Search results for "randomized"
showing 10 items of 2323 documents
Effectiveness of Antipsychotic Medication in the Treatment of BPD
2017
IntroductionThough prescription is off-lable, “atypical” or “second-generation” antipsychotics (SGAs) are prevalently given to borderline personality disorder (BPD) patients. They have also been the focus of research on pharmacological agents in BPD in recent years, as the previous version of the relating cochrane systematic review shows.ObjectivesWe are currently updating this cochrane systematic review on pharmacological interventions for BPD. First findings on the up-to-date evidence relating to SGAs will be presented.MethodsWe conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) according to cochrane collaboration standards. Any randomized comparisons o…
Enteral Nutrition in Pancreaticoduodenectomy: A Literature Review
2015
Pancreaticoduodenectomy (PD) is considered the gold standard treatment for periampullory carcinomas. This procedure presents 30%–40% of morbidity. Patients who have undergone pancreaticoduodenectomy often present perioperative malnutrition that is worse in the early postoperative days, affects the process of healing, the intestinal barrier function and the number of postoperative complications. Few studies focus on the relation between enteral nutrition (EN) and postoperative complications. Our aim was to perform a review, including only randomized controlled trial meta-analyses or well-designed studies, of evidence regarding the correlation between EN and main complications and outcomes af…
Rapid Steroid Withdrawal after Renal Transplantation Reduces Mortality: Five Year Follow-Up of a Randomized Controlled Trial (Harmony Study) Confirms…
2021
Background: We previously reported excellent efficacy and improved safety aspects of rapid steroid withdrawal (RSWD) in the randomized controlled one year “Harmony” trial, in which 587 predominantly deceased-donor kidney transplant recipients were randomized either to basiliximab or rabbit ATG induction therapy and compared to standard immunosuppressive therapy consisting of basiliximab, low tacrolimus once daily, mycophenolate mofetil, and corticosteroids. Methods: Following the end of the original one-year study period, patients were asked to participate in the observational follow-up (FU) study examining most of the end points of the original study. Hereby, de novo incidences between yea…
Shifting effects in randomised controlled trials of complex interventions: a new kind of performance bias?
2012
Gold C, Erkkila J, Crawford MJ. Shifting effects in randomised controlled trials of complex interventions: a new kind of performance bias? Objective: Randomised controlled trials (RCTs) aim to provide unbiased estimates of treatment effects. However, the process of implementing trial procedures may have an impact on the performance of complex interventions that rely strongly on the intuition and confidence of therapists. We aimed to examine whether shifting effects over the recruitment period can be observed that might indicate such impact. Method: Three RCTs investigating music therapy vs. standard care were included. The intervention was performed by experienced therapists and based on …
Prevention of thromboembolic complications in patients with superficial-vein thrombosis given rivaroxaban or fondaparinux: the open-label, randomised…
2017
Summary Background Superficial-vein thrombosis can lead to deep-vein thrombosis and pulmonary embolism. Rivaroxaban, an oral factor Xa inhibitor, might simplify treatment compared with fondaparinux because it does not require daily subcutaneous injection and is cheaper. We compared efficacy outcomes in patients with superficial-vein thrombosis and additional risk factors given either rivaroxaban or fondaparinux to assess whether rivaroxaban is non-inferior to fondaparinux in the prevention of thromboembolic complications. Methods In this open-label, masked endpoint, randomised, non-inferiority phase 3b trial, we recruited patients aged 18 years or older with symptomatic superficial-vein thr…
Primary percutaneous transluminal coronary angioplasty for Acute Myocardial Infarction in patients not included in randomized studies
1999
Abstract Patients with acute myocardial infarction included in randomized trials comparing primary percutaneous transluminal coronary angioplasty (pPTCA) with thrombolysis represent a special subgroup of patients with a low event rate. Patients excluded from these trials represent a variety of different subgroups, with different patient characteristics and possibly different clinical event rates. Primary PTCA was performed in 491 consecutive patients with acute myocardial infarction in the prospective multicenter observational Maximal Individual Therapy in Acute Myocardial Infarction trial. They were divided into the following groups: group I, patients fulfilling the inclusion criteria of t…
Anthropometric measurements and nutritional assessment in autism spectrum disorders: A systematic review
2015
Abstract Adequate nutrient intake is essential for health. Due to food selectivity and restrictive diets, people with autism spectrum disorder (ASD) may have impaired nutritional status, which could affect their growth. We present a systematic review of publications (1970–2013) on anthropometric measurements and nutritional assessment in this population. The limited research published on growth and nutritional status has found contradictory results. Nutritional assessment has indicated limited food variety in the ASD population but has not confirmed significant differences with respect to recommended intakes or controls. In addition to the lack of control groups, studies in this area have s…
Health Policy Model: Long-Term Predictive Results Associated with the Management of HCV-Induced Diseases in Italy
2014
Background: This study is aimed at describing the epidemiological and economic burden that HCV will generate in the next few years in Italy. Furthermore, the impact that future anti-HCV treatments may have on the burden of disease was considered. The analysis has been developed over the period 2013-2030 from the Italian National Health Service (NHS) perspective.Methods: A published system dynamic model was adapted for Italy in order to quantify the HCV-infected population, the disease progression and the associated cost from 1950 to 2030. The model structure was based on transition probabilities reflecting the natural history of the disease. In order to estimate the efficacy of current anti…
Carbohydrate Antigen-125–Guided Therapy in Acute Heart Failure
2016
Abstract Objectives This study sought to evaluate the prognostic effect of carbohydrate antigen-125 (CA125)–guided therapy (CA125 strategy) versus standard of care (SOC) after a hospitalization for acute heart failure (AHF). Background CA125 has emerged as a surrogate of fluid overload and inflammatory status in AHF. After an episode of AHF admission, elevated values of this marker at baseline as well as its longitudinal profile relate to adverse outcomes, making it a potential tool for treatment guiding. Methods In a prospective multicenter randomized trial, 380 patients discharged for AHF and high CA125 were randomly assigned to the CA125 strategy (n = 187) or SOC (n = 193). The aim in th…
Interaction of Diet/Lifestyle Intervention and TCF7L2 Genotype on Glycemic Control and Adiposity among Overweight or Obese Adults: Big Data from Seve…
2021
Objective . The strongest locus which associated with type 2 diabetes (T2D) by the common variant rs7903146 is the transcription factor 7-like 2 gene ( TCF7L2 ). We aimed to quantify the interaction of diet/lifestyle interventions and the genetic effect of TCF7L2 rs7903146 on glycemic traits, body weight, or waist circumference in overweight or obese adults in several randomized controlled trials (RCTs). Methods . From October 2016 to May 2018, a large collaborative analysis was performed by pooling individual-participant data from 7 RCTs. These RCTs reported changes in glycemic control and adiposity of the variant rs7903146 after dietary/lifestyle-related interventions in overweight or ob…