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Article ; Online: COVID-19 disparities: An urgent call for race reporting and representation in clinical research.

Borno, Hala T / Zhang, Sylvia / Gomez, Scarlett

Contemporary clinical trials communications

2020 Volume 19, Page(s) 100630

Abstract: Background: Racial/ethnic disparities in disease burden have gained the spotlight in the United States with the spread of SARS-CoV-2 and surge of COVID-19 cases. The problem of underrepresentation in clinical research persists today. In light of the ... ...

Abstract	Background: Racial/ethnic disparities in disease burden have gained the spotlight in the United States with the spread of SARS-CoV-2 and surge of COVID-19 cases. The problem of underrepresentation in clinical research persists today. In light of the considerable COVID-19 disparities observed, this study sought to assess the race reporting and representation among COVID-19 therapeutic studies published to date. Methods: All published COVID-19 treatment-related clinical research studies with study participants in the United States were identified. For each study, the date published, treatment investigated, study design, race/ethnicity of participants, sample size and study site were recorded. For each study site, the race/ethnicity demographics of confirmed COVID-19 positive cases were identified utilizing online publicly available department of public health data. Results: Six studies (n = 3, observational; n = 3, randomized clinical trial) have been published to date with participants in the United States. A subset (n = 4) reported race/ethnicity data in the publication. Black patients were underrepresented in all studies relative to the affected population in the cities in which the studies took place. Conclusions: Given that racial/ethnic disparities in COVID-19 disease burden and outcomes have emerged in the United States, it is essential that all investigators uniformly report race/ethnicity data as well as attempt, in earnest, to obtain representativeness among study participants in order to ensure that we do not develop a further widening of the treatment gap during this pandemic.
Keywords	covid19
Language	English
Publishing date	2020-07-30
Publishing country	Netherlands
Document type	Journal Article
ISSN	2451-8654
ISSN (online)	2451-8654
DOI	10.1016/j.conctc.2020.100630
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Experiences of a Multiethnic Cohort of Patients Enrolled in a Financial Reimbursement Program for Cancer Clinical Trials.

Medina, Sheyla P / Zhang, Sylvia / Nieves, Elena / Dornsife, Dana L / Johnson, Robert / Spicer, Darcy / Borno, Hala T

JCO oncology practice

2023 Volume 19, Issue 5, Page(s) e801–e810

Abstract: Purpose: Financial reimbursement programs (FRPs) offset out-of-pocket (OOP) expenses from therapeutic clinical trial (TCT) participation. The study explores patients' experience in TCTs after enrollment in a FRP at two academic medical centers, ... ...

Abstract	Purpose: Financial reimbursement programs (FRPs) offset out-of-pocket (OOP) expenses from therapeutic clinical trial (TCT) participation. The study explores patients' experience in TCTs after enrollment in a FRP at two academic medical centers, including barriers and opportunities to improve trial participation. Methods: From May 2019 to January 2020, adults diagnosed with cancer and eligible for TCTs and FRP were recruited from the Improving Patient Access to Cancer Clinical Trials randomized trial at the University of California San Francisco and University of Southern California. Patients with income ≤ 700% of national poverty guidelines were eligible. Semistructured interviews were conducted in patients' preferred language. Qualitative analysis was performed by site and preferred language by two independent coders. Results: Of 65 trial patients, 53 participated (38%, University of California San Francisco; 62%, USC). The median age was 59 (IQR, 46-65) years, and 58% were female. Nearly half (49%) identified as Latinx/Hispanic compared with 32% non-Hispanic White, 10% Asian, 4% Black, 1% Native American, and 4% Others. A third were non-English speakers, 42% had college education or more, and 55% were retired/unemployed. Most common malignancies were gastrointestinal (42%), breast (19%), and genitourinary (13%), and 66% had metastatic disease. Patients experienced long travel time (1-4.5 hours) among 57% and financial toxicity from OOP costs (68%). High acceptability of the FRP was reported (81%). Although 30% of patients reported willingness to discuss finances of cancer treatment/trial with physicians, majority (87%) preferred discussion with social workers or TCT staff. Proposed modifications to TCTs included decentralization, recruitment strategies, voucher structure, and established rates for OOP expenses. Conclusion: Patients' experience with TCTs reveal financial and logistical stressors that may be lessened by the Improving Patient Access to Cancer Clinical Trial reimbursement program. FRPs may address inequities in clinical trial access among low-income and diverse populations.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Middle Aged ; Academic Medical Centers ; Hispanic or Latino ; Neoplasms/therapy ; Reimbursement Mechanisms ; Health Expenditures ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2023-02-17
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.22.00429
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Examining reporting and representation of patients with cancer in COVID-19 clinical trials.

Rabow, Maya / Wang, Christine / Zhang, Sylvia / Tahir, Peggy Mary / Small, Eric J / Borno, Hala T

Cancer reports (Hoboken, N.J.)

2021 Volume 4, Issue 4, Page(s) e1355

Abstract: Background: Patients with cancer are particularly vulnerable in the current COVID-19 pandemic. Emerging evidence suggests that patients with a cancer diagnosis are three times more likely to die from COVID-19 compared to non-cancer patients. Due to ... ...

Abstract	Background: Patients with cancer are particularly vulnerable in the current COVID-19 pandemic. Emerging evidence suggests that patients with a cancer diagnosis are three times more likely to die from COVID-19 compared to non-cancer patients. Due to these observed risks, it is critical that emerging COVID-19 therapies demonstrate safety and efficacy among patients with cancer. Aim: This study sought to examine reporting and representation of patients with cancer among published COVID-19 treatment-related research studies. Methods and results: All published COVID-19 treatment-related clinical research studies published from March 1 to August 20, 2020 recruiting from North America and Europe were identified. The date published, study design, therapeutics studied, and study population were evaluated. Of the 343 studies identified through initial search and researcher knowledge, 55 (16%) reported on COVID-19 treatments. Twenty-one COVID-19 therapeutic studies (n = 15, prospective; n = 6, retrospective) that recruited from the United States and Europe were identified. Among these studies, eight (38%) reported on the number of trial participants with a cancer diagnosis in the publication and two (10%) specified tumor type. Four of the studies (19%) did not collect cancer history. Among studies where cancer history was available, patients with a cancer diagnosis participated at a proportion higher than overall cancer prevalence and greater than the known proportion of COVID-19 patients with cancer. Conclusion: This study observed that cancer history was not uniformly collected or reported among published COVID-19 therapeutic studies. Among reported publications, we observed that patients with a cancer diagnosis were generally overrepresented. However, patients with a cancer diagnosis were notably underrepresented in outpatient COVID-19 therapeutic studies.
MeSH term(s)	COVID-19/complications ; COVID-19/transmission ; COVID-19/virology ; Clinical Trials as Topic/statistics & numerical data ; Europe/epidemiology ; Humans ; Neoplasms/epidemiology ; Neoplasms/virology ; North America/epidemiology ; Prospective Studies ; Retrospective Studies ; SARS-CoV-2/isolation & purification
Language	English
Publishing date	2021-02-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2573-8348
ISSN (online)	2573-8348
DOI	10.1002/cnr2.1355
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: COVID-19 disparities: An urgent call for race reporting and representation in clinical research

Borno, Hala T / Zhang, Sylvia / Gomez, Scarlett

Contemp Clin Trials Commun

Abstract	Background: Racial/ethnic disparities in disease burden have gained the spotlight in the United States with the spread of SARS-CoV-2 and surge of COVID-19 cases. The problem of underrepresentation in clinical research persists today. In light of the considerable COVID-19 disparities observed, this study sought to assess the race reporting and representation among COVID-19 therapeutic studies published to date. Methods: All published COVID-19 treatment-related clinical research studies with study participants in the United States were identified. For each study, the date published, treatment investigated, study design, race/ethnicity of participants, sample size and study site were recorded. For each study site, the race/ethnicity demographics of confirmed COVID-19 positive cases were identified utilizing online publicly available department of public health data. Results: Six studies (n = 3, observational; n = 3, randomized clinical trial) have been published to date with participants in the United States. A subset (n = 4) reported race/ethnicity data in the publication. Black patients were underrepresented in all studies relative to the affected population in the cities in which the studies took place. Conclusions: Given that racial/ethnic disparities in COVID-19 disease burden and outcomes have emerged in the United States, it is essential that all investigators uniformly report race/ethnicity data as well as attempt, in earnest, to obtain representativeness among study participants in order to ensure that we do not develop a further widening of the treatment gap during this pandemic.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #688730
Database	COVID19

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Article ; Online: COVID-19 disparities

Borno, Hala T. / Zhang, Sylvia / Gomez, Scarlett

Contemporary Clinical Trials Communications

An urgent call for race reporting and representation in clinical research

2020 Volume 19, Page(s) 100630

Keywords	covid19
Language	English
Publisher	Elsevier BV
Publishing country	us
Document type	Article ; Online
ISSN	2451-8654
DOI	10.1016/j.conctc.2020.100630
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study.

Wang, Elizabeth Y / Borno, Hala T / Washington Iii, Samuel L / Friedlander, Terence / Zhang, Sylvia / Trejo, Evelin / Van Blarigan, Erin L / Chan, June M / Shariff-Marco, Salma / Beatty, Alexis L / Kenfield, Stacey A

JMIR cancer

2023 Volume 9, Page(s) e45432

Abstract: Background: Healthy diet and exercise can improve quality of life and prognosis among men with prostate cancer. Understanding the perceived barriers to lifestyle change and patient preferences in a diverse cohort of men with prostate cancer is necessary ...

Abstract	Background: Healthy diet and exercise can improve quality of life and prognosis among men with prostate cancer. Understanding the perceived barriers to lifestyle change and patient preferences in a diverse cohort of men with prostate cancer is necessary to inform mobile health (mHealth) lifestyle interventions and increase health equity. Objective: We conducted a multisite study to understand the preferences, attitudes, and health behaviors related to diet and lifestyle in this patient population. This report focuses on the qualitative findings from 4 web-based focus groups comprising a racially and ethnically diverse group of patients with advanced prostate cancer who are on androgen deprivation therapy. Methods: We used grounded theory analyses including open, axial, and selective coding to generate codes. Qualitative data were analyzed as a whole rather than by focus group to optimize data saturation and the transferability of results. We present codes and themes that emerged for lifestyle intervention design and provide recommendations and considerations for future mHealth intervention studies. Results: Overall, 14 men participated in 4 racially and ethnically concordant focus groups (African American or Black: 3/14, 21%; Asian American: 3/14, 21%; Hispanic or Latino: 3/14, 21%; and White: 5/14, 36%). Analyses converged on 7 interwoven categories: context (home environment, access, competing priorities, and lifestyle programs), motivation (accountability, discordance, feeling supported, fear, and temptation), preparedness (health literacy, technological literacy, technological preferences, trust, readiness to change, identity, adaptability, and clinical characteristics), data-driven design (education, psychosocial factors, and quality of life), program mechanics (communication, materials, customization, and being holistic), habits (eg, dietary habits), and intervention impressions. These results suggest actionable pathways to increase program intuitiveness. Recommendations for future mHealth intervention design and implementation include but are not limited to assessment at the individual, household, and neighborhood levels to support a tailored intervention; prioritization of information to disseminate based on individuals' major concerns and the delivery of information based on health and technological literacy and communication preferences; prescribing a personalized intervention based on individuals' baseline responses, home and neighborhood environment, and support network; and incorporating strategies to foster engagement (eg, responsive and relevant feedback systems) to aid participant decision-making and behavior change. Conclusions: Assessing a patient's social context, motivation, and preparedness is necessary when tailoring a program to each patient's needs in all racial and ethnic groups. Addressing the patients' contexts and motivation and preparedness related to diet and exercise including the household, access (to food and exercise), competing priorities, health and technological literacy, readiness to change, and clinical characteristics will help to customize the intervention to the participant. These data support a tailored approach leveraging the identified components and their interrelationships to ensure that mHealth lifestyle interventions will engage and be effective in racially and ethnically diverse patients with cancer. Trial registration: ClinicalTrials.gov NCT05324098; https://clinicaltrials.gov/ct2/show/NCT05324098.
Language	English
Publishing date	2023-06-01
Publishing country	Canada
Document type	Journal Article
ISSN	2369-1999
ISSN	2369-1999
DOI	10.2196/45432
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Integration of electronic pathology reporting with clinical trial matching for advanced prostate cancer.

Borno, Hala T / Duffy, Christine / Zhang, Sylvia / Canchola, Alison J / Loya, Zinnia / Golden, Todd / Oh, Debora L / Odisho, Anobel Y / Gomez, Scarlett

Urologic oncology

2021 Volume 39, Issue 8, Page(s) 494.e7–494.e14

Abstract: Introduction: Racial/ethnic diversity in prostate cancer (CaP) clinical trials (CTs) is essential to address CaP disparities. California Cancer Registry mandated electronic reporting (e-path) of structured data elements from pathologists diagnosing ... ...

Abstract	Introduction: Racial/ethnic diversity in prostate cancer (CaP) clinical trials (CTs) is essential to address CaP disparities. California Cancer Registry mandated electronic reporting (e-path) of structured data elements from pathologists diagnosing cancer thereby creating an opportunity to identify and approach patients rapidly. This study tested the utility of an online CT matching tool (called Trial Library) used in combination with e-path to improve matching of underrepresented CaP patients into CTs at time of diagnosis. Methods: This was a nonrandomized, single-arm feasibility study among patients with a new pathologic diagnosis of high-risk CaP (Gleason Score ≥8). Eligible patients were sent recruitment materials and enrolled patients were introduced to Trial Library. Results: A total of 419 case listings were assessed. Patients were excluded due to physician contraindication, not meeting baseline eligibility, or unable to be reached. Final participants (N = 52) completed a baseline survey. Among study participants, 77% were White, 10% were Black/Hispanic/Missing, and 14% were Asian. The majority of the study participants were over 65 years of age (81%) and Medicare insured (62%). Additionally, 81% of participants reported using the Internet to learn about CaP. The majority (62%) of participants reported that Trial Library increased their interest in CT participation. Conclusions: The current study demonstrated that leveraging structured e-path data reporting to a population-based cancer registry to recruit men with high risk CaP to clinical research is feasible and acceptable. We observed that e-path may be linked with an online CT matching tool, Trial Library. Future studies will prioritize recruitment from reporting facilities that serve more racially/ethnically diverse patient populations.
MeSH term(s)	Aged ; Aged, 80 and over ; Clinical Trials as Topic/statistics & numerical data ; Electronic Health Records/statistics & numerical data ; Ethnicity/statistics & numerical data ; Feasibility Studies ; Follow-Up Studies ; Health Knowledge, Attitudes, Practice ; Humans ; Male ; Middle Aged ; Non-Randomized Controlled Trials as Topic ; Pathology, Clinical/methods ; Patient Selection ; Prognosis ; Prostatic Neoplasms/pathology ; Racial Groups/statistics & numerical data
Language	English
Publishing date	2021-01-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1336505-8
ISSN	1873-2496 ; 1078-1439
ISSN (online)	1873-2496
ISSN	1078-1439
DOI	10.1016/j.urolonc.2020.12.010
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Serological Testing for Mycobacterial Heat Shock Protein

Zhang, Peilin / Minardi, Lawrence M / Kuenstner, John Todd / Zhang, Sylvia T / Zekan, Steve M / Kruzelock, Rusty

Microorganisms

2019 Volume 8, Issue 1

Abstract: Mycobacterial heat shock protein 65 gene ( ...

Abstract	Mycobacterial heat shock protein 65 gene (
Language	English
Publishing date	2019-12-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms8010047
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Article: Serological Testing for Mycobacterial Heat Shock Protein Hsp65 Antibody in Health and Diseases

Zhang, Peilin / Minardi, Lawrence M. / Kuenstner, John Todd / Zhang, Sylvia T. / Zekan, Steve M. / Kruzelock, Rusty

Microorganisms. 2019 Dec. 25, v. 8, no. 1

2019

Abstract: Mycobacterial heat shock protein 65 gene (Hsp65) has been widely used for classification of Mycobacterial species, and detection of Mycobacterial genes by molecular methods and has proven useful in identification of Mycobacterial infection in various ... ...

Abstract	Mycobacterial heat shock protein 65 gene (Hsp65) has been widely used for classification of Mycobacterial species, and detection of Mycobacterial genes by molecular methods and has proven useful in identification of Mycobacterial infection in various clinical conditions. Circulating antibody against Mycobacterial hsp65 has been found in many clinical diseases including autoimmune diseases (Crohn’s disease, lupus erythematosus, multiple sclerosis, diabetes, etc.), atherosclerosis and cancers. The prevalence of anti-Hsp65 antibody in the normal healthy population is unknown. We determined the blood levels of antibody against Mycobacterial hsp65 in the normal population represented by 288 blood donors of the American Red Cross and tested the blood of 109 patients with Crohn’s disease and 28 patients with Sjogren’s syndrome for comparison. The seroprevalence of anti-Hsp65 IgG in the normal population of Red Cross donors was 2.8% (8 of 288 positive). The Hsp65 antibody levels were significantly elevated in patients with Crohn’s disease and Sjogren’s syndrome. The prevalence of Hsp65 antibody in Crohn’s disease patients was 67.9% (74 of 109 patients), and 85.7% for Sjogren’s patients (24 of 28 patients). Our data indicate that anti-Hsp65 antibody is rare in the normal population, but frequent in chronic diseases. The presence of circulating Hsp65 antibody reflects an abnormal immune (adaptive) response to Mycobacterial exposure in patients with chronic diseases, thus differentiating the patients with chronic diseases from those clinical mimics.
Keywords	antibodies ; atherosclerosis ; blood ; diabetes ; genes ; heat shock proteins ; lupus erythematosus ; mycobacterial diseases ; sclerosis ; seroprevalence
Language	English
Dates of publication	2019-1225
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms8010047
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Implementation of a Multisite Financial Reimbursement Program in Cancer Clinical Trials Integrated With Patient Navigation: A Pilot Randomized Clinical Trial.

Borno, Hala T / Zhang, Li / Zhang, Sylvia / Lin, Tracy K / Skafel, Andrea / Nieves, Elena / Dornsife, Dana / Johnson, Robert / Rhoads, Kim / Small, Eric / Spicer, Darcy

JCO oncology practice

2022 Volume 18, Issue 6, Page(s) e915–e924

Abstract: Purpose: Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical ... ...

Abstract	Purpose: Cancer clinical trial participants face considerable indirect costs associated with participation, such as travel and lodging, which may contribute to poor enrollment. Here, we report the findings in IMproving Patient Access to Cancer clinical Trials, a pilot feasibility study investigating the efficacy of offering a financial reimbursement program (FRP) during a therapeutic clinical trial discussion with or without additional outreach in improving patient enrollment. Methods: Study participants for this study were recruited at two National Cancer Institute-designated comprehensive cancer centers (CCCs) from April 8, 2019, to September 19, 2019. Eligible participants were adults with a cancer diagnosis being approached to consider enrollment in a clinical trial. Participants were randomly assigned 1:1 to receive no follow-up (usual care) or a follow-up telephone call to facilitate FRP utilization stratified by study site. The target enrollment was 132 patients, with 66 patients in each study arm. The primary outcome was the consent rate to the multisite interventional study on the FRP among participants enrolling in clinical trials. Results: The study had a 78% consent rate and enrolled a total of 132 participants, of whom 51% were non-White compared with 28% of CCC treatment clinical trial participants in 2019. No difference in enrollment in clinical trials between the two study arms was observed as the proportion of enrollment was 70% for both study arms. The most common reason for not enrolling in a clinical trial was due to ineligibility determined through screening procedures (75%). Conclusion: The current study observed that implementation of FRP at CCCs is feasible and serves a diverse patient population. Future studies will measure the impact of programs on overall clinical trial accrual and among racial/ethnic minorities.
MeSH term(s)	Adult ; Feasibility Studies ; Humans ; National Cancer Institute (U.S.) ; Neoplasms/epidemiology ; Neoplasms/therapy ; Patient Navigation ; Pilot Projects ; United States
Language	English
Publishing date	2022-02-23
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.21.00328
Database	MEDical Literature Analysis and Retrieval System OnLINE

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