Search results for "Randomized Controlled Trial"

Icatibant, a New Bradykinin-Receptor Antagonist, in Hereditary Angioedema

2010

BACKGROUND Hereditary angioedema is characterized by recurrent attacks of angioedema of the skin, larynx, and gastrointestinal tract. Bradykinin is the key mediator of symptoms. Icatibant is a selective bradykinin B2 receptor antagonist. METHODS In two double-blind, randomized, multicenter trials, we evaluated the effect of icatibant in patients with hereditary angioedema presenting with cutaneous or abdominal attacks. In the For Angioedema Subcutaneous Treatment (FAST) 1 trial, patients received either icatibant or placebo; in FAST-2, patients received either icatibant or oral tranexamic acid, at a dose of 3 g daily for 2 days. Icatibant was given once, subcutaneously, at a dose of 30 mg. …

Economic evaluation of caspofungin vs liposomal amphotericin B for empirical therapy of suspected systemic fungal infection in the German hospital se…

2007

As antifungal agents are frequently used in hematology and oncology, economic data on the empirical therapy of suspected systemic fungal infection are pivotal. Data were analyzed according to: (1) the rate of nephrotoxicity related to treatment with caspofungin in comparison to liposomal amphotericin B (L-AmB) from a randomized clinical trial, (2) the effect of nephrotoxicity on length of hospital stay from a European observational study, and (3) an example of total bottom-up cost in a department of hematology in Germany. All estimates include 95% confidence intervals (CI) using two-stage Monte Carlo simulation on binominal and Gaussian random variables from separate studies with comparable…

Can supplementation with vitamin C and E alter physiological adaptations to strength training?

2014

Published version of an article from the journal: BMC Sports Science, Medicine and Rehabilitation. Also available from the publisher: http://dx.doi.org/10.1186/2052-1847-6-28 Background: Antioxidant supplementation has recently been demonstrated to be a double-edged sword, because small to moderate doses of exogenous antioxidants are essential or beneficial, while high doses may have adverse effects. The adverse effects can be manifested in attenuated effects of exercise and training, as the antioxidants may shut down some redox-sensitive signaling in the exercised muscle fibers. However, conditions such as age may potentially modulate the need for antioxidant intake. Therefore, this paper …

Vitamin E Paradox in Alzheimer's Disease: It Does Not Prevent Loss of Cognition and May Even Be Detrimental

2009

There is controversy as to whether vitamin E is beneficial in Alzheimer's disease (AD). In this study, we tested if vitamin E prevents oxidative stress and loss of cognition in AD. Fifty-seven AD patients were recruited and divided in two groups: placebo or treated with 800 IU of vitamin E per day for six months. Of these 57 patients, only 33 finished the study. We measured blood oxidized glutathione (GSSG) and used the following cognitive tests: Mini-Mental State Examination, Blessed-Dementia Scale, and Clock Drawing Test. Of those patients treated with vitamin E, we found two groups. In the first group, "respondents" to vitamin E, GSSG levels were lower after the treatment and scores on t…

Safety of rofecoxib in subjects with a history of adverse cutaneous reactions to aspirin and/or non-steroidal anti-inflammatory drugs

2002

Background Adverse reactions to non-steroidal anti-inflammatory drugs (NSAID)s are frequent, and the need to identify a safe alternative drug is a common problem in clinical practice. Objective To assess the tolerability of rofecoxib, a drug that specifically inhibits COX-2, in a group of NSAID-sensitive patients. Methods One-hundred and four subjects (29 males and 75 females, mean age 35.6 ± 14.1) were enrolled. All subjects had experienced one or more episode characterized by cutaneous symptoms (erythema, and/or urticaria angioedema) following the assumption of NSAIDs; 92 subjects experienced reactions to only one NSAID (single intolerance: SI) and 12 subjects had reactions to multiple NS…

Effects of l-Carnitine in Patients with Autism Spectrum Disorders: Review of Clinical Studies

2019

Carnitine is an amino acid derivative, which plays several important roles in human physiology, in the central nervous system, and for mitochondrial metabolism, in particular. Altered carnitine metabolic routes have been associated with a subgroup of patients with autism spectrum disorders (ASD) and could add to the pathophysiology associated with these disorders. We review the current evidence about the clinical effects of carnitine administration in ASD in both non-syndromic forms and ASD associated with genetic disorders. Two randomized clinical trials and one open-label prospective trial suggest that carnitine administration could be useful for treating symptoms in non-syndromic ASD. Th…

Cardiovascular and Other Health Benefits of Sauna Bathing:A Review of the Evidence

2018

Sauna bathing, an activity that has been a tradition in Finland for thousands of years and mainly used for the purposes of pleasure and relaxation, is becoming increasingly popular in many other populations. Emerging evidence suggests that beyond its use for pleasure, sauna bathing may be linked to several health benefits, which include reduction in the risk of vascular diseases such as high blood pressure, cardiovascular disease, and neurocognitive diseases; nonvascular conditions such as pulmonary diseases; mortality; as well as amelioration of conditions such as arthritis, headache, and flu. The beneficial effects of sauna bathing on these outcomes have been linked to its effect on circu…

Impact or No Impact for Women With Mild Knee Osteoarthritis: A Bayesian Meta‐Analysis of Two Randomized Controlled Trials With Contrasting Interventi…

2022

Objective We aim to predict the probability of a benefit from two contrasting exercise programs for a woman with a new diagnosis of mild knee osteoarthritis (OA). The short and long-term effects of aquatic resistance training (ART) and high-impact aerobic land training (HLT) compared with the control will be estimated. Methods Original data sets from two previously conducted randomised controlled trials (RCT) were combined and used in a Bayesian meta-analysis. Group differences in multiple response variables were estimated. Variables included cardiorespiratory fitness, dynamic maximum leg muscle power, maximal isometric knee extension and flexion force, pain, other symptoms and quality of l…

2015

Summary Background The ICON7 trial previously reported improved progression-free survival in women with ovarian cancer with the addition of bevacizumab to standard chemotherapy, with the greatest effect in patients at high risk of disease progression. We report the final overall survival results of the trial. Methods ICON7 was an international, phase 3, open-label, randomised trial undertaken at 263 centres in 11 countries across Europe, Canada, Australia and New Zealand. Eligible adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease (International Federation of Gynecology and Obstetrics [FIGO] stage I–IIa, grade 3 or clear cell histology) or more adv…

Intravitreal anti-vascular endothelial growth factors, panretinal photocoagulation and combined treatment for proliferative diabetic retinopathy: a s…

2020

Purpose: to conduct a systematic review with network meta‐analysis (NMA) of randomized clinical trials (RCTs) comparing panretinal photocoagulation (PRP) versus anti‐vascular endothelial growth factor (VEGF) treatment alone or in combination with PRP, for proliferative diabetic retinopathy (PDR).Methods: PubMed, Medline and Embase databases were searched for RCTs comparing PRP versus intravitreal anti‐VEGF therapy and/or combined PRP and intravitreal anti‐VEGF for PDR. The primary outcome measures were the mean best corrected visual acuity (BCVA) change and the regression of neovascularization. Mean change of central macular thickness (CMT), the subgroup analyses of patients without diabeti…