Search results for "Multicenter studies"
showing 10 items of 76 documents
Aging and disability affect misdiagnosis of COPD in elderly asthmatics: the SARA study
2003
STUDY OBJECTIVES: This study investigated to what extent a diagnosis of COPD is erroneously made or the disease remains unrecognized in elderly asthmatic patients, and identified factors leading to misdiagnosis and underdiagnosis of asthma in such patients. DESIGN: A multicenter study involving 24 Italian pulmonary or geriatric institutions. PATIENTS: One hundred twenty-eight asthmatic patients (98 women, 76.6%) aged 73 +/- 6.4 years (mean +/- SD) were selected from the cohort of the Salute Respiratoria nell'Anziano (respiratory health in the elderly) study. METHODS: All patients underwent a clinical evaluation that included clinical history and spirometry with a bronchodilator test. A diag…
From Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines to Current Clinical Practice
2006
Background: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines have been promulgated to improve the management of chronic obstructive pulmonary disorder (COPD). Objective: To evaluate the extent to which the current therapeutic approach to COPD conforms to GOLD guidelines. Methods: This was a multicentre observational study of elderly COPD patients enrolled for acute care in general medicine or geriatric wards in tertiary hospitals in Italy in April 2002. Our series consisted of 471 patients >64 years of age consecutively admitted for acute exacerbations of COPD to wards participating in the study. Data describing drugs used prior to exacerbation and prescribed at …
Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at H…
2019
Abstract Background The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. Design COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled p…
Beta‐blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity…
2020
Abstract Background The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta‐blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients. Hypothesis We postulate beta‐blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short‐term effect of beta‐blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI. Methods This is a prospective, crossover, randomized (1…
Spirometry Reference Values for Women and Men Aged 65–85 Living in Southern Europe: The Effect of Health Outcomes
2002
<i>Background:</i> Spirometry is more and more frequently used for the diagnosis of respiratory diseases in the elderly people. Unfortunately, reliable predictive values for the spirometric variables in the elderly are lacking. <i>Objectives:</i> Data obtained from 429 subjects participating in the multicenter Italian study SARA on respiratory health in the elderly were analyzed in order to derive reference values for spirometry in the age range of 65–85 years. The second aim of this study was to assess the influence of variables describing many dimensions of the health status on the prediction of spirometric variables in that age range. <i>Methods:</i> S…
Salvage reirradiation for locoregional failure after radiation therapy for prostate cancer: Who, when, where and how?
2014
Even in the current era of dose-escalated radiotherapy for prostate cancer, biochemical recurrence is not uncommon. Furthermore, biochemical failure is not specific to the site of recurrence. One of the major challenges in the management of prostate cancer patients with biochemical failure after radiotherapy is the early discrimination between those with locoregional recurrence only and those with metastatic disease. While the latter are generally considered incurable, patients with locoregional disease may benefit from emerging treatment options. Ultimately, the objective of salvage therapy is to control disease while ensuring minimal collateral damage, thereby optimizing both cancer and t…
Cohort Profile: Design and methods of the PREDIMED-Plus randomized trial
2019
The PREDIMED (in Spanish: PREvención con DIeta MEDiterránea) primary prevention trial1–3 reported in 2013 that long-term adherence to an energy-unrestricted Mediterranean diet (MedDiet), supplemented with either extra-virgin olive oil (EVOO) or nuts, reduced cardiovascular disease (CVD). PREDIMED showed a 30% relative reduction in the composite cardiovascular primary endpoint (stroke, myocardial infarction or cardiovascular death).2,,3 However, the PREDIMED trial tested only the composition of the diet, but did not test other lifestyle interventions (i.e. energy reduction, increased physical activity (PA) and behavioural modification) frequently applied in the context of the current unprece…
The use of statins in people at risk of developing diabetes mellitus: Evidence and guidance for clinical practice
2014
Reducing low-density lipoprotein cholesterol (LDL-C) levels using statins is associated with significant reductions in cardiovascular (CV) events in a wide range of patient populations. Although statins are generally considered to be safe, recent studies suggest they are associated with an increased risk of developing Type 2 diabetes (T2D). This led the US Food and Drug Administration (FDA) to change their labelling requirements for statins to include a warning about the possibility of increased blood sugar and HbA1c levels and the European Medicines Agency (EMA) to issue guidance on a small increased risk of T2D with the statin class. This review examines the evidence leading to these clai…
Booster vaccination with hexavalent DTPa-HBV-IPV/Hib vaccine in the second year of life is as safe as concomitant DTPa-IPV/Hib + HBV administered sep…
2003
The safety and reactogenicity of a booster dose of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (N=4725) was compared with the separate administration of GSK Biologicals' DTPa-IPV/Hib and HBV vaccines (N=4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N=1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N=8050), where fever was the only solicited sympt…
Evolution Over Time of Ventilatory Management and Outcome of Patients With Neurologic Disease
2021
OBJECTIVES: To describe the changes in ventilator management over time in patients with neurologic disease at ICU admission and to estimate factors associated with 28-day hospital mortality. DESIGN: Secondary analysis of three prospective, observational, multicenter studies. SETTING: Cohort studies conducted in 2004, 2010, and 2016. PATIENTS: Adult patients who received mechanical ventilation for more than 12 hours. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among the 20,929 patients enrolled, we included 4,152 (20%) mechanically ventilated patients due to different neurologic diseases. Hemorrhagic stroke and brain trauma were the most common pathologies associated with the need fo…