Data-Gouv-ML/pcri-informations-sur-les-projets-laureats huggingface dataset:
Randomised controlled trial to evaluate electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology for patients with cancers (ESMART)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,Greece,Ireland,United States,Netherlands,Austria,Norway,United Kingdom,Netherlands,United Kingdom
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2019-07-31
Duration (months): 66.0
Total project cost (EUR): 7737318.0
EU funding (EUR): 5999991.0
Participants: 14
Project status: CLOSED

The eSMART programme of work will demonstrate the effects of a real-time, mobile phone based, remote patient monitoring intervention on key patient outcomes and delivery of care provided to people with cancer during and after chemotherapy. Utilising the remote patient monitoring system, the Advanced Symptom Management System (ASyMS), will reduce the symptom burden experienced by patients receiving chemotherapy, improve their quality of life (QoL) during acute treatment and survivorship, and result in changes in clinical practice and improved delivery of care for patients with cancer. eSMART involves 11 European and one American partner as well as cancer care clinicians from all partner countries. A two-group, multicentre, repeated-measures randomised controlled trial (RCT) will be conducted across 14 sites in Europe, 1108 patients will be recruited. Adult (>18 years) patients diagnosed with breast, colorectal cancer or haematological cancers, commencing first-line chemotherapy and planned to receive at least 3 cycles of chemotherapy will be invited to participate. Work will take place in four consecutive phases. Members of the European Cancer Patient Coalition have an integral role as advisors at every stage of the programme to provide advice and feedback and ensure that work is conducted in line with patients’ perspectives and needs. eSMART will demonstrate how delivering patient focused, anticipatory care via technology can improve outcomes for people with cancer whilst simultaneously addressing the increasing demands on acute services across Europe by; enhancing patient outcomes and quality-of-life improvement; promoting of advances in cancer care; reducing social and economic barriers in cancer care; accelerating interoperability and collaboration across Europe and enhancing the economic stimulation of the National Health markets.

Keywords: quality of life chemotherapy toxicity patient reported outcomes remote patient monitoring
Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in EUrope (EU-CERT-ICD)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Germany,Netherlands,Germany,Sweden,Spain,Slovakia,Finland,Germany,Poland,Hungary,Switzerland,Denmark,Belgium,Germany,Greece,United Kingdom,Croatia
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): 7674687.79
EU funding (EUR): 5999562.0
Participants: 26
Project status: CLOSED

An estimated 500.000 sudden cardiac deaths (SCD) occur each year in the European Union. Patients at risk for SCD may benefit from prophylactic treatment with an implantable cardioverter-defibrillator (ICD). ICD implantations have dramatically increased in recent years leading to multi-billion Euros of costs with significant regional disparities across Europe. Information on risks, benefits and costs supporting current guideline recommendations may be outdated, and the influence of gender remains unclear. EU-CERT-ICD (Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe) aims to generate contemporary clinical outcome data on ICD effectiveness in Europe. Clinical outcomes including all-cause mortality, appropriate and inappropriate ICD shocks, and quality of life (QoL) are assessed by: - a prospective study of patients undergoing indicated ICD treatment for primary SCD prevention, with a control group of patients not undergoing ICD treatment - a large European registry collecting available data on prophylactic ICD treatment - meta-analyses of available and emerging ICD outcome studies QoL-adjusted cost-effectiveness will be estimated from actual cost comparisons and Markov decision models with attention to sub-groups, regional, and sex comparisons. Outcomes in patients receiving ICDs for primary SCD prevention will be compared in sub-strata, and with patients fulfilling guideline criteria but not undergoing therapy as per prior decision of treating physicians. Sub-groups with particularly large or small benefit from ICD implantation will be identified using risk markers and clinical characteristics with specific emphasis on gender. EU-CERT-ICD is expected to provide important novel information to validate or challenge current guideline indications for primary prophylactic ICD treatment.

Keywords: implantable cardioverter-defibrillator,sudden cardiac death,cardiovascular mortality,risk markers,gender,electrocardiography,cost-effectiveness,comparative effectiveness,quality of life
THE MILESTONE PROJECT: Managing the Link and Strengthening Transition from Child to Adult Mental Health Care (MILESTONE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Optimising the delivery of healthcare to European citizens
Action type: Collaborative project
Countries involved: United Kingdom,Italy,United Kingdom,France,Germany,Belgium,Ireland,Croatia,Netherlands,Germany
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-02-01
End date: 2019-04-30
Duration (months): 63.0
Total project cost (EUR): 7758027.79
EU funding (EUR): 6000000.0
Participants: 12
Project status: CLOSED

Transition to adulthood is the period of onset of most of the serious mental disorders that disable or kill in adult life. Current service configuration of distinct Child and Adolescent Mental Health (CAMHS) and Adult Mental Health (AMHS) Services is considered the weakest link where the care pathway should be most robust. Transition-related discontinuity of care is a major socioeconomic and societal challenge for the EU. The MILESTONE project is an EU-wide study determining care gaps in current services across diverse healthcare systems and robustly evaluating an innovative transitional care model. In ten high-quality work packages we will map current services and transitional policies across EU; develop and validate transition-specific outcomes measures; conduct a longitudinal cohort study of transition process and outcomes across eight EU countries; develop and test, in a cluster-randomised trial, the clinical and cost-effectiveness of an innovative transitional care model; create clinical, organisational, policy and ethics guidelines for improving care and outcomes for transition age youth; and develop and implement training packages for clinicians across EU. The project will provide robust evidence for the most cost-effective way to meet the as-yet-unmet need of young people who fall through the CAMHS-AMHS divide; facilitate the development of integrated models of care and function; improve health care outcomes and system efficiencies; and ensure take-up of best practice. The project has active and intensive participation of young people, carers, advocacy groups and key stakeholders and involves two SMEs, Concentris and HealthTracker. Findings from the project will transform mental health care in EU for young people. Our results will assist policy makers in making informed and evidence-based decisions for improving health systems, enhancing patient outcomes, quality of life, service satisfaction, and improving health status at individual and population levels.

Keywords: transition,transitional care,youth mental health,continuity of care,health services research,child and adolescent mental health services,integrated care pathways
Advance Care Planning; an Innovative Palliative Care Intervention to Improve Quality of Life in Cancer Patients - a Multi-Centre Cluster Randomized Clinical Trial (ACTION)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Netherlands,Netherlands,Belgium,Italy,United Kingdom,United Kingdom,Slovenia,Denmark
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-12-01
End date: 2019-05-31
Duration (months): 66.0
Total project cost (EUR): 6122871.2
EU funding (EUR): 4784656.0
Participants: 8
Project status: CLOSED

Advanced cancer typically involves multiple symptoms and seriously affects patients´ quality of life. Anxiety and depression are common. Medical care for patients with advanced cancer should be aimed at symptom control, psychosocial support, spiritual needs, and practical issues. Patients’ preferences regarding care should be central. Open and respectful communication are of key importance, but have been found to be a challenge for health care professionals as well as patients and relatives. Advance care planning (ACP) is a formalised process of communication between patients, relatives and caregivers about patients’ care preferences. It raises awareness of the need to anticipate future deterioration of health. ACP can improve current and future health care decision making, provide patients with a sense of control, increase adequate symptom control and improve quality of life. This project aims to study the effects of formalized ACP on symptom burden and quality of life of patients with advanced cancer. In a phase III multicentre cluster randomized controlled trial at least 20 hospitals in 6 countries will be randomized to provide patients with advanced cancer with either ACP or ‘care as usual’. 1334 patients diagnosed with lung or stage IV colorectal cancer will be included. Patients will fill in questionnaires at inclusion, and at 2.5 and 4.5 months post-inclusion. A relative will fill in a questionnaire after the patient’s death. Use of medical care will be assessed through medical files. Primary endpoints are quality of life (QLQ-C30 emotional functioning) and symptoms at 2.5 months post-inclusion. Secondary endpoints are the extent to which care as received was in line with patients’ preferences, patients’ evaluation of the decision making process, quality of dying and cost-effectiveness of the intervention. Our project will assess the impact of ACP on quality of life, and contribute to improving comfort and quality of care for patients with advanced cancer.

Keywords: - palliative care - cancer patients - quality-of-life - end of life - clinical trial - multi-center - ethics - advance care planning
Multimodal Imaging of rare Synucleinopathies (MULTISYN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Biotechnology, generic tools and medical technologies for human health
Action type: Collaborative project
Countries involved: Germany,Sweden,Austria,Greece,Denmark,Austria,Germany,Switzerland
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): 6392292.8
EU funding (EUR): 4895082.2
Participants: 8
Project status: CLOSED

Despite remarkable progress in the understanding of the molecular pathogenesis of neurodegenerative diseases (NDD), no causative or disease-modifying treatment is currently available. Aggregation of misfolded proteins are thought to play a crucial role in the pathogenesis, but attempts to exploit this knowledge for novel treatments have not been successful. Also, pathogenetically relevant biomarkers of protein aggregation are lacking. In order to overcome this critical road-block, we have assembled an interdisciplinary consortium, consisting of world-leading experts in structural biology and ligand development, multimodal neuroimaging, animal models and clinical trials to develop a novel imaging system for combined simultaneous molecular and functional imaging (PET-MRI/fMRI) for two rare diseases caused by excessive accumulation of misfolded alpha-synuclein (αSYN), multiple systems atrophy (MSA) and parkinsonism caused by mutations in the alpha-synuclein gene (SNCA), which will serve as proof-of-principle models for the more common and heterogeneous NDD. With this technology we will pioneer the monitoring of protein aggregation as a biomarker for therapeutic effects in the framework of individualized causative treatment. The central aspects of the work-flow including ligand design, software development and drug trials will be driven by three highly specialized SMEs, while translation to animal models and clinical use will be implemented by top academic centers. The groundbreaking progress will include: 1. Establish a multimodal imaging algorithm based on a new PET tracer and embracing structural and functional MRI methods to yield an αSYN specific tool 2. Test this multimodal, molecular neuroimaging algorithm in animal models with regard to its potential for diagnosis, mirroring the natural disease course and response to therapy 3. Translate the algorithm including the therapeutic modality (i.e. immunotherapy with PD01, NCT01568099) to the clinical setting.

Keywords: multimodal neuroimaging,pet/mri,synucleinopathies,alpha synuclein,therapeutic biomarker immunotherapy
Collaborative REsearch on ACute Traumatic brain Injury in intensiVe care medicine in Europe (CREACTIVE)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Italy,Hungary,Poland,Slovenia,Cyprus,Israel,Greece,Italy
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-10-01
End date: 2019-03-31
Duration (months): 66.0
Total project cost (EUR): 6983726.8
EU funding (EUR): 5443350.0
Participants: 10
Project status: CLOSED

Traumatic brain injury (TBI) is among the leading causes of death and disability and the main cause of death among the under-45s. Most patients with moderate to severe TBI are admitted to intensive care units (ICUs) The “PROSAFE” ICU network was recently established in 6 European countries through EU funding (PHEA 2007331), and has continued to collect high-quality data beyond the grant duration. In 2011, 225 ICUs had joined PROSAFE, recruiting a total of 73,163 patients, 2,694 of whom were admitted for TBI. Hence the network can expect to enrol 7-9,000 moderate to severe TBI patients in 4 years. The PROSAFE consortium has already focused attention on TBI and has just started collecting additional information on this condition in order to develop a prognostic model to identify centres of excellence in TBI management Aims of proposal are to consolidate the existing network in order to better describe the epidemiology of moderate-severe TBI in 7 countries (Greece has now joined the consortium); build a prognostic model based on short- and long-term outcome measures; identify most effective clinical interventions for optimally treating TBI patients, and recognize the determinants of optimal vs suboptimal performance All TBI-CDEs endorsed by InTBIR will be collected, along with other items needed to develop a sensible prognostic model, permitting the consortium to join forces with international collaborative initiatives in the field Availing of the coordinating institute’s biobank and consolidated expertise in biochemical and genetic biomarkers, the aim is to identify prognostic markers and underlying genetic factors influencing response to treatment and final outcome The PROSAFE consortium is thus in a position to guarantee superior quality data collection in 7 countries and ensure it continues beyond the life of the project. These conditions are essential if the consortium is to contribute to Europe playing a key role in the success of the InTBIR initiative

Keywords: collaborative research,acute traumatic brain injury,intensive care unit,prognostic model,effective treatments,best practices,biomarkers
Health and the Understanding of Metabolism, Aging and Nutrition (HUMAN)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Sweden,France,Italy,Netherlands,United Kingdom,United Kingdom,Germany,Switzerland,Sweden,Sweden,United States
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): 16154075.44
EU funding (EUR): 11994553.0
Participants: 16
Project status: CLOSED

Recently intense research identified around 4,000 single nucleotide polymorphisms (SNPs) associated with human age related diseases such as metabolic disorders. Despite their highly significant association to pathology, the functional role of these genetic variants is, in most cases, yet to be elucidated. The evolutionary distance of most animal models from humans represents a major limitation for the functional validation of these SNPs. To overcome these difficulties, HUMAN will generate mouse models carrying human hepatocytes or pancreatic βcells from either primary cells (hepatocytes) or induced pluripotent stem cells (iPSCs). This innovative approach offers the unique possibility of studying function of genetic risk variants associated with metabolic diseases in an integrated living system (the mouse body), but within human-derived organs, i.e. liver and pancreas. iPSCs used to generate hepatocytes and βcells will derive from extreme phenotypes, i.e. patients affected by severe metabolic diseases such as type 2 diabetes (T2D) or subjects selected for exceptional healthy longevity (subjects over 105 years and offspring of nonagenarian sibships) all fully clinically and metabolically characterised and genotyped; they will be selected according to the best combination of risk and protective alleles. We will test the effect of different nutritional regimes (e.g. high fat diet, caloric restriction), to disentangle the complex molecular mechanisms and circuitry across organs (e.g. hypothalamus-liver axis) which lead to pathology. HUMAN associates a core of outstanding basic research institutions to leading European biotech SMEs, and has the capability to produce at least 500 humanised mice. HUMAN will generate iPSCs biobanks and comprehensively manage all associated information. HUMAN is uniquely situated to drive innovation towards a better knowledge of the genetic basis of human metabolic diseases, thereby contributing to healthier aging of European citizens.

Keywords: metabolic diseases,humanised mouse models,ipsc,hepatocyte differentiation,beta-cell differentiation
Aggression in Children: Unraveling gene-environment interplay to inform Treatment and InterventiON strateg (ACTION)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: Netherlands,Netherlands,Australia,Sweden,Finland,United Kingdom,United States,Italy,Belgium
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2014-06-01
End date: 2019-05-31
Duration (months): 60.0
Total project cost (EUR): 8736901.84
EU funding (EUR): 5999079.4
Participants: 12
Project status: CLOSED

Aggression inflicts a huge personal, psychological and financial burden on affected individuals, their relatives, and society at large. Despite large scientific, preventive, and treatment investments, no decrease in aggressive behavior is seen. This calls for a shift to new approaches. By capitalising on comprehensive longitudinal cohorts, recent advances in genetic, biological, epidemiological, and clinical fields, and combining such interdisciplinary expertise the ACTION consortium will dissect the etiology and pathogenesis of aggression. Based on new insights, ACTION will inform the development of novel diagnostic tools and causative targets and guide the development of treatment and prevention strategies. ACTION is built on interrelated work packages with a focus on a) clinical epidemiology and current classification and treatment problems; b) genetic epidemiology, including Genome Wide Association studies and epigenetics; c) gene-environment correlation and interaction; d) biomarkers and metabolomics. ACTION will deliver an overarching framework that combines a thorough understanding of pathways leading to aggression with a map of current gaps, best practices on clinical, ethical, legal, and social issues. Based on this framework, ACTION will develop novel biomarkers suitable for large-scale applications in children and combine biomarker data with new insights into the effects of gender, age, and comorbidity. ACTION will provide guidance in optimising current intervention programs and deliver new biological targets to pave the way for novel therapeutic interventions. ACTION will provide a decision tree to guide personalised intervention programmes and will have direct and sustained impact on reducing paediatric aggression. Its overarching aim is to reduce aggression by developing approaches that take individual differences in genetic and environmental susceptibility into account, thereby leading to better understanding of personalised intervention programs.

Keywords: aggression,genetics,gene-environment interplay,epigenetics,metabolomics,biomarker,intervention
Kinetoplastid Drug Development: strengthening the preclinical pipeline (KINDRED)

Framework: FP7 — Cooperation
Programme: Health
Destination: Translating research for human health
Action type: Collaborative project
Countries involved: United Kingdom,Portugal,United States,France,Switzerland,France,France,Spain,Germany,Brazil,France,Germany,India
Call:  (FP7-HEALTH-2013-INNOVATION-1, 2013)
Start date: 2013-09-01
End date: 2016-08-31
Duration (months): 36.0
Total project cost (EUR): 7915469.55
EU funding (EUR): 5999991.25
Participants: 14
Project status: CLOSED

The trypanosomatid diseases, leishmaniasis, Human African trypanosomiasis (HAT) and Chagas disease (CD), continue to impart a heavy toll on human health. The treatments available are limited and threatened by drug resistance with few newdrugs in the pipeline. The KINDReD consortium integrates five leading academic laboratories in Europe (Portugal, United Kingdom, and Switzerland), the USA (California) and South America (Brazil) with high throughput screening (HTS) facilities equally distributed between all three major kinetoplastid parasites. Intracellular amastigote screening will be employed as the most relevant for Leishmania spp and T cruzi. Compound libraries (focused, diversity oriented or natural) will be screened in these systems, as well as compound series devised through target screening and in silico approaches. For carefully chosen protein targets, all three kinetoplastid parasite homologs will be screened against the closest human homolog to establish selectivity. Promising lead compounds will be optimised for efficacy and tolerability in cell-based and animal disease models. Toxicological markers will be evaluated in human cell lines prior to toxicity (acute,subacute,chronic) testing in lower then higher mammals. In parallel, and in line with the FDA's ‘Critical Path Initiative’, several check point controls will be built into the pipeline to flag, identify and allow early correction of potential toxicity/efficacy issues. These will include (i) a systems biology approach to identify drug target and off-target interactions via activity-based chemoproteomics (ii) ‘uptake and metabolism’as potential modulators of drug efficacy and/or resistance and (iii) the establishment of a firm set of rules for drug efficacy and safety in kinetoplastid chemotherapy. Our goal is to strengthen the drug development pipeline in order to achieve at least one new Phase I clinical candidate for each trypanosomatid disease at or shortly after the project completion date.

Keywords: trypanosomatid,kinetoplastid,protozoan,parasite,chemotherapy,drug,screening,platform,efficacy,tolerability,preclinical