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Nevin Manimala Statistics

A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine, Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic Grade I-II Cervical Sprains

Clin Drug Investig. 2024 Jun 6. doi: 10.1007/s40261-024-01370-2. Online ahead of print.

ABSTRACT

BACKGROUND: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders.

OBJECTIVE: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains.

METHODS: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0.

RESULTS: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± – 1.5 and – 2.6 ± – 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC.

CONCLUSIONS: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains.

CLINICAL TRIALS REGISTRATION: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).

PMID:38842764 | DOI:10.1007/s40261-024-01370-2

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Proteomic profiling of human dental enamel affected by molar incisor hypomineralisation of different clinical severity grades: an in vitro study

Eur Arch Paediatr Dent. 2024 Jun 6. doi: 10.1007/s40368-024-00911-9. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study was to explore the potential to profile and distinguish varying clinical severity grades of MIH, compared to normal enamel, using proteomics.

METHODS: Liquid chromatography-mass spectrometry analyses were conducted on enamel samples of extracted teeth, from 11 children and adolescents, spanning an age range of 6-18 years. Enamel powder samples were collected from extracted, third molars (n = 3) and first permanent molars diagnosed with MIH (n = 8). The MIH tooth samples were categorized into subgroups based on clinical severity grade. The data were statistically analyzed using ANOVA and Welch’s t test.

RESULTS: Teeth affected by MIH exhibited a diverse array of proteins, each with different functions related to dental enamel, distinguishing them from their normal enamel counterparts. The application of microdissection combined with LC-MS techniques has revealed the potential to discern unique proteomic profiles among MIH-affected teeth, characterized by varying clinical severity grades. Both analyzed MIH groups displayed consistent trends in the presentation of biological processes, including underabundance of proteins primarily associated with cell organization and biogenesis. Furthermore, proteins linked to cell death were overabundant in both MIH groups.

CONCLUSION: Proteomics enabled the detection and differentiation of various proteins across different clinical severity grades of MIH.

PMID:38842758 | DOI:10.1007/s40368-024-00911-9

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Non-syndromic tooth agenesis in Latvian adolescent dental patients: a retrospective study with relevant literature review

Eur Arch Paediatr Dent. 2024 Jun 6. doi: 10.1007/s40368-024-00901-x. Online ahead of print.

ABSTRACT

AIM: To investigate the prevalence of tooth agenesis and associated dental anomalies in Latvian adolescent dental patients and compare it to other European countries.

DESIGN: Cross-sectional study of 2692 11-to-14-year-old patients (39.9% males and 60.1% females) attending Riga Stradins University Institute of Stomatology with panoramic radiographs taken between August 2020 and September 2021. Patients with any genetic syndromes were excluded. Data on tooth agenesis (excluding third molars) and other dental anomalies were recorded.

RESULTS: The prevalence of tooth agenesis in Latvian adolescent dental patients was 9.3% with no statistically significant difference between genders (χ2 test, p = 0.472). The most commonly missing teeth were mandibular second premolars, followed by upper lateral incisors and upper second premolars. There was a statistically significant association with the presence of other dental anomalies in tooth agenesis patients (p < 0.001).

CONCLUSIONS: This study found that the prevalence of non-syndromic tooth agenesis in Latvian adolescent dental patients was 9.3% with no statistically significant differences between the genders. Patients with tooth agenesis have a statistically significant possibility of the presence of other dental anomalies (p < 0.001).

PMID:38842757 | DOI:10.1007/s40368-024-00901-x

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Nevin Manimala Statistics

Effect of low-level laser therapy on en masse retraction in females with bimaxillary dentoalveolar protrusion : A single-center randomized clinical trial

J Orofac Orthop. 2024 Jun 6. doi: 10.1007/s00056-024-00525-2. Online ahead of print.

ABSTRACT

BACKGROUND: Acceleration of tooth movement has gained remarkable attention during the last decade. The aim of this study was to evaluate the effect of low-level laser therapy (LLLT) on en masse retraction of upper anterior teeth in adult women with bimaxillary dentoalveolar protrusion.

MATERIALS AND METHODS: In this two-arm parallel trial, 36 women with bimaxillary dentoalveolar protrusion were randomly divided into two equal groups. Eligibility criteria included class I Angle molar relationship, good general and oral health as well as no systemic disease or syndrome. Four temporary anchorage devices (TADs) were used in the upper and lower arches for anchorage purposes. A 0.019×0.025-inch stainless steel wire with crimped hooks just distal to the maxillary canines was inserted. Nickle titanium (NiTi) closed coil springs (200 g/side) were employed for en masse retraction following extraction of the first premolars. In the laser group (LG), retraction of the upper anterior teeth was done along with the application of LLLT on days 0, 3, 7, and 14 after extraction and then repeated biweekly until the end of retraction. Retraction was completed without LLLT application in the nonlaser group (NLG). Data concerning the rate of retraction as well as first molars and anterior positional changes were gained from digitized models and cone beam computed tomography (CBCT) scans taken just before extraction and at the end of retraction. Treatment-associated pain and root resorption were evaluated using visual analogue scale (VAS) and CBCT scans, respectively.

RESULTS: Four patients dropped out prior to follow-up. The duration of retraction was 10.125 ± 2.876 and 13.643 ± 3.455 months in the LG and NLG, respectively. The LG showed a statistically significant faster rate of en masse retraction (0.833 ± 0.371 mm/month) compared to the NLG (0.526 ± 0.268 mm/month; P ≤ 0.035). The observed root resorption was significantly less in the LG (P ≤ 0.05) with comparable pain scores in both groups.

CONCLUSIONS: Within the constraints of the parameters of the LLLT used in the current study and despite the statistically significant results on the rate of en masse retraction and the associated root resorption, LLLT did not demonstrate a clinically relevant effect that justifies its use to enhance en masse retraction.

NAME OF THE REGISTRY: Clinicaltrials.gov TRIAL REGISTRATION NUMBER: NCT05183451 DATE OF REGISTRATION: January 10, 2022, “Retrospectively registered” URL OF TRIAL REGISTRY RECORD: https://www.

CLINICALTRIALS: gov/study/NCT05183451.

PMID:38842738 | DOI:10.1007/s00056-024-00525-2

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Nevin Manimala Statistics

Conditional bias adjusted estimator of treatment effect in 2-in-1 adaptive design

J Biopharm Stat. 2024 Jun 6:1-20. doi: 10.1080/10543406.2024.2359147. Online ahead of print.

ABSTRACT

For implementation of adaptive design, the adjustment of bias in treatment effect estimation becomes an increasingly important topic in recent years. While adaptive design literature traditionally focuses on the control of type I error rate and the adjustment of overall unconditional bias, the research on adjusting conditional bias has been limited. This paper proposes a conditional bias adjustment estimator of treatment effect under the context of 2-in-1 adaptive design and aims to provide a comprehensive investigation on their statistical properties including bias, mean squared error and coverage probability of confidence intervals. It demonstrated that conditional bias adjusted estimators greatly reduce the conditional bias and have similarly negligible unconditional bias compared with mean and median (unconditional) unbiased estimators. In addition, the test statistics is constructed based on the conditional bias adjustment estimators and compared with the naive unadjusted test.

PMID:38841980 | DOI:10.1080/10543406.2024.2359147

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Nevin Manimala Statistics

Evaluation of nail fold capillaroscopy changes in patients with diabetic retinopathy and healthy controls, and its correlation with disease duration, HbA1c levels and severity of diabetic retinopathy: An observational study

Indian J Dermatol Venereol Leprol. 2024 Apr 29:1-7. doi: 10.25259/IJDVL_232_2023. Online ahead of print.

ABSTRACT

Background Diabetic retinopathy (DR) is an important microvascular complication of long-term type 2 diabetes mellitus (T2DM) leading to blindness if not properly diagnosed and managed. It can develop as early as 7 years before the diagnosis of diabetes. Nail fold capillaroscopy (NFC) is a non-invasive technique for observing capillary microvasculature and there are few studies which have explored the use of NFC in diabetes mellitus patients. Objective To study the nail fold capillaroscopic alterations in patients with T2DM having diabetic retinopathy and compare them to healthy controls. The secondary objective was to correlate the NFC findings with the duration of diabetes, haemoglobin A1c (HbA1c) levels and the severity of DR. Materials and methods This cross-sectional observational study enrolled 200 patients – 100 cases with T2DM having diabetic retinopathy (as per the American Diabetes Association criteria and Diabetic Retinopathy Disease Severity Scale) and 100 healthy age and sex-matched controls. All patients were subjected to NFC and ophthalmological assessment. Results NFC revealed that patients with DR showed significantly higher frequencies of tortuous, dilated, bushy, meandering, angulated capillaries, avascular areas and micro-haemorrhages as compared to healthy controls (p < 0.05). In proliferative DR (PDR), the frequency of tortuous, bushy capillaries, and avascular areas was statistically high and the capillary density was reduced as compared to non-proliferative DR. The DR patients with longer disease duration (>20) years had a significantly higher frequency of tortuous capillaries, avascular areas, meandering, angulated and dilated capillaries. The frequency of tortuosity, avascular areas, and bushy areas was significantly higher in patients with poor glycaemic control (HbA1c >11). Limitations A larger sample size study with different demographic populations could have provided a broader picture of NFC changes in T2DM patients with DR. Discussion NFC may act as a surrogate marker of retinal involvement in patients with DM and should be performed at regular intervals. Conclusion NFC is a quick, simple, safe, and non-invasive method to assess the capillaroscopic alterations in diabetic patients which inturn can help in assessing the severity of DR.

PMID:38841954 | DOI:10.25259/IJDVL_232_2023

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Nevin Manimala Statistics

Serum levels of tumour necrosis factor (TNF-α) and interleukin-17 (IL-17) in patients with nail psoriasis: A cross-sectional study

Indian J Dermatol Venereol Leprol. 2024 May 4:1-5. doi: 10.25259/IJDVL_367_2023. Online ahead of print.

ABSTRACT

Background Psoriasis is a common chronic inflammatory disorder affecting all aspects of a patient’s life. Nail involvement is frequent, but little is known about its associated inflammatory biomarker profile, including similarities or differences from cutaneous disease. Aims We conducted this cross-sectional study to evaluate serum levels of inflammatory cytokines [tumour necrosis factor-alpha (TNF-α) and interleukin -17 (IL-17)] in patients with nail psoriasis and compared these to psoriasis patients without nail involvement, as well as in non-psoriatic healthy controls. Methods Adult psoriasis patients with (Group I, n = 30) and without nail involvement (Group-II, n = 30) were sequentially recruited. In addition, non-psoriatic healthy controls (Group-III, n = 20) were recruited. The nail disease severity by NAPSI score was determined for patients in Group I. Cutaneous disease severity (by PASI score) and presence of psoriatic arthritis (through CASPAR criteria) were evaluated for patients in Groups I and II. Serum levels of TNF-α, IL-17, erythrocyte sedimentation rate (ESR), rheumatoid factor (RA factor), and anti-cyclic citrullinated peptide antibody (Anti-CCP) were evaluated for all three groups. Results The median age was significantly higher for Group I as compared to Group II patients (41 ± 12.6 years vs 30 ± 12.4 years, p = 0.017). Group I patients also had higher median PASI score than Group II patients, although the difference was not statistically significant (10 ± 11.41 vs 6.50 ± 5.46, p = 0.275). The mean serum IL-17 levels were significantly higher for Group-I (113.39 ± 251.30 pg/mL) than Group II (27.91 ± 18.22 pg/mL, p = 0.002) and Group III (25.67 ± 12.08 pg/mL, p = 0.005). A weak positive correlation was found between NAPSI and serum IL-17 levels (Spearman’s Rho = 0.355) though not statistically significant (p = 0.054). Correlation between serum IL-17 and PASI was poor for Group-I patients (Spearman’s Rho = 0.13, p = 0.944) and strongly negative for Group-II patients (Spearman’s Rho = -0.368, statistically significant with p = 0.045). The mean serum levels of TNF-α were below the detection threshold of the assay kit, hence no meaningful comparison could be made. Limitations A small sample size and low sensitivity of TNF-α assay kit. Conclusion Our study showed that nail psoriasis could be independently associated with an elevation of IL-17. This can help choose appropriate drugs and estimate drug response in patients with nail psoriasis.

PMID:38841938 | DOI:10.25259/IJDVL_367_2023

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Nevin Manimala Statistics

Simultaneous clustering and estimation of networks in multiple graphical models

Biostatistics. 2024 Jun 5:kxae015. doi: 10.1093/biostatistics/kxae015. Online ahead of print.

ABSTRACT

Gaussian graphical models are widely used to study the dependence structure among variables. When samples are obtained from multiple conditions or populations, joint analysis of multiple graphical models are desired due to their capacity to borrow strength across populations. Nonetheless, existing methods often overlook the varying levels of similarity between populations, leading to unsatisfactory results. Moreover, in many applications, learning the population-level clustering structure itself is of particular interest. In this article, we develop a novel method, called Simultaneous Clustering and Estimation of Networks via Tensor decomposition (SCENT), that simultaneously clusters and estimates graphical models from multiple populations. Precision matrices from different populations are uniquely organized as a three-way tensor array, and a low-rank sparse model is proposed for joint population clustering and network estimation. We develop a penalized likelihood method and an augmented Lagrangian algorithm for model fitting. We also establish the clustering accuracy and norm consistency of the estimated precision matrices. We demonstrate the efficacy of the proposed method with comprehensive simulation studies. The application to the Genotype-Tissue Expression multi-tissue gene expression data provides important insights into tissue clustering and gene coexpression patterns in multiple brain tissues.

PMID:38841872 | DOI:10.1093/biostatistics/kxae015

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Nevin Manimala Statistics

Rationale for issuing neuroimaging requests for patients with primary headaches in China

Brain Behav. 2024 Jun;14(6):e3583. doi: 10.1002/brb3.3583.

ABSTRACT

OBJECTIVE: To investigate the prevalence of neuroimaging in patients with primary headaches and the clinician-based rationale for requesting neuroimaging in China.

DATA SOURCES AND STUDY SETTING: This study included patients with primary headaches admitted to hospitals and clinicians in China. We identified whether neuroimaging was requested and the types of neuroimaging conducted.

STUDY DESIGN: This was a cross-sectional study, and convenience sampling was used to recruit patients with primary headaches. Clinicians were interviewed using a combination of personal in-depth and topic-selection group interviews to explore why doctors requested neuroimaging.

DATA COLLECTION: We searched for the diagnosis of primary headache in the outpatient and inpatient systems according to the International Classification of Diseases-10 code of patients admitted to six hospitals in three provincial capitals by 2022.We selected three public and three private hospitals with neurology specialties that treated a corresponding number of patients.

PRINCIPLE FINDINGS: Among the 2263 patients recruited for this study, 1942 (89.75%) underwent neuroimaging. Of the patients, 1157 (51.13%) underwent magnetic resonance imaging (MRI), 246 (10.87%) underwent both head computed tomography (CT) and MRI, and 628 (27.75%) underwent CT. Fifteen of the 16 interviewed clinicians did not issue a neuroimaging request for patients with primary headaches. Furthermore, we found that doctors issued a neuroimaging request for patients with primary headaches mostly, to exclude the risk of misdiagnosis, reduce uncertainty, avoid medical disputes, meet patients’ medical needs, and complete hospital assessment indicators.

CONCLUSIONS: For primary headaches, the probability of clinicians requesting neuroimaging was higher in China than in other countries. There is considerable room for improvement in determining appropriate strategies to reduce the use of low-value care for doctors and patients.

PMID:38841826 | DOI:10.1002/brb3.3583

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Nevin Manimala Statistics

Shape variation in cranium, mandible and teeth in selected mouse strains

Anat Histol Embryol. 2024 Jul;53(4):e13064. doi: 10.1111/ahe.13064.

ABSTRACT

There are different strains of laboratory mouse used in many different fields. These strains differ anatomically. In order to determine these anatomical differences, shape analysis was conducted according to species. CD-1, C57bl/6 and Balb-c strains were preferred to study these differences. Forty-eight adult mouse strains belonging to these strains were utilized. The bones were photographed and geometric morphometry was applied to these photographs. Principal Component Analysis was applied to determine shape variations. In Principal component 1 for cranium, CD-1 and C57bl/6 strain groups showed different shape variations, while Balb-c strain group showed similar shape variations to the other strain groups. Principal Component 1 for the mandible separated the CD-1 and C57bl/6 strain groups in terms of shape variation. Principal Component 2 explained most of the variation between the C57bl/6 and CD-1 lineage groups. In PC1 for molars, the CD-1 group showed a different shape variation from the other groups. Mahalanobis distances and Procrustes distances were measured using Canonical variance analysis to explain the differences between the lineage groups. These measurements were statistically significant. For cranium, in canonical variate 1, CD-1 group of mouse and Balb-c group of mouse were separated from each other. In canonical variate 2, C57bl/6 group of mouse were separated from the other groups. For mandible, Balb-c group of mouse in canonical variate 1 and CD-1 group of mouse in canonical variate 2 were separated from the other groups. For molars, CD-1 group of mouse in canonical variate 1 and Balb-c group of mouse in canonical variate 2 were separated from the other groups. It was thought that these anatomical differences could be caused by genotypic factors as well as dietary differences and many different habits that would affect the way their muscles work.

PMID:38841825 | DOI:10.1111/ahe.13064