bluuebunny/crossref_metadata_2025_split huggingface dataset:
Regulatory anticipation of postmarket safety problems for novel medicines approved by the EMA between 2001 and 2010: a cross‐sectional study
Authors: Zeitoun Jean‐David , Lefèvre Jérémie H. , Downing Nicholas S. , Bergeron Henri , Ross Joseph S. 
Published: November 2015

AbstractPurposeThe aim of the study is to describe preapproval safety concerns expressed by the European Medicines Agency (EMA) following regulatory review and to compare those concerns with subsequent issuance of postmarket safety communications.MethodsAll novel medicines approved by the EMA through the centralized authorization procedure from 2001 to 2010 were included. Preapproval safety concerns were identified through examination of information related to regulatory review publicly available on the EMA's website. Relevant postmarket safety events were identified through Dear Healthcare Professional Communications (DHPCs), including those resulting in a withdrawal, issued by at least one of four leading national regulators of the European Union.ResultsAmong the 184 novel medicines included, the EMA had expressed at least one preapproval safety concern for 110 (59.8%) of them. Then, at least one safety communication was issued for 53 (28.8%) medicines within the postmarket period of study, totaling 90 DHPCs and 5 withdrawals. Overall, these 95 DHPCs and withdrawals were pertaining to 66 different clinical safety events. The EMA had expressed a preapproval concern consistent with the postmarket safety event for 22.7% (15 of 66). The rate of issuance of a postmarket safety communication was not statistically different between medicines with or without any preapproval safety concern (31.8% vs. 24%, p = 0.25).ConclusionsPreapproval safety concerns are frequently expressed by the EMA following regulatory review. However, when comparing postmarket safety communications with prior concerns, anticipation was low. Our findings emphasize the need to systematically conduct postmarket studies dedicated to safety evaluation. Copyright © 2015 John Wiley & Sons, Ltd.
A comparative human health, ecotoxicity, and product environmental assessment on the production of organic and silicon solar cells
Authors: Tsang Michael P. , Sonnemann Guido W. , Bassani Dario M. 
Published: November 2015

AbstractA life cycle assessment case study involving organic photovoltaic technology using phenyl‐C61‐butyric acid methyl ester and poly(3‐hexylthiophene) is presented. Although solar technology converts freely available solar radiation into more useful forms of energy, potential environmental impacts can occur during the life cycle of the product. A cradle‐to‐gate life cycle assessment is completed, comparing organic solar cells with traditional silicon‐based cells across 18 multiple criteria. The functional unit is defined as the production of 1 watt‐peak of electricity produced. The inventory is based on prospective organic solar cell technology and two traditional silicon technologies. The results demonstrate that from a life cycle perspective, organic solar cells can outperform conventional silicon solar cells with impacts reduced by 93%. The energy payback time for the default organic photovoltaic cell was 0.21 years (75 days) compared with multicrystalline silicon and amorphous silicon's 2.7 and 2.2 years, respectively. The minimum required lifetime of the organic cells, so that their impacts were no worse than amorphous silicon's over 25 years, was measured between 1.2 and 8.9 years. Results of the sensitivity analysis demonstrate that consideration of manufacturing routes (e.g., fullerene or solar cell production) can be targeted using life cycle assessment for further improvements in the environmental, human health, and ecotoxicity profile of organic solar cells. Copyright © 2015 John Wiley & Sons, Ltd.
Tropical cyclones and climate change
Authors: Walsh Kevin J.E. , McBride John L. , Klotzbach Philip J. , Balachandran Sethurathinam , Camargo Suzana J. , Holland Greg , Knutson Thomas R. , Kossin James P. , Lee Tsz‐cheung , Sobel Adam , Sugi Masato 
Published: November 2015

Recent research has strengthened the understanding of the links between climate and tropical cyclones (TCs) on various timescales. Geological records of past climates have shown century‐long variations in TC numbers. While no significant trends have been identified in the Atlantic since the late 19th century, significant observed trends in TC numbers and intensities have occurred in this basin over the past few decades, and trends in other basins are increasingly being identified. However, understanding of the causes of these trends is incomplete, and confidence in these trends continues to be hampered by a lack of consistent observations in some basins. A theoretical basis for maximum TC intensity appears now to be well established, but a climate theory of TC formation remains elusive. Climate models mostly continue to predict future decreases in global TC numbers, projected increases in the intensities of the strongest storms and increased rainfall rates. Sea level rise will likely contribute toward increased storm surge risk. Against the background of global climate change and sea level rise, it is important to carry out quantitative assessments on the potential risk of TC‐induced storm surge and flooding to densely populated cities and river deltas. Several climate models are now able to generate a good distribution of both TC numbers and intensities in the current climate. Inconsistent TC projection results emerge from modeling studies due to different downscaling methodologies and warming scenarios, inconsistencies in projected changes of large‐scale conditions, and differences in model physics and tracking algorithms. WIREs Clim Change 2016, 7:65–89. doi: 10.1002/wcc.371This article is categorized under:

Paleoclimates and Current Trends > Earth System Behavior
How to price carbon in good times … and bad!
Authors: Doda Baran 
Published: November 2015

Emissions trading systems and carbon taxes are two market‐based policy instruments for responding to the climate change externality. This article focuses on the relationship between the design of these carbon pricing instruments and business cycle fluctuations. In particular, whether and how these instruments should respond to business cycles is a topical policy question. To answer it, the article brings together the relevant empirical and theoretical results from the academic literature. It finds that building responsiveness into the design of carbon pricing instruments can reduce the burden of regulation by distributing it more evenly over time. Specifically, relative to a fixed cap emissions trading system, this can be achieved by relaxing the cap during economic expansions and tightening it during recessions. Similarly, a carbon tax regime in which the tax is higher during expansions, and lower during recessions, is likely to improve welfare compared to a cyclically unresponsive tax. In practice, a mechanism which renders real‐world carbon pricing instruments responsive is challenging to construct. The article provides an overview of the trade‐offs involved by focusing on the broad classes of mechanisms explored in the literature. The choice of responsiveness‐inducing mechanism must crucially consider country characteristics such as the properties of fluctuations in the country's GDP and emissions, any relevant political economy concerns and its institutional background. WIREs Clim Change 2016, 7:135–144. doi: 10.1002/wcc.375This article is categorized under:

Climate Economics > Economics of Mitigation
Changes of Laryngeal Mobility and Symptoms Following Thyroid Surgery: 6‐Month Follow‐Up
Authors: Gohrbandt Antje E. , Aschoff Anna , Gohrbandt Bernhard , Keilmann Annemarie , Lang Hauke , Musholt Thomas J. 
Published: November 2015

AbstractObjectiveSwallowing disorders are frequent complaints after thyroidectomy even in the absence of recurrent laryngeal nerve palsy. The aim of this study was to assess different symptoms in relation to laryngeal mobility following thyroidectomy.Materials and methods53 patients (mean age 52.4 ± 12.5 years; 36 female) with initially benign diagnosis and intact recurrent nerve functioning were prospectively evaluated. Laryngeal movement was analyzed by ultrasound preoperatively and 1, 3, and 6 months postoperatively. In addition, a dysphagia and voice‐specific quality‐of‐life questionnaire was used.ResultsMean laryngeal movement differed between genders preoperatively and postoperatively resulting in a recovery predominantly in women (reduction of mobility at 1, 3, and 6 months postoperatively in females was 6.0, 3.7, and 1.5 mm, and in males 13.8, 11.7, and 10.3 mm, respectively). Mainly, women reported hoarseness (9 females) and cervical discomfort (7 females, 3 males) 1 month postoperatively. After 6 months, these complaints resolved (cervical discomfort 1 female).ConclusionLaryngeal mobility was significantly impaired postoperatively and only females revealed a recovery close to baseline after 6 months. Although showing only a small grade of recovery of laryngeal movement, subjective clinical symptoms were found to be rare in male patients.
Building psychosocial assets and wellbeing among adolescent girls: A randomized controlled trial
Authors: Leventhal Katherine Sachs , Gillham Jane , DeMaria Lisa , Andrew Gracy , Peabody John , Leventhal Steve 
Published: November 2015

ABSTRACTWe conducted a randomized controlled trial of a 5‐month resilience‐based program (Girls First Resilience Curriculum or RC) among 2308 rural adolescent girls at 57 government schools in Bihar, India. Local women with at least a 10th grade education served as group facilitators. Girls receiving RC improved more (vs. controls) on emotional resilience, self‐efficacy, social‐emotional assets, psychological wellbeing, and social wellbeing. Effects were not detected on depression. There was a small, statistically significant negative effect on anxiety (though not likely clinically significant). Results suggest psychosocial assets and wellbeing can be improved for girls in high‐poverty, rural schools through a brief school‐day program. To our knowledge, this is one of the largest developing country trials of a resilience‐based school‐day curriculum for adolescents.
The Swedish Aging With Spinal Cord Injury Study (SASCIS): Methodology and Initial Results
Authors: Jörgensen Sophie , Iwarsson Susanne , Norin Lizette , Lexell Jan 
Published: November 2015

AbstractBackgroundAdvances in acute treatment, physiatric care, and rehabilitation have improved survival greatly after spinal cord injury (SCI) and increased longevity. This has led to a need for an in‐depth understanding of factors associated with healthy aging in people with long‐term SCI.ObjectiveTo present the methodology and initial results of the Swedish Aging with Spinal Cord Injury Study, a longitudinal cohort survey targeting older adults with long‐term SCI.DesignCross‐sectional cohort study.SettingHome and community settings.ParticipantsPeople aged 50 years or older with SCI for at least 10 years.MethodsData were collected through interviews and assessments during home visits and from the participants' medical records.Main Outcome MeasurementsStudy‐specific protocol with custom‐designed questions, and validated generic and SCI‐specific assessment tools focusing on functioning, disability, health, well‐being, lifestyle, and personal and environmental factors.ResultsOf 795 potential participants, 184 matched the inclusion criteria and the final sample comprised 123 participants (67% response rate; 36 women and 87 men, mean age 63 ± 9 years, mean time since injury 24 ± 12 years). Traumatic SCI accounted for 62%, and 31% had sustained a complete SCI. A majority was married or had a partner, and used some form of assistance and/or mobility device. Thirty‐five percent were working full‐time or part‐time. Based on the American Spinal Injury Association Impairment Scale (AIS), 3 groups of SCI severity were formed. There were no significant differences in chronological age, marital status, or vocational situation between the tetraplegia AIS A‐C group (n = 22), the paraplegia AIS A‐C group (n = 41), and the all AIS D group (n = 60). Participants in the all AIS D group were significantly older at injury, had a shorter time since injury, and were less likely to use mobility devices compared with the other 2 groups.ConclusionThese baseline data of the Swedish Aging with Spinal Cord Injury Study provide a description of older adults with long‐term SCI. Forthcoming studies and subsequent follow‐ups will generate new insights into factors that promote healthy aging, minimize disability and enhance participation, quality of life, and life satisfaction in people aging with long‐term SCI.
Postural Stability in Osteoarthritis of the Knee and Hip: Analysis of Association With Pain Catastrophizing and Fear‐Avoidance Beliefs
Authors: Sánchez‐Herán Ángel , Agudo‐Carmona Diego , Ferrer‐Peña Raúl , López‐de‐Uralde‐Villanueva Ibai , Gil‐Martínez Alfonso , Paris‐Alemany Alba , La Touche Roy 
Published: November 2015

AbstractBackgroundPersons with knee osteoarthritis (OA) are at risk of having sensations of instability and sometimes experience buckling. The instability has been associated with psychosocial dysfunction, such as fear of movement, and impaired physical functioning. A high degree of fear of movement is positively correlated with avoidance in other conditions.ObjectiveTo evaluate the relationship between postural stability, the degree of pain catastrophizing, and fear‐avoidance beliefs in subjects with knee and hip OA.DesignDescriptive, cross‐sectional study.SettingFour primary health care centers.SubjectsEighty subjects with knee or combined knee and hip OA.InterventionsNot applicable.Main Outcome MeasurementsPostural stability was evaluated using the Multi‐Directional Functional Reach Test (MDFRT), and a battery of self‐reports was used to assess the following aspects: pain catastrophizing (Pain Catastrophizing Scale), fear‐avoidance beliefs (Tampa Scale for Kinesiophobia [TSK‐11] and the Fear‐Avoidance Beliefs Questionnaire), pain (visual analog scale), disability (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]), and self‐efficacy (Chronic Pain Self‐Efficacy Scale [CPSS]).ResultsThe correlation analysis showed that scores on the MDFRT were negatively associated with scores on the TSK‐11 for activity avoidance (r = −0.54; P < .001) and positively associated with the scores on the CPSS for coping (r = 0.59; P < .001). The scores for the MDFRT to the right and the total WOMAC were negatively associated (r = −0.61, P <.001). The scores for the MDFRT to the left were positively associated with the CPSS scores for coping (r = 0.64, P < .001). The scores for the MDFRT forward were predicted by CPSS and TSK‐11 scores (28.9% of variance), as well as activity avoidance, avoidance of physical activity, helplessness (34.7% of variance), and CPSS pain coping (34.3% of variance).ConclusionsThese findings suggest that pain catastrophizing and fear‐avoidance beliefs are related with postural stability in subjects with knee and hip OA. Postural stability is negatively correlated with pain catastrophizing and TSK activity avoidance. Thus, based on these results, psychosocial factors should be taken into consideration in the assessment and treatment of patients with hip and knee OA.
ON THE MERTENS–CESÀRO THEOREM FOR NUMBER FIELDS
Authors: FERRAGUTI ANDREA , MICHELI GIACOMO 
Published: November 2015

Let $K$ be a number field with ring of integers ${\mathcal{O}}$. After introducing a suitable notion of density for subsets of ${\mathcal{O}}$, generalising the natural density for subsets of $\mathbb{Z}$, we show that the density of the set of coprime $m$-tuples of algebraic integers is $1/{\it\zeta}_{K}(m)$, where ${\it\zeta}_{K}$ is the Dedekind zeta function of $K$. This generalises a result found independently by Mertens [‘Ueber einige asymptotische Gesetze der Zahlentheorie’, J. reine angew. Math. 77 (1874), 289–338] and Cesàro [‘Question 75 (solution)’, Mathesis 3 (1883), 224–225] concerning the density of coprime pairs of integers in $\mathbb{Z}$.
Keeping a House for Science: Sofia Kristensson as Matriarch and Gatekeeper at Kristineberg Zoological Station as a Scientific Household, 1877–1889
Authors: Ekerholm Helena 
Published: November 2015

ArgumentField research stations are households as a result of allegoric notions of the scientific family, and because they fulfill the purpose of a home in the field in a literal sense. They meet the practical and physical need for bed and board, as well as the emotional and intellectual need for social cohesion. I argue that this, in combination with local gender identity, opened the door for a woman of lower social strata, the daughter of a fisherman, to take upon herself the role as station household matriarch, thus gaining an integral role within an inner circle of influential scientists. Secondly, I argue that locally employed members of the research station were valued primarily for their social skills. For the sake of ensuring necessary conditions for scientific work, being abrasive was just as important as being agreeable.
Vibrio cholerae O1 El Tor from southern Vietnam in 2010 was molecularly distinct from that present from 1999 to 2004
Authors: NGUYEN V. H. , PHAM H. T. , DIEP T. T. , PHAN C. D. H. , NGUYEN T. Q. , NGUYEN N. T. N. , NGO T. C. , NGUYEN T. V. , DO Q. K. , PHAN H. C. , NGUYEN B. M. , EHARA M. , OHNISHI M. , YAMASHIRO T. , NGUYEN L. T. P. , IZUMIYA H. 
Published: November 2015

SUMMARYThe Vibrio cholerae O1 (VCO1) El Tor biotype appeared during the seventh cholera pandemic starting in 1961, and new variants of this biotype have been identified since the early 1990s. This pandemic has affected Vietnam, and a large outbreak was reported in southern Vietnam in 2010. Pulsed-field gel electrophoresis (PFGE) and multilocus variable-number tandem-repeat analyses (MLVA) were used to screen 34 VCO1 isolates from the southern Vietnam 2010 outbreak (23 patients, five contact persons, and six environmental isolates) to determine if it was genetically distinct from 18 isolates from outbreaks in southern Vietnam from 1999 to 2004, and two isolates from northern Vietnam (2008). Twenty-seven MLVA types and seven PFGE patterns were identified. Both analyses showed that the 2008 and 2010 isolates were distinctly clustered and separated from the 1999–2004 isolates.
Genotype distribution characteristics of high-risk human papillomaviruses in women from Shanghai, China
Authors: GU Y. , YI M. , XU Y. , ZHAO H. , FU F. , ZHANG Y. 
Published: November 2015

SUMMARYHigh-risk human papillomaviruses (HPVs) are highly prevalent worldwide, and HPV genotype distribution varies regionally. Molecular surveys of HPVs are important for effective HPV control and prevention. Fifteen high-risk HPV strains (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) and six low-risk HPV strains (HPV6, 11, 42, 43, 44, CP8304) were detected by cervical cytology from 10 501 subjects. High-risk HPVs, low-risk HPVs, and both high- and low-risk HPVs were detected in 14·5%, 2·8%, and 2·4% of cases, respectively. Of 1782 subjects with high-risk HPV infection, 75·5%, 18·1%, and 6·4% were infected with one, two, and ⩾3 strains of high-risk HPVs, respectively. HPV52, HPV16, and HPV58 were the top three most dominant high-risk HPV genotypes in our population with positivity rates of 23·0%, 17·7% and 16·9%, respectively. Multiple infection was common, with significantly higher co-infection rates of HPV58/HPV33 (12·9%) and HPV58/HPV52 (11·3%). Further data comparisons showed that HPV genotype distribution varied markedly between domestic and international regions. In conclusion, a monolithic vaccination strategy is obviously impractical, and regional HPV surveillance is essential to optimize current HPV control and prevention.
Research and Evaluations of the Health Aspects of Disasters, Part III: Framework for the Temporal Phases of Disasters
Authors: Birnbaum Marvin L. , Daily Elaine K. , O’Rourke Ann P. 
Published: November 2015

AbstractEach of the elements described in the Conceptual Framework for disasters has a temporal designation; each has a beginning and end time. The Temporal Framework defines these elements as phases that are based on characteristics rather than on absolute times. The six temporal phases include the: (1) Pre-event; (2) Event; (3) Structural Damage; (4) Functional Damage (changes in levels of functions of the Societal Systems); (5) Relief; and (6) Recovery phases. Development is not a phase of a disaster. The use of the Temporal Framework in studying and reporting disasters allows comparisons to be made between similar phases of different disasters, regardless of the hazard involved and/or the community impacted. For research and evaluation purposes, assessments, plans, and interventions must be described in relation to the appropriate temporal phase.BirnbaumML,DailyEK,O’RourkeAP.Research and evaluations of the health aspects of disasters, part III: framework for the temporal phases of disasters.Prehosp Disaster Med.2015;30(6):628–632.
Automated sample preparation for mercury analysis in wood materials
Authors: Vorberg Ellen , Fleischer Heidi , Junginger Steffen , Stoll Norbert , Thurow Kerstin 
Published: November 2015

Laboratories that provide element‐specific measurements will gain on improved quality and better economical results by automating the required sample pre‐treatment. Commercially available, automated workstations are usually configured for handling the standardised multi‐titer‐plate‐format facilitating biological applications. In contrast, automating analytical processes, such as element‐specific applications, is still an unsolved challenge due to the required, specific process conditions. Therefore, the purpose of the presented work was the design and the realisation of an automated system providing precise sample pre‐treatment for element‐specific measurements. Finally, the developed system was successfully evaluated and ensures reliable sample pre‐treatment. The designed, flexible performance solution enables both system adaption and simultaneous sample handling. Moreover, the developed system allows for environmental investigations in a 24/7 manner. The results of the automated mercury analysis are in excellent agreement with the true value corresponding to a level of confidence of ∼95% (P = 95%) while using referenced and real wood materials.
Meshless analysis of bilayer graphene nanoribbon for radio frequency interconnects
Authors: Kanthamani S. , Gayathiri G. , Rohini S. 
Published: November 2015

Numerical analysis of a bilayer graphene nanoribbon (BLGNR) using the reproducing kernel particle method (RKPM) – a true meshless approach – is reported. Electrostatic analysis of the BLGNR is performed using the RKPM approach. Validation of the structure is executed by comparing the result with an equivalent single conductor model and shows better accordance. Radio frequency (RF) analysis of the BLGNR as the interconnect is studied using advanced design systems with the quasi‐static analysis derived through the RKPM method. The simulation results in a return loss of −89.69 dB and transmission loss of −0.00028 dB at 1 THz which is suitable for RF interconnect applications.