bluuebunny/crossref_metadata_2025_split huggingface dataset:
Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial
Authors: Vink Peter , Ramon Torrell Josep Maria , Sanchez Fructuoso Ana , Kim Sung-Joo , Kim Sang-il , Zaltzman Jeff , Ortiz Fernanda , Campistol Plana Josep Maria , Fernandez Rodriguez Ana Maria , Rebollo Rodrigo Henar , Campins Marti Magda , Perez Rafael , González Roncero Francisco Manuel , Kumar Deepali , Chiang Yang-Jen , Doucette Karen , Pipeleers Lissa , Agüera Morales Maria Luisa , Rodriguez-Ferrero Maria Luisa , Secchi Antonio , McNeil Shelly A , Campora Laura , Di Paolo Emmanuel , El Idrissi Mohamed , López-Fauqued Marta , Salaun Bruno , Heineman Thomas C , Oostvogels Lidia 
Published: February 2019

Abstract

Background
The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy.

Methods
In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1–2 months (M) apart 4–18M posttransplant. Anti–glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post–dose 1, and 1M and 12M post–dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post–dose 2.

Results
Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post–dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups.

Conclusions
RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose.

Clinical Trials Registration
NCT02058589.
Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial
Authors: Kaye Keith S , Rice Louis B , Dane Aaron L , Stus Viktor , Sagan Olexiy , Fedosiuk Elena , Das Anita F , Skarinsky David , Eckburg Paul B , Ellis-Grosse Evelyn J 
Published: February 2019

Abstract

Background
ZTI-01 (fosfomycin for injection) is an epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has broad in vitro spectrum of activity, including multidrug-resistant Gram-negative pathogens, and is being developed for treatment of complicated urinary tract infection (cUTI) and acute pyelonephritis (AP) in the United States.

Methods
Hospitalized adults with suspected or microbiologically confirmed cUTI/AP were randomized 1:1 to 6 g ZTI-01 q8h or 4.5 g intravenous (IV) piperacillin-tazobactam (PIP-TAZ) q8h for a fixed 7-day course (no oral switch); patients with concomitant bacteremia could receive up to 14 days.

Results
Of 465 randomized patients, 233 and 231 were treated with ZTI-01 and PIP-TAZ, respectively. In the microbiologic modified intent-to-treat (m-MITT) population, ZTI-01 met the primary objective of noninferiority compared with PIP-TAZ with overall success rates of 64.7% (119/184 patients) vs 54.5% (97/178 patients), respectively; treatment difference was 10.2% (95% confidence interval [CI]: −0.4, 20.8). Clinical cure rates at test of cure (TOC, day 19–21) were high and similar between treatments (90.8% [167/184] vs 91.6% [163/178], respectively). In post hoc analysis using unique pathogens typed by pulsed-field gel electrophoresis, overall success rates at TOC in m-MITT were 69.0% (127/184) for ZTI-01 versus 57.3% (102/178) for PIP-TAZ (difference 11.7% 95% CI: 1.3, 22.1). ZTI-01 was well tolerated. Most treatment-emergent adverse events, including hypokalemia and elevated serum aminotransferases, were mild and transient.

Conclusions
ZTI-01 was effective for treatment of cUTI including AP and offers a new IV therapeutic option with a differentiated MOA for patients with serious Gram-negative infections.

Clinical Trial Registration
NCT02753946
Responses of the renin–angiotensin–aldosterone system in pregnant chronic kidney disease patients with and without superimposed pre-eclampsia
Authors: Kurlak Lesia O , Broughton Pipkin Fiona , Mohaupt Markus G , Mistry Hiten D 
Published: February 2019

Abstract

Background
Women with chronic kidney disease (CKD) are at increased risk of superimposed pre-eclampsia (SPE). Accurate identification of SPE is challenging. We hypothesized that specific components of the renin–angiotensin–aldosterone system (RAAS) would discriminate between CKD and SPE. The aim of the study was to establish differences in circulating and intrarenal RAAS in women with CKD with and without SPE and compare these to normotensive controls (NCs) and women with pre-eclampsia (PE).

Methods
White European NC women (n = 20), women with PE (n = 9), normotensive CKD without SPE (n = 8) and with SPE (n = 11) were recruited in the third trimester. Plasma renin, plasma and urine total angiotensinogen (AGT) concentrations were quantified by enzyme-linked immunosorbent assay, urinary tetrahydroaldosterone (TH-aldo) concentration by gas chromatography-mass spectrometry and placental growth factor (PlGF) by immunoassay.

Results
Urinary TH-aldo:creatinine ratios were lower in women with PE or SPE compared with NC or women with CKD (P &lt; 0.05 for all). The same group differences were observed for plasma active renin and PlGF concentrations (P &lt; 0.05 for all). Urine total AGT was higher in women with PE compared with NC (P &lt; 0.05) and urine TH-aldo:urine AGT was lower (P &lt; 0.05). However, women with SPE had lower urinary AGT concentrations compared with women with PE (P &lt; 0.05). No differences in plasma total AGT were observed between groups.

Conclusions
Women with SPE have a lower urinary TH-aldo:creatinine ratio, lower plasma active renin and lower PlGF concentrations than women with CKD, comparable to women with PE without pre-existing disease, suggestive of similar pathophysiology. These data suggest disruption of the RAAS pathway in SPE similar to PE. Exploration of the predictive value of RAAS components for adverse pregnancy events in women with CKD is required.
Increased rotational flow in the proximal aortic arch is associated with its dilation in bicuspid aortic valve disease
Authors: Dux-Santoy Lydia , Guala Andrea , Teixidó-Turà Gisela , Ruiz-Muñoz Aroa , Maldonado Giuliana , Villalva Nicolás , Galian Laura , Valente Filipa , Gutiérrez Laura , González-Alujas Teresa , Sao-Avilés Augusto , Johnson Kevin M , Wieben Oliver , Huguet Marina , García-Dorado David , Evangelista Arturo , Rodríguez-Palomares José F 
Published: February 2019

Abstract

Aims
Aortic dilation in bicuspid aortic valve (BAV) might extend to the proximal arch. Arch flow dynamics and their relationship with this segment dilation are still unexplored. Using 4D-flow cardiovascular magnetic resonance, we analysed flow dynamics in the arch for each BAV morphotype and their association with this segment dilation.

Methods and results
One hundred and eleven BAV patients (aortic diameters ≤55 mm, non-severe valvular disease), 21 age-matched tricuspid aortic valve (TAV) patients with dilated arch and 24 healthy volunteers (HV) underwent 4D-flow. BAV were classified per fusion morphotype: 75% right-left (RL-BAV), and per arch dilation: 57% dilated, mainly affecting the right-noncoronary (RN) BAV (86% dilated vs. 47% in RL-BAV). Peak velocity, jet angle, normalized displacement, in-plane rotational flow (IRF), wall shear stress, and systolic flow reversal ratio (SFRR) were calculated along the thoracic aorta. ANCOVA and multivariate linear regression analyses were used to identify correlates of arch dilation. BAV had higher rotational flow and eccentricity than TAV in the proximal arch. Dilated compared with non-dilated BAV had higher IRF being more pronounced in the RN-morphotype. RN-BAV, IRF, and SFRR were independently associated with arch dilation. Aortic stenosis and male sex were independently associated with arch dilation in RL-BAV. Flow parameters associated with dilation converged to the values found in HV in the distal arch.

Conclusion
Increased rotational flow could explain dilation of the proximal arch in RN-BAV and in RL-BAV patients of male sex and with valvular stenosis. These patients may benefit from a closer follow-up with cardiac magnetic resonance or computed tomography.
Trap Location and Premises Condition Influences on Aedes aegypti (Diptera: Culicidae) Catches Using Biogents Sentinel Traps During a ‘Rear and Release’ Program: Implications for Designing Surveillance Programs
Authors: Staunton Kyran M , Yeeles Peter , Townsend Michael , Nowrouzi Somayeh , Paton Christopher J , Trewin Brendan , Pagendam Daniel , Bondarenco Artiom , Devine Gregor J , Snoad Nigel , Beebe Nigel W , Ritchie Scott A 
Published: February 2019

AbstractAs the incidence of arboviral diseases such as dengue, Zika, chikungunya, and yellow fever increases globally, controlling their primary vector, Aedes aegypti (L.) (Diptera: Culicidae), is of greater importance than ever before. Mosquito control programs rely heavily on effective adult surveillance to ensure methodological efficacy. The Biogents Sentinel (BGS) trap is the gold standard for surveilling adult Aedes mosquitoes and is commonly deployed worldwide, including during modern ‘rear and release’ programs. Despite its extensive use, few studies have directly assessed environmental characteristics that affect BGS trap catches, let alone how these influences change during ‘rear and release’ programs. We assessed male and female Ae. aegypti spatial stability, as well as premises condition and trap location influences on BGS trap catches, as part of Debug Innisfail ‘rear and release’ program in northern Australia. We found similar trends in spatial stability of male and female mosquitoes at both weekly and monthly resolutions. From surveillance in locations where no males were released, reduced catches were found at premises that contained somewhat damaged houses and unscreened properties. In addition, when traps were located in areas that were unsheltered, more than 10 m from commonly used sitting areas or more visually complex catches were also negatively affected. In locations where males were released, we found that traps in treatment sites, relative to control sites, displayed increased catches in heavily shaded premises and were inconsistently influenced by differences in house sets and building materials. Such findings have valuable implications for a range of Ae. aegypti surveillance programs.
External Validation of Difficult-to-Treat Resistance Prevalence and Mortality Risk in Gram-Negative Bloodstream Infection Using Electronic Health Record Data From 140 US Hospitals
Authors: Kadri Sameer S , Lai Yi Ling (Elaine) , Ricotta Emily E , Strich Jeffrey R , Babiker Ahmed , Rhee Chanu , Klompas Michael , Dekker John P , Powers John H , Danner Robert L , Adjemian Jennifer ,   NIH Antimicrobial Resistance Outcomes Research Initiative (NIH-ARORI)
Published: February 2019

Abstract
Difficult-to-treat resistance (DTR; ie, co-resistance to all first-line antibiotics) in gram-negative bloodstream infection (GNBSI) is associated with decreased survival in administrative data models. We externally validated DTR prevalence and associated mortality risk in GNBSI using detailed clinical data from electronic health records to adjust for baseline differences in acute illness severity.
Flexed Posture in Parkinson Disease: Associations With Nonmotor Impairments and Activity Limitations
Authors: Forsyth Aimi L , Joshi Riddhi Y , Canning Colleen G , Allen Natalie E , Paul Serene S 
Published: February 2019

Abstract

Background
People with Parkinson disease (PD) are twice as likely to develop flexed truncal posture as the general older population. Little is known about the mechanisms responsible beyond associations with age, axial motor impairments, and disease severity.

Objective
The objective was to explore: (1) the associations of the nonmotor impairments of PD with flexed posture, and (2) the relationships of flexed posture with activity limitations.

Design
This was a cross-sectional study.

Methods
Seventy people with PD participated. Posture was measured in standing as the distance between the seventh cervical vertebra and a wall. Nonmotor impairments (cognition, depression, pain, fatigue, and proprioception) and activity performance (upper limb activity, bed transfers, respiratory function, and speech volume) were variously assessed using objective measures and self-report questionnaires. Univariate and multivariate regression analyses were performed to ascertain relationships between nonmotor impairments and truncal posture, and between truncal posture and activities.

Results
Greater disease severity, greater axial impairment, poorer spinal proprioception, greater postural fatigue, and male sex were significantly associated with flexed truncal posture. The multivariate model containing these factors in addition to age explained 30% of the variability in flexed truncal posture, with male sex and axial motor impairment continuing to make independent contributions. A significant association was found between greater flexed truncal posture and poorer upper limb activity performance and respiratory function.

Limitations
A limitation to this study was that participants had mild-to-moderate disease severity.

Conclusions
Spinal proprioception and postural fatigue were the only nonmotor impairments to make significant contributions to flexed posture. Given the negative influence of flexed posture on upper limb activity and respiratory function, interventions targeting spinal proprioception and postural awareness should be considered for people with PD who might develop flexed posture.
How Many Days Are Necessary to Represent an Infant's Typical Daily Leg Movement Behavior Using Wearable Sensors?
Authors: Deng Weiyang , Trujillo-Priego Ivan A , Smith Beth A 
Published: February 2019

Abstract

Background
Characteristics of movement can differentiate infants with typical development and infants with or at risk of developmental disabilities. We used wearable sensors to measure infants’ typical movement patterns in the natural environment.

Objective
Our objectives were to determine (1) how many days were sufficient to represent an infant's typical daily performance, and (2) if there was a difference in performance between weekdays and weekend days.

Design
This was a prospective, observational study.

Methods
We used wearable sensors to collect 7 consecutive days of data for leg movement activity, from 10 infants with typical development (1–5 months old). We identified each leg movement, and its average acceleration, peak acceleration, and duration. Bland-Altman plots were used to compare the standard (average of 7 days) with 6 options (1 day, the average of days 1 and 2, through the average of days 1 through 6). Additionally, the average of the first 2 weekdays was compared with the average of 2 weekend days.

Results
The absolute difference between the average of the first 2 days and the standards fell below 10% of the standards (movement rate = 8.5%; duration = 3.7%; average acceleration = 2.8%; peak acceleration = 3.8%, respectively). The mean absolute difference between weekdays and weekends for leg movement rate, duration, average acceleration, and peak acceleration was 11.6%, 3.7%, 7.2%, and 7.3% of the corresponding standard.

Limitations
The small sample size and age range limit extrapolation of the results.

Conclusions
Our results suggest the best option is to collect data for 2 consecutive days and that movement did not differ between weekdays and weekend days. Our results will inform the clinical measurement of full-day infant leg movement for neuromotor assessment and outcome purposes.
Discrete Actions in Information-Constrained Decision Problems
Authors: Jung Junehyuk , Kim Jeong Ho (John) , Matějka Filip , Sims Christopher A 
Published: February 2019

AbstractIndividuals are constantly processing external information and translating it into actions. This draws on limited resources of attention and requires economizing on attention devoted to signals related to economic behaviour. A natural measure of such costs is based on Shannon’s “channel capacity”. Modelling economic agents as constrained by Shannon capacity as they process freely available information turns out to imply that discretely distributed actions, and thus actions that persist across repetitions of the same decision problem, are very likely to emerge in settings that without information costs would imply continuously distributed behaviour. We show how these results apply to the behaviour of an investor choosing portfolio allocations, as well as to some mathematically simpler “tracking” problems that illustrate the mechanism. Trying to use costs of adjustment to explain “stickiness” of actions when interpreting the behaviour in our economic examples would lead to mistaken conclusions.
Product Market Competition and Option Prices
Authors: Morellec Erwan , Zhdanov Alexei 
Published: February 2019

Abstract
Most firms face some form of competition in product markets. The degree of competition a firm faces feeds back into its cash flows and affects the values of the securities it issues. Through its effects on stock prices, product market competition affects the prices of options on equity and leads to an inverse relationship between equity returns and volatility, generating a negative volatility skew in option prices. Using a large sample of U.S. equity options, we provide empirical support for this finding and demonstrate the importance of accounting for product market competition when explaining the cross-sectional variation in option skew.
Received June 28, 2017; editorial decision October 23, 2018 by Editor Andrew Karolyi. Authors have furnished supplementary Internet Appendices, which is available on the Oxford University Press Web site next to the link to the final published paper online.
Acute monoarthritis
Authors: Ellis Jill M. 
Published: February 2019

ABSTRACT
Acute monoarthritis affects a single joint and has many potential underlying causes, including crystal deposition diseases, infection, trauma, and osteoarthritis. A comprehensive health history and physical examination can help narrow the list of differential diagnoses; judicious diagnostic testing can help pinpoint the diagnosis. Clinicians also must be able to recognize which patients require emergency referral to prevent long-term adverse consequences.
What is the role of cannabidiol in refractory epilepsy?
Authors: LaFleur Kathryn M. , Nemec Eric C. 
Published: February 2019

ABSTRACT
The FDA recently approved the first cannabidiol oral medication to treat refractory epilepsy in patients with Dravet syndrome and Lennox-Gastaut syndrome. This article describes the safety and efficacy of cannabidiol treatment in patients with refractory epilepsy.
Trends in total hip arthroplasty
Authors: Aumiller Wade D. , Kleuser Thomas M. 
Published: February 2019

ABSTRACT
This article discusses developments in total hip arthroplasty related to the use of highly cross-linked polyethylene (HXLPE) liner material as the new standard of care for acetabular cup articulation surfaces. The pathologic implications of metal-on-metal hip prostheses in asymptomatic patients also are discussed.
Accuracy of 6 Commercially Available Activity Monitors in Measuring Heart Rate, Caloric Expenditure, Steps Walked, and Distance Traveled
Authors: Boolani Ali , Towler Christopher , LeCours Baley , Blank Holly , Larue John , Fulk George 
Published: February 2019

Purpose:
The purpose of this study was to determine the accuracy of 5 different commercially available activity monitors (AMs) and 1 smartphone application in identifying mean number of steps, mean distance traveled, estimated caloric expenditure, and heart rate (HR).

Methods:
Subjects (N = 120) performed two 6-minute walks (MWs), one at a comfortable pace (C6MW) and the other at a fast pace (F6MW), around an indoor track wearing all 6 AMs and a StepWatch Activity Monitor in the community. Accuracy and agreement between AM-estimated metrics and actual metrics were examined using the intraclass correlation coefficient (ICC2,1) and Bland–Altman technique (BAM).

Results:
The ICC2,1 and BAM varied for all 3 conditions with the Fitbit Zip being the most accurate.

Conclusions:
The AMs exhibited varying degrees of accuracy for identifying steps, calories expended, HR, and distance walked across all different walking conditions. No single AM was accurate across conditions or metrics. Clinicians should be cautious when using data from these AMs to estimate patient activity levels.
Galectin-1 and Galectin-3 and Their Potential Binding Partners in the Dermal Thickening of Keloid Tissues
Authors: Arciniegas Enrique , Carrillo Luz Marina , Rojas Héctor , Ramírez Richard , Chopite Marina 
Published: February 2019

Abstract:Keloids are defined histopathologically as an inflammatory disorder characterized by exhibiting numerous fibroblasts, abnormal vascularization, increased number of proinflammatory immune cells as well as uncontrolled cell proliferation, and exacerbated and disorganized deposition of extracellular matrix (ECM) molecules. Importantly, many of these ECM molecules display N- and O-linked glycan residues and are considered as potential targets for galectin-1 (Gal-1) and galectin-3 (Gal-3). Nevertheless, the presence and localization of Gal-1 and Gal-3 as well as the interactions with some of their binding partners in keloid tissues have not been considered. Here, we show that in the dermal thickening of keloids, versican, syndecan-1, fibronectin, thrombospondin-1, tenascin C, CD44, integrin β1, and N-cadherin were immunolocalized in the elongated fibroblasts that were close to the immune cell infiltrate, attached to collagen bundles, and around the microvasculature and in some immune cells. We also show that Gal-1 and Gal-3 were present in the cytoplasm and along the cell membrane of some fibroblasts and immune and endothelial cells of the dermal thickening. We suggest that Gal-1 and Gal-3, in concert with some of the ECM molecules produced by fibroblasts and by immune cells, counteract the inflammatory response in keloids. We also proposed that Gal-1 and Gal-3 through their binding partners may form a supramolecular structure at the cell surface of fibroblasts, immune cells, endothelial cells, and in the extracellular space that might influence the fibroblast morphology, adhesion, proliferation, migration, and survival as well as the inflammatory responses.