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1. Viral contamination in biologic manufacture and implications for emerging therapies

Author

Barone, Paul W., Wiebe, Michael E., Leung, James C., Hussein, Islam T. M., Keumurian, Flora J., Bouressa, James, Brussel, Audrey, Chen, Dayue, Chong, Ming, Dehghani, Houman, Gerentes, Lionel, Gilbert, James, Gold, Dan, Kiss, Robert, Kreil, Thomas R., Labatut, René, Li, Yuling, Müllberg, Jürgen, Mallet, Laurent, Menzel, Christian, Moody, Mark, Monpoeho, Serge, Murphy, Marie, Plavsic, Mark, Roth, Nathan J., Roush, David, Ruffing, Michael, Schicho, Richard, Snyder, Richard, Stark, Daniel, Zhang, Chun, Wolfrum, Jacqueline, Sinskey, Anthony J., and Springs, Stacy L.

Published
2020
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2. IORT with electrons as boost strategy during breast conserving therapy in limited stage breast cancer: Long term results of an ISIORT pooled analysis

Author

Fastner, Gerd, Sedlmayer, Felix, Merz, Florian, Deutschmann, Heinrich, Reitsamer, Roland, Menzel, Christian, Stierle, Christoph, Farmini, Armando, Fischer, Torsten, Ciabattoni, Antonella, Mirri, Alessandra, Hager, Eva, Reinartz, Gabriele, Lemanski, Claire, Orecchia, Roberto, and Valentini, Vincenzo

Published
2013
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3. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial

Author

Gnant, Michael, Mlineritsch, Brigitte, Stoeger, Herbert, Luschin-Ebengreuth, Gero, Heck, Dietmar, Menzel, Christian, Jakesz, Raimund, Seifert, Michael, Hubalek, Michael, Pristauz, Gunda, Bauernhofer, Thomas, Eidtmann, Holger, Eiermann, Wolfgang, Steger, Guenther, Kwasny, Werner, Dubsky, Peter, Hochreiner, Gerhard, Forsthuber, Ernst-Pius, Fesl, Christian, and Greil, Richard

Published
2011
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5. Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 5-year follow-up of the ABCSG-12 bone-mineral density substudy

Author

Gnant, Michael, Mlineritsch, Brigitte, Luschin-Ebengreuth, Gero, Kainberger, Franz, Kässmann, Helmut, Piswanger-Sölkner, Jutta Claudia, Seifert, Michael, Ploner, Ferdinand, Menzel, Christian, Dubsky, Peter, Fitzal, Florian, Bjelic-Radisic, Vesna, Steger, Günther, Greil, Richard, Marth, Christian, Kubista, Ernst, Samonigg, Hellmut, Wohlmuth, Peter, Mittlböck, Martina, and Jakesz, Raimund

Published
2008
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7. Endocrine therapy plus zoledronic acid in premenopausal breast cancer

Author

Gnant, Michael, Mlineritsch, Brigitte, Schippinger, Walter, Luschin-Ebengreuth,Gero, Postlberger, Sabine, Menzel, Christian, Jakesz, Raimund, Seifert, Michael, Hubalek, Michael, Bjelic-Radisic, Vesna, Samonigg, Hellmut, Tausch, Christoph, Eidtmann, Holger, Steger, Gunther, Kwasny, Werner, Dubsky, Peter, Fridrik, Michael, Fitzal, Florian, Stierer, Michael, Rucklinger, Ernst, and Greil, Richard

Subjects
Breast cancer -- Care and treatment, Function tests (Medicine) -- Health aspects, Zoledronic acid -- Usage, Zoledronic acid -- Health aspects
Abstract

A study was conducted to evaluate the efficacy of addition of zoledronic acid to regular endocrine therapy in the treatment of premenopausal breast cancer. Results indicated that addition of zoledronic acid improved disease-free survival in such women.

Published
2009

8. Exemestane as primary systemic treatment for hormone receptor positive post-menopausal breast cancer patients: a phase II trial of the Austrian Breast and Colorectal Cancer Study Group (ABCSG-17)

Author

Mlineritsch, Brigitte, Tausch, Christoph, Singer, Christian, Luschin-Ebengreuth, Gero, Jakesz, Raimund, Ploner, Ferdinand, Stierer, Michael, Melbinger, Elisabeth, Menzel, Christian, Urbania, Andrea, Fridrik, Michael, Steger, Günther, Wohlmuth, Peter, Gnant, Michael, Greil, Richard, and on behalf of the Austrian Breast, Colorectal Cancer Study Group (ABCSG)

Published
2008
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10. Klinische Performance eines neuen SARS-CoV-2-Antigen-Tests in der Notaufnahme eines Maximalversorgers

Author

Paul, Gregor, Plecko, Thomas, Sethi, Shneh, Schilling, Tobias, Wienand, Oliver, Jürgensen, Jan Steffen, and Menzel, Christian Ulrich

Subjects
Diagnostik, Antigentest, SARS-CoV-2, Spezifität, ddc:610, 610 Medizin und Gesundheit, Sensitivität
Abstract

Ein Baustein zur Eindämmung der COVID-19-Pandemie ist die Verfügbarkeit von Tests mit hoher Sensitivität und Spezifität zur Detektion von SARS-CoV-2, insbesondere um Infizierte in vulnerablen Einrichtungen, z. B. Krankenhäusern und Pflegeeinrichtungen, zeitnah identifizieren und isolieren zu können. Dies betrifft alle Personengruppen dieser Einrichtungen, also Patient*innen/Bewohner*innen, Besucher*innen als auch Personal. Bisheriger Goldstandard für den Nachweis einer SARS-CoV-2-Infektion ist die RT-PCR. SARS-CoV-2-Antigen-Tests sind aufgrund ihres Point-of-Care-Ansatzes, der einfachen Handhabung und des günstigeren Preises eine wertvolle Ergänzung zur RT-PCR-Diagnostik. Sie erkennen mit ausreichender Sicherheit SARS-CoV-2-Infektionen bei symptomatischen Patient*innen und in Proben mit niedrigen Ct-Werten in der RT-PCR. Als Einzeltestung bei asymptomatischen Patient*innen ist ihre Wertigkeit dagegen deutlich eingeschränkt. Hier sollten repetitive Antigen-Testungen oder primär PCR-basierte Verfahren zur Anwendung kommen.

Published
2020

11. Nutzung von Routinedaten aus Notaufnahmen: Beschreibung zweier Häufungen von Notaufnahmevorstellungen in Wolfsburg und Stuttgart während der COVID-19-Pandemie

Author

Schranz, Madlen, Greiner, Felix, Kocher, Theresa, Grabenhenrich, Linus, Majeed, Raphael W., Erdmann, Bernadett, Menzel, Christian Ulrich, Schilling, Tobias, and Boender, T. Sonia

Subjects
Notaufnahme, Routinedaten, Surveillance, COVID-19-Pandemie, Corona Ambulanz, ddc:610, 610 Medizin und Gesundheit
Abstract

Nutzung von Routinedaten aus Notaufnahmen: Beschreibung zweier Häufungen von Notaufnahmevorstellungen in Wolfsburg und Stuttgart während der COVID-19-Pandemie Während des ab Mitte März 2020 zu beobachtenden Rückgangs der täglichen Notaufnahmevorstellungen von bis zu 40 %, waren in den Notaufnahmen Wolfsburg und Stuttgart zwei deutliche kurzzeitige Anstiege der absoluten Notaufnahmevorstellungen zu beobachten. Wie im Epidemiologischen Bulletin 27/2020 berichtet, stellte sich heraus, dass in beiden Fällen der Anstieg der Fallzahlen auf strukturelle Änderungen in den Notaufnahmen im Rahmen der COVID-19-Pandemie zurückzuführen war.

Published
2020

12. Viral contamination in biologic manufacture and implications for emerging therapies

Author

Massachusetts Institute of Technology. Center for Biomedical Innovation, Barone, Paul, Wiebe, Michael E, Leung, James, Hussein, Islam, Keumurian, Flora J., Bouressa, James, Brussel, Audrey, Chen, Dayue, Chong, Ming, Dehghani, Houman, Gerentes, Lionel, Gilbert, James, Gold, Dan, Kiss, Robert, Kreil, Thomas R., Labatut, René, Li, Yuling, Müllberg, Jürgen, Mallet, Laurent, Menzel, Christian, Moody, Mark, Monpoeho, Serge, Murphy, Marie, Plavsic, Mark, Roth, Nathan J., Roush, David, Ruffing, Michael, Schicho, Richard, Snyder, Richard, Stark, Daniel, Zhang, Chun, Wolfrum, Jacqueline M, Sinskey, Anthony J, Springs, Stacy, Massachusetts Institute of Technology. Center for Biomedical Innovation, Barone, Paul, Wiebe, Michael E, Leung, James, Hussein, Islam, Keumurian, Flora J., Bouressa, James, Brussel, Audrey, Chen, Dayue, Chong, Ming, Dehghani, Houman, Gerentes, Lionel, Gilbert, James, Gold, Dan, Kiss, Robert, Kreil, Thomas R., Labatut, René, Li, Yuling, Müllberg, Jürgen, Mallet, Laurent, Menzel, Christian, Moody, Mark, Monpoeho, Serge, Murphy, Marie, Plavsic, Mark, Roth, Nathan J., Roush, David, Ruffing, Michael, Schicho, Richard, Snyder, Richard, Stark, Daniel, Zhang, Chun, Wolfrum, Jacqueline M, Sinskey, Anthony J, and Springs, Stacy

Abstract

Recombinant protein therapeutics, vaccines, and plasma products have a long record of safety. However, the use of cell culture to produce recombinant proteins is still susceptible to contamination with viruses. These contaminations cost millions of dollars to recover from, can lead to patients not receiving therapies, and are very rare, which makes learning from past events difficult. A consortium of biotech companies, together with the Massachusetts Institute of Technology, has convened to collect data on these events. This industry-wide study provides insights into the most common viral contaminants, the source of those contaminants, the cell lines affected, corrective actions, as well as the impact of such events. These results have implications for the safe and effective production of not just current products, but also emerging cell and gene therapies which have shown much therapeutic promise.

Published
2021

15. Pressure-based lift estimation and its application to feedforward load control employing trailing-edge flaps

Author

Bartholomay, Sirko, primary, Wester, Tom T. B., additional, Perez-Becker, Sebastian, additional, Konze, Simon, additional, Menzel, Christian, additional, Hölling, Michael, additional, Spickenheuer, Axel, additional, Peinke, Joachim, additional, Nayeri, Christian N., additional, Paschereit, Christian Oliver, additional, and Oberleithner, Kilian, additional

Published
2021
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19. Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial

Author

Jakesz, Raimund, Jonat, Walter, Gnant, Michael, Mittlboeck, Martina, Greil, Richard, Tausch, Christoph, Hilfrich, Joern, Kwasny, Werner, Menzel, Christian, Samonigg, Hellmut, Seifert, Michael, Gademann, Guenther, and Kaufmann, Manfred

Subjects
Tamoxifen -- Complications and side effects, Postmenopausal women -- Drug therapy, Breast cancer -- Drug therapy, Breast cancer -- Risk factors
Published
2005

24. Pressure Based Lift Estimation and its Application to Feedforward Load Control employing Trailing Edge Flaps

Author

Bartholomay, Sirko, primary, Wester, Tom T. B., additional, Perez-Becker, Sebastian, additional, Konze, Simon, additional, Menzel, Christian, additional, Hölling, Michael, additional, Spickenheuer, Axel, additional, Peinke, Joachim, additional, Nayeri, Christian N., additional, Paschereit, Oliver P., additional, and Oberleithner, Kilian, additional

Published
2020
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41. Randomized Trial of Tamoxifen Versus Tamoxifen Plus Aminoglutethimide as Adjuvant Treatment in Postmenopausal Breast Cancer Patients With Hormone Receptor-Positive Disease: Austrian Breast and Colorectal Cancer Study Group Trial 6

Author

Schmid, Marianne, Jakesz, Raimund, Samonigg, Hellmut, Kubista, Ernst, Gnant, Michael, Menzel, Christian, Seifert, Michael, Haider, Karin, Taucher, Susanne, Mlineritsch, Brigitte, Steindorfer, Peter, Kwasny, Werner, Stierer, Michael, Tausch, Christoph, Fridrik, Michael, Wette, Viktor, Steger, Günther, and Hausmaninger, Hubert

Published
2003

43. Randomized Adjuvant Trial of Tamoxifen and Goserelin Versus Cyclophosphamide, Methotrexate, and Fluorouracil: Evidence for the Superiority of Treatment With Endocrine Blockade in Premenopausal Patients With Hormone-Responsive Breast Cancer—Austrian Breast and Colorectal Cancer Study Group Trial 5

Author

Jakesz, Raimund, Hausmaninger, Hubert, Kubista, Ernst, Gnant, Michael, Menzel, Christian, Bauernhofer, Thomas, Seifert, Michael, Haider, Karin, Mlineritsch, Brigitte, Steindorfer, Peter, Kwasny, Werner, Fridrik, Michael, Steger, Guenther, Wette, Viktor, and Samonigg, Hellmut

Published
2002

48. 5G New Radio for Terrestrial Broadcast: A Forward-Looking Approach for NR-MBMS

Author

Universitat Politècnica de València. Instituto Universitario de Telecomunicación y Aplicaciones Multimedia - Institut Universitari de Telecomunicacions i Aplicacions Multimèdia, Universitat Politècnica de València. Departamento de Comunicaciones - Departament de Comunicacions, Gimenez, Jordi Joan, Carcel, Jose Luis, Fuentes, Manuel, Garro, Eduardo, Elliott, Simon, Vargas, David, Menzel, Christian, Gomez-Barquero, David, Universitat Politècnica de València. Instituto Universitario de Telecomunicación y Aplicaciones Multimedia - Institut Universitari de Telecomunicacions i Aplicacions Multimèdia, Universitat Politècnica de València. Departamento de Comunicaciones - Departament de Comunicacions, Gimenez, Jordi Joan, Carcel, Jose Luis, Fuentes, Manuel, Garro, Eduardo, Elliott, Simon, Vargas, David, Menzel, Christian, and Gomez-Barquero, David

Abstract

"© 2019 IEEE. Personal use of this material is permitted. Permissíon from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertisíng or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works.", [EN] 3GPP LTE eMBMS release (Rel-) 14, also referred to as further evolved multimedia broadcast multicast service (FeMBMS) or enhanced TV (EnTV), is the first mobile broadband technology standard to incorporate a transmission mode designed to deliver terrestrial broadcast services from conventional high power high tower (HPHT) broadcast infrastructure. With respect to the physical layer, the main improvements in FeMBMS are the support of larger inter-site distance for single frequency networks (SFNs) and the ability to allocate 100% of a carrier's resources to the broadcast payload, with self-contained signaling in the downlink. From the system architecture perspective, a receive-only mode enables free-to-air (FTA) reception with no need for an uplink or SIM card, thus receiving content without user equipment registration with a network. These functionalities are only available in the LTE advanced pro specifications as 5G new radio (NR), standardized in 3GPP from Rel-15, has so far focused entirely on unicast. This paper outlines a physical layer design for NR-MBMS, a system derived, with minor modifications, from the 5G-NR specifications, and suitable for the transmission of linear TV and radio services in either single-cell or SFN operation. This paper evaluates the NR-MBMS proposition and compares it to LTE-based FeMBMS in terms of flexibility, performance, capacity, and coverage.

Published
2019

49. Single chain Fab (scFab) fragment

Author

Brenneis Mariam, Mohr Anja, Voedisch Bernd, Menzel Christian, Jostock Thomas, Hust Michael, Kirsch Martina I, Meier Doris, and Dübel Stefan

Subjects
Biotechnology, TP248.13-248.65
Abstract

Abstract Background The connection of the variable part of the heavy chain (VH) and and the variable part of the light chain (VL) by a peptide linker to form a consecutive polypeptide chain (single chain antibody, scFv) was a breakthrough for the functional production of antibody fragments in Escherichia coli. Being double the size of fragment variable (Fv) fragments and requiring assembly of two independent polypeptide chains, functional Fab fragments are usually produced with significantly lower yields in E. coli. An antibody design combining stability and assay compatibility of the fragment antigen binding (Fab) with high level bacterial expression of single chain Fv fragments would be desirable. The desired antibody fragment should be both suitable for expression as soluble antibody in E. coli and antibody phage display. Results Here, we demonstrate that the introduction of a polypeptide linker between the fragment difficult (Fd) and the light chain (LC), resulting in the formation of a single chain Fab fragment (scFab), can lead to improved production of functional molecules. We tested the impact of various linker designs and modifications of the constant regions on both phage display efficiency and the yield of soluble antibody fragments. A scFab variant without cysteins (scFabΔC) connecting the constant part 1 of the heavy chain (CH1) and the constant part of the light chain (CL) were best suited for phage display and production of soluble antibody fragments. Beside the expression system E. coli, the new antibody format was also expressed in Pichia pastoris. Monovalent and divalent fragments (DiFabodies) as well as multimers were characterised. Conclusion A new antibody design offers the generation of bivalent Fab derivates for antibody phage display and production of soluble antibody fragments. This antibody format is of particular value for high throughput proteome binder generation projects, due to the avidity effect and the possible use of common standard sera for detection.

Published
2007
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50. (123I)IBZM SPECT for imaging of striatal D2 dopamine receptors in 56 schizophrenic patients taking various neuroleptics

Author

Klemm, Edzard, Grunwald, Frank, Kasper, Siegfried, Menzel, Christian, Broich, Karl, Danos, Peter, Reichmann, Karl, Krappel, Christian, Rieker, Olaf, Briele, Bernd, Hotze, Andreas L., Moller, Hans-Jurgen, and Biersack, Hans-Jurgen

Subjects
SPECT imaging -- Usage, Dopamine receptors -- Research, Schizophrenics -- Research, Antipsychotic drugs -- Evaluation, Health, Psychology and mental health
Abstract

Objective: The purpose of this study was to compare the binding of various typical and atypical neuroleptics to striatal [D.sub.2] dopamine receptors in schizophrenic patients. Method: Fifty-six inpatients with schizophrenia, including 14 with schizoaffective disorder and one with schizophreniform disorder, were evaluated. Fourteen patients were neuroleptic free. Single photon emission computed tomography (SPECT) was performed 90 minutes after intravenous injection of [123I]benzamide ([123I]IBZM). Subsequent semiquantitative analysis of [D.sub.2] receptor binding was done with the use of the basal ganglia (striatum)/frontal cortex (BG/FC) ratio of activity. Clinical symptoms were rated with the Positive and Negative Syndrome Scale and the Hamilton Depression Rating Scale. Results: The BG/FC ratios in patients taking typical neuroleptics were significantly lower than those in the neuroleptic-free subjects but not lower than those in the patients taking atypical neuroleptics (clozapine, remoxipride). For atypical antipsychotics, a dose-dependent relationship with striatal [D.sub.2] receptor binding could not be demonstrated. BG/FC ratios were not significantly correlated with clinical symptoms or with duration of illness. Conclusions: The results indicate that [123I]IBZM SPECT is useful for semiquantitative imaging of striatal [D.sub.2] dopamine receptors and for estimating their blockade by neuroleptics. Thus, it may improve drug monitoring in psychiatric patients. Furthermore, the findings suggest a complex relationship between the antipsychotic effect of atypical neuroleptics and [D.sub.2] receptor blockade.

Published
1996

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