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Montréal, Canada

Weiss J.P.,Brooklyn College | Herschorn S.,University of Toronto | Albei C.D.,Clinical Research | Van Der Meulen E.A.,Ferring International PharmaScience Center
Journal of Urology | Year: 2013

Purpose: We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids). Materials and Methods: In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo. The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period. Results: The full analysis set comprised 385 men (age range 20 to 87 years). The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months. Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively). The response to desmopressin was seen by 1 week of treatment and was sustained. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg). Conclusions: Desmopressin (orally disintegrating tablet) is an effective and well tolerated treatment for men with nocturia. Treatment with 50 μg desmopressin, the minimum effective dose, provided sustained improvement of nocturia throughout the study and meaningful benefits to patients with an improved safety profile. © 2013 American Urological Association Education and Research, Inc. Source


Moya F.,Coastal Carolina Neonatology | Sisk P.M.,Wake forest University | Walsh K.R.,Research and Development | Berseth C.L.,Clinical Research
Pediatrics | Year: 2012

OBJECTIVES: To evaluate the growth, tolerance, and safety of a new ultraconcentrated liquid human milk fortifier (LHMF) designed to provide optimal nutrients for preterm infants receiving human breast milk in a safe, nonpowder formulation. METHODS: Preterm infants with a body weight ≤1250 g fed expressed and/or donor breast milk were randomized to receive a control powder human milk fortifier (HMF) or a new LHMF for 28 days. When added to breast milk, the LHMF provided ∼20% more protein than the control HMF. Weight, length, head circumference, and serum prealbumin, albumin, blood urea nitrogen, electrolytes, and blood gases were measured. The occurrence of sepsis, necrotizing enterocolitis, and serious adverse events were monitored. RESULTS: This multicenter, third party-blinded, randomized controlled, prospective study enrolled 150 infants. Achieved weight and linear growth rate were significantly higher in the LHMF versus control groups (P = .04 and 0.03, respectively). Among infants who adhered closely to the protocol, the LHMF had a significantly higher achieved weight, length, head circumference, and linear growth rate than the control HMF (P = .004, P = .003, P = .04, and P = .01, respectively). There were no differences in measures of feeding tolerance or days to achieve full feeding volumes. Prealbumin, albumin, and blood urea nitrogen were higher in the LHMF group versus the control group (all P < .05). There was no difference in the incidence of confirmed sepsis or necrotizing enterocolitis. CONCLUSIONS: Use of a new LHMF in preterm infants instead of powder HMF is safe. Benefits of LHMF include improvements in growth and avoidance of the use of powder products in the NICU. Copyright © 2012 by the American Academy of Pediatrics. Source


Williams G.P.,Clinical Research
European Journal of Cancer Prevention | Year: 2010

A detailed review of the literature was performed in a bid to identify the presence of a common link between specific hormone interactions and the increasing prevalence of global disease. The synergistic action of unopposed oestrogen and leptin, compounded by increasing insulin, cortisol and xeno-oestrogen exposure directly initiate, promote and exacerbate obesity, type 2 diabetes, uterine overgrowth, prostatic enlargement, prostate cancer and breast cancer. Furthermore these hormones significantly contribute to the incidence and intensity of anxiety and depression, Alzheimer's disease, heart disease and stroke. This review, in collaboration with hundreds of evidence-based clinical researchers, correlates the significant interactions these hormones exert upon the upregulation of p450 aromatase, oestrogen, leptin and insulin receptor function; the normal status quo of their binding globulins; and how adduct formation alters DNA sequencing to ultimately produce an array of metabolic conditions ranging from menopausal symptoms and obesity to Alzheimer's disease and breast and prostate cancer. It reveals the way that poor diet, increased stress, unopposed endogenous oestrogens, exogenous oestrogens, pesticides, xeno-oestrogens and leptin are associated with increased aromatase activity, and how its products, increased endogenous oestrogen and lowered testosterone, are associated with obesity, type 2 diabetes, Alzheimer's disease and oestrogenic disease. This controversial break-through represents a paradigm shift in medical thinking, which can prevent the raging pandemic of diabetes, obesity and cancer currently sweeping the world, and as such, it will reshape health initiatives, reduce suffering, prevent waste of government expenditure and effectively transform preventative medicine and global health care for decades. © 2010 Lippincott Williams & Wilkins, Inc. Source


Wingerchuk D.M.,Clinical Research | Weinshenker B.G.,Mayo Medical School
CONTINUUM Lifelong Learning in Neurology | Year: 2013

Purpose of Review: This review defines current clinical criteria for diagnosis, differential diagnosis, and clinical evaluation of acute disseminated encephalomyelitis, transverse myelitis, and neuromyelitis optica, and summarizes principles of treatment. Recent Findings: Consensus criteria for transverse myelitis and acute disseminated encephalomyelitis have been proposed. A specific biomarker, aquaporin-4 autoantibody, has been discovered for neuromyelitis optica that allows for early and accurate diagnosis even in the absence of cardinal findings of optic neuritis andmyelitis. The antibody is pathogenic and is facilitating an understanding of the pathophysiology of neuromyelitis optica and development of antigen-specific treatments. Summary: Clinical and radiologic findings combined with serologic findings may permit classification of syndromes of transverse myelitis and acute disseminated encephalomyelitis in ways that may predict risk of relapse, type of relapse, and prognosis. Treatment, especially to prevent relapse, is dependent on the specific disease context in which syndromes such as transverse myelitis occur. © 2013, American Academy of Neurology. Source


Yurko-Mauro K.,Clinical Research | Alexander D.D.,EpidStat Institute
PLoS ONE | Year: 2015

Introduction: Subjective memory complaints are common with aging. Docosahexaenoic acid (DHA; 22:6 n-3) is a long-chain polyunsaturated fatty acid (LCPUFA) and an integral part of neural membrane phospholipids that impacts brain structure and function. Past research demonstrates a positive association between DHA plasma status/dietary intake and cognitive function. Objectives: The current meta-analysis was designed to determine the effect of DHA intake, alone or combined with eicosapentaenoic acid (EPA; 20:5 n-3), on specific memory domains: episodic, working, and semantic in healthy adults aged 18 years and older. A secondary objective was to systematically review/summarize the related observational epidemiologic literature. Methods: A systematic literature search of clinical trials and observational studies that examined the relationship between n-3 LCPUFA on memory outcomes in healthy adults was conducted in Ovid MEDLINE and EMBASE databases. Studies of subjects free of neurologic disease at baseline, with or without mild memory complaints (MMC), were included. Random effects meta-analyses were conducted to generate weighted group mean differences, standardized weighted group mean differences (Hedge's g), z-scores, and p-values for heterogeneity comparing DHA/EPA to a placebo. A priorisub-group analyses were conducted to evaluate the effect of age at enrollment, dose level, and memory type tested. Results: Episodic memory outcomes of adults with MMC were significantly (P<.004) improved with DHA/EPA supplementation. Regardless of cognitive status at baseline, > 1 g/day DHA/EPA improved episodic memory (P<.04). Semantic and working memory changes from baseline were significant with DHA but no between group differences were detected. Observational studies support a beneficial association between intake/blood levels of DHA/EPA and memory function in older adults. Conclusion: DHA, alone or combined with EPA, contributes to improved memory function in older adults with mild memory complaints. © 2015 Yurko-Mauro et al. Source

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