Tag: statistics

Biomed Pharmacother. 2021 Oct 11;144:112308. doi: 10.1016/j.biopha.2021.112308. Online ahead of print.

ABSTRACT

INTRODUCTION: Extensive evidence suggests that alpha-lipoic acid (ALA) is effective in diabetic neuropathy pain management. However, little is known on its safety and efficacy in reducing idiopathic pain in normoglycemic subjects. The aim of this study was to evaluate ALA food supplement safety and efficacy in the reduction of different forms of idiopathic pain.

METHODS: Two-hundred and ten normoglycemic adults suffering from idiopathic pain (i.e. 57 subjects with primitive neuropathic pain, 141 subjects with arthralgia with unknown etiology, and 12 subjects with idiopathic myalgia) were randomized to receive placebo, 400 mg/day, or 800 mg/day of ALA. Participants underwent two visits (at baseline = t0, and after 2 months = t1) in which two validated questionaries for pain (numerical rating scale [NRS] and visual analogue scale [VAS]) were collected; fasting blood glucose assessment, adverse effects, and renal and hepatic toxicity were also monitored.

RESULTS: At t1, none of subjects treated with ALA reported a decreased glycemia or adverse effects. The treated subjects showed a significant reduction in NRS (p < 0.001) while the placebo group did not show any NRS reduction (p = 0.86). Similar results were also obtained for VAS. Statistical analysis aimed at detecting possible differences in NRS and VAS scores among treatment groups based on the source of pain did not reveal any significant effect.

CONCLUSIONS: Since the management of idiopathic pain is challenging for physicians, the use of ALA food supplements could be a feasible option, based on its safety and efficacy compared to commonly-used analgesic drugs.

PMID:34649217 | DOI:10.1016/j.biopha.2021.112308

Diagn Microbiol Infect Dis. 2021 Jul 31;102(1):115513. doi: 10.1016/j.diagmicrobio.2021.115513. Online ahead of print.

ABSTRACT

Identification of asymptomatic patients is necessary to control the COVID-19 pandemic and testing is one of the measures to detect this population. We evaluated the clinical correlation of the DiaSorin Molecular Simplexa COVID-19 Direct (DiaSorin Molecular) and Roche Cobas 6800 SARS-CoV-2 (Roche) assays using 253 oropharyngeal (OP) swab specimens collected from asymptomatic patients. Agreement between DiaSorin Molecular and Roche was 97% (95% CI, 0.94 to 0.99), with a κ statistic of 0.90 (95% CI, 0.83 to 0.97) and a PPA of 89% (95% CI, 0.76 to 0.96) and NPA of 99% (95% CI, 0.97 to 0.99). Simple regression analysis of Ct values revealed a regression line of y = 1.065*X – 5.537 with a Pearson’s r of 0.8542, indicating a good correlation between both platforms. The DiaSorin Molecular assay demonstrates clinical performance comparable to that of Roche in this population.

PMID:34649190 | DOI:10.1016/j.diagmicrobio.2021.115513

J Environ Radioact. 2021 Oct 11;240:106756. doi: 10.1016/j.jenvrad.2021.106756. Online ahead of print.

ABSTRACT

The volumetric activity of the divalent ⁹⁰Sr ion in groundwater at the Chornobyl NPP industrial site ranges from 1 to 2 to 400-3800 Bq/l. The increase in groundwater radionuclides concentrations is associated with the reduced sorption properties of local sediments, which affect the migration capacity of radionuclides in the environment. The decrease of the ⁹⁰Sr sorption properties of sediments is caused by changes in the chemical composition of groundwater. A new statistical method has been performed. Method based on the Monte Carlo method in order to evaluate the correlations between the ⁹⁰Sr volumetric activity and the groundwater chemical composition components. Simulation results using this method suggest a correlation between the volumetric activity of ⁹⁰Sr, the concentrations cations, the pH, and the oxidation index (organic contents). A direct correlation was established between the volumetric activity of ⁹⁰Sr, Ca²⁺ concentrations and the pH of groundwater in the range from 7 to 12.4. It was revealed that the concentrations of Na⁺ and K⁺ do not affect the conditions of ⁹⁰Sr migration with groundwater. There is an inverse correlation between the concentration of ⁹⁰Sr and the oxidation index, which is an indirect indicator of the organic substances content in water. Thus, the presence of organic substances in the groundwater effectively promotes sorption of ⁹⁰Sr. The proposed method of geochemical statistics enables a quantitative assessment of groundwater monitoring results.

PMID:34649194 | DOI:10.1016/j.jenvrad.2021.106756

Gait Posture. 2021 Oct 6;91:48-51. doi: 10.1016/j.gaitpost.2021.10.001. Online ahead of print.

ABSTRACT

BACKGROUND: The Rizzoli Foot Model (RFM) and Oxford Foot Model (OFM) are used to analyze segmented foot kinematics with independent tracking markers. Alternatively, rigid marker clusters can be used to improve markers’ visualization and facilitate analyzing shod gait.

RESEARCH QUESTION: Are there differences in angles from the RFM and OFM, obtained with independent and clustered tracking markers, during the stance phase of walking?

METHODS: Walking kinematics of 14 non-disabled participants (25.2 years (SD 2.8)) were measured at self-selected speed. Rearfoot-shank and forefoot-rearfoot angles were measured from two models with two tracking methods: RFM, OFM, RFM-cluster, and OFM-cluster. In RFM-cluster and OFM-cluster, the rearfoot and forefoot tracking markers were rigidly clustered, fixed on rods’ tips attached to a metallic base. Statistical Parametric Mapping (SPM) One-Way Repeated Measures ANOVAs and SPM Paired t-tests were used to compare waveforms. Coefficients of Multiple Correlation (CMC) quantified the similarity between waveforms. One-way Repeated Measures ANOVAs were conducted to compare the ranges of motion (ROMs), and pre-planned contrasts investigated differences between the models and tracking methods. Intraclass Correlation Coefficients (ICC) were computed to verify the similarity between ROMs.

RESULTS: Differences occurred mostly in small parts of the stance phase for the cluster vs. non-cluster comparisons and the RFM vs. OFM comparisons. ROMs were slightly different between the models and tracking methods in most comparisons. The curves (CMC ≥ 0.71) were highly similar between the models and tracking methods. The ROMs (ICC ≥ 0.67) were moderatetly to highly similar in most comparisons. RFM vs. RFM-cluster (forefoot-rearfoot angle – transverse plane), OFM vs. OFM-cluster and RFM vs. OFM (forefoot-rearfoot angle – frontal plane) were not similar (non-significant).

SIGNIFICANCE: Rigid clusters are an alternative for tracking rearfoot-shank and forefoot-rearfoot angles during the stance phase of walking. However, specific differences should be considered to contrast results from different models and tracking methods.

PMID:34649170 | DOI:10.1016/j.gaitpost.2021.10.001

Res Vet Sci. 2021 Sep 29;141:26-32. doi: 10.1016/j.rvsc.2021.09.013. Online ahead of print.

ABSTRACT

High-mobility group box-1 (HMGB1) is an intranuclear molecule that is released extracellularly in cytotoxic conditions. In acute pancreatitis, extracellular HMGB1 acts as a stimulating factor in the mechanism associated with pancreatic injury. To evaluate the prognostic property of serum HMGB1 levels at the time of diagnosis of pancreatitis, the blood samples collected over 10 months from canine patients in Seoul National University Veterinary Medical Teaching Hospital (n = 29). The HMGB1 levels were measured with ELISA kit and results were analyzed correlation with patient’s death, hospitalization cost and period. HMGB1 levels in patients with acute pancreatitis (mean = 76 ng/mL, standard deviation [SD] = 46.99 ng/mL) were higher than that of normal individuals (mean = 31.65 ng/mL, SD = 18.41 ng/mL, p = 0.0082). Similarly, non-survivors demonstrated statistically significant difference than the survivors (p = 0.008). Clinical severity of acute pancreatitis was categorized into three stages: mild, moderate, and severe based on the disease activity index (DAI). The HMGB1 levels and mortality were associated with moderate DAI (p = 0.0236). However, the correlation between serum HMGB1 and patients’ hospitalization period and cost were not found to be significant (R² = 0.01991). The evaluation of serum HMGB1 level at the time of diagnosis was identified as a potential prognostic factor to estimate the prognosis of acute pancreatitis in canines.

PMID:34649188 | DOI:10.1016/j.rvsc.2021.09.013

Transl Oncol. 2021 Oct 11;15(1):101240. doi: 10.1016/j.tranon.2021.101240. Online ahead of print.

ABSTRACT

BACKGROUND: Ewing’s sarcoma (ES) is an aggressive cancer affecting children and young adults. We pre-clinically demonstrated that mesenchymal stromal/stem cells (MSCs) can deliver tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) against primary ES after local injection. However, ES is often metastatic calling for approaches able to support MSC targeting to the ES multiple remote sites. Considering that the disialoganglioside GD2 is expressed by ES and to optimise MSC tumour affinity, bi-functional (BF) MSCs expressing both TRAIL and a truncated anti-GD2 chimeric antigen receptor (GD2 tCAR) were generated and challenged against ES.

METHODS: The anti-GD2 BF MSCs delivering a soluble variant of TRAIL (sTRAIL) were tested in several in vitro ES models. Tumour targeting and killing by BF MSCs was further investigated by a novel immunodeficient ES metastatic model characterized by different metastatic sites, including lungs, liver and bone, mimicking the deadly clinical scenario.

FINDINGS: In vitro data revealed both tumour affinity and killing of BF MSCs. In vivo, GD2 tCAR molecule ameliorated the tumour targeting and persistence of BF MSCs counteracting ES in lungs but not in liver.

INTERPRETATION: We here generated data on the potential effects of BF MSCs within a complex ES metastatic in vivo model, exploring also the biodistribution of MSCs. Our BF MSC-based strategy promises to pave the way for potential improvements in the therapeutic delivery of TRAIL for the treatment of metastatic ES and other deadly GD2-positive malignancies.

PMID:34649148 | DOI:10.1016/j.tranon.2021.101240

Int J Pediatr Otorhinolaryngol. 2021 Oct 5;150:110935. doi: 10.1016/j.ijporl.2021.110935. Online ahead of print.

ABSTRACT

INTRODUCTION: The olfactory sense is of paramount importance for the adequate development of a child. Olfactory loss in children might have different origins. One of the most common is conductive, when nasal obstruction prevents odorants from reaching the olfactory epithelium. Rhinitis and turbinate enlargement have been proven to diminish the sense of smell in pediatric patients. A common treatment for resistant rhinitis in these patients is turbinate radiofrequency ablation (TRA). However, despite an increasing research effort in this field, there are no studies instrumentally assessing olfaction in children undergoing turbinate surgery to date. This study was designed with the aim of assessing changes in olfaction through validated instrumental tools in pediatric patients undergoing TRA for the first time.

METHODS: A prospective uncontrolled intervention clinical trial design was conducted. Two cohorts of children ranging 4-15 years old were consecutively selected from a third level referral Hospital and subjected to the universal sniff test (U-Sniff), alcohol sniff test (AST), and sniffin sticks threshold test (SST) before and 1, 3 and 6 months after surgery. Cohort A consisted of children solely undergoing TRA. Cohort B consisted of children on whom adenoidectomy and TRA had been performed. Additionally, a cohort of Spanish healthy controls, paired by sex and age, were asked to perform the U-Sniff.

RESULTS: A total of 81 participants with a mean age of 10.31 ± 2.56 years were included. Fifty-three patients underwent TRA exclusively and 28 were subjected to associated adenoidectomy. Despite a tendency toward improvement in the U-sniff scores, there were no statistically significant differences after surgery. However, statistically significant differences were obtained for threshold tasks measured with SST and AST, revealing differences at 1, 3 and 6 months after surgery compared to preoperative scores.

CONCLUSIONS: In summary, this research demonstrated adequate levels in the sense of smell regarding identification tasks, but decreased olfactory threshold scores in pediatric patients suffering from TE. TRA, alone or with adenoidectomy, improved smell threshold scores, but had no significant effect on identification tasks.

PMID:34649156 | DOI:10.1016/j.ijporl.2021.110935

Parkinsonism Relat Disord. 2021 Sep 21;91:167-172. doi: 10.1016/j.parkreldis.2021.09.014. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Given the overlapping clinical manifestations and pathology, the differentiation between essential tremor (ET) and Parkinson’s disease (PD) is difficult. Our aims were to examine the plasma metabolomics profiling and their association with motor and non-motor symptoms (NMS) in patients with PD, and to determine differences between de novo PD compared to moderate-advanced PD vs. controls and patients with ET.

METHODS: Plasma samples were collected from 137 subjects including 35 age matched controls, 29 NOVO-PD, 35 PD and 38 ET patients. PD severity, motor and NMS including cognitive function were assessed using the UPDRS, NMS and PD cognitive rating scales, respectively. Metabolomics analysis was performed by UPLC-ESI-QToF-MS followed by unsupervised multivariate statistics. The area under the curve of the biomarkers according to distribution of their concentrations and the diagnosis of PD (NOVO-PD, advanced PD) vs ET and healthy controls was used as a measurement of diagnostic ability.

RESULTS: Several acyl-carnitines, bilirubin, tyramine and tetrahydro-21-deoxycortisol (THS) presented good predictive accuracy (AUC higher than 0.8) for differentiating de novo PD and advanced PD from controls and ET, suggesting an alteration in the lipid oxidation pathway. In multivariate regression analysis, metabolite levels were not significantly associated with motor and NMS severity in PD.

CONCLUSIONS: Diverse acyl-carnitines, bilirubin, tyramine and some adrenal gland derived metabolites are suggested as potential biomarkers able to distinguish between PD from controls and ET.

PMID:34649109 | DOI:10.1016/j.parkreldis.2021.09.014

Int J Med Inform. 2021 Sep 21;156:104586. doi: 10.1016/j.ijmedinf.2021.104586. Online ahead of print.

ABSTRACT

BACKGROUND AND PURPOSE: Intravenous recombinant tissue plasminogen activator (rt-PA) remains the only FDA approved pharmacological therapy for acute ischemic stroke (AIS), but this treatment is associated with symptomatic intracerebral haemorrhage (SICH). The aim of this study was to derive and validate an accurate measure of SICH risk in ischemic stroke patients treated with rt-PA using data readily available from patient clinical records.

METHODS: Demographics, physiological parameters, and clinical data were obtained from 1,270 ischemic stroke patients treated with thrombolysis at 20 hospitals. This included age, sex, weight, blood pressure, glucose levels, smoking preferences, and presence of previous clinical conditions. Using a bivariate analysis on a training dataset of 890 patients, SICH cases were compared against SICH-free patients and key risk factors associated with SICH were identified. Continuous variables were stratified using k-means clustering, and odds ratios computed for each of the categorical risk factors employed in the risk score. The SICH risk score, which was assessed using an independent validation dataset comprising 380 patients, was defined between 0 and 53, and stratified into 4 categories: very low risk (0-6), low risk (7-12), moderate risk (13-19), and high risk (>20).

RESULTS: Older age (age > 75 years), higher blood pressure, higher severity of stroke, pre-treatment antithrombotic and history of hypertension and hyperlipidaemia, were shown to be significant risk factors for SICH following rt-PA treatment (p < 0.05). A number of interaction effects with age produced greater overall SICH risk than that of individual variables alone, including age*weight, age*NIHSS, age*diastolic blood pressure, and age*hypertension. The SICH prediction tool demonstrated a C-statistic of 0.75 for continuous risk scoring (0-53) and 0.71 for stratified risk levels.

CONCLUSION: A novel, computationally efficient risk score utilising data readily available from patient clinical records was shown to predict SICH risk following thrombolysis treatment with high accuracy. This tool may be useful for pre-screening patients for SICH risk to reduce the morbidity and mortality associated with thrombolysis treatment.

PMID:34649112 | DOI:10.1016/j.ijmedinf.2021.104586

Biosens Bioelectron. 2021 Oct 6;196:113687. doi: 10.1016/j.bios.2021.113687. Online ahead of print.

ABSTRACT

Despite the existing rapid and reliable analytical methods for determining biogenic amine in food matrices, recently special efforts have been devoted for development of portable and inexpensive devices for discrimination of biogenic amines (BAs) in food products to achieve onsite detection of food-spoilage. Thus, in this context, a field deployable cross-reactive sensor array and a field-portable array reader has been developed for determination of food quality. The sensor array consisting of metal complexes (C1 – C11) of single azophenol dye-based receptor generated a unique visible response on interaction with different amines (A1 – A7). Further, the colorimetric pattern and discrimination efficacy of the sensor array was evaluated using multivariate statistical techniques such as principal component analysis and linear discriminant analysis. Motivated by outstanding discriminatory power of sensor array, titration experiment was performed with BAs, and colorimetric response of array was linearly corelated to concentrations of BAs such as tryptamine and spermine with R² values of 0.9596 and 0.967 respectively. Finally, for practical utility and the field analysis, a portable reader was developed and utilized for quantification of biogenic amines in meat and cottage cheese samples spiked with spermine and tryptamine up to the concentrations of 40 μM; therefore, apparently proving the potential applicability of the designed sensing method for food quality monitoring.

PMID:34649095 | DOI:10.1016/j.bios.2021.113687