435 research outputs found

    Continuing the Restoration and Transformation of the FDA

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    Health, Wealth, and the 21st Century Cures Act

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    Americans are increasingly apprehensive about our future, so it is inspiring when Congress produces legislation intended to both enhance our health and expand our economy. The 21st Century Cures Act,1 recently passed by the House with an impressive bipartisan majority vote of 344 to 77, intends to accelerate the many-step process of drug discovery and development, from basic scientific research to clinical development to delivery, distribution, and ongoing monitoring. Among other things, the legislation boosts National Institute of Health funding, dramatically speeds up the US Food and Drug Administration (FDA) approval process, and aims to make use of new information technology to better monitor the performance of medical products after they reach the market. This landmark bill now awaits a comparable piece of legislation being developed by the Senate Health Education, Labor, and Pensions Committee. Together, they will transform the biomedical ecosystem and provide the foundation for the next several decades of innovative life-saving and health-enhancing solutions for our nation and the world

    Vaginal hydrolytic enzymes, immunoglobulin A against Gardnerella vaginalis toxin, and risk of early preterm birth among women in preterm labor with bacterial vaginosis or intermediate flora

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    Objective: The purpose of this study was to determine whether the microbial hydrolytic enzymes, sialidase and prolidase, and immunoglobulin A against the Gardnerella vaginalis cytolysin (anti-Gvh IgA) increase the risk for early preterm birth ( 6434 weeks of gestation) among women with bacterial vaginosis or intermediate flora. Study Design: Two hundred eighteen afebrile women in preterm labor with intact membranes had a vaginal Gram stain performed, and sialidase, prolidase, and anti-Gvh IgA concentrations were determined. Results: Women with bacterial vaginosis or intermediate flora had significantly higher sialidase and prolidase concentrations than women with normal flora. Among women with bacterial vaginosis or intermediate flora, the women with sialidase had a higher rate of early preterm birth (P =.05). Sialidase had a sensitivity of 43% and specificity of 77% for early preterm birth. Prolidase and anti-Gvh IgA did not predict early preterm birth. Conclusion: Women in preterm labor with bacterial vaginosis or intermediate flora and detectable sialidase are at increased risk of early preterm birth

    Einfluss von BodenwasserverfĂŒgbarkeit und Mikroklima auf die Transpirationsdynamik von StadtbĂ€umen

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    StadtbĂ€ume leisten aufgrund ihrer KĂŒhlfunktion durch Transpiration einen positiven Beitrag zum urbanen Mikroklima. Gesteuert wird die Transpiration zum einen durch Klimaparameter und die artspezifische Physiologie, zum anderen durch die BodenwasserverfĂŒgbarkeit in der Wurzelzone. Unterschiedliche Standortbedingungen des stĂ€dtischen Raums fĂŒhren allerdings zu einer rĂ€umlichen sowie zeitlichen VariabilitĂ€t des zur Transpiration benötigten Bodenwassers. Unter welchen Bedingungen dies zu Trockenstress und damit einer eingeschrĂ€nkten KĂŒhlfunktion bei StadtbĂ€umen fĂŒhrt, hĂ€ngt dabei sowohl von der Baumart als auch von den standörtlichen Gegebenheiten ab. FĂŒr eine Verbesserung eines Stadtbaum-Managements wie auch von Klimamodellen des urbanen Raums ist es notwendig, weitere Kenntnisse ĂŒber die spezies- und standortspezifische VariabilitĂ€t der Transpirationsdynamik von StadtbĂ€umen zu erlangen. Zur direkten Erfassung der Transpirationsdynamik wurden wĂ€hrend der Vegetationsperioden 2013 und 2014 Xylemsaftflussmessung an etablierten Stieleichen (Quercus robur L.), eine der hĂ€ufigsten Stadtbaumarten in Hamburg, vorgenommen. Untersucht wurden je drei Eichen auf drei UntersuchungsflĂ€chen im Hamburger Stadtgebiet, welche durch unterschiedliche bodenhydrologische Eigenschaften gekennzeichnet waren. Die rĂ€umlich-zeitliche VariabilitĂ€t der BodenwasserverfĂŒgbarkeit wurde mittels kontinuierlicher Messungen von Bodenwassergehalt und Bodenwasserspotenzial ermittelt. Zur Erfassung der atmosphĂ€rischen Wassernachfrage sowie von Lufttemperatur und Strahlung wurden an allen Standorten Klimamessstationen errichtet. Basierend auf Klima- und Saftflussdaten wurde schließlich die potentielle Saftflussdynamik mithilfe eines Jarvis-Modells berechnet. WĂ€hrend beider Vegetationsperioden konnten deutliche standörtliche Unterschiede hinsichtlich Bodenhydrologie und Mikroklima aufgezeigt werden. Auf allen UntersuchungsflĂ€chen kam es zu unterschiedlich stark ausgeprĂ€gten Austrocknungen des Oberbodens, bei der in Tiefen zwischen 0 und 80 cm Bodenwasserpotenziale bis pF 3.95 festgestellt wurden. Es zeigte sich jedoch, dass im Untersuchungszeitraum die Saftflussdynamik auch bei deutlich verringerter BodenwasserverfĂŒgbarkeit allein durch Klimaparameter gesteuert wurde und damit weiterhin der potentiellen Saftflussdynamik folgte. Eine Limitierung des Saftflusses und damit der Transpiration dieser gut etablierten StadtbĂ€ume durch moderate Trockenheit konnte zu keinem Zeitpunkt festgestellt werden

    The Structure of Spatial Localization

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    Material objects, such as tables and chairs, have an intimate relationship with space. They have to be somewhere. They must possess an address at which they are found. Under this aspect, they are in good company. Events, too, such as Caesar’s death and John’s buttering of the toast, and more elusive entities, such as the surface of the table, have an address, difficult as it may be to specify. A stronger notion presents itself, though. Some entities may not only be located at an address; they may also own (as it were) the place at which they are located, so as to exclude other entities from being located at the same address. Thus, for certain kinds of entities, no two tokens of the same kind can be located at the same place at the same time. This is typically the case with material objects. Likewise, no two particularized properties of the same level or degree of determinacy can be located at the same place at the same time (although particularized properties of different degree, such as the red of this table and the color of this table, can). Other entities seem to evade the restriction. Two events can be perfectly co-located without competing for their address. Or, to use a different terminology, events do not occupy the spatial region at which they are located, and can therefore share it with other events. The rotation of the Earth and the cooling down of the Earth take place at exactly the same regio

    Inhibition of Vaginal Lactobacilli by a Bacteriocin-Like Inhibitor Produced by Enterococcus faecium 62-6: Potential Significance for Bacterial Vaginosis

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    Objective: Bacterial vaginosis (BV) is characterized by a shift in vaginal tract ecology, which includes a decrease in the concentration and/or prevalence of facultative lactobacilli. Currently, mechanisms which could account for the disappearance of lactobacilli are not well understood. The objective of this study was to determine whether vaginal streptococci/enterococci can produce bacteriocin-like inhibitors antagonistic to vaginal lactobacilli. Methods: Seventy strains of vaginal streptococci or enterococci were tested for antagonistic activities against vaginal lactobacilli using the deferred antagonism technique. Results: One strain, Enterococcus faecium 62-6, which strongly inhibited growth of lactobacilli was selected for further characterization. The spectrum of inhibitory activity of strain 62-6 included Gram-positive organisms from the vaginal environment, although native lactobacilli from the same host were resistant to inhibitor action. Following growth inMRSbroth the strain 62-6 inhibitor was shown to be heat- (100℃, 30 minutes), cold- (4℃, less than 114 days) and pH- (4–7) stable. The sensitivity of inhibitor-containing supernatants to pepsin and α-chymotrypsin suggested an essential proteinaceous component. The inhibitor was sensitive to lipase but resistant to lysozyme. Dialysis of inhibitor-containing culture supernatants suggested a molecular mass greater than 12 000 Da. All physicochemical properties were consistent with its classification as a bacteriocin-like inhibitor. Kinetic assays demonstrated a sharp onset of inhibitor production coinciding with a concentration of 62-6 of 10(7) cfu/ml, suggesting that production may be regulated by quorum sensing. Conclusions: These results may have clinical significance as a novel mechanism to account for the decline of vaginal Lactobacillus populations and contribute to both the establishment and recurrence of BV
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