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Frontiers in Public Health 2021Recommender systems offer several advantages to hospital data management units and patients with special needs. These systems are more dependent on the extreme subtle...
Recommender systems offer several advantages to hospital data management units and patients with special needs. These systems are more dependent on the extreme subtle hospital-patient data. Thus, disregarding the confidentiality of patients with special needs is not an option. In recent times, several proposed techniques failed to cryptographically guarantee the data privacy of the patients with special needs in the diet recommender systems (RSs) deployment. In order to tackle this pitfall, this paper incorporates a blockchain privacy system (BPS) into deep learning for a diet recommendation system for patients with special needs. Our proposed technique allows patients to get notifications about recommended treatments and medications based on their personalized data without revealing their confidential information. Additionally, the paper implemented machine and deep learning algorithms such as RNN, Logistic Regression, MLP, etc., on an Internet of Medical Things (IoMT) dataset acquired the internet and hospitals that comprises the data of 50 patients with 13 features of various diseases and 1,000 products. The product section has a set of eight features. The IoMT data features were analyzed with BPS and further encoded prior to the application of deep and machine learning-based frameworks. The performance of the different machine and deep learning methods were carried out and the results verify that the long short-term memory (LSTM) technique is more effective than other schemes regarding prediction accuracy, precision, F1-measures, and recall in a secured blockchain privacy system. Results showed that 97.74% accuracy utilizing the LSTM deep learning model was attained. The precision of 98%, recall, and F1-measure of 99% each for the allowed class was also attained. For the disallowed class, the scores were 89, 73, and 80% for precision, recall, and F1-measure, respectively. The performance of our proposed BPS is subdivided into two categories: the secured communication channel of the recommendation system and an enhanced deep learning approach using health base medical dataset that spontaneously identifies what food a patient with special needs should have based on their disease and certain features including gender, weight, age, etc. The proposed system is outstanding as none of the earlier revised works of literature described a recommender system of this kind.
Topics: Algorithms; Blockchain; Data Management; Deep Learning; Humans; Internet of Things
PubMed: 34616709
DOI: 10.3389/fpubh.2021.737269 -
BMC Medical Ethics Jun 2023The US Food and Drug Administration (FDA) regulates goods accounting for 20% of US consumers' total expenditure. The agency's potential susceptibility to corporate...
BACKGROUND
The US Food and Drug Administration (FDA) regulates goods accounting for 20% of US consumers' total expenditure. The agency's potential susceptibility to corporate lobbying and political influence may adversely affect the its abilities to fulfill its duties as a vital federal agency. This study assesses whether the FDA's product recall classifications in recall scenarios are influenced by firms' lobbying activities.
METHODS
The universe of all FDA recalls between 2012 and 2019 is obtained from the FDA's website. Firm names are matched to federal-level lobbying data obtained from the Center for Responsive Politics - a non-profit and nonpartisan organization that tracks lobbying expenditures and campaign contributions. Analyses are conducted using ordinary-least-squares regressions, in which the dependent variable is recall classification and independent variables are three different measures of firms' lobbying activities in the one year prior to the recall.
RESULTS
Firms that engage in lobbying appear more likely to receive favourable classifications from the FDA. When examining the above results by product type, we find that classification of food recalls seems to be subject to lobbying influence, but the same does not appear to be true for drug and device recalls. Evidence is consistent with the conjecture that the distinction between medical and food firms may be a result of medical firms targeting lobbying efforts at FDA approvals, rather than recalls.
CONCLUSIONS
Between 2012 and 2019, the FDA's product recall classifications seem to be significantly influenced by firms' lobbying activities. Lobbying firms appear to have received more favorable (i.e., less severe) recall classifications compared to non-lobbying firms.
Topics: Humans; United States; Pharmaceutical Preparations; Lobbying; Politics; United States Food and Drug Administration
PubMed: 37340417
DOI: 10.1186/s12910-023-00921-0 -
The Journal of Medicine Access 2022Substandard and falsified (SF) medical products are removed from circulation through a process called 'product recall' by medicines regulatory agencies. In Zambia, the...
BACKGROUND
Substandard and falsified (SF) medical products are removed from circulation through a process called 'product recall' by medicines regulatory agencies. In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) is responsible for recalling SF medical products from the Zambian market through passive and active surveillance methods. This study aimed to describe the prevalence of recalls of SF medical products and to analyse the frequently recalled therapeutic categories, dosage forms, categories of defects that led to the recalls and their sources with respect to the country of the marketing authorisation holder (MAH) or manufacturer.
METHODS
We conducted a descriptive cross-sectional review of the product recalls issued by ZAMRA between January 2018 and December 2021. A search for all medical product alerts and recalls issued by ZAMRA was carried out by reviewing the internal post-marketing surveillance database kept at ZAMRA headquarters. Data were extracted using a structured Excel database and analysed using Microsoft Excel.
RESULTS
A total of 119 alerts were received during the review period, of which 83 (69.7%) were product recalls. Oral solid dosage forms were the most recalled dosage form (53%). Furthermore, the number of recalls increased in 2020 (44.6%) and 2021 (22.9%), with the majority (20.5%) of the recalled products being substandard products classified as antiseptics and disinfectants and were attributed to the high demand during the COVID-19 pandemic. Manufacturing laboratory control issues were the reason for product recall in almost half (47.4%) of the cases. Most of the products recalled originated from India (38.6%), followed by Zambia (25.3%). Only one suspected falsified product was recalled between 2018 and 2021. A total of 66 recalls of the 83 products were initiated by ZAMRA, with only 17 voluntarily by foreign MAHs. No product recall was initiated by the local representatives of foreign manufacturers or MAH.
CONCLUSION
The majority of the pharmaceutical product recalls in Zambia were substandard products. Manufacturing laboratory control issues lead to most recalls and require investigation of the root causes, preventive action, and strict compliance with the good manufacturing practices guidelines by manufacturers.
PubMed: 36601496
DOI: 10.1177/27550834221141767 -
The Cochrane Database of Systematic... Jan 2021This is the third update of this review, first published in July 2009. All major guidelines on treatment of hypertension recommend weight loss; anti-obesity drugs may be... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is the third update of this review, first published in July 2009. All major guidelines on treatment of hypertension recommend weight loss; anti-obesity drugs may be able to help in this respect.
OBJECTIVES
Primary objectives: To assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on all-cause mortality, cardiovascular morbidity, and adverse events (including total serious adverse events, withdrawal due to adverse events, and total non-serious adverse events).. Secondary objectives: To assess the long-term effects of pharmacologically-induced reduction in body weight in adults with essential hypertension on change from baseline in systolic and diastolic blood pressure, and on body weight reduction.
SEARCH METHODS
For this updated review, the Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to March 2020: the Cochrane Hypertension Specialised Register, CENTRAL, MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. The searches had no language restrictions. We contacted authors of relevant papers about further published and unpublished work.
SELECTION CRITERIA
Randomised controlled trials of at least 24 weeks' duration in adults with hypertension that compared approved long-term weight-loss medications to placebo. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias, and extracted data. Where appropriate and in the absence of significant heterogeneity between studies (P > 0.1), we pooled studies using a fixed-effect meta-analysis. When heterogeneity was present, we used the random-effects method and investigated the cause of the heterogeneity.
MAIN RESULTS
This third update of the review added one new trial, investigating the combination of naltrexone/bupropion versus placebo. Two medications, which were included in the previous versions of this review (rimonabant and sibutramine) are no longer considered relevant for this update, since their marketing approval was withdrawn in 2010 and 2009, respectively. The number of included studies in this review update is therefore six (12,724 participants in total): four RCTs comparing orlistat to placebo, involving a total of 3132 participants with high blood pressure and a mean age of 46 to 55 years; one trial comparing phentermine/topiramate to placebo, involving 1305 participants with high blood pressure and a mean age of 53 years; and one trial comparing naltrexone/bupropion to placebo, involving 8283 participants with hypertension and a mean age of 62 years. We judged the risks of bias to be unclear for the trials investigating orlistat or naltrexone/bupropion. and low for the trial investigating phentermine/topiramate. Only the study of naltrexone/bupropion included cardiovascular mortality and morbidity as predefined outcomes. There were no differences in the rates of all-cause or cardiovascular mortality, major cardiovascular events, or serious adverse events between naltrexone/bupropion and placebo. The incidence of overall adverse events was significantly higher in participants treated with naltrexone/bupropion. For orlistat, the incidence of gastrointestinal side effects was consistently higher compared to placebo. The most frequent side effects with phentermine/topiramate were dry mouth and paraesthesia. After six to 12 months, orlistat reduced systolic blood pressure compared to placebo by mean difference (MD) -2.6 mm Hg (95% confidence interval (CI) -3.8 to -1.4 mm Hg; 4 trials, 2058 participants) and diastolic blood pressure by MD -2.0 mm Hg (95% CI -2.7 to -1.2 mm Hg; 4 trials, 2058 participants). After 13 months of follow-up, phentermine/topiramate decreased systolic blood pressure compared to placebo by -2.0 to -4.2 mm Hg (1 trial, 1030 participants) (depending on drug dosage), and diastolic blood pressure by -1.3 to -1.9 mm Hg (1 trial, 1030 participants) (depending on drug dosage). There was no difference in the change in systolic or diastolic blood pressure between naltrexone/bupropion and placebo (1 trial, 8283 participants). We identified no relevant studies investigating liraglutide or lorcaserin in people with hypertension.
AUTHORS' CONCLUSIONS
In people with elevated blood pressure, orlistat, phentermine/topiramate and naltrexone/bupropion reduced body weight; the magnitude of the effect was greatest with phentermine/topiramate. In the same trials, orlistat and phentermine/topiramate, but not naltrexone/bupropion, reduced blood pressure. One RCT of naltrexone/bupropion versus placebo showed no differences in all-cause mortality or cardiovascular mortality or morbidity after two years. The European Medicines Agency refused marketing authorisation for phentermine/topiramate due to safety concerns, while for lorcaserin the application for European marketing authorisation was withdrawn due to a negative overall benefit/risk balance. In 2020 lorcaserin was also withdrawn from the US market. Two other medications (rimonabant and sibutramine) had already been withdrawn from the market in 2009 and 2010, respectively.
Topics: Adult; Anti-Obesity Agents; Appetite Depressants; Bias; Blood Pressure; Body Weight; Bupropion; Diet, Reducing; Drug Combinations; Female; Fructose; Humans; Hypertension; Lactones; Male; Middle Aged; Naltrexone; Orlistat; Phentermine; Piperidines; Pyrazoles; Randomized Controlled Trials as Topic; Safety-Based Drug Withdrawals; Time; Topiramate
PubMed: 33454957
DOI: 10.1002/14651858.CD007654.pub5 -
Journal of Medical Internet Research Sep 2023The innovative method of sentiment analysis based on an emotional lexicon shows prominent advantages in capturing emotional information, such as individual attitudes,...
BACKGROUND
The innovative method of sentiment analysis based on an emotional lexicon shows prominent advantages in capturing emotional information, such as individual attitudes, experiences, and needs, which provides a new perspective and method for emotion recognition and management for patients with breast cancer (BC). However, at present, sentiment analysis in the field of BC is limited, and there is no emotional lexicon for this field. Therefore, it is necessary to construct an emotional lexicon that conforms to the characteristics of patients with BC so as to provide a new tool for accurate identification and analysis of the patients' emotions and a new method for their personalized emotion management.
OBJECTIVE
This study aimed to construct an emotional lexicon of patients with BC.
METHODS
Emotional words were obtained by merging the words in 2 general sentiment lexicons, the Chinese Linguistic Inquiry and Word Count (C-LIWC) and HowNet, and the words in text corpora acquired from patients with BC via Weibo, semistructured interviews, and expressive writing. The lexicon was constructed using manual annotation and classification under the guidance of Russell's valence-arousal space. Ekman's basic emotional categories, Lazarus' cognitive appraisal theory of emotion, and a qualitative text analysis based on the text corpora of patients with BC were combined to determine the fine-grained emotional categories of the lexicon we constructed. Precision, recall, and the F1-score were used to evaluate the lexicon's performance.
RESULTS
The text corpora collected from patients in different stages of BC included 150 written materials, 17 interviews, and 6689 original posts and comments from Weibo, with a total of 1,923,593 Chinese characters. The emotional lexicon of patients with BC contained 9357 words and covered 8 fine-grained emotional categories: joy, anger, sadness, fear, disgust, surprise, somatic symptoms, and BC terminology. Experimental results showed that precision, recall, and the F1-score of positive emotional words were 98.42%, 99.73%, and 99.07%, respectively, and those of negative emotional words were 99.73%, 98.38%, and 99.05%, respectively, which all significantly outperformed the C-LIWC and HowNet.
CONCLUSIONS
The emotional lexicon with fine-grained emotional categories conforms to the characteristics of patients with BC. Its performance related to identifying and classifying domain-specific emotional words in BC is better compared to the C-LIWC and HowNet. This lexicon not only provides a new tool for sentiment analysis in the field of BC but also provides a new perspective for recognizing the specific emotional state and needs of patients with BC and formulating tailored emotional management plans.
Topics: Humans; Female; Breast Neoplasms; Sentiment Analysis; Emotions; Fear; Sadness
PubMed: 37698914
DOI: 10.2196/44897 -
Nature Microbiology May 2023Vaccines play a critical role in combating the COVID-19 pandemic. Future control of the pandemic requires improved vaccines with high efficacy against newly emerging...
Vaccines play a critical role in combating the COVID-19 pandemic. Future control of the pandemic requires improved vaccines with high efficacy against newly emerging SARS-CoV-2 variants and the ability to reduce virus transmission. Here we compare immune responses and preclinical efficacy of the mRNA vaccine BNT162b2, the adenovirus-vectored spike vaccine Ad2-spike and the live-attenuated virus vaccine candidate sCPD9 in Syrian hamsters, using both homogeneous and heterologous vaccination regimens. Comparative vaccine efficacy was assessed by employing readouts from virus titrations to single-cell RNA sequencing. Our results show that sCPD9 vaccination elicited the most robust immunity, including rapid viral clearance, reduced tissue damage, fast differentiation of pre-plasmablasts, strong systemic and mucosal humoral responses, and rapid recall of memory T cells from lung tissue after challenge with heterologous SARS-CoV-2. Overall, our results demonstrate that live-attenuated vaccines offer advantages over currently available COVID-19 vaccines.
Topics: Animals; Cricetinae; Humans; Vaccines, Attenuated; SARS-CoV-2; COVID-19; COVID-19 Vaccines; BNT162 Vaccine; Pandemics; Mesocricetus
PubMed: 37012419
DOI: 10.1038/s41564-023-01352-8 -
Journal of Food Protection Jan 2022This review covers 18 years of voluntary recalls of tuna sold commercially in the United States. Recall information is a valuable indicator of failure to implement... (Review)
Review
ABSTRACT
This review covers 18 years of voluntary recalls of tuna sold commercially in the United States. Recall information is a valuable indicator of failure to implement procedures for food safety. The voluntary recalls involve tuna that was fresh, frozen, processed, hermetically sealed, retorted in a shelf-stable pack (i.e., canned), and formulated into other tuna products. U.S. Food and Drug Administration regulations address the capture, processing, transportation, and sale of raw and processed seafood. These regulations include current good manufacturing practices, the Food Modernization Act, emergency permit controls, and guidelines for low-acid canned foods, seafood hazard analysis and critical control points, food labeling, and sanitary food transportation. Traceability and the food safety culture are important for successfully preventing or implementing recalls. The recalls themselves were separated into product treatment groups: uncooked products, canned shelf-stable products, and products in which tuna was used as an ingredient. The recalls were further categorized and summarized by reason or cause, such as biological and chemical contamination, undeclared ingredients, underprocessing, and foreign materials. The primary causes of recalls of the reviewed tuna products were (in order) Listeria monocytogenes, undeclared allergens, elevated histamine concentrations, and underprocessing of retorted tuna products. The recalls for elevated histamine concentrations primarily affected uncooked (raw) tuna. Recalls for Listeria contamination and the presence of undeclared allergens were primarily class I recalls, and recalls for elevated histamine concentrations and underprocessing were almost always assigned to the less serious recall class II.
Topics: Allergens; Animals; Food Contamination; Food Labeling; Food Safety; Seafood; Tuna; United States
PubMed: 34591090
DOI: 10.4315/JFP-21-254 -
Foods (Basel, Switzerland) Dec 2022Nuts are widely consumed worldwide, mainly due to their characteristic flavor and texture, ease of consumption, and their functional properties. In addition, consumers... (Review)
Review
Nuts are widely consumed worldwide, mainly due to their characteristic flavor and texture, ease of consumption, and their functional properties. In addition, consumers increasingly demand natural or slightly processed foods with high quality. Consequently, non-thermal treatments are a viable alternative to thermal treatments used to guarantee safety and long shelf life, which produce undesirable changes that affect the sensory quality of nuts. Non-thermal treatments can achieve results similar to those of the traditional (thermal) ones in terms of food safety, while ensuring minimal loss of bioactive compounds and sensory properties, thus obtaining a product as similar as possible to the fresh one. This article focuses on a review of the main non-thermal treatments currently available for nuts (cold plasma, high pressure, irradiation, pulsed electric field, pulsed light, ultrasound and ultraviolet light) in relation to their effects on the quality and safety of nuts. All the treatments studied have shown promise with regard to the inhibition of the main microorganisms affecting nuts (e.g., , , and ). Furthermore, by optimizing the treatment, it is possible to maintain the organoleptic and functional properties of these products.
PubMed: 36496699
DOI: 10.3390/foods11233891 -
Drug Safety Sep 2021Substandard medicines are medicines that fail to meet their quality standards and/or specifications. Substandard medicines can lead to serious safety issues affecting...
INTRODUCTION
Substandard medicines are medicines that fail to meet their quality standards and/or specifications. Substandard medicines can lead to serious safety issues affecting public health. With the increasing number of pharmaceuticals and the complexity of the pharmaceutical manufacturing supply chain, monitoring for substandard medicines via manual environmental scanning can be laborious and time consuming.
METHODS
A web crawler was developed to automatically detect and extract alerts on substandard medicines published on the Internet by regulatory agencies. The crawled data were labelled as related to substandard medicines or not. An expert-derived keyword-based classification algorithm was compared against machine learning algorithms to identify substandard medicine alerts on two validation datasets (n = 4920 and n = 2458) from a later time period than training data. Models were comparatively assessed for recall, precision and their F1 scores (harmonic mean of precision and recall).
RESULTS
The web crawler routinely extracted alerts from the 46 web pages belonging to nine regulatory agencies. From October 2019 to May 2020, 12,156 unique alerts were crawled of which 7378 (60.7%) alerts were set aside for validation and contained 1160 substandard medicine alerts (15.7%). An ensemble approach of combining machine learning and keywords achieved the best recall (94% and 97%), precision (85% and 80%) and F1 scores (89% and 88%) on temporal validation.
CONCLUSIONS
Combining robust web crawler programmes with rigorously tested filtering algorithms based on machine learning and keyword models can automate and expand horizon scanning capabilities for issues relating to substandard medicines.
Topics: Algorithms; Humans; Internet; Machine Learning; Singapore; Substandard Drugs
PubMed: 34148223
DOI: 10.1007/s40264-021-01084-w -
Frontiers in Medicine 2023Manually keeping up-to-date with regulations such as directives, guidance, laws, and ordinances related to cell and gene therapy is a labor-intensive process. We used...
BACKGROUND
Manually keeping up-to-date with regulations such as directives, guidance, laws, and ordinances related to cell and gene therapy is a labor-intensive process. We used machine learning (ML) algorithms to create an augmented intelligent system to optimize systematic screening of global regulations to improve efficiency and reduce overall labor and missed regulations.
METHODS
Combining Boolean logic and artificial intelligence (i.e., augmented intelligence) for the search process, ML algorithms were used to identify and suggest relevant cell and gene therapy regulations. Suggested regulations were delivered to a landing page for further subject matter expert (SME) tagging of words/phrases to provide system relevance on functional words. Ongoing learning from the repository regulations continued to increase system reliability and performance. The automated ability to train and retrain the system allows for continued refinement and improvement of system accuracy. Automated daily searches for applicable regulations in global databases provide ongoing opportunities to update the repository.
RESULTS
Compared to manual searching, which required 3-4 SMEs to review ~115 regulations, the current system performance, with continuous system learning, requires 1 full-time equivalent to process approximately 9,000 regulations/day. Currently, system performance has 86% overall accuracy, a recommend recall of 87%, and a reject recall of 84%. A conservative search strategy is intentionally used to permit SMEs to assess low-recommended regulations in order to prevent missing any applicable regulations.
CONCLUSION
Compared to manual searches, our custom automated search system greatly improves the management of cell and gene therapy regulations and is efficient, cost effective, and accurate.
PubMed: 36950510
DOI: 10.3389/fmed.2023.1072767