bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficient Methods for Signal Detection From Correlated Adverse Events in Clinical Trials
Authors: Diao Guoqing , Liu Guanghan F. , Zeng Donglin , Wang William , Tan Xianming , Heyse Joseph F. , Ibrahim Joseph G. 
Published: January 2019

AbstractIt is an important and yet challenging task to identify true signals from many adverse events that may be reported during the course of a clinical trial. One unique feature of drug safety data from clinical trials, unlike data from post-marketing spontaneous reporting, is that many types of adverse events are reported by only very few patients leading to rare events. Due to the limited study size, the p-values of testing whether the rate is higher in the treatment group across all types of adverse events are in general not uniformly distributed under the null hypothesis that there is no difference between the treatment group and the placebo group. A consequence is that typically fewer than percent of the hypotheses are rejected under the null at the nominal significance level of . The other challenge is multiplicity control. Adverse events from the same body system may be correlated. There may also be correlations between adverse events from different body systems. To tackle these challenging issues, we develop Monte-Carlo-based methods for the signal identification from patient-reported adverse events in clinical trials. The proposed methodologies account for the rare events and arbitrary correlation structures among adverse events within and/or between body systems. Extensive simulation studies demonstrate that the proposed method can accurately control the family-wise error rate and is more powerful than existing methods under many practical situations. Application to two real examples is provided.
Analysing multisource feedback with multilevel structural equation models: Pitfalls and recommendations from a simulation study
Authors: Mahlke Jana , Schultze Martin , Eid Michael 
Published: January 2019

When multisource feedback instruments, for example, 360‐degree feedback tools, are validated, multilevel structural equation models are the method of choice to quantify the amount of reliability as well as convergent and discriminant validity. A non‐standard multilevel structural equation model that incorporates self‐ratings (level‐2 variables) and others’ ratings from different additional perspectives (level‐1 variables), for example, peers and subordinates, has recently been presented. In a Monte Carlo simulation study, we determine the minimal required sample sizes for this model. Model parameters are accurately estimated even with the smallest simulated sample size of 100 self‐ratings and two ratings of peers and of subordinates. The precise estimation of standard errors necessitates sample sizes of 400 self‐ratings or at least four ratings of peers and subordinates. However, if sample sizes are smaller, mainly standard errors concerning common method factors are biased. Interestingly, there are trade‐off effects between the sample sizes of self‐ratings and others’ ratings in their effect on estimation bias. The degree of convergent and discriminant validity has no effect on the accuracy of model estimates. The χ2 test statistic does not follow the expected distribution. Therefore, we suggest using a corrected level‐specific standardized root mean square residual to analyse model fit and conclude with further recommendations for applied organizational research.
Evaluation of L‐PRF combined with deproteinized bovine bone mineral for early implant placement after maxillary sinus augmentation: A randomized clinical trial
Authors: Pichotano Elton Carlos , de Molon Rafael Scaf , de Souza Ricardo Violante , Austin Rupert S. , Marcantonio Elcio , Zandim‐Barcelos Daniela Leal 
Published: January 2019

AbstractPurposeTo investigate the effectiveness of adding leukocyte and platelet‐rich fibrin (L‐PRF) to deproteinized bovine bone mineral (DBBM) for early implant placement after maxillary sinus augmentation.Materials and MethodsTwelve patients requiring two‐stage bilateral maxillary sinus augmentation were enrolled to the study. The elevated sinus cavities were randomly grafted with DBBM + L‐PRF (test) or DBBM alone (control) in a split‐mouth design. Implants were placed in the augmented sites after 4 months in the test group and 8 months in the control group. Bone biopsies were collected during implant placement for histomorphometric evaluation. Resonance frequency analysis was performed immediately after implant placement and at implant loading in both groups. Cone‐beam computed tomography was obtained preoperatively and postoperatively for evaluation of graft volume changes.ResultsBoth procedures were effective for maxillary sinus augmentation. Cone‐beam computed tomography analysis did not reveal differences in graft volume between test and control group at any of the evaluated time points (P > .05). Histological evaluation demonstrated increased percentage of newly formed bone for the test group (44.58% ± 13.9%) compared to the control group (30.02% ± 8.42%; P = .0087). The amount of residual graft in the control group was significantly higher (13.75% ± 9.99%) than in the test group (3.59 ± 4.22; P = .0111). Implant stability quotient (ISQ) immediately after implant placement was significantly higher in the control group (75.13 ± 5.69) compared to the test group (60.9 ± 9.35; P = .0003). The ISQ values at loading did not differ between the groups (P = .8587). Implant survival rate was 100% for both groups.ConclusionThe addition of L‐PRF to the DBBM into the maxillary sinus allowed early implant placement (4 months) with increased new bone formation than DBBM alone after 8 months of healing.
Implant vs abutment level connection in implant supported screw‐retained fixed partial dentures with cobalt‐chrome framework: 1‐year interim results of a randomized clinical study
Authors: Toia Marco , Stocchero Michele , Becktor Jonas P. , Chrcanovic Bruno , Wennerberg Ann 
Published: January 2019

AbstractBackgroundScrew‐retained fixed partial dentures (FPD) have shown a lower incidence of biologic complications and an easier retrievability compared with cemented FPD.PurposeTo compare the marginal bone loss at conical connection implant restored with a screw retained cobalt‐chrome FPD in an implant‐level (IL) or an abutment‐level (AL) setup.Materials and MethodsPatients with at least two adjacent missing teeth were randomly allocated to be restored with IL or AL FPD. Periapical radiographs and clinical examination were taken at implant placement, prosthetic connection, 6 and 12 months to evaluate marginal bone loss (MBL), and soft tissue conditions. Complications were used to calculate prognostic indexes.ResultsFifty patients were treated with 50 FPD supported by 119 implants. The difference of MBL between the IL and AL groups was statistically significant (P = 0.003). At 1 year, MBL was 0.086 ± 0.313 mm and 0.005 ± 0.222 mm in the IL and AL groups, respectively. The presence of BoP increased with time in IL, whereas it decreased in AL group (P < 0.001). A minor complication was encounted in one FPD.ConclusionsA low grade of MBL was present after 1 year. IL showed greater amount of MBL and soft tissue inflammation indexes than AL. In FPD, AL may be a safer procedure than IL setup in order to preserve a healthy periimplant tissue.
Perceived challenges in the informed consent process: Mismatches between enrollers and researchers at a South African clinical research site
Authors: Scott Megan , Watermeyer Jennifer , Nolle Samantha , Penn Claire 
Published: January 2019

AbstractEnrollers play a critical yet often overlooked role in clinical research, particularly in informed consent processes. Study retention may depend in part on how complex information is conveyed to potential participants. This qualitative study aimed to assess communicative barriers during consent and enrolment in two South African TB/HIV clinical studies. In particular, we compared our own perceptions of potential challenges to consent with that of thirteen enrollers, gained via reflective journaling and focus group discussions. Some overlap of identified challenges was evident, including terminology, jargon and consent document format. However there were mismatches to identified challenges. Enrollers provided further insights into potential challenges to consent, in particular, blood withdrawal, discussion of sexual issues and misunderstanding of study participation. Enrollers also reported feeling ill‐equipped to provide counselling when participants became distressed. We offer several recommendations for strengthening the inclusion of enrollers in the development of clinical research protocols and consent documents.
The neoliberal turn in Higher Education
Authors: Tight Malcolm 
Published: January 2019

AbstractRecent writing on Higher Education has seen much policy and practice attributed to the advent or impact of neoliberalism. This paper examines the origins and meaning of the term, its application to Higher Education and Higher Education research, and the issues and critique that have been raised in this context. It is argued that neoliberalism is just one more in a whole series of ‘fright terms’ used in an attempt to galvanise opposition and resistance to the current directions of Higher Education policy and practice.
Changes in phenolics, γ‐aminobutyric acid content and antioxidant, antihypertensive and hypoglycaemic properties during ale white sorghum (Sorghum bicolor (L.) Moench) brewing process
Authors: Garzón Antonela G. , Torres Roberto L. , Drago Silvina R. 
Published: January 2019

SummaryEffects of white sorghum brewing process on free amino‐acids, γ‐aminobutyric acid (GABA), phenolics and bioactivity, including antioxidant (by ABTS+ and reducing power, RP, methods), antihypertensive (angiotensin converting enzyme‐I, ACE‐I inhibition assay), and hypoglycaemic activity (α‐glucosidase inhibition assay) were evaluated. From the wort to the beer, free amino acids decreased, but GABA and phenolics increased significantly, positively modifying the bioactive potential. ABTS and α‐glucosidase inhibition activity correlated positively with at least one of the phenolic acids evaluated. Ale white sorghum beer presented high content of GABA (7.8 mg L−1), phenolics (40.7 mg total phenolic acids L−1), antioxidant activity (9.14 mmol Trolox equivalent L−1, and 48.8 mmol ascorbic acid equivalent L−1, for ABTS+ and RP, respectively), and exhibit ACE‐I inhibition (1.0 μg captopril equivalent L−1) and α‐glucosidase inhibition (34.5 mg acarbose equivalent L−1) activities. The level of bioactive compounds and its low ethanol content (2.3%), make beer obtained from malted white sorghum a potential functional beverage.
Children and adolescents' exposure to food and beverage marketing in social media apps
Authors: Potvin Kent Monique , Pauzé Elise , Roy Elisabeth‐Anne , de Billy Nicholas , Czoli Christine 
Published: January 2019

SummaryBackgroundUnhealthy food marketing is a powerful determinant of unhealthy diets and obesity among children. Although it is known that food marketers target young people on social media, no study has yet quantified children's exposure on these platforms.ObjectivesTo compare the frequency and healthfulness of food marketing seen by children and adolescents on social media apps as well as estimate their weekly exposure.Methods101 children and adolescents (ages 7‐16 years) completed a survey on their media use and were recorded using their two favourite social media apps for 5 minutes each on the mobile device they usually use. Recordings of app use were reviewed to identify food marketing exposures.ResultsOverall, 72% of participants were exposed to food marketing. Of the 215 food marketing exposures identified, most promoted unhealthy products such as fast food (44%) and sugar‐sweetened beverages (9%). Adolescents viewed more instances of food marketing, on average, per 10‐minute period compared with children (Mean [SD] = 2.6 [2.7] versus 1.4 [2.1], U = 1606, z = 2.94, P = 0.003). It was also estimated that children and adolescents see food marketing 30 and 189 times on average per week on social media apps, respectively.ConclusionsStatutory regulations restricting unhealthy food marketing to adolescents and children on social media should be considered.
Development of a perceived exertion scale for dogs using selected physiologic parameters
Authors: Swanson K. D. J. , Harper T. A. M. , McMichael M. , Fries R. C. , Lascola K. M. , Chandler C. , Schaeffer D. J. , Chinnadurai S. K. 
Published: January 2019

ObjectiveTo develop a perceived exertion scale for dogs exercising on a treadmill and to assess intra‐ and inter‐observer variability.Materials and MethodsFifteen healthy client‐owned dogs participated in paired exercise trials. Measurements of lactate, glucose, heart rate, temperature, respiratory rate and regional tissue oximetry were obtained before, during and after exercise. Perceived exertion scale scores were recorded during exercise and using video recordings to evaluate inter‐observer variability. Correlations were evaluated using the Spearman's non‐parametric method.ResultsThirteen dogs completed both trials. Dogs walked or trotted on the treadmill with an average perceived exertion score of 2 in both trials. Holter heart rate was positively correlated with perceived exertion scale scores from all observers for both trials. In trial 1, plasma glucose decreased in association with increase in perceived exertion and, in trial 2, cutaneous oximetry decreased, respiratory rate increased and temperature increased with increases on the perceived exertion scale. Inter‐observer perceived exertion scale scores were positively correlated in both trials. There was no intra‐observer variability between trials.Clinical SignificanceThe perceived exertion scale correlated with the measured physiologic parameters in dogs exercising at mild to moderate intensity. The perceived exertion scale was consistent and repeatable but larger study numbers and further validation are needed before it can be widely applied.
In vitro digestion of bread: How is it influenced by the bolus characteristics?
Authors: Gao Jing , Lin Suyun , Jin Xiaoxuan , Wang Yong , Ying Jian , Dong Zhizhong , Zhou Weibiao 
Published: January 2019

AbstractThis study aimed to understand the impact of in vitro oral processing methods on bolus formation and the kinetics of starch hydrolysis of refined white bread during in vitro gastrointestinal digestion. Four in vitro oral processing methods (i.e., cut, cut‐and‐pestle, blend, and grind) were performed at two levels of disintegration (less and more intensive) and compared with human mastication. Boluses prepared using the in vitro methods had a larger particle size (20–69 mm2 vs. 14 mm2), a higher moisture content (64–68% vs. 47%), a softer texture (1.3–2.3 N vs. 6.3 N) and a less adhesive surface (0.3–1.0 vs. 1.6 N•s) as compared to the in vivo masticated ones. Moreover, in vitro prepared blouses were digested more rapidly than in vivo masticated ones during the stimulated intestinal digestion from 150 min onward, with a higher hydrolysis rate (0.011–0.012 mg/mL • min vs. 0.010 mg/mL • min) and a higher equilibrium concentration of reducing sugar (5.5–6.3 mg/mL vs. 4.9 mg/mL). Among all the in vitro methods, the blending and grinding methods produced boluses that most closely resemble the in vivo masticated ones in terms of their physical characteristics. The blending method also produced boluses having the highest amount of reducing sugar released (6.32 mg/mL). The amount of reducing sugar present in the PBS buffer outside the dialysis tube might be controlled by the diffusion efficiency at the beginning of the digestion (≤120 min) and then be largely influenced by the particle size of the bolus in the latter stage of the digestion.Practical applicationStudying the in vitro starch amyloysis is valuable for predicting the postprandial glycemic potential of starchy food. This work provides novel insights on the role of in vitro oral processing in the prediction of the glycemic potential of carbohydrate‐rich staple food. Blending method is recommended because of its ability to produce boluses with similar physical characteristics as the in vivo masticated boluses. But the excessive structural breakdown occurred during blending also resulted in a higher enzymatic accessibility and a higher rate of starch digestion. Further study is needed to propose a new in vitro method that stimulates multiple actions occurred during mastication (cutting, grinding, and shearing), in order to match both physical properties and digestion profiles. Moreover, the amount of artificial saliva added should be adjusted according to the specific type of food.
Zum Stil einer digital geprägten Leserealität
Authors: Kraxenberger Maria 
Published: January 2019

Der vorliegende Beitrag setzt sich mit der Trilogie Fifty Shades of Grey von EL James auseinander, die aufgrund ihres großen internationalen Erfolgs ein Beispiel für ein massenphänomenales Leseereignis zu Beginn des einundzwanzigsten Jahrhunderts darstellt. Ziel der vorrangig deskriptiven Auseinandersetzung, die durch ein Interview mit der deutschen Lektorin der Trilogie ergänzt wird, ist ein besseres Verständnis dieser Leserealität, die insbesondere durch eine Beschreibung des Stils von Fifty Shades of Grey in ihrer Funktionalität und potentiellen Wirkung auf die LeserInnen erklärbar wird. Hierbei wird Fifty Shades of Grey auch vor dem Hintergrund des beteiligten Sozialsystems Literatur diskutiert um aufzuzeigen, wie und in welchem Ausmaß die Trilogie, beziehungsweise deren Entstehung und Verbreitung, von digitalen Aspekten bestimmt und beeinflusst ist. In einem ersten Schritt werden hierfür die relevanten Eigenschaften des Dargestellten und der Darstellung der Texte identifiziert.In einem zweiten Schritt dienen diese Merkmalsbeschreibungen in der Synthese einer Stilbeschreibung von Fifty Shades of Grey. Zusammenfassend kann dieser Stil als überaus emotional sowie von großem Affizierungspotential für die LeserInnen beschrieben werden und scheint auf einen Lustgewinn durch verschiedene Begehrlichkeiten der Trilogie angelegt. Der Beitrag endet mit einem Ausblick auf zukünftige Untersuchungen populärer und polarisierender Leserealitäten, welche vor dem Hintergrund des beginnenden einundzwanzigsten Jahrhunderts besonders relevant erscheinen.
Development of an integrated 200K SNP genotyping array and application for genetic mapping, genome assembly improvement and genome wide association studies in pear (Pyrus)
Authors: Li Xiaolong , Singh Jugpreet , Qin Mengfan , Li Siwei , Zhang Xun , Zhang Mingyue , Khan Awais , Zhang Shaoling , Wu Jun 
Published: January 2019

SummaryPear (Pyrus; 2n = 34), the third most important temperate fruit crop, has great nutritional and economic value. Despite the availability of many genomic resources in pear, it is challenging to genotype novel germplasm resources and breeding progeny in a timely and cost‐effective manner. Genotyping arrays can provide fast, efficient and high‐throughput genetic characterization of diverse germplasm, genetic mapping and breeding populations. We present here 200K AXIOM® PyrSNP, a large‐scale single nucleotide polymorphism (SNP) genotyping array to facilitate genotyping of Pyrus species. A diverse panel of 113 re‐sequenced pear genotypes was used to discover SNPs to promote increased adoption of the array. A set of 188 diverse accessions and an F1 population of 98 individuals from ‘Cuiguan’ × ‘Starkrimson’ was genotyped with the array to assess its effectiveness. A large majority of SNPs (166 335 or 83%) are of high quality. The high density and uniform distribution of the array SNPs facilitated prediction of centromeric regions on 17 pear chromosomes, and significantly improved the genome assembly from 75.5% to 81.4% based on genetic mapping. Identification of a gene associated with flowering time and candidate genes linked to size of fruit core via genome wide association studies showed the usefulness of the array in pear genetic research. The newly developed high‐density SNP array presents an important tool for rapid and high‐throughput genotyping in pear for genetic map construction, QTL identification and genomic selection.
“Good” Philosophical Reasons for “Bad” Editorial Philology? On Rhees and Wittgenstein's Philosophical Grammar
Authors: Erbacher Christian 
Published: January 2019

AbstractUsing new archival material, this article reconstructs the editorial history of Philosophical Grammar, an edition that Rush Rhees crafted from Wittgenstein's papers. Contrasting the often‐held view that Rhees, in editing Philosophical Grammar, arbitrarily interfered with Wittgenstein's Big Typescript, the article illuminates the work, motives and reasons that underlie Rhees’ editing. Although recent philological evidence supports his editorial decisions, Rhees, at the time, made them based on his desire to do justice to his understanding of Wittgenstein's philosophical orientation. Against this background, purely text‐philological criticism of Philosophical Grammar seems to come from a philosophical culture that was alien to Rhees.
Three Problems for the Knowledge Rule of Assertion
Authors: Tsohatzidis Savas L. 
Published: January 2019

AbstractTimothy Williamson has argued that, unless the speech act of assertion were supposed to be governed by his so‐called Knowledge Rule, one could not explain why sentences of the form ‘A and I do not know that A’ are unassertable. This paper advances three objections against that argument, of which the first two aim to show that, even assuming that Williamson's explanandum has been properly circumscribed, his explanation would not be correct, and the third aims to show that his explanandum has not been properly circumscribed.
BMI but not central obesity predisposes to airway closure during bronchoconstriction
Authors: Peters Ubong , Subramanian Meenakumari , Chapman David G. , Kaminsky David A. , Irvin Charles G. , Wise Robert A. , Skloot Gwen S. , Bates Jason H.T. , Dixon Anne E. 
Published: January 2019

ABSTRACTBackground and objectiveObesity produces restrictive effects on lung function. We previously reported that obese patients with asthma exhibit a propensity towards small airway closure during methacholine challenge which improved with weight loss. We hypothesized that increased abdominal adiposity, a key contributor to the restrictive effects of obesity on the lung, mediates this response. This study investigates the effect of body mass index (BMI) versus waist circumference (WC) on spirometric lung function, sensitivity to airway narrowing and closure, and airway closure during bronchoconstriction in patients with asthma.MethodsParticipants underwent spirometry and methacholine challenge. Sensitivity to airway closure and narrowing was assessed from the dose–response slopes of the forced vital capacity (FVC) and the ratio of forced expiratory volume in 1 s (FEV1) to FVC, respectively. Airway closure during bronchoconstriction (closing index) was computed as the percent reduction in FVC divided by the percent reduction in FEV1 at maximal bronchoconstriction.ResultsA total of 116 asthmatic patients (56 obese) underwent methacholine challenge. Spirometric lung function was inversely related to WC (P < 0.05), rather than BMI. Closing index increased significantly during bronchoconstriction in obese patients and was related to increasing BMI (P = 0.01), but not to WC. Sensitivity to airway closure and narrowing was not associated with BMI or WC.ConclusionAlthough WC is associated with restrictive effects on baseline lung function, increased BMI, rather than WC, predisposes to airway closure during bronchoconstriction. These findings suggest that obesity predisposes to airway closure during bronchoconstriction through mechanisms other than simple mass loading.