Category: Nevin Manimala

Acta Oncol. 2022 Aug 1:1-7. doi: 10.1080/0284186X.2022.2103387. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to investigate phase IV efficacy, of the PD-1 inhibitor nivolumab among an unselected and unbiased national cohort of recurrent/metastatic Head and Neck Squamous Cell Carcinoma (rmHNSCC) patients.

MATERIAL AND METHODS: Inclusion criteria included histologically confirmed rmHNSCC and nivolumab as a second-line palliative treatment. Data were collected from patient files at the five Danish head and neck cancer centers and from the DAHANCA database. The iRECIST criteria were used for treatment evaluation.Endpoints were response rate (RR), overall survival (OS), and progression-free survival (PFS), calculated from the start of treatment to the date of event/censoring by the KM-method. Descriptive statistics were used to describe patients and treatment. Analyses were two-sided, with p < .05 considered significant.

RESULTS: A total of 146 patients were identified in the period 2017-2020. They had a RR of 14%, median OS of 10.2 months [95% CI: 8.2-12.2] and median PFS of 3.1 months [95% CI: 2.3-4.2]. Patient age (≥ 70 years) or comorbidity did not significantly affect outcome. WHO performance status (PS) =1 was associated with an increased risk of death (HR: 2.1 [95% CI: 1.2-4.0], p = .02) and progression (HR: 1.9 [95% CI: 1.2-3.2], p = .01). Concomitant glucocorticoid-treatment during immunotherapy (≥ 50% of treatment time) appeared important for risk of death (HR: 6.4 [95% CI: 2.3-17.8], p < .001) and risk of progression (HR: 4.8 [95% CI: 1.8-12.5], p = .001). PD-L1 expression ≥ 20% was associated with a lowered risk of progression (HR: 0.5 [95% CI: 0.3-0.7], p = .001), but not lowered risk of death.

CONCLUSION: In this unselected national cohort, outcome of second-line treatment reflects data from the registration studies. Furthermore, the results suggest that immunotherapy should be used with great care in treatment of rmHNSCC in patients with poor performance.

PMID:35913523 | DOI:10.1080/0284186X.2022.2103387

Minerva Pediatr (Torino). 2022 Aug 1. doi: 10.23736/S2724-5276.22.06968-3. Online ahead of print.

ABSTRACT

INTRODUCTION: Breastfeeding is considered the gold standard for infants’ nutrition and provides unique benefits for infants’ health.

EVIDENCE ACQUISITION: Great research interest has been raised about the use of bioactive components in neonatal medicine, both as standalone products and as addition to infant formula, in the attempt to reproduce human milk beneficial effects. Thus, the aim of this narrative review is to summarize most recent evidence on biotics’ use in the neonatal period, with a focus on infant formula (IF) supplemented with probiotics, prebiotics, synbiotics and postbiotics.

EVIDENCE SYNTHESIS: Growing data indicate overall positive effects of biotic supplemented formula on microbiome composition and metabolic activity. Furthermore, some benefits are also emerging from randomized controlled trials (RCTs) evaluating the clinical impact these enriched formulas may have on the health of formula fed infants. However, clear evidence still lacks and none of this supplemented IF has demonstrated conclusive superiority.

CONCLUSIONS: To date, whereas no routine recommendations can be done, biotics supplemented IF have generally proven to be well-tolerated and safe in ensuring infants’ normal growth, paving the way for future IF alternatives for those infants who are not able to be (fully) breastfed. More RCTs, with adequate design and statistical power, are still needed to better clarify, if present, which benefits the supplementation of IF may confer to infants’ short and long-term outcomes.

PMID:35912792 | DOI:10.23736/S2724-5276.22.06968-3

Work. 2022 Jul 24. doi: 10.3233/WOR-211054. Online ahead of print.

ABSTRACT

BACKGROUND: Otorhinolaryngology practitioners are known to be susceptible to work-related musculoskeletal disorders (WMSDs), but the incidence of WMSDs in Saudi Arabia has not been documented.

OBJECTIVES: This study aimed to establish the prevalence, characteristics, contributing factors, work sector, and impact of WMSDs among otorhinolaryngology practitioners in Saudi Arabia.

METHODS: A cross-sectional survey was conducted on 104 otorhinolaryngology practitioners in Saudi Arabia using a six-component questionnaire. Descriptive statistics, prevalence, percentages, and chi-square tests were used for data analysis.

RESULTS: The response rate was 65.3% . The reported 12-month incidence of WMSDs was 72.7% . The neck region (67.3%) was the most common site of disorders, followed by the shoulder (49%). The elbow and hip (10.5%) regions were the least commonly affected regions. WMSD prevalence was related to gender, with men more affected than women (neck, shoulders, low back); age, with younger otorhinolaryngology practitioners more affected than older ones (neck, shoulder); work sector, with greater prevalence in government than other sectors (neck); and sub-specialty, with general otolaryngology reporting the highest WMSD frequency, followed by otology and neurotology (neck, shoulder, low back, upper back, knees). Most otorhinolaryngology practitioners experienced two to four episodes of neck, shoulder, and low-back WMSDs. The most significant risk factor for WMSDs was sustained posture for long periods of time (61.5%). The most common strategy implemented against WMSDs was modifying the practitioner’s position during treatment (58.6%).

CONCLUSIONS: WMSDs among otorhinolaryngology practitioners in Saudi Arabia are very common, with the neck and shoulders regions most often involved. Improved professional skills and an understanding of the principles of ergonomics can prevent the initial development of WMSDs in otorhinolaryngology practitioners.

PMID:35912780 | DOI:10.3233/WOR-211054

J Alzheimers Dis. 2022 Jul 26. doi: 10.3233/JAD-220246. Online ahead of print.

ABSTRACT

BACKGROUND: Aging is a risk factor for several pathologies as Alzheimer’s disease (AD). Great interest exists, therefore, in discovering diagnostic biomarkers and indicators discriminating biological aging and health status. To this aim, omic investigations of biological matrices, as saliva, whose sampling is easy and non-invasive, offer great potential.

OBJECTIVE: Investigate the salivary proteome through a statistical comparison of the proteomic data by several approaches to highlight quali-/quantitative variations associated specifically either to aging or to AD occurrence, and, thus, able to classify the subjects.

METHODS: Salivary proteomic data of healthy controls under-70 (adults) and over-70 (elderly) years old, and over-70 AD patients, obtained by liquid chromatography/mass spectrometry, were analyzed by multiple Mann-Whitney test, Kendall correlation, and Random-Forest (RF) analysis.

RESULTS: Almost all the investigated proteins/peptides significantly decreased in relation to aging in elderly subjects, with or without AD, in comparison with adults. AD subjects exhibited the highest levels of α-defensins, thymosin β4, cystatin B, S100A8 and A9. Correlation tests also highlighted age/disease associated differences. RF analysis individuated quali-/quantitative variations in 20 components, as oxidized S100A8 and S100A9, α-defensin 3, P-B peptide, able to classify with great accuracy the subjects into the three groups.

CONCLUSION: The findings demonstrated a strong change of the salivary protein profile in relation to the aging. Potential biomarkers candidates of AD were individuated in peptides/proteins involved in antimicrobial defense, innate immune system, inflammation, and in oxidative stress. RF analysis revealed the feasibility of the salivary proteome to discriminate groups of subjects based on age and health status.

PMID:35912740 | DOI:10.3233/JAD-220246

Hum Antibodies. 2022 Jul 19. doi: 10.3233/HAB-220010. Online ahead of print.

ABSTRACT

BACKGROUND: Thyroglobulin (anti-TG) and/or thyroid peroxidase (anti-TPO) autoantibodies are associated with higher rates of poor gestational outcomes.

OBJECTIVE: To demonstrate the impact of anti-TPO and anti-TG autoantibodies on the gestational outcomes of euthyroid pregnant women with a history of poor gestational outcome and thyroid gland disorders.

METHODS: This retrospective study included totally 75 euthyroid pregnant, 30 of women with high thyroid autoantibodies (Anti-TPO/Thyroglobulin-positive group) and 45 of them without autoantibodies (control group).

RESULTS: We could not demonstrate significant differences between two groups in terms of risk factors/co-morbidities, obstetric complications, gestational outcomes, and birth data (p> 0.05). However, enhanced miscarriage rates were observed among the Anti-TPO/Thyroglobulin-positive and control groups without significance (36.7% and 17.8% respectively, p= 0.116). High neonatal intensive care unit (NICU) admission rates were found for control and Anti-TPO/Thyroglobulin-positive groups (16.2% and 21.1%, respectively) (p= 0.720). Clinically, we compared the two groups in terms of the existence and the types of goiter (diffuse and nodular), and demonstrated that nodular goiter was statistically more frequent in the control group (40.0% vs. 8.7%, p= 0.015). Alongside, relatively high hereditary thrombophilia and type-2 diabetes mellitus rates were found in the Anti-TPO/Thyroglobulin-positive group (20.0% and 20.0%).

CONCLUSION: Thyroid autoantibody positivity is likely a risk factor for early pregnancy loss and NICU admission.

PMID:35912736 | DOI:10.3233/HAB-220010

Clin Hemorheol Microcirc. 2022 Jul 28. doi: 10.3233/CH-221554. Online ahead of print.

ABSTRACT

BACKGROUND & OBJECTIVE: To quantify the hemodynamic and thrombotic effect of COVID-19 on the eye microcirculation of patients with thromboprophylaxis, shortly after hospital discharge.

METHODS: This case-control study included 17 COVID-19 survivors (named “COVID-19 Group”) and 17 healthy volunteers (named “Control Group”). Axial blood velocity (Vax) and percentage of occluded vessels (POV) were quantified by Conjunctival Video Capillaroscopy (CVC). Microvessels were identified and classified as “capillaries” (CAP), “postcapillary venules of size 1” (PC1), and “postcapillary venules of size 2” (PC2).

RESULTS: The COVID-19 Group did not differ significantly in basic demographics from the Control Group. In the COVID-19 Group, there was a statistically significant (p < 0.001) reduction of Vax (39%, 49% and 47%, for CAP, PC1, and PC2, respectively) in comparison to the Control Group and a sizeable (p < 0.001) increase of POV (600%) in comparison to the Control Group.

CONCLUSIONS: COVID-19 not only reduces significantly axial blood velocity in the capillaries and postcapillary venules of the eye but has also a devastating effect on microthrombosis (POV) despite thromboprophylaxis treatment. This gives a possible explanation for long COVID and a hint about the existence of a possibly unknown coagulation factor.

PMID:35912735 | DOI:10.3233/CH-221554

Acta Ophthalmol. 2022 Aug 1. doi: 10.1111/aos.15219. Online ahead of print.

ABSTRACT

PURPOSE: To identify correlations between the vascular characteristics of macular neovascularization (MNV) obtained by optical coherence tomography angiography (OCTA) and distinct retinal fluid volumes in neovascular age-related macular degeneration (nAMD).

METHODS: In this prospective interventional study, 54 patients with treatment-naïve type 1 or 2 nAMD were included and treated with intravitreal aflibercept. At baseline and month 1, each patient underwent a SD-OCT volume scan and volumetric flow scan using a swept-source OCTA. A deep learning algorithm was used to automatically detect and quantify fluid in OCT scans. Angio Tool, a National Cancer Institute algorithm, was used to skeletonize MNV properties and quantify lesion size (LS), vessel area (VA), vessel density (VD), total number of endpoints (TNE), total number of junctions (TNJ), junction density (JD), total vessel length (TVL), average vessel length (AVL) and mean-e-lacunarity (MEL). Subsequently, linear regression models were used to investigate a correlation between OCTA parameters and fluid quantifications.

RESULTS: The median amount of fluid within the central 6-mm EDTRS ring was 173.7 nl at baseline, consisting of 156.6 nl of subretinal fluid (SRF) and 2.3 nl of intraretinal fluid (IRF). Fluid decreased significantly in all compartments to 1.76 nl (SRF) and 0.64 nl (IRF). The investigated MNV parameters did not change significantly after the first treatment. There was no significant correlation between MNV parameters and relative fluid decrease after anti-VEGF treatment. Baseline fluid correlated statistically significant but weakly with TNE (p = 0.002, R² = 0.17), SRF with TVL (p = 0.04, R² = 0.08), VD (p = 0.046, R² = 0.08), TNE (p = 0.001, R² = 0.20) and LS (p = 0.033, R² = 0.09). IRF correlated with VA (p = 0.042, R² = 0.08).The amount of IRF at month 1 correlated significantly but weakly with VD (p = 0.036, R² = 0.08), JD (p = 0.019, R² = 0.10) and MEL (p = 0.005, R² = 0.14).

CONCLUSION: Macular neovascularization parameters at baseline and month 1 played only a minor role in the exudation process in nAMD. None of the MNV parameters were correlated with the treatment response.

PMID:35912717 | DOI:10.1111/aos.15219

J Clin Sleep Med. 2022 Aug 1. doi: 10.5664/jcsm.10158. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Transgender or gender nonconforming (TGNC) identity is associated with higher burden of sleep disorders relative to cisgender identity. However, the role of gender-affirming therapy (GAT) in sleep disorders is poorly understood. This study examined relationships between TGNC identity, transition, and sleep disorders among TGNC and cisgender youth.

METHODS: This retrospective cross-sectional study utilized a large US-based administrative claims database (de-identified Optum Clinformatics Data Mart Database) to identify youth aged 12-25 years who obtained a diagnosis of TGNC identity and those who pursued GAT. Descriptive statistics estimated distributions of demographic and health characteristics by gender identity. Unadjusted and age-adjusted logistic regression models were used to examine associations between TGNC identity, GAT, and sleep disorders.

RESULTS: This study included 1,216,044 youth, of which 2,603 (0.2%) were identified as TGNC. Among the 1,387 TGNC who pursued GAT, 868 and 519 were identified as transmasculine and transfeminine, respectively. Adjusted analysis showed increased odds of insomnia (OR=5.4, 95% CI 4.7, 6.2), sleep apnea (OR=3.0, 95% CI 2.3, 4.0), and other sleep disorders (OR=3.1, 95% CI 2.5, 3.9) in TGNC relative to cisgender youth. Decreased odds of any sleep disorder were observed in the TGNC youth on GAT (OR=0.5, 95% CI 0.4, 0.7) relative to those not on GAT.

CONCLUSIONS: This study demonstrated a high burden of sleep disorders in TGNC youth in comparison to cisgender. However, GAT may confer a protective effect on sleep disorders among TGNC youth. Longitudinal assessments of sleep disorders prior to and post-GAT are needed to uncover their temporal relationships.

PMID:35912700 | DOI:10.5664/jcsm.10158

J Clin Sleep Med. 2022 Aug 1. doi: 10.5664/jcsm.10152. Online ahead of print.

ABSTRACT

STUDY OBJECTIVES: Initial reports of intravenous (IV) iron administration have been promising for children with restless legs syndrome (RLS), periodic limb movement disorder (PLMD), and restless sleep disorder (RSD). The aim of the current study was to further evaluate the clinical response to IV iron supplementation in children seen in a pediatric sleep clinic.

METHODS: We performed a retrospective chart review of children cared for in a single pediatric sleep clinic who also underwent IV iron infusion. Pre and post IV data regarding their sleep symptoms and ferritin levels were abstracted.

RESULTS: Overall, 63 pediatric sleep patients underwent IV iron infusion, mostly with ferric carboxymaltose (n=60), for RLS (n=30), PLMD (n=22), and RSD (n=17) Of the 59 patients with clinical follow-up, 39 (73%) noted improvement in at least one symptom, and 14 (26%) did not notice improvement or noticed worsening symptoms. Of the 59 patients with pre- and post-infusion labs, the average ferritin level increased from 21.7 (13.3) to 147.9 (120.9), p<0.001. Comparing patients who experienced clinical improvement versus those who did not, there were no statistically significant differences in change in ferritin levels (p=0.278), sex (p=0.452), or age (p=0.391). Ferritin change with infusion according to diagnostic subgroups (RLS/PLMD/RSD) was examined, and no significant differences were noted (F(2,56)=0.852, p=0.432). In terms of immediate adverse reactions to the IV infusion, 7 (11%) experienced at least 1 side effect, with the most common being behavior change (n=6) or gastrointestinal discomfort (n=4); no episodes of anaphylaxis or extravasation were noted.

CONCLUSIONS: These data provide additional support for the efficacy and safety of IV iron for pediatric RLS, PLMD, and RSD recalcitrant to oral iron.

PMID:35912699 | DOI:10.5664/jcsm.10152

Palliat Support Care. 2022 Aug 1:1-7. doi: 10.1017/S1478951522000992. Online ahead of print.

ABSTRACT

OBJECTIVES: Final conversations (FCs) go beyond how patients want to be cared for at the end of life (EOL) and focus on messages of love, identity specific, and unique to an individual and relationship that requires self-examination, everyday talk that normalizes a difficult situation, religious/spiritual messages, and if needed, difficult relationship talk to heal broken relationships. The purpose of the Catalyzing Relationships at the End of Life (CAREol) program was to provide interdisciplinary education to nursing and medical students and clinical faculty about facilitating FCs among patients and families.

METHOD: This two-part, quasi-experimental program consisted of a cognitive (online) and experiential (live simulation) curriculum experience. Program curriculum, including video vignettes, readings, and live simulation (utilizing actors), was developed by the study team. Reflective journaling and researcher designed pre- and post-tests were used to assess comfort, confidence, importance, and distress regarding FCs and collaboration with other disciplines.

RESULTS: The pre-/post-test questions demonstrate statistical significance based on a paired t-test with effect sizes supporting the practical importance of the findings for effect size. Preliminary content and thematic analysis of qualitative responses describe categories of the mock team meeting experience and interaction with the actors to change patient and family outcomes.

SIGNIFICANCE OF RESULTS: Early intervention with the CAREol program provides a framework to help students and clinical faculty facilitate FCs that may result in peace and comfort for patients and families during a difficult time.

PMID:35912673 | DOI:10.1017/S1478951522000992