Search results for "clinical research"
showing 10 items of 474 documents
Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol…
2017
Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ accordin…
NEONAX trial: Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer, a phase II study of the AI…
2019
4128 Background: Survival in pancreatic cancer (PDAC) is still poor even after curatively intended resection. Perioperative treatment approaches improve outcome in various tumor entities. Data on perioperative treatment in resectable PDAC are limited and there is a debate whether neoadjuvant treatment might impair subsequent surgery by adding perioperative morbidity or mortality. Methods: NEONAX is a randomized phase II study (planned 166 patients) of perioperative gemcitabine/nab-paclitaxel (Arm A: 2 pre- and 4 post-operative cycles, Arm B: 6 cycles adjuvant) for patients with primarily resectable PDAC. Primary objective is DFS at 18 months after randomization. Secondary objectives are 3-…
Known knowns and known unknowns on behavior change interventions and mechanisms of action.
2020
Systematic reviews and meta-analyses of research play an important role in summarizing current knowledge on the efficacy of the behavior change techniques and mechanisms of action that comprise behavioral interventions. The current reviews in the science of behavior change (SOBC) special issue represent a ‘step change’ in evaluating current evidence on behavior change interventions and mechanisms. This concluding article outlines the key findings and emerging issues identified in the reviews (‘known knowns’), and summarizes the evidence gaps highlighted by the reviews that need to be addressed in future research (‘known unknowns’). Specifically, findings of the reviews indicate that: tests …
Characteristics and treatment regimens across ERS SHARP severe asthma registries
2020
Little is known about the characteristics and treatments of patients with severe asthma across Europe, but both are likely to vary. This is the first study in the European Respiratory Society Severe Heterogeneous Asthma Research collaboration, Patient-centred (SHARP) Clinical Research Collaboration and it is designed to explore these variations. Therefore, we aimed to compare characteristics of patients in European severe asthma registries and treatments before starting biologicals.This was a cross-sectional retrospective analysis of aggregated data from 11 national severe asthma registries that joined SHARP with established patient databases.Analysis of data from 3236 patients showed many …
Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) …
2017
Background HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12. Methods This multicentre, open-label, single-arm study (NCT01846832) evaluated efficacy and safety of simepre…
Self-Efficacy, Planning, or a Combination of Both? A Longitudinal Experimental Study Comparing Effects of Three Interventions on Adolescents’ Body Fat
2016
Author(s): Luszczynska, Aleksandra; Hagger, Martin S; Banik, Anna; Horodyska, Karolina; Knoll, Nina; Scholz, Urte | Abstract: BackgroundThe superiority of an intervention combining two sets of theory-based behavior change techniques targeting planning and self-efficacy over an intervention targeting planning only or self-efficacy only has rarely been investigated.PurposeWe compared the influence of self-efficacy, planning, and self-efficacy+planning interventions with an education-based control condition on adolescents' body fat, assuming mediating effects of respective social cognitive variables and moderate-to-vigorous physical activity (MVPA). The moderating role of the built environment…
Predicting school students’ physical activity intentions in leisure-time and school recess contexts: Testing an integrated model based on self-determ…
2021
BackgroundIdentifying psychological correlates of children's physical activity intentions may signpost potentially modifiable targets for interventions aimed at promoting physical activity participation. School recess and leisure-time outside of school are appropriate contexts in which such interventions may be delivered. However, few studies have identified correlates of physical activity intentions in these environments. Examining correlates in these contexts may provide formative evidence on which to base interventions to promote physical activity.PurposeThe current study adopted an integrated theoretical model to test relations between motivational constructs from self-determination the…
Predictors of school students’ leisure-time physical activity : An extended trans-contextual model using Bayesian path analysis
2021
Abstract Background:The trans-contextual model (TCM) has been applied to identify the determinants of leisure-time physical activity participation in secondary school students. In the current study, the TCM was extended to include additional constructs that represent non-conscious, implicit processes that lead to leisure-time physical activity participation alongside the motivational and social cognition constructs from the TCM. The current study used baseline and follow-up data from an intervention study to test the extended TCM.Methods:The current study adopted a two-wave prospective design. Secondary-school students (N = 502) completed measures of perceived autonomy support from physical…
Social cognition theories and behavior change in COVID-19: A conceptual review.
2022
The COVID-19 pandemic has had unprecedented health, economic, and social consequences worldwide. Although contact reductions and wearing face coverings have reduced infection rates, and vaccines have reduced illness severity, emergence of new variants of the coronavirus that causes COVID-19, and the shift from pandemic to endemic patterns of infection, highlights the importance of ongoing preventive behavior adherence to manage future outbreaks. Research applying social cognition theories may assist in explaining variance in these behaviors and inform the development of efficacious behavior change interventions to promote adherence. In the present article, we summarize research applying the…
Sorafenib In Combination with Standard Induction and Consolidation Therapy In Elderly AML Patients: Results From a Randomized, Placebo-Controlled Pha…
2010
Abstract Abstract 333 Background: Standard chemotherapy for elderly AML patients results in a median overall survival of only about one year. Case reports and early phase I/II data have shown that the kinase inhibitor Sorafenib might show clinical benefit for Flt3-ITD-positive AML patients (Metzelder S Blood 2009; 113:6567) and that its addition to standard chemotherapy is feasible (Ravandi F JCO 2010; 28:1856). Sorafenib is a potent Raf, c-Kit and FLT3 inhibitor that may also affect AML blasts and bone marrow (BM) stroma cells via VEGFR and PDGFR-β inhibition. Therefore, we performed a multicenter, randomized, placebo-controlled, double-blind phase II trial in elderly (>60 y) AML pa…