Tag: nevin manimala

J Clin Pharmacol. 2025 Oct 13. doi: 10.1002/jcph.70120. Online ahead of print.

ABSTRACT

Malnutrition occurs at higher rates in children with complex medical conditions and can independently influence drug disposition and action. Yet FDA-approved product labels rarely address dosing in malnutrition. This study explores the extent to which malnourished children are expressly excluded from clinical trials. Industry-sponsored, pediatric, phase I-III studies deposited in ClinicalTrials.Gov through December 2024 with a full study protocol were reviewed. Protocols were evaluated for inclusion and exclusion (I/E) criteria related to anthropometric and clinical indicators of malnutrition. I/E criteria were fully characterized along with the study phase, intervention type, and treatment indication. 9882 studies were identified, 1759 with an uploaded protocol. 616 studies (35%) contained 777 distinct I/E criteria related to malnutrition (1-6 per study). Across all protocols, 71% exclusively restricted participation of children with evidence of undernutrition, 9% with overnutrition, and 20% with both. There were no statistical differences observed based on intervention type, though differences by study phase were observed. Restrictions were seen most frequently for respiratory, mental/behavioral, obstetric/perinatal, and emergency use indications and least frequently for dermatologic, oncologic, and eyes, ears, nose, and throat disorders. Non-specific I/E criteria suggest that these findings likely underestimate the extent of malnutrition-based exclusions. Despite growing attention paid to obesity, pediatric clinical trials are far more likely to restrict the participation of undernourished children. Though unrealistic to relax malnutrition related I/E criteria for all studies, consideration should be given for conditions where high rates of malnutrition are expected to avoid trial populations that do not reflect clinical practice.

PMID:41078146 | DOI:10.1002/jcph.70120

Int J Gynaecol Obstet. 2025 Oct 13. doi: 10.1002/ijgo.70585. Online ahead of print.

ABSTRACT

OBJECTIVE: This study compares the effectiveness and safety of three prophylactic uterotonic regimens-intravenous carbetocin, oxytocin infusion, and oxytocin-ergometrine combination-in preventing postpartum hemorrhage (PPH) in women with isolated polyhydramnios.

METHODS: This retrospective cohort study included 286 term pregnancies complicated by isolated polyhydramnios, managed at a tertiary obstetric center between January 2020 and April 2024. Participants received a single prophylactic uterotonic immediately after placental delivery: carbetocin (n = 124), oxytocin (n = 116), or oxytocin-ergometrine (n = 46). Patients with additional PPH risk factors were excluded. Primary outcomes included hemoglobin and hematocrit changes, estimated blood loss, and 6-h postpartum shock index. Secondary outcomes were rates of transfusion, surgical intervention, and uterine-sparing procedures.

RESULTS: Carbetocin was associated with significantly smaller drops in hemoglobin and hematocrit, lower estimated blood loss, and more favorable shock index values compared to the other groups. These advantages were consistent across cesarean, primiparous, and multiparous vaginal deliveries. Although not statistically significant, fewer secondary interventions (e.g., transfusion, balloon tamponade, and compression sutures) were recorded in the carbetocin group.

CONCLUSION: Among women with isolated polyhydramnios, carbetocin offers superior prophylactic control of PPH compared to oxytocin and oxytocin-ergometrine regimens. Its long-acting effect provides sustained uterine contraction, reducing the need for additional interventions. Carbetocin might be especially beneficial in high-risk cases of uterine overdistension, supporting its targeted use in individualized obstetric care.

PMID:41078143 | DOI:10.1002/ijgo.70585

Anal Methods. 2025 Oct 13. doi: 10.1039/d5ay01251a. Online ahead of print.

ABSTRACT

This study presents a low-cost, 3D-printed portable device that integrates computer vision and an artificial neural network (ANN) to quantify biodiesel content (1-30% v/v) in fossil diesel blends using a solvatochromic assay with Reichardt’s dye. A total of 105 samples (35 biodiesel blend levels in triplicate) were analyzed with both the proposed method and the official Brazilian standard ABNT NBR 15568/2008 (FT-IR). While the standard method requires laboratory infrastructure and specialized equipment, the proposed system provides comparable accuracy directly at the point of fuel distribution. It achieved a mean absolute error (MAE) of 1.5% (R² = 0.969) for training data and 0.5% (R² = 0.995) for independent test data. Robust cross-validation confirmed model stability and absence of overfitting, and a paired Student’s t-test showed no statistically significant difference between the two methods (p > 0.05), confirming statistical equivalence. Beyond analytical performance, the device offers practical advantages: controlled lighting and webcam-based image acquisition coupled with ANN processing enable rapid, on-site biodiesel determination without specialized training. This contrasts with the official method, which is restricted to laboratory settings. By combining portability, low operational complexity, and real-time analysis capability, this system represents a significant advancement for fuel quality monitoring, allowing reliable control of BX diesel blends directly at fueling stations and other non-laboratory environments. BX diesel, dye solution, and ethanol.

PMID:41078134 | DOI:10.1039/d5ay01251a

Disaster Med Public Health Prep. 2025 Oct 13;19:e291. doi: 10.1017/dmp.2025.10212.

ABSTRACT

OBJECTIVE: CBRN events can occur randomly or intentionally. Rapid and appropriate response to CBRN events can significantly mitigate the adverse effects on physical health and reduce mortality rates. The effectiveness of these responses largely depends on the preparedness of hospital emergency Clinical staff.

METHODS: This study was a mixed-methods research aiming to develop and validate a psychometric research instrument in 2025. Based on the review of the literature regarding CBRN events, the items were extracted, rewritten, and validated. In the quantitative phase, the validity of the questionnaire was evaluated in terms of face, content, and construct validity, and its reliability was evaluated based on internal consistency and stability (Cronbach’s alpha and Interclass Correlation Coefficient [ICC]).

RESULTS: The designed questionnaire included 6 dimensions and 65 items. The dimensions included (1) programs and guidelines, treatment of the injured; (2) exercise; (3) decontamination and waste management; (4) education and human resources; (5) prevention, coordination, and security; and (6) PPE. The content and face validity of the questionnaire were approved by the specialists and experts of hospital emergency and health in disasters and emergencies. The content validity ratio was >0.6 for all items. The content validity index was also approved for all items. The Cronbach’s alpha coefficient and ICC were respectively 0.977 and 0.972 for the total questionnaire.

CONCLUSION: Hospital Emergency Clinical Staff play a vital role in responding to CBRN events; therefore, policies, programs, coordination efforts, budgets, and other necessary measures are strongly recommended to increase ED clinical staff preparedness against CBRN events.

PMID:41078130 | DOI:10.1017/dmp.2025.10212

J Viral Hepat. 2025 Nov;32(11):e70094. doi: 10.1111/jvh.70094.

ABSTRACT

This study aimed to evaluate the status of hepatitis B virus (HBV) mother-to-child transmission (MTCT) among infants born to hepatitis B surface antigen (HBsAg)-positive mothers from 2021 to 2023 and identify key factors influencing HBV MTCT, providing critical insights to inform future HBV prevention strategies. Data were obtained from the case records of HBsAg-positive pregnant women and their newborns in Guangdong Province from January 1, 2021, to December 31, 2023. For HBsAg and anti-HBs positive rates, bivariate analysis was conducted to examine associations between maternal and infant characteristics. Additionally, Firth’s bias reduction logistic regression analysis was conducted to identify factors influencing MTCT. Our study analysed data from 131,781 HBsAg-positive pregnant women and their newborns in Guangdong Province from 2021 to 2023. Among 131,781 infants completing PVST, the overall HBV MTCT rate was 0.44%, with an anti-HBs positivity rate of 93.48%. Maternal age, administration of HepB-BD and HBIG and use of antiviral treatment during pregnancy were significantly associated with HBV MTCT. However, birth weight, maternal education level, mode of delivery and number of births were not significantly associated with HBV MTCT risk. This study provides a comprehensive analysis of HBV MTCT among HBsAg-positive pregnant women and their infants in Guangdong Province from 2021 to 2023. Despite significant advancements in HBV MTCT prevention, our findings underscore the need for enhanced strategies, particularly for pregnant women with high HBV viral loads. Strengthening maternal antiviral treatment, ensuring timely and comprehensive infant follow-up, and implementing targeted health education programs will be essential for further reducing MTCT rates and improving long-term outcomes.

PMID:41078127 | DOI:10.1111/jvh.70094

J Cachexia Sarcopenia Muscle. 2025 Oct;16(5):e13743. doi: 10.1002/jcsm.13743.

ABSTRACT

BACKGROUND: Polytrauma patients with an Injury Severity Score (ISS) ≥ 16 have a high mortality rate. Early identification of patients at risk of mortality is key. Different risk stratification models are available; however, body composition on third lumbar computed tomography (L3 CT) is not routinely used. The aim of this study is to determine the effect of CT body composition on 1-year mortality in adult polytrauma patients.

METHODS: Body composition analysis (L3 CT) was performed on 593 adult polytrauma patients. The associations with 1-year mortality were assessed using uni- and multivariable logistic regression analysis. As a sensitivity analysis, 1-year mortality was analysed using Kaplan-Meier survival curves, log-rank tests and Cox regression.

RESULTS: The study population was predominantly male (69.5%), with a mean age of 55 (±20) years and an average BMI of 25.34 kg/m² (±4.07). Comorbidities were present in 327 (55.4%) patients, with an average Charlson Comorbidity Index (CCI) of 2.07 points (±2.1). The mean ISS score was 27.59 (±11.06); 323 (54.5%) patients had an ISS ≥ 25 points. Age, CCI, ISS, skeletal muscle index and skeletal muscle radiation attenuation (OR 1.053, 5.713, 3.711, 0. 563 and 0.533, respectively; p < 0.001), subcutaneous adipose tissue radiation attenuation (SATRA OR 1.253, p = 0.028) and visceral adipose tissue index (OR 1.242, p = 0.038) were significantly associated with 1-year mortality. In multivariable logistic regression, age, ISS and SATRA remained statistically significantly associated with 1-year mortality (OR 1.062, p < 0.001; OR 4.761, p < 0.001; OR 1.396, p = 0.009).

CONCLUSIONS: This study demonstrated that subcutaneous adipose tissue radiation attenuation on emergency trauma CT scans is significantly associated with 1-year mortality in adult polytrauma patients. Additionally, we found a significant effect of age and ISS on 1-year mortality. Incorporating body composition analysis could lead to a better selection of patients at risk for 1-year mortality and aid in treatment decision-making.

PMID:41078117 | DOI:10.1002/jcsm.13743

J Cardiovasc Electrophysiol. 2025 Oct 13. doi: 10.1111/jce.70135. Online ahead of print.

ABSTRACT

INTRODUCTION: Cannabis use is significantly increasing worldwide yet its cardiovascular effects and arrhythmogenic potential remain unclear. As legalization expands, it is critical to understand public health risks and clinical implications. This study evaluates the relationship between cannabis use and the risk of arrhythmias using a large, real-world dataset.

METHODS: This retrospective cohort study utilized deidentified electronic health records from 68 U.S. healthcare organizations within the TriNetX network. A total of 210 817 adult cannabis users were identified and matched 1:1 with 210 817 ibuprofen users using propensity score matching across 17 baseline variables, including demographics, cardiovascular risk factors, and medication use. The primary outcomes were incident diagnoses of atrial fibrillation/flutter (AF/AFL), paroxysmal tachycardia, premature beats, and ventricular tachycardia/fibrillation (VT/VF). Outcomes were assessed using Cox proportional hazards models and Kaplan-Meier survival analyses.

RESULTS: Cannabis use was significantly associated with an increased risk of multiple arrhythmias compared to ibuprofen use. The incidence of AF/AFL was 1895 versus 1332 cases (HR = 1.549, 95% CI: 1.444-1.662, p < 0.001). Paroxysmal tachycardia occurred in 1065 versus 672 patients (HR = 1.791, 95% CI: 1.626-1.973, p < 0.001), and premature beats in 1135 versus 745 patients (HR = 1.739, 95% CI: 1.585-1.908, p < 0.001). The most pronounced relative risk was observed for VT/VF, with 97 versus 35 cases (HR = 3.078, 95% CI: 2.089-4.533, p < 0.001). All associations remained statistically significant after adjustment, and Kaplan-Meier curves demonstrated lower arrhythmia-free survival in cannabis users across all endpoints.

CONCLUSION: Cannabis use was associated with an increased risk of multiple arrhythmias, particularly atrial fibrillation and ventricular arrhythmias. These findings highlight the need for further research on the cardiovascular effects of cannabis and reinforce the importance of patient counseling regarding its potential arrhythmogenic risks.

PMID:41078108 | DOI:10.1111/jce.70135

Aging Cell. 2025 Oct 13:e70265. doi: 10.1111/acel.70265. Online ahead of print.

ABSTRACT

While preclinical studies suggest that Phosphodiesterase 5 (PDE5) inhibition may reduce cognitive impairment, findings from observational studies on whether PDE5 inhibitors reduce Alzheimer’s disease (AD) risk have been inconsistent. We performed a two-sample cis-Mendelian Randomisation (MR) analysis to estimate the causal effect of PDE5 inhibition on AD risk. The analysis was performed across four different genome-wide association studies (GWAS) of AD to enhance reliability through triangulation. Additionally, a sex-stratified MR analysis using data from UK Biobank was performed to assess potential sex-specific effects. No evidence of a causal association between PDE5 inhibition and AD risk was found in the main analyses. Similar findings were obtained in the sex-stratified analysis. Our study uses genetic data to triangulate the evidence and suggests that PDE5 inhibitors are unlikely to decrease the risk of AD. Further research is needed to thoroughly understand the impact of PDE5 inhibitors on the risk of Alzheimer’s disease.

PMID:41078087 | DOI:10.1111/acel.70265

Genome Biol Evol. 2025 Oct 13:evaf194. doi: 10.1093/gbe/evaf194. Online ahead of print.

ABSTRACT

NUPTs are DNA sequences of plastid origin present in plant nuclear genomes to varying, though typically low, amounts. It is assumed that they are continuously formed and, due to their potentially mutagenic effect, removed at a constant turnover rate, which should result in an exponential decay of their age distributions and a negative correlation between age and size. However, these assumptions are based on analysis from a limited number of species and have never been explicitly tested. To gain insight into the mechanisms driving the origin and evolution of NUPTs, here we surveyed the plastid and nuclear genomes of 30 species representing the main angiosperm (flowering plants) lineages. By modeling the distribution of ages and sizes, examining their linear arrangement across the plastid genome, and statistically assessing spatial biases with respect to other genomic features, we showed that NUPTs are i) formed by both continuous and episodic mechanisms; ii) unevenly represented across the plastid genome; iii) consistently associated with certain classes of RNA genes, in particular rRNA, tRNA and regulatory RNA genes; iv) differentially contributing to structural genes; and v) closer than expected to different superfamilies of transposons in a species-specific manner. Our results reveal the unexpected complexity in the mechanisms driving the origin of NUPTs, which do not only involve their continuous formation but also episodic, highlight their role as a major source of non-coding RNA genes and other genomic features and provide a more complete picture of the different drivers of evolutionary change at the genome level.

PMID:41078074 | DOI:10.1093/gbe/evaf194

Dig Dis. 2025 Oct 13:1-20. doi: 10.1159/000548588. Online ahead of print.

ABSTRACT

INTRODUCTION: Green tea polyphenols (GTPs) and aspirin were demonstrated to be novel candidates for cancer chemoprevention. This study aimed to investigate effects of GTPs and aspirin on esophageal diseases.

METHODS: This non-randomized prospective cohort study recruited participants from January 2012 to January 2013, who self-reported long-term GTPs intake, aspirin intake and no medicine use in questionnaire and underwent gastroscopy. Regression was defined as any reversal of process from normal epithelium to esophageal high-grade intraepithelial neoplasia. The primary outcome was regression rates after a one-year follow-up.

RESULTS: A total of 159, 151,160 participants self-reported GTPs intake, aspirin intake, and no medication. After one year, 78, 81, and 83 participants received follow-up endoscopy in GTPs, aspirin, and control groups, respectively. There was no statistically significant difference in baseline pathology between the final cohort and lost to follow-up group. The average age of participants was 50.11  5.62 years old, consisting of 42 female and 200 male. The regression rates of esophageal precursor diseases were 68%, 55%, and 48% in GTPs, aspirin, and control groups, respectively (P = 0.036). Analyzing esophagitis subgroup, the regression rate of GTPs group (43/69, 62%) was significantly higher than aspirin group (32/67, 48%) and control group (27/70, 39%) (P = 0.019). One person experienced nausea for GTPs (1/159) and one person experienced gastrointestinal bleeding in the aspirin group (1/151).

CONCLUSIONS: GTPs, rather than aspirin, was associated with esophagitis remission compared with the control group. The benefits of GTPs on esophageal precursor diseases make it a promising health supplement.

PMID:41078050 | DOI:10.1159/000548588