Indian J Ophthalmol. 2024 Jul 1;72(Suppl 4):S615-S616. doi: 10.4103/IJO.IJO_9_24. Epub 2024 Jul 1.
NO ABSTRACT
PMID:38953132 | DOI:10.4103/IJO.IJO_9_24
Tag: nevin manimala
Pediatrics. 2024 Jul 2:e2023063466. doi: 10.1542/peds.2023-063466. Online ahead of print.
ABSTRACT
OBJECTIVES: This study assessed the state of pediatric medical device (PMD) development by comparing PMD clinical trials to pediatric trials evaluating drugs and biologics, from 1999 to 2022.
METHODS: The site https://www.clinicaltrials.gov was used to identify and quantify both PMD clinical trials and pediatric trials for drugs and biologics. Clinical specialty was also assessed. The institutions included were the 7 children’s hospitals primarily affiliated with the Food and Drug Administration (FDA) Pediatric Device Consortia (PDC) grant program between 2018 and 2023. For a national comparison, an additional search assessed PMD trials across all US medical institutions.
RESULTS: A total of 243 PMD clinical trials were identified at the FDA-PDC institutions on the basis of the year of initiation; the average number of PMD trials initiated per year per institution was 1.5 from 1999 to 2022. However, PMD trials significantly increased during the period 2014 to 2022 compared with 1999 to 2013 (P < .001); the rate of initiation of drug and biologic pediatric trials demonstrated no significant differences between these time periods. A national survey of all institutions initiating PMD trials, and drugs and biologics trials, identified 1885 PMD trials out of a total 12 943. A comparable trend was noted in the national survey with initiation of PMD trials increasing significantly from 2014 to 2022 (P < .001), compared with 1999 to 2013, whereas the rate of initiation of drug and biologic trials during these periods did not demonstrate a significant change.
CONCLUSIONS: Although pediatric clinical trial initiation for drugs and biologics remained stable from 1999 to 2022, the rate of new PMD trials significantly increased during the period 2014 to 2022 at FDA-PDC institutions and nationally.
PMID:38953121 | DOI:10.1542/peds.2023-063466
Front Pharmacol. 2024 Jun 17;15:1346357. doi: 10.3389/fphar.2024.1346357. eCollection 2024.
ABSTRACT
INTRODUCTION: Hypertension during pregnancy is one of the most frequent causes of maternal and fetal morbimortality. Perinatal and maternal death and disability rates have decreased by 30%, but hypertension during pregnancy has increased by approximately 10% in the last 30 years. This research aimed to describe the pharmacological treatment and pregnancy outcomes of pregnancies with hypertension.
METHODS: We carried out an observational cohort study from the Information System for the Development of Research in Primary Care (SIDIAP) database. Pregnancy episodes with hypertension (ICD-10 codes for hypertension, I10-I15 and O10-O16) were identified. Antihypertensives were classified according to the ATC WHO classification: β-blocking agents (BBs), calcium channel blockers (CCBs), agents acting on the renin-angiotensin system (RAS agents), diuretics, and antiadrenergic agents. Exposure was defined for hypertension in pregnancies with ≥2 prescriptions during the pregnancy episode. Descriptive statistics for diagnoses and treatments were calculated.
RESULTS: In total, 4,839 pregnancies with hypertension diagnosis formed the study cohort. There were 1,944 (40.2%) pregnancies exposed to an antihypertensive medication. There were differences in mother’s age, BMI, and alcohol intake between pregnancies exposed to antihypertensive medications and those not exposed. BBs were the most used (n = 1,160 pregnancy episodes; 59.7%), followed by RAS agents (n = 825, 42.4%), and CCBs were the least used (n = 347, 17.8%).
DISCUSSION: Pregnancies involving hypertension were exposed to antihypertensive medications, mostly BBs. We conduct a study focused on RAS agent use during pregnancy and its outcomes in the offspring.
PMID:38953107 | PMC:PMC11215181 | DOI:10.3389/fphar.2024.1346357
Infect Drug Resist. 2024 Jun 27;17:2685-2699. doi: 10.2147/IDR.S468482. eCollection 2024.
ABSTRACT
BACKGROUND: The occurrence and dissemination of hypermucoviscous and hypervirulent Klebsiella pneumoniae (hm-hvKp) isolates in clinical settings are a critical public health problem in the world. However, the data on these isolates in community populations are limited. This study aims to understand the prevalence and molecular characteristics of hm-hvKp isolates in community patients in Shanghai, China.
METHODS: In 2018, an active surveillance system focused on hm-hvKp in community diarrhoeal cases was implemented in Pudong New Area, Shanghai, China, involving 12 sentinel hospitals. The antimicrobial susceptibility of hm-hvKp isolates from fecal samples was tested, and whole-genome sequencing (WGS) was performed to predict the serotypes and sequence types and to identify antimicrobial resistance determinants, virulence determinants, and phylogenetic clusters.
RESULTS: The overall prevalence of hm K. pneumoniae isolates was 2.48% (31/1252), with the proportions of 1.76% (22/1252) for hm-hvKp and 0.72% (9/1252) for hm not hv K. pneumoniae. The prevalence of hm-hvKp isolates among different age groups and different months was statistically significant. All the 22 hm-hvKp isolates were susceptible to 20 antimicrobial agents and only carried bla SHV gene, and KL1 and KL2 accounted for eight (36.36%) cases and seven (31.82%) cases, respectively. The eight ST23/KL1 isolates belonged to the predominant CG23-I clade, which typically possessed the virulence determinants profile of rmpA/rmpA2-iro-iuc-ybt-irp-clb. The five ST86/KL2 isolates were assigned to the global clusters ST86/KL2-1 (n=2), ST86/KL2-2 (n=2), ST86/KL2-3 (n=1), all lack of the clb gene. Shanghai ST23/KL1 and ST86/KL2 isolates were closely related to the global isolates from liver abscesses, blood, and urine.
CONCLUSION: Hm-hvKp is carried by the community population of Shanghai, with ST23/KL1 and ST86/KL2 isolates predominant. Hm-hvKp isolates of different continents, different sources, and different virulence levels were closely related. Ongoing surveillance of hm-hvKp isolates in the community population is warranted.
PMID:38953096 | PMC:PMC11216552 | DOI:10.2147/IDR.S468482
Cureus. 2024 May 31;16(5):e61457. doi: 10.7759/cureus.61457. eCollection 2024 May.
ABSTRACT
This study investigates the effectiveness of multiple COVID-19 vaccinations on daily confirmed cases in Seoul City. Utilizing comprehensive data on vaccinated individuals and confirmed cases sourced from the official website of the Korean Ministry of the Interior and Safety, we conducted detailed statistical analyses to assess the impact of each vaccination dose. The study covers data from April 21, 2021, to September 29, 2022. Statistical multiple linear regression was employed to analyze the relationship between daily confirmed cases (positive outcomes from PCR tests) and multiple vaccine doses, using p-values as the criteria for determining the effectiveness of each dose. The analysis included data from four vaccination doses. The analysis reveals that the first, second, and third doses of the COVID-19 vaccines have a statistically significant positive effect associated with the daily confirmed cases. However, the study finds that the fourth dose does not show a statistically significant impact on the reduction of daily confirmed cases. This suggests that while the initial three doses are crucial for establishing and maintaining high levels of immunity, the incremental benefit of subsequent doses may diminish.
PMID:38953092 | PMC:PMC11216110 | DOI:10.7759/cureus.61457
Cureus. 2024 May 30;16(5):e61392. doi: 10.7759/cureus.61392. eCollection 2024 May.
ABSTRACT
OBJECTIVE: Obesity is not only a risk factor for lifestyle-related diseases but also causes skin barrier dysfunction, which leads to a reduced quality of life due to dryness, itching, and scratching, and thus requires appropriate treatment. However, there are no studies on this issue. Therefore, this study aimed to examine whether oral intake of linseed oil is effective for skin barrier function in obesity and to confirm how the effect is demonstrated.
METHODS: TSOD mice received either sterile distilled water (Control group) or linseed oil (Omega group), containing a high level of omega-3 fatty acids, including α-linolenic acid, orally for eight weeks. Mice were then irradiated with ultraviolet B (UVB) and three days later, transepidermal water loss (TEWL), which is the primary outcome of skin barrier function, was measured and gross skin appearance was observed. Hematoxylin and eosin (HE) staining and Ki-67 immunostaining were performed on skin samples. mRNA expression levels of the inflammatory markers Tnfα, Cox2, Mcp1, and Hmox1 were measured by real-time reverse transcriptase-polymerase chain reaction (RT-PCR). We also performed fatty acid analysis of skin and erythrocytes by gas chromatography. Statistical analysis was performed using unpaired Student’s t-test and Pearson’s correlation analysis.
RESULTS: Compared with the Control group, the Omega group exhibited lower TEWL values and little skin erythema. Histological analysis revealed thinner epidermis and fewer Ki-67 positive cells. Additionally, in the Omega group, mRNA levels of four inflammation-related genes were lower, α-linolenic acid levels in both skin and erythrocytes were higher, and a lower n-6/n-3 ratio was observed. And α-linolenic acid levels in the skin were negatively correlated with the expression levels of inflammation-related genes.
CONCLUSION: Oral intake of linseed oil was found to inhibit skin barrier dysfunction in obesity. This effect was mediated by α-linolenic acid, a major component of linseed oil with anti-inflammatory properties, which was taken up by erythrocytes and supplied to the skin. Therefore, oral intake of linseed oil is expected to be a useful therapeutic method for skin barrier dysfunction in obesity.
PMID:38953090 | PMC:PMC11215935 | DOI:10.7759/cureus.61392
BMJ Open. 2024 Jul 1;14(6):e085930. doi: 10.1136/bmjopen-2024-085930.
ABSTRACT
OBJECTIVE: We systematically assessed prediction models for the risk of in-hospital and 30-day mortality in post-percutaneous coronary intervention (PCI) patients.
DESIGN: Systematic review and narrative synthesis.
DATA SOURCES: Searched PubMed, Web of Science, Embase, Cochrane Library, CINAHL, CNKI, Wanfang Database, VIP Database and SinoMed for literature up to 31 August 2023.
ELIGIBILITY CRITERIA: The included literature consists of studies in Chinese or English involving PCI patients aged ≥18 years. These studies aim to develop risk prediction models and include designs such as cohort studies, case-control studies, cross-sectional studies or randomised controlled trials. Each prediction model must contain at least two predictors. Exclusion criteria encompass models that include outcomes other than death post-PCI, literature lacking essential details on study design, model construction and statistical analysis, models based on virtual datasets, and publications such as conference abstracts, grey literature, informal publications, duplicate publications, dissertations, reviews or case reports. We also exclude studies focusing on the localisation applicability of the model or comparative effectiveness.
DATA EXTRACTION AND SYNTHESIS: Two independent teams of researchers developed standardised data extraction forms based on CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies to extract and cross-verify data. They used Prediction model Risk Of Bias Assessment Tool (PROBAST) to assess the risk of bias and applicability of the model development or validation studies included in this review.
RESULTS: This review included 28 studies with 38 prediction models, showing area under the curve values ranging from 0.81 to 0.987. One study had an unclear risk of bias, while 27 studies had a high risk of bias, primarily in the area of statistical analysis. The models constructed in 25 studies lacked clinical applicability, with 21 of these studies including intraoperative or postoperative predictors.
CONCLUSION: The development of in-hospital and 30-day mortality prediction models for post-PCI patients is in its early stages. Emphasising clinical applicability and predictive stability is vital. Future research should follow PROBAST’s low risk-of-bias guidelines, prioritising external validation for existing models to ensure reliable and widely applicable clinical predictions.
PROSPERO REGISTRATION NUMBER: CRD42023477272.
PMID:38951013 | DOI:10.1136/bmjopen-2024-085930
BMJ Open. 2024 Jul 1;14(6):e079864. doi: 10.1136/bmjopen-2023-079864.
ABSTRACT
INTRODUCTION: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery.
METHODS AND ANALYSES: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways.
ETHICS AND DISSEMINATION: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.
PMID:38951012 | DOI:10.1136/bmjopen-2023-079864
BMJ Open. 2024 Jul 1;14(6):e081557. doi: 10.1136/bmjopen-2023-081557.
ABSTRACT
PURPOSE: The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and acceptability of the Strong Families programme in enhancing child behaviour and family functioning in low-resource settings in Gilgit-Baltistan, Pakistan.
METHODS AND ANALYSIS: This is a two-arm, multisite feasibility randomised controlled trial with an embedded process evaluation in three districts of Gilgit-Baltistan, namely Gilgit, Hunza and Skardu. 90 families living in these challenged settings, comprising a female primary caregiver aged 18 or above, and at least one child aged 8-15 years, will participate. Participants will be randomly assigned to either receive the Strong Families programme or to the waitlist group. Strong Families is a 7-hour family skills group intervention programme attended by children and their primary caregivers over 3 weeks. The waitlist group will be offered the intervention after their outcome assessment. Three raters will conduct blind assessments at baseline, 2 and 6 weeks postintervention. The primary outcome measures include the feasibility of Strong Families, as determined by families’ recruitment and attendance rates, and programme completeness (mean number of sessions attended, attrition rates). The secondary outcomes include assessment of child behaviour, parenting practices, parental adjustment and child resilience. Purposefully selected participants, including up to five caregivers from each site, researchers and facilitators delivering the intervention, will be interviewed. Descriptive statistics will be used to analyse primary and secondary outcomes. The process evaluation will be conducted in terms of programme context, reach, fidelity, dose delivered and received, implementation, and recruitment.
ETHICS AND DISSEMINATION: This study has been approved by the UNODC Drug Prevention and Health Branch in the Headquarters office of Vienna and the National Bioethics Committee of Pakistan. Findings will be disseminated through publication in reputable journals, newsletters and presentations at conferences.
TRIAL REGISTRATION NUMBER: NCT05933850.
PMID:38951006 | DOI:10.1136/bmjopen-2023-081557
BMJ Open. 2024 Jul 1;14(6):e082571. doi: 10.1136/bmjopen-2023-082571.
ABSTRACT
INTRODUCTION: The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population of 3.2 million childbearing-age migrant women, most of whom migrated to the city with their husbands for economic reasons. There is a general lack of help-seeking behaviour for mental disorders in China due to the perceived risk of social stigmatisation. In Shanghai, 70% of women did not seek professional help for perinatal mental health problems. We aim to gather information from multiple perspectives, such as the migrant women with PPD and perinatal depression (PND), their caregivers, health service providers and communities, to understand the help-seeking behaviour of postpartum migrant women with PPD or PND in China.
METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for Scoping Reviews will guide this review. A bilingual research librarian developed a comprehensive search strategy to retrieve published and unpublished English and Chinese studies involving factors influencing women’s PPD or PND help-seeking behaviour in China. This literature includes perceptions, views, patterns, acceptance and refusal, tendencies, probability, service accessibility and utilisation, and facts. We will search PubMed, Embase, Web of Science and CINAHL for English literature and CINKI for Chinese literature. Backward and forward snowball approaches will be used to identify additional relevant papers from the reference lists of selected papers. Two independent reviewers will screen the title and abstract and review the full text of selected papers to identify eligible articles for data extraction. We will build a Microsoft Access database to record the extracted data. The results will be presented in tables and a causal map to demonstrate the relationships between extracted variables and help-seeking behaviours for PPD and PND. A conceptual simulation model will be formulated based on the information from the literature to validate the logic of the relationships between variables, identify knowledge gaps and gain insights into potential intervention approaches. Experts and stakeholders will be invited to critique and comment on the results during group model building (GMB) workshops in Shanghai. These comments will be essential to validate the findings, receive feedback and obtain additional insights.
ETHICS AND DISSEMINATION: The literature review component of our study does not require ethical approval because the information and data collected will be obtained from publicly available sources and will not involve human subjects. Our collaborating research partner, International Peach Maternal Child Hospital, obtained the IRB approval (GKLW-A-2023-020-01) for screening and enrolling participants in GMB workshops. Stanford University received IRB approval under protocol number 67 419. The full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report findings.
PMID:38951005 | DOI:10.1136/bmjopen-2023-082571