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Nevin Manimala Statistics

Real life data on nintedanib safety: idiopathic pulmonary fibrosis versus systemic sclerosis-interstitial lung disease and strategies adopted to manage adverse effects

Inflammopharmacology. 2023 Aug 3. doi: 10.1007/s10787-023-01286-x. Online ahead of print.

ABSTRACT

OBJECTIVE: Nintedanib (NIN) is an antifibrotic drug approved to slow the progression of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-related interstitial lung disease (SSc-ILD). NIN can frequently cause gastrointestinal adverse effects. We aimed to investigate the NIN safety profile in a real life setting, comparing IPF and SSc-ILD patients and evaluating the strategies adopted to manage NIN adverse effects.

METHODS: Patients taking NIN for IPF or SSc-ILD were enrolled. Alongside epidemiological and disease-specific data, the period of NIN use and the need for dosage reduction and/or interruption were investigated. Particular attention was paid to possible adverse effects and strategies adopted to manage them.

RESULTS: Twenty-seven SSc-ILD and 82 IPF patients were enrolled. No significant differences emerged between the two cohorts regarding the frequency of any possible adverse effect. Although the rates of NIN dosage reduction or interruption were similar between the two subgroups, SSc-ILD presented a mean period before NIN dosage reduction and NIN interruption significantly shorter than IPF (3 ± 2.6 vs 10.5 ± 8.9 months-p < 0.001 and 2.3 ± 0.5 vs 10.3 ± 9.9 months-p = 0.008, respectively). Several different strategies were tried to manage NIN adverse effects: especially in SSc-ILD, the variable combination of diet adjustment set by a nutritionist, probiotics and diosmectite was ultimately successful in maintaining patients on an adequate dose of NIN.

CONCLUSION: We presented data on the NIN safety profile in a real life setting, which was similar between SSc-ILD and IPF. A combination of multiple managing strategies and dose adjustment appears essential to cope optimally with NIN adverse effects.

PMID:37535212 | DOI:10.1007/s10787-023-01286-x

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Clinical therapeutic trials

Inflammopharmacology. 2023 Aug 3. doi: 10.1007/s10787-023-01303-z. Online ahead of print.

ABSTRACT

The term clinical trial implies an investigation of a therapeutic intervention in the pursuit of evidence of benefit, short or sustained, and observations on the possibility of toxicity related to the therapeutic intervention. It is possible that the first clinical trial took place in the court of the Babylonian King Nebuchadnezzar circa 600 BC, as recorded in Chapter 1 of the Book of Daniel, verse 3-20. However, it is in the last 500 years that there has been good written documentation at attempts to interpret therapeutic benefit from the use of treatments. Lind’s demonstration on the usefulness of oranges and lemons in the treatment of scurvy in 1747, and the unethical experiment by Edward Jenner (1749-1823) on the inoculation in 1796, of an 8-year-old boy, with cow pox obtained from a milk maid, followed by an attempt to give the young boy smallpox by direct inoculation 18 days later, are striking examples of clinical trials. Human ethics, strict clinical observations, statistics, the governed scientific purity of therapeutic agents, and safety testing of therapeutics, devices, and physical interventions, have created the basis for the modern clinical trial.

PMID:37535211 | DOI:10.1007/s10787-023-01303-z

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Probing real-world Central European population midfacial skeleton symmetry for maxillofacial surgery

Clin Oral Investig. 2023 Aug 3. doi: 10.1007/s00784-023-05185-x. Online ahead of print.

ABSTRACT

OBJECTIVES: Symmetry is essential for computer-aided surgical (CAS) procedures in oral and maxillofacial surgery (OMFS). A critical step for successful CAS is mirroring the unaffected side to create a template for the virtual reconstruction of the injured anatomical structure. The aim was to identify specific anatomical landmarks of the midfacial skeleton, to evaluate the symmetry in a group of the real-world Central European population, and to use these landmarks to assess midfacial symmetry in CT scans.

MATERIAL AND METHODS: The retrospective cross-sectional study defined landmarks of the midface’s bony contour using viscerocranial CT data. The distances of the skeletal landmarks (e.g., the frontozygomatic suture and temporozygomatic suture) of the left and right sides from the midline were measured and statistically compared. Midfacial symmetry for reference points was defined as a difference within 0 mm and their mean difference plus one standard deviation.

RESULTS: We examined a total of 101 CT scans. 75% of our population shows symmetrical proportions of the midface. The means of the differences for the left and right sides ranged from 0.8 to 1.3 mm, averaging 1.1 ± 0.2 mm for all skeletal landmarks. The standard deviations ranged from 0.6 to 1.4 mm, with a computed mean of 0.9 ± 0.3 mm.

CONCLUSION: We established a methodology to assess the symmetry of the bony midface. If the determined differences were equal to or lower than 2.5 mm in the mentioned midfacial skeletal landmarks, then the symmetry of the bony midface was considered present, and symmetry-based methods for CAS procedures are applicable.

CLINICAL RELEVANCE: Many CAS procedures require facial symmetry. We provide an easy-to-apply method to probe for symmetry of the midface. The method may be used for population-based research, to check for proper reduction of fractures after reposition or to screen for symmetry prior to CAS planning.

PMID:37535197 | DOI:10.1007/s00784-023-05185-x

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Ca 125 is an independent prognostic marker in resected pancreatic cancer of the head of the pancreas

Updates Surg. 2023 Aug 3. doi: 10.1007/s13304-023-01587-4. Online ahead of print.

ABSTRACT

The prognostic value of carbohydrate antigen 125 (Ca 125) is emerging also in pancreatic cancer (PDAC). In this study, we aim to define the prognostic value of Ca 125 in resected PDAC of the head of the pancreas. This is a single-center, retrospective study. Data from patients with a pre-operative assay of Ca 125 who underwent a pancreatic resection for PDAC between 2010 and 2018 were analyzed. As per National Comprehensive Cancer Guidelines, tumors were classified in resectable (R-PDAC), borderline resectable (BR-PDAC), and locally advanced (LA-PDAC). The Kaplan-Meier method was used to evaluate the overall survival. Cox proportional hazard regression was used to evaluate the role of pre-operative Ca 125 in predicting survival (while adjusting for confounders). The maximally selected log-rank statistic was used to identify a Ca 125 cut-off defining two groups with different survival probability. Inclusion criteria were met by 207 patients (R-PDAC: 80, BR-PDAC: 91, and LA-PDAC: 36). Ca 125 predicted overall survival before and after adjusting for confounding factors in all categories of anatomic resectability (R-PDAC: HR = 4.3; p = 0.0249) (BR-PDAC: HR = 7.82; p = 0.0024) (LA-PDAC: HR = 11.4; p = 0.0043). In BR-PDAC and LA-PDAC (n = 127), the division in two groups (high vs. low Ca 125) correlated with T stage (p = 0.0317), N stage (p = 0.0083), mean LN ratio (p = 0.0292), and tumor grading (p = 0.0143). This study confirmed the prognostic value of Ca125 in resected pancreatic cancer and, therefore, the importance of biologic over anatomic resectability. Ca 125 should be routinely assayed in surgical candidates with PDAC.

PMID:37535191 | DOI:10.1007/s13304-023-01587-4

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Predicting sugar intake using an extended theory of planned behavior in a sample of adolescents: The role of habit and self-control

Brain Behav. 2023 Aug 3:e3200. doi: 10.1002/brb3.3200. Online ahead of print.

ABSTRACT

INTRODUCTION: High levels of sugar intake are associated with multiple maladaptive health outcomes in adult and younger populations. Identifying the psychological determinants of sugar intake in adolescents, and the processes involved, may help identify potentially modifiable targets and inform intervention development. We tested the predictions of an extended theoretical model based on the theory of planned behavior (TPB), which specified social cognition constructs, habit, and self-control as correlates of sugar intake in an adolescent sample.

METHODS: Adolescents aged 12 to 14 years (N = 88) recruited via a survey panel company and consenting to participate in the study completed online self-report measures of constructs from the TPB alongside measures of habit and self-control. One month later, participants completed a follow-up measure of free-sugar intake. Hypothesized effects of our proposed extended model were tested using partial least squares structural equation modeling.

RESULTS: We found statistically significant effects of attitude, subjective norm, and perceived behavioral control on sugar intake intentions. We also found significant effects of habit and self-control on sugar intake measured at follow-up, but no effect for intention. Perceived behavioral control moderated the intention-behavior relationship such that intention effects on behavior were larger when perceived behavioral control was high. However, self-control did not moderate the intention-behavior relationship.

CONCLUSION: Results indicate that sugar intake in this sample was a function of habits and self-control, and the effect of sugar intake intentions was conditional on perceived behavioral control. Results contribute to an evidence base of determinants and associated processes that relate to sugar intake in adolescents and may signal potentially modifiable targets for intervention.

PMID:37534544 | DOI:10.1002/brb3.3200

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The use of radiomics in magnetic resonance imaging for the pre-treatment characterisation of breast cancers: A scoping review

J Med Radiat Sci. 2023 Aug 3. doi: 10.1002/jmrs.709. Online ahead of print.

ABSTRACT

Radiomics is an emerging field that aims to extract and analyse a comprehensive set of quantitative features from medical images. This scoping review is focused on MRI-based radiomic features for the molecular profiling of breast tumours and the implications of this work for predicting patient outcomes. A thorough systematic literature search and outcome extraction were performed to identify relevant studies published in MEDLINE/PubMed (National Centre for Biotechnology Information), EMBASE and Scopus from 2015 onwards. The following information was retrieved from each article: study purpose, study design, extracted radiomic features, machine learning technique(s), sample size/characteristics, statistical result(s) and implications on patient outcomes. Based on the study purpose, four key themes were identified in the included 63 studies: tumour subtype classification (n = 37), pathologically complete response (pCR) prediction (n = 15), lymph node metastasis (LNM) detection (n = 7) and recurrence rate prediction (n = 6). In all four themes, reported accuracies widely varied among the studies, for example, area under receiver characteristics curve (AUC) for detecting LNM ranged from 0.72 to 0.91 and the AUC for predicting pCR ranged from 0.71 to 0.99. In all four themes, combining radiomic features with clinical data improved the predictive models. Preliminary results of this study showed radiomics potential to characterise the whole tumour heterogeneity, with clear implications for individual-targeted treatment. However, radiomics is still in the pre-clinical phase, currently with an insufficient number of large multicentre studies and those existing studies are often limited by insufficient methodological transparency and standardised workflow. Consequently, the clinical translation of existing studies is currently limited.

PMID:37534540 | DOI:10.1002/jmrs.709

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The CKD-EPI 2021 Equation and Other Creatinine-Based Race-Independent eGFR Equations in Chronic Kidney Disease Diagnosis and Staging

J Appl Lab Med. 2023 Aug 3:jfad047. doi: 10.1093/jalm/jfad047. Online ahead of print.

ABSTRACT

BACKGROUND: Recent debate on the race correction factor in creatinine-based estimated glomerular filtration rate (eGFR) has led to the development of a new race-independent equation (Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI_2021). Previously, some institutions have already modified the early version of the CKD-EPI or Modification of Diet in Renal Disease (MDRD) equations by removing the race factors (CKD-EPI_2009_non-Black (NB), MDRD_NB) for Black populations although this approach remains controversial.

METHODS: In this study, the CKD-EPI_2009_NB, MDRD_NB, and European Kidney Function Consortium (EKFC) equations were compared directly with the CKD-EPI_2021 equation in eGFR calculation, chronic kidney disease (CKD) diagnosis, and staging in a local population.

RESULTS: These 3 previous methods underestimated eGFR compared to CKD-EPI_2021 for eGFR < 90 mL/min/1.73 m2 but overestimated eGFR at the high end (>120 mL/min/1.73 m2). Around the CKD diagnosis cutoff (60 mL/min/1.73 m2), both MDRD_NB and EFKC equations resulted in an increase in CKD cases compared to CKD-EPI_2021. CKD-EPI_2009_NB demonstrated a similar trend although the difference was not statistically significant. In a population with low eGFR (<60 mL/min/1.73 m2), the EKFC equation showed a CKD staging pattern significantly different from that by CKD-EPI_2021, but all 3 previous methods resulted in a similar number of end-stage renal failure cases. In general, the EKFC equation demonstrated a weaker agreement in eGFR calculation and concordance in classification with the CKD-EPI_2021 equation than MDRD_NB and CKD-EPI_2009_NB.

CONCLUSIONS: Our study provides a direct visual comparison to demonstrate the potential clinical impact between 3 previously used race-independent methods and the CKD-EPI_2021 equation and aids the communication with healthcare providers during the implementation of this new equation.

PMID:37534520 | DOI:10.1093/jalm/jfad047

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Assessing Adherence to Provider’s Recommendations in Caries Risk Assessment and Management: A Retrospective Data Review

J Contemp Dent Pract. 2023 Jun 1;24(6):409-413. doi: 10.5005/jp-journals-10024-3527.

ABSTRACT

AIM: To evaluate the distribution of caries risk category of patients at a dental institution and determine adherence to providers’ recommendations.

MATERIALS AND METHODS: A cross-sectional retrospective review of 1,235 patients records that included data collection on demographics, the sum of the number of decayed, missing due to caries, and filled teeth in the permanent teeth (DMFT), presence of frequent snacking, stimulated salivary flow rate, stimulated saliva pH, saliva buffering capacity, biofilm activity, caries risk category, anti-caries prescription accept/decline, and change in the caries risk category. Statistical analysis was carried out through Pearson’s Chi-squared test and linear model ANOVA with a significance level of 0.05.

RESULTS: Pearson’s Chi-squared test showed a statistically significant difference in frequency by risk category (p < 0.001) indicating that patients were skewed toward high and extreme caries risk. Linear model ANOVA showed that higher risk categories were associated with lower salivary flow rates (p = 0.010) and higher biofilm activity (p < 0.001). About, 1 out of 3 patients were reported to have frequent snacking (N = 391, 32%). Frequent snacking patients were more likely to present with higher caries risk assessment (p < 0.001), younger age (p < 0.001), and female (p < 0.001). Despite recommendations from the dental student provider, only 27% accepted the anti-cavity prescriptions while 61% declined the recommendation.

CONCLUSION: Distribution of caries risk category is not evenly distributed, but rather skewed toward high and extreme caries risk levels. Despite the identified risks, there is low adherence to the recommendations provided by healthcare providers. The results underscore the necessity for targeted interventions and initiatives aimed at fostering behavioral changes to enhance oral health outcomes.

CLINICAL SIGNIFICANCE: There is a high need for targeted interventions and initiatives that promote behavioral changes to enhance oral health outcomes.

PMID:37534508 | DOI:10.5005/jp-journals-10024-3527

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Comparative Evaluation of the Horizontal Condylar Guidance Using Protrusive Interocclusal Records, OPG, and CBCT in Edentulous Patients: An In Vivo Study

J Contemp Dent Pract. 2023 Jun 1;24(6):403-408. doi: 10.5005/jp-journals-10024-3517.

ABSTRACT

AIMS: A clinical study to compare the horizontal condylar guidance using protrusive interocclusal records, orthopantomography (OPG), and cone-beam computed tomography (CBCT) in edentulous patients.

SUBJECTS AND METHODS: Thirty-six edentulous subjects were selected as per predetermined criteria. Horizontal condylar guidance was recorded using protrusive interocclusal records (PIR), OPG, and CBCT for each patient. The PIR were obtained using extraoral Gothic arch tracers to program the Hanau articulator. The horizontal condylar guidance angles (HCGAs) were digitally constructed using appropriate software along the posterior slope of articular eminence for all radiographs. The collected data were recorded, tabulated, and statistically analyzed.

RESULTS: The condylar guidance angle values were tested for significance to compare the different angles. The correlation of HCGA measurements on both sides between the three groups was analyzed. The PIR and OPG methods (p = 0.001), as well as the OPG and CBCT methods (p = 0.001), show substantial differences on both sides. On the contrary, the PIR and CBCT methods did not differ significantly (p = 0.11).

CONCLUSION: Cone-beam computed tomography is as reliable and accurate as the clinical method. A significant correlation exists between the clinical method and CBCT. It can be used as a dependable adjunct to the clinical method of HCGA measurement.

CLINICAL SIGNIFICANCE: Cone-beam computed tomography can overcome the shortcomings of the conventional clinical methods to determine the accurate horizontal condylar guidance angulation measurement. It is safer with minimum discomfort and wastage of time for the patients.

PMID:37534507 | DOI:10.5005/jp-journals-10024-3517

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Comparative Evaluation of 0.25% Lemongrass Oil Mouthwash and 0.2% Chlorhexidine Mouthwash in Fixed Orthodontic Patients Suffering from Gingivitis

J Contemp Dent Pract. 2023 Jun 1;24(6):396-402. doi: 10.5005/jp-journals-10024-3516.

ABSTRACT

AIM: The aim of this study is to compare the antiplaque and antigingivitis efficacy of 0.25% lemongrass oil mouthwash and 0.2% chlorhexidine mouthwash in patients undergoing fixed orthodontic treatment, who are suffering from gingivitis.

MATERIALS AND METHODS: A total of 60 patients undergoing fixed orthodontic treatment with mild-to-moderate gingivitis were selected for the study. The patients were randomly divided into three groups of twenty each, that is, group I: 0.25% lemongrass oil mouthwash (n = 20); group II: 0.2% chlorhexidine mouthwash (n = 20); and group III: oral prophylaxis (n = 20). Baseline gingival index (GI) and plaque index (PI) were accessed followed by oral prophylaxis was done and the PI score was set to zero for all the patients. Patients were asked to swish their mouth with their respective mouthwashes and brushing (twice daily), that is, morning and before bedtime for 21 days. The PI and GI scores were recorded for all three groups on the 14th and the 21st days. The post hoc Bonferroni test was used for multiple comparisons of mean differences among variables after the application of the analysis of variance (ANOVA) test for comparison within the groups.

RESULTS: A lower PI and the GI were found in the lemongrass oil mouthwash group by the 14th and the 21st days, respectively, a statistically significant difference (p < 0.001) compared to the chlorhexidine mouthwash group.

CONCLUSION: The findings of the current study suggested that 0.25% lemongrass oil mouthwash has the potential to be used as a natural or herbal alternative to chlorhexidine mouthwash.

CLINICAL SIGNIFICANCE: It can be suggested that 0.25% lemongrass oil mouthwash may be a good herbal alternative to mouthwash containing 0.2% chlorhexidine gluconate.

PMID:37534506 | DOI:10.5005/jp-journals-10024-3516