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D'Ascenzo F.,University of Turin | Conrotto F.,University of Turin | Giordana F.,University of Turin | Moretti C.,University of Turin | And 27 more authors.
International Journal of Cardiology | Year: 2013

Aims Coronary artery disease (CAD) negatively affects prognosis in patients undergoing surgical aortic valve replacement, being currently evaluated in the most common used risk score. Our meta-analysis aims to clarify the prognostic role of CAD on mid-term survival in patients undergoing TAVI. Methods and results Studies reporting multivariate predictors of adverse outcomes in patients undergoing TAVI were systematically searched for and pooled, when appropriate, using a random-effect method. 960 citations were first screened and finally 7 studies (2472 patients) were included. Diagnosis of CAD was reported in 52%(42-65) of patients and 1169 Edwards SAPIEN and 1303 CoreValve prostheses were implanted. After a median follow up of 452 days (357-585) 24% of patients (19-33) died, and 23 (14-32) for cardiovascular death. At pooled analysis of multivariate approach, diagnosis of coronary artery disease did not increase risk of death (OR 1.0, 95% CI, confidence interval, 0.67-1.50 I2 0%). Conclusion CAD does not affect mid-term TAVI outcome: this finding should be weighted to accurately evaluate risk and strategies for patients with severe aortic stenosis. © 2013 Elsevier Ireland Ltd. All rights reserved.

Reni M.,San Raffaele Scientific Institute | Pasetto L.M.,University of Padua | Passardi A.,Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Milella M.,Regina Elena Scientific Institute | And 10 more authors.
Digestive and Liver Disease | Year: 2011

Background: Since gemcitabine became the standard treatment for metastatic pancreatic adenocarcinoma, combination chemotherapy obtained conflicting impact on survival (OS). Aims: To evaluate Italian treatment trends in metastatic pancreatic cancer. Methods: Data on treatment outcome of 943 chemo-naive patients with pathological diagnosis of stage IV pancreatic adenocarcinoma treated between 1997 and 2007 in Italian centres were analysed. Results: Four treatment groups could be identified: (1) single agent gemcitabine (n=529); (2) gemcitabine-platinating agent doublets (n=105); (3) gemcitabine-free three-drug intraarterial combination (n=75); (4) four-drug gemcitabine-cisplatin-fluoropyrimidine based combinations (n=170).Median and actuarial 1. y OS of the whole population were 6.2 months and 20%, respectively. Gemcitabine (median OS 5.1 months) appeared significantly inferior to gemcitabine-free triplets (median OS 6.0 months; p=04), gemcitabine-platinating agent doublets (median OS 7.4 months; p=00001), or gemcitabine-based four drug combinations (median OS 9.1 months; p<00001). Conclusion: These data mirror the Italian clinical practice in the therapeutic management of pancreatic cancer and suggest that four-drug combination chemotherapy may be included amongst the candidate regimens for phase III testing. © 2010 Editrice Gastroenterologica Italiana S.r.l.

Reni M.,San Raffaele Scientific Institute | Sartori N.,Chirurgia B | Mambrini A.,Ospedale Civile | Berardi R.,Marche Polytechnic University | And 10 more authors.
Anti-Cancer Drugs | Year: 2010

A series of 650 patients treated between 1997 and 2007 at 10 Italian centers was analyzed to assess treatment trends and efficacy in stage III pancreatic adenocarcinoma. Data on patient characteristics, treatment and outcomes were collected. The inclusion criteria were pathological diagnosis of stage III pancreatic adenocarcinoma; age more than 18 years, Eastern Cooperative Oncology Group performance status less than 3, and no past therapy. Most patients (95%) received upfront chemotherapy, which mainly consisted of gemcitabine alone (N=323), gemcitabine-based four-drug combinations (N=107), gemcitabine-platinum compound doublets (N=87), or intra-arterial gemcitabine-free triplets (N=57). The use of gemcitabine-platinum compound doublets increased over time (1997-2001: 2%; 2002-2007: 21%) whereas an inverse trend was observed for gemcitabine (71-61%). No overall survival (OS) difference was observed between patients enrolled in clinical trials and those not enrolled. The median and 1-year OS were 9.5 months and 35.5% for patients treated with gemcitabine; 8.9 months and 36.8% for those treated with gemcitabine-free intra-arterial triplets; 13.3 months and 55.8% for those treated with gemcitabine-platinating agent doublets; and 16.2 months and 62.6% for those treated with gemcitabine-based four-drug combinations. Moreover, the median and 1-year OS were 12.7 months and 51.4% in patients who underwent planned consolidation chemoradiation, and 8.4 months and 30.4% in patients who did not. The use of a strategy consisting of a gemcitabine-platinating agent containing chemotherapy followed by consolidation chemoradiation has been increasing over time and may represent a suitable choice in the therapeutic management of stage III pancreatic adenocarcinoma. Copyright © 2010 by Lippincott Williams & Wilkins.

PubMed | Regina Elena Cancer Institute, Hopitaux de Lyon, Hospital Lluis Alcanyis, USL and 24 more.
Type: Journal Article | Journal: Journal of experimental & clinical cancer research : CR | Year: 2016

Tumor-positive sentinel lymph node (SLN) biopsy results in a risk of non sentinel node metastases in micro- and macro-metastases ranging from 20 to 50%, respectively. Therefore, most patients underwent unnecessary axillary lymph node dissections. We have previously developed a mathematical model for predicting patient-specific risk of non sentinel node (NSN) metastases based on 2460 patients. The study reports the results of the validation phase where a total of 1945 patients were enrolled, aimed at identifying a tool that gives the possibility to the surgeon to choose intraoperatively whether to perform or not axillary lymph node dissection (ALND).The following parameters were recorded: Clinical: hospital, age, medical record number; Bio pathological: Tumor (T) size stratified in quartiles, grading (G), histologic type, lymphatic/vascular invasion (LVI), ER-PR status, Ki 67, molecular classification (Luminal A, Luminal B, HER-2 Like, Triple negative); Sentinel and non-sentinel node related: Number of NSNs removed, number of positive NSNs, cytokeratin 19 (CK19) mRNA copy number of positive sentinel nodes stratified in quartiles. A total of 1945 patients were included in the database. All patient data were provided by the authors of this paper.The discrimination of the model quantified with the area under the receiver operating characteristics (ROC) curve (AUC), was 0.65 and 0.71 in the validation and retrospective phase, respectively. The calibration determines the distance between predicted outcome and actual outcome. The mean difference between predicted/observed was 2.3 and 6.3% in the retrospective and in the validation phase, respectively. The two values are quite similar and as a result we can conclude that the nomogram effectiveness was validated. Moreover, the ROC curve identified in the risk category of 31% of positive NSNs, the best compromise between false negative and positive rates i.e. when ALND is unnecessary (<31%) or recommended (>31%).The results of the study confirm that OSNA nomogram may help surgeons make an intraoperative decision on whether to perform ALND or not in case of positive sentinel nodes, and the patient to accept this decision based on a reliable estimation on the true percentage of NSN involvement. The use of this nomogram achieves two main gools: 1) the choice of the right treatment during the operation, 2) to avoid for the patient a second surgery procedure.

Salvatore G.,Center for Metacognitive Interpersonal Therapy | Salvatore G.,Humanitas, Inc. | Ottavi P.,Center for Metacognitive Interpersonal Therapy | Popolo R.,Center for Metacognitive Interpersonal Therapy | Dimaggio G.,Center for Metacognitive Interpersonal Therapy
Journal of Contemporary Psychotherapy | Year: 2016

Auditory verbal hallucinations (AVHs) are perceptive-like experiences happening without appropriate stimuli, occurring in two thirds of schizophrenia patients, where they often cause emotional suffering and dangerous behaviors, and interfere with social relationships. Patients with schizophrenia involving AVHs can also be drug-resistant or they may discontinue medications. The most well-known psychotherapeutic intervention for voice-hearing is cognitive behavioral therapy (CBT), which focuses on reducing distress by modifying hearers’ beliefs about their voices. We hypothesize that it is possible to reinforce the clinical approach to AVHs by taking into consideration (a) that patients generally hear voices in particular interpersonal contexts where they experience negative emotions; (b) the relationship between AVHs and metacognition, namely the ability to make sense of mental states. On this basis, AVHs can be seen not just as a cause of emotional distress as CBT postulates, but the outcome of difficulties in meta-cognitively making sense of interpersonal exchanges. In this paper, we describe the treatment of a young man at the onset of schizophrenia with pervasive negative AVHs. The patient was treated with metacognitive interpersonal therapy (MIT), aimed to promote the patient’s metacognition. With this aim, in the first part of the treatment, each time AVHs emerged, the patient’s level of arousal was high and his metacognitive ability very low, the therapist treated AVHs helping the patient to understand and cope with the emotional suffering connected with AVHs. At a more advanced stage of therapy, the therapist helped the patient reach the point of understanding the social triggers which, together with the patient’s self-schemas, ignited his auditory hallucinations; this created the conditions for a significant reduction of the pervasiveness of AVHs. © 2016 Springer Science+Business Media New York

Gale T.J.,University of Tasmania | Stack C.R.,Humanitas, Inc. | Dargaville P.A.,University of Tasmania | Dargaville P.A.,Menzies Research Institute
BMEiCON-2011 - 4th Biomedical Engineering International Conference | Year: 2011

Achieving quality outcomes from our Biomedical Engineering research relies on effective engagement with the Medical community. This typically takes the form of collaborative research with clinicians, or clinician-researchers, on issues they identify. While this presents opportunities, there are also significant challenges, and the goal of effective engagement and collaboration can be difficult to achieve. Engaging is a complex process - not only does it bring a "second party" into the research, but the project itself becomes more complex. Here we aim to promote engagement and stimulate discussion by considering the process and challenges together with relevant examples. We can identify a number of stages in the process of typical clinically-relevant research. The first is the preliminary stage of establishing the collaboration, including identifying appropriate potential clinical partners, identifying the real medical needs, educating biomedical engineers on the required medical knowledge and the surrounding medical culture, and developing mutual understanding and trust between engineering researchers and clinicians. The next stage is defining the problem and issues, and the specific aims and methods for the research. A further stage is attracting sufficient funding and competent research personnel. Subsequent stages are undertaking the core technical developments, gaining appropriate ethical and regulatory approvals, conducting an experimental program and trials, and finally, potentially commercialising developed technology. A particular challenge for clinicians is to invest the required time and energy in the process. Government, professional and personal incentives for clinicians to be involved in successful collaborative research programs are key factors. Two case study projects are given as examples. The first involves collaborative research in hospital-based neonatal care. This project comprises research into methods and technology directed at improving the delivery of supplementary oxygen to premature babies, including logging data from babies to assess the performance of current systems, and prototyping an improved oxygen controller. The second case study involves collaborative research in drug addiction rehabilitation with local community-based clinicians. The research in this project relates to improving the safety of take-home narcotic substitute medication. This includes development of technology for secure storage and delivery of the medication and remote assessment of patients, gaining ethics and regulatory approvals for patient trials, conducting trials and analysing results. Despite inherent difficulties, the case studies illustrate that the benefits of engagement are substantial, and the insight and expert knowledge of clinician-researchers is paramount to achieving quality outcomes. It is hoped that by exposing the issues, difficulties and benefits of engaging the Medical community, wider discussion will be promoted and effective collaboration encouraged. © 2011 IEEE.

Padua R.,Fondazione Don C. Gnocchi | Padua L.,Fondazione Don C. Gnocchi | Galluzzo M.,San Camillo Hospital | Ceccarelli E.,Anzio Hospital | And 2 more authors.
Musculoskeletal Surgery | Year: 2011

Four-part proximal humeral fractures are frequently treated with shoulder replacement. Outcome of this procedure has not been standardized, and there are controversy data on range of motion (ROM) and active function of the shoulder. The aim of this study is to compare shoulder prosthesis position (SPP) in terms of version of humeral head and height of stem with clinical subjective and objective outcome. Fifty patients were treated with shoulder hemiarthroplasty for four-part proximal humeral fracture or fracture-dislocation of the humeral head. Radiological examination and CT-scan were performed preoperatively and at follow-up. Clinical outcome evaluation included active and passive ROM, and subjective perspective collected through SF-36, OSQ, ASES, and DASH. No significant correlation between stem height and clinical outcome were found. The prosthesis version correlates with all subjective questionnaires. The ROM was not correlated with stem height and prosthesis version. SPP involves clinical outcome, with great relevance of implant version. © 2011 Springer-Verlag.

Barbon A.,University of Brescia | Fumagalli F.,University of Milan | Caracciolo L.,University of Brescia | Madaschi L.,University of Milan | And 9 more authors.
Journal of Neurochemistry | Year: 2010

Spinal cord injury (SCI) triggers a complex ischemic and inflammatory reaction, involving activation of neurotransmitter systems, in particular glutamate, culminating in cell death. We hypothesized that SCI might lead to alteration in the RNA editing of α-amino-3-hydroxy-5-methyl-4- isoxazolepropionate (AMPA) receptors that govern critical determinants of neuronal survival. To this end, we examined the molecular changes set in motion by SCI that affect the channel properties of AMPA receptors. SCI strongly reduced the level of AMPA receptor R/G editing, involving not only the site of the lesion but also adjacent areas of the cord spared by the lesion. The effects, with changes for some subunits and loci, were observed as long as 30 days after lesioning and may correlate with a partial decrease in enzymatic activity of adenosine deaminase acting on RNA 2 (ADAR2), as deduced from the analysis of ADAR2 self-editing. The reduced editing at the R/G site of glutamate receptor subunits (GluRs) is likely to reduce post-synaptic excitatory responses to glutamate, thus limiting the progression of cell death; however, prolonged suppression of GluR function in later stages may hinder synaptic plasticity. These observations provide the first direct evidence of the potential contribution of RNA editing to excitatory neural injury and recovery after SCI. © 2010 The Authors.

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