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"text": "\n183970\nPrevalence of sarcopenia in community-dwelling older adults using the updated EWGSOP2 definition according to kidney function and albuminuria : The Screening for CKD among Older People across Europe (SCOPE) study.\n\nMoreno-Gonzalez, R\n\nCorbella, X\n\nMattace-Raso, F\n\nTap, L\n\nSieber, C\n\nFreiberger, E\n\nKostka, T\n\nGuligowska, A\n\nMelzer, I\n\nMelzer, Y\n\nCarlsson, AC\n\nÄrnlöv, J\n\nRoller-Wirnsberger, R\n\nWirnsberger, G\n\nGil, P\n\nMartinez, SL\n\nFabbietti, P\n\nCorsonello, A\n\nLattanzio, F\n\nFormiga, F\n\nSCOPE investigators\n\nBeiträge in Fachzeitschriften\nISI:000576901000004\n33008317.0\n10.1186/s12877-020-01700-x\nPMC7531109\nLoss of muscle mass and function may be more pronounced in older adults with chronic kidney disease (CKD) and with albuminuria. Thus, we investigated the prevalence of sarcopenia among community-dwelling older adults according to kidney function and grade of albuminuria. We also explored differences in the prevalence of sarcopenia according to three different equations for the estimation of glomerular filtration rate (eGFR).\n A cross-sectional analysis of 1420 community-dwelling older adults (≥75 years old) included in the SCOPE study, a multicenter prospective cohort study, was conducted. Comprehensive geriatric assessment including short physical performance battery (SPPB), handgrip strength test and bioelectrical impedance analysis (BIA) was performed. Sarcopenia was defined using the updated criteria of the European Working Group on Sarcopenia in Older People (EWGSOP2). eGFR was calculated using Berlin Initiative Study (BIS), Chronic Kidney Disease Epidemiological Collaboration (CKD-EPI) and Full Age Spectrum (FAS) equations, and urinary albumin-to-creatinine ratio (ACR) was collected to categorize CKD according to Kidney Disease Improving Global Outcomes guidelines.\n Median age was 79.5 years (77.0-83.0), 804 (56.6%) were women. Using EWGSOP2 definition, 150 (10.6%) participants met diagnostic criteria for sarcopenia. Moreover, 85 (6%) participants had severe sarcopenia. Sarcopenia was more prevalent in participants with more advanced stages of CKD according to BIS eq. (9.6% in stages 1 and 2 and 13.9% in stages 3a, 3b and 4, p = 0.042), and also according to CKD-EPI (9.8% vs. 14.2%, p = 0.042) and FAS although not reaching statistical signification (9.8% vs. 12.7%, p = 0.119). Thus, differences in prevalence are observed among CKD categories as estimated by different equations. Prevalence of sarcopenia was also higher with increasing albuminuria categories: 9.3% in normoalbuminuric, 13.2% in microalbuminuric and 16.8% in macroalbuminuric participants, (p = 0.019).\n Sarcopenia is common among community-dwelling older adults, especially among those with more advanced CKD categories, with prevalence estimates differing slightly depending on the equation used for the estimation of eGFR; as well as among those with higher albuminuria categories.\n\nRoller-Wirnsberger, Regina\n\nWirnsberger, Gerhard\n\n\n"
},
{
"text": "\n1565\nMagnesium abolishes inadequate kinetics of frequency adaptation of the Q-aT interval in the presence of sotalol.\n\nStark, G\n\nSchwarzl, I\n\nHeiden, U\n\nStark, U\n\nTritthart, HA\n\nBeiträge in Fachzeitschriften\nISI:A1997XR57400008\n9302346.0\n10.1016%2FS0008-6363%2897%2900074-6\nNone\nOBJECTIVE: It has been well established that class III antiarrhythmic drugs can also induce ventricular arrhythmias. Marked changes in the QT interval are correlated with an increased dispersion of repolarization which is an important factor for the induction of ventricular arrhythmias. The aim of the present study was to investigate the effects of sotalol alone and in combination with MgSO4 and the Q-aT interval during abrupt changes in heart rate. METHODS: The experiments were performed on isolated guinea-pig hearts perfused by the method of Langendorff. The rate adaptation of the Q-aT interval was estimated after abruptly changing the ventricular pacing rate from 220 to 180 ms and back to 220 ms. RESULTS: In the presence of 10 microM sotalol, at a constant pacing cycle length of 220 ms, the QT interval was prolonged significantly (P < 0.01) from 152 +/- 4 to 166 +/- 3 ms (mean +/- s.e.m., n = 8 in each group). The addition of 3.4 mM MgSO4 caused a slight further prolongation of the QT interval. After abruptly shortening the pacing cycle length from 220 to 180 ms, the Q-aT interval shortened within 2 min by 11.3 +/- 0.5 ms with a time constant (tau) of 77 +/9 beats under control conditions, by 15.4 +/- 0.9 ms (P < 0.05 vs. control with tau = 52 +/- 7 beats (P < 0.05 vs. control) in the presence of sotalol, and by 13.1 +/- 1.2 ms with tau = 158 +/- 13 beats under the combination of sotalol (10 microM) and MgSO4 (3.4 mM). After abrupt shortening of the pacing cycle length the Q-aT interval of the first beat was shortened by 3.3 +/- 0.3 ms under control conditions, by 7.1 +/- 0.2 ms (P < 0.01 vs. control) under sotalol, and by 4.2 +/- 0.2 ms with the combination of sotalol and MgSO4. If the pacing cycle length was abruptly increased from 180 to 220 ms, the effects were comparable to those described above. CONCLUSIONS: Sotalol led to inadequate kinetics of fate adaptation of the Q-aT interval indicated by a high amplitude of Q-aT interval change, especially within the first beat after abrupt change in the pacing rate. MgSO4 abolished this effect of sotalol. These findings suggest that MgSO4 could reduce sotalol-induced inadequate kinetics of rate adaptation and therefore also dispersion of repolarization, which may result in a reduction of sotalol-induced ventricular arrhythmias.\n\nTritthart, Helmut\n\n\n"
},
{
"text": "\n80019\nCalcitonin increases the concentration of insulin-like growth factors in serum-free cultures of human osteoblast-line cells.\n\nFarley, J\n\nDimai, HP\n\nStilt-Coffing, B\n\nFarley, P\n\nPham, T\n\nMohan, S\n\nBeiträge in Fachzeitschriften\nISI:000088781400010\n10954780.0\n10.1007/s002230001112\nNone\nThe current studies were intended to determine whether the anabolic effects of calcitonin (CT) on human osteoblast-line cells were (1) unique to osteosarcoma cells or also evident in osteoblast-line cells derived from normal human bone; and/or (2) associated with effects on several insulin-like growth factor (IGF) system components. Preliminary studies identified several osteoblastic cell lines, derived from normal human bone, which showed calcitonindependent increases in cell proliferation, alkaline phosphatase activity, and/or (45)Ca uptake (P < 0.05-P < 0.001). Two of these cell lines-(human vertebrae) HBV-155 and HBV-163-were included with the human osteosarcoma cell line, SaOS-2, in most of our subsequent studies of calcitonin effects on selected IGF system components: IGF-II, IGF-I, and IGF binding proteins -3, -4, and -5. The results of those studies revealed that a 48 hour exposure to salmon CT caused a dose-dependent (0.03-3 mU/ml) increase in the net extracellular level of IGF-II (r = 0.96, P < 0.01) in serum-free cultures of SaOS-2 cells, with a maximal 60% increase at the highest tested dose (P < 0.02). Similar effects were seen with HBV-163 cells (r = 0.90, P < 0.01) and HBV-155 cells (r = 0.55, P < 0.02). The effect of calcitonin on the extracellular level of IGF-II was biphasic with respect to time: it decreased at 6 hours (P < 0.005 and P < 0.001, for SaOS-2 cells and HBV-163 cells, respectively) and increased at 24 hours (P < 0.02 and P < 0.05). These calcitonin-dependent increases in the extracellular level of IGF-II were associated with parallel increases in IGF-I (P < 0.005 for SaOS-2 cells and P < 0.03 for HBV-163 cells), but calcitonin did not affect the extracellular level of transforming growth factor (TGF)-beta. The calcitonin-dependent changes in IGF-II were not associated with changes in the extracellular levels of IGF binding proteins -3, -4, or -5. Finally, our studies showed that two other members of the CT superfamily-CT gene-related peptide and amylin-did not mimic the effect of CT to increase the extracellular level of IGF-II. Together, these data demonstrate that human osteoblast-line cells derived from normal human bone can respond to CT, and that those responses can include CT dose- and time-dependent increases in the extracellular levels of IGF-I and IGF-II.\n\nDimai, Hans\n\n\n"
},
{
"text": "\n117951\nPotentiation of granulocyte colony-stimulating factor-induced mobilization of circulating progenitor cells by seven-day pretreatment with interleukin-3.\n\nGeissler, K\n\nPeschel, C\n\nNiederwieser, D\n\nStrobl, H\n\nGoldschmitt, J\n\nOhler, L\n\nBettelheim, P\n\nKahls, P\n\nHuber, C\n\nLechner, K\n\nHöcker, P\n\nKolbe, K\n\nBeiträge in Fachzeitschriften\nISI:A1996UC77600014\n8639889.0\n10.1182/blood.V87.7.2732.bloodjournal8772732\nNone\nGranulocyte colony-stimulating factor (G-CSF) as a single agent is increasingly used for the mobilization of peripheral blood progenitor cells (PBPCs) for stem cell transplantation. In patients with perturbed hematopoiesis the mobilizing capacity of G-CSF alone may be inadequate. We have shown in rhesus monkeys that interleukin-3 (IL-3) pretreatment markedly potentiated the increase in PBPC numbers by subsequent administration of granulocyte/macrophage-CSF (GM-CSF). Here we studied the effect of IL-3 pretreatment on G-CSF-induced mobilization of PBPCs in 6 patients with Hodgkin's disease (n = 5) or non-Hodgkin's lymphoma (n = 1) who had low progenitor cell numbers because of previous chemotherapy. Patients were treated in cycle 1 with G-CSF at a dose of 5 microgram/kg/d for 5 days and, after a treatment-free interval, received cycle 2 consisting of 5 microgram/kg/d of IL-3 for 7 days followed by G-CSF again at a dose of 5 microgram/kg/d for 5 days. G-CSF alone increased the mean number of circulating colony-forming units-GM (CFU-GM) by 21-fold, the number of burst-forming units-erythroid (BFU-E) by 9-fold, and the number of CFU-mix by 24-fold over pretreatment values. Treatment with 5 microgram/kg/d of IL-3 for 7 days did not mobilize by itself but significantly potentiated G-CSF-induced mobilization of all progenitor cell types leading to a 56-, 15-, and 46-fold increase over baseline of CFU-GM, BFU-E, and CFU-mix numbers, respectively. In 2 patients in whom leukapheresis was performed after G-CSF alone the target number of 2 x 10(6)/kg CD34+ cells was not reached. However, leukapheresis after the IL-3/G-CSF combination obtained > or =2 x 10(6)/kg CD34+ cells in 3 of 6 patients, including both patients who had inadequate collection after G-CSF alone. In one patient adequate function of mobilized progenitors could be shown by the demonstration of rapid trilineage engraftment after infusion of progenitors after myeloablative chemotherapy. Seven-day pretreatment with IL-3 may be a useful mean to augment mobilization of circulating progenitors by G-CSF. The combination of IL-3 and G-CSF seems to allow the procurement of sufficient numbers of PBPCs in some patients who cannot be mobilized adequately by G-CSF alone.\n\nStrobl, Herbert\n\n\n"
},
{
"text": "\n154848\nExpanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial.\n\nPanés, J\n\nGarcía-Olmo, D\n\nVan Assche, G\n\nColombel, JF\n\nReinisch, W\n\nBaumgart, DC\n\nDignass, A\n\nNachury, M\n\nFerrante, M\n\nKazemi-Shirazi, L\n\nGrimaud, JC\n\nde la Portilla, F\n\nGoldin, E\n\nRichard, MP\n\nLeselbaum, A\n\nDanese, S\n\nADMIRE CD Study Group Collaborators\n\nBeiträge in Fachzeitschriften\nISI:000383704000031\n27477896.0\n10.1016/S0140-6736(16)31203-X\nNone\nComplex perianal fistulas in Crohn's disease are challenging to treat. Allogeneic, expanded, adipose-derived stem cells (Cx601) are a promising new therapeutic approach. We aimed to assess the safety and efficacy of Cx601 for treatment-refractory complex perianal fistulas in patients with Crohn's disease.\n We did this randomised, double-blind, parallel-group, placebo-controlled study at 49 hospitals in seven European countries and Israel from July 6, 2012, to July 27, 2015. Adult patients (≥18 years) with Crohn's disease and treatment-refractory, draining complex perianal fistulas were randomly assigned (1:1) using a pre-established randomisation list to a single intralesional injection of 120 million Cx601 cells or 24 mL saline solution (placebo), with stratification according to concomitant baseline treatment. Treatment was administered by an unmasked surgeon, with a masked gastroenterologist and radiologist assessing the therapeutic effect. The primary endpoint was combined remission at week 24 (ie, clinical assessment of closure of all treated external openings that were draining at baseline, and absence of collections >2 cm of the treated perianal fistulas confirmed by masked central MRI). Efficacy was assessed in the intention-to-treat (ITT) and modified ITT populations; safety was assessed in the safety population. This study is registered with ClinicalTrials.gov, number NCT01541579.\n 212 patients were randomly assigned: 107 to Cx601 and 105 to placebo. A significantly greater proportion of patients treated with Cx601 versus placebo achieved combined remission in the ITT (53 of 107 [50%] vs 36 of 105 [34%]; difference 15·2%, 97·5% CI 0·2-30·3; p=0·024) and modified ITT populations (53 of 103 [51%] vs 36 of 101 [36%]; 15·8%, 0·5-31·2; p=0·021). 18 (17%) of 103 patients in the Cx601 group versus 30 (29%) of 103 in the placebo group experienced treatment-related adverse events, the most common of which were anal abscess (six in the Cx601 group vs nine in the placebo group) and proctalgia (five vs nine).\n Cx601 is an effective and safe treatment for complex perianal fistulas in patients with Crohn's disease who did not respond to conventional or biological treatments, or both.\n TiGenix.\n Copyright © 2016 Elsevier Ltd. All rights reserved.\n\n\n"
},
{
"text": "\n155405\nRisk and safety requirements for diagnostic and therapeutic procedures in allergology: World Allergy Organization Statement.\n\nKowalski, ML\n\nAnsotegui, I\n\nAberer, W\n\nAl-Ahmad, M\n\nAkdis, M\n\nBallmer-Weber, BK\n\nBeyer, K\n\nBlanca, M\n\nBrown, S\n\nBunnag, C\n\nHulett, AC\n\nCastells, M\n\nChng, HH\n\nDe Blay, F\n\nEbisawa, M\n\nFineman, S\n\nGolden, DB\n\nHaahtela, T\n\nKaliner, M\n\nKatelaris, C\n\nLee, BW\n\nMakowska, J\n\nMuller, U\n\nMullol, J\n\nOppenheimer, J\n\nPark, HS\n\nParkerson, J\n\nPassalacqua, G\n\nPawankar, R\n\nRenz, H\n\nRueff, F\n\nSanchez-Borges, M\n\nSastre, J\n\nScadding, G\n\nSicherer, S\n\nTantilipikorn, P\n\nTracy, J\n\nvan Kempen, V\n\nBohle, B\n\nCanonica, GW\n\nCaraballo, L\n\nGomez, M\n\nIto, K\n\nJensen-Jarolim, E\n\nLarche, M\n\nMelioli, G\n\nPoulsen, LK\n\nValenta, R\n\nZuberbier, T\n\nBeiträge in Fachzeitschriften\nISI:000385037200001\n27777642.0\n10.1186/s40413-016-0122-3\nPMC5062928\nOne of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment) of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing), deliberate induction in the office of allergic symptoms to offending compounds (provocation tests) or intentional application of potentially dangerous substances (allergy vaccine) to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided. However, adverse reactions can be minimized or even avoided if a physician is fully aware of potential risk and is prepared to appropriately handle the situation. Information on the risk of diagnostic and therapeutic procedures in allergic diseases has been accumulated in the medical literature for decades; however, except for allergen specific immunotherapy, it has never been presented in a systematic fashion. Up to now no single document addressed the risk of the most commonly used medical procedures in the allergy office nor attempted to present general requirements necessary to assure the safety of these procedures. Following review of available literature a group of allergy experts within the World Allergy Organization (WAO), representing various continents and areas of allergy expertise, presents this report on risk associated with diagnostic and therapeutic procedures in allergology and proposes a consensus on safety requirements for performing procedures in allergy offices. Optimal safety measures including appropriate location, type and required time of supervision, availability of safety equipment, access to specialized emergency services, etc. for various procedures have been recommended. This document should be useful for allergists with already established practices and experience as well as to other specialists taking care of patients with allergies.\n\nAberer, Werner\n\n\n"
},
{
"text": "\n170573\nProbiotic Treatment in Individuals with Euthymic Bipolar Disorder: A Pilot-Study on Clinical Changes and Compliance.\n\nReininghaus, EZ\n\nWetzlmair, LC\n\nFellendorf, FT\n\nPlatzer, M\n\nQueissner, R\n\nBirner, A\n\nPilz, R\n\nHamm, C\n\nMaget, A\n\nRieger, A\n\nPrettenhofer, A\n\nWurm, W\n\nMörkl, S\n\nDalkner, N\n\nBeiträge in Fachzeitschriften\nISI:000510871600007\n30343291.0\n10.1159/000493867\nNone\nThe importance of the microbiome for psychological well-being has gained rising interest in the last decade. A strategy to examine the role of the microbiome in different diseases is the intake of supplements that modulate the gut microbiome. Despite promising results in animal studies, research in humans is sparse to date and especially in individuals with psychiatric disorders almost missing. The current report of the ProbioBIP-one pilot study aims at describing general effects of the intake of the probiotic OMNi-BiOTiC Stress repair® on psychological parameters as well as gastrointestinal symptoms and general compliance in a cohort of euthymic individuals with bipolar disorder (BD), receiving daily probiotic treatment over a time period of 3 months. Twenty-seven individuals with BD took part in the present study (mean age = 50.7 years, SD = 12.2; females 40.7%). In sum, there was a high compliance rate with 81.5% of the study participants completing all 3 study visits and 85% of planned probiotic ingestions taken. Gastrointestinal problems were prevalent in more than half of the patients at the time of inclusion (t1). Expectedly, in the whole cohort, a high proportion of study participants experienced changes concerning digestion during probiotic treatment, around one third reported positive changes (reduced flatulence and easier and more frequent bowel movements) after 1 month (t2) and further after 3 months (t3). In contrast, a smaller part of study participants reported gastrointestinal discomfort after 1 and after 3 months (mainly flatulence and obstipation). We found a significantly reduced cognitive reactivity to sad mood between t2 and t3 indicating that participants under probiotic supplementation perceived themselves to be less distracted by ruminative thoughts. Further changes in psychiatric symptoms were small due to the euthymic state and already low scoring at the time of inclusion. Nevertheless, we found a significant symptom reduction in the rating scales measuring manic symptoms. From a clinical point of view, probiotic supplementation might provide a well-tolerated tool to positively influence gastrointestinal quality of life as well as mental and somatic health, cognition and immune response and potentially have effects on psychiatric symptoms.\n © 2018 S. Karger AG, Basel.\n\nBirner, Armin\n\nDalkner, Nina\n\nFellendorf, Frederike\n\nHamm, Carlo\n\nMaget, Alexander\n\nMörkl, Sabrina\n\nPilz, Rene\n\nPlatzer, Martina\n\nQueissner, Robert\n\nReininghaus, Eva\n\nRieger, Alexandra\n\nWurm, Walter Ernst\n\n\n"
},
{
"text": "\n185097\nVariation in hospital admission in febrile children evaluated at the Emergency Department (ED) in Europe: PERFORM, a multicentre prospective observational study.\n\nBorensztajn, DM\n\nHagedoorn, NN\n\nRivero Calle, I\n\nMaconochie, IK\n\nvon Both, U\n\nCarrol, ED\n\nDewez, JE\n\nEmonts, M\n\nvan der Flier, M\n\nde Groot, R\n\nHerberg, J\n\nKohlmaier, B\n\nLim, E\n\nMartinon-Torres, F\n\nNieboer, D\n\nNijman, RG\n\nPokorn, M\n\nStrle, F\n\nTsolia, M\n\nVermont, C\n\nYeung, S\n\nZavadska, D\n\nZenz, W\n\nLevin, M\n\nMoll, HA\n\nPERFORM consortium: Personalised Risk assessment in febrile children to optimise Real-life Management across the European Union\n\nBeiträge in Fachzeitschriften\nISI:000608044300109\n33411810.0\n10.1371/journal.pone.0244810\nPMC7790386\nHospitalisation is frequently used as a marker of disease severity in observational Emergency Department (ED) studies. The comparison of ED admission rates is complex in potentially being influenced by the characteristics of the region, ED, physician and patient. We aimed to study variation in ED admission rates of febrile children, to assess whether variation could be explained by disease severity and to identify patient groups with large variation, in order to use this to reduce unnecessary health care utilization that is often due to practice variation.\n MOFICHE (Management and Outcome of Fever in children in Europe, part of the PERFORM study, www.perform2020.org), is a prospective cohort study using routinely collected data on febrile children regarding patient characteristics (age, referral, vital signs and clinical alarming signs), diagnostic tests, therapy, diagnosis and hospital admission.\n Data were collected on febrile children aged 0-18 years presenting to 12 European EDs (2017-2018).\n We compared admission rates between EDs by using standardised admission rates after adjusting for patient characteristics and initiated tests at the ED, where standardised rates >1 demonstrate higher admission rates than expected and rates <1 indicate lower rates than expected based on the ED patient population.\n We included 38, 20 children. Of those, 9.695 (25.4%) were admitted to a general ward (range EDs 5.1-54.5%). Adjusted standardised admission rates ranged between 0.6 and 1.5. The largest variation was seen in short admission rates (0.1-5.0), PICU admission rates (0.2-2.2), upper respiratory tract infections (0.4-1.7) and fever without focus (0.5-2.7). Variation was small in sepsis/meningitis (0.9-1.1).\n Large variation exists in admission rates of febrile children evaluated at European EDs, however, this variation is largely reduced after correcting for patient characteristics and therefore overall admission rates seem to adequately reflect disease severity or a potential for a severe disease course. However, for certain patient groups variation remains high even after adjusting for patient characteristics.\n\nKohlmaier, Benno\n\nZenz, Werner\n\n\n"
},
{
"text": "\n121665\nProbiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial.\n\nLamprecht, M\n\nBogner, S\n\nSchippinger, G\n\nSteinbauer, K\n\nFankhauser, F\n\nHallstroem, S\n\nSchuetz, B\n\nGreilberger, JF\n\nBeiträge in Fachzeitschriften\nISI:000309875800001\n22992437.0\n10.1186/1550-2783-9-45\nPMC3465223\nProbiotics are an upcoming group of nutraceuticals claiming positive effects on athlete's gut health, redox biology and immunity but there is lack of evidence to support these statements.\n We conducted a randomized, double-blinded, placebo controlled trial to observe effects of probiotic supplementation on markers of intestinal barrier, oxidation and inflammation, at rest and after intense exercise. 23 trained men received multi-species probiotics (1010 CFU/day, Ecologic®Performance or OMNi-BiOTiC®POWER, n = 11) or placebo (n = 12) for 14 weeks and performed an intense cycle ergometry over 90 minutes at baseline and after 14 weeks. Zonulin and α1-antitrypsin were measured from feces to estimate gut leakage at baseline and at the end of treatment. Venous blood was collected at baseline and after 14 weeks, before and immediately post exercise, to determine carbonyl proteins (CP), malondialdehyde (MDA), total oxidation status of lipids (TOS), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6). Statistical analysis used multifactorial analysis of variance (ANOVA). Level of significance was set at p < 0.05, a trend at p < 0.1.\n Zonulin decreased with supplementation from values slightly above normal into normal ranges (<30 ng/ml) and was significantly lower after 14 weeks with probiotics compared to placebo (p = 0.019). We observed no influence on α1-antitrypsin (p > 0.1). CP increased significantly from pre to post exercise in both groups at baseline and in the placebo group after 14 weeks of treatment (p = 0.006). After 14 weeks, CP concentrations were tendentially lower with probiotics (p = 0.061). TOS was slightly increased above normal in both groups, at baseline and after 14 weeks of treatment. There was no effect of supplementation or exercise on TOS. At baseline, both groups showed considerably higher TNF-α concentrations than normal. After 14 weeks TNF-α was tendentially lower in the supplemented group (p = 0.054). IL-6 increased significantly from pre to post exercise in both groups (p = 0.001), but supplementation had no effect. MDA was not influenced, neither by supplementation nor by exercise.\n The probiotic treatment decreased Zonulin in feces, a marker indicating enhanced gut permeability. Moreover, probiotic supplementation beneficially affected TNF-α and exercise induced protein oxidation. These results demonstrate promising benefits for probiotic use in trained men.\n http://www.clinicaltrials.gov, identifier: NCT01474629.\n\nGreilberger, Joachim\n\nHallström, Seth\n\n\n"
},
{
"text": "\n128379\nLong-term effects of weight-reducing drugs in hypertensive patients.\n\nSiebenhofer, A\n\nJeitler, K\n\nHorvath, K\n\nBerghold, A\n\nSiering, U\n\nSemlitsch, T\n\nBeiträge in Fachzeitschriften\nISI:000316887200024\n23543553.0\n10.1002/14651858.CD007654.pub3\nNone\nAll major guidelines for antihypertensive therapy recommend weight loss; anti-obesity drugs might be a helpful option.\n \n To assess the long-term effects of pharmacologically induced reduction in body weight with orlistat, sibutramine or rimonabant on:- all cause mortality - cardiovascular morbidity - adverse events\n - changes in systolic and/or diastolic blood pressure - body weight reduction even though sibutramine and rimonabant have been withdrawn from the market.\n Studies were obtained from computerised searches of Ovid MEDLINE, EMBASE, CENTRAL and from hand searches in reference lists and systematic reviews (status as of 17(th) August, 2012).\n Randomized controlled trials in adult hypertensive patients with a study duration of at least 24 weeks comparing pharmacologic interventions (orlistat, sibutramine, rimonabant) for weight loss with placebo.\n Two authors independently assessed risk of bias and extracted data. Studies were pooled using fixed-effect meta-analysis in the absence of significant heterogeneity between studies (p>0.1). Otherwise, we used the random effects method and investigated the cause of heterogeneity.\n After the updated literature search, the number of studies remained the same, with eight studies comparing orlistat or sibutramine to placebo fulfilling our inclusion criteria. No relevant studies investigating rimonabant for weight loss were identified. No study included mortality and cardiovascular morbidity as a pre-defined outcome. Incidence of gastrointestinal side effects was consistently higher in orlistat treated vs. placebo treated patients. Most frequent side effects with sibutramine were dry mouth, constipation and headache. Patients assigned to weight loss diets, orlistat or sibutramine reduced their body weight more effectively than patients in the usual care/placebo groups. Blood pressure reduction in patients treated with orlistat was for systolic blood pressure (SBP): weighted mean difference (WMD): -2.5 mm Hg; 95% CI, -4.0 to -0.9 mm Hg and for diastolic blood pressure (DBP): WMD -1.9 mm Hg; 95% CI, -3.0 to -0.9 mm Hg. Meta-analysis showed DBP increase under therapy with sibutramine: WMD +3.2 mm Hg; 95%CI +1.4 to +4.9 mm Hg.\n In patients with elevated blood pressure, orlistat and sibutramine reduced body weight to a similar degree. In the same trials, orlistat reduced blood pressure and sibutramine increased blood pressure. No trials investigating rimonabant in people with elevated blood pressure could be included. Long-term trials assessing the effect of orlistat, sibutramine and rimonabant on mortality and morbidity are lacking. Rimonabant and sibutramine have been withdrawn from the market for the time being.\n\nBerghold, Andrea\n\nHorvath, Karl\n\nJeitler, Klaus\n\nSemlitsch, Thomas\n\nSiebenhofer-Kroitzsch, Andrea\n\n\n"
},
{
"text": "\n135591\nIN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial.\n\nZeller, T\n\nBaumgartner, I\n\nScheinert, D\n\nBrodmann, M\n\nBosiers, M\n\nMicari, A\n\nPeeters, P\n\nVermassen, F\n\nLandini, M\n\nIN.PACT DEEP Trial Investigators\n\nBeiträge in Fachzeitschriften\nISI:000333471400001\n24552184.0\n10.1186/1745-6215-15-63\nPMC3936931\nThe effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL).\n IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.\n This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.\n NCT00941733.\n\nBrodmann, Marianne\n\n\n"
},
{
"text": "\n153890\nCorrigendum: Genetic variants associated with subjective well-being, depressive symptoms, and neuroticism identified through genome-wide analyses.\n\nOkbay, A\n\nBaselmans, BM\n\nNeve, JE\n\nTurley, P\n\nNivard, MG\n\nFontana, MA\n\nMeddens, SF\n\nLinnér, RK\n\nRietveld, CA\n\nDerringer, J\n\nGratten, J\n\nLee, JJ\n\nLiu, JZ\n\nde Vlaming, R\n\nAhluwalia, TS\n\nBuchwald, J\n\nCavadino, A\n\nFrazier-Wood, AC\n\nFurlotte, NA\n\nGarfield, V\n\nGeisel, MH\n\nGonzalez, JR\n\nHaitjema, S\n\nKarlsson, R\n\nvan der Laan, SW\n\nLadwig, KH\n\nLahti, J\n\nvan der Lee, SJ\n\nLind, PA\n\nLiu, T\n\nMatteson, L\n\nMihailov, E\n\nMiller, MB\n\nMinica, CC\n\nNolte, IM\n\nMook-Kanamori, D\n\nvan der Most, PJ\n\nOldmeadow, C\n\nQian, Y\n\nRaitakari, O\n\nRawal, R\n\nRealo, A\n\nRueedi, R\n\nSchmidt, B\n\nSmith, AV\n\nStergiakouli, E\n\nTanaka, T\n\nTaylor, K\n\nThorleifsson, G\n\nWedenoja, J\n\nWellmann, J\n\nWestra, HJ\n\nWillems, SM\n\nZhao, W\n\nLifeLines Cohort Study\n\nAmin, N\n\nBakshi, A\n\nBergmann, S\n\nBjornsdottir, G\n\nBoyle, PA\n\nCherney, S\n\nCox, SR\n\nDavies, G\n\nDavis, OS\n\nDing, J\n\nDirek, N\n\nEibich, P\n\nEmeny, RT\n\nFatemifar, G\n\nFaul, JD\n\nFerrucci, L\n\nForstner, AJ\n\nGieger, C\n\nGupta, R\n\nHarris, TB\n\nHarris, JM\n\nHolliday, EG\n\nHottenga, JJ\n\nJager, PL\n\nKaakinen, MA\n\nKajantie, E\n\nKarhunen, V\n\nKolcic, I\n\nKumari, M\n\nLauner, LJ\n\nFranke, L\n\nLi-Gao, R\n\nLiewald, DC\n\nKoini, M\n\nLoukola, A\n\nMarques-Vidal, P\n\nMontgomery, GW\n\nMosing, MA\n\nPaternoster, L\n\nPattie, A\n\nPetrovic, KE\n\nPulkki-Råback, L\n\nQuaye, L\n\nRäikkönen, K\n\nRudan, I\n\nScott, RJ\n\nSmith, JA\n\nSutin, AR\n\nTrzaskowski, M\n\nVinkhuyzen, AE\n\nYu, L\n\nZabaneh, D\n\nAttia, JR\n\nBennett, DA\n\nBerger, K\n\nBertram, L\n\nBoomsma, DI\n\nSnieder, H\n\nChang, SC\n\nCucca, F\n\nDeary, IJ\n\nvan Duijn, CM\n\nEriksson, JG\n\nBültmann, U\n\nde Geus, EJ\n\nGroenen, PJ\n\nGudnason, V\n\nHansen, T\n\nHartman, CA\n\nHaworth, CM\n\nHayward, C\n\nHeath, AC\n\nHinds, DA\n\nHyppönen, E\n\nIacono, WG\n\nJärvelin, MR\n\nJöckel, KH\n\nKaprio, J\n\nKardia, SL\n\nKeltikangas-Järvinen, L\n\nKraft, P\n\nKubzansky, LD\n\nLehtimäki, T\n\nMagnusson, PK\n\nMartin, NG\n\nMcGue, M\n\nMetspalu, A\n\nMills, M\n\nde Mutsert, R\n\nOldehinkel, AJ\n\nPasterkamp, G\n\nPedersen, NL\n\nPlomin, R\n\nPolasek, O\n\nPower, C\n\nRich, SS\n\nRosendaal, FR\n\nden Ruijter, HM\n\nSchlessinger, D\n\nSchmidt, H\n\nSvento, R\n\nSchmidt, R\n\nAlizadeh, BZ\n\nSørensen, TI\n\nSpector, TD\n\nStarr, JM\n\nStefansson, K\n\nSteptoe, A\n\nTerracciano, A\n\nThorsteinsdottir, U\n\nThurik, AR\n\nTimpson, NJ\n\nTiemeier, H\n\nUitterlinden, AG\n\nVollenweider, P\n\nWagner, GG\n\nWeir, DR\n\nYang, J\n\nConley, DC\n\nSmith, GD\n\nHofman, A\n\nJohannesson, M\n\nLaibson, DI\n\nMedland, SE\n\nMeyer, MN\n\nPickrell, JK\n\nEsko, T\n\nKrueger, RF\n\nBeauchamp, JP\n\nKoellinger, PD\n\nBenjamin, DJ\n\nBartels, M\n\nCesarini, D\n\nBeiträge in Fachzeitschriften\nISI:000380755100026\n27463399.0\n10.1038/ng0816-970c\nNone\nNone\n\nSchmidt, Helena\n\nSchmidt, Reinhold\n\n\n"
},
{
"text": "\n161284\nIncidence of Atrophic Lesions in Stargardt Disease in the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: Report No. 5.\n\nStrauss, RW\n\nMuñoz, B\n\nHo, A\n\nJha, A\n\nMichaelides, M\n\nMohand-Said, S\n\nCideciyan, AV\n\nBirch, D\n\nHariri, AH\n\nNittala, MG\n\nSadda, S\n\nScholl, HPN\n\nProgStar Study Group\n\nBeiträge in Fachzeitschriften\nISI:000405531700006\n28542697.0\n10.1001/jamaophthalmol.2017.1121\nPMC5710205\nOutcome measures that are sensitive to disease progression are needed as clinical end points for future treatment trials in Stargardt disease.\n To examine the incidence of atrophic lesions of the retinal pigment epithelium in patients with Stargardt disease as determined by fundus autofluorescence imaging.\n In this retrospective multicenter cohort study, 217 patients 6 years and older at baseline at tertiary referral centers in Europe, the United States, and the United Kingdom who were harboring disease-causing variants in the adenosine triphosphate (ATP)-binding cassette subfamily A member 4 (ABCA4) gene and who met the following criteria were enrolled: (1) at least 1 well-demarcated area of atrophy with a minimum diameter of 300 µm, with the total area of all atrophic lesions being less than or equal to 12 mm2 in at least 1 eye at the most recent visit, and (2) fundus autofluorescence images for at least 2 visits with a minimum of 6 months between at least 2 visits. Data were collected between August 22, 2013, and December 12, 2014. Data analysis was performed from March 15, 2015, through January 31, 2017.\n Images were evaluated by staff at a central reading center. Areas of definitely decreased autofluorescence (DDAF) and questionably decreased autofluorescence (QDAF) were outlined and quantified. Lesion-free survival rates were estimated using Kaplan-Meier survival curves.\n Incidence of atrophic lesions as determined by fundus autofluorescence.\n The 217 patients (mean [SD] age, 21.8 [13.3] years; 127 female [57.5%]; 148 white [68.2%]) contributed 390 eyes for which the mean (SD) follow-up time was 3.9 (1.6) years (range, 0.7-12.1 years). Among eyes without DDAF at first visit, the median time to develop a DDAF lesion was 4.9 years (95% CI, 4.3-5.6 years). Among eyes without QDAF, the median time to develop a QDAF lesion was 6.3 years (95% CI, 5.6-9.7 years). Eyes with a lesion of DDAF at the first visit were less likely to develop a QDAF lesion compared with eyes without a lesion of DDAF (hazard ratio, 0.19; 95% CI, 0.05-0.70; P = .01).\n An estimated 50% of the eyes without DDAF at first visit will develop the lesion in less than 5 years, suggesting that incidence of DDAF could serve as an outcome measure for treatment trials.\n\nStrauß, Rupert\n\n\n"
},
{
"text": "\n182735\nTiming of Initiation of Renal-Replacement Therapy in Acute Kidney Injury.\n\nSTARRT-AKI Investigators\n\nCanadian Critical Care Trials Group, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the United Kingdom Critical Care Research Group, the Canadian Nephrology Trials Network, and the Irish Critical Care Trials Group\n\nBagshaw, SM\n\nWald, R\n\nAdhikari, NKJ\n\nBellomo, R\n\nda Costa, BR\n\nDreyfuss, D\n\nDu, B\n\nGallagher, MP\n\nGaudry, S\n\nHoste, EA\n\nLamontagne, F\n\nJoannidis, M\n\nLandoni, G\n\nLiu, KD\n\nMcAuley, DF\n\nMcGuinness, SP\n\nNeyra, JA\n\nNichol, AD\n\nOstermann, M\n\nPalevsky, PM\n\nPettilä, V\n\nQuenot, JP\n\nQiu, H\n\nRochwerg, B\n\nSchneider, AG\n\nSmith, OM\n\nThomé, F\n\nThorpe, KE\n\nVaara, S\n\nWeir, M\n\nWang, AY\n\nYoung, P\n\nZarbock, A\n\nBeiträge in Fachzeitschriften\nISI:000553165300014\n32668114.0\n10.1056/NEJMoa2000741\nNone\nAcute kidney injury is common in critically ill patients, many of whom receive renal-replacement therapy. However, the most effective timing for the initiation of such therapy remains uncertain.\n We conducted a multinational, randomized, controlled trial involving critically ill patients with severe acute kidney injury. Patients were randomly assigned to receive an accelerated strategy of renal-replacement therapy (in which therapy was initiated within 12 hours after the patient had met eligibility criteria) or a standard strategy (in which renal-replacement therapy was discouraged unless conventional indications developed or acute kidney injury persisted for >72 hours). The primary outcome was death from any cause at 90 days.\n Of the 3019 patients who had undergone randomization, 2927 (97.0%) were included in the modified intention-to-treat analysis (1465 in the accelerated-strategy group and 1462 in the standard-strategy group). Of these patients, renal-replacement therapy was performed in 1418 (96.8%) in the accelerated-strategy group and in 903 (61.8%) in the standard-strategy group. At 90 days, death had occurred in 643 patients (43.9%) in the accelerated-strategy group and in 639 (43.7%) in the standard-strategy group (relative risk, 1.00; 95% confidence interval [CI], 0.93 to 1.09; P = 0.92). Among survivors at 90 days, continued dependence on renal-replacement therapy was confirmed in 85 of 814 patients (10.4%) in the accelerated-strategy group and in 49 of 815 patients (6.0%) in the standard-strategy group (relative risk, 1.74; 95% CI, 1.24 to 2.43). Adverse events occurred in 346 of 1503 patients (23.0%) in the accelerated-strategy group and in 245 of 1489 patients (16.5%) in the standard-strategy group (P<0.001).\n Among critically ill patients with acute kidney injury, an accelerated renal-replacement strategy was not associated with a lower risk of death at 90 days than a standard strategy. (Funded by the Canadian Institutes of Health Research and others; STARRT-AKI ClinicalTrials.gov number, NCT02568722.).\n Copyright © 2020 Massachusetts Medical Society.\n\nEller, Philipp\n\n\n"
},
{
"text": "\n91340\nTemporal relationship between the circulating profiles of melatonin and ovarian steroids under natural photo-thermal conditions in an annual reproductive cycle in carp Catla catla\n\nChattoraj, A\n\nSeth, M\n\nBasu, A\n\nShrivastav, TG\n\nPorta, S\n\nMaitra, SK\n\nBeiträge in Fachzeitschriften\nISI:000266774000008\nNone\n10.1080/09291010802404218\nNone\nA temporal relationship between the serum profiles of pineal-hormone melatonin (N-acetyl-5-methoxytryptamine) and two major ovarian steroids, i.e., 17- estradiol (E2) and 17, 20-dihydroxy-4-pregnen-3-one (17, 20 DHP) or maturation inducing hormone (MIH), has been sought for the first time in any free-living teleost. The study was carried under natural conditions in a carp Catla catla following collection of blood samples at different time-points in a diurnal cycle during each of the four distinct reproductive phases in an annual cycle. The levels of melatonin and the steroids were measured following specific RIA and ELISA techniques, respectively. A time-bound change in the serum melatonin was noted in a 24h cycle, though the pattern of fluctuations was not identical throughout the reproductive cycle. Melatonin reached its peak during the mid-night in each reproductive phase, other than the preparatory phase (January-March) when the diurnal peak value was recorded in the late dark phase. In an annual cycle, melatonin titer was found to be maximum during the post-spawning phase (September-December). However, in each reproductive phase, a minimum daily value of melatonin was recorded in the mid-day. Serum E2, irrespective of reproductive phase, exhibited a daily peak in the mid-day and nadir in the early morning. However, in a seasonal cycle, E2 was found to be maximum in the spawning phase (July-August). The serum MIH, however, did not show any significant daily variations, and underwent significant changes in an annual cycle with a very low value in the preparatory phase followed by a gradual increase in the pre-spawning (April-June), a peak in the spawning phase, and was undetectable during the post-spawning phase. The simple correlation-coefficient analysis of the seasonal peak values of melatonin revealed a significant negative correlation with photoperiods, water temperature and serum E2, while a positive correlation was found between the seasonal values of serum E2, photoperiod and water temperature. In a seasonal cycle, serum MIH values exhibited a positive correlation with both water temperature and serum E2, and a negative correlation with melatonin. Collectively, the present study underlines the importance of environmental photo-thermal conditions, especially water temperature, as the functional correlate of seasonal changes in serum melatonin and ovarian steroids in carp.\n\n\n"
},
{
"text": "\n103041\nCombination amoxycillin and metronidazole with famotidine in the eradication of Helicobacter pylori - a randomized, double-blind comparison of a three times daily and twice daily regimen\n\nGoh, KL\n\nParasakthi, N\n\nChuah, SY\n\nToetsch, M\n\nBeiträge in Fachzeitschriften\nISI:A1997YE14300012\n9431900.0\n10.1097/00042737-199711000-00012\nNone\nObjectives: To determine the efficacy of a three times daily (t. i. d.) versus a twice daily (b. i. d.) regimen of combination amoxycillin and metronidazole and famotidine in the eradication of Helicobacter pylori and the influence of metronidazole resistance on the outcome of treatment. Patients: Patients selected had unequivocal evidence of H. pylori infection based on the urease test, culture and histology and had either peptic ulcer disease or non-ulcer dyspepsia. Design: The study was a comparative and double-blind study and patients were randomized to receive either amoxycillin 750 mg t. i. d. and metronidazole 500 mg t. i. d. for 12 days or amoxycillin 1000 mg b. i. d. and metronidazole 500 mg b. i. d. for 12 days. Both groups also received famotidine 40 mg for 6 weeks. Main outcome measure: Patients were assessed for successful eradication, defined as absence of bacteria in all tests, at least 4 weeks after completion of antibiotic therapy by repeat gastroscopy. Results: One hundred and twenty-nine patients were recruited for the study. Two patients defaulted follow-up, two patients were withdrawn from the study and six patients were found to be non-compliant with medications. The eradication rates of the t. i. d. regimen was higher than the b. i. d. regimen (per protocol (PP) analysis: 83.3% (50/60) vs. 76.3% (45/59), P = 0.337; intention-to-treat (ITT) analysis: 78.5% (51/65) vs. 75.0% (48/64), P = 0.642). Seventy-five patients had pre-treatment cultures checked for metronidazole resistance, 33 (44.0%) were found to be resistant. Acquired resistance occurred in 3/40 (7.5%) patients. Eradication rates of metronidazole-sensitive and metronidazole-resistant patients: t. i. d. regimen - 100% (17/17) and 88.2% (15/17), b. i. d. regimen -19/21 (90.5%) and 11/15 (73.3%). Side effects were reported in up to 70% of patients but were mild and tolerable in the majority. Two patients were withdrawn from the study because of a fixed drug eruption in one and generalized macular rash in the other. Conclusion: Combination amoxycillin and metronidazole is effective in eradicating H. pylori. There was a tendency for the t. i. d. regimen to be better than the b. i. d. regimen and for metronidazole-resistant infections to be associated with a lower eradication rate but these differences did not reach statistical significance.\n\n\n"
},
{
"text": "\n155368\nHigh-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial.\n\nMacher, S\n\nDrexler, C\n\nLindenau, I\n\nSareban, N\n\nSchlenke, P\n\nAmrein, K\n\nBeiträge in Fachzeitschriften\nISI:000386736300002\n27793204.0\n10.1186/s13063-016-1648-y\nPMC5084417\nAbout 2-3 % of the population participates in blood donation programmes. Each whole blood donation or ten apheresis donations cause a loss of 200-250 mg of iron. As a result, one of the most common risks of regular blood donors is iron deficiency. Although this has been known for decades, in most countries, iron status is currently not assessed or treated in this population. Premenopausal women are particularly affected, as they have lower iron reserves and higher daily requirements. Besides anaemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Current iron preparations for intravenous administration are well tolerated and allow for application of large doses up to 1 g in one visit. Our hypothesis is that in blood donors with iron deficiency, intravenously administered iron is more efficient and as safe as oral iron supplementation. Since anaemia is one of the most frequent reasons for permanent or intermittent donor deferral, maintaining an iron-replete donor pool may help to prevent shortages in blood supply and to avoid iron deficiency-related comorbidities.\n In this randomised clinical trial we include male and female blood donors aged ≥18 and ≤65 years with a ferritin value of ≤30 ng/ml. Stratified by gender, participants are randomized with a web-based randomisation tool in a 1:1 ratio to either 1 g of intravenously administered ferric carboxymaltose or 10 g of iron fumarate supplements at one to two daily doses of 100 mg each. Eight to 12 weeks after the first visit, iron status, blood count and symptoms are assessed in both groups. The primary endpoint is the difference in transferrin saturation (%) following the intervention between both groups. Secondary endpoints include other parameters of iron metabolism and red blood cell count, the number of patients with drug-related adverse events, and subjective symptoms including those of the restless legs syndrome, quality of life, and fatigue.\n Iron supplementation administered intravenously in non-anaemic but iron-deficient blood donors could represent an effective strategy to protect blood donors from comorbidities related with iron deficiency and therefore improve blood donor wellbeing. Furthermore, iron supplementation will help to maintain an iron-replete blood donor pool.\n EudraCT: 2013-000327-14, Clinical Trials Identifier: NCT01787526 . Registered on 6 February 2013.\n\nAmrein, Karin\n\nLindenau, Ines\n\nSchlenke, Peter\n\n\n"
},
{
"text": "\n168753\nBreast ultrasound: recommendations for information to women and referring physicians by the European Society of Breast Imaging.\n\nEvans, A\n\nTrimboli, RM\n\nAthanasiou, A\n\nBalleyguier, C\n\nBaltzer, PA\n\nBick, U\n\nCamps Herrero, J\n\nClauser, P\n\nColin, C\n\nCornford, E\n\nFallenberg, EM\n\nFuchsjaeger, MH\n\nGilbert, FJ\n\nHelbich, TH\n\nKinkel, K\n\nHeywang-Köbrunner, SH\n\nKuhl, CK\n\nMann, RM\n\nMartincich, L\n\nPanizza, P\n\nPediconi, F\n\nPijnappel, RM\n\nPinker, K\n\nZackrisson, S\n\nForrai, G\n\nSardanelli, F\n\nEuropean Society of Breast Imaging (EUSOBI) , with language review by Europa Donna–The European Breast Cancer Coalition\n\nBeiträge in Fachzeitschriften\nISI:000442680100005\n30094592.0\n10.1007/s13244-018-0636-z\nPMC6108964\nThis article summarises the information that should be provided to women and referring physicians about breast ultrasound (US). After explaining the physical principles, technical procedure and safety of US, information is given about its ability to make a correct diagnosis, depending on the setting in which it is applied. The following definite indications for breast US in female subjects are proposed: palpable lump; axillary adenopathy; first diagnostic approach for clinical abnormalities under 40 and in pregnant or lactating women; suspicious abnormalities at mammography or magnetic resonance imaging (MRI); suspicious nipple discharge; recent nipple inversion; skin retraction; breast inflammation; abnormalities in the area of the surgical scar after breast conserving surgery or mastectomy; abnormalities in the presence of breast implants; screening high-risk women, especially when MRI is not performed; loco-regional staging of a known breast cancer, when MRI is not performed; guidance for percutaneous interventions (needle biopsy, pre-surgical localisation, fluid collection drainage); monitoring patients with breast cancer receiving neo-adjuvant therapy, when MRI is not performed. Possible indications such as supplemental screening after mammography for women aged 40-74 with dense breasts are also listed. Moreover, inappropriate indications include screening for breast cancer as a stand-alone alternative to mammography. The structure and organisation of the breast US report and of classification systems such as the BI-RADS and consequent management recommendations are illustrated. Information about additional or new US technologies (colour-Doppler, elastography, and automated whole breast US) is also provided. Finally, five frequently asked questions are answered.\n • US is an established tool for suspected cancers at all ages and also the method of choice under 40. • For US-visible suspicious lesions, US-guided biopsy is preferred, even for palpable findings. • High-risk women can be screened with US, especially when MRI cannot be performed. • Supplemental US increases cancer detection but also false positives, biopsy rate and follow-up exams. • Breast US is inappropriate as a stand-alone screening method.\n\nFuchsjäger, Michael\n\n\n"
},
{
"text": "\n182599\nCross-sectional and Longitudinal Assessment of Brain Iron Level in Alzheimer Disease Using 3-T MRI.\n\nDamulina, A\n\nPirpamer, L\n\nSoellradl, M\n\nSackl, M\n\nTinauer, C\n\nHofer, E\n\nEnzinger, C\n\nGesierich, B\n\nDuering, M\n\nRopele, S\n\nSchmidt, R\n\nLangkammer, C\n\nBeiträge in Fachzeitschriften\nISI:000561055300037\n32602825.0\n10.1148/radiol.2020192541\nNone\nBackground Deep gray matter structures in patients with Alzheimer disease (AD) contain higher brain iron concentrations. However, few studies have included neocortical areas, which are challenging to assess with MRI. Purpose To investigate baseline and change in brain iron levels using MRI at 3 T with R2* relaxation rate mapping in individuals with AD compared with healthy control (HC) participants. Materials and Methods In this prospective study, participants with AD recruited between 2010 and 2016 and age-matched HC participants selected from 2010 to 2014 were evaluated. Of 100 participants with AD, 56 underwent subsequent neuropsychological testing and brain MRI at a mean follow-up of 17 months. All participants underwent 3-T MRI, including R2* mapping corrected for macroscopic B0 field inhomogeneities. Anatomic structures were segmented, and median R2* values were calculated in the neocortex and cortical lobes, basal ganglia (BG), hippocampi, and thalami. Multivariable linear regression analysis was applied to study the difference in R2* levels between groups and the association between longitudinal changes in R2* values and cognition in the AD group. Results A total of 100 participants with AD (mean age, 73 years ± 9 [standard deviation]; 58 women) and 100 age-matched HC participants (mean age, 73 years ± 9; 60 women) were evaluated. Median R2* levels were higher in the AD group than in the HC group in the BG (HC, 29.0 sec-1; AD, 30.2 sec-1; P = .01) and total neocortex (HC, 17.0 sec-1; AD, 17.4 sec-1; P < .001) and regionally in the occipital (HC, 19.6 sec-1; AD, 20.2 sec-1; P = .007) and temporal (HC, 16.4 sec-1; AD, 18.1 sec-1; P < .001) lobes. R2* values in the temporal lobe were associated with longitudinal changes in Consortium to Establish a Registry for Alzheimer's Disease total score (β = -3.23 score/sec-1, P = .003) in participants with AD independent of longitudinal changes in brain volume. Conclusion Iron concentration in the deep gray matter and neocortical regions was higher in patients with Alzheimer disease than in healthy control participants. Change in iron levels over time in the temporal lobe was associated with cognitive decline in individuals with Alzheimer disease. © RSNA, 2020 Online supplemental material is available for this article.\n\nDamulina, Anna\n\nEnzinger, Christian\n\nHofer, Edith\n\nLangkammer, Christian\n\nPirpamer, Lukas\n\nRopele, Stefan\n\nSackl, Maximilian\n\nSchmidt, Reinhold\n\nSöllradl, Martin\n\nTinauer, Christian Gerhard\n\n\n"
},
{
"text": "\n184272\nThe dramatic COVID 19 outbreak in Italy is responsible of a huge drop of urological surgical activity: a multicenter observational study.\n\nRocco, B\n\nSighinolfi, MC\n\nSandri, M\n\nAltieri, V\n\nAmenta, M\n\nAnnino, F\n\nAntonelli, A\n\nBaio, R\n\nBertolo, R\n\nBocciardi, A\n\nBorghesi, M\n\nBove, P\n\nBozzini, G\n\nBrunocilla, E\n\nCacciamani, G\n\nCalori, A\n\nCafarelli, A\n\nCelia, A\n\nCarbone, A\n\nCocci, A\n\nCorsaro, A\n\nCosta, G\n\nCeruti, C\n\nCindolo, L\n\nCrivellaro, S\n\nDalpiaz, O\n\nD'Agostino, D\n\nDall'Oglio, B\n\nDente, D\n\nFalabella, R\n\nFalsaperla, M\n\nFerrari, G\n\nFinocchiaro, M\n\nFlammia, S\n\nGaboardi, F\n\nGalfano, A\n\nGallo, F\n\nGatti, L\n\nGreco, F\n\nKhorrami, S\n\nLeonardo, C\n\nMarenghi, C\n\nNucciotti, R\n\nOderda, M\n\nPagliarulo, V\n\nParma, P\n\nPastore, AL\n\nPini, G\n\nPorreca, A\n\nPucci, L\n\nSchenone, M\n\nSchiavina, R\n\nSciorio, C\n\nSpirito, L\n\nTafuri, A\n\nTerrone, C\n\nUmari, P\n\nVarca, V\n\nVeneziano, D\n\nVerze, P\n\nVolpe, A\n\nMicali, S\n\nBerti, L\n\nZaramella, S\n\nZegna, L\n\nBertellini, E\n\nMinervini, A\n\nBeiträge in Fachzeitschriften\nISI:000579184800001\n32558053.0\n10.1111/bju.15149\nPMC7322984\nTo describe the trend in surgical volume in urology in Italy during the coronavirus disease 2019 (COVID-19) outbreak, as a result of the abrupt reorganisation of the Italian national health system to augment care provision to symptomatic patients with COVID-19.\n A total of 33 urological units with physicians affiliated to the AGILE consortium (Italian Group for Advanced Laparo-Endoscopic Surgery; www.agilegroup.it) were surveyed. Urologists were asked to report the amount of surgical elective procedures week-by-week, from the beginning of the emergency to the following month.\n The 33 hospitals involved in the study account overall for 22 945 beds and are distributed in 13/20 Italian regions. Before the outbreak, the involved urology units performed overall 1213 procedures/week, half of which were oncological. A month later, the number of surgeries had declined by 78%. Lombardy, the first region with positive COVID-19 cases, experienced a 94% reduction. The decrease in oncological and non-oncological surgical activity was 35.9% and 89%, respectively. The trend of the decline showed a delay of roughly 2 weeks for the other regions.\n Italy, a country with a high fatality rate from COVID-19, experienced a sudden decline in surgical activity. This decline was inversely related to the increase in COVID-19 care, with potential harm particularly in the oncological field. The Italian experience may be helpful for future surgical pre-planning in other countries not so drastically affected by the disease to date.\n © 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.\n\nDalpiaz, Orietta\n\n\n"
}
]
}