bluuebunny/crossref_metadata_2025_split huggingface dataset:
Speech development in aphonic children
Authors: Tucker Harvey M. , Rusnov Melinda , Cohen Lindy 
Published: October 2006

AbstractIt has been well established that pre‐lingually hearing‐impaired children experience difficulties in speech development. Little appears in the literature, however, about speech development in aphonic children. The authors have had the opportunity to manage several children who, for various reasons, were unable to phonate from a pre‐lingual age to approximately the age of 5 or 6 years. The children in this report developed various compensatory means of communication, including unusual laryngeal, non‐laryngeal and nonverbal communication. Representative cases are reviewed and observations are made regarding the effects of aphonia on speech development.
Composite autograft for tympanoplasty and tympanomastoid surgery
Authors: Adkins Warren Y. 
Published: October 2006

AbstractIn 1982, 40 composite cartilage perichondrial autografts performed to prevent recurrent cholesteatoma secondary to canal wall defects were reviewed. A follow‐up of those cases, plus 62 new cases, as well as the composite autografts for severe tympanic membrane retractions (55 cases) and selected tympanoplasties (22 cases) is presented. No recurrent cholesteatomas or retraction pockets developed at the graft sites, with one graft failure in the latter group.
Rhinosurgical experience with the transseptal‐transsphenoidal hypophysectomy: Technique and long‐term results
Authors: Gammert Christian 
Published: October 2006

AbstractMany modifications of extracranial transsphenoidal hy‐pophysectomy exist, but knowledge of the rhinological implications of these procedures is rare. At our institution the transseptal approach is performed as a joint rhinosurgical and neurosurgical procedure. Three hundred nineteen patients were operated on from 1979 to 1984,113 of whom had a rhinological follow‐up for 5 years. Most of the complications were asymptomatic. Thirteen percent of the patients had septal perforations, 3.5% epistaxis, and 36% complained of mild dryness of the nose. An improvement in breathing was noted in 24% of the patients. There was no difference in rhinological complaints between patients who underwent the sublabial approach and those operated via a transnasal approach. Twenty percent of the patients operated on with the sublabial approach had additional temporary complaints in the upper lip; therefore, the transnasal‐transsep‐tal approach is currently our procedure of choice.
Markedly Increased Vitamin B12 Concentrations Attributable to IgG–IgM–Vitamin B12 Immune Complexes
Authors: Bowen Raffick AR , Drake Steven K , Vanjani Rachna , Huey Edward D , Grafman Jordan , Horne McDonald K 
Published: October 2006

AbstractBackground: High serum vitamin B12 concentrations have been reported in patients with hepatic disease, disseminated neoplasia, myeloproliferative disorders, and hypereosinophilic syndromes. We recently discovered an extraordinarily increased vitamin B12 concentration in a patient without these underlying conditions.Methods: Affinity and size-exclusion chromatography, sodium dodecyl sulfate–polyacrylamide gel electrophoresis (SDS–PAGE), matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), and ELISA methods were used to determine the cause of the increased vitamin B12 concentrations in this patient’s serum.Results: The protein G column eluates from 2 apparently healthy volunteers and 2 patients with recent vitamin B12 treatment for anemia had vitamin B12 concentrations of &lt;74 pmol/L, whereas the vitamin B12 concentration in the protein G column eluate from the patient was 7380 pmol/L. The elution profile from size-exclusion chromatography of vitamin B12-binding proteins in the patient’s serum revealed an abnormal vitamin-B12-binding protein. SDS–PAGE analysis of the concentrated eluates from the protein G column, under reducing conditions, revealed an additional band with an apparent molecular mass of 76 kDa, which was not present in control column eluates. MALDI-TOF MS identified this band as an IgM heavy chain. By use of a modified ELISA, we determined that the IgM present in the patient’s eluates was associated with the IgG to form IgG-IgM immune complexes.Conclusions: This case demonstrates the unusual circumstance of a patient with markedly increased vitamin B12 concentrations attributed to immune complexes composed of IgG, IgM, and vitamin B12 and illustrates techniques that can be used to identify this occurrence.
Uniform Application of Copper Sulfate as a Potential Treatment for Controlling Snail Populations in Channel Catfish Production Ponds
Authors: Wise David J , Mischke Charles C , Greenway Terry , Byars Todd S , Mitchell Andrew J 
Published: October 2006

Abstract
A digenetic trematode identified as Bolbophorus sp. has been implicated as a cause of severe mortality and reduced production in commercially raised channel catfish Ictalurus punctatus in the southeastern United States. Currently, chemical control measures to limit the impact of this disease focus on pond shoreline treatments with hydrated lime or copper sulfate to kill the marsh ram's-horn snail Planorbella trivolvis, an intermediate host that inhabits aquatic vegetation around the pond perimeter. Although effective, these treatments have little impact on snails that are not within close proximity to the pond bank. Tests were conducted to determine the feasibility of using elevated levels of copper sulfate pentahydrate (CSP; CuSO4·5H2O), uniformly applied to the surface of the pond water, to eradicate snails from the pond environment. Results demonstrated that uniform application to deliver between 2.5- and 5.0-ppm CSP (0.64–1.27-ppm Cu) was effective in killing snails around the margins of the pond and throughout the water column but may have negatively affected fish health at the high treatment dose. On average, pond treatments killed more than 96% of the test snails, while mortality of the control snails was less than 8.5%. Results of the commercial field trial were similar to those of tests conducted in experimental ponds, where application of CSP at 5.0 ppm was effective in killing snails at all sampling sites. The treatment was also shown to reduce the natural population of snails along the pond margin by 98.3%. These trials indicate that CSP, when uniformly applied to the water, can be used with caution as an effective treatment against the marsh ram's-horn snail in commercial channel catfish production ponds that have chemical characteristics similar to those of tested waters (alkalinity and hardness &gt;200 ppm as CaCO3).
Evaluation of Substrate Type and Density as Factors in Optimizing Growth of Least Chub
Authors: Wagner Eric J , Billman Eric J , Arndt Ronney 
Published: October 2006

Abstract
The least chub Iotichthys phlegethontis is a diminutive and rare cyprinid endemic to the Bonneville Basin of Utah. As part of a species recovery effort, aquaculture techniques were investigated. Three experiments are summarized here: Two compared silt substrate and no substrate, and one evaluated the effect of three different densities on growth and survival. The substrate experiments were an attempt to compare extensive versus intensive culture. In the first test, growth of 4–7-month-old least chub in outdoor aquaria containing 2–3 cm of silt substrate was significantly higher than that of fish in indoor or outdoor aquaria with no substrate. Survival was unaffected by substrate treatment. In another test using fry that had just hatched, mortality rates were significantly higher in the aquaria treatment (mean ± SD = 95.3 ± 2.3%) than in the silt substrate treatment (45.3 ± 23.1%; P = 0.009). Final length was also significantly higher in the simulated ponds (mean ± SD = 10.2 ± 1.2 mm) than in the aquaria with no sediment (6.2 ± 2.7 mm; P &lt; 0.001). In a final, 8-week test, fish rearing densities of 2.27, 11.36, and 22.7 fish/L were compared among 5–6-week-old least chub. Growth and survival were not significantly affected within this range of rearing densities. These results indicate that extensive aquaculture using fertile fry ponds would produce more and faster-growing least chub than intensive raceways or tanks, assuming predation and disease were not factors. High rearing densities are also possible with this schooling species of cyprinid.
Trends in Hyperinsulinemia Among Nondiabetic Adults in the U.S.
Authors: Li Chaoyang , Ford Earl S. , McGuire Lisa C. , Mokdad Ali H. , Little Randie R. , Reaven Gerald M. 
Published: October 2006

OBJECTIVE—Insulin resistance and compensatory hyperinsulinemia have been proposed as increasing risk for a variety of abnormalities and clinical syndromes, including type 2 diabetes and cardiovascular disease. Our aim was to assess the trends in the mean concentrations of fasting serum insulin and the prevalence of hyperinsulinemia among nondiabetic adults during the periods of 1988–1994 and 1999–2002 in the U.S.
RESEARCH DESIGN AND METHODS—We conducted analyses of data among men and nonpregnant women without diabetes aged ≥20 years from the Third National Health and Nutrition Examination Survey (NHANES III; 1988–1994; n = 7,926) and NHANES 1999–2002 (n = 2,993). Both surveys were designed to represent the noninstitutionalized civilian U.S. population. We calculated age-adjusted mean concentrations of fasting insulin and the prevalence of hyperinsulinemia defined using the 75th percentile of fasting insulin among nondiabetic individuals as the cutoff value.
RESULTS—The geometric mean concentrations of fasting insulin increased by ∼5% from 1988–1994 to 1999–2002 among nondiabetic adults aged ≥20 years in the U.S. Mexican-American men, men and women aged 20–39 years, and non-Hispanic white women had a greater relative increase in the mean concentrations of fasting insulin than their counterparts. The prevalence of hyperinsulinemia increased by 35.1% overall (38.3% among men and 32.1% among women).
CONCLUSIONS—In parallel with the obesity epidemic, concentrations of fasting insulin and prevalence of hyperinsulinemia have increased remarkably among nondiabetic U.S. adults.
Plasma Retinol-Binding Protein-4 Concentrations Are Elevated in Human Subjects With Impaired Glucose Tolerance and Type 2 Diabetes
Authors: Cho Young Min , Youn Byung-Soo , Lee Hyewon , Lee Namseok , Min Sung-Shik , Kwak Soo Heon , Lee Hong Kyu , Park Kyong Soo 
Published: October 2006

OBJECTIVE—The dysregulation of adipokines is closely associated with the pathogenesis of insulin resistance and type 2 diabetes. Retinol-binding protein-4 (RBP4), a new adipokine, was recently reported to provide a link between obesity and insulin resistance. Here, we examined the relation between plasma RBP4 concentrations and various metabolic parameters in humans.
RESEARCH DESIGN AND METHODS—An enzyme-linked immunosorbent assay was developed to measure human RBP4 plasma concentrations, which were then compared with various parameters related to insulin resistance in subjects with normal glucose tolerance (NGT; n = 57), impaired glucose tolerance (IGT; n = 48), and type 2 diabetes (n = 49).
RESULTS—Plasma RBP4 concentrations were higher in the IGT and type 2 diabetic groups than in the NGT group (median 18.9 [range 11.2–45.8], 20.9 [9.9–48.5], and 18.1 μg/ml [9.3–30.5], respectively). However, no difference was found between plasma RBP4 concentrations in the IGT and type 2 diabetic groups. Plasma RBP4 concentrations were found to be associated with sex, waist circumference, fasting plasma glucose, and insulin resistance. Of these, sex and fasting plasma glucose levels were found to be independent determinants of plasma RBP4 concentration.
CONCLUSIONS—Plasma RBP4 concentrations were found to be elevated in subjects with IGT or type 2 diabetes and to be related to various clinical parameters known to be associated with insulin resistance.
Health Care Use and Costs in the Decade After Identification of Type 1 and Type 2 Diabetes
Authors: Johnson Jeffrey A. , Pohar Sheri L. , Majumdar Sumit R. 
Published: October 2006

OBJECTIVE—To analyze trends in health care costs in the decade after identification of diabetes, contrasting type 1 and 2 diabetes.
RESEARCH DESIGN AND METHODS—The Canadian National Diabetes Surveillance System criteria were applied to administrative databases to identify incident diabetes cases in 1992. Cases were categorized as type 1 or type 2 diabetes based on patterns of drug use. Per capita health care costs (in 2001 Canadian dollars) for five resource categories were estimated according to the type of diabetes, for the year before identification (1991) and 10 years after (1992–2001) identification of the cases.
RESULTS—We identified 156 type 1 and 3,469 type 2 incident cases of diabetes, from a population base of ∼950,000. The mean (±SD) age of case subjects at index was 61.2 ± 16.7 years, and 54% of subjects were male. Overall annual per capita health expenditures rose considerably in the year after identification of diabetes but then stabilized at a lower level for the next 9 years, ranging from $3,800 to $4,400. From 1992 to 2001, diabetic individuals used $137.1 million in health care resources, most of which (96%) was attributable to type 2 diabetes. The average 10-year cost per individual with diabetes was $37,820 ($33,684 per type 1 and $38,006 per type 2 diabetes case; adjusted P = 0.45).
CONCLUSIONS—Total health expenditures for diabetes are driven by the much larger prevalence of type 2 compared with type 1 diabetes. Policymakers need to acknowledge and allocate resources for diabetes prevention and management accordingly.
Celiac Disease and Risk of Subsequent Type 1 Diabetes
Authors: Ludvigsson Jonas F. , Ludvigsson Johnny , Ekbom Anders , Montgomery Scott M. 
Published: October 2006

OBJECTIVE—Earlier studies suggest that children with type 1 diabetes are more likely to have a subsequent diagnosis of celiac disease. However, research is sparse on the risk of subsequent type 1 diabetes in individuals with celiac disease. We sought to determine the risk of subsequent type 1 diabetes diagnosed before the age of 20 years in children and adolescents with celiac disease in a national, general population–based cohort.
RESEARCH DESIGN AND METHODS—We identified 9,243 children with a diagnosis of celiac disease in the Swedish national inpatient register between 1964 and 2003. We then identified five reference individuals matched at time of diagnosis for age, calendar year, sex, and county (n = 45,680). Only individuals with &gt;1 year of follow-up after study entry (diagnosis of celiac disease) were included in the analyses.
RESULTS—Celiac disease was associated with a statistically significantly increased risk of subsequent type 1 diabetes before age 20 years (hazard ratio 2.4 [95% CI 1.9–3.0], P &lt; 0.001). This risk increase was seen regardless of whether celiac disease was first diagnosed between 0 and 2 (2.2 [1.7–2.9], P &lt; 0.001) or 3 and 20 (3.4 [1.9–6.1], P &lt; 0.001) years of age. Individuals with prior celiac disease were also at increased risk of ketoacidosis or diabetic coma before the age of 20 years (2.3 [1.4–3.9], P = 0.001).
CONCLUSIONS—Children with celiac disease are at increased risk of subsequent type 1 diabetes. This risk increase is low considering that 95% of individuals with celiac disease are HLA-DQ2 positive.
Cigarette Smoking Is Associated With Low Glomerular Filtration Rate in Male Patients With Type 2 Diabetes
Authors: De Cosmo Salvatore , Lamacchia Olga , Rauseo Anna , Viti Raffaella , Gesualdo Loreto , Pilotti Alessandra , Trischitta Vincenzo , Cignarelli Mauro 
Published: October 2006

OBJECTIVE—The relationship between cigarette smoking and renal dysfunction in diabetes has predominantly been documented in patients with type 1 diabetes. The aim of the present study was to explore the relationship between cigarette smoking and glomerular filtration rate (GFR) in a large cross-sectional study carried out in male subjects with type 2 diabetes. The role of metabolic syndrome in modulating this relationship was also investigated.RESEARCH DESIGN AND METHODS—One hundred fifty-eight current smokers and 158 never smokers with type 2 diabetes were consecutively recruited. Low GFR was defined as GFR &lt;60 ml/min per 1.73 m2.RESULTS—The proportion of patients affected by low GFR was significantly higher in current smokers (20.9 vs. 12.0%, P = 0.03). The adjusted risk (odds ratio [OR]) of low GFR in current smokers was 2.20 (95% CI 1.14–4.26, P = 0.02) and markedly higher in patients from the first tertile of disease duration (4.27 [1.26–14.40], P = 0.02). When metabolic syndrome was added to the statistical model exploring the relationship between smoking and low GFR, the risk of low GFR showed a small change, although it did not become any more significant (1.84 [0.98–3.45], P = 0.06). Current smokers showed even higher free oxygen radical test unit values (560.0 ± 91.5 vs. 442.7 ± 87.2, P &lt; 0.0001).CONCLUSIONS—In a large population of male patients with type 2 diabetes, the risk of low GFR is markedly enhanced by smoking and is at least partially mediated by metabolic syndrome.
The Columbus Program: Building a Community Model of a 21st Century Intelligent Health System
Authors: Leichter Steven B. , Gingrich Newt , Linn Laura , Butler Barbara , Griggs Sheree 
Published: October 2006

IN BRIEF
There is widespread and growing interest in modernization of the American health care system. Based in part on initiatives in the Medicare Modernization Act, diabetes has become a focus of initiatives in health care modernization. In this article, the authors describe approaches to health care reform in diabetes leading to an effort to standardize diabetes care according to national guidelines in one city, Columbus, Ga.
Stability Study Designs
Authors: Daphne Lin Tsae‐Yun , Chen Chi Wan 
Published: October 2006

AbstractA good stability study design is the key to a successful stability program. In this article, stability designs including full, bracketing, and matrixing designs will be exemplified. A full design involves complete testing of all factor combinations at all time points, which can be costly. The pharmaceutical industry would like to apply bracketing or matrixing design so that not every factor combination will be tested at every time point. The statistical aspects of these stability designs will be discussed in relation to the recent Internation Conference on Harmonization (ICH) guidelines. Several commonly used criteria for design comparison will be presented. The statistical and regulatory considerations on the selection of stability design will also be discussed. The stability study should be well designed so the shelf life of the drug product can be estimated with the high degree of accuracy and precision.
Flexible Designs
Authors: Posch Martin , Bauer Peter , Brannath Werner 
Published: October 2006

AbstractFlexible designs allow for mid‐trial design adaptations in an adaptive interim analysis based on all information collected while controlling the type I error rate. Examples of such adaptations are, for example, sample size reassessment, addition or dropping of interim analysis, or dropping of treatment arms. The crucial feature of the adaptive procedure is that the adaptation rules need not be specified in advance.
Confidence Interval
Authors: Reiczigel Jeno 
Published: October 2006

Abstract
A confidence interval (CI) or interval estimate for an unknown parameter θ is a “from‐to” range calculated from the sample so that it contains θ with a high—usually 90%, 95%, or 99%—probability. CIs can be given for unknown population parameters like the mean, variance, median, proportion, or for model parameters like a regression coefficient, odds ratio, correlation coefficient, or for functions of the above‐mentioned parameters like, for example, the variance/mean ratio, the difference of two proportions or two means, and so on. In clinical studies, CIs are typically given for the mean or median treatment effect, proportion of cure, difference in these outcome measures comparing two treatments, and so on. Practically for anything for which an estimate from the sample is meaningful at all, a CI is also meaningful. For curves like a regression line or a ROC curve, interval estimation results in a so‐called confidence band.
Sample Size Calculation for Comparing Means
Authors: Wang Hansheng , Chow Shein‐Chung 
Published: October 2006

Abstract
In this article, the focus will be on sample size calculation based on a continuous study endpoint for comparing means (i.e., treatment effects) under some study designs. These designs include parallel designs, crossover designs, titration designs, and enrichment designs (2). Among these designs, parallel designs and crossover designs are probably the two mostly commonly used designs.
Sample Size Calculation for Comparing Variabilities
Authors: Wang Hansheng , Chow Shein‐Chung 
Published: October 2006

Abstract
In clinical research, in addition to comparing mean responses between treatment groups, it is also of interest to compare variabilities of responses between treatment groups. In practice, it is a concern that (1) larger variability may result in a worse safety profile and (2) larger variability may decrease the probability of reproducibility of the observed clinical results. Besides, efficacy and safety assessment are often done based on mean responses by assuming that the associated variabilities are the same, which may not be true in many cases. As a result, comparing variabilities of responses between treatment groups has received much attention lately. In order to achieve a desired statistical power when comparing variabilities of responses between treatment groups, commonly used procedures or formulas, which are derived based on comparing mean responses, cannot be applied directly and are necessarily modified.
Analysis of Variance
ANOVA
Authors: Kaufmann Jörg , Schering AG 
Published: October 2006

Abstract
The development of analysis of variance (ANOVA) methodology has in turn had an influenced on the types of experimental research being carried out in many fields. ANOVA is one of the most commonly used statistical techniques, with applications across the full spectrum of experiments in agriculture, biology, chemistry, toxicology, pharmaceutical research, clinical development, psychology, social science, and engineering. The procedure involves the separation of total observed variation in the data into individual components attributable to various factors as well as those caused by random or chance fluctuation. It allows performing hypotheses tests of significance to determine which factors influence the outcome of the experiment. However, although hypothesis testing is certainly a very useful feature of the ANOVA, it is by no means the only aspect. The methodology was originally developed by Sir Ronald A. Fisher, the pioneer and innovator of the use and applications of statistical methods in experimental design who coined the name “Analysis of Variance – ANOVA.”
Diagnostic Studies
Authors: Schwenke Carsten 
Published: October 2006

AbstractDiagnostic studies are performed to investigate the clinical usefulness of a new diagnostic procedure, for example, a new contrast agent for imaging or a new laboratory test to detect antibodies or antigens in blood. Sometimes, these studies are invented to substitute the standard procedure by an improved or less expensive procedure, which is not inferior in terms of efficacy and has some benefit compared with the standard procedure. Before starting a diagnostic study, first the unit for analysis should be defined in the terms “experimental unit” and “observational unit.”