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Journal of Clinical Medicine Aug 2023The aim of the study was to evaluate the effectiveness of extra virgin olive (EVO) oil and fruity oil for the treatment of gingivitis.
OBJECTIVES
The aim of the study was to evaluate the effectiveness of extra virgin olive (EVO) oil and fruity oil for the treatment of gingivitis.
MATERIALS AND METHODS
A sample of 75 patients over 18 years of age with gingivitis induced by plaque bacteria was divided into three groups: study group A, with extra virgin olive oil; study group B, with fruity oil; and control group C. In the two study groups, EVO oil was administered as a mouthwash to patients with gingival inflammation. The protocol included a daily application of the product for 30 days, with three recalls 15 days apart. Clinical parameters of plaque formation and gingivitis, including plaque index (PI) and bleeding index (BI), were assessed at each recall and scored on a specific periodontal chart. The control group received no mouthwash treatment in addition to normal daily oral hygiene procedures, and the same clinical parameters as the study group were evaluated. Data were evaluated using SPSS 27.0 software for Windows (SPSS Inc., Chicago, IL, USA). Then, the pre- and post-treatment values of the groups were compared using Student's -test, setting < 0.05 as the significance level.
RESULTS
Comparison of the three groups showed that extra-virgin olive oil was an adjuvant in the treatment of gingival inflammation, improving PI and BI. In group A, the mean plaque index showed a 48% reduction, and the bleeding index showed a 64% reduction after 30 days. In group B, the mean plaque index showed a 35% reduction and a bleeding index reduction of 43% after 30 days.
CONCLUSIONS
The collected data showed significant improvements in the formation of bacterial plaque and gingivitis. The exact mechanism of such treatment is still to be elucidated. As a result of this, further studies with a different sample of patients than those used and a comparison with other products need to be addressed to verify and demonstrate the antibacterial and anti-inflammatory effects of the components of this natural product.
PubMed: 37629298
DOI: 10.3390/jcm12165256 -
Journal of Clinical Oncology : Official... May 2024Intimate care products may contain substances associated with increased risk of hormone-related cancers. The relationship between genital talc use and ovarian cancer, in...
PURPOSE
Intimate care products may contain substances associated with increased risk of hormone-related cancers. The relationship between genital talc use and ovarian cancer, in particular, has been well studied, but concerns about recall bias and exposure misclassification have precluded conclusions. We examined the association between intimate care products and female hormone-related cancers, accounting for potential biases, using data from a US-based cohort study.
METHODS
The Sister Study enrolled 50,884 women who had a sister with breast cancer. Data on genital talc use and douching were collected at enrollment (2003-2009) and follow-up (2017-2019). We used Cox proportional hazards models to estimate hazard ratios (HRs) for associations between intimate care product use and breast, ovarian, and uterine cancers. To account for potential exposure misclassification and recall bias, we conducted quantitative bias analyses under various exposure reassignment assumptions.
RESULTS
Across considered scenarios, 41%-64% of participants douched and 35%-56% used genital talc. In models adjusted for exposure misclassification, genital talc use was positively associated with ovarian cancer (HR range, 1.17-3.34) Frequent douching and douching during young adulthood were positively associated with ovarian cancer, but neither douching nor talc was associated with breast or uterine cancer. Differential reporting of talc use by cases and noncases likely produces positive biases, but correcting for error still resulted in HRs above 1.0. For example, HR, 1.40 (95% CI, 1.04 to 1.89) when 25% of exposed cases and 10% of unexposed noncases had talc status reassigned.
CONCLUSION
Although results show how differential recall would upwardly bias estimates, corrected results support a positive association between use of intimate care products, including genital talc, and ovarian cancer.
PubMed: 38748950
DOI: 10.1200/JCO.23.02037 -
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 -
North American Spine Society Journal Sep 2023Bone grafting is commonly used in spine surgery to supplement or replace the need for autografts. This is harvested, prepared, and utilized predominantly for...
BACKGROUND
Bone grafting is commonly used in spine surgery to supplement or replace the need for autografts. This is harvested, prepared, and utilized predominantly for osteoconductive properties. Anterior cervical discectomy and fusion, a procedure to decompress and fuse the spine which treats herniated discs and compressed nerves, commonly uses Polyetheretherketone (PEEK) interbody filled with allograft bone matrices to reconstruct the disc space after a discectomy is performed.
CASE DESCRIPTION
The presented case is one of a 57-year-old male patient who underwent an uneventful cervical 5-6 and cervical 6-7 discectomy and fusion using a PEEK interbody and bone allograft. The allograft had been prepared using cancellous bone particles with preserved living cells and demineralized cortical bone fibers to facilitate bone repair and healing, which is a common technique. The allograft was aseptically processed to preserve native factors that can support bone repair and prevent contamination and cross-contamination of the product. Additionally, the product was sterilized using gamma irradiation to further prevent contamination.
OUTCOME
Unfortunately, with the presented case, the State's Department of Health and The Center for Diseases Control and Prevention identified that the graft was from a source contaminated with tuberculosis. The patient being reported went on to develop disseminated tuberculosis, including lung abscesses and osteomyelitis.
CONCLUSIONS
The current case highlights that there was contamination of the donor bone sources. Tuberculosis was not screened in the tissue donor even though he had risk factors, symptoms, and signs consistent with tuberculosis. Although there are methods to screen potential organ donors for tuberculosis, there is currently no approved standard laboratory tuberculosis screening tool for bone grafts. Thus, this emphasizes the importance of proper screening among individual institutions for even the most uncommon diseases in all donated bone grafts.
PubMed: 37483264
DOI: 10.1016/j.xnsj.2023.100241 -
BMC Medical Informatics and Decision... Jul 2023Real-world evidence (RWE)-based on information obtained from sources such as electronic health records (EHRs), claims and billing databases, product and disease...
BACKGROUND
Real-world evidence (RWE)-based on information obtained from sources such as electronic health records (EHRs), claims and billing databases, product and disease registries, and personal devices and health applications-is increasingly used to support healthcare decision making. There is variability in the collection of EHR data, which includes "structured data" in predefined fields (e.g., problem list, open claims, medication list, etc.) and "unstructured data" as free text or narrative. Healthcare providers are likely to provide more complete information as free text, but extracting meaning from these fields requires newer technologies and a rigorous methodology to generate higher-quality evidence. Herein, an approach to identify concepts associated with the presence and progression of migraine was developed and validated using the complete patient record in EHR data, including both the structured and unstructured portions.
METHODS
"Traditional RWE" approaches (i.e., capture from structured EHR fields and extraction using structured queries) and "Advanced RWE" approaches (i.e., capture from unstructured EHR data and processing by artificial intelligence [AI] technology, including natural language processing and AI-based inference) were evaluated against a manual chart abstraction reference standard for data collected from a tertiary care setting. The primary endpoint was recall; differences were compared using chi square.
RESULTS
Compared with manual chart abstraction, recall for migraine and headache were 66.6% and 29.6%, respectively, for Traditional RWE, and 96.8% and 92.9% for Advanced RWE; differences were statistically significant (absolute differences, 30.2% and 63.3%; P < 0.001). Recall of 6 migraine-associated symptoms favored Advanced RWE over Traditional RWE to a greater extent (absolute differences, 71.5-88.8%; P < 0.001). The difference between traditional and advanced techniques for recall of migraine medications was less pronounced, approximately 80% for Traditional RWE and ≥ 98% for Advanced RWE (P < 0.001).
CONCLUSION
Unstructured EHR data, processed using AI technologies, provides a more credible approach to enable RWE in migraine than using structured EHR and claims data alone. An algorithm was developed that could be used to further study and validate the use of RWE to support diagnosis and management of patients with migraine.
Topics: Humans; Electronic Health Records; Artificial Intelligence; Algorithms; Natural Language Processing; Migraine Disorders
PubMed: 37452338
DOI: 10.1186/s12911-023-02190-8 -
Journal of the American Nutrition... Jan 2024The association between nutrient intake and obesity and coronary problems has received great attention. So, this study aimed to examine the association between vitamin...
OBJECTIVE
The association between nutrient intake and obesity and coronary problems has received great attention. So, this study aimed to examine the association between vitamin D, calcium, and magnesium intake and obesity and coronary indices.
METHODS
A total of 491 male and female university employees (18-64 years) were randomly included in a cross-sectional study. Blood samples were drawn, and the lipid profile was analyzed. Different anthropometrics were measured. Obesity and coronary indices were calculated based on standard formulas. A 24-h recall was used to measure the average dietary intake of vitamin D, calcium, and magnesium.
RESULTS
For the total sample, vitamin D had a significantly weak correlation with the abdominal volume index (AVI) and weight-adjusted waist index (WWI). However, calcium intake had a significant moderate correlation with the AVI and a weak correlation with the conicity index (CI), body roundness index (BRI), body adiposity index (BAI), WWI, lipid accumulation product (LAP), and atherogenic index of plasma (AIP). In males, there was a significant weak correlation between calcium and magnesium intake and the CI, BAI, AVI, WWI, and BRI. Additionally, magnesium intake had a weak correlation with the LAP. In female participants, calcium and magnesium intake had a weak correlation with CI, BAI, AIP, and WWI. Additionally, calcium intake showed a moderate correlation with the AVI and BRI and a weak correlation with the LAP.
CONCLUSION
Magnesium intake had the greatest impact on coronary indices. Calcium intake had the greatest impact on obesity indices. Vitamin D intake had minimal effects on obesity and coronary indices.
Topics: Humans; Male; Female; Calcium; Magnesium; Risk Factors; Vitamin D; Cross-Sectional Studies; Obesity; Vitamins
PubMed: 37159492
DOI: 10.1080/27697061.2023.2203225 -
Sensors (Basel, Switzerland) Jan 2024Transactional data from point-of-sales systems may not consider customer behavior before purchasing decisions are finalized. A smart shelf system would be able to...
Transactional data from point-of-sales systems may not consider customer behavior before purchasing decisions are finalized. A smart shelf system would be able to provide additional data for retail analytics. In previous works, the conventional approach has involved customers standing directly in front of products on a shelf. Data from instances where customers deviated from this convention, referred to as "cross-location", were typically omitted. However, recognizing instances of cross-location is crucial when contextualizing multi-person and multi-product tracking for real-world scenarios. The monitoring of product association with customer keypoints through RANSAC modeling and particle filtering (PACK-RMPF) is a system that addresses cross-location, consisting of twelve load cell pairs for product tracking and a single camera for customer tracking. In this study, the time series vision data underwent further processing with R-CNN and StrongSORT. An NTP server enabled the synchronization of timestamps between the weight and vision subsystems. Multiple particle filtering predicted the trajectory of each customer's centroid and wrist keypoints relative to the location of each product. RANSAC modeling was implemented on the particles to associate a customer with each event. Comparing system-generated customer-product interaction history with the shopping lists given to each participant, the system had a general average recall rate of 76.33% and 79% for cross-location instances over five runs.
Topics: Humans; Supermarkets; Commerce; Research Personnel; Sprains and Strains; Standing Position
PubMed: 38257460
DOI: 10.3390/s24020367 -
Therapeutic Innovation & Regulatory... Jul 2024This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of...
PURPOSE
This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects.
METHODS
A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports.
RESULTS
During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies.
CONCLUSION
The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.
Topics: Saudi Arabia; Drug Recalls; Retrospective Studies; Humans; Drug Industry; Product Recalls and Withdrawals
PubMed: 38546962
DOI: 10.1007/s43441-024-00635-4 -
American Journal of Obstetrics &... Aug 2023There is currently a shortage of fetal scalp electrodes because of a recent recall due to concerns about the breakage of the electrode tip with possible injury to the...
There is currently a shortage of fetal scalp electrodes because of a recent recall due to concerns about the breakage of the electrode tip with possible injury to the neonate. Although the recall is presumably intended to improve safety, the resulting shortage of fetal scalp electrodes poses risks to patients because of inadequate fetal heart rate monitoring in cases where an adequate signal cannot be obtained with external fetal monitoring and/or when maternal heart rate artifact cannot be resolved by repositioning of transducers and application of a maternal pulse oximeter.
Topics: Pregnancy; Infant, Newborn; Female; Humans; Scalp; Patient Safety; Fetal Monitoring; Cardiotocography; Electrodes
PubMed: 37201795
DOI: 10.1016/j.ajogmf.2023.101021 -
Drug Discovery Today Jun 2024To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or... (Review)
Review
To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process.
Topics: United States; United States Food and Drug Administration; Drug Industry; Drug Recalls; Humans; Retrospective Studies
PubMed: 38670257
DOI: 10.1016/j.drudis.2024.103993