Category: Statistics

Pharm Dev Technol. 2021 Oct 7:1-33. doi: 10.1080/10837450.2021.1990946. Online ahead of print.

ABSTRACT

It is widely accepted that the use of topical sunscreens has medical importance with potential to prevent skin damage by protecting from solar ultraviolet radiation (UVR) effects. Pharmaceutical emulsions require an optimal qualitative and quantitative combination of emollients, emulsifiers and others compounds such as softening agents and, for sunscreens, a combination of chemical and physical UV filters. Herein, we applied the quality by design (QbD) concept to achieve stable and effective compounded sunscreen emulsions. By using the statistical tool of design of experiments, it was possible to identify the influence of emulsifier type (with low and high Hydrophile-Lipophile Balance) and concentrations of emollient and softening agent on the achievement of formulations with suitable organoleptic and physicochemical features. Compounded emulsions with pleasant macroscopic aspects were obtained. Three formulations with physicochemical properties in targeted ranges were selected, namely pH ∼6.0, conductivity >0.0 µS/cm², spreadability factor ∼1-1.5 g/mm², viscosity ∼12000 mPa.s and sunscreen protection factor ∼30. Freeze-thaw cycle and accelerated stability study under different storage conditions allowed selecting a stable emulsion that ensured photoprotection in biological assays. The QbD approach was essential to select the best, low-cost compounded sunscreen emulsion, with targeted physicochemical parameters.

PMID:34617471 | DOI:10.1080/10837450.2021.1990946

Biotechniques. 2021 Oct 7. doi: 10.2144/btn-2021-0034. Online ahead of print.

ABSTRACT

We designed and validated a test system that simulates a growth environment for Zea mays L. maize seedlings under conditions of low moisture gradient in darkness. This system allowed us to simultaneously measure mesocotyl elongation and the primary root hydrotropic response in seedlings before the emergence phase in a collection of maize hybrids. We found great variation in these two traits with statistically significant reduction of their elongations under the low moisture gradient condition that indicate the richness of maize genetic diversity. Hence, the objective of designing a new test system that evaluates the association between these underground traits with the potential use to measure other traits in maize seedlings related to early vigor was achieved.

PMID:34617460 | DOI:10.2144/btn-2021-0034

Sci Rep. 2021 Oct 6;11(1):19853. doi: 10.1038/s41598-021-99310-z.

ABSTRACT

Cognitive decline in early-stage Alzheimer’s disease (AD) may depend on genetic variability. In the Swedish BioFINDER study, we used polygenic scores (PGS) (for AD, intelligence, and educational attainment) to predict longitudinal cognitive change (measured by mini-mental state examination (MMSE) [primary outcome] and other cognitive tests) over a mean of 4.2 years. We included 260 β-amyloid (Aβ) negative cognitively unimpaired (CU) individuals, 121 Aβ-positive CU (preclinical AD), 50 Aβ-negative mild cognitive impairment (MCI) patients, and 127 Aβ-positive MCI patients (prodromal AD). Statistical significance was determined at Bonferroni corrected p value < 0.05. The PGS for intelligence (beta = 0.1, p = 2.9e-02) was protective against decline in MMSE in CU and MCI participants regardless of Aβ status. The polygenic risk score for AD (beta = – 0.12, p = 9.4e-03) was correlated with the rate of change in MMSE and was partially mediated by Aβ-pathology (mediation effect 20%). There was no effect of education PGS on cognitive measures. Genetic variants associated with intelligence mitigate cognitive decline independent of Aβ-pathology, while effects of genetic variants associated with AD are partly mediated by Aβ-pathology.

PMID:34615922 | DOI:10.1038/s41598-021-99310-z

Transl Psychiatry. 2021 Oct 6;11(1):510. doi: 10.1038/s41398-021-01636-9.

ABSTRACT

Randomized controlled trials (RCTs) have been considered as gold standard for establishing the efficacy and safety of investigational new drugs; nonetheless, the generalizability of their findings has been questioned. To address this issue, an increasing number of naturalistic studies and real-world database analyses have been conducted. The question of how much information from these two approaches is congruent or discrepant with each other is of great importance for the clinical practice. To answer this question, we focused on data from the antipsychotic (AP) treatment of schizophrenia. Our aim was two-fold: to conduct a meta-analysis of real-world studies (RWS), and to compare the results of RWS meta-analysis with previously published meta-analyses of RCTs. The principal measure of effectiveness was all-cause treatment discontinuation for both RWS and RCTs (when not available, then drop out for RCTs). We included publications for 8 selected APs (oral formulations of amisulpride, aripiprazole, clozapine, haloperidol, olanzapine, quetiapine, risperidone, and long-acting injectable (LAI) risperidone). We identified 11 RWS and 7 RCT meta-analyses for inclusion. Our results indicated that the RWS yielded statistically conclusive and consistent findings across individual investigations. For the overwhelming majority of the comparisons where both RWS and RCT meta-analyses were available, there was good congruency between the RWS and the RCT results. Our results support that RCTs, despite their limitations, provide evidence which is generalizable to real-world settings. This is an important finding for both regulators and clinicians. RWS can provide guidance for situations where no evidence is available from double-blind clinical trials.

PMID:34615850 | DOI:10.1038/s41398-021-01636-9

Sci Rep. 2021 Oct 6;11(1):19859. doi: 10.1038/s41598-021-99132-z.

ABSTRACT

Non-alcoholic fatty liver disease (NAFLD) is one of the most common causes of cardiometabolic diseases in overweight individuals. While liver biopsy is the current gold standard to diagnose NAFLD and magnetic resonance imaging (MRI) is a non-invasive alternative still under clinical trials, the former is invasive and the latter costly. We demonstrate electrical impedance tomography (EIT) as a portable method for detecting fatty infiltrate. We enrolled 19 overweight subjects to undergo liver MRI scans, followed by EIT measurements. The MRI images provided the a priori knowledge of the liver boundary conditions for EIT reconstruction, and the multi-echo MRI data quantified liver proton-density fat fraction (PDFF%) to validate fat infiltrate. Using the EIT electrode belts, we circumferentially injected pairwise current to the upper abdomen, followed by acquiring the resulting surface-voltage to reconstruct the liver conductivity. Pearson’s correlation analyses compared EIT conductivity or MRI PDFF with body mass index, age, waist circumference, height, and weight variables. We reveal that the correlation between liver EIT conductivity or MRI PDFF with demographics is statistically insignificant, whereas liver EIT conductivity is inversely correlated with MRI PDFF (R = -0.69, p = 0.003, n = 16). As a pilot study, EIT conductivity provides a portable method for operator-independent and cost-effective detection of hepatic steatosis.

PMID:34615918 | DOI:10.1038/s41598-021-99132-z

J Oleo Sci. 2021;70(10):1403-1416. doi: 10.5650/jos.ess21149.

ABSTRACT

The present study was aimed to prepare and evaluated solid lipid nanoparticles (SLNs) of olive leaves extract powder (OLP) which contained many anti-oxidant and antimicrobial agents like oleuropein, a natural polyphenol. The major issue concern OLP was the instability due to environmental conditions and hence compromised bioactivity. To overcome this problem, SLNs were designed by hot homogenous followed by sonication technique to protect the drug and improve its antioxidant and antimicrobial activity. Lipids like compritol 888ATO and surfactant like tween 80 were used for the development and stabilization of SLNS and optimization was done by Box-Behnken statistical design (3×3). The optimized batch (F9) showed particle size, entrapment efficiency, PDI, and zeta potential 277.46 nm, 80.48%, 0.275, and －23.18 mV respectively. Optimized formulation (F9) exhibited a sustained release pattern up to 24 h with first-order release kinetic (R² = 0.9984) and the mechanism of drug release was found to be Fickian diffusion type (n = 0.441). Upon the stability study, it could be found that SLNs formulation was stable. Anti-oxidation and anti-microbial studies were conducted on optimized formulation and findings suggested that SLNs showed an improved radical scavenging activity and anti-microbial activity against Gram-positive (Staphylococcus aureus) and Gram-negative (Pseudomonas aeruginosa) bacteria. Finally, it was concluded that developed SLNs were able to protect and suitable for the delivery of OLP.

PMID:34615828 | DOI:10.5650/jos.ess21149

J Prosthodont Res. 2021 Oct 6. doi: 10.2186/jpr.JPR_D_21_00081. Online ahead of print.

ABSTRACT

PURPOSE: The purpose of this systematic review was to evaluate the survival rate, biological complications, technical complications, and clinical behavior of single crowns supported by teeth made up in monolithic zirconia with CAD/CAM technology.

STUDY SELECTION: An extensive electronic search was conducted through Medline/PubMed, Embase, and Cochrane Library databases. Additional manual search was performed on the references of included articles to identify relevant publications. Two reviewers independently performed the selection and electronic and manual search.

RESULTS: From nine articles included, there was a total of 594 participants and 1657 single-tooth restorations with a mean exposure time of 1.07 years, and follow-up period between 0.3 and 2.1 years. All studies showed a moderate level of quality, with a consequent moderate possibility of associated bias, using the Newcastle-Ottawa Scale (NOS), with survival rate (SR) ranging between 91% to 100%. Bleeding on probing (BOP) were reported with an average value of 29.12%. Marginal integrity showed high success rate values for the observation periods, except for one that included patients with bruxism which obtained a SR of 31.60%. Failures and/or fractures, mostly total and requiring replacement, were observed in three studies. Linear regression showed that there was no statistical correlation between survival rate and type of cementation and the average years of follow-up (p=0.730 e p=0.454). There was high heterogeneity between studies (I2 = 93.74% and Q = 79.672).

CONCLUSIONS: Within the limitation of this study, monolithic zirconia might be considered as a possible option for restoring single crowns, especially in the posterior zone.

PMID:34615842 | DOI:10.2186/jpr.JPR_D_21_00081

J Contemp Dent Pract. 2021 Jul 1;22(7):829-832.

ABSTRACT

AIM: The aim of the present study was to compare the capacity of three dissimilar commercially accessible desensitizing products for the occlusion of dentinal tubules using a scanning electron microscope (SEM).

MATERIALS AND METHODS: The nondiseased human mandibular premolar teeth, ninety in number, were amassed for this study. The blocks subsequently made were subjected to polishing using abrasive paper to facilitate dentinal surface exposure. The samples were randomly allocated to one of the following three groups: Group I, samples to be treated with Admira Protect; Group II, samples to be treated with MI paste, Group III, samples to be treated with Remin Pro. Photomicrograph of every sample was taken to evaluate the occlusion of the dentin tubule under 2000× magnification of the SEM.

RESULTS: MI paste exhibited the greatest dentin tubular occlusion with a value of 2.746 ± 0.530 followed by Admira Protect (3.498 ± 0.202) and Remin Pro (4.594 ± 0.364) in that order. Amid the various desensitizing materials used, statistically significant differences (p <0.001) were noted.

CONCLUSION: Within the confines of the limitations of the present research, following a comparative assessment of the three desensitizing materials used, it can be concluded that all of them were efficient in sealing off the dentin tubules in spite of differing chemical constitutions and techniques of application. When compared with the agents, Admira Protect and Remin Pro, MI paste exhibited the maximum occluding capacity of the dentinal tubules.

CLINICAL SIGNIFICANCE: A short, sharp shooting pain characterizes the frequent problem of dentin hypersensitivity (DH). Sealing off the open dentin tubules, thereby reducing dentinal permeability, is a known method in the treatment of DH. As several agents exist to reduce DH, the best commercially marketed product for decreasing this condition by occluding the tubules should be identified by the clinicians.

PMID:34615790

J Contemp Dent Pract. 2021 Jul 1;22(7):850-853.

ABSTRACT

AIM AND OBJECTIVE: The aim of this study was to determine the clinical utility of body mass index (BMI), tonsil size, and Mallampati scoring in predicting both the presence of and severity of pediatric obstructive sleep apnea (OSA).

MATERIALS AND METHODS: This prospective cross-sectional study comprised 78 growing children in the age range of 11-14 years with polysomnography (PSG)-proven OSA and 86 non-OSA corresponding controls. BMI, tonsil size (Friedman grading scale), and Mallampati score were determined for both groups, and related differences were assessed with a t-test, while their independent association with OSA severity was tested with a regression analysis. Statistical significance was set at p <0.05.

RESULTS: Male gender, BMI, tonsil size, and Mallampati score were significantly higher in the OSA group (p < 0.05). A significant correlation was recorded between the Mallampati score and OSA severity (p < 0.01), but not with BMI or tonsil size (p > 0.05). For every 1-point increase in the Mallampati scale, the apnea-hypopnea index (AHI) increased by more than five events per hour in the bivariate analysis and by more than three events per hour in the multivariate analysis.

CONCLUSION: Male gender, increased BMI, high tonsil, and Mallampati scores were clinical indicators of the presence of OSA. However, only Mallampati scale had a significant association with OSA severity. Clinical diagnostic indicators should be established and encouraged especially in community-based studies.

CLINICAL SIGNIFICANCE: Clinical diagnostic indicators are very useful in examining and screening children who are at risk of developing OSA as PSG is expensive and unsuitable for universal use in the pediatric population.

PMID:34615793

J Contemp Dent Pract. 2021 Jul 1;22(7):793-798.

ABSTRACT

AIM AND OBJECTIVE: The aim of the present study was to perform quantitative and mathematical analysis of mental foramen (MF) along with its correlation with study subject’s sex and age using three-dimensional imaging like cone-beam computed tomography (CBCT).

MATERIALS AND METHODS: The CBCT scan images stored in the database were used in this study. Two-hundred sixty-seven scans were selected. They were divided into four different age-groups. These age-groups were 16-23 years, 24-38 years, 39-55 years, and more than 56 years. Each age-group was further divided into two subgroups. One subgroup was of males, while the other subgroup was of females. Following this, there was evaluation of all CBCT-scanned images considering certain parameters like position of MF, size of MF, distance X, distance Y, and distance Z.

RESULTS: The MF was located generally apically to the premolar and molar. It was more commonly located between the first premolar and second premolar among females, while in males, it was mostly located along the long axis of the second premolar. In most of the age-groups, the MF was located between the long axis of the first premolar and second premolar. The average distance of MF from the apex of first premolar was 5.01 mm. Further, the average size of MF and its distance from the base of the mandible were greater in males as compared with females. When all these measurements were compared in different age-groups, the difference was not statistically significant.

CONCLUSION: The average distance of MF from the apex of the first premolar was 5.01 mm. The average size of MF and its distance from the base of the mandible were greater in males as compared with females. When the measurements were compared in different age-groups, then the difference was not statistically significant.

CLINICAL SIGNIFICANCE: MF is an important structure in the mandible because it acts as an important landmark in the anesthetic procedure; therefore, there was a need to carry out detailed quantitative and mathematical analysis for MF.

PMID:34615786