Search results for "Randomized controlled"
showing 10 items of 2220 documents
Confirming the mechanisms behind cognitive-behavioural therapy effectiveness in chronic pain using structural equation modeling in a sample of patien…
2016
Objective To evaluate whether therapeutic mechanisms assumed to explain the effect of cognitive behavioural therapy (CBT) concerning temporomandibular symptoms are confirmed by structural equation modelling. Method Patients were randomly assigned to either an experimental group receiving CBT (N = 41) or a standard therapy control group (N = 31). Subjects were assessed before and after intervention using mediator variables hypothesized according to the CBT model, as well as outcome variables and other socio-demographic and clinical measures. Results The results confirm that the effect of treatment on pain intensity was partially mediated by distress, catastrophizing, perceived control, distr…
Acetic acid-guided biopsies after magnifying endoscopy compared with random biopsies in the detection of Barrett's esophagus: a prospective randomize…
2006
Background In contrast to standard video endoscopy, magnifying endoscopy after local acetic acid application enables recognition of mucosal surface architecture. Objective To investigate the diagnostic yield of magnifying endoscopy with acetic acid–targeted biopsies compared to random, 4-quadrant biopsies. Design Prospective randomized trial (ratio 1:1) with crossover design. Setting Two referral hospitals in Germany. Patients Thirty-one patients with Barrett's esophagus or visible columnar-lined lower esophagus. Interventions Patients were randomized to undergo either standard video endoscopy with 4-quadrant biopsies or magnifying endoscopy in conjunction with acetic acid application. All …
Effect of omalizumab on angioedema in H1-antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled …
2016
Background Chronic spontaneous urticaria (CSU) severely impacts quality of life (QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied. Objective The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives. Methods X-ACT was a phase III, rand…
Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase
2011
Background A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma. Objectives We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO. Methods In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had pers…
Efficacy and cost-effectiveness of a blended cognitive behavioral therapy for depression in Spanish primary health care:Study protocol for a randomis…
2018
Background: Data from primary health care in Spain show a high prevalence of the major depressive disorder. Blended treatment (combination of face-to-face and online components) seems to be a very promising tool for the optimization and dissemination of psychological treatments in a cost-effective form. Although there is growing data that confirm the advantages of blended therapies, few studies have analyzed their application in regular clinical practice. The objective of the present paper is to describe the protocol for a clinical study aimed at exploring the clinical and cost-effectiveness of a blended cognitive behavioral therapy (b-CBT) for depression, compared to treatment as usual (TA…
Efficacy of a fasting-mimicking diet in functional therapy for depression: A randomised controlled pilot trial.
2020
Objective: This randomized controlled trial examined the efficacy of adding a fasting‐mimicking diet to a structured psychotherapy protocol for treating depression.Design: Of 20 patients with depression, 10 were randomly assigned to psychotherapy and dieting (i.e., experimental group) and the other 10 to psychotherapy only (i.e., control group). Patients in both groups received20 individual sessions of functional therapy along with nutrition consultation. Patients in the control group were instructed to maintain their usual daily diets. Results: Both treatments were effective in reducing depression as well as increasing self‐esteem and quality of life. The experimental group showed improved…
Efficacy of Short-term Treatment of Internet and Computer Game Addiction
2019
Importance Internet and computer game addiction represent a growing mental health concern, acknowledged by the World Health Organization. Objective To determine whether manualized cognitive behavioral therapy (CBT), using short-term treatment for internet and computer game addiction (STICA), is efficient in individuals experiencing internet and computer game addiction. Design, Setting, and Participants A multicenter randomized clinical trial was conducted in 4 outpatient clinics in Germany and Austria from January 24, 2012, to June 14, 2017, including follow-ups. Blinded measurements were conducted. A consecutive sample of 143 men was randomized to the treatment group (STICA; n = 72) or wai…
Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy.
2009
Udgivelsesdato: Sep-28 A randomized-controlled single-blind trial was conducted to investigate the clinical, structural and functional effects of peritendinous corticosteroid injections (CORT), eccentric decline squat training (ECC) and heavy slow resistance training (HSR) in patellar tendinopathy. Thirty-nine male patients were randomized to CORT, ECC or HSR for 12 weeks. We assessed function and symptoms (VISA-p questionnaire), tendon pain during activity (VAS), treatment satisfaction, tendon swelling, tendon vascularization, tendon mechanical properties and collagen crosslink properties. Assessments were made at 0 weeks, 12 weeks and at follow-up (half-year). All groups improved in VISA-…
Effect of caffeine on simulator flight performance in sleep-deprived military pilot students.
2007
Caffeine has been suggested to act as a countermeasure against fatigue in military operations. In this randomized, double-blind, placebo-controlled study, the effect of caffeine on simulator flight performance was examined in 13 military pilots during 37 hours of sleep deprivation. Each subject performed a flight mission in simulator four times. The subjects received either a placebo (six subjects) or 200 mg of caffeine (seven subjects) 1 hour before the simulated flights. A moderate 200 mg intake of caffeine was associated with higher axillary temperatures, but it did not affect subjectively assessed sleepiness. Flight performance was similar in both groups during the four rounds flown und…
Influence of information concerning a computerized anesthesia system on dental anxiety: a randomized controlled clinical trial
2020
Background A single-blinded randomized controlled trial among patients requiring an upper third molar extraction was performed to evaluate the anxiety degree after receiving information or not about the functioning of The Wand system. Secondarily, perceived pain and the need of re-anesthesia were assessed. Material and Methods Patients were randomly assigned to the experimental group (detailed explanation about The Wand) or control group (no specific information). Local anesthesia with The Wand consisted in a supraperiosteal infiltrative technique injection 1.6 mL at the buccal and 0.2 mL at the palatal side. Distinct questionnaires for assessing dental anxiety and 100-mm visual analog scal…