312 research outputs found

    PIH53 Assessment of PRO Labels Claims Granted by the FDA as Compared to the EMA

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    PHP1 Incorporating the Patient's Voice Into the Assessment of Medical Devices: A Comparison of the United States and Europe

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    PMC21 PATIENT-REPORTED OUTCOMES IN PRODUCT DEVELOPMENT GUIDANCE

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    PMC21 PATIENT-REPORTED OUTCOMES IN PRODUCT DEVELOPMENT GUIDANCE

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    Medina Campeny, XavierHomenatge a Mercè Rodoreda amb una reproducció del personatge de la Colometa, a la Plaça del Diamant, novel·la de l'escriptora. Al 1984 es va posar provisionalment a la pl. Rius i Taulet. Al 1990 es va traslladar a l'actual emplaçament

    Recent environmental changes in the area of La Maddalena Harbour (Sardinia, Italy): data from mollusks and benthic foraminifera

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    Mollusks and benthic foraminifera are reliable tools to paleo-environmental reconstructions because they commonly occur in most marine habitats and are sensitive to major and short-lived changes of environmental drivers, induced by both natural and anthropogenic events. Their community structure provides useful information about the characteristics of their habitat and some species are sensitive to specific environmental controls. Features such as changes in species composition and community, or variation in test morphology provide evidence of fluctuation of several environmental factors. Therefore, both mollusks and benthic foraminifera can be used as an efficient method for identifying the history and ecological trajectory of marine ecosystems. This study focuses on the macro- (mollusks) and micropaleontological (benthic foraminifera) study of a 3 m long sediment core collected in the former military arsenal of the La Maddalena harbor (N Sardinia, Italy), at a depth of 15 m. The core site is located on the S-E coast of La Maddalena island, that underwent a complex history of human occupation along with natural environmental evolution and human-derived pressures. We aimed to reconstruct the main environmental changes recorded in the fossil benthic communities along the core, and to propose the most likely factors that caused these changes. Both mollusks and benthic foraminifera have been picked from the core, identified at genus/species level and counted. Ecological indications for each species have been extracted from literature. Univariate and multivariate statistics have been applied to highlight the community dynamics. More than 90 species of benthic foraminifera have been identified, and 101 mollusk species (846 specimens). The foraminifera diversity indices show a general reduction from the first 50 cm downcore. This slight decline is accompanied by changes in foraminiferal assemblages. The results concerning changes in foraminiferal species composition, their abundance and biodiversity, supported by statistical analyses (cluster analysis), allowed identification of three major foraminiferal associations corresponding to different marine coastal settings. The same results have been obtained by using mollusks and their ecological significance in the framework of benthic marine bionomics. Species are related to infralittoral vegetated bottom such as Posidonia meadows (HP) or photophilous algae through the core, but with variation in percentage of abundance, and HP species decreases from the bottom to the top, whereas species related to muddy bottom follow the opposite trend (coastal detritic mud, deep mud). This testifies that the area underwent a progressive reduction of Posidonia meadows and light-loving algae with a shift toward muddy bottoms, possibly related to the effect of the intensive renovation works of the harbor area. Moreover, radiocarbon dating obtained from Cerithium specimens indicated that the sedimentation rate increases in the upper portion of the core, according to the ecological signal reconstructed by the analysis of the mollusk assemblage

    PHP97 PRO LABEL CLAIMS: AN ANALYSIS BASED ON A REVIEW OF PROS AMONG NEW MOLECULAR ENTITIES AND BIOLOGIC LICENSE APPLICATIONS 2006-2010

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    Natural vs. Anthropic influence on the multidecadal shoreline changes of mediterranean urban beaches: Lessons from the Gulf of Cagliari (Sardinia)

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    Urban Mediterranean beaches are often characterized by a fragile and unstable equilibrium that can be easily altered by ongoing climate change and by the increase in human pressure. This may pose serious threats to the survival of beach systems that cannot accommodate these modifications. In this paper, the spatio-temporal shift of the shoreline was investigated along two urban beaches in the Gulf of Cagliari (Poetto and Giorgino; southern Sardinia, western Mediterranean Sea) across a time frame of 62 years (1954–2016). The Digital Shoreline Analysis System (DSAS) ArcGIS™ extension was used to extract different statistical parameters which allowed us to quantify the erosion and accretion rates. These data were further examined in relation to a number of anthropic and natural forcings in order to disentangle the factors controlling shoreline evolution. Eight sectors with interchanging net erosive and accretion trends were identified along the Poetto and Giorgino beaches. In six decades, some sectors of the two study sites appeared to have undergone great shoreline modification as a result of the intense anthropogenic activities impacting these coastal areas. The westernmost portions of both beaches were found to be the most vulnerable to erosion processes; such conditions were likely controlled by the interplaying of local hydrodynamics and by the intense coastal development which affected these sectors. The highest retreat rates (mean end point rate (EPR) = −0.51/year) were recorded in the western limit of Giorgino beach. Along the western limit of Poetto beach, EPR erosion rates (mean EPR = −2.92/year) considerably increased in the years after the artificial beach nourishment carried out in 2002, suggesting that the majority of the nourished material was lost offshore or partly redistributed along the beach. Coastal structures, urban development, river catchment modification, industrial and port activities, beach cleaning and touristic and recreational activities have been identified as the ongoing causes of coastal alteration. If these factors remain constant, under projected climate change scenarios, these beaches are at risk of further increased flooding and erosion. In this context, the application of DSAS appeared as an essential tool, supporting a monitoring system able to provide understanding and, potentially, predictions of the short-to long-term evolution of these beach systems

    Mortality and causes of death in patients with sporadic inclusion body myositis: Survey study based on the clinical experience of specialists in Australia, Europe and the USA

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    Background: There is a paucity of data on mortality and causes of death (CoDs) in patients with sporadic inclusion body myositis (sIBM), a rare, progressive, degenerative, inflammatory myopathy that typically affects those aged over 50 years. Objective: Based on patient records and expertise of clinical specialists, this study used questionnaires to evaluate physicians’ views on clinical characteristics of sIBM that may impact on premature mortality and CoDs in these patients. Methods: Thirteen physicians from seven countries completed two questionnaires online between December 20, 2012 and January 15, 2013. Responses to the first questionnaire were collated and presented in the second questionnaire to seek elaboration and identify consensus. Results: All 13 physicians completed both questionnaires, providing responses based on 585 living and 149 deceased patients under their care. Patients were reported to have experienced dysphagia (60.2%) and injurious falls (44.3%) during their disease. Over half of physicians reported that a subset of their patients with sIBM had a shortened lifespan (8/13), and agreed that bulbar dysfunction/dysphagia/oropharyngeal involvement (12/13), early-onset disease (8/13), severe symptoms (8/13), and falls (7/13) impacted lifespan. Factors related to sIBM were reported as CoDs in 40% of deceased patients. Oropharyngeal muscle dysfunction was ranked as the leading feature of sIBM that could contribute to death. The risk of premature mortality was higher than the age-matched comparison population. Conclusions: In the absence of data from traditional sources, this study suggests that features of sIBM may contribute to premature mortality and may be used to inform future studies

    Label-Free Optical Detection of Biomolecular Translocation through Nanopore Arrays

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    In recent years, nanopores have emerged as exceptionally promising single-molecule sensors due to their ability to detect biomolecules at subfemtomole levels in a label-free manner. Development of a high-throughput nanopore-based biosensor requires multiplexing of nanopore measurements. Electrical detection, however, poses a challenge, as each nanopore circuit must be electrically independent, which requires complex nanofluidics and embedded electrodes. Here, we present an optical method for simultaneous measurements of the ionic current across an array of solid-state nanopores, requiring no additional fabrication steps. Proof-of-principle experiments are conducted that show simultaneous optical detection and characterization of ssDNA and dsDNA using an array of pores. Through a comparison with electrical measurements, we show that optical measurements are capable of accessing equivalent transmembrane current information
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