Lee Memorial Hospital

Abstract BackgroundWell-annotated, high-quality biorepositories provide a valuable platform to support translational research and discovery. However, most biorepositories have poor representation of minority groups, limiting the ability to address cancer health disparities and improve disease outcomes. This report describes the establishment of the Florida Pancreas Collaborative (FPC), the first state-wide prospective longitudinal cohort study and biorepository specifically designed to address the higher burden of pancreatic cancer (PaCa) in African Americans (AA) compared to Non-Hispanic Whites (NHW) and Hispanic/Latinx (H/L).MethodsWe describe rationale for establishing the FPC and provide an overview of key stakeholders; study eligibility and design; ascertainment and recruitment strategies; and standard operating procedures (SOPs) developed to collect, process, store, and transfer biospecimens, medical images, and data. We also describe the customized cloud-based, secure data management platform built to facilitate recruitment, track study-related workflow, house data, and perform queries. We also present progress to date regarding recruitment and biobanking.ResultsThe FPC consists of multidisciplinary teams from fifteen Florida medical institutions. From March 2019 through August 2020, 350 patients were assessed for study eligibility, 323 met inclusion/exclusion criteria, and 305 (94%) enrolled, including 228 NHW, 30 AA, and 47 H/L, with 94%, 100%, and 94% participation rates, respectively. A high percentage of participants have donated blood (87%), pancreatic tumor tissue (41%), computed tomography scans (76%), and baseline questionnaire data (62%).ConclusionsThis biorepository addresses a critical gap in PaCa research with the potential to advance basic, clinical, population-based, and translational studies intended to minimize disparities, increase quality of life, and reduce PaCa-related morbidity and mortality.ImpactThis multi-institutional infrastructure can serve as a prototype for development of similar resources across the country and disease sites.

Critical Care Medicine: January 2020 - Volume 48 - Issue 1 - p 842 doi: 10.1097/01.ccm.0000649240.59638.26

BackgroundThe purpose of this study was to determine the effect of L-carnitine supplementation on fatigue in patients with terminal human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).MethodsIn this randomized, double-blind, placebo-controlled, parallel-group study, patients who had end-stage HIV/AIDS with carnitine deficiency and fatigue received 3 g of oral L-carnitine or placebo for 2 weeks, followed by a 2-week, open-label phase with the same amount of L-carnitine for all patients. The primary outcome was the degree of fatigue according to the Brief Fatigue Inventory. Secondary outcomes included serum carnitine and lactate levels, physical, emotional, social, and functional well-being, performance status, mood, and CD4 count.ResultsEighteen patients in the treatment arm and 17 in the placebo arm completed the trial. At the end of the double-blind phase, total and free carnitine levels in the treatment arm rose from 28±9 to 48±17 nM/L (P<0.001) and from 24±8 to 40±13 nM/L (P<0.001) respectively, with no changes in the placebo arm. The primary outcome, ie, fatigue measured at the end of the blinded phase, did not improve. Secondary outcomes of function, quality of life, and mood did not show improvement either. The secondary outcome of serum lactate decreased from baseline in the treatment group (1.45±0.76 to 1.28±0.52 mmol/L) and increased in the placebo group (1.38±0.62 to 1.84±0.74 mmol/L; P<0.005).ConclusionOur study suggests that 3 g of oral L-carnitine supplementation for 2 weeks in terminally ill HIV/AIDS patients does not improve fatigue. This study might help to determine the dose and duration of treatment used in future clinical trials, as higher doses and/or longer periods of supplementation might be needed in order to detect an improvement. The reduction in serum lactate levels suggests a potential role for L-carnitine supplementation in patients undergoing certain types of antiretroviral therapy. This study contributes evidence-based data to the field of alternative and complementary medicine, a multibillion dollar industry in which controlled studies are not the norm.

More than 11 million individuals receive proton pump inhibitor (PPI) prescriptions each year in the United States. Although PPIs are effective treatment for peptic ulcers and esophagitis and provide symptom relief for many other conditions, their use carries risks. They decrease gastric acid and can lower blood levels of drugs whose absorption is acid dependent, including several antiretroviral and cancer therapy drugs. Other drugs, such as digoxin, may be absorbed more extensively when gastric acid is reduced; thus, digoxin toxicity may occur with PPI use. Warfarin's effect also is increased in patients taking PPIs. Decreased gastric acid can lower absorption of vitamin B12, calcium, iron, and magnesium; deficiencies in these nutrients are a concern. Several medical conditions, including Clostridium difficile infection, osteoporotic fractures, and community-acquired pneumonia, are more likely to occur among PPI users. Interstitial nephritis also has been reported. Because of these risks, clinicians should try to use the lowest possible dose of PPI and to discontinue PPI therapy if it is not essential. Step-down regimens can be used to decrease/discontinue treatment; these regimens may prevent or minimize the rebound acid hypersecretion that can occur with abrupt discontinuation. For some patients, occasional treatment with intermittent or on-demand regimens may be sufficient to control symptoms.