25 research outputs found

    1.14 New working group – Testing side effects of microbials

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    For the developments with this working group, see these proceedings:Thomas Steeger - Working groups of the ICPPR Bee Protection Group – Developments and progress.For the developments with this working group, see these proceedings:Thomas Steeger - Working groups of the ICPPR Bee Protection Group – Developments and progress

    Minimal information for studies of extracellular vesicles 2018 (MISEV2018):a position statement of the International Society for Extracellular Vesicles and update of the MISEV2014 guidelines

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    The last decade has seen a sharp increase in the number of scientific publications describing physiological and pathological functions of extracellular vesicles (EVs), a collective term covering various subtypes of cell-released, membranous structures, called exosomes, microvesicles, microparticles, ectosomes, oncosomes, apoptotic bodies, and many other names. However, specific issues arise when working with these entities, whose size and amount often make them difficult to obtain as relatively pure preparations, and to characterize properly. The International Society for Extracellular Vesicles (ISEV) proposed Minimal Information for Studies of Extracellular Vesicles (“MISEV”) guidelines for the field in 2014. We now update these “MISEV2014” guidelines based on evolution of the collective knowledge in the last four years. An important point to consider is that ascribing a specific function to EVs in general, or to subtypes of EVs, requires reporting of specific information beyond mere description of function in a crude, potentially contaminated, and heterogeneous preparation. For example, claims that exosomes are endowed with exquisite and specific activities remain difficult to support experimentally, given our still limited knowledge of their specific molecular machineries of biogenesis and release, as compared with other biophysically similar EVs. The MISEV2018 guidelines include tables and outlines of suggested protocols and steps to follow to document specific EV-associated functional activities. Finally, a checklist is provided with summaries of key points

    Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension

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    OBJECTIVE: To evaluate whether eculizumab helps patients with anti-acetylcholine receptor-positive (AChR+) refractory generalized myasthenia gravis (gMG) achieve the Myasthenia Gravis Foundation of America (MGFA) post-intervention status of minimal manifestations (MM), we assessed patients' status throughout REGAIN (Safety and Efficacy of Eculizumab in AChR+ Refractory Generalized Myasthenia Gravis) and its open-label extension. METHODS: Patients who completed the REGAIN randomized controlled trial and continued into the open-label extension were included in this tertiary endpoint analysis. Patients were assessed for the MGFA post-intervention status of improved, unchanged, worse, MM, and pharmacologic remission at defined time points during REGAIN and through week 130 of the open-label study. RESULTS: A total of 117 patients completed REGAIN and continued into the open-label study (eculizumab/eculizumab: 56; placebo/eculizumab: 61). At week 26 of REGAIN, more eculizumab-treated patients than placebo-treated patients achieved a status of improved (60.7% vs 41.7%) or MM (25.0% vs 13.3%; common OR: 2.3; 95% CI: 1.1-4.5). After 130 weeks of eculizumab treatment, 88.0% of patients achieved improved status and 57.3% of patients achieved MM status. The safety profile of eculizumab was consistent with its known profile and no new safety signals were detected. CONCLUSION: Eculizumab led to rapid and sustained achievement of MM in patients with AChR+ refractory gMG. These findings support the use of eculizumab in this previously difficult-to-treat patient population. CLINICALTRIALSGOV IDENTIFIER: REGAIN, NCT01997229; REGAIN open-label extension, NCT02301624. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that, after 26 weeks of eculizumab treatment, 25.0% of adults with AChR+ refractory gMG achieved MM, compared with 13.3% who received placebo

    Minimal Symptom Expression' in Patients With Acetylcholine Receptor Antibody-Positive Refractory Generalized Myasthenia Gravis Treated With Eculizumab

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    The efficacy and tolerability of eculizumab were assessed in REGAIN, a 26-week, phase 3, randomized, double-blind, placebo-controlled study in anti-acetylcholine receptor antibody-positive (AChR+) refractory generalized myasthenia gravis (gMG), and its open-label extension

    A House But Not A Home? Measuring “Householdness” in the Daily Lives of Monticello's “Nail Boys”

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    Monticello, the plantation home of Thomas Jefferson, was also home to more than 100 African American slaves between 1771 and 1826. As many as 40 members of this community lived and worked on Mulberry Row, once a bustling avenue of residential and industrial activity adjacent to the Palladian mansion. Archaeological excavations in 1957 and 1982–1983 uncovered the remains of Mulberry Row's nailery, where preteen and teenaged enslaved “nail boys” manufactured nails for internal use and sale. These excavations revealed surprisingly high amounts of domestic artifacts, particularly ceramics and glass, indicating the young nailers also may have lived inside the nailery. This study investigates whether the nail boys maintained some semblance of childhood through ongoing participation in their parents’ households or fully took on the mantle of adulthood by forming a household of their own, independent of their parents, as expressed in the local production and consumption of household goods. This question is explored within the contexts of the archaeology of slavery, household archaeology, and the archaeology of children. The intersection of these three themes provides a richer and more realistic understanding of the boys’ complex lives. In this study, artifact abundance indices and Pearson residuals are used to compare artifacts from the nailery to artifacts from industrial and dwelling sites across Monticello plantation. I hypothesized that if the nail boys were participating in food production and consumption, the abundance of refined and utilitarian ceramics and glass would be similar to or higher than the abundance of those artifacts in dwelling sites. If the abundance of the nailery artifacts was lower than those for dwelling sites and was therefore more similar to those for industrial sites, the nail boys probably did not participate in domestic activities. The indices and residuals reveal a high abundance of refined ceramics and glass in the nailery and a low abundance of utilitarian ceramics, which would have been needed to cook and store food. The data suggest the nail boys engaged in the consumption of food and associated artifacts but participated in little or no food production. It is likely that their age and gender prevented them from fully engaging in food production within the nailery. This project adds to the fledgling research into slave children, who have traditionally been ignored by childhood, slave, and household archaeologists

    A House But Not A Home? Measuring Householdness in the Daily Lives of Monticello\u27s Nail Boys

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    Monticello, the plantation home of Thomas Jefferson, was also home to more than 100 African American slaves between 1771 and 1826. As many as 40 members of this community lived and worked on Mulberry Row, once a bustling avenue of residential and industrial activity adjacent to the Palladian mansion. Archaeological excavations in 1957 and 1982–-1983 uncovered the remains of Mulberry Row\u27s nailery, where preteen and teenaged enslaved “nail boys” manufactured nails for internal use and sale. These excavations revealed surprisingly high amounts of domestic artifacts, particularly ceramics and glass, indicating the young nailers also may have lived inside the nailery. This study investigates whether the nail boys maintained some semblance of childhood through ongoing participation in their parents\u27’ households or fully took on the mantle of adulthood by forming a household of their own, independent of their parents, as expressed in the local production and consumption of household goods. This question is explored within the contexts of the archaeology of slavery, household archaeology, and the archaeology of children. The intersection of these three themes provides a richer and more realistic understanding of the boys\u27’ complex lives. In this study, artifact abundance indices and Pearson residuals are used to compare artifacts from the nailery to artifacts from industrial and dwelling sites across Monticello plantation. I hypothesized that if the nail boys were participating in food production and consumption, the abundance of refined and utilitarian ceramics and glass would be similar to or higher than the abundance of those artifacts in dwelling sites. If the abundance of the nailery artifacts was lower than those for dwelling sites and was therefore more similar to those for industrial sites, the nail boys probably did not participate in domestic activities. The indices and residuals reveal a high abundance of refined ceramics and glass in the nailery and a low abundance of utilitarian ceramics, which would have been needed to cook and store food. The data suggest the nail boys engaged in the consumption of food and associated artifacts but participated in little or no food production. It is likely that their age and gender prevented them from fully engaging in food production within the nailery. This project adds to the fledgling research into slave children, who have traditionally been ignored by childhood, slave, and household archaeologists

    Overview of the testing and assessment of effects of microbial pesticides on bees : strengths, challenges and perspectives

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    Currently, there is a growing interest in developing biopesticides and increasing their share in the plant protection market as sustainable tools in integrated pest management (IPM). Therefore, it is important that regulatory requirements are consistent and thorough in consideration of biopesticides’ unique properties. While microbial pesticides generally have a lower risk profile, they present special challenges in non-target organism testing and risk assessment since, in contrast to chemical pesticides, their modes of action include infectivity and pathogenicity rather than toxicity alone. For this reason, non-target organism testing guidelines designed for conventional chemical pesticides are not necessarily directly applicable to microbial pesticides. Many stakeholders have recognised the need for improvements in the guidance available for testing microbial pesticides with honey bees, particularly given the increasing interest in development and registration of microbial pesticides and concerns over risks to pollinators. This paper provides an overview of the challenges with testing and assessment of the effects of microbial pesticides on honey bees (Apis mellifera), which have served as a surrogate for both Apis and non-Apis bees, and provides a foundation toward developing improved testing methods
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