Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial.

Background: In a phase 2 study, dexpramipexole (25-150 mg twice daily) was well tolerated for up to 9 months and showed a significant benefit at the high dose in a combined assessment of function and mortality in patients with amyotrophic lateral sclerosis. We aimed to assess efficacy and safety of dexpramipexole in a phase 3 trial of patients with familial or sporadic disease.

Methods: In our randomised, double-blind, placebo-controlled phase 3 trial (EMPOWER), we enrolled participants aged 18-80 years (with first amyotrophic lateral sclerosis symptom onset 24 months or less before baseline) at 81 academic medical centres in 11 countries.

The association between height and prostate cancer grade in the Early Stage Prostate Cancer Cohort Study.

Objective: We examined the relationship between height and prostate cancer grade.

Methods: The Early Stage Prostate Cancer Cohort Study is an observational cohort of 1,037 men diagnosed with early-stage prostate cancer, T(0-3)N(x)M(0). High-grade prostate cancer was defined as a biopsy Gleason score ≥ 7 (4 + 3).

Clinical meaningfulness of the changes in muscle performance and physical function associated with testosterone administration in older men with mobility limitation.

Context: Testosterone in Older Men with Mobility Limitations Trial determined the effects of testosterone on muscle performance and physical function in older men with mobility limitation. Trial's Data and Safety Monitoring Board recommended enrollment cessation due to increased frequency of adverse events in testosterone arm. The changes in muscle performance and physical function were evaluated in relation to participant's perception of change.

Statins and prostate cancer diagnosis and grade in a veterans population.

Background: Although prostate cancer is commonly diagnosed, few risk factors for high-grade prostate cancer are known and few prevention strategies exist. Statins have been proposed as a possible treatment to prevent prostate cancer.

Methods: Using electronic and administrative files from the Veterans Affairs New England Healthcare System, we identified 55,875 men taking either a statin or antihypertensive medication.

Comparative effectiveness research and medical informatics.

As is the case for environmental, ecological, astronomical, and other sciences, medical practice and research finds itself in a tsunami of data. This data deluge, due primarily to the introduction of digitalization in routine medical care and medical research, affords the opportunity for improved patient care and scientific discovery. Medical informatics is the subdiscipline of medicine created to make greater use of information in order to improve healthcare.

Prevalence and characteristics of tinnitus among US adults.

Background: Tinnitus is common; however, few risk factors for tinnitus are known.

Methods: We examined cross-sectional relations between several potential risk factors and self-reported tinnitus in 14,178 participants in the 1999-2004 National Health and Nutrition Examination Surveys, a nationally representative database. We calculated the prevalence of any and frequent (at least daily) tinnitus in the overall US population and among subgroups.

Evaluation of a generalizable approach to clinical information retrieval using the automated retrieval console (ARC).

Reducing custom software development effort is an important goal in information retrieval (IR). This study evaluated a generalizable approach involving with no custom software or rules development. The study used documents "consistent with cancer" to evaluate system performance in the domains of colorectal (CRC), prostate (PC), and lung (LC) cancer.

Adverse events associated with testosterone administration.

Background: Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied.

Methods: Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.

Serum anion gap, bicarbonate and biomarkers of inflammation in healthy individuals in a national survey.

Background: In vitro data suggest that lower extracellular pH activates the immune system. We conducted a population-based study of the relation between serum acid-base status and inflammation.

Methods: We examined the serum anion gap and serum levels of bicarbonate and inflammatory biomarkers in 4525 healthy adults who participated in the National Health and Nutrition Examination Survey during 1999-2006.

Primary care visit duration and quality: does good care take longer?

Background: It is unclear if increasing pressure on primary care physicians to be more efficient has affected visit duration or quality of care. We sought to describe changes in the duration of adult primary care visits and in the quality of care provided during these visits and to determine whether quality of care is associated with visit duration.

Methods: We conducted a retrospective analysis of visits by adults 18 years or older to a nationally representative sample of office-based primary care physicians in the United States.

Lack of cholesterol awareness among physicians who smoke.

Cigarette use is a known risk factor for the development of coronary artery disease (CAD) as it adversely affects HDL cholesterol levels and promotes thrombogenesis. Smoking may also be associated with behavioral characteristics that potentiate the risk of CAD. A lack of cholesterol knowledge would indicate an aversion to a prevention-oriented lifestyle.

The relationship between total plasma carotenoids and risk factors for chronic disease among middle-aged and older men.

Individual plasma carotenoids have been associated with various chronic diseases but little is known about the relationship between total plasma carotenoids and risk factors for chronic diseases. In the Physicians' Health Study, we examined 492 men free of CVD and cancer for the relationship between total plasma carotenoids (the sum of alpha-carotene, beta-carotene, lycopene, zeaxanthin, lutein and beta-cryptoxanthin) and a wide variety of factors that predict chronic disease. Multivariate linear and logistic regression was performed to calculate parameter estimates (95% CI) and OR (95% CI) for total plasma carotenoids.

The association between statins and cancer incidence in a veterans population.

Background: Meta-analyses of trials of 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors or statins for cardiovascular disease prevention have failed to show any statistically significant benefit of statins for cancer prevention. However, these trials included relatively young participants, who develop few cancers, and their follow-up periods may have been too short to detect an association between statin use and cancer incidence. We investigated this association in a population of veterans.

Trends in prostate-specific antigen testing from 1995 through 2004.

Background: The utility of the prostate-specific antigen (PSA) test to screen for prostate cancer has been widely debated for several years. Whether PSA testing rates have changed during this period of controversy is not well known.

Methods: We examined the National Ambulatory Medical Care Survey (1995-2004) of visits to primary care providers by healthy men aged 35 years or older.

Serum anion gap and blood pressure in the national health and nutrition examination survey.

Increased production of organic acid can result in an elevated serum anion gap and may play a role in the development of hypertension. We studied the cross-sectional associations between anion gap and blood pressure and between serum bicarbonate and blood pressure in the 1999-2000 and 2001-2002 National Health and Nutrition Examination Surveys. We included 5043 adult participants who were not taking antihypertensive medications or diuretics and who denied hypertension, cardiovascular disease, diabetes, and other diseases.

Non-high-density lipoprotein cholesterol versus low-density lipoprotein cholesterol as a risk factor for a first nonfatal myocardial infarction.

Low-density lipoprotein (LDL) cholesterol is the primary lipid parameter targeted to prevent myocardial infarction. Alternatively, non-high-density lipoprotein (HDL) cholesterol includes LDL cholesterol and other atherogenic particles but does not require a fasting sample. Non-HDL cholesterol and LDL cholesterol as predictors of first nonfatal myocardial infarction were compared in 303 patients and 297 controls matched for age, gender, and community within the Boston Area Health Study.

Weight gain and new onset diabetes associated with olanzapine and risperidone.

Objective: To assess whether newer antipsychotic medications are associated with weight gain and development of diabetes.

Design: Retrospective cohort study.

Setting: Data from a comprehensive electronic medical record serving an urban public hospital and a citywide network of mental health clinics.