Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia (NEUROSIS)

Framework: FP7 — Cooperation
Programme: Health
Destination: Other Actions across the Health Theme
Action type: Collaborative project
Countries involved: Germany,United Kingdom,Czechia,Finland,Israel,France,Italy,Netherlands,Germany,Greece,Germany,Germany,Belgium,Switzerland
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-03-01
End date: 2015-08-31
Duration (months): 78.0
Total project cost (EUR): 7379459.92
EU funding (EUR): 5623414.0
Participants: 15
Project status: CLOSED

HYPOTHESIS: Early inhalation of Budesonide (BS) reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born between 23 and 27 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: Survival without BPD at 36 weeks GA. SECONDARY OBJECTIVES: (1) neurodevelopment at a corrected age of 18-22 months; (2) adverse treatment effects; (3) mortality at 36 weeks GA; (4) BPD incidence at 36 weeks GA; (5) duration of positive pressure respiratory support or supplemental oxygen; (6) pharmacokinetic-pharamacodynamic analyses. RATIONALE: Inflammation is central to the development of BPD. Corticosteroids (CS) have antiinflammatory properties and early inhalation of CS may allow for beneficial local effects on the pulmonary system with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial and genetic/pharmacogenetic substudy. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to BS or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD contributes to the mortality of preterm infants and is associated with impaired neurosensory development and an increased risk of pulmonary morbidity in adolescence and young adulthood. Systemic CS are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of CS has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

Keywords: randomised controlled trial,preterm infants,inhaled corticosteroids,bronchopulmonary dysplasia,pharamcokinetic-pharmacodynamic analyses,pharmacogenetics,genetics
A pharmacogenomic approach to coumarin anticoagulant therapy (EU-PACT)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Netherlands,Netherlands,Germany,United Kingdom,United Kingdom,France,Sweden,Greece,Austria
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2008-10-01
End date: 2013-03-31
Duration (months): 54.0
Total project cost (EUR): 3575385.6
EU funding (EUR): 2544891.0
Participants: 12
Project status: CLOSED

The effectiveness of treatment with oral anticoagulants in the prevention of thrombotic disorders is well established, but these drugs are potentially dangerous because of their narrow therapeutic index. In Europe three coumarins are used: warfarin, acenocoumarol, and phenprocoumon. Genetic factors that have been recently demonstrated to change the pharmacokinetics and pharmacodynamics of coumarins are the presence of polymorphisms in the genes encoding for CYP2C9 and VKOR (vitamin K epoxide reductase complex). Polymorphisms in these genes are associated with increased risk for severe overanticoagulation and bleedings. A clinical trial will be performed in seven European countries to determine whether knowledge of the genotype of patients at the start of coumarin treatment will increase the safety of use of these compounds and whether such gene testing is cost-effective. Patients will be randomized to receive treatment with a coumarin either dosed with an algorithm that does not include information on their genotype, or with an algorithm that does contain this information. The primary outcome will be time within therapeutic INR range. Secondary outcomes include INR>4 and bleedings.

Keywords: coumarin,acenocoumarol,warfarin,phenprocoumon,randomized clinical trial,vkorc1,cyp2c9
Saving and Empowering Young Lives in Europe: Promote health through prevention of risk-taking and self-destructive behaviors (SEYLE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: Sweden,Austria,Estonia,France,Germany,Hungary,Ireland,Israel,Italy,Romania,Slovenia,Spain
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-01-01
End date: 2011-12-31
Duration (months): 36.0
Total project cost (EUR): 4781263.0
EU funding (EUR): 2983941.0
Participants: 12
Project status: CLOSED

Promoting healthy behaviors is multi-faceted and no health is possible without mental health. The ultimate outcome of unhealthy and risk-taking behaviors is suicide. Risk-taking and suicidal behavior can be prevented. A pilot intervention study will be implemented to assess the effects of three different health promoting / suicide prevention programs in 11000 students across 11 European countries: 1. TeenScreen - screening by professionals of at-risk students through a questionnaire. 2. QPR (Question, Persuade & Refer) – a gatekeepers’ program, training all adult staff at schools (teachers, counselors, nurses etc.) and parents on how to recognize & refer a student at-risk of suicide or suffering from mental illness to mental-health help resources; 3. A general health promotion program targeting students’ awareness on healthy/unhealthy behaviors; Objectives of the research program are: I. Gather information on health and well-being in adolescents - Produce an epidemiological database for adolescents in Europe containing data on student's healthy and at-risk lifestyles and their relation with health measured by well-being, depression and suicidality. II. Perform interventions in adolescents leading to better health trough decreased risk-taking and suicidal behaviors III. Evaluate outcomes of interventions in adolescents from a multidisciplinary perspective including social, psychological and economical aspects IV. Recommend an effective trans-cultural model for promoting health for adolescents in Europe -Provide information for evidence-based prevention programs for adolescents in culturally diverse populations -Increase awareness and knowledge in policy makers, professionals and the public. -Disseminate results through a public website, media, health promotion conferences and through events focused on adolescents such as pop concerts or sport events.

Keywords: adolescent health promotion intervention prevention suicide alcohol drug tobacco nutrition physical activity risk-taking behaviors sexual promiscuity
Identification and validation of novel drug targets in Gram-negative bacteria by global search: a trans-system approach (ANTIPATHOGN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Spain,France,Germany,Germany,Spain,Germany,Germany
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-02-01
End date: 2013-07-31
Duration (months): 54.0
Total project cost (EUR): 7692588.01
EU funding (EUR): 5943961.0
Participants: 11
Project status: CLOSED

Multi-drug-resistant bacterial infections are increasing at an alarming pace in both developing and developed countries and in both community and nosocomial settings. The few antimicrobial agents that have been launched during the last decade (e.g. linezolid, daptomycin) have a good activity against Gram-positive bacteria. However, multi-drug-resistant bacteria are often found among the Gram-negative group. To tackle this problem, the AntiPathoGN project proposes a novel strategy for the discovery of new antimicrobial drug targets in a number of Gram-negative bacteria. This strategy is based on a comparative, system-level analysis of molecular processes involved in pathogenicity, drug resistance, cell division and/or growth of selected pathogenic Gram-negative bacteria through a combination of computational biology, interactome discovery, in-vivo protein-blocking and structural biology techniques. This comparative analysis, at one organization level above genomics, shall permit the discovery of new potential drug targets, relevant to both species-specific and broad-spectrum antimicrobial strategies. In addition, the AntiPathoGN project will pursue the identification of novel antibacterial compounds acting against previously validated targets by screening purpose-specific libraries of products derived from natural resources and from synthetic compounds. An important aspect of the project is that more than one approach is planned for the key objectives of target identification, target validation, target characterisation, and hit finding. The AntiPathoGN consortium is composed of 1 university bringing expertises in computational biology and microbiology, 3 research centres with expertises in computational and experimental interactomics, structural biology and clinical microbiology, and 7 SMEs with records on recombinant-antibody technology, structural biology, drug discovery and clinical research. The AntiPathoGN project fully addresses topic HEALTH-2007-2.3.1-1.

Keywords: interactomics,computational biology,structural biology,clinical microbiology,target discovery,drug discovery,antibody technology
Impact on equity of access and efficiency of Integrated Health care Networks (IHN) in Colombia and Brazil (EQUITY-LA)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: Belgium,Brazil,Spain,Colombia
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-03-01
End date: 2013-08-31
Duration (months): 54.0
Total project cost (EUR): 2130850.79
EU funding (EUR): 1722053.0
Participants: 4
Project status: CLOSED

The research focuses on different types of integrated health care networks (IHN), widely promoted in Latin America in spite of lack of knowledge on their impact. It will look at their impact on equity and efficiency, and its implication for an universal and equitable access to maternal and child care. Research general objective is to provide evidence on the impact of different types of integrated health care networks (IHN) to a) health care access and b) health care provision efficiency in two Latin American countries: Colombia and Brazil. Methodology. The research will be two-pronged: a) a country case study and b) a cross-country comparative analysis. In phase a) it will assess actual IHN’s performance regarding equity of access, and efficiency, in the light of policy framework. In phase b) results will be compared across countries, in order to determine factors and actors affecting results in different contexts. Using an innovative multi-disciplinary approach, it will combine qualitative and quantitative (cross-sectional study) research methods of social sciences. Analysis will be conducted at three levels: health system, institution and services’ potential users from a gender perspective. Results and relevance. The research will produce evidence-based policy lessons for better quality health care providers; it will develop appropriate methods to assess the performance of health providers; and will be conducive to more efficient and effective health care, as well as to an improvement in access to health care, particularly to maternal and childcare. It will contribute to FP7 Cooperation Work Programe Health (SICA)’s objectives by 1) addressing priority areas of health systems’ research to contribute to achieving MDGs in maternal and child health 2) promoting evidence-based policy making, 3) strengthening research capacity of universities and 4) developing new European and Latin American institutional links.

Keywords: integrated health care delivery system equity in access continuity of care latin american health systems
Initiative on Optimizing Malaria Vaccine Lab Assays Evaluation (OPTIMALVAC)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Coordination and support actions
Countries involved: France,Netherlands,Sweden,United Kingdom,United Kingdom,Netherlands,Switzerland,Spain,United States,Denmark,Germany,Belgium,United Kingdom
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-04-01
End date: 2012-03-31
Duration (months): 36.0
Total project cost (EUR): 1702610.87
EU funding (EUR): 1000000.0
Participants: 14
Project status: CLOSED

A broad-range of candidate malaria vaccines derived from diverse novel technologies have resulted from the multiple approaches being taken by different groups in developing malaria vaccines. The majority of the candidates are recombinant proteins based on complex native antigens found on the surface of the parasite. Vaccine potential of these parasite surface antigens is often supported by epidemiological data, and by the ability to induce specific antibodies or potential protective responses in animals and later, in humans. Individual groups have developed assays within the context of the vaccine discovery efforts, with identification of measurable processes for parasite growth and virulence to test specific antigens. In-house assays are strain, stage and even process specific and the ability to compare results between different candidates is further limited by diverse methodologies and assay components such as parasites, cells and reagents. The absence of some level of harmonization of practices also makes interpreting the meaning and relevance of vaccine research outcomes complex. Lack of an enabling environment for comparability of research results generated in different labs could unfortunately lead to scepticism of the results that in turn generate uncertainty about the efficacy of the vaccines and rationale of the development pathway. To compare the relative merits of different candidate vaccines and approaches in a credible and informed manner, efforts must be made to create this enabling environment by supporting the development of a baseline level of standardization around key assays that can be utilized a) in the evaluation of malaria vaccines, and b) throughout the Development process. Consistent, reproducible and comparable intra- and inter-lab performance and increased accuracy and precision of assay data, will strengthen the quality of the data on vaccine performance and generate greater confidence in the vaccine potential of the candidate.

Keywords: malaria vaccine,assays,evaluation,emvi,optimalvac,who
Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era (GP-TCM)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Coordination and support actions
Countries involved: United Kingdom,Austria,Belgium,China,Hong Kong,Estonia,Germany,Germany,Germany,Ireland,Italy,Netherlands,Portugal,Spain,United Kingdom,United Kingdom,Germany,Netherlands,United Kingdom
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-05-01
End date: 2012-10-31
Duration (months): 42.0
Total project cost (EUR): 1117778.0
EU funding (EUR): 995100.0
Participants: 30
Project status: CLOSED

In contrast to the reductionist approach of Western medicine that is based on modern anatomy, cell and molecular biology, Traditional Chinese Medicine (TCM) uses a unique theory system and an individualised and holistic approach to describe health and disease, based on the philosophy of Yin-Yang balance and an emphasis on harmony of functions. These two medicine systems disagree with each other in many situations as both of them may observe health from their limited perspective. “GP-TCM” aims to inform best practice and harmonise research of the safety and efficacy of TCM, especially Chinese herbal medicines (CHM) and acupuncture, in EU Member States using a functional genomics approach through exchange of opinions, experience and expertise among scientists in EU Member States and China. In 10 proposed work packages, we will take actions to review the current status, identify problems and solutions in the quality control, extraction and analysis of CHM. While these fundamental issues are addressed, discussion forums emphasising the use of functional genomics methodology in research of the safety, efficacy and mechanisms of CHM and acupuncture will be the core of this Coordination project. It will include the application of the technique in cell-based models, animal models and in clinical studies. Guidelines about good practice and agreed protocols in related research areas will be published to promote future TCM research in all the EU member states; online tools and research resources will be made available to EU member states; EU member states and additional China partners will be invited to join this network; The GP-TCM Research Association will be established during this project and kept running autonomously to continue the guidance and coordination of EU-China collaboration in TCM research.

Keywords: traditional chinese medicine,herbal medicine,acupuncture,functional genomics,holistic,good practice,quality control,database,safety,efficacy,mechanisms,european society of tcm research
Collaborative Oncological Gene-environment Study (COGS)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Sweden,United Kingdom,Australia,Germany,Spain,Sweden,Finland,Netherlands,Denmark,Belgium,United Kingdom,France,United Kingdom
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-05-01
End date: 2014-01-31
Duration (months): 57.0
Total project cost (EUR): 16703903.2
EU funding (EUR): 11715501.0
Participants: 16
Project status: CLOSED

The overarching goal of COGS is to identify individuals with an increased risk of breast, ovary and prostate cancer. Furthermore, we will evaluate the effect of inherited genetic variation on tumour characteristics and clinical outcome. We will do this through quantifying the role of genetic and environmental/lifestyle risk in the largest data set ever generated. In all, we will include over 200,000 individuals in the COGS project. We will use detailed knowledge of the architecture of genetic susceptibility and interactions with environmental/lifestyle factors which will result in much more accurate individual risk prediction and improved intervention strategies. We are taking advantage of a unique possibility by incorporating seven existing consortia into one large project – COGS. Members of these consortia have collaborated successfully over the past years and results have been presented in world leading scientific journals such as Nature, Nature Genetics and Journal of the National Cancer Institute. These papers reflect that collaboration has been ongoing and that is has so far been very successful. We will also build on an existing European Commission project, TRANSBIG, thus adding value to already spent money. Results generated through COGS will lead to an improved understanding of the biological processes that underlie carcinogenesis, that in turn could guide new therapeutic strategies. Results will also lead to the development of new tests for risk prediction for breast, ovarian and prostate cancer.

Keywords: breast cancer,ovarian cancer,prostate cancer,lifestyle,genetic susceptibility,gene-environment interaction
Large-scale, high-throughput automated systems for phenotyping mouse models of human disease (PHENOSCALE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: United Kingdom,Italy,Germany,Italy,Germany
Call:  (FP7-HEALTH-2007-B, 2007)
Start date: 2009-03-01
End date: 2012-02-29
Duration (months): 36.0
Total project cost (EUR): 3984135.33
EU funding (EUR): 2999461.0
Participants: 5
Project status: CLOSED

We are now entering an era of genomic exploration. The mouse is a pre-eminent model not only to map all mammalian genes, but to determine the function of each of these genes. There are now many large-scale projects to create collections of mutant and knock-out mice. However the next step which will add immense value to these collections will be the determination of the phenotype of each of these models. This will be an immense effort and will require input from laboratories and mouse phenotyping centres across the world. For the phenotype to be comparable across strains and between centres, it needs to be determined using standard protocols or SOPs, such as those contained in the European Mouse Phenotyping Resource of Standardised Screens (EMPReSS - www.empress.har.mrc.ac.uk). The goal of PhenoScale is to automate phenotyping in large-scale phenotyping using EMPReSS protocols; with the aim of adding economies of scale, enhancing automated data capture and increasing throughput. The technical development within the project is lead by the SME, TSE Systems GmbH, who will work with some of the leading mouse phenotyping centres in Europe at MRC, UK, CNR, Italy and GSF, Germany. The objectives are: 1) High-throughput Phenotyping: a) Development of a new high-throughput automated phenotyping platform PSS009 using home cage monitoring. 2) Development of new EMPReSS SOPs using PSS009 and validation of this approach with selected mouse models at different sites / European mouse clinics (cross-checking / cross-validation). 3) Optimization of the high-throughput technology systems by advanced interfacing and extended software capabilities. 4) Promotion of the new high-throughput systems and novel established SOPs to other phenotyping centres.

Keywords: phenotyping mouse models