995 resultados para 58AA_2001-04
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[Helsingfors] 1902
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Helsinki 1893
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Helsinki 1904
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[Helsinki] 1900, Weilin & Göös
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Helsingfors 1899
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Helsingfors 1891
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Helsingfors 1907
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Helsinki 1913
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Aim: We have previously documented the feasibility of neoadjuvant chemotherapy and EPP in a multicenter trial of MPM (Weder, Ann Oncol 18: 1196, 2007). The objectives of the trimodality trial SAKK17/04 (NCT00334594) were to evaluate the time to loco-regional relapse with or without high dose hemithoracic radiotherapy in a prospective multicenter randomized phase II trial in patients with R0 and R1 resection after neoadjuvant chemotherapy and EPP. Methods: Eligible patients had pathologically confirmed MPM, surgically resectable TNM stage (T1-3 N0-2 M0), PS0-1, ages 18-70 years. Part 1 had a phase II design, and included neoadjuvant chemotherapy with 3 cycles of cisplatin and pemetrexed, followed by restaging and EPP. The primary endpoint of part 1 was complete macroscopic resection (R0-1). Part 2 randomized consenting patients with R0-1 resection into two parallel phase II arms (control arm A and radiotherapy arm B). The primary endpoint for part 2 was loco-regional relapse-free survival (RFS). To detect a 1 year increase with 80% power and 10% alpha, 37 patients were needed for arm B. Secondary endpoints included operability, tolerability of chemotherapy and radiotherapy, survival, and translational research Results: Because accrual of part 2 was slower than planned, the trial was stopped in 2013. Overall, 153 patients entered the trial, of whom 125 underwent surgery and 99 had a complete macroscopic resection (primary endpoint part 1). Of the later patients, 54 could be randomized 1:1 into each arm. Reasons for non-randomization included patient refusal in 24 and ineligibility or protocol deviations in 21. Of the 27 patients randomized to hemithoracic radiotherapy, 25 completed the treatment as planned. For part 1 the median RFS was 8.8 (95%CI: 7.3-10.7) and median OS was 15.0 (95% CI: 12.1-19.3) months. For part 2 the median local RFS for group A was 7.6 (95%CI: 5.5-10.7) and for group B 9.4 (95%CI: 6.5-11.9) months (primary endpoint part 2), while the overall RFS and OS for group A were 5.7 (95%CI: 3.5-8.8) and 16.9 (95%CI: 10.7-23.6) months and for group B 7.6 (95% CI:5.2-10.6) and 14.9 (95%CI: 7.0-17.6) months. Conclusions: This study did not reach the primary endpoint which was defined as one-year increase in loco-regional relapse-free survival and thus does not support the routine use of hemithoracic RT after neoadjuvant chemotherapy and EPP. Disclosure: All authors have declared no conflicts of interest.
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BACKGROUND: Postoperative hemithoracic radiotherapy has been used to treat malignant pleural mesothelioma, but it has not been assessed in a randomised trial. We assessed high-dose hemithoracic radiotherapy after neoadjuvant chemotherapy and extrapleural pneumonectomy in patients with malignant pleural mesothelioma. METHODS: We did this phase 2 trial in two parts at 14 hospitals in Switzerland, Belgium, and Germany. We enrolled patients with pathologically confirmed malignant pleural mesothelioma; resectable TNM stages T1-3 N0-2, M0; WHO performance status 0-1; age 18-70 years. In part 1, patients were given three cycles of neoadjuvant chemotherapy (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 given every 3 weeks) and extrapleural pneumonectomy; the primary endpoint was complete macroscopic resection (R0-1). In part 2, participants with complete macroscopic resection were randomly assigned (1:1) to receive high-dose radiotherapy or not. The target volume for radiotherapy encompassed the entire hemithorax, the thoracotomy channel, and mediastinal nodal stations if affected by the disease or violated surgically. A boost was given to areas at high risk for locoregional relapse. The allocation was stratified by centre, histology (sarcomatoid vs epithelioid or mixed), mediastinal lymph node involvement (N0-1 vs N2), and T stage (T1-2 vs T3). The primary endpoint of part 1 was the proportion of patients achieving complete macroscopic resection (R0 and R1). The primary endpoint in part 2 was locoregional relapse-free survival, analysed by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00334594. FINDINGS: We enrolled patients between Dec 7, 2005, and Oct 17, 2012. Overall, we analysed 151 patients receiving neoadjuvant chemotherapy, of whom 113 (75%) had extrapleural pneumonectomy. Median follow-up was 54·2 months (IQR 32-66). 52 (34%) of 151 patients achieved an objective response. The most common grade 3 or 4 toxic effects were neutropenia (21 [14%] of 151 patients), anaemia (11 [7%]), and nausea or vomiting (eight [5%]). 113 patients had extrapleural pneumonectomy, with complete macroscopic resection achieved in 96 (64%) of 151 patients. We enrolled 54 patients in part 2; 27 in each group. The main reasons for exclusion were patient refusal (n=20) and ineligibility (n=10). 25 of 27 patients completed radiotherapy. Median total radiotherapy dose was 55·9 Gy (IQR 46·8-56·0). Median locoregional relapse-free survival from surgery, was 7·6 months (95% CI 4·5-10·7) in the no radiotherapy group and 9·4 months (6·5-11·9) in the radiotherapy group. The most common grade 3 or higher toxic effects related to radiotherapy were nausea or vomiting (three [11%] of 27 patients), oesophagitis (two [7%]), and pneumonitis (two [7%]). One patient died of pneumonitis. We recorded no toxic effects data for the control group. INTERPRETATION: Our findings do not support the routine use of hemithoracic radiotherapy for malignant pleural mesothelioma after neoadjuvant chemotherapy and extrapleural pneumonectomy. FUNDING: Swiss Group for Clinical Cancer Research, Swiss State Secretariat for Education, Research and Innovation, Eli Lilly.
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En aquests últims anys, són moltes les empreses que han optat per la utilització de sistemes de gestió normalitzats, per a garantir la rendibilitat i fiabilitat dels resultats de la implantació del sistema de gestió en qüestió. A la dècada dels 90 va ser quan la implantació de sistemes de gestió va començar a ser important en la majoria de sectors econòmics. L’evolució en els sistemes de gestió a trets generals va iniciar-se primerament en l’àmbit de la qualitat, seguidament en la gestió ambiental i en última instància en la prevenció de riscos laborals. Aquests tres tipus de sistemes de gestió, en els últims anys s’han anat integrant, de manera que s’han reduït els recursos i els esforços emprats en la gestió, millorant significativament l’eficàcia i l’eficiència d’aquests sistemes. L’objectiu principal que persegueix aquest projecte, és definir un sistema de gestió que permeti a l’empresa conduir les seves activitats de forma simplificada i ordenada, i que alhora faciliti la informació necessària per a corregir i millorar les activitats. Un altre objectiu que pretén aconseguir aquest projecte, és el de dissenyar un SGI que aprofiti les sinèrgies generades en els diferents àmbits de la pròpia empresa i fomenti les interaccions entre els diferents nivells de l’organització. En conseqüència, millorarà de forma important els fluxos d’informació dins de l’empresa minimitzant els esforços i la pèrdua d’informació. El mètode escollit per a la implantació del SGI, ha estat la Gestió per Processos, la qual es basa en la definició i seguiment dels processos de l’empresa, partint de les necessitats del client i acabant quan aquestes estan satisfetes. En conclusió, a la finalització del present projecte s’obtindrà un SGI, amb tots els processos de l’empresa definits i implantats, que doni compliment a les normes UNEEN-ISO 9001:00, UNE-EN-ISO 14001:04 i OHSAS 18001:07. Aquest SGI, que s’ha realitzat des d’un punt de vista documental i teòric, suposarà una millora de l’eficàcia operativa dels processos i una important millora competitiva de l’empresa.
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In the current study, we performed a soybean production spatial distribution analysis in Paraná State. Seven crop-year data, from 2003-04 to 2009-10, obtained from the Paraná Department of Agriculture and Supply (SEAB) were used to develop a Boxmap for each crop-year, show soybean production throughout this time interval. Moran's index was used to measure spatial autocorrelation among municipalities at an aggregate level, while LISA index local correlation. For each index, different contiguity matrix and order were used and there was a significance level study. As a result, we have showed spatial relationship among cities regarding the production, which allowed the indication of high and low production clusters. Finally, identifying main soybean-producing cities, what may provide supply chain members with information to strengthen the crop production in Paraná.
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14 x 22 cm
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Invokaatio: D.D.