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Nevin Manimala Statistics

Elevated baseline soluble FcεRI may be linked to early response to omalizumab treatment in chronic spontaneous urticaria

J Eur Acad Dermatol Venereol. 2023 Aug 29. doi: 10.1111/jdv.19485. Online ahead of print.

ABSTRACT

BACKGROUND: Omalizumab, an anti-IgE monoclonal antibody, is an effective treatment in chronic spontaneous urticaria (CSU). Predictors of fast and good response for omalizumab treatment have not yet been identified and characterized.

OBJECTIVE: To evaluate if soluble FcεRI (sFcεRI), a marker of IgE-mediated mast cell activation, predicts the time of response to omalizumab in CSU.

METHODS: Sera of 67 CSU patients were obtained before omalizumab treatment and analysed for sFcεRI levels by ELISA (2 ng/mL was used as cut-off for elevated sFcɛRI). Treatment response during the first 4 weeks was assessed with the urticaria activity score (UAS7), urticaria control test (UCT) and the rolling UAS7 (rUAS7).

RESULTS: Elevated pre-treatment sFcɛRI levels were detected in more than 70% of patients with completely controlled disease (UCT = 16) and well controlled disease (UCT = 12-15) and were significantly associated with disease control (χ2 = 4.94, p < 0.05). More than half of the patients (14/25) with low levels had poor disease control (UCT < 12). Of the patients who achieved complete and marked UAS7 response, respectively, 75% and 63% had elevated baseline sFcɛRI levels. Post-treatment UAS7 scores were lower in patients with elevated sFcɛRI levels reaching statistical significance at week 3 (p < 0.05). Patients with elevated baseline sFcɛRI levels achieved rUAS7 ≤ 6 and = 0 earlier than those with lower levels (day 9 vs 13 and day 12 vs 14, respectively).

CONCLUSION: Elevated sFcεRI serum levels predict early and good response to treatment with omalizumab, which may help to better design treatment options for CSU patients.

PMID:37641982 | DOI:10.1111/jdv.19485

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Patient-level indirect treatment comparison of lanadelumab versus pdC1-INH i.v. in hereditary angioedema patients: PATCH study

Allergy. 2023 Aug 29. doi: 10.1111/all.15861. Online ahead of print.

ABSTRACT

BACKGROUND: Hereditary angioedema (HAE) is an autosomal dominant inherited disease in which patients suffer from local attacks primarily affecting skin and gastrointestinal tract, and sometimes even the upper respiratory tract leading to asphyxiation. Since head-to-head trials between authorized treatments are lacking, this study compares efficacy and safety of lanadelumab and intravenous plasma-derived C1-esterase inhibitor (pdC1-INH i.v.) in HAE patients on long-term prophylaxis by means of an indirect treatment comparison.

METHODS: Efficacy and safety of lanadelumab against pdC1-INH i.v. were analyzed in a fully prespecified indirect comparison based on individual patient data (n = 231) from the HELP and CHANGE clinical trials. Primary and secondary efficacy endpoints were compared using a generalized linear model for count data. Confounding variables were identified a priori via systematic literature research and validated by clinical experts. Adjustment of confounders was implemented using a conditional regression model.

RESULTS: Lanadelumab showed a statistically significant improvement in reduction of HAE attack rates compared to pdC1-INH i.v. across multiple endpoints: Monthly attack rate of patients treated with lanadelumab was less than half compared to pdC1-INH i.v. (Rate ratio: 0.486; 95% CI: 0.253, 0.932). Monthly rate of laryngeal attacks was found to be five times lower for lanadelumab (Rate ratio: 0.2; 95% CI: 0.044, 0.915) and monthly rate of acute treated HAE attacks among lanadelumab patients was about one third of the attack rate of pdC1-INH i.v. patients (Rate ratio: 0.366; 95% CI: 0.185, 0.727).

CONCLUSION: This study contributes to current knowledge in the treatment of HAE by indicating a statistically significant reduction of HAE attacks under lanadelumab compared to pdC1-INH i.v.

PMID:37641968 | DOI:10.1111/all.15861

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Assessing the reliability of CBCT-based AI-generated STL files in diagnosing osseous changes of the mandibular condyle: a comparative study with ground truth diagnosis

Dentomaxillofac Radiol. 2023 Aug 29:20230141. doi: 10.1259/dmfr.20230141. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aims to evaluate the reliability of AI-generated STL files in diagnosing osseous changes of the mandibular condyle and compare them to a ground truth (GT) diagnosis made by six radiologists.

METHODS: A total of 432 retrospective CBCT images from four universities were evaluated by six dentomaxillofacial radiologists who identified osseous changes such as flattening, erosion, osteophyte formation, bifid condyle formation, and osteosclerosis. All images were evaluated by each radiologist blindly and recorded on a spreadsheet. All evaluations were compared and for the disagreements, a consensus meeting was held online to create a uniform GT diagnosis spreadsheet. A web-based dental AI software was used to generate STL files of the CBCT images, which were then evaluated by two dentomaxillofacial radiologists. The new observer, GT, was compared to this new STL file evaluation, and the interclass correlation (ICC) value was calculated for each pathology.

RESULTS: Out of the 864 condyles assessed, the ground truth diagnosis identified 372 cases of flattening, 185 cases of erosion, 70 cases of osteophyte formation, 117 cases of osteosclerosis, and 15 cases of bifid condyle formation. The ICC values for flattening, erosion, osteophyte formation, osteosclerosis, and bifid condyle formation were 1.000, 0.782, 1.000, 0.000, and 1.000, respectively, when comparing diagnoses made using STL files with the ground truth.

CONCLUSIONS: AI-generated STL files are reliable in diagnosing bifid condyle formation, osteophyte formation, and flattening of the condyle. However, the diagnosis of osteosclerosis using AI-generated STL files is not reliable, and the accuracy of diagnosis is affected by the erosion grade.

PMID:37641960 | DOI:10.1259/dmfr.20230141

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Rhodiola Rosea as an Adaptogen to Enhance Exercise Performance: A Review of the Literature

Br J Nutr. 2023 Aug 29:1-27. doi: 10.1017/S0007114523001988. Online ahead of print.

ABSTRACT

Rhodiola rosea (RR) is a plant whose bioactive components may function as adaptogens, thereby increasing resistance to stress and improving overall resilience. Some of these effects may influence exercise performance and adaptations. Based on studies of rodents, potential mechanisms for the ergogenic effects of RR include modulation of energy substrate stores and use, reductions in fatigue and muscle damage, and altered antioxidant activity. At least 16 investigations in humans have explored the potential ergogenicity of RR. These studies indicate acute RR supplementation (∼200 mg RR containing ∼1% salidroside and ∼3% rosavin, provided 60 minutes before exercise) may prolong time-to-exhaustion and improve time trial performance in recreationally active males and females, with limited documented benefits of chronic supplementation. Recent trials providing higher doses (∼1,500 to 2,400 mg RR/day for 4 to 30 days) have demonstrated ergogenic effects during sprints on bicycle ergometers and resistance training in trained and untrained adults. The effects of RR on muscle damage, inflammation, energy system modulation, antioxidant activity, and perceived exertion are presently equivocal. Collectively, it appears that adequately dosed RR enhances dimensions of exercise performance and related outcomes for select tasks. However, the current literature does not unanimously show that RR is ergogenic. Variability in supplementation dose and duration, concentration of bioactive compounds, participant characteristics, exercise tests, and statistical considerations may help explain these disparate findings. Future research should build on the longstanding use of RR and contemporary clinical trials to establish the conditions in which supplementation facilitates exercise performance and adaptations.

PMID:37641937 | DOI:10.1017/S0007114523001988

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Identification of Design Principles for the Preparation of Colloidal Plexcitonic Materials

Langmuir. 2023 Aug 29. doi: 10.1021/acs.langmuir.3c01642. Online ahead of print.

ABSTRACT

Colloidal plexcitonic materials (CPMs) are a class of nanosystems where molecular dyes are strongly coupled with colloidal plasmonic nanoparticles, acting as nanocavities that enhance the light field. As a result of this strong coupling, new hybrid states are formed, called plexcitons, belonging to the broader family of polaritons. With respect to other families of polaritonic materials, CPMs are cheap and easy to prepare through wet chemistry methodologies. Still, clear structure-to-properties relationships are not available, and precise rules to drive the materials’ design to obtain the desired optical properties are still missing. To fill this gap, in this article, we prepared a dataset with all CPMs reported in the literature, rationalizing their design by focusing on their three main relevant components (the plasmonic nanoparticles, the molecular dyes, and the capping layers) and identifying the most used and efficient combinations. With the help of statistical analysis, we also found valuable correlations between structure, coupling regime, and optical properties. The results of this analysis are expected to be relevant for the rational design of new CPMs with controllable and predictable photophysical properties to be exploited in a vast range of technological fields.

PMID:37641919 | DOI:10.1021/acs.langmuir.3c01642

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Effectiveness of hemocoagulase, tranexamic acid, and their combination for reducing blood loss in bimaxillary orthognathic surgery: a retrospective study

J Korean Assoc Oral Maxillofac Surg. 2023 Aug 31;49(4):208-213. doi: 10.5125/jkaoms.2023.49.4.208.

ABSTRACT

OBJECTIVES: Orthognathic surgery is a corrective intervention for maxillofacial deformities. Bleeding is a major concern for oral and maxillofacial surgeons. Various agents, such as hemocoagulase, tranexamic acid, and aprotinin have been developed to reduce intraoperative bleeding and transfusion requirements. Therefore, in this study we aimed to investigate the effects of hemocoagulase and tranexamic acid, as well as their simultaneous use, to reduce bleeding during orthognathic surgery. Patients and.

METHODS: This retrospective study included patients who had undergone simultaneous orthognathic surgery of the maxilla and mandible between January 2013 and September 2022 and were classified into three groups based on drugs administered: hemocoagulase (Botropase), tranexamic acid, and a combination of both drugs. We recorded patient age, sex, weight, blood loss, and duration of surgery. Red blood cell (RBC), hemoglobin, hematocrit, and platelet levels were measured before, immediately after, and one day after surgery.

RESULTS: No statistically significant differences were found in blood loss, RBC, hemoglobin, hematocrit, or platelet levels between any of the groups. There were no differences in the drug effects between Le Fort I and bilateral mandibular sagittal split osteotomies, with or without double genioplasty. However, there were significant reductions in RBC, hemoglobin, hematocrit, and platelet levels during genioplasty.

CONCLUSION: Tranexamic acid, hemocoagulase, and their combination had similar efficacy in patients who underwent Le Fort Ⅰ and bilateral mandibular sagittal split osteotomies with and without genioplasty.

PMID:37641903 | DOI:10.5125/jkaoms.2023.49.4.208

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Radiographic evaluation before surgical extraction of impacted third molar to reduce the maxillary sinus related complication

J Korean Assoc Oral Maxillofac Surg. 2023 Aug 31;49(4):192-197. doi: 10.5125/jkaoms.2023.49.4.192.

ABSTRACT

OBJECTIVES: Surgical extraction of maxillary third molars is routine in departments devoted to oral and maxillofacial surgery. Because maxillary third molars are anatomically adjacent to the maxillary sinus, complications such as oroantral fistula and maxillary sinusitis can occur. Here we explore the factors that can cause radiographic postoperative swelling of the maxillary sinus mucosa after surgical extraction.

MATERIALS AND METHODS: This retrospective study reviewed the clinical records and radiographs of patients who underwent maxillary third-molar extraction. Preoperative panoramas, Waters views, and cone-beam computed tomography were performed for all patients. The patients were divided into two groups; those with and those without swelling of the sinus mucosa swelling or air-fluid level in a postoperative Waters view. We analyzed the age and sex of patients, vertical position, angulation, number of roots, and relation to the maxillary sinus between groups. Statistical analysis used logistic regression and P<0.05 was considered statistically significant.

RESULTS: A total of 91 patients with 153 maxillary third molars were enrolled in the study. Variables significantly related to swelling of the maxillary sinus mucosa after surgical extraction were the age and the distance between the palatal cementoenamel junction (CEJ) and the maxillary sinus floor (P<0.05). Results of the analysis show that the relationship between the CEJ and sinus floor was likely to affect postoperative swelling of the maxillary sinus mucosa.

CONCLUSION: Maxillary third molars are anatomically adjacent to the maxillary sinus and require careful handling when the maxillary sinus is pneumatized to the CEJ of teeth.

PMID:37641901 | DOI:10.5125/jkaoms.2023.49.4.192

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Heterogeneity and Gaps in Reporting Primary Outcomes From Neonatal Trials

Pediatrics. 2023 Aug 29:e2022060751. doi: 10.1542/peds.2022-060751. Online ahead of print.

ABSTRACT

OBJECTIVES: Clear outcome reporting in clinical trials facilitates accurate interpretation and application of findings and improves evidence-informed decision-making. Standardized core outcomes for reporting neonatal trials have been developed, but little is known about how primary outcomes are reported in neonatal trials. Our aim was to identify strengths and weaknesses of primary outcome reporting in recent neonatal trials.

METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials’ primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.

RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.

CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.

PMID:37641881 | DOI:10.1542/peds.2022-060751

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Effect of number of diffusion encoding directions in neonatal diffusion tensor imaging using Tract-Based Spatial Statistical analysis

Eur J Neurosci. 2023 Aug 29. doi: 10.1111/ejn.16135. Online ahead of print.

ABSTRACT

Diffusion tensor imaging (DTI) has been used to study the developing brain in early childhood, infants and in utero studies. In infants, number of used diffusion encoding directions has traditionally been smaller in earlier studies down to the minimum of 6 orthogonal directions. Whereas the more recent studies often involve more directions, number of used directions remain an issue when acquisition time is optimized without compromising on data quality and in retrospective studies. Variability in the number of used directions may introduce bias and uncertainties to the DTI scalar estimates that affect cross-sectional and longitudinal study of the brain. We analysed DTI images of 133 neonates, each data having 54 directions after quality control, to evaluate the effect of number of diffusion weighting directions from 6 to 54 with interval of 6 to the DTI scalars with Tract-Based Spatial Statistics (TBSS) analysis. The TBSS analysis was applied to DTI scalar maps, and the mean region of interest (ROI) values were extracted using JHU atlas. We found significant bias in ROI mean values when only 6 directions were used (positive in fractional anisotropy [FA] and negative in fractional anisotropy [MD], axial diffusivity [AD] and fractional anisotropy [RD]), while when using 24 directions and above, the difference to scalar values calculated from 54 direction DTI was negligible. In repeated measures voxel-wise analysis, notable differences to 54 direction DTI were observed with 6, 12 and 18 directions. DTI measurements from data with at least 24 directions may be used in comparisons with DTI measurements from data with higher numbers of directions.

PMID:37641861 | DOI:10.1111/ejn.16135

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Findings of Intravenous Gadolinium Inner Ear MRI in Patients with Acute Low-Tone Sensorineural Hearing Loss

Clin Exp Otorhinolaryngol. 2023 Aug 23. doi: 10.21053/ceo.2023.00486. Online ahead of print.

ABSTRACT

OBJECTIVES: Acute low-tone sensorineural hearing loss (ALHL) is thought to have a different etiology than idiopathic sudden sensorineural hearing loss. We hypothesized that endolymphatic hydrops (EH) in the inner ear organ contributes to ALHL, even in patients without vertigo. This study aimed to evaluate the presence of EH in ALHL and to compare the clinical characteristics of patients with or without EH.

METHODS: We retrospectively reviewed 38 patients diagnosed with ALHL without vertigo from January 2017 to March 2022. EH was measured in all patients using inner ear magnetic resonance imaging (MRI). In addition, we selected patients who showed only mid- or high-frequency hearing loss and had available MRI data as a control group and compared the difference between the ALHL and control groups.

RESULTS: After treatment, the pure-tone average at low frequencies was significantly improved compared with the initial hearing (P<0.001). Hearing recovery was observed in 63.1% of patients; however, the recovery rate did not differ based on treatment method. During the follow-up period, 6 patients (15.8%) progressed to Meniere’s disease, and 18 (47.4%) experienced recurrence. In the ALHL group, the cochlear hydrops ratio on the affected side (0.34 ± 0.09) was significantly higher than on the contralateral side (0.29 ± 0.12, P=0.005), and most patients showed hydrops in the apex area of the cochlea. Compared with the control group (0.25 ± 0.15), the ALHL group showed significantly higher cochlear hydrops ratio (P=0.043). The correlation analysis showed a tendency for hearing thresholds at low frequencies to increase as hydrops ratio increased, although there was no statistical significance.

CONCLUSION: Our study showed that the cochlear hydrops ratio, especially in the apex area on the affected side, was significantly higher in patients with ALHL, indicating that EH in the cochlea contributes to the pathogenesis of ALHL.

PMID:37641856 | DOI:10.21053/ceo.2023.00486