Search results for "trial design"
showing 10 items of 26 documents
Advances on mechanics, design engineering and manufacturing
2018
The theme of the present editorial is dedicated to the“Advances on Mechanics, Design Engineering and Manufac-turing” that emerge in different engineering and architecturalfields.The theme has been chosen as leitmotiv of a series ofevents that have been organized by three societies operatingin Italy, Spain and France, respectively: ADM (Associ-azione nazionale Disegno e Metodi dell’ingegneria indus-triale), INGEGRAF (Asociación Española de IngenieríaGráfica and AIP-PRIMECA (Ateliers Inter-établissementsde Productique—Pôles de Resources Informatiques pour laMECAnique). Since 2014, a series of JCM conferences havebeen organized. JCM is the acronym of “Joint Conference onMechanics, Design Engin…
The calm before the storm: a report from the International Liver Cancer Association Congress 2015 – part 2
2016
International Liver Cancer Association Congress 2015, Paris, France, 4–6 September 2015 Since its creation 9 years ago, in 2007, the International Liver Cancer Association has focused on the multidisciplinary approach to liver cancer due to advances in hepatology science and care worldwide. In its 2015 annual conference, held on 4–6 September in Paris, France, the most recent progresses in the basic biology, management and treatment of liver cancer have been presented. This report, divided into two parts, introduces and critically reviews some of the most intriguing topics discussed at the meeting.
Opportunities and challenges for drug development: public-private partnerships, adaptive designs and big data
2016
Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public-private partnerships, adaptive designs and big data. Public-private partnerships come in many different forms with regard to scope, duration and typ…
Multidisciplinary management of stage II-III gastric and gastro-oesophageal junction cancer.
2019
The aim of this manuscript is to discuss the viewpoint of the European Organisation for Research and Treatment of Cancer (EORTC) Gastric Cancer Taskforce and Japan Clinical Oncology Group (JCOG) Gastric Cancer Study Group on the current challenges in the multidisciplinary management of stage II-III gastric and gastro-oesophageal junction (GEJ) cancer. We seek to outline how these challenges are addressed in current trials of both groups. Key elements of future trials of EORTC and JCOG in this indication are described, and a joint vision on how multidisciplinary research of gastric and GEJ cancer patients should be organised is outlined. ispartof: EUROPEAN JOURNAL OF CANCER vol:124 pages:67-…
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…
Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale…
2021
BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, im…
VirDe: A new virtual reality design approach
2008
Virtual reality (VR), even if it does not represent any more a novel technology, is one of the most powerful tool to help designers during the development of new projects. This is proved by very numerous research activities related to this field. In this research, we have studied a new way to approach the development of a product. We present the ongoing development of a system, called VirDe, acronym of virtual design, which can allow the designers to perform the whole design process, from the modelling phase to the finite element method (FEM) simulation analysis, in a virtual reality environment. This new method allows remarkable time and money saving in the overall product design process, …
L'insegnamento della composizione architettonica nella formazione dell'industrial designer : note su una esperienza didattica a Palermo
2021
Questo contributo porta a conoscenza alcuni risultati didattici ottenuti all’interno del laboratorio di Architectural Design (10 cfu), guidato dall'autore durante l’anno accademico 19-20 presso il Dipartimento di Architettura dell’Università degli Studi di Palermo, corso di laurea in Disegno Industriale. L’obiettivo che si pone è mostrare una sintetica selezione dei progetti eseguiti dagli allievi del laboratorio e, più in generale, per riflettere sulla “tenuta” dell’insegnamento del progetto d’architettura nella formazione dell’industrial designer: una figura professionale che sempre più spesso sottrae, a quella dell’architetto, il controllo sugli interventi a “piccola scala” (allestimenti…
Chairs' welcome message
2004
In this paper we present techniques for comparison between behavioral level and register transfer level (RTL) design descriptions by mapping the designs into virtual controllers and virtual datapaths. We also discuss about how the equivalence between behavioral level and RTL designs can be defined precisely using the proposed "attribute statements" in an interactive fashion. Implementation issues as well as considerations on real life industrial design examples are presented as well.
Beta‐blockers withdrawal in patients with heart failure with preserved ejection fraction and chronotropic incompetence: Effect on functional capacity…
2020
Abstract Background The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence (ChI) has emerged as a crucial pathophysiological mechanism. Beta‐blockers, drugs with negative chronotropic effects, are commonly used in HFpEF, although current evidence does not support its routine use in these patients. Hypothesis We postulate beta‐blockers may have deleterious effects in HFpEF and ChI. This work aims to evaluate the short‐term effect of beta‐blockers withdrawal on functional capacity assessed by the maximal oxygen uptake (peakVO2) in patients with HFpEF and ChI. Methods This is a prospective, crossover, randomized (1…