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Article ; Online: Small Airways: Not Just Air Ducts - Pathophysiological Aspects and Clinical Implications.

Frizzelli, Annalisa / Nicolini, Gabriele / Chetta, Alfredo

Respiration; international review of thoracic diseases

2022 Volume 101, Issue 10, Page(s) 953–958

Abstract: The airways smaller than 2 mm diameter are named small airways. They are essential for the transport and exchange of oxygen and carbon dioxide and at the same time play a relevant role in pulmonary mechanics, contributing to the subdivision of lung ... ...

Abstract	The airways smaller than 2 mm diameter are named small airways. They are essential for the transport and exchange of oxygen and carbon dioxide and at the same time play a relevant role in pulmonary mechanics, contributing to the subdivision of lung volumes. Measurement of small airway function is, therefore, crucial in patients with respiratory disease. This overview focuses on the physiological aspects of the small airways, considered as air ducts as well as determinants of pulmonary mechanics, the most common tools for evaluating their function and treatment implications.
MeSH term(s)	Carbon Dioxide ; Humans ; Lung/diagnostic imaging ; Lung Volume Measurements ; Oxygen ; Respiratory Mechanics
Chemical Substances	Carbon Dioxide (142M471B3J) ; Oxygen (S88TT14065)
Language	English
Publishing date	2022-07-12
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	206674-9
ISSN	1423-0356 ; 0025-7931
ISSN (online)	1423-0356
ISSN	0025-7931
DOI	10.1159/000525666
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Article ; Online: Beclometasone dipropionate/formoterol maintenance and reliever therapy asthma exacerbation benefit increases with blood eosinophil level.

Brusselle, Guy / Nicolini, Gabriele / Santoro, Luigi / Guastalla, Daniele / Papi, Alberto

The European respiratory journal

2021 Volume 58, Issue 1

MeSH term(s)	Administration, Inhalation ; Anti-Asthmatic Agents/therapeutic use ; Asthma/drug therapy ; Beclomethasone/therapeutic use ; Bronchodilator Agents/therapeutic use ; Budesonide/therapeutic use ; Drug Combinations ; Eosinophils ; Ethanolamines ; Formoterol Fumarate/therapeutic use ; Humans
Chemical Substances	Anti-Asthmatic Agents ; Bronchodilator Agents ; Drug Combinations ; Ethanolamines ; Budesonide (51333-22-3) ; Beclomethasone (KGZ1SLC28Z) ; Formoterol Fumarate (W34SHF8J2K)
Language	English
Publishing date	2021-07-08
Publishing country	England
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.040982020
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Article: Efficacy of Nasal High-Flow Oxygen Therapy in Chronic Obstructive Pulmonary Disease Patients in Long-Term Oxygen and Nocturnal Non-Invasive Ventilation during Exercise Training.

Volpi, Valeria / Volpato, Eleonora / Compalati, Elena / Lebret, Marius / Russo, Giuseppe / Sciurello, Salvatore / Pappacoda, Gabriele / Nicolini, Antonello / Banfi, Paolo

Healthcare (Basel, Switzerland)

2022 Volume 10, Issue 10

Abstract: High-flow oxygen therapy (HFOT) improves gas exchange and dead space washout and reduces the level of work required for breathing. This study aimed to evaluate pulmonary rehabilitation (PR) combined with HFOT in COPD patients treated with nocturnal non- ... ...

Abstract	High-flow oxygen therapy (HFOT) improves gas exchange and dead space washout and reduces the level of work required for breathing. This study aimed to evaluate pulmonary rehabilitation (PR) combined with HFOT in COPD patients treated with nocturnal non-invasive ventilation (NIV) and long-term oxygen therapy (LTOT). In particular, we sought to discover whether the addition of HFOT during exercise training could improve patients’ performance, mainly with regard to their Six-Minute Walking Test (6MWT) outcomes, and reduce the exacerbation rates, periods of rehospitalization or need to resort to unscheduled visits. Thirty-one COPD subjects (13 female) who used nocturnal NIV were included in a randomized controlled trial and allocated to one of two groups: the experimental group (EG), with 15 subjects, subjected to PR with HFOT; and the control group (CG), with 16 subjects, subjected to PR without HFOT. The primary outcome of the study was the observation of changes in the 6MWT. The secondary outcome of the study was related to the rate of exacerbation and hospitalization. Data were collected at baseline and after one, two and three cycles of cycle-ergometer exercise training performed in 20 supervised sessions of 40 min thrice per week, with a washout period of 3 months between each rehabilitation cycle. Statistical significance was not found for the 6MWT distance (W = 0.974; p = 0.672) at the last follow-up, but statistical significance was found for the Borg scale in regard to dyspnea (W = 2.50; p < 0.001) and fatigue (W = 2.00; p < 0.001). HFOT may offer a positive option for dyspnea-affected COPD patients in the context of LTOT and nocturnal NIV.
Language	English
Publishing date	2022-10-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2721009-1
ISSN	2227-9032
ISSN	2227-9032
DOI	10.3390/healthcare10102001
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Article ; Online: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment.

Panigone, Sara / Sandri, Federica / Ferri, Rossella / Volpato, Andrea / Nudo, Elena / Nicolini, Gabriele

BMJ open respiratory research

2020 Volume 7, Issue 1

Abstract: Patients with asthma and Chronic Obstructive Respiratory Disease (COPD) rely on three main device classes for inhalation therapy: metered-dose inhalers (MDIs), dry powder inhalers (DPIs) and soft-mist inhalers (SMIs). The carbon footprint (CF) of these ... ...

Abstract	Patients with asthma and Chronic Obstructive Respiratory Disease (COPD) rely on three main device classes for inhalation therapy: metered-dose inhalers (MDIs), dry powder inhalers (DPIs) and soft-mist inhalers (SMIs). The carbon footprint (CF) of these inhalers differs with MDIs having a higher impact than DPIs and SMIs due to the propellant in MDIs. However, the certified CF of specific MDI products may differ significantly. MDIs still represent an essential option for many patients. Consequently, novel approaches shall be considered to balance environmental goals with patient health and well-being while maintaining a diverse range of choices for patients and physicians.
MeSH term(s)	Administration, Inhalation ; Adrenergic beta-Agonists/administration & dosage ; Asthma/drug therapy ; Carbon Footprint ; Humans ; Nebulizers and Vaporizers ; Precision Medicine/methods ; Pulmonary Disease, Chronic Obstructive/drug therapy
Chemical Substances	Adrenergic beta-Agonists
Language	English
Publishing date	2020-03-31
Publishing country	England
Document type	Journal Article
ZDB-ID	2736454-9
ISSN	2052-4439 ; 2052-4439
ISSN (online)	2052-4439
ISSN	2052-4439
DOI	10.1136/bmjresp-2020-000571
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Article: Antioxidant and Anti-Melanogenesis Effects of

Pruccoli, Letizia / Nicolini, Benedetta / Lianza, Mariacaterina / Teti, Gabriella / Falconi, Mirella / Tarozzi, Andrea / Antognoni, Fabiana

Plants (Basel, Switzerland)

2024 Volume 13, Issue 6

Abstract: ... Teucrium ... ...

Abstract	Teucrium chamaedrys
Language	English
Publishing date	2024-03-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2704341-1
ISSN	2223-7747
ISSN	2223-7747
DOI	10.3390/plants13060808
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Article ; Online: A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial.

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

2024 Volume 20, Issue 8, Page(s) e504–e510

Abstract: The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the ... ...

Abstract	The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.
MeSH term(s)	Humans ; Aortic Valve Stenosis/surgery ; Aortic Valve Stenosis/complications ; Coronary Angiography ; Coronary Artery Disease/diagnostic imaging ; Coronary Artery Disease/surgery ; Fractional Flow Reserve, Myocardial ; Percutaneous Coronary Intervention ; Prospective Studies ; Transcatheter Aortic Valve Replacement ; Treatment Outcome ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2024-04-15
Publishing country	France
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2457174-X
ISSN	1969-6213 ; 1774-024X
ISSN (online)	1969-6213
ISSN	1774-024X
DOI	10.4244/EIJ-D-23-00679
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Article ; Online: Environmental impact of inhalers for respiratory diseases

Sara Panigone / Federica Sandri / Rossella Ferri / Andrea Volpato / Elena Nudo / Gabriele Nicolini

BMJ Open Respiratory Research, Vol 7, Iss

decreasing the carbon footprint while preserving patient-tailored treatment

2020 Volume 1

Abstract	Patients with asthma and Chronic Obstructive Respiratory Disease (COPD) rely on three main device classes for inhalation therapy: metered-dose inhalers (MDIs), dry powder inhalers (DPIs) and soft-mist inhalers (SMIs). The carbon footprint (CF) of these inhalers differs with MDIs having a higher impact than DPIs and SMIs due to the propellant in MDIs. However, the certified CF of specific MDI products may differ significantly. MDIs still represent an essential option for many patients. Consequently, novel approaches shall be considered to balance environmental goals with patient health and well-being while maintaining a diverse range of choices for patients and physicians.
Keywords	Medicine ; R ; Diseases of the respiratory system ; RC705-779
Language	English
Publishing date	2020-05-01T00:00:00Z
Publisher	BMJ Publishing Group
Document type	Article ; Online
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Article ; Online: Development of a tool to detect small airways dysfunction in asthma clinical practice.

Kocks, Janwillem / van der Molen, Thys / Voorham, Jaco / Baldi, Simonetta / van den Berge, Maarten / Brightling, Chris / Fabbri, Leonardo M / Kraft, Monica / Nicolini, Gabriele / Papi, Alberto / Rabe, Klaus F / Siddiqui, Salman / Singh, Dave / Vonk, Judith / Leving, Marika / Flokstra-de Blok, Bertine

The European respiratory journal

2023 Volume 61, Issue 3

Abstract: Background: Small airways dysfunction (SAD) in asthma is difficult to measure and a gold standard is lacking. The aim of this study was to develop a simple tool including items of the Small Airways Dysfunction Tool (SADT) questionnaire, basic patient ... ...

Abstract	Background: Small airways dysfunction (SAD) in asthma is difficult to measure and a gold standard is lacking. The aim of this study was to develop a simple tool including items of the Small Airways Dysfunction Tool (SADT) questionnaire, basic patient characteristics and respiratory tests available depending on the clinical setting to predict SAD in asthma. Methods: This study was based on the data of the multinational ATLANTIS (Assessment of Small Airways Involvement in Asthma) study including the earlier developed SADT questionnaire. Key SADT items together with clinical information were now used to build logistic regression models to predict SAD group (less likely or more likely to have SAD). Diagnostic ability of the models was expressed as area under the receiver operating characteristic curve (AUC) and positive likelihood ratio (LR+). Results: SADT item 8, "I sometimes wheeze when I am sitting or lying quietly", and the patient characteristics age, age at asthma diagnosis and body mass index could reasonably well detect SAD (AUC 0.74, LR+ 2.3). The diagnostic ability increased by adding spirometry (percentage predicted forced expiratory volume in 1 s: AUC 0.87, LR+ 5.0) and oscillometry (resistance difference between 5 and 20 Hz and reactance area: AUC 0.96, LR+ 12.8). Conclusions: If access to respiratory tests is limited (
MeSH term(s)	Humans ; Asthma/diagnosis ; Respiratory Function Tests ; Spirometry ; Forced Expiratory Volume ; ROC Curve
Language	English
Publishing date	2023-03-30
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639359-7
ISSN	1399-3003 ; 0903-1936
ISSN (online)	1399-3003
ISSN	0903-1936
DOI	10.1183/13993003.00558-2022
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Article ; Online: A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial.

Lombardo, Flavia L / Spila Alegiani, Stefania / Mayer, Flavia / Cipriani, Marta / Lo Giudice, Maria / Ludolph, Albert Christian / McDermott, Christopher J / Corcia, Philippe / Van Damme, Philip / Van den Berg, Leonard H / Hardiman, Orla / Nicolini, Gabriele / Vanacore, Nicola / Dickie, Brian / Albanese, Alberto / Puopolo, Maria

Trials

2023 Volume 24, Issue 1, Page(s) 792

Abstract: Background: Amyotrophic lateral sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic ... ...

Abstract	Background: Amyotrophic lateral sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately 3 months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the efficacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is the treatment response defined as a minimum of 20% improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) slope during the randomized treatment period (18 months) compared to the lead-in period (3 months). Randomization will be stratified by country. Primary analysis will be conducted based on the intention-to-treat principle through an unadjusted logistic regression model. Patient recruitment commenced on February 22, 2019, and was closed on December 23, 2021. The database will be locked in September 2023. Discussion: This paper provides a comprehensive description of the statistical analysis plan in order to ensure the reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS. Trial registration: ClinicalTrials.gov NCT03800524 . Registered on January 11, 2019.
MeSH term(s)	Humans ; Amyotrophic Lateral Sclerosis/diagnosis ; Amyotrophic Lateral Sclerosis/drug therapy ; Riluzole ; Neuroprotective Agents/adverse effects ; Reproducibility of Results ; Double-Blind Method ; Treatment Outcome ; Disease Progression
Chemical Substances	Riluzole (7LJ087RS6F) ; ursodoxicoltaurine (60EUX8MN5X) ; Neuroprotective Agents
Language	English
Publishing date	2023-12-05
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Clinical Trial, Phase III ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07638-w
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Article ; Online: The role of small airway dysfunction in asthma control and exacerbations: a longitudinal, observational analysis using data from the ATLANTIS study.

Kraft, Monica / Richardson, Matthew / Hallmark, Brian / Billheimer, Dean / Van den Berge, Maarten / Fabbri, Leonardo M / Van der Molen, Thys / Nicolini, Gabriele / Papi, Alberto / Rabe, Klaus F / Singh, Dave / Brightling, Chris / Siddiqui, Salman

The Lancet. Respiratory medicine

2022 Volume 10, Issue 7, Page(s) 661–668

Abstract: Background: Although small airway disease is a feature of asthma, its association with relevant asthma outcomes remains unclear. The ATLANTIS study was designed to identify the combination of physiological and imaging variables that best measure the ... ...

Abstract	Background: Although small airway disease is a feature of asthma, its association with relevant asthma outcomes remains unclear. The ATLANTIS study was designed to identify the combination of physiological and imaging variables that best measure the presence and extent of small airway disease in asthma, both cross-sectionally and longitudinally. In this longitudinal analysis, we evaluated which small airway parameters studied were most strongly associated with asthma control, exacerbations, and quality of life. Methods: In this observational cohort study, participants with mild, moderate, or severe stable asthma were recruited between June 30, 2014, and March 3, 2017, via medical databases and advertisements in nine countries worldwide. Eligible participants were aged 18-65 years with a clinical asthma diagnosis for at least 6 months. Participants were followed up for 1 year, with visits at baseline, 6 months, and 12 months. Physiological tests included spirometry, lung volumes, impulse oscillometry, multiple breath nitrogen washout (MBNW), and percentage decrease in forced vital capacity during methacholine challenge. CT densitometry was performed to evaluate small airway disease. We examined the associations between these measurements and asthma exacerbations, asthma control, and quality of life using univariate and multivariate analyses. A composite ordinal score comprising percent predicted R5-20 (resistance of small-to-mid-sized airways), AX (area of reactance), and X5 (reactance of more central, conducting small airways at 5 Hz) was constructed. Findings: 773 participants (median age 46 years [IQR 34-54]; 450 [58%] female) were included in this longitudinal study. Univariate analyses showed that components of impulse oscillometry, lung volumes, MBNW, and forced expiratory flow at 25-75% of FVC were significantly correlated with asthma control and exacerbations (Spearman correlations 0·20-0·25, p<0·0001 after Bonferroni correction). As a composite of impulse oscillometry, the ordinal score independently predicted asthma control and exacerbations in a multivariate analysis with known exacerbation predictors. CT parameters were not significantly correlated with asthma control, exacerbation, or quality of life. Interpretation: Small airway disease, as measured by physiological tests, is longitudinally associated with clinically important asthma outcomes, such as asthma control and exacerbations. Funding: Chiesi Farmaceutici.
MeSH term(s)	Asthma ; Female ; Forced Expiratory Volume ; Humans ; Longitudinal Studies ; Male ; Middle Aged ; Oscillometry ; Pulmonary Disease, Chronic Obstructive ; Quality of Life ; Respiratory System ; Spirometry
Language	English
Publishing date	2022-03-02
Publishing country	England
Document type	Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2686754-0
ISSN	2213-2619 ; 2213-2600
ISSN (online)	2213-2619
ISSN	2213-2600
DOI	10.1016/S2213-2600(21)00536-1
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