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Azienda Sanitaria Unità Locale di Reggio Emilia

Azienda Sanitaria Unità Locale di Reggio Emilia

10 Projects, page 1 of 2
  • Funder: European Commission Project Code: 945119
    Overall Budget: 7,216,440 EURFunder Contribution: 7,161,440 EUR

    Ventricular tachycardia (VT) is an unpredictable and potentially deadly condition and should be promptly treated with catheter ablation and medication, before irreversible and potentially fatal organ damage follows. Unfortunately, this combination of treatments does not prevent VT reoccurrence in 30-50% of VT patients and while they can undergo multiple invasive ablations, technical difficulties or refusal of the patient can lead to a lack of effective treatment options. A promising novel, non-invasive treatment option for VT is stereotactic arrhythmia radioablation (STAR). Besides being non-invasive, STAR can also be used to reach locations that are inaccessible for catheter ablation, which may potentially improve effectiveness of overall VT treatment. Small scale first in men/early phase trials have been performed for STAR, providing proof-of-concept for clinical safety and efficacy. However, patients with recurrent VT are not a homogenous group and each center deals with different inclusion criteria, imaging and/or target definition. Many questions remain and the available studies lack the power to clinically validate the approach and prepare for late stage phase III trials. The STOPSTORM consortium sets out to consolidate all current and future European efforts to clinically validate STAR treatment by merging all data in a validation cohort study, standardising pre-treatment and follow-up, in order to collect the data sets and statistical power needed to unanimously establish clinical safety, efficacy and benefit for STAR. The STOPSTORM consortium also sets out to refine protocols and guidelines, determine volumes of interest, define and model the optimal target region and target dose, also in relation to surrounding healthy tissues (i.e. organs at risk) and determine which patient population and underlying cardiopathies respond best to STAR. By doing so the STOPSTORM consortium paves the way to consensus and future late stage clinical trials for STAR.

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  • Funder: European Commission Project Code: 755394
    Overall Budget: 12,499,000 EURFunder Contribution: 12,436,900 EUR

    MyPeBS addresses the crucial and timely question of the future of breast cancer screening in Europe. Indeed current standard mammographic screening, with entry stratified by age alone, has recently been largely questioned. Despite a demonstrated mean 20% reduction in breast cancer-specific mortality, together with reduction of late-stage disease in women older than 50, it is associated with potential harms including false positive recalls and over-diagnosis. Individual breast cancer risk estimation, through models including clinical variables, mammographic breast density and more than 100 genetic polymorphisms, now has substantial clinical and scientific bases. Personalized screening strategies, based on individual risk levels, could potentially improve the individual benefit/harms ratio of screening (earlier cancer detection and less intensive treatments in high risk women, less false positives and over-diagnoses in low risk ones), and increase the cost-efficacy for health insurances. MyPEBS will conduct an international randomized phase III trial to validate this hypothesis. It will primarily assess the ability of an individual risk-based screening strategy to be non-inferior, and possibly superior, to the standard of care screening, in reducing the cumulative incidence of stage II+ breast cancers. The trial, conducted in 5 countries (France, Italy, UK, Belgium and Israel) will include 85000 European women aged 40-70, all followed for 4 years. MyPEBS will also evaluate if an individual risk-based screening strategy, compared with the standard, reduces screening-related harms (unnecessary biopsies, overdiagnoses) in low-risk women, is overall at least as cost-effective as well as more accepted by women resulting in a larger screening coverage. After analyses of all components, the final objective of MyPEBS is to deliver recommendations for the best future breast cancer screening strategy in Europe.

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  • Funder: European Commission Project Code: 602202
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  • Funder: European Commission Project Code: 770492
    Overall Budget: 4,960,720 EURFunder Contribution: 4,841,540 EUR

    There is growing consensus that public services can be improved through experiments which bring together service providers and their users. This proposal is for H2020-SC6-Co-Creation-2016-217: Applied co-creation to deliver public services. The CoSIE project contributes to democratic dimensions and social inclusion through co-creating public services by engaging diverse citizen groups and stakeholders. Utilizing blended data sources (open data, social media) with innovative deployment of ICT (data-analytics, Living Lab, Community reporting) in nine pilots, the project introduces the culture of experiments that encompasses various stakeholders for co-creating service innovations. The CoSIE project has two overarching aims: i) advance the active shaping of service priorities by end users and their informal support networks, ii) engage citizens, especially groups often called ‘hard to reach’, in the collaborative design of public services. The aims are divided into six objectives: 1) develop practical resources grounded in asset based knowledge to support new ways for public service actors to re-define operational processes, 2) produce and deliver nine real-life pilots to co-create a set of relational public services with various combinations of public sector, civil society and commercial actors, 3) draw together cross-cutting lessons from pilots and utilise innovative visualisation methods to share and validate new ideas and models of good governance, 4) apply innovative approaches appropriate to local contexts and user groups to gather the necessary user insight to co-create services, 5) ensure sustainability by establishing local trainers for animating dialogue and collating user voice, embedded in community networks, 6) mobilise new knowledge from piloting and validating by creating an accessible, user friendly roadmap to co-creation for service providers and their partners. The project will be implemented as a joint venture with 24 partners from 10 EU countries.

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  • Funder: European Commission Project Code: 825319
    Overall Budget: 3,791,500 EURFunder Contribution: 3,770,000 EUR

    The BETTER-B consortium tests whether mirtazapine, currently used as an antidepressant, is an effective treatment to reduce chronic or refractory breathlessness (CB) in patients with advanced chronic obstructive pulmonary or interstitial lung disease (COPD or ILD) needing palliative care or at the end of life. Our focus is on breathlessness that persists despite optimal treatment of the underlying condition. This widespread and frightening symptom has a major detrimental impact on patients’ quality of life and distresses their family, friends and carers. It is associated with physical and psychosocial morbidity and results in high use of health care services, including emergency care. There are no licenced medicines for CB in the world. It is a major challenge to clinical management, care quality and patient wellbeing. We have completed a feasibility trial in 60 patients, reviews and case studies that suggest mirtazapine is a promising treatment. To assess if mirtazapine is effective, we conduct a randomised double blind clinical trial of mirtazapine versus placebo in patients with CB and COPD or ILD. The trial recruits 324 patients over 18 months across respiratory, palliative care and community services in Poland, Ireland, Italy, Germany and the UK. We study the effects of treatment over time on patients, their family or caregivers and care costs. We survey clinicians and produce accessible European guidance on treating CB. The consortium unites a unique multi-disciplinary group of clinician scientists from respiratory, palliative, geriatric and rehabilitation fields, alongside statisticians, trialists, health economists, health care researchers, patient and consumer groups and a European Society. This ensures the optimal design and operation of the trial and the widest impact from its results. Using an existing medicine for a different purpose offers a highly cost-effective approach for treatment that can be implemented and sustained internationally.

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