bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adaptive designs for confirmatory clinical trials
Authors: Bretz Frank , Koenig Franz , Brannath Werner , Glimm Ekkehard , Posch Martin 
Published: February 2009

AbstractAdaptive designs play an increasingly important role in clinical drug development. Such designs use accumulating data of an ongoing trial to decide how to modify design aspects without undermining the validity and integrity of the trial. Adaptive designs thus allow for a number of possible adaptations at midterm: Early stopping either for futility or success, sample size reassessment, change of population, etc. A particularly appealing application is the use of adaptive designs in combined phase II/III studies with treatment selection at interim. The expectation has arisen that carefully planned and conducted studies based on adaptive designs increase the efficiency of the drug development process by making better use of the observed data, thus leading to a higher information value per patient.In this paper we focus on adaptive designs for confirmatory clinical trials. We review the adaptive design methodology for a single null hypothesis and how to perform adaptive designs with multiple hypotheses using closed test procedures. We report the results of an extensive simulation study to evaluate the operational characteristics of the various methods. A case study and related numerical examples are used to illustrate the key results. In addition we provide a detailed discussion of current methods to calculate point estimates and confidence intervals for relevant parameters. Copyright © 2009 John Wiley & Sons, Ltd.
Experimental and Modeling Studies on the Synthesis and Properties of Higher Fatty Esters of Corn Starch
Authors: Junistia Laura , Sugih Asaf K. , Manurung Robert , Picchioni Francesco , Janssen Leon P. B. M. , Heeres Hero J. 
Published: February 2009

AbstractThis paper describes a systematic study on the synthesis of higher fatty esters of corn starch (starch laurate and starch stearate) by using the corresponding vinyl esters. The reactions were carried out in DMSO using basic catalysts (Na2HPO4, K2CO3, and Na‐acetate). The effect of the process variables (vinyl ester to starch ratio, catalyst intake, reaction temperature and type of the catalyst) on the degree of substitution (DS) of the starch laurate and starch stearate esters was determined by performing a total of 54 experiments. The results were adequately modeled using a non‐linear multivariable regression model (R2≥0.96). The basicity of the catalyst and the reaction temperature have the highest impact on the product DS. The thermal and mechanical properties of some representative product samples were determined. High‐DS products (DS = 2.26‐2.39) are totally amorphous whereas the low‐DS ones (DS = 1.45‐1.75) are still partially crystalline. The thermal stability of the esterified products is higher than that of native starch. Mechanical tests show that the products have a tensile strength (stress at break) between 2.7–3.5 MPa, elongation at break of 3–26%, and modulus of elasticity of 46–113 MPa.
A review of wind energy activities in Japan
Authors: Maeda Takao , Kamada Yasunari 
Published: February 2009

AbstractBy 2012, Japan must cut down on its annual emissions of greenhouse gases by 6% from 1990 levels. However, greenhouse emissions increased by 6.4% in 2006. More effective responses to reduce greenhouse gases are required. Attention is currently focused on increasing the use of renewable energy, and wind energy has received a lot of attention. The national target for wind power capacity in the year 2010 is 3000 MW; however, there are many barriers to the development of wind energy. Japan's climate differs from that of the European Union countries. It often experiences typhoons and lightning strikes because of its meteorological characteristics. Wind has a stronger turbulence level due to the complex terrain. Furthermore, power fluctuation of wind causes power system problems because of issues related to the grid connection. Many endeavours have been made to find the best solutions for these problems. This paper reviews the wind energy activities in Japan, including wind resources, market trends, environment, prospects and research and development. Copyright © 2009 John Wiley & Sons, Ltd.
Identification of wind turbines in closed‐loop operation in the presence of three‐dimensional turbulence wind speed: torque demand to measured generator speed loop
Authors: Iribas M. , Landau I.‐D. 
Published: February 2009

AbstractIn order to get reliable linear models for tuning controllers in real operation conditions, a procedure for identification in closed‐loop operation of wind turbine (WT) models at any time and placement is presented in this paper. This procedure has been tested using data from a nonlinear aeroelastic code, generated in a context reproducing real operation conditions of WTs, with the presence of three‐dimensional turbulence. The algorithms for model identification of WTs operating in closed loop together with the corresponding validation techniques are presented. To illustrate the procedure, data from one Bladed® WT model is used. Identification and validation of the model are presented and the resulting model is analysed and its characteristics are plotted. In the final sections of the paper, the model obtained from identification in closed loop and the model obtained by linearization are comparatively tested in terms of the performances obtained with the corresponding model‐based designed controllers applied to the Bladed® WT model. A description of future work concludes the paper. Copyright © 2009 John Wiley & Sons, Ltd.
PRE‐ and POST‐THIN: a tool for the probabilistic design and analysis of composite rotor blade strength
Authors: Lekou D. J. , Philippidis T. P. 
Published: February 2009

AbstractStructural reliability is a key factor in the design of wind turbine rotor blades. However, the use of composite materials in the blade structure and the many stochastic variables that are thus involved in the analysis makes the available probabilistic methods unattractive for integration in the design procedure. To overcome this, a numerical tool is developed for the probabilistic strength analysis of Fibre Reinforced Plastic (FRP) rotor blades. The stochastic nature of the anisotropic material properties is considered for the reliability estimation of the laminate and in turn the information is included in a pre‐ and post‐processor of current aero‐elastic codes. Copyright © 2009 John Wiley & Sons, Ltd.
Growth responses of Salix gracilistyla cuttings to a range of substrate moisture and oxygen availability
Authors: Nakai Arisa , Yurugi Yutaka , Kisanuki Hiromitsu 
Published: February 2009

AbstractThe objective of this study is to determine the effects of substrate moisture and oxygen availability on growth traits of Salix gracilistyla Miquel, which colonizes gravel bars along rivers, the shoot growth schedule, biomass production, and resource allocation were examined under greenhouse conditions. We used four treatments representing a range of substrate moisture and oxygen availability: drought (D), flooding with standing water (FS), flooding with running water (FR), and control without drought or flooding (C). Cuttings in D stopped flushing and had low biomass production, reduced total leaf mass, and small leaves. Under anaerobic conditions, cuttings in FS stopped flushing and had low biomass production, small root biomass, low biomass allocation to roots, shallow roots, high biomass allocation to hypertrophied lenticels, and a few small, thick leaves. Under aerobic conditions, cuttings in FR showed continuous branch elongation and flushing, large biomass production, and large leaf biomass, similar to cuttings in C, in addition to low allocation to hypertrophied lenticels and many large leaves. The growth of cuttings was not inhibited by flooding of the roots throughout the experiment unless the conditions were anaerobic. Thus, cuttings respond to water stress under low moisture conditions by reducing the transpiration area and respond to flooding under low oxygen conditions by high allocation to hypertrophied lenticels and reduced transpiration area. Plasticity in the shoot growth schedule, biomass production, and resource allocation according to moisture conditions and the ability to develop hypertrophied lenticels upon flooding allow S. gracilistyla to colonize sites in which both desiccation and flooding occur.
Proposed diagnostic criteria for apathy in Alzheimer’s disease and other neuropsychiatric disorders
Authors: Robert P. , Onyike C.U. , Leentjens A.F.G. , Dujardin K. , Aalten P. , Starkstein S. , Verhey F.R.J. , Yessavage J. , Clement J.P. , Drapier D. , Bayle F. , Benoit M. , Boyer P. , Lorca P.M. , Thibaut F. , Gauthier S. , Grossberg G. , Vellas B. , Byrne J. 
Published: February 2009

AbstractThere is wide acknowledgement that apathy is an important behavioural syndrome in Alzheimer’s disease and in various neuropsychiatric disorders. In light of recent research and the renewed interest in the correlates and impacts of apathy, and in its treatments, it is important to develop criteria for apathy that will be widely accepted, have clear operational steps, and that will be easily applied in practice and research settings. Meeting these needs is the focus of the task force work reported here.The task force includes members of the Association Française de Psychiatrie Biologique, the European Psychiatric Association, the European Alzheimer’s Disease Consortium and experts from Europe, Australia and North America. An advanced draft was discussed at the consensus meeting (during the EPA conference in April 7th 2008) and a final agreement reached concerning operational definitions and hierarchy of the criteria.Apathy is defined as a disorder of motivation that persists over time and should meet the following requirements. Firstly, the core feature of apathy, diminished motivation, must be present for at least four weeks; secondly two of the three dimensions of apathy (reduced goal-directed behaviour, goal-directed cognitive activity, and emotions) must also be present; thirdly there should be identifiable functional impairments attributable to the apathy. Finally, exclusion criteria are specified to exclude symptoms and states that mimic apathy.
Three‐dimensional power Doppler imaging in the diagnosis of polycystic ovary syndrome
Authors: Mala Yedla M. , Ghosh Sharda B. , Tripathi Reva 
Published: February 2009

AbstractObjectiveTo determine the role of three‐dimensional (3D) power Doppler imaging in the diagnosis of polycystic ovary syndrome (PCOS).MethodsPulsatility index (PI) and resistance index (RI) of the uterine artery and ovary were measured by two‐dimensional (2D) Doppler imaging, while vascularization index (VI), flow index (FI), and vascularization flow index (VFI) were measured by 3D power Doppler in 25 patients with PCOS and 25 women with normal menstrual cycles used as a control group.ResultsUterine artery PI and RI were significantly higher (P < 0.001) and ovarian PI and RI were significantly lower (P < 0.001) in women with PCOS compared with controls. Ovarian VI and VFI were significantly higher in women with PCOS compared with the control group (P < 0.001).Conclusion3D power Doppler indices were higher in women with PCOS than in the control group and were positively correlated with 2D color Doppler indices, and clinical and hormonal parameters. High 3D power Doppler indices may be useful as one of the diagnostic criteria for PCOS.
Fluoxetine treatment for anxiety in women undergoing in vitro fertilization
Authors: Serafini Paulo , Lobo Daniela Sabatini , Grosman Adriana , Seibel Debora , Rocha Andre M. , Motta Eduardo L.A. 
Published: February 2009

AbstractObjectiveTo compare anxiety levels experienced during 4 stressful periods of in vitro fertilization (IVF) and treatment outcomes between women taking fluoxetine and a placebo.MethodsA prospective, randomized, double‐blind, placebo‐controlled trial of patients allocated to receive either fluoxetine (FLX) or folic acid (FA). Anxiety state was assessed at the beginning of ovarian stimulation (OS), ovum pick‐up, embryo transfer, and on the day of the pregnancy test (DPT) using the State‐Trait Anxiety Inventory (STAI).ResultsBaseline STAI‐S and STAI‐T were normal. From OS to DPT, STAI‐S increased from 42.8 ± 10.6 to 44 ± 9.0 in the FLX group and from 40.9 ± 8.1 to 45.3 ± 8.3 in the FA group (P = 0.03 and P = 0.001, respectively). IVF outcome was not affected by the treatment in the two groups.ConclusionsCaution is needed in prescribing fluoxetine to alleviate anxiety in patients undergoing IVF. Studies are needed to determine whether other selective serotonin reuptake inhibitors or higher fluoxetine doses can relieve emotional distress without affecting IVF outcome.
Maternal mortality in low‐income countries: What interventions have been evaluated and how should the evidence base be developed further?
Authors: Burchett Helen E. , Mayhew Susannah H. 
Published: February 2009

AbstractObjectiveThis article reviews the evidence for the effectiveness of non‐clinical interventions to reduce maternal mortality in low‐income settings and identifies the gaps in the evidence base.MethodsA systematic search was conducted to identify reviews and evaluations of non‐clinical interventions to reduce maternal mortality in lower‐income countries with high maternal mortality published between 1997 and 2008. Studies were reviewed to identify the topic focus, study design, and outcomes measured.ResultsThere were 109 intervention evaluations and 30 reviews identified. Studies had been conducted in less than half of the countries and were generally poor quality. More studies focused on tertiary prevention (i.e., preventing death) rather than secondary prevention (i.e., preventing complications). More interventions sought to address quality of care than delays in seeking or accessing care.ConclusionsWhile evidence partly reflects difficulties in evaluating complex public health interventions, more robust study designs are possible to evaluate interventions to reduce maternal mortality. In addition, better standardized outcome measures are needed. This overview identifies topic areas neglected by intervention research.
Decreased FoxP3 gene expression in the nasal secretions from patients with allergic rhinitis
Authors: Lee Sang‐Myeong , Gao Beixue , Dahl Matthew , Calhoun Karen , Fang Deyu 
Published: February 2009

ObjectiveTo determine whether patients with allergic rhinitis have altered FoxP3 gene expression and/or mutations.Study Design and MethodsWe collected nasal secretions from 14 volunteers (five of whom have allergic rhinitis) and five ENT allergy patients. Total RNA was isolated from these nasal secretions. The gene expression levels of FoxP3 were quantified by both semi‐quantitative RT‐PCR and real‐time PCR using Actin as a housekeeping gene. The cDNA fragments amplified by RT‐PCR were analyzed by DNA sequencing.ResultsWe found that patients with allergic rhinitis had significantly lower FoxP3 mRNA compared to nonallergic controls (P < 0.01). In addition, we found a point mutation in the FoxP3 gene from a patient who not only has severe allergic rhinitis, but also has asthma. This mutation locates in a highly conserved region of FoxP3 gene and partially impaired FoxP3 functions.ConclusionOur data indicate that either reduced FoxP3 gene expression or impaired FoxP3 functions are involved in the development of allergic disease in humans.
1α,25‐Dihydroxyvitamin D3 to skew intratumoral levels of immune inhibitory CD34+ progenitor cells into dendritic cells
Authors: Kulbersh Jonathan S. , Day Terry A. , Gillespie M. Boyd , Young M. Rita I. 
Published: February 2009

ObjectivesPrior studies showed that immune inhibitory CD34+ progenitor cells, whose numbers are increased in head and neck squamous cell carcinoma (HNSCC) patients, can be differentiated into immune stimulatory dendritic cells by culture with 1α,25‐dihydroxyvitamin D3 (1,25[OH]2D3). This was extended to a pilot study to diminish intratumoral levels of CD34+ progenitor cells by inducing their maturation into dendritic cells with 1,25(OH)2D3.Study DesignNewly diagnosed HNSCC patients were untreated for 3 weeks or received 3 weeks of 1,25(OH)2D3 treatment befoer surgical treatment.Subjects and MethodsHNSCC tissue was collected by biopsy from six patients who had no prior 1,25(OH)2D3 treatment and at the time of surgical treatment from six untreated patients and 11 patients who completed 1,25(OH)2D3 treatment. Tissues were analyzed by immunohistochemistry for levels of CD34+ cells and dendritic cells.ResultsAfter 1,25(OH)2D3 treatment, intratumoral levels of CD34+ cells and levels of immature dendritic cells declined. However, levels of intratumoral mature dendritic cells increased. Clinical effects of 1,25(OH)2D3 treatment are premature to analyze.ConclusionsTreatment of HNSCC patients with 1,25(OH)2D3 reduced levels of immune inhibitory CD34+ cells while increasing maturation of dendritic cells. This supports added studies to determine the effect of 1,25(OH)2D3 on intratumoral immune competence.
A devastating outcome after adenoidectomy and tonsillectomy: Ideas for improved prevention and management
Authors: Windfuhr Jochen P. , Schloendorff Georg , Sesterhenn Andreas M. , Prescher Andreas , Kremer Bernd 
Published: February 2009

ObjectiveTo develop strategies that may assist the surgeon to prevent and manage severe bleeding complications after adenoidectomy and tonsillectomy.Study DesignRetrospective.Subjects and MethodsExpert reports for malpractice lawsuits or professional boards were reviewed. The review was restricted to “deaths” and “permanent generalized neurological deficiencies.”ResultsForty‐three cases matched our search criteria, including 32 deaths. Adenoidectomy cases (2) were associated with immediate bleeding because of direct vascular injury resulting in one death. Tonsillectomy cases were associated with delayed and repeated episodes of bleeding resulting in 31 deaths, including 19 children. Autopsy verified predominantly aspiration and vascular injuries. An apallic syndrome prevailed in surviving patients.ConclusionCareful inspection of the nasopharynx immediately before adenoidectomy and curettage in a piecemeal fashion under visual control is helpful to prevent direct injury to aberrant arteries. Tonsillectomy cases are associated with delayed and episodic bleeding with spontaneous cessation and young age. Inpatient observation should be strongly considered in cases with repeated bleeding episodes to provide immediate treatment. The follow‐up should be focused on disturbed wound healing. Outcome appears to be dependant on adequate airway management. Rigid instruments and tracheotomy in case of intubation failure are highly recommended to facilitate airway protection and ventilation.
Reporting of harms and adverse events in otolaryngology journals
Authors: Bibawy Haidy , Cossu Anne , Cogan Sophia , Rosenfeld Richard 
Published: February 2009

ObjectiveTo identify the frequency and quality of harms and adverse events reporting in otolaryngology journals.Study DesignA literature review.MethodsFour major otolaryngology journals from 2006 and 1996 were reviewed. Clinical research studies offering therapeutic recommendations were evaluated for frequency and quality of harms and adverse events reporting.ResultsOf 1,835 total articles reviewed, 576 (31%) offered therapeutic recommendations. Sixty‐five percent provided any mention of harms or adverse events, 47 percent explicitly defined the events, and 24 percent described methodology for collecting harms data. The median number of harms or adverse events reported was three. Studies concluding a beneficial effect of therapy were more likely to not mention adverse events (odds ratio 2.99, P =. 007) compared with studies concluding no benefit. Studies of surgical therapy were more likely to report harms or adverse events (odds ratio 1.46, P =. 046).ConclusionsHarms and adverse events are underreported and poorly described in otolaryngology journals with about one third of clinical research not mentioning adverse events at all. Most authors do not explicitly describe harms or adverse events (53%) or the methodology behind collecting adverse events data (76%). Underreporting is more likely when a therapeutic effect is found to be beneficial.
Otitis media with effusion: A possible role for Helicobacter pylori?
Authors: Fancy Tanya , Mathers Peter H. , Ramadan Hassan H. 
Published: February 2009

ObjectivesTo compare Helicobacter pylori prevalence rates in the nasopharynx of pediatric patients with and without otitis media with effusion (OME).Study DesignProspective, controlled.MethodsThe study group consisted of patients undergoing adenoidectomy for persistent OME. A control group of patients with no history of OME undergoing adenoidectomy was simultaneously enrolled. As a substudy, middle ear effusion samples were also analyzed for Helicobacter pylori. Polymerase chain reaction assays were run by using primers against the Helicobacter pylori gene.ResultsHelicobacter pylori was detected in the adenoids of 10 of 45 study group patients, and 6 of 37 controls (P = 0.49). Thirty‐two percent of middle ear aspirates were positive for Helicobacter pylori.ConclusionThe current study confirms the presence of Helicobacter pylori in the nasopharynx and middle ear space, but our results do not support a role for this bacterium in the pathogenesis of otitis media with effusion.
Die Bedeutung von Bäumen und Wäldern für die Gesundheit des Menschen
Authors: Seeland Klaus 
Published: February 2009

Einleitung
Die Bedeutung von Bäumen und Wäldern für die Gesundheit in vorwiegend städtischen Lebensräumen nimmt seit Jahren zu. Die Sozialfunktionen natürlicher Lebensumgebungen gehören seit geraumer Zeit zur „sozio-politischen Architektur“ der grossen Ballungszentren, und ihnen ist in der Raumplanung vermehrt Beachtung geschenkt worden. Indizien hierfür sind die Zunahme innerstädtischer Grünflächen, die Entstehung neuer Parks und Naturerlebnisräume.
The emergence of renewable heating and cooling policy in the United States
Authors: Rickerson Wilson , Halfpenny Tina , Cohan Sander 
Published: February 2009

Abstract
This article discusses the lack of integrated renewable heating and cooling policy in the United States in light of the Obama Administration's proposed energy and climate strategies. The article argues that renewable heating and cooling will be a necessary component of future climate mitigation and fuel diversification strategies in the US, and surveys emerging state-level renewable heating and cooling policies as potential models for future policy development.