85 research outputs found

    Utilizing the Disc in Some Corporate Repatriations under Section 367

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    In an effort to help the balance-of-payments deficit, the Revenue Act of 1971 included provisions authorizing creation of Domestic International Sales Corporations. Designed to discourage the continued use of foreign incorporated sales subsidiaries by domestic companies, election of DISC status permits an exporter to take maximum advantage of certain tax deferral provisions. However, the decision to bring home foreign sales subsidiaries to a domestic tax haven requires careful evaluation by the parent company. The author analyzes the problems incident to a decision to repatriate foreign subsidiaries and discusses the advantages in utilizing the DISC to overcome them

    Fexofenadine is Efficacious and Safe in Children (Aged 6-11 Years) with Seasonal Allergic Rhinitis

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    Background: This is the first prospective, randomized, doubleblind, placebo-controlled study showing statistical improvement of an H1-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period. Objective: This randomized, placebo-controlled, parallelgroup,double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis. Methods: This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (±1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point

    Structural basis of malaria transmission blockade by a monoclonal antibody to gamete fusogen HAP2.

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    Funder: Isaac Newton Trust; FundRef: http://dx.doi.org/10.13039/501100004815Funder: Alborada Trust; FundRef: http://dx.doi.org/10.13039/100008288Funder: Wellcome Trust; FundRef: http://dx.doi.org/10.13039/100004440Funder: University of Cambridge; FundRef: http://dx.doi.org/10.13039/501100000735Funder: Global Health Innovative Technology Fund; FundRef: http://dx.doi.org/10.13039/501100013996Funder: Rosetrees Trust; FundRef: http://dx.doi.org/10.13039/501100000833Funder: Royal Society; FundRef: http://dx.doi.org/10.13039/501100000288HAP2 is a transmembrane gamete fusogen found in multiple eukaryotic kingdoms and is structurally homologous to viral class II fusogens. Studies in Plasmodium have suggested that HAP2 is an attractive target for vaccines that block transmission of malaria. HAP2 has three extracellular domains, arranged in the order D2, D1, and D3. Here, we report monoclonal antibodies against the D3 fragment of Plasmodium berghei HAP2 and crystal structures of D3 in complex with Fab fragments of two of these antibodies, one of which blocks fertilization of Plasmodium berghei in vitro and transmission of malaria in mosquitoes. We also show how this Fab binds the complete HAP2 ectodomain with electron microscopy. The two antibodies cross-react with HAP2 among multiple plasmodial species. Our characterization of the Plasmodium D3 structure, HAP2 ectodomain architecture, and mechanism of inhibition provide insights for the development of a vaccine to block malaria transmission

    How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India

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    <p>Abstract</p> <p>Background</p> <p>A requisite for ethical human subjects research is that participation should be informed and voluntary. Participation during the informed consent process by way of asking questions is an indicator of the extent to which consent is informed.</p> <p>Aims</p> <p>The aims of this study were to assess the extent to which parents providing consent for children's participation in an observational tuberculosis (TB) research study in India actively participated during the informed consent discussion, and to identify correlates of that participation.</p> <p>Methods</p> <p>In an observational cohort study of tuberculosis in infants in South India, field supervisors who were responsible for obtaining informed consent noted down questions asked during the informed consent discussions for 4,382 infants who were enrolled in the study. These questions were post-coded by topic. Bivariate and multivariate analysis was conducted to examine factors associated with asking at least one question during the informed consent process.</p> <p>Results</p> <p>In total, 590 out of 4,382 (13.4%) parents/guardians asked any question during the informed consent process. We found that the likelihood of parents asking questions during the informed consent process was significantly associated with education level of either parent both parents being present, and location.</p> <p>Conclusions</p> <p>The findings have implications for planning the informed consent process in a largely rural setting with low levels of literacy. Greater effort needs to be directed towards developing simple participatory communication materials for the informed consent process. Furthermore, including both parents in a discussion about a child's participation in a research study may increase the extent to which consent is truly informed. Finally, continuing efforts need to be made to improve the communication skills of research workers with regard to explaining research processes and putting potential research participants at ease.</p

    Engaging diverse communities participating in clinical trials: case examples from across Africa

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    <p>Abstract</p> <p>Background</p> <p>In the advent of increasing international collaborative research involving participants drawn from populations with diverse cultural backgrounds, community engagement becomes very critical for the smooth conduction of the research. The African Malaria Network Trust (AMANET) is a pan-African non-governmental organization that sponsors and technically supports malaria vaccine trials in various African countries.</p> <p>Case description</p> <p>AMANET sponsored phase Ib or IIb clinical trials of several malaria vaccine candidates in various Africa countries. In Burkina Faso, Mali and Tanzania trials of the merozoite surface protein 3 -- in its Long Synthetic Peptide configuration (MSP3 LSP) -- were conducted. In Mali, the apical membrane antigen 1 (AMA1) was tested, while a hybrid of glutamate rich protein (GLURP) and MSP3 (GMZ2) was tested in Gabon. AMANET recognizes the importance of engaging with the communities from which trial participants are drawn, hence community engagement was given priority in all project activities conducted in the various countries.</p> <p>Discussion and evaluation</p> <p>Existing local social systems were used to engage the communities from which clinical trial participants were drawn. This article focuses on community engagement activities employed at various AMANET-supported clinical trial sites in different countries, highlighting subtle differences in the approaches used. The paper also gives some general pros and cons of community engagement.</p> <p>Conclusions</p> <p>Community engagement enables two-way sharing of accurate information and ideas between researchers and researched communities, which helps to create an environment conducive to smooth research activities with enhanced sense of research ownership by the communities.</p

    High rates of adherence and treatment success in a public and public-private HIV clinic in India: potential benefits of standardized national care delivery systems

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    <p>Abstract</p> <p>Background</p> <p>The massive scale-up of antiretroviral treatment (ART) access worldwide has brought tremendous benefit to populations affected by HIV/AIDS. Optimising HIV care in countries with diverse medical systems is critical; however data on best practices for HIV healthcare delivery in resource-constrained settings are limited. This study aimed to understand patient characteristics and treatment outcomes from different HIV healthcare settings in Bangalore, India.</p> <p>Methods</p> <p>Participants from public, private and public-private HIV healthcare settings were recruited between 2007 and 2009 and were administered structured interviews by trained staff. Self-reported adherence was measured using the visual analogue scale to capture adherence over the past month, and a history of treatment interruptions (defined as having missed medications for more than 48 hours in the past three months). In addition, CD4 count and viral load (VL) were measured; genotyping for drug resistance-associated mutations was performed on those who were in virological failure (VL > 1000 copies/ml).</p> <p>Results</p> <p>A total of 471 individuals were included in the analysis (263 from the public facility, 149 from the public-private facility and 59 from the private center). Private facility patients were more likely to be male, with higher education levels and incomes. More participants reported ≄ 95% adherence among public and public-private groups compared to private participants (public 97%; private 88%; public-private 93%, p < 0.05). Treatment interruptions were lowest among public participants (1%, 10%, 5% respectively, p < 0.001). Although longer clinic waiting times were experienced by more public participants (48%, compared to private 27%, public-private 19%, p < 0.001), adherence barriers were highest among private (31%) compared with public (10%) and public-private (17%, p < 0.001) participants. Viral load was detectable in 13% public, 22% private and 9% public-private participants (p < 0.05) suggesting fewer treatment failures among public and public-private settings. Drug resistance mutations were found more frequently among private facility patients (20%) compared to those from the public (9%) or public-private facility (8%, p < 0.05).</p> <p>Conclusions</p> <p>Adherence and treatment success was significantly higher among patients from public and public-private settings compared with patients from private facilities. These results suggest a possible benefit of the standardized care delivery system established in public and public-private health facilities where counselling by a multi-disciplinary team of workers is integral to provision of ART. Strengthening and increasing public-private partnerships can enhance the success of national ART programs.</p

    Delivering in‐school interventions to improve dietary behaviours amongst 11‐ to 16‐year‐olds: A systematic review

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    Childhood obesity is a global health concern, which has both short‐and long‐term health consequences for the individual, and is a potential burden on health care services and the wider economy. The school environment is a setting where changes can be applied to dietary behaviours, as schools have direct and intensive contact with children. This systematic review evaluated school‐based interventions designed to improve dietary behaviours among adolescents (11‐to 16‐year‐olds). The aims were to review types of interventions delivered, dietary behaviours targeted, and interventions' effectiveness in improving dietary behaviour and associated intervention components. Twenty‐nine school‐based interventional studies with this population were identified for review. The data were synthesized by identifying and comparing individual studies' results, intervention components, and characteristics.Interventions appeared more effective when they involved peers, used educational media to deliver health messages, increased availability of healthy foods in school,and incorporated computer‐based individualized feedback with normative information on eating behaviours. A limitation of the review was the lack of description in cer-tain reviewed studies and the nonfeasibility of conducting a meta‐analysis owing to study heterogeneity. Future interventions with this population could consider including the aforementioned components, gender‐specific feedback, and both short‐and long‐term follow‐ups as change may not be apparent immediately and to determine if changes are sustained
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