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Cureus Oct 2023With the burgeoning numbers of clinical trials, the competition among sponsors for research subjects has grown intensely. Many clinical trials fail to meet their...
With the burgeoning numbers of clinical trials, the competition among sponsors for research subjects has grown intensely. Many clinical trials fail to meet their recruitment goals. Contract research organizations (CROs) that help conduct all or portions of a clinical study have transitioned from highly specialized niches, such as biostatistical analysis or regulatory compliance, to more overall functions to keep a trial moving forward. CROs establish agreements with sponsors, including how much a site will be paid per study subject. CROs are locked into that pricing, but over the course of a study's recruitment period, sponsors with deeper pockets may step in and offer more compensation per subject. The result is a competitive market place that favors big sponsors and puts smaller CROs and start-ups at a disadvantage.
PubMed: 38022306
DOI: 10.7759/cureus.47819 -
Biochemistry. Biokhimiia Dec 2017Based upon evolvability theory, phenotypes like aging that offer no apparent individual benefit may evolve nonetheless. Pursuant to that concept, the evolution of a... (Review)
Review
Based upon evolvability theory, phenotypes like aging that offer no apparent individual benefit may evolve nonetheless. Pursuant to that concept, the evolution of a hypothetical, genome-based aging program called phenoptosis was proposed. However, while aging may facilitate evolvability, it need not result from a program specifically selected for that purpose. Instead, it is possible that the potential for aging is conserved within the genome as a part of a beneficial program that orchestrates and integrates developmental transformation of the soma from conception to maturation. Because somatic remodeling is inherently unstable, its continued non-programmatic expression beyond young adulthood (developmental inertia) erodes internal order, initiating and exacerbating aging. Thus, aging may result paradoxically from post-maturational expression of the same programmatic function for somatic transformation that previously provided individual benefit. It did so by ensuring acquisition of reproductive competence, post-reproductive development of parents to nurture offspring and thereby, to guarantee species survival. In an attempt to identify genes capable of controlling developmental inertia, we sequenced DNA from a series of subjects displaying extreme neoteny, i.e. retention of youthful characteristics during adulthood. We hoped to identify mutations associated with delayed development and to compare each subject's biological and chronological ages. De novo mutations of coding-genes were found in all the subjects, but they could not be definitively identified as a cause of developmental delay. Nonetheless, genetic and epigenetic studies of neotenic subject's DNA are on-going. We are attempting to determine if phenoptosis specifically evolved to cause aging, or rather if it exists as a cryptic component of the developmental program that expresses its lethal potential serendipitously and only after individual benefit is realized.
Topics: Aging; Animals; Biological Evolution; Genes, Developmental; Humans; MicroRNAs; Models, Theoretical; Reproduction; Sequence Analysis, DNA
PubMed: 29486697
DOI: 10.1134/S0006297917120069 -
Frontiers in Neuroscience 2021Magnetic resonance imaging (MRI) is a safe method to examine human brain. However, a typical MR scan is very sensitive to motion, and it requires the subject to lie... (Review)
Review
Magnetic resonance imaging (MRI) is a safe method to examine human brain. However, a typical MR scan is very sensitive to motion, and it requires the subject to lie still during the acquisition, which is a major challenge for pediatric scans. Consequently, in a clinical setting, sedation or general anesthesia is often used. In the research setting including healthy subjects anesthetics are not recommended for ethical reasons and potential longer-term harm. Here we review the methods used to prepare a child for an MRI scan, but also on the techniques and tools used during the scanning to enable a successful scan. Additionally, we critically evaluate how studies have reported the scanning procedure and success of scanning. We searched articles based on special subject headings from PubMed and identified 86 studies using brain MRI in healthy subjects between 0 and 6 years of age. Scan preparations expectedly depended on subject's age; infants and young children were scanned asleep after feeding and swaddling and older children were scanned awake. Comparing the efficiency of different procedures was difficult because of the heterogeneous reporting of the used methods and the success rates. Based on this review, we recommend more detailed reporting of scanning procedure to help find out which are the factors affecting the success of scanning. In the long term, this could help the research field to get high quality data, but also the clinical field to reduce the use of anesthetics. Finally, we introduce the protocol used in scanning 2 to 5-week-old infants in the FinnBrain Birth Cohort Study, and tips for calming neonates during the scans.
PubMed: 34321992
DOI: 10.3389/fnins.2021.666020 -
Journal of Clinical and Diagnostic... May 2014Stereognosis means the ability of a person to recognize the shape and surface characters of an object using tactile sensations, without looking at them. The purpose of... (Review)
Review
Stereognosis means the ability of a person to recognize the shape and surface characters of an object using tactile sensations, without looking at them. The purpose of this study was to determine and compare the oral stereognostic levels of different age groups having full complement of teeth, for edentulous patients with and without prosthesis and also for denture satisfaction. In this study, oral stereognosis was tested with the aid of small metallic pellets referred as test forms, which had surface alterations as well as alterations in basic shape. The seven test forms were cube forms of 5mm x 5mm x 5mm & plaster replicas of these forms were five times larger which served as visual aid to the patient during tests. To start, each subject was given sufficient time to get acquainted with general shapes and surface characters of test form by visual inspection of plaster replicas. One of the metallic test form was randomly selected & placed on the subject's tongue and asked to indicate the identification by pointing at the appropriate plaster replica. In this study, inverse relationship was found between stereognostic level and age of the subject. The stereognostic scores of dentulous subjects were higher than edentulous. There were no significant differences in edentulous persons with or without denture. Stereognostic score was low in most satisfied denture wearers and was high in dissatisfied denture wearers.
PubMed: 24995263
DOI: 10.7860/JCDR/2014/9212.4341 -
Otology & Neurotology : Official... Mar 2019This study investigated the safety and efficacy of remote programming of cochlear implants. (Clinical Trial)
Clinical Trial
OBJECTIVE
This study investigated the safety and efficacy of remote programming of cochlear implants.
STUDY DESIGN
Single-subject design SETTING:: Four North American clinical sites PATIENTS:: Forty cochlear implant recipients aged 12 years or older INTERVENTION:: Subjects had their cochlear implants programmed at a location that was remote from their audiologist using telecommunication with and without the support of a facilitator.
MAIN OUTCOME MEASURES
Consonant-Nucleus-Consonant (CNC) word scores and the Speech, Spatial, and Qualities of Hearing Scale-C (SSQ-C) were compared using the subject's in-office MAP (program) and MAPs programmed remotely with and without the assistance of a facilitator. Additional subjective preference data were gathered from subjects and audiologists via questionnaires.
RESULTS
MAPs programmed via the three different models did not yield significantly different group mean CNC word scores. No device/procedure-related adverse events occurred. SSQ-C questionnaire results indicated that recipients received similar subjective benefit from familiar in-office, remote-facilitated, and remote-unassisted MAPs.
CONCLUSIONS
Remote programming is an effective means of cochlear implant service delivery. The practice was approved by the FDA on November 17, 2017 supported by the results of this study.
Topics: Adult; Aged; Child; Cochlear Implantation; Cochlear Implants; Computers, Handheld; Female; Humans; Male; Middle Aged; Software; Telemedicine; Young Adult
PubMed: 30741905
DOI: 10.1097/MAO.0000000000002119 -
Journal of Intelligence Jun 2023Scholarly research has increasingly examined the role of STEM (Science, Technology, Engineering, and Mathematics) education, and that of creativity as a transversal...
Scholarly research has increasingly examined the role of STEM (Science, Technology, Engineering, and Mathematics) education, and that of creativity as a transversal skill. However, far fewer studies have investigated the relationship between the two, particularly in secondary-school contexts, and they have obtained inconsistent results. This paper contributes to the literature by asking: The study utilises a pre-existing dataset gathered in Malta (EU) from some 400 students aged between 11 and 16 years old. It yields information on both the engagement in STEM (measured by exposure to STEM chosen by students as optional subjects, and the enjoyment of STEM considered by students to be their favourite subjects), as well as creativity levels (measured by Divergent Thinking performance on Alternate Uses Tests). Correlation analysis revealed a strong positive link between the two phenomena, lending support to the notion that STEM students tend to be more creative than other students. Using regression analysis, a model is estimated to identify the possible effects of engaging in STEM subjects on creativity, once the other co-determinants of creativity are controlled. The results indicate that both the exposure to STEM subject/s and enjoyment thereof significantly and positively predict creativity, even after controlling for the other possible determinants of creativity (such as age, gender, parental education, and participation in creative activities). These findings offer encouraging insights into 21st century education and for curriculum development as they suggest that, in addition to having value in their own right, STEM subjects can contribute to the development of creativity in young people.
PubMed: 37367508
DOI: 10.3390/jintelligence11060106 -
Heliyon Jul 2023A high level of preparedness for engagement is essential for a smooth transition into tertiary studies. Regardless, many first-year nursing students appear...
BACKGROUND
A high level of preparedness for engagement is essential for a smooth transition into tertiary studies. Regardless, many first-year nursing students appear underprepared, a situation likely exacerbated by today's increasingly diverse student population. Students' preparedness to begin tertiary education can be hampered by factors such as environmental changes, technical issues and paid work demands. For first year students, this period is frequently marked by apprehension and a sense of unpreparedness.
OBJECTIVES
To report the difference in first-year nursing students' pre- and post-subject preparedness and understanding after participating in a Unit Warm-Up.
DESIGN
A quantitative survey.
SETTINGS
An online pre- and post-survey prior to the commencement of a subject.
PARTICIPANTS
First-year, first-semester nursing students.
METHODS
Students could choose to participate in a "Unit Warm-Up" strategy before commencing a subject. Those who participated were invited to complete the pre- and post-survey created with the Qualtrics survey software. Survey questions focused on students' subject preparedness, level of anxiety about the subject's content, level of motivation and understanding of the subject's learning outcomes. Data was collected over a four-year period.
RESULTS
The findings revealed that participating in the Unit Warm-Up from 2019 to 2021 had a significant impact on students' preparedness and understanding of the subject's learning outcomes. In 2022, no significant changes were observed, which could have been influenced by extreme flooding in the regions. Anxiety levels among students decreased from 2019 to 2021, but not in 2022. Motivation remained consistent over time. When compared to overall pass rate and student satisfaction trends, such a Unit Warm-Up strategy may have a positive impact.
CONCLUSION
A Unit-Warm-Up strategy has merit as a jump start into tertiary studies. Nevertheless, external factors such as the Covid pandemic and environmental disasters can disrupt students' anxiety and readiness for participating in a subject.
PubMed: 37483746
DOI: 10.1016/j.heliyon.2023.e18113 -
The Science of the Total Environment Mar 2022Pyrethroid insecticides have been the subject of numerous epidemiology studies in the past two decades. We examined the pyrethroids epidemiology literature published... (Review)
Review
Pyrethroid insecticides have been the subject of numerous epidemiology studies in the past two decades. We examined the pyrethroids epidemiology literature published between 2016 and 2021. Our objective with this exercise was to inform interested readers regarding information on methodological elements that strengthen a study's use for translation (i.e., use in risk assessment) and to describe aspects of future research methods that could improve utility for decision-making. We focused on the following elements: (i) study design that provided evidence that pyrethroid exposure preceded the outcome, (ii) evidence that the method used for exposure characterization was reliable and sufficiently accurate for the intended purpose, and (iii) use of a robust approach for outcome ascertainment. For each of the 74 studies identified via the literature search, we categorized the methodological elements as Acceptable or Supplemental. A study with three Acceptable elements was considered Relevant for risk assessment purposes. Based on our evaluative approach, 18 (24%) of the 74 publications were considered to be Relevant. These publications were categorized as Acceptable for all three elements assessed: confirmed exposure (N = 24), confirmed outcome (N = 64), exposure preceded the outcome (N = 44). Three of these studies were birth cohorts. There were 15 Relevant publications of adults which included 10 Agricultural Health Study cohort publications of self-reported permethrin. Overall, the majority of the reviewed studies used methods that did not permit a determination that pyrethroid exposure preceded the outcome, and/or did not utilize robust methods for exposure assessment and outcome ascertainment. There is an opportunity for investigators and research sponsors to build on the studies reviewed here and to incorporate more translational approaches to studying exposure/outcome associations related to pesticides and other chemicals.
Topics: Adult; Epidemiologic Studies; Humans; Insecticides; Permethrin; Pesticides; Pyrethrins; Risk Assessment
PubMed: 34954171
DOI: 10.1016/j.scitotenv.2021.152568