Challenges in the Detection of Polymyxin Resistance: From Today to the Future.

Antimicrobial resistance is known to be one of the greatest global threats to human health, and is one of the main causes of death worldwide. In this scenario, polymyxins are last-resort antibiotics to treat infections caused by multidrug-resistant bacteria. Currently, the reference test to evaluate the susceptibility of isolates to polymyxins is the broth microdilution method; however, this technique has numerous complications and challenges for use in laboratory routines.

Opt-Out Design for an Observational Toxicology Study Involving Intoxicated Patients at a Dance Music Event.

At electronic dance music events in Belgium in 2013 to 2015, seemingly intoxicated patients were included without their informed consent in an observational toxicology study when the attending physicians determined that they needed treatment with an intravenous line. All included patients received an information letter inviting them to contact the principal investigator (PI) to obtain more information about the study and/or to inform the PI that they wanted to be excluded from it. Overall, 238 patients were included in the study.

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.

Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease.

Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations.

Objectives: IPX203 is an investigational oral extended-release capsule formulation of carbidopa and levodopa. The pharmacodynamics and efficacy of IPX203 were compared with immediate-release carbidopa-levodopa (IR CD-LD) in this open-label, rater-blinded, multicenter, crossover study in patients with advanced Parkinson disease (PD).

Methods: Twenty-eight patients were randomized to 2 weeks of treatment with IR CD-LD followed by IPX203 or IPX203 followed by IR CD-LD.

Single-Dose Pharmacokinetics and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson Disease: A Comparison With Immediate-Release Carbidopa-Levodopa and With Extended-Release Carbidopa-Levodopa Capsules.

Objective: IPX203 is an investigational oral extended-release capsule formulation of carbidopa-levodopa (CD-LD). The aim of this study was to characterize the single-dose pharmacodynamics, pharmacokinetics, and safety of IPX203 in subjects with advanced Parkinson disease compared with immediate-release (IR) CD-LD and extended-release CD-LD (Rytary).

Methods: This was a randomized, open-label, rater-blinded, multicenter, single-dose crossover study.

Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations.

Background: IPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD). Following an initial peak at about one hour, plasma LD concentrations are maintained for about 4-5 hours.

Objective: To present dosing factors that may affect the successful conversion to ER CD-LD from other LD formulations.

Effect of Concomitant Medications on the Safety and Efficacy of Extended-Release Carbidopa-Levodopa (IPX066) in Patients With Advanced Parkinson Disease: A Post Hoc Analysis.

Objectives: Extended-release (ER) carbidopa-levodopa (CD-LD) (IPX066/RYTARY/NUMIENT) produces improvements in "off" time, "on" time without troublesome dyskinesia, and Unified Parkinson Disease Rating Scale scores compared with immediate-release (IR) CD-LD or IR CD-LD plus entacapone (CLE). Post hoc analyses of 2 ER CD-LD phase 3 trials evaluated whether the efficacy and safety of ER CD-LD relative to the respective active comparators were altered by concomitant medications (dopaminergic agonists, monoamine oxidase B [MAO-B] inhibitors, or amantadine).

Methods: ADVANCE-PD (n = 393) assessed safety and efficacy of ER CD-LD versus IR CD-LD.

Conversion to carbidopa and levodopa extended-release (IPX066) followed by its extended use in patients previously taking controlled-release carbidopa-levodopa for advanced Parkinson's disease.

Background: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD).

Methods: In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance.

Conversion to IPX066 from Standard Levodopa Formulations in Advanced Parkinson's Disease: Experience in Clinical Trials.

Background: Due to the short half-life of levodopa, immediate-release carbidopa-levodopa (IR CD-LD) produces fluctuating LD concentrations, contributing to a risk of eventual motor complications. IPX066 was designed to rapidly attain therapeutic LD concentrations and maintain them to allow a dosing interval of ∼6 hours.

Objective: To extensively analyze the dosing data collected in IPX066 studies during open-label conversions from IR CD-LD alone or with entacapone (CLE) and identify patterns relevant for managing conversion in the clinical setting.

Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial.

Purpose: Report the efficacy and safety of pasireotide sc in patients with Cushing's disease during an open-ended, open-label extension to a randomized, double-blind, 12-month, Phase III study.

Methods: 162 patients entered the core study. 58 patients who had mean UFC ≤ ULN at month 12 or were benefiting clinically from pasireotide entered the extension.

Comparison of IPX066 with carbidopa-levodopa plus entacapone in advanced PD patients.

Background: IPX066, an investigational extended-release carbidopa-levodopa (CD-LD) preparation, has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson's disease (PD). This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone (CL + E).

Karyotyping, is it worthwhile in transsexualism?

Introduction: Karyotyping is often performed in transsexual individuals.

Aim: Quantification and characterization of karyotype findings and abnormalities in transsexual persons.

Main Outcome Measures: Karyotypes were listed both in male-to-female and in female-to-male transsexual persons.

A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.

Background: Longer-term pharmacologic studies for insomnia in older individuals are sparse.

Objective: To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia.

Methods: Participants (65-85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) < or = 6 h, and wake time after sleep onset (WASO) > or = 45 min.

The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: a pilot study.

Objective: To evaluate the efficacy and safety of eszopiclone 3 mg, a nonbenzodiazepine medication/hypnotic indicated for the treatment of insomnia with comorbid rheumatoid arthritis (RA).

Method: This multicenter, double-blind, placebo-controlled pilot study was conducted in 153 patients aged 25-64 years with American College of Rheumatology-defined RA who met DSM-IV criteria for insomnia. The data were collected from February to November of 2004.

Quantification of testosterone undecanoate in human hair by liquid chromatography-tandem mass spectrometry.

Testosterone undecanoate (T-C11) can be used by athletes in order to improve performance. After oral intake, T-C11 is rapidly metabolized, hampering discrimination between exogenous and endogenous testosterone. A possible alternative is to detect the intact ester in hair.

The female-to-male transsexual and his female partner versus the traditional couple: a comparison.

In this explorative study, nine stable relationships between female-to-male transsexuals and their biologically female partners were compared to an equal number of "traditional" heterosexual couples. The aim was to investigate any differences between these two groups on three aspects: satisfaction about the partner relationship, sexual satisfaction, and partnership sex typing. Data do not show any significant differences in relational and sexual satisfaction between the transsexuals' female partner and the women in the "traditional" couples.

A polysomnographic placebo-controlled evaluation of the efficacy and safety of eszopiclone relative to placebo and zolpidem in the treatment of primary insomnia.

Study Objectives: To evaluate the polysomnographic efficacy and the safety of a range of doses of eszopiclone relative to placebo in patients with primary insomnia. Zolpidem 10 mg was included as an active control.

Methods: This multicenter, randomized, crossover study enrolled patients aged 21-64 years meeting the DSM-IV criteria for primary insomnia (n = 65).

Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder.

Context: Insomnia and generalized anxiety disorder (GAD) are prevalent disorders that may coexist.

Objective: To determine the efficacy of eszopiclone combined with escitalopram oxalate in treating insomnia comorbid with GAD.

Design: Double-blind, randomized, placebo-controlled, parallel-group, add-on therapy 10-week study.

Next-day cognition, psychomotor function, and driving-related skills following nighttime administration of eszopiclone.

Objective: To evaluate next-day driving ability, as assessed by brake reaction time (BRT), and cognitive/psychomotor function following nighttime administration of 3 mg eszopiclone.

Methods: Two randomized, double-blind, placebo-controlled, cross-over studies were performed in healthy volunteers (n = 32) and patients with primary insomnia (n = 32). Study participants received nighttime dosing of 3 mg eszopiclone or placebo.

Hypoactive sexual desire in transsexual women: prevalence and association with testosterone levels.

Objective: An unknown proportion of transsexual women (defined as post-operative male-to-female transsexuals on oestrogen replacement) experience hypoactive sexual desire disorder (HSDD). It has been suggested that the absence of ovarian androgen production together with oestrogen treatment-related increase in sex hormone-binding globulin (SHBG) levels could be leading to HSDD, due to low levels of biologically available testosterone. This study wishes to document the HSDD prevalence among transsexual women and the possible association to androgen levels.

Nightly treatment of primary insomnia with eszopiclone for six months: effect on sleep, quality of life, and work limitations.

Study Objectives: To evaluate 6 months' eszopiclone treatment upon patient-reported sleep, fatigue and sleepiness, insomnia severity, quality of life, and work limitations.

Design: Randomized, double blind, controlled clinical trial.

Setting: 54 research sites in the U.

Evaluation of eszopiclone discontinuation after cotherapy with fluoxetine for insomnia with coexisting depression.

Background: Insomnia and major depressive disorder (MDD) may coexist. This study evaluated hypnotic discontinuation effects following an 8-week placebo-controlled study of eszopiclone/fluoxetine cotherapy in patients with insomnia and comorbid MDD.

Methods: Patients meeting DSM-IV criteria for MDD and insomnia received fluoxetine each morning for 8 weeks and were randomized to concomitant treatment with nightly eszopiclone 3 mg (cotherapy) or placebo (monotherapy).

Prevalence and demography of transsexualism in Belgium.

Aim: The Belgian medical world has acknowledged the diagnosis of transsexualism and accepted Sex Reassignment Surgery (SRS) as one of the steps in the treatment of choice since 1985. This prevalence and demographic study analyses data on all Belgian individuals who have undergone SRS since that year.

Methods: All (188) plastic surgeons as well as all gender teams (Antwerp, Bruges, Ghent, and Liège) in Belgium were sent demographic questionnaires to be completed for each of their transsexual patients.