Search results for "Randomized controlled"
showing 10 items of 2220 documents
Adjuvant vs. neoadjuvant radiochemotherapy for locally advanced rectal cancer: the German trial CAO/ARO/AIO-94.
2003
Aim The standard treatment for patients with clinically resectable rectal cancer is surgery. Postoperative radiochemotherapy (RCT) is recommended for advanced disease (pT3/4 or pN+). In recent years, encouraging results of pre-operative radiotherapy have been reported. This prospective randomized phase-III-trial (CAO/ARO/AIO-94) compares the efficacy of neoadjuvant RCT to standard postoperative RCT. We report on the design of the study and first results with regard to toxicity of RCT and postoperative morbidity. Patients and methods Patients with locally advanced operable rectal cancer (uT3/4 or uN+, Mason CS III/IV) were randomly assigned to pre or postoperative RCT: A total dose of 50.4…
Reduction of low-density lipoprotein cholesterol in patients with coronary heart disease and metabolic syndrome: analysis of the Treating to New Targ…
2006
BACKGROUND: Despite the prognostic value of metabolic syndrome for predicting cardiovascular events, few trials have investigated the effects of statin therapy on cardiovascular morbidity and mortality in patients with the metabolic syndrome. Our post hoc analysis of the Treating to New Targets (TNT) study assessed whether intensive lowering of low-density lipoprotein cholesterol with high-dose atorvastatin therapy results in cardiovascular benefits for patients with both coronary heart disease and the metabolic syndrome. METHODS: The TNT study was a prospective, double blind, parallel-group trial done at 256 sites in 14 countries between April, 1998, and August, 2004, with a median follow-…
Are media warnings about the adverse health effects of modern life self-fulfilling? An experimental study on idiopathic environmental intolerance att…
2013
article i nfo Objective: Medically unsubstantiated 'intolerances' to foods, chemicals and environmental toxins are com- mon and are frequently discussed in the media. Idiopathic environmental intolerance attributed to electro- magnetic fields (IEI-EMF) is one such condition and is characterized by symptoms that are attributed to exposure to electromagnetic fields (EMF). In this experiment, we tested whether media reports promote the development of this condition. Methods: Participants (N=147) were randomly assigned to watch a television report about the adverse health effects of WiFi (n=76) or a control film (n=71). After watching their film, participants received a sham exposure to a WiFi …
The Norwegian Healthy Life Centre Study: A pragmatic RCT of physical activity in primary care.
2018
Aims: The aim of this study was to evaluate the effect of behaviour change interventions at Norwegian Healthy Life Centres (HLCs) on participants’ moderate to vigorous intensity physical activity (MVPA) six months after baseline. We also explore predictors of change in MVPA, and if level of education and MVPA at baseline modify the effect. Methods: A randomised controlled trial with inclusion criteria age ⩾ 18 years and ability to participate in group-based physical activity. Participants were randomised to either behaviour change interventions or a waiting list (control). Objective recordings of physical activity were the main outcome, analysed with simple and multiple linear regression. …
Are postural restrictions necessary for management of posterior canal benign paroxysmal positional vertigo?
2011
Objectives: An important component of management of benign paroxysmal positional vertigo (BPPV) has been the application of postural restrictions after use of a canalith repositioning maneuver (CRM) to prevent the return of otolithic debris into the posterior semicircular canal (PSC). This study was designed to explore the effectiveness of postural restrictions in patients with BPPV caused by otolithic debris in the PSC. Methods: Seventy-four adult patients with unilateral PSC BPPV were enrolled into this study. All patients were managed with a CRM — Either the modified Epley maneuver or the Semont maneuver. The patients were divided randomly into 2 groups: Group A, with postural restrictio…
Comparison of repositioning maneuvers for benign paroxysmal positional vertigo of posterior semicircular canal: advantages of hybrid maneuver.
2012
Objective: The prevalence of benign paroxysmal positional vertigo (BPPV) is becoming more frequent in elderly population. The presence of comorbid factors has to be considered before assessment as well as before commencing any repositioning treatment. Our aims were evaluation of the maneuvers efficacy and evaluation of the applicability of hybrid maneuver (HM) in patients with physical limitation. Study design and setting: This is a randomized study in 2 tertiary referral centers. Intervention: This is a therapeutic intervention. Patients: All consecutive patients with diagnosis of BPPV of posterior canal matching the inclusion criteria were enrolled. Patients underwent treatment soon after…
Therapy for Recurrent High-Grade Gliomas: Results of a Prospective Multicenter Study on Health-Related Quality of Life
2017
Objective To assess the impact of therapy on patients' health-related quality of life (HRQoL) in recurrent high-grade glioma (HGG) in an unselected cohort. Methods In this prospective multicenter study, we analyzed European Organization for Research and Treatment of Cancer Quality of Life core questionnaire and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Brain Neoplasm module questionnaires of 92 patients within 1 year after diagnosis of tumor recurrence of a HGG and respective treatment. We evaluated the influence of re-radiation, second- and third-line chemotherapies, and number of recurrent surgeries on summary scores for functioning, symptoms…
Prospective randomized comparison of short-access mother-baby cholangioscopy versus direct cholangioscopy with ultraslim gastroscopes
2012
Mother-baby technologies, the criterion standard for cholangioscopy, have several limitations. A novel, short-access, mother-baby (SAMBA) system may improve this technique. Direct cholangioscopy (DC) was recently developed as an alternative to mother-baby cholangioscopy.Comparison of success rates with SAMBA and DC.Single-center, randomized, controlled trial.Academic tertiary-care referral center.Sixty patients with suspected cholangiopathies randomized to either SAMBA (n = 30) or DC (n = 30).Cholangioscopy under deep sedation.Technical success rate of diagnostic or therapeutic procedure.A total of 24 and 21 diagnostic procedures were performed in the SAMBA and DC groups, respectively. Ther…
Do patients with bipolar disorder and subsyndromal symptoms benefit from functional remediation? A 12-month follow-up study
2016
We analyzed the efficacy of functional remediation, in a sample of patients with bipolar disorder who presented with subsyndromal symptoms. From a total sample of 239 patients with bipolar I and II disorder, according to DSM-IV-TR diagnostic criteria, entering a randomized clinical trial, those patients who presented with subsyndromal symptoms were selected based on a method already described by Berk and colleagues was applied. It consists of using the Clinical Global Impression-Bipolar version (CGI-BP) to establish the scores of the Hamilton Depression Rating Scale (HAM-D) and of the Young Mania Rating Scale (YMRS) that correspond with 1 in the CGI-BP. Functional outcome and mood symptoms …
Functional remediation for patients with bipolar II disorder: improvement of functioning and subsyndromal symptoms.
2014
Recently, Functional Remediation (FR) has proven to be effective in improving the functional outcome of euthymic bipolar patients. The aim of this study was to test the efficacy of the FR program in a subsample of euthymic bipolar II patients (BPII). A post-hoc analyses were undertaken using data of 53 BPII outpatients who had participated in a multicenter, rater-blind, randomized, controlled trial exploring the efficacy of FR (n=17) as compared with a Psychoeducation group (PSY) (n=19) and a treatment as usual control group (TAU n=17). The primary outcome variable was the functional improvement defined as the mean change in the Functioning Assessment Short Test (FAST) from baseline to endp…