Search results for "observational study"
showing 10 items of 776 documents
FRI0189 POOLED ANALYSIS OF THE REAL-WORLD EFFECTIVENESS OF BELIMUMAB IN TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS USING MULTI-COUNTRY DATA FROM THE O…
2019
Background: Real-world evidence of belimumab effectiveness in patients with systemic lupus erythematosus (SLE) has been reported separately for several countries through the OBSErve (evaluation Of use of Belimumab in clinical practice SEttings) programme. Objectives: To evaluate the effectiveness of belimumab in patients with SLE using pooled data from the individual OBSErve studies. Methods: This was a post hoc meta-analysis (GSK study 206351) of patient level data pooled from six retrospective observational cohort studies (Argentina, Canada, Germany, Spain, Switzerland, United States of America). Physicians provided data for adults (≥18 years; clinical diagnosis of SLE) who had initiated …
The evolution of European Medicines Agency drug approval: the adaptive licensing: Table 1
2015
In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations. The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authori…
Long-Term Efficacy of Radiofrequency Treatment of Turbinate Hypertrophy: A Patient Based Point of View
2010
Nasal turbinate hypertrophy is a major cause of nasal airway obstruction that affects up to 20% of the European general population. This study aims to determine the efficacy of radiofrequency treatment as perceived by patients during a 2-years period. From 2007 to 2009, an observational study was conducted on 36 patients who consecutively underwent temperature-controlled radiofrequency tissue volume reduction. A questionnaire was administered to each patient in order to collect demographic data, lifestyle habits, health status and visual analogue scale (VAS) score of perceived symptoms. Mean VAS scores of nasal obstruction, headache, rhinorrhoea and anosmia after treatment were significantl…
Validation study of Italian version of inventory for déjà vu experiences assessment (I-IDEA): A screening tool to detect déjà vu phenomenon in Italia…
2017
The Inventory Déjà Vu Experiences Assessment (IDEA) is the only screening instrument proposed to evaluate the Déjà vu (DV) experience. Here, we intended to validate the Italian version of IDEA (I-IDEA) and at the same time to investigate the incidence and subjective qualities of the DV phenomenon in healthy Italian adult individuals on basis of an Italian multicentre observational study. In this study, we report normative data on the I-IDEA, collected on a sample of 542 Italian healthy subjects aging between 18-70 years (average age: 40) with a formal educational from 1-19 years. From September 2013 to March 2016, we recruited 542 healthy volunteers from 10 outpatient neurological clinics i…
Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study
2020
Background: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip®
Heart rate variability as predictor of mortality in sepsis: A systematic review.
2018
Background Autonomic dysregulation is one of the recognized pathophysiological mechanisms in sepsis, generating the hypothesis that heart rate variability (HRV) can be used to predict mortality in sepsis. Methods This was a systematic review of studies evaluating HRV as a predictor of death in patients with sepsis. The search was performed by independent researchers in PubMed, LILACS and Cochrane, including papers in English, Portuguese or Spanish, indexed until August 20th, 2017 with at least 10 patients. Study quality was assessed by Newcastle-Ottawa Scale. To analyze the results, we divided the articles between those who measured HRV for short-term recordings ( 1 hour), and those who did…
What Is the Role of Dietary Inflammation in Severe Mental Illness? A Review of Observational and Experimental Findings
2019
Severe mental illnesses (SMI), including major depressive disorder, bipolar disorder, and schizophrenia, are associated with increased inflammation. Given diet's role in modulating inflammatory processes, excessive calorie-dense, nutrient-deficient processed food intake may contribute toward the heightened inflammation observed in SMI. This review assesses the evidence from observational and experimental studies to investigate how diet may affect physical and mental health outcomes in SMI through inflammation-related pathways. Cross-sectional studies indicate that individuals with SMI, particularly schizophrenia, consume more pro-inflammatory foods and fewer anti-inflammatory nutrients than…
Hypoxic burden and angiogenic factors in patients with myocardial infarction and obstructive sleep apnea
2019
Introduction: The amount and severity of hypoxia have been related to risk of cardiovascular events. Aim: To determine the relationship between nocturnal hypoxic burden and pro- angiogenic factors in patients with obstructive sleep apnea (OSA) and myocardial infarction (MI). Method: A prospective, observational study in patients with a first acute MI. Eligible patients underwent a polysomnography within 30 days after MI, and a serum blood sample was drawn in order to measure a panel of angiogenic factors by Luminex technology. A hypoxic burden index (HBI) was calculated as the integral area under the desaturation curve (obtained by calculating the integral of the oxygen saturation reduction…
Assessment and treatment of the withdrawal syndrome in paediatric intensive care units
2020
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Pharmacokinetics of Direct Oral Anticoagulants in Emergency Situations: Results of the Prospective Observational RADOA-Registry
2021
Thrombosis and haemostasis 122(4), 552-559 (2022). doi:10.1055/a-1549-6556