Search results for "SAFE"
showing 10 items of 2099 documents
Safety and Pharmacokinetics of Isavuconazole as Antifungal Prophylaxis in Acute Myeloid Leukemia Patients with Neutropenia: Results of a Phase 2, Dos…
2015
ABSTRACT Isavuconazole is a novel broad-spectrum triazole antifungal agent. This open-label dose escalation study assessed the safety and pharmacokinetics of intravenous isavuconazole prophylaxis in patients with acute myeloid leukemia who had undergone chemotherapy and had preexisting/expected neutropenia. Twenty-four patients were enrolled, and 20 patients completed the study. The patients in the low-dose cohort ( n = 11) received isavuconazole loading doses on day 1 (400/200/200 mg, 6 h apart) and day 2 (200/200 mg, 12 h apart), followed by once-daily maintenance dosing (200 mg) on days 3 to 28. The loading and maintenance doses were doubled in the high-dose cohort ( n = 12). The mean ± …
Are Your Eyes “on the Road”? Findings from the 2019 National Study on Vision and Driving Safety in Spain
2020
Background: Vision is an undisputable contributor to the explanation of many human-factor related traffic crashes happening every day. The Inland Transport Committee (ITC), the United Nations regulatory platform, included on 1st April 2020 special action on the vision of road users inside the ITC Recommendations for Enhancing Road Safety Systems. The results of this wide-scale study on drivers&rsquo
Safety and Feasibility of a New Minimally Invasive Diagnostic Laparoscopy Technique
1998
Background and Study Aims: Laparoscopy combined with guided liver biopsy offers many advantages in the diagnosis and staging of chronic liver diseases and is superior to other diagnostic procedures. We developed a new minilaparoscopic technique and evaluated the utility of this minimally invasive laparoscopic system in the first 320 patients who underwent diagnostic assessment for liver disease or peritoneal carcinosis. Patients and Methods: Between July 1996 and February 1998, minilaparoscopy, with analgesia and sedation was carried out in 320 patients. It was done using a 1.9-mm optical instrument, which was inserted through the same 2.75-mm trocar as the Veress needle used for inflating …
Sickness presenteeism in Spanish-born and immigrant workers in Spain
2010
Abstract Background Previous studies have shown that immigrant workers face relatively worse working and employment conditions, as well as lower rates of sickness absence than native-born workers. This study aims to assess rates of sickness presenteeism in a sample of Spanish-born and foreign-born workers according to different characteristics. Methods A cross-sectional survey was conducted amongst a convenience sample of workers (Spanish-born and foreign-born), living in four Spanish cities: Barcelona, Huelva, Madrid and Valencia (2008-2009). Sickness presenteeism information was collected through two items in the questionnaire ("Have you had health problems in the last year?" and "Have yo…
Safety and efficacy of implantable defibrillator therapy with programmed shock energy at twice the augmented step-down defibrillation threshold: resu…
1999
Whether the safety and efficacy of implantable cardioverter defibrillator (ICD) therapy can be assured with lower output devices is an important question. The purpose of this study was to evaluate whether programming the device output at twice the augmented defibrillation threshold was as safe and effective as using the maximum energy. Patients indicated for ICD therapy, but without slow monomorphic ventricular tachycardia (MVT), who achieved an augmented defibrillation threshold (DFT plus)or = 15 joules (J) with a single endocardial lead system and a biphasic defibrillator were included in the study. Prior to ICD implantation, patients were randomized into 2 groups. The shock energies in t…
A prospective randomized trial of high and standard dosages of recombinant factor VIIa for treatment of hemarthroses in hemophiliacs with inhibitors.
2006
Summary. Aim: A multicenter randomized open-label crossover prospective trial was designed to compare the efficacy, safety, and cost of standard and high dosages of recombinant factor VIIa (rFVIIa) for home treatment of hemarthroses in hemophiliacs with inhibitors. Methods: Patients were instructed to treat, within 6 h from the onset of bleeding, four consecutive hemarthroses of ankles, knees, or elbows, either with the rFVIIa standard dose of 90 μg kg−1 (repeated as necessary every 3 h) or with a single high dose of 270 μg kg−1. Patients who did not achieve a clinical success within 9 h continued rFVIIa treatment with repeated standard doses. Response to treatment was assessed for up to 48…
Parental occupational exposure to organic solvents and anencephaly in Mexico
2009
Objective: To assess the relationship between parental occupational exposure to organic solvents, and the risk of anencephaly in Mexico. Methods: A case-control study was conducted based on the registers of the Epidemiological Surveillance System for Neural Tube Defects in Mexico; 151 cases of anencephaly of ≥20 weeks’ gestation were included. A control, born alive and without any apparent congenital malformations at birth, was selected for each case in the same maternity service in which the case was born. Information on occupational exposures, lifestyle habits, reproductive history, use of medicines, supplementation with multivitamins and folic acid, was obtained by a general questionnair…
Peginterferon alfa-2b plus ribavirin for naïve patients with genotype 1 chronic hepatitis C: a randomized controlled trial
2004
We assessed the effectiveness and safety of an induction dose of peginterferon alfa-2b (PEG-IFN) plus ribavirin for initial treatment of patients with genotype 1 chronic HCV infection in a randomized, controlled, multicenter trial.Three hundred and eleven naïve patients infected with genotype 1 and chronic hepatitis were randomly assigned to 48-week treatment with PEG-IFN once weekly (80-100 micrograms depending on body weight for 8 weeks, followed by 50 micrograms for the next 40 weeks), or standard interferon alfa-2b (IFN) 6 million units on alternate days, both in combination with ribavirin (1000-1200 mg/day).PEG-IFN plus ribavirin significantly increased sustained virological response (…
Violence Against Women from Different Relationship Contexts and Health Care Utilization in Spain
2011
Abstract Background Studies reported an excess of health services utilization among women with violence by an intimate partner (IPV). However, little is known about health utilization by women victims of other forms of interpersonal violence than IPV. This study aimed to determine the effect of violence from different relationship contexts on health care utilization. Methods A cross-sectional study following a multistage cluster sampling scheme was conducted. Women aged 18 to 70 years were randomly selected according to their scheduled health care visit. The number of women invited to participate was 16,419 and 73% accepted. After exclusion, the final sample consisted of 10,815 women. The o…
Hanging disguised as bondage: accidental or suicidal death?
2020
The concept of autoerotic asphyxiation refers to the use of devices or substances intended to enhance one's arousal by inducing cerebral hypoxia, which can involuntarily lead to death. Although in most cases death occurs accidentally, it is nonetheless true that the same devices might be used by the practitioners in order to attempt suicide. The case of a 34-year-old practitioner of autoerotic asphyxiation found dead in his apartment with bondage-like ligatures and masking is reported here. The case raised some issues concerning the accidental or suicidal nature of the act. The aspects taken into account in the management of the case are discussed, along with a compared approach to the data…