Search results for "Placebo"

Update of REVEL: A randomized, double-blind, phase III study of docetaxel (DOC) and ramucirumab (RAM; IMC-1121B) versus DOC and placebo (PL) in the s…

2015

A randomized study of tucatinib (ONT-380) vs. placebo in combination with capecitabine and trastuzumab in patients with pretreated HER2-pos. metastat…

2018

Evaluation of the efficacy of low-level laser in improving the symptoms of burning mouth syndrome

2015

Background: Burning mouth syndrome (BMS) is common condition that affects menopause women, patients suffer from sever burning sensation. Up to now there is no definitive treatment for this disease. Present study was undertaken to evaluate the efficacy of low-level laser (LLL) in improving t he symptoms of burning mouth syndrome. Material and Methods: Twenty patients with BMS were enrolled in this study; they were divided in two groups randomly. In the laser group, in each patient, 10 areas on the oral mucosa were selected and underwent LLL irradiation at a wavelength of 630 nm, and a power of 30 mW for 10 seconds twice a week for 4 weeks. In the placebo group, silent/off laser therapy was c…

Interventions for the treatment of xerostomia: A randomized controlled clinical trial

2020

Background Xerostomia or dry mouth sensation corresponds to a common clinical problem that can significantly impair the oral health related quality of life (OHRQoL). Currently, there is a large variety of local agents available for the treatment of xerostomia, but there is a lack robust evidence supporting the use of one treatment over another. We aimed to compare the effectiveness of a 1% malic acid salivary stimulant spray with a 1.33% betaine-based saliva substitute mouthwash in the improvement of xerostomia. Material and methods Fifty-one participants with drug induced or idiopathic xerostomia were randomly allocated into three groups, two intervention and one control group (placebo). O…

Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

2015

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular deat…

Efficacy of ozonized water for the treatment of erosive oral lichen planus : a randomized controlled study

2020

Background Management of erosive Oral Lichen Planus (eOLP) is challenging. Currently, topical corticosteroids are widely used as first-line therapy, but they might be associated with side-effects and incomplete clinical response. Among non-pharmacological strategies, ozone at low medical concentration has proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases. The aim of this randomized controlled study was to investigate the effectiveness of ozonized water in association with conventional topical corticosteroids for the treatment of eOLP. Material and Methods Fifty-one patients were included in the study and r…

Erratum: Bosch-Sierra, N., et al. Effect of Fibre-Enriched Orange Juice on Postprandial Glycaemic Response and Satiety in Healthy Individuals: An Acu…

2021

The authors have requested that the following changes be made to their paper [...]

Somatic Symptom Perception From a Predictive Processing Perspective: An Empirical Test Using the Thermal Grill Illusion.

2020

OBJECTIVE In a predictive processing perspective, symptom perceptions result from an integration of preexisting information in memory with sensory input. Physical symptoms can therefore reflect the relative predominance of either sensory input or preexisting information. In this study, we used the thermal grill illusion (TGI), which applies interlaced warm and cool temperatures to the skin to create a paradoxical heat-pain experience. Assuming that the TGI compared with single-temperature stimulation relies more importantly on an active integration process of the brain to create this paradoxical sensation, we tested the hypothesis whether a manipulation of the expectations during TGI would …

The direct effect of magnetic tape ® on pain and lower-extremity blood flow in subjects with low-back pain: A randomized clinical trial

2021

Low-back pain has a high impact on the world population, and solutions are in demand. The behavior of specific physiological processes has been modified using magnetic fields, whether for pain relief, bone consolidation, or improvement of vascularization. The use of tape with magnetic properties could help in these cases. A double-blind randomized clinical trial was designed to use Magnetic Tape® versus placebo Kinesio tape. Blood flow variables were evaluated using pulsed power Doppler ultrasound. Resistance index, pulsatility index, systolic velocity, and diastolic velocity were measured. The pressure pain threshold was measured using algometry in 22 subjects. The results reveal significa…

EPA-0685 – Guanfacine XR (GXR) for children and adolescents with attention-deficit/hyperactivity disorder (ADHD): phase 3, randomized, double-blind, …

2014

Introduction GXR, a selective α2A-adrenergic agonist, is a non-stimulant treatment for ADHD (approved in the USA for children and adolescents and in Canada for children). Objectives To assess the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. Aims To evaluate the efficacy (symptom and function) and safety of GXR for the treatment of ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo (NCT01244490). Methods Patients (6–17 years) were randomly assigned at baseline to dose-optimized GXR (6–12 years, 1–4 mg/day; 13–17 years, 1–7 mg/day), ATX (10–100mg/day) or placebo for 4 or 7 week…