Catalogue Search | MBRL
Are you sure you want to remove the book from the shelf?
{{itemTitle}}
203
result(s) for
"Harris, Gavin"
Sort by:
Exclusion of pregnant people from emergency vaccine clinical trials: A systematic review of clinical trial protocols and reporting from 2009 to 2019
•Pregnant people are underrepresented in emergency vaccine clinical trials.•Incident pregnancies and related outcomes are underreported in vaccine clinical trials.•Public health emergencies often present disproportionate risk to pregnant people and neonates.•It is both ethical and feasible to enroll pregnant people safely into vaccine trials.•Plans for generating pregnancy-specific data during emergencies are needed.
Existing ethics guidance and regulatory requirements emphasize the need for pregnancy-specific safety and efficacy data during the development of vaccines in health emergencies. Our objective was to conduct a systematic review of vaccine clinical trials during active epidemic periods.
We searched for Phase II and Phase III vaccine clinical trials initiated during the H1N1 influenza, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Zika, and Ebola virus disease (EVD) outbreaks from 2009 to 2019. Data were extracted from clinical trial protocols identified in the following registries: ClinicalTrials.gov, Pan African Clinical Trial Registry (PACTR), and all primary registries indicated by the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). Published studies from registered clinical trials were located through PubMed. Data was extracted on eligibility criteria and pregnancy outcomes. Data from this study is available in the Center for Open Science Data Repository: https://osf.io/nfk2p/?view_only=47deb3b206724af9b46c9c0c0083a267.
We identified 96 vaccine clinical trial protocols and included 84 in analysis. 5 records were excluded in screening for irrelevant abstracts, 7 were excluded in full-text assessment (1 for a therapeutic drug trial, 3 for enrolling elderly adults only, 3 for enrolling children/adolescents only). There were no eligible trials for MERS-CoV or Zika virus vaccines. Overall, 8 protocols explicitly included pregnant people; of these, 3 were completed trials with published results. Incidental pregnancies and outcomes of pregnant participants were reported in 2 studies, 10 studies reported serious adverse events related to pregnancy without mentioning total incidental pregnancies. A total of 411 recorded pregnancy outcomes were reported, with 293 from the 3 pregnancy-eligible studies with results. 71 serious adverse events pertaining to pregnancy were reported from all clinical trials with results.
Pregnant people are underrepresented in vaccine clinical trials conducted during outbreaks, resulting in underreporting of pregnancy-related outcomes and a lack of protection for pregnant people and neonates from infectious diseases.
Journal Article
The layout book
\"A fascinating exploration of this fundamental aspect of graphic design, The Layout Book explains the hows, whys and why-nots of the placing of elements on a page or screen layout. A historical overview of the subject is followed by a systematic look at key theoretical principles and practical applications.Offering a huge array of potential layout options and with over 250 colour illustrations from some of the world's leading design studios, this is a uniquely inspiring guide to graphic design. The second edition has also been updated to include interviews with practising designers, as well as new study points to aid readers in their own explorations.Invaluable for design students looking for a better understanding of layout design, and inspiring for working designers, The Layout Book proves itself as a graphic design must-have\"-- Provided by publisher.
Book
Metaplastic breast cancers frequently express immune checkpoint markers FOXP3 and PD-L1
Background
Metaplastic breast carcinoma encompasses a heterogeneous group of tumours with differentiation into squamous and/or spindle, chondroid, osseous or rhabdoid mesenchymal-looking elements. Emerging immunotherapies targeting Programmed Death Ligand 1 (PD-L1) and immune-suppressing T cells (Tregs) may benefit metaplastic breast cancer patients, which are typically chemo-resistant and do not express hormone therapy targets.
Methods
We evaluated the immunohistochemical expression of PD-L1 and FOXP3, and the extent of tumour infiltrating lymphocytes (TILs) in a large cohort of metaplastic breast cancers, with survival data.
Results
Metaplastic breast cancers were significantly enriched for PD-L1 positive tumour cells, compared to triple-negative ductal breast cancers (
P
< 0.0001), while there was no significant difference in PD-L1 positive TILs. Metaplastic breast cancers were also significantly enriched for TILs expressing FOXP3, with FOXP3 positive intra-tumoural TILs (iTILs) associated with an adverse prognostic outcome (
P
= 0.0226). Multivariate analysis identified FOXP3 iTILs expression status as an important independent prognostic factor for patient survival.
Conclusions
Our findings indicate the clinical significance and prognostic value of FOXP3, PD-1/PD-L1 checkpoint and TILs in metaplastic breast cancer and confirm that a subset of metaplastics may benefit from immune-based therapies.
Journal Article
Format for graphic designers
From traditional print to digital formats for mobile phones and tablets, this book provides a clear introduction to the creative use of format in graphic design. Using 200 inspirational examples from contemporary international designers, Format for Graphic Designers guides the student through the role of format in both the purpose and the narrative of a design. The authors look at the physical aspects of formats - traditional and experimental, print and digital - to explore innovative solutions and, through case studies, explore how and why professional designers choose particular formats for a job. Covering everything from books and magazines, point-of-purchase displays, packaging, direct mail, brochures, and screen-based formats, the new edition illuminates this critical element of design practice for students, and provides them with a solid foundation on which to build their own designs.
Book
Interactive Effects of Climate and Large Herbivore Assemblage Drive Plant Functional Traits and Diversity
Large herbivore communities are changing globally, with populations of wild herbivores generally declining while domestic herbivore populations are increasing, influencing ecosystem function along with the impacts of climate change. Manipulative experiments have rarely captured the interaction between patterns of large herbivore assemblage change and climatic conditions. This interaction may affect the functional traits and functional diversity of herbaceous communities; this requires investigation, as these metrics have been useful proxies for ecosystem function. We used a large herbivore exclosure experiment replicated along a topo-climatic gradient to explore the interaction between climate and herbivore assemblage on community-level functional traits and the functional diversity of herbaceous plant understories. Our findings demonstrate interacting effects between large herbivore assemblages and climate. We found a shift from drought-tolerant traits to drought-avoidant traits with increasing aridity, specifically with regard to plant leaf area and specific leaf area. We also determined that plant community responses to grazing changed from an herbivore avoidance strategy at drier sites to a more herbivore-tolerant strategy at wetter sites. We observed that the effects of herbivores on community-level traits can sometimes counteract those of climate. Finally, we found that cattle and large wild herbivores can differ in the magnitude and direction of effects on functional traits and diversity.
Journal Article
Design thinking for visual communication
\"Now in its second edition, the highly popular Design Thinking for Visual Communication identifies methods and thought processes used by designers in order to start the process that eventually leads to a finished piece of work. Step-by-step guidance for each part of the process is highlighted by real-life case studies, enabling the student to see teaching in practice. This focus on ideas and methods eschews an abstract, academic approach in favour of a useable approach to design as a problem-solving activity. The new edition now includes contributions from a broader international range of design practices and adds depth to existing case studies by looking in greater detail at some of the processes used\"--Amazon.Com.
Book
Dual-Color Fluorescence In Situ Hybridization Reveals an Association of Chromosome 8q22 but Not 8p21 Imbalance with High Grade Invasive Breast Carcinoma
We previously reported molecular karyotype analysis of invasive breast tumour core needle biopsies by comparative genomic hybridization (CGH) and fluorescence in situ hybridization (FISH) (Walker et al, Genes Chromosomes Cancer, 2008 May;47(5):405-17). That study identified frequently recurring gains and losses involving chromosome bands 8q22 and 8p21, respectively. Moreover, these data highlighted an association between 8q22 gain and typically aggressive grade 3 tumors. Here we validate and extend our previous investigations through FISH analysis of tumor touch imprints prepared from excised breast tumor specimens. Compared to post-surgical tumor excisions, core needle biopsies are known to be histologically less precise when predicting tumor grade. Therefore investigating these chromosomal aberrations in tumor samples that offer more reliable pathological assessment is likely to give a better overall indication of association. A series of 60 breast tumors were screened for genomic copy number changes at 8q22 and 8p21 by dual-color FISH. Results confirm previous findings that 8p loss (39%) and 8q gain (74%) occur frequently in invasive breast cancer. Both absolute quantification of 8q22 gain across the sample cohort, and a separate relative assessment by 8q22:8p21 copy number ratio, showed that the incidence of 8q22 gain significantly increased with grade (p = 0.004, absolute and p = 0.02, relative). In contrast, no association was found between 8p21 loss and tumor grade. These findings support the notion that 8q22 is a region of interest for invasive breast cancer pathogenesis, potentially harboring one or more genes that, when amplified, precipitate the molecular events that define high tumor grade.
Journal Article
US Hospital Capacity Managers’ Experiences and Concerns Regarding Preparedness for Seasonal Influenza and Influenza-like Illness
The 2017-2018 influenza season in the US was marked by a high severity of illness, wide geographic spread, and prolonged duration compared with recent previous seasons, resulting in increased strain throughout acute care hospital systems.
To characterize self-reported experiences and views of hospital capacity managers regarding the 2017-2018 influenza season in the US.
In this qualitative study, semistructured telephone interviews were conducted between April 2018 and January 2019 with a random sample of capacity management administrators responsible for throughput and hospital capacity at short-term, acute care hospitals throughout the US.
Each participant's self-reported experiences and views regarding high patient volumes during the 2017-2018 influenza season, lessons learned, and the extent of hospitals' preparedness planning for future pandemic events. Interviews were recorded and transcribed and then analyzed using thematic content analysis. Outcomes included themes and subthemes.
A total of 53 key hospital capacity personnel at 53 hospitals throughout the US were interviewed; 39 (73.6%) were women, 48 (90.6%) had a nursing background, and 29 (54.7%) had been in the occupational role for more than 4 years. Participants' experiences were categorized into several domains: (1) perception of strain, (2) effects of influenza and influenza-like illness on staff and patient care, (3) immediate staffing and capacity responses to influenza and influenza-like illness, and (4) future staffing and capacity preparedness for influenza and influenza-like illness. Participants reported experiencing perceived strain associated with concerns about preparedness for seasonal influenza and influenza-like illness as well as concerns about staffing, patient care, and capacity, but future pandemic planning within hospitals was not reported as being a high priority.
The findings of this qualitative study suggest that during the 2017-2018 influenza season, there were systemic vulnerabilities as well as a lack of hospital preparedness planning for future pandemics at US hospitals. These issues should be addressed given the current coronavirus disease 2019 pandemic.
Journal Article