Tag: statistics

Ann Hematol. 2021 Jul 24. doi: 10.1007/s00277-021-04558-0. Online ahead of print.

ABSTRACT

We conducted a phase II clinical trial to develop an autologous EBV-specific T cell product (baltaleucel T) for advanced, relapsed ENKTL. Among 47 patients who provided whole blood starting material for manufacturing the product, 15 patients received a median of 4 doses of baltaleucel T. Thirty-two (68%) patients did not receive baltaleucel-T due to manufacturing failure, rapid disease progression, and death. Of the 15 patients, 10 patients had measurable disease at baseline (salvage cohort), and 5 patients had no disease at baseline assessment (adjuvant cohort). In the 15 patients, the median follow-up duration was 10.2 months (range 2.0-23.5 months), median progression-free survival (PFS) was 3.9 months, and the median overall survival (OS) was not reached. Patients in the salvage cohort achieved a 30% complete response (CR) and a 50% overall response rate (ORR). In the adjuvant cohort, disease progression was reported in three patients and two patients did not relapse during study follow-up. When we compared survival outcomes of seven responders and eight non-responders, the PFS (P = 0.001) and OS (P = 0.014) of responders proved statistically superior to that of non-responders. Baltaleucel-T was well tolerated. We have performed a phase II clinical trial of autologous EBV-specific T cell treatment (baltaleucel-T) in R/R ENKTL. Autologous EBV-specific T cells were well tolerated and demonstrated single-agent activity in R/R ENTKL.

PMID:34304287 | DOI:10.1007/s00277-021-04558-0

Abdom Radiol (NY). 2021 Jul 25. doi: 10.1007/s00261-021-03225-2. Online ahead of print.

ABSTRACT

PURPOSE: To assess chronic liver disease (CLD) using multiparametric US in a private practice setting in a cohort of patients with increased skin-to-liver distance.

METHODS: 110 consecutive patients with increased skin-to-liver distance scheduled for US assessment of CLD were reviewed for study completion time, liver stiffness values (LS), attenuation imaging, and shear wave dispersion slope. The ROI was placed 2 cm below the liver capsule. The study included patients with NAFLD/NASH (68), hepatitis C (30), prior Fontan surgery (1), elevated liver function tests (5), alcohol abuse (3), hepatitis B (2), and primary biliary cirrhosis (1). IQR/M values were obtained. Comparison of less experienced sonographers (LES) and more experienced sonographers (MES) were evaluated through Student’s t test for independent data. Pearson coefficient r of correlation among quantitative variables was calculated.

RESULTS: The mean time to perform the exam was 129.7 ± 62.1 s. There was a statistically significant difference between LES and MES. The mean IQR/M for LS was 12.3 ± 5.5% m/s. Overall, in a cohort of difficult patients, 4.5% of LS values were not reliable. Fat quantification using attenuation imaging had a mean value of 0.60 ± 0.15 dB/cm/MHz (range 0.35-0.98 cm/dB/MHz) with an IQR/M of 14.7 ± 9.2%. Less reliable measurements of steatosis were obtained in 4.5% of patients. The mean shear wave dispersion slope was 12.74 ± 4.05 (m/s)/kHz (range 7.7-27.5 (m/s)/kHz) with an IQR/M of 38.7 ± 20.2% (range 3-131%). 20.9% of patients had values suggestive of compensated advanced chronic liver disease (cACLD).

CONCLUSION: Multiparametric US can provide assessment of CLD in less than 3 min in most patients and identify patients at risk for cACLD.

PMID:34304291 | DOI:10.1007/s00261-021-03225-2

Anal Bioanal Chem. 2021 Jul 25. doi: 10.1007/s00216-021-03536-9. Online ahead of print.

ABSTRACT

Immuno-mass spectrometry imaging (iMSI) uses laser ablation-inductively coupled plasma-mass spectrometry (LA-ICP-MS) to determine the spatial expression of biomolecules in tissue sections following immunolabelling with antibodies conjugated to a metal reporter. As with all immunolabelling techniques, the binding efficiency of multiplexed staining can be affected by a number of factors including epitope blocking and other forms of steric hindrance. To date, the effects on the binding of metal-conjugated antibodies to their epitopes in a multiplexed analysis have yet to be quantitatively explored by iMSI. Here we describe a protocol to investigate the effects of multiplexing on reproducible binding using the muscle proteins, dystrophin, sarcospan, and myosin as a model, with antibodies conjugated with Maxpar® reagents before histological application to murine quadriceps sections using standard immunolabelling protocols and imaging with LA-ICP-MS. The antibodies were each individually applied to eight sections, and multiplexed to another eight sections. The average concentrations of the lanthanide analytes were determined, before statistical analyses found there was no significant difference between the individual and multiplexed application of the antibodies. These analyses provide a framework for ensuring reproducibility of antibody binding during multiplexed iMSI, which will allow quantitative exploration of protein-protein interactions and provide a greater understanding of fundamental biological processes during healthy and diseased states.

PMID:34304281 | DOI:10.1007/s00216-021-03536-9

Rom J Intern Med. 2021 Jul 23. doi: 10.2478/rjim-2021-0028. Online ahead of print.

ABSTRACT

INTRODUCTION: Thyroid hormones affect the cardiovascular system, but the precise mechanisms of their effects on the development of atherosclerosis are not entirely clear. The relationship between subclinical hypothyroidism, dyslipidemia and carotid atherosclerosis has been widely investigated, but the findings were controversial. The aim of the present study was to determine whether female subjects with subclinical hypothyroidism (SHypo) have increased carotid intima-media thickness (IMT) compared with euthyroid subjects, as well as to examine the association of SHypo, carotid atherosclerosis and dyslipidemia.

METHODS: This research included 100 women aged 30 to 70 years who were divided into two groups: the SHypo group including subjects with signs of subclinical hypothyroidism and the control group of euthyroid subjects. Carotid IMT thickness using B mode ultrasound was determined and its correlation with serum concentrations of fT4, TSH, CRP, and lipid profile including small dense LDL (sdLDL) was analysed.

RESULTS: Subjects with SHypo had significantly increased carotid IMT (IMT ≥ 75th centile) in all three measured segments of the right (p <0.001) and the left (p = 0.001) carotid artery compared to the control group, with a significantly more frequent appearance of plaque (25% vs. 9%; p = 0.05). Significant positive correlations were found between higher TSH and higher IMT values. Increased age, LDL cholesterol, and TSH predicted thickening of the carotid artery IMT.

CONCLUSIONS: It is important to screen people showing early, subclinical signs of thyroid gland dysfunction due to its impact on carotid atherosclerosis development.

PMID:34303321 | DOI:10.2478/rjim-2021-0028

Eur J Dent. 2021 Jul 24. doi: 10.1055/s-0041-1729454. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to evaluate the cleaning efficacy of irrigant activation with a new ultrasonic tip in root-end preparations and to determine its influence on the bond strength of calcium silicate-based material.

MATERIALS AND METHODS: Maxillary canines were prepared and filled, and their root ends resected. Root-end cavities were ultrasonically prepared and randomly distributed into four groups according to the final irrigation protocols: G1 (ultrasonic irrigation [UI] + saline solution [SS]), G2 (syringe irrigation [SI] + SS), G3 (UI + ethylenediaminetetraacetic acid [EDTA]), and G4 (SI + EDTA). Cleaning efficacy analysis employed 72 specimens (n = 18) split longitudinally for imaging of the same areas by scanning electron microscopy (SEM). The percentage of dentinal tubules opened before and after irrigation was used as evaluation parameter. Push-out testing employed 40 specimens (n = 10) sectioned apical region perpendicularly, which slice was placed on a testing machine for the bond strength measurement and failure mode was assessed by SEM. The data were statistically analyzed (α ≤ 0.05).

RESULTS: G3 (UI + EDTA) removed the smear layer more effectively, showed the best tubule opening (p < 0.05), and presented the highest mean bond strength values (p < 0.05). Failure modes were predominantly adhesive, except for the G3 (UI + EDTA) group, in which they were mainly mixed (80%).

CONCLUSION: The results of this study suggest that EDTA 17% agitation promoted better cleaning and smear layer removal, improving the push-out bond strength of calcium silicate material in retrograde obturation.

PMID:34303319 | DOI:10.1055/s-0041-1729454

Horm Mol Biol Clin Investig. 2021 Jul 26. doi: 10.1515/hmbci-2021-0012. Online ahead of print.

ABSTRACT

OBJECTIVES: As a systemic inflammatory disease, rheumatoid arthritis (RA) is the most common inflammatory arthritis in the population and there is no specific diagnostic marker in laboratory tests. The purpose of the study was to determine whether serum neopterin and pentraxin 3 (PTX3) levels may be a marker of increased inflammation in RA patients.

MATERIALS AND METHODS: The study were consist of 30 RA patients and 30 healthy controls who were admitted to the department of rheumatology. Blood specimens were taken from both group, and the levels of neopterin were analyzed by chromatography method (HPLC) and the PTX 3 levels were measured by enzyme-linked immunosorbent assay (ELISA). All data and demographic characteristics of participants were also recorded.

RESULTS: Serum neopterin and PTX 3 levels of the patient group (25.99 ± 7.24 ng/mL and 4.19 ± 1.01 ng/dL, respectively) was higher than the control group (9.55 ± 0.74 ng/mL and 2.23 ± 0.39 ng/dL, respectively). These results were remarkable significant (p<0.01). No statistically significant correlation was found between age-PTX 3, age-neopterin and PTX 3-neopterin parameters in the patient group. In the control group, a significant negative correlation was found between age and PTX 3 (p<0.05), and a positive correlation between neopterin and PTX 3.

CONCLUSIONS: Consequently, the serum neopterin and PTX 3 levels were higher in RA patients as compared to the healthy individuals. Our study suggest that there is a relation between neopterin and PTX 3 levels with RA patients. These findings suggest that neopterin and PTX 3 are important markers in the monitoring of RA disease.

PMID:34303320 | DOI:10.1515/hmbci-2021-0012

Eur J Dent. 2021 Jul 24. doi: 10.1055/s-0041-1729458. Online ahead of print.

ABSTRACT

OBJECTIVE: The study aimed to evaluate the influence of smoking habit on the prevalence of dental caries lesions in a follow-up study.

MATERIALS AND METHODS: A total of 3,675 patients (2,186 females and 1,489 males) with an average age of 51.4 years were included. Outcome measures were the incidence of dental caries defined as incipient noncavitated, microcavitated, or cavitated lesions which had been diagnosed through clinical observation with mouth mirror and probe examination evaluating change of texture, translucency, and color; radiographic examination through bitewing radiographs; or secondary caries through placement of a new restoration during the follow-up of the study.

STATISTICAL ANALYSIS: Cumulative survival (time elapsed with absence of dental caries) was estimated through the Kaplan-Meier product limit estimator with comparison of survival curves (log-rank test). A multivariable Cox proportional hazards regression model was used to evaluate the effect of smoking on the incidence of dental caries lesions when controlled to age, gender, systemic status, frequency of dental hygiene appointments, and socioeconomic status. The significance level was set at 5%.

RESULTS: Eight hundred sixty-three patients developed caries (23.5% incidence rate). The cumulative survival estimation was 81.8% and 48% survival rate for nonsmokers and smokers, respectively (p < 0.001), with an average of 13.5 months between the healthy and diseased state diagnosis. Smokers registered a hazard ratio for dental caries lesions of 1.32 (p = 0.001) when controlled for the other variables of interest.

CONCLUSION: Within the limitations of this study, it was concluded that smoking habit might be a predictor for dental caries.

PMID:34303317 | DOI:10.1055/s-0041-1729458

Eur J Dent. 2021 Jul 24. doi: 10.1055/s-0041-1726670. Online ahead of print.

ABSTRACT

OBJECTIVES: The aims of the study were to assess smile attractiveness of a collection of 68 smiling photographs of successfully treated cases submitted to the American Board of Orthodontics (ABO) clinical examination and identify variables that influence the assessment.

MATERIALS AND METHODS: A panel of 81 non-Caucasian assessors from various clinical disciplines were instructed to score the smile attractiveness on a visual analog scale from 1 (least attractive) to 10 (most attractive) and to select which components contributed to a lesser attractive smile. The mean, standard deviations (SDs), and quartiles of the smile attractiveness were obtained with descriptive statistics. Multilinear regression analysis was performed to investigate the scores of the perceived quality of smile attractiveness when the clinical disciplines and gender of the assessors were the factors taken into consideration. Receiver operating characteristic (ROC) curve was generated to establish the relationship between smile attractiveness and the achievement of a perfect smile.

RESULTS: The mean (SD) rating of each clinical photograph of the anterior occlusion on smiling ranged from 3.11 (1.47) as the least attractive smile to 7.59 (1.45) as the most attractive smile. The overall mean (SD) score for smile attractiveness was 5.30 (1.10). Problems associated with teeth, gingiva, and lips corresponded with a reduction of the smile attractiveness score by 1.56, 1.82, and 1.47, respectively. Gender was not associated with smile attractiveness ratings. Orthodontists, periodontists, and prosthodontists demonstrated no difference in the ratings, while plastic surgeons were more critical than orthodontists regarding smile attractiveness.

CONCLUSIONS: The study suggested that only 2 out of 68 AOB validated treatment finishes had a perfect and attractive smile.

PMID:34303318 | DOI:10.1055/s-0041-1726670

J Aging Phys Act. 2021 Jul 24:1-9. doi: 10.1123/japa.2020-0299. Online ahead of print.

ABSTRACT

This study examined the relationship between walking and cognitive function among Chicago Health and Aging Project participants. Data collection occurred during six 3-year cycles, of which Cycles 4-6 were used for this specific analysis. Information was obtained regarding walking frequency and duration, demographics, chronic conditions, cognitive activities, apolipoprotein E4, physical function, and cognitive function (global and domains). A composite walking measure was developed and categorized as follows: no walking, ≤105 min/week, and >105 min/week. Mixed-effects regression analyses tested associations between walking and global cognitive function, episodic memory, and perceptual speed. The sample consisted of 4,320 participants (African American/Black: 65%; female: 65%; mean education: 13 years; mean age: 75 years). Composite or total walking had a statistically significant association with global cognitive function and perceptual speed, after adjustments were made.

PMID:34303310 | DOI:10.1123/japa.2020-0299

J Sport Rehabil. 2021 Jul 24:1-6. doi: 10.1123/jsr.2020-0549. Online ahead of print.

ABSTRACT

CONTEXT: Knowledge on how to utilize a kinetic chain approach in foot and ankle rehabilitation is important.

OBJECTIVE: The aim of this study was to investigate the immediate effects of hip-focused neuromuscular exercise on foot pronation and single-leg neuromuscular control.

DESIGN: Cross-over study.

SETTING: University laboratory.

PARTICIPANTS: This cross-over study included 44 asymptomatic volunteers with foot pronation.

INTERVENTIONS: All participants performed (1) a hip-focused neuromuscular exercise and (2) a sham exercise in randomized order.

MAIN OUTCOME MEASURES: Foot pronation was assessed by the navicular drop test, and lower-extremity neuromuscular control was assessed by the Modified Star Excursion Balance Test and frontal plane projection angle during single-leg squat before and after the experiments.

RESULTS: Navicular drop test scores were significantly lower after the hip-focused neuromuscular exercise than after the sham exercise (mean difference [95% CI] = 2.84 [-1.08 to 6.77], P = .003). Modified Star Excursion Balance Test scores in the anterior (P = .008), posteromedial (P = .04), and posterolateral (P < .001) directions were significantly increased after hip-focused neuromuscular exercise. No statistically significant condition × time interaction was found for the frontal plane projection angle (P > .05). However, a main effect of time (P = .003) indicated that less dynamic knee valgus occurred during single-leg squat after both experiments.

CONCLUSIONS: Hip-focused neuromuscular exercise produced immediate alterations in foot pronation and dynamic balance. Thus, the hip-focused neuromuscular exercise may be used to control foot posture in foot rehabilitation integrated with a kinetic chain approach and could be an effective prevention and treatment strategy.

PMID:34303314 | DOI:10.1123/jsr.2020-0549