A5014419185- Health Systems, Economic Evaluations, Quality of Life
- Ethics in Clinical Research
- Biomedical Ethics and Regulation
- Health and Medical Research Impacts
- Bipolar Disorder and Treatment
- Statistical Methods in Clinical Trials
- Neurotransmitter Receptor Influence on Behavior
- Meta-analysis and systematic reviews
- Clinical practice guidelines implementation
- Receptor Mechanisms and Signaling
- Pharmaceutical Economics and Policy
- Scientific Computing and Data Management
- Hepatitis C virus research
- Health, Environment, Cognitive Aging
- Neuroendocrine regulation and behavior
- Stress Responses and Cortisol
- Electroconvulsive Therapy Studies
- Pharmaceutical studies and practices
- Neuroscience and Neuropharmacology Research
- Hypothalamic control of reproductive hormones
- Pharmaceutical industry and healthcare
- Tryptophan and brain disorders
- Mental Health Treatment and Access
- Research Data Management Practices
- Healthcare Systems and Practices
European Clinical Research Infrastructure Network
2016-2025
Inserm
2006-2023
Royal Australasian College of Surgeons
2020
The University of Adelaide
2020
New York University Press
2020
Cambridge University Press
2020
Agencia de Evaluación de Tecnologías Sanitarias
2020
European Institute for Systems Biology and Medicine
2017
Hospital Clínic de Barcelona
2017
Ministère de l’Enseignement Supérieur et de la Recherche
2006-2017
Objectives We examined major issues associated with sharing of individual clinical trial data and developed a consensus document on providing access to participant from trials, using broad interdisciplinary approach. Design methods This was consensus-building process among the members multistakeholder task force, involving wide range experts (researchers, patient representatives, methodologists, information technology experts, representatives funders, infrastructures standards development...
Abstract Despite the high impact of mental disorders in society, European health research is at a critical situation with relatively low level funding, and few advances been achieved during last decade. The development coordinated policies integrated networks lagging behind other disciplines Europe, resulting lower degree cooperation scientific impact. To reduce more efficiently burden concerted new agenda necessary. ROAMER (Roadmap for Mental Health Research Europe) project, funded under...
Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, also outcome randomized clinical trials patients with hypoxic-ischemic brain injury after cardiac arrest. awake stroke has been shown feasible phase II trials.To determine whether systemic cooling to a target body temperature between 34·0 35·0°C, started within six-hours of symptom onset maintained for 24 h, improves functional at three-months acute stroke.International, multicenter,...
Psychiatric side effects are common during interferon-alfa (IFN-alfa) therapy and often responsible for early treatment discontinuation, thus limiting its therapeutic potential. Depression is considered the hallmark of these effects. However, irritability, anger/hostility, manic/hypomanic episodes have also been reported, suggesting that symptoms important features IFN-alfa-induced neuropsychiatric effects.The aim this prospective study was to use item-by-item analysis thoroughly...
Background: Normothymic states in bipolar disorders are generally considered to be devoid of severe symptoms. However, patients present subsyndromal symptoms for half their lives, and often have comorbid psychiatric disorders. If we go beyond the concept temperamental features, can identify certain emotional characteristics distinguishing normothymic from normal controls? We previously showed, using self‐completed questionnaires, that display higher levels lability intensity than controls....
Introduction We assessed whether modest systemic cooling started within 6 hours of symptom onset improves functional outcome at three months in awake patients with acute ischaemic stroke. Patients and methods In this European randomised open-label clinical trial blinded assessment, adult stroke were to a target body temperature 34.0–35.0°C, h after maintained for 12 or 24 , versus standard treatment. The primary was the score on modified Rankin Scale 91 days, as analysed ordinal logistic...
Last September, the European Commission published proposals to update regulations for medical devices in order improve patient safety.1 The are being discussed by parliament where critical debate is led Committee on Environment, Public Health and Food Safety. Medical range from bandages life support machines, manufacturers classify them into four risk categories low (such as urine drainage bags) high drug eluting cardiac stents) according EU rules.2 associated with device depends duration...
The psychiatric side effects of interferon, often responsible for dose reduction or treatment discontinuation, represent a major limitation in the chronic hepatitis C (CHC).To prospectively assess impact on adherence and sustained virological response (SVR) occurrence during peginterferon ribavirin therapy CHC.Ninety-eight consecutive treatment-naïve CHC patients receiving standard course plus were systematically screened effects, using DSM-IV, at baseline both after treatment.Psychiatric...
'Compassionate use' programmes allow medicinal products that are not authorised, but in the development process, to be made available patients with a severe disease who have no other satisfactory treatment them. We sought understand how such regulated ten European Union countries. The Clinical Research Infrastructures Network (ECRIN) conducted comprehensive survey on clinical research regulatory requirements, including questions regulations of 'compassionate programmes. Ten countries,...
Data standards are not only key to making data processing efficient but also fundamental ensuring interoperability. When clinical trial structured according international standards, they become significantly easier analyze, reducing the efforts required for cleaning, preprocessing, and secondary use. A common language a shared set of expectations facilitate interoperability between systems devices. The main objectives this study were identify commonalities differences in metadata, protocols,...
Abstract Background The relationship between depression and mania remains poorly understood is responsible for much of the confusion about mixed states. difficulty in conceptualizing opposite states such as euphoric depressive moods during same episode may account considerable differences reported frequencies states, among acutely manic patients. It possible that fundamental mood characteristic not tonality (e.g. euphoric, irritable or depressed mood), but rather intensity emotions. Methods...