39 research outputs found

    Grandi Byen-supporting child growth and development through integrated, responsive parenting, nutrition and hygiene: Study protocol for a randomized controlled trial

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    BACKGROUND: Poor child growth and development outcomes stem from complex relationships encompassing biological, behavioral, social, and environmental conditions. However, there is a dearth of research on integrated approaches targeting these interwoven factors. The Grandi Byen study seeks to fill this research gap through a three-arm longitudinal randomized controlled trial which will evaluate the impact of an integrated nutrition, responsive parenting, and WASH (water, sanitation and hygiene) intervention on holistic child growth and development. METHODS: We will recruit 600 mother-infant dyads living in Cap-Haitien, Haiti and randomize them equally into one of the following groups: 1) standard well-baby care; 2) nutritional intervention (one egg per day for 6 months); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, WASH + one egg per day for 6 months). Primary outcomes include child growth as well as cognitive, language, motor, and social-emotional development. The study also assesses other indicators of child health (bone maturation, brain growth, diarrheal morbidity and allergies, dietary intake, nutrient biomarkers) along with responsive parenting as mediating factors influencing the primary outcomes. An economic evaluation will assess the feasibility of large-scale implementation of the interventions. DISCUSSION: This study builds on research highlighting the importance of responsive parenting interventions on overall child health, as well as evidence demonstrating that providing an egg daily to infants during the complementary feeding period can prevent stunted growth. The multicomponent Grandi Byen intervention may provide evidence of synergistic or mediating effects of an egg intervention with instruction on psychoeducational parenting and WASH on child growth and development. Grandi Byen presents key innovations with implications for the well-being of children living in poverty globally. TRIAL REGISTRATION: NCT04785352 . Registered March 5, 2021 at https://clinicaltrials.gov/

    The design and development of a personalized medicine support system

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    The use of a patient\u27s genetic data to aid clinical diagnosis and drug treatment represents a major milestone in the contribution of genomic research to healthcare practices. Initial implementation of a personalized medicine system is currently possible, uniting the areas of medicine, genomics, and informatics, built upon a foundation of the latest advances in information technology. The aim of a clinical application of pharmacogenomics is to tailor therapeutic drug regimens to an individual\u27s genetic profile, thereby maximizing the effectiveness of drug therapy and minimizing the likelihood of an adverse drug response (ADR). The fulfillment of these goals is of the utmost importance. Only half of all patients treated with conventional blockbuster drugs respond adequately and ADRs currently rank as the fourth leading cause of death in the US with more than 50% classified as dose-related (Olivier, Williams-Jones, Godard, Mikalson, & Ozdemir, 2008; Brockmöller & Tzvetkov, 2008). This represents a major financial and social burden. Though the link between allelic variants and altered drug metabolism is well established, the technology for implementing such considerations toward individualized dose adjustments does not currently exist. In order to leverage current advances in pharmacogenomics and assume a proactive role for the more rapid adoption of future technologies and advancements, a societal-scale personalized medicine system has been designed and developed. Given the very recent nature of the advances in human genomic knowledge and biotechnology methods as well as the lack of formal pharmacogenomics education, the system has been developed to serve as an education tool for physicians and pharmacists. The system represents a fully operational software system and incorporates development methodologies and technology that a business organization would use in order to implement a commercially viable product. This in particular allows the system to contribute toward the development of current data standards, exemplify an interface between genotypic analysis and its practical application to clinical decision support, allow for an analysis of current gaps within the supporting infrastructure, and enable the final dissemination of a best practices report with regard to real-world design, development, and implementation

    Improving reuse in software development for the life sciences

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    The last several years have seen unprecedented advancements in the application of technology to the life sciences, particularly in the area of data generation. Novel scientific insights are now often driven primarily by software development supporting new multidisciplinary and increasingly multifaceted data analysis. However, despite the availability of tools such as best practice frameworks, the current rate of software development is not able to keep up with the needs of scientists. This bottleneck in software development is largely due to code reuse generally not being applied in practice. This dissertation presents Legwork, a class library of reuse-optimized design pattern implementations for desktop applications written in the C# programming language using Microsoft\u27s .NET Framework. Two case studies were used to evaluate the effect of Legwork on improving code reusability as compared to Microsoft\u27s best practices Prism framework. First, a collection of six established web service-based workflows leveraging the National Center for Biotechnology\u27s Entrez database retrieval system. Second, a modular genomics data analysis and visualization application based on the open source .NET Bio bioinformatics toolkit. Employing quantitative and qualitative methods, code reusability was evaluated at the class, subsystem, and system levels of software design through comparing established class metrics for code reuse, code control flow, and code composition, respectively. The results from both case studies demonstrate that using Legwork provides a consistent improvement in code reusability over Microsoft\u27s Prism framework across all three levels of program design evaluated

    Agreement of cut point definitions within the NEXT Plus dataset

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    Department of Health and Exercise Science.Includes bibliographical references.Purpose: Accelerometers are used to assess physical activity intensity levels and durations across populations. This is done by dividing the device output into categories that correspond to light, moderate, and vigorous physical activity. Cut points provide where these dividing lines should be. However, there is not a consistent set of cut points for any given population. This makes inter-study comparison difficult and it is unknown how using different cut point sets affects outcomes. The aim of this study is to determine agreement between four different commonly used cut points. Procedure/Description: The NEXT Generation Health Study is longitudinal study funded by the NIH Intramural Research programs. NEXT Plus is a subset of the larger sample that wore accelerometers for one week intervals (n=150). The physical activity monitors used in this trial were the GT3X by ActiGraph. Data files were first converted to .agd files with a 10 second epoch using ActiLife software. Next, each cut point definition was used to give time spent in each intensity. The cut points used to evaluate the data were by Freedson, Romanzini (which has two sets), and Santos-Lozano. Physical activity guidelines from the CDC were applied to each cut point definition output. An agreement analysis was then calculated for each output. Statistical analyses were performed in SAS software version 9.4. P values < 0.05 were considered statistically significant. Results/Outcomes: There were significant differences in time spent in light, moderate, vigorous, and moderate and vigorous combined between each pair of cut point definitions (p<0.0001). Also, there was significant disagreement between each cut point definition regarding if individuals met the CDC guidelines (p<0.0001). Implications/Future Direction: Cut point definition selection has a noteworthy effect on determining the duration of time spent in each intensity of physical activity. As this measure is often used as a main outcome of interest, past studies’ conclusions may be based on inaccurate data. These findings further complicate inter-study comparison when different cut point definitions are used. Future studies should determine if common cut point definitions used in other populations provide similar outcomes and perhaps rethink monolithic cut point definitions to express greater variability seen within groups

    Eribulin mesylate versus ixabepilone in patients with metastatic breast cancer: a randomized Phase II study comparing the incidence of peripheral neuropathy

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    Peripheral neuropathy is a common toxicity associated with tubulin-targeted chemotherapeutic agents. This Phase II study compares the incidence and severity of neuropathy associated with eribulin mesylate or ixabepilone in metastatic breast cancer (MBC). The primary objective was to assess the incidence of neuropathy; the study was designed to detect a difference in neuropathy rate of 35 % for eribulin versus 63 % for ixabepilone (odds ratio 0.316, 80 % power, 0.05 two-sided significance level). Eligibility criteria included: MBC; prior taxane therapy; at least one chemotherapy for advanced disease; no or minimal pre-existing neuropathy (Grade 0 or 1). The intent-to-treat population comprised 104 patients randomized (1:1) to eribulin mesylate (1.4 mg/m 2 , 2–5 min intravenous on days 1 and 8) or ixabepilone (40 mg/m 2 , 3 h intravenous on day 1) on a 21-day cycle. 101 patients in the safety population received a median of 5.0 eribulin and 3.5 ixabepilone cycles. Incidence of neuropathy (any grade) was 33.3 and 48.0 %, and peripheral neuropathy was 31.4 and 44.0 % for eribulin and ixabepilone, respectively. After controlling for pre-existing neuropathy and number of prior chemotherapies, these differences were not significant. Compared with ixabepilone, fewer patients receiving eribulin discontinued treatment due to neuropathy (3.9 vs. 18.0 %) or adverse events (AEs) in general (11.8 vs. 32.0 %). Time to onset of neuropathy was 35.9 weeks for eribulin and 11.6 weeks for ixabepilone, and time to resolution was 48 versus 10 weeks, respectively; other AEs were comparable. Objective responses were 15.4 versus 5.8 % and clinical benefit rates were 26.9 versus 19.2 %. In conclusion, after controlling for pre-existing neuropathy and number of prior chemotherapies, the differences in the incidence of neuropathy with eribulin and ixabepilone were not statistically significant. Onset of neuropathy tended to occur later with eribulin and resolve later
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