bluuebunny/crossref_metadata_2025_split huggingface dataset:
Product Quality of Parenteral Vancomycin Products in the United States
Authors: Nambiar S. , Madurawe R. D. , Zuk S. M. , Khan S. R. , Ellison C. D. , Faustino P. J. , Mans D. J. , Trehy M. L. , Hadwiger M. E. , Boyne M. T. , Biswas K. , Cox E. M. 
Published: February 2012

ABSTRACT

In response to concerns raised about the quality of parenteral vancomycin products, the U.S. Food and Drug Administration (FDA) is investigating the product quality of all FDA-approved parenteral vancomycin products available in the United States. Product quality was evaluated independently at two FDA Office of Testing and Research (FDA-OTR) sites. In the next phase of the investigation, being done in collaboration with the National Institute of Allergy and Infectious Diseases, the
in vivo
activity of these products will be evaluated in an appropriate animal model. This paper summarizes results of the FDA investigation completed thus far. One site used a validated ultrahigh-pressure liquid chromatography method (OTR-UPLC), and the second site used the high-performance liquid chromatography (HPLC) method for related substances provided in the British Pharmacopeia (BP) monograph for vancomycin intravenous infusion. Similar results were obtained by the two FDA-OTR laboratories using two different analytical methods. The products tested had 90 to 95% vancomycin B (active component of vancomycin) by the BP-HPLC method and 89 to 94% vancomycin by OTR-UPLC methods. Total impurities were 5 to 10% by BP-HPLC and 6 to 11% by OTR-UPLC methods. No single impurity was >2.0%, and the CDP-1 level was ≤2.0% across all products. Some variability in impurity profiles of the various products was observed. No adverse product quality issues were identified with the six U.S. vancomycin parenteral products. The quality parameters of all parenteral vancomycin products tested surpassed the United States Pharmacopeia acceptance criteria. Additional testing will characterize
in vivo
performance characteristics of these products.
The F423Y Mutation in the
pfmdr2
Gene and Mutations N51I, C59R, and S108N in the
pfdhfr
Gene Are Independently Associated with Pyrimethamine Resistance in Plasmodium falciparum Isolates
Authors: Briolant Sébastien , Bogreau Hervé , Gil Marine , Bouchiba Housem , Baret Eric , Amalvict Rémy , Rogier Christophe , Pradines Bruno 
Published: February 2012

ABSTRACT

Screening for
in vitro
susceptibility to pyrimethamine and sequencing of the
pfmdr2
and
pfdhfr
genes were performed in 140
Plasmodium falciparum
isolates. The risk of
in vitro
resistance to pyrimethamine was analyzed with a logistic regression model. The mutation F423Y in
pfmdr2
(odds ratio [OR] = 2.12 [confidence interval {CI}, 1.02 to 4.59];
P
= 0.0489) and the mutation N51I, C59R, or S108N in
pfdhfr
(OR = 42.34 [CI, 5.52 to 324.61];
P
= 0.0003) were independently associated with
in vitro
resistance to pyrimethamine.
Antibiotic Exposure as a Risk Factor for Fluconazole-Resistant Candida Bloodstream Infection
Authors: Ben-Ami Ronen , Olshtain-Pops Keren , Krieger Michal , Oren Ilana , Bishara Jihad , Dan Michael , Wiener-Well Yonit , Weinberger Miriam , Zimhony Oren , Chowers Michal , Weber Gabriel , Potasman Israel , Chazan Bibiana , Kassis Imad , Shalit Itamar , Block Colin , Keller Nathan , Kontoyiannis Dimitrios P. , Giladi Michael ,   for the Israeli Candidemia Study Group
Published: February 2012

ABSTRACT

Recent exposure to azoles is an important risk factor for infection with fluconazole-resistant
Candida
spp., but little is known about the role of antibacterial drug exposure in the emergence of drug-resistant
Candida
. We did a prospective nationwide surveillance study of candidemia in Israel and analyzed the propensity score-adjusted association between antifungal and antibacterial drug exposure and bloodstream infection with
C. glabrata
and fluconazole-resistant
Candida
isolates. Four hundred forty-four episodes of candidemia (450
Candida
isolates, 69 [15%]
C. glabrata
isolates, and 38 [8.5%] fluconazole-resistant isolates) from 18 medical centers in Israel were included.
C. glabrata
bloodstream infection was strongly associated with recent metronidazole exposure (odds ratio [OR], 3.2;
P
< 0.001). Infection with a fluconazole-resistant isolate was associated with exposure to carbapenems, trimethoprim-sulfamethoxazole, clindamycin, and colistin (odds ratio, 2.8;
P
= 0.01). The inclusion of antibacterial drug exposure in a multivariable model significantly enhanced the model's predictive accuracy for fluconazole-resistant
Candida
bloodstream infection. Our findings may be relevant to the selection of empirical antifungal treatment and broaden the scope of antibiotic-associated collateral damage.
Induction of Oxidative Stress in Trypanosoma brucei by the Antitrypanosomal Dihydroquinoline OSU-40
Authors: He Shanshan , Dayton Alex , Kuppusamy Periannan , Werbovetz Karl A. , Drew Mark E. 
Published: February 2012

ABSTRACT

Dihydroquinoline derivative OSU-40 (1-benzyl-1,2-dihydro-2,2,4-trimethylquinolin-6-yl acetate) is selectively potent against
Trypanosma brucei rhodesiense in vitro
(50% inhibitory concentration [IC
50
], 14 nM; selectivity index, 1,700) and has been proposed to cause the formation of reactive oxygen species (ROS) in African trypanosomes (J. Fotie et al., J. Med. Chem. 53:966–982, 2010). In the present study, we sought to provide further support for the hypothesis that OSU-40 kills trypanosomes through oxidative stress. Inducible RNA interference (RNAi) was applied to downregulate key enzymes in parasite antioxidant defense, including
T. brucei
trypanothione synthetase (TbTryS) and superoxide dismutase B (TbSODB). Both TbTryS RNAi-induced and TbSODB RNAi-induced cells showed impaired growth and increased sensitivity toward OSU-40 by 2.4-fold and 3.4-fold, respectively. Decreased expression of key parasite antioxidant enzymes was thus associated with increased sensitivity to OSU-40, consistent with the hypothesis that OSU-40 acts through oxidative stress. Finally, the dose-dependent formation of free radicals was observed after incubation of
T. brucei
with OSU-40 utilizing electron spin resonance (ESR) spectroscopy. These data support the notion that the mode of antitrypanosomal action for this class of compounds is to induce oxidative stress.
Virulence of Escherichia coli Clinical Isolates in a Murine Sepsis Model in Relation to Sequence Type ST131 Status, Fluoroquinolone Resistance, and Virulence Genotype
Authors: Johnson James R. , Porter Stephen B. , Zhanel George , Kuskowski Michael A. , Denamur Erick 
Published: February 2012

ABSTRACT

Escherichia coli
sequence type ST131 (O25b:H4) has emerged over the past decade as a globally disseminated, multidrug-resistant pathogen. Unlike traditional antimicrobial-resistant
E. coli
, ST131 derives from virulence-associated phylogenetic group B2 and exhibits extraintestinal virulence factors. This, plus preliminary evidence of virulence in experimental animals, has suggested that ST131's epidemic emergence may be due to high virulence potential, compared with other
E. coli
types. To test this hypothesis, we compared a large number of matched ST131 and non-ST131
E. coli
clinical isolates, both fluoroquinolone resistant and susceptible, plus isolates from classic extraintestinal pathogenic
E. coli
(ExPEC) sequence types (STs) and case report ST131 household transmission isolates, for virulence in a mouse subcutaneous sepsis model. Overall, in mice, the study isolates produced a wide range of lethality and clinical illness. However, neither ST131 status nor fluoroquinolone phenotype correlated with this diversity of illness severity, which occurred within each of the 6 study groups. In contrast, multiple known or suspected ExPEC virulence genes, including
pap
(P fimbriae),
vat
(vacuolating toxin),
kpsM
II (group 2 capsule),
ibeA
(invasion of brain endothelium), and
clbB/N
(colibactin synthesis), plus molecularly defined ExPEC status, were significantly associated with virulence. These findings point away from ST131 isolates as having higher virulence potential compared with other
E. coli
types in causing invasive extraintestinal infections and suggest instead that ST131's epidemiological success may reflect enhanced fitness for upstream steps in pathogenesis or in colonization and transmission. Additionally, the extensive within-ST virulence diversity suggests an opportunity to compare closely related strains to identify the responsible genetic determinants.
Baby knows best? The impact of weaning style on food preferences and body mass index in early childhood in a case–controlled sample
Authors: Townsend Ellen , Pitchford Nicola J 
Published: February 2012

ObjectiveThe impact of different weaning methods on food preferences and body mass index (BMI) in early childhood is not known. Here, we examine if weaning method—baby-led weaning versus traditional spoon feeding—influences food preferences and health-related outcomes.Design, setting and participantsParents (n=155) recruited through the Nottingham Toddler laboratory and relevant internet sites completed a questionnaire concerning (1) infant feeding and weaning style (baby-led=92, spoon-fed=63, age range 20–78 months), (2) their child's preference for 151 foods (analysed by common food categories, eg, carbohydrates, proteins, dairy) and (3) exposure (frequency of consumption). Food preference and exposure data were analysed using a case–controlled matched sample to account for the effect of age on food preference. All other analyses were conducted with the whole sample.Main outcome measuresThe primary outcome measures were food preferences, exposure and weaning style. The secondary outcome measures were BMI and picky eating.ResultsCompared to the spoon-fed group, the baby-led group demonstrated (1) significantly increased liking for carbohydrates (no other differences in preference were found) and (2) carbohydrates to be their most preferred foods (compared to sweet foods for the spoon-fed group). Preference and exposure ratings were not influenced by socially desirable responding or socioeconomic status, although an increased liking for vegetables was associated with higher social class. There was an increased incidence of (1) underweight in the baby-led group and (2) obesity in the spoon-fed group. No difference in picky eating was found between the two weaning groups.ConclusionsWeaning style impacts on food preferences and health in early childhood. Our results suggest that infants weaned through the baby-led approach learn to regulate their food intake in a manner, which leads to a lower BMI and a preference for healthy foods like carbohydrates. This has implications for combating the well-documented rise of obesity in contemporary societies.
A CONTINUUM MODEL FOR ALIGNMENT OF SELF-PROPELLED PARTICLES WITH ANISOTROPY AND DENSITY-DEPENDENT PARAMETERS
Authors: FROUVELLE AMIC 
Published: February 2012

We consider the macroscopic model derived by Degond and Motsch from a time-continuous version of the Vicsek model, describing the interaction orientation in a large number of self-propelled particles. In this paper, we study the influence of a slight modification at the individual level, letting the relaxation parameter depend on the local density and taking in account some anisotropy in the observation kernel (which can model an angle of vision). The main result is a certain robustness of this macroscopic limit and of the methodology used to derive it. With some adaptations to the concept of generalized collisional invariants, we are able to derive the same system of partial differential equations, the only difference being in the definition of the coefficients, which depend on the density. This new feature may lead to the loss of hyperbolicity in some regimes. We then provide a general method which enables us to get asymptotic expansions of these coefficients. These expansions shows, in some effective situations, that the system is not hyperbolic. This asymptotic study is also useful to measure the influence of the angle of vision in the final macroscopic model, when the noise is small.
The Value of Multiple Read/Write Streams for Approximating Frequency Moments
Authors: Beame Paul , Huynh Trinh 
Published: February 2012

We consider the read/write streams model, an extension of the standard data stream model in which an algorithm can create and manipulate multiple read/write streams in addition to its input data stream. Like the data stream model, the most important parameter for this model is the amount of internal memory used by such an algorithm. The other key parameters are the number of streams the algorithm uses and the number of passes it makes on these streams. We consider how the addition of multiple streams impacts the ability of algorithms to approximate the frequency moments of the input stream.

We show that any randomized read/write stream algorithm with a fixed number of streams and a sublogarithmic number of passes that produces a constant factor approximation of the
k
-th frequency moment
F
k
of an input sequence of length of at most
N
from {1,...,
N
} requires space
Ω
(
N
1−4/k−δ
) for any
δ
> 0. For comparison, it is known that with a single read-only one-pass data stream there is a randomized constant-factor approximation for
F
k
using
Õ
(
N
1−2/k
) space, and that by sorting, which can be done deterministically in
O
(log
N
) passes using 3 read/write streams,
F
k
can be computed exactly. Therefore, although the ability to manipulate multiple read/write streams can add substantial power to the data stream model, with a sublogarithmic number of passes this does not significantly improve the ability to approximate higher frequency moments efficiently. We obtain our results by showing a new connection between the read/write streams model and the multiparty number-in-hand communication model.
Effect of Domperidone on Insufficient Lactation in Puerperal Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
Authors: Osadchy Alla , Moretti Myla E. , Koren Gideon 
Published: February 2012

Background. There is a controversy within the medical community regarding the role of domperidone as a galactagogue and the drug has been removed from the US market owing to safety concerns.Objective. To perform a systematic review and meta-analysis of the available data assessing the effect of domperidone on breast milk production in women experiencing insufficient lactation.Study Selection. Randomized controlled trials (RCTs) examining the effect of domperidone on breast milk production of puerperal women were eligible for inclusion.Data Analysis. Absolute and relative changes from baseline were calculated for individual studies and pooled using a random effects model.Results. Three RCTs including 78 participants met the inclusion criteria. All showed a statistically significant increase in breast milk production following treatment with domperidone. The analysis of pooled data demonstrated a statistically significant relative increase of 74.72% (95%  CI=54.57; 94.86,P<0.00001) in daily milk production with domperidone treatment compared to placebo. No maternal or neonatal adverse events were observed in any of the trials.Conclusions. Evidence from a few small RCTs of moderate to high quality suggests that domperidone produces a greater increase in breast milk supply than placebo.
Breast Cancer Screening Trends in the United States and Ethnicity
Authors: Miranda Patricia Y. , Tarraf Wassim , González Patricia , Johnson-Jennings Michelle , González Hector M. 
Published: February 2012

Abstract
Background: The study objectives were to compare and examine mammography use trends among ethnic/racial women in the context of United States Healthy People 2010 goals.
Methods: We analyzed pooled, multistage probability sample data from the 1996–2007 Medical Expenditure Panel Survey. Included in the sample were female respondents of ages 40 to 75 years (N = 64,811) from six ethnic/racial groups (Black, White, Mexican, Other Latinas, Puerto Rican, and Cuban). The primary outcome was self-reported, past two-year mammography use consistent with screening practice guidelines.
Results: We found that for most U.S. women, the Healthy People 2010 mammography goal (70%) was achieved between 1996 and 2007. Puerto Rican and White women, respectively, had the highest mammography rates, and Black and Cuban women had rates that approached the 2010 goal.
Conclusion: Mexican Latinas reported the lowest rates of past two-year mammography; however, factors enabling healthcare access markedly moderated this lower likelihood. From 2000, Mexican Latinas' mammography use was markedly below (10%) the Healthy People 2010 goal and remained there for the duration.
Impact: Our findings indicate that healthcare equity goals are attainable if efforts are made to reach a sizeable portion of vulnerable populations. Cancer Epidemiol Biomarkers Prev; 21(2); 351–7. ©2011 AACR.
TLE3 Expression Is Associated with Sensitivity to Taxane Treatment in Ovarian Carcinoma
Authors: Samimi Goli , Ring Brian Z. , Ross Doug T. , Seitz Robert S. , Sutherland Robert L. , O'Brien Philippa M. , Hacker Neville F. , Huh Warner K. 
Published: February 2012

Abstract
Background: We have previously shown that transducin-like enhancer of split 3 (TLE3) is associated with outcome specifically in patients with taxane-treated breast cancer and not in patients treated with anthracycline-based regimens without a taxane. The purpose of this study was to assess the association between TLE3 expression and recurrence in patients with ovarian carcinoma treated with a taxane containing regimen as opposed to those treated with a platinum-based agent alone.
Methods: We carried out immunohistochemical staining of TLE3 in two series of ovarian cancer specimens from the University of Alabama at Birmingham, Birmingham, AL and the Royal Hospital for Women, Sydney, Australia. Local and distant recurrences within the first five years of follow-up were analyzed using Kaplan–Meier, Cox proportional hazard, and multivariate analysis to assess an association between TLE3 expression and response to therapy.
Results: TLE3 was expressed in approximately 30% of tumors and expression was associated with a favorable outcome only in patients who had received taxane as part of their treatment regimen (n = 173, HR = 0.62, P = 0.012; Pinteraction = 0.024). Further analysis revealed that the predictive association between TLE3 expression and outcome was strongest in patients with nonserous histology.
Conclusion: High TLE3 expression predicts a favorable response to taxane containing chemotherapy regimens in ovarian carcinoma.
Impact: Our findings warrant an independent evaluation of TLE3 as a potential therapeutic response marker for taxane-based chemotherapy in ovarian cancer. Cancer Epidemiol Biomarkers Prev; 21(2); 273–9. ©2011 AACR.
Dried Blood Spot Samples for Seroepidemiology of Infections with Human Papillomaviruses, Helicobacter pylori, Hepatitis C Virus, and JC Virus
Authors: Waterboer Tim , Dondog Bolormaa , Michael Kristina M. , Michel Angelika , Schmitt Markus , Vaccarella Salvatore , Franceschi Silvia , Clifford Gary , Pawlita Michael 
Published: February 2012

Abstract
Background: To establish antibody analysis from dried blood spots (DBS) on filter paper for seroepidemiologic infection and cancer association studies, we analyzed data from a population-based study in Mongolia.
Methods: Using multiplex serology, we analyzed 985 paired DBS and serum samples from the same donors for antibodies to 12 different proteins from four groups of infectious agents: human papillomaviruses (HPV), Helicobacter pylori (H. pylori), hepatitis C virus (HCV), and JC polyomavirus (JCV).
Results: Quantitative antibody reactivities in serum and DBS showed good correlation, with median correlation coefficients (Pearson R2) of 0.88 (range, 0.80–0.90) for high-titer (i.e., H. pylori, HCV, JCV) and 0.79 (range, 0.72–0.85) for low-titer antibodies (i.e., HPV). For high-titer antibodies, serum and DBS data were comparable (median slope of linear trend line, 1.14; range, 1.09–1.21), whereas for low-titer antibodies, DBS reactivities were lower than in serum (median slope, 0.54; range, 0.50–0.80). By extrapolating seropositivity cutoff points previously defined for serum to DBS, we found high agreement (&gt;89% for all antigens) of dichotomized DBS and serum results and median kappa values for high- and low-titer antibodies of 0.86 and 0.78 (range, 0.78–0.92 and 0.55–0.86), respectively. Epidemiologic associations with known risk factors for HPV antibodies were as strong for DBS as for serum.
Conclusions: DBS provide a reliable alternative to serum or plasma for detection of antibodies against various pathogens by multiplex serology.
Impact: DBS do not require blood centrifugation and allow storage and shipment at ambient temperature, thus facilitating field work for seroepidemiologic studies especially in environments with limited technical infrastructure. Cancer Epidemiol Biomarkers Prev; 21(2); 287–93. ©2011 AACR.
Clinical Predictors of Fidelis Lead Failure
Authors: Birnie David H. , Parkash Ratika , Exner Derek V. , Essebag Vidal , Healey Jeffrey S. , Verma Atul , Coutu Benoit , Kus Teresa , Mangat Iqwal , Ayala-Paredes Felix , Nery Pablo , Wells George , Krahn Andrew D. 
Published: February 2012

Background—
Approximately 268 000 Fidelis leads were implanted worldwide until distribution was suspended because of a high rate of early failure. Careful analyses of predictors of increased lead failure hazard are required to help direct future lead design and also to inform decision making on lead replacement. We sought to perform a comprehensive analysis of all potential predictors in a multicenter study.

Methods and Results—

A total of 3169 Sprint Fidelis leads were implanted in 11 centers with a total of 251 failures. Lead failure rates at 3, 4, and 5 years were 5.3%, 10.6%, and 16.8%, respectively. The rate of lead failure continues to accelerate (
P
<0.001). There were 4 independent predictors of failure: center, sex, access vein, and previous lead failure. Women had a higher hazard of failure (hazard ratio 1.51; 95% confidence interval, 1.14–2.04;
P
=0.005). Both axillary and subclavian access increased the hazard of failure (
P
=0.007); hazard ratio for axillary was 1.94, (95% confidence interval, 1.23–3.04) and for subclavian 1.63 (95% confidence interval, 1.08–2.46). Previous lead failure increased the hazard of a subsequent Fidelis failure with a hazard ratio of 3.12 (95% confidence interval, 1.80–5.41;
P
<0.001).

Conclusions—
The rate of Fidelis failure continues to increase over time, with failures approaching 17% at 5 years. Women, patients with leads inserted via the subclavian or axillary vein, and those with a previous lead fracture were at greatest risk of Fidelis failure. Our data suggest that Fidelis replacement should be strongly considered at the time of generator replacement.