80 research outputs found

    Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

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    <p>Abstract</p> <p>Background</p> <p>Natural rubber latex allergy is a common and unsolved health problem. Since the avoidance of exposure is very difficult, immunotherapy is strongly recommended, but before its use in patients, it is essential to prove the efficacy and safety of extracts.</p> <p>The aim of the present randomised, double-blind, placebo-controlled clinical trial was to assess the efficacy and tolerability of latex sublingual immunotherapy in adult patients undergoing permanent latex avoidance.</p> <p>Methods</p> <p>Twenty-eight adult latex-allergic patients (5 males and 23 females), with mean age of 39 years (range 24-57) were randomized to receive a commercial latex-sublingual immunotherapy or placebo during one year, followed by another year of open, active therapy. The following outcomes were measured at baseline and at the end of first and second year of follow-up: skin prick test, gloves-use score, conjunctival challenge test, total and specific IgE, basophil activation test, and adverse reactions monitoring.</p> <p>Results</p> <p>No significant difference in any of the efficacy <it>in vivo </it>variables was observed between active and placebo groups at the end of the placebo-controlled phase, nor when each group was compared with their baseline values at the end of the two year-study. An improvement in the average percentage of basophils activated was observed. During the induction phase, 4 reactions in the active group and 5 in the placebo group were recorded. During the maintenance phase, two patients dropped out due to pruritus and to acute dermatitis respectively.</p> <p>Conclusion</p> <p>Further studies are needed to evaluate latex-sublingual immunotherapy, since efficacy could not be demonstrated in adult patients with avoidance of the allergen.</p> <p>Trial registration number</p> <p><a href="http://www.anzctr.org.au/ACTRN12611000543987.aspx">ACTRN12611000543987</a></p

    Equine-Assisted Psychotherapy for Childhood Trauma: A Randomized Controlled Trial of the EAGALA Model

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    Childhood trauma is a widespread problem that impacts millions of children, yet effectively engaging children in treatment post-trauma is challenging. Research on animal-assisted therapies and, specifically, equine-assisted psychotherapy (EAP), an animal-assisted form of treatment that partners with horses in the therapeutic process, suggests that it may be an efficacious treatment for children and adolescents with trauma-related mental health symptoms and diagnoses. However, the vast majority of this research consists of small, nonrandomized groups. This study is a longitudinal, randomized controlled trial of adolescents initially screened for trauma symptoms, who then received either EAGALA Model (EAP) (n = 55) or treatment as usual (TAU) (n = 49), with 10 sessions of active treatment, followed by a 10-week post-intervention follow-up assessment. Although both interventions demonstrated significant declines in anxiety, depression, and posttraumatic stress symptoms, it was the EAP group that demonstrated a significantly greater decrease in overall trauma symptoms that continued to decline longitudinally at 10-weeks post-intervention. The EAP group showed an improvement in emotion awareness from baseline to Week 5, although gains on emotional awareness were not maintained at Week 10 or at post-intervention follow-up. Attachment was only a significant predictor of therapeutic alliance at Week 1 but not at Week 5 or 10. Treatment group did not moderate the relationship between attachment and therapeutic alliance. Contrary to prediction, TAU had higher scores on therapeutic alliance but results did not reach statistical significance. Overall, these findings provide evidence for EAP as an effective form of treatment for trauma-impacted adolescents, but identifies caveats to be considered in future interventions and research

    Mobile ranging with low accuracy clocks

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