Journal of women's health
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Journal of women's health · May 2013
Analysis and reporting of sex differences in phase III medical device clinical trials-how are we doing?
Over the past decade, the scientific community has begun to recognize the importance of biological sex differences in disease pathology, diagnosis, prevention, and treatment; however, the practice of sex-specific analysis and reporting is not integrated as standard practice by either our federal health agencies or by major medical journals. Despite the reforms of 20 years ago and the general inclusion of women in drug clinical trials, we have yet to see data routinely analyzed and reported by sex. ⋯ We conducted a search on ClinicalTrials.gov for phase III device clinical trials and assessed their practice of sex differences evaluation. Reporting of clinical trial results by sex will maximize scientific value of research investments, significantly impact clinical decision-making, and transform medical care.
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High cholesterol often precedes cardiovascular disease (CVD) and guidelines recommend cholesterol screening among at-risk women. Definitions of CVD risk vary and prevalence of dyslipidemia (abnormal total cholesterol, high-density lipoprotein (HDL-C), or non-HDL-C) among at-risk women may vary by age and definition of CVD risk. ⋯ The AHA risk definition identified 45% more young women and 25% more older women than the USPSTF risk definition; however, both definitions of at-risk identified similar prevalence estimates of dyslipidemia among women. Given a high prevalence of dyslipidemia among younger women, future research is needed to assess whether identification and treatment of young women with dyslipidemia will decrease CVD mortality among them later in life.
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Journal of women's health · Apr 2013
Randomized Controlled Trial Multicenter StudyImpact of estradiol valerate/dienogest on work productivity and activities of daily living in women with heavy menstrual bleeding.
To quantify the change in work productivity and activities of daily living in North American women with heavy menstrual bleeding (HMB) treated with estradiol valerate/dienogest (E2V/DNG; Qlaira(®)/Natazia(®)) compared to placebo. ⋯ E2V/DNG was shown to have a consistent positive impact on work productivity and activities of daily living in U.S. and Canadian women with HMB. In addition, these improvements in work productivity and activities of daily living were associated with a reduction in HMB-related monetary burden compared to the placebo group.
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Journal of women's health · Apr 2013
Persistent genital tract HIV-1 RNA shedding after change in treatment regimens in antiretroviral-experienced women with detectable plasma viral load.
To longitudinally assess the association between plasma viral load (PVL) and genital tract human immunodeficiency virus (GT HIV) RNA among HIV-1 infected women changing highly active antiretroviral therapy (HAART) because of detectable PVL on current treatment. ⋯ Some treatment-experienced HIV-infected women continue to have detectable virus in both the plasma and GT following a change in HAART, highlighting the difficulty of viral suppression in this patient population.
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Journal of women's health · Apr 2013
The lipid accumulation product for the early prediction of gestational insulin resistance and glucose dysregulation.
Recent insights linking insulin resistance and lipid overaccumulation suggest a novel approach for the early identification of women who may soon experience glucose dysregulation. Among women without a history of gestational diabetes, we tested the association between the lipid accumulation product (LAP) obtained in early pregnancy and glucose dysregulation or insulin resistance in the second trimester. ⋯ An increased value of LAP at the beginning of a pregnancy could be associated with an increased risk of insulin resistance or hyperglycemia later in gestation.