60 research outputs found

    Antithrombin supplementation during extracorporeal membrane oxygenation: Study protocol for a pilot randomized clinical trial

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    Background: Normal levels of plasma antithrombin (AT) activity might decrease heparin requirements to achieve an adequate level of anticoagulation during treatment with extracorporeal membrane oxygenation (ECMO). Acquired AT deficiency during ECMO is common, but formal recommendations on target, timing, and rate of AT supplementation are lacking. Thus, we conceived a pilot trial to evaluate the feasibility and safety of prolonged AT supplementation in patients requiring veno-venous ECMO for respiratory failure. Methods: Grifols Antithrombin Research Awards (GATRA) is a prospective, randomized, single blinded, multicenter, controlled two-arm trial. Patients undergoing veno-venous ECMO will be randomized to either receive AT supplementation to maintain a functional AT level between 80 and 120% (AT supplementation group) or not (control group) for the entire ECMO course. In both study groups, anticoagulation will be provided with unfractionated heparin following a standardized protocol. The primary endpoint will be the dose of heparin required to maintain the ratio of activated partial thromboplastin time between 1.5 and 2. Secondary endpoints will be the adequacy of anticoagulation and the incidence of hemorrhagic and thrombotic complications. Discussion: GATRA is a pilot trial that will test the efficacy of a protocol of AT supplementation in decreasing the heparin dose and improving anticoagulation adequacy during ECMO. If positive, it might provide the basis for a future larger trial aimed at verifying the impact of AT supplementation on a composite outcome endpoint including hemorrhagic events, transfusion requirements, and mortality. Trial registration: ClinicalTrials.gov, NCT03208270. Registered on 5 July 2017

    Digital transformation, for better or worse: a critical multi-level research agenda

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    For better or worse, digital technologies are reshaping everything, from customer behaviors and expectations to organizational and manufacturing systems, business models, markets, and ultimately society. To understand this overarching transformation, this paper extends the previous literature which has focused mostly on the organizational level by developing a multi‐level research agenda for digital transformation (DT). In this regard, we propose an extended definition of DT as “a socioeconomic change across individuals, organizations, ecosystems, and societies that are shaped by the adoption and utilization of digital technologies.” We suggest four lenses to interpret the DT phenomenon: individuals (utilizing and adopting digital technologies), organizations (strategizing and coordinating both internal and external transformation), ecosystems (harnessing digital technologies in governance and co‐producing value propositions), and geopolitical frameworks (regulating the environments in which individuals and organizations are embedded). Based on these lenses, we build a multi‐level research agenda at the intersection between the bright and dark sides of DT and introduce the PIAI framework, which captures a process of perception, interpretation, and action that ultimately leads to possible impact. The PIAI framework identifies a critical research agenda consisting of a non‐exhaustive list of topics that can assist researchers to deepen their understanding of the DT phenomenon and provide guidance to managers and policymakers when making strategic decisions that seek to shape and guide the DT.</jats:p

    A shift from distal to proximal neoplasia in the colon: a decade of polyps and CRC in Italy

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    <p>Abstract</p> <p>Background</p> <p>In the last years a trend towards proximalization of colorectal carcinomas (CRC) has been reported. This study aims to evaluate the distribution of CRC and adenomatous polyps (ADP) to establish the presence of proximalization and to assess the potential predictors.</p> <p>Methods</p> <p>We retrieved histology reports of colonic specimens excised during colonoscopy, considering the exams performed between 1997 and 2006 at Cuneo Hospital, Italy. We compared the proportion of proximal lesions in the period 1997-2001 and in the period 2002-2006.</p> <p>Results</p> <p>Neoplastic lesions were detected in 3087 people. Proximal CRC moved from 25.9% (1997-2001) to 30.0% (2002-2006). Adjusting for sex and age, the difference was not significant (OR 1.23; 95% CI: 0,95-1,58). The proximal ADP proportion increased from 19.2% (1997-2001) to 26.0% (2002-2006) (OR: 1.43; 95% CI: 1.17-1.89). The corresponding figures for advanced proximal ADP were 6.6% and 9.5% (OR: 1.48; 95% CI: 1.02-2.17). Adjusting for gender, age, diagnostic period, symptoms and number of polyps the prevalence of proximal advanced ADP was increased among people ≄ 70 years compared to those aged 55-69 years (OR 1.49; 95% CI: 1.032.16). The main predictor of proximal advanced neoplasia was the number of polyps detected per exam (> 1 polyp versus 1 polyp: considering all ADP: OR 2.16; 95% CI: 1.59-2.93; considering advanced ADP OR 1.63; 95% CI: 1.08-2.46). Adjusting for these factors, the difference between the two periods was no longer significant.</p> <p>Conclusions</p> <p>CRC do not proximalize while a trend towards a proximal shift in adenomas was observed among people ≄ 70 years.</p

    African-American inflammatory bowel disease in a Southern U.S. health center

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    <p>Abstract</p> <p>Background</p> <p>Inflammatory Bowel Diseases (IBD) remain significant health problems in the US and worldwide. IBD is most often associated with eastern European ancestry, and is less frequently reported in other populations of African origin e.g. African Americans ('AAs'). Whether AAs represent an important population with IBD in the US remains unclear since few studies have investigated IBD in communities with a majority representation of AA patients. The Louisiana State University Health Sciences Center in Shreveport (LSUHSC-S) is a tertiary care medical center, with a patient base composed of 58% AA and 39% Caucasian (W), ideal for evaluating racial (AA vs. W) as well and gender (M vs. F) influences on IBD.</p> <p>Methods</p> <p>In this retrospective study, we evaluated 951 visits to LSUHSC-S for IBD (between 2000 to 2008) using non-identified patient information based on ICD-9 medical record coding (Crohn's disease 'CD'-555.0- 555.9 and ulcerative colitis 'UC'-556.0-556.9).</p> <p>Results</p> <p>Overall, there were more cases of CD seen than UC. UC and CD affected similar ratios of AA and Caucasian males (M) and females (F) with a rank order of WF > WM > AAF > AAM. Interestingly, in CD, we found that annual visits per person was the highest in AA M (10.7 ± 1.7); significantly higher (* -p < 0.05) than in WM (6.3 ± 1.0). Further, in CD, the female to male (F: M) ratio in AA was significantly higher (*- p < 0.05) (1.9 ± 0.2) than in Caucasians (F:M = 1.3 ± 0.1) suggesting a female dominance in AACD; no differences were seen in UC F: M ratios.</p> <p>Conclusion</p> <p>Although Caucasians still represent the greatest fraction of IBD (~64%), AAs with IBD made up >1/3 (36.4%) of annual IBD cases from 2000-2008 at LSUHSC-S. Further studies on genetic and environments risks for IBD risk in AAs are needed to understand differences in presentation and progression in AAs and other 'non-traditional' populations.</p

    ESPEN Guideline: Clinical Nutrition in inflammatory bowel disease

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    Introduction: The ESPEN guideline presents a multidisciplinary focus on clinical nutrition in inflammatory bowel disease (IBD). Methodology: The guideline is based on extensive systematic review of the literature, but relies on expert opinion when objective data were lacking or inconclusive. The conclusions and 64 recommendations have been subject to full peer review and a Delphi process in which uniformly positive responses (agree or strongly agree) were required. Results: IBD is increasingly common and potential dietary factors in its aetiology are briefly reviewed. Malnutrition is highly prevalent in IBD – especially in Crohn's disease. Increased energy and protein requirements are observed in some patients. The management of malnu-trition in IBD is considered within the general context of support for malnourished patients. Treatment of iron deficiency (parenterally if necessary) is strongly recommended. Routine provision of a special diet in IBD is not however supported. Parenteral nutrition is indicated only when enteral nutrition has failed or is impossible. The recommended perioperative man-agement of patients with IBD undergoing surgery accords with general ESPEN guidance for patients having abdominal surgery. Probiotics may be helpful in UC but not Crohn's disease. Primary therapy using nutrition to treat IBD is not supported in ulcerative colitis, but is mod-erately well supported in Crohn's disease, especially in children where the adverse conse-quences of steroid therapy are proportionally greater. However, exclusion diets are generally not recommended and there is little evidence to support any particular formula feed when nutritional regimens are constructed. Conclusions: Available objective data to guide nutritional support and primary nutritional therapy in IBD are presented as 64 recommendations, of which 9 are very strong recom-mendations (grade A), 22 are strong recommendations (grade B) and 12 are based only on sparse evidence (grade 0); 21 recommendations are good practice points (GPP)

    Prevalenza della colelitiasi in una serie consecutiva di pazienti con malattie infiammatorie croniche intestinali

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    In 1969 Heaton el al. documented an increase of 4-5 times in the prevalence of cholelithiasis (GD) in patients with Crohn s disease (CD). These data were later confirmed by several Authors, but the mechanisms involved are controversal. Only three studies reported the prevalence of gallstones disease in ulcerative colitis (UC) and they gave controversial results as well. The aim of our study was to look at the prevalence of cholelithiasis in a consecutive series of patiens with CD and UC and to evaluate the possible risk factors involved. These results represent preliminary data for the first study about the incidence of GD and IBD. We included 412 patients with CD and 183 with UC, performed an abdominal US and evaluated several parameters as possible risk factors. We calculated the OR and the 95% CI by the regression logistic models after adjustment for the considered variables. The prevalence of GD was 9% in CD and 7 % in UC. Female sex and a high BMI did not correlate with an increase of GD. Older age was a risk factor for CD but not for UC. Previous bowel resections represent a risk factor for both CD an UC and, in particular, ileal resection was strongly associated with an increase of GD in CD. A number of hospitalizations > 3 and a cumulative number of days of hospitalization > 40 resulted to be a risk factor for CD and UC

    Pancreatic Cancer

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    Treatment options for patients with Helicobacter pylori infection resistant to one or more eradication attempts

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    Proton pump inhibitor-based triple regimens fail to cure Helicobacter pylori infection in at least 10-23% of treated patients. Re-treatment strategies after initial failure remain poorly defined. Of the factors leading to eradication failure, patients' compliance, gender, primary resistance to clarithromycin and metronidazole, and intragastric bacterial load appear to be the most important in determining treatment outcome. Empirical re-treatment should depend mainly upon the antibiotics initially used, as re-administration of the same compound (namely, metronidazole and clarithromycin) is not recommended. Quadruple therapy is usually suggested in this situation, but there is some reluctance to use it in clinical practice on account of the high number of tablets to be taken and concern about side-effects. The use of ranitidine bismuth citrate instead of a proton pump inhibitor plus a bismuth compound in triple second-line regimens has recently proven to be highly effective. Finally, rifabutin-based triple therapies have been shown to be a promising rescue strategy in patients who have failed two or more eradication attempt
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