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https://www.readbyqxmd.com/read/28647377/establishing-rarity-in-the-context-of-orphan-medicinal-product-designation-in-the-european-union
#1
REVIEW
Stelios Tsigkos, Matthias Hoffer, Maria Sheean, Segundo Mariz, Kristina Larsson, Frauke Naumann-Winter, Laura Fregonese, Bruno Sepodes
In the European Union (EU) legislative framework for orphan medicinal product designation, establishing that a condition affects not more than five in 10 000 people is a prerequisite for applications based on rarity. Demonstrating this requirement to the Committee of Orphan Medicinal Products (COMP) can be a particularly challenging task for sponsors. Here, we identify and examine three common issues with the estimation of prevalence in orphan drug applications in the EU (the discernment between diagnosed and undiagnosed cases; the duration of the disease; and the need for an explicit contemporary conclusion) as critical factors for acceptable prevalence estimation...
June 21, 2017: Drug Discovery Today
https://www.readbyqxmd.com/read/28634928/comparison-of-formulas-and-methods-for-high-myopia-patients-requiring-intraocular-lens-powers-less-than-six-diopters
#2
Harry S Geggel
PURPOSE: To determine the best method to minimize postoperative hyperopia and achieve mild myopia in patients requiring low-powered (<6.00 D) MN60MA intraocular lenses (IOLs). METHODS: This retrospective non-comparative case series consists of 32 eyes (20 patients). Postoperative spherical equivalent (SE) refractions were compared using four methods: standard formulas with varying target refractions (Haigis -1.00 D, Hoffer Q -1.75 D, Holladay 1 -1.50 D and SRK/T -1...
June 20, 2017: International Ophthalmology
https://www.readbyqxmd.com/read/28623327/exendin-4-attenuates-blast-traumatic-brain-injury-induced-cognitive-impairments-losses-of-synaptophysin-and-in-vitro-tbi-induced-hippocampal-cellular-degeneration
#3
Lital Rachmany, David Tweedie, Vardit Rubovitch, Yazhou Li, Harold W Holloway, Dong Seok Kim, Whitney A Ratliff, Jessica N Saykally, Bruce A Citron, Barry J Hoffer, Nigel H Greig, Chaim G Pick
Mild blast traumatic brain injury (B-TBI) induced lasting cognitive impairments in novel object recognition and less severe deficits in Y-maze behaviors. B-TBI significantly reduced the levels of synaptophysin (SYP) protein staining in cortical (CTX) and hippocampal (HIPP) tissues. Treatment with exendin-4 (Ex-4) delivered by subcutaneous micro-osmotic pumps 48 hours prior to or 2 hours immediately after B-TBI prevented the induction of both cognitive deficits and B-TBI induced changes in SYP staining. The effects of a series of biaxial stretch injuries (BSI) on a neuronal derived cell line, HT22 cells, were assessed in an in vitro model of TBI...
June 16, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28613158/sexual-selection-gradients-change-over-time-in-a-simultaneous-hermaphrodite
#4
Jeroen Na Hoffer, Janine Mariën, Jacintha Ellers, Joris M Koene
Sexual selection is generally predicted to act more strongly on males than on females. The Darwin-Bateman paradigm predicts that this should also hold for hermaphrodites. However, measuring this strength of selection is less straightforward when both sexual functions are performed throughout the organism's lifetime. Besides, quantifications of sexual selection are usually done during a short time window, while many animals store sperm and are long-lived. To explore whether the chosen timeframe affects estimated measures of sexual selection, we recorded mating success and reproductive success over time, using a simultaneous hermaphrodite...
June 14, 2017: ELife
https://www.readbyqxmd.com/read/28590287/effect-of-gender-and-race-on-ocular-biometry
#5
Kenneth J Hoffer, Giacomo Savini
No abstract text is available yet for this article.
2017: International Ophthalmology Clinics
https://www.readbyqxmd.com/read/28504550/liver-abscesses-factors-that-influence-outcome-of-percutaneous-drainage
#6
Steffen J Haider, Massimo Tarulli, Nancy J McNulty, Eric K Hoffer
OBJECTIVE: The purpose of this study was to identify the details of percutaneous catheter drainage (PCD) of pyogenic liver abscesses, the etiologic factors, and the management techniques that contribute to successful treatment. MATERIALS AND METHODS: The records of 75 consecutively registered patients who underwent PCD of 96 abscesses at a single institution between May 2009 and May 2014 were retrospectively reviewed. Thirty-nine patients (52%) were oncology patients, and 36 (48%) had recently undergone abdominal surgery...
May 15, 2017: AJR. American Journal of Roentgenology
https://www.readbyqxmd.com/read/28502046/adapting-the-vegetative-vigour-terrestrial-plant-test-for-assessing-ecotoxicity-of-aerosol-samples
#7
Nora Kováts, Eszter Horváth, Bettina Eck-Varanka, Eszter Csajbók, András Hoffer
Plants, being recognized to show high sensitivity to air pollution, have been long used to assess the ecological effects of airborne contaminants. However, many changes in vegetation are now generally attributed to atmospheric deposition of aerosol particles; the dose-effect relationships of this process are usually poorly known. In contrast to bioindication studies, ecotoxicological tests (or bioassays) are controlled and reproducible where ecological responses are determined quantitatively. In our study, the No...
May 13, 2017: Environmental Science and Pollution Research International
https://www.readbyqxmd.com/read/28464806/the-effect-of-ocular-biometric-factors-on-the-accuracy-of-various-iol-power-calculation-formulas
#8
Jinho Jeong, Han Song, Jimmy K Lee, Roy S Chuck, Ji-Won Kwon
BACKGROUND: To evaluate how differences in ocular biometry affects the Hoffer Q, Holladay 1, SRK/T, and Haigis intraocular lens power calculation formulae predictions. METHODS: This study was performed on 91 eyes of 91 patients who underwent uneventful cataract surgery. Ocular biometry values were measured using the IOL Master 500, and intraocular lens (IOL) power was calculated using the Haigis, Hoffer Q, Holladay 1, and SRK/T formulas. We calculated the expected difference (ED) of each 3rd generation formula from the Haigis formula by subtracting the predicted refraction of the Haigis formula from the predicted refraction of each 3rd generation formula...
May 2, 2017: BMC Ophthalmology
https://www.readbyqxmd.com/read/28447573/improving-neurorepair-in-stroke-brain-through-endogenous-neurogenesis-enhancing-drugs
#9
Kuo-Jen Wu, Seongjin Yu, Jea-Young Lee, Barry Hoffer, Yun Wang
Stroke induces not only cell death but also neurorepair. De novo neurogenesis has been found in the subventricular zone(SVZ) of adult mammalian brain days after stroke. Most of these newly generated cells die shortly after the insult. Recent studies have shown that pharmacological manipulation can improve the survival of endogenous neuroprogenitor cells and neural regeneration in stroke rats. As these drugs target the endogenous reparative processes which occur days after stroke, they may provide a prolonged window for stroke therapy...
April 26, 2017: Cell Transplantation
https://www.readbyqxmd.com/read/28447569/a-new-treatment-strategy-for-parkinson-s-disease-through-the-gut-brain-axis-the-glucagon-like-peptide-1-receptor-pathway
#10
Dong Seok Kim, Ho-Il Choi, Yun Wang, Yu Luo, Barry J Hoffer, Nigel H Greig
Molecular communications in the gut-brain axis, between the central nervous system and the gastrointestinal tract, arecritical for maintaining healthy brain function particularly in aging. Epidemiological analyses indicate type 2 diabetes mellitus (T2DM) is a risk factor for neurodegenerative disorders, including Alzheimer's disease (AD) and Parkinson's diseases (PD) for which aging shows a major correlative association. Common pathophysiological features exist between T2DM, AD and PD, including oxidative stress, inflammation, insulin resistance, abnormal protein processing and cognitive decline, and suggest that effective drugs for T2DM that positively impact the gut-brain axis could provide an effective treatment option for neurodegenerative diseases...
April 26, 2017: Cell Transplantation
https://www.readbyqxmd.com/read/28441238/diaphragm-activation-in-ventilated-patients-using-a-novel-transvenous-phrenic-nerve-pacing-catheter
#11
Steven Reynolds, Adrian Ebner, Tracy Meffen, Viral Thakkar, Matt Gani, Kaity Taylor, Linda Clark, Gautam Sadarangani, Ramasamy Meyyappan, Rodrigo Sandoval, Elizabeth Rohrs, Joaquín A Hoffer
OBJECTIVES: Over 30% of critically ill patients on positive-pressure mechanical ventilation have difficulty weaning from the ventilator, many of whom acquire ventilator-induced diaphragm dysfunction. Temporary transvenous phrenic nerve pacing using a novel electrode-bearing catheter may provide a means to prevent diaphragm atrophy, to strengthen an atrophied diaphragm, and mitigate the harms of mechanical ventilation. We tested the initial safety, feasibility, and impact on ventilation of this novel approach...
July 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28397157/the-dynamics-of-de-adoption-a-case-study-of-policy-change-de-adoption-and-replacement-of-an-evidence-based-hiv-intervention
#12
Virginia R McKay, M Margaret Dolcini, Lee D Hoffer
Evidence-based intervention (EBI) de-adoption and its influence on public health organizations are largely unexplored within public health implementation research. However, a recent shift in support for HIV prevention EBIs by the Centers for Disease Control and Prevention provides an opportunity to explore EBI de-adoption. The current mixed-method study examines EBI de-adoption and the subsequent impact on a community-based organization (CBO) dedicated to HIV prevention. We conducted a case study with a CBO implementing RESPECT, an HIV prevention EBI, over 5 years (2010-2014), but then de-adopted the intervention...
April 10, 2017: Translational Behavioral Medicine
https://www.readbyqxmd.com/read/28388374/summary-points-and-consensus-recommendations-from-the-international-protein-summit
#13
Ryan T Hurt, Stephen A McClave, Robert G Martindale, Juan B Ochoa Gautier, Jorge A Coss-Bu, Roland N Dickerson, Daren K Heyland, L John Hoffer, Frederick A Moore, Claudia R Morris, Douglas Paddon-Jones, Jayshil J Patel, Stuart M Phillips, Saúl J Rugeles, Menaka Sarav Md, Peter J M Weijs, Jan Wernerman, Jill Hamilton-Reeves, Craig J McClain, Beth Taylor
The International Protein Summit in 2016 brought experts in clinical nutrition and protein metabolism together from around the globe to determine the impact of high-dose protein administration on clinical outcomes and address barriers to its delivery in the critically ill patient. It has been suggested that high doses of protein in the range of 1.2-2.5 g/kg/d may be required in the setting of the intensive care unit (ICU) to optimize nutrition therapy and reduce mortality. While incapable of blunting the catabolic response, protein doses in this range may be needed to best stimulate new protein synthesis and preserve muscle mass...
April 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28388370/will-we-ever-agree-on-protein-requirements-in-the-intensive-care-unit
#14
L John Hoffer, Roland N Dickerson, Robert G Martindale, Stephen A McClave, Juan B Ochoa Gautier
The precise value of the normal adult protein requirement has long been debated. For many reasons-one of them being the difficulty of carrying out long-term nutrition experiments in free-living people-uncertainty is likely to persist indefinitely. By contrast, the controlled environment of the intensive care unit and relatively short trajectory of many critical illnesses make it feasible to use hard clinical outcome trials to determine protein requirements for critically ill patients in well-defined clinical situations...
April 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28366365/intraocular-lens-power-calculations-in-eyes-with-previous-hyperopic-laser-in-situ-keratomileusis-or-photorefractive-keratectomy
#15
Eric B Hamill, Li Wang, Hayley K Chopra, Warren Hill, Douglas D Koch
PURPOSE: To evaluate the accuracy of 7 intraocular lens (IOL) calculation formulas in patients with previous hyperopic laser in situ keratomileusis (LASIK) or excimer laser photorefractive keratectomy (PRK). DESIGN: Retrospective case series. SETTING: Cullen Eye Institute, Baylor College of Medicine, Houston, Texas, and private practice, Mesa, Arizona, USA. METHODS: The 7 formulas evaluated were the adjusted Atlas 0-3, Masket, Modified Masket, Haigis-L, Shammas-PL, Barrett True-K, and Barrett True-K No-History...
February 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/28362569/calorie-and-protein-content-of-parenteral-amino-acid-solutions
#16
L John Hoffer
No abstract text is available yet for this article.
April 2017: Nutrition in Clinical Practice
https://www.readbyqxmd.com/read/28358346/a-data-driven-diagnostic-framework-for-wind-turbine-structures-a-holistic-approach
#17
Simona Bogoevska, Minas Spiridonakos, Eleni Chatzi, Elena Dumova-Jovanoska, Rudiger Höffer
The complex dynamics of operational wind turbine (WT) structures challenges the applicability of existing structural health monitoring (SHM) strategies for condition assessment. At the center of Europe's renewable energy strategic planning, WT systems call for implementation of strategies that may describe the WT behavior in its complete operational spectrum. The framework proposed in this paper relies on the symbiotic treatment of acting environmental/operational variables and the monitored vibration response of the structure...
March 30, 2017: Sensors
https://www.readbyqxmd.com/read/28355262/correction-accuracy-of-optical-biometry-combined-with-placido-disc-corneal-topography-for-intraocular-lens-power-calculation
#18
Giacomo Savini, Kenneth J Hoffer, Piero Barboni, Nicole Balducci, Domenico Schiano-Lomoriello, Pietro Ducoli
[This corrects the article DOI: 10.1371/journal.pone.0172634.].
2017: PloS One
https://www.readbyqxmd.com/read/28328234/quantification-of-basal-insulin-peglispro-and-human-insulin-in-adipose-tissue-interstitial-fluid-by-open-flow-microperfusion
#19
Katrin Tiffner, Beate Boulgaropoulos, Christian Höfferer, Thomas Birngruber, Niels Porksen, Helle Linnebjerg, Parag Garhyan, Eric Chen Quin Lam, Mary Pat Knadler, Thomas R Pieber, Frank Sinner
BACKGROUND: Restoration of the physiologic hepatic-to-peripheral insulin gradient may be achieved by either portal vein administration or altering insulin structure to increase hepatic specificity or restrict peripheral access. Basal insulin peglispro (BIL) is a novel, PEGylated basal insulin with a flat pharmacokinetic and glucodynamic profile and altered hepatic-to-peripheral action gradient. We hypothesized reduced BIL exposure in peripheral tissues explains the latter, and in this study assessed the adipose tissue interstitial fluid (ISF) concentrations of BIL compared with human insulin (HI)...
May 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28298445/the-structure-and-function-of-mycobacterium-tuberculosis-mazf-mt6-toxin-provide-insights-into-conserved-features-of-mazf-endonucleases
#20
Eric D Hoffer, Stacey J Miles, Christine M Dunham
Toxin-antitoxin systems are ubiquitous in prokaryotic and archaeal genomes and regulate growth in response to stress. Escherichia coli contains at least 36 putative toxin-antitoxin gene pairs, and some pathogens such as Mycobacterium tuberculosis have over 90 toxin-antitoxin operons. E. coli MazF cleaves free mRNA after encountering stress, and nine M. tuberculosis MazF family members cleave mRNA, tRNA, or rRNA. Moreover, M. tuberculosis MazF-mt6 cleaves 23S rRNA Helix 70 to inhibit protein synthesis. The overall tertiary folds of these MazFs are predicted to be similar, and therefore, it is unclear how they recognize structurally distinct RNAs...
May 12, 2017: Journal of Biological Chemistry
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