Home About us Contact
|
Home About us Contact | ||
|
|
||
Approval
Kinds of Approval Terms modified by Approval Selected AbstractsDouble-Blind, Randomized, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Botulinum Toxin Type A in Subjects with Crow's FeetDERMATOLOGIC SURGERY, Issue 3 2005Nicholas J. Lowe MD Background Published evidence suggests that botulinum toxin type A (BTX-A) is an effective treatment for crow's feet. However, few dose-ranging studies have been performed. Objectives To assess the safety and efficacy of a single treatment with one of four doses of BTX-A (Botox/Vistabel, Allergan Inc) compared with placebo for the improvement of crow's feet. Methods Subjects received a single bilateral treatment of 18, 12, 6, or 3 U of BTX-A or placebo injected into the lateral aspect of the orbicularis oculi muscle (parallel-group, double,blind design). Investigators and subjects rated crow's feet severity at maximum smile on day 7 and at 30-day intervals from days 30 to 180. Results As observed by both investigators and subjects, all doses of BTX-A resulted in improvements in crow's feet severity when compared with placebo. A dose-dependent treatment effect for efficacy was observed, with higher doses having an increased magnitude and duration of effect. However, a clear differentiation between the 18 U and 12 U doses was not apparent. Few adverse events were reported, with no statistically significant differences between BTX-A and placebo in the incidence of subjects experiencing adverse events. Conclusion BTX-A is safe and effective in decreasing the severity of crow's feet, with 12 U per side suggested as the most appropriate dose. THIS STUDY WAS FUNDED BY ALLERGAN, WHICH WAS ALSO INVOLVED IN THE DESIGN AND CONDUCT OF THE STUDY; COLLECTION, MANAGEMENT, ANALYSIS, AND INTERPRETATION OF THE DATA; AND PREPARATION, REVIEW, AND APPROVAL OF THE MANUSCRIPT. DRS. LOWE AND FRACZEK ARE PAID CONSULTANTS FOR ALLERGAN, DRS. KUMAR AND EADIE ARE EMPLOYEES OF ALLERGAN, AND DRS. LOWE AND KUMAR HOLD STOCK OPTIONS. [source] Congress, Presidential Approval, and U.S. Dispute InitiationFOREIGN POLICY ANALYSIS, Issue 4 2008David J. Brulé Do presidents initiate disputes in response to low public approval ratings? Although research on the diversionary use of force finds links between poor economic conditions and military disputes, findings evaluating the effect of presidential approval ratings typically fail to support the diversionary hypothesis. But this research tends to neglect the role of presidential-congressional relations in the president's foreign policy making processes. This paper applies the policy availability argument to the puzzle: legislative constraints on presidential action during periods of low public approval compel the president to pursue alternatives that he can implement largely on his own in order to display his leadership skills,including the use of military force abroad. The argument is tested by examining the interactive effects of congressional support for the president and presidential approval ratings on the propensity to initiate militarized interstate disputes from 1949 to 2000. The results indicate that the president is more likely to use force in response to low presidential approval when faced with low congressional support. [source] Tenth Summit Meeting Consensus: Recommendations for Regulatory Approval for Hormonal Male ContraceptionINTERNATIONAL JOURNAL OF ANDROLOGY, Issue 1 2007Article first published online: 26 JAN 200 No abstract is available for this article. [source] Sixth Summit Meeting Consensus: Recommendations for Regulatory Approval for Hormonal Male ContraceptionINTERNATIONAL JOURNAL OF ANDROLOGY, Issue 6 2002Article first published online: 23 OCT 200 No abstract is available for this article. [source] Could interchangeable use of dry powder inhalers affect patients?INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2005D. Price Summary The aim of asthma treatment is optimal disease control. Poor asthma control results in considerable patient morbidity, as well as contributing to the considerable burden placed by the disease on healthcare budgets. There is a need for costs to be carefully scrutinised, with the switching of patients to inhaler devices with lower acquisition costs likely to be increasingly considered. However, before such practice becomes widespread, it is important to establish whether or not this could adversely impact on patients and the level of disease control. For approval to have been given, all marketed inhalers must have satisfied current regulatory requirements for devices. Full preclinical and clinical development programmes are not required when application is made for authorisation to market a new inhaler containing an existing chemical entity, although clinical equivalence testing must be used. Both beneficial and adverse effects should be tested, and the limits of equivalence must be clearly defined, based on therapeutic relevance. It should be noted that equivalence studies are invalid when the end point is not responding (i.e. at the top of the dose,response curve) and when equivalence limits approach or are equal to the magnitude of the drug effect. Approval on the basis of regulations designed to safeguard quality of dry powder inhalers does not mean that devices are interchangeable. When using an inhaler, there are many stages between the patient and the therapeutic effect, involving device design, pharmaceutical performance and patient behaviour. Regulations governing new devices cover only a few of the many factors affecting disease control. Furthermore, clinical trials to assess equivalence may not take into account factors in patient behaviour or variations in patient inhaler technique that may affect use of devices in real-life situations. When assessing the consequences of interchangeable use of dry powder inhalers on healthcare costs, it is important to ensure that the acquisition cost of the devices is not the only cost considered. Other costs that should be considered include the cost of time spent demonstrating to the patient how to use the new device, the cost of additional physician visits to address patient concerns and the management costs if disease control is adversely affected. [source] Do Local Landscape Patterns Affect the Demand for Landscape Amenities Protection?JOURNAL OF AGRICULTURAL ECONOMICS, Issue 1 2003Felix Schläpfer Agricultural support is increasingly flowing into the maintenance and improvement of landscape quality. While variations in the demand for landscape protection have been successfully attributed to variations in socio-economic characteristics, the effect of the local landscape setting as a potential determinant of environmental preferences has received less attention. A framework is formulated that describes public support for regional landscape protection as a function of socio-economic variables and land use patterns. Models are then estimated using detailed local land use statistics and voting records from a referendum on increasing public funding for local landscape amenities protection in the Swiss canton of Zurich. The land use variables represent proportions of open landscape and landscape features that are viewed as particularly valuable for aesthetic and other reasons. Cross-sectional estimation results suggest that attitudes towards public landscape protection are indeed strongly associated with the local landscape. Approval for protection programmes increased with local scarcity of open space and with the presence of high-amenity landscape features. Comparison with referendum outcomes on a national-level environmental issue suggests that the positive association with high-amenity landscape features may be partly attributable to individuals' self-selection of residency. [source] Lower urinary tract symptoms: a hermeneutic phenomenological study into men's lived experienceJOURNAL OF CLINICAL NURSING, Issue 2 2005BSc (Hons), Mark Wareing MSc Aim., This was an investigation to discover the lived experience of men with lower urinary tract symptoms arising from benign prostatic hyperplasic. Design., A hermeneutic phenomenological study. Methods., Approval was granted by the local Applied and Qualitative Research Ethics Committee (AQREC) prior to the commencement of the study. Data were gathered via semi-structured interviews that were audio taped, and subsequently transcribed. Each transcripted interview was analysed by the investigator and a team of ,expert readers'. The team agreed on a total of 57 sub-themes divided into seven categories with unanimity, therefore obviating the need for participant validation. Findings., The major findings of the study suggest that men experience a broad and dramatic spectrum of phenomena while living with a benign prostate condition. This includes profound embarrassment, fear, revulsion as well as humour that require a range of methods and life adjustments to manage and contain their symptoms. Conclusions., The participant's narratives provide a thick, rich and meaningful insight into how men understand their bodies, and make sense of prostate disease; a significant men's health issue. Relevance to clinical practice., Several studies have already been published describing men's lived experience of prostate surgery for benign prostatic hyperplasia. This research has captured men's lived experience of lower urinary tract symptoms ahead of surgical intervention. Men experience a broad scope of phenomena resulting from life with a benign prostate condition that encompasses fear and embarrassment and the development of coping mechanisms and changes in life style. Recent media awareness campaigns to raise public awareness of prostate disease as a men's health issue appear to be changing how men perceive their bodies, how they converse with one another, and their help seeking behaviour. [source] Internet Seals of Approval: Effects on Online Privacy Policies and Consumer PerceptionsJOURNAL OF CONSUMER AFFAIRS, Issue 1 2002ANTHONY D. MIYAZAKI The use of Internet seal of approval programs has been touted as an alternative to potential legislation concerning consumer-related online privacy practices. Questions have been raised, however, regarding the effectiveness of such programs with respect to maintaining privacy standards and aiding online consumers. The authors examine these issues in a series of three studies, the first of which is an exploratory application of Federal Trade Commission privacy standards to various online privacy policies in an effort to determine the ability of seal of approval program participation to act as a valid cue to a firm's stated privacy practices. The second and third studies are experiments designed to ascertain how online firm participation in Internet seal of approval programs affects consumers. Implications for consumer policy are discussed. [source] Caterers' experiences and perceptions of implementing the 2006 school meal standardsJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 5 2008C.J. Weir Background:, School meal standards were introduced in 2006 (Department for Education and Skills) and caterers are expected to comply with these standards. No research has been conducted looking at the caterer's experiences and perceptions of implementing these standards. This area has 32 school meal provider organisations for 103 schools. Half the schools are with one provider and the others are, mostly, single-handed in-house operations, often managed by a local community member. The aim of the current study was to explore caterers' understanding of the school meal standards, the barriers to implementation, and proposed solutions, to inform local practice. Methods:, A combined quantitative and qualitative design was used. A questionnaire was used to assess understanding and implementation of the standards and distributed to all the catering provider organisations (n = 32), with a good response rate of 78% (n = 25). For each question about achievement of the ten food-based standards the responses were scored 0,4 where: 0 = ,Do not intend to achieve this standard'; to 4 = ,Fully achieved'. This gave a total standards achievement score for each catering provider organisation, where the minimum score that could be achieved was zero which indicated the minimum level of achievement and the maximum score which could be achieved was forty which indicated all ten standards fully achieved. Four focus group were undertaken involving 40 people who considered themselves to be in a management role within a catering provider organisation. Semi structured interviews were undertaken with 11 people (until saturation), using purposive sampling, to explore barriers and solutions to implementation of the standards in detail. Descriptive and appropriate inferential statistics (Fisher's Exact tests and independent samples t- tests) were performedon the datausingStatistical Package for Social Sciences (SPSS). The process undertaken for the qualitative analysis was thematic analysis, and used analytic hierarchy (Richie & Lewis, 2003). Approval for this study was obtained from Leeds Metropolitan University ethics committee. Results:, The qualitative discussions led to caterers' identifying two main themes. These were: support from various groups, and the roles and responsibilities caterers believed these groups had and should be performing in order to achieve successful implementation of the standards ,Think it's good someone's shaken up school meals but who is doing the actually work , it's us isn't it'.(Semi structured interview respondent medium primary provider) ,I've found it really difficult as I'm on my own at the school, totally on my own without anyone to help'. (Focus group participant primary school group). The groups that caterers identified as those who had roles and responsibilities and who should be providing support were the ,whole school'; catering provider organisations; parents; the local authority; and, the broader environment/whole population. Caterers felt the standards had ,gone too far too soon' and did not allow choice. Caterers felt finances were a barrier, and that training was required across all sectors to achieve success. The standards implementation achievement score were statistically higher for caterers who had received formal training compared with those with only food and hygiene (P = 0.001); and, between caterers who provided to a secondary school as opposed to a primary school only (P = 0.034). There was a statistically significant relationship between providers and qualifications with those providing to secondary schools more likely to have had formal qualifications (P = 0.015). Discussion:, Caterers felt all those involved in schools and school meals needed to undertake their roles and responsibilities, to provide support, and, to implement the ethos of a whole school approach. The caterers in this study identified many barriers and practical obstacles either experienced or perceived to implementing the new school meals standards. Conclusions:, The results will be used to inform the Local Authority and Primary Care Trust to ensure the effective implementation of the school meal standards. There may be opportunity to transfer these results to other school caterers, and to develop support and training to assist implementation. [source] The efficacy of dietetic intervention in patients with chronic obstructive pulmonary diseaseJOURNAL OF HUMAN NUTRITION & DIETETICS, Issue 4 2008L. Bottle Background:, Clinical trials have shown that pulmonary rehabilitation can improve the functional status and quality of life of chronic obstructive pulmonary disease (COPD) patients (Lacasse, 2006) but there is no research examining the efficacy of group dietetic intervention during standard 8 week rehabilitation courses. Current input is usually limited to a 1 h nutrition education session. This pilot study aimed to investigate whether patients receiving additional dietetic intervention during pulmonary rehabilitation significantly increased their general nutritional knowledge, thereby facilitating improvements in dietary intake and nutritional status. Methods:, Patients were recruited from two courses of pulmonary rehabilitation and randomly allocated to a control group or an intervention group. Anthropometry (height, weight, body mass index, mid arm circumference and triceps skinfold), 3 day food diaries and nutritional knowledge questionnaires covered guidelines, food groups, choosing healthy options and diet and COPD were completed at baseline and at the end of 8 weeks. In week 2 both groups received the same nutrition education session which covered healthy eating during periods of stability as well as advice on coping with loss of appetite and reduced intake during illness and exacerbations. The intervention group was followed up during weeks 4, 6 and 7 when further anthropometric measurements were taken and additional dietary advice was provided, which addressed issues raised by individual patients. Information from food diaries was converted to nutrients using Windiets dietary analysis software. Statistical analyses were carried out using SPSS (v14) and included Mann,Whitney U non parametric tests, paired t -tests and Spearman correlations used for comparisons over time and between groups. For analysis purposes patients were classified as normal weight (NW) and overweight (OW). Approval was obtained from the appropriate Ethics Committee. Results:, Changes reported were not statistically significant (P > 0.05). Complete data sets were obtained for six control (NW = 2, OW = 4) and five intervention (NW = 1, OW = 4) patients. Nutritional knowledge increased in the control group by 5% compared to 3% in the intervention group. Control NW patients increased their energy intake resulting in a mean weight gain of 0.5 kg (SD 3.3). OW control group patients increased their energy intake by 12.4% (16.9) with a mean weight gain of 0.2 kg (2.5). All control patients increased their intake of in total fat, saturated fatty acids (SFA), sugars and sodium. Conversely there was a decrease in energy intake in the intervention group of 14.4% (17.8) and a mean weight loss of 1.5 kg (1.2) (three out of four overweight patients lost weight). Improvements in diet were shown with reduced intakes of total fat, SFA, sugars and sodium. The NW patient in the intervention group regained weight that had previously been lost. These changes did not correlate with changes in nutritional knowledge. Discussion:, An increase in nutritional knowledge was expected to facilitate appropriate changes in dietary intake and nutritional status. Despite the lack of correlation between dietary knowledge and intake, beneficial outcomes were none-the-less observed in the intervention group. The trend for weight gain in OW control group patients, and weight loss in OW intervention group patients contrasted with results seen by Slinde et al. (2002) where the control OW patients lost weight, and OW intervention patients gained weight. It is possible that in the current study, patients in the intervention group were motivated to lose weight with repeated exposure to the dietitian, rather than an increase in nutritional knowledge. Significant anthropometrical changes were unlikely to be observed in 8 weeks, and further follow up may be necessary to establish sufficient evidence for the most efficacious level of dietetic intervention. The small sample sizes, especially with regard to weight sub groups, limits the conclusions which can be drawn. Further research is recommended, using a larger sample size, in order to make recommendations for dietetic best practice. Conclusion:, The results of this study did not show statistical significance and the association between nutritional knowledge and improved nutritional outcomes remains unclear. However, the findings may have clinical significance since they appear to show that additional dietetic intervention may benefit the nutritional status of patients with COPD attending pulmonary rehabilitation. References, Lacasse, Y., Goldstein, R., et al. (2006) Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 4, CD003793. Slinde, F., Gronberg, A.M., et al. (2002) Individual dietary intervention in patients with COPD during multidisciplinary rehabilitation. Respir. Med. 96, 330,336. [source] Development of a robust once-a-day glipizide matrix systemJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 6 2007Shahla Jamzad The robustness of a new hydroxypropylmethylcellulose (HPMC) based modified release glipizide (10 mg) formulation was studied. The tablet formulations were prepared by dry blending the ingredients and direct compression, incorporating a range of release modifying agents up to ± 20% w/w relative to an optimized formulation. The dissolution was assessed in 900 mL pH 6.8 buffer at 75 rev min,1 paddle speed. Calculated difference and similarity factors (f1 and f2) and results of analysis of variance suggest that the overall release profiles were similar. Compositional changes up to ± 20% w/w and a reduction of drug dose to half did not change the general release pattern of this low dose/pH-dependent drug in a significant way. It is concluded that the drug release from the developed matrix systems is highly dependent on the kinetics of hydration and erosion, and that the proposed compositional changes within ± 20% w/w did not alter this relationship. The particulate systems used were characterized by determining the Carr index, Hausner ratio and the rheological properties using a texture analyser. Results indicate that the release is reproducible and the system has potential for successful scale-up operation, while complying with recommended Food and Drug Administration guidelines "Scale Up and Post Approval Changes". [source] Chromium Picolinate Intake and Risk of Type 2 Diabetes: An Evidence-Based Review by the United States Food and Drug AdministrationNUTRITION REVIEWS, Issue 8 2006Paula R. Trumbo PhD The labeling of both health claims that meet significant scientific agreement (SSA) and qualified health claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain. SUMMARY In summary (Table 1), there was one intervention study that showed a beneficial effect of chromium picolinate intake on risk of insulin resistance. One other intervention study that provided chromium chloride showed no beneficial effect on insulin resistance. None of the five intervention studies showed a statistically significant beneficial effect of chromium picolinate on FBS and/or OGTT. Furthermore, none of the 10 intervention studies using other forms of chromium showed a beneficial effect of on FBS or OGTT in individuals with normal glucose tolerance. Based on FDA's evidence-based review, the agency concluded that there is very limited credible evidence for a qualified health claim for chromium picolinate and reduced risk of insulin resistance, and therefore reduced risk of type 2 diabetes. The findings of Cefalu et al. have not been replicated, and replication of scientific findings is important to substantiate results. For these reasons, FDA concluded that the existence of a relationship between chromium picolinate intake and reduced risk of either insulin resistance or type 2 diabetes is highly uncertain. On August 25, 2005, FDA issued a letter of enforcement discretion for the labeling of dietary supplements with the following qualified health claim: "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain." The agency concluded that there was no credible evidence to suggest that chromium picolinate intake may reduce the risk of elevated blood glucose levels. [source] Cell Types Obtained from the Epidural Space of Patients with Low Back Pain/RadiculopathyPAIN PRACTICE, Issue 3 2009James E. Heavner PhD Abstract Background: We investigated if correlations exist between medical history, tissue abnormalities, and cell types retrieved from the epidural space of patients with chronic low back pain (LBP) and chronic radicular pain (RP). Methods: Approval was obtained from the Institutional Review Board for the Protection of Human Subjects to study 191 patients undergoing epiduroscopy. Visual inspection was performed and abnormal areas were identified. A specimen obtained from the area using a cytology brush was processed by the Thin Prep technique. Patients were divided into four groups based on the presence or absence and intensity of LBP and RP. The gender and age of the patients were recorded, as was any history of prior back surgery. Areas of tissue abnormalities were rated according to changes in vascularity and amount of fat, fibrosis, and inflammation. Stenosis was assessed from magnetic resonance imaging or computerized tomography scan images. Cytologic assessments included notations of the presence or absence of erythrocytes, leukocytes, cell groups, lipocytes, spindled cells, and large round cells. Results: There was a significant difference in the number of patients from whom big round cells were obtained who had a high degree of LBP compared with the number of patients who had a high degree of both LBP and RP. Conclusions: The findings provide a foundation for future studies of cells obtained from similar patients with the goal of furthering the understanding of the pathogenesis of LBP/RP. [source] An interim analysis of a cohort study on the preoperative anxiety and postoperative behavioural changes in children having repeat anaestheticsPEDIATRIC ANESTHESIA, Issue 9 2002A. Watson Introduction Anxiety in the preoperative period and at induction of anaesthesia in children is associated with disturbances in postoperative behaviour (1,4). There is little work looking at the effects of repeat anaesthetic procedures on anxiety and subsequent postoperative behaviour disturbances. The aim of this study was to see if the effect of repeat anaesthetics was cumulative on postoperative behavioural problems and whether repeated anaesthetics provoke increasing anxiety. We investigated factors that may identify children who are susceptible to behavioural changes following repeat anaesthetics. We present an interim analysis of data on 8 patients as part of a long-term cohort study on 40 children with retinoblastoma who have required repeat anaesthetics for assessment and treatment of their condition. Method Approval for this study was granted by the East London and City Health Authority ethics committee. 40 patients are being recruited and being followed over a two year period. All children have retinoblastoma and are between the ages of 18 months to 4 years. The anaesthetic technique was not standardised but details of it were collected. Data collected were demographic details of child (age, sex, weight, ASA grade, siblings, stressful events in the last 3 months, recent immunisations, number of previous anaesthetics, problems with previous general anaesthetics, medical history of children, temperament of child using the EASI scoring system (4); demographic data of parents (age, parental education, family members affected, baseline measure of parental anxiety using State trait anxiety inventory (STAI). Anxiety on entry into the anaesthetic room and at induction was measured by the modified Yale preoperative anxiety scale (mYPAS), cooperation of the child at induction was measured by the Induction compliance checklist (ICC). Anxiety of the parent after induction was measured by the STAI score. Behaviour was measured at 1 day, 1 week, 1 month and 4 months after each procedure by means of the post hospital behaviour score (PHBQ) (5). A comparison with preoperative behaviour was made and data is presented of the percentage of children with new negative behavioural problems. A detailed analysis of the types of behaviour change was noted. anova for repeat measures with multiple dependent measures was used to analyse data on child anxiety and postoperative behavioural problems. Results Eight patients have had 3 separate anaesthetics over one and a half years. These have been at 4 monthly intervals. There was no significant increase in anxiety levels with repeat anaesthetics. The median mYPAS score at induction were 100 for all 3 anaesthetics. (P = 0.41). The type of behavioural change was variable and demonstrated no trend. No patient was identified as being prone to behavioural changes after every anaesthetic. Patients who displayed new negative behavioural problems would have them after any anaesthetic with no obvious cumulative effect with each repeat anaesthetic. Conclusions Our patients had maximum anxiety scores at induction, so the mYPAS scoring system is not sensitive enough to show that repeat anaesthetics provoke increasing anxiety. There is a very random pattern to behavioural disturbances after repeat anaesthetics with no evidence that negative behavioural changes are compounded with repeated anaesthetics. Collection of complete data from the remaining 32 patients may yield some trends regarding behavioural disturbances but our use of the mYPAS to measure anxiety in this very anxious population is unlikely to be helpful. [source] The Asymmetric Impact of Inflation on Presidential ApprovalPOLITICS & POLICY, Issue 3 2002Sungdai Cho This article examines the impact of unexpected inflation on U.S. presidential approval levels for the period 1953,96. Unlike most previous considerations of economic expectations and presidential approval, we find clear evidence that unexpected inflation affects approval, but it does so in an asymmetric fashion. Higher than expected inflation has a negative impact on presidential approval, and VAR results indicate that the effects linger for more than two years. In contrast, lower than expected inflation has a negligible impact on presidential approval. [source] Polls, Elite Opinion, and the President: How Information and Issue Saliency Affect ApprovalPRESIDENTIAL STUDIES QUARTERLY, Issue 4 2006MICHAEL R. WOLF Our experiment examines the effect of information and issue saliency on presidential approval. Subjects received either pro-Bush or anti-Bush information on the president's Iraq War and Social Security policies in the form of newspaper opinion pieces and/or polls, and then evaluated Bush's overall job performance and his handling of these two issues. Information and polls that supported Bush's Social Security policy led subjects to support Bush on this issue, but attitudes were resistant on the more salient Iraq issue. The experiment demonstrates that poll results, more than simply reflecting aggregate opinion, influence attitudes on less salient issues. [source] Building Public Support from the Grassroots Up: The Impact of Presidential Travel on State-Level ApprovalPRESIDENTIAL STUDIES QUARTERLY, Issue 1 2005JEFFREY E. COHEN Presidential travel around the nation has become commonplace, yet very little research exists on its impact on public opinion. Although presidents "go public" for a variety of reasons, such as building and maintaining public support, existing research has been limited to examining the effects of going public on national-level support for the president. In this study, we argue that presidents target state publics (and other sub-national publics) when they travel around the nation. To test this possible linkage between travel and approval, we utilize data on presidential travel and newly available data on state-level presidential approval ratings. After controlling for various factors that affect the level of presidential approval at the state level, we find that a presidential visit results in a modest, statistically significant increase in the president's state-level job approval rating. Our analysis indicates that this effect is present only in non-election periods and in large states, suggesting that presidents are more likely to stimulate public support when appearing presidential rather than as candidates for office or as partisan leaders. [source] The Polls: State-Level Presidential Approval: Results from the Job Approval ProjectPRESIDENTIAL STUDIES QUARTERLY, Issue 1 2003JEFFREY E. COHEN In this article, the author reports on the state job approval data set. Although the data set includes state-level job approval for governors and U. S. senators, it also contains similar data on the president. These data allow us to test propositions about public opinion toward the president at a level of aggregation lower than the national level but higher than the individual level. More than one thousand state-level presidential job approval readings exist in this data set. Such a large N allows us to test ideas and bypotheses that other limited N designs cannot accomplish. In the first part of this article, the author discusses the properties of these data. In the second part, he uses these data to test two competing theories of the impact of economic perceptions on presidential approval, the retrospection versus the prospection model, which provides one example of how these data can be put to use. [source] International Organization as a Seal of Approval: European Union Accession and Investor RiskAMERICAN JOURNAL OF POLITICAL SCIENCE, Issue 4 2009Julia Gray Much of the literature on international institutions argues that membership regularizes expectations about members' future behavior. Using the accession of the postcommunist countries as a test case, this article argues that the EU can send strong signals to financial markets about the trajectory of a particular country. Examining spreads on sovereign debt from 1990 to 2006, this article shows that closing negotiation chapters on domestic economic policy,in other words, receiving a seal of approval from Brussels that previously existing policy reform is acceptable to the wider EU,substantially decreases perceptions of default risk in those countries. That decrease operates independently from policy reform that the country has taken and is also distinct from selection processes (modeled here with new variables, including UNESCO World Heritage sites and domestic movie production, that proxy for cultural factors). Thus, this particular international organization has played an important role in coordinating market sentiment on members, conferring confidence that policy reform alone could not accomplish. [source] The Dynamics of Partisan Conflict on Congressional ApprovalAMERICAN JOURNAL OF POLITICAL SCIENCE, Issue 3 2009Mark D. Ramirez Partisan divisions in American politics have been increasing since the 1970s following a period where scholars thought parties were in decline. This polarization is observed most frequently within the debates and deliberation across issues within Congress. Given that most studies of public opinion place the behavior of elites at the center of public attitudes, surprisingly little research examines the effect of partisan conflict on the mass public. This research examines quarterly congressional approval data from 1974 to 2000 to determine the consequences, if any, of party conflict on the dynamics of congressional approval. The findings indicate that over-time changes in partisan conflict within Congress have a direct and lasting effect on how citizens think about Congress. [source] Flaws in the U.S. Food and Drug Administration's Rationale for Supporting the Development and Approval of BiDil as a Treatment for Heart Failure Only in Black PatientsTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2008George T. H. Ellison The U.S. Food and Drug Administration's (FDA) rationale for supporting the development and approval of BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials (V-HeFT I and II), which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial (A-HeFT) amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. [source] Successful Lung Transplantation in an HIV- and HBV-Positive Patient with Cystic FibrosisAMERICAN JOURNAL OF TRANSPLANTATION, Issue 9 2009A. Bertani Prior to the advent of highly active antiretroviral therapy (HAART), HIV-infected patients were usually not considered as transplant candidates because of the poor prognosis of their underlying disease and concerns regarding the potential detrimental effects of immunosuppression on viral load and immune status. However, with the significant HAART-associated improvements in morbidity and mortality, good short-term outcomes after liver and kidney transplantation for patients with HIV infection have been reported. Nevertheless, HIV infection is currently considered a contraindication to lung transplantation in most transplant centers worldwide. The results of a double lung transplant performed in an HIV and HBV co-infected patient with cystic fibrosis (CF) and end-stage respiratory failure (ESRF) are presented after a 2-year follow-up. Approval of and recommendations for the management of this patient were obtained from the Italian National Center for Transplantation as an extension of the ongoing Italian protocol for liver and kidney transplantation in HIV-infected individuals. The operation was successful and the patient recovered rapidly after surgery. A cautious infectious and immunosuppressive management allowed so far the avoidance of major infectious complications and rejection. To the best of our knowledge, this is the first report of lung transplantation in an HIV and HBV co-infected patient. [source] Institutional Review Board Approval for Clinical Application of New Medical Devices Rather Than Government AgencyARTIFICIAL ORGANS, Issue 12 2004Ph.D. Emeritus Editor in Chief, Yukihiko Nosé M.D. No abstract is available for this article. [source] Messung der Betondeckung , Auswertung und AbnahmeBETON- UND STAHLBETONBAU, Issue 3 2004Wolfgang Brameshuber Prof. Dr.-Ing. Abstract Eine Möglichkeit an fertigen Betonbauteilen die Zuverlässigkeit der Ausführungsergebnisse zu beurteilen, ist die Messung der Betondeckung. Aufgrund der bauseitig nicht zu vermeidenden Streuungen ist die Betondeckung keine feste geometrische Größe, sondern unterliegt einer statistischen Verteilung. Es wird ein Näherungsverfahren zur Auswertung der Betondeckungsmessung vorgestellt, das mit einfachster Rechnerausstattung genutzt werden kann. Anwendung findet dieses Näherungsverfahren als quantitativer Nachweis im DBV-Merkblatt ,Betondeckung und Bewehrung", Fassung Juli 2002. Measurement of Concrete Cover , Evaluation and Approval The measurement of concrete cover is a method to estimate the quality of building execution. The concrete cover is a probabilistic dimension. The paper gives an approximate method basing on the Neville-distribution to evaluate the results of a concrete cover measurement. This approximation is usable with simple software. The approximate method is used in a code of practice "Concrete Cover and Reinforcement" of the German Society for Concrete and Construction Technology (DBV). [source] 2265: Safety evaluation of intravitreal use of a beta2-agonist in rabbit eyesACTA OPHTHALMOLOGICA, Issue 2010J VAN CALSTER Purpose There is no known information on the use and safety of a long-acting beta-agonist, such as Clenbuterol when administered by intravitreal injection. Therefore, it is appropriate to perform this intravitreal injection in an animal model prior to start with a human experiment. The aim is to investigate the safety of an intravitreal injection of the beta2-agonist Clenbuterol in rabbit eyes. This study is in preparation of using of this molecule in human eyes. That trial will be a monocentric, academic (investigator driven) trial to investigate the safety and efficacy of an intravitreal beta2-agonist in patients with persistent subfoveal fluid after retinal detachment surgery. Approval of the ethics committee for the human trial has already been obtained, pending a re-evaluation after the results of the animal study will be known. Methods An intravitreal injection of 0,1 ml solution containing 0.08µg Clenbuterol or 0.1ml NaCl 0.9% was given in 10 eyes of 10 rabbits. The distribution occurred at random and was masked. A masked investigator examined both eyes after 1, 3 and 7 days (biomicroscopy, intraocular pression and ophthalmoscopy). After one week, the rabbits were sacrificed, the eyes enucleated and fixated for histopathological examination and electron microscopy by a masked investigator. Cell death was monitored by a DNase type I/II activity assay. Results There was no clinical or histopathological difference between the clenbuterol and the control group. Conclusion Clenbuterol is not toxic for the retina of rabbit eyes after intravitreal injection. It can be considered for the use in human eyes. Final approval of the ethics committee for the human trial is awaited. [source] Safety evaluation of intravitreal use of a beta2-agonist in rabbit eyesACTA OPHTHALMOLOGICA, Issue 2009J VAN CALSTER Purpose There is no known information on the use and safety of a long-acting beta-agonist, such as Clenbuterol when administered by intravitreal injection. Therefore, it is appropriate to perform this intravitreal injection in an animal model prior to start with a human experiment. The aim is to investigate the safety of an intravitreal injection of the beta2-agonist Clenbuterol in rabbit eyes. This study is in preparation of using of this molecule in human eyes. That trial will be a monocentric, academic (investigator driven) trial to investigate the safety and efficacy of an intravitreal beta2-agonist in patients with persistent subfoveal fluid after retinal detachment surgery. Approval of the ethics committee for the human trial has already been obtained, pending a re-evaluation after the results of the animal study will be known. Methods 5 rabbits will receive an injection of 0.1 ml solution containing 0.08µg Clenbuterol in one eye and an injection of 0.1ml NaCl 0.9% in the other eye. Since the volume of an adult rabbit eye is only one third of an adult human eye, the achieved concentration with be three time the concentration suggested for use in a human eye. [source] Versuche zur Tragfähigkeit von Ankerplatten mit einbetonierten Kopfbolzendübeln in schmalen StahlbetonstützenBETON- UND STAHLBETONBAU, Issue 6 2010Stephan Fromknecht Dr.-Ing. Versuche; Befestigung Abstract Müssen große Lasten von Stahl- in Betonbauteile eingebracht werden, sind Ankerplattendetails mit aufgeschweißten Kopfbolzendübeln oft praktikable Lösungen. Dies gilt auch für die Befestigung von Stahlträgern an Stützen aus Stahlbeton. Hier können die Ankerplatten z. B. bauseits an der Schalung befestigt und mit dem Ortbeton einbetoniert werden. Die Dimensionierung dieser Einbauteile kann, wie auch die Berechnung von nachträglich installierten Befestigungsmitteln, derzeit nach Europäischen Technischen Zulassungen (ETA) erfolgen. Im Unterschied zu nachträglich installierten Befestigungen ist für die Ankerplatte mit einbetonierten Kopfbolzendübeln eine rechnerische Nutzung der Tragfähigkeit der Bewehrung möglich. Allerdings führen die diesbezüglichen Regelungen , im Vergleich zu den in den Versuchen ermittelten Tragfähigkeiten , rechnerisch zu stark eingeschränkten Tragfähigkeiten. Dies beruht einerseits auf der Reduktion der Tragfähigkeit wegen geringer Randabstände und andererseits auf der stark eingeschränkten Nutzbarkeit der Bewehrung. Im folgenden Beitrag werden Versuchsergebnisse vorgestellt, welche den Einfluss der Betondruckfestigkeit, der Verankerungslänge, der Lastexzentrizität sowie der Bewehrungsmenge und -position auf das Versagensgeschehen und die Tragfähigkeit zeigen. Results of Experimental Investigations on the Load-Bearing Capacity of Steel Anchor Plates with in Concrete Encased Headed Studs in Reinforced Narrow Concrete Columns Anchor plates with welded shear studs are often used to transfer high loads from steel to reinforced concrete elements. This is for example the case for the fixation of steel beams to reinforced concrete columns. The anchor plates are fixed on site on the formwork and cast in-place in the concrete. The design is calculated according to European Technical Approvals like the design of post-installed anchors. In contrast to post-installed fastenings, the utilisation of the reinforcement of in concrete encased headed studs is theoretically possible. But the regulations of the ETAs lead to great reductions in the analysed load-bearing capacities compared to the capacities, obtained in tests. These tests have been conducted to investigate the load bearing behaviour and failure modes of anchor plates, especially in narrow reinforced concrete columns. In the following article the results of the experimental investigations are presented, which show the influence of concrete compression strength, shear stud length, load eccentricity as well as amount and position of reinforcement. [source] Market Consequences of Earnings Management in Response to Security Regulations in China,CONTEMPORARY ACCOUNTING RESEARCH, Issue 1 2005IN-MU HAW Abstract Under the 1996-98 security regulations in China, the accounting rate of return on equity (ROE) has to be greater than 10 percent for three "consecutive" years for a firm to qualify for stock rights offers. Despite declining economic conditions during this period, the percentage of firms reporting ROE between 10 and 11 percent is about "three" times that for 1994-95. This unique regulatory environment provides a natural experimental setting for the empirical assessment of earnings-management behavior and its consequences. This study examines whether listed Chinese firms manage earnings to meet regulatory benchmarks and whether regulators and investors consider the quality of earnings in their respective regulatory and investment decisions. On the basis of a sample of listed Chinese firms from 1996 to 1998, we observe that managers execute transactions involving below-the-line items and use income-increasing accounting accruals to meet regulatory ROE targets for stock rights offerings. The firms that apply for, but fail to receive, regulatory approval manage earnings more significantly than do firms that receive approval and pair-matched control firms. Our market study also suggests that investors differentiate the quality of earnings and put less value on earnings suspected of a greater degree of management. Overall, our results imply that the regulatory bodies and investors to some extent make rational adjustments for the quality of earnings. [source] Aggressive behaviour and social problem-solving strategies: a review of the findings of a seven-year follow-up from childhood to late adolescenceCRIMINAL BEHAVIOUR AND MENTAL HEALTH, Issue 4 2001Liisa Keltikangas-Järvinen PhD Professor Objectives In a seven-year follow-up study, the author and colleagues examined the development of social skills from childhood to late adolescence, with a particular focus on aggressive behaviour. This paper presents a review of the most important findings of the project. Results and conclusions Social strategies explained aggressive behaviour, and changes of strategies predicted changes of behaviour. Aggressive behaviour was, however, very stable, and spontaneous change from an aggressive child to a sociable adolescent was not observed. This emphasizes an importance of early prevention of aggression. Disagreement between the children's and their parents' problem-solving strategies was apparent, suggesting that interventions to reduce a child's aggression should be augmented by educating the parents about their children's behaviour. The role of peers was important because the child's concept of his or her strategies was dependent on his or her social acceptance, and this should be taken into account in interventions. Finally, as approval or disapproval of aggression is related to behaviour, moral cognitions should be included in the interventions. Copyright © 2001 Whurr Publishers Ltd. [source] Incretins and other peptides in the treatment of diabetesDIABETIC MEDICINE, Issue 3 2007J. F. Todd Abstract Glucagon-like peptide-1 (7-36) amide (GLP-1) is a gut hormone, released postprandially, which stimulates insulin secretion and insulin gene expression as well as pancreatic B-cell growth. Together with glucose-dependent insulinotropic polypeptide (GIP), it is responsible for the incretin effect which is the augmentation of insulin secretion following oral administration of glucose. Patients with Type 2 diabetes have greatly impaired or absent incretin-mediated insulin secretion which is mainly as a result of decreased secretion of GLP-1. However, the insulinotropic action of GLP-1 is preserved in patients with Type 2 diabetes, and this has encouraged attempts to treat Type 2 diabetic patients with GLP-1. GLP-1 also possesses a number of potential advantages over existing agents for the treatment of Type 2 diabetes. In addition to stimulating insulin secretion and promoting pancreatic B-cell mass, GLP-1 suppresses glucagon secretion, delays gastric emptying and inhibits food intake. Continuous intravenous and subcutaneous administration significantly improves glycaemic control and causes reductions in both HbA1c and body weight. However, GLP-1 is metabolized extremely rapidly in the circulation by the enzyme dipeptidyl peptidase IV (DPP-IV). This is the probable explanation for the short-lived effect of single doses of native GLP-1, making it an unlikely glucose-lowering agent. The DPP-IV resistant analogue, exenatide, has Food and Drug Administration (FDA) approval for the treatment of Type 2 diabetes and selective DPP-IV inhibitors are under development. Both approaches have demonstrated remarkable efficacy in animal models and human clinical studies. Both are well tolerated and appear to have advantages over current therapies for Type 2 diabetes, particularly in terms of the effects on pancreatic B-cell restoration and potential weight loss. [source] | |||||||||||||||||||||||||||||||||||||||||||||||||