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Study Reports (study + report)
Selected AbstractsGender Differences in Alcohol Treatment: An Analysis of Outcome From the COMBINE StudyALCOHOLISM, Issue 10 2010Shelly F. Greenfield Background:, Relatively few studies have examined gender differences in the effectiveness of specific behavioral or pharmacologic treatment of alcohol dependence. The aim of this study is to assess whether there were gender differences in treatment outcomes for specific behavioral and medication treatments singly or in combination by conducting a secondary analysis of public access data from the national, multisite NIAAA-sponsored COMBINE study. Methods:, The COMBINE study investigated alcohol treatment among 8 groups of patients (378 women, 848 men) who received medical management (MM) with 16 weeks of placebo, naltrexone (100 mg/day), acamprosate (3 g/day), or their combination with or without a specialist-delivered combined behavioral intervention. We examined efficacy measures separately for men and women, followed by an overall analysis that included gender and its interaction with treatment condition in the analyses. These analyses were performed to confirm whether the findings reported in the parent trial were also relevant to women, and to more closely examine secondary outcome variables that were not analyzed previously for gender effects. Results:, Compared to men, women reported a later age of onset of alcohol dependence by approximately 3 years, were significantly less likely to have had previous alcohol treatment, and drank fewer drinks per drinking day. Otherwise, there were no baseline gender differences in drinking measures. Outcome analyses of 2 primary (percent days abstinent and time to first heavy drinking day) and 2 secondary (good clinical response and percent heavy drinking days) drinking measures yielded the same overall pattern in each gender as that observed in the parent COMBINE study report. That is, only the naltrexone by behavioral intervention interaction reached or approached significance in women as well as in men. There was a naltrexone main effect that was significant in both men and women in reduction in alcohol craving scores with naltrexone-treated subjects reporting lower craving than placebo-treated subjects. Conclusions:, This gender-focused analysis found that alcohol-dependent women responded to naltrexone with COMBINE's Medical Management, similar to the alcohol-dependent men, on a wide range of outcome measures. These results suggest that clinicians can feel comfortable prescribing naltrexone for alcohol dependence in both men and women. In this study, it is also notable that fewer women than men reported receiving any alcohol treatment prior to entry into the COMBINE study. Of note, women tend to go to primary health care more frequently than to specialty substance abuse programs for treatment, and so the benefit we confirm for women of the naltrexone and MM combination has practical implications for treating alcohol-dependent women. [source] Confidence Interval Calculation Methods Are Infrequently Reported in Emergency-medicine LiteratureACADEMIC EMERGENCY MEDICINE, Issue 1 2007Amy Marr MD Abstract Background There are many different confidence interval calculation methods, each providing different as well as in some cases inadequate interval estimates. Readers who know which method is used are better able to understand potentially significant limitations in study reports. Objectives To quantify how often confidence interval calculation methods are disclosed by authors in four peer-reviewed North American emergency-medicine journals. Methods The authors independently performed searches of four journals for all studies in which comparisons were made between means, medians, proportions, odds ratios, or relative risks. Case reports, editorials, subject reviews, and letters were excluded. Using a standardized abstraction form developed on a spreadsheet, the authors evaluated each article for the reporting of confidence intervals and evaluated the description of methodology used to calculate the confidence intervals. Results A total of 212 articles met the inclusion criteria. Confidence intervals were reported in 123 articles (58%; 95% CI = 51% to 64%); of these, a description of methodology was reported in 12 (9.8%; 95% CI = 5.7% to 16%). Conclusions Confidence interval methods of calculation are disclosed infrequently in emergency medicine literature. [source] Reliability of the V-scope system in the measurement of arm movement in children with obstetric brachial plexus palsyDEVELOPMENTAL MEDICINE & CHILD NEUROLOGY, Issue 11 2006Andrea E Bialocerkowski PhD BApp Sc (Physio) MApp Sc (Physio) This study reports on a novel methodology using the V-scope to quantify elbow and shoulder movement in young children with obstetric brachial plexus palsy (OBPP), and the intra-and interreliability of this method. The V-scope, a portable, inexpensive movement analysis system, was configured in an L-shape, with two transmitting towers placed on the floor and one 1.35m off the ground. These towers received ultrasonic pulses from buttons that were placed over standardized landmarks of the child's trunk, chest, and upper limb. Two physiotherapists (a paediatric and a generalist) facilitated the maximum range of active elbow flexion/extension and shoulder abduction/flexion in 30 children with OBPP (18 females, 12 males; age range 6mo-4y 7mo; mean age 2y 6mo [SD 1y 2mo]). Assessments were conducted on two occasions, one week apart. The V-scope was found to be feasible to use by a specialist and a generalist physiotherapist, demonstrating moderate to high reliability coefficients, small measurement errors, and lack of missing data. The pediatric physiotherapist was more reliable in measuring elbow and shoulder movement compared with the generalist physiotherapist, which suggests that the same experienced, pediatric physiotherapist should assess elbow and shoulder movement across all occasions of testing. [source] Influence of reed stem density on foredune developmentEARTH SURFACE PROCESSES AND LANDFORMS, Issue 11 2001S. M. Arens Abstract Vegetation density on foredunes exerts an important control on aeolian sediment transport and deposition, and therefore on profile development. In a long-term monitoring field experiment, three plots were planted with regular grids of reed bundles in three different densities: 4, 2 and 1 bundles per m2. This study reports on the differences in profile development under the range of vegetation densities. Topographic profiles were measured between May 1996 and April 1997. Results indicate important differences in profile development for the three reed bundle densities: in the highest density plot a distinct, steep dune developed, while in the lowest density a more gradual and smooth sand ramp was deposited. When the stems had been completely buried, differences in profile evolution vanished. After a second planting of reed stems in January 1997 the process was repeated. In May 1997, all plots had gained a sand volume ranging from 11·5 to 12·3 m3 m,1, indicating that the sediment budget is relatively constant, regardless of the particular profile evolution. The field evidence is compared with simulations of profile development, generated by the foredune development model SAFE. The model successfully reproduces the overall profile development, but in general, the equations used for vegetation,transport interaction overestimate the effect of vegetation. This causes some deviations between field and model results. Several reasons for this are discussed. Based on the experiments reported here, recommendations are given for further research. Copyright © 2001 John Wiley & Sons, Ltd. [source] Enhancement of electrokinetically driven microfluidic T-mixer using frequency modulated electric field and channel geometry effectsELECTROPHORESIS, Issue 18 2009Deguang Yan Abstract This study reports improved electrokinetically driven microfluidic T-mixers to enhance their mixing efficiency. Enhancement of electrokinetic microfluidic T-mixers is achieved using (i) an active approach of utilizing a pulsating EOF, and (ii) a passive approach of using the channel geometry effect with patterned blocks. PDMS-based electrokinetic T-mixers of different designs were fabricated. Experimental measurements were carried out using Rhodamine B to examine the mixing performance and the micro-particle image velocimetry technique to characterize the electrokinetic flow velocity field. Scaling analysis provides an effective frequency range of applied AC electric field. Results show that for a T-mixer of 10,mm mixing length, utilizing frequency modulated electric field and channel geometry effects can increase the mixing efficiency from 50 to 90%. In addition, numerical simulations were performed to analyze the mixing process in the electrokinetic T-mixers with various designs. The simulation results were compared with the experimental data, and reasonable agreement was found. [source] Mutagenicity of nitroaromatic degradation compoundsENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 10 2003Ranjit S. Padda Abstract The mutagenicity of 2,4-dinitrotoluene (24DNT), and 2,6-dinitrotoluene (26DNT), and their related transformation products such as hydroxylamine and amine derivatives, which are formed by Clostridium acetobutylicum, were tested in crude cell extracts using Salmonella typhimurium TA100. A previous publication already reported the mutagenic activities of 2,4,6-trinitrotoluene (TNT) and its related hydroxylamine derivatives in this test system. A time course of the mutagenicity during the anaerobic transformation of TNT, 24DNT, and 26DNT was also investigated under the same conditions to compare with the results from the pure compounds. The monohydroxylamino intermediates 2-hydroxylamino-4-nitrotoluene (2HA4NT), 4-hydroxylamino-2-nitrotoluene (4HA2NT) and 2-hydroxylamino-6-nitrotoluene (2HA6NT) formed during anaerobic transformation of dinitrotoluenes were proven to be mutagenic in the Ames test using Salmonella typhimurium TA100. This study reports that 4HA2NT is the most stable derivative, whereas 2HA4NT and 2HA6NT are less stable and these intermediates are mutagenic in the Ames test. Both 24DNT and 26DNT and their final metabolites 2,4-diaminotoluene (24DAT) and 2,6-aminotoluene (26DAT) appeared nonmutagenic. In a time-course study of TNT degradation, the temporal sample containing 85% of 2,4-dihydroxylamino-6-nitrotoluene (24HA6NT) is most mutagenic. These observations suggest that the bioremediation approach for treatment of 24DNT and 26DNT should be carried past the hydroxylamino intermediate. [source] Investigation of an onsite wastewater treatment system in sandy soil: Site characterization and fate of anionic and nonionic surfactantsENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 12 2002Allen M. Nielsen Abstract This study reports on the fate of linear alkylbenzene sulfonate (LAS), alcohol ethoxylate (AE), and alcohol ether sulfate (AES) surfactants in a home septic system near Jacksonville (FL, USA) that has been used since 1976. The drainfield at this site resides in fine sand (<6% silt and clay) with an unsaturated zone that ranges from 0 to 1.3 m. During the wettest times of the year, it is likely that effluent from the septic system passes directly into the groundwater without exposure to an unsaturated zone of soil. Groundwater was collected during two sampling events, representing seasonal high and low groundwater table levels, and analyzed for the surfactants LAS, AES, and AE. During the wet season, the unsaturated zone was approximately 0.01 m beneath the drainfield. During the dry season, the unsaturated zone was about 0.4 m below the drainfield. Alcohol ethoxylate was not detected in any groundwater samples during either sampling. Alcohol ether sulfate was not found in the dry season sampling, but traces of AES had migrated downgradient about 4.7 m horizontally and 1.8 m vertically in the wet season. Linear alkylbenzene sulfonate was detected in some dry season samples and had moved downgradient some 11.7 m horizontally and 3.7 m vertically in the wet season. These observations demonstrate that these surfactants were removed to a great extent; otherwise, they would have traveled more than 260 m downgradient, which is the calculated distance that a conservative tracer like bromide would have moved downgradient over the life of the system. The most likely removal mechanisms for these surfactants were biodegradation and sorption. Therefore, this study indicates that LAS, AE, and AES are readily removed from groundwater in soils below septic system drainfields even in situations with minimal unsaturated soil zones. [source] Development of a fish reporter gene system for the assessment of estrogenic compounds and sewage treatment plant effluentsENVIRONMENTAL TOXICOLOGY & CHEMISTRY, Issue 9 2002Gabriele E. Ackermann Abstract This study reports on the development and application of a fish-specific estrogen-responsive reporter gene assay. The assay is based on the rainbow trout (Oncorhynchus mykiss) gonad cell line RTG-2 in which an acute estrogenic response is created by cotransfecting cultures with an expression vector containing rainbow trout estrogen receptor a complementary DNA (rtER, cDNA) in the presence of an estrogen-dependent reporter plasmid and an estrogen receptor (ER) agonist. In a further approach, RTG-2 cells were stably transfected with the rtER, cDNA expression vector, and clones responsive to 17,-estradiol (E2) were selected. The estrogenic activity of E2, 17,-ethinylestradiol, 4-nonylphenol, nonylphenoxy acetic acid, 4- tert -octylphenol, bisphenol A, o,p,-DDT, p,p,-DDT, o,p,-2,2-bis(chlorophenyl)-1,1-dichloroethylene (o,p,-DDE), p,p,-DDE, o,p,-2,2-bis(chlorophenyl)-1,1-di-chloroethane (o,p,-DDD), p,p,-DDD, and p,p,-2,2-bis(chlorophenyl)acetic acid (p,p,-DDA) was assessed at increasing concentrations. All compounds except o,p,-DDT, p,p,-DDE, and p,p,-DDA showed logistic dose-response curves, which allowed the calculation of lowest-observed-effect concentrations and the concentrations at which half-maximal reporter gene activities were reached. To check whether estrogen-responsive RTG-2 cells may be used to detect the estrogenic activity of environmental samples, an extract from a sewage treatment plant (STP) effluent was assessed and found to have estrogenic activity corresponding to the transcriptional activity elicited by 0.05 nM of E2. Dose-response curves of nonylphenol, octylphenol, bisphenol A, and o,p,-DDD revealed that the RTG-2 reporter gene assay is more sensitive for these compounds when compared to transfection systems recombinant for mammalian ERs. These differences may have an effect on the calculation of E2 equivalents when estrogenic mixtures of known constitution, or environmental samples, such as STP effluents, are assessed. [source] CLINICAL STUDY: Proof-of-concept human laboratory study for protracted abstinence in alcohol dependence: effects of gabapentinADDICTION BIOLOGY, Issue 1 2009Barbara J. Mason ABSTRACT There is a need for safe medications that can effectively support recovery by treating symptoms of protracted abstinence that may precipitate relapse in alcoholics, e.g. craving and disturbances in sleep and mood. This proof-of-concept study reports on the effectiveness of gabapentin 1200 mg for attenuating these symptoms in a non-treatment-seeking sample of cue-reactive, alcohol-dependent individuals. Subjects were 33 paid volunteers with current Diagnostic and Statistical Manual of Mental Disorders-IV alcohol dependence and a strength of craving rating 1 SD or greater for alcohol than water cues. Subjects were randomly assigned to gabapentin or placebo for 1 week and then participated in a within-subjects trial where each was exposed to standardized sets of pleasant, neutral and unpleasant visual stimuli followed by alcohol or water cues. Gabapentin was associated with significantly greater reductions than placebo on several measures of subjective craving for alcohol as well as for affectively evoked craving. Gabapentin was also associated with significant improvement on several measures of sleep quality. Side effects were minimal, and gabapentin effects were not found to resemble any major classes of abused drugs. Results suggest that gabapentin may be effective for treating the protracted abstinence phase in alcohol dependence and that a randomized clinical trial would be an appropriate next step. The study also suggests the value of cue-reactivity studies as proof-of-concept screens for potential antirelapse drugs. [source] Construction of Polyethyleneimine-,-cyclodextrin/pDNA Multilayer Structure for Improved In Situ Gene Transfection,ADVANCED ENGINEERING MATERIALS, Issue 1-2 2010Yan Hu This study reports in situ gene delivery from gene-functionalized poly(D,L -lactic acid) (PDLLA, Mw of around 2.0,×,105,g,mol,1) films, which were constructed via layer-by-layer (LbL) assembly technique with low molecular weight polyethylenimine-,-cyclodextrin (PEI-CD) conjugate and plasmid DNA (pDNA). PEI-CD was characterized by Fourier transform infrared spectroscopy (FTIR) and nuclear magnetic resonance (NMR), respectively. The buildup of multilayered PEI-CD/pDNA pairs onto PDLLA films was monitored with contact angle measurements and UV,Vis spectrometer, respectively. A sustained release of pDNA from multilayered films was observed for 28,h. The mechanism of in situ gene delivery on PDLLA film was investigated in this study as well. Spherical PEI-CD/pDNA complexes were formed and released following the deconstruction of multilayered films, which was confirmed by transmission electron microscopy (TEM) and gel electrophoresis, respectively. Surface mediated in situ gene transfection was achieved when culturing hepatoma G2 (HepG2) and human embryonic kidney 293 (HEK293) onto PEI-CD/pDNA multilayered films. Furthermore, PEI-CD improved the gene transfection efficiency when compared with that of PEI. Such gene-functionalized biomaterial reported here has potential application in tissue engineering and implant technology. [source] Inclusive Design in Apparel Product Development for Working Women With Physical DisabilitiesFAMILY & CONSUMER SCIENCES RESEARCH JOURNAL, Issue 4 2007Kate E. Carroll Consumers with physical limitations want apparel products and retail environments that work for them. Inclusive design is a framework for developing products to satisfy multiple consumers, regardless of their physical ability. This qualitative study reports on physical limitations and apparel preferences of working women (n = 9) with a variety of limitations. A prototype for a garment was developed, wear-tested, and evaluated using inclusive design criteria. Subsequently, manufacturers (n = 6) were interviewed regarding production and distribution within the existing system. Results indicate that (a) the effect of disability on the body supercedes clinical definition for apparel product development, (b) working women with various disabilities have similar apparel needs, (c) inclusive design can be a successful strategy for product development, and (d) current industry perceptions about disability present the greatest barrier to successful implementation. The researchers conclude that further studies should focus on industry "buy-in" of inclusive design as a framework for product development. [source] Void growth and damage models for predicting ductile fracture in weldsFATIGUE & FRACTURE OF ENGINEERING MATERIALS AND STRUCTURES, Issue 2 2000Wilsius This study reports on a numerical and experimental investigation of ductile tearing using a local approach to fracture. Two models have been analysed: (i) the Rice,Tracey (RT) void growth model; and (ii) the Rousselier continuum damage theory. The effects of the model parameters, including the mesh size, on the crack growth behaviour have been analysed, and a significant influence on both the J -values and the slopes dJ/da has been noted. The crack propagation in an overmatched welded joint has also been investigated. For the RT model, crack propagation has been simulated using the release node technique. Because this method requires one to previously assign the crack propagation path, using such a model is somewhat restrictive. This problem vanishes when dealing with Rousselier's model (and more generally with coupled models) because the elements which are damaged automatically give the crack path. [source] Fine-scale movements of the swordfish Xiphias gladius in the Southern California BightFISHERIES OCEANOGRAPHY, Issue 4 2010CHUGEY A. SEPULVEDA Abstract This study reports on the fine-scale movements of swordfish (Xiphias gladius) outfitted with pop-off satellite archival transmitters (PSATs) in the Southern California Bight (SCB). PSATs were deployed on basking swordfish using traditional harpoon methods from 2004 to 2006. Transmitters were programmed for short-term deployment (2,90 days) and re-acquired using a signal direction finder. High-resolution (min,1) depth and temperature data from nine swordfish (approximately 45,120 kg) were collected (>193 days). All swordfish displayed diurnal vertical movements similar to those reported for other geographic locations. The dominant diurnal movement pattern entailed swordfish remaining below the thermocline (>68 ± 15 m) during the day and near the surface, within the upper-mixed layer, at night. Collectively, the average daytime depth (±SE) was 273 ± 11 m and the average night depth 31 ± 5 m. Three distinct vertical behaviors were recorded: 35% of the records following a strict diurnal pattern, with the entire day below the thermocline and the entire night near the surface; 52% of the records revealed routine surface-basking events during the day, with an otherwise similar distribution at night; and 13% of the records exhibited surface-oriented activity during the day and night. Surface basking (<3 m during the day) was recorded for eight individuals and occurred on 131 of the 193 days (68% of the dataset). Collectively, surface basking accounted for 8% of the total daytime records. The relevance of these vertical behaviors to SCB fisheries is discussed. [source] Competition in variable environments: experiments with planktonic rotifersFRESHWATER BIOLOGY, Issue 6 2002KEVIN L. KIRK 1.,In a constant environment, competition often tends to reduce species diversity. However, several theories predict that temporal variation in the environment can slow competitive exclusion and allow competing species to coexist. This study reports on laboratory competition experiments in which two pairs of planktonic rotifer species competed for a phytoplankton resource under different conditions of temporal variability in resource supply. 2.,For both species pairs, Keratella cochlearis dominated under all conditions of temporal variability, and the other species (Brachionus calyciflorus or Synchaeta sp.) almost always went extinct. Increasing temporal variation in resource supply slowed competitive exclusion but did not change competitive outcome or allow coexistence. 3.,Rotifers show a gleaner,opportunist trade-off, because gleaner species have low threshold resource levels (R*) and low maximum population growth rates, while opportunist species have the opposite characteristics. In the competition experiments, the gleaner always won and the opportunists always lost. Thus, a gleaner,opportunist trade-off was not sufficient to facilitate coexistence under conditions of resource variability. Instead, the winning species had both the lowest R* and the greatest ability to store resources and ration their use during times of extreme resource scarcity. [source] Acute leukemias with ETV6/ABL1 (TEL/ABL) fusion: Poor prognosis and prenatal originGENES, CHROMOSOMES AND CANCER, Issue 10 2010Jan Zuna The ETV6/ABL1 (TEL/ABL) fusion gene is a rare aberration in malignant disorders. Only 19 cases of ETV6/ABL1 -positive hematological malignancy have been published, diagnosed with chronic myeloid leukemia, other types of chronic myeloproliferative neoplasm, acute myeloid leukemia or acute lymphoblastic leukemia (ALL). This study reports three new cases (aged 8 months, 5 years, and 33 years) of ALL with the ETV6/ABL1 fusion found by screening 392 newly diagnosed ALL patients (335 children and 57 adults). A thorough review of the literature and an analysis of all published data, including the three new cases, suggest poor prognosis of ETV6/ABL1 -positive acute leukemias. The course of the disease in the two pediatric patients is characterized by minimal residual disease monitoring, using quantification of both the ETV6/ABL1 transcript and immunoreceptor gene rearrangements. Eosinophilia could not be confirmed as a hallmark of the ETV6/ABL1 -positive disease. Studies of neonatal blood spots demonstrated that, in the child diagnosed at five years, the ETV6/ABL1 fusion initiating the ALL originated prenatally. © 2010 Wiley-Liss, Inc. [source] Radiation synovectomy by 188Re-Sulfide in haemophilic synovitisHAEMOPHILIA, Issue 5 2004P. Li Summary., Radiation synovectomy is a safe and effective treatment for chronic haemophilic synovitis causing recurrent haemarthroses. This study reports results of 29 188Re-sulfide radiation synovectomies in knee joint with a follow-up 18 months. Using the absorbed dose factor, three groups of radioactivity dose (555 MBq, 687 MBq and 917 MBq) were used according to the synovium thickness that measured by MRI. Excellent and good results (haemarthrosis reduction from 75 to 100%) were obtained in 71% of cases at 18 months. Comparison of the results, no significant difference was found among the radioactivity dose groups. Radiation was well contained within the knee. There were no observed or identified complications including the detectable harm to the articular cartilage, as shown by MRI. [source] Going Dutch: The Development of Collaborative Practices Between Higher Education and Museums and GalleriesINTERNATIONAL JOURNAL OF ART & DESIGN EDUCATION, Issue 1 2003Liz Smith This study reports on a very successful collaboration between teacher education courses in Manchester and Amsterdam and the Van Gogh Museum in Amsterdam. The central aim of the initiative was to promote and sustain partnerships between Higher Education (HE) institutions, public galleries and schools with a view to developing, delivering and sharing good practice in art and design within a European context. [source] The Demand Attributes of Assurance Services Providers and the Role of Independent AccountantsINTERNATIONAL JOURNAL OF AUDITING, Issue 2 2006W. Robert Knechel This study reports on desirable attributes of assurance services providers for assurance services based on responses from a sample of Dutch senior accounting and financial officers. In general, overall expertise and objectivity are perceived as the most important attributes for selecting an assurance service provider. Cost is perceived as the least important attribute. In general, accountants are perceived as more likely to be the preferred service provider for assurance over information systems and/or when professional reputation and integrity is important for providing a service. These attributes are in line with the projected image of the profession. An accountant is less likely to be the preferred provider when cost and independence are not important. We interpret this result as an indication that independence in the audit is important and, thus, other services are acceptable only when independence is not an issue. [source] Paliperidone palmitate , review of the efficacy, safety and cost of a new second-generation depot antipsychotic medicationINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2010L. Citrome Summary Objective:, To describe the efficacy, safety and cost of paliperidone palmitate, a depot antipsychotic medication recently approved for the treatment of schizophrenia. Data sources:, A literature search was conducted by querying the websites http://www.pubmed.gov, http://www.fda.gov, http://www.accessdata.fda.gov/scripts/cder/drugsatfda and http://www.clinicaltrials.gov for the search term ,paliperidone palmitate'. Cost information was obtained from the pharmaceutical vendor servicing a local state-operated psychiatric facility. Study selection:, All available reports of studies were identified. Product labelling provided additional information. Data extraction:, Descriptions of the principal results and calculation of the number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports and synopses. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Data synthesis:, Paliperidone palmitate is a newly available depot formulation of paliperidone (the 9-OH metabolite of risperidone). Upon injection into the deltoid or gluteal muscle, the release of the drug starts as early as day 1, reaches maximum plasma concentrations at 13 days and lasts for as long as 126 days. Maximum concentration following deltoid injection is approximately 28% higher compared with injection into the gluteal muscle, and thus paliperidone palmitate requires initiation by two initial deltoid injections spread 1 week apart to achieve therapeutic concentrations rapidly. Subsequent injections are at 4-week intervals. Acute efficacy was evidenced by four short-term double-blind, randomised, placebo-controlled, fixed-dose studies of acutely relapsed adult inpatients who met DSM-IV criteria for schizophrenia. NNT for a 30% or greater decrease in the Positive and Negative Syndrome Scale total score compared with placebo was consistently lower for the higher dose strengths of 156 and 234 mg, suggesting a therapeutic dose,response. Treatment with paliperidone palmitate at doses between 39 and 156 mg significantly delayed the time to recurrence of symptoms of schizophrenia after 24 weeks of maintained symptom stability. The NNT vs. placebo to avoid a recurrence of symptoms was 5 (95% CI 4,7). Overall, paliperidone palmitate was reasonably well tolerated, with low rates of extrapyramidal symptoms or body weight gain; however, these may be more common at higher doses. Injection site reactions occurred at a rate ranging from 4% to 10%, depending on the dose regimen, compared with 2% for the pooled placebo arms. The acquisition cost of a maintenance dose of paliperidone palmitate calculated on a per day basis is similar to that for risperidone microspheres, but about double the cost for oral paliperidone and approximately 19 times the cost of oral generic risperidone. Conclusions:, Paliperidone palmitate is efficacious for the acute and maintenance treatment of schizophrenia and is reasonably well tolerated. It offers several advantages over other available second-generation depot antipsychotics: it comes in prefilled syringes in a number of different dosage strengths; it does not require refrigeration; it does not require supplementation with oral antipsychotics; it can be administered once monthly; it can be administered with a very small bore needle; the injection volume is small; the injection site can be either the deltoid or gluteal muscles; it does not require an additional precautionary observation period after the injection. For patients for whom oral risperidone or paliperidone is otherwise effective, paliperidone palmitate offers a guaranteed delivery system that enhances adherence. However, the high acquisition cost of paliperidone palmitate will likely be an important obstacle to its routine use. [source] Iloperidone for schizophrenia: a review of the efficacy and safety profile for this newly commercialised second-generation antipsychoticINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 8 2009L. Citrome Summary Objective:, The aim of the study was to describe the efficacy and safety of iloperidone for the treatment of schizophrenia. Data sources:, The pivotal registration trials were accessed by querying http://www.pubmed.gov, http://www.fda.gov and http://www.clinicaltrials.gov for the search term ,iloperidone'. Study selection:, Four published primary reports of phase III studies were identified as well as preclinical animal and receptor affinity studies that describe potential mechanisms of action and pharmacogenomic studies that identify potential genetic biomarkers for efficacy and tolerability. Product labelling provided additional data. Data extraction:, Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the study reports. Additional safety outcomes subject to NNH analysis were obtained from product labelling. Data synthesis:, Iloperidone is a second-generation antipsychotic agent indicated for the acute treatment of schizophrenia in adults. Iloperidone has been evaluated in several double-blind placebo-controlled clinical trials. The oral formulation has demonstrated efficacy in reducing the symptoms of acute schizophrenia at fixed daily doses ranging from 12 to 24 mg. Data reported for categorical definitions of response using the Positive and Negative Syndrome Scale were limited to one study and specifically to rates of achieving a , 20% decrease in the positive subscale from baseline; significantly more patients receiving iloperidone 24 mg/day (72%) than placebo (52%) met this criterion, yielding a NNT of five. Iloperidone should be titrated slowly to avoid orthostatic hypotension, potentially delaying the achievement of a therapeutic dose level. There appears to be a dose relationship for adverse events such as dizziness, somnolence and dry mouth; for example NNH vs. placebo for somnolence was 25 for iloperidone 10,16 mg/day and 10 for 20,24 mg/day. There is a possibility of a therapeutic dose response as well. Iloperidone is essentially free of extra-pyramidal side effects. Iloperidone is associated with weight gain comparable with risperidone. Long-term double-blind maintenance studies have demonstrated iloperidone's non-inferiority to haloperidol for relapse prevention. Product labelling includes a warning about the potential for QT interval prolongation. At present there are no efficacy studies available that are powered to directly compare iloperidone with other second-generation antipsychotics. The development of a depot formulation of iloperidone as well as efforts to identify genetic biomarkers for prediction of both efficacy and tolerability are in progress. Conclusions:, Aside from paliperidone, iloperidone is the first new second-generation antipsychotic to be commercialised in the USA since 2002. From the limited registration data, iloperidone appears to be relatively well tolerated once titrated to a therapeutic level and can be a useful option to consider. The development of a depot formulation and potential for genetic biomarkers may make this agent compelling. Further comparisons with other available agents among patients with schizophrenia in the ,real world' are needed. [source] Twenty-year follow-up of bulimia nervosa and related eating disorders not otherwise specifiedINTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 6 2010Pamela K. Keel PhD Abstract Objective This study reports 20-year outcome of bulimia nervosa (BN) and related eating disorders not otherwise specified (EDNOS) and point prevalence of BN and EDNOS for a cohort of women and men in late adolescence (mean age = 20 ± 2 years), adulthood (30 ± 2 years), and mid-life (40 ± 2 years). Method N = 654 women and men, 73% of those assessed in 1982, completed 20-year follow-up in a two-stage design including questionnaires and structured clinical interviews. Results Approximately 75% of women with BN were in remission at 20-year follow-up, and outcome did not differ significantly between BN and EDNOS. Eating disorder point prevalence declined in women but not men from late adolescence to mid-life. Discussion Despite patterns of improvement in women, 4.5% reported a clinically significant eating disorder at mid-life, suggesting the need for more research on potential risk factors in this age group, such as pressures for women to maintain a youthful appearance. © 2009 by Wiley Periodicals, Inc. Int J Eat Disord 2010; 43:492,497 [source] Regional cerebral blood flow responses to hyperventilation during sevoflurane anaesthesia studied with PETACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 5 2010L. SCHLÜNZEN Background: Arterial carbon dioxide tension (PaCO2) is an important factor controlling cerebral blood flow (CBF) in neurosurgical patients. It is still unclear whether the hypocapnia-induced decrease in CBF is a general effect on the brain or rather linked to specific brain regions. We evaluated the effects of hyperventilation on regional cerebral blood flow (rCBF) in healthy volunteers during sevoflurane anaesthesia measured with positron emission tomography (PET). Methods: Eight human volunteers were anaesthetized with sevoflurane 1 MAC, while exposed to hyperventilation. During 1 MAC sevoflurane at normocapnia and 1 MAC sevoflurane at hypocapnia, one H215O scan was performed. Statistical parametric maps and conventional regions of interest analysis were used for estimating rCBF differences. Results: Cardiovascular parameters were maintained constant over time. During hyperventilation, the mean PaCO2 was decreased from 5.5 ± 0.7 to 3.8 ± 0.9 kPa. Total CBF decreased during the hypocapnic state by 44%. PET revealed wide variations in CBF between regions. The greatest values of vascular responses during hypocapnia were observed in the thalamus, medial occipitotemporal gyrus, cerebellum, precuneus, putamen and insula regions. The lowest values were observed in the superior parietal lobe, middle and inferior frontal gyrus, middle and inferior temporal gyrus and precentral gyrus. No increases in rCBF were observed. Conclusions: This study reports highly localized and specific changes in rCBF during hyperventilation in sevoflurane anaesthesia, with the most pronounced decreases in the sub cortical grey matter. Such regional heterogeneity of the cerebral vascular response should be considered in the assessment of cerebral perfusion reserve during hypocapnia. [source] Planning for stingray tourism at Hamelin Bay, Western Australia: the importance of stakeholder perspectivesINTERNATIONAL JOURNAL OF TOURISM RESEARCH, Issue 5 2003Anna Lewis Abstract Stingray tourism continues to be developed at various locations around the world with the concept being marketed on television travel programmes, documentaries, internet sites and travel brochures. Food provisioned stingray tourism, for example, now attracts some 100,000 visitors a year to ,tingray city' in the Caymen Islands. At Hamelin Bay in southwest Western Australia, up to 16 large stingrays (Dasyatis brevicaudata and Dasyatis thetidis) and numerous eaglerays (Myliobatis australis) are fed by visitors from the waters edge. This study reports on stakeholder perspectives relating to tourism development and potential management of the Hamelin Bay site. From the results of this study it is clear that there is sufficient interest in stingray tourism (by all the stakeholders surveyed) to develop Hamelin Bay as a permanent feeding site. Visitors on average gave their experience with the rays a satisfaction value of 8.9 out of 10. Twenty-five per cent of visitors surveyed did not want commercialisation, tour groups or excessive visitor numbers. Their main concern was that the health and safety of the rays may deteriorate with an increase of visitors if the situation is not managed correctly. Visitors desire to be educated about the rays, and how to best interact with them safely. Visitors also acknowledged that the site needs management through more signs, information and a management plan. Management for the site is therefore likely to be best implemented through the application of signage, development of guidelines/codes of conduct, protection of the rays and zoning the beach according to specific recreational purposes. Management regimes should also use various indicators to monitor the impacts of stingray tourism at Hamelin Bay. Copyright © 2003 John Wiley & Sons, Ltd. [source] Fishing near sea-cage farms along the coast of the Turkish Aegean SeaJOURNAL OF APPLIED ICHTHYOLOGY, Issue 1 2010O. Akyol Summary This study reports on the yield of commercially important species captured intentionally around and under fish-cage farms using specific types of gear from both sea-cage farmers and artisanal fishermen, and to identify the species composition of these catches. The 2004,2008 research was carried out in 21 fish farms, randomly chosen along the coast of Izmir Province on the Aegean Sea. A total of 91 persons were interviewed, including directors, fishers from the fish farms and artisanal fishermen. The technical characteristics of a special trap used by some fish farmers were diagramed. Total wild fish catch quantities as well the species raised in the sea-cages were recorded. A total of 34 finfish and four invertebrate species were identified from the sea-cage farm fishery. Eight fish species according to the descending quantities raised were bogue (Boops boops), grey mullet (Mugil spp.), blackspot seabream (Pagellus bogaraveo), salema (Sarpa salpa), common two-banded seabream (Diplodus vulgaris), annular seabream (Diplodus annularis), striped seabream (Lithognathus mormyrus) and gilthead seabream (Sparus aurata). Mean quantities of wild fish caught from 2004 to 2008 in a sampled farm were 13 998 ± 210, 34 434 ± 482, 30 116 ± 529, 27 893 ± 429, and 32 366 ± 808 kg, respectively. There were significant differences between fish amounts and years (P < 0.05). [source] Activity and diversity of methanotrophs in the soil,water interface and rhizospheric soil from a flooded temperate rice fieldJOURNAL OF APPLIED MICROBIOLOGY, Issue 1 2009L. Ferrando Abstract Aims:, To combine molecular and cultivation techniques to characterize the methanotrophic community in the soil,water interface (SWI) and rhizospheric soil from flooded rice fields in Uruguay, a temperate region in South America. Methods and Results:, A novel type I, related to the genus Methylococcus, and three type II methanotrophs were isolated from the highest positive dilution steps from the most probable number (MPN) counts. Potential methane oxidation activities measured in slurried samples were higher in the rhizospheric soil compared to the SWI and were stimulated by N-fertilization. PmoA (particulate methane monooxygenase) clone libraries were constructed for both rice microsites. SWI clones clustered in six groups related to cultivated and uncultivated members from different ecosystems of the genera Methylobacter, Methylomonas, Methylococcus and a novel type I sublineage while cultivation and T-RFLP (terminal restriction fragment length polymorphism) analysis confirmed the presence of type II methanotrophs. Conclusions:, Cultivation techniques, cloning analysis and T-RFLP fingerprinting of the pmoA gene revealed a diverse methanotrophic community in the rice rhizospheric soil and SWI. Significance and Impact of the Study:, This study reports, for the first time, the analysis of the methanotrophic diversity in rice SWI and this diversity may be exploited in reducing methane emissions. [source] Hydrogenated natural rubber blends: Aspect on thermal stability and oxidative behaviorJOURNAL OF APPLIED POLYMER SCIENCE, Issue 3 2009N. Hinchiranan Abstract Hydrogenated natural rubber (HNR) prepared from natural rubber (NR) is a new sustainable elastomer with excellent thermal properties. This study reports on the effect of vulcanization system and blend ratio on the thermal and oxidative resistance of HNR/NR vulcanizates. The various HNR/NR ratios vulcanized by peroxide and sulfur donor system exhibited the highest retention of tensile strength after thermal aging due to the formation of zinc-dimethyldithiocarbamate (ZDMDC) which is an efficient antioxidant. The results from thermogravimetric analysis (TGA) indicated that the saturated structure of HNR had higher decomposition temperature and activation energy to enhance the thermal stability of HNR/NR vulcanizates. The initial and maximum decomposition temperatures of NR and HNR phases in vulcanizates were not affected by rubber blend ratio. This suggests that the decomposition pattern of HNR has no influence on another constituent. The increase in HNR content in the blends could retard the ozonolysis resulting in the surface cracking attacked by ozone. © 2009 Wiley Periodicals, Inc. J Appl Polym Sci, 2009 [source] Relationship between the crystalline structure and mechanical behavior in isotropic and oriented polyamide 12JOURNAL OF APPLIED POLYMER SCIENCE, Issue 1 2008Nadya Dencheva Abstract This study reports on the relationship between the crystalline structure and mechanical behavior of differently processed and annealed polyamide 12 (PA12) samples. Two sets of samples were obtained: isotropic PA12 films prepared by hot pressing and oriented cables prepared by consecutive extrusion and cold drawing. These samples were isothermally annealed in the range of 80,160°C and then subjected to tensile tests at room temperature. A combination of solid-state 13C-NMR and synchrotron wide- and small-angle X-ray scattering was used to obtain reliable structural data from these samples before and after the tensile tests. These structural data were related to the mechanical properties of the respective PA12 samples. Deformation models explaining all the experimental results were suggested for the different PA12 samples. © 2008 Wiley Periodicals, Inc. J Appl Polym Sci, 2008 [source] Evidence for redox cycling of lawsone (2-hydroxy-1,4-naphthoquinone) in the presence of the hypoxanthine/xanthine oxidase systemJOURNAL OF APPLIED TOXICOLOGY, Issue 4 2003A. M. Osman Abstract This study reports that lawsone (2-hydroxy-1,4-naphthoquinone) undergoes redox cycling in the presence of the hypoxanthine/xanthine oxidase system. The rate of cytochrome c reduction obtained in the presence of 80 µM lawsone was almost three times the rate of cytochrome c reduction measured in its absence. This increase in the rate of cytochrome c reduction was partially inhibited by superoxide dismutase, suggesting the involvement of O2,, in this process. It is remarkable to note that, even though lawsone is considered to be a non-redox-cycling quinone in vitro, this quinone was shown to be more toxic in vivo in rats than menadione, causing haemolytic anemia of an oxidative nature and renal damage. The view that this quinone is a non-redox-cycling quinone was based on the inability of one-electron-transferring ,avoenzymes such as NADPH-cytochrome c reductase to reduce this naphthoquinone. Our ,nding that lawsone, like menadione, undergoes redox cycling in the presence of the hypoxanthine/xanthine oxidase system could explain the observed oxidative damage of tissues in,icted by this quinone in rats in vivo. Such an observation therefore reconciles the in vivo toxicity results of this naphthoquinone with those of in vitro experiments. Copyright © 2003 John Wiley & Sons, Ltd. [source] Oestrogenic activity of isobutylparaben in vitro and in vivoJOURNAL OF APPLIED TOXICOLOGY, Issue 4 2002P. D. Darbre Abstract The alkyl esters of p -hydroxybenzoic acid (parabens) are used widely as preservatives in foods, pharmaceuticals and cosmetics to which the human population is exposed. Recent studies have reported that methylparaben, ethylparaben, n -propylparaben and n -butylparaben all possess oestrogenic activity in several in vitro assays and in animal models in vivo. This study reports on the oestrogenic activity of isobutylparaben in a panel of assays in vitro and in vivo. Isobutylparaben was able to displace [3H]oestradiol from cytosolic oestrogen receptor , of MCF7 human breast cancer cells by 81% at 100 000-fold molar excess. Using a clonal line of MCF7 cells containing a stably transfected oestrogen-responsive ERE-CAT reporter gene, CAT gene expression could be increased by isobutylparaben such that the magnitude of the response was the same at 10,5 M isobutylparaben as with 10,8 M 17,-oestradiol. Isobutylparaben could also increase expression of the endogenous oestrogen-responsive pS2 gene in MCF7 cells and maximal expression at 10,5 M isobutylparaben could be inhibited with the anti-oestrogen ICI 182 780. The proliferation of two oestrogen-dependent human breast cancer cell lines MCF7 and ZR-75-1 could be increased with isobutylparaben such that at concentrations of 10,5 M the proliferation response was of the same magnitude as with 10,8 M 17,-oestradiol. Evidence for oestrogen receptor mediation of proliferation effects was provided by the inability of isobutylparaben to influence the growth of oestrogen-unresponsive MDA-MB-231 human breast cancer cells and by the ability of the anti-oestrogen ICI 182 780 to inhibit the isobutylparaben effects on MCF7 cell growth. The proliferation response to 10,10 M 17,-oestradiol was not antagonized with isobutylparaben at any concentration from 10,9 M to 10,4 M in either MCF7 or ZR-75-1 cells. Finally, subcutaneous administration of isobutylparaben was able to increase the uterine weight in the immature mouse after three daily doses of 1.2 or 12.0 mg per mouse. Previous work using linear-alkyl-chain parabens has shown that oestrogenic activity increases with alkyl chain length from methylparaben to n -butylparaben. The results here show that branching of the alkyl chain to isobutylparaben increases oestrogenic activity beyond that of the equivalent length linear alkyl chain in n -butylparaben. Copyright © 2002 John Wiley & Sons, Ltd. [source] Long-Term Results of Heart Transplantation for End-Stage Valvular Heart DiseaseJOURNAL OF CARDIAC SURGERY, Issue 5 2009D.Sc., F.I.C.S., M.P.H., M.Sc., Ph.D., Yanto Sandy Tjang M.D. However, the outcomes of heart transplantation for patients with end-stage valvular heart disease are less well reported. This is a substantial group of patients, many of whom have had previous cardiac surgery. They therefore may be considered a subgroup with a poor prognosis. This study reports on the outcomes of heart transplantation for patients with end-stage valvular heart disease. Patients and methods: From March 1989 to December 2004, 75 consecutive adult heart transplantations were performed for end-stage valvular heart disease. Clinical characteristics were retrieved from a computerized database. Results: The early mortality risk in heart transplantation for end-stage valvular heart disease was 13%, compared to 8% for other indications (p = 0.12). The main causes of early death were rejection (20%) and right ventricular failure (20%). The total follow-up time was 415 patient-years. During the follow-up, another 23 patients died (55/1000 patient-years of late mortality rate), mostly due to infection (43%) and multiorgan failure (22%). Multivariable analysis demonstrated that increased waiting time to heart transplantation correlated with increased survival (HR = 0.998, p = 0.04). The survival at 1, 5, 10, and 15 years was 70%, 64%, 56%, and 46% compared to 78%, 68%, 53%, and 41% for other indications, respectively (p = 0.5). Conclusion: The outcomes of heart transplantation for patients with end-stage valvular heart disease are similar to those for other patients. Apparently, the longer the waiting time to heart transplantation the better the outcome becomes. [source] | |||||||||||||||||||||||||||||||||||||