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Baseline Phase (baseline + phase)

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Medical Sciences	100%

Selected Abstracts

Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials

EPILEPSIA, Issue 3 2010
Michael R. Sperling
Summary Purpose:, To assess the efficacy, safety, and tolerability of the investigational drug carisbamate as adjunctive treatment for partial-onset seizures (POS). Methods:, Two identical, randomized, placebo-controlled, double-blind studies were conducted in adults with POS uncontrolled for ,1 year. Therapy-refractory epilepsy patients (,16 years) remained on stable doses of prescribed antiepileptic drugs (,2) for an 8-week prospective baseline phase and were then randomized (1:1:1) to carisbamate 200 mg/day, carisbamate 400 mg/day, or placebo, for a 12-week double-blind phase. Primary efficacy end points were percent reduction in seizure frequency and responder rate (patients with ,50% reduction in POS frequency) during the double-blind phase compared with the prospective baseline phase. Results:, Of the 565 patients randomized in study 1, 93% completed the study; of the 562 randomized in study 2, 94% completed the study. Patient characteristics were similar across both studies and treatment arms: mean age, 35 years (study 1, range 16,75 years) and 36 years (study 2, range 16,74 years); approximately 50% were men. Treatment with carisbamate 400 mg/day resulted in significant improvement (p < 0.01) in both efficacy measures compared with placebo in study 1 but not in study 2. Carisbamate 200 mg/day did not differ statistically from placebo in either study. Among the most common treatment-emergent adverse events (,5% in any group), those with an incidence exceeding placebo (,3%) were dizziness (400 mg/day group) and somnolence. Conclusions:, Carisbamate 400 mg/day was effective in patients with refractory partial-onset seizures in one of these global studies. More than 200 mg/day of carisbamate is required for efficacy. Carisbamate was well-tolerated in both studies. [source]

Prevalence of Tooth Loss and Dental Service Use in Older Mexican Americans

JOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2001
Whitney M. Randolph BS
OBJECTIVES: To describe the prevalence of tooth loss, to examine risk factors for having fewer teeth or no teeth, and to describe the use of dental services in an older Mexican-American population. DESIGN: Data from the baseline phase of the Hispanic Established Population for the Epidemiological Study of the Elderly survey conducted from 1993 to 1994, a cross-sectional survey of older Mexican Americans. SETTING: Five southwestern states: Texas, California, Arizona, New Mexico, and Colorado. PARTICIPANTS: 3,050 noninstitutionalized Mexican Americans age 65 to 99. RESULTS: Twenty-seven percent of the sample was completely edentulous and 22% reported visiting or speaking with a dental care professional in the preceding year. Logistic regression analyses showed that being older or being female was significantly associated with tooth loss, adjusting for education, income, smoking status, and diabetes mellitus. Current smokers (odds ratio (OR) = 1.69; 95% CI = 1.31,2.20) and diabetics (OR = 1.53; 95% CI = 1.27,1.84) were more at risk for tooth loss, as were persons of lower socioeconomic status. CONCLUSIONS: The prevalence of tooth loss and use of dental services in this population of older Mexican Americans is lower than what has been previously found among older people in the general population. [source]

Discrepancies in Perceptions of Maternal Aggression: Implications for Children of Methadone-Maintained Mothers

AMERICAN JOURNAL OF ORTHOPSYCHIATRY, Issue 3 2010
Jessica L. Borelli
Despite a long history of documenting discrepancies in parent and child reports of parental care and child psychopathology, it has only been in recent years that researchers have begun to consider these discrepancies as meaningful indicators of parent,child relationship quality and as predictors of long-term child adjustment. Discrepancies in perceptions of parenting may be particularly important for the children of mothers with a history of substance abuse who may be less aware of the impact of their behavior on their child and of their child's internalizing symptoms. This study examined associations between (a) mother,child discrepancies in reports of maternal aggression, and (b) mother and child reports of child internalizing and externalizing symptoms. Data collected from 99 mother,child dyads (with children 4,16 years of age) during the baseline phase of a randomized clinical trial testing a parenting intervention were used in this study. Measures included parent and child versions of the Parental Acceptance,Rejection Questionnaire and the Behavioral Assessment Scale for Children. Findings indicated that as children viewed their mothers as increasingly more aggressive than mothers viewed themselves, children reported more internalizing and externalizing symptoms but mothers only reported more child externalizing symptoms. Mother,child discrepancies in reports of parenting behavior have potentially meaningful implications for child emotional and behavioral problems. [source]

Distress among rural residents: Does employment and occupation make a difference?

AUSTRALIAN JOURNAL OF RURAL HEALTH, Issue 1 2010
Lyn Fragar
Abstract Objective:,This study investigates the relationship between levels of mental health and well-being (in terms of self-reported levels of distress) with employment and occupational status of rural residents, to better inform the provision of mental health services to those in greatest need in rural communities. Method:,A stratified random sample of community residents in rural and remote New South Wales with over-sampling of remote areas as first stage of a cohort study. Psychological distress was measured using Kessler-10, inclusive of additional items addressing functional impairment (days out of role). Occupational data were classified using Australian and New Zealand Standard Classification of Occupations categories. Results:,A total of 2639 adults participated in this baseline phase. Among them, 57% were in paid employment, 30% had retired from the workforce, 6% were permanently unable to work and 2% were unemployed. The highest levels of distress and functional impairment were reported in those permanently unable to work and the unemployed group with rates of ,caseness' (likely mental health disorder) varying from 57% to 69%, compared with 34% of farmers and farm managers and 29% of health workers (P < 0.01). Conclusion:,The rural unemployed suffer considerable psychological distress and ,disability', yet they are not the target of specific mental health promotion and prevention programs, which are often occasioned by rural adversity, such as drought, and delivered through work-based pathways. Policy-makers and health service providers need to consider the needs of the rural unemployed and those permanently unable to work and how they might be addressed. [source]