Analyses of Safety Profile and Homologous Antibody Responses to a Mammalian Cell-Based, MF59-Adjuvanted, A/H5N1, Pandemic Influenza Vaccine across Four Phase II/III Clinical Trials in Healthy Children, Adults, and Older Adults.

Modern cell culture-based technology eliminates vaccine manufactures reliance on embryonated chicken eggs, which may become compromised during an avian influenza pandemic. Four studies (total N = 6230) assessed the immunogenicity and safety of mammalian cell-based, MF59-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ™) as two doses administered on Days 1 and 22 in children (NCT01776554), adults (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330). Immunogenicity of formulations at 7.

Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer.

Background: Enzalutamide is an androgen receptor (AR) inhibitor that acts on different steps in the AR signaling pathway. In PREVAIL, an international, phase III, double-blind, placebo-controlled trial, enzalutamide significantly reduced the risk of radiographic progression by 81% (hazard ratio [HR], 0.19; P < .

Reference intervals and longitudinal changes in copeptin and MR-proADM concentrations during pregnancy.

Background: Vasopressin and adrenomedullin and their stable by-products copeptin and midregional part of proadrenomedullin (MR-proADM) are promising biomarkers for the development of preeclampsia. However, clinical use is hampered by the lack of trimester-specific reference intervals. We therefore estimated reference intervals for copeptin and MR-proADM in disease-free Dutch women throughout pregnancy.

Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study.

Unlabelled: Enzalutamide significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) among men with chemotherapy-naïve metastatic castration-resistant prostate cancer at the prespecified interim analysis of PREVAIL, a phase 3, double-blind, randomized study. We evaluated the longer-term efficacy and safety of enzalutamide up to the prespecified number of deaths in the final analysis, which included an additional 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and 4 mo of follow-up for safety. Enzalutamide reduced the risk of radiographic progression or death by 68% (hazard ratio [HR] 0.

The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients.

Purpose: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial.

Materials And Methods: Asymptomatic or mildly symptomatic chemotherapy-naive men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS).

Enzalutamide in Japanese patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer: A post-hoc analysis of the placebo-controlled PREVAIL trial.

Objectives: To evaluate the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients.

Methods: This was a post-hoc analysis of the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naïve patients with metastatic castration-resistant prostate cancer progressing on androgen deprivation therapy were randomized one-to-one to 160 mg/day oral enzalutamide or placebo until discontinuation on radiographic progression or skeletal-related event and initiation of subsequent antineoplastic therapy.

Effect of medication reconciliation on unintentional medication discrepancies in acute hospital admissions of elderly adults: a multicenter study.

Objectives: To investigate the effect of pharmacy-based medication reconciliation on the frequency of unintentional medication discrepancies in acutely admitted individuals aged 65 and older.

Design: Multicenter intervention study with pre-post design.

Setting: Twelve Dutch hospitals.

Pardoprunox as adjunct therapy to levodopa in patients with Parkinson's disease experiencing motor fluctuations: results of a double-blind, randomized, placebo-controlled, trial.

Aims: To determine the efficacy and safety of pardoprunox in levodopa-treated patients with Parkinson's disease (PD) experiencing motor fluctuations.

Methods: Patients were randomized to pardoprunox (up to 42 mg/day, n = 150) or placebo (n = 144). Pardoprunox was titrated to an optimal dose over 7 weeks, followed by a 12-week stable dose period.

Temporal stability of the Unified Dyskinesia Rating Scale.

Background: The objective of this study was to establish temporal stability characteristics for objective components of the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS has strong internal consistency and a reliable factor structure, but the important issue of temporal stability has not been established.

Methods: Using intraclass correlation coefficient (ICC) analyses, we examined UDysRS temporal stability for the objective scale components (Part III and IV) over an 8-hour observation period.

Pardoprunox in early Parkinson's disease: results from 2 large, randomized double-blind trials.

This report presents the results of 2 randomized trials-Rembrandt and Vermeer-on the efficacy and safety of pardoprunox in patients with early Parkinson's disease. Patients with Parkinson's disease with a Unified Parkinson's Disease Rating Scale-Motor score ≥ 10 and modified Hoehn and Yahr stage ≤ 3 were randomized to pardoprunox (fixed doses of 6 mg/day [n = 115] or 12 mg/day [n = 118] or a flexible-dose range of 12-42 mg/day [n = 116]) or placebo (n = 119) in Rembrandt and pardoprunox 12-42 mg/day (n = 108), pramipexole 1.5-4.

Double-blind study of pardoprunox, a new partial dopamine agonist, in early Parkinson's disease.

This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks.

Effects of betahistine on patient-reported outcomes in routine practice in patients with vestibular vertigo and appraisal of tolerability: experience in the OSVaLD study.

This was a 3-month multicentre, open-label post-marketing surveillance study of betahistine (24 mg b.i.d.

Safety and tolerability of pardoprunox, a new partial dopamine agonist, in a randomized, controlled study of patients with advanced Parkinson's disease.

Aims: To investigate the safety and tolerability of pardoprunox (SLV308), a novel partial dopamine agonist, as an adjunct to levodopa in patients with advanced Parkinson's disease, using two titration schedules.

Methods: Patients were randomized to pardoprunox (n = 51) or placebo (n = 11). Pardoprunox was titrated to the highest tolerated dose (range, 0.

The effects of CTR-24, a biphasic oral contraceptive combination, compared to Diane-35 in women with acne.

One-hundred-and-eighty-three women were enrolled in an open, randomized, multicentre study in which the effects on acne of a low-dose biphasic oral contraceptive containing a daily dosage of 25 micrograms desogestrel and 40 micrograms ethinylestradiol (7 days) and a daily dosage of 125 micrograms desogestrel and 30 micrograms ethinylestradiol (15 days) were compared to Diane-35 containing a daily dosage of 2.0 mg cyproterone acetate and 30 micrograms ethinylestradiol (21 days) during four cycles of treatment. Clinical and photographic evaluation of acne plus laboratory assessments were done before treatment and at the end of cycle 4.

Skin vascular reactivity in healthy subjects: influence of hormonal status.

To investigate the influence of the hormonal status on skin vascular reactivity, 18 males, 18 women using oral contraceptives (oc), 17 premenopausal, and 18 postmenopausal women were studied. Finger skin temperature (FST, in degrees C) and laser Doppler flux (LDF, in perfusion units) were measured during heating (45 degrees C water bath) and cooling (15 degrees C) followed by a subsequent recovery period. Maximal heat-induced vasodilation was significantly higher in women using oc and in premenopausal women when compared with males.

Reproducibility of the finger cooling test.

A finger cooling test is used to objectify Raynaud's phenomenon and to assess its severity. For this purpose, finger skin temperature (FST) and laser Doppler flux (LDF) are measured on the fingertips before and during cooling of the hand (16 degrees water bath for 5 min) and a subsequent recovery period (20 min). To study reproducibility, this test was performed twice within 3 months in 34 healthy subjects and in 56 Raynaud patients.

Perioperative factors associated with septic arthritis after arthroplasty. Prospective multicenter study of 362 knee and 2,651 hip operations.

Perioperative factors associated with late septic arthritis after knee and hip arthroplasties were prospectively investigated. All patients received a short course of perioperative cefuroxime. After a follow-up of 1 year, septic arthritis was diagnosed in 9/362 patients (2.

Effect of perioperative blood transfusion and cell saver on the incidence of postoperative infective complications in patients with an aneurysm of the abdominal aorta.

Objective: To find out if there was an association between perioperative blood transfusion and the development of infective complications, and whether the use of the cell saver for autologous transfusion had any influence.

Design: Retrospective study.

Setting: University Hospital.

Cefuroxime for prevention of postoperative coxitis. One versus three doses tested in a randomized multicenter study of 2,651 arthroplasties.

Infection prophylaxis in hip replacement with one perioperative dose of cefuroxime was evaluated in a randomized controlled multicenter study using a three-dose regimen as a control. All the operations were performed in conventionally ventilated operating theaters. Of the 2,796 hip replacements entered in the study, 145 replacements were excluded because of protocol violations.

Value of biochemical markers in the management of disseminated prostatic cancer.

The biochemical markers alkaline phosphatase (Alk P), prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA) were measured 3-monthly in 61 patients with disseminated prostatic cancer who were treated with LHRH analogues. The decrease in Alk P and PSA during the first 6 months of treatment was significantly related to a better survival. In this follow-up study, only PSA was useful for monitoring prostatic cancer during hormonal treatment.

Myotonic dystrophy. Predictive value of normal results on clinical examination.

Myotonic dystrophy (DM) is well known for its highly variable clinical picture, including the age at which symptoms are first detected. In order to assess the proportion of asymptomatic gene carriers at different ages, we have used linked DNA markers to study individuals at 50% genetic risk of DM, in whom neurological examination, slit-lamp examination and electromyography (EMG) had failed to show diagnostic signs. A total of 139 asymptomatic offspring of DM patients were studied.

Antibiotic use after cefuroxime prophylaxis in hip and knee joint replacement.

The amount of additional antibiotics measured by defined daily dose (DDD) methods after 2651 hip and 362 knee replacements was assessed after prophylaxis with one or three doses (1502/1511 patients) of cefuroxime. No differences were observed between the two regimens with respect to total amount, type, indication, and duration of additional antibiotics. The incidence of joint sepsis did not differ significantly between the two trial arms, but the sample was too small for definite conclusions.

Transvaginal ultrasonography and urodynamic evaluation after suspension operations: comparison among the Gittes, Stamey and Burch suspensions.

Radiological and ultrasonographic imaging enables the objective determination of bladder neck position and movement in stress urinary incontinence. Postoperative results were evaluated in 60 patients after Burch colposuspension (29) or bladder neck suspension according to the Gittes (18) or Stamey (13) method. No differences in continence rates were noted 3 months postoperatively (Gittes 83%, Stamey 85% and Burch 93% of the patients).

Improvement of lesion detection by echographic image processing: signal-to-noise-ratio imaging.

Signal-to-noise-ratio (SNR) images were constructed by a sliding window technique. Theoretical derivations of the first order statistical properties of SNR images are given for the case of intensity coding of the original images for low number densities and for the limit case of fully developed speckle. The original images were obtained by realistic simulations of backscattering by homogeneous media, while using a range of number densities of the scatterers (isotropic scattering).

Effectiveness in inhibition of recovery of cell survival by cisplatin and carboplatin: influence of treatment sequence.

Clinical protocols have been designed to combine platinum-based drugs and radiation in the treatment of cancer. The rationale for this approach has been developed from preclinical studies demonstrating that platinum compounds can potentiate the cytotoxic effects of radiation toward cells. In the present study multicellular spheroids derived from squamous cell carcinoma cell line HN-1 have been used to study the effects of both cisplatin and carboplatin when administered prior to, concurrently, and after irradiation treatment.