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Article: Ivermectin for COVID-19: Addressing Potential Bias and Medical Fraud.

Hill, Andrew / Mirchandani, Manya / Pilkington, Victoria

2022 Volume 9, Issue 2, Page(s) ofab645

Abstract: Ivermectin has become a controversial potential medicine for coronavirus disease 2019. Some early studies suggested clinical benefits in treatment of infection. However, the body of evidence includes studies of varying quality. Furthermore, some trials ... ...

Abstract	Ivermectin has become a controversial potential medicine for coronavirus disease 2019. Some early studies suggested clinical benefits in treatment of infection. However, the body of evidence includes studies of varying quality. Furthermore, some trials have now been identified as potentially fraudulent. We present a subgroup meta-analysis to assess the effects of stratifying by trial quality on the overall results. The stratification is based on the Cochrane Risk of Bias measures and raw data analysis where possible. The results suggest that the significant effect of ivermectin on survival was dependent on largely poor-quality studies. According to the potentially fraudulent study (risk ratio [RR], 0.08; 95% CI, 0.02-0.35), ivermectin improved survival ~12 times more in comparison with low-risk studies (RR, 0.96; 95% CI, 0.56-1.66). This highlights the need for rigorous quality assessments, for authors to share patient-level data, and for efforts to avoid publication bias for registered studies. These steps are vital to facilitate accurate conclusions on clinical treatments.
Language	English
Publishing date	2022-01-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofab645
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Article: Facilitating COVID-19 Testing in Historically Marginalized Populations by Leveraging Community Partnerships.

Brown, Laurin / Billings, Victoria / Pilkington, William / Kumar, Deepak

North Carolina medical journal

2021 Volume 82, Issue 4, Page(s) 301

Language	English
Publishing date	2021-07-06
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	422795-5
ISSN	0029-2559
ISSN	0029-2559
DOI	10.18043/ncm.82.4.301
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Article ; Online: Global COVID-19 Vaccine Inequity: Failures in the First Year of Distribution and Potential Solutions for the Future.

Pilkington, Victoria / Keestra, Sarai Mirjam / Hill, Andrew

Frontiers in public health

2022 Volume 10, Page(s) 821117

Abstract: Within the first year of distribution of vaccines against COVID-19, high-income countries (HICs) have achieved vaccination rates of 75-80%, whilst low-income countries (LICs) vaccinated <10%. This disparity in access has been one of the greatest failures ...

Abstract	Within the first year of distribution of vaccines against COVID-19, high-income countries (HICs) have achieved vaccination rates of 75-80%, whilst low-income countries (LICs) vaccinated <10%. This disparity in access has been one of the greatest failures of international cooperation during the SARS-CoV-2 pandemic. Global COVID-19 vaccine inequity affects us all, with ongoing risk of new variants emerging until global herd immunity is strengthened. The current model of global vaccine distribution is based on financial competition for limited vaccine supplies, resulting in HICs getting first access to vaccines, with LICs being forced to rely on voluntary donations through schemes like COVAX. Pharmaceutical companies own the intellectual property (IP) rights for COVID-19 vaccines, allowing them to control manufacturing, distribution, and pricing. However, the pharmaceutical industry did not develop these vaccines alone, with billions of dollars of public funding being instrumental in their discovery and development. Solutions to enable global equitable access already exist. The next step in scale up of manufacture and distribution worldwide is equitable knowledge sharing and technology transfer. The World Health Organization centralized technology transfer hub would facilitate international cooperation. Investments made into developing this infrastructure benefit the COVID-19 response whilst promoting future pandemic preparedness. Whilst globally there is majority support for waivers of IP to facilitate this next step, key opponents blocking this move include the UK and other European countries which host large domestic pharmaceutical industries. A nationalistic approach is not effective during a global pandemic. International cooperation is essential to achieve global goals against COVID-19.
MeSH term(s)	COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Technology Transfer ; World Health Organization
Chemical Substances	COVID-19 Vaccines
Language	English
Publishing date	2022-03-07
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2711781-9
ISSN	2296-2565 ; 2296-2565
ISSN (online)	2296-2565
ISSN	2296-2565
DOI	10.3389/fpubh.2022.821117
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Article ; Online: Ivermectin for the prevention of COVID-19: addressing potential bias and medical fraud.

Hill, Andrew / Mirchandani, Manya / Ellis, Leah / Pilkington, Victoria

The Journal of antimicrobial chemotherapy

2022 Volume 77, Issue 5, Page(s) 1413–1416

Abstract: Background: Ivermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials.: Objectives: To conduct a meta-analysis with randomized ... ...

Abstract	Background: Ivermectin is an antiparasitic drug being investigated in clinical trials for the prevention of COVID-19. However, there are concerns about the quality of some of these trials. Objectives: To conduct a meta-analysis with randomized controlled trials of ivermectin for the prevention of COVID-19, while controlling for the quality of data. The primary outcome was RT-PCR-confirmed COVID-19 infection. The secondary outcome was rate of symptomatic COVID-19 infection. Methods: We conducted a subgroup analysis based on the quality of randomized controlled trials evaluating ivermectin for the prevention of COVID-19. Quality was assessed using the Cochrane risk of bias measures (RoB 2) and additional checks on raw data, where possible. Results: Four studies were included in the meta-analysis. One was rated as being potentially fraudulent, two as having a high risk of bias and one as having some concerns for bias. Ivermectin did not have a significant effect on preventing RT-PCR-confirmed COVID-19 infection. Ivermectin had a significant effect on preventing symptomatic COVID-19 infection in one trial with some concerns of bias, but this result was based on post hoc analysis of a multi-arm study. Conclusions: In this meta-analysis, the use of ivermectin was not associated with the prevention of RT-PCR-confirmed or symptomatic COVID-19. The currently available randomized trials evaluating ivermectin for the prevention of COVID-19 are insufficient and of poor quality.
MeSH term(s)	Antiparasitic Agents ; COVID-19/drug therapy ; Fraud ; Humans ; Ivermectin/therapeutic use ; Randomized Controlled Trials as Topic ; Treatment Outcome
Chemical Substances	Antiparasitic Agents ; Ivermectin (70288-86-7)
Language	English
Publishing date	2022-02-18
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkac052
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Article ; Online: Clinical Presentation of Mpox in People With and Without HIV in the United Kingdom During the 2022 Global Outbreak.

Pilkington, Victoria / Quinn, Killian / Campbell, Lucy / Payne, Lara / Brady, Michael / Post, Frank A

AIDS research and human retroviruses

2023 Volume 39, Issue 11, Page(s) 581–586

Abstract: Early UK surveillance data revealed that people living with HIV were overrepresented among cases of monkeypox (mpox). However, it remains unknown whether mpox infection is more severe in people living with well-controlled HIV. All laboratory-confirmed ... ...

Abstract	Early UK surveillance data revealed that people living with HIV were overrepresented among cases of monkeypox (mpox). However, it remains unknown whether mpox infection is more severe in people living with well-controlled HIV. All laboratory-confirmed mpox cases presenting between May and December 2022 to one London hospital service were identified via pathology reporting systems. We extracted demographic and clinical data to allow comparison of clinical presentation and severity of mpox among people with and without HIV. We identified 150 people with mpox (median age 36 years, 99.3% male, 92.7% reporting sex with other men). HIV status was available for 144 individuals, 58 (40.3%) of whom were HIV positive (only 3/58 had CD4 cell counts <200 cells/mm
MeSH term(s)	Humans ; Male ; Adult ; Female ; HIV Infections/complications ; HIV Infections/epidemiology ; Mpox (monkeypox) ; United Kingdom/epidemiology ; Body Fluids ; Disease Outbreaks
Language	English
Publishing date	2023-05-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	639130-8
ISSN	1931-8405 ; 0889-2229
ISSN (online)	1931-8405
ISSN	0889-2229
DOI	10.1089/AID.2023.0014
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Article ; Online: Global COVID-19 Vaccine Inequity

Victoria Pilkington / Sarai Mirjam Keestra / Andrew Hill

Frontiers in Public Health, Vol

Failures in the First Year of Distribution and Potential Solutions for the Future

2022 Volume 10

Abstract	Within the first year of distribution of vaccines against COVID-19, high-income countries (HICs) have achieved vaccination rates of 75-80%, whilst low-income countries (LICs) vaccinated <10%. This disparity in access has been one of the greatest failures of international cooperation during the SARS-CoV-2 pandemic. Global COVID-19 vaccine inequity affects us all, with ongoing risk of new variants emerging until global herd immunity is strengthened. The current model of global vaccine distribution is based on financial competition for limited vaccine supplies, resulting in HICs getting first access to vaccines, with LICs being forced to rely on voluntary donations through schemes like COVAX. Pharmaceutical companies own the intellectual property (IP) rights for COVID-19 vaccines, allowing them to control manufacturing, distribution, and pricing. However, the pharmaceutical industry did not develop these vaccines alone, with billions of dollars of public funding being instrumental in their discovery and development. Solutions to enable global equitable access already exist. The next step in scale up of manufacture and distribution worldwide is equitable knowledge sharing and technology transfer. The World Health Organization centralized technology transfer hub would facilitate international cooperation. Investments made into developing this infrastructure benefit the COVID-19 response whilst promoting future pandemic preparedness. Whilst globally there is majority support for waivers of IP to facilitate this next step, key opponents blocking this move include the UK and other European countries which host large domestic pharmaceutical industries. A nationalistic approach is not effective during a global pandemic. International cooperation is essential to achieve global goals against COVID-19.
Keywords	manufacturing—R&D interface ; pricing ; vaccines ; COVID-19 ; inequality ; Public aspects of medicine ; RA1-1270
Subject code	306
Language	English
Publishing date	2022-03-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
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Article ; Online: Disparities in who is asked about their perinatal mental health: an analysis of cross-sectional data from consecutive national maternity surveys.

Harrison, Sian / Pilkington, Victoria / Li, Yangmei / Quigley, Maria A / Alderdice, Fiona

BMC pregnancy and childbirth

2023 Volume 23, Issue 1, Page(s) 263

Abstract: Background: The perinatal period is a vulnerable time, with one in five women experiencing mental health problems. Antenatal and postnatal appointments are key contact points for identifying women in need of support. Since 2014, the UK National ... ...

Abstract	Background: The perinatal period is a vulnerable time, with one in five women experiencing mental health problems. Antenatal and postnatal appointments are key contact points for identifying women in need of support. Since 2014, the UK National Institute for Health and Care Excellence (NICE) has recommended that all women be asked about their mental health at their antenatal booking appointment and early in the postnatal period. The aim of this study was to assess the proportions of women who reported being asked about their mental health during the perinatal period across consecutive national maternity surveys (NMS) in England and to evaluate sociodemographic disparities in who was asked. Methods: Secondary analysis was performed on cross-sectional data from the NMS in 2014-2020. In each survey, women reported whether they had been asked about their mental health antenatally (during their booking appointment) and postnatally (up to six months after giving birth). The proportions of women in each survey who reported being asked about their mental health were calculated and compared according to key sociodemographic characteristics and across survey years. Logistic regression was conducted to identify disparities in who was asked. Results: The proportion of women who reported being asked about their mental health antenatally increased from 80.3% (95%CI:79.0-81.5) in 2014 to 83.4% (95%CI:82.1-84.7) in 2020, yet the proportion of women who reported being asked postnatally fell from 88.2% (95%CI:87.1-89.3) in 2014 to 73.7% (95%CI:72.2-75.2) in 2020. Ethnic minority women (aOR range:0.20 ~ 0.67) were less likely to report being asked about their mental health antenatally and postnatally across all surveys compared to White women. Women living in less socioeconomically advantaged areas (aOR range:0.65 ~ 0.75) and women living without or separately from a partner (aOR range:0.61 ~ 0.73) were also less likely to report being asked about their mental health, although there was less consistency in these disparities across the antenatal and postnatal periods and across surveys. Conclusions: Despite NICE recommendations, many women are still not asked about their mental health during the perinatal period, particularly after giving birth. Women from ethnic minority backgrounds are less likely to be asked and these disparities have persisted over time.
MeSH term(s)	Female ; Humans ; Pregnancy ; Cross-Sectional Studies ; Ethnicity ; Mental Health ; Minority Groups ; Parturition ; England ; Healthcare Disparities
Language	English
Publishing date	2023-04-27
Publishing country	England
Document type	Journal Article
ZDB-ID	2059869-5
ISSN	1471-2393 ; 1471-2393
ISSN (online)	1471-2393
ISSN	1471-2393
DOI	10.1186/s12884-023-05518-4
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Article ; Online: Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs.

Rodgers, Florence / Pepperrell, Toby / Keestra, Sarai / Pilkington, Victoria

Trials

2021 Volume 22, Issue 1, Page(s) 59

Abstract: Background: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable ... ...

Abstract	Background: Several drugs are being repurposed for the treatment of the coronavirus disease 2019 (COVID-19) pandemic based on in vitro or early clinical findings. As these drugs are being used in varied regimens and dosages, it is important to enable synthesis of existing safety data from clinical trials. However, availability of safety information is limited by a lack of timely reporting of overall clinical trial results on public registries or through academic publication. We aimed to analyse the evidence gap in this data by conducting a rapid review of results posting on ClinicalTrials.gov and in academic publications to quantify the number of trials missing results for drugs potentially being repurposed for COVID-19. Methods: ClinicalTrials.gov was searched for 19 drugs that have been identified as potential treatments for COVID-19. Relevant clinical trials for any prior indication were listed by identifier (NCT number) and checked for results and for timely result reporting (within 395 days of the primary completion date). Additionally, PubMed and Google Scholar were searched to identify publications of results not listed on the registry. A second, blinded search of 10% of trials was conducted to assess reviewer concordance. Results: Of 3754 completed trials, 1516 (40.4%) did not post results on ClinicalTrials.gov or in the academic literature. Tabular results were available on ClinicalTrials.gov for 1172 (31.2%) completed trials. A further 1066 (28.4%) had published results in the academic literature, but did not report results on ClinicalTrials.gov . Key drugs missing clinical trial results include hydroxychloroquine (37.0% completed trials unreported), favipiravir (77.8%) and lopinavir (40.5%). Conclusions: There is an important evidence gap for the safety of drugs being repurposed for COVID-19. This uncertainty could cause unnecessary additional morbidity and mortality during the pandemic. We recommend caution in experimental drug use for non-severe disease and urge clinical trial sponsors to report missing results retrospectively.
MeSH term(s)	Amides/therapeutic use ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Clinical Trials as Topic ; Drug Combinations ; Drug Repositioning ; Enzyme Inhibitors/therapeutic use ; Evidence-Based Medicine ; Humans ; Hydroxychloroquine/therapeutic use ; Lopinavir/therapeutic use ; PubMed ; Pyrazines/therapeutic use ; Registries ; Research Design ; Research Report ; Ritonavir/therapeutic use ; SARS-CoV-2
Chemical Substances	Amides ; Antiviral Agents ; Drug Combinations ; Enzyme Inhibitors ; Pyrazines ; lopinavir-ritonavir drug combination ; Lopinavir (2494G1JF75) ; Hydroxychloroquine (4QWG6N8QKH) ; favipiravir (EW5GL2X7E0) ; Ritonavir (O3J8G9O825)
Language	English
Publishing date	2021-01-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1468-6708
ISSN (online)	1745-6215 ; 1468-6694
ISSN	1468-6708
DOI	10.1186/s13063-021-05024-y
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Article ; Online: Is tenofovir disoproxil fumarate associated with weight loss?

Shah, Shahini / Pilkington, Victoria / Hill, Andrew

AIDS (London, England)

2021 Volume 35, Issue Suppl 2, Page(s) S189–S195

Abstract: Background: Recent clinical trials have shown weight gain associated with newer antiretrovirals. It is unclear how the nucleoside reverse transcriptase inhibitor backbone affects weight. Recent evidence suggests greater weight gain with tenofovir ... ...

Abstract	Background: Recent clinical trials have shown weight gain associated with newer antiretrovirals. It is unclear how the nucleoside reverse transcriptase inhibitor backbone affects weight. Recent evidence suggests greater weight gain with tenofovir alafenamide (TAF) compared with tenofovir disoproxil fumarate (TDF). However, it is not fully understood whether TDF contributes to weight suppression. Methods: A systematic search of PubMed, Embase and clinicaltrials.gov was conducted to identify all randomized control trials comparing TDF/FTC or TDF to control in HIV-negative individuals. The primary endpoint included the number of events of 5% weight loss. Mantel-Haenszel test with random-effects modelling was used to calculate the odds ratio (OR) and 95% confidence intervals (95% CI). Further analyses of gastrointestinal (GI) adverse events were also undertaken. Results: Seven PrEP trials: PARTNERS, VOICE, TDF-2, Bangkok PrEP, iPrEX, FEM-PrEP and HPTN 084 were included in the analysis of weight loss, with a total sample size of 19 359. One study (HPTN 084) compared TDF/FTC to cabotegravir (CAB). HIV-negative individuals taking TDF were more likely to experience weight loss compared with control [odds ratio (OR) 1.44; 95% CI 1.12-1.85; P = 0.005). Exposure to TDF was also linked to greater odds of vomiting (OR 1.81; 95% CI 1.20-2.73; P < 0.005). There were no increased odds of nausea, diarrhoea or loss of appetite. Conclusion: There is evidence in HIV-negative individuals that TDF may be associated with weight loss. Further research should be carried out in HIV-positive individuals, and clinical trials of TDF/FTC should publish weight data to widen the evidence base.
MeSH term(s)	Anti-HIV Agents/adverse effects ; Emtricitabine/therapeutic use ; HIV Infections/drug therapy ; Humans ; Randomized Controlled Trials as Topic ; Tenofovir/adverse effects ; Thailand ; Weight Loss
Chemical Substances	Anti-HIV Agents ; Tenofovir (99YXE507IL) ; Emtricitabine (G70B4ETF4S)
Language	English
Publishing date	2021-11-27
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003083
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Article: A review of the safety of favipiravir - a potential treatment in the COVID-19 pandemic?

Pilkington, Victoria / Pepperrell, Toby / Hill, Andrew

Journal of virus eradication

2020 Volume 6, Issue 2, Page(s) 45–51

Abstract: Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19). Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for ... ...

Abstract	Background: Repurposing broad-spectrum antivirals is an immediate treatment opportunity for 2019 coronavirus disease (COVID-19). Favipiravir is an antiviral previously indicated for influenza and Ebola, which has shown some promise in early trials for treatment of COVID-19. We aim to review existing favipiravir safety evidence, which is vital to informing the potential future use of favipiravir in COVID-19. Methods: A search was conducted across EMBASE and MEDLINE databases, supplemented by relevant grey-literature and ClinicalTrials.gov. All studies assessing the use of favipiravir in humans by 27 March 2020 were considered for inclusion. Further analysis of available safety data from phase 2 and 3 studies was undertaken. Data extracted were adverse events (AEs) grade 1-4, serious AEs and discontinuation for AEs. Specific AEs of interest highlighted in early-phase studies, including gastrointestinal AEs and hyperuricaemia, were also examined. Results: Twenty-nine studies were identified as potential sources of evidence of the clinical safety of favipiravir. Six were phase 2 and 3 studies reporting relevant safety data for statistical comparison, representing a total of 4299 participants, an estimated 175 person-years-of-follow-up (PYFU). Comparator drugs were oseltamivir, umifenovir, lopinavir/ritonavir or placebo. Study follow-up was between 5 and 21 days. The proportions of grade 1-4 AEs on favipiravir was 28.2% Conclusions: Favipiravir demonstrates a favourable safety profile regarding total and serious AEs. However, safety concerns remain: hyperuricaemia, teratogenicity and QTc prolongation have not yet been adequately studied. Favipiravir may be safe and tolerable in short-term use, but more evidence is needed to assess the longer-term effects of treatment. Given the limitations of the evidence and unresolved safety concerns, caution is warranted in the widespread use of favipiravir against pandemic COVID-19.
Keywords	covid19
Language	English
Publishing date	2020-04-30
Publishing country	England
Document type	Editorial
ZDB-ID	2868549-0
ISSN	2055-6659 ; 2055-6640
ISSN (online)	2055-6659
ISSN	2055-6640
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