bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pazopanib in Locally Advanced or Metastatic Renal Cell Carcinoma: Results of a Randomized Phase III Trial
Authors: Sternberg Cora N. , Davis Ian D. , Mardiak Jozef , Szczylik Cezary , Lee Eunsik , Wagstaff John , Barrios Carlos H. , Salman Pamela , Gladkov Oleg A. , Kavina Alexander , Zarbá Juan J. , Chen Mei , McCann Lauren , Pandite Lini , Roychowdhury Debasish F. , Hawkins Robert E. 
Published: January 2010

Purpose Pazopanib is an oral angiogenesis inhibitor targeting vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and c-Kit. This randomized, double-blind, placebo-controlled phase III study evaluated efficacy and safety of pazopanib monotherapy in treatment-naive and cytokine-pretreated patients with advanced renal cell carcinoma (RCC). Patients and Methods Adult patients with measurable, locally advanced, and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, tumor response rate (Response Evaluation Criteria in Solid Tumors), and safety. Radiographic assessments of tumors were independently reviewed. Results Of 435 patients enrolled, 233 were treatment naive (54%) and 202 were cytokine pretreated (46%). PFS was significantly prolonged with pazopanib compared with placebo in the overall study population (median, PFS 9.2 v 4.2 months; hazard ratio [HR], 0.46; 95% CI, 0.34 to 0.62; P < .0001), the treatment-naive subpopulation (median PFS 11.1 v 2.8 months; HR, 0.40; 95% CI, 0.27 to 0.60; P < .0001), and the cytokine-pretreated subpopulation (median PFS, 7.4 v 4.2 months; HR, 0.54; 95% CI, 0.35 to 0.84; P < .001). The objective response rate was 30% with pazopanib compared with 3% with placebo (P < .001). The median duration of response was longer than 1 year. The most common adverse events were diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting. There was no evidence of clinically important differences in quality of life for pazopanib versus placebo. Conclusion Pazopanib demonstrated significant improvement in PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC.
Impact of Ethnicity on Primary Treatment Choice and Mortality in Men With Prostate Cancer: Data From CaPSURE
Authors: Moses Kelvin A. , Paciorek Alan T. , Penson David F. , Carroll Peter R. , Master Viraj A. 
Published: January 2010

Purpose Men diagnosed with prostate cancer have multiple options available for treatment. Previous reports have indicated a trend of differing modalities of treatment chosen by African American and white men. We investigated the role of ethnicity in primary treatment choice and how this affected overall and cancer-specific mortality. Methods By utilizing data abstracted from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), patients were compared by ethnicity, primary treatment, number of comorbidities, risk level according to modified D'Amico criteria, age, highest educational level attained, type of insurance, treatment facility, and perception of general health. Multinomial logistic regression analysis was performed to determine the effect of the tested variables on primary treatment and mortality. Results African American men were more likely to receive nonsurgical therapy than white men with equivalent disease characteristics. Whites were 48% less likely than African Americans to receive androgen deprivation therapy (ADT) compared with surgery (P = .02) and were 25% less likely than African Americans to receive radiation therapy compared with surgery (P = .08). Whites with low-risk disease were 71% less likely to receive ADT than African American men with similar disease (P = .01). Adjusted overall and prostate cancer–specific mortality were not significantly different between whites and African Americans (hazard ratios, 0.73 and 0.37, respectively). Risk level, type of treatment, and type of insurance had the strongest effects on risk of mortality. Conclusion There is a statistically significant difference in primary treatment for prostate cancer between African American and white men with similar risk profiles. Additional research on the influence of patient/physician education and perception and the role that socioeconomic factors play in mortality from prostate cancer may be areas of focus for public health initiatives.
What is grievance thinking and how can we measure this in sexual offenders?
Authors: Barnett Georgia D. 
Published: January 2010

Purpose. This study proposes and examines a three‐stage model of the grievance process, one of the dynamic risk factors related to risk of sexual recidivism, and aims to evaluate some of the existing measures of this construct. Methods. The research used a sample of 322 male sexual offenders who had completed a cognitive–behavioural programme that aims to reduce recidivism in higher‐risk sexual offenders (as measured using a static actuarial tool). Participants completed two questionnaires measuring aspects of grievance thinking pre‐ and post‐treatment. Results. The results indicated some support for stages 1 and 2 of the proposed model. Contrary to the study hypotheses, results indicated that both measures used have similar psychometric properties. Pre‐ to post‐change analyses suggest that the custodial treatment programme may be having some effect on grievance thinking. However, generally offenders' scores on both measures were low pre‐ and post‐treatment and as a result, according to individual change analyses, the majority did not demonstrate reliable or clinically significant change. Those who were classed as high scorers on either measure did, however, demonstrate such change. Conclusions. Further exploration of a three‐stage model of grievance is warranted. It appears that current measures of grievance in sexual offenders are not adequate to capture this concept fully.
Evolutionary and Functional Properties of a Two-Locus β-Globin Polymorphism in Indian House Mice
Authors: Runck Amy M , Weber Roy E , Fago Angela , Storz Jay F 
Published: January 2010

AbstractElectrophoretic surveys of hemoglobin (Hb) polymorphism in house mice from South Asia and the Middle East have revealed that two alternative β-globin haplotypes, Hbbd and Hbbp, are often present at intermediate frequencies in geographically disparate populations. Both haplotypes harbor two functionally distinct β-globin paralogs, HBB-T1 (which encodes the β-chain subunits of the major Hb isoform) and HBB-T2 (which encodes the β-chains of the minor Hb isoform). The Hbbd and Hbbp haplotypes share identical HBB-T1 alleles, but products of the alternative HBB-T2 alleles (dminor and pminor) are distinguished by two amino acid substitutions. To investigate the possible adaptive significance of the Hbbd/Hbbp polymorphism we conducted a population genetic analysis of the duplicated β-globin genes of Indian house mice (Mus castaneus) in conjunction with experimental studies of Hb function in inbred strains of mice that carry the alternative Hbbd and Hbbp haplotypes. The main objectives of this study were (i) to characterize patterns of nucleotide polymorphism and linkage disequilibrium in the duplicated β-globin genes of M. castaneus, (ii) to test the hypothesis that the Hbbd and Hbbp haplotypes are maintained as a balanced polymorphism, and (iii) to assess whether allelic differences in the alternative minor Hb isoforms (dminor and pminor) are associated with different O2-binding properties. A multilocus analysis of polymorphism and divergence revealed that levels of diversity at the HBB-T2 gene exceeded neutral expectations, and reconstructed haplotype networks for both β-globin paralogs revealed extensive allele sharing with several other closely related species of Mus. However, despite this suggestive evidence for balancing selection, O2-equilibrium curves revealed no discernible functional differences between red cell lysates containing the dminor and pminor Hb isoforms. If the dminor and pminor alleles are maintained as a balanced polymorphism, our results indicate that the associated fitness variance is not directly related to respiratory functions of Hb.
Performance of 2004 American Heart Association Recommendations for Treatment of Kawasaki Disease
Authors: Yellen Elizabeth S. , Gauvreau Kimberlee , Takahashi Masato , Burns Jane C. , Shulman Stanford , Baker Annette L. , Innocentini Nancy , Zambetti Chiara , Pancheri Joan M. , Ostrow Adam , Frazer Jeffrey R. , Sundel Robert P. , Fulton David R. , Newburger Jane W. 
Published: January 2010

OBJECTIVE:The 2004 American Heart Association (AHA) statement included a clinical case definition and an algorithm for diagnosing and treating suspected incomplete Kawasaki disease (KD). We explored the performance of these recommendations in a multicenter series of US patients with KD with coronary artery aneurysms (CAAs).METHODS:We reviewed retrospectively records of patients with KD with CAAs at 4 US centers from 1981 to 2006. CAAs were defined on the basis of z scores of &gt;3 or Japanese Ministry of Health and Welfare criteria. Our primary outcome was the proportion of patients presenting at illness day ≤21 who would have received intravenous immunoglobulin (IVIG) treatment by following the AHA guidelines at the time of their initial presentation to the clinical center.RESULTS:Of 195 patients who met entry criteria, 137 (70%) met the case definition and would have received IVIG treatment at presentation. Fifty-three patients (27%) had suspected incomplete KD and were eligible for algorithm application; all would have received IVIG treatment at presentation. Of the remaining 5 patients, 3 were excluded from the algorithm because of fever for &lt;5 days at presentation and 2 because of &lt;2 clinical criteria at &gt;6 months of age. Two of these 5 patients would have entered the algorithm and received IVIG treatment after follow-up monitoring. Overall, application of the AHA algorithm would have referred ≥190 patients (97%) for IVIG treatment.CONCLUSIONS:Application of the 2004 AHA recommendations, compared with the classic criteria alone, improves the rate of IVIG treatment for patients with KD who develop CAAs. Future multicenter prospective studies are needed to assess the performance characteristics of the AHA algorithm in febrile children with incomplete criterion findings and to refine the algorithm further.
New Intrauterine Growth Curves Based on United States Data
Authors: Olsen Irene E. , Groveman Sue A. , Lawson M. Louise , Clark Reese H. , Zemel Babette S. 
Published: January 2010

OBJECTIVE:The objective of this study was to create and validate new intrauterine weight, length, and head circumference growth curves using a contemporary, large, racially diverse US sample and compare with the Lubchenco curves.METHODS:Data on 391 681 infants (Pediatrix Medical Group) aged 22 to 42 weeks at birth from 248 hospitals within 33 US states (1998–2006) for birth weight, length, head circumference, estimated gestational age, gender, and race were used. Separate subsamples were used to create and validate curves. Smoothed percentile curves (3rd to 97th) were created by the Lambda Mu Sigma (LMS) method. The validation sample was used to confirm representativeness of the curves. The new curves were compared with the Lubchenco curves.RESULTS:Final sample included 257 855 singleton infants (57.2% male) who survived to discharge. Gender-specific weight-, length-, and head circumference-for-age curves were created (n = 130 111) and successfully validated (n = 127 744). Small-for-gestational age and large-for-gestational age classifications using the Lubchenco curves differed significantly from the new curves for each gestational age (all P &lt; .0001). The Lubchenco curves underestimated the percentage of infants who were small-for-gestational-age except for younger girls (≤36 weeks), for whom it was more likely to be overestimated; underestimated percentage of infants (≤36 weeks) who were large-for-gestational-age; and overestimated percentage of infants (&gt;36 weeks) who were large-for-gestational-age.CONCLUSIONS:The Lubchenco curves may not represent the current US population. The new intrauterine growth curves created and validated in this study, based on a contemporary, large, racially diverse US sample, provide clinicians with an updated tool for growth assessment in US NICUs. Research into the ability of the new definitions of small-for-gestational-age and large-for-gestational-age to identify high-risk infants in terms of short-term and long-term health outcomes is needed.
Management of Acute Otitis Media After Publication of the 2004 AAP and AAFP Clinical Practice Guideline
Authors: Coco Andrew , Vernacchio Louis , Horst Michael , Anderson Angela 
Published: January 2010

OBJECTIVES:Observation without initial antibiotic therapy was accepted as an option for acute otitis media (AOM) management in the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline. The guideline also recommended amoxicillin as the first-line treatment for most children, and analgesic treatment to reduce pain if it was present. Our objective was to compare the management of AOM after publication of the 2004 guideline.PATIENTS AND METHODS:We analyzed the National Ambulatory Medical Care Survey, 2002–2006 (N = 1114), which occurred in US physicians' offices. The patients were children aged 6 months to 12 years who were diagnosed with AOM. The time comparisons were the 30-month periods before and after the guideline. The main outcome was the encounter rate at which no antibiotic-prescribing was reported. Secondary outcomes were the identification of factors associated with encounters at which no antibiotic-prescribing was reported and antibiotic- and analgesic-prescribing rates.RESULTS:The rate of AOM encounters at which no antibiotic-prescribing was reported did not change after guideline publication (11%–16%; P = .103). Independent predictors of an encounter at which no antibiotic-prescribing was reported were the absence of ear pain, absence of reported fever, and receipt of an analgesic prescription. After guideline publication, the rate of amoxicillin-prescribing increased (40%–49%; P = .039), the rate of amoxicillin/clavulanate-prescribing decreased (23%–16%; P = .043), the rate of cefdinir-prescribing increased (7%–14%; P = .004), and the rate of analgesic-prescribing increased (14%–24%; P = .038).CONCLUSIONS:Although management of AOM without antibiotics has not increased after the publication of the 2004 American Academy of Pediatrics and American Academy of Family Physicians clinical practice guideline, children who did not receive antibiotics were more likely to have mild infections. In accordance with the guideline, the prescribing of amoxicillin and analgesics has increased. Contrary to the guideline, the prescribing of amoxicillin/clavulanate has decreased, whereas the prescribing of cefdinir has increased.
Factors Associated With Pediatric Use of Complementary and Alternative Medicine
Authors: Birdee Gurjeet S. , Phillips Russell S. , Davis Roger B. , Gardiner Paula 
Published: January 2010

BACKGROUND:
Limited data are available on the use of complementary and alternative medicine (CAM) and factors associated with use among the pediatric population in the United States.

METHODS:
Using the 2007 National Health Interview Survey data among individuals &lt;18 years of age (n = 9417), we compared CAM users (excluding those using vitamins and minerals) and non-CAM users. Using bivariable and multivariable logistic regression models, we examined independent associations of CAM use with sociodemographic factors, prescription medication use, delays in health care caused by access difficulties, and common medical conditions/symptoms.

RESULTS:
In an adjusted multivariable logistic model, CAM users were more likely than non-CAM users to be adolescents rather than infants or toddlers (adjusted odds ratio [aOR]: 1.61 [95% confidence interval (CI): 1.11–2.34]); live in the West (aOR: 2.05 [95% CI: 1.62–2.59]), Northeast (aOR: 1.36 [95% CI: 1.02–1.80]), or Midwest (aOR: 1.35 [95% CI: 1.04–1.74]) compared with those in the South; more likely to have a parent with a college education (aOR: 4.33 [95% CI: 2.92–6.42]); and more likely to use prescription medication (aOR: 1.51 [95% CI: 1.19–1.92]). Pediatric CAM users were more likely to have anxiety or stress (aOR: 2.54 [95% CI: 1.89–3.42]), dermatologic conditions (aOR: 1.35 [95% CI: 1.03–1.78]), musculoskeletal conditions (aOR: 1.94 [95% CI: 1.31–2.87]), and sinusitis (aOR: 1.54 [95% CI: 1.11–2.14]). Use of CAM by a parent was strongly associated with the child's use of CAM (aOR: 3.83 [95% CI: 3.04–4.84]).

CONCLUSIONS:
In 2007, pediatric CAM users were more likely to take prescription medications, have a parent who used CAM, and have chronic conditions such as anxiety or stress, musculoskeletal conditions, dermatologic conditions, or sinusitis. Research is required to guide pediatricians in making recommendations on CAM modalities for children including potential risks and/or benefits and interactions with conventional therapies.
Effect of Telavancin on the Pharmacokinetics of the Cytochrome P450 3A Probe Substrate Midazolam: A Randomized, Double‐Blind, Crossover Study in Healthy Subjects
Authors: Wong Shekman L. , Goldberg Michael R. , Ballow Charles H. , Kitt Michael M. , Barriere Steven L. 
Published: January 2010

Study Objective. To examine the effect of telavancin, a lipoglycopeptide antibiotic with potent gram‐positive activity, on the pharmacokinetics of midazolam, a cytochrome P450 (CYP) 3A probe substrate.Design. Phase I, randomized, double‐blind, placebo‐controlled, crossover studySetting. Clinical research center.Participants. Sixteen healthy adult volunteers.Intervention. Subjects were randomly assigned to receive an intravenous infusion of telavancin 10 mg/kg or placebo once/day for 7 days. On day 7, a single dose of intravenous midazolam 1 mg was given immediately after completion of the last infusion of telavancin or placebo. Patients crossed over to the alternate treatment regimen after a washout period of at least 7 days.Measurements and Main Results. Pharmacokinetic sampling was performed on study days 7 and 21. Blood was collected before telavancin or placebo dosing and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours after midazolam administration. Formal equivalence analysis using the two onesided t test method showed that the geometric mean ratios for maximum plasma concentration (Cmax) and areas under the plasma concentrationtime curve (AUC) for midazolam coadministered with telavancin versus midazolam coadministered with placebo were close to unity. The 90% confidence intervals (CIs) around the ratios fell within the 0.8‐1.25 bioequivalence bounds (geometric mean ratio for AUC from time zero to the last measured plasma concentration 0.95, 90% CI 0.910‐0.984; Cmax geometric mean ratio 1.03, 90% CI 0.956‐1.11). The multiple‐dose pharmacokinetic profile of telavancin with concomitant administration of midazolam (Cmax 97 μg/ml, concentration 24 hrs after completion of telavancin infusion 9 μg/ml, terminal‐phase elimination half‐life 8.9 hrs, clearance 13.3 ml/hr/kg) was consistent with data from earlier studies.Conclusion. These pharmacokinetic data show that intravenous telavancin administered at the intended therapeutic dose does not affect the pharmacokinetics of intravenous midazolam. The results indicate that telavancin is unlikely to inhibit hepatic CYP3A activity to a clinically meaningful extent.
Sentence imitation as a tool in identifying expressive morphosyntactic difficulties in children with severe speech difficulties
Authors: Seeff‐Gabriel Belinda , Chiat Shula , Dodd Barbara 
Published: January 2010

Background: Sentence imitation has been identified as a good indicator of children's language skills, with performance differentiating children with specific language impairment and showing relationships with other language measures. It has a number of advantages over other methods of assessment. The assessment of morphosyntax in children who have severe speech difficulties presents unique challenges which currently available sentence imitation assessments do not address.Aims: This paper presents a new sentence imitation test (The Sentence Imitation Test (SIT‐61)) and reports on an investigation which sets out to determine whether this test (1) reveals differences in performance between a group of children diagnosed with specific language impairment and a group of typically developing children (2) reveals distinct profiles of performance amongst children with different speech difficulties, and (3) provides information about morphosyntactic strengths and difficulties.Methods & Procedures: SIT‐61 is a finely graded sentence imitation test in which the phonotactic structure, segmental phonology and length of words were kept as developmentally simple as possible. Responses are scored for number of content words, function words and inflections correct. A novel scoring system was devised to credit a child where there was evidence of targeting a morpheme even if it was mispronounced. The test was administered to four groups of children between the ages of 4 and 6 years: 33 children with typical development, 13 children with known expressive morphosyntactic difficulties (specific language impairment), and two groups of 14 children with different types of speech disorder: a group with consistent phonological disorder, who used atypical phonological error patterns consistently; and a group with inconsistent phonological disorder, who produced atypical phonological errors inconsistently.Outcomes & Results: SIT‐61 found differences in performance between the group of typically developing participants and the three clinic groups. While the consistent phonological disorder group obtained extremely high scores for content and function words, they obtained lower inflection scores reflective of their speech difficulties. The scores of the specific language impairment and inconsistent phonological disorder groups were comparable for content and function words, but the groups were differentiated through an analysis of their errors. Further analyses confirmed that low scores obtained by some children in the inconsistent phonological disorder group were due to morphosyntactic difficulties and not speech difficulties.Conclusions & Implications: A new sentence imitation test, the SIT‐61, is shown to be valuable tool for identifying expressive morphosyntactic difficulties in children. It is informative about the morphosyntactic abilities of children with speech disorders and raises questions as to the nature of their difficulties.