Search results for "Randomized Controlled Trial"

2019

IntroductionTeachers and student teachers in Germany are a high-risk population for stress and stress-related mental health problems. This often leads to early retirement in subsequent professional life. Various trials have demonstrated positive effects of stress prevention training on the perceived stress and stress-related symptoms of teachers. Although many studies show positive effects of mindfulness-based stress interventions, there is not yet any mindfulness-based intervention for teachers or student teachers in Germany. The aim of this trial is to evaluate a training that combines mindfulness-based and cognitive interventions into one programme, addressing to the specific burdens of …

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of…

2021

Introduction: Frailty is very frequent among patients with chronic kidney disease (CKD) who are awaiting deceased donor kidney transplantation (KT), and transplant outcomes are worsened in those frail recipients. Frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after KT. Intervention is essential to improve survival and quality of life for frail CKD patients, regardless of their age. Studies of post-transplant physical therapy intervention have been met with limited success, in large part due to high dropout rates. A pre-transplant clinical framework for multimodal prehabilitation interventions including physical therapy, nutritional m…

Non-valvular Atrial Fibrillation in CKD: Role of Vitamin K Antagonists and Direct Oral Anticoagulants. A Narrative Review

2021

Atrial fibrillation (AF) is the most common arrhythmia in chronic kidney disease (CKD), with a close bidirectional relationship between the two entities. The presence of CKD in AF increases the risk of thromboembolic events, mortality and bleeding. Vitamin K antagonists (VKA) have been the mainstay of treatment for the prevention of thromboembolic events in AF until recently, with confirmed benefits in AF patients with stage 3 CKD. However, the risk-benefit profile of VKA in patients with AF and stages 4–5 CKD is controversial due to the lack of evidence from randomized controlled trials. Treatment with VKA in CKD patients has been associated with conditions such as poorer anticoagulation q…

Chemotherapy for advanced gastric cancer

2017

Background Gastric cancer is the fifth most common cancer worldwide. In "Western" countries, most people are either diagnosed at an advanced stage, or develop a relapse after surgery with curative intent. In people with advanced disease, significant benefits from targeted therapies are currently limited to HER-2 positive disease treated with trastuzumab, in combination with chemotherapy, in first-line. In second-line, ramucirumab, alone or in combination with paclitaxel, demonstrated significant survival benefits. Thus, systemic chemotherapy remains the mainstay of treatment for advanced gastric cancer. Uncertainty remains regarding the choice of the regimen. Objectives To assess the effica…

Urinary Tartaric Acid, a Biomarker of Wine Intake, Correlates with Lower Total and LDL Cholesterol.

2021

Postmenopausal women are at higher risk of developing cardiovascular diseases due to changes in lipid profile and body fat, among others. The aim of this study was to evaluate the association of urinary tartaric acid, a biomarker of wine consumption, with anthropometric (weight, waist circumference, body mass index (BMI), and waist-to-height ratio), blood pressure, and biochemical variables (blood glucose and lipid profile) that may be affected during the menopausal transition. This sub-study of the PREDIMED (Prevención con Dieta Mediterránea) trial included a sample of 230 women aged 60–80 years with high cardiovascular risk at baseline. Urine samples were diluted and filtered, and tartari…

Self-regulation Training and Job Search Behavior: A Natural Field Experiment Within an Active Labor Market Program

2019

Recent evidence suggests that self-regulation abilities play an important role for the job finding success of unemployed persons. We conduct a randomized controlled trial embedded in an established labor market reactivation program to examine the effect of a self-regulation training on job search effort of long-term unemployed participants. Our treatment involves teaching a self-regulation strategy based on mental contrasting with implementation intentions. We find that the treatment has a positive effect on the quality of application documents as well as on the probability of participants submitting their documents on time. However, we do not find a significant positive effect on labor mar…

Pegylated liposomal doxorubicin in the management of ovarian cancer

2014

Ovarian cancer is the leading cause of death among gynecological tumors. Carboplatin/paclitaxel represents the cornerstone of front-line treatment. Instead, there is no consensus for management of recurrent/progressive disease, in which pegylated liposomal doxorubicin (PLD) ± carboplatin is widely used. We performed a systematic review and metaanalysis to evaluate impact of PLD-based compared with no-PLD-based regimens in the ovarian cancer treatment. Data were extracted from randomized trials comparing PLD-based treatment to any other regimens in the January 2000-January 2013 time-frame. Study end-points were overall survival (OS), progression free survival (PFS), response rate (RR), CA125…

Anodal tDCS over the left prefrontal cortex does not cause clinically significant changes in circulating metabolites

2020

Background: Transcranial direct current stimulation (tDCS), a putative treatment for depression, has been proposed to affect peripheral metabolism. Metabolic products from brain tissue may also cross the blood–brain barrier, reflecting the conditions in the brain. However, there are no previous data regarding the effect of tDCS on circulating metabolites.\ud Objective: To determine whether five daily sessions of tDCS modulate peripheral metabolites in healthy adult men.\ud Methods: This double-blind, randomized controlled trial involved 79 healthy males (aged 20–40 years) divided into two groups, one receiving tDCS (2 mA) and the other sham stimulated. The anode was placed over the left dor…

Oral antiseptics against coronavirus: in-vitro and clinical evidence

2021

Background Angiotensin converting enzyme II (ACE2) is the cellular receptor for SARS-CoV-2, so ACE2-expressing cells can act as target cells and are susceptible to infection. ACE2 receptors are highly expressed in the oral cavity so this may be a potential high-risk route for SARS-CoV-2 infection. Furthermore, the virus can be detected in saliva, even before COVID-19 symptoms appear, with the consequent high risk of virus transmission in asymptomatic/pre-symptomatic patients. Reducing oral viral load could lead to a lower risk of transmission via salivary droplets or aerosols and therefore contribute to the control of the pandemic. Aim To evaluate the available evidence testing the in vitro…

Fecal microbiota transplantation to maintain remission in Crohn’s disease: a pilot randomized controlled study

2020

Abstract Background The role of the gut microbiota in Crohn’s disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. Method Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6…