Search results for "Randomized"
showing 10 items of 2323 documents
Dietary intake and major food sources of polyphenols in a Spanish population at high cardiovascular risk: the PREDIMED study.
2013
[Background and aims]: Epidemiological data have shown an inverse association between the consumption of polyphenol-rich foods and the risk of cardiovascular disease or overall mortality. A comprehensive estimation of individual polyphenol intake in nutritional cohorts is needed to gain a better understanding of this association. The aim of this study was to estimate the quantitative intake of polyphenols and the major dietary sources in the PREDIMED (PREvención con DIeta MEDiterránea) cohort using individual food consumption records. [Methods and results]: The PREDIMED study is a large, parallel-group, multicentre, randomised, controlled 5-year feeding trial aimed at assessing the effects …
Statins, Fracture Risk, and Bone Remodeling: What Is True?
2006
Besides the action on plasma lipid levels, statins show a series of ancillary effects defined as all of their vascular and nonvascular effects independent from the cholesterol reduction. It has been recently hypothesized that one of these ancillary effects could be the improvement of bone health, due to the interference with bone metabolism. This may potentially represent the rationale for statins' use in the treatment of osteoporosis, the most common disease of the bone. Both experimental observations and clinical studies on this topic generated a number of conflicting results; however, the largest randomized clinical trials, the Scandinavian Simvastatin Survival Study (4S), Long Term Inte…
Effect of hydrolyzed infant formula vs conventional formula on risk of type 1 diabetes the TRIGR randomized clinical trial
2018
IMPORTANCE Early exposure to complex dietary proteins may increase the risk of type 1 diabetes in children with genetic disease susceptibility. There are no intact proteins in extensively hydrolyzed formulas. OBJECTIVE To test the hypothesis that weaning to an extensively hydrolyzed formula decreases the cumulative incidence of type 1 diabetes in young children. DESIGN, SETTING, AND PARTICIPANTS An international double-blind randomized clinical trial of 2159 infants with human leukocyte antigen-conferred disease susceptibility and a first-degree relative with type 1 diabetes recruited from May 2002 to January 2007 in 78 study centers in 15 countries; 1081 were randomized to be weaned to the…
Association of Mediterranean diet with peripheral artery disease: the PREDIMED randomized trial.
2014
Association of Mediterranean Diet With Peripheral Artery Disease: The PREDIMED Randomized Trial The role of nutrition in preventing peripheral artery disease (PAD) remains elusive. 1 Mediterranean diets reduce the risk of myocardial infarction and stroke. 2,3. They also may reduce the risk of PAD, but this hypothesis has never been tested in a randomized trial. We assessed the association of Mediterranean diets with the occurrence of symptomatic PAD in an exploratory, nonprespecified analysis of a randomized trial...
Long-term follow-up study of endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis trial
2014
Background and Purpose— We aimed at comparing the long-term benefit–risk balance of carotid stenting versus endarterectomy for symptomatic carotid stenosis. Methods— Long-term follow-up study of patients included in Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis (EVA-3S), a randomized, controlled trial of carotid stenting versus endarterectomy in 527 patients with recently symptomatic severe carotid stenosis, conducted in 30 centers in France. The main end point was a composite of any ipsilateral stroke after randomization or any procedural stroke or death. Results— During a median follow-up of 7.1 years (interquartile range, 5.1–8.8 years; maximum 1…
Prevention of Tungiasis and Tungiasis-Associated Morbidity Using the Plant-Based Repellent Zanzarin: A Randomized, Controlled Field Study in Rural Ma…
2013
Background Tungiasis, a parasitic skin disease caused by the female sand flea Tunga penetrans, is a prevalent condition in impoverished communities in the tropics. In this setting, the ectoparasitosis is associated with important morbidity. It causes disfigurement and mutilation of the feet. Feasible and effective treatment is not available. So far prevention is the only means to control tungiasis-associated morbidity. Methodology In two villages in Central Madagascar, we assessed the efficacy of the availability of closed shoes and the twice-daily application of a plant-based repellent active against sand fleas (Zanzarin) in comparison to a control group without intervention. The study pop…
Mongersen, an oral SMAD7 antisense oligonucleotide, and crohn's disease
2015
Crohn's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor β1 (TGF-β1) due to high levels of SMAD7, an inhibitor of TGF-β1 signaling. Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide, mongersen, targets ileal and colonic SMAD7.In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of mongersen for the treatment of persons with active Crohn's disease. Patients were randomly assigned to receive 10, 40, or 160 mg of mongersen or placebo per day for 2 weeks. The primary outcomes were clinical remission at day 15, defined as a Crohn's Disease Activit…
Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients
2017
Item does not contain fulltext BACKGROUND: Bococizumab is a humanized monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 (PCSK9) and reduces levels of low-density lipoprotein (LDL) cholesterol. We sought to evaluate the efficacy of bococizumab in patients at high cardiovascular risk. METHODS: In two parallel, multinational trials with different entry criteria for LDL cholesterol levels, we randomly assigned the 27,438 patients in the combined trials to receive bococizumab (at a dose of 150 mg) subcutaneously every 2 weeks or placebo. The primary end point was nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent re…
Effectiveness of malic acid 1% in patients with xerostomia induced by antihypertensive drugs
2012
Objectives: Assessing the clinical effectiveness of a topical sialogogue on spray (malic acid, 1%) in the treatment of xerostomia induced by antihypertensive drugs. Study Design: This research has been carried out through a randomized double-blind clinical trial. 45 patients suffering from hypertensive drugs-induced xerostomia were divided into 2 groups: the first group (25 patients) received a topical sialogogue on spray (malic acid, 1%) whereas the second group (20 patients) received a placebo. Both of them were administered on demand for 2 weeks. Dry Mouth Questionnaire (DMQ) was used in order to evaluate xerostomia levels before and after product/placebo application. Unstimulated and st…
Liraglutide and Renal Outcomes in Type 2 Diabetes.
2017
BACKGROUND: In a randomized, controlled trial that compared liraglutide, a glucagon-like peptide 1 analogue, with placebo in patients with type 2 diabetes and high cardiovascular risk who were receiving usual care, we found that liraglutide resulted in lower risks of the primary end point (nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes) and death. However, the long-term effects of liraglutide on renal outcomes in patients with type 2 diabetes are unknown. METHODS: We report the prespecified secondary renal outcomes of that randomized, controlled trial in which patients were assigned to receive liraglutide or placebo. The secondary renal outcome was a co…