176 research outputs found

    Klimaschutz im Quartier

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    KLIMASCHUTZ IM QUARTIER Klimaschutz im Quartier / Uong, David (Rights reserved) ( -

    Septic rupture of the ascending aorta after aortocoronary bypass surgery

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    We describe an exceptional case of non-fatal septic rupture of the ascending aorta in a patient with sternal dehiscence, deep sternal wound infection (DSWI) and pleural empyema after aortocoronary bypass surgery. Routine follow-up computed tomography (CT) detected a mediastinal pseudoaneurysm originating from the ascending aorta. Thereby, massive and irregular sternal bone defects and contrast-enhancing mediastinal soft tissue suggest osteomyelitis and highly-active and aggressive DSWI as initial triggers. Urgent thoracotomy 1 day later included ascending aorta reconstruction, total sternum resection and broad wound debridement. Follow-up CT 1 year later showed a regular postoperative result in a fully recovered patient

    Pharmacodynamic approach for proving equivalence of two ophtalmic solutions containing Brimonidine Tartarate 0.2% in healthy volunteers

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    Introduction: Bromonidine tartarate ophthalmic solution (CAS registry-number: 70359- 46-5) is a relatively selective alpha-2 adrenergic agonist, indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Aim: The purpose of the present phase-1 clinical trial was to assess the pharmacodynamic equivalence of two ophtalmic solutions containing brimonidine tartarate 0,2% in healthy volunteers. Methods: The study was performed as a single center, randomized, single-dose, observer-blinded, single period trial in 36 healthy volunteers. Each volunteer received successively and in a random way a single dose of 1 drop of the test or the reference product in the conjunctival sac of the right and left eye, respectively. Measurement of intraocular pressure (IOP) of both eyes was performed at screening examination, pre-dose and 2 hours post dosing and at final examination by means of a Goldmann applanation tonometer. The primary target parameter for proving pharmacodynamic equivalence was defined as the absolute decrease in IOP 2 hours post dose. The 95% confidence interval was calculated for the difference (test-reference) of the primary target parameter and compared with the predefined equivalence range of ±1.5 mmHg. Results: A decrease in the IOP of 4.60±1.26 mmHg and 4.40±0.89 mmHg was observed after administration of the test and reference formulation, respectively. The mean difference was +0.197 mmHg with a 95% confidence interval between -0.275 and 0.670 mmHg and thus entirely within the predefined equivalence range. Both products showed a very good local safety profile and similar tolerability. Conclusion: Brimonidine Tartrate Ophthalmic Solution 0.2% was pharmacodynamically equivalent to the reference preparation (Alphagan®) with respect both to efficacy and safety

    Expertise – Förderung von Lesekompetenz

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    Die in vielen Facetten unbefriedigenden Ergebnisse zur Lesekompetenz von Jugendlichen in Deutschland stellen den Ausgangspunkt für die vorliegende Expertise zum Thema „Förderung von Lesekompetenz“ dar, die vom Bundesministerium für Bildung und Forschung in Auftrag gegeben wurde. Das Ziel der Expertise gilt dem Nachweis, welche Möglichkeiten der Förderung von Lesekompetenz existieren, die die umfangreichen Länderaktivitäten der Förderung sinnvoll ergänzen. (DIPF/Orig.

    Plio-Pleistocene trends in ice rafted debris on the Lomonosov Ridge

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    Although more than 700 sediment cores exist from the Arctic Ocean, the Plio-Pleistocene evolution of the basin and its marginal seas remains virtually unknown. This is largely due the shallow penetration of most of these records, and difficulties associated with deriving chronologies for the recovered material. The Integrated Ocean Drilling Program’s (IODP) Expedition 302 (Arctic Coring Expedition, ACEX) recovered 197 m of Neogene/Quaternary sediment from the circumpolar regions of the Lomonosov Ridge. As detailed analyses of this material emerge, research is beginning to formulate a long-term picture of paleoceanographic changes in the central Arctic Ocean. This paper reviews the ACEX Plio-Pleistocene age model, identifies uncertainties, and addresses ways in which these may be eliminated. Within the established stratigraphic framework, a notable reduction in the abundance of ice rafted debris (IRD) occurs in the early part of the Pleistocene and persists until Marine Isotope Stage 6 (MIS 6). Therefore, while global oceanographic proxies indicate the gradual growth of terrestrial ice-sheets during this time, IRD delivery to the central Arctic Ocean remained comparatively low and stable. Within the resolution of existing data, the Pleistocene reduction in IRD is synchronous with predicted changes in both the inflow of North Atlantic and Pacific waters, which in modern times are known to exert a strong influence on sea ice stability

    A randomized, phase III trial of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in first-line treatment of metastatic colorectal cancer: The AIO KRK 0110 Trial/ML22011 Trial

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    <p>Abstract</p> <p>Background</p> <p>Several randomized trials have indicated that combination chemotherapy applied in metastatic colorectal cancer (mCRC) does not significantly improve overall survival when compared to the sequential use of cytotoxic agents (CAIRO, MRC Focus, FFCD 2000-05). The present study investigates the question whether this statement holds true also for bevacizumab-based first-line treatment including escalation- and de-escalation strategies.</p> <p>Methods/Design</p> <p>The AIO KRK 0110/ML22011 trial is a two-arm, multicenter, open-label randomized phase III trial comparing the efficacy and safety of capecitabine plus bevacizumab (Cape-Bev) versus capecitabine plus irinotecan plus bevacizumab (CAPIRI-Bev) in the first-line treatment of metastatic colorectal cancer. Patients with unresectable metastatic colorectal cancer, Eastern Cooperative Oncology Group (ECOG) performance status 0-1, will be assigned in a 1:1 ratio to receive either capecitabine 1250 mg/m<sup>2 </sup>bid for 14d (d1-14) plus bevacizumab 7.5 mg/kg (d1) q3w (Arm A) or capecitabine 800 mg/m<sup>2 </sup>BID for 14d (d1-14), irinotecan 200 mg/m<sup>2 </sup>(d1) and bevacizumab 7.5 mg/kg (d1) q3w (Arm B). Patients included into this trial are required to consent to the analysis of tumour tissue and blood for translational investigations. In Arm A, treatment escalation from Cape-Bev to CAPIRI-Bev is recommended in case of progressive disease (PD). In Arm B, de-escalation from CAPIRI-Bev to Cape-Bev is possible after 6 months of treatment or in case of irinotecan-associated toxicity. Re-escalation to CAPIRI-Bev after PD is possible. The primary endpoint is time to failure of strategy (TFS). Secondary endpoints are overall response rate (ORR), overall survival, progression-free survival, safety and quality of life.</p> <p>Conclusion</p> <p>The AIO KRK 0110 trial is designed for patients with disseminated, but asymptomatic mCRC who are not potential candidates for surgical resection of metastasis. Two bevacizumab-based strategies are compared: one starting as single-agent chemotherapy (Cape-Bev) allowing escalation to CAPIRI-Bev and another starting with combination chemotherapy (CAPIRI-Bev) and allowing de-escalation to Cape-Bev and subsequent re-escalation if necessary.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier <a href="http://www.clinicaltrials.gov/ct2/show/NCT01249638">NCT01249638</a></p> <p>EudraCT-No.: 2009-013099-38</p

    DNA methylation-based classification of sinonasal tumors

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    The diagnosis of sinonasal tumors is challenging due to a heterogeneous spectrum of various differential diagnoses as well as poorly defined, disputed entities such as sinonasal undifferentiated carcinomas (SNUCs). In this study, we apply a machine learning algorithm based on DNA methylation patterns to classify sinonasal tumors with clinical-grade reliability. We further show that sinonasal tumors with SNUC morphology are not as undifferentiated as their current terminology suggests but rather reassigned to four distinct molecular classes defined by epigenetic, mutational and proteomic profiles. This includes two classes with neuroendocrine differentiation, characterized by IDH2 or SMARCA4/ARID1A mutations with an overall favorable clinical course, one class composed of highly aggressive SMARCB1-deficient carcinomas and another class with tumors that represent potentially previously misclassified adenoid cystic carcinomas. Our findings can aid in improving the diagnostic classification of sinonasal tumors and could help to change the current perception of SNUCs

    Recommendations for enterovirus diagnostics and characterisation within and beyond Europe.

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    Enteroviruses (EV) can cause severe neurological and respiratory infections, and occasionally lead to devastating outbreaks as previously demonstrated with EV-A71 and EV-D68 in Europe. However, these infections are still often underdiagnosed and EV typing data is not currently collected at European level. In order to improve EV diagnostics, collate data on severe EV infections and monitor the circulation of EV types, we have established European non-polio enterovirus network (ENPEN). First task of this cross-border network has been to ensure prompt and adequate diagnosis of these infections in Europe, and hence we present recommendations for non-polio EV detection and typing based on the consensus view of this multidisciplinary team including experts from over 20 European countries. We recommend that respiratory and stool samples in addition to cerebrospinal fluid (CSF) and blood samples are submitted for EV testing from patients with suspected neurological infections. This is vital since viruses like EV-D68 are rarely detectable in CSF or stool samples. Furthermore, reverse transcriptase PCR (RT-PCR) targeting the 5'noncoding regions (5'NCR) should be used for diagnosis of EVs due to their sensitivity, specificity and short turnaround time. Sequencing of the VP1 capsid protein gene is recommended for EV typing; EV typing cannot be based on the 5'NCR sequences due to frequent recombination events and should not rely on virus isolation. Effective and standardized laboratory diagnostics and characterisation of circulating virus strains are the first step towards effective and continuous surveillance activities, which in turn will be used to provide better estimation on EV disease burden
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