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Pharmaceuticals (Basel, Switzerland) Dec 2023Levothyroxine tablets, although highly prescribed in the United States, have been one of the most frequently recalled products. Because of the importance of the...
Levothyroxine tablets, although highly prescribed in the United States, have been one of the most frequently recalled products. Because of the importance of the medication, several efforts have been put in place by the United States Food and Drug Administration (US FDA) to control the quality of levothyroxine tablets available to patients using the drug. The choice of excipients used in the formulation has been shown to impact the hygroscopicity and microenvironment, and ultimately the stability of the levothyroxine tablets formulations. Based on information generated from the US FDA Enforcement Report database, one of the main reasons for recalls is the low potency of different batches of the product. The yearly product recall trends for levothyroxine formulations were determined using the FDA Enforcement Report database. Three brands of levothyroxine tablets were selected with excipient lists similar to those products that have been historically recalled. The samples were placed at ambient (~23 °C), accelerated stability (40 °C/75% RH), and stress (50 °C/75% RH) conditions for up to 6 months. Sample potencies were determined at 0, 1.5, 3, and 6 months using the methods for assay and impurities in the United States Pharmacopeia (USP) monograph for levothyroxine tablets. Additional sample monitoring was conducted by overlaying the initial powder X-ray diffractograms (PXRD) of the samples from 0 months with the patterns generated thereafter. There has been a decline in the number of levothyroxine tablets recalled over the years. The highest numbers of recalls were recorded in the years 2013 [33] and 2020 [23]; no recalls occurred in the years 2019 and 2022. All of the brands evaluated met the USP 95.0-105.0% assay requirements at 1.5 months under accelerated conditions; only one of the brands complied at 3 months. Under ambient conditions, two brands were stable at 6 months, with borderline assay results. For stability, levothyroxine was found in microgram quantities in the formulations and PXRD could not detect changes at these low levels. However, we found some distinguishing data for samples under stress conditions.
PubMed: 38256876
DOI: 10.3390/ph17010042 -
Bioengineering (Basel, Switzerland) Jan 2024Corneal endothelial decompensation is treated by the corneal transplantation of donor corneas, but donor shortages and other problems associated with corneal...
Corneal endothelial decompensation is treated by the corneal transplantation of donor corneas, but donor shortages and other problems associated with corneal transplantation have prompted investigations into tissue engineering therapies. For clinical use, cells used in tissue engineering must undergo strict quality control to ensure their safety and efficacy. In addition, efficient cell manufacturing processes are needed to make cell therapy a sustainable standard procedure with an acceptable economic burden. In this study, we obtained 3098 phase contrast images of cultured human corneal endothelial cells (HCECs). We labeled the images using semi-supervised learning and then trained a model that predicted the cell centers with a precision of 95.1%, a recall of 92.3%, and an F-value of 93.4%. The cell density calculated by the model showed a very strong correlation with the ground truth (Pearson's correlation coefficient = 0.97, value = 8.10 × 10). The total cell numbers calculated by our model based on phase contrast images were close to the numbers calculated using a hemocytometer through passages 1 to 4. Our findings confirm the feasibility of using artificial intelligence-assisted quality control assessments in the field of regenerative medicine.
PubMed: 38247948
DOI: 10.3390/bioengineering11010071 -
Preventive Medicine Reports Jan 2024Cannabis legalization provides an opportunity to communicate with consumers through mandated health warnings on cannabis packaging. However, research on cannabis health... (Review)
Review
BACKGROUND
Cannabis legalization provides an opportunity to communicate with consumers through mandated health warnings on cannabis packaging. However, research on cannabis health warnings is a nascent field. Therefore, a review is needed to synthesize cannabis health warning research and inform ongoing policy discussions.
METHODS
This paper used systematic review guidelines to search online databases, including PubMed Central, Scopus, Web of Science, Jstor, Communication and Mass Media Complete, Medline, PsycINFO, and Google Scholar. Search strings combined the terms "cannabis" or "marijuana" with "health warning" or "health warning message" or "warning label" or "health warning label" or "health information label." Results were synthesized narratively.
RESULTS
The search identified 90 research articles. After screening, 17 studies on the impact of cannabis health warnings were retained. Retained studies focused on the hypothetical effects of cannabis health warnings ( = 11; 64.7 %) and "real world" effects of implementing warnings post-legalization ( = 6; 35.3 %). Evidence indicated mandated cannabis health warnings improved noticing and recall of health warning content. Cannabis health warnings describing risks of addiction were consistently rated the least effective. Pictorial cannabis health warnings generally outperformed text-only warnings when displayed on their own, while experiments with warnings on products had mixed results. Cannabis health warnings decreased product appeal, mainly when package branding was minimized.
CONCLUSIONS
Health warnings on cannabis packaging are an important strategy to communicate risk to consumers. Mandating warnings increased notice, recall, and health knowledge. Warnings with pictures and describing specific risks were most effective, as was showing warnings without product branding.
PubMed: 38222305
DOI: 10.1016/j.pmedr.2023.102573 -
The American Journal of Geriatric... Apr 2024To investigate the preliminary efficacy of a combined physical exercise + cognitive training intervention for older adults with amnestic mild cognitive impairment (aMCI). (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To investigate the preliminary efficacy of a combined physical exercise + cognitive training intervention for older adults with amnestic mild cognitive impairment (aMCI).
DESIGN
Randomized clinical trial.
SETTING
Veteran Affairs Hospital, Palo Alto, CA.
PARTICIPANTS
Sample included 72 community-dwelling volunteers (mean age 72.4 ± 9.5) diagnosed with aMCI.
INTERVENTION
Participants were randomized to either a combined aerobic and resistance exercise + cognitive training (CARE+CT) or stretching exercise + CT (SE+CT).
MEASUREMENTS
Primary outcomes included intervention specific assessments of word list and name-face recall. Secondary cognitive outcomes included standardized composite scores that reflect cognitive domains (e.g., learning and memory, executive function, processing speed, visuospatial ability, language). Secondary physiological outcomes included VO2 max and functional capacity (e.g., distance walked 6-minute walk test). APOE and BDNF were determined from whole blood samples.
RESULTS
Controlling for age and employment status, linear mixed effects models revealed that all participants experienced significant improvement in the delayed recall of word list, learning and memory and executive function. Only the CARE+CT condition had significant improvement in processing speed and functional capacity. APOE4 status impacted cognitive benefits of those in the SE+CT condition.
CONCLUSIONS
Results provide preliminary support for combined exercise and cognitive training interventions for older adults with aMCI. Further research is needed to understand the mechanisms involved as well as the impact of these interventions in diverse samples.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01962038.
Topics: Humans; Aged; Aged, 80 and over; Cognitive Training; Treatment Outcome; Cognition; Cognitive Dysfunction; Exercise; Exercise Therapy
PubMed: 38220592
DOI: 10.1016/j.jagp.2023.12.002 -
Alzheimer's Research & Therapy Jan 2024Disease-modifying treatments for Alzheimer's disease highlight the need for early detection of cognitive decline. However, at present, most primary care providers do not... (Review)
Review
BACKGROUND
Disease-modifying treatments for Alzheimer's disease highlight the need for early detection of cognitive decline. However, at present, most primary care providers do not perform routine cognitive testing, in part due to a lack of access to practical cognitive assessments, as well as time and resources to administer and interpret the tests. Brief and sensitive digital cognitive assessments, such as the Digital Clock and Recall (DCR™), have the potential to address this need. Here, we examine the advantages of DCR over the Mini-Mental State Examination (MMSE) in detecting mild cognitive impairment (MCI) and mild dementia.
METHODS
We studied 706 participants from the multisite Bio-Hermes study (age mean ± SD = 71.5 ± 6.7; 58.9% female; years of education mean ± SD = 15.4 ± 2.7; primary language English), classified as cognitively unimpaired (CU; n = 360), mild cognitive impairment (MCI; n = 234), or probable mild Alzheimer's dementia (pAD; n = 111) based on a review of medical history with selected cognitive and imaging tests. We evaluated cognitive classifications (MCI and early dementia) based on the DCR and the MMSE against cohorts based on the results of the Rey Auditory Verbal Learning Test (RAVLT), the Trail Making Test-Part B (TMT-B), and the Functional Activities Questionnaire (FAQ). We also compared the influence of demographic variables such as race (White vs. Non-White), ethnicity (Hispanic vs. Non-Hispanic), and level of education (≥ 15 years vs. < 15 years) on the DCR and MMSE scores.
RESULTS
The DCR was superior on average to the MMSE in classifying mild cognitive impairment and early dementia, AUC = 0.70 for the DCR vs. 0.63 for the MMSE. DCR administration was also significantly faster (completed in less than 3 min regardless of cognitive status and age). Among 104 individuals who were labeled as "cognitively unimpaired" by the MMSE (score ≥ 28) but actually had verbal memory impairment as confirmed by the RAVLT, the DCR identified 84 (80.7%) as impaired. Moreover, the DCR score was significantly less biased by ethnicity than the MMSE, with no significant difference in the DCR score between Hispanic and non-Hispanic individuals.
CONCLUSIONS
DCR outperforms the MMSE in detecting and classifying cognitive impairment-in a fraction of the time-while being not influenced by a patient's ethnicity. The results support the utility of DCR as a sensitive and efficient cognitive assessment in primary care settings.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT04733989.
Topics: Humans; Female; Male; Dementia; Cognitive Dysfunction; Alzheimer Disease; Mental Status and Dementia Tests; Neuropsychological Tests
PubMed: 38167251
DOI: 10.1186/s13195-023-01367-7 -
Heliyon Jan 2024The Rapid Alert System for Food and Feed (RASFF) plays a pivotal role in regulating food safety in the European Union by enabling the competent authorities in each...
The Rapid Alert System for Food and Feed (RASFF) plays a pivotal role in regulating food safety in the European Union by enabling the competent authorities in each Member State to issue warnings for removing unsafe or illegal items from the market. This article undertakes a comprehensive analysis of RASFF data on Slovak food from 2002 to 2020, to investigate the trends in notifications, actions executed, hazard categories, and product categories within the food industry. Our scrutiny of the RASFF data revealed fluctuations in the counts of alerts and information notifications across years, indicating periods of heightened hazard detection and enhanced transparency within the system. Various measures, including destruction, recall, notification, and prohibition, were employed to address these hazards and ensure the safety and compliance of food products. The hazard categories exhibited sporadic patterns, underscoring the necessity for ongoing surveillance and regulatory interventions. Specific product categories, such as dietetic foods, food supplements, and fortified foods, registered higher incidences of hazards in specific years, implying the need for intensified safety precautions. These findings highlight the importance of sustained efforts in maintaining food safety and managing risks within the industry.
PubMed: 38163176
DOI: 10.1016/j.heliyon.2023.e23146 -
Vision Research Feb 2024The capacity of visuospatial working memory (VSWM) is limited. However, there is continued debate surrounding the nature of this capacity limitation. The resource model...
The capacity of visuospatial working memory (VSWM) is limited. However, there is continued debate surrounding the nature of this capacity limitation. The resource model (Bays et al., 2009) proposes that VSWM capacity is limited by the precision with which visuospatial features can be retained. In one of the few studies of spatial working memory, Schneegans and Bays (2016) report that memory guided pointing responses show a monotonic decrease in precision as set size increases, consistent with resource models. Here we report two conceptual replications of this study that use mouse responses rather than pointing responses. Overall results are consistent with the resource model, as there was an exponential increase in localisation error and monotonic increases in the probability of misbinding and guessing with increases in set size. However, an unexpected result of Experiment One was that, unlike Schneegans and Bays (2016), imprecision did not increase between set sizes of 2 and 8. Experiment Two replicated this effect and ruled out the possibility that the invariance of imprecision at set sizes greater than 2 was a product of oculomotor strategies during recall. We speculate that differences in imprecision are related to additional visuomotor transformations required for memory-guided mouse localisation compared to memory-guided manual pointing localisation. These data demonstrate the importance of considering the nature of the response modality when interpreting VSWM data.
Topics: Animals; Mice; Memory, Short-Term; Mental Recall; Spatial Memory
PubMed: 38160653
DOI: 10.1016/j.visres.2023.108343 -
Annals of Work Exposures and Health Feb 2024Cleaning product use has been associated with adverse respiratory health effects such as asthma in cleaning staff and healthcare workers. Research in health effects from...
BACKGROUND
Cleaning product use has been associated with adverse respiratory health effects such as asthma in cleaning staff and healthcare workers. Research in health effects from cleaning products has largely depended upon collecting exposure information by questionnaires which has limitations such as recall bias and underestimation of exposure. The aim of this study was to develop a Cleaning and Hazardous Products Exposure Logging (CHaPEL) app with a barcode scanner and to test the feasibility of this app with university cleaners.
METHODS
The CHaPEL app was developed to collect information on demographics, individual product information, and exposure information. It also included an ease-of-use survey. A pilot study with university cleaning workers was undertaken in which cleaning workers scanned each product after use and answered the survey. Respiratory hazards of cleaning substances in the scanned cleaning products were screened by safety data sheets, a Quantitative Structure-Activity Relationship model and an asthmagen list established by an expert group in the US.
RESULTS
Eighteen university cleaners participated in this study over a period of 5 weeks. In total, 77 survey responses and 6 cleaning products were collected and all reported that using the app was easy. The most frequently used product was a multi-surface cleaner followed by a disinfectant. Out of 14 substances in cleaning products, ethanolamine and Alkyl (C12-16) dimethyl benzyl ammonium chloride were found as respiratory hazardous substances.
CONCLUSION
The CHaPEL app is a user-friendly immediate way to successfully collect exposure information using the barcodes of cleaning products. This tool could be useful for future epidemiological studies focused on exposure assessment with less interruption to the workers.
Topics: Humans; Occupational Exposure; Pilot Projects; Mobile Applications; Hazardous Substances; Asthma
PubMed: 38142412
DOI: 10.1093/annweh/wxad082 -
Current Research in Food Science 2023Plant-based foods (PBFs) are considered healthy, especially, minimally processed whole foods, fruits, whole grains, and legumes while highly processed PBFs maybe less...
Plant-based foods (PBFs) are considered healthy, especially, minimally processed whole foods, fruits, whole grains, and legumes while highly processed PBFs maybe less nutritious. Educating consumers on nurient quality will help to guide their choices. This study was aimed at estimating and predicting the nutrient quality of PBFs using their Nutri-Score and micronutrient content. The NHANES (2017-2020) data shows the output for foods consumed in the US and their nutrient composition based on a 24-h recall. Though the Nutri-Score label has been used to discriminate food quality, it still needs to be implemented in most countries. It computes mostly macronutrients with less consideration for micronutrients which also contributes to product quality. ML methods used in this study combine the Nutri-Score grade and micronutrient content in predicting food quality. The FNDDS data of PBFs for 2017-2020 were split into training (n = 300) and testing (n = 74) datasets. Eight ML models were used to predict the Nutri-Score and the Nutri-Score grade of PBFs. Random forest (RF) and light gradient boost model (LightGBM) performed best with accuracy and coefficient of determination (R) scores of 0.88 and 0.96, respectively, while DT had the least scores in predicting the Nutri-Score grade (0.81) and Nutri-Score (0.93). These results suggest that ML can be effectively leveraged to predict PBFs quality.
PubMed: 38115895
DOI: 10.1016/j.crfs.2023.100544 -
Food Additives & Contaminants. Part A,... Jan 2024Analysis of N-nitroso folic acid, a nitrosamine impurity found in folic acid, is challenging due to the complex sample matrices. Many of such supplements contain not...
Analysis of N-nitroso folic acid, a nitrosamine impurity found in folic acid, is challenging due to the complex sample matrices. Many of such supplements contain not only a variety of vitamins, including vitamin A, Bs, C, D and E, but also other ingredients such as minerals, docosahexaenoic acid (DHA), glucose syrup, sugar, and herbs. On the other hand, the strength of folic acid is typically low, ranging from 50 µg to 5 mg per unit. In this study, a highly selective and sensitive LC-MS/MS method was developed to accurately quantify N-nitroso folic acid in supplements containing folic acid. The sample was extracted by 0.1% ammonia solution: MeOH (9:1, v/v) containing 5 ng/mL of N-nitroso folic acid-d (Isotope internal standard). The quantification was performed by MRM in negative ionization mode. Mobile phases A and B were 0.1% formic acid in deionized water and methanol, respectively. The method was validated and found to have sufficient linearity (R > 0.995), accuracy (recovery 83-110%), precision (RSD 3%) and low LOD, LOQ (4 and 10 µg/g respectively, with respect to folic acid). The method was applied to the determination of N-nitroso folic acid in 40 supplements containing folic acid with different strengths and formulation. The content of N-nitroso folic acid was found to be up to 898 ng/unit (1794 µg/g with respect to folic acid). It enabled regulatory actions, such as product recall, to safeguard public health from unsafe products.
Topics: Folic Acid; Chromatography, Liquid; Liquid Chromatography-Mass Spectrometry; Tandem Mass Spectrometry; Vitamins; Vitamin A; Reproducibility of Results
PubMed: 38100531
DOI: 10.1080/19440049.2023.2292603