Browsing by Subject "clinical trials"
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Item Adipose Tissue-Derived Mesenchymal Stem Cells(MDPI, 2021-12-06) Bunnell, Bruce A.The long-held belief about adipose tissue was that it was relatively inert in terms of biological activity. It was believed that its primary role was energy storage; however, that was shattered with the discovery of adipokines. Scientists interested in regenerative medicine then reported that adipose tissue is rich in adult stromal/stem cells. Following these initial reports, adipose stem cells (ASCs) rapidly garnered interest for use as potential cellular therapies. The primary advantages of ASCs compared to other mesenchymal stem cells (MSCs) include the abundance of the tissue source for isolation, the ease of methodologies for tissue collection and cell isolation, and their therapeutic potential. Studies conducted both in vitro and in vivo have demonstrated that ASCs are multipotent, possessing the ability to differentiate into cells of mesodermal origins, including adipocytes, chondrocytes, osteoblast and others. Moreover, ASCs produce a broad array of cytokines, growth factors, nucleic acids (miRNAs), and other macromolecules into the surrounding milieu by secretion or in the context of microvesicles. The secretome of ASCs has been shown to alter tissue biology, stimulate tissue-resident stem cells, change immune cell activity, and mediate therapeutic outcomes. The quality of ASCs is subject to donor-to-donor variation driven by age, body mass index, disease status and possibly gender and ethnicity. This review discusses adipose stromal/stem cell action mechanisms and their potential utility as cellular therapeutics.Item Enhancing the Effectiveness of Serious Adverse Event Reporting in Clinical Trials: A Framework for Continuous Improvement(2023-12) Bonsu, Chelsea O.; Chaudhary, PankajItem Factors Responsible For Loss To Follow Up In A Longitudinal StudyComparing Coronary Artery Bypass Surgery And PercutaneousCoronary Intervention(2010-12-01) Vera, Orlando; Patricia GwirtzItem Factors that Impact Patient Enrollment in Clinical Trials(2014-12-01) Duong, Phong; Shi, Xiangrong; Gwirtz, Patricia A.; Lovely, Rehana S.Introduction: Medical progress, now more than ever, demands clinicians to provide tangible proof over sound hypotheses. This is where clinical research steps in as a combatant to the unknown provoked by logical theories and sound hypotheses. The one constant in clinical research is that recruitment strategies are always changing. Analyzing factors that impact recruitment will effectively serve to improve the quality of clinical research conduction. Objective: The purpose of this project is to determine if there are certain factors in an individual’s life that has influenced them to participate in a clinical research study. Methods: To address the specific aims of the practicum project, a fifteen-question survey was administered to subjects enrolled in four different studies at Plaza Medical Center of Fort Worth. Data analysis was conducted using the Chi-Square Significance Test. Results: The data yielded Chi-Square values of 11.355 (Personal Influence), 14.129 (Family Influence), 186.242 (Research Staff influence), 40.581 (Financial Influence), and 56.871(Physician Influence). The values were tested under the following parameters: α=0.05 with four degrees of freedom. Conclusions: This leads to a rejection of the null hypothesis and implies that there are factors in a subject’s life that influences their decision to participate in a research study.Item HIPAA's Effect on Patient Enrollment in Clinical Trials(2002-08-01) Ommani, Sophia J.; Kaman, Robert; Arredondo, LaChelle; Bens, Annita V.Ommani, Sophia J., HIPAA’s Effect on Patient Enrollment in Clinical Trials. Master of Medical Science, August, 2002, pp. 88, 10 tables, 11 figures, references, 34 titles. The new regulation disseminated under the Health Insurance Portability and Accountability Act may impose serious restrictions as to how medical information can be used and disclosed. The law’s basic provisions began to take effect in 1997 with three principles: 1) to make it possible for people to get coverage even when they have past or present medical conditions/health factors, 2) to help people maintain the coverage needed when changing insurance or jobs, and 3) to make insurance more accessible for those who work in small businesses. A separate provision in the law imposes strict regulations on the privacy and security or patient health information. This provision has created the need to conduct research on the impact that this will have on a variety of health care issues. While some clinical practice research may be conducted without information linked to medical records, other research relies on personal identifiers to track treatment of an individual over time or link multiple sources of patient information. A randomized study was conducted to test the hypothesis that HIPAA would effect patient enrollment in clinical trials, and results supported the hypothesis. A lack of 1) willingness to authorize release of medical information and 2) a lack of understanding of the informed consent with the HIPAA language were the two predominant reasons given for refusing to sign.Item Identifying and Overcoming Barriers in Clinical Research Management: A Review of Clinical Trials within an Academic Medical Center(2008-12-01) Hatfield, ElishaOver the decades, clinical research has grown and evolved into what one would consider now as the cornerstone of medical advancement. Through the use of clinical trials, new and improved prevention and treatments continue to be discovered. These trials are not only an essential part of the process of drug discovery and development, but are required for drug approval. Conducting these clinical trials takes diligent cooperation between the pharmaceutical industry, government agencies, investigators, and academic medical centers (AMC’s). With the implementation of new regulations as well as continual changes to policies and procedures overseeing clinical research, management of such trials has become a very meticulous and a lengthy process. Additionally, escalating costs of drug development and an increased need for new treatments in the market at faster rates have made the need for more effective and productive means of conducting clinical trials a priority for competitive research sites. With the landscape of clinical research constantly evolving, adaptation of study management and procedures is a continuous hurdle that clinical research sites must overcome. Changes in regulations, limitations of funds and the need for more effective subject recruitment methods are all barriers that most AMC’s are facing today. Finding ways to overcome these obstacles is an essential part of conducting effective and productive clinical trials. In order to keep up with this change and maintain a high quality of research, continual review and audit of current research standards and procedures has become a necessity. Review of standard operating procedures and study documentation can help identify barriers which inhibit the process and initiate appropriate modifications in order to maintain efficient and effective study trials. As such, for this Internship Practicum Project, the intern reviewed the standard procedures and monitored clinical studies with the Gastrointestinal Disease Oriented Team (GI DOT) in an attempt to identify barriers affecting the overall productivity and efficiency of the team. Once these barriers had been outlined, recommendations for changes in standard procedures were made in order to help improve the functionality of the GI DOT and, subsequently, enhance the success of GI protocols within the Simmons Cancer Center Clinical Research Office.Item Increasing Knowledge of Patients in Clinical Trials Through New Means of Communication(2015-12-01) Skrivanek, Jordan E.; Shi, Xiangrong; Gwirtz, Patricia A.; Lovely, Rehana S.Introduction: The Internet can be an efficient resource for research departments to utilize. Because of this, an Internet portal was created for the research department under the current Plaza Medical Center of Fort Worth’s website. The portal is expected to educate current research patients and the general public, support patient involvement in their medical care, encourage patient communication, and improve the overall outcomes for the studies taking place. Objective: The main goal of this practicum project is to determine the effectiveness of the research portal in educating patients. Method: An online research portal and patient questionnaire was created in order to complete the project. The surveys were administered to current research patients, and the answers were analyzed using the chi‐square method, including the Mantel‐Haenszel chi‐square test. Results: The data analysis determined that the research portal was effective in increasing patient knowledge, as well as patient involvement in their medical care and communication with others. It was also decided that the portal is viewed as an accurate source of information. Additionally, demographical factors were analyzed, and it was determined that estimated annual household income does effect the way some patients answered a few of the questions. Conclusion: The portal is an effective method for the research department to utilize, although there are a few improvements that can be made.Item Recruitment, Retention and Compliance in Randomized, Phase III Clinical Trials Involving Obese Patients Diagnosed with Type 2 Diabetes Mellitus with Respect to Weight Loss.(2012-12-01) Mithani, Moez S.; Robert WordingerHuman research and clinical trials face many obstacles that prevent or hinder efficient and reliable data and results from being collected, analyzed, and reported. This is especially true in clinical trials involving type 2 diabetes. The purpose of this study is to understand issues relating to the recruitment, retention, and compliance of Type 2 diabetic subjects in phase III clinical trials. The data used in this study was collected from a parent study already conducted at the investigator site. The results indicate that issues with recruitment are attributed primarily to the inclusion/exclusion criteria, especially HbA1c values and changes in medication usage. Decreases in retention were primarily due to a lack of involvement in the control group on part of the subject and the coordinator and also due to a lack of significant results in a timely manner. Issues with compliance were found to be due to a lack of discipline on the part of the subject to make lifestyle adjustments and a lack of time in the daily schedule to add an exercise program and employ healthy dieting regimen.Item The Analysis of Current Recruitment Methods: Measuring the Potential of Social Media in Clinical Research Trials(2015-12-01) Nguyen, Denise T.; John A. Schetz; Dong-Ming Su; Patricia A. GwirtzClinical research has an important role as the intermediate step before an investigational drug or procedure is approved for distribution to the public. Before an investigational drug is approved, researchers must prove there is a benefit to the public by conducting an ethical clinical research trial. This process relies on recruiting the study population that is representative of the general population. If too few individuals participate, this could skew the data and prevent the eventual approval of an investigational drug or procedure. Recruiting study participants for certain populations has become increasingly difficult, which is why this practicum report explores the communication habits of the population around Baylor All Saints Medical Center via survey. The results of this survey will help Baylor Research Institute in Fort Worth, Texas better address clinical trial recruitment by possibly implementing social media into their current recruitment practices.Item Views on Clinical Trials(2016-05-01) Tran, Bryan Q.; Gwirtz, Patricia A.; Guttmann, Geoffrey; Maynard, BrianClinical Drug Trials have had a significant role in the public health arena dating all the way back to World War II. Although not always apparent to consumers, clinical trials have exerted a strong presence in the health of many individuals today. The purpose of this practicum research project is to understand the attitudes and opinions of individuals with chronic illness, drug related injuries, who are participating in a clinical trials compared to non-participating controls, relative to the risks and benefits of pharmacological treatment and clinical trial participation. A survey method was employed to collect attitudes and opinions of subjects from North Texas Clinical Trials and individuals from the general public. This survey was designed to illustrate potential differences in the perspectives of the two groups of subjects in a quantifiable manner. These clinical trials research materials have been designed and approved by the appropriate Institutional Review Board (IRB) committee. Upon the completion of this study we hope gain a deeper understanding of the perception of Clinical Trials and, hopefully, this knowledge may prove to be insightful towards developing innovative methods to obtain a stronger recruitment turnout.