Search results for "Research Design"
showing 10 items of 487 documents
Transition Care in Anorexia Nervosa Through Guidance Online from Peer and Carer Expertise (TRIANGLE): Study Protocol for a Randomised Controlled Trial
2017
TRIANGLE is a multicentre trial investigating whether the addition of a novel intervention for patients and carers (ECHOMANTRA) to treatment as usual (TAU) improves outcomes for people with anorexia nervosa (AN). ECHOMANTRA is based on the cognitive interpersonal model of AN and includes assessments, workbooks, videos, online groups and joint Skype sessions for patients and carers. People receiving intensive hospital treatment (N = 380) will be randomised to TAU or TAU plus ECHOMANTRA. Participants will be assessed over an 18-month period following randomisation. The primary outcome is patient psychological well-being at 12 months postrandomisation. Secondary outcomes include (i) patient's …
Evidence of bias in randomized clinical trials of hepatitis C interferon therapies
2017
Introduction: Bias may occur in randomized clinical trials in favor of the new experimental treatment because of unblinded assessment of subjective endpoints or wish bias. Using results from published trials, we analyzed and compared the treatment effect of hepatitis C antiviral interferon therapies experimental or control. Methods: Meta-regression of trials enrolling naïve hepatitis C virus patients that underwent four therapies including interferon alone or plus ribavirin during past years. The outcome measure was the sustained response evaluated by transaminases and/or hepatitis C virus-RNA serum load. Data on the outcome across therapies were collected according to the assigned arm (exp…
Perceiving Need for Lifestyle Counseling
2012
OBJECTIVE To investigate the proportion of individuals at high risk of type 2 diabetes who perceive the need for lifestyle counseling, factors associated with this perception, and whether the perceived need is associated with subsequent attendance in lifestyle intervention. RESEARCH DESIGN AND METHODS Baseline and intervention data were obtained from 10,149 participants in a Finnish National Diabetes Prevention Project. RESULTS In total, 36% of men and 52% of women perceived the need for counseling. Most of the risk factors did not increase the perceived need for counseling. Those agreeing to attend supervised lifestyle intervention were more likely to report a perceived need than those wh…
Treatment of Recent-Onset Type 1 Diabetic Patients With DiaPep277: Results of a Double-Blind, Placebo-Controlled, Randomized Phase 3 Trial.
2014
OBJECTIVE To evaluate safety and efficacy of DiaPep277 in preserving β-cell function in type 1 diabetic patients. RESEARCH DESIGN AND METHODS DIA-AID 1 is a multinational, phase 3, balanced-randomized, double-blind, placebo-controlled, parallel-group clinical study. Newly diagnosed patients (N = 457, aged 16–45 years) were randomized to subcutaneous injections of DiaPep277 or placebo quarterly for 2 years. The primary efficacy end point was the change from baseline in the area under the glucagon-stimulated C-peptide curve. Secondary end points were the change from baseline in mixed-meal stimulated C-peptide secretion and in fasting C-peptide and achieving target HbA1c ≤7% (≤53 mmol/mol). P…
Straining at work and its relationship with personality profiles and individual consequences in healthcare workers (HCWs)
2020
Straining is an attenuated form of mobbing, in which the continuity of vexatious actions is not driven by a discriminatory intent. With the objective of testing the possible moderating role of personality in the relationship between perceptions about straining at work and individual consequences, a correlational design research involved 374 healthcare workers (HCWs) from two Italian hospitals. The following questionnaires were administered: (1) Short Negative Acts Questionnaire (S-NAQ), to assess discriminative actions at work)
Computer simulations for bioequivalence trials: Selection of analyte in BCS class II and IV drugs with first-pass metabolism, two metabolic pathways …
2018
A semi-physiological two compartment pharmacokinetic model with two active metabolites (primary (PM) and secondary metabolites (SM)) with saturable and non-saturable pre-systemic efflux transporter, intestinal and hepatic metabolism has been developed. The aim of this work is to explore in several scenarios which analyte (parent drug or any of the metabolites) is the most sensitive to changes in drug product performance (i.e. differences in in vivo dissolution) and to make recommendations based on the simulations outcome. A total of 128 scenarios (2 Biopharmaceutics Classification System (BCS) drug types, 2 levels of KM Pgp, in 4 metabolic scenarios at 2 dose levels in 4 quality levels of t…
Direct-acting antiviral agents and risk of hepatocellular carcinoma: is it still a clinical dilemma?
2019
Direct-acting antivirals (DAAs) revolutionised the treatment of chronic HCV-related disease achieving high rates of sustained virological response (SVR), also in more advanced patients, with a good safety profile and a proven positive effect on the reduction of risk of HCC occurrence. Nevertheless, patients with an history of successfully treated early HCC were initially excluded from pivotal trials. Although some initial retrospective studies, affected by several methodological issues, raised concerns regarding a possible harmful effect on the risk of HCC recurrence after antiviral therapy, more recent prospective studies and meta-analyses provided evidence that risk of HCC recurrence afte…
Enzyme replacement therapy for mucopolysaccharidosis VI: evaluation of long-term pulmonary function in patients treated with recombinant human N-acet…
2010
Pulmonary function is impaired in untreated mucopolysaccharidosis type VI (MPS VI). Pulmonary function was studied in patients during long-term enzyme replacement therapy (ERT) with recombinant human arylsulfatase B (rhASB; rhN-acetylgalactosamine 4-sulfatase). Pulmonary function tests prior to and for up to 240 weeks of weekly infusions of rhASB at 1 mg/kg were completed in 56 patients during Phase 1/2, Phase 2, Phase 3 and Phase 3 Extension trials of rhASB and the Survey Study. Forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and, in a subset of patients, maximum voluntary ventilation (MVV), were analyzed as absolute volume in liters. FEV1 and FVC showed little change f…
Safety and feasibility of atropine added in patients with sub-maximal heart rate during exercise myocardial perfusion SPECT.
2006
Failure to reach 80% of maximal predicted heart rate (HR) during exercise may render a myocardial perfusion single photon emission computed tomography (SPECT) study non-diagnostic for ischemia detection. We sought to investigate the injection of atropine in patients who fail to achieve 80% of age-predicted HR during exercise performed for myocardial perfusion SPECT (MPS), defining its safety and efficacy to raise HR to adequate levels as well as its effect on MPS interpretation.Between January 2002 and December 2004, we studied 3,150 consecutive patients (2,253 men and 897 women, mean age 55 +/- 6 years) who were referred to a single office-based nuclear cardiology laboratory for MPS using …
Association between COX-2 rs 6681231 genotype and interleukin-6 in periodontal connective tissue. A pilot study.
2014
[Objectives] The aim of this pilot study was to investigate associations between IL-6 and COX-2 expression in gingival biopsies and both clinical diagnosis and genotypes in the IL-6 and COX-2 genes. [Design] A case-control study included 41 gingival biopsies obtained from Caucasian patients grouped according to clinical diagnosis of gingival health (n = 10), gingivitis (n = 15) or chronic periodontitis (n = 16). Immunohistochemistry analyses were performed to determine COX-2 expression in lamina propria, IL-6 expression in lamina propria and gingival epithelium and level of inflammatory cell infiltrate. Individual DNA was extracted and genotyped by real-time PCR for IL6 SNPs rs 2069827 and …