Search results for "Randomized"

Effect of exercise and dietary intervention on serum metabolomics in men with insomnia symptoms: a 6-month randomized-controlled trial

2020

AbstractBackgroundAccumulating evidences have shown that lifestyle interventions such as exercise and diet are associated with improved sleep quality. However, the underlying molecular mechanisms remain unclear. Assessing exercise and diet intervention associated changes in circulating metabolomics profile in people with insomnia symptoms may help to identify molecular biomarkers that may link lifestyle changes to improved sleep outcomes.MethodsThe present study is a part of a 6-month randomized lifestyle intervention on sleep disorder subjects. Seventy-two Finnish men (aged: 51.6 ± 10.1 years; body mass index, BMI: 29.3 ± 3.9 kg/m2) with chronic insomnia symptoms who were assigned into dif…

A106 Gastroesophageal reflux disease in patients with severe obesity and type 2 diabetes one year after sleeve gastrectomy or Roux-en-Y gastric bypas…

2019

Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalen…

2020

Abstract Background We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia. Methods This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12–22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirme…

Motivational strategies in interventions for intimate partner violence offenders: a systematic review and meta-analysis of randomized controlled tria…

2020

ABSTRACT Previous research suggests that the inclusion of motivational strategies in interventions for intimate partner violence (IPV) offenders could increase their effectiveness. This review evaluated the effectiveness of interventions for IPV offenders that includes motivational strategies to reduce physical and psychological IPV, treatment dropout, official recidivism to IPV offending, and to increase intervention attendance dose. The present systematic review and meta-analysis were conducted using PRISMA guidelines. The following databases were searched from 1983 to 2018 for randomized controlled trials (RCTs) of interventions for IPV offenders that incorporated motivational strategies…

Asking Sensitive Questions

2013

This article is an empirical contribution to the evaluation of the randomized response technique (RRT), a prominent procedure to elicit more valid responses to sensitive questions in surveys. Based on individual validation data, we focus on two questions: First, does the RRT lead to higher prevalence estimates of sensitive behavior than direct questioning (DQ)? Second, are there differences in the effects of determinants of misreporting according to question mode? The data come from 552 face-to-face interviews with subjects who had been convicted by a court for minor criminal offences in a metropolitan area in Germany. For the first question, the answer is negative. For the second, it is po…

HCC therapies--lessons learned.

2014

The antiangiogenic multikinase inhibitor sorafenib was the first systemic agent to demonstrate a significant improvement in the overall survival of patients with advanced hepatocellular carcinoma (HCC), thereby introducing molecularly-targeted therapy in a therapeutic field of unmet needs. However, survival benefits for patients on sorafenib treatment are modest in clinical practice and advancing the field is far more challenging than initially anticipated. Molecular and clinical heterogeneity diminishes signals of potential activity in unselected populations, and underlying liver cirrhosis seals the fate of many novel targeted agents by causing relevant toxicity and mortality. The failure …

Field-practice study of sorafenib therapy for hepatocellular carcinoma: a prospective multicenter study in Italy

2011

A multicenter randomized controlled trial established sorafenib as a standard of care for patients with advanced hepatocellular carcinoma (HCC). Because the study was prematurely interrupted due to survival benefits in the sorafenib arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice. Starting in 2008, all clinically compensated patients with advanced HCC and those with an intermediate HCC who were unfit or failed to respond to ablative therapies were consecutively evaluated in six liver centers in Italy, for tolerability as well as radiologic and survival response to 800-mg/d sorafenib therapy. Treatment was down-dosed or inter…

Outcomes of hepatocellular carcinoma patients treated with sorafenib: a meta-analysis of Phase III trials

2019

Aim: To benchmark overall survival (OS) and time to radiological progression (TTP) of patients enrolled in randomized controlled trials (RCTs) assessing sorafenib in advanced hepatocellular carcinoma using individual participant survival data, and to meta-analyze prognostic factors for OS and TTP. Methods: RCTs were identified through literature search until December 2018. Individual participant survival was reconstructed with an algorithm from published Kaplan–Meier curves. Results: Ten RCTs were included. Median OS was 10.0 months (95% CI: 9.6–10.5), and median TTP was 4.1 months (95% CI: 3.8–4.3). Multivariable analyses showed HCV positivity, absence of macrovascular invasion and extra-…

Systemic therapy for intermediate and advanced hepatocellular carcinoma: Sorafenib and beyond.

2018

The hepatocellular carcinoma (HCC) treatment landscape changed a decade ago, with sorafenib demonstrating survival benefit in the first-line setting and becoming the first systemic therapy to be approved for HCC. More recently, regorafenib and nivolumab have received approval in the second-line setting after sorafenib, with further positive phase 3 studies emerging in the first line (lenvatinib non-inferior to sorafenib) and second line versus placebo (cabozantinib and ramucirumab). A key recommendation in the management of patients receiving sorafenib is to promote close communication between the patient and the physician so that adverse events (AEs) are detected early and severe AEs can b…

Immediate effects of the respiratory stimulation on ventilation parameters in ischemic stroke survivors: A randomized interventional study (CONSORT).

2019

Background: Post-stroke brain damage, which affects the central control of respiration, leads to various respiratory disorders. They can be caused by the weakening of the respiratory muscles and chest movements, which can indirectly contribute to an impairment of the ventilation function. The aim of the study is an objective assessment of the effect of a single-session intervention of respiratory stimulation through Proprioceptive Neuromuscular Facilitation (PNF) on chosen respiratory parameters and the following comparison of these changes with a group in which positioning was used (intra- and intergroup comparison). Methods: This was a randomized interventional study evaluating the respir…