Search results for " Clinical trial"
showing 10 items of 139 documents
Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA(2) LEN taskforce position…
2011
To cite this article: Baiardini I, Braido F, Bindslev-Jensen C, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, Gerth van Wijk R, Giménez-Arnau A, Godse K, Grattan C, Grob JJ, La Grutta S, Kalogeromitros D, Kocatürk E, Lombardi C, Mota-Pinto A, Ridolo E, Saini SS, Sanchez-Borges M, Senna GE, Terreehorst I, Todo Bom A, Toubi E, Bousquet J, Zuberbier T, Maurer M. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA(2) LEN taskforce position paper. Allergy 2011; 66: 840-844. ABSTRACT: The aim of this Global Allergy and Asthma European Network (GA(2) LEN) consensus report is to provide recommendations …
Aspirin use and breast cancer risk: a meta-analysis and meta-regression of observational studies from 2001 to 2005
2007
Purpose To examine the recent epidemiological studies on aspirin use and breast cancer risk published from 2001 to 2005 within a meta-analysis, to investigate reasons for heterogeneity between the individual studies and to analyse a dose-response-relationship considering frequency and duration of use. Methods We systematically searched for cohort-studies and case-control-studies from 2001–2005, which evaluated the association between aspirin and breast cancer risk. We calculated a pooled estimate for the relative risk (RR) and investigated reasons for heterogeneity between the individual studies and analysed a dose-response-relationship using random effects mixed models. Results We identifi…
Optimizing the Personalized, Risk-Adjusted Management of Pulmonary Embolism: An Integrated Clinical Trial Programme
2018
Acute pulmonary embolism (PE) contributes significantly to the global burden of cardiovascular disease. The severity of the acute PE event determines the expected estimated risk of early death. This risk is influenced by the degree of dysfunction of the right ventricle (RV), as assessed by the presence of acute RV pressure overload on imaging and/or elevated cardiac biomarkers, and by demographic and clinical factors, including relevant comorbidities. Haemodynamic instability and cardiogenic shock is at the top of the PE severity spectrum, as it represents the most extreme manifestation of RV failure and a key determinant of poor prognosis. Ideally, risk-adjusted treatment should implement:…
randomized clinical trials in perianal disease.
2012
Abstract: Crohn’s disease can be complicated by the development of fistulas, 54% of which involve the perianal region. The presence of perianal fistulas predicts a disabling course of Crohn’s disease. The treatment of complex perianal disease is difficult and the chance of complete fistula healing is no more than 50%. The best management of this condition is a combining medical and surgical therapy. Studies which evaluated the efficacy of medical treatments in this setting are small, open label and considered the efficacy on perianal disease as a second outcome or as the result of a subgroup analysis. In the few available trials the efficacy outcomes were evaluated by the Fistula Drainage A…
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-…
Effect of a common exercise programme with an individualised progression criterion based on the measurement of neuromuscular capacity versus current …
2021
IntroductionHigh-load resistance training has shown positive effects in pain and function in lower limb tendinopathies. However, some authors suggest that current exercise programmes produce an increase in tolerance to load and exercise in general but without fixing some existing issues in tendinopathy. This may indicate the need to include training aspects not currently taken into account in the current programmes. The main objective of this study will be to compare the effect of a common exercise protocol for the three predominant lower limb tendinopathies (Achilles, patellar and gluteal), based on an individualised control of the dose and training of specific aspects of the neuromuscular…
Multiple Comparisons of Treatments with Stable Multivariate Tests in a Two‐Stage Adaptive Design, Including a Test for Non‐Inferiority
2000
The application of stabilized multivariate tests is demonstrated in the analysis of a two-stage adaptive clinical trial with three treatment arms. Due to the clinical problem, the multiple comparisons include tests of superiority as well as a test for non-inferiority, where non-inferiority is (because of missing absolute tolerance limits) expressed as linear contrast of the three treatments. Special emphasis is paid to the combination of the three sources of multiplicity - multiple endpoints, multiple treatments, and two stages of the adaptive design. Particularly, the adaptation after the first stage comprises a change of the a-priori order of hypotheses.
Test and power considerations for multiple endpoint analyses using sequentially rejective graphical procedures
2009
A variety of powerful test procedures are available for the analysis of clinical trials addressing multiple objectives, such as comparing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, etc. However, some of these procedures have reached a level of complexity that makes it difficult to communicate the underlying test strategies to clinical teams. Graphical approaches have been proposed instead that facilitate the derivation and communication of Bonferroni-based closed test procedures. In this paper we give a coherent description of the methodology and illustrate it with a real clinical trial example. We further discuss suitable power measur…
A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial
2019
Background: Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist. The aim of this study will be to compare the effectiveness of a central nervous system (CNS)-directed treatment program versus a standard medical and physical therapy care program on outcomes in participants with FS. Methods/design: The study is a two-group, randomized clinical trial with blinding of participants and assessors. Participants will be recruited via referrals fr…
The mediating role of emotion regulation in transdiagnostic cognitive behavioural therapy for emotional disorders in primary care: Secondary analyses…
2022
Background: Emotional disorders are highly prevalent in primary care. Transdiagnostic cognitive behavior therapy (TD-CBT) is a promising treatment of emotional disorders. In this study, we evaluated several emotion regulation strategies as potential mediators of treatment outcomes in a clinical sample of primary care. Methods: A total of 1061 primary care patients were included in a randomized clinical trial comparing treatment- as-usual (TAU) to TD-CBT+TAU. Of these, 631 (TAU=316; TD-CBT+TAU=315) completed the full treatment and all pre- and post-treatment scales to assess symptoms (anxiety, depression, somatization), emotion regulation strategies (worry, rumination, negative metacognition…