Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation

Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron–sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron–sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/139940/1/nyas13461.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139940/2/nyas13461_am.pd

Data Narratives: Increasing Scholarly Value

Data narratives or data stories have emerged as a new form of the scholarly communication focused on data. In this paper, we explore the potential value of data narratives and the requirements for data stories to enhance scholarly communication. We examine three types of data stories that form a continuum from the less to the more structured: the DataONE data stories, the Data Curation Profiles, and the Data Descriptors from the journal Scientific Data. We take the position that these data stories will increase the value of scholarly communication if they are linked to the datasets and to the publications that describe results, and have instructional value

Exploring Public Speaking: 4th Edition

Instructors: The Fourth Edition includes a set of test banks which are not available to the public. For access to these resources, please contact Dr. Barbara Tucker at [email protected]. This Open Textbook for Public Speaking was first created under a Round Three ALG Textbook Transformation Grant. Since then, the book has undergone three new editions. Authors\u27 Description: 4th Edition: Changes to be added here soon. 3rd Edition: Exploring Public Speaking: The Free College Public Speaking Textbook began as the brainchild of Dr. Kris Barton, Chair of the Department of Communication at Dalton State College. It also was made possible through a generous Textbook Transformation Grant in 2015 from Affordable Learning Georgia, a highly successful program of the University System of Georgia. Dr. Barton asked me to help him author/compile the text. The goal was to provide a high-quality, usable, accessible, and low-cost textbook for the hundreds of students who take COMM 1110 at Dalton State College every year. This course is required of all degree-seeking students. We have been able to save students hundreds of thousands of dollars already with this text. Unexpectedly and happily, the text has also been downloaded close to 14,000 times (as of August 2018) all over the world and has been adopted at many other institutions. Dr. Barton and I worked on creating the textbook from July 2015 until May 2016, with the goal of going live with the text in Summer of 2016. Tragically Dr. Barton passed away in early May, a reality that still does not seem real. He has been greatly missed as a friend, colleague, father, scholar, teacher, and mentor. The launch of the book proceeded; however, due to the loss of Dr. Barton, the ancillaries were not finished. In Summer 2017 I took on a significant revision and updating which I named the Second Edition. I included in that edition information on college student success in the appendices. In January 2018, a colleague, Matthew LeHew, and I won a grant from the University System to create the ancillaries and improve the format for more accessibility. I decided to remove the “Dalton State” from the title and most examples for wider appeal. An appendix on library research retains the information for specific use of Roberts Library on our campus. Over 90% of the book is original with Dr. Barton, me, or other colleagues at Dalton State College. Some parts, specifically from Chapters 9, 10, and 15, are adapted from another open resource public speaking text whose author prefers not to be cited. This Third Edition, along with including necessary updates and being formatted with different software, includes four more appendices: one on online speaking, one on APA, one on humor and storytelling in public speaking, and one on Dalton State’s Library. I have also tried to clarify concepts, to provide “case studies” to show the rhetorical process, and include more outlines and examples. We think this book is especially useful in coverage of PowerPoint, audience responsiveness, ethics in public speaking, special occasion speeches, and structure of speeches. Three ancillaries are available: electronic “flash cards” for study, Powerpoints on the 15 main chapters, and test banks for the 15 main chapters. Thank you for downloading Exploring Public Speaking, and the co-authors and I truly wish you happy teaching and learning with it. We welcome input. If you choose to use it, let us know at [email protected]. Accessible files with optical character recognition (OCR) and auto-tagging provided by the Center for Inclusive Design and Innovation.https://oer.galileo.usg.edu/communication-textbooks/1000/thumbnail.jp

Impact of COVID-19 on the mental health of children and young people: an umbrella review

Background: Over the past 3 years, a multitude of studies have highlighted the impact of the COVID-19 pandemic on the mental health of children and young people (CYP). In this umbrella review, we synthesise global evidence on the impact of COVID-19 on the mental health of CYP from existing systematic reviews with and/or without meta-analysis. Methods: Adopting the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we evaluated 349 citations and identified 24 eligible reviews with medium to high methodological quality to be reviewed narratively. Results: Most of the reviews reported a high prevalence of anxiety disorders, depression, suicidal behaviour, eating disorders and other mental health problems. Most studies that used data at multiple time points indicate a significant increase in mental health problems in CYP, particularly in females and older adolescents. Conclusions: Multipronged psychosocial care services, policies and programmes are needed to alleviate the burden of mental health problems in CYP as a consequence of the COVID-19 pandemic and associated global health measures. PROSPERO registration number: CRD42021276312

Kupffer Cells and Blood Monocytes Orchestrate the Clearance of Iron-Carbohydrate Nanoparticles from Serum.

Intravenous (IV) iron nanoparticle preparations are widely used to treat iron deficiency. The mechanism of mononuclear phagocyte system-mediated clearance of IV iron nanoparticles is unknown. The early uptake and homeostasis of iron after injection of ferric carboxymaltose (FCM) in mice was studied. An increase in serum iron was observed at 2.5 h followed by a return to baseline by 24 h. An increase in circulating monocytes was observed, particularly Ly6Chi and Ly6Clow. FCM was also associated with a time-dependent decrease in liver Kupffer cells (KCs) and increase in liver monocytes. The increase in liver monocytes suggests an influx of iron-rich blood monocytes, while some KCs underwent apoptosis. Adoptive transfer experiments demonstrated that following liver infiltration, blood monocytes differentiated to KCs. KCs were also critical for IV iron uptake and biodegradation. Indeed, anti-Colony Stimulating Factor 1 Receptor (CSF1R)-mediated depletion of KCs resulted in elevated serum iron levels and impaired iron uptake by the liver. Gene expression profiling indicated that C-C chemokine receptor type 5 (CCR5) might be involved in monocyte recruitment to the liver, confirmed by pharmaceutical inhibition of CCR5. Liver KCs play a pivotal role in the clearance and storage of IV iron and KCs appear to be supported by the expanded blood monocyte population

Efficacy of group exercise–based cancer rehabilitation delivered via telehealth (TeleCaRe) : protocol for a randomized controlled trial

Background: Access to rehabilitation to support cancer survivors to exercise is poor. Group exercise–based rehabilitation may be delivered remotely, but no trials have currently evaluated their efficacy. Objective: We aimed to evaluate the efficacy of a group exercise–based cancer rehabilitation program delivered via telehealth compared to usual care for improving the quality of life of cancer survivors. Methods: A parallel, assessor-blinded, pragmatic randomized controlled trial with embedded cost and qualitative analysis will be completed. In total, 116 cancer survivors will be recruited from a metropolitan health network in Melbourne, Victoria, Australia. The experimental group will attend an 8-week, twice-weekly, 60-minute exercise group session supervised via videoconferencing supplemented by a web-based home exercise program and information portal. The comparison group will receive usual care including standardized exercise advice and written information. Assessments will be completed at weeks 0 (baseline), 9 (post intervention), and 26 (follow-up). The primary outcome will be health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at week 9. Secondary measures include walking capacity (6-minute walk test), physical activity (activPAL accelerometer), self-efficacy (Health Action Process Approach Questionnaire), and adverse events. Health service data including hospital length of stay, hospital readmissions, and emergency department presentations will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore the patient experience. The primary outcome will be analyzed using linear mixed effects models. A cost-effectiveness analysis will also be performed. Results: The trial commenced in April 2022. As of June 2022, we enrolled 14 participants. Conclusions: This trial will inform the future implementation of cancer rehabilitation by providing important data about efficacy, safety, cost, and patient experience. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12621001417875; https://tinyurl.com/yc5crwtr International Registered Report Identifier (IRRID): PRR1-10.2196/3855

Quantification of Lipoteichoic Acid in Hemodialysis Patients With Central Venous Catheters

Hemodialysis patients with central venous catheters (CVCs) have chronic systemic inflammation, the source of which may be related to intraluminal bacterial biofilm. There is currently no non-invasive method to adequately evaluate intraluminal biofilm. Lipoteichoic acid (LTA) is a Gram-positive bacterial cell wall component that is spontaneously shed. The purpose of this study was to determine whether LTA could be quantified in biological samples and to evaluate potential relationships to markers of inflammation. Heparin-locked catheter aspirate was drawn from both the arterial and venous ports of each CVC prior to dialysis initiation. Venous blood from the dialysis circuit was collected 30 min after dialysis initiation. LTA was quantified in aspirate and plasma. Key markers of inflammation (interleukin-6, and hepcidin) and endothelial dysfunction (soluble vascular endothelial cadherin) were also determined in plasma samples. Catheter aspirate and systemic blood samples were obtained from 40 hemodialysis patients. The median (range) duration of catheter use was 130 (20–1635) days. Unexpectedly, median (range) plasma LTA concentrations (ng/mL) were significantly higher than catheter aspirate LTA concentrations [3.93 (0.25–15) vs. 2.38 (0.1–8.1), respectively, p = 0.01] in the majority (70%) of patients. Area under the receiver operator characteristic (ROC) curve showed good potential prognostic value of catheter aspirate LTA predicting systemic LTA concentrations with an area under the curve of 0.815 (95% CI, 0.68–0.95). A significant correlation was found between LTA and serum ferritin (r = 0.32, p = 0.04), however, there were no significant correlations between LTA and the other inflammation biomarkers assessed. LTA is quantifiable in aspirate and plasma of hemodialysis patients with CVCs and warrants further investigation to determine potential clinical application to intraluminal biofilm evaluation