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Evidence-based Complementary and... 2021The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha ( (L.)...
BACKGROUND
The global prevalence of stress is increasing. Stress adversely affects cognitive ability, sleep quality, and overall psychological well-being. Ashwagandha ( (L.) Dunal), an essential medicine in Ayurveda, is reportedly beneficial in reducing stress and improving memory. This double-blind, randomized, placebo-controlled clinical study evaluated the effect of Ashwagandha root extract sustained-release capsule 300 mg (Prolanza™; hereafter Ashwagandha SR) on cognitive functions, stress levels, sleep quality, overall well-being, and safety in stressed subjects.
METHODS
Subjects (130 healthy cognitively sound adults [20-55 years, body mass index:18-29 kg/m]) having a Perceived Stress Scale (PSS) score of 14-24 were randomized to receive either Ashwagandha SR or placebo. Subjects took one capsule of Ashwagandha SR or placebo daily for 90 consecutive days. This study was registered on Clinical Trials Registry-India (CTRI) on 13/11/2019 [number: CTRI/2019/11/021990]. The primary endpoint was the change in cognitive function as measured by CANTAB from baseline to the end of the study period (90 ± 7 days). The secondary outcomes included the change in PSS-10 score, serum cortisol level (9-11 am), the OHQ score, the PSQI, and serum BDNF levels.
RESULTS
Only 125 completed the study and were evaluated. The Cambridge Neuropsychological Test Automated Battery (CANTAB) reported significantly improved recall memory, and the total error rate in recalling patterns significantly decreased at visit 4 in the Ashwagandha SR group vs. the placebo group (first attempt memory score:12.9 ± 6.7 vs. 10.1 ± 6.3; total errors:17.5 ± 23.3 vs. 27.7 ± 23.6). At visit 4, lower PSS-10 score (13.0 ± 5.0 vs. 18.7 ± 4.6; < .0001), serum cortisol levels (=0.0443), and Pittsburgh Sleep Quality Index (PSQI) score ( < .0001) but higher Oxford Happiness Questionnaire (OHQ) scores ( < .0001) were seen in Ashwagandha SR vs. the placebo group, suggesting significantly lower stress levels and significantly better psychological well-being and sleep quality in the former. No adverse events were reported.
CONCLUSIONS
This is the first clinical study assessing Ashwagandha SR for its safety and efficacy. Treatment with one Ashwagandha SR capsule once daily for 90 days improved memory and focus, psychological well-being, and sleep quality, reduced stress levels, and was safe and well-tolerated.
PubMed: 34858513
DOI: 10.1155/2021/8254344 -
JAMA Network Open Mar 2020Mammography screening currently relies on subjective human interpretation. Artificial intelligence (AI) advances could be used to increase mammography screening accuracy...
IMPORTANCE
Mammography screening currently relies on subjective human interpretation. Artificial intelligence (AI) advances could be used to increase mammography screening accuracy by reducing missed cancers and false positives.
OBJECTIVE
To evaluate whether AI can overcome human mammography interpretation limitations with a rigorous, unbiased evaluation of machine learning algorithms.
DESIGN, SETTING, AND PARTICIPANTS
In this diagnostic accuracy study conducted between September 2016 and November 2017, an international, crowdsourced challenge was hosted to foster AI algorithm development focused on interpreting screening mammography. More than 1100 participants comprising 126 teams from 44 countries participated. Analysis began November 18, 2016.
MAIN OUTCOMES AND MEASUREMENTS
Algorithms used images alone (challenge 1) or combined images, previous examinations (if available), and clinical and demographic risk factor data (challenge 2) and output a score that translated to cancer yes/no within 12 months. Algorithm accuracy for breast cancer detection was evaluated using area under the curve and algorithm specificity compared with radiologists' specificity with radiologists' sensitivity set at 85.9% (United States) and 83.9% (Sweden). An ensemble method aggregating top-performing AI algorithms and radiologists' recall assessment was developed and evaluated.
RESULTS
Overall, 144 231 screening mammograms from 85 580 US women (952 cancer positive ≤12 months from screening) were used for algorithm training and validation. A second independent validation cohort included 166 578 examinations from 68 008 Swedish women (780 cancer positive). The top-performing algorithm achieved an area under the curve of 0.858 (United States) and 0.903 (Sweden) and 66.2% (United States) and 81.2% (Sweden) specificity at the radiologists' sensitivity, lower than community-practice radiologists' specificity of 90.5% (United States) and 98.5% (Sweden). Combining top-performing algorithms and US radiologist assessments resulted in a higher area under the curve of 0.942 and achieved a significantly improved specificity (92.0%) at the same sensitivity.
CONCLUSIONS AND RELEVANCE
While no single AI algorithm outperformed radiologists, an ensemble of AI algorithms combined with radiologist assessment in a single-reader screening environment improved overall accuracy. This study underscores the potential of using machine learning methods for enhancing mammography screening interpretation.
Topics: Adult; Aged; Algorithms; Artificial Intelligence; Breast Neoplasms; Deep Learning; Early Detection of Cancer; Female; Humans; Image Interpretation, Computer-Assisted; Mammography; Middle Aged; Radiologists; Radiology; Sensitivity and Specificity; Sweden; United States
PubMed: 32119094
DOI: 10.1001/jamanetworkopen.2020.0265 -
Nicotine & Tobacco Research : Official... Apr 2020We examined the effect of visual optimizations on warning text recall. (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
We examined the effect of visual optimizations on warning text recall.
METHODS
We used Amazon's Mechanical Turk to recruit 1854 young adult (18-34 years) electronic cigarette (e-cigarette) users or susceptible nonusers. We conducted a between-subjects 3 × 2 × 2 experiment to examine the influence of color (black text on white background [BW] vs. black on yellow [BY] vs. yellow on black [YB]), shape (rectangle vs. novel), and signal word (presence vs. absence of the word "warning"). We randomized participants to view one of 12 warnings on a fictional e-cigarette advertisement. We coded open-ended recall responses into three categories: (1) recalled nothing, (2) recalled something, (3) recalled the concept. We examined main effects on warning text recall using multinomial regression. We examined differences in attention, perceived message effectiveness, and appeal.
RESULTS
Those exposed to BW or BY warnings were more likely than those exposed to YB to recall something (AOR = 1.6, AOR = 1.5, respectively) or the concept (OR = 1.4, BW). Those exposed to novel shape (44.7% novel vs. 37.9% rectangle; p = .003) or color (44.5% BY vs. 41.9% YB vs. 37.5% BW; p = .04) warnings were more likely to report attention to the warning. In aided recall, those exposed to the signal word were more likely than those not exposed to select the correct response (64.0% vs. 31.3%; p < .0001). We did not find differences for message effectiveness or appeal.
CONCLUSIONS
Visual optimizations such as color may influence warning text recall and should be considered for new warnings. Research should continue exploring variations for advertisement warnings to maximize attention to warning text.
IMPLICATIONS
This study examines the impact of visual optimizations on recall of the US Food and Drug Administration-mandated e-cigarette advertisement warning text. We found that color might influence warning text recall, but we did not find effects for shape or signal word. It is possible the newly mandated e-cigarette advertisement warnings, which are required to occupy at least 20% of the advertisement, are currently novel enough to attract attention. Future research should examine optimizations following implementation of the new advertisement warnings.
Topics: Adolescent; Adult; Advertising; Attention; Electronic Nicotine Delivery Systems; Female; Humans; Male; Mental Recall; Product Labeling; Smokers; United States; United States Food and Drug Administration; Young Adult
PubMed: 31132095
DOI: 10.1093/ntr/ntz091 -
Nutrients Sep 2023The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of...
The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of accurate labeling of food products for the presence of wheat, other gluten-containing cereals, or gluten itself as refined ingredient. The purpose of this study was to gain more insights into recent food recalls related to undeclared gluten/wheat contamination and consumer experiences with these recalls. Recalls of products triggered by gluten contamination are relatively scarce and are not often triggered by a consumer complaint. The impact of these recalls on consumer trust was evaluated through an online survey that was distributed among supporters of Celiac Canada (CCA) and covered (i) strategies to adhere to a gluten-free diet, (ii) experiences with gluten-free recalls and their impact on consumer trust, and (iii) demographic information. Consumer concern regarding gluten-free product recalls is significant, but the concern regarding recalls is not heightened after experiencing a recall. Companies pursuing transparency in the process, identification of the source of contamination, and mitigation strategies going forward are likely to retain consumer trust in their product and brand. Based on the survey results, further efforts focusing on consumer education regarding interpreting nutrient labels, identifying sources of information on product recalls, and understanding procedures to follow upon suspected gluten contamination of a gluten-free product are recommended.
Topics: Humans; Diet, Gluten-Free; Food Labeling; Trust; Glutens; Product Recalls and Withdrawals; Celiac Disease
PubMed: 37836454
DOI: 10.3390/nu15194170 -
Journal of the American Pharmacists... 2021Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements,...
OBJECTIVE
Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges.
METHODS
A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls.
RESULTS
Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20).
CONCLUSIONS
This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.
Topics: Cross-Sectional Studies; Humans; Medical Device Recalls; Pharmaceutical Preparations; United States; United States Food and Drug Administration
PubMed: 32753251
DOI: 10.1016/j.japh.2020.07.005 -
Signal Transduction and Targeted Therapy Oct 2023Long-term humoral immunity to SARS-CoV-2 is essential for preventing reinfection. The production of neutralizing antibody (nAb) and B cell differentiation are tightly...
Long-term humoral immunity to SARS-CoV-2 is essential for preventing reinfection. The production of neutralizing antibody (nAb) and B cell differentiation are tightly regulated by T follicular help (T) cells. However, the longevity and functional role of T cell subsets in COVID-19 convalescents and vaccine recipients remain poorly defined. Here, we show that SARS-CoV-2 infection and inactivated vaccine elicited both spike-specific CXCR3 T cell and CXCR3 T cell responses, which showed distinct response patterns. Spike-specific CXCR3 T cells exhibit a dominant and more durable response than CXCR3 T cells that positively correlated with antibody responses. A third booster dose preferentially expands the spike-specific CXCR3 T cell subset induced by two doses of inactivated vaccine, contributing to antibody maturation and potency. Functionally, spike-specific CXCR3 T cells have a greater ability to induce spike-specific antibody secreting cells (ASCs) differentiation compared to spike-specific CXCR3 T cells. In conclusion, the persistent and functional role of spike-specific CXCR3 T cells following SARS-CoV-2 infection and vaccination may play an important role in antibody maintenance and recall response, thereby conferring long-term protection. The findings from this study will inform the development of SARS-CoV-2 vaccines aiming to induce long-term protective immune memory.
Topics: Humans; SARS-CoV-2; COVID-19; COVID-19 Vaccines; Antibodies, Neutralizing; Vaccines, Inactivated
PubMed: 37802996
DOI: 10.1038/s41392-023-01650-x -
Medicine Access @ Point of Care 2021The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient...
The entry of falsified and substandard medicines into the legitimate pharmaceutical supply chain has negative impacts on healthcare systems, patient safety, and patient access to medicine. The COVID-19 pandemic has highlighted the importance of access to safe medicine through legitimate pharmaceutical supply chains and the willingness of criminals to target medical products such as PPE (personal protective equipment) and COVID-19 treatments. In this article, we analyse data from the United Kingdom (UK) national medicine alert and recall database to identify and understand recent cases of substandard and falsified medicine in the UK's healthcare systems. Using the UK as a case study, we describe that national drug alert and recall data are useful in their current form to record and understand cases of substandard and falsified medicines in the supply chain. However, if regulatory agencies published further data, these drug recall databases may be useful to support longitudinal and international comparative medicine quality studies. We suggest that regulatory agencies publish the number of affected medicine packs in each recalled batch, as part of the recall process. This will help policy makers, practitioners, and researchers to better understand, monitor and compare the quality of medicines within legitimate supply chains.
PubMed: 36204504
DOI: 10.1177/23992026211052272 -
FEMS Microbiology Letters Dec 2019Preventing microbial contamination of non-food products is a major area of industrial microbiology where preservatives are used to stop microbial growth. However,... (Review)
Review
Preventing microbial contamination of non-food products is a major area of industrial microbiology where preservatives are used to stop microbial growth. However, microorganisms occasionally overcome product preservation, causing recalls and the implementation of multiple procedures to prevent further contamination. Correct reporting of microbial contamination in non-food industrial products is vital, especially if spoilage organisms are antimicrobial resistant and pose a health threat. Gram-negative bacteria such as Pseudomonas, Burkholderia and Enterobacteriaceae are frequently reported as non-food product contaminants, including species that overlap current antimicrobial resistance priorities. Historical analysis of recall databases highlighted that for greater than 15% of contamination incidents, the causative microbial agents are reported as unidentified. Here we review the current antimicrobial resistant bacterial species associated with non-food product contamination and evaluate recall reporting in Europe from 2005 to 2018. Our review shows that 49% of microbial contaminants are reported as unidentified despite frequent detection of antimicrobial resistant pathogens; in contrast, 98% of food-related microbial contaminants are classified. Recommendations to fill this microbial identification gap in non-food product recalls are made. Overall, reporting standards for microbial contamination in non-food products must be improved to enable surveillance and for understanding the risks associated with antimicrobial resistant microorganisms.
Topics: Bacteria; Bacterial Physiological Phenomena; Drug Resistance, Bacterial; Equipment Contamination
PubMed: 31977006
DOI: 10.1093/femsle/fnaa010 -
Hypertension (Dallas, Tex. : 1979) Dec 2019Losartan was the ninth most prescribed drug in the United States in 2016, and several other angiotensin-II receptor blockers (ARBs) are widely prescribed. Since July... (Review)
Review
Losartan was the ninth most prescribed drug in the United States in 2016, and several other angiotensin-II receptor blockers (ARBs) are widely prescribed. Since July 2018, >2 dozen specific ARB products have been recalled owing to the presence of potentially carcinogenic nitrosamine impurities in selected lots. As is the case with all U.S. drug recalls, the ARB recalls have been voluntary on the part of the companies involved. In April 2019, the Food and Drug Administration categorized marketed ARB products with respect to nitrosamine impurities: (1) not present, (2) to be determined with no prior lots removed from the market (TBD), or (3) to be determined in the context of prior lots having been removed from the market (TBD*). The data were structured as hundreds of rows of products. Owing to the complexity of these data, more than a year into the recalls, it remains difficult for clinicians to understand which ARB products are free of impurities.
Topics: Angiotensin Receptor Antagonists; Antihypertensive Agents; Carcinogens; Drug Recalls; Drug Utilization; Female; Humans; Hypertension; Losartan; Male; United States; United States Food and Drug Administration
PubMed: 31630573
DOI: 10.1161/HYPERTENSIONAHA.119.13955 -
Drug Delivery and Translational Research Apr 2021The current situation, heavily influenced by the ongoing pandemic, puts vaccines back into the spotlight. However, the conventional and traditional vaccines present... (Review)
Review
The current situation, heavily influenced by the ongoing pandemic, puts vaccines back into the spotlight. However, the conventional and traditional vaccines present disadvantages, particularly related to immunogenicity, stability, and storage of the final product. Often, such products require the maintenance of a "cold chain," impacting the costs, the availability, and the distribution of vaccines. Here, after a recall of the mode of action of vaccines and the types of vaccines currently available, we analyze the past, present, and future of vaccine formulation. The past focuses on conventional formulations, the present discusses the use of nanoparticles for vaccine delivery and as adjuvants, while the future presents microneedle patches as alternative formulation and administration route. Finally, we compare the advantages and disadvantages of injectable solutions, nanovaccines, and microneedles in terms of efficacy, stability, and patient-friendly design. Different approaches to vaccine formulation development, the conventional vaccine formulations from the past, the current development of lipid nanoparticles as vaccines, and the near future microneedles formulations are discussed in this review.
Topics: Humans; Liposomes; Nanoparticles; Needles; Vaccination; Vaccines
PubMed: 33598818
DOI: 10.1007/s13346-021-00924-7