Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Optimized Diagnostics for Improved Treatment Stratification in Invasive Fungal Diseases (FUNGITECT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Austria,Germany,Bosnia and Herzegovina,Switzerland,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2019-01-31
Duration (months): 60.0
Total project cost (EUR): 7630575.6
EU funding (EUR): 5844418.0
Participants: 6
Project status: CLOSED

Invasive fungal disease (IFD) is a leading cause of morbidity and mortality in the growing number of immunocompromised individuals, including particularly cancer patients, and bone-marrow or organ transplant recipients. The majority of IFD events are still caused by Candida and Aspergillus species, but there is an increasing incidence of resistant or previously uncommon moulds, yeasts and Zygomycetes. Timely pathogen detection is a prerequisite for effective therapy in patients with IFD. FUNGITECT will focus on this medical priority and develop, validate and market a specific set of novel molecular diagnostic tests for IFD targeting fungal DNA-, RNA- and protein motifs, as well as the enzymatic activity of fungal pathogens. Additionally, FUNGITECT will provide a unique opportunity to establish and implement highly effective diagnostic assays supported by Next-Generation Sequencing and a bioinformatics service platform, facilitating optimized treatment strategies adapted to individual patient requirements with the following paramount aims: i) to provide the diagnostic basis for stratified and timely administration of the most appropriate antifungal therapy permitting improved management of patients with IFD, ii) to decrease the rate of overtreatment and the ensuing adverse side effects including fungal resistance, and iii) to help reduce the enormous healthcare costs for clinical antifungal therapy. The consortium includes leading academic research institutions, SMEs and Industry already successfully positioned in the market.

Keywords: invasive fungal disease,next-generation sequencing,molecular diagnostics,treatment stratification,bioinformatics,drug resistance,antimicrobials,antibodies,pcr,dna,rna,sops
MicroRNAs in the Pathogenesis, Treatment and Prevention of Epilepsy (EPIMIRNA)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Ireland,Germany,Netherlands,United Kingdom,Italy,Germany,United States,Brazil,Denmark,Denmark,France,Finland,Germany,Netherlands
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2018-08-31
Duration (months): 60.0
Total project cost (EUR): 15567904.02
EU funding (EUR): 11586858.0
Participants: 19
Project status: CLOSED

Epilepsy is a major burden for patients and health systems worldwide. It is a common chronic neurological disorder affecting people of all ages, and the shortfall in existing treatments means that 30% of patients continue to suffer uncontrolled seizures. MicroRNAs (miRNA) are a recently-discovered, network-level layer of gene expression regulation that controls protein levels of entire signaling pathways. Research on miRNAs has unprecedented potential to (i) further our understanding of the underlying disease processes, (ii) deliver novel signatures and prognostic markers for response to therapy, and (iii) deliver novel therapeutics and drug targets. EpiMiRNA consortium members have pioneered discoveries on brain-specific miRNAs, established that miRNA changes are a feature of the pathophysiology of human temporal lobe epilepsy and have demonstrated experimentally that altering miRNA function can potently suppress epileptic seizures and seizure-damage. EpiMiRNA brings together experts on the neurobiology of miRNAs with the leading researchers working on miRNAs in epilepsy, epilepsy geneticists, leaders in miRNA-target detection, proteomics, and systems biology with research-intensive SMEs pursuing miRNA therapeutics and treatments for pharmacoresistant epilepsy. Through highly collaborative, inter-disciplinary and inter-sectorial research, EpiMiRNA will explain the mechanism by which miRNAs contribute to epileptogenesis, characterize genetic variation of miRNA in patients, evaluate seizure-suppressing effects of miRNAs in experimental models, identify novel miRNA modulatory molecules as potential future therapeutics, and develop miRNAs as prognostic markers to identify patients who respond to novel, non-pharmacological therapeutic interventions including brain stimulation. EpiMiRNA will generate the necessary critical mass in biomedical, clinical and industry/SME research to track, treat and prevent seizures and improve the clinical management of epilepsy patients.

Keywords: anti-epileptic drugs,epileptogenesis,epigenetics,hippocampal sclerosis,deep brain stimulation,non-coding rna,next generation sequencing,neuroprotection,proteomics,systems biology,tolerance
Social innovation to improve physical activity and sedentary behaviour through elite European football clubs: European Fans in Training (EUROFIT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: United Kingdom,Netherlands,Netherlands,Norway,Portugal,Ireland,United Kingdom,United Kingdom,United Kingdom,Belgium,United Kingdom,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-11-01
End date: 2018-10-31
Duration (months): 60.0
Total project cost (EUR): 7771992.42
EU funding (EUR): 5957158.0
Participants: 14
Project status: CLOSED

Concept and aim: 20 million fans attend top division football games each week and many more watch on TV. Our social innovation is to attract people to lifestyle change through the personal connection and loyalty to the club they support. Our aim is to use this social innovation to change physical activity and sedentary behaviour, specially targeting low-SES groups, and men as well as women. EuroFIT is supported by UEFA and top football clubs. Workplan: End-users and policy-makers are involved throughout. We will: a) produce a device (SitFIT) that provides real-time feedback on objectively measured sedentary time and physical activity; b) deploy and evaluate smartphone games to drive activity through social interaction (MatchFIT); c) integrate these with state-of-the-art evidence on behavioural change and its maintenance in a web-supported lifestyle programme delivered by top EU football clubs (EuroFIT)). We will evaluate EuroFIT in a multi-centre randomised controlled trial to assess impact on physical activity and sedentary behaviour, physical and mental health and weight. We will investigate the correlates of long-term changes and impact on participants’ families. Finally we will develop a robust strategy for replication of EuroFIT Impact: We will generate excellent research evidence on the use of social innovation for health. Social impact will include reductions in health risk, improvements in well-being and the decreased inequalities as more men, especially those in low SES groups, are attracted to lifestyle change. Research impact will be achieved through new understanding of the how health indicators respond to change in sedentary behaviour and physical activity and through new knowledge of longterm maintenance of lifestyle changes. Policy impact will result from the production of clear implementation strategies and involvement of policy makers and opinion leaders from the outset, supported by a targeted communication strategy.

Keywords: social innovation,behavioural change,loyalty,peer pressure,football,reaching hard-to-reach audiences,social impact,biomarkers of health improvement
Taking imaging into the therapeutic domain: Self-regulation of brain systems for mental disorders (BRAINTRAIN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,France,Germany,Israel,Portugal,United Kingdom,Netherlands,Netherlands
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-11-01
End date: 2018-10-31
Duration (months): 60.0
Total project cost (EUR): 7782124.05
EU funding (EUR): 5998661.0
Participants: 13
Project status: CLOSED

Our proposal is based on the idea that real-time functional neuroimaging can be used to train patients to regulate their own brain activity via neurofeedback training and thus modulate the brain networks of mental disorder, restore function, improve symptoms and promote resilience. We have brought together the core groups that have been instrumental in the development of methods for real-time functional imaging and fMRI (functional magnetic resonance)-based neurofeedback and have led the initial clinical applications in neuropsychiatric disorders. Our proposal has three main components, the development and refinement of methods for the real-time analysis and feedback of fMRI data and combination with other imaging modalities (WP2), the adaptation of fMRI mapping techniques to localise disease-relevant networks and development of protocols for their self-regulation through neurofeedback (WP3) and the assessment of feasibility and clinical effects in several mental disorders that are characterised by dysfunctional brain systems for motivation, emotion regulation and social communication and by important therapeutic gaps (autism spectrum disorders, alcohol addiction, post-traumatic stress disorder, childhood anxiety disorders, binge-eating disorder) (WP4). We will also explore the potential transfer of (laboratory-based) imaging feedback training into everyday settings through ambulatory and assistive technologies such as electroencephalography (EEG) and gaming (WP5). We will engage with potential users of these technologies (healthcare professionals and providers, medical instrument and software manufacturers, patient and carer associations) through several workshops, liaise with regulatory authorities and disseminate findings to the academic and user communities in WP6.

Keywords: magnetic resonance imaging,neurofeedback,addiction,anxiety,autism,obesity,treatment
Metformin for treatment of polycystic ovary syndrome in children (METFIZZ)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Collaborative project
Countries involved: France,Switzerland,United Kingdom,Denmark,Spain
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2017-03-31
Duration (months): 42.0
Total project cost (EUR): 8624558.2
EU funding (EUR): 5999962.0
Participants: 7
Project status: TERMINATED

PCOS, a common disorder affecting 5-10% of women of reproductive age is characterized by cystic ovarian morphology, androgen excess, and/or irregular periods and emerges during or shortly after puberty. The common off-label use of metformin for treating PCOS in children appears to have no greater risk than that in adults; drug tolerance is good with limited adverse effects. However, clinical trials are needed and requested by EMA to validate the safety and efficacy of this agent in PCOS. In January 2012, the EMA released a revised priority list of PUMA generic medicines and Metformin was identified as a requested drug for treatment of PCOS in children. The call requests data on pharmacokinetics, efficacy and safety in this indication. A PIP was submitted to EMA in August 2012. In its final opinion of 17 May 2013 the PDCO recommend to agree to the PIP. The PDCO and the consortium have agreed that by restricting exposure to no more than 2000 mg metformin / day, no additional pharmacokinetic investigations are required or even requested by EMA. METFIZZ will conduct the required product development and clinical studies to establish efficacy and safety of administering age-appropriate innovative effervescent soluble formulations of metformin. The studies will focus attention on ethics in this psychologically sensitive condition, guided by the current legislation and by engaging patients and caregivers along with an independent ethics expert. Currently, there are no age-appropriate dosing forms of metformin for treatment of PCOS in paediatric populations. This can result in over or under dosing, lack of medication compliance, dangers of iatrogenic harms. METFIZZ embraces clinical development, manufacturing scale up, and registration aspects of this pharmaceutical development programme. Coordinator SME EffRx together with 4 SME-CROs and at least 20-30 related study centres will carry out the clinical study in 4 EU member states. The statistical analysis plan requires approximately 150 patients to be randomized into the PCOS study. EffRx will lead the METFIZZ product commercialisation to benefit children in Europe.

Keywords: metformin,pcos,pharmacokinetics,safety,efficacy,juveniles and adolescents,effervescent soluble formulations,epm,pip,puma
European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: United Kingdom,Netherlands,Germany,Spain,Belgium,United Kingdom,Hungary,United Kingdom,United Kingdom,Croatia
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2016-09-30
Duration (months): 36.0
Total project cost (EUR): 2565241.3
EU funding (EUR): 2047908.0
Participants: 11
Project status: CLOSED

Tobacco smoking costs the EU an estimated 98 to 130 billion Euros each year – just above 1% of the EU Gross Domestic Product in 2000. A large, robust and consistent evidence base indicates that coordinated, high impact and comprehensive approaches are the most effective way to reduce smoking initiation, prevalence and intensity. Despite this, policy makers and public health procurers often lack the data and financial justification to make the case for investment in tackling the scourge of tobacco. The CER project “EQUIPT” brings together expertise from multiple disciplines and aims to provide health care policy makers with bespoke information about the economic and wider returns that investing in evidence-based tobacco control including smoking cessation agendas can generate. Learning from a very recent UK experience, EQUIPT will co-create and test a “return on investment” (ROI) tool, designed for use by tobacco control advocates, policy makers and public health procurers. The first stage of the project will develop the existing ROI tool for use in four EU Member States – Germany, Spain, Hungary and the Netherlands. Following this, it will test the transferability of the ROI methods to other EU countries (including lower-income Member States) with a view to guiding comprehensive tobacco control policies. The innovation of this project is its focus beyond simply estimating the cost-effectiveness of individual interventions: instead it will evaluate comprehensive tobacco control in an approach that mirrors real practice, where various interventions are delivered concurrently. In combination with a structured dissemination plan involving key stakeholders, this will improve investment in effective tobacco control and cessation services, in turn reducing the incidence of major chronic diseases and improving quality of life at the population level. The resulting cost-saving across the EU has the potential to be enormous.

Keywords: tobacco,smoking cessation,behaviour change intervention,cost-effectiveness,return on investment,decision tool,evidence transfer,quit rate,comparative effectiveness research,cer
Treating stroke with Affibody molecules targeting the inflammatory mediator HMGB1 (COUNTERSTROKE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Sweden,United Kingdom,Italy,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2018-09-30
Duration (months): 60.0
Total project cost (EUR): 7843758.8
EU funding (EUR): 5989631.0
Participants: 6
Project status: CLOSED

The scope of the project is to generate a candidate drug targeting the inflammatory mediator High mobility group box 1 protein (HMGB1) to be used in treatment of stroke. The candidate drug will be validated in animal models, characterized and optimized for subsequent clinical development. Stroke remains a leading cause of death and disability throughout the world. Within EU, more than 500 000 persons die of stroke each year. Of those surviving stroke, 50% are left with physical or cognitive impairment and the total annual cost of stroke is estimated at Euro 27 billion. Stroke occurs as a consequence of hemorrhagic insult or artery occlusion due to underlying cardiovascular disease. Pivotal in beneficial treatment of stroke is instant intervention. Blood clot dissolution using recombinant tissue plasminogen activator is the only pharmacological treatment demonstrated to limit neurological damage in stroke, but is only effective for patients who present within 3 hours after stroke onset. Thus there is an unmet need for an efficacious therapy that can be administered within and beyond 3 hours to achieve neuroprotection. HMGB1, released during the cerebral ischemic event and the subsequent neuroinflammation, is a well-characterized mediator of inflammation. Beneficial effects of blocking HMGB1 is proven in preclinical stroke studies. The drug to be developed is an Affibody molecule binding to and neutralizing HMGB1. Affibody molecules are engineered proteins significantly smaller than antibodies and therefore having favorable biodistribution properties, and a history of being efficient and non-toxic in clinical trials. In this application, we describe a multidisciplinary research consortium with Europe´s leading scientists in HMGB1 research and in registry-based clinical trial and dissemination methodology. The consortium has unique potentials to bring a new treatment principle against cerebral stroke to clinical reality.

Keywords: stroke,hmgb1,affibody molecule,neuroinflammation,treatment,cardiovascular disease,novel target
MEsenchymal stem cells to Reduce Liver INflammation (MERLIN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: United Kingdom,Ireland,Netherlands,United Kingdom,United Kingdom,Ireland,Italy,United States
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2019-01-31
Duration (months): 60.0
Total project cost (EUR): 7035658.93
EU funding (EUR): 5382958.0
Participants: 9
Project status: CLOSED

Prevalence of liver disease is c6% (29 million people) in the EU with mortality rates from chronic liver diseases estimated at 14.3 per 100.000 in the EU-25 in 2004. Most liver diseases have a significant inflammatory component that underpins liver damage and fibrogenesis, yet current therapies have limited effectiveness. Safe novel anti-inflammatory therapies would satisfy a large unmet need for inflammatory liver conditions such as primary sclerosing cholangitis (PSC). Mesenchymal Stromal Cells (MSC) are a mixed population of plastic-adherent (PA) cells isolated from bone marrow, umbilical cord and adipose tissue. Preclinical studies show that intravenous administration of PA-MSC reduces liver inflammation/damage, however only one MSC-based clinical study has been reported to date. MERLIN will examine if MSC can safely reduce biliary damage in mouse models followed by a clinical study in patients with PSC. We have identified an antibody (S2) that isolates comparable MSC from human & mouse marrow, enabling testing of pure functionally distinct cell S2+ & S2- and PA-MSC populations. We will use the world’s first GMP-compliant non-bead-based cell sorter to select S2+ MSC to comply with future therapeutic regulatory requirements. MERLIN partners will use novel methods to enhance MSC efficacy in PSC - by reducing immune clearance of MSC & by promoting MSC functionality & localisation in vivo. We will assess if MSC sub-sets exert differing levels of control upon liver inflammation in pre-clinical models, as well as defining their proliferation and mechanism of action. We will develop entirely novel biomarkers for PSC within the disease pathway pre and post cell infusion. The optimal combination of MSC sub-set and “efficacy enhancement”, will be selected for progression to a Phase 2 clinical safety study in patients with PSC. MERLIN will deliver a comprehensive data-set on optimised purified MSC and their efficacy/safety in pre-clinical models prior to a clinical trial in patients with PSC.

Keywords: stem cell therapies,greater purity,multi-source,multi-species,novel antigen,gmp,liver disease.
Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – tuberous sclerosis complex (EPISTOP)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Poland,Italy,France,Belgium,Czechia,Germany,Netherlands,Netherlands,Belgium,Austria,United States,Netherlands,Australia
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-11-01
End date: 2019-04-30
Duration (months): 66.0
Total project cost (EUR): 13019934.8
EU funding (EUR): 9451675.0
Participants: 17
Project status: CLOSED

Despite a great progress in the management of epilepsy, still one third of patients is refractory to available medications. The incidence of epilepsy is highest in infancy and 50% of children experience epilepsy-related comorbidities, such as developmental delay and autism. The development of epilepsy (epileptogenesis), extensively studied in animals, is barely studied in humans, as patients usually present AFTER the seizure onset. EPISTOP is the first prospective study of epileptogenesis in humans, beginning BEFORE seizures and continuing through age 2+ years, permitting detailed analysis of the onset, drug-resistance, and comorbidities of epilepsy. To maximize information derived from the study we have chosen homogenous group of patients with prenatal or early infantile diagnosis of Tuberous Sclerosis Complex (TSC). A clinical randomized study of pre-seizure treatment in TSC infants is a part of the project. The aim of EPISTOP is to examine the risk factors and biomarkers of epilepsy and to identify possible new therapeutic targets to block or otherwise modify epileptogenesis in humans. Biomarker analysis will be performed by a multidisciplinary, systematic approach in three clinical settings: 1/ prospective study of epilepsy development in infants with TSC, including analysis of clinical, neuroimaging, and molecular, blood-derived biomarkers at predefined time points: before the onset of seizures, at the onset of epileptiform discharges on EEG, at seizure onset and at the age of 24 months 2/ prospective study of blood-based biomarkers in infants with TSC treated with antiepileptic drugs prior to seizure onset in comparison to children treated only after clinical seizures appearance. 3/ analysis of biomarkers of epileptogenesis and drug-resistant epilepsy in brain specimens obtained from TSC patients who have had epilepsy surgery and TSC autopsy cases. EPISTOP will be carried out by a consortium of 14 partners from 9 countries, including 2 SMEs.

Keywords: epileptogenesis,tsc,infants,molecular biomarkers,prevention,drug-resistant epilepsy,autism