Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: the TACROVID trial protocol

Introduction: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. Methods: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the ef- ficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature≤37.5 ◦C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. Discussion: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries

Water intake, hydration status and 2-year changes in cognitive performance: a prospective cohort study

BackgroundWater intake and hydration status have been suggested to impact cognition; however, longitudinal evidence is limited and often inconsistent. This study aimed to longitudinally assess the association between hydration status and water intake based on current recommendations, with changes in cognition in an older Spanish population at high cardiovascular disease risk.MethodsA prospective analysis was conducted of a cohort of 1957 adults (aged 55-75) with overweight/obesity (BMI between >= 27 and = 300 mmol/L (dehydrated). Water intake was assessed as total drinking water intake and total water intake from food and beverages and according to EFSA recommendations. Global cognitive function was determined as a composite z-score summarizing individual participant results from all neuropsychological tests. Multivariable linear regression models were fitted to assess the associations between baseline hydration status and fluid intake, continuously and categorically, with 2-year changes in cognitive performance.ResultsThe mean baseline daily total water intake was 2871 +/- 676 mL/day (2889 +/- 677 mL/day in men; 2854 +/- 674 mL/day in women), and 80.2% of participants met the ESFA reference values for an adequate intake. Serum osmolarity (mean 298 +/- 24 mmol/L, range 263 to 347 mmol/L) indicated that 56% of participants were physiologically dehydrated. Lower physiological hydration status (i.e., greater serum osmolarity) was associated with a greater decline in global cognitive function z-score over a 2-year period (beta: - 0.010; 95% CI - 0.017 to - 0.004, p-value = 0.002). No significant associations were observed between water intake from beverages and/or foods with 2-year changes in global cognitive function.ConclusionsReduced physiological hydration status was associated with greater reductions in global cognitive function over a 2-year period in older adults with metabolic syndrome and overweight or obesity. Future research assessing the impact of hydration on cognitive performance over a longer duration is needed

El palau Marc, el palau Moja

Se explica la historia de dos palacios que se encuentran en la Rambla de Barcelona. Del palacio Marc se hace una síntesis de su historia, basada en el libro 'El Palau Marc' de J.M. Fuguet y M. Arranz. Del palacio Moja se hace también un recorrido histórico con explicaciones del contexto social, cultural y político con los que coexistió.CataluñaUniversitat de Barcelona. Biblioteca de Ciències de l'Educació; Passeig de la Vall d'Hebron, 171; 08035 Barcelona; +34934021035; +34934021034;ES

Use of Multispectral Airborne Images to Improve In-Season Nitrogen Management, Predict Grain Yield and Estimate Economic Return of Maize in Irrigated High Yielding Environments

Vegetation indices (VIs) derived from active or passive sensors have been used for maize growth monitoring and real-time nitrogen (N) management at field scale. In the present multilocation two-year study, multispectral VIs (green- and red-based), chlorophyll meter (SPAD) and plant height (PltH) measured at V12–VT stage of maize development, were used to distinguish among the N status of maize, to predict grain yield and economic return in high yielding environments. Moreover, linear plateau-models were performed with VIs, SPAD and PltH measurements to determine the amount of N needed to achieve maximum maize grain yields and economic return. The available N in the topsoil (0–30 cm) was measured, and its relationship with VIs, maize yield and maize N requirements was analyzed. Green-based VIs were the most accurate indices to predict grain yield and to estimate the grain yield optimum N rate (GYONr) (216.8 kg N ha−1), but underestimated the grain yield optimum N available (GYONa) (248.6 kg N ha−1). Red-based VIs slightly overestimated the GYONr and GYONa, while SPAD highly underestimated both of them. The determination of the available N did not improve the accuracy of the VIs to determine the grain yield. The green chlorophyll index (GCI) distinguished maize that would yield less than 84% of the maximum yield, showing a high potential to detect and correct maize N deficiencies at V12 stage. The economic optimum nitrogen rate (EONr) and economic optimum nitrogen available (EONa) were determined below the GYONr and the GYONa, demonstrating that maximum grain yield strategies in maize are not normally the most profitable for farmers. Further research is needed to fine-tune the response of maize to N applications when deficiencies are detected at V12 stage, but airborne imagery could be useful for practical farming implementation in irrigated high yielding environments

Fem projectes! : guia de disseny i gestió de projectes associatius

Aquesta guia compagina l’explicació teòrica sobre el disseny i la gestió de projectes amb un exemple de projecte redactat exclusivament per a fer-vos la guia més entenedora i mostrar una aplicació pràctica del contingut teòric. A més, no ens oblidem de les dimensions que també s’han d’incorporar durant la redacció i el desenvolupament del projecte, com són els aspectes transversals: la participació, la perspectiva de gènere, la sostenibilitat, el nostre codi ètic i la inclusió, entre d’altres

Intraoperative laparoscopic ICG-guidance extended pelvic lymph node dissection in patients with intermediate and high-risk prostate cancer who underwent radical prostatectomy: A matched case-control study

Introduction & Objectives: To date there is still insufficient quality evidence supporting oncological effectiveness of sentinel node (SN) biopsy in prostate cancer (PCa). In the last decade, the potential to identify nodes visually has stimulated a movement towards the use of near-infrared (NIR) fluorescent dye ICG: this may be useful during prostatectomy based on its ability to act as a lymphangiography agent to visualize sentinel prostatic drainage. However this techinque still cannot replace ePLND, it could improves outcomes from ePLND. The current study aim to compare the pathological and clinical outcomes between standard ePLND with the ICG-guided ePLND with additional dissection of fluorescent nodes in the setting of a matched case-control study. Materials & Methods: 214 patients underwent 3D laparoscopic radical prostatectomy with ICG-guided ePLND. These patients constituted the case group and were matched 1:1 for clinical risk groups according to the NCCN classification with patients underwent the same procedure at our Insitute without fluorescence guidance (control group). Data about the ICG-guided ePLND group were collected prospectively while for the control group were retrieved using our prospectively collected electronic PCa database. Results: Both group were omogeneous for preoperative data (age, initial PSA, percentage of positive core). Median operative time, median number of lymph nodes retrieved and median number of positive lymph nodes was significanlty higher in the ICG-guided ePLND (p<0.001). Overall, 7978 lymph nodes were removed with a median of 17.5 dissected nodes: in particular 3314(41.5%) using regular ePLND template and 4664(58.5%) with fluorescence guidance (median values 14 vs 22, p<0.001). Node-positive disease was found in 92(21.5%) patients and and most of them had a single metastasis (53.6%). A total of 208(2.6%) metastatic lymph nodes were found: 71(34.1%) coming from regular ePLND and 137(65.9%) from the ICG-guided group, respectively. Out of the 4664 lymph nodes coming from the intervention group there were 4170(89.4%) negative and 46(0.99%) positive nonstained nodes, 403(8.6%) free of disease and 91(1.9%) metastatic ICG stained nodes at final pathological report. After a median follow-up of 36 months, 104 patients experienced a BCR: 38(17.76%) in the ICG group vs 66 (30.84%) in the control one (p=0.002). Finally, considering the subset of pN positive disease, the Kaplan-Meier curve shown a significant difference in the trend of BCR in favour of the intervention group (p=0.04). Conclusions: However fluorescence-guidance ePNLD can\u2019t replace the standard of care, can be a useful tool to integrate the extended template of pelvic lymph node dissection during radical prostatectom

Laparoscopic radical prostatectomy using a real-time lymphangiography with transperineal injection of indocyanine green: Results from a prospective study

Introduction:Current standard imaging procedures have limited ability to predict lymph node (LN) involvement in clinically localized prostate cancer (PCa) and extended pelvic lymph node dissection(ePLND) during radical prostatectomy (RP) remains the most accurate staging procedure. However, meticulous ePLND is time- consuming and associated with an increased risk of morbidity. In order to improve these aspects, sentinel LN mapping with different guided techniques has been proposed over the years. The primary aim of this study is to evaluate the effectiveness of indocyanine green (ICG)-guided ePLND to assess regional LN status in patients who underwent RP. Secondary objective is to evaluate the potential role of a selective ICG lymph node dissection (LND) in patients with 642 LN metastasis which according to the literature are those who may more benefit from ePLND.Materials and methods:Data about 226 consecutive patients underwent laparoscopic RP with ICG-guided ePLND at ourDepartment were prospectively evaluated. A solution of 25 mg ICGin 5 ml sterile water was transperineally injected. PLND started with the ICG stained nodes followed by extended template. Primary outcome measures were sensitivity (S), negative predictive value(NPV) and likelihood ratio of a negative test (LRn) of ICG-guided procedure. To our knowledge this study shows data about the largest cohort of patients underwent ICG-guided ePLND.Results:Overall, median age of patients was 64.8 years with a medianPSA of 6.6 ng/ml. Extracapsular disease occurred in 50.9% of patients,Gleason score 658 was reported in 11.9% cases and positive surgical margins rate was 24.3%. Median number of nodes retrieved was 22(IQR 16\u201327) and median number of ICG stained per patient nodes was6 (IQR 4\u20139). Overall 4939 nodes were removed and 1599 (32.4%) were fluorescent in vivo. Node- positive disease was found in 58 (25.7%), of which 53 (91.4%) had some of the metastatic LNs stained by ICG while5 (8.6%) were false negative. Therefore 97.8% of the sample was properly classified byICG-guided ePNLD (S: 91.4%, NPV: 97.1% and LRn:8.6%). Considering 209 (92.5%) patients with 0, 1 or 2 metastatic LNs,39 (18.7%) had a node-positive disease of which 34 (87.2%) had metastatic ICG stained LNs. Again, 97.6% were properly classified byICG approach (S: 87.2%, NPV: 97.1% and LRn: 12.8%). These 39 node-positive patients had a total of 48 metastatic LNs and all except 9(18.8%) were fluorescent in vivo (S: 81.2%).Conclusions:ICG guidance correctly stage 97% of cases. Furthermore, its high NPV will allow to avoid ePLND as soon as an accurate intraoperative analysis is available. Among those patients in whom theLND may have a potentially curative role, ICG alone would have lost only 9 metastatic LNs. This suggest that maybe there is a place for selective LND in patients with limited LN metastatic burden

Undetectable PSA after radical prostatectomy is more likely in low burden N+ prostate cancer patients when an extended lymph node dissection is performed

Objectives: To analyze the likelihood of undetectable PSA (&lt; 0.01 ng/mL) after extended (ePLND) versus standard pelvic lymph-nodes dissection (sPLND) in pN+ patients. Materials and methods: The institutional prospectively maintained Prostate Cancer Database was queried for patients who underwent radical prostatectomy with PLND and were found with 3or less lymph-nodal metastases between 2007 and 2017. The extension of the PLND was defined according to the number of lymph-nodes (LN) removed. Patients in the 75th or higher percentile of lymph-nodes removed were considered as the ePLND group; patients in the 25th or lower percentile in the sPLND group. Groups were compared in clinical and pathological variables. Student T-test was used for comparing continuous variables; chi-square test was used for categorical variables. Multivariable logistic regression assessed the probability of undetectable PSA at 3rd month postoperatively. Kaplan-Meier method estimated the probability of biochemical recurrence. Differences between the groups were compared by Log-rank test. Results: 1478 patients were treated within the time span considered. 95 with 1 to 3 lymph-nodal metastases were extracted. After accounting for inclusion criteria, 23 patients with a median of 11 LN removed were included in the sPLND group (25th percentile); 23 patients with &gt; 27 LN were included in ePLND group (75th percentile). Surgical time was longer for ePLND. Sixteen patients (69.6%) who underwent ePLND had undetectable PSA postoperatively. At multivariable analysis, the probability of undetectable PSA at 3rd month was higher in patients who received an ePLND (HR=5.18; IC 95%=1.16-23.11; P=.03). Conclusions: ePLND is more likely to predict undetectable PSA at third month after radical prostatectomy, irrespective of disease characteristics