Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial.

Background: There is an urgent unmet need for new therapies in amyotrophic lateral sclerosis. In a clinical study with healthy volunteers, levosimendan, a calcium sensitiser, was shown to improve neuromechanical efficiency and contractile function of the human diaphragm. We aimed to evaluate the safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis, with a focus on respiratory function.

Oral levosimendan in amyotrophic lateral sclerosis: a phase II multicentre, randomised, double-blind, placebo-controlled trial.

Objective: To evaluate the efficacy and safety of oral levosimendan in patients with amyotrophic lateral sclerosis (ALS). This phase II, randomised, double-blind, placebo-controlled, crossover, three-period study with 6 months open-label follow-up enrolled adults with ALS and sitting slow vital capacity (SVC) 60%-90 % of predicted from 11 sites in four countries.

Methods: Patients received levosimendan 1 mg daily, 1 mg two times a day or placebo during three 14-day crossover periods and levosimendan 1-2 mg daily during open-label follow-up.

Bactericidal/permeability-increasing protein in lacrimal gland and in tears of healthy subjects.

Background: To determine the expression of bactericidal/permeability-increasing protein (BPI), a novel antimicrobial molecule, in the main lacrimal gland and its content in tears of young healthy subjects.

Methods: BPI concentration of tears was measured in 42 healthy volunteers, 13 men and 29 women, with ages ranging from 22 to 30 (mean 24.7+/-2.

Group IIA phospholipase A(2) concentration of tears in patients with ocular rosacea.

Purpose: To determine the concentration of group IIA phospholipase A(2) (GIIAPLA(2)) in tears of patients with ocular rosacea, and to compare it with GIIAPLA(2) concentration in tears of age-matched healthy controls.

Methods: The GIIAPLA(2) concentration in tears was measured with a time-resolved fluoroimmunoassay in 21 patients with ocular rosacea (mean age 55.6+/-9.

Group IIA phospholipase A2 content of tears in patients with atopic blepharoconjunctivitis.

Background: To determine the concentration of group IIA phospholipase A(2) (GIIAPLA(2)) in tears of patients with atopic blepharoconjunctivitis (ABC), and to compare it with the GIIAPLA(2) concentration of tears in age-matched healthy controls.

Methods: The diagnosis of ABC was confirmed with a positive skin prick test and the presence of atopic dermatitis in lids. Conjunctival brush cytology was taken, and the cells including eosinophils, neutrophils, lymphocytes, squamous epithelial cells, columnar epithelial cells, metaplastic changes and the goblet cells were calculated separately.

Group IIA phospholipase A(2) content in tears of patients having photorefractive keratectomy.

Purpose: To study the effect of photorefractive keratectomy (PRK) on the concentration of group IIA phospholipase A(2) (GIIAPLA(2)) in tears.

Setting: Departments of Ophthalmology and Pathology, University of Turku, Turku, and Helsinki University Eye Hospital, Helsinki, Finland.

Methods: Tear samples were collected from 25 eyes of 23 patients (mean age 32.

Diurnal variation in group IIa phospholipase A2 content in tears of contact lens wearers and normal controls.

Purpose: To study the diurnal rhythm in group IIA phospholipase A(2) (GIIAPLA(2)) content of tears and the effect of the wearing time of soft contact lenses (CL) on the content of GIIAPLA(2 )in tears.

Methods: The GIIAPLA(2 )content of tears was measured by a time-resolved fluoroimmunoassay in 22 healthy controls at 8 a.m.

Group IIA phospholipase A2 content of basal, nonstimulated and reflex tears.

Purpose: To determine the concentration of group IIA phospholipase A2 (GIIAPLA(2)) in basal, nonstimulated and reflex tears of young normal subjects.

Methods: The GIIAPLA(2) content of tears was measured in left eye of 16 healthy subjects (mean age 24.5 +/- 2.

Group IIA phospholipase A2 content of tears in patients with keratoconjunctivitis sicca.

Purpose: To determine the concentration of group IIA phospholipase A2 (GIIAPLA(2)) in tears of patients with keratoconjunctivitis sicca (KCS) and to compare it with the GIIAPLA(2) content of tears in age-matched healthy controls.

Methods: The GIIAPLA(2)content of tears was measured with time-resolved fluoroimmunoassay in 20 patients with KCS (mean age 70.7+/-8.