Search results for "Intention-to-treat analysis"
showing 10 items of 60 documents
Preventive Effect of Cow's Milk Fermented with Lactobacillus paracasei CBA L74 on Common Infectious Diseases in Children: A Multicenter Randomized Co…
2017
Background: Fermented foods have been proposed to prevent common infectious diseases (CIDs) in children attending day care or preschool. Objectives: To investigate the efficacy of dietary supplementation with cow’s skim milk fermented with the probiotic Lactobacillus paracasei CBA L74 in reducing CIDs in children attending day care or preschool. Methods: Multicenter, randomized, double-blind, placebo-controlled trial on healthy children (aged 12–48 months) consuming daily 7 grams of cow’s skim milk fermented with L. paracasei CBA L74 (group A), or placebo (maltodextrins group B) attending day care or preschool during the winter season. The main outcome was the proportion of children who exp…
The Intention-to-Treat Effect of Bridging Treatments in the Setting of Milan Criteria–In Patients Waiting for Liver Transplantation
2019
In patients with hepatocellular carcinoma (HCC) meeting the Milan criteria (MC), the benefit of locoregional therapies (LRTs) in the context of liver transplantation (LT) is still debated. Initial biases in the selection between treated and untreated patients have yielded conflicting reported results. The study aimed to identify, using a competing risk analysis, risk factors for HCC-dependent LT failure, defined as pretransplant tumor-related delisting or posttransplant recurrence. The study was registered at www.clinicaltrials.gov (identification number NCT03723304). In order to offset the initial limitations of the investigated population, an inverse probability of treatment weighting (IP…
Lifestyle intervention to limit gestational weight gain: the Norwegian Fit for Delivery randomised controlled trial
2015
Objective To examine whether a lifestyle intervention in pregnancy limits gestational weight gain (GWG) and provides measurable health benefits for mother and newborn. Design Randomised controlled trial. Setting Healthcare clinics of southern Norway. Population Healthy, non-diabetic, nulliparous women, aged ≥18 years, with a body mass index of ≥19 kg/m2 , and with a singleton pregnancy at ≤20 weeks of gestation. Methods Women were randomised to an intervention group (with dietary counselling twice by telephone and access to twice-weekly exercise groups) or to a control group (with standard prenatal care). Participants were measured three times during pregnancy and at delivery, and newborns …
Hepatocellular carcinoma in Child's A cirrhosis: a retrospective analysis of matched pairs following liver transplantation vs. liver resection accord…
2013
This is the first matched pair analysis on the puzzling clinical problem of whether to perform liver transplantation (LT) or liver resection (LR) for Child's A hepatocellular carcinoma (HCC) patients. A total of 201 patients diagnosed with HCC and Child's A liver cirrhosis were treated with LT transarterial chemoembolization (TACE) or LR between 1998 and 2012. To achieve the most accurate study design, two groups of 57 patients were matched retrospectively according to their tumor characteristics detected by the initial computerized tomography (CT) scan. Sixteen of 57 LT candidates were not transplanted due to tumor progress during pre-treatment (TACE). Nevertheless, the retrospective analy…
PAN-EX: a pooled analysis of two trials of neoadjuvant chemotherapy followed by chemoradiotherapy in MRI-defined, locally advanced rectal cancer
2016
This analysis confirms that administering neoadjuvant chemotherapy (NACT) before chemoradiotherapy (CRT) could be a potential option for high-risk, locally advanced rectal cancer. In this setting, MRI tumour regression grade is an independent prognostic factor and, when assessed after NACT, may predict the probability and magnitude of incremental benefit from sequential CRT.EXPERT and EXPERT-C were phase II clinical trials of neoadjuvant chemotherapy (NACT) followed by chemoradiotherapy (CRT) in high-risk, locally advanced rectal cancer (LARC). We pooled individual patient data from these trials. The primary objective was overall survival (OS) in the intention-to-treat (ITT) population. Pro…
Virtual reality versus computer-aided exposure treatments for fear of flying
2011
Evidence is growing that two modalities of computer-based exposure therapies—virtual reality and computer-aided psychotherapy—are effective in treating anxiety disorders, including fear of flying. However, they have not yet been directly compared. The aim of this study was to analyze the efficacy of three computer-based exposure treatments for fear of flying: virtual reality exposure therapy (VRET), computer-aided exposure with a therapist’s (CAE-T) assistance throughout exposure sessions, and self-administered computer-aided exposure (CAE-SA). A total of 60 participants with flying phobia were randomly assigned to VRET, CAE-T, or CAE-SA. Results indicate that the three interventions were …
Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised…
2015
Elevated numbers of blood eosinophils are a risk factor for asthma exacerbations. Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death. We aimed to assess the efficacy and safety of reslizumab in patients with inadequately controlled, moderate-to-severe asthma.We did two duplicate, multicentre, double-blind, parallel-group, randomised, placebo-controlled phase 3 trials. Both trials enrolled patients with asthma aged 12-75 years (from 128 clinical research centres in study 1 and 104 centres in study 2) from Asia, Australia, North America, South America, South Africa, and Europe, whose asthma was inadequately c…
Teprotumumab for Thyroid-Associated Ophthalmopathy
2017
Thyroid-associated ophthalmopathy, a condition commonly associated with Graves' disease, remains inadequately treated. Current medical therapies, which primarily consist of glucocorticoids, have limited efficacy and present safety concerns. Inhibition of the insulin-like growth factor I receptor (IGF-IR) is a new therapeutic strategy to attenuate the underlying autoimmune pathogenesis of ophthalmopathy.We conducted a multicenter, double-masked, randomized, placebo-controlled trial to determine the efficacy and safety of teprotumumab, a human monoclonal antibody inhibitor of IGF-IR, in patients with active, moderate-to-severe ophthalmopathy. A total of 88 patients were randomly assigned to r…
Knee arthroscopy and exercise versus exercise only for chronic patellofemoral pain syndrome: 5-year follow-up.
2011
Objective To study the long-term outcome of arthroscopy in patients with chronic patellofemoral pain syndrome (PFPS), the authors conducted a randomised controlled trial. The authors also investigated factors predicting the outcome in patients with PFPS. Methods Fifty-six patients with PFPS were randomised into two groups: an arthroscopy group (N=28), treated with knee arthroscopy and an 8-week home exercise programme, and a control group (N=28), treated with a similar 8-week home exercise programme only. The primary outcome was the Kujala score on pain and function at 5-year. Secondary outcomes were visual analogue scales (VASs) to assess activity-related symptoms. Results According to the…
Infliximab three-dose induction regimen in severe corticosteroid-refractory ulcerative colitis: Early and late outcome and predictors of colectomy
2014
Abstract Background Infliximab is effective as rescue therapy in severe corticosteroid-refractory ulcerative colitis. The optimal dose regimen and the long term benefits are not well defined. The aim of the present study was to evaluate short- and long-term colectomy rate in a cohort of patients with severe corticosteroid-refractory ulcerative colitis who received a three-dose infliximab induction regimen. Methods One hundred and thirteen patients admitted to 11 Italian IBD referral centres and treated with infliximab according to an intention to treat three-dose regimen were included. The co-primary endpoints were 3- and 12-month colectomy rate. The secondary end-points were the overall co…