Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.

Background: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD.

Response rate profiles for major depressive disorder: Characterizing early response and longitudinal nonresponse.

Background: Definition of response is critical when seeking to establish valid predictors of treatment success. However, response at the end of study or endpoint only provides one view of the overall clinical picture that is relevant in testing for predictors. The current study employed a classification technique designed to group subjects based on their rate of change over time, while simultaneously addressing the issue of controlling for baseline severity.

Brain Correlates of Mental Stress-Induced Myocardial Ischemia.

Objective: Coronary artery disease (CAD) is a major cause of morbidity and mortality, and despite important advances in our understanding of this disorder, the underlying mechanisms remain under investigation. Recently, increased attention has been placed on the role of behavioral factors such as emotional stress on CAD risk. Brain areas involved in memory and the stress response, including medial prefrontal cortex, insula, and parietal cortex, also have outputs to the peripheral cardiovascular system.

Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

Background: Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking.

Methods: We conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.

Distal splenorenal shunt versus transjugular intrahepatic portal systematic shunt for variceal bleeding: a randomized trial.

Background & Aims: Variceal bleeding refractory to medical treatment with beta-blockers and endoscopic therapy can be managed by variceal decompression with either surgical shunts or transjugular intrahepatic portal systemic shunts (TIPS). This prospective randomized trial tested the hypothesis that patients receiving distal splenorenal shunts (DSRS) would have significantly lower rebleeding and encephalopathy rates than TIPS in management of refractory variceal bleeding.

Methods: A prospective randomized controlled clinical trial at 5 centers was conducted.

Reduction in fear of falling through intense tai chi exercise training in older, transitionally frail adults.

Objectives: To determine whether an intense tai chi exercise program could reduce fear of falling better than a wellness education (WE) program in older adults who had fallen previously and meet criteria for transitioning to frailty.

Design: Cluster-randomized, controlled trial of 48 weeks' duration.

Setting: Ten matched pairs of congregate living facilities in the greater Atlanta area.

The Dialysis Outcomes and Practice Patterns Study (DOPPS): design, data elements, and methodology.

The Dialysis Outcomes and Practice Patterns Study (DOPPS) is a prospective, observational study designed to elucidate aspects of hemodialysis practice that are associated with the best outcomes for hemodialysis patients. In DOPPS I, 308 hemodialysis units from 7 countries participated, including 145 facilities from the United States (1996-2001), 62 facilities from Japan (1999-2001), and 101 facilities from France, Germany, Italy, Spain, and the United Kingdom (all 1998-2000). DOPPS II (2002-2004) has included 320 hemodialysis units and more than 12,400 hemodialysis patients from the 7 DOPPS I countries as well as Australia, Belgium, Canada, New Zealand, and Sweden.

Sleep-disordered breathing and nocturia in older adults.

Objectives: To investigate the relationship between sleep-disordered breathing (SDB) and nocturia episodes in community-dwelling older adults.

Design: A cross-sectional study.

Setting: Community.

Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Cooperative Study Trial.

Purpose: We evaluate the efficacy of medical therapy on nocturia in men with benign prostatic hyperplasia (BPH).

Materials And Methods: We performed a secondary analysis of data from the VA Cooperative Study Program Trial in which 1,229 men with BPH 45 to 80 years old were randomly assigned to receive terazosin, finasteride, combination or placebo.

Results: The 1,078 men who completed 12 months of the trial are included in this study.