Agency: European Commission | Branch: H2020 | Program: MSCA-ITN-ETN | Phase: MSCA-ITN-2016 | Award Amount: 3.47M | Year: 2017
Alzheimers disease (AD) affects more than 7 million people in Europe and this figure is expected to double every 20 years. Despite intensive efforts, no disease-modifying treatments or preventive strategies are available. The lack of specific, sensitive and minimally invasive diagnostics to identify people with early-stage AD to be included in clinical drug intervention trials is among the main reasons for many notable trial failures. The main challenges in developing the required diagnostics are identification of AD biomarkers and development of their detection techniques. The complex and interdisciplinary nature of the research underlines the need for innovative training of a new generation of researchers in the field. BBDiag responds to such a need and establishes a much-needed ETN for blood based early-AD diagnostics to address these challenges. It brings together leading academic and industrial experts from five major consortia in Europe and uses their synergies to build a triple-i research & training platform with the required multidisciplinary expertise and cutting-edge technologies. BBDiag Fellows will be trained under the Vitae Researcher Development Framework innovatively combined with the BBDiag platform for gaining interdisciplinary scientific and transferable skills as well as personal quality, creative thinking and business mind-set. The ETN has a highly innovative research programme for the discovery of AD biomarkers, development of novel biosensing techniques and point of care tools, and for technological exploitation of the diagnostics. These advances will strongly support improved care provision and development of disease-modifying treatments and preventive strategies for AD patients. More importantly, BBDiag will deliver its first generation of 13 highly-skilled, creative and entrepreneurial Fellows, setting them on a path to successful careers in academia or industry to ensure that the medical and societal challenges imposed by AD are met.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-03-2015 | Award Amount: 6.19M | Year: 2016
Understanding mechanisms underlying comorbid disorders poses a challenge for developing precision medicine tools. Psychiatric disorders are highly comorbid, and are among the last areas of medicine, where classification is driven by phenomenology rather than pathophysiology. We will study comorbidity between the most frequent psychiatric conditions, ADHD, mood/anxiety, and substance use disorders, and a highly prevalent somatic disease, obesity. ADHD, a childhood-onset disorder, forms the entry into a lifelong negative trajectory characterized by these comorbidities. Common mechanisms underlying this course are unknown, despite their relevance for early detection, prevention, and treatment. Our interdisciplinary team of experts will integrate epidemiologic/genetic approaches with experimental designs to address those issues. We will determine disease burden of comorbidity, calculate its socioeconomic impact, and reveal risk factors. We will study biological pathways of comorbidity and derive biomarkers, prioritizing two candidate mechanisms (circadian rhythm and dopaminergic neurotransmission), but also leveraging large existing data sets to identify new ones. A pilot clinical trial to study non-pharmacologic, dopamine-based and chronobiological treatments will be performed, employing innovative mHealth to monitor and support patients daily life. Integration of findings will lead to prediction algorithms enhancing early diagnosis and prevention of comorbidity. Finally, we will screen to repurpose existing pharmacological compounds. Integrating complementary approaches based on large-scale, existing data and innovative data collection, we maximize value for money in this project, leading to insight into the mechanisms underlying this comorbidity triad with its huge burden for healthcare, economy, and society. This will facilitate early detection and non-invasive, scalable, and low-cost treatment, creating opportunities for substantial and immediate societal impact.
Agency: European Commission | Branch: H2020 | Program: MSCA-ITN-ETN | Phase: MSCA-ITN-2015-ETN | Award Amount: 2.54M | Year: 2016
Soft chemical-ionization mass-spectrometry (SCIMS) is an exquisitely sensitive analytical technique with applications to health, the environment and security that are vital to the EU. However, the recent, rapid and widespread adoption of this technique has caught Europe unprepared. The resultant shortage in analytical chemical expertise has created an urgent need for highly skilled young researchers to be trained in the wide variety of SCIMS methods. IMPACT addresses this skills shortage by establishing an intersectoral and multidisciplinary SCIMS training network. IMPACT also brings cohesion to the fragmented SCIMS research and development activities within the EU. To date, most SCIMS developments have been driven not by users but by manufacturers, whose main focus has been on increased sensitivity. However, just as crucial is improved selectivity. Indeed, many users consider improved selectivity to be the key to taking SCIMS technology to a whole new level. Instead of private and public sectors working independently, we need a fresh, intersectoral approach. IMPACT will achieve this through intersectoral work packages and multidisciplinary research projects. In place of major and costly changes in instrumental design, IMPACTs projects will focus on developing new methods for improved chemical specificity by manipulating ion chemistry. Hence, IMPACTs fresh approach will produce a step change in SCIMS instrumentation to deliver both economic and societal benefit to the EU. Specifically, IMPACT will train 10 ESRs within an integrated partnership of commercial, governmental and academic organisations, with planned secondments, 5 Advanced Training Courses, 7 interactive Complementary Skills Workshops, and 4 ESR Centred Research Meetings. IMPACT will therefore provide Europe with both a world-class capability in SCIMS technology and a cohort of highly trained researchers who will bring the benefits of that technology to citizens across the EU.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-01-2014 | Award Amount: 7.31M | Year: 2015
Healthspan (the life period when one is generally healthy and free from serious disease) depends on nature (genetic make-up) and nurture (environmental influences, from the earliest stages of development throughout life). Genetic studies increasingly reveal mutations and polymorphisms that may affect healthspan. Similarly, claims abound about lifestyle modifications or treatments improving healthspan. In both cases, rigorous testing is hampered by the long lifespan of model organisms like mice (let alone humans) and the difficulty of introducing genetic changes to examine the phenotype of the altered genome. We will develop C. elegans as a healthspan model. Already validated extensively as an ageing model, this organism can be readily modified genetically, and effects of environmental manipulations on healthspan can be measured in days or weeks. Once validated as a healthspan model, it can be used for an initial assessment of preventive and therapeutic measures for humans, as well as for risk identification and the initial evaluation of potential biomarkers. It will also prove useful to study interactions between genetic and various environmental factors.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-26-2014 | Award Amount: 4.59M | Year: 2015
HEARTEN will design, develop and validate an ICT co-operative environment that will enable the HF patients to achieve sustainable behavior change regarding their adherence and compliance, and the ecosystem actors to be engaged and improve the patients HF management. HEARTEN targets all actors related to the management of patients suffering from HF, including healthcare professionals, caregivers (formal/informal), healthcare providers nutritionists, fitness experts and health insurance experts, towards developing a multi-stakeholder patient centered mHealth ecosystem. The target population of HEARTEN are patients with chronic and acute HF, either post-ischemic or with dilated cardiomyopathy, requiring occasionally re-admittance into hospitals. The idea is to develop biosensors that detect and quantify novel breath and saliva HF biomarkers, being identified through analytical techniques. These biomarkers reflect the health status of the patient and identify whether the patient adheres to the administered drugs. The breath biosensor will be integrated into the smartphone while the saliva biosensor will be integrated into the patients cup. Additional sensors for monitoring the ECG, the blood pressure and the physical activity constitute the sensor kit of the patient. The input data are complemented with nutrition information from the patients smartphone, weight monitoring through wireless weight scales as well as the patients profile and information directly added by the caregivers and the healthcare professionals. The multiparametric data are transmitted to the HEARTEN cloud architecture, where a knowledge management system analyses them and delivers critical information at hand. HF patients are empowered in self-management, by using their smartphones and tracking their medical vital signs, while the healthcare professionals and the caregivers can issue warnings, coordinate therapies, improve adherence and intervene before frailty incidences occur.
Agency: European Commission | Branch: FP7 | Program: BSG-SME | Phase: SME-2013-1 | Award Amount: 1.43M | Year: 2014
Ageing, sedentary behaviour,and obesity are predictors of osteoarthritis, and the combination of arthritis and obesity causes an undue stress on joints, and when conservative treatments no longer yield a satisfactory response, joint replacement becomes necessary. Despite the standardized procedures, a significant share of total joint replacements fail because the prosthesis becomes loose or because of osteolysis, and the prosthesis must be replaced. Bone loosening is usually diagnosed by radiography and clinical symptoms, but pre-operative radiographic diagnosis of loosening has a sensitivity of 80%, and a considerable number of revision surgeries is not necessary because loosening of the total joint replacement was diagnosed false positively.Currently clinically applied methods of assessing implant fixation and implant loosening are of sub-optimal precision, leading to unsecure indication of revision surgery and late recognition of bone defects.To solve this technology gap, the SMART-HIP goal is to develop a new intelligent hip prosthesis, enabling timely and accurately diagnosis of bone loosening, thus allowing for a fast and reliable support to the orthopaedists while deciding upon revision surgery of joint replacements.The final SMART-HIP system will be composed of two fundamental sub-systems:A) The Intelligent Prosthesis, whose basic component will be the Oscillator Unit consisting of a magnetic or magnetisable body which is fixed on a flat steel spring, which will enable to perform an acoustic-mechanical analysis of the variation of the resonance frequencies of total joint replacements, correlating them with the loosening status of the bone.B)The Diagnostic Device, which is placed outside the patients body and used during the clinical test to excite the oscillator.This excitation within the implant bending modes leads to a sound emission to the surrounding bone and soft tissue, which can be detected by a vibration sensor, which is applied outside the patient.
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.2.2-2 | Award Amount: 5.96M | Year: 2012
Background: Treatment of chronic diseases in the elderly with polypharmacy poses a threat to patient outcome and involves extensive costs. Little evidence exists regarding the benefits of polypharmacy, but rising evidence shows its harmful effects. Several approaches to reduce polypharmacy have been proposed, but none have been evaluated using clinically relevant endpoints. Aims: Based on a systematic review we will gather current best evidence and develop recommendations to optimize treatment of polymorbid elderly with cardiovascular disease, heart failure, hypertension, atrial fibrillation, diabetes mellitus type 2, musculoskeletal disorders, COPD, and mental diseases. We will then design an electronic decision support (eDS) tool incorporating the recommendations to be applied in primary care. The tool will be evaluated in a randomised controlled trial (RCT) to show that reduction of polypharmacy in the treatment of the target-diseases is beneficial and safe. Using the results of the RCT, the eDS-tool will be optimized and then disseminated for general utilization. Workplan: The project is scheduled for 4 years and will contain 12 work packages. WP1 comprises management of the project. The evidence regarding treatment of chronic diseases gathered within WP2 will be used to develop the eDS tool and an electronic case report form (eCRF) in WPs 3-4. After recruitment of surgeries and patients, and implementation of the tool in WP 5, the tool will be evaluated within a cluster-randomized controlled trial (WPs 6-10). The results of the RCT will be used to optimize the eDS tool (WP 11) which will then be disseminated (WP 12). Impact: The project will contribute to the EIP Active and Healthy Ageing. It will improve treatments suited to the needs of older people and lower health care costs by promoting standardized care and reducing hospital admissions. The tool will be exploited by one of the partners (Duodecim Medical Publications) to achieve widespread implementation
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: SC1-PM-09-2016 | Award Amount: 7.85M | Year: 2017
Liver disease incidence is increasing and about 170K patients die from liver failure each year in Europe. In liver failure, the accumulation of protein bound toxins and increased susceptibility to infection cause multiorgan failure and death. Liver transplantation is the only treatment known to prolong the life but is limited by availability of organs. A clinically efficacious liver dialysis device is an unmet clinical need. The ALIVER Consortium has developed and optimised a novel liver dialysis device, DIALIVE. The DIALIVE device is protected by world-wide patents and is based upon our discovery that (i) albumin, a circulating protein involved in detoxification is reduced irreversibly in function and (ii) endotoxemia contributes to increased risk of infection in liver failure. DIALIVE incorporates albumin removal and replacement and, endotoxin removal and is a TRL5. In animal models of liver failure, DIALIVE was shown to be easy to use, safe, reduced endotoxemia and, improved albumin and immune function and, prolonged survival. The ALIVER Consortium, which is comprised of experts in liver failure, SMEs and charities proposes to perform clinical trials of DIALIVE in patients with acute on chronic liver failure (ACLF). During the grant period a CE-mark will be obtained and the device will progress to a TRL7/8. Consultation with Regulatory bodies confirms that if the trials are successful, a CE-mark is highly likely. Grifols, a large plasma proteins company is a potential licensee of the technology if the studies proposed by the ALIVER Consortium are positive. We plan to take the project through regulatory and ethics approval and perform two studies to define its safety and efficacy in ACLF patients in 18 European hospitals; define health economic benefits to the EU and define a reimbursement strategy. The results will be disseminated widely and results exploited to benefit patients, EU healthcare system, create new jobs and grow healthcare Industry in Europe.
Pau H.W.,Universitatsmedizin Rostock
HNO | Year: 2015
Balloon dilatation is a promising new treatment for Eustachian tube dysfunction which is becoming more and more popular in Germany. There are a number of single publications and even meta-analyses on this topic, which demonstrate good results but also reveal the need for better studies. Initially tube dilatation was applied only in adults with tube dysfunctions but recently some centers even recommend it for children with long-lasting or frequently recurring middle ear effusion, which is resistant to conventional therapy. This article provides a critical appraisal based on the current literature and emphasizes the need for controlled studies. Due to the poor definition of tube dysfunctions it may be difficult to establish informative studies but in terms of evidence-based medicine there is need for a precise definition of indications and inclusion criteria. Most important is that such studies must include control groups, which has so far not been the case. Moreover, there should be a consensus about the criteria for defining success. Although all publications claim that balloon tuboplasty is a safe method, the question whether or not preoperative computed tomography (CT) scans are needed should be considered in each individual case. Nevertheless, balloon dilatation is a very promising method offering a new approach to the problem of Eustachian tube dysfunction. © 2015, Springer-Verlag Berlin Heidelberg.
Mittlmeier T.,Universitatsmedizin Rostock
Unfallchirurg | Year: 2013
In general, for the treatment of end-stage osteoarthritis of the ankle joint arthrodesis is considered to be the gold standard based on its versatility and eligibility for numerous indications. Nowadays, total ankle arthroplasty represents a viable alternative to ankle arthrodesis taking into account distinct premises as both procedures provide a calculable reduction of the preoperative pain level and a comparable functional gain. Furthermore, current 10-year-survival rates of total ankle replacement are reported to range between 76 % and 89 %. Revision rates of up to 10 % for both techniques have been reported with manifest differences within the respective spectrum of complications. Due to the fact that more than two thirds of patients suffer from post-traumatic osteoarthritis with a relatively low average of age concomitant malalignment, soft tissue damage or instability may frequently occur. A restoration of anatomic axes and an adequate centering of the talus under the tibia appear to be crucial for the outcome as well as an adequate soft tissue balancing, in particular in total ankle replacement. Thus, the selection of the correct indication and the right choice of treatment on the basis of complete preoperative diagnostics considering necessary additive surgical measures are of paramount importance for the final outcome. © 2013 Springer-Verlag Berlin Heidelberg.