Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone.

Aims: To conduct a phase III study to evaluate the efficacy and safety of ertugliflozin monotherapy in people with type 2 diabetes.

Materials And Methods: This was a 52-week, double-blind, multicentre, randomized, parallel-group study with a 26-week, placebo-controlled treatment period (phase A), followed by a 26-week active-controlled treatment period (phase B) in 461 men and women, aged ≥18 years with inadequate glycaemic control (glycated haemoglobin [HbA1c] concentration 7.0% to 10.

Respiratory-swallow training in patients with head and neck cancer.

Objective: To test a novel intervention to train swallowing to occur in the midexpiratory to low expiratory phase of quiet breathing to improve swallowing safety and efficiency.

Design: Safety and efficacy nonrandomized controlled trial with 1-month follow-up.

Setting: Ambulatory clinics.

Desvenlafaxine 50 and 100 mg/d versus placebo for the treatment of major depressive disorder: a phase 4, randomized controlled trial.

Objective: To assess short-term efficacy and safety of desvenlafaxine 50 and 100 mg/d versus placebo for treating major depressive disorder (MDD). Assessment of sexual function was a secondary objective.

Method: Outpatients (≥ 18 years) who met criteria for MDD from the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision and had screening and baseline 17-item Hamilton Depression Rating Scale (HDRS17) total scores ≥ 20 were randomly assigned to placebo or desvenlafaxine 50 or 100 mg/d in an 8-week study conducted from October 2011 to August 2012.

Stroboscopic Parameters Reported as Voice Outcome Measures in Patients Treated for Laryngeal Cancer: A Systematic Review.

Background: A systematic review of the use of stroboscopy as a treatment outcome measure of vocal fold function in patients treated for laryngeal cancer is presented.

Methods: Computerized literature searches were performed. Eligible articles were admitted when stroboscopy was used to measure vocal fold function before and after treatment in patients with laryngeal cancer.

Rater methodology for stroboscopy: a systematic review.

Objectives: Laryngeal endoscopy with stroboscopy (LES) remains the clinical gold standard for assessing vocal fold function. LES is used to evaluate the efficacy of voice treatments in research studies and clinical practice. LES as a voice treatment outcome tool is only as good as the clinician interpreting the recordings.

Gender differences in stroke recognition among stroke survivors.

Background: Studies suggest that gender differences exist in the recognition of stroke warning signs. Poor recognition of stroke warning signs has been attributed to negative treatment-seeking behaviors, which can result in poor outcomes.

Objective: The aim of this study was to examine gender differences in the recognition of traditional early warning signs of stroke and first action to initiate treatment in a sample of stroke survivors.

Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.

Objective: Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.

Method: This phase 4, multicenter, parallel-group, randomized, double-blind, placebo-controlled study was conducted from June 30, 2010, to June 8, 2011. Patients received placebo or desvenlafaxine 50 mg/d (1:1 ratio; n = 217 in each group).

Baseline prevalence of heart diseases, hypertension, diabetes, and obesity in persons with acute traumatic spinal cord injury: potential threats in the recovery trajectory.

Background: Chronic diseases impede the recovery trajectory of acutely injured persons with traumatic spinal cord injury (TSCI). This study compares the odds of prevalent heart disease, hypertension, diabetes mellitus, and obesity between persons with TSCI and persons with lower extremity fractures (LEF) who were discharged from acute care facilities.

Methods: 1,776 patients with acute TSCI (cases) and 1,780 randomly selected patients with LEF (controls) discharged from January 1, 1998, through December 31, 2009, from all nonfederal hospitals were identified.

Perceptions of stroke recovery: an exclusion of communication and cognition.

Background: Perceptions of stroke recovery can differ substantially between stroke survivors and their healthcare providers. Concordance between the two is important for collaborative goal setting to facilitate optimal outcomes.

Objective: To explore stroke survivors' perceptions of their own recovery and residual impairments with specific emphasis on communication and cognition.

Cytochrome P450 2D6 phenoconversion is common in patients being treated for depression: implications for personalized medicine.

Objective: Determine the point prevalence of phenoconversion to cytochrome P450 2D6 (CYP2D6) poor metabolizer status in clinical practice.

Method: This multicenter, open-label, single-visit naturalistic study was conducted from October 2008 to July 2009 in adult patients (≥ 18 years) who had been receiving venlafaxine extended-release (ER) (37.5-225 mg/d) treatment for up to 8 weeks.

An evaluation of sexual functioning in employed outpatients with major depressive disorder treated with desvenlafaxine 50 mg or placebo.

Introduction: The symptoms of major depressive disorder (MDD) include sexual dysfunction, but antidepressant pharmacotherapies are also associated with treatment-emergent sexual dysfunction.

Aim: These secondary and post hoc analyses evaluated sexual functioning in employed adult outpatients with MDD treated with desvenlafaxine (administered as desvenlafaxine succinate) and placebo.

Method: Patients were randomly assigned (2:1 ratio) to 12 weeks of double-blind treatment with desvenlafaxine 50 mg/day or placebo.

Prediction of postinjury employment and percentage of time worked after spinal cord injury.

Objective: To use a 2-part model to identify biographic, injury, educational, and vocational predictors of postinjury employment and the percentage of time employed after spinal cord injury (SCI) onset.

Design: Survey.

Setting: Data were collected at 3 hospitals in the Southeastern and Midwestern United States.

Symptomatic and functional improvement in employed depressed patients: a double-blind clinical trial of desvenlafaxine versus placebo.

Objective: This is the first study to assess the efficacy of desvenlafaxine (administered as desvenlafaxine succinate) for improving depressive symptoms and functioning exclusively in employed patients with major depressive disorder (MDD).

Methods: Gainfully employed (≥20 h/wk) male and female outpatients with MDD were randomly assigned (2:1 ratio) to 12 weeks of double-blind treatment with desvenlafaxine 50 mg/d or placebo. Analysis of covariance was used to compare differences in week 12 adjusted mean changes from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D₁₇) (primary outcome) and Sheehan Disability Scale (SDS) (key secondary outcome) in the intent-to-treat (ITT) population.

A longitudinal study of depression in survivors of spinal cord injury.

Study Design: Cohort study.

Objectives: The objective of this study is to assess depression over a 5-year period in persons with spinal cord injury (SCI) and to assess risk factors for depression over time.

Setting: Rehabilitation hospitals in the Southeast and Midwest.

Open-label treatment with desvenlafaxine in postmenopausal women with major depressive disorder not responding to acute treatment with desvenlafaxine or escitalopram.

Background: Preliminary clinical evidence indicates that menopausal status might impact on the efficacy of certain classes of antidepressants.

Objective: The aim of this study was to evaluate open-label desvenlafaxine treatment (administered as desvenlafaxine succinate) in postmenopausal women who did not achieve clinical response to acute, double-blind treatment with desvenlafaxine or escitalopram.

Study Design: This phase IIIb, multicentre study included a 6-month open-label extension phase of patients who did not respond in the initial 8-week, randomized, double-blind acute phase.

Pharmacokinetics of venlafaxine extended release 75 mg and desvenlafaxine 50 mg in healthy CYP2D6 extensive and poor metabolizers: a randomized, open-label, two-period, parallel-group, crossover study.

Background: Genetically driven variations in the level of cytochrome P450 (CYP) 2D6 metabolic activity have been shown to significantly affect the pharmacokinetic behaviour of medications that are substrates of this enzyme.

Objective: To evaluate the impact of CYP2D6 extensive metabolizer (EM) and poor metabolizer (PM) phenotypes on the pharmacokinetics of single doses of venlafaxine extended release (ER) and desvenlafaxine (administered as desvenlafaxine succinate).

Methods: This study used a randomized, open-label, two-period, parallel-group, crossover design.

Desvenlafaxine and escitalopram for the treatment of postmenopausal women with major depressive disorder.

Objective: This study assessed the efficacy, safety, and tolerability of the serotonin-norepinephrine reuptake inhibitor desvenlafaxine and the selective serotonin reuptake inhibitor escitalopram for major depressive disorder (MDD) in postmenopausal women.

Methods: In this randomized, double-blind study, postmenopausal outpatients (aged 40-70 y) with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition MDD received flexible-dose desvenlafaxine (100-200 mg/d) or escitalopram (10-20 mg/d) for 8 weeks. Acute-phase responders, that is, women with a 50% or greater reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score, were eligible to continue the same double-blind treatment in the 6-month continuation phase.

Enzymatic catalysis and dynamics in low-water environments.

Enzymes suspended in organic solvents represent a versatile system for studying the involvement of water in enzyme structure and function. Addition of less than 1% (vol/vol) water to tetrahydrofuran containing 1 M 1-propanol leads to a substantial increase in the transesterification activity of subtilisin Carlsberg (from Bacillus licheniformis) that correlates with a sharp increase in the active-site polarity and a 90% decrease in the rotational correlation time (i.e.