Tag: pubmed

Perspect Clin Res. 2024 Jul-Sep;15(3):134-140. doi: 10.4103/picr.picr_213_23. Epub 2024 Feb 3.

ABSTRACT

BACKGROUND: Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria.

MATERIALS AND METHODS: Data were retrieved after the Ethics Committee’s approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as “BEFORE” data, while the remaining data were categorized as “AFTER.” Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann-Whitney tests were used to compare the “BEFORE” and “AFTER” groups.

RESULTS: A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants (23.59%) with approximately 48% of these being vascular. The “AFTER” group noticed a decrease in the total number and length of SAE subcommittee meetings. In the “AFTER” group, there was a significantly higher median number of agenda items/meetings (8 [4.5-10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1-5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the “AFTER” group, there were no discrepancies in reporting SAE.

CONCLUSION: There is acceptable adherence to SAE reporting criteria.

PMID:39140018 | PMC:PMC11318791 | DOI:10.4103/picr.picr_213_23

Perspect Clin Res. 2024 Jul-Sep;15(3):141-146. doi: 10.4103/picr.picr_108_23. Epub 2024 Jul 4.

ABSTRACT

AIM: The aim of this study was to monitor prescription patterns, clinical outcomes, and adverse drug reactions (ADR) among patients of various interstitial lung diseases (ILDs).

MATERIALS AND METHODS: This prospective study was conducted in the Department of Pharmacology and Therapeutics in collaboration with the Department of Respiratory Medicine, King George’s Medical University, Lucknow, for a period of 12 months (October 2020-September 2021). A total of 77 patients were enrolled after satisfying the inclusion and exclusion criteria. The prescriptions were collected, and necessary details were noted on the case report form. After completion of the study, the data were analyzed for prescription patterns, clinical outcomes, and quality of life with the help of a validated questionnaire-King’s Brief ILD (KBILD) questionnaire. At the same time, ADRs, if any, were assessed using Hartwig’s Severity Assessment Scale and Naranjo Causality Assessment Scale.

RESULTS: The most common ILD was acute/chronic hypersensitivity pneumonitis (HP). Average number of drugs per encounter was 4.45. Crepitations were the most common clinical signs. Clubbing and rhonchi were reported maximum in idiopathic pulmonary fibrosis. It was found that psychological, breathlessness and activities, chest symptoms, and total KBILD reduced significantly after 3 months as compared to baseline with a statistically significant difference as P < 0.01. ADRs were found in 23.38% (18) of the subjects. Maximum ADR reported was gastritis (9.09%), followed by hepatitis (3.90%).

CONCLUSION: The high proportion of patients clinically diagnosed with HP in our study highlights the importance of a detailed environmental exposure history in the diagnostic evaluation of patients with ILD to avoid inaccurate diagnoses. ADR-related hospital admissions are a significant problem in the health-care system.

PMID:39140017 | PMC:PMC11318784 | DOI:10.4103/picr.picr_108_23

BMJ Open. 2024 Aug 13;14(7):e079365. doi: 10.1136/bmjopen-2023-079365.

ABSTRACT

OBJECTIVE: To compare life expectancy levels and within-country geographic variation in life expectancy across six high-income Anglophone countries between 1990 and 2018.

DESIGN: Demographic analysis using aggregated mortality data.

SETTING: Six high-income Anglophone countries (USA, UK, Canada, Australia, Ireland and New Zealand), by sex, including an analysis of subnational geographic inequality in mortality within each country.

POPULATION: Data come from the Human Mortality Database, the WHO Mortality Database and the vital statistics agencies of six high-income Anglophone countries.

MAIN OUTCOME MEASURES: Life expectancy at birth and age 65; age and cause of death contributions to life expectancy differences between countries; index of dissimilarity for within-country geographic variation in mortality.

RESULTS: Among six high-income Anglophone countries, Australia is the clear best performer in life expectancy at birth, leading its peer countries by 1.26-3.95 years for women and by 0.97-4.88 years for men in 2018. While Australians experience lower mortality across the age range, most of their life expectancy advantage accrues between ages 45 and 84. Australia performs particularly well in terms of mortality from external causes (including drug- and alcohol-related deaths), screenable/treatable cancers, cardiovascular disease and influenza/pneumonia and other respiratory diseases compared with other countries. Considering life expectancy differences across geographic regions within each country, Australia tends to experience the lowest levels of inequality, while Ireland, New Zealand and the USA tend to experience the highest levels.

CONCLUSIONS: Australia has achieved the highest life expectancy among Anglophone countries and tends to rank well in international comparisons of life expectancy overall. It serves as a potential model for lower-performing countries to follow to reduce premature mortality and inequalities in life expectancy.

PMID:39138004 | DOI:10.1136/bmjopen-2023-079365

J Dent Hyg. 2024 Aug;98(4):20-27.

ABSTRACT

Purpose Empathetic engagement is considered a vital component in forming respect-based relationships between patients and clinicians, leading to more optimal patient care. The purpose of this study was to explore whether there was a relationship between dental hygiene students’ levels of empathy and student demographics including age, gender, year in school, and the degree type of dental hygiene program attending.Methods This was a cross-sectional observation study conducted among dental hygiene undergraduate students attending three dental hygiene programs in the Midwestern United States. Two programs offered associate degrees and one offered a baccalaureate degree. Participants completed the 20-item Jefferson Scale of Empathy^©, student edition (JSE-S) along with demographic questions including age, gender, year in dental hygiene program, and degree type of dental hygiene program. Descriptive statistics and comparisons of the empathy scores were conducted using t-test and one-way analysis of variance (ANOVA). Regressions were conducted to determine whether the students’ year in dental hygiene program and the type of degree program were predictors of empathy.Results Forty-one participants completed the questionnaire for a 65% response rate. The mean empathy score was 83.05 ± 10.04 among the participants. There were no statistically significant differences between levels of empathy of first- and second-year students or those attending a two-year institution versus a four-year university. Age, year in program, and type of degree were not shown to be predictors of empathy.Conclusion Results from this study did not show relationships or predictors of empathy with dental hygiene students’ demographics or type of degree program. Future research should expand beyond a small homogenous convenience sample and include a longitudinal gauge to assess potential fluctuations in empathy as students progress throughout the curriculum and as practicing clinicians.

PMID:39137992

J Dent Hyg. 2024 Aug;98(4):28-36.

ABSTRACT

Purpose Herpes Simplex Virus type 1 (HSV-1) is a highly contagious virus that manifests as a painful lesion and recurrences can be distressing to patients. The purpose of this pilot study was to determine if the use of a 70% ethanol alcohol hand sanitizer alters the duration, size of the lesion, level of pain upon administering treatment, and overall daily discomfort during outbreak.Methods This study was a double-blind randomized controlled trial (RCT) using 70% ethanol alcohol hand sanitizer for the experiment and medical grade mineral oil for the control group. The treatment and the control were dispensed in lip gloss applicators for applying medicament. Data was collected through the initial examination, a daily journal, photographs, and a reexamination day. Descriptive statistics and the independent sample t-test were used to analyze data (p=0.05).Results A total of 20 individuals completed the research study: ten in the experimental group and ten in the control group. The mean duration of HSV-1 lesions for the control group was 10.3 days while the mean duration of the HSV-1 lesions for the experimental group was 7.6 days. The mean size of lesions for the control group was 4.87 mm; the mean size for the experimental group was 4.25 mm. The mean pain score for the control group was 1.08 and the mean pain score for the experimental group was 2.74. The mean discomfort score for the control group was 1.33 while the mean discomfort score for the experimental group was 1.72. There was no statistically significant difference between the experimental and control groups in terms of duration, size of lesions, pain, and discomfort.Conclusion Based on the results of this pilot study, 70% ethanol alcohol hand sanitizer did not demonstrate statistical significance in the treatment and management of HSV-1 lesions. Additional research is needed with a larger sample size to determine if statistical differences can be measured.

PMID:39137990

J Nucl Med Technol. 2024 Aug 13:jnmt.124.267965. doi: 10.2967/jnmt.124.267965. Online ahead of print.

ABSTRACT

Myocardial perfusion imaging (MPI) provides physiologic and functional information about the heart muscle and its blood flow. Extracardiac radioactivity can interfere with visualization of the inferior wall of the myocardium, leading to poor-quality images, difficulties in interpretation, and delays in routine practice. This study aimed to identify the efficiency of having the patient consume a carbonated lemon drink to minimize the extracardiac radioactivity of ^99mTc-sestamibi in comparison to ^99mTc-tetrofosmin during MPI. Methods: This was a retrospective study that recruited 158 patients with known or suspected coronary artery disease referred to undergo ^99mTc-sestamibi or ^99mTc-tetrofosmin rest/stress single-day MPI. The patients were divided into 2 groups of mixed sexes and different ages. The first group comprised 78 patients injected with ^99mTc-sestamibi, and the second group comprised 80 patients injected with ^99mTc-tetrofosmin. For both groups, the patients drank 30 mL of fresh lemon juice diluted with 150 mL of soda water, and then we gave the patients about 100 mL of straight soda water, before imaging for both the rest and the stress phases. Results: Generally, in both groups, the ^99mTc-tetrofosmin produced a good-quality image in comparison with the ^99mTc-sestamibi. The mean rank of the total score for ^99mTc-tetrofosmin (62.75) was less than that for ^99mTc-sestamibi (96.68), and this difference was highly statistically significant (P = 0.000). There were statistically significant differences in the ratios and mean ranks for both groups in favor of ^99mTc-tetrofosmin in patients having coronary artery disease. Conclusion: The use of a carbonated lemon drink minimizes extracardiac activity from both ^99mTc-labeled MPI radiopharmaceuticals. This finding was more statistically significant for ^99mTc-tetrofosmin MPI, providing better image quality and earlier imaging in both the rest and the stress phases because of faster hepatobiliary clearance.

PMID:39137982 | DOI:10.2967/jnmt.124.267965

J Neurol Neurosurg Psychiatry. 2024 Aug 13:jnnp-2024-333465. doi: 10.1136/jnnp-2024-333465. Online ahead of print.

ABSTRACT

BACKGROUND: Calorie restriction (CR) ameliorates preclinical models of multiple sclerosis (MS) via multiple mechanisms. These include decreased leptin, a proinflammatory adipokine, but mechanistic studies in humans are lacking. Tests of daily and intermittent CR (iCR) in people with MS (pwMS) showed improvements in fatigue and well-being measures. This trial studied the effects of 12-week iCR on metabolic, immunological, and clinical outcomes in pwMS.

METHOD: Relapsing-remitting MS participants were randomised to iCR or a control group. Study visits were conducted at baseline, 6 and 12 weeks. The primary outcome was reduction in serum leptin levels at 12 weeks. Feasibility and safety were assessed by diet adherence and adverse events (AEs). Secondary outcomes included changes in anthropometric and body composition measures, metabolic and immunologic profiling, and clinical measures. Mixed effects linear regression models were used to evaluate outcome differences between and within groups over time.

RESULTS: Forty-two pwMS were randomised, 34 completed the study (17/group). Leptin serum levels at 12 weeks were significantly lower in the iCR versus the control group (mean decrease -6.98 µg/dL, 95% CI: -28.02 to 14.06; p=0.03). Adherence to iCR was 99.5% and 97.2% at 6 and 12 weeks, respectively, and no serious AEs were reported. An increase in blood CD45RO⁺ regulatory T-cell numbers was seen after 6 weeks of iCR. Exploratory cognitive testing demonstrated a significant improvement in the Symbol Digit Modality Test Score in the iCR group at 12 weeks.

CONCLUSIONS: iCR has the potential to benefit metabolic and immunologic profiles and is safe and feasible in pwMS.

TRIAL REGISTRATION NUMBER: NCT03539094 .

PMID:39137977 | DOI:10.1136/jnnp-2024-333465

Genome Res. 2024 Aug 13:gr.279274.124. doi: 10.1101/gr.279274.124. Online ahead of print.

ABSTRACT

Chromatin loop identification plays an important role in molecular biology and 3D genomics research, as it constitutes a fundamental process in transcription and gene regulation. Such precise chromatin structures can be identified across genome-wide interaction matrices via Hi-C data analysis, which is essential for unraveling the intricacies of transcriptional regulation. Given the increasing number of genome-wide contact maps, derived from both in situ Hi-C and single-cell Hi-C experiments, there is a pressing need for efficient and resilient algorithms capable of processing data from diverse experiments rapidly and adaptively. Here, we propose YOLOOP, a novel detection-based framework that is different from the conventional paradigm. YOLOOP stands out for its speed, surpassing the performance of previous state-of-the-art (SOTA) chromatin loop detection methods. It achieves a 30-fold acceleration compared to classification-based methods, up to 20-fold acceleration compared to the SOTA kernel-based framework, and a 5-fold acceleration compared to statistical algorithms. Furthermore, our proposed framework exhibits exceptional generalization capabilities across various cell types, multi-resolution Hi-C maps, and diverse experimental protocols. Compared with the existing paradigms, YOLOOP shows up to a 10% increase in recall and a 15% increase in F1-score, particularly noteworthy in the GM12878 cell line. YOLOOP also offers fast adaptability with straightforward fine-tuning, making it readily applicable to extremely sparse single-cell Hi-C contact maps. It maintains its exceptional speed, completing genome-wide detection at a 10 kb resolution for one single-cell contact map within 1 minute, and for 900-cells-superimposed contact map within 3 minutes, enabling fast analysis on massive amounts of single-cell data.

PMID:39137961 | DOI:10.1101/gr.279274.124

BMJ Glob Health. 2024 Aug 13;9(8):e015475. doi: 10.1136/bmjgh-2024-015475.

ABSTRACT

INTRODUCTION: Despite the progress in reducing child mortality, the rate remains high, particularly in sub-Saharan African countries. Limited data exist on child survival and other birth outcomes by sex. This study compared survival rates and birth outcomes by sex among neonates and children under 2 in Ethiopia.

METHODS: Women who gave birth after 28 weeks of gestation and their newborns were included in the analysis. Survival probabilities were estimated for males and females in the neonatal period as well as the 2-year period following birth using Kaplan-Meier curves. HRs and 95% CIs were compared between males and females under 2. Descriptive statistics and χ² tests were used to determine the sex-disaggregated variation in the birth outcomes of preterm birth, low birth weight (LBW), stillbirth, small for gestational age (SGA) and large for gestational age (LGA).

RESULTS: The study included a total of 3904 women and child pairs. The neonatal mortality rate for males (3.4%, 95% CI 2.6% to 4.2%) was higher compared with females (1.7%, 95% CI 1.1% to 2.3%). The hazard of death during the first 28 days of life was approximately two times higher for males compared with females (HR 1.99, 95% CI 1.30 to 3.06) but was not significantly different after this period. While there was a non-significant difference between males and females in the proportion of preterm, LBW and LGA births, we found a significantly higher proportion of stillbirth (2.7% vs 1.3%, p=0.003) and SGA (20.5% vs 15.6%, p<0.001) for males compared with females.

CONCLUSIONS: This study identified a significant sex difference in mortality and birth outcomes. We recommend focusing future research on the mechanisms of these sex differences in order to better design intervention programmes to reduce disparities and improve outcomes for neonates.

PMID:39137954 | DOI:10.1136/bmjgh-2024-015475

BMJ. 2024 Aug 13;386:e079694. doi: 10.1136/bmj-2024-079694.

NO ABSTRACT

PMID:39137944 | DOI:10.1136/bmj-2024-079694