Clinical trials in oncology are important tools to identify and establish new effective drugs for cancer treatment. Since the development of the concept of precision oncology, a huge number of multi-centric biomarker-driven clinical trials have been performed and promoted by either academic institutions or pharmaceutical companies. In this scenario, the role of pathologists is essential in multiple aspects, with new challenges that should be addressed. In this position paper of the European Society of Pathology, the role of pathologists as contributors to the design of the clinical trial, as local collaborators, or as members of central review laboratories is discussed. Moreover, the paper emphasizes the important role of pathologists in guiding methods and criteria of tissue biomarker testing in the biomarker-driven clinical trials. The paper also addresses issues regarding quality control, training, and the possible role of digital pathology.
- MeSH
- Clinical Trials as Topic * MeSH
- Pathology, Clinical standards methods MeSH
- Humans MeSH
- Biomarkers, Tumor * analysis MeSH
- Neoplasms * pathology drug therapy MeSH
- Pathologists * MeSH
- Societies, Medical MeSH
- Research Design standards MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Geographicals
- Europe MeSH
This study deals with the comprehensive phytochemical composition and antiviral activity against SARS-CoV-2 of acidic (non-decarboxylated) and neutral (decarboxylated) ethanolic extracts from seven high-cannabidiol (CBD) and two high-Δ9-tetrahydrocannabinol (Δ9-THC) Cannabis sativa L. genotypes. Their secondary metabolite profiles, phytocannabinoid, terpenoid, and phenolic, were determined by LC-UV, GC-MS, and LC-MS/MS analyses, respectively. All three secondary metabolite profiles, cannabinoid, terpenoid, and phenolic, varied significantly among cannabinoid extracts of different genotypes. The dose-response analyses of their antiviral activity against SARS-CoV-2 showed that only the single predominant phytocannabinoids (CBD or THC) of the neutral extracts exhibited antiviral activity (all IC50 < 10.0 μM). The correlation matrix between phytoconstituent levels and antiviral activity revealed that the phenolic acids, salicylic acid and its glucoside, chlorogenic acid, and ferulic acid, and two flavonoids, abietin, and luteolin, in different cannabinoid extracts from high-CBD genotypes are implicated in the genotype-distinct antagonistic effects on the predominant phytocannabinoid. On the other hand, these analyses also suggested that the other phytocannabinoids and the flavonoid orientin can enrich the extract's pharmacological profiles. Thus, further preclinical studies on cannabinoid extract formulations with adjusted non-phytocannabinoid compositions are warranted to develop supplementary antiviral treatments.
OBJECTIVES: Nonpharmacologic interventions (NPIs) constitute an important part of treatment for older adults, cover a broad and diverse range of interventions, and have advantages over pharmacologic interventions (eg, limited adverse side effects). However, an unambiguous definition of NPIs is still lacking. Defining NPIs may facilitate research on this topic and enhance comparability of results between studies, and might help to face the challenges of recognition, acceptation, funding, and implementation. Therefore, the aim of this review was to provide an overview and comparison of the definitions of NPIs used in the current literature on older adults. DESIGN: A systematic review was performed to provide an overview of the definitions of NPIs that are used in the current literature on older populations and to organize the characteristics involved in the definitions. SETTING AND PARTICIPANTS: People ≥60 years of age were included, not limited to a specific setting. METHODS: A systematic search was performed in the following 5 databases: PubMed, Embase, Clarivate Analytics/Web of Science Core Collection, Cumulative Index to Nursing and Allied Health Literature, and Wiley/Cochrane Library. The time frame within the databases was from inception to December 4, 2023. Review articles, editorials and consensus papers were included. RESULTS: We included 28 articles. We organized the definitions of NPI according to 4 different aspects: types of interventions involved, target population, goals the interventions addressed, and requirements of the interventions. Definitions in the current literature can generally be divided into 2 groups: NPIs described as not involving medication, and more elaborated multidomain definitions. Based on the results, we formulated criteria for types of interventions that can be considered an NPI. CONCLUSIONS AND IMPLICATIONS: Using current descriptions and characteristics, elements for a new definition for NPIs were proposed. To improve research in this field, consensus needs to be reached regarding elements covered by a definition of NPIs.
- MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Therapeutics * methods MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Systematic Review MeSH
This study focused on the relationship between emerging didactical strategies and delivery of quality education service to students with learning disabilities in Cross River State, Nigeria. It adopted quantitative methodology and descriptive survey as the design. The population consist of all stakeholders with bias in learning disabilities in the state with 61 participants purposively sampled for the study, two null hypotheses were formulated to guide the study. A 20 item self-developed and validated questionnaire of 4 points Likert scale titled; Delivery of quality Education Service (QDES) was used for data collection. Data were statistically analyzed using Pearson Product Moment Cor- relation Analysis at 0.05 level of significance with assistance of SPSS software. Findings indicate strong positive relationship between the variables, this means that, ICT-tools and instructional accommodations are essential to the provision of quality education service to students with learning disabilities. It was recommended among others that, ICT-tools and instructional accommodations should compulsorily be an integral part of educational plan for these learners, the capacity of teachers and learners should be upgraded to meet the emerging realities of the 21st century education system and finally, policy and legislative frame work should support practical use of these strategies to improve and sustain quality service delivery in schools
The largest obstacle in the promotion of biopesticides is the existence of counterfeit products available in the market. Identification and quantification of antagonistic organisms in biopesticide products are the key to the reduction of spurious microbial pesticides. In this study, we have developed a simple, sensitive, isothermal-based colourimetric assay for specific detection of Bacillus subtilis from the biopesticide formulations and soil samples. A region specific to B. subtilis which codes for shikimate dehydrogenase was identified through in silico analysis. We employed conventional PCR, loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and qPCR for specific detection of B. subtilis in soil samples and biopesticide formulations. Specificity tests showed that the PCR primers amplified an amplicon of 521 bp in four strains of B. subtilis only, and no amplification was found in negative control samples. Similarly, the LAMP assay showed sky blue colour in all four strains of B. subtilis and violet colour in negative control samples. Whereas in the RPA assay, upon the addition of SYBR Green dye, a bright green colour was seen in B. subtilis strains, while a brick-red colour was observed in negative control samples by visualizing under a UV transilluminator. The qPCR assay showed specific amplifications with a Ct value of 12 for B. subtilis strains and no amplification in negative control samples. In the sensitivity test, PCR could amplify DNA of B. subtilis up to 500 pg/μL. DNA concentration as low as 10 pg/μL was enough to show the colour change in the LAMP as well as the RPA assays, whereas the qPCR assay showed sensitivity till 100 pg/μL. All four diagnostic assays developed in the study have been validated in soil samples and B. subtilis-based biopesticides. Compared to conventional PCR, the qPCR assay has the advantage of quantification and visualizing the result in real-time, whereas LAMP and RPA assays have the benefits of being colourimetric and less time-consuming. The other advantages are that the results can be visualized with the naked eye, and these assays do not require a costly thermal cycler and gel documentation system. Hence, LAMP and RPA assays are highly suitable for developing point-of-need diagnostic kits and, in turn, help regulators assess the quality of biopesticides in the market.
- MeSH
- Alcohol Oxidoreductases * genetics MeSH
- Bacillus subtilis * genetics isolation & purification enzymology MeSH
- Bacterial Proteins genetics MeSH
- Molecular Diagnostic Techniques * methods MeSH
- Colorimetry * methods MeSH
- Real-Time Polymerase Chain Reaction MeSH
- Soil Microbiology MeSH
- Sensitivity and Specificity MeSH
- Nucleic Acid Amplification Techniques * methods MeSH
- Publication type
- Journal Article MeSH
Východiska. S globalizací internetu se stala online pornografie snadno dostupnou, což výrazně proměnilo celý pornografický průmysl. Významné rozšíření online pornografie dokládá i skutečnost, že pornografické webové portály patřily v roce 2024 mezi 25 světově nejnavštěvovanějších webových stránek. Z dostupných dat se ukazuje, že se sledováním této formy pornografie má zkušenost většina dospělé populace (70–90 %), současně ale nebyly v českém prostředí blíže prozkoumány deskriptivní charakteristiky její konzumace dospělou populací. Cíle. Z toho důvodu si tato studie klade za cíl zmapovat obecné charakteristiky užívání pornografického obsahu dospělou populací v České republice, se zaměřením na věk první expozice, frekvenci sledování za posledních 30 dní a průměrnou dobu strávenou konzumací pornografie v pracovních dnech a ve dnech volna. Metodologie. Pro naplnění cílů byl zvolen kvantitativní design výzkumu, pro deskripci obecného užívání pornografie byly formulovány vlastní otázky. Data byla sbírána prostřednictvím online dotazníkového šetření distribuovaného skrze sociální sítě. Soubor. Výzkumný soubor byl sestaven na základě samovýběru respondentů. Výběrový soubor tvořilo celkem 1061 respondentů české dospělé populace ve věkovém rozmezí 18 až 72 let, z toho 397 mužů (37,4 %) a 664 žen (62,6 %). Výsledky. Medián věku prvního sledování pornografie byl u mužů i u žen 13 let. Muži vykazovali signifikantně vyšší četnost i průměrnou dobu sledování pornografického obsahu než ženy. Diskuse a závěry. Medián věku prvního sledování pornografie u českých mužů odpovídá zahraničním výzkumům, zatímco u českých žen je výrazně nižší. Diskutovány jsou možné dopady pandemie covidu-19 a technologického pokroku na změny v užívání pornografického obsahu.
Background. With the globalisation of the Internet, online pornography has become easily accessible, which has significantly transformed the entire pornography industry. This phenomenon is underscored by the fact that pornographic online web portals were among the world‘s top 25 most visited websites in 2024. The extant data demonstrate that the majority of the adult population (70-90%) has experience of viewing pornography; however, the descriptive characteristics of its consumption by the adult population in the Czech environment have not been further explored. Aims. The objective of this study was to map the general characteristics of pornographic content use in the adult population in the Czech Republic. The specific focus of the study was on the age of first exposure, the frequency of viewing over the last 30 days, and the average time spent consuming pornography on work and leisure days. Methodology. To achieve the objectives, a quantitative research design was chosen, and specific questions were formulated to describe the general use of pornography. Data was collected through an online questionnaire distributed via social sites. Sample. The research population was derived from a self-selected sample of respondents. The sample consisted of 1,061 respondents from the Czech adult population aged between 18 and 72 years, of which 397 were male (37.4%) and 664 were female (62.6%). Results. The median age at which respondents first viewed pornography was 13 years, irrespective of gender. The results indicate that, overall, males had a significantly higher frequency and median duration of viewing pornographic content than females. Discussion and conclusions. The median of the age of first viewing pornography for men is consistent with foreign research, but is significantly lower for Czech women. The possible effects of the covid-19 pandemic and technological advances on changes in pornographic content use are discussed.
PURPOSE OF REVIEW: This review explores the design and endpoints of perioperative platforms in clinical trials for muscle-invasive bladder cancer (MIBC). RECENT FINDINGS: The choice of clinical trial design in perioperative platforms for MIBC must align with specific research objectives to ensure robust and meaningful outcomes. Novel designs in perioperative platforms for MIBC integrate bladder-sparing approaches. Primary endpoints such as pathological complete response and disease-free survival are highlighted for their role in expediting trial results in perioperative setting. Incorporating patient-reported outcomes is important to inform healthcare decision makers about the outcomes most meaningful to patients. Given the growing body of evidence, potential biomarkers, predictive and prognostic tools should be considered and implemented when designing trials in perioperative platforms for MIBC. SUMMARY: Effective perioperative platforms for MIBC trials are critical in enhancing patient outcomes. The careful selection and standardization of study designs and endpoints in the perioperative platform are essential for the successful implementation of new therapies and the advancement of personalized treatment approaches in MIBC.
- MeSH
- Cystectomy methods adverse effects MeSH
- Neoplasm Invasiveness * MeSH
- Clinical Trials as Topic MeSH
- Humans MeSH
- Urinary Bladder Neoplasms * surgery pathology therapy mortality MeSH
- Perioperative Care methods standards MeSH
- Endpoint Determination MeSH
- Treatment Outcome MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
OBJECTIVE: This scoping review aims to identify, catalogue, and characterize previously reported tools, techniques, methods, and processes that have been recommended or used by evidence synthesizers to detect fraudulent or erroneous data and mitigate its impact. INTRODUCTION: Decision-making for policy and practice should always be underpinned by the best available evidence-typically peer-reviewed scientific literature. Evidence synthesis literature should be collated and organized using the appropriate evidence synthesis methodology, best exemplified by the role systematic reviews play in evidence-based health care. However, with the rise of "predatory journals," fraudulent or erroneous data may be invading this literature, which may negatively affect evidence syntheses that use this data. This, in turn, may compromise decision-making processes. INCLUSION CRITERIA: This review will include peer-reviewed articles, commentaries, books, and editorials that describe at least 1 tool, technique, method, or process with the explicit purpose of identifying or mitigating the impact of fraudulent or erroneous data for any evidence synthesis, in any topic area. Manuals, handbooks, and guidance from major organizations, universities, and libraries will also be considered. METHODS: This review will be conducted using the JBI methodology for scoping reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Databases and relevant organizational websites will be searched for eligible studies. Title and abstract, and, subsequently, full-text screening will be conducted in duplicate. Data from identified full texts will be extracted using a pre-determined checklist, while the findings will be summarized descriptively and presented in tables. REVIEW REGISTRATION: Open Science Framework https://osf.io/u8yrn.
- MeSH
- Humans MeSH
- Fraud prevention & control MeSH
- Systematic Reviews as Topic MeSH
- Scientific Misconduct * MeSH
- Research Design standards MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
The soil microbiota exhibits an important function in the ecosystem, and its response to climate change is of paramount importance for sustainable agroecosystems. The macronutrients, micronutrients, and additional constituents vital for the growth of plants are cycled biogeochemically under the regulation of the soil microbiome. Identifying and forecasting the effect of climate change on soil microbiomes and ecosystem services is the need of the hour to address one of the biggest global challenges of the present time. The impact of climate change on the structure and function of the soil microbiota is a major concern, explained by one or more sustainability factors around resilience, reluctance, and rework. However, the past research has revealed that microbial interventions have the potential to regenerate soils and improve crop resilience to climate change factors. The methods used therein include using soil microbes' innate capacity for carbon sequestration, rhizomediation, bio-fertilization, enzyme-mediated breakdown, phyto-stimulation, biocontrol of plant pathogens, antibiosis, inducing the antioxidative defense pathways, induced systemic resistance response (ISR), and releasing volatile organic compounds (VOCs) in the host plant. Microbial phytohormones have a major role in altering root shape in response to exposure to drought, salt, severe temperatures, and heavy metal toxicity and also have an impact on the metabolism of endogenous growth regulators in plant tissue. However, shelf life due to the short lifespan and storage time of microbial formulations is still a major challenge, and efforts should be made to evaluate their effectiveness in crop growth based on climate change. This review focuses on the influence of climate change on soil physico-chemical status, climate change adaptation by the soil microbiome, and its future implications.
Cohort studies are a robust analytical observational study design that explore the difference in outcomes between two cohorts, differentiated by their exposure status. Despite being observational in nature, they are often included in systematic reviews of effectiveness, particularly when randomized controlled trials are limited or not feasible. Like all studies included in a systematic review, cohort studies must undergo a critical appraisal process to assess the extent to which a study has considered potential bias in its design, conduct, or analysis. Critical appraisal tools facilitate this evaluation. This paper introduces the revised critical appraisal tool for cohort studies, completed by the JBI Effectiveness Methodology Group, who are currently revising the suite of JBI critical appraisal tools for quantitative study designs. The revised tool responds to updates in methodological guidance from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group and reporting guidance from PRISMA 2020, providing a robust framework for evaluating risk of bias in a cohort study. Transparent and rigorous assessment using this tool will assist reviewers in understanding the validity and relevance of the results and conclusions drawn from a systematic review that includes cohort studies. This may contribute to better evidence-based decision-making in health care. This paper discusses the key changes made to the tool, outlines justifications for these changes, and provides practical guidance on how this tool should be interpreted and applied by systematic reviewers.
- MeSH
- Cohort Studies MeSH
- Humans MeSH
- Research Design * standards MeSH
- Bias * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
