Search results for "Randomized controlled trial"

Prevention of eating disorders-Efficacy and cost-benefit of a school-based program ("MaiStep") in a randomized controlled trial (RCT).

2021

Objective Given the severity of eating disorders, effective and easily implementable prevention programs which reduce incidence rates and in addition have health-economic benefits are essential. The majority of research on prevention programs focuses on questionnaire-based efficacy or the reduction of eating disorder symptoms while neglecting the health-economic perspective. By contrast, the present study focuses on both an efficacy analysis considering diagnostic criteria (DSM-5) and on evaluating the cost-benefit of a universal prevention program for eating disorders ("MaiStep"). Method A three-arm randomized controlled trial with baseline, posttreatment and 12-month follow-up was conduct…

Higher levels of IgA and IgG at sepsis onset are associated with higher mortality: results from the Albumin Italian Outcome Sepsis (ALBIOS) trial

2021

Abstract Background The role of intravenous immunoglobulins (IVIG) during sepsis is controversial, as different trials on IVIG have observed inconsistent survival benefits. We aimed to elucidate the possible association and clinical significance between circulating levels of immunoglobulins. Methods In a subset of 956 patients with severe sepsis and septic shock of the multicentre, open-label RCT ALBIOS, venous blood samples were serially collected 1, 2, and 7 days after enrolment (or at ICU discharge, whichever came first). IgA, IgG and IgM concentrations were assayed in all patients on day 1 and in a subgroup of 150 patients on days 2 and 7. Ig concentrations were measured employing a tur…

Non-Celiac Gluten Sensitivity: The New Frontier of Gluten Related Disorders

2013

Non Celiac Gluten sensitivity (NCGS) was originally described in the 1980s and recently a “re-discovered” disorder characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects that are not affected with either celiac disease (CD) or wheat allergy (WA). Although NCGS frequency is still unclear, epidemiological data have been generated that can help establishing the magnitude of the problem. Clinical studies further defined the identity of NCGS and its implications in human disease. An overlap between the irritable bowel syndrome (IBS) and NCGS has been detected, requiring even more stringent diagnostic criteria. Several studies sug…

BENEFICIAL EFFECT OF PROBIOTICS ADMINISTRATION IN INFLAMMATORY BOWEL DISEASE AND RELATED SPONDYLOARTHROPATHY: A PROSPECTIVE STUDY

2015

Background: Therapeutic treatment for inflammatory bowel disease (IBD) may follow different approaches, systemic as well as local, especially when the target is the osteoarticular apparatus. Although some clinical trials have suggested benefits from probiotics administration in IBD, there is still a great deal of controversy on their use. The aim of this study was to further investigate the effects of probiotics in patients with IBD and related spondyloarthropathy. Material/Methods: Fifty-nine patients affected by IBD with extra-intestinal involvement where evaluated from 2006 to 2010. Twenty-eight patients received administration of a standard therapy with mesalazine and 31 where treated w…

Short Message Service (SMS)-based strategy to improve antipsychotic adherence in schizophrenia

2011

ObjectivePoor adherence to antipsychotic treatment is a well-recognized challenge among patients with schizophrenia and is associated with increased morbidity and consumption of health care resources.We evaluated the effect of daily Short Message Service (SMS) reminders on patients’ adherence to antipsychotic medication in schizophrenia.MethodsClinically stabilized outpatients with schizophrenia and considered to be poor adherent (at least one affirmative answer of Morisky-Green questionnaire -MAQ) to antipsychotic monotherapy were included in a multicenter, randomized, open-label, controlled trial. Participants were randomized to receive a daily SMS reminder on their cell phone to take the…

A prospective, randomized pilot study on the safety and efficacy of recombinant human growth and differentiation factor-5 coated onto β-tricalcium ph…

2010

Objectives: The aim of this prospective, randomized clinical trial was to investigate the potential of recombinant human growth and differentiation factor-5 (rhGDF-5) coated onto β-tricalcium phosphate (β-TCP) (rhGDF-5/β-TCP) to support bone formation after sinus lift augmentation. Material and methods: In total, 31 patients participated in this multicenter clinical trial. They required a two-stage unilateral maxillary sinus floor augmentation (residual bone height <5 mm). According to a parallel-group design, the patients were randomized to three treatment groups: (a) augmentation with rhGDF-5/β-TCP and a 3-month healing period, (b) augmentation with rhGDF-5/β-TCP and a 4-month healing per…

Couple therapy for depression in a naturalistic setting in Finland: a 2-year randomized trial

2012

The dialogical and narrative processes in couple therapy (CT) for depressions project was conducted to develop therapy for depression and to investigate the effectiveness of CT in everyday clinical practice; thus aiming at high external validity. Patients with moderate or major depression were randomized to a CT group (n = 29) and a control group (n = 22). The CT group needed significantly fewer therapy sessions. There were significant differences in favour of the CT group in terms of general mental health (symptom check list), Hamilton depression rating scale, global assessment of functioning and decreasing alcohol use. As regards depressive symptoms using the Beck depression inventory, 79…

Neuromuscular Training Warm-up Prevents Acute Noncontact Lower Extremity Injuries in Children’s Soccer : A Cluster Randomized Controlled Trial

2021

Background: Prevention of sports injuries is essential in youth, as injuries are associated with less future physical activity and thus greater all-cause morbidity. Purpose: To investigate whether a neuromuscular training warm-up operated by team coaches is effective in preventing acute lower extremity (LE) injuries in competitive U11-U14 soccer players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Twenty top-level U11 to U14 soccer clubs in Finland were randomized into intervention and control groups and assessed for 20 weeks. Participants included 1403 players (280 female, 1123 male; age range, 9-14 years): 673 players (44 teams) in the intervention group and …

Effect of Chronic Exercise Training on Blood Lactate Metabolism Among Patients With Type 2 Diabetes Mellitus : A Systematic Review and Meta-Analysis

2021

Purpose: To assess the effect of chronic exercise training on blood lactate metabolism at rest (i.e., basal lactate concentrations) and during exercise (i.e., blood lactate concentration at a fixed load, load at a fixed blood lactate concentration, and load at the individual blood lactate threshold) among patients with type 2 diabetes mellitus (T2DM).Methods: PubMed (MedLine), Embase, Web of Science, and Scopus were searched. Randomized controlled trials, non-randomized controlled trials, and case-control studies using chronic exercise training (i.e., 4 weeks) and that assessed blood lactate concentrations at rest and during exercise in T2DM patients were included.Results: Thirteen studies …

2021

Sports-related pain and injury is directly linked to tissue inflammation, thus involving the autonomic nervous system (ANS). In the present experimental study, we disable the sympathetic part of the ANS by applying a stellate ganglion block (SGB) in an experimental model of delayed onset muscle soreness (DOMS) of the biceps muscle. We included 45 healthy participants (female 11, male 34, age 24.16 ± 6.67 years [range 18–53], BMI 23.22 ± 2.09 kg/m2) who were equally randomized to receive either (i) an SGB prior to exercise-induced DOMS (preventive), (ii) sham intervention in addition to DOMS (control/sham), or (iii) SGB after the induction of DOMS (rehabilitative). The aim of the study was t…