Search results for "Adverse effect"
showing 10 items of 1065 documents
Tu1253 How Safe Is Sedation in Gastrointestinal Endoscopy? a Prospective Multicenter Trial: an Interim Analysis of 73,941 Endoscopies. Data From Pros…
2013
were those plausibly associated with the procedure and severe enough for the patient to seek medical attention. We compared the proportion of patients with adverse events associated with gastrointestinal endoscopy identified with direct patient contact to the proportion identified through our current infrastructure using the chi-square statistic. Results: During the study period, 11,710 endoscopic procedures were performed on 9,683 patients. Our study personnel made 3205 calls over a three month period and ultimately made contact with 1999 (17%; 84.5% of those called) patients. 28 (1.4%) adverse events were identified through direct patient contact. Our adverse event tracking infrastructure…
Hyaluronic Acid in the Treatment of Pain Due to Knee Joint Immobilisation
1995
This open, randomised study was carried out in order to evaluate the safety and efficacy of a course of 5 intra-articular injections (one per week) of hyaluronic acid (HA), administered to patients with pain and joint stiffness resulting from immobilisation of the knee in a plaster cast. The study was made in comparison with an untreated control group. 30 patients of both genders, aged between 18 and 65 years, immobilised in a plaster cast for at least 20 days and presenting with pain and reduced mobility, were included in the study. The results of the study show that, in comparison with the control group, treatment with HA produced a more rapid and effective reduction in pain and increase …
Mirabegron in overactive bladder: A review of efficacy, safety, and tolerability
2013
Aims Mirabegron, the first β3-adrenoceptor agonist to enter clinical practice, has a different mechanism of action from antimuscarinic agents. This review presents data on the efficacy, safety, and tolerability of mirabegron in studies conducted to date. Methods All clinical data on mirabegron that are currently in the public domain are included, including some in-press manuscripts. Results In Phase III clinical trials in patients with overactive bladder (OAB), mirabegron at daily doses of 25, 50, and 100 mg demonstrated significant efficacy in treating the symptoms of OAB, including micturition frequency, urgency incontinence, and urgency. Significant improvements in micturition frequency,…
Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: Open-label extension of the SO…
2013
Aims To assess the long-term safety, tolerability, and efficacy of flexible-dose fesoterodine in elderly patients with OAB. Methods Patients aged ≥65 years who completed a 12-week, randomized, double-blind, placebo-controlled trial were eligible for the 12-week, open-label (OL) extension phase. Patients who received double-blind placebo started on fesoterodine 4 mg and could increase to 8 mg after 4 or 8 weeks of OL treatment, while fesoterodine-treated patients continued on their double-blind dose; only one dose escalation or de-escalation was permitted. Discontinuations and adverse events (AEs) were monitored, and patients completed 3-day bladder diaries and patient-reported outcomes at t…
Effect of comprehensive vasodilation vs usual care on mortality and heart failure rehospitalization in women with acute heart failure
2020
Abstract Background Guidelines recommend evaluating the risk/benefit ratio of novel therapies individually in women and men, as the pathophysiology and the response to treatment may differ between women and men. Among patients with acute heart failure (AHF), a strategy of intensive vasodilation, compared with usual care, overall did provide comparable outcomes. Purpose To evaluate the effect of a strategy that emphasized early intensive and sustained vasodilation in women with AHF. Methods In a randomized, open-label blinded-end-point trial patients hospitalized for AHF were enrolled in 10 hospitals in Switzerland, Bulgaria, Germany, Brazil, and Spain. Inclusion criteria were AHF expressed …
Evaluation of Safety, Tolerability and Efficacy of Temsirolimus in Patients with Relapsed or Refractory Mantle Cell Lymphoma (REL/REFR MCL) in the Us…
2012
ABSTRACT Background Temsirolimus (TEMS), an mTOR-inhibitor, is approved the EU for the treatment of patients (pts) with relapsed or refractory MCL (rel/refr). A pivotal study demonstrated significantly longer progression free survival with TEMS (175mg weekly for 3 weeks followed by 75mg weekly) in rel/refr MCL pts compared to investigatoŕs choice therapy (4.8 mo vs 1.9 mo; P = .0009). To better identify safety and efficacy of TEMS in an unselected patient population during clinical routine a prospective non-interventional study with TEMS in rel/refr MCL-pts was started. Here we report on interim results of the study. Methods A registry for rel/refr MCL pts treated with TEMS was started in G…
Environmental stressors and cardiovascular risk: Impact of environmental noise exposure on vascular oxidative stress and damage
2018
Epidemiological studies have demonstrated that traffic noise exposure is associated with cardiovascular diseases such as arterial hypertension, myocardial infarction and stroke. Persistent chronic noise exposure increases the risk of cardiovascular and metabolic diseases such as arterial hypertension, coronary artery disease, diabetes and stroke. Large epidemiological studies (reviewed in Munzel et al. Eur. Heart J. 2017, 38 (8):550–556) point towards a link between the incidence of ischemic heart diseases and exposure to noise, supporting its role as an independent cardiovascular risk factor. Recently, the underlying molecular mechanisms leading to noise-dependent adverse effects on the va…
Role of CRT upgrading in pacing induced heart failure: A case report
2014
Abstract We submit a case report of a 78-year-old male came to our department for systolic heart, failure (EF of 25%). He has clinical history of recurring atrial tachycardia and atrial flutter previously treated in our department unsuccessfully with antiarrhythmic drug therapy. The echocardiographic evidence of left atrial enlargement (left atrium area 40 cm 2 ) and the clinical history of permanent atrial tachycardia has discouraged any attempt of substrate ablation. As it is impossible get rhythm and rate control with drug therapy, the patient was subjected to an "ablate and pace" procedure with implantation of a VVIR mode pacemaker. Also, for the absence of indications (QRS width During…
Comparison of pegylated interferon α-2b plus psoralen PUVA versus standard interferon α-2a plus PUVA in patients with cutaneous T-cell lymphoma
2011
Objective The aim of this study was to evaluate the safety and efficacy profile of pegylated interferon α-2b (PEG-IFN α-2b) in combination with photochemotherapy (PUVA) in the treatment of cutaneous T-cell lymphoma (CTCL) in comparison with standard IFN α plus PUVA. Design Retrospective cohort study over a period of 7 years. Patients and interventions A total of 17 consecutive CTCL patients (stage IA–IV) were retrospectively analysed for toxicity and response rates associated with PEG-IFN α-2b (1.5 μg/kg weekly) plus PUVA (n = 9) or standard IFN α-2a (9 MIU 3×/week) plus PUVA (n = 8). Main outcome measures Differences of response rates (complete/partial remission), progression-free surv…
Efficacy of subcutaneous and sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: a meta-analysis–based comparison
2012
Background: Subcutaneous (SCIT) and sublingual (SLIT) immunotherapy are the 2 most prescribed routes for administering allergen-specific immunotherapy. They were shown to be effective in control of symptoms and in reducing rescue medication use in patients with allergic diseases, but their effectiveness has to be balanced against side effects. In recent years, SLIT has been increasingly prescribed, instead of SCIT, because of improved safety and easy administration. Objective: We assessed which route is the most effective in the treatment of patients with seasonal allergic rhinitis to grass pollen. Methods: An indirect meta-analysis–based comparison between SCIT and SLIT was performed. Trea…