Categories
Nevin Manimala Statistics

The SINTART 2 Study. A phase II non-randomised controlled trial of induction chemotherapy, photon-, proton- and carbon-ion-based radiotherapy integration in patients with locally advanced unresectable sinonasal tumours

Eur J Cancer. 2023 Apr 7;187:134-143. doi: 10.1016/j.ejca.2023.03.034. Online ahead of print.

ABSTRACT

PURPOSE: Unresectable, locally advanced sinonasal epithelial tumours are rare diseases with poor prognosis. Multimodal approach is widely used, although no standard therapy has been established in prospective trials. This study assessed activity and safety of an innovative integration of multimodality treatment-induction chemotherapy (ICT), surgery and radiotherapy (RT)-modulated by histology and response to ICT.

METHODS: Patients with untreated, unresectable sinonasal epithelial tumours with selected histotypes (squamous cell carcinoma, intestinal-type adenocarcinoma, sinonasal undifferentiated and neuroendocrine carcinoma, olfactory neuroblastoma) were enroled in a single-arm, open-label, phase II, multicentre clinical trial. Patients were treated with up to 5 ICT cycles, whose regimen was selected according to histotype. Photon and/or proton/carbon-ion-based RT was employed according to disease site, stage and ICT response. Primary end-point was 5-years progression-free survival (PFS), secondary end-points were overall survival (OS), ICT objective response rate per RECIST 1.1 and safety.

RESULTS: Twenty-five patients were evaluable for primary end-point. Five-year PFS was 26.8% (95% confidence interval [CI]: 12.6-57.1), with a median PFS of 18 months. Five-year OS was 23.8% (95% CI: 9.5-59.3), with a median OS of 27 months. The overall response rate to ICT was 40%. Three-year PFS for patients achieving major volumetric partial response (mPRv) versus non-mPRv was 40% (95% CI: 13.7-100%) versus 23.1% (95% CI: 8.3-64.7%) (P = 0.318) and 3-year OS was 53.3% (95% CI: 21.4-100%) versus 37.7% (95% CI: 20.0-71.0%) (P = 0.114).

CONCLUSION: Multimodal combination of ICT and innovative RT did not provide a significant improvement in survival rates with respect to previous experiences. This finding underscores the need for future research in this rare disease, still characterised by a heavy burden and poor prognosis. We observed longer survival in subjects achieving response to ICT. The overall treatment safety is acceptable.

PMID:37163806 | DOI:10.1016/j.ejca.2023.03.034

Categories
Nevin Manimala Statistics

A novel investigations on medical and non-medical mask performance with influence of marine waste microplastics (polypropylene)

Mar Pollut Bull. 2023 May 8;192:115004. doi: 10.1016/j.marpolbul.2023.115004. Online ahead of print.

ABSTRACT

The entire human race is struggling with the spread of COVID-19. Worldwide, the wearing of face masks is indispensable to prevent such spread. Despite numerous studies reporting on the fabrication of face masks and surgical masks to reduce spread and thus human deaths, this novel work is considered the marine waste of microplastics, namely Polypropylene (PP) polymer, used to fabricate non-woven fabric masks through the melt-blown process. This experimental work aims to maximize the mask’s quality and minimize its fabrication cost by optimizing the melt-blown process parameters and using microplastics. The melt-blown process was used to make masks. Parameters such as extruder temperature, hot air temperature, melt flow rate, and die-to-collector distance (DCD) were investigated as independent variables. The quality of the mask was investigated in terms of bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), and differential pressure. The Taguchi L16 orthogonal array and Taguchi analysis were employed for experimental design and statistical optimization, respectively. The results reveal that the higher BFE and PFE are recorded at 96.7 % and 98.6 %, respectively. The surface morphological investigation on different layers ensured the fine and uniform porosity of the layers and exhibited minimum breath resistance (a low differential pressure of 0.00152 kPa/cm2). Hence the chemically treated marine waste microplastics improved the masks’ performance.

PMID:37163794 | DOI:10.1016/j.marpolbul.2023.115004

Categories
Nevin Manimala Statistics

A comprehensive overview by region of condoms, natural family planning, and spermicide as a contraceptive method among men aged 13-54 years attending contraceptive services in England

Public Health. 2023 May 8;219:110-116. doi: 10.1016/j.puhe.2023.03.023. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to (1) provide a comprehensive overview of contraceptive methods self-reported by men in England, over 5 years, focusing on condoms in comparison to any male method; and (2) explore condom as a contraceptive method by region and ethnicity.

STUDY DESIGN: Data were from the Sexual and Reproductive Health Services (Contraception) England census data set from 2014/15 to 2018/19. Once missing data were removed, this left a total of 365,292 men. Two binomial logistic regression models were performed. Model 1 examined ethnicity, region, and time on condom as a method of contraception; and Model 2 examined ethnicity, region, and time by any male contraceptive. Descriptive statistics were run for natural family planning and spermicide.

RESULTS: Model 1 revealed a significant model, χ2 (15) = 30,976, P < 0.001, and predicted that condoms as a method decreased in London with a greater decrease in Midlands. London saw the lowest rate of decline among the non-White ethnic group, whereas North and South regions increased probability over time. The North started at a higher probability and the South at the lowest. Model 2 also revealed a significant model, χ2 (15) = 32,472, P < 0.001, with a similar pattern to Model 1. Contingency tables showed natural family planning and spermicide were the least reported methods and decreased over time.

CONCLUSIONS: As any male contraceptive method appears to be decreasing in both models, reproductive health promotion is required. This study has implications for commissioning funds and for identifying regional areas of further investigation.

PMID:37163786 | DOI:10.1016/j.puhe.2023.03.023

Categories
Nevin Manimala Statistics

Assessment of indoor bioaerosol exposure using direct-reading versus traditional methods – potential application to home health care

J Occup Environ Hyg. 2023 May 10:1-18. doi: 10.1080/15459624.2023.2212007. Online ahead of print.

ABSTRACT

Home healthcare workers (HHCWs) can be occupationally exposed to bioaerosols in their clients’ homes. However, choosing the appropriate method to measure bioaerosol exposures remains a challenge. Therefore, a systematic comparison of existing measurement approaches is essential. Bioaerosol measurements with a real-time, fluorescence-based Wideband Integrated Bioaerosol Sensor (WIBS) were compared to measurements with four traditional off-line methods (TOLMs). The TOLMS included optical microscopic counting of spore trap samples, microbial cultivation of impactor samples, qPCR, and next-generation sequencing (NGS) of filter samples. Measurements were conducted in an occupied apartment simulating the environments that HHCWs could encounter in their patients’ homes. Descriptive statistics and Spearman’s correlation test were computed to compare the real-time measurement to each TOLM. The results showed that the geometric mean number concentrations of the total fluorescent aerosol particles (TFAPs) detected with the WIBS were several orders of magnitude higher than those of total fungi or bacteria measured with the TOLMs. Among the TOLMs, concentrations obtained with qPCR and NGS were the closest to the WIBS detections. Correlations between the results obtained with the WIBS and TOLMs were not consistent. No correlation was found between the concentrations of fungi detected using microscopic counting and any of the WIBS fluorescent aerosol particle (FAP) types, either indoors or outdoors. In contrast, total concentrations detected with microbial cultivation correlated with the WIBS TFAP results, both indoors and outdoors. Outdoors, total concentration of culturable bacteria correlated with FAP type AC. In addition, fungal and bacterial concentrations obtained with qPCR correlated with FAP types AB and AC. For a continuous, high time resolution but broad scope, the real-time WIBS could be considered, whereas a TOLM would be the best choice for specific and more accurate microbial characterization. HHCWs’ activities tend to re-aerosolize bioaerosols causing wide temporal variation in bioparticle concentrations. Thus, the advantage of using the real-time instrument is to capture those variations. This study lays a foundation for future exposure assessment studies targeting HHCWs.

PMID:37163743 | DOI:10.1080/15459624.2023.2212007

Categories
Nevin Manimala Statistics

Adjustable, Dynamic Subcortical Stimulation Technique for Brain Tumor Resection: A Case-Series

Oper Neurosurg (Hagerstown). 2023 May 10. doi: 10.1227/ons.0000000000000724. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVES: Subcortical stimulation (SCS) is the gold standard neuromonitoring technique for intraoperative identification of descending white matter tracts. Dynamic SCS confers several advantages over more commonly used static devices; however, current commercially available devices for dynamic SCS have not been widely adopted.

METHODS: We fashioned a dynamic SCS device using a stainless-steel suction and commonly available materials and assessed its efficacy in a series of 14 patients with brain tumors. The device was used to provide continuous SCS during tumor resection. Preoperative and postoperative motor function were characterized, and preoperative and postoperative imaging were analyzed to determine extent of tumor resection and proximity to motor-eloquent structures. Inferential statistics were used to correlate study parameters.

RESULTS: Fourteen patients (12 male and 2 female, median age 52.5 years) were analyzed. The lowest intraoperative SCS intensities were 10 to 15 mA (3 surgeries), 5 to 10 mA (4 surgeries), and <5 mA (2 surgeries). SCS with this device did not elicit motor evoked potentials in 5 surgeries because of distance from the corticospinal tract (CST) and served as negative controls. Three patients (21.4%) experienced new postoperative motor deficits immediately after surgery that resolved by discharge. We observed no instances of mechanical CST injury resulting in permanent postoperative motor deficits using this technique and no correlation between lower SCS intensity and the presence of new motor impairments after surgery. No patient experienced an intraoperative seizure.

CONCLUSION: The novel dynamic SCS device is easily adoptable and allows accurate intraoperative identification of the CST, facilitating safe resection of tumors near motor-eloquent structures.

PMID:37163705 | DOI:10.1227/ons.0000000000000724

Categories
Nevin Manimala Statistics

Efficacy of Buzzy Device Versus EMLA Cream for Reducing Pain During Needle-Related Procedures in Children: A Randomized Controlled Trial

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002965. Online ahead of print.

ABSTRACT

OBJECTIVES: Several pain management tools exist but with limitations in their efficacy or applicability. The EMLA (eutectic mixture of local anesthetics) cream is currently used for pain relief for needle-related procedures; however, it needs a minimum of 30 to 45 minutes to be effective. The Buzzy is a device that generates vibrations with cold leading to quicker pain relief. Our aim was to evaluate the effect of the Buzzy device in pain and anxiety reduction compared with EMLA cream in children requiring intravenous cannulation or venepuncture.

METHODS: This was a randomized clinical trial comparing pain and anxiety reduction by Buzzy device with the standard care (EMLA cream) in children aged 2 to 14 years who required blood extraction or intravenous cannulation based on their clinical needs. Eligible patients were randomized to either Buzzy device as the intervention or EMLA cream as the control. The outcome measures were the degree of pain scores and anxiety ratings at different stages of the needle-related procedures.

RESULTS: A total of 300 patients with a mean age of 6.5 ± 3.1 years were enrolled. Baseline characteristics were similar between the Buzzy device and EMLA cream groups. The observed pain scores by research nurses and a parent were significantly lower in the EMLA group compared with the Buzzy device group; however, the pain scores by the self-assessment scale were not statistically significant with mean difference of -0.332, 95% confidence interval, -0.635 to -0.028 (P = 0.062). The level of anxiety was significantly lower in EMLA compared with Buzzy device (P = 0. 0.0001). Both staff and parents’ satisfaction, success rate of cannulation, type of blood tests, and comment on the physician on the results were similar in both groups.

CONCLUSIONS: Pain and anxiety relief using the Buzzy device is not as effective as EMLA cream in children requiring venepuncture. However, rapid onset of action of the Buzzy device is valuable in decreasing waiting time in a busy emergency department.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT05354739.

PMID:37163686 | DOI:10.1097/PEC.0000000000002965

Categories
Nevin Manimala Statistics

Semi-Empirical Shadow Molecular Dynamics: A PyTorch Implementation

J Chem Theory Comput. 2023 May 10. doi: 10.1021/acs.jctc.3c00234. Online ahead of print.

ABSTRACT

Extended Lagrangian Born-Oppenheimer molecular dynamics (XL-BOMD) in its most recent shadow potential energy version has been implemented in the semiempirical PyTorch-based software PySeQM. The implementation includes finite electronic temperatures, canonical density matrix perturbation theory, and an adaptive Krylov subspace approximation for the integration of the electronic equations of motion within the XL-BOMB approach (KSA-XL-BOMD). The PyTorch implementation leverages the use of GPU and machine learning hardware accelerators for the simulations. The new XL-BOMD formulation allows studying more challenging chemical systems with charge instabilities and low electronic energy gaps. The current public release of PySeQM continues our development of modular architecture for large-scale simulations employing semi-empirical quantum-mechanical treatment. Applied to molecular dynamics, simulation of 840 carbon atoms, one integration time step executes in 4 s on a single Nvidia RTX A6000 GPU.

PMID:37163680 | DOI:10.1021/acs.jctc.3c00234

Categories
Nevin Manimala Statistics

The Effect of Developmental Delay and Autism Spectrum Disorder on External Auditory Canal Foreign Body Extraction

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002960. Online ahead of print.

ABSTRACT

OBJECTIVES: To determine the effect of developmental delay (DD) and autism spectrum disorder (ASD) on pediatric external auditory canal foreign body (EAC FB) retrieval outcomes.

METHODS: A retrospective chart review of children presenting with EAC FB at a tertiary children’s hospital was performed between January 2018 and December 2019. Charts were reviewed for demographics, presence of otalgia, complications, number of EAC FB episodes, indications for operating room removal, DD, and ASD status.

RESULTS: A total of 1467 patients underwent EAC FB removal. One hundred thirty-seven children (9.3%) had DD, and, of those with DD, 63 (46%) had ASD. Children with DD were 1.76 years older compared with children with non-DD (NDD) (P < 0.0001) at the time of presentation, whereas children with ASD were 1.45 years older than children with NDD (P = 0.0023). Children with DD and ASD were more likely to require removal of FB in the operating room (OR) compared with the NDD group (36.5% vs 16.7%, P = 0.0001). This was not true for children with DD without ASD. Patients with DD reported significantly less otalgia when compared with NDD patients (26.3% vs 37.4%, P = 0.0097). A similar trend, although not statistically significant, was observed when comparing children with ASD with NDD patients. The NDD patients (1.1) had fewer EAC FB episodes than patients with DD (1.6, P < 0.0001) and ASD (1.8, P < 0.0016). Hazard ratios for multiple episodes of FB were 4.5 (95% confidence interval, 2.9-6.8) for DD, and 5.6 for ASD (95% confidence interval, 3.2-9.9). The complication rate for all groups was low.

CONCLUSIONS: Due to the different ways that children with DD and ASD present compared with NDD children, physicians should be vigilant when evaluating symptoms and conducting physical examinations for EAC FB in those patients. A lower threshold for referral to otolaryngologists may result in more favorable outcomes.

PMID:37163677 | DOI:10.1097/PEC.0000000000002960

Categories
Nevin Manimala Statistics

Asynchronous Learning Module for Pediatric Emergency Medicine Physicians on How to Manage Vaginal Birth and Neonatal Resuscitation in the Emergency Department

Pediatr Emerg Care. 2023 May 11. doi: 10.1097/PEC.0000000000002959. Online ahead of print.

ABSTRACT

OBJECTIVES: Newborn deliveries and neonatal resuscitation events are rare but essential skills for pediatric emergency medicine (PEM) physicians. We sought to evaluate the effect of an online module on PEM physicians’ knowledge and confidence in managing newborn deliveries and neonatal resuscitation.

METHODS: A team of experts in PEM, obstetrics, neonatology, and medical education developed a self-directed, 1-hour online module on managing newborn deliveries with neonatal resuscitation. The module was designed to address the learning needs of the targeted group. The module was piloted before dissemination to PEM faculty. A 10-question multiple choice test was given to assess knowledge of the material covered. A 10-point Likert scale questions survey was used to evaluate confidence. Measures were administered before initiation, after module completion, and 6 months after completion. Paired t tests were used to compare mean knowledge scores, and rank sum tests were used to compare median confidence levels.

RESULTS: Most (n = 47, 89%) of the PEM faculty members completed the module. The majority (n = 43, 91%) thought the information was relevant to their practice. After completing the module, physicians’ overall knowledge scores improved by 18% (mean [SD]: 74% [14.7] vs 92% [8.0], P < 0.01). Self-assessed confidence improved after the module in terms of managing uncomplicated vaginal deliveries (median 5 vs 7, P < 0.01), care of patients with complicated vaginal deliveries (2 vs 5, P < 0.01), and managing neonatal resuscitation (7 vs 8, P < 0.01). During the 6-month follow-up, there was sustained improvement in physicians’ overall knowledge score (82% [16.9], P = 0.007) and self-assessed confidence in managing complicated vaginal deliveries (median 2 vs 4, P = 0.0012); however, other measures were not statistically significant.

CONCLUSIONS: An online module is an appropriate method for training PEM providers about rarely used but essential skills such as managing vaginal deliveries and neonatal resuscitation.

PMID:37163676 | DOI:10.1097/PEC.0000000000002959

Categories
Nevin Manimala Statistics

A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements

Dermatol Surg. 2023 May 9. doi: 10.1097/DSS.0000000000003802. Online ahead of print.

ABSTRACT

BACKGROUND: Skin quality may be assessed by degrees of skin smoothness, fine lines, and hydration. VYC-12L is a recently developed hyaluronic acid filler to improve skin quality.

OBJECTIVE: This was a randomized, evaluator-blind study assessing safety and effectiveness of intradermal VYC-12L treatment for improving cheek skin smoothness, fine lines, and hydration.

METHODS: Participants (≥22 years) with moderate-to-severe investigator-assessed Allergan Cheek Smoothness Scale (ACSS) scores were randomized in 2:1 ratio to receive VYC-12L or control (no treatment with optional treatment). Effectiveness was assessed 1 month after last injection (initial or touch-up) by a responder rate (≥1-grade improvement from baseline on both cheeks) using investigator-rated ACSS and Allergan Fine Lines Scale (AFLS), and tissue dielectric constant probe-measured skin hydration. Safety was evaluated throughout.

RESULTS: Participants (VYC-12L, n = 131; control, n = 71) were 86.1% female with a median age of 58.0 years. At month 1, ACSS and AFLS responder rates were statistically significantly higher in the VYC-12L group (57.9%, 58.3%, respectively) than in the untreated controls (4.5%, 5.4%, respectively; p < .001). VYC-12L ACSS and AFLS responder rates remained consistent throughout the 6-month follow-up. Six participants reported treatment-related adverse events; none led to study discontinuation.

CONCLUSION: VYC-12L is an effective, well-tolerated treatment for lasting improvement of cheek skin smoothness, fine lines, and hydration.

PMID:37163665 | DOI:10.1097/DSS.0000000000003802