Search results for "SAFE"
showing 10 items of 2099 documents
Changes in At-Risk Behavior for HIV Infection among HIV-Positive Persons in Italy
2009
Many HIV-positive persons reportedly continue to engage in at-risk behavior. We compared the sexual and drug-using practices of HIV-positive persons before and after the diagnosis of HIV infection to determine whether their behavior had changed. To this end, in 2006, we conducted a cross-sectional study involving clinical centers in five Italian cities. Each center was asked to enroll 100 persons aged 18 years or older who had a diagnosis of HIV infection that dated back at least 2 years. Data were collected with a specifically designed questionnaire, administered during a structured interview. The McNemar chi2 test was used to compare the data before and after the diagnosis. A total of 497…
Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients – Results of the COMPAS Study
2020
Abstract Introduction The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. Methods MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an “as received” basis during week 0–52. Electrocardiogram data were recorded at baseline and week 24. Results Comparing 205 patients who received ≥1 dose of MPH with 209 patients wh…
Concentrations of 9-Tetrahydrocannabinol and 11-Nor-9-Carboxytetrahydrocannabinol in Blood and Urine After Passive Exposure to Cannabis Smoke in a C…
2010
Cannabinoid concentrations in blood and urine after passive exposure to cannabis smoke under real-life conditions were investigated in this study. Eight healthy volunteers were exposed to cannabis smoke for 3 h in a well-attended coffee shop in Maastricht, Netherlands. An initial blood and urine sample was taken from each volunteer before exposure. Blood samples were taken 1.5, 3.5, 6, and 14 h after start of initial exposure, and urine samples were taken after 3.5, 6, 14, 36, 60, and 84 h. The samples were subjected to immunoassay screening for cannabinoids and analyzed using gas chromatography-mass spectrometry (GC-MS) for Delta(9)-tetrahydrocannabinol (THC), 11-nor-hydroxy-Delta(9)-tetra…
Plaque removal efficacy of power and manual toothbrushes: a comparative study
2009
The aim of this study was to compare the plaque removal efficacy of a new oscillating/rotating/pulsating toothbrush [Oral-B® Professional Care® 8500 (PC 8500)] with two manual toothbrushes [Oral-B® CrossAction™ Vitalizer (CAV) and Oral-B® Indicator™ (IND), respectively]. The safety of the PC 8500 was also assessed. The study was a single-use, observer-masked, randomised 3×3 Latin square crossover design balanced for carryover effects. The enrolled subjects (n=66) refrained from brushing for 23–25 h before each clinical examination. Plaque scores were recorded before and after brushing with the allocated toothbrush using the Turesky et al. modification of the Quigley and Hein plaque index. T…
Surveillance for adverse events following immunization (AEFI) for 7 years using a computerised vaccination system
2016
Objectives: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. Study design: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. Method…
Dose escalating safety study of CNS 5161 HCl, a new neuronal glutamate receptor antagonist (NMDA) for the treatment of neuropathic pain
2007
What is already known about this subject • Despite encouraging effects of N-methyl-D-aspartate (NMDA) receptor antagonists in reducing neuropathic pain of different aetiologies, the clinical use of these agents has been limited by their mainly psychotropic side-effects. • In a recent study in healthy volunteers, CNS 5161, a novel noncompetetive NMDA receptor antagonist, was well tolerated up to a dosage of 2000 µg without psychotropic side-effects. • This is the first study to evaluate the maximal tolerated dosage of CNS 5161 and to gain experience about the analgesic effect of CNS 5161 in patients with different pain syndromes. What this study adds • In patients with neuropathic pain CNS 5…
A phase II/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II (Hunter syndrome)
2006
Purpose: To evaluate the safety and efficacy of recombinant human iduronate-2-sulfatase (idursulfase) in the treatment of mucopolysaccharidosis II. Methods: Ninety-six mucopolysaccharidosis II patients between 5 and 31 years of age were enrolled in a double-blind, placebo-controlled trial. Patients were randomized to placebo infusions, weekly idursulfase (0.5 mg/kg) infusions or every-other-week infusions of idursulfase (0.5 mg/kg). Efficacy was evaluated using a composite endpoint consisting of distance walked in 6 minutes and the percentage of predicted forced vital capacity based on the sum of the ranks of change from baseline. Results: Patients in the weekly and every-other-week idursul…
Prolonged Grief Disorder, Depression, and Posttraumatic Stress Disorder Among Bereaved Kosovar Civilian War Survivors: a Preliminary Investigation
2010
Background: This study aimed at examining diagnostic concordance between Prolonged Grief Disorder (PGD), Major Depressive Disorder (MDD), and Posttraumatic Stress Disorder (PTSD) among bereaved war survivors who had lost relatives due to war-related violence.Method: We investigated the rates of PGD and its association with PTSD and MDD among 60 bereaved people who had lost first-degree relatives due to war-related violence seven years ago and had also experienced other war-related events.Results: The results indicated that 38.3% of the sample fulfilled the criteria for PGD, 55.0% for PTSD, and 38.3% for MDD. Thirty per cent of the participants without PTSD and 21.6% of those without MDD met…
Psychosocial safety climate as a lead indicator of workplace bullying and harassment, job resources, psychological health and employee engagement
2011
Psychosocial safety climate (PSC) is defined as shared perceptions of organizational policies, practices and procedures for the protection of worker psychological health and safety, that stem largely from management practices. PSC theory extends the Job Demands-Resources (JD-R) framework and proposes that organizational level PSC determines work conditions and subsequently, psychological health problems and work engagement. Our sample was derived from the Australian Workplace Barometer project and comprised 30 organizations, and 220 employees. As expected, hierarchical linear modeling showed that organizational PSC was negatively associated with workplace bullying and harassment (demands) a…
Prevalence and incidence of workplace bullying among Spanish employees working with people with intellectual disability
2012
Abstract Background Although workplace bullying is a severe psychosocial risk with a high prevalence, there is a lack of studies addressing its incidence, particularly among staff working with people with intellectual disability. Objectives We examined the prevalence and incidence of workplace bullying in a sample of Spanish employees working with people with intellectual disability. The socio-demographic characteristics of victims and non-victims of workplace bullying were also analyzed. Methods Multicenter study with two phases (T1 and T2) carried out in Valencia (Spain). The sample consisted of 696 employees from 66 centers in T1. One year later (T2), 422 employees from 61 centers agreed…