Micro-Flow Imaging: Flow Microscopy Applied to Sub-visible Particulate Analysis in Protein Formulations

The need to monitor, measure, and control sub-visible proteinaceous particulates in biopharmaceutical formulations has been emphasized in recent publications and commentaries. Some of these particulates can be highly transparent, fragile, and unstable. In addition, for much of the size range of concern, no practical measurement method with adequate sensitivity and repeatability has been available. A complication in measuring protein particulates in many formulations is the simultaneous presence of other particle types such as silicone micro-droplets, air bubbles, and extrinsic contaminants. The need has therefore been identified for new analytical methods which can accurately measure and characterize sub-visible particulates in formulations. Micro-flow imaging has been shown to provide high sensitivity in detecting and imaging transparent protein particles and a unique capability to independently analyze such populations even when other particle types are present

The critical need for pooled data on coronavirus disease 2019 in African children : an AFREhealth call for action through multicountry research collaboration

Globally, there are prevailing knowledge gaps in the epidemiology, clinical manifestations, and outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among children and adolescents; and these gaps are especially wide in African countries. The availability of robust age-disaggregated data is a critical first step in improving knowledge on disease burden and manifestations of coronavirus disease 2019 (COVID-19) among children. Furthermore, it is essential to improve understanding of SARS-CoV-2 interactions with comorbidities and coinfections such as human immunodeficiency virus (HIV), tuberculosis, malaria, sickle cell disease, and malnutrition, which are highly prevalent among children in sub-Saharan Africa. The African Forum for Research and Education in Health (AFREhealth) COVID-19 Research Collaboration on Children and Adolescents is conducting studies across Western, Central, Eastern, and Southern Africa to address existing knowledge gaps. This consortium is expected to generate key evidence to inform clinical practice and public health policy-making for COVID-19 while concurrently addressing other major diseases affecting children in African countries.The US National Institutes of Health (NIH)/ Fogarty International Centre (FIC) to the African Forum for Research and Education in Health (AFREhealth).https://academic.oup.com/cidam2022Paediatrics and Child Healt

Tourists' on unsafe grounds

Trolltunga har på noen få år blitt en verdenskjent naturattraksjon, og i takt med et økende besøkstall har antallet redningsaksjoner på Trolltunga steget de siste årene. Med denne studien har jeg forsøkt å skaffe kunnskap om forutsetningene et utvalg av turister på Trolltunga har for ferdsel i norsk natur. Studien har som formål å generere informasjon om hvilken kunnskap og erfaringer turistene besitter tilknyttet den type ferdsel i naturen som det å besøke noen kjente norske fjellattraksjoner innebærer, herunder hvordan de forstår og opplever risiko relatert til fjellvandring. Brukerkunnskap om turistene som besøker norsk natur er nødvendig for å sikre gode og trygge opplevelser, og bærekraftig forvaltning av natur, reiseliv og friluftsliv. Datamaterialet er samlet inn gjennom dybdeintervjuer (både av enkeltpersoner og grupper), og observasjoner gjennomført på mine turer til og fra Trolltunga. Det teoretiske rammeverket for diskusjonen består av relevante teorier fra ulike fagfelt; Pyles teori ”extinction of experience”, sammenhengen mellom personlig kontakt og erfaring med natur og tilgang på naturområder gjennom oppveksten, og kunnskapen, natursynet og besøksvilligheten man besitter i voksen alder, samt Beedies kropps- og erfaringsbaserte naturkunnskap, representert ved en "alpinisme habitus”. Informantenes risikopersepsjon tilknyttet ferdsel i naturen blir diskutert i lys av de overnevnte psykologiske, sosiale og kulturelle bidragene. Flertallet av informantene beskriver turen til Trolltunga som en av hovedgrunnene for valget av Norge som feriedestinasjon. Informantene representerer store variasjoner i kunnskap og erfaringer ved ferdsel i naturen. Et fåtall av informantene kan vise til erfaringer fra lignende turer, og mange beskriver turen som den lengste og hardeste turen de har tatt del i. Flertallet av informantenes mangel på direkte kontakt og erfaringer med naturen avdekker ulike oppfatninger av hva som er natur og videre hva begrepet turerfaring innebærer, noe som får videre komplikasjoner for hvordan de oppfatter kravene for deltagelse på turen til Trolltunga. Observasjonene mine avdekker til sammenligning også enkelte turisters mangel på kroppslige erfaringer med ferdsel i ulendt terreng, som arter seg for eksempel gjennom dårlig balanse og koordinasjon. Mangelen på kropps- og erfaringsbasert kunnskap med ferdsel i naturen viser seg å fremme færre refleksjoner rundt egen risikopersepsjon i forhold til turen, og mangel på erfaring fra lignende turer vanskeliggjør også informantenes tolkning og forståelse av den informasjonen som gis om utstyr, fysiske krav for at turen skal kunne gjennomføres. Det fremkommer generelt få refleksjoner over risikoaspekter ved ferdsel i naturen, noe som kan forklares ved psykologiske, sosiologiske og kulturelle bidrag til informantenes risikoVIII persepsjon. Oppgaven gir innsikt til videre arbeid med informasjon og forebygging av ulykker på trolltunga og andre attraksjoner i norske fjell som tiltrekker seg mange uerfarne besøkende. Norge som reiselivsdestinasjon behøver kunnskap om tilreisende turisters motiver for naturopplevelser og tilhørende forståelser av risiko. Ved et større fokus på turistenes kroppslige kontakt med natur kan videre forskning bidra med å belyse både psykologiske og sosiale prosesser som angår risikopersepsjonen mellom menneske og natur.In a few years Trolltunga has become a world-renowned natural attraction. As a growing number of visitors, the number of rescue operations on Trolltunga has increased in recent years. This study attempts to generate knowledge about the Trolltunga-tourist’s prerequisites for hiking in Norwegian nature, by focusing on which knowledge and experience the tourists have with hiking in nature, and how they understand and experience the risk associated with mountain hiking. User knowledge about the tourists who visit Norwegian nature is necessary to ensure good experiences, sustainable management of nature, tourism and outdoor life. The data is collected through in-depth semi-structured interviews (15 informants) and observations conducted along my hikes to Trolltunga during the field work. The theoretical framework for the discussion consists of relevant theories from different disciplines; Pyle's theory of "extinction of experience", the connection between personal contact with nature and access to natural areas through the childhood, and the knowledge, perception of nature, and willingness to visit nature areas in adult life, as well as Paul A. Beedie's body and experience-based nature knowledge, represented by a "alpinism Habitus ". The informants' risk perception associated with the trip is discussed in the light of psychological, social and cultural contributions. The majority of the informants describe the trip to Trolltunga as one of the main reasons for visiting Norway. My informants represents large variations according to knowledge and experience with outdoor hiking. Few of the informants can refer to experiences from similar hikes and many describe the hike as the longest and hardest hike they have participated in. The majority of informants' lack of direct contact and experience with nature reveals different perceptions of what nature is and what the term hiking-experience implies, which causes further complications for how they perceive the requirements for participation on the hike to Trolltunga. My observations also reveal a lack of bodily experience with hiking in rough terrain, which came visible through lack of balance and coordination. The lack of bodily and experience-based knowledge with hiking in nature turns out to promote fewer reflections about own risk perception in relation to the hike. The informants had generally few reflections on the risk aspect regarded to hiking in nature, which can also be explained by psychological, sociological and cultural contributions to the informants' risk perception. This assignment provides insight into further work with the information and further prevention of accidents at Trolltunga and other attractions in Norwegian mountains that attract many inexperienced visitors. As a tourism destination Norway need knowledge about the tourists' motives for nature experiences and accompanying perceptions of risk. By focusing on the physical contact with nature, further research may help to illuminate both psychological and social processes that concern the risk reception between man and nature.Reisemål Hardanger Fjord ASsubmittedVersionM-REI

Lower Gascoyne land resources survey map sheet 1

Map sheet 1 from - Tille, P J, Smolinski, H J, Wells, M R, Bessell-Browne, J A, Keating, C D, Oma, V P, and Holm, A M. (2003), Lower Gascoyne land resources survey. Department of Agriculture and Food, Western Australia. Report 17.https://researchlibrary.agric.wa.gov.au/lr_images/1051/thumbnail.jp

Optima: Optimal personalised treatment of early breast cancer using multi-parameter analysis, an international randomized trial of tumor gene expression test-directed chemotherapy treatment in a largely node-positive population

Background: Multi-parameter tumor gene expression assays (MPAs) are validated tools to assist adjuvant chemotherapy decisions for post-menopausal women with luminal-type node-negative breast cancer. Currently there is less certainty for women with 1-3 involved axillary lymph nodes and no information on MPA use for patients with higher level nodal involvement. Three RCTs with available data report chemotherapy benefit for premenopausal women; with limited use of ovarian function suppression (OFS) for non-chemotherapy treated participants, chemotherapy-induced menopause may explain these results. Methods: OPTIMA is an international academic, partially-blinded RCT of test-directed chemotherapy treatment with an adaptive design. Women and men aged 40 or older with resected luminal-type breast cancer may participate if they fulfil one of the following stage criteria: pN1-2; pN1mi with pT ≥20mm; pN0 with pT ≥30mm. Consenting patients are randomized between standard treatment with chemotherapy followed by endocrine therapy or to undergo Prosigna testing; those with high-Prosigna Score ( &gt; 60) tumors receive standard treatment whilst those with low-score tumors are treated with endocrine therapy alone. Patients are informed only of their treatment; test details, and randomization for chemotherapy-treated patients are masked. Clinical choice of chemotherapy is declared at randomization from a menu of standard regimens. Endocrine therapy must be for at least 5 years. Women postmenopausal at trial entry should receive an AI; men, tamoxifen; and premenopausal women, either an AI or tamoxifen, and OFS for 3 or more years; OFS initiation may be deferred because of post-chemotherapy amenorrhea. OPTIMA aims to randomize 2250 patients in each arm to demonstrate non-inferiority of test directed treatment, defined as not more than 3% below the estimated 85% 5-year IDFS for the control arm with a one sided 5% significance level. Power is 81% assuming recruitment over 96-months from January 2017 and 12 months minimum follow-up. OPTIMA also has at least 80% power to demonstrate 3.5% non-inferiority of IDFS for patients with low Prosigna Score tumors (estimated 65% of participants). Cox proportional hazards models will be used to explore important prognostic factors including menopausal status. Additional secondary endpoints include DRFI. A cost-effectiveness analysis of protocol specified MPA driven treatment against standard clinical practice will be conducted. At 31/01/2021, 2004 patients had been randomized. The DMC reviewed the trial in December 2020 with knowledge of related trial results and suggested that the trial continues as planned.<br/