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5. The South Asian monsoon—pollution pump and purifier

Author

Lelieveld, J., Bourtsoukidis, E., Brühl, C., Fischer, H., Fuchs, H., Harder, H., Hofzumahaus, A., Holland, F., Marno, D., Neumaier, M., Pozzer, A., Schlager, H., Williams, J., Zahn, A., and Ziereis, H.

Published
2018

6. 5-AZACYTIDINE IN COMBINATION WITH A NOVEL PAN-LYSYL OXIDASE INHIBITOR SYNERGISTICALLY RESTORES ERYTHROPOIESIS IN MYELODYSPLASTIC MALIGNANCIES

Author

Xu, Q., primary, Streuer, A., additional, Jann, J.-C., additional, Altrock, E., additional, Schmitt, N., additional, Flach, J., additional, Sens-Albert, C., additional, Rapp, F., additional, Wolf, J., additional, Nowak, V., additional, Weimer, N., additional, Obländer, J., additional, Palme, I., additional, Kuzina, M., additional, Jawhar, A., additional, Darwich, A., additional, Weis, C.-A., additional, Marx, A., additional, Wuchter, P., additional, Costina, V., additional, Jaeger, E., additional, Sperk, E., additional, Neumaier, M., additional, Fabarius, A., additional, Metzgeroth, G., additional, Nolte, F., additional, Steiner, L., additional, Levkin, P., additional, Jawhar, M., additional, Hofmann, W.-K., additional, Riabov, V., additional, and Nowak, D., additional

Published
2023
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7. ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.

Author

Vanstapel, F.J.L.A., Orth, M., Streichert, T., Capoluongo, E.D., Oosterhuis, W.P., Çubukçu, H.C., Bernabeu-Andreu, F.A., Thelen, M.H.M., Jacobs, L.H.J., Linko, S., Bhattoa, H.P., Bossuyt, P.M., Meško Brguljan, P., Boursier, G., Cobbaert, C.M., Neumaier, M., Vanstapel, F.J.L.A., Orth, M., Streichert, T., Capoluongo, E.D., Oosterhuis, W.P., Çubukçu, H.C., Bernabeu-Andreu, F.A., Thelen, M.H.M., Jacobs, L.H.J., Linko, S., Bhattoa, H.P., Bossuyt, P.M., Meško Brguljan, P., Boursier, G., Cobbaert, C.M., and Neumaier, M.

Abstract

Item does not contain fulltext, The EU In-Vitro Diagnostic Device Regulation (IVDR) aims for transparent risk-and purpose-based validation of diagnostic devices, traceability of results to uniquely identified devices, and post-market surveillance. The IVDR regulates design, manufacture and putting into use of devices, but not medical services using these devices. In the absence of suitable commercial devices, the laboratory can resort to laboratory-developed tests (LDT) for in-house use. Documentary obligations (IVDR Art 5.5), the performance and safety specifications of ANNEX I, and development and manufacture under an ISO 15189-equivalent quality system apply. LDTs serve specific clinical needs, often for low volume niche applications, or correspond to the translational phase of new tests and treatments, often extremely relevant for patient care. As some commercial tests may disappear with the IVDR roll-out, many will require urgent LDT replacement. The workload will also depend on which modifications to commercial tests turns them into an LDT, and on how national legislators and competent authorities (CA) will handle new competences and responsibilities. We discuss appropriate interpretation of ISO 15189 to cover IVDR requirements. Selected cases illustrate LDT implementation covering medical needs with commensurate management of risk emanating from intended use and/or design of devices. Unintended collateral damage of the IVDR comprises loss of non-profitable niche applications, increases of costs and wasted resources, and migration of innovative research to more cost-efficient environments. Taking into account local specifics, the legislative framework should reduce the burden on and associated opportunity costs for the health care system, by making diligent use of existing frameworks.

Published
2023

11. Integrated Workflow for Natural H2 Exploration

Author

Rigollet, C., primary, Ars, J., additional, Dupuy, J., additional, Fabre, G., additional, Ferran, J., additional, Kremer, T., additional, Lefeuvre, N., additional, Neumaier, M., additional, Prinzhofer, A., additional, Thomas, E., additional, and Voisin, C., additional

Published
2023
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12. O12 - 5-AZACYTIDINE IN COMBINATION WITH A NOVEL PAN-LYSYL OXIDASE INHIBITOR SYNERGISTICALLY RESTORES ERYTHROPOIESIS IN MYELODYSPLASTIC MALIGNANCIES

Author

Xu, Q., Streuer, A., Jann, J.-C., Altrock, E., Schmitt, N., Flach, J., Sens-Albert, C., Rapp, F., Wolf, J., Nowak, V., Weimer, N., Obländer, J., Palme, I., Kuzina, M., Jawhar, A., Darwich, A., Weis, C.-A., Marx, A., Wuchter, P., Costina, V., Jaeger, E., Sperk, E., Neumaier, M., Fabarius, A., Metzgeroth, G., Nolte, F., Steiner, L., Levkin, P., Jawhar, M., Hofmann, W.-K., Riabov, V., and Nowak, D.

Published
2023
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17. Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta-analysis, and modelling study

Author

Lee, K.K., Doudesis, D., Anwar, M., Astengo, F., Chenevier-Gobeaux, C., Claessens, Y.E., Wussler, D., Kozhuharov, N., Strebel, I., Sabti, Z., deFilippi, C., Seliger, S., Moe, G., Fernando, C., Bayes-Genis, A., Kimmenade, R.R.J. van, Pinto, Yigal, Gaggin, H.K., Wiemer, J.C., Möckel, M., Rutten, J.H.W., Meiracker, A.H. van den, Gargani, L., Pugliese, N.R., Pemberton, C., Ibrahim, I., Gegenhuber, A., Mueller, T., Neumaier, M., Behnes, M., Akin, I., Bombelli, M., Grassi, G., Nazerian, P., Albano, G., Bahrmann, P., Newby, D.E., Japp, A.G., Tsanas, A., Shah, A.S.V., Richards, A.M.S., McMurray, J.J., Mueller, C., Januzzi, J.L., Jr., Mills, N.L., Lee, K.K., Doudesis, D., Anwar, M., Astengo, F., Chenevier-Gobeaux, C., Claessens, Y.E., Wussler, D., Kozhuharov, N., Strebel, I., Sabti, Z., deFilippi, C., Seliger, S., Moe, G., Fernando, C., Bayes-Genis, A., Kimmenade, R.R.J. van, Pinto, Yigal, Gaggin, H.K., Wiemer, J.C., Möckel, M., Rutten, J.H.W., Meiracker, A.H. van den, Gargani, L., Pugliese, N.R., Pemberton, C., Ibrahim, I., Gegenhuber, A., Mueller, T., Neumaier, M., Behnes, M., Akin, I., Bombelli, M., Grassi, G., Nazerian, P., Albano, G., Bahrmann, P., Newby, D.E., Japp, A.G., Tsanas, A., Shah, A.S.V., Richards, A.M.S., McMurray, J.J., Mueller, C., Januzzi, J.L., Jr., and Mills, N.L.

Abstract

Item does not contain fulltext, OBJECTIVES: To evaluate the diagnostic performance of N-terminal pro-B-type natriuretic peptide (NT-proBNP) thresholds for acute heart failure and to develop and validate a decision support tool that combines NT-proBNP concentrations with clinical characteristics. DESIGN: Individual patient level data meta-analysis and modelling study. SETTING: Fourteen studies from 13 countries, including randomised controlled trials and prospective observational studies. PARTICIPANTS: Individual patient level data for 10 369 patients with suspected acute heart failure were pooled for the meta-analysis to evaluate NT-proBNP thresholds. A decision support tool (Collaboration for the Diagnosis and Evaluation of Heart Failure (CoDE-HF)) that combines NT-proBNP with clinical variables to report the probability of acute heart failure for an individual patient was developed and validated. MAIN OUTCOME MEASURE: Adjudicated diagnosis of acute heart failure. RESULTS: Overall, 43.9% (4549/10 369) of patients had an adjudicated diagnosis of acute heart failure (73.3% (2286/3119) and 29.0% (1802/6208) in those with and without previous heart failure, respectively). The negative predictive value of the guideline recommended rule-out threshold of 300 pg/mL was 94.6% (95% confidence interval 91.9% to 96.4%); despite use of age specific rule-in thresholds, the positive predictive value varied at 61.0% (55.3% to 66.4%), 73.5% (62.3% to 82.3%), and 80.2% (70.9% to 87.1%), in patients aged <50 years, 50-75 years, and >75 years, respectively. Performance varied in most subgroups, particularly patients with obesity, renal impairment, or previous heart failure. CoDE-HF was well calibrated, with excellent discrimination in patients with and without previous heart failure (area under the receiver operator curve 0.846 (0.830 to 0.862) and 0.925 (0.919 to 0.932) and Brier scores of 0.130 and 0.099, respectively). In patients without previous heart failure, the diagnostic performance was consistent across al

Published
2022

18. Development and validation of a decision support tool for the diagnosis of acute heart failure: Systematic review, meta-analysis, and modelling study

Author

Lee, K, Doudesis, D, Anwar, M, Astengo, F, Chenevier-Gobeaux, C, Claessens, Y, Wussler, D, Kozhuharov, N, Strebel, I, Sabti, Z, Defilippi, C, Seliger, S, Moe, G, Fernando, C, Bayes-Genis, A, van Kimmenade, R, Pinto, Y, Gaggin, H, Wiemer, J, Möckel, M, Rutten, J, van den Meiracker, A, Gargani, L, Pugliese, N, Pemberton, C, Ibrahim, I, Gegenhuber, A, Mueller, T, Neumaier, M, Behnes, M, Akin, I, Bombelli, M, Grassi, G, Nazerian, P, Albano, G, Bahrmann, P, Newby, D, Japp, A, Tsanas, A, Shah, A, Richards, A, Mcmurray, J, Mueller, C, Januzzi, J, Mills, N, Lee, Kuan Ken, Doudesis, Dimitrios, Anwar, Mohamed, Astengo, Federica, Chenevier-Gobeaux, Camille, Claessens, Yann-Erick, Wussler, Desiree, Kozhuharov, Nikola, Strebel, Ivo, Sabti, Zaid, deFilippi, Christopher, Seliger, Stephen, Moe, Gordon, Fernando, Carlos, Bayes-Genis, Antoni, van Kimmenade, Roland R J, Pinto, Yigal, Gaggin, Hanna K, Wiemer, Jan C, Möckel, Martin, Rutten, Joost H W, van den Meiracker, Anton H, Gargani, Luna, Pugliese, Nicola R, Pemberton, Christopher, Ibrahim, Irwani, Gegenhuber, Alfons, Mueller, Thomas, Neumaier, Michael, Behnes, Michael, Akin, Ibrahim, Bombelli, Michele, Grassi, Guido, Nazerian, Peiman, Albano, Giovanni, Bahrmann, Philipp, Newby, David E, Japp, Alan G, Tsanas, Athanasios, Shah, Anoop S V, Richards, A Mark, McMurray, John J V, Mueller, Christian, Januzzi, James L, Mills, Nicholas L, Lee, K, Doudesis, D, Anwar, M, Astengo, F, Chenevier-Gobeaux, C, Claessens, Y, Wussler, D, Kozhuharov, N, Strebel, I, Sabti, Z, Defilippi, C, Seliger, S, Moe, G, Fernando, C, Bayes-Genis, A, van Kimmenade, R, Pinto, Y, Gaggin, H, Wiemer, J, Möckel, M, Rutten, J, van den Meiracker, A, Gargani, L, Pugliese, N, Pemberton, C, Ibrahim, I, Gegenhuber, A, Mueller, T, Neumaier, M, Behnes, M, Akin, I, Bombelli, M, Grassi, G, Nazerian, P, Albano, G, Bahrmann, P, Newby, D, Japp, A, Tsanas, A, Shah, A, Richards, A, Mcmurray, J, Mueller, C, Januzzi, J, Mills, N, Lee, Kuan Ken, Doudesis, Dimitrios, Anwar, Mohamed, Astengo, Federica, Chenevier-Gobeaux, Camille, Claessens, Yann-Erick, Wussler, Desiree, Kozhuharov, Nikola, Strebel, Ivo, Sabti, Zaid, deFilippi, Christopher, Seliger, Stephen, Moe, Gordon, Fernando, Carlos, Bayes-Genis, Antoni, van Kimmenade, Roland R J, Pinto, Yigal, Gaggin, Hanna K, Wiemer, Jan C, Möckel, Martin, Rutten, Joost H W, van den Meiracker, Anton H, Gargani, Luna, Pugliese, Nicola R, Pemberton, Christopher, Ibrahim, Irwani, Gegenhuber, Alfons, Mueller, Thomas, Neumaier, Michael, Behnes, Michael, Akin, Ibrahim, Bombelli, Michele, Grassi, Guido, Nazerian, Peiman, Albano, Giovanni, Bahrmann, Philipp, Newby, David E, Japp, Alan G, Tsanas, Athanasios, Shah, Anoop S V, Richards, A Mark, McMurray, John J V, Mueller, Christian, Januzzi, James L, and Mills, Nicholas L

Abstract

Objectives: To evaluate the diagnostic performance of N-terminal pro-B-type natriuretic peptide (NT-proBNP) thresholds for acute heart failure and to develop and validate a decision support tool that combines NT-proBNP concentrations with clinical characteristics. Design: Individual patient level data meta-analysis and modelling study. Setting: Fourteen studies from 13 countries, including randomised controlled trials and prospective observational studies. Participants: Individual patient level data for 10 369 patients with suspected acute heart failure were pooled for the meta-analysis to evaluate NT-proBNP thresholds. A decision support tool (Collaboration for the Diagnosis and Evaluation of Heart Failure (CoDE-HF)) that combines NT-proBNP with clinical variables to report the probability of acute heart failure for an individual patient was developed and validated. Main outcome measure: Adjudicated diagnosis of acute heart failure. Results: Overall, 43.9% (4549/10 369) of patients had an adjudicated diagnosis of acute heart failure (73.3% (2286/3119) and 29.0% (1802/6208) in those with and without previous heart failure, respectively). The negative predictive value of the guideline recommended rule-out threshold of 300 pg/mL was 94.6% (95% confidence interval 91.9% to 96.4%); despite use of age specific rule-in thresholds, the positive predictive value varied at 61.0% (55.3% to 66.4%), 73.5% (62.3% to 82.3%), and 80.2% (70.9% to 87.1%), in patients aged [removed]75 years, respectively. Performance varied in most subgroups, particularly patients with obesity, renal impairment, or previous heart failure. CoDE-HF was well calibrated, with excellent discrimination in patients with and without previous heart failure (area under the receiver operator curve 0.846 (0.830 to 0.862) and 0.925 (0.919 to 0.932) and Brier scores of 0.130 and 0.099, respectively). In patients without previous heart failure, the diagnostic performance was consistent across all subgroups

Published
2022

20. Development and validation of a decision support tool for the diagnosis of acute heart failure: systematic review, meta- analysis, and modelling study

Author

Lee, KK, Doudesis, D, Anwar, M, Astengo, F, Chenevier-Gobeaux, C, Claessens, YE, Wussler, D, Kozhuharov, N, Strebel, I, Sabti, Z, deFilippi, C, Seliger, S, Moe, G, Fernando, C, Bayes-Genis, A, van Kimmenade, RRJ, Pinto, Y, Gaggin, HK, Wiemer, JC, Mockel, M, Rutten, JHW, van den Meiracker, AH, Gargani, L, Pugliese, NR, Pemberton, C, Ibrahim, I, Gegenhuber, A, Mueller, T, Neumaier, M, Behnes, M, Akin, I, Bombelli, M, Grassi, G, Nazerian, P, Albano, G, Bahrmann, P, Newby, DE, Japp, AG, Tsanas, A, Shah, ASV, Richards, AM, McMurray, JJV, Mueller, C, Januzzi, JL, and Mills, NL

Abstract

OBJECTIVES To evaluate the diagnostic performance of N-terminal pro-B-type natriuretic peptide (NT-proBNP) thresholds for acute heart failure and to develop and validate a decision support tool that combines NT-proBNP concentrations with clinical characteristics. DESIGN Individual patient level data meta-analysis and modelling study. SETTING Fourteen studies from 13 countries, including randomised controlled trials and prospective observational studies. PARTICIPANTS Individual patient level data for 10 369 patients with suspected acute heart failure were pooled for the meta-analysis to evaluate NT-proBNP thresholds. A decision support tool (Collaboration for the Diagnosis and Evaluation of Heart Failure (CoDE-HF)) that combines NT-proBNP with clinical variables to report the probability of acute heart failure for an individual patient was developed and validated. MAIN OUTCOME MEASURE Adjudicated diagnosis of acute heart failure. RESULTS Overall, 43.9% (4549/10 369) of patients had an adjudicated diagnosis of acute heart failure (73.3% (2286/3119) and 29.0% (1802/6208) in those with and without previous heart failure, respectively). The negative predictive value of the guideline recommended rule-out threshold of 300 pg/mL was 94.6% (95% confidence interval 91.9% to 96.4%); despite use of age specific rule-in thresholds, the positive predictive value varied at 61.0% (55.3% to 66.4%), 73.5% (62.3% to 82.3%), and 80.2% (70.9% to 87.1%), in patients aged 75 years, respectively. Performance varied in most subgroups, particularly patients with obesity, renal impairment, or previous heart failure. CoDE-HF was well calibrated, with excellent discrimination in patients with and without previous heart failure (area under the receiver operator curve 0.846 (0.830 to 0.862) and 0.925 (0.919 to 0.932) and Brier scores of 0.130 and 0.099, respectively). In patients without previous heart failure, the diagnostic performance was consistent across all subgroups, with 40.3% (2502/6208) identified at low probability (negative predictive value of 98.6%, 97.8% to 99.1%) and 28.0% (1737/6208) at high probability (positive predictive value of 75.0%, 65.7% to 82.5%) of having acute heart failure. CONCLUSIONS In an international, collaborative evaluation of the diagnostic performance of NT-proBNP, guideline recommended thresholds to diagnose acute heart failure varied substantially in important patient subgroups. The CoDE-HF decision support tool incorporating NT-proBNP as a continuous measure and other clinical variables provides a more consistent, accurate, and individualised approach. STUDY REGISTRATION PROSPERO CRD42019159407.

Published
2022

29. Verbesserung des Outcomes bei proximaler Fermurfraktur im Alter durch Immunonutrition

Author

Neumaier, M, Vester, H, and Nüssler, A

Subjects
Immunonutrition, ddc: 610, Medicine and health, Alterstraumatologie, Mangelernährung
Abstract

Fragestellung: Bei proximalen Femurfrakturen im Alter zeigt sich weiterhin - trotz moderner Implantate und OP-Techniken - eine hohe Morbidität und Mortalität. Dies ist v.a. bedingt durch die meist vorhandnen Co-Morbiditäten und den schlechten Allgemeinzustand der älteren Patienten. [zum vollständigen Text gelangen Sie über die oben angegebene URL]

Published
2021
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37. Rheuma-VOR: Nutzung und Validierung des PEST- und EARP-Fragebogen in der Frühdiagnostik der Psoriasis Arthritis

Author

Neumaier, M, Dreher, M, Wegner, J, Staubach-Renz, P, and Schwarting, A

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Einleitung: Die Psoriasis Arthritis (PsA) ist eine autoimmun-inflammatorische Erkrankung mit chronischem, schubweise auftretendem und gelenkdestruierendem Verlauf. Dementsprechend sind eine frühzeitige Diagnose und eine zügige Therapieeinleitung relevant [ref:1]. Obwohl in Deutschland[zum vollständigen Text gelangen Sie über die oben angegebene URL], Deutscher Rheumatologiekongress 2020, 48. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 34. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh)

Published
2020
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38. Kollagen-Abbauprodukte als serologische Marker für strukturelle Instabilität von intrakraniellen Aneurysmen

Author

Hackenberg, K, Richter, P, Abdulazim, A, Böhme, J, Neumaier, M, Neumaier-Probst, E, Alzghloul, MM, Groden, C, and Etminan, N

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Objective: The estimation of the individual rupture risk of intracranial aneurysms (IA) remains challenging. Structural integrity of IA is predominantly determined by collagen type I, the main molecular constituent in IA. A hallmark of IA pathogenesis is ongoing collagen remodelling in the IA wall and[for full text, please go to the a.m. URL], 71. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), 9. Joint Meeting mit der Japanischen Gesellschaft für Neurochirurgie

Published
2020
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39. Direct comparison study between droplet digital PCR and a combination of allele-specific PCR, asymmetric rapid PCR and melting curve analysis for the detection of BRAF V600E mutation in plasma from melanoma patients

Author

Tzanikoua, E. Haselmanna, V. Markou, A. Duda, A. Utikal, J. Neumaier, M. Lianidou, E.S.

Abstract

Background: In metastatic melanoma, 40%-50% of patients harbor a BRAF V600E mutation and are thereby eligible to receive a combined BRAF/MEK inhibitor therapy. Compared to standard-of-care tissue-based genetic testing, analysis of circulating tumor DNA (ctDNA) from blood enables a comprehensive assessment of tumor mutational status in real-time and can be used for monitoring response to therapy. The aim of our study was to directly compare the performance of two highly sensitive methodologies, droplet digital PCR (ddPCR) and a combination of ARMS/asymmetric-rapid PCR/melting curve analysis, for the detection of BRAF V600E in plasma from melanoma patients. Methods: Cell-free DNA (cfDNA) was isolated from 120 plasma samples of stage I to IV melanoma patients. Identical plasma-cfDNA samples were subjected to BRAF V600E mutational analysis using in parallel, ddPCR and the combination of ARMS/asymmetric-rapid PCR/melting curve analysis. Results: BRAF V600E mutation was detected in 9/117 (7.7%) ctDNA samples by ddPCR and in 22/117 (18.8%) ctDNA samples by the combination of ARMS/asymmetricrapid PCR/melting curve analysis. The concordance between these two methodologies was 85.5% (100/117). The comparison of plasma-ctDNA analysis using ddPCR and tissue testing revealed an overall agreement of 79.4% (27/34), while the corresponding agreement using the combination of ARMS/asymmetric-rapid PCR/melting curve analysis was 73.5% (25/34). Moreover, comparing the detection of BRAF-mutant ctDNA with the clinics, overall agreement of 87.2% (48/55) for ddPCR and 79.2% (42/53) was demonstrated. Remarkably, the duration of sample storage was negatively correlated with correctness of genotyping results highlighting the importance of preanalytical factors. Conclusions: Our direct comparison study has shown a high level of concordance between ddPCR and the combination of ARMS/asymmetric-rapid PCR/melting curve analysis for the detection of BRAF V600E mutations in plasma. © 2020 De Gruyter. All rights reserved.

Published
2020

46. Makrophagen exprimieren variable Immunrezeptoren und sind bei der Arteriosklerose von Bedeutung

Author

Puellmann, K., primary, Fuchs, T., additional, Kzhyshkowska, J., additional, Gratchev, A., additional, Emmert, A., additional, Fleig, J., additional, Oniga, S., additional, Laird, R., additional, Wessels, J.T., additional, Heida, N.M., additional, Schäfer, K., additional, Becker, H., additional, Ganser, A., additional, Neumaier, M., additional, Kaminski, W.E., additional, and Beham, A.W., additional

Published
2010
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49. Preanalytical challenges — time for solutions (In Russ.)

Author

Lippi, G., primary, Betsou, F., additional, Cadamuro, J., additional, Cornes, M., additional, Fleischhacker, M., additional, Fruekilde, P., additional, Neumaier, M., additional, Nybo, M., additional, Padoan, A., additional, Plebani, M., additional, Sciacovelli, L., additional, Vermeersch, P., additional, von Meyer, A., additional, and Simunic, A-M., additional

Published
2020
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