulate ATRA, FR and valrubicin into rHDL preparations with a predictable efficiency; these nano-particles show a dose dependent cytotoxic effect on NB cell lines. We anticipate that the results of our studies will facilitate the application of liposomal nano-particles and these novel drugs in the treatment of HRNB in the future.Item The Three "R"s of Research(2014-05-01) Goodman, Frank P.; Patricia A. GwirtzThe primary purpose of this practicum project is to outline the steps a Site Management Organization (SMO) must take in order to successfully reach their enrollment goal as set forth by the CRO or Sponsor. In order to conduct this practicum project, I participated in a 6 month, full-time internship at ACRC trials in Plano, Texas. ACRC Trials is a Site Management Organization (SMO) with 9 years of experience in conducting research in the Dallas area. The acronym for ACRC Trials stands for Advanced Care Research Centers Trials. ACRC Trials handles all aspects of the research process except, those duties which are the sole responsibility of the physician. The duties of the Principal Investigator (PI) include, but are not limited to, performing physical exams, assessing adverse events and laboratory values, and performing any medical procedures. At ACRC Trials, I participated in clinical research topics of regulations, recruiting, and study coordination, with the primary purpose being to outline how ACRC Trials conducts a study with a primary goal reaching their specified enrollment goal. My primary site mentor was Mrs. Heema Marwah, CCRC, who is the Research Director at ACRC Trials. During my studies at UNTHSC in the Clinical Research Management program, a required course was Introduction to Clinical Research and Studies. In this course students focused primarily on the regulatory documents involved in research and also on roles of specific positions throughout clinical research. During my first few weeks at ACRC Trials, the variation from classroom education to the reality of how research was conducted at my site was evident. For example, I found that many of the operations discussed in the classroom are handled jointly by multiple positions at ACRC Trials, which is different from the rigid discussion of the role and responsibilities of research personnel presented in the classroom. For this practicum project, I used what I observed at ACRC Trials to demonstrate how a team approach may have benefits to the conduct of clinical research compared to separating the responsibilities to individuals. Personnel working closely together at ACRC Trials created accountability and proficiency across many studies at different sites. ACRC Trials has multiple research locations with which they contract and they must ensure that the studies’ strict metrics are achieved within a specific time period at each location. ACRC Trials has a separate regulatory specialist that works with the clinical research coordinators to complete regulatory documents. There are two patient recruiters, one dedicated to recruiting from the research database as well as from marketing campaigns geared towards the community. The other recruiter is dedicated to conducting chart review of the potential subject charts within the practices associated with ACRC Trials, which recruits clinic patients. Once the subjects are screened and scheduled, the subject is seen by the clinical research coordinator. There are a total of four study coordinators that are responsible for their own studies, but they also serve as a backup coordinator for other studies within ACRC Trials. The goal of this practicum project is to 1) demonstrate how to effectively attain subject enrollment goals, 2) focus on two subtopics regarding recent changes in research, and 3) to demonstrate the importance of regulatory affairs and its department at an SMO.Item Use of Social Media and its Potential for Subject Recruitment in Clinical Trials.(2014-05-01) Reyes, Mario C.; Jerry SimeckaEffective research subject recruitment is crucial for clinical trial success. Low enrollment prolongs clinical trials and delays researchers from determining the safety and efficacy of new medical devices or drugs. The goal of this thesis was to survey the patient community at the University of North Texas Health Science Center to determine their views and knowledge on social media and the effectiveness of social media as a potential platform for subject recruitment. The research questions were aimed at identifying factors that motivate potential research subjects to participate in clinical trials. The results showed individuals were less likely to participate in a clinical trial via social media advertisements. The preferred recruitment method selected was a physician’s referral across all of the groups compared. The conclusion proposes that a physician’s participation is essential in recruiting subjects for clinical trials. The current study was limited by a single center cohort. Future studies will require a secondary subject pool.