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Background: Simultaneous pancreas kidney transplantation (SPK), pancreas transplantation alone (PTA) or pancreas transplantation after kidney (PAK) are the only curative treatment options for patients with type 1 (juvenile) diabetes mellitus with or without impaired renal function. Unfortunately, transplant waiting lists for this indication are increasing because the current organ acceptability criteria are restrictive; morbidity and mortality significantly increase with time on the waitlist. Currently, only pancreas organs from donors younger than 50 years of age and with a body mass index (BMI) less than 30 are allocated for transplantation in the Eurotransplant (ET) area. To address this issue we designed a study to increase the available donor pool for these patients.
Methods/Design: This study is a prospective, multicenter (20 German centers), single blinded, non-randomized, two armed trial comparing outcome after SPK, PTA or PAK between organs with the currently allowed donor criteria versus selected organs from donors with extended criteria. Extended donor criteria are defined as organs procured from donors with a BMI of 30 to 34 or a donor age between 50 and 60 years. Immunosuppression is generally standardized using induction therapy with Myfortic, tacrolimus and low dose steroids. In principle, all patients on the waitlist for primary SPK, PTA or PAK are eligible for the clinical trial when they consent to possibly receiving an extended donor criteria organ. Patients receiving an organ meeting the current standard criteria for pancreas allocation (control arm) are compared to those receiving extended criteria organ (study arm); patients are blinded for a follow-up period of one year. The combined primary endpoint is survival of the pancreas allograft and pancreas allograft function after three months, as an early relevant outcome parameter for pancreas transplantation.
Discussion: The EXPAND Study has been initiated to investigate the hypothesis that locally allocated extended criteria organs can be transplanted with similar results compared to the currently allowed standard ET organ allocation. If our study shows a favorable comparison to standard organ allocation criteria, the morbidity and mortality for patients waiting for transplantation could be reduced in the future.
Trial registered at: NCT01384006
Background: 15-20% of all patients initially diagnosed with colorectal cancer develop metastatic disease and surgical resection remains the only potentially curative treatment available. Current 5-year survival following R0-resection of liver metastases is 28-39%, but recurrence eventually occurs in up to 70%. To date, adjuvant chemotherapy has not improved clinical outcomes significantly. The primary objective of the ongoing LICC trial (L-BLP25 In Colorectal Cancer) is to determine whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer patients following R0/R1 resection of hepatic metastases. L-BLP25 targets MUC1 glycoprotein, which is highly expressed in hepatic metastases from colorectal cancer. In a phase IIB trial, L-BLP25 has shown acceptable tolerability and a trend towards longer survival in patients with stage IIIB locoregional NSCLC.
Methods: This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 patients from 20 centers in 3 countries. Patients with stage IV colorectal adenocarcinoma limited to liver metastases are included. Following curative-intent complete resection of the primary tumor and of all synchronous/metachronous metastases, eligible patients are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with s.c. L-BLP25 930 mug once weekly for 8 weeks, followed by s.c. L-BLP25 930 mug maintenance doses at 6-week (years 1&2) and 12-week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint is the comparison of recurrence-free survival (RFS) time between groups. Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. The primary endpoint will be assessed in Q3 2016. Follow-up will end Q3 2017. Interim analyses are not planned.
Discussion: The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrence-free and overall survival rates of groups in an unbiased fashion. Trial Registration EudraCT Number 2011-000218-20
Mit Hilfe von lnsektizidbenebelungen wurden die Spinnengemeinschaften von Eichen in Bayern (Deutschland) gesammelt und mit Gemeinschaften verglichen, in denen Formica polyctena-Ameisen numerisch dominierten. Von den mit Ameisen belaufenen Baumen wurden signifikant mehr Spinnen gesammelt und das Verhältnis von Adulten zu Juvenilen war zu den Juvenilen hin verschoben. Die Spinnengemeinschaften zeigten deutliche Unterschiede auf dem Niveau der Familien- und Artenzusammensetzung. Insbesondere wurden bei Anwesenheit von Ameisen mehr Clubioniden, Salticiden, Araneiden und Linyphiiden gesammelt. Dagegen wurden weniger Theridiiden (insbesondere Enoplognatha ovata) und Anyphaeniden auf den „Ameisenbäumen“ gefunden. Innerhalb der abundanz- und artenmäßig dominanten Linyphiiden wurde Linyphia triangularis in sehr viel höherer Anzahl aus den Bäumen mit Ameisen gesammelt.
Evaluierung des Gesetzes über die Anerkennung ausländischer
Berufsqualifikationen des Landes Berlin
(2019)
The canopy spiders of the floodplain forest in Leipzig have become a focus of ecological studies in recent years. In 2006 we sampled 30 tree canopies in the ‘Burgaue’ nature reserve with pyrethrum knock-down fogging, recording 502 adult spiders belonging to 48 species and 11 families. Based on these data and the results of a previous fogging study, the studied spider community was dominated by forest and forest-edge species with a preference for the shrub and canopy strata as well as by spiders of the web spider feeding guild. The community structure was typical for arboreal spider communities from northern temperate forests but very different from communities in the tropics. Species richness and evenness were similar to the old growth near-primary Białowieża Forest in Poland. The checklist of 96 canopy spider species of the floodplain forest of Leipzig includes 54 additions to the spider fauna of Leipzig and vicinity by recent canopy studies and eight first canopy records for Leipzig from our field work. The theridiid Dipoena torva (Thorell, 1875) was recorded for the first time in Saxony. The floodplain forest of Leipzig sustains a large and species-rich arboreal spider community and is thus a valuable habitat for a large proportion of endangered species (12%).