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Århus, Denmark

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2011.2.4.2-1 | Award Amount: 16.05M | Year: 2011

WAKE-UP is an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial designed to test efficacy and safety of MRI-based intravenous thrombolysis in patients with wake-up stroke. Every year 1.5 million patients suffer a stroke in the EU. Up to 20% of stroke patients wake up with stroke symptoms. Currently these patients are excluded from thrombolysis which is the only approved specific treatment available for acute stroke. However, recently the potential of MRI to identify patients likely to be within a time-window for thrombolysis (4.5 hours) was demonstrated. WAKE-UP will use a specific MRI pattern, i.e. the mismatch between a visible lesion on diffusion weighted imaging (DWI) and a normal fluid attenuated inversion recovery (FLAIR) image, to randomise patients waking up with stroke symptoms to either treatment with Alteplase or placebo. The primary endpoint will be favourable outcome at 3 months. A total of 800 patients will be enrolled in 40 centres in six EU countries. Additional MRI information such as vessel occlusion or perfusion lesion will not be used for enrolment but will be studied as possible modifiers of the response to thrombolysis. Software will be developed to facilitate the processing and analysis of multiparametric stroke MRI and to assist the integration of modern stroke imaging into acute treatment decisions. The trial will be accompanied by activities increasing the awareness for acute stroke in the public and results will be disseminated within the scientific community as well as within the public. WAKE-UP is aimed to promote a paradigm-change in acute stroke treatment, and to provide effective treatment to a large new group of patients. The results of WAKE-UP are expected to change guidelines of acute stroke management and clinical practice. WAKE-UP will help to reduce the burden of stroke related disability in the EU.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.1.3-2 | Award Amount: 7.79M | Year: 2014

Immune system response is the most complex barrier to long-term success of tissue transplants/implants from allogeneic and bio-artificial sources. While newly developed tissue transplant procedures are not yet performed frequently enough for robust analysis of adverse immune responses in humans, corneal transplantation (CT) is a well-established allogeneic tissue transplant with >100,000 full- and partial-thickness procedures performed annually. Adverse immune responses occur in up to 30% of CT recipients causing rejection and failure. The high levels of CT clinical activity and immune complications create an ideal opportunity to comprehensively profile immune responses associated with adverse tissue transplant outcomes and to develop new approaches for their prevention or early diagnosis. VISICORT is a multi-disciplinary project with expertise in basic immunology, bio-sampling, systems biology/immune profiling, bioinformatics, clinical tissue transplantation and cell therapy. It will complete the first systematic immune profiling of biological samples from animal and human CT recipients with diverse outcomes. Clinical data and bio-specimens from over 700 CT recipients at 5 leading transplant centres will be centrally collated and distributed to cutting-edge university- and SME-based laboratories for multi-platform profiling and integrated bioinformatics analyses. Profiling data will generate better understanding of adverse immune reactions to tissue transplants. This knowledge will be used to develop novel biomarker-based surveillance strategies and, coupled with SME-based expertise in cell product development, will also inform the design and initiation of an optimised clinical trial strategy of immunomodulatory stromal stem cell therapy in high-risk human CT recipients. VISICORT research will strongly impact multiple EU research/scientific communities, patient cohorts and SMEs and will have high commercialisation value for the biopharmaceutical and biotechnology industries.

Agency: Cordis | Branch: FP7 | Program: MC-ITN | Phase: FP7-PEOPLE-2012-ITN | Award Amount: 3.77M | Year: 2013

The REtinal VAscular Modeling, Measurement And Diagnosis (REVAMMAD) project will train a new generation of scientists able to effectively translate the latest vascular modeling theory and computerized image analysis techniques into effective interventions for some of the most important chronic medic conditions afflicting the EU, including hypertension and diabetes. It will particularly ensure that there is rich clinical and industrial involvement to ensure that the training is focused with end-users and exploitation in mind. The vasculature undergoes changes in response to early stages of these diseases, reflecting fundamental physiological processes within the vessels. The retina provides a unique window onto the vasculature, allowing it to be viewed and measurements made in vivo, and advances in imaging technologies make it increasingly possible to measure subtle changes using computer vision algorithms, including through routine medical checks such as eye tests. The field is currently fragmented, with many excellent pockets of collaboration focused on defined specialisms, particularly between clinicians and modelers, or clinicians and measurement specialists, but lacking overall structure. Despite the importance and incidence of the diseases and the evidence for the possibility of better diagnosis through imaging, there has been relatively little translation of theory into clinical practice. Integrative action is required to train researchers who understand the medical, clinical, technological and commercial aspects of the problem domain and to establish common working methodologies and tools across the field. REVAMMAD will train early careers researchers who combine these skills in order to motivate the introduction of high impact interventions in the future.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: KBBE.2013.2.2-03 | Award Amount: 7.95M | Year: 2013

Vitamin D deficiency has significant implications for human health and impacts on healthy growth and development and successful aging. Fundamental knowledge gaps are barriers to implementing a safe and effective public health strategy to prevent vitamin D deficiency and optimize status. ODIN will provide the evidence to prevent vitamin D deficiency in Europe and improve nutrition and public health through food. By establishing an internationally standardized analytical platform for 25OHD, ODIN will measure the distribution of circulating 25OHD and describe the prevalence of vitamin D deficiency in Europe. Using available biobanks and databases from National nutrition surveys ODIN will delineate the relative contributions of sun and dietary sources of vitamin D to circulating 25OHD. In support of planned EFSA revisions of vitamin D recommendations, ODIN will carry out three RCT in pregnant women, children and teenagers and a fourth RCT in ethnic immigrant groups to provide experimental data to specify vitamin D intake requirements. Using dietary modeling, innovative food-based solutions to increase vitamin D in the food supply through a combination of bio-fortification of meats, fish, eggs, mushrooms and yeast will be developed and ODIN will test the efficacy and safety of these products in food-based RCT varying in scale from small product-specific trials to a large total diet study in vulnerable indigenous and immigrant sub-groups. ODIN has assembled the largest critical mass of prospective adult, pregnancy and birth cohort studies to date and will conduct meta-analyses and individual subject-level meta-regression analyses to integrate standardized data on vitamin D status, a priori defined clinical endpoints and genotype to examine relationships between vitamin D and human health, including beneficial and adverse effects, on perinatal outcomes, bone growth and body composition and allergic disease in children and cardiovascular disease and mortality in adults.

Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-01-2014 | Award Amount: 5.98M | Year: 2015

Neuropathic pain (NP) is common (population prevalence of 7-8%) and will present a rising health burden in the future. NP results in significant morbidity, reduces quality of life and has a major deleterious impact on health in aging. The reason why some subjects develop neuropathic pain and others do not following the same injury is not known. The exact nature of risk factors for NP and their interaction are currently poorly understood and will be the focus of this project. We will establish an international consortium of leading researchers in the field of NP (DOLORisk consortium) involving members of established academic European consortia studying pain/genomics and neuropathy as well as the SMEs Neuroscience Technologies and Mentis Cura. The project will be highly translational and the starting point will be the study of patients with NP or at risk of developing NP. Specific objectives will be to: 1) Identify the influence of demographic factors, environmental/societal and clinical factors on the risk of developing and maintenance of NP 2) To apply modern genomics to validate (using a targeted approach) and find novel (using genome wide association) genetic risk factors for NP. 3) Use tissue samples and patient derived cells from Biobanks to validate of molecular pathways contributing to chronic pain in patients. 4) To determine if patient stratification using physiological (sensory profile, endogenous analgesic mechanisms and nerve excitability) and psychological factors can predict NP risk and progression. 5) Development of a risk model/algorithm for (severe) NP, combining measurable genetic and environmental factors. Our aim is to understand pain pathophysiology in terms of risk factors and protective mechanisms ranging from molecular pathways to societal impacts. The desired impact is to provide a firm platform to improve diagnosis and stratify patients according to risk profile, employ preventive strategies and ultimately develop novel therapeutics.

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