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Article ; Online: Challenges and issues of SARS-CoV-2 pool testing.

Eberhardt, Jens N / Breuckmann, Nikolas P / Eberhardt, Christiane S

2020 Volume 20, Issue 11, Page(s) 1233–1234

MeSH term(s)	Betacoronavirus ; COVID-19 ; Coronavirus Infections ; Humans ; Pandemics ; Pneumonia, Viral ; SARS Virus ; SARS-CoV-2
Keywords	covid19
Language	English
Publishing date	2020-07-14
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(20)30467-9
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Article: Challenges and issues of SARS-CoV-2 pool testing

Eberhardt, Jens N / Breuckmann, Nikolas P / Eberhardt, Christiane S

Lancet Infect Dis

Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #641828
Database	COVID19

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Article ; Online: Challenges and issues of SARS-CoV-2 pool testing

Eberhardt, Jens N / Breuckmann, Nikolas P / Eberhardt, Christiane S

The Lancet Infectious Diseases

2020 Volume 20, Issue 11, Page(s) 1233–1234

Keywords	Infectious Diseases ; covid19
Language	English
Publisher	Elsevier BV
Publishing country	us
Document type	Article ; Online
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/s1473-3099(20)30467-9
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Article ; Online: Challenges and issues of SARS-CoV-2 pool testing

Eberhardt, Jens N / Breuckmann, Nikolas P / Eberhardt, Christiane Sigrid

ISSN: 1473-3099 ; The Lancet Infectious Diseases, Vol. 20, No

2020 Volume 11, Issue pp. 1233-1234

Keywords	info:eu-repo/classification/ddc/616.07 ; info:eu-repo/classification/ddc/618 ; covid19
Language	English
Publishing country	ch
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Rationale and design of the prevention of paclitaxel-related neurological side effects with lithium trial - Protocol of a multicenter, randomized, double-blind, placebo- controlled proof-of-concept phase-2 clinical trial.

Huehnchen, Petra / Bangemann, Nikola / Lischewski, Sandra / Märschenz, Stefanie / Paul, Friedemann / Schmitz-Hübsch, Tanja / Blohmer, Jens-Uwe / Eberhardt, Cornelia / Rauch, Geraldine / Flöel, Agnes / Adam, Sophie / Schwenkenbecher, Philipp / Meinhold-Heerlein, Ivo / Hoffmann, Oliver / Ziemssen, Tjalf / Endres, Matthias / Boehmerle, Wolfgang

Frontiers in medicine

2022 Volume 9, Page(s) 967964

Abstract: Introduction: Chemotherapy-induced polyneuropathy (CIPN) and post-chemotherapy cognitive impairment (PCCI) are frequent side effects of paclitaxel treatment. CIPN/PCCI are potentially irreversible, reduce quality of life and often lead to treatment ... ...

Abstract	Introduction: Chemotherapy-induced polyneuropathy (CIPN) and post-chemotherapy cognitive impairment (PCCI) are frequent side effects of paclitaxel treatment. CIPN/PCCI are potentially irreversible, reduce quality of life and often lead to treatment limitations, which affect patients' outcome. We previously demonstrated that paclitaxel enhances an interaction of the Neuronal calcium sensor-1 protein (NCS-1) with the Inositol-1,4,5-trisphosphate receptor (InsP Methods and analysis: The PREPARE study will be conducted as a multicenter, randomized, double-blind, placebo-controlled phase-2 trial with parallel group design. Ethics and dissemination: The study protocol was approved by the Berlin ethics committee (reference: 21/232 - IV E 10) and the respective federal agency (Bundesinstitut für Arzneimittel und Medizinprodukte, reference: 61-3910-4044771). The results of the study will be published in peer-reviewed medical journals as well as presented at relevant (inter)national conferences. Clinical trial registration: [https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00027165], identifier [DRKS00027165].
Language	English
Publishing date	2022-08-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.967964
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Article ; Online: Neoadjuvant and adjuvant end-points in health technology assessment in oncology.

Harbeck, Nadia / Schneeweiss, Andreas / Thuss-Patience, Peter / Miller, Kurt / Garbe, Claus / Griesinger, Frank / Eberhardt, Wilfried E E / Klussmann, Jens P / Wollenberg, Barbara / Grimm, Marc-Oliver / Zander, Thomas / Lüftner, Diana

European journal of cancer (Oxford, England : 1990)

2021 Volume 147, Page(s) 40–50

Abstract: Health technology assessment (HTA) of clinical and economic value of a new intervention is an integral step in providing the access of patients to innovative cancer care and treatment. Overall survival (OS) is the preferred criterion for demonstrating ... ...

Abstract	Health technology assessment (HTA) of clinical and economic value of a new intervention is an integral step in providing the access of patients to innovative cancer care and treatment. Overall survival (OS) is the preferred criterion for demonstrating the therapeutic efficacy in HTA given its direct clinical and patient relevance. However, with often long life expectancy of patients with early cancer, analysis of OS becomes less practical. Partially due to this reason, pathological complete response (pCR) and time-to-event end-points like disease-free survival are frequently incorporated into the pivotal clinical trials in the neoadjuvant and adjuvant settings. However, there exists a discrepancy between different national HTA bodies regarding the acknowledgement of patient relevance of these end-points. In this article, we analysed the perspectives of patients on different aspects of end-points used in clinical trials in early cancer. Gathered evidence strongly suggests that complete tumour eradication and reduced risk of recurrence provide important psychological benefits thus signifying that pCR and time-to-event end-points are directly relevant to patients. Additionally, we reviewed opinions on patient relevance of neoadjuvant and adjuvant therapy end-points adopted by HTA bodies during the recent evaluations. We found that improvements in end-points used in the adjuvant setting were commonly considered as valuable to patients. In contrast, opinions on patient relevance of neoadjuvant therapy end-points varied between the national HTA bodies. Universal acknowledgement of patient relevance of therapeutic end-points for early cancer by HTA bodies is necessary to balance the inequality in uptake of innovative therapies into national healthcare systems.
MeSH term(s)	Chemotherapy, Adjuvant ; Clinical Trials, Phase III as Topic ; Disease Progression ; Disease-Free Survival ; Endpoint Determination ; Humans ; Neoadjuvant Therapy/adverse effects ; Neoadjuvant Therapy/mortality ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Neoplasms/mortality ; Neoplasms/pathology ; Neoplasms/psychology ; Neoplasms/therapy ; Patient Preference ; Patients/psychology ; Progression-Free Survival ; Quality of Life ; Radiotherapy, Adjuvant ; Research Design ; Technology Assessment, Biomedical ; Time Factors
Language	English
Publishing date	2021-02-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2021.01.006
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Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 583: Show issues

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Article ; Online: Checkpoint Inhibitor Monotherapy in Potentially Trial-Eligible or Trial-Ineligible Patients With Metastatic NSCLC in the German Prospective CRISP Registry Real-World Cohort (AIO-TRK-0315).

Griesinger, Frank / Sebastian, Martin / Brueckl, Wolfgang M / Hummel, Horst-Dieter / Jaeschke, Bastian / Kern, Jens / Wesseler, Claas / Jänicke, Martina / Fleitz, Annette / Zacharias, Stefan / Hipper, Annette / Groth, Annika / Weichert, Wilko / Dörfel, Steffen / Petersen, Volker / Schröder, Jan / Wilke, Jochen / Eberhardt, Wilfried E E / Thomas, Michael

JTO clinical and research reports

2023 Volume 5, Issue 4, Page(s) 100626

Abstract: ... eligible" patients (n = 403, 54.0%): median progression-free survival: 6.2 (95% confidence interval [CI]: 5 ...

Abstract	Introduction: Patients with metastatic NSCLC (mNSCLC) treated with immune checkpoint inhibitors in clinical practice may often not meet the strict inclusion criteria of clinical trials. Our aim was to assess the trial eligibility of patients with mNSCLC treated with pembrolizumab monotherapy in real-world and to compare the outcome of "trial-ineligible" and "potentially trial-eligible" patients. Methods: Data from the prospective, clinical research platform CRISP were used to compare patient characteristics, treatment, and outcome of patients with programmed cell death-ligand 1 tumor proportion score greater than or equal to 50% tumors treated with pembrolizumab monotherapy who are deemed either "potentially trial-eligible" or "trial-ineligible" according to inclusion and exclusion criteria of the registrational studies (KEYNOTE-024 and -042). Results: Of 746 patients included, 343 patients (46.0%) were classified as "trial-ineligible" and had significantly worse outcomes compared with "potentially trial-eligible" patients (n = 403, 54.0%): median progression-free survival: 6.2 (95% confidence interval [CI]: 5.2-8.4) versus 10.3 (95% CI: 8.4-13.8) months, hazard ratio (trial-ineligible versus potentially trial-eligible) of 1.43 (95% CI: 1.19-1.72), Conclusions: Our data reveal that a considerable proportion of patients with mNSCLC are not eligible to participate in a clinical trial and were found to have worse outcomes than potentially trial-eligible patients, whose outcomes were comparable with those obtained from pivotal clinical trials. This is of substantial clinical relevance for physicians discussing outcomes to be expected with their patients and stresses the need for real-world effectiveness analyses.
Language	English
Publishing date	2023-12-25
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2023.100626
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Article ; Online: Monitoring of Anti-Hepatitis E Virus Antibody Seroconversion in Asymptomatically Infected Blood Donors: Systematic Comparison of Nine Commercial Anti-HEV IgM and IgG Assays.

Vollmer, Tanja / Diekmann, Juergen / Eberhardt, Matthias / Knabbe, Cornelius / Dreier, Jens

Viruses

2016 Volume 8, Issue 8

Abstract: ... their analytical and diagnostic sensitivities, with anti-HEV IgM assays (n = 5) being more divergent compared ... to anti-HEV IgG (n = 4) assays in this study. Considerable variations were observed particularly ...

Abstract	Diagnosis of hepatitis E virus (HEV) is usually determined serologically by detection of the presence of immunoglobulin (Ig)M antibodies or rising anti-HEV IgG titers. However, serological assays have demonstrated a significant variation in their sensitivities and specificities. In this study, we present the systematic comparison of different immunological anti-HEV assays using complete seroconversion panels of 10 virologically confirmed HEV genotype 3 infected individuals. Assay sensitivities were further evaluated by testing serially diluted World Health Organization (WHO) reference reagent for hepatitis E virus antibody and one patient sample infected with HEV genotype 3. Anti-HEV IgM and IgG antibody presence was determined using the immunological assays Wantai HEV IgM/IgG enzyme-linked immunosorbent assay (ELISA) (Sanbio, Uden, The Netherlands), recomWell HEV IgM/IgG (Mikrogen, Neuried, Germany), HEV IgM ELISA 3.0, HEV ELISA, HEV ELISA 4.0, Assure HEV IgM Rapid Test (all MP Biomedicals Europe, Illkirch Cedex, France) and Anti-HEV ELISA (IgM/IgG, Euroimmun, Lübeck, Germany). The assays showed differences regarding their analytical and diagnostic sensitivities, with anti-HEV IgM assays (n = 5) being more divergent compared to anti-HEV IgG (n = 4) assays in this study. Considerable variations were observed particularly for the detection period of IgM antibodies. This is the first study systematically characterizing serologic assays on the basis of seroconversion panels, providing sample conformity for a conclusive comparison. Future studies should include the assay comparison covering the four different genotypes.
MeSH term(s)	Antibodies, Viral/blood ; Blood Donors ; Hepatitis E/diagnosis ; Hepatitis E virus/immunology ; Humans ; Immunoassay/methods ; Immunoglobulin G/blood ; Immunoglobulin M/blood ; Sensitivity and Specificity ; Seroconversion
Chemical Substances	Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M
Language	English
Publishing date	2016-08-22
Publishing country	Switzerland
Document type	Comparative Study ; Evaluation Studies ; Journal Article
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v8080232
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Article ; Online: Prävention, Diagnostik, Therapie und Nachsorge des Lungenkarzinoms.

Schütte, Wolfgang / Gütz, Sylvia / Nehls, Wiebke / Blum, Torsten Gerriet / Brückl, Wolfgang / Buttmann-Schweiger, Nina / Büttner, Reinhard / Christopoulos, Petros / Delis, Sandra / Deppermann, Karl M / Dickgreber, Nikolas / Eberhardt, Wilfried / Eggeling, Stephan / Fleckenstein, Jochen / Flentje, Michael / Frost, Nikolaj / Griesinger, Frank / Grohé, Christian / Gröschel, Andreas /

Guckenberger, Matthias / Hecker, Erich / Hoffmann, Hans / Huber, Rudolf M / Junker, Klaus / Kauczor, Hans-Ulrich / Kollmeier, Jens / Kraywinkel, Klaus / Krüger, Marcus / Kugler, Christian / Möller, Miriam / Nestle, Ursula / Passlick, Bernward / Pfannschmidt, Joachim / Reck, Martin / Reinmuth, Niels / Rübe, Christian / Scheubel, Robert / Schumann, Christian / Sebastian, Martin / Serke, Monika / Stoelben, Erich / Stuschke, Martin / Thomas, Michael / Tufman, Amanda / Vordermark, Dirk / Waller, Cornelius / Wolf, Jürgen / Wolf, Martin / Wormanns, Dag

Pneumologie (Stuttgart, Germany)

2023 Volume 77, Issue 10, Page(s) 671–813

Abstract: The current S3 Lung Cancer Guidelines are edited with fundamental changes to the previous edition based on the dynamic influx of information to this field:The recommendations include de novo a mandatory case presentation for all patients with lung cancer ...

Title translation	Prevention, Diagnosis, Therapy, and Follow-up of Lung Cancer - Interdisciplinary Guideline of the German Respiratory Society and the German Cancer Society - Abridged Version.
Abstract	The current S3 Lung Cancer Guidelines are edited with fundamental changes to the previous edition based on the dynamic influx of information to this field:The recommendations include de novo a mandatory case presentation for all patients with lung cancer in a multidisciplinary tumor board before initiation of treatment, furthermore CT-Screening for asymptomatic patients at risk (after federal approval), recommendations for incidental lung nodule management , molecular testing of all NSCLC independent of subtypes, EGFR-mutations in resectable early stage lung cancer in relapsed or recurrent disease, adjuvant TKI-therapy in the presence of common EGFR-mutations, adjuvant consolidation treatment with checkpoint inhibitors in resected lung cancer with PD-L1 ≥ 50%, obligatory evaluation of PD-L1-status, consolidation treatment with checkpoint inhibition after radiochemotherapy in patients with PD-L1-pos. tumor, adjuvant consolidation treatment with checkpoint inhibition in patients withPD-L1 ≥ 50% stage IIIA and treatment options in PD-L1 ≥ 50% tumors independent of PD-L1status and targeted therapy and treatment option immune chemotherapy in first line SCLC patients.Based on the current dynamic status of information in this field and the turnaround time required to implement new options, a transformation to a "living guideline" was proposed.
MeSH term(s)	Humans ; Lung Neoplasms/diagnosis ; Lung Neoplasms/prevention & control ; B7-H1 Antigen/genetics ; B7-H1 Antigen/therapeutic use ; Follow-Up Studies ; ErbB Receptors/genetics ; Carcinoma, Non-Small-Cell Lung/pathology
Chemical Substances	B7-H1 Antigen ; ErbB Receptors (EC 2.7.10.1)
Language	German
Publishing date	2023-10-26
Publishing country	Germany
Document type	English Abstract ; Journal Article
ZDB-ID	607630-0
ISSN	1438-8790 ; 0934-8387
ISSN (online)	1438-8790
ISSN	0934-8387
DOI	10.1055/a-2029-0134
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Uh II Zs.142: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
Zs.MO 54: Show issues

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Article ; Online: Improving putrescine production by Corynebacterium glutamicum by fine-tuning ornithine transcarbamoylase activity using a plasmid addiction system.

Schneider, Jens / Eberhardt, Dorit / Wendisch, Volker F

Applied microbiology and biotechnology

2012 Volume 95, Issue 1, Page(s) 169–178

Abstract: ... of the key enzyme N-acetylglutamate kinase (ArgB) by L-arginine, a plasmid addiction system for low-level ...

Abstract	Corynebacterium glutamicum shows a great potential for the production of the polyamide monomer putrescine (1,4-diaminobutane). Previously, we constructed the putrescine-producing strain PUT1 by deletion of argF, the gene for ornithine transcarbamoylase (OTC), and argR, encoding the L-arginine repressor, combined with heterologous expression of the Escherichia coli gene for L-ornithine decarboxylase SpeC. As a consequence of argF deletion, this strain requires supplementation of L-arginine and shows growth-decoupled putrescine production. To avoid costly supplementation with L-arginine and the strong feedback inhibition of the key enzyme N-acetylglutamate kinase (ArgB) by L-arginine, a plasmid addiction system for low-level argF expression was developed. By fine-tuning argF expression through modifications of the promoter, the translational start codon and/or the ribosome binding site, high productivity and titer could be obtained. OTC activity varied almost thousandfold between 960 and 1 mU mg⁻¹ resulting in putrescine yields on glucose from less than 0.001 up to 0.26 g g⁻¹, the highest yield in bacteria reported to date. The most promising strain, designated PUT21, was characterized comprehensively. PUT21 strain grew with a rate of 0.19 h⁻¹ in mineral salt medium without the need for L-arginine supplementation and produced putrescine with a yield of 0.16 g g⁻¹ glucose at a volumetric productivity of 0.57 g L⁻¹ h⁻¹ and a specific productivity of 0.042 g g⁻¹ h⁻¹. The carbon balance suggested that no major unidentified by-product was produced. Compared to the first-generation strain PUT1, the putrescine yield observed with PUT21 was increased by 60%. In fed-batch cultivation with C. glutamicum PUT21, a putrescine titer of 19 g L⁻¹ at a volumetric productivity of 0.55 g L⁻¹ h⁻¹ and a yield of 0.16 g g⁻¹ glucose could be achieved. Moreover, while plasmid segregation of the initial strain required antibiotic selection, plasmid segregation in C. glutamicum PUT21 was fully stable for more than 60 generations without antibiotic selection even in the presence of L-arginine. The ornithine decarboxylase gene speC was expressed from this argF addiction plasmid ensuring stable putrescine production by the engineered C. glutamicum strain.
MeSH term(s)	Bacterial Proteins/genetics ; Bacterial Proteins/metabolism ; Biotechnology ; Corynebacterium glutamicum/enzymology ; Corynebacterium glutamicum/genetics ; Corynebacterium glutamicum/metabolism ; Culture Media ; Escherichia coli/enzymology ; Escherichia coli/genetics ; Escherichia coli/metabolism ; Fermentation ; Genes, Bacterial ; Genetic Engineering/methods ; Ornithine Carbamoyltransferase/genetics ; Ornithine Carbamoyltransferase/metabolism ; Plasmids/genetics ; Putrescine/biosynthesis
Chemical Substances	Bacterial Proteins ; Culture Media ; Ornithine Carbamoyltransferase (EC 2.1.3.3) ; Putrescine (V10TVZ52E4)
Language	English
Publishing date	2012-07
Publishing country	Germany
Document type	Evaluation Studies ; Journal Article
ZDB-ID	392453-1
ISSN	1432-0614 ; 0171-1741 ; 0175-7598
ISSN (online)	1432-0614
ISSN	0171-1741 ; 0175-7598
DOI	10.1007/s00253-012-3956-9
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