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Luzzatto L.,Instituto Toscano Tumori | Gianfaldoni G.,Azienda Ospedaliero Universitaria Careggi | Notaro R.,Instituto Toscano Tumori
British Journal of Haematology | Year: 2011

Paroxysmal nocturnal haemoglobinuria (PNH) is a serious form of acquired haemolytic anaemia with several features that make it unique, including the fact that it is caused by clonal expansion, in the context of bone marrow failure, of a haematopoietic stem cell that has a somatic mutation in a gene crucial for the synthesis of glycosylphosphatidylinositol anchors; and that this also produces a life-threatening acquired thrombophilic state. Until recently, the two only main options for patients with PNH were either allogeneic bone marrow transplantation or supportive management, including blood transfusion: both options require some skill and good patient-doctor collaboration. Since the start of this millennium a major advance has been the introduction of eculizumab, a monoclonal antibody that targets the C5 protein of the complement system: blockade of C5 prevents activation of the complement distal pathway, and thus abrogates the complement-mediated intravascular haemolysis that severely plagues patients with PNH. This review outlines an approach to the management of all three major components of the clinical picture of PNH - namely haemolysis, thrombosis and bone marrow failure - based on the literature and on personal experience. We consider specifically how the use of eculizumab has modified other aspects of the management of PNH, and even the pathophysiology itself of this disease. Finally, we develop a treatment algorithm which others might find helpful. © 2011 Blackwell Publishing Ltd.

Agency: Cordis | Branch: FP7 | Program: CSA-SA | Phase: HEALTH-2007-4.1-8 | Award Amount: 925.80K | Year: 2008

Background Tuberculosis and HIV/AIDS are on the rise worldwide, representing a global public health problem with considerable mutual interaction: TB is the leading cause of mortality for people living with HIV/AIDS, and HIV is the most potent force driving the TB epidemic in countries with a high prevalence of HIV . Especially in rural areas of Africa, Latin America, India and Russia both diseases form a deadly combination affecting large populations: In 2006, 39.5 million people suffered from HIV , and 2 billion people were infected with Mycobacterium tuberculosis, the causative agent of TB . Approximately 11 million people are co-infected with both diseases. Up to now, there is a massive failure to respond to the dual epidemic in an integrated way , and despite an increasing awareness worldwide, greater commitment and increased funding, current prevention and treatment efforts as well as coordinated research initiatives need to be strengthened to address the challenge of TB-HIV coinfection . TB and HIV programmes worldwide still work largely in isolation from each other and are focussing on national levels, although the urgent need to combat HIV and TB is recognized internationally. Additionally, scientists still primarily work with colleagues from the same field of research instead of collaborating with partners in complementary fields. Objective The objective of the support action is to provide an overview of the state of the art in HIV and TB research and disease management in the different partner countries, to identify global research priorities and to boost international cooperation between leading HIV and TB experts from Europe and those countries mainly affected by the two diseases - Russia, Latin America, South Africa and India.

Agency: Cordis | Branch: FP7 | Program: CP-IP | Phase: EeB.NMP.2013-5 | Award Amount: 11.03M | Year: 2013

STREAMER is an industry-driven collaborative research project on Energy-efficient Buildings (EeB) with cases of mixed-use healthcare districts. Such districts are the best real examples of neighbourhood with integrated energy system consisting of mixed building types (i.e. hospitals and clinics; offices and retails; laboratories and educational buildings; temporary care homes, rehabilitation and sport facilities). The energy use of 1 healthcare district could exceed that of 20,000 dwellings. In almost every European city there is at least one healthcare district making a huge impact on the whole citys energy performance. STREAMER aims at 50% reduction of the energy use and carbon emission of new and retrofitted buildings in healthcare districts. Healthcare-related buildings are among the top EU priorities since they play a key role for a sustainable community, but their energy use and carbon emission are among the highest of all building types. Take for instance a typical hospital building that is part of the healthcare district. It uses 2.5 times more energy than an office. In the EU, there are some 15,000 hospitals producing 250 million tonnes of carbon per annum. The EeB design complexity is extremely high; and therefore, both holistic and systemic approaches are crucial. STREAMER will resolve this by optimising Semantics-driven Design methodologies with interoperable tools for Geo and Building Information Modelling (Semantic BIM and GIS) to validate the energy performance during the design stage. STREAMER will enable designers, contractors, clients and end-users to integrate EeB innovations for: 1) building envelope and space layout; 2) medical, MEP and HVAC systems; and 3) building and neighbourhood energy grids. STREAMER results will be validated in the 4 real projects involving the Implementers Communities. The outcome will be used to extend the standardisation in EeB design and operation, open BIMGIS (IFCCityGML), and Integrated Project Delivery (IPD).

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2007-2.4.2-6 | Award Amount: 3.43M | Year: 2009

The main purpose of the EVINCI-study is to test the impact of combined anatomo-functional non invasive cardiac imaging for detection and characterization of Ischemic Heart Disease (IHD). The EVINCI-study is a prospective clinical European multicenter trial performed in a cohort of 700 patients with suspected IHD. Patients with intermediate pre-test probability will undergo clinical and biohumoral characterization, including novel circulating markers of cardiovascular risk. They will be admitted to a non-invasive cardiac evaluation, consisting of anatomic imaging, by multislice computerized tomography, combined with functional tests among radionuclide, magnetic resonance and ultrasound imaging. Heart catheterization will be performed to validate non-invasive diagnosis and follow-up to assess outcome. The diagnostic accuracy of combined non-invasive anatomo-functional imaging will be tested against reference methods for diagnosing epicardial coronary lesions (coronary angiography), vessel wall atherosclerosis (intracoronary ultrasound) and impaired coronary flow reserve (intracoronary doppler/pressure wire). The individual profiles from anatomo-functional cardiac imaging and clinical-biohumoral data will be combined and tested against outcome. A cost-benefit analysis (including an estimate of procedural/radiological risks) of the new diagnostic work-up will also be performed. A relevant part of the EVINCI-study will be dedicated to the development, in cooperation with the industry, of an advanced informatics platform able to synthetically present to the end-user (patients, physicians, etc.) the integrated cardiological diagnostic profile of the individual patient as resulting from clinical-biohumoral and multi-imaging assessment. Overall results will be disseminated in cooperation with the European Society of Cardiology (ESC) and will guide the work of a dedicated ESC Commission which will release specific European Recommendations.

Agency: Cordis | Branch: FP7 | Program: CP | Phase: ICT-2007.5.1 | Award Amount: 10.28M | Year: 2008

Chronic diseases are those that occur across the whole spectrum of illness, mental health problems and injuries. Management includes medication and/or lifestyle changes such as diet and exercise. At the same time, it should be noted that chronic diseases may get worse, lead to death, be cured, remain dormant or require continual monitoring. CHRONIOUS primary goal is to define a European framework for a generic health status monitoring platform schema addressing people with chronic health conditions. This will be achieved by developing an intelligent, ubiquitous and adaptive chronic disease platform to be used by both patients and healthcare professionals. CHRONIOUS addresses a smart wearable platform, based on multi-parametric sensor data processing, for monitoring people suffering from chronic diseases in long-stay setting. It is constantly monitoring their activity using audio observation methods and activity sensors while at the same time tracking their medical condition via vital signs sensors. Any trait of abnormal health status and possible alerting incidents are detected by CHRONIOUS Intelligence. The system generates alerts in case of invalid medical data or if current activity and behaviour lay outside the well established activity patterns and locomotion behaviour. Furthermore, CHRONIOUS objective is to face Europes challenge for delivering quality healthcare to all its citizens by offering a ubiquitous and more personalised care solution that addresses the user needs, personal data security, confidentiality and privacy of information and all that at an affordable cost. Our proposed solution will be applied to the chronic diseases of Chronic Obstructive Pulmonary Disease (COPD) and Chronic Kidney Disease (CKD) and Renal Insufficiency.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.2.4.5-2 | Award Amount: 8.55M | Year: 2012

Inflammatory bowel diseases affect 0.8% of the Europeans, and are associated with high morbidity, definite mortality and an increasing economic burden. Current diagnostic tools and therapeutics for IBD are unsatisfactory. Development of biomarkers allowing insights into pathogenesis, prognosis and targeted therapy is a major unmet need. This programme addresses that need. IBD-BIOM is a multidisciplinary consortium of leading academic and industrial SME researchers in inflammatory bowel disease, genomics, glycomics, glycoproteomics and activomics. Recent genome-wide association studies performed by IBD-BIOM partners have identified nearly 100 genes associated with IBD, but clinical application of these is so far limited. IBD-BIOM will capitalise on its existing high quality clinical, genetic, biochemical and immunological data and biological samples on over 6000 very well characterised IBD patients and controls by exploiting novel technological approaches made available through the expertise and global leading position of IBD-BIOM partners. These comprise cutting edge epigenetic, glycomic, glycoproteomic and activomic approaches which were all previously reported to be associated with inflammation and disturbances to the immune system. The inclusion of these complementary analyses in the diagnostics of IBD should also facilitate elucidation of pathways through which environmental exposures influence IBD risk and progression. A complex systems biology approach will be used to integrate, interrogate and understand this multidimensional dataset to identify novel early diagnostic and prognostic biomarkers and new targets for therapeutic intervention. The track record of achievement of IBD-BIOM partners coupled to the central and leading positions of the research-intensive SME partners in IBD-BIOM is a strong indication that the ambitions work programme will be achieved and a framework to facilitate swift conversion of research discoveries into commercial products.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: NMP.2011.2.2-2 | Award Amount: 5.46M | Year: 2012

Age-related cancers, especially of the trachea, are neoplastic lesions that significantly impact upon the lives of thousands of European patients each year. Unfortunately, most present with inoperable lesions for which median survival is less than 12 months. Based on our previous clinically successful experiences with in vivo completely tissue engineered tracheal replacement in benign tracheal diseases, we recently applied this technology in 2 patients with otherwise inoperable primary tracheal cancers. The successful observed outcome confirms the unique opportunity to scale-up an effective therapeutic approach into a widely accessible clinical technology, which could enhance not only the quality of life but even cure otherwise untreatable patients. However, a limitation of our current technology is the time it takes to re-populate the decellularized trachea. This may prove critical in the case of cancer patients. Further, the size of the transplant is currently limited due to the fact that the transplanted tissue needs to be efficiently and rapidly vascularised to prevent necrosis in vivo. To surmount these limitations, we aim to: i) improve our current technique of in vivo tissue engineering human tracheae in a small number of patients and subsequently begin a formal clinical trial, ii) develop pharmacological approaches to activate endogenous stem cells, stimulate tissue regeneration and vascularisation in situ, iii) develop a synthetic tracheal scaffold using a novel nanocomposite polymer as alternatives to natural human scaffolds and iv) develop good medical practice manufacturing process for safe, efficient and cost effective commercial production. This research project is aimed to define a robust airway implantation technique assuring a better outcome for thousands of patients each year. Moreover, we aim to use these results as a starting point to develop clinical approaches that could improve the treatment of age-related cancers of other hollow organs.

Azienda Ospedaliero Universitaria Careggi | Date: 2015-02-03

An apparatus for sampling, preparing and collecting biomedical samples for a subsequent diagnostic, clinical and/or therapeutic use in a closed sterile environment is provided.

Mazzini C.,Azienda Ospedaliero Universitaria Careggi
Case Reports in Ophthalmology | Year: 2013

Purpose: The aim of this study was to evaluate and report the visual, refractive and aberrometric outcomes of cataract surgery with implantation of the new aspheric Tecnis ZCT toric intraocular lens (IOL) in eyes with low to moderate corneal astigmatism. Methods: We conducted a prospective study of 19 consecutive eyes of 17 patients (mean age: 78 years) with a visually significant cataract and moderate corneal astigmatism [higher than 1 diopter (D)] undergoing cataract surgery with implantation of the aspheric Tecnis ZCT toric IOL (Abbott Medical Optics). Visual, refractive and aberrometric changes were evaluated during a 6-month follow-up. Ocular aberrations as well as IOL rotation were evaluated by means of the OPD-Station II (Nidek). Results: The six-month postoperative spherical equivalent and power vector components of the refractive cylinder were within ±0.50 D in all eyes (100%). Postoperative logMAR uncorrected and corrected distance visual acuities (UDVA/CDVA) were 0.1 (about 20/25) or better in almost all eyes (94.74%). The mean logMAR CDVA improved significantly from 0.41 ± 0.23 to 0.02 ± 0.05 (p < 0.01). No significant changes were found in corneal astigmatism (p = 0.73). The mean IOL rotation was 3.33 ± 1.94°. This parameter did not correlate with higher-order aberrations (r = -0.09, p = 0.73). A significant improvement in the Strehl ratio was also observed (p < 0.01), which was consistent with the significant reduction in higher-order aberrations (p = 0.02). Conclusion: Cataract surgery with implantation of the aspheric Tecnis ZCT IOL is a predictable and effective procedure for visual rehabilitation in eyes with cataract and low to moderate corneal astigmatism, providing an excellent postoperative ocular optical quality. © 2013 S. Karger AG, Basel.

SYLMAR, Calif.--(BUSINESS WIRE)--Second Sight Medical Products, Inc. (Nasdaq:EYES), ("Second Sight" or "the Company"), a developer, manufacturer and marketer of implantable visual prosthetics to provide some useful vision to blind patients, today announced that Professor Stanislao Rizzo (Professor Rizzo) has completed his 30th implant of the Argus® II Retinal Prosthesis (Argus II) at the Azienda Ospedaliero Universitaria Careggi located in Florence, Italy. Will McGuire, President and CEO of Second Sight Medical Products, stated, “This represents an exciting milestone in Italy and an important achievement for Second Sight as we continue to advance our goal of making the Argus II available to patients with Retinitis Pigmentosa (RP). Professor Rizzo sets a standard in both quality of outcomes and volume, which serves as a goal for our centers of excellence all around the world.” The 30th surgery, out of more than 220 Argus II implants worldwide, was performed by Professor Rizzo on February 9, 2017 at Azienda Ospedaliero Universitaria Careggi, one of three centers in Italy capable of performing the surgical procedure and post-operative rehabilitation required for Argus II patients. Professor Rizzo has implanted the Argus II at centers in Florence and Pisa, Italy since the system became available in 2011; he has trained surgeons at several international centers. Professor Rizzo commented, “Over the last five years, I realized not only that the system is safe, but above all, I was able to personally see that its validity and benefits can be maintained for a long time, and that the satisfaction for patients who recover vision is truly rewarding.” In Europe, Argus II is indicated for blind people suffering from advanced outer retinal degenerative diseases such as RP. RP is an inherited disease that often results in nearly complete blindness, affecting an estimated 167,000 Europeans. Second Sight's Argus II System provides electrical stimulation that bypasses the defunct retinal cells and stimulates remaining viable cells inducing visual perception in individuals with severe to profound Retinitis Pigmentosa. The Argus II works by converting images captured by a miniature video camera mounted on the patient's glasses into a series of small electrical pulses, which are transmitted wirelessly to an array of electrodes implanted on the surface of the retina. These pulses are intended to stimulate the retina's remaining cells, resulting in the perception of patterns of light in the brain. The patient then learns to interpret these visual patterns, thereby regaining some visual function. The Argus II is the first artificial retina to receive widespread approval, and is offered at approved centers in Canada, France, Germany, Italy, Saudi Arabia, Spain, Turkey, United Kingdom, and the U.S. Second Sight's mission is to develop, manufacture and market innovative implantable visual prosthetics to enable blind individuals to achieve greater independence. Second Sight has developed and manufactures the Argus II Retinal Prosthesis System. Second Sight is currently underway in a trial to test the safety and utility of the Argus II in individuals with Dry Age-Related Macular Degeneration. Second Sight is also developing the Orion™ I Visual Cortical Prosthesis to restore some vision to individuals who are blind due to causes other than preventable or treatable conditions. U.S. Headquarters are in Sylmar, California, and European Headquarters are in Lausanne, Switzerland. For more information, visit www.secondsight.com. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange and Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans," or "planned," "seeks," "may," "will," "expects," "intends," "believes," "should" and similar expressions or the negative versions thereof and which also may be identified by their context. All statements that address operating performance or events or developments that Second Sight expects or anticipates will occur in the future are forward-looking statements. While management has based any forward looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K as filed on March 11, 2016, as amended on August 8, 2016, and our other reports filed from time to time with the Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

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