Tag: nevin manimala

Epilepsia Open. 2022 Jul 31. doi: 10.1002/epi4.12635. Online ahead of print.

ABSTRACT

OBJECTIVE: Eslicarbazepine acetate (ESL) is a once-daily (QD), oral anti-seizure medication for the treatment of focal (partial-onset) seizures. Here, we evaluate risk factors for the development of psychiatric treatment-emergent adverse events (TEAEs) in clinical trials of adjunctive ESL in adults with focal seizures.

METHODS: This post-hoc analysis evaluated data pooled from three Phase III, randomized, double-blind, placebo-controlled trials (BIA-2093-301, -302, -304). After an 8-week baseline period, patients were randomized equally to receive placebo, ESL 400 mg (not reported here), 800 mg, or 1200 mg QD (up to 2-week titration; 12-week maintenance; optional open-label extension [OLE]). Incidences of psychiatric TEAEs were evaluated according to three separate criteria: medical history of psychiatric disorders (yes/no); baseline use of psychotropic drugs (yes/no); Montgomery-Åsberg Depression Rating Scale (MADRS) score at baseline (0-6: normal; 7-19: mild depression; 20-34: moderate depression).

RESULTS: The analysis populations comprised 1251 patients for the controlled study period and 1137 patients for the 1-year OLE. Psychiatric TEAE incidence was similar between patients taking ESL and placebo in the controlled and OLE study periods and was not related to ESL dose. Psychiatric TEAEs generally occurred more frequently in patients with a medical history of psychiatric disorders, using psychotropic drugs, or with depressive symptoms than in those without a history, not using psychotropic drugs, or with no depressive symptoms. Depression and anxiety were the most frequently reported psychiatric TEAEs.

SIGNIFICANCE: Overall, in clinical trials of ESL in adults with focal seizures, incidences of psychiatric events were not statistically different between patients taking ESL and placebo, were not related to ESL dose, and generally occurred more frequently in patients with baseline psychiatric symptoms or a history of psychiatric disorders. Long-term exposure to ESL was not associated with a marked increase in the incidence of psychiatric TEAEs.

PMID:35908275 | DOI:10.1002/epi4.12635

J Biophotonics. 2022 Jul 31:e202200121. doi: 10.1002/jbio.202200121. Online ahead of print.

ABSTRACT

High-dose-rate-brachytherapy (HDR-BT) is an increasingly attractive alternative to external beam radiation-therapy for patients with intermediate risk prostate cancer. Despite this, no bio-marker based method currently exists to monitor treatment response, and the changes which take place at the biochemical level in hypo-fractionated HDR-BT remain poorly understood. The aim of this pilot study is to assess the capability of Raman spectroscopy (RS) combined with principal component analysis (PCA) and random-forest classification (RF) to identify radiation response profiles after a single dose of 13.5 Gy in a cohort of 9 patients. We here demonstrate, as a proof-of-concept, how RS-PCA-RF could be utilised as an effective tool in radiation response monitoring, specifically assessing the importance of low variance PCs in complex sample sets. As RS provides information on the biochemical composition of tissue samples, this technique could provide insight into the changes which take place on the biochemical level, as result of HDR-BT treatment. This article is protected by copyright. All rights reserved.

PMID:35908273 | DOI:10.1002/jbio.202200121

Int J Clin Oncol. 2022 Jul 31. doi: 10.1007/s10147-022-02209-6. Online ahead of print.

ABSTRACT

BACKGROUND: The treatment strategies for colorectal cancer (CRC) must ensure a radical cure of cancer and prevent over/under treatment. Biopsy specimens used for the definitive diagnosis of T1 CRC were analyzed using artificial intelligence (AI) to construct a risk index for lymph node metastasis.

METHODS: A total of 146 T1 CRC cases were analyzed. The specimens for analysis were mainly biopsy specimens, and in the absence of biopsy specimens, the mucosal layer of the surgical specimens was analyzed. The pathology slides for each case were digitally imaged, and the morphological features of cancer cell nuclei were extracted from the tissue images. First, statistical methods were used to analyze how well these features could predict lymph node metastasis risk. A lymph node metastasis risk model using AI was created based on these morphological features, and accuracy in test cases was verified.

RESULTS: Each developed model could predict lymph node metastasis risk with a > 90% accuracy in each region of interest of the training cases. Lymph node metastasis risk was predicted with 81.8-86.3% accuracy for randomly validated cases, using a learning model with biopsy data. Moreover, no case with lymph node metastasis or lymph node risk was judged to have no risk using the same model.

CONCLUSIONS: AI models suggest an association between biopsy specimens and lymph node metastases in T1 CRC and may contribute to increased accuracy of preoperative diagnosis.

PMID:35908272 | DOI:10.1007/s10147-022-02209-6

Int Ophthalmol. 2022 Jul 31. doi: 10.1007/s10792-022-02444-w. Online ahead of print.

ABSTRACT

PURPOSE: To compare the difference and agreement of axial length (AL) and anterior segment parameters obtained from the MYAH device with Pentacam AXL and IOLMaster 700 in myopic children.

METHODS: The study included 60 eyes of 60 myopic children. AL, keratometry (K), and horizontal corneal diameter (CD) were measured with Pentacam AXL, IOLMaster 700, and MYAH, respectively. The Friedman test was used to assess the differences. The Intraclass Correlation Coefficient (ICC) and Bland-Altman plots were used to assess the consistency of measurements.

RESULTS: The mean age was 10.2 ± 1.8 years (7-16 years). No statistically significant difference was determined between the Pentacam AXL, IOLMaster 700, and MYAH devices in terms of mean AL values (23.61 ± 1.42, 23.62 ± 1.45, 23.61 ± 1.42, respectively) (p = 0.06). The difference between devices in the mean steep K, flat K, mean K, and CD was statistically significant but clinically insignificant (steep K; 44.45 ± 1.25, 44.59 ± 1.23, 44.51 ± 1.24, flat K; 43.29 ± 1.28, 43.43 ± 1.29, 43.35 ± 1.30, mean K; 43.85 ± 1.21, 44.00 ± 1.19, 43.94 ± 1.20, and CD; 11.90 ± 0.34, 12.11 ± 0.38, 11.96 ± 0.31, respectively; p < 0.05). ICC and Bland-Altman plot analysis revealed a high correlation between the three devices in AL, steep K, flat K, mean K, and CD measurements.

CONCLUSION: There was a quite good agreement between the MYAH, Pentacam AXL, and IOLMaster 700 devices regarding AL and anterior segment parameters. MYAH provides reliable measurements and will be a good option in the diagnosis of and follow-up with myopic children.

PMID:35908260 | DOI:10.1007/s10792-022-02444-w

Community Ment Health J. 2022 Jul 31. doi: 10.1007/s10597-022-01010-z. Online ahead of print.

ABSTRACT

This study evaluated level of service need before and after a short-term community mental health case management intervention from the perspective of both clients and case managers. Ontario Common Assessment of Need data were used to describe client needs. McNemar’s test was applied to assess differences in pre- and post- need scores. Psychological distress, company, daytime activities, and physical health were most commonly rated by clients as unmet needs at enrolment. At discharge, there was a significant change in psychological distress from the perspective of clients, and in psychological distress and daytime activities from the perspective of case managers. Statistically significant changes were observed for Total Need, Total Unmet Need and Met Need scores from the perspective of case managers. While both clients and case managers reported changes in total service needs between admission and discharge from short-term case management, clients were less likely to report a difference in needs.

PMID:35908257 | DOI:10.1007/s10597-022-01010-z

Hepatology. 2022 Jul 31. doi: 10.1002/hep.32692. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The sensitivity of current surveillance methods for detecting early-stage hepatocellular carcinoma (HCC) is suboptimal. Extracellular vesicles (EVs) are promising circulating biomarkers for early cancer detection. In this study, we aim to develop an HCC EV-based surface protein assay for early detection of HCC.

APPROACH AND RESULTS: Tissue microarray was used to evaluate four potential HCC-associated protein markers. An HCC EV Surface Protein Assay, comprised of covalent chemistry-mediated HCC EV purification and real-time immuno-PCR readouts, was developed and optimized for quantifying subpopulations of EVs. An HCC EV ECG score, calculated from the readouts of three HCC EV subpopulations (EpCAM⁺ CD63⁺ , CD147⁺ CD63⁺ , and GPC3⁺ CD63⁺ HCC EVs), was established for detecting early-stage HCC. A phase 2 biomarker study was conducted to evaluate the performance of ECG score in a training cohort (n=106) and an independent validation cohort (n=72). Overall, 99.7% of tissue microarray stained positive for at least one of the four HCC-associated protein markers (EpCAM, CD147, GPC3, and ASGPR1), which were subsequently validated in HCC EVs. In the training cohort, HCC EV ECG score demonstrated an area under the receiver operating curve (AUROC) of 0.95 (95% CI=0.90-0.99) for distinguishing early-stage HCC from cirrhosis with a sensitivity of 91% and a specificity of 90%. The AUROCs of HCC EV ECG score remained excellent in the validation cohort (0.93, 95% CI=0.87-0.99), and the subgroups by etiology (viral: 0.95, 95% CI=0.90-1.00; nonviral: 0.94, 95% CI=0.88-0.99).

CONCLUSION: HCC EV ECG score demonstrated great potential for detecting early-stage HCC. It could augment current surveillance methods and improve patients’ outcomes.

PMID:35908246 | DOI:10.1002/hep.32692

J Clin Endocrinol Metab. 2022 Jul 31:dgac461. doi: 10.1210/clinem/dgac461. Online ahead of print.

ABSTRACT

CONTEXT: Predicting the onset of menopause is important for family planning and to ensure prompt intervention in women at risk of developing menopause-related diseases.

OBJECTIVE: To summarize risk prediction models of natural menopause onset and their performance.

DATA SOURCES AND STUDY SELECTION: Five bibliographic databases were searched up to March 2022. We included prospective studies on perimenopausal women or women in menopausal transition, that reported either the univariable or multivariable model for risk prediction of natural menopause onset.

DATA EXTRACTION: Two authors independently extracted data according to the CHARMS (critical appraisal and data extraction for systematic reviews of prediction modelling studies) checklist. Risk of bias was assessed using PROBAST (prediction model risk of bias assessment tool).

DATA SYNTHESIS: Of 8’132 references identified, we included 14 articles based on 8 unique studies comprising 9’588 women (mainly Caucasian) and 3’289 natural menopause events. All the included studies used onset of natural menopause (ONM) as outcome, while four studies predicted early ONM as well. Overall, there were 180 risk prediction models investigated, with age, anti-Müllerian hormone (AMH) and follicle-stimulating hormone (FSH) being the most investigated predictors. Estimated C-statistic for the prediction models ranged from 0.62 to 0.95. Although all studies were rated at high risk of bias mainly due to the methodological concerns related to the statistical analysis, their applicability was satisfactory.

CONCLUSION: Predictive performance and generalizability of current prediction models on ONM is limited given that these models were generated from studies at high risk of bias and from specific populations/ethnicities. Although in certain settings such models may be useful, efforts to improve their performance are needed as use becomes more widespread.

PMID:35908226 | DOI:10.1210/clinem/dgac461

Eur J Clin Invest. 2022 Jul 31:e13852. doi: 10.1111/eci.13852. Online ahead of print.

ABSTRACT

BACKGROUND: Snoring and impaired glucose metabolism are common clinical manifestations and associated. The purpose of our study is to estimate the causal associations between snoring and glycemic traits.

METHODS: We compared the weighted mean differences (WMD) for fasting insulin (FINS), glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG) and 2h-glucose post-challenge (2hGlu) levels between snorers and non-snorers by meta-analysis. Then, we obtained summary statistics from published GWAS of snoring and glycemic traits to perform bidirectional two-sample MR. Inverse variance weighting (IVW) method was applied as major estimate while MR Egger, Weighted median and MR-Robust Adjusted Profile Score (RAPS) played a subsidiary role.

RESULTS: Snoring participants had higher FBG (WMD=0.14mmol/L, 95%CI=[0.10,0.19]), HbA1c (WMD=0.10%, 95%CI=[0.07,0.13]), FINS (WMD=0.92μIU/mL, 95%CI=[0.59,1.26]) and 2hGlu (WMD=0.30mmol/L, 95%CI=[0.06,0.55]) levels than non-snorers. Further, elevated FINS levels shown robust causal effect on snoring (IVW: OR=1.07, 95%CI=[1.02,1.12], p=2.2×10^-3 ), which was consistent by complementary methods of MR Egger (OR=1.14, 95%CI=[1.01-1.30], p=4.72×10^-2 ), Weighted median (OR=1.11, 95%CI=[1.07,1.15], p=1.53×10^-7 ) and MR RAPS (OR=1.07, 95% CI=[1.05,1.10], p=2.81×10^-9 ). Such causal situation was stable after identifying and removing the outliers in sensitivity analysis. However, there was no causality of snoring on increasing FINS levels. Additionally, there were no causal associations between snoring and other three traits of FBG, HbA1c and 2hGlu levels from either direction.

CONCLUSIONS: Snorers are subjected to higher FBG, HbA1c, FINS and 2hGlu levels, and elevated FINS levels further provides robust causality on snoring, suggesting that behind common snoring may lie hyperinsulinemia or insulin resistance.

PMID:35908195 | DOI:10.1111/eci.13852

Anat Histol Embryol. 2022 Jul 30. doi: 10.1111/ahe.12840. Online ahead of print.

ABSTRACT

The caudal colliculus serves as an integrative station and switchboard, controlling nucleus of lower auditory pathway and motor-auditory reflex production. The rostral colliculus coordinates reflexive movement of the head, neck, eye and focus the lens for visual tracking of objects. There is no information comparing mesencephalic tectum among neonates, juveniles and adults of African giant rat (AGR). Hence, this study aimed to compare the gross features and morphometric parameters of mesencephalic tectum postnatally in AGR. The following were found and reported: (a) Paired dorsal tips of caudal colliculi were observed through transverse fissure of the intact brain and so, corpora quadrigemina were partly occluded by cerebral cortex in neonates and juveniles. (b) The lateral and medial geniculate bodies were visible, though the lateral was grossly bigger than the medial in adults and juveniles but, only the lateral was distinguishable in neonates. (c) Live body weight, absolute brain weight, caudal colliculus width, nose-rump and tail lengths increased as AGRs developed with age; mean values of rostral colliculus weight, caudal colliculus height and weight of caudal colliculus in neonates and juveniles were statistically same; while midbrain weight and rostral colliculus height tends to decrease as rats aged. (d) The mean weight of caudal colliculi and width of rostral colliculi were not affected by age. (e) Caudal colliculi were grossly wider than rostral in juveniles and adults, but not neonates. Established regression formulae are necessary to avoid future sacrifice of this rodent.

PMID:35908185 | DOI:10.1111/ahe.12840

Aesthet Surg J. 2022 Jul 31:sjac211. doi: 10.1093/asj/sjac211. Online ahead of print.

ABSTRACT

BACKGROUND: Supratip depression is a common complication after preservation rhinoplasty.

OBJECTIVES: This paper presents a simple surgical maneuver to prevent supratip depression.

METHODS: Thirty-six patients who underwent closed-approach low-septal-resection dorsal preservation rhinoplasty between January and June 2021 were included in this retrospective study. Depending on the operation performed on Pitanguy’s midline ligament, the patients were divided into two main groups as follows: (1) a group in which Pitanguy’s midline ligament was transected (the transection group), and (2) a group in which Pitanguy’s midline ligament was preserved (the preservation group). Standardized postoperative 6-month lateral-view photographs were scanned for the presence of supratip depression or pollybeak deformity. The Rhinoplasty Outcome Evaluation (ROE) scale was applied at 6 months.

RESULTS: Supratip depression was observed in four patients in the preservation group (n = 16), and it was not observed in any of the patients in the transection group (n = 20; p < 0.05). There was no pollybeak deformity in either group. For the ROE scores and number of satisfied patients, no statistically significant difference was found between the groups with Pitanguy’s midline ligament transected versus preserved (p > 0.05).

CONCLUSIONS: Transecting Pitanguy’s midline ligament reduces the likelihood of supratip depression and does not affect the likelihood of pollybeak deformity in closed-approach low-septal-resection dorsal preservation rhinoplasty.

PMID:35908175 | DOI:10.1093/asj/sjac211