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Nevin Manimala Statistics

Indocyanine green in diagnostics and reconstructive surgery for breast cancer

Khirurgiia (Mosk). 2023;(9. Vyp. 2):20-24. doi: 10.17116/hirurgia202309220.

ABSTRACT

OBJECTIVE: To analyze the efficacy of sentinel lymph node detection using indocyanine green (ICG) in breast cancer.

MATERIAL AND METHODS: The study included 153 breast cancer patients (stage 0-I-II-III, cN0 or cN1-ycN0) between October 2022 and April 2023. All patients underwent sentinel lymph node biopsy using ICG.

RESULTS: Sentinel lymph node was successfully detected in 150 cases out of 153 ICG injections. Optimal period between ICG injection and its accumulation in regional lymph nodes was 10-12 min. Sensitivity of sentinel lymph node detection was 98.0% that exceeds the approximate value of radioisotope method adopted as a standard (96.9-97.2%), as well as sensitivity of proprietary blue dye (90.6-95.0%). Specificity of this method was 100%.

CONCLUSION: The authors’ experience regarding application of indocyanine green is consistent with numerous world statistics and proves the possibility of its effective use for sentinel lymph node biopsy. It is necessary to introduce this diagnostic method as a leading or alternative method for analysis of sentinel lymph node in national clinical guidelines.

PMID:37682543 | DOI:10.17116/hirurgia202309220

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Nevin Manimala Statistics

Establishing Normative Values for Healthy Term Infant Feeding Performance: Neonatal Eating Assessment Tool-Mixed, Oral Feeding Scale, and Early Feeding Skills Assessment

Am J Speech Lang Pathol. 2023 Sep 8:1-10. doi: 10.1044/2023_AJSLP-22-00372. Online ahead of print.

ABSTRACT

PURPOSE: Infants with perceived feeding problems are frequently referred for assessment of their feeding abilities. However, little is known regarding how healthy nondysphagic infants perform on commonly used assessments, making determination of impairment difficult. The aim of this investigation was to elucidate the characteristics of healthy term infant feeding performance using three commonly employed clinical assessments: Neonatal Eating Assessment Tool-Mixed (NeoEat-Mixed), Oral Feeding Scale, and Early Feeding Skills (EFS).

METHOD: In this prospective case-control study, we recruited 30 infants without feeding impairments to undergo video-monitored bottle feeds under their normal feeding conditions. Caregiver perception of infant feeding was evaluated using the NeoEat-Mixed. Milk ingestion was monitored real time using the Oral Feeding Scale for rate of milk transfer and modified proficiency as characterized by the total volume consumed out of the total volume the caregiver provided. Videos were analyzed by two speech pathologists using the EFS assessment. Descriptive statistics were used to characterize performance.

RESULTS: Participants underwent feeding monitoring at an average chronological age of 4 ± 2 months. Caregivers primarily reported normal, nonconcerning feeding patterns across all of the NeoEAT-Mixed outcomes. Infants consumed milk at an average rate of transfer of 7 ± 3 ml/min, a modified proficiency of 50 ± 21%, and achieved the highest OFS score of 4 (93%, n = 28). The majority of infants scored the best EFS score (mature-3) as it related to the absence of color changes during the feed (97%, n = 29), although commonly scored in the worst EFS score (immature-1) in their presentation of one or more compelling stress cues (63%, n = 19).

CONCLUSION: Establishing healthy term infant normative values for commonly used feeding assessments is critical in accurately distinguishing infants with feeding impairments from those with normal developmental variants.

PMID:37682537 | DOI:10.1044/2023_AJSLP-22-00372

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Nevin Manimala Statistics

Kalium 3.0 is a comprehensive depository of natural, artificial, and labeled polypeptides acting on potassium channels

Protein Sci. 2023 Sep 8:e4776. doi: 10.1002/pro.4776. Online ahead of print.

ABSTRACT

Here, we introduce the third release of Kalium database (http://kaliumdb.org/), a manually curated comprehensive depository that accumulates data on polypeptide ligands of potassium channels. The major goal of this amplitudinous update is to summarize findings for natural polypeptide ligands of K+ channels, as well as data for the artificial derivatives of these substances obtained over the decades of exploration. We manually analyzed more than 700 original manuscripts and systematized the information on mutagenesis, production of radio- and fluorescently labeled derivatives, and the molecular pharmacology of K+ channel ligands. In result, data on more than 1200 substances were processed and added enriching the database content fivefold. We also included the electrophysiological data obtained on the understudied and neglected K+ channels including the heteromeric and concatenated channels. We associated target channels in Kalium with corresponding entries in the official database of the International Union of Basic and Clinical Pharmacology (IUPHAR). Kalium was supplemented with an adaptive Statistics page, where users are able to obtain actual data output. Several other improvements were introduced, such as a color code to distinguish the range of ligand activity concentrations and advanced tools for filtration and sorting. Kalium is a fully open-access database, crosslinked to other databases of interest. It can be utilized as a convenient resource containing ample up-to-date information about polypeptide ligands of K+ channels. This article is protected by copyright. All rights reserved.

PMID:37682529 | DOI:10.1002/pro.4776

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Nevin Manimala Statistics

Workforce affiliation in primary and secondary prevention Implantable Cardioverter Defibrillator patients – a nationwide Danish study

Eur Heart J Qual Care Clin Outcomes. 2023 Sep 8:qcad054. doi: 10.1093/ehjqcco/qcad054. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: There are a paucity of studies investigating workforce affiliation in connection with first-time ICD-implantation. This study explored workforce affiliation and risk markers associated with not returning to work in patients with ICDs.

METHODS: Using the nationwide Danish registers, patients with a first-time ICD-implantation between 2007-2017 and of working age (30-65 years) were identified. Descriptive statistic and logistic regression models were used to describe workforce affiliation and to estimate risk markers associated with not returning to work, respectively. All analyses were stratified by indication for implantation (primary and secondary prevention).

RESULTS: Of the 4,659 ICD-patients of working age, 3,300 patients (71%) were members of the workforce (employed, on sick leave or unemployed) (primary: 1428 (43%); secondary:1872 (57%)). At baseline, 842 primary and 1477 secondary prevention ICD-patients were employed. Of those employed at baseline, 81% primary and 75% secondary prevention ICD-patients returned to work within one-year, whereof more than 80% remained employed the following year. Among patients receiving sick leave benefits at baseline, 25% were employed after one-year. Risk markers of not returning to work were ‘younger age’ in primary prevention ICD-patients, while ‘female sex’, ‘LVEF ≤40’, ‘lower income’ and ‘≥3 comorbidities’ were risk markers in secondary prevention ICD-patients. Lower educational level was a risk marker in both patient groups.

CONCLUSIONS: High return-to-work proportions following ICD-implantation, with a subsequent high level of employment maintenance were found. Several significant risk markers of not returning to work were identified including ‘lower educational level’, that posed a risk in both patient groups.Trial registration number: Capital Region of Denmark, P-2019-051.

PMID:37682525 | DOI:10.1093/ehjqcco/qcad054

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Nevin Manimala Statistics

Prevalence and influencing factors for artifact development in breast MRI-derived maximum intensity projections

Acta Radiol. 2023 Sep 8:2841851231198349. doi: 10.1177/02841851231198349. Online ahead of print.

ABSTRACT

BACKGROUND: Magnetic resonance imaging (MRI) provides high diagnostic sensitivity for breast cancer. However, MRI artifacts may impede the diagnostic assessment. This is particularly important when evaluating maximum intensity projections (MIPs), such as in abbreviated MRI (AB-MRI) protocols, because high image quality is desired as a result of fewer sequences being available to compensate for problems.

PURPOSE: To describe the prevalence of artifacts on dynamic contrast enhanced (DCE) MRI-derived MIPs and to investigate potentially associated attributes.

MATERIAL AND METHODS: For this institutional review board approved retrospective analysis, MIPs were generated from subtraction series and cropped to represent the left and right breasts as regions of interest. These images were labeled by three independent raters regarding the presence of MRI artifacts. MRI artifact prevalence and associations with patient characteristics and technical attributes were analyzed using descriptive statistics and generalized linear models (GLMMs).

RESULTS: The study included 2524 examinations from 1794 patients (median age 50 years), performed on 1.5 and 3.0 Tesla MRI systems. Overall inter-rater agreement was kappa = 0.54. Prevalence of significant unilateral artifacts was 29.2% (736/2524), whereas bilateral artifacts were present in 37.8% (953/2524) of all examinations. According to the GLMM, artifacts were significantly positive associated with age (odds ratio [OR] = 1.52) and magnetic field strength (OR = 1.55), whereas a negative effect could be shown for body mass index (OR = 0.95).

CONCLUSION: MRI artifacts on DCE subtraction MIPs of the breast, as used in AB-MRI, are a relevant topic. Our results show that, besides the magnetic field strength, further associated attributes are patient age and body mass index, which can provide possible targets for artifact reduction.

PMID:37682521 | DOI:10.1177/02841851231198349

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Nevin Manimala Statistics

The role of upper airway and facial skeleton anatomy in the evolution of obstructive sleep apnea: an 8-year follow-up

Sleep Breath. 2023 Sep 8. doi: 10.1007/s11325-023-02907-z. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the role of anatomic alterations of the upper airway and facial skeleton in the evolution of obstructive sleep apnea (OSA) in a prospective population-based study with an 8-year follow-up.

METHODS: This was a population-based, longitudinal, prospective study, which took place from 2007 to 2015 at the Instituto do Sono, Sao Paulo, Brazil. In 2007, type I polysomnography (PSG), otorhinolaryngological examination, and collection of anthropometric measurements of all volunteers were performed. Volunteers were classified according to their anatomical features of the upper airway and facial skeleton. After 8 years, volunteers were invited for reevaluation. The relationship between anatomical characteristics and polysomnographic evolution was evaluated.

RESULTS: The study included 554 patients. After 8 years of follow-up, there was an increase in neck circumference and body mass index of the participants. There was a worsening in all polysomnographic parameters analyzed, with an increase in the apnea-hypopnea index, a decrease in minimum saturation values, and an increase in the percentage of sleep time with peripheral oxyhemoglobin saturation <90%. There was no statistical relationship between the anatomical findings considered unfavorable and the worsening of polysomnographic parameters.

CONCLUSIONS: In a sample of the general population, after 8 years, we did not find any relationship between upper airway and facial skeleton characteristics and the progression of OSA.

PMID:37682494 | DOI:10.1007/s11325-023-02907-z

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Nevin Manimala Statistics

Immunoprecipitation-Mass Spectrometry (IP-MS) of Protein-Protein Interactions of Nuclear-Localized Plant Proteins

Methods Mol Biol. 2023;2698:163-181. doi: 10.1007/978-1-0716-3354-0_11.

ABSTRACT

Transcription factors that act within a gene regulatory network (GRN) often interact with other proteins such as chromatin remodeling factors, histone modifiers, and other co-regulators. Characterizing these interactions is crucial for understanding the function and mechanism of action of a transcription factor. Here, a method for the identification of protein-protein interactions of nuclear-localized, transcription-associated factors is described. The method is based on the immunoprecipitation (IP) of a fluorophore-tagged target, followed by mass spectrometry (MS), peptide identification, and quantification of interacting proteins. By applying label-free quantification to IPs and their input protein extracts, statistically controlled protein enrichment ratios uncover high-confidence interaction partners of the target. A complete step-by-step procedure, including sample preparation, MS settings, data analysis, and visualization is provided.

PMID:37682475 | DOI:10.1007/978-1-0716-3354-0_11

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Nevin Manimala Statistics

Comparison of In Vitro Corneal Permeation and In Vivo Ocular Bioavailability in Rabbits of Three Marketed Latanoprost Formulations

Eur J Drug Metab Pharmacokinet. 2023 Sep 8. doi: 10.1007/s13318-023-00853-5. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: All latanoprost formulations currently available for the treatment of glaucoma or ocular hypertension contain the same concentration of latanoprost (0.005%) but differ in excipients, which may affect corneal drug permeability or stability. This study aimed at comparing corneal penetration of three marketed latanoprost solutions with different excipient formulations in in vitro and in vivo drug permeability studies.

METHODS: Three latanoprost formulations were tested under good laboratory practice conditions: a formulation containing benzalkonium chloride (BAK) but no surfactant (Preserved latanoprost); the same formulation except preservative-free (PF) without BAK or surfactant (SF) (PF SF latanoprost); and a different formulation without BAK but containing a non-ionic surfactant (MGHS 40 at 5%) combined with thickening agents (Carbomer 974P, Macrogol 4000) (PF latanoprost). Corneal permeation of latanoprost acid (LAT) was first determined in vitro using a reconstructed human corneal epithelium tissue. Then, in vivo pharmacokinetic studies were performed on pigmented rabbits, for which LAT concentration was measured in the aqueous humour (AH) and iris-ciliary body (ICB).

RESULTS: In vitro, the cumulative transport of LAT was linear between 1 h and 4 h for preserved latanoprost and PF SF latanoprost, and LAT concentrations matched exactly at each timepoint. By contrast, the permeation of PF latanoprost was linear between 2 h and 12 h and was significantly lower than that of preserved latanoprost and PF SF latanoprost at 4 and 8 h (p < 0.001). In rabbits, the concentrations of LAT in AH and ICB were not statistically different between preserved latanoprost and PF SF latanoprost at each timepoint, except at 1 h in ICB (p = 0.005). By comparison, the LAT concentration of PF latanoprost was statistically (p < 0.05) lower than that of preserved latanoprost and PF SF latanoprost in AH and ICB from 0.5 to 3 h.

CONCLUSION: BAK did not influence the corneal penetration of latanoprost in in vitro and in vivo studies. The formulation containing a non-ionic surfactant resulted in lower and slower ocular penetration compared with preserved or PF SF formulations. This raises questions about the relevance of BAK and some surfactants in enhancing corneal penetration of ocular formulations.

PMID:37682463 | DOI:10.1007/s13318-023-00853-5

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Nevin Manimala Statistics

Planning Benefit-Risk Assessments Using Visualizations

Ther Innov Regul Sci. 2023 Sep 8. doi: 10.1007/s43441-023-00563-9. Online ahead of print.

ABSTRACT

A Benefit Risk Assessment Plan (BRAP) describes the assessments planned to determine whether the benefits of an investigational drug outweigh the risks. The plan can have two sections, one with timelines for aligning resources with decision milestones and the other for pre-specifying assessments for decision milestones. Regulatory guidance recommends a proactive planning process over an ad-hoc process. However, very little has been published about proactive plans themselves. This article works through a hypothetical example visualizing a series of assessments across the drug development lifecycle. Based on a regulatory framework, the planning process starts with assessing the medical condition and current treatment options. These early assessments bring out major considerations in assessing the investigational drug.

PMID:37682462 | DOI:10.1007/s43441-023-00563-9

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Nevin Manimala Statistics

Diagnostic Utility of Parent Ratings on the Behavior Assessment System for Children-Third Edition in Children who are Deaf and Hard of Hearing and Diagnosed with Autism Spectrum Disorder

Res Child Adolesc Psychopathol. 2023 Sep 8. doi: 10.1007/s10802-023-01115-3. Online ahead of print.

ABSTRACT

Between 1 to 2 of every 1,000 children are born deaf or hard of hearing (DHH) and, of those, 30-50% have additional disabilities, including Autism Spectrum Disorder (ASD). Most measures assessing ASD characteristics rely on some degree of behavioral response to sound (e.g., responding to name, listening response), and may not be appropriate for use with children who are DHH. Further, ASD specific measures do not provide information on a child’s functional abilities across developmental domains. We conducted a cross-sectional analysis comparing mean T-scores on a standardized multidimensional measure, the Behavior Assessment System for Children, Third Edition, Parent Rating Scale (BASC-3 PRS), across three groups matched for age and sex: children who are DHH and diagnosed with ASD (DHH + ASD; n = 16); children who are DHH without ASD (DHH-ASD; n = 16); and children who are typically hearing with ASD (H + ASD; n = 16). Analyses revealed statistically significant differences across scales of Attention Problems, Atypicality, Withdrawal, Behavioral Symptoms Index, Social Skills, Leadership, Functional Communication, Activities of Daily Living, Adaptive Skills, Autism Probability Indices, and Developmental Social Disorders. Pairwise comparisons showed DHH + ASD and H + ASD mean T-scores were statistically similar and distinct from DHH-ASD mean T-scores on all these scales except for Withdrawal, Leadership, Functional Communication, and Activities of Daily Living, where pairwise comparisons varied. The findings add to the literature on ASD and DHH children and call for further exploration of the BASC-3 as a tool for both evaluation of ASD and the development of individualized treatment plans in this unique population.

PMID:37682456 | DOI:10.1007/s10802-023-01115-3