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Article: Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review.

Wang, Juan / Cheng, Chung Wah / Jiao, Yalin / Shi, Dongni / Wang, Yaochen / Li, Han / Wang, Nana / Wang, Xihong / Li, Yuqin / Liang, Feng / Luo, Shufeng / Han, Fei / Li, Ji / Wang, Ping / Lyu, Aiping / Bian, Zhaoxiang / Zhang, Xuan

Frontiers in pharmacology

2024 Volume 15, Page(s) 1287262

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2024-02-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2024.1287262
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study.

Deng, Jiashuai / He, Juan / Wang, Juan / Cheng, Chung Wah / Jiao, Yalin / Wang, Nana / Li, Ji / Wang, Ping / Han, Fei / Lyu, Aiping / Bian, Zhaoxiang / Zhang, Xuan

BMC medical research methodology

2023 Volume 23, Issue 1, Page(s) 124

Abstract: Background and objective: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the ... ...

Abstract	Background and objective: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions. Methods: Through a search of 7 electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1 Results: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44-28.19), 14.17 (13.98-14.37) and 21.06 (20.69-21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items. Conclusion: Although the CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.
MeSH term(s)	Humans ; Angina Pectoris/therapy ; Cross-Sectional Studies ; Randomized Controlled Trials as Topic/standards ; Medicine, Chinese Traditional
Language	English
Publishing date	2023-05-23
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2041362-2
ISSN	1471-2288 ; 1471-2288
ISSN (online)	1471-2288
ISSN	1471-2288
DOI	10.1186/s12874-023-01953-1
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Article ; Online: Reporting assessment of multicenter clinical trial protocols: A cross-sectional study.

Zhang, Xuan / Wang, Nana / Zhang, Lin / Cheng, Chung Wah / Liu, Ziyi / Liang, Feng / Xiong, Weifeng / Deng, Jiashuai / Shi, Dongni / Cui, Wanting / Ma, Yanfang / Wu, Taixiang / Chan, Chun Pong / Lyu, Aiping / Yao, Chen / Bian, Zhaoxiang

Journal of evidence-based medicine

2023 Volume 16, Issue 1, Page(s) 16–18

MeSH term(s)	Cross-Sectional Studies ; Research Design ; Multicenter Studies as Topic
Language	English
Publishing date	2023-03-03
Publishing country	England
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	2474496-7
ISSN	1756-5391 ; 1756-5383
ISSN (online)	1756-5391
ISSN	1756-5383
DOI	10.1111/jebm.12519
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Article: A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients.

Cheng, Chung-Wah / Mok, Hoi-Fung / Yau, Cora W S / Chan, Jasmine T M / Kang, Yu-Chen / Lam, Pui-Yan / Zhong, Linda L D / Zhao, Chen / Ng, Bacon F L / Kwok, Annie O L / Tse, Doris M W / Bian, Zhao-Xiang

Chinese medicine

2022 Volume 17, Issue 1, Page(s) 31

Abstract: Background: Constipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by ... ...

Abstract	Background: Constipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation. Methods: This is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened. Results: Sixty patients, with mean age 75.2 years (range 47-95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication. Conclusion: This pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care. Trial registration: The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [ https://clinicaltrials.gov/ct2/show/NCT02795390 ] on June 10, 2016.
Language	English
Publishing date	2022-03-02
Publishing country	England
Document type	Journal Article
ZDB-ID	2260322-0
ISSN	1749-8546
ISSN	1749-8546
DOI	10.1186/s13020-022-00580-0
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Article ; Online: Impact of psychological stress on irritable bowel syndrome.

Qin, Hong-Yan / Cheng, Chung-Wah / Tang, Xu-Dong / Bian, Zhao-Xiang

World journal of gastroenterology

2014 Volume 20, Issue 39, Page(s) 14126–14131

Abstract: Psychological stress is an important factor for the development of irritable bowel syndrome (IBS). More and more clinical and experimental evidence showed that IBS is a combination of irritable bowel and irritable brain. In the present review we discuss ... ...

Abstract	Psychological stress is an important factor for the development of irritable bowel syndrome (IBS). More and more clinical and experimental evidence showed that IBS is a combination of irritable bowel and irritable brain. In the present review we discuss the potential role of psychological stress in the pathogenesis of IBS and provide comprehensive approaches in clinical treatment. Evidence from clinical and experimental studies showed that psychological stresses have marked impact on intestinal sensitivity, motility, secretion and permeability, and the underlying mechanism has a close correlation with mucosal immune activation, alterations in central nervous system, peripheral neurons and gastrointestinal microbiota. Stress-induced alterations in neuro-endocrine-immune pathways acts on the gut-brain axis and microbiota-gut-brain axis, and cause symptom flare-ups or exaggeration in IBS. IBS is a stress-sensitive disorder, therefore, the treatment of IBS should focus on managing stress and stress-induced responses. Now, non-pharmacological approaches and pharmacological strategies that target on stress-related alterations, such as antidepressants, antipsychotics, miscellaneous agents, 5-HT synthesis inhibitors, selective 5-HT reuptake inhibitors, and specific 5-HT receptor antagonists or agonists have shown a critical role in IBS management. A integrative approach for IBS management is a necessary.
MeSH term(s)	Animals ; Brain/physiopathology ; Humans ; Intestines/innervation ; Irritable Bowel Syndrome/etiology ; Irritable Bowel Syndrome/physiopathology ; Irritable Bowel Syndrome/psychology ; Irritable Bowel Syndrome/therapy ; Prognosis ; Risk Factors ; Stress, Psychological/complications ; Stress, Psychological/physiopathology ; Stress, Psychological/psychology ; Stress, Psychological/therapy
Language	English
Publishing date	2014-10-21
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2185929-2
ISSN	2219-2840 ; 1007-9327
ISSN (online)	2219-2840
ISSN	1007-9327
DOI	10.3748/wjg.v20.i39.14126
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration.

Zhang, Xuan / Lan, Liang / Chan, Jacky C P / Zhong, Linda L D / Cheng, Chung-Wah / Lam, Wai-Ching / Tian, Ran / Zhao, Chen / Wu, Tai-Xiang / Shang, Hong-Cai / Lyu, Ai-Ping / Bian, Zhao-Xiang

BMC medical research methodology

2020 Volume 20, Issue 1, Page(s) 192

Abstract: Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting ... ...

Abstract	Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion-are elaborated. Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.
MeSH term(s)	Checklist ; Humans ; Medicine, Chinese Traditional ; Registries ; Research Report ; World Health Organization
Language	English
Publishing date	2020-07-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1471-2288
ISSN (online)	1471-2288
DOI	10.1186/s12874-020-01077-w
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Article ; Online: PRISMA extension for moxibustion 2020: recommendations, explanation, and elaboration.

Zhang, Xuan / Tan, Ran / Lam, Wai Ching / Cheng, Chung Wah / Yao, Liang / Wang, Xiao-Qin / Li, Si-Yao / Aixinjueluo, Qi-Ying / Yang, Ke-Hu / Shang, Hong-Cai / Wu, Tai-Xiang / Lyu, Ai-Ping / Bian, Zhao-Xiang

Systematic reviews

2020 Volume 9, Issue 1, Page(s) 247

Abstract: Background: Moxibustion is a common intervention of Chinese medicine (CM). Systematic reviews (SRs) on moxibustion are increasing. Although the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement provides guidelines for ...

Abstract	Background: Moxibustion is a common intervention of Chinese medicine (CM). Systematic reviews (SRs) on moxibustion are increasing. Although the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement provides guidelines for SRs, the quality of moxibustion-related SRs is still not satisfactory. In particular, descriptions of the interventions and the rationale for using moxibustion are insufficient. To address these inadequacies, the working group developed this PRISMA extension for reporting SRs of moxibustion (PRISMA-M 2020). Methods: A group of CM clinical professionals, methodologists of SRs, reporting guideline developers, and journal editors developed this PRISMA-M 2020 through a comprehensive process that includes registration, literature review, consensus meetings, Delphi exercises for soliciting comments, and revision, resulting in this final draft. Results: Seven of the 27 PRISMA checklist items, namely title (1), rationale (3), eligibility criteria (6), data item (11), additional analyses (16), study characteristics (18), and additional analysis (23), were extended, with specific reference to the application of moxibustion. Illustrative examples and explanations for each item are provided. Conclusion: The PRISMA-M 2020 will help improve the reporting quality of SRs with moxibustion. Systematic review registration: We have registered it on the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network, particularly under the item of PRISMA-TCM: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-systematic-reviews/#65 .
MeSH term(s)	Checklist ; Humans ; Meta-Analysis as Topic ; Moxibustion ; Research Report ; Systematic Reviews as Topic/standards
Language	English
Publishing date	2020-10-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2662257-9
ISSN	2046-4053 ; 2046-4053
ISSN (online)	2046-4053
ISSN	2046-4053
DOI	10.1186/s13643-020-01502-7
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Extension for Chinese Herbal Medicines 2020 (PRISMA-CHM 2020).

Zhang, Xuan / Tan, Ran / Lam, Wai Ching / Yao, Liang / Wang, Xiaoqin / Cheng, Chung Wah / Liu, Fan / Chan, Jacky Cp / Aixinjueluo, Qiying / Lau, Chung Tai / Chen, Yaolong / Yang, Kehu / Wu, Taixiang / Lyu, Aiping / Bian, Zhaoxiang

The American journal of Chinese medicine

2020 Volume 48, Issue 6, Page(s) 1279–1313

Abstract: Chinese Herbal Medicines (CHM) are the most common interventions of traditional Chinese medicine (TCM), typically administered as either single herbs or formulas. Systematic reviews (SRs) are essential references for evaluating the efficacy and safety of ...

Abstract	Chinese Herbal Medicines (CHM) are the most common interventions of traditional Chinese medicine (TCM), typically administered as either single herbs or formulas. Systematic reviews (SRs) are essential references for evaluating the efficacy and safety of CHM treatments accurately and reliably. Unfortunately, the reporting quality of SRs with CHM is not optimal, especially the reporting of CHM interventions and the rationale of why these interventions were selected. To address this problem, a group of TCM clinical experts, methodologists, epidemiologists, and editors has developed a PRISMA extension for CHM interventions (PRISMA-CHM) through a comprehensive process, including registration, literature review, consensus meeting, three-round Delphi survey, and finalization. The PRISMA checklist was extended by introducing the concept of TCM Pattern and the characteristics of CHM interventions. A total of twenty-four items (including sub-items) are included in the checklist, relating to title (1), structured summary (2), rationale (3), objectives (4), eligibility criteria (6), data items (11), synthesis of results (14, 21), additional analyses (16, 23), study characteristics (18), summary of evidence (24), and conclusions (26). Illustrative examples and explanations are also provided. The group hopes that PRISMA-CHM 2020 will improve the reporting quality of SRs of CHM.
MeSH term(s)	Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional ; Meta-Analysis as Topic ; Safety ; Systematic Reviews as Topic ; Treatment Outcome
Chemical Substances	Drugs, Chinese Herbal
Language	English
Publishing date	2020-09-09
Publishing country	Singapore
Document type	Journal Article ; Review
ZDB-ID	193085-0
ISSN	1793-6853 ; 0090-2942 ; 0192-415X
ISSN (online)	1793-6853
ISSN	0090-2942 ; 0192-415X
DOI	10.1142/S0192415X20500639
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Article: Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial.

Zheng, Ya / Ching, Jessica / Cheng, Chung Wah / Lam, Wai Ching / Chan, Kam Leung / Zhang, Xuan / Lam, Pui Yan / Wu, Xing Yao / Zhong, Linda L D / Cao, Pei Hua / Lo, Cho Wing / Cheong, Pui Kuan / Lin, Zhixiu / Koh, Matthew / Wu, Justin / Bian, Zhao Xiang

Chinese medicine

2021 Volume 16, Issue 1, Page(s) 117

Abstract: Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work ... ...

Abstract	Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods: This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. RESULTS: A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion: The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1.
Language	English
Publishing date	2021-11-13
Publishing country	England
Document type	Journal Article
ZDB-ID	2260322-0
ISSN	1749-8546
ISSN	1749-8546
DOI	10.1186/s13020-021-00530-2
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Article ; Online: CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Traditional Chinese Version).

Cheng, Chung-Wah / Wu, Tai-Xiang / Shang, Hong-Cai / Li, You-Ping / Altman, Douglas G / Moher, David / Bian, Zhao-Xiang

Annals of internal medicine

2017 Volume 167, Issue 2, Page(s) W7–W20

Abstract: Editors' Note: This article is the traditional Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 ...

Abstract	Editors' Note: This article is the traditional Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112-21. [Epub 27 June 2017]. doi:10.7326/M16-2977).
MeSH term(s)	Checklist ; Drugs, Chinese Herbal/standards ; Humans ; Publishing/standards ; Quality Control ; Randomized Controlled Trials as Topic/standards ; Research Design/standards
Chemical Substances	Drugs, Chinese Herbal
Language	English
Publishing date	2017-06-27
Publishing country	United States
Document type	Guideline ; Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/IsTranslatedFrom_M17-2977_1
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