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Nevin Manimala Statistics

Adverse events occurring post-covid-19 vaccination among healthcare professionals – A mixed method study

Int Immunopharmacol. 2021 Sep 16;100:108136. doi: 10.1016/j.intimp.2021.108136. Online ahead of print.

ABSTRACT

BACKGROUND: Healthcare professionals (HCPs) are at the front line of the nation’s fight against COVID-19 and are always at a greater risk of contracting contagious disease. But amidst the crisis, the vaccines were not accepted by all the HCPs due to adverse events occurring post-COVID-19 vaccination. Hence, the present study was designed to assess adverse events occurring among HCPs post-COVID-19 vaccination both quantitatively and qualitatively.

METHOD: Sequential mixed-method approach was employed. A cross-sectional E-survey was conducted among the healthcare professionals of a North Indian (*Statistically significant (p < 0.05)) college and hospital. The second phase included a semi-structured qualitative interview of the participants who were willing to participate.

RESULTS: Among all the HCPs with age groups ranging from 20 to 70 years, majority of them experienced pain at the site of injection (88.8-100%) followed by tiredness (87.7-60%) and body ache (86.6-40%) post-vaccination. There is an increased frequency of adverse events in females as compared to males. Qualitative findings are summarised in three major domains i.e vaccine adverse effects, fear and hesitancy for vaccines and vaccine acceptance.

CONCLUSION: Short term adverse events of COVISHIELD vaccine were very few and were mild in severity yet interviews showed hesitancy of study participants for vaccination.

PMID:34587578 | DOI:10.1016/j.intimp.2021.108136

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Comparison of genuine, generic and counterfeit Cialis tablets using vibrational spectroscopy and statistical methods

J Pharm Biomed Anal. 2021 Sep 20;206:114383. doi: 10.1016/j.jpba.2021.114383. Online ahead of print.

ABSTRACT

The dubious online market in phosphodiesterase type 5 inhibitors is growing on a global scale. Counterfeit medical products can represent health issues for the user and cause medical mistrust. Within this work, genuine Cialis containing the active pharmaceutical ingredient (API) tadalafil, its generics available in the Czech Republic and the Cialis tablets from questionable online pharmacies were analysed. The methods of infra-red and Raman spectroscopy were used for the identification of the counterfeit tablets and for the verification of their API and excipients. All 9 tablets from online pharmacies were counterfeit with 2 of them even containing a different API (sildenafil, vardenafil). In addition, Raman mapping was used to determine the API and excipients’ distribution and, in combination with multivariate data analysis, to separate similar tablets in clusters and to identify the outliers. Scanning electron microscopy of the samples revealed that the process of a wet granulation of micronized API was used during the formulation of the tablets. This comprehensive approach of analysis can be used for advanced exploration of the dubious samples of various medical products.

PMID:34587570 | DOI:10.1016/j.jpba.2021.114383

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Cerebellar theta burst stimulation for the treatment of negative symptoms of schizophrenia: A multicenter, double-blind, randomized controlled trial

Psychiatry Res. 2021 Sep 5;305:114204. doi: 10.1016/j.psychres.2021.114204. Online ahead of print.

ABSTRACT

Given the importance of the cerebellum in the pathophysiology of schizophrenia, the cerebellar vermis has been proposed as a new rTMS stimulation site for negative symptoms. In this study, 64 patients from 7 psychiatric hospitals were randomized into the study (n=32) or control (n=32) group. Intermittent theta burst stimulation (iTBS) (or sham stimulation) to the cerebellar midline was administered 5 times/week for 2 weeks. Psychotic symptoms were assessed with the Positive and Negative Symptoms Scale (PANSS) at baseline, the end of treatment, and 2, 6, 12, and 24 weeks after the treatment. Regarding the negative symptoms, the interaction effect between group and time was statistically significant, with the scores in the study group significantly lower than those in the control group at the 4 follow-ups after treatment, and the group difference was maximal at 24 weeks of follow-up. The main effect of time was significant; however, the main effect of group did not show statistical significance. Our study revealed that cerebellar iTBS may improve negative symptoms in schizophrenia patients, and the effect was more pronounced at 24 weeks after the end of treatment, which provides preliminary empirical evidence for the maintenance of efficacy after stimulation of this new site.

PMID:34587567 | DOI:10.1016/j.psychres.2021.114204

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Investigation of the bio-stimulation of children’s reading interest by chromatic pattern visual evoked potential

Comput Methods Programs Biomed. 2021 Sep 10;211:106410. doi: 10.1016/j.cmpb.2021.106410. Online ahead of print.

ABSTRACT

PURPOSE: The characteristics of children’s reading interest, stimulated by the visual evoked potentials of colour graphics in children’s picture books, were tested to explore their normal reference value. The characteristics of chromatic pattern visual evoked potential (CP-VEP) can be harnessed by our methodology and may be applied to the visual screening of children in clinical ophthalmology.

METHODS: The PR-650 spectral colour metre can strictly control factors, such as brightness and colour retention, based on colour contrast. This is performed in order to reduce the brightness contrast method. In our paper, we set up three kinds of visual stimulation conditions and performed CP-VEP inspections of the eye, based on 64 cases (128 eyes) of normal children (32 males and 32 females). Using CP-VEP detection, the latency and amplitude of the P100 wave were recorded and the waveforms of each group, under different spectral modes were compared. Art therapy combined with children’s colour physiology and psychology will be more skilfully practiced in clinical practice.

RESULTS: There was no significant difference in the amplitude and peak time of visual evoked potential (VEP) waveforms between the left and right eyes of the children using the three stimuli, indicating that the visual function and visual conduction pathway of children can vary. There was no significant difference in the latency and amplitude of the NPN complex wave. Note that the P1 wave of the right and left eyes of normal children is not statistically different (P > 0.05). We also found that there is insignificant difference in the visual impact of the colours for both male and female children in terms of reading interest, and red is a more stimulating colour for both sexes.

CONCLUSION: Our study can provide normal reference value and methodological reference for clinical visual acuity detection in children. Combined with the visual characteristics of children, this paper selects the visual impact created by the colour of picture books and combines it with medical treatment. Make the whole test cover the scope of ophthalmology clinical more comprehensive.

PMID:34587563 | DOI:10.1016/j.cmpb.2021.106410

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Mass spectrometry determination of seized oil-based anabolic-androgenic steroids products

Forensic Sci Int. 2021 Sep 22;328:111012. doi: 10.1016/j.forsciint.2021.111012. Online ahead of print.

ABSTRACT

INTRODUCTION: The presence of anabolic-androgenic steroids (AAS) in illegal commercial products has been pointed as a global threat for public health. Due the correlation with adverse toxicological effects, there is a growing interest in the implementation of straightforward methods for the determination of AAS in seized products. This work exploited the development of a mass spectrometry approach to characterize the illegal oil formulations containing AAS.

METHODS: The optimization of sample preparation was performed through a simplex-centroid design and the best condition was described as follow: an aliquot of 5 μL of sample were added with 995 μL of acetonitrile and water (75:25, v/v). The solution was vortexed and centrifuged. After that, 10 μL of supernatant were added with 35 μL of acetonitrile and water and internal standard (testosterone-d3, 1.25 ng). An aliquot of 5 μL was injected into the analytical system.

RESULTS: The method developed was validated and successfully applied in 115 seized samples. Testosterone and its esters had the highest incidence, found in more than 50% of the samples. Besides that, drugs such as boldenone, methandienone, and trenbolone have also been found, where the low quality of the samples was evidenced by the wide variation in the concentration of the drugs, always quantified in sub-doses. Finally, at least one AAS was detected in each sample analyzed. The statistical results were grouped by principal components analysis, to better understand the profile of the seized samples.

CONCLUSION: This work successfully established a fast and simple method for determination of AAS and can be applied to verify the profile of seized samples.

PMID:34587560 | DOI:10.1016/j.forsciint.2021.111012

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Mental health over nine months during the SARS-CoV2 pandemic: Representative cross-sectional survey in twelve waves between April and December 2020 in Austria

J Affect Disord. 2021 Sep 4;296:49-58. doi: 10.1016/j.jad.2021.08.153. Online ahead of print.

ABSTRACT

BACKGROUND: There is accumulating evidence about detrimental impacts of the pandemic on population mental health, but knowledge on risk of groups specifically affected by the pandemic and variations across time is still limited.

METHODS: We surveyed approximately n=1,000 Austrian residents in 12 waves between April and December 2020 (n=12,029). Outcomes were suicidal ideation (Beck Suicidal Ideation Scale), depressive symptoms (Patient Health Questionnaire-9), anxiety (Hospital Anxiety Depression Scale), and domestic violence. We also assessed the perceived burden from the pandemic. Demographic and Covid-19 specific occupational and morbidity-related variables were used to explain outcomes in multivariable regression analyses, controlling for well-established risk factors of mental ill-health, and variations over time were analyzed.

RESULTS: Young age, working in healthcare or from home, and own Covid-19 illness were consistent risk factors controlling for a wide range of known mental health risk factors. Time patterns in the perceived burden from Covid-19-related measures were consistent with the time sequence of restrictions and relaxations of governmental measures. Depressive and anxiety symptoms were relatively stable over time, with some increase of depression during the second phase of lockdowns. Domestic violence increased immediately after both hard lockdowns. Suicidal ideation decreased slightly over time, with a low during the second hard lockdown. Mental health indicators for women and young people showed some deterioration over time, whereas those reporting own Covid-19 illness improved.

LIMITATIONS: Data from before the pandemic were not available.

CONCLUSIONS: Among mental health outcomes, increases in domestic violence and, to some smaller extent, depressive symptoms, appeared most closely related to the timing of hard lockdowns. Healthcare staff, individuals working from home, those with Covid-19, as well as young people and women are non-traditional risk groups who warrant heightened attention in prevention during and in the aftermath of the pandemic.

PMID:34587549 | DOI:10.1016/j.jad.2021.08.153

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Efficacy of pomegranate extract loaded solid lipid nanoparticles transdermal emulgel against Ehrlich ascites carcinoma

Nanomedicine. 2021 Sep 26:102466. doi: 10.1016/j.nano.2021.102466. Online ahead of print.

ABSTRACT

The purpose of this work was to incorporate an optimized pomegranate extract loaded solid lipid nanoparticles (PE-SLNs) formula in a transdermal emulgel to evaluate its anticancer effect. The prepared emulgel formulae were evaluated for their physicochemical properties. An ex vivo permeation study was done through mouse skin and the kinetic parameters were determined. Kinetic data showed that the ex vivo permeation of PE from SLNs transdermal emulgel through mouse skin followed non-Fickian diffusion transport. Further, in vivo study was done by applying the optimized PE-SLNs transdermal emulgel on mice skin bearing a solid form of Ehrlich ascites carcinoma (EAC) as well as free PE, control, placebo, and standard groups for comparison. In addition, histopathological examinations of the samples obtained from the EAC mice model were performed. The results proved that application of the selected PE-SLNs emulgel formulation on the mice skin bearing solid tumor revealed statistically significant anticancer effects.

PMID:34587542 | DOI:10.1016/j.nano.2021.102466

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Rates of Circumpapillary Retinal Nerve Fiber Layer Thinning and Capillary Density Loss in Glaucomatous Eyes with Disc Hemorrhage

Am J Ophthalmol. 2021 Sep 26:S0002-9394(21)00470-0. doi: 10.1016/j.ajo.2021.09.013. Online ahead of print.

ABSTRACT

PURPOSE: To investigate longitudinal changes in rates of optic nerve head circumpapillary retinal nerve fiber layer (cpRNFL) thinning and vessel density loss in primary open angle glaucoma (POAG) with or without history of disc hemorrhage (DH).

DESIGN: Observational cohort METHODS: In this longitudinal study, 34 eyes with DH and 134 eyes without DH that had at least 1.5 years of follow-up and three OCT and OCTA follow-up scans were enrolled. A linear mixed-effect model was used to compare the rates of cpRNFL thinning and vessel density loss between DH and non-DH eyes.

RESULTS: Rates of whole image capillary density (wiCD) loss were faster in the DH group compared to non-DH group (mean difference (95% CI): -0.32 (-0.59,-0.04) %/year, P=0.027). Faster mean rates of vessel density loss were found in the inferotemporal, inferonasal, and nasal sectors in eyes with DH than without DH (P<0.05). There was no statistically significant difference in the global rate of cpRNFL thinning between the two groups (P=0.679). The mean rate of cpRNFL thinning was faster in the DH group compared to the non-DH group only in the inferotemporal sector (mean difference (95% CI): -1.01 (-1.62,-0.40) μm/year; P=0.001).

CONCLUSIONS: Mean rates of vessel density loss between DH and non-DH eyes were different not only in the affected area but also in the other regions. In contrast, a significant difference in cpRNFL thinning between the two groups was detected only in the inferotemporal sector. Disc hemorrhage is an independent predictor of faster vessel density loss in glaucoma suspects and POAG patients.

PMID:34587496 | DOI:10.1016/j.ajo.2021.09.013

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Impact of Stellate Ganglion Block on Tissue Blood Flow/Oxygenation and Postoperative Mandibular Nerve Hypoesthesia: A Cohort Study

J Oral Maxillofac Surg. 2021 Aug 28:S0278-2391(21)00998-8. doi: 10.1016/j.joms.2021.08.161. Online ahead of print.

ABSTRACT

PURPOSE: Although a stellate ganglion block (SGB) increases tissue blood flow in the mandibular region, the change in tissue oxygenation after SGB and therapeutic effect of SGB for postoperative mandibular nerve hypoesthesia remain to be established. The study aim was to measure the change in tissue oxygenation in the mandibular region after SGB.

METHODS: To determine the variation in tissue oxygenation in the mandibular region, the tissue oxygen index (TOI; percentage of oxygenated hemoglobin in the total hemoglobin) was measured at the skin near the mental foramen bilaterally, at the primary site of unilateral SGB, achieved using 6 mL of 1% lidocaine hydrochloride, for the treatment of bilateral postoperative mandibular nerve injury. The primary outcome of this study is the temporal variation in TOI after SGB (0.5, 1, 5, 10, 15, 20, and 25 minutes after SGB), and the control group in this study is the TOI at the end of SGB injection (0 minute). All data are expressed as the mean ± standard deviation and 95% confidence interval (CI). Repeated-measures analysis of variance with Dunnett’s test was used to determine parametric statistical significance. A P-value <.05 was considered statistically significant.

RESULTS: Thirteen patients were enrolled in this study. On both the blocked and contralateral side, the TOI was significantly increased compared to that before SGB (ΔTOI at 15 minute after SGB, 5.87 ± 2.89%, P < .001, 95% CI: 4.122 to 7.617% in the blocked side, 1.88 ± 2.73%, P = .005, 95% CI: 1.877 to 2.725% in the contralateral side).

CONCLUSIONS: Unilateral SGB using 6 mL of 1% lidocaine hydrochloride results in an increase in tissue oxygenation in the mandibular region. Based on these findings, we hypothesize that a series of SGBs may contribute to a more rapid recovery of postoperative trigeminal nerve injury.

PMID:34587486 | DOI:10.1016/j.joms.2021.08.161

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Open Repair Versus Closed Repair: A Cost-Analysis of the Two Surgical Approaches for the Treatment of Craniosynostoses

J Oral Maxillofac Surg. 2021 Sep 1:S0278-2391(21)01002-8. doi: 10.1016/j.joms.2021.08.165. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this study was to quantify the hospitalization charges of the 2 general surgical approaches in the treatment of craniosynostosis and determine if there was a significant difference between the 2. Several studies compared them side-by-side according to specific variables, such as success rates, postoperative complications, blood loss, and length of stay, but were limited by small sample sizes.

METHODS: This is a retrospective cohort study that was conducted using the Kids’ Inpatient Database (KID). All patients diagnosed with craniosynostosis (Q75.0) were identified. The procedures were grouped according to the approach taken, whether it was a traditional, open approach, or a closed, minimally invasive approach. The primary predictor variable was the surgical approach (open vs closed). The outcome variables were the hospital charges (US dollars) and length of stay (days). Statistical analyses were based on the univariate and multivariate linear regression models, and P value less than .05 marked the significance level.

RESULTS: Among a sample of 2,585 cases, an open approach was employed in 2,353 cases and a closed approach in 232 cases. Race, payer information, hospital region, admission status (elective vs not elective), patient location, and surgical approach (open vs closed) were all significant predictors (P < .15) of increased hospitalization charges. Relative to white patients, being in the ‘other’ racial class added $10,987 in hospital charges (P < .05). Relative to the Northeast, being a patient in the West added $33,459 in hospital charges (P < .01). Not being admitted electively added $72,572 (P < .01) relative to elective admissions. Finally, open repair added $59,539 (P < .01) in charges relative to closed repair.

CONCLUSIONS: The traditional open approach added nearly $60,000 to the cost of the procedure when compared with the closed, endoscopic approach. The scope and invasiveness of the open approach demand greater surgical services, hospital services, supplies, and equipment, ultimately contributing to this increased cost.

PMID:34587484 | DOI:10.1016/j.joms.2021.08.165