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Clinical Trials: Kidney, Bladder, Prostate and Urinary
IRB No. 16-111-1: Novel Paradigm to Improve Inflammatory Burden in ERSD
The study proposes to examine, for the first time in dialysis patients, the short and long-term effect of systemic and repeated oral health interventions on inflammation and clinical oral parameters. The ultimate goal of this proposal is to improve access to oral care and quality of life by implementing continuous and repeated in-center oral health programs in dialysis populations.
IRB No. 13-061C-6.2 (Dr. Biree Andemariam, PI): CASIRE Sickle Cell Renal Disease Cohort International Study Protocol
Study design: This study's design is cross-sectional. Our cross-sectional study approach will allow us to determine particular age cohorts (young children, adolescents and young adults) that might be at risk for developing early renal dysfunction. Further, it will also allow us to determine which estimates of GFR have the best correlation to the changes in renal function. Specifically, we will determine if estimates in GFR, increasing microalbuminuria, or blood pressure changes will be predictive of early renal dysfunction. Study procedures: The research staff, which includes study coordinators from UCHC and CCMC, co-investigators from CCMC, and a principal investigator from UCHC, will only enroll subjects with sickle cell disease who are at steady state and have not had an infection, pain crisis, emergency room visit or hospitalization within two weeks of the time that they are enrolled in the study. Subjects will be screened by the PI or co-investigators, with whom they have a treating relationship. Potential subjects will be told about the study by the PI or co-investigators during a routine clinical visit. Those potential subjects who verbalize interest in learning more about the study will then have an opportunity to discuss the study further with a member of the research staff. If the subject then verbalizes desire to participate, informed consent will be obtained. The questionnaire will then be administered in its entirety by a member of the research staff by verbally asking the subject to answer each question. If there is any uncertainty about the answer to a particular question, the medical chart will be reviewed for verification. We estimate it will take about 20-30 minutes for the subjects to fill out the questionnaire with a research staff member. The subject's involvement ends once the questionnaire is completed.