Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Targeted Action for Curing Trauma Induced Coagulopathy (TACTIC)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: Denmark,Netherlands,Germany,Norway,United Kingdom,United Kingdom,United States,Germany
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): 7702521.08
EU funding (EUR): 5880010.31
Participants: 10
Project status: CLOSED

Trauma remains one of the world’s biggest contributors to the global burden of disease. Predominantly affecting young adults and children, 800,000 European injury related deaths were recorded in 2002. Outcomes for critically injured trauma patients remain poor with severe bleeding, brain injury and tissue damage being associated with high mortality and disability. Nearly half of all trauma fatalities result from haemorrhage, with many patients developing a clotting disorder (coagulaopthy) within minutes of injury or during their clinical care, that worsens bleeding and hampers emergency surgery. Current treatment of bleeding and coagulopathy is based on empirical ”blind” administration of blood products, with large variations in practice between trauma centres. Important advances in care will only be made by a coordinated European national level approach that pulls discovery research into patients, into clinical guidelines and into national and global policy. “Targeted Action for Curing Trauma Induced Coagulopathy” (TACTIC) is a comprehensive programme of comparative clinical research that will deliver this quantum step in the global health care management of coagulopathic trauma patients, and potentially all patients with acute critical illness. TACTIC will recruit patients from a network of trauma centres in Amsterdam, Cologne, Copenhagen, London, Oslo and Oxford to compare the effectiveness of different current practices across Europe. It will deliver universal guidelines for how coagulaopathy should be monitored and treated, enabling the individualised treatment of all critically bleeding patients, and and resolve barriers to the subsequent continental implementation of patient-matched targeted transfusion policy, which is expected to reduce trauma haemorrhage-related mortality by approximately ten percent, saving 30.000 lives per year as well as significantly reducing hospital and societal costs.

Keywords: trauma,coagulopathy,hemorrhage,mortality,transfusion,vasculopathy
DEVELOPMENT OF TAILORED ANTIMICROBIAL TREATMENT REGIMENS AND NOVEL HOST- PATHOGEN INSIGHTS FOR RESPIRATORY TRACT INFECTIONS AND SEPSIS (TAILORED-TREATMENT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Netherlands,Netherlands,Israel,Sweden,Spain
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-08-01
End date: 2017-07-31
Duration (months): 48.0
Total project cost (EUR): 7768171.99
EU funding (EUR): 5975383.0
Participants: 7
Project status: CLOSED

Though of tremendous benefit, the overuse of antibiotics has lead to the emergence of antibiotic resistance and may cause adverse events that impact on patient healthcare. Current diagnostic tools for facilitating the appropriate use of antibiotics in patients are inadequate. We will establish a broad-based strategy (not limited to a particular antibiotic group) that can be implemented on a broad scale to increase the effectiveness of antimicrobial therapy, reduce adverse events, and help limit the emergence of antimicrobial resistance in children and adults. At the heart of the TAILORED-Treatment project is a prospective clinical study in which we will recruit 1200 patients (>2000 patient samples) presenting with respiratory tract infections and/or sepsis. Patient cohorts will include equal representation of genders, children and adults. State-of-the-art molecular technologies will be applied to characterize host-pathogen interactions at the genomic, transcriptomic, proteomic and clinical level, resulting in a large-scale and unique multi-dimensional dataset. The consortium partners will develop new computational tools to interrogate this data, in order to provide new insights into personalized host-pathogen interactions, including the discovery of novel biomarkers for physicians to use in patient diagnosis and disease monitoring. Concurrently, using this data, we will construct a predictive personalized treatment algorithm that will lead to informed and personalized antimicrobial treatment regimens (indication, dosage, and duration) that are tailored to the needs (type of infection, presence of novel biomarkers etc) of children and adults presenting with respiratory infections and sepsis. This unique multi-dimensional dataset and personalized predictive treatment algorithm will be built into an easily navigable web-based, free-to-use, decision support system for use by physicians to explore and assist in patient-tailored antimicrobial treatment decisions.

Keywords: stratified approaches personalized medicine sepsis respiratory patient cohort host immune response antibiotics / antifungals microbiology
Neuropathic pain: biomarkers and druggable targets within the endogenous analgesia system (NEUROPAIN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Spain,United Kingdom,France,Germany,Poland,Iceland,Germany,Finland,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-01-01
End date: 2018-12-31
Duration (months): 60.0
Total project cost (EUR): 8529808.29
EU funding (EUR): 5992577.0
Participants: 11
Project status: CLOSED

Neuropathic pain has a high incidence in Europe and often affects the patient’s emotional balance and quality of life. Recent meta-analyses have shown that conventional analgesic drugs are not sufficiently effective in these patients and are limited by serious side effects. The search for new analgesics is extremely difficult despite identification of several new potential targets and enormous investment by the pharmaceutical industry. Important reasons for this failure are the poor predictive validity of currently available animal models of chronic pain, that do not simulate multidimensional clinical pain, and the high inter-individual variability of neuropathic pain manifestations and treatment responses. We will overcome these obstacles by an interdisciplinary collaboration between basic science groups, clinicians and leading private companies. This consortium will validate new animal models to evaluate the electrophysiological, behavioural, emotional and cognitive manifestations of neuropathic pain and the effectiveness of novel compounds. The use of these models in combination with other behavioural paradigms and new conditional knockout mouse lines for specific components of the endogenous opioid and cannabinoid system will permit the identification of novel druggable targets and biomarkers for neuropathic pain. Novel analgesic compounds acting on these endogenous systems developed by the private companies of the consortium will be tested in these new paradigms. Clinical studies will identify novel biomarkers for neuropathic pain using powerful genetics approaches and investigate treatment effectiveness with a translational focus based on cross validation of the findings in animals and humans.

Keywords: chronic pain,analgesia,neuropathic pain,biomarkers,druggable targets,pre-clinical models,opioid,cannabinoid
Understanding chronic pain and new druggable targets: Focus on glial-opioid receptor interface (GLORIA)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Finland,Sweden,Germany,France,Estonia
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): 7838510.67
EU funding (EUR): 5997079.0
Participants: 5
Project status: CLOSED

Chronic pain is prevalent and it causes decreased quality of life and significant costs to the society in terms of lost working capacity. Currently available analgesics are either not effective enough or patients cannot take them due to adverse effects. Non-steroidal anti-inflammatory drugs are a major cause of drug-related morbidity and mortality. Opioids can cause tolerance and addiction when used for long-term management of chronic pain. Analgesic efficacy can be improved by targeting specific mechanisms that are involved in pain processing of specific conditions, e.g. fibromyalgia, osteoarthritis, rheumatoid arthritis, and neuropathic pain, and by improving the safety profile of the current analgesics. This project focuses on the role of glial activation by tissue and nerve injury, inflammation, and opioids in large cohorts of chronic pain patients. We will develop a biomarker profile for the clinical conditions by assessing inflammatory markers in cerebrospinal fluid and glial activation in the brain with PET, by performing well-validated experimental pain tests, and genetics. Interindividual differences in pain perception will be studied using experimental pain tests including activation of descending inhibitions as a biomarker of endogenous analgesia and fMRI. Individual differences with the glial activation and pain perception will be used to design different research lines across the board aiming at developing personalized treatments for pain. We will use well-validated animal models relevant for arthritis, fibromyalgia, and neuropathic pain. Glial activation in these animal models will be studied using novel methodology to better understand the pathophysiology of these conditions. They will also be used as targets for new drug discovery which will focus on the design and synthesis of compounds that block TLR4-mediated activation of glia and also on small compounds that mimic the actions of the GDNF-family.

Keywords: inflammation,opioid,glia,fibromyalgia,osteoarthritis,nerve injury,pet,biomarkers,genetics,tlr4,gdnf
Identification and validation of novel pharmaceutical drug targets for cardiovascular disease (CARTARDIS)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Netherlands,Germany,Sweden,Netherlands,Switzerland,Denmark,France,Sweden,Iceland,Germany,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2017-09-30
Duration (months): 48.0
Total project cost (EUR): 7980425.0
EU funding (EUR): 5973521.0
Participants: 13
Project status: CLOSED

Cardiovascular disease (CVD) is one of the major diseases in Europe and the Western world, killing over 2 million people per year in Europe alone and is the foremost cause of premature mortality and disability-adjusted life years, representing an annual economic cost of ∼€ 192 billion in direct and indirect healthcare expenses. The available therapies are insufficient to fulfill the need. The introduction of statins has reduced morbidity and mortality of atherosclerosis by 30%, however a large untreatable residual cardiovascularrisk remains even in cohorts of treated patients. Currently, many targets for CVD treatment have been selected based on mechanism of action and inference of functions in cellular models to clinical systems, and lack the rigorous clinical validation needed to maximize the chance for successful clinical drug development. Consequently, new drugs that modulate the activity of such targets fail later in clinical development by lack of efficacy or induction of safety liabilities due to off-target effects. To increase the success rate for clinical development of novel therapies in CVD, we will follow an innovative approach by using: 1. Independent and large-scale population studies from which novel targets with strong correlation to clinical phenotypes are deduced; 2. Translational disease-mimicking models (cellular and animal) to validate novel drug targets; 3. High quality human biobanks to confirm the molecular relevance of targets in diseased cardiovascular tissues; 4. A stringent pharmaceutical drug discovery process for prioritization of drugable targets. An important concept, in line with the changed pharmaceutical business model, is that these steps can best be executed by a functional network of clinical academic centers and specialized SMEs under the guidance of established and experienced drug discovery researchers from industry that brings together the right components and expertise to execute such a modular target discovery process.

Keywords: cardiovascular target discovery,population studies,in vitro models,in vivo models,validation,biobank,sme,multidisciplinary
European-COMPARative Effectiveness research on online Depression (E-COMPARED)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: Netherlands,Sweden,Germany,United Kingdom,Spain,Germany,Ireland,Switzerland,Spain,Poland,Portugal,France,Belgium,France
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-01-01
End date: 2017-06-30
Duration (months): 42.0
Total project cost (EUR): 7743088.84
EU funding (EUR): 5827000.0
Participants: 16
Project status: CLOSED

In 2010, 30 million Europeans were affected by depression and their number is still growing. Half of Europeans in need of mental care for depression do not have access to care services, do not always receive evidence-based treatments, are confronted with long waiting lists or high care expenditures. Internet-based treatment has the potential to addresses the drawbacks of standard care and keep depression treatment of high quality and affordable. E-COMPARED will conduct comparative effectiveness research in routine specialized mental care settings on the (cost-) effectiveness of internet-based treatment for depression in comparison with standard care. Health care systems, and -policies, existing ICT infrastructures and their uptake will be taken into account. E-COMPARED aims to 1)Evaluate EU mental health policies/guidelines for standard and internet-based care for depression in specialized care settings in countries with different health care systems and access levels of standard and internet-based care; 2)Compare clinical efficacy and cost-effectiveness of internet-based treatment and treatment as usual within controlled research settings, 3)Carry out pragmatic randomized controlled trials to study how internet-based depression treatment can be effectively implemented within routine specialized care settings, 4)Predict which patient groups could benefit from internet-based treatment vs. standard treatment by modeling patient characteristics; 5)Develop evidence based recommendations on how internet-based depression treatment can be cost-effectively integrated into routine specialized care systems for depression in EU mental health care systems, and develop a business case to ensure structural implementation of these services. E-COMPARED is multidisciplinary (psychology, HTA, ICT, care) and its members have a front runners position in internet-based treatment for common mental health disorders, e.g. through participating in FP7 projects (ICT4Depression, ROAMER).

Keywords: comparative effectiveness research,internet-based treatment,depression,routine specialized care settings,clinical efficacy,cost-effectiveness,health care systems,implementation,recommendations
Advances in Small Trials dEsign for Regulatory Innovation and eXcellence (ASTERIX)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Collaborative project
Countries involved: Netherlands,Germany,Austria,Netherlands,Spain,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2017-09-30
Duration (months): 48.0
Total project cost (EUR): 4141786.0
EU funding (EUR): 2999881.0
Participants: 7
Project status: CLOSED

ASTERIX will contribute towards the expected impact listed in the work program by delivering validated innovative statistical design methodologies for cost efficient clinical trials deriving reliable results from trials in small population groups, especially focusing on rare diseases. It directly addresses the rights of the estimated 30 million European patients suffering from rare diseases to the same quality or treatment as other patients. By choosing an integrated approach leveraging statistical methods, smartly combining observational and clinical data as well as improved sequential and adaptive approaches ASTERIX will improve statistical power of clinical trial design in small populations. ASTERIX will systematically include patients and the patient perspective into its research, but moreover develop the approach to involve patients in clinical trial design in a methodological sound manner. Pre-clinical data, historical data on disease characteristics, and benefit and risk as perceived by patients will systematically inform and weigh relevant endpoint measures. Thus the clinical value of trial results will be enhanced considerably. Key methodological innovations include: new standards of evidence that take into account the rare prevalence of disease, leveraging prior information and the availability of multiple endpoints, enabling adaptive designs and sequential meta-analysis using multiple endpoints and providing a blue print to pro-actively share information on trials in the planning stage. The latter will ensure that each new trial in an orphan disease provides the optimum additional knowledge for patient treatment. Relevance and clinical value of the newly designed methodological approaches are validated twofold. Firstly, by cross testing with available clinical trial data of a broad range of highly relevant rare diseases and secondly, by assessing the methods against current and improved regulatory approval strategies.

Keywords: clinical trial,small population groups,trial design,statistical,rare diseases,randomisation,patient perspective,patient registry,regulatory models
New Medicines for Trypanosomatidic Infections (NMTRYPI)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Italy,Germany,Portugal,Germany,Sudan,United Kingdom,Greece,Spain,Belgium,Germany,Brazil
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2017-01-31
Duration (months): 36.0
Total project cost (EUR): 7639176.11
EU funding (EUR): 5901411.15
Participants: 14
Project status: CLOSED

The infectious diseases burden imposed by the parasites of Trypanosomatidae family represents a huge problem on people’s lives in countries where these diseases are endemic. Problems associated with existing drugs include inefficient delivery, insufficient efficacy, excessive toxicity and increasing resistance. New drugs are urgently needed now and in the foreseeable future. The New Medicine for Trypanosomatid Infections (NMTrypI) consortium uses a highly interdisciplinary approach to optimize pteridine, benzothiazole and miltefosine derivatives, as well as natural products against Trypanosomatids. The lead compounds target mechanisms that are associated with protozoa virulence and pathogenicity. The major objectives of this 3-year project are: i) development of drug leads which may be used in combination with a known or an investigational drugs, by using a common drug discovery platform established by experts in their respective fields, ii) development of pharmacodynamic biomarkers enabling the proteomic profiling of compound efficacy and early identification of drug resistance. NMTrypI addresses sleeping sickness, leishmaniasis, and Chagas disease. The partners are SMEs (5) and academics (8) in Europe and in disease-endemic countries (Italy, Greece, Portugal, Sudan, and Brazil). The new platform enables high throughput screening of compound libraries, lead development, testing in relevant animal models, as well as toxicology and safety testing. NMTrypI will translate drug leads into drug candidacy through 6 scientific work packages (WPs1-6) supported by two transversal WPs dedicated to project dissemination and management. The major strength of the consortium lies in the complementary partners’expertise and the integrated platform that will provide: - at least 1-2 innovative, less toxic and safer drug candidates for Trypanosomatid infections compared to existing ones, - early phase biomarkers for efficacy prediction (overall improved efficacy and safety)

Keywords: trypanosomatids,lead optimization,highthroughput screening,relevant animal models,drug discovery platform,drug combination,drug repositioning,toxicity,safety biomarker,translational research
Impact of Biogenic versus Anthropogenic emissions on Clouds and Climate: towards a Holistic UnderStanding (BACCHUS)

Framework: FP7 — Cooperation
Programme: Environment (including Climate Change)
Destination: Coping with climate change
Action type: Collaborative project
Countries involved: Switzerland,Finland,Germany,United Kingdom,Norway,United Kingdom,United Kingdom,Germany,Germany,Greece,Italy,Ireland,Bulgaria,Israel,France,Germany,Cyprus,Sweden
Call:  (FP7-ENV-2013-two-stage, 2013)
Start date: 2013-12-01
End date: 2018-05-31
Duration (months): 54.0
Total project cost (EUR): 11463091.4
EU funding (EUR): 8746587.0
Participants: 21
Project status: CLOSED

Clouds are a very important, yet not well understood feedback factor in climate change and they contribute to the effective radiative forcing (ERF) from aerosol-cloud interactions (ACI). The uncertainty in ERFaci is larger than for any other forcing agent. Also, feedbacks between the terrestrial and marine biosphere and the atmosphere involving ACI are thought to play an important role in regulating climate change but their relevance remains poorly quantified. BACCHUS proposes to quantify key processes and feedbacks controlling ACI, by combining advanced measurements of cloud and aerosol properties with state-of-the-art numerical modelling. The analysis of contrasting environments will be the guiding strategy for BACCHUS. We will investigate the importance of biogenic versus anthropogenic emissions for ACI in regions that are key regulators of Earth's climate (Amazonian rain forest) or are regarded as tipping elements in the climate system (Arctic). BACCHUS will generate a unique database linking long-term observations and field campaign data of aerosol, cloud condensation and ice nuclei and cloud microphysical properties; this will enable a better quantification of the natural aerosol concentrations and the anthropogenic aerosol effect. BACCHUS will advance the understanding of biosphere aerosol-cloud-climate feedbacks that occur via emission and transformation of biogenic volatile organic compounds, primary biological aerosols, secondary organic aerosols and dust. Integration of new fundamental understanding gained in BACCHUS in Earth Systems Models allows to reduce the uncertainty in future climate projections. This will have a direct impact on decision-making addressing climate change adaptation and mitigation. BACCHUS brings together a critical mass of experimentalists and modellers with the required scientific expertise to address these complex topics and a high commitment to communicate their findings in many ways in order to ensure a high-impact project.

Keywords: aerosol-cloud-interactions,climate feedbacks,biosphere,vocs,climate-change,arctic,amazon,ice nucleation,field studies,satellite studies,long-term observations,process & earth system models