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Predictive biomarker is an important element in the realization of precision medicine and with the introduction of the drug-diagnostic codevelopment model, the number of regulatory approved companion diagnostics (CDx) have steadily increased. This short perspective is based on an analysis of the FDA List of Cleared or Approved Companion Diagnostic Devices and focus on the biomarkers, drugs, clinical indications, analytical platforms, regulatory paths and status related to the different assays. By the end of 2020, the total number of CDx assays approved by the FDA had reached 44. These assays are almost exclusively linked to different hematological and oncological drugs. Without an accurate and reliable CDx assay these drugs will lose their value. The analytical platforms are diverse and cover technologies like immunohistochemistry, in situ hybridization, polymerase chain reaction, next generation sequencing, and imaging. CDx assays are high risk devices and the regulatory path almost exclusively requires submission of a Premarket Application (PMA); however, a relatively large group of the CDx assays is PMA approved Laboratory Developed Test.
Understanding the stroke mechanism of middle cerebral artery (MCA) atherosclerosis is important for stroke triage and future trial design. The aim of this study was to characterize intrinsic MCA plaque and acute cerebral infarct in vivo by using high-resolution black-blood (BB) and diffusion-weighted magnetic resonance (MR) imaging and to investigate the relationship between plaque features and infarct patterns.
A single-center retrospective study was conducted at a tertiary referral center between March 2017 and August 2019. Patients consecutively admitted for acute ischemic stroke with MCA stenosis underwent diffusion-weighted and BB MR imaging. Plaque features and infarct patterns were assessed. The association between plaque features and infarct patterns (binary variable single/multiple) was evaluated using a multivariate logistic regression model.
Of 49 patients with MCA atherosclerotic stenosis, diffusion-weighted MR imaging showed that 28 patients (57%) had multiple acute cerebral infarcts and 21burden may promote subcortical single infarct size by occluding penetrating arteries. Our results provide important insight into stroke mechanism of MCA atherosclerosis.
Increased plaque burden, plaque surface irregularity in patients with MCA stenosis is associated with its likelihood to have caused an artery-to-artery embolism that produces multiple cerebral infarcts, especially along the border zone region, and increased plaque burden may promote subcortical single infarct size by occluding penetrating arteries. Our results provide important insight into stroke mechanism of MCA atherosclerosis.
It has been argued that the beginning of life is one of the most significant, universally-shared life events, impacting parental health biologically, sociologically, psychologically and spiritually. In maternity care settings, only a few educational initiatives exist focusing on increasing competencies in spiritual care.
To explore the characteristics of content in existing under- and post-graduate education of healthcare professionals in spiritual care in the field of maternity care.
We conducted an integrative review, searching seven databases for studies describing the content of existing education in spiritual care in maternity care settings.
From 235 studies assessed eligible and full text screened, only two were included, originating from the same project. The majority of existing studies about spiritual care focus on the perspective of women related to loss, sickness or bereavement, whereas research related to the field of maternity care is sparser. Furthermore, the perspective of the professional seems overlooked.
There is a lack of research exploring the content and structure of educational initiatives related to spiritual care in maternity care. In order to strengthen spiritual care competencies in maternity care, for both women/partners and professionals, future research should investigate how education is planned and evaluated.
There is a lack of research exploring the content and structure of educational initiatives related to spiritual care in maternity care. In order to strengthen spiritual care competencies in maternity care, for both women/partners and professionals, future research should investigate how education is planned and evaluated.The Middle to Later Stone Age transition is a critical period of human behavioral change that has been variously argued to pertain to the emergence of modern cognition, substantial population growth, and major dispersals of Homo sapiens within and beyond Africa. However, there is little consensus about when the transition occurred, the geographic patterning of its emergence, or even how it is manifested in the stone tool technology that is used to define it. Here, we examine a long sequence of lithic technological change at the cave site of Panga ya Saidi, Kenya, that spans the Middle and Later Stone Age and includes human occupations in each of the last five Marine Isotope Stages. In addition to the stone artifact technology, Panga ya Saidi preserves osseous and shell artifacts, enabling broader considerations of the covariation between different spheres of material culture. Several environmental proxies contextualize the artifactual record of human behavior at Panga ya Saidi. We compare technological change between the Middle and Later Stone Age with on-site paleoenvironmental manifestations of wider climatic fluctuations in the Late Pleistocene. The principal distinguishing feature of Middle from Later Stone Age technology at Panga ya Saidi is the preference for fine-grained stone, coupled with the creation of small flakes (miniaturization). Monomethyl auristatin E ic50 Our review of the Middle to Later Stone Age transition elsewhere in eastern Africa and across the continent suggests that this broader distinction between the two periods is in fact widespread. We suggest that the Later Stone Age represents new short use-life and multicomponent ways of using stone tools, in which edge sharpness was prioritized over durability.
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