Search results for "observational [Methods]"
showing 10 items of 897 documents
Factors associated with dental fluorosis in three zones of Ecuador
2019
Background To determine the prevalence of dental fluorosis in 10-12 year-old school children, in three provinces of the inter-andean Region of Ecuador: Imbabura, Pichincha and Chimborazo, as well as the relationship between certain factors, considering that the latest studies go back to the year 2009. Material and methods A cross-sectional and observational study was proposed. A sample of 599 was calculated at 95% of confidence considering population projections for children between 10 and 12 old of three zones of Ecuador. However, 608 school children, who had the acceptance and informed consent of their parents to participate, completed a survey about factors associated with dental fluoros…
Rapid Steroid Withdrawal after Renal Transplantation Reduces Mortality: Five Year Follow-Up of a Randomized Controlled Trial (Harmony Study) Confirms…
2021
Background: We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal (RSWD) in the randomized controlled one year “Harmony” trial, in which 587 predominantly deceased-donor kidney transplant recipients were randomized either to basiliximab or rabbit ATG induction therapy and compared to standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil, and corticosteroids. Methods: Following the end of the original one-year study period, patients were asked to participate in the observational follow-up (FU) study examining most of the end points of the original study. Hereby, de novo incidences between yea…
Prevalence of traumatic injuries in deciduous dentition and associated risk factors in a Spanish children population
2021
Background: The frequency of traumatic dental injuries (TDI) in primary dentition and those agents that favor them present a great variability. Therefore, the objective of this study was to determine the prevalence of TDI in a population of Spanish preschoolers in temporary dentition and identify the factors associated with these injuries. Materials and Methods: an epidemiological observational prevalence study was carried out. A total of 343 children aged between 3 and 5 years were selected. A questionnaire was completed in relation to socioeconomic factors, cultural level, dietary habits and oral parafunction. Through an intraoral examination, information was collected on the occlusal cha…
Transfemoral Transcatheter Tricuspid Valve Replacement With the EVOQUE System
2021
Abstract Objectives The purpose of this observational first-in-human experience was to investigate the feasibility and safety of the EVOQUE tricuspid valve replacement system and its impact on short-term clinical outcomes. Background Transcatheter tricuspid intervention is a promising option for selected patients with severe tricuspid regurgitation (TR). Although transcatheter leaflet repair is an option for some, transcatheter tricuspid valve replacement (TTVR) may be applicable to a broader population. Methods Twenty-five patients with severe TR underwent EVOQUE TTVR in a compassionate-use experience. The primary outcome was technical success, with NYHA (NYHA) functional class, TR grade, …
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…
Eye disease and mortality, cognition, disease, and modifiable risk factors: an umbrella review of meta-analyses of observational studies
2022
Globally, 2.2 billion people live with some form of vision impairment and/or eye disease. To date, most systematic reviews examining associations have focused on a single eye disease and there is no systematic evaluation of the relationships between eye diseases and diverse physical and mental health outcomes. Moreover, the strength and reliability of the literature is unclear. We performed an umbrella review of observational studies with meta analyses for any physical and/or mental comorbidities associated with eye disease. For each association, random-effects summary effect size, heterogeneity, small-study effect, excess significance bias and 95% prediction intervals were calculated, and …
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…
The Prevalence of Urinary Incontinence among Adolescent Female Athletes: A Systematic Review
2021
This review aimed to synthesize the most up-to-date evidence regarding the prevalence of urinary incontinence (UI) among adolescent female athletes. We conducted a systematic review of studies regarding UI in female athletes less than 19 years of age. This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRIMSA). The electronic databases of PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, and Web of Science (WOS) were searched between October and November 2020. After blinded peer evaluation, a total of 215 studies were identified and nine were included. Risk of bias was assessed using the Strengt…