bluuebunny/crossref_metadata_2025_split huggingface dataset:
Factors That Influence FDA Decisions for Postmarketing Requirements and Commitments During Review of Oncology Products
Authors: Hyogo Atsushi , Kaneko Masayuki , Narukawa Mamoru 
Published: November 2017

Purpose: With the recent use of expedited drug development and approval programs for several oncology products in the United States, the importance of postmarketing plans to confirm clinical benefits and safety is increasing. To discuss postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required for oncology products approved in the United States, we investigated the factors that influenced the US Food and Drug Administration (FDA) decisions for PMR/PMCs during FDA review. Methods: Characteristics of new drug approvals and PMR/PMCs for oncology products (new molecular entities and new therapeutic biologic products) in the United States between 2008 and 2015 were analyzed. Results: Of the 58 oncology products analyzed, PMR/PMCs were required for 54 products. The proportion of approvals that required confirmatory PMR/PMCs was 100% for accelerated approval (AA) and was 39% for regular approval (RA). Median development times for AA and RA were 7.41 and 7.50 years, respectively. Randomization, number of patients, and end point in pivotal studies were identified as key potential factors that influenced the decision to require PMR/PMCs for both confirmatory and clinical safety studies. Conclusion: Robustness of the pivotal study design was identified as one of the key factors for the decision by the FDA to require PMR/PMCs—in particular, significant PMR/PMCs, such as those for confirmatory studies. That is, the FDA approved products with surrogate markers and smaller studies but required PMR/PMCs to fully prove the risk-benefit profile in the postmarketing period.
Assurance of Myeloid Growth Factor Administration in an Infusion Center: Pilot Quality Improvement Initiative
Authors: Ramirez Pamela Maree , Peterson Barry , Holtshopple Christine , Borja Kristina , Torres Vincent , Valdivia-Peppers Lucille , Harriague Julio , Joe Melanie D. 
Published: November 2017

Purpose: Four incident reports involving missed doses of myeloid growth factors (MGFs) triggered the need for an outcome-driven initiative. From March 1, 2015, to February 29, 2016, at University of California Irvine Health Chao Infusion Center, 116 of 3,300 MGF doses were missed (3.52%), including pegfilgrastim, filgrastim, and sargramostim. We hypothesized that with the application of Lean Six Sigma methodology, we would achieve our primary objective of reducing the number of missed MGF doses to < 0.5%. Methods: This quality improvement initiative was conducted at Chao Infusion Center as part of a Lean Six Sigma Green Belt Certification Program. Therefore, Lean Six Sigma principles and tools were used throughout each phase of the project. Retrospective and prospective medical record reviews and data analyses were performed to evaluate the extent of the identified problem and impact of the process changes. Improvements included systems applications, practice changes, process modifications, and safety-net procedures. Results: Preintervention, 24 missed doses (20.7%) required patient supportive care measures, resulting in increased hospital costs and decreased quality of care. Postintervention, from June 8, 2016, to August 7, 2016, zero of 489 MGF doses were missed after 2 months of intervention ( P < .001). Chao Infusion Center reduced missed doses from 3.52% to 0%, reaching the goal of < 0.5%. Conclusion: The establishment of simplified and standardized processes with safety checks for error prevention increased quality of care. Lean Six Sigma methodology can be applied by other institutions to produce positive outcomes and implement similar practice changes.
Ultrasound-Guided Dynamic Needle Tip Positioning Technique Versus Palpation Technique for Radial Arterial Cannulation in Adult Surgical Patients: A Randomized Controlled Trial
Authors: Kiberenge Roy K. , Ueda Kenichi , Rosauer Brett 
Published: November 2017

BACKGROUND:
Radial arterial cannulation is most commonly done using palpation, but the use of ultrasound has increased the cannulation success rate. This improvement, albeit significant, has not led to a very high success rate especially in trainees. A modified ultrasound technique for vascular cannulation (dynamic needle tip positioning) has been described for peripheral venous cannulation. We therefore assessed the success rate of this technique compared to the palpation technique for radial artery cannulation in adult surgical patients.

METHODS:
We enrolled patients who were having nonemergent operations that required a radial arterial catheter for intraoperative monitoring. Patients were randomized to either palpation or dynamic needle tip positioning technique. Arterial cannulation was performed by anesthesia residents or faculty members. The primary end point was successful cannulation on the first pass. Secondary end points were overall 5-minute success rate and number of attempts within 5 minutes.

RESULTS:
Two hundred sixty patients were evaluated. The first-pass success rate was 83% in the dynamic needle tip positioning technique group (n = 132) and 48% in the palpation group (n = 128; P < .001); relative risk was 2.5; 95% confidence interval, 1.7–3.6. The overall 5-minute success rate was 89% in the dynamic needle tip positioning technique group compared to 65% in the palpation group (P < .001), relative risk was 2.4; 95% confidence interval, 1.2–1.6. The number of skin puncture attempts was significantly more in the palpation group (P < .001). The median cannulation times and interquartile ranges were 81.5 (61–122) seconds in the dynamic needle tip positioning and 76 (48–175) seconds (P = .7) in the palpation group.

CONCLUSIONS:
The use of the ultrasound-guided dynamic needle tip positioning technique increased the first and overall success rates compared to palpation in anesthesia residents and faculty members.
Aircraft gas turbine engine vibration diagnostics
Authors: Fábry Stanislav , Češkovič Marek 
Published: November 2017

In the Czech and Slovak aviation are in service elderly aircrafts, usually produced in former Soviet Union. Their power units can be operated in more efficient way, in case of using additional diagnostic methods that allow evaluating their health. Vibration diagnostics is one of the methods indicating changes of rotational machine dynamics. Ground tests of aircraft gas turbine engines allow vibration recording and analysis. Results contribute to airworthiness evaluation and making corrections, if needed. Vibration sensors distribution, signal recording and processing are introduced in a paper. Recorded and re-calculated vibration parameters are used in role of health indicators.
Enero 17, 2003
Authors: Mendez Rafael Mauricio 
Published: November 2017

ResumenUna de las fotografías más célebres de Jesús Abad Colorado, muestra una escena en la cual dos personajes, Karina, una niña de corta edad, y Misael, su padre, huyen, acarreando sus pertenencias más preciadas, de un grupo armado que los persigue. Se trataría, simplemente, de una imagen más que da cuenta de las tribulaciones que han vivido, y viven, infinidad de seres humanos expulsados de sus territorios a causa de la guerra que azota al país desde hace décadas. Y, sin embargo, haciendo eco de la sutileza y la profundidad con la que el pensador alemán Aby Warburg se enfrenta a las imágenes, ésta en particular se encuentra muy distante de la continuidad simple de la percepción cotidiana. Hay allí sobrevivencias de un ritual bárbaro que, a pesar de haber, en apariencia, sido borrado de la faz de la tierra, se encuentra allí y coexiste atrozmente con la civilización.
The LILLIAD Innovation Learning Centre
Authors: Roche Julien 
Published: November 2017

Abstract
LILLIAD Innovation Learning Centre is a new building that incorporates a refurbishment of the former Central Library of Lille University of Science and Technologies, France, and an extension. LILLIAD is a project that has been developed over ten years and opened in September 2016. Three hubs have been created inside the new building: the library, the research showcase and the events facilities.
Library and Technology: The IE Library as a tool in the digital transformation of education’s reinvention
Authors: Real Zoco Bélen , de la Peña Martín María 
Published: November 2017

Abstract
The traditional view of the library is no longer applicable to the current, globalized and hyper-connected world. Users, eager for knowledge, demand data and information through the technology they use. The IE Library detects and anticipates the latest trends in technology and integrates them into the user experience. It is an essential part of the digital transformation in education. Being aware of the challenges and possibilities this transformation entails, the IE Library takes it to the next level by offering new formats and environments that are already part of its identity.
Neue Zentralbibliothek Dresden – gemeinsam mit Konzertsaal im denkmalgeschützten Kulturpalast eröffnet
Authors: Rabe Roman 
Published: November 2017

Zusammenfassung
Die Städtischen Bibliotheken Dresden konnten ihre beiden zentralen Einrichtungen und die Verwaltung jetzt in einem unter Denkmalschutz stehenden Bestandsgebäude von 1969 vereinen, in dem mit dem Umbau der alte Mehrzwecksaal durch einen Konzertsaal für die Dresdner Philharmonie ersetzt wurde. Ausgehend von einem bibliothekarischen Konzept entstand in einem fast zehnjährigen Planungsprozess eine Einrichtung, in der Anforderungen an eine moderne Öffentliche Bibliothek und Anforderungen, die das Gebäude stellte, zu tragfähigen Kompromisslösungen geführt werden mussten.
Formal Asymmetries between Active and Passive Clauses in Modern English: The Avoidance of Preposition Stranding with Verbs Featuring Omissible Prepositions
Authors: Rohdenburg Günter 
Published: November 2017

AbstractThis paper reports on the results of a corpus-based study that deals with a hitherto neglected kind of formal asymmetry between active and passive clauses involving two-place prepositional verbs like agree. These contrasts are found in the context of two satisfied conditions:
a)	The preposition in question is omissible, which holds for agree in present-day British English as in They agreed (on/upon/to/with) the proposal.
b)	Unlike active uses, passivization of relevant prepositional options necessarily results in preposition stranding as in The proposal has been agreed on/upon/to/with.
It is shown that – in both passive and active clauses – stranded prepositions tend to be omitted more often than non-stranded ones. Unlike the passive, the active provides only a restricted range of contexts compatible with the potential use of stranded prepositions. What is more, these environments are relatively infrequent with most verbs. This is what largely explains the active-passive asymmetries with the verbs explored in this paper. Crucially, however, stranded prepositions can in several cases be demonstrated to be more strongly avoided in the passive than the active, thus mirroring their cross-linguistic distribution (see e. g. Maling and Zaenen 1985; Truswell 2009). The voice contrast is found to be independent of diachronic changes resulting in either the loss or the acquisition of the prepositions involved.
Assessment of Characteristic Boundary Conditions Based on the Artificial Compressibility Method in Generalized Curvilinear Coordinates for Solution of the Euler Equations
Authors: Parseh Kaveh , Hejranfar Kazem 
Published: November 2017

Abstract
The characteristic boundary conditions are applied and assessed for the solution of incompressible inviscid flows. The two-dimensional incompressible Euler equations based on the artificial compressibility method are considered and then the characteristic boundary conditions are formulated in the generalized curvilinear coordinates and implemented on both the far-field and wall boundaries. A fourth-order compact finite-difference scheme is used to discretize the resulting system of equations. The solution methodology adopted is more suitable for this assessment because the Euler equations and the high-accurate numerical scheme applied are quite sensitive to the treatment of boundary conditions. Two benchmark test cases are computed to investigate the accuracy and performance of the characteristic boundary conditions implemented compared to the simplified boundary conditions. The sensitivity of the solution obtained by applying the characteristic boundary conditions to the different numerical parameters is also studied. Indications are that the characteristic boundary conditions applied improve the accuracy and the convergence rate of the solution compared to the simplified boundary conditions.
Are health care provider organizations ready to tackle diagnostic error? A survey of Leapfrog-participating hospitals
Authors: Newman-Toker David E. , Austin J. Matthew , Derk Jordan , Danforth Melissa , Graber Mark L. 
Published: November 2017

Abstract

Background:
A 2015 National Academy of Medicine report on improving diagnosis in health care made recommendations for direct action by hospitals and health systems. Little is known about how health care provider organizations are addressing diagnostic safety/quality.

Methods:
This study is an anonymous online survey of safety professionals from US hospitals and health systems in July–August 2016. The survey was sent to those attending a Leapfrog Group webinar on misdiagnosis (n=188). The instrument was focused on knowledge, attitudes, and capability to address diagnostic errors at the institutional level.

Results:
Overall, 61 (32%) responded, including community hospitals (42%), integrated health networks (25%), and academic centers (21%). Awareness was high, but commitment and capability were low (31% of leaders understand the problem; 28% have sufficient safety resources; and 25% have made diagnosis a top institutional safety priority). Ongoing efforts to improve diagnostic safety were sparse and mostly included root cause analysis and peer review feedback around diagnostic errors. The top three barriers to addressing diagnostic error were lack of awareness of the problem, lack of measures of diagnostic accuracy and error, and lack of feedback on diagnostic performance. The top two tools viewed as critically important for locally tackling the problem were routine feedback on diagnostic performance and culture change to emphasize diagnostic safety.

Conclusions:
Although hospitals and health systems appear to be aware of diagnostic errors as a major safety imperative, most organizations (even those that appear to be making a strong commitment to patient safety) are not yet doing much to improve diagnosis. Going forward, efforts to activate health care organizations will be essential to improving diagnostic safety.
Operator m-convex functions
Authors: Rooin Jamal , Alikhani Akram , Moslehian Mohammad Sal 
Published: November 2017

Abstract
The aim of this paper is to present a comprehensive study of operator m-convex functions.
Let

m
∈

[
0
,
1
]

{m\in[0,1]}

, and

J
=

[
0
,
b
]

{J=[0,b]}

for some

b
∈
ℝ

{b\in\mathbb{R}}

or

J
=

[
0
,
∞
)

{J=[0,\infty)}

.
A continuous function

φ
:

J
→
ℝ

{\varphi\colon J\to\mathbb{R}}

is called operator m-convex if for any

t
∈

[
0
,
1
]

{t\in[0,1]}

and any self-adjoint operators

A
,
B

∈

𝔹
⁢

(
ℋ
)

{A,B\in\mathbb{B}({\mathscr{H}})}

, whose spectra are contained in J, we have

φ
⁢

(

t
⁢
A

+

m
⁢

(

1
-
t

)

⁢
B

)

≤

t
⁢
φ
⁢

(
A
)

+

m
⁢

(

1
-
t

)

⁢
φ
⁢

(
B
)

{\varphi(tA+m(1-t)B)\leq t\varphi(A)+m(1-t)\varphi(B)}

.
We first generalize the celebrated Jensen inequality for continuous m-convex functions and Hilbert space operators and then use suitable weight functions to give some weighted refinements.
Introducing the notion of operator m-convexity, we extend the Choi–Davis–Jensen inequality for operator m-convex functions.
We also present an operator version of the Jensen–Mercer inequality for m-convex functions and generalize this inequality for operator m-convex functions involving continuous fields of operators and unital fields of positive linear mappings.
Employing the Jensen–Mercer operator inequality for operator m-convex functions, we construct the m-Jensen operator functional and obtain an upper bound for it.
Accuracy and reliability of gyro measurements at today’s tunnelling projects
Authors: Heunecke Otto , Liebl Wolfgang 
Published: November 2017

Abstract
Gyro theodolites – briefly gyros – allow the orientation transfer from a reference line to another line without need for a connecting geodetic network. They are routinely used for orientation control of networks in tunnelling projects. This is currently the only way to stabilize accuracy and reliability in tunnelling networks and is indispensable with respect of today’s requirements for excavation and breakthrough accuracy. In order to archive a reliable assessment of correctness, the measuring method has to be planned in a way that systematic influences in the determination of an underground directional angle are minimized. For this purpose, the principle of differential measurements is used for an azimuth determination both in terms of time as well as in space. All required corrections and reductions must be considered correctly to obtain the directional angle of interest with a measurement uncertainty less than 1 mgon ($\stackrel{\wedge }{=}3.{3^{\prime\prime }}$). Some accuracy considerations obtained from own experiences are discussed to state whether the specified standard deviations of the used gyros according to DIN 18723-7 can be confirmed.
Mitigation of Atmospheric Turbulences Using Mode Division Multiplexing based on Decision Feedback Equalizer for Free Space Optics
Authors: Almogahed Abdullah , Amphawan Angela , Fazea Yousef 
Published: November 2017

AbstractIn mode division multiplexing (MDM) free space optical (FSO) communication system, the atmospheric turbulences such as fog, rain, and haze cause adverse effects on system performance. This paper investigates the mitigation of atmospheric turbulences of FSO using MDM and decision feedback equalizer (DFE) with minimum mean square error (MMSE) algorithm. The implementation of the MMSE algorithm is used to optimize both the feedforward and the feedback filter coefficients of DFE. The proposed system comprises three parallel 2.5Gbit/s channels using Hermite–Gaussian modes. A data rate of 7.5Gbit/s over 40 m, 800 m, 1400 m, and 2km under medium fog, rain, haze, and clear weather, respectively, has been achieved. In addition, it is noticed that the link distance is reduced while increasing the attenuation. The simulation results revealed that a DFE improves the performance MDM FSO system while maintaining high throughput and desired low bit error rate.
Explaining asymmetries in number marking: Singulatives, pluratives, and usage frequency
Authors: Haspelmath Martin , Karjus Andres 
Published: November 2017

AbstractThis paper claims that crosslinguistic tendencies of number marking asymmetries can be explained with reference to usage frequency: The kinds of nouns which, across languages, tend to show singulative coding (with special marking of the uniplex member of a pair), rather than the more usual plurative coding (with special marking of the multiplex member), are also the kinds of nouns which tend to occur more frequently in multiplex use. We provide crosslinguistic coding evidence from a range of languages from different families and areas, and crosslinguistic corpus evidence from five languages, using large written corpora. Thus, the crosslinguistic pattern of singulative vs. plurative coding is a special instance of the tendency to devote more marking to rarer forms, and can be explained by the grammatical form-frequency correspondence principle.
On the interplay of object animacy and verb type during sentence comprehension in German: ERP evidence from the processing of transitive dative and accusative constructions
Authors: Czypionka Anna , Spalek Katharina , Wartenburger Isabell , Krifka Manfred 
Published: November 2017

AbstractComprehension of transitive sentences relies on different kinds of information, like word order, case marking, and animacy contrasts between arguments. When no formal cues like case marking or number congruency are available, a contrast in animacy helps the parser to decide which argument is the grammatical subject and which the object. Processing costs are enhanced when neither formal cues nor animacy contrasts are available in a transitive sentence. We present an ERP study on the comprehension of grammatical transitive German sentences, manipulating animacy contrasts between subjects and objects as well as the verbal case marking pattern. Our study shows strong object animacy effects even in the absence of violations, and in addition suggests that this effect of object animacy is modulated by the verbal case marking pattern.
Effects of temperature on the extraction of U(VI) and Pu(IV) by tris(2-methylbutyl) phosphate from nitric acid media
Authors: Suresh A. , Jayalakshmi S. , Sarkar Subramee , Sivaraman N. 
Published: November 2017

Abstract
Extraction behavior of tris(2-methylbutyl) phosphate (T2MBP), a higher homologue of tri-n-butyl phosphate (TBP), in the extraction of U(VI) and Pu(IV) from nitric acid media has been evaluated in the present study. Distribution ratios for the extraction of these metal ions by T2MBP were measured as a function of equilibrium aqueous phase nitric acid concentration, extractant concentration and temperature to understand the temperature effects on extraction. Enthalpies of extraction of T2MBP/n-dodecane-U(VI)-HNO3 and T2MBP/n-dodecane-Pu(IV)-HNO3 systems were calculated from the distribution ratio data using “second law” method. The data reveal that the extraction of U(VI) by T2MBP is exothermic in nature, whereas that of Pu(IV) is endothermic.
Temperatur-Komparator auf Basis eines druckgeregelten Wärmerohres
Authors: Krenek Stephan , Rudtsch Steffen 
Published: November 2017

Zusammenfassung
Der Vergleich der Temperaturwerte, die von unterschiedlichen Thermometern wiedergegeben werden, ist eine fundamentale
Aufgabe in der Thermometrie. Hierzu ist es notwendig die verschiedenen Interpolationsinstrumente zwischen den Fixpunkten
der Internationalen Temperaturskala von 1990 (ITS‑90) zu vergleichen, um konsistente Temperaturwerte mit geringsten
Unsicherheiten zu messen. Besonders zwischen den Erstarrungspunkten von Aluminium (660.323 ○C) und Silber
(961.78 ○C) sind diese Vergleiche wichtig. Trotzdem gibt es nur sehr wenige Vergleichsmessplätze für
diesen Temperaturbereich mit einer ausreichenden Temperaturstabilität.
Ein führender Hersteller von Wärmerohren und die PTB haben gemeinsam ein neues System entwickelt, das auf einem
Natriumwärmerohr und einer mechanischen Druckregelung basiert. Dieser sogenannte „Very Stable Temperature Comparator
(VSTC)“ kombiniert die exzellente Temperaturhomogenität, die von Wärmerohröfen bekannt ist, mit einer Stabilität im
Millikelvinbereich, die durch die Regelung des Natriumdampfdruckes erreicht wird. Mit diesem Messplatz können die
Messwerte von bis zu fünf Thermometern bei beliebigen Temperaturen zwischen 600 ○C und
1000 ○C verglichen werden. Erste Messungen zeigen eine Temperaturstabilität von 1.4 mK bei
1000 ○C.
Der VSTC und seine mechanische Druckregelung werden genauer beschrieben. Dabei werden auch die Aspekte diskutiert, die
notwendig sind, um ein sicheres Arbeiten mit Natrium als Arbeitsmedium des Wärmerohres zu gewährleisten.