Search results for "Randomized controlled"
showing 10 items of 2220 documents
Mediterranean diet and quality of life: Baseline cross-sectional analysis of the PREDIMED-PLUS trial
2018
We assessed if a 17-item score capturing adherence to a traditional Mediterranean diet (MedDiet) was associated with better health-related quality of life among older Spanish men and women with overweight or obesity harboring the metabolic syndrome. We analyzed baseline data from 6430 men and women (age 55-70 years) participating in the PREDIMED-Plus study. PREDIMED-Plus is a multi-centre randomized trial testing an energy-restricted MedDiet combined with promotion of physical activity and behavioral therapy for primary cardiovascular prevention compared to a MedDiet alone. Participants answered a 36-item questionnaire about health-related quality of life (HRQoL) and a 17-item questionnaire…
Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: Results from a randomized controlled trial
2013
[Background]: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern.
Mediterranean dietary pattern and depression: the PREDIMED randomized trial
2013
Background: A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. Methods: This was a multicenter, randomized, primary prevention field trial of cardiovascular disease (Prevencion con Dieta Mediterranea (PREDIMED Study)) based on community-dwelling men aged 55 to 80 years and wome…
A metabolomics-driven approach to predict cocoa product consumption by designing a multimetabolite biomarker model in free-living subjects from the P…
2014
Scope The aim of the current study was to apply an untargeted metabolomics strategy to characterize a model of cocoa intake biomarkers in a free-living population. Methods and results An untargeted HPLC-q-ToF-MS based metabolomics approach was applied to human urine from 32 consumers of cocoa or derived products (CC) and 32 matched control subjects with no consumption of cocoa products (NC). The multivariate statistical analysis (OSC-PLS-DA) showed clear differences between CC and NC groups. The discriminant biomarkers identified were mainly related to the metabolic pathways of theobromine and polyphenols, as well as to cocoa processing. Consumption of cocoa products was also associated wit…
Clarithromycin Versus Azithromycin in the Treatment of Mediterranean Spotted Fever in Children: A Randomized Controlled Trial
2002
We conducted an open-label randomized controlled trial to compare the efficacy and safety of clarithromycin (15/mg/kg/day in 2 divided doses for 7 days) with those of azithromycin (10 mg/kg/day in 1 dose for 3 days) in the treatment of children with Mediterranean spotted fever. Until now, there has not been a gold-standard therapy for this rickettsial disease in children. Eighty-seven children were randomized to receive 1 of the 2 drugs. The mean time to defervescence (+/- standard deviation) was 46.2+/-36.4 h in the clarithromycin group and 39.3+/-31.3 h in the azithromycin group. These differences were not statistically significant and both drugs were equally well-tolerated. Clarithromyci…
Efficacy of low-intensity psychological intervention applied by ICTs for the treatment of depression in primary care: a controlled trial
2015
Background: Depression is one of the most common disorders in Psychiatric and Primary Care settings and is associated with significant disability and economic costs. Low-intensity psychological interventions applied by Information and Communication Technologies (ICTs) could be an efficacious and cost-effective therapeutic option for the treatment of depression. The aim of this study is to assess 3 low-intensity psychological interventions applied by ICTs (healthy lifestyle, positive affect and mindfulness) in Primary Care; significant efficacy for depression treatment has previously showed in specialized clinical settings by those interventions, but ICTs were not used. Method: Multicenter c…
Effect of the local administration of betamethasone on pain, swelling and trismus after impacted lower third molar extraction. A randomized, triple b…
2013
Objectives: The aim of this study is to compare the analgesic and anti-inflammatory effects of the local postoperative administration of a single 12-mg dose of betamethasone after the surgical removal of impacted lower third molars. Study Design: A split-mouth, triple-blind, randomized, placebo-controlled clinical trial of 25 patients requiring the surgical removal of symmetrical lower third molars was performed. In the experimental side, a 12-mg dose of betamethasone was administered submucosally after the surgical procedure, while in the control side a placebo (sterile saline solution) was injected in the same area. To assess postoperative pain, visual analogue scales and the consumption …
Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period
2014
Objectives: To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. Study Design: This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for inde…
A randomized clinical trial compared the effect of intra-alveolar 0.2 % Chlorohexidine bio-adhesive gel versus 0.12% Chlorohexidine rinse in reducing…
2014
Objectives: To evaluate socket healing, incidence of acute alveolar ostieitis (AO) and associated pain following single molar tooth extraction in patients who receive intra-alveolar 0.2% chlorhexidine (CHX) gel, and those who rinsed with 0.12 % CHX rinse. Study Design: A prospective randomized clinical trial was conducted on two parallel groups of patients. Group1 (141 patients): Rinsed with 0.12 % CHX rinse from the second postoperative day, two times daily for a week. Group2 (160 patients): Who had direct intra-alveolar application of 0.2% CHX gel and day 3 post-operatively. The socket was evaluated 3 and 7 day postoperatively for the presence of AO by checking probing tenderness in the s…
Efficacy of methylprednisolone on pain, trismus and quality of life following surgical removal of mandibular third molars: a double-blind, split-mout…
2021
Background The objective of the present study was to compare the efficacy of different doses of methylprednisolone on postoperative sequelae and quality of life (QoL) following surgical removal of mandibular third molars (SRM3). Material and Methods Fifty-two patients (16 men and 36 women, mean age 25.9 years, range: 18-39) with bilateral impacted mandibular third molars were randomly allocated into intraoperative muscular injection of either 20mg, 30mg, 40mg methylprednisolone or saline injection. Baseline measurements were obtained preoperatively and compared with assessment after one day, three days, seven days and one month. Pain and trismus were estimated by visual analog scale score a…