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center Ljubljana, Slovenia

Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-24-2015 | Award Amount: 18.47M | Year: 2016

The management of febrile patients is one of the most common and important problems facing healthcare providers. Distinction between bacterial infections and trivial viral infection on clinical grounds is unreliable, and as a result innumerable patients worldwide undergo hospitalization, invasive investigation and are treated with antibiotics for presumed bacterial infection when, in fact, they are suffering from self-resolving viral infection. We aim to improve diagnosis and management of febrile patients, by application of sophisticated phenotypic, transcriptomic (genomic, proteomic) and bioinformatic approaches to well characterised large-scale, multi-national patient cohorts already recruited with EU funding. We will identify, and validate promising new discriminators of bacterial and viral infection including transcriptomic and clinical phenotypic markers. The most accurate markers distinguishing bacterial and viral infection will be evaluated in prospective cohorts of patients reflecting the different health care settings across European countries. By linking sophisticated new genomic and proteomic approaches to careful clinical phenotyping, and building on pilot data from our previous studies we will develop a comprehensive management plan for febrile patients which can be rolled out in healthcare systems across Europe.

Agency: Cordis | Branch: H2020 | Program: RIA | Phase: PHC-15-2014 | Award Amount: 6.00M | Year: 2015

Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE (SCIENCE) With more than 17 million deaths worldwide each year, ischemic heart disease (IHD) caused by coronary artery disease is the most common cause of death and a major cause of hospital admissions in industrialised countries. IHD caused over four million deaths in Europe in the year 2012 constituting 47% of all deaths. Today IHD is the main cause of death among women throughout Europe and the main cause of death among men in all but six European countries. Conventional therapies have reduced mortality of IHD significantly, but have left an increasing number of patients with chronic IHD and/or heart failure without further treatment options. An increasing morbidity rate of this nature in an ageing population is a huge burden for society. The overall aim of the SCIENCE project is to implement an effective stem cell-based therapy with allogeneic adipose derived stromal cells to improve myocardial function in patients with ischemic heart disease and heart failure. This goal will be achieved by conducting a multicentre clinical trial in a strong consortium of experienced international scientists and experts as well as significant representatives of the biomedical industry within translational medicine and a close collaboration with relevant authorities. The consortium will ensure feasibility of treatment by simplifying and rationalising cell production and distribution using state-of-the art manufacturing technology that makes cell therapy a realistic option for clinical practise. The consortium expects the SCIENCE project to pave the way for future approval of this treatment by national authorities throughout Europe as the standard form of care for patients with ischemic heart disease and heart failure. This concept will establish a new platform for growth and consolidation of innovative small and medium-size companies within stem cell research and development. Such a platform will ease implementati

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.2.4.2-2 | Award Amount: 7.80M | Year: 2013

Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) represents a major European health care concern with mortality rates between 40-70%. Approximately 70-80% of these patients present with multivessel disease defined as coronary lesions in more than one vessel. The clinician is faced with the decision to either 1) intervene only on the culprit lesion acutely responsible for the initiation of cardiogenic shock, or 2) treat additional lesions considered hemodynamically significant but not acutely triggering the CS cascade as well. Current guidelines recommend percutaneous coronary intervention of all critical lesions. However, due to a lack of randomized trials, these recommendations are solely based on registry data and pathophysiological considerations. Aim of the randomized CULPRIT-SHOCK trial is therefore to compare a) immediate multivessel PCI versus b) culprit lesion only PCI in patients with AMI complicated by CS. A total of 706 CS patients will be randomized in several European countries. The primary endpoint will be 30-day all-cause mortality and/or severe renal failure requiring renal replacement therapy. CULPRIT-SHOCK will therefore determine the optimal percutaneous revascularization strategy in patients with AMI and multivessel disease complicated by CS. In addition, a comprehensive array of efficacy, safety and socio-economic parameters for the chosen population will be assessed. Multiple secondary endpoints and several substudies (microcirculation, biomarkers, angiography) will serve to further understand the presumed differential effects of the 2 treatment arms and to understand the underlying pathophysiology and prognostic markers. From these parameters a multivariable regression model and a risk score for the prediction of clinical prognosis and a cost-effectiveness model in AMI and CS will be developed. Furthermore, CULPRIT-SHOCK will obtain data on CS patients not meeting inclusion criteria by instituting a separate registry.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2013.2.2.1-1 | Award Amount: 7.03M | Year: 2013

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 institutes 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

Stupnik T.,Univerzitetni klinicni center Ljubljana | Perme M.P.,University of Ljubljana
Statistics in Medicine | Year: 2016

When analyzing time to disease recurrence, we sometimes need to work with data where all the recurrences are recorded, but no information is available on the possible deaths. This may occur when studying diseases of benign nature where patients are only seen at disease recurrences or in poorly-designed registries of benign diseases or medical device implantations without sufficient patient identifiers to obtain their dead/alive status at a later date. When the average time to disease recurrence is long enough in comparison with the expected survival of the patients, statistical analysis of such data can be significantly biased. Under the assumption that the expected survival of an individual is not influenced by the disease itself, general population mortality tables may be used to remove this bias. We show why the intuitive solution of simply imputing the patient's expected survival time does not give unbiased estimates of the usual quantities of interest in survival analysis and further explain that cumulative incidence function analysis does not require additional assumptions on general population mortality. We provide an alternative framework that allows unbiased estimation and introduce two new approaches: an iterative imputation method and a mortality adjusted at risk function. Their properties are carefully studied, with the results supported by simulations and illustrated on a real-world example. © 2016 John Wiley & Sons, Ltd.

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