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https://www.readbyqxmd.com/read/29214572/incentivizing-orphan-product-development-united-states-food-and-drug-administration-orphan-incentive-programs
#1
Tran T Le
Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29206624/use-of-highways-in-the-sky-and-a-virtual-pad-for-landing-head-up-display-symbology-to-enable-improved-helicopter-pilots-situation-awareness-and-workload-in-degraded-visual-conditions
#2
Neville A Stanton, Katherine L Plant, Aaron P Roberts, Craig K Allison
Flight within degraded visual conditions is a great challenge to pilots of rotary-wing craft. Environmental cues typically used to guide interpretation of speed, location and approach can become obscured, forcing the pilots to rely on data available from in-cockpit instrumentation. To ease the task of flight during degraded visual conditions, pilots require easy access to flight critical information. The current study examined the effect of "Highways in the Sky" symbology and a conformal virtual pad for landing presented using a Head Up Display (HUD) on pilots' workload and situation awareness for both clear and degraded conditions across a series of simulated rotary-wing approach and landings...
December 5, 2017: Ergonomics
https://www.readbyqxmd.com/read/29192858/head-up-display-may-facilitate-safe-keyhole-surgery-for-cerebral-aneurysm-clipping
#3
Terushige Toyooka, Naoki Otani, Kojiro Wada, Arata Tomiyama, Satoru Takeuchi, Kazuya Fujii, Kosuke Kumagai, Takashi Fujii, Kentaro Mori
OBJECTIVE The head-up display (HUD) is a modern technology that projects images or numeric information directly into the observer's sight line. Surgeons will no longer need to look away from the surgical view using the HUD system to confirm the preoperative or navigation image. The present study investigated the usefulness of the HUD system for performing cerebral aneurysm clipping surgeries. METHODS Thirty-five patients underwent clipping surgery, including 20 keyhole surgeries for unruptured cerebral aneurysm, using the HUD system...
December 1, 2017: Journal of Neurosurgery
https://www.readbyqxmd.com/read/29168866/chemical-composition-and-bioactive-properties-of-the-wild-mushroom-polyporus-squamosus-huds-fr-a-study-with-samples-from-romania
#4
Andrei Mocan, Ângela Fernandes, Lillian Barros, Gianina Crişan, Marija Smiljković, Marina Soković, Isabel C F R Ferreira
In Eastern Europe, wild mushrooms are widely collected in mountain areas and used for their medicinal properties or as healthy foods. This study aimed at determining the chemical composition (nutritional value, free sugars, organic acids, phenolic compounds, fatty acids and tocopherols) and bioactive properties (antioxidant, antimicrobial and antiquorum sensing) of wild Polyporus squamosus (Huds.) Fr from Romania. The results indicate that the fruiting bodies of P. squamosus are rich in carbohydrates (74.22 g per 100 g dw) and proteins (18...
November 23, 2017: Food & Function
https://www.readbyqxmd.com/read/29161650/how-the-morphological-properties-of-mentha-longifolia-l-huds-may-be-affected-by-geographical-differences
#5
Mohammad Mohammadi, Hossein Ali Asadi-Gharneh
With respect to the benefits of medicinal plants for human health and their use as food, they are extensively being researched and planted in different parts of the world including Iran. Among the most important parameters, which may affect the growth and the yield of medicinal plants is their geographical (ecotype) properties. Accordingly, a research work was proposed to investigate the effects of 10 different regions or ecotypes on the morphological properties of pennyroyal [Mentha longifolia. (L.) Huds.] from the Lamiaceae family in one of the Iranian provinces, namely Ilam...
October 28, 2017: Journal of Photochemistry and Photobiology. B, Biology
https://www.readbyqxmd.com/read/29145836/clinical-utility-of-computed-tomography-hounsfield-characterization-for-percutaneous-nephrolithotomy-a-cross-sectional-study
#6
Andrea Gallioli, Elisa De Lorenzis, Luca Boeri, Maurizio Delor, Stefano Paolo Zanetti, Fabrizio Longo, Alberto Trinchieri, Emanuele Montanari
BACKGROUND: Computed Tomography (CT) is considered the gold-standard for the pre-operative evaluation of urolithiasis. However, no Hounsfield (HU) variable capable of differentiating stone types has been clearly identified. The aim of this study is to assess the predictive value of HU parameters on CT for determining stone composition and outcomes in percutaneous nephrolithotomy (PCNL). METHODS: Seventy seven consecutive cases of PCNL between 2011 and 2016 were divided into 4 groups: 40 (52%) calcium, 26 (34%) uric acid, 5 (6%) struvite and 6 (8%) cystine stones...
November 16, 2017: BMC Urology
https://www.readbyqxmd.com/read/29091779/towards-a-psychopathology-specific-to-substance-use-disorder-should-emotional-responses-to-life-events-be-included
#7
Angelo G I Maremmani, Marco Maiello, Manuel Glauco Carbone, Alessandro Pallucchini, Francesca Brizzi, Iacopo Belcari, Ciro Conversano, Giulio Perugi, Icro Maremmani
INTRODUCTION: The severity of emotional responses to life events (PTSD spectrum) as part of Post Traumatic Stress Disorder (PTSD) in Substance Use Disorder (SUD) patients has often been considered from a unitary perspective. Light has also been shed on the possible definition of a specific psychopathology of SUD patients. This psychopathology has been proved to be independent of treatment choice, of being active in using substances, of lifetime psychiatric comorbidity and primary substance of abuse (heroin, alcohol, cocaine)...
October 6, 2017: Comprehensive Psychiatry
https://www.readbyqxmd.com/read/29061699/hud-and-the-survival-motor-neuron-protein-interact-in-motoneurons-and-are-essential-for-motoneuron-development-function-and-mrna-regulation
#8
Le Thi Hao, Phan Q Duy, Min An, Jared Talbot, Chitra C Iyer, Marc Wolman, Christine E Beattie
Motoneurons establish a critical link between the central nervous system and muscles. If motoneurons do not develop correctly, they cannot form the required connections resulting in movement defects or paralysis. Compromised development can also lead to degeneration since the motoneuron is not set up to function properly. Little is known, however, regarding the mechanisms that control vertebrate motoneuron development particularly the later stages of axon branch and dendrite formation. The motoneuron disease spinal muscular atrophy (SMA) is caused by low levels of the survival motor neuron (SMN) protein leading to defects in vertebrate motoneuron development and synapse formation...
October 23, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/29040677/navigation-linked-heads-up-display-in-intracranial-surgery-early-experience
#9
Justin R Mascitelli, Leslie Schlachter, Alexander G Chartrain, Holly Oemke, Jeffrey Gilligan, Anthony B Costa, Raj K Shrivastava, Joshua B Bederson
BACKGROUND: The use of intraoperative navigation during microscope cases can be limited when attention needs to be divided between the operative field and the navigation screens. Heads-up display (HUD), also referred to as augmented reality, permits visualization of navigation information during surgery workflow. OBJECTIVE: To detail our initial experience with HUD. METHODS: We retrospectively reviewed patients who underwent HUD-assisted surgery from April 2016 through April 2017...
October 10, 2017: Operative Neurosurgery (Hagerstown, Md.)
https://www.readbyqxmd.com/read/28944277/secondhand-smoke-exposure-and-smoke-free-policy-in-philadelphia-public-housing
#10
Ann C Klassen, Nora L Lee, Aaron Pankiewicz, Rikki Ward, Michelle Shuster, Bethany Townsend Ogbenna, Anita Wade, Maxwell Boamah, Olufunlayo Osayameh, Ana M Rule, Dorota Szymkowiak, Ryan Coffman, Virginius Bragg, Giridhar Mallya
OBJECTIVES: Multi-unit housing environments remain significant sources of secondhand smoke (SHS) exposure, especially for vulnerable populations in subsidized housing. In Philadelphia, the largest US housing authority to implement smoke-free policies, we measured baseline resident smoking-related behaviors and attitudes, and longitudinal exposures to airborne nicotine, during policy development and implementation. METHODS: In 4 communities, we collected data in 2013, 2014, and 2016, before and after introduction of comprehensive smoke-free policies, interviewing persons in 172 households, and monitoring air-borne nicotine in non-smoking homes and public areas...
April 2017: Tobacco Regulatory Science
https://www.readbyqxmd.com/read/28935182/eudesmane-sesquiterpenes-from-chinese-liverwort-are-substrates-of-cdrs-and-display-antifungal-activity-by-targeting-erg6-and-erg11-of-candida-albicans
#11
Siwen Li, Hongzhuo Shi, Wenqiang Chang, Yi Li, Ming Zhang, Yanan Qiao, Hongxiang Lou
We isolated twelve sesquiterpenes from Chinese liverwort Tritomaria quinquedentata (Huds.) Buch., including four new compounds. Among them, five eudesmane sesquiterpenes were ineffective against Candida albicans wild strain SC5314 but active towards efflux pumps-deficient strain DSY654 using Alamar blue assay. Further test of the most active agent of ent-isoalantolactone (8, ent-iLL) showed that it also inhibited the yeast-to-hyphal switch of DSY654 cells. The intracellular content measurement using high performance liquid chromatography (HPLC) revealed that ent-iLL was intracellularly accumulated in C...
September 9, 2017: Bioorganic & Medicinal Chemistry
https://www.readbyqxmd.com/read/28931264/assessment-of-the-accuracy-and-errors-of-head-up-display-by-an-optical-neuronavigation-system-in-brain-tumor-surgery
#12
Kenichiro Asano, Kosuke Katayama, Kiyohide Kakuta, Kanae Oyama, Hiroki Ohkuma
BACKGROUND: A head-up display (HUD) in which navigational information is projected into the microscope view may enable surgeons to perform operations more efficiently. Projecting depictions of both tumor and important intracranial structures on the HUD may facilitate safe surgery. OBJECTIVE: To investigate accuracy and errors regarding important intracranial structures, errors due to brain shifts, and preservation rates for important intracranial structures. METHODS: A total of 184 surgeries in 172 patients were performed using this operation system...
February 1, 2017: Operative Neurosurgery (Hagerstown, Md.)
https://www.readbyqxmd.com/read/28930381/intraocular-pressure-and-big-bubble-diameter-in-deep-anterior-lamellar-keratoplasty-an-ex-vivo-microscope-integrated-oct-with-heads-up-display-study
#13
Paramjit K Bhullar, Oscar M Carrasco-Zevallos, Alexandria Dandridge, Neel D Pasricha, Brenton Keller, Liangbo Shen, Joseph A Izatt, Cynthia A Toth, Anthony N Kuo
PURPOSE: To investigate the relationship between intraocular pressure (IOP) and big bubble (BB) formation in a model of deep anterior lamellar keratoplasty (DALK). DESIGN: Ex-vivo. METHODS: Corneoscleral buttons from human donors were loaded onto an artificial anterior chamber connected to a column of balanced salt solution. A surgeon-in-training learned to perform DALK via the BB technique using swept-source microscope-integrated optical coherence tomography (SS-MIOCT) with heads-up display (HUD)...
September 2017: Asia-Pacific Journal of Ophthalmology
https://www.readbyqxmd.com/read/28871047/axonal-localization-of-neuritin-cpg15-mrna-is-limited-by-competition-for-hud-binding
#14
Cynthia Gomes, Seung Joon Lee, Amy S Gardiner, Terika Smith, Pabitra K Sahoo, Priyanka Patel, Elizabeth Thames, Reycel Rodriguez, Ross Taylor, Soonmoon Yoo, Tilman Heise, Amar N Kar, Nora Perrone-Bizzozero, Jeffery L Twiss
HuD protein has been shown to stabilize mRNAs with AU-rich elements (ARE) in their 3'UTRs, including Gap43 that has been linked to axon growth. HuD also binds to Neuritin (Nrn1), whose 3'UTR contains ARE sequences. Although Nrn1's 3'UTR was shown to have axonal localizing activity in embryonic hippocampal neurons, it was not active in adult DRG neurons. Here, we asked why the 3'UTR is not sufficient to localize Nrn1 mRNA into DRG axons. HuD overexpression increases the axonal localizing activity of Nrn1's 3'UTR in DRG...
September 4, 2017: Journal of Cell Science
https://www.readbyqxmd.com/read/28860962/cell-proliferation-migration-and-neurogenesis-in-the-adult-brain-of-the-pulse-type-weakly-electric-fish-gymnotus-omarorum
#15
Valentina Olivera-Pasilio, Moira Lasserre, María E Castelló
Adult neurogenesis, an essential mechanism of brain plasticity, enables brain development along postnatal life, constant addition of new neurons, neuronal turnover, and/or regeneration. It is amply distributed but negatively modulated during development and along evolution. Widespread cell proliferation, high neurogenic, and regenerative capacities are considered characteristics of teleost brains during adulthood. These anamniotes are promising models to depict factors that modulate cell proliferation, migration, and neurogenesis, and might be intervened to promote brain plasticity in mammals...
2017: Frontiers in Neuroscience
https://www.readbyqxmd.com/read/28851914/simulated-forward-and-backward-self-motion-based-on-realistic-parameters-causes-motion-induced-blindness
#16
Victoria Thomas, Matthew Davidson, Parisa Zakavi, Naotsugu Tsuchiya, Jeroen van Boxtel
Motion Induced Blindness (MIB) is a well-established visual phenomenon whereby highly salient targets disappear when viewed against a moving background mask. No research has yet explored whether contracting and expanding optic flow can also trigger target disappearance. We explored MIB using mask speeds corresponding to driving at 35, 50, 65 and 80 km/h in simulated forward (expansion) and backward (contraction) motion as well as 2-D radial movement, random, and static mask motion types. Participants (n = 18) viewed MIB targets against masks with different movement types, speed, and target locations...
August 29, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28825670/further-evidence-of-a-specific-psychopathology-of-addiction-differentiation-from-other-psychiatric-psychopathological-dimensions-such-as-obesity
#17
Angelo G I Maremmani, Luca Cerniglia, Silvia Cimino, Silvia Bacciardi, Luca Rovai, Alessandro Pallucchini, Vincenza Spera, Giulio Perugi, Icro Maremmani
Introduction: In this study, we used a symptomatology checklist (SCL-90) to substantiate the hypothesis that Substance Use Disorder (SUD) has its own five-dimensional psychopathology. The aim of the present study was to test whether this psychopathology can be differentiated from other psychiatric psychopathological dimensions (such as obesity). Methods: The severity and frequency of each of the five dimensions were investigated, at univariate and multivariate levels, by comparing 972 Heroin Use Disorder (HUD) patients (83...
August 21, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28739747/application-of-serum-elavl4-hud-antigen-assay-for-small-cell-lung-cancer-diagnosis
#18
Feifei Wang, Jianyi Lu, Shentao Li, Xueyun Huo, Xin Liu, Xiaoyan Du, Changlong Li, Jinghui Wang, Zhenwen Chen
BACKGROUND/AIM: The ELAVL4 (HuD) is a neuron-specific RNA-binding protein expressed in 100% of small cell lung cancer (SCLC) cells and over 50% of neuroblastoma cells. The aim of this study was to investigate the serum HuD concentration in SCLC patients and the possibility of its utilization as a biomarker of small cell lung cancer. MATERIALS AND METHODS: Our study included 47 SCLC cases and 29 normal controls. Indirect competitive inhibition ELISA method was established to detect HuD antigen of serum samples...
August 2017: Anticancer Research
https://www.readbyqxmd.com/read/28704196/antioxidant-capacity-and-phenolic-content-of-two-algerian-mentha-species-m-rotundifolia-l-huds-m-pulegium-l-extracted-with-different-solvents
#19
Fatiha Brahmi, Farid Dahmoune, Nabil Kadri, Mohmed Chibane, Soufiane Dairi, Hocine Remini, Sonia Oukmanou-Bensidhoum, Lotfi Mouni, Khodir Madani
Background It is important to consider the optimum conditions and processing factors (like solvent type) influencing activity of plant antioxidants for utilization in food and biological systems. Methods The antioxidant capacity and phenolic content of two Mentha species, namely, Mentha pulegium L. (MP) and Mentha rotundifolia (L.) Huds (MR), were studied and six solvent systems were used. The total antioxidant capacity of the mint species extracts was evaluated using phosphomolybdenum method and the free radical-scavenging capacity by 2,2-diphenyl-1-picrylhydrazyl radical-scavenging assay...
July 8, 2017: Journal of Complementary & Integrative Medicine
https://www.readbyqxmd.com/read/28661422/silicate-promoted-phosphorylation-of-glycerol-in-non-aqueous-solvents-a-prebiotically-plausible-route-to-organophosphates
#20
Maheen Gull, Brian J Cafferty, Nicholas V Hud, Matthew A Pasek
Phosphorylation reactions of glycerol were studied using different inorganic phosphates such as sodium phosphate, trimetaphosphate (a condensed phosphate), and struvite. The reactions were carried out in two non-aqueous solvents: formamide and a eutectic solvent consisting of choline-chloride and glycerol in a ratio of 1:2.5. The glycerol reacted in formamide and in the eutectic solvent with phosphate to yield its phosphorylated derivatives in the presence of silicates such as quartz sand and kaolinite clay...
June 29, 2017: Life
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