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Nevin Manimala Statistics

Safety Profile and Effectiveness of Rivaroxaban for Patients With Venous Thromboembolism in Japan - Results From Post-Marketing Surveillance (XASSENT)

Circ J. 2023 May 27. doi: 10.1253/circj.CJ-23-0104. Online ahead of print.

ABSTRACT

BACKGROUND: The incidence of venous thromboembolism (VTE; pulmonary embolism [PE] and/or deep vein thrombosis [DVT]) in Japan is increasing, but relatively small numbers of patients from Japan have been included in studies investigating rivaroxaban (a direct factor Xa inhibitor) for the treatment of VTE and preventing its recurrence.Methods and Results: An open-label, prospective, observational study (XASSENT [NCT02558465]) investigated the safety profile and effectiveness of rivaroxaban for ≤2 years in the treatment of VTE and prevention of its recurrence in Japanese clinical practice. Primary outcomes were major bleeding and symptomatic recurrent VTE. Statistical analyses were exploratory and descriptive. Overall, 2,540 patients were enrolled (safety analysis population [SAP], n=2,387; effectiveness analysis population [EAP], n=2,386). In the SAP, >80% of patients received the approved rivaroxaban dose, the mean (standard deviation) age was 66.6 (15.0) years, ≈74% were >50 kg, and 43% had a creatinine clearance ≥80 mL/min. PE+DVT, PE only, and DVT only were reported in 42%, 8%, and 50% of patients, respectively, and active cancer in 17% of patients. Major bleeding was reported in 69 patients (2.89%; 3.60%/patient-year; SAP) and symptomatic PE/DVT recurrence in 26 patients (1.09%; 1.36%/patient-year; EAP) during the treatment period.

CONCLUSIONS: XASSENT provided information on the expected proportions of bleeding and VTE recurrence during rivaroxaban treatment in Japanese clinical practice; no new concerns of safety or effectiveness were found.

PMID:37245989 | DOI:10.1253/circj.CJ-23-0104

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Nevin Manimala Statistics

Diagnostic Utility of an Adjusted DWI Lexicon Using Multiple b-values to Evaluate Breast Lesions in Combination with BI-RADS

Magn Reson Med Sci. 2023 May 26. doi: 10.2463/mrms.mp.2022-0056. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to investigate the diagnostic feasibility of an adjusted diffusion-weighted imaging (DWI) lexicon using multiple b values to assess breast lesions according to DWI-based breast imaging reporting and data system (BI-RADS).

METHODS: This Institutional Review Board (IRB)-approved prospective study included 127 patients with suspected breast cancer. Breast MRI was performed using a 3T scanner. Breast DW images were acquired using five b-values of 0, 200, 800, 1000, and 1500 s/mm2 (5b-value DWI) on 3T MRI. Two readers independently assessed lesion characteristics and normal breast tissue using DWI alone (5b-value DWI and 2b-value DWI with b = 0 and 800 s/mm2) according to DWI-based BI-RADS and in combination with the standard dynamic contrast-enhanced images (combined MRI). Interobserver and intermethod agreements were assessed using kappa statistics. The specificity and sensitivity of lesion classification were evaluated.

RESULTS: Ninety-five breast lesions (39 malignant and 56 benign) were evaluated. Interobserver agreement for lesion assessment on 5b-value DWI was very good (k ≥ 0.82) for DWI-based BI-RADS categories, lesion type, and mass characteristics; good (k = 0.75) in breast composition; and moderate (k ≥ 0.44) in background parenchymal signal (BPS) and non-mass distribution. Intermethod agreement between assessments performed using either 5b-value DWI or combined MRI was good-to-moderate (k = 0.52-0.67) for lesion type; moderate (k = 0.49-0.59) for DWI-based BI-RADS category and mass characteristics; and fair (k = 0.25-0.40) for mass shape, BPS, and breast composition. The sensitivity and positive predictive values (PPVs) for 5b-value DWI were 79.5%, 84.6% and 60.8%, 61.1% for each reader, respectively; 74.4%, 74.4% and 63.0%, 61.7% for 2b-value DWI; and 97.4%, 97.4% and 73.1%, 76.0% for combined MRI. The specificity and negative predictive values (NPVs) were 64.3%, 62.5% and 81.8%, 85.4% for 5b-value DWI; 69.6%, 67.9% and 79.6%, 79.2% for 2b-value DWI; and 75.0%, 78.6% and 97.7%, 97.8% for combined MRI.

CONCLUSION: Good observer agreement was observed in the 5b-value DWI. The 5b-value DWI based on multiple b-values might have the potential to complement the 2b-value DWI; however, their diagnostic performance tended to be inferior to that of combined MRI for the characterization of breast tumors.

PMID:37245964 | DOI:10.2463/mrms.mp.2022-0056

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Nevin Manimala Statistics

Clinical performance of two onlay designs for molars after root canal treatment

J Oral Sci. 2023 May 29. doi: 10.2334/josnusd.22-0450. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the clinical performance of two proposed onlay designs.

METHODS: Molars with occlusal and/or mesial/distal defects after root canal treatment were classified by design into three groups. Onlays without shoulders were the control group (Group C, n = 50). The designed onlays were Group O (n = 50) and the designed mesio-occlusal/disto-occlusal onlays were Group MO/DO (n = 80). All onlays had an occlusal thickness of approximately 1.5-2.0 mm, and the designed onlays had a shoulder depth and width of approximately 1 mm. In Groups C and O, the box-shaped retention was 1.5 mm in depth. The proximal box was connected with a dovetail retention in Group MO/DO. Patients were examined every 6 months and followed for 36 months. Restorations were evaluated by using the modified United States Public Health Service Criteria. Statistical analysis was performed by using Kaplan-Meier analysis, the chi-square test, and Fisher’s exact test.

RESULTS: No tooth fracture, debonding, secondary caries, or gingivitis was observed in any group. Groups O and MO/DO had satisfactory survival and success rates, and there was no significant difference in performance characteristics among the three groups (P > 0.05).

CONCLUSION: The two proposed onlay designs were effective in protecting molars.

PMID:37245963 | DOI:10.2334/josnusd.22-0450

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Nevin Manimala Statistics

A nested case-control study of factors contributing to the development of medication-related osteonecrosis of the jaw in patients using bone resorption inhibitors in Mishima City

J Oral Sci. 2023 May 29. doi: 10.2334/josnusd.23-0096. Online ahead of print.

ABSTRACT

PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is characterized by necrosis of the jawbone with intraoral bacterial infection and has a significant negative impact on oral health-related quality of life. Risk factors for the onset are unknown, and definitive therapeutic approaches have not yet been defined. A case-control study at a single institution in Mishima City was conducted. The purpose of this study was to examine in detail the factors that contribute to the development of MRONJ.

METHODS: Medical records of MRONJ patients who visited Mishima Dental Center, Nihon University School of Dentistry, during the period 2015-2021 were extracted. Counter-matched sampling design was used to select participants matched for sex, age, and smoking for this nested case-control study. The incidence factors were statistically examined by logistic regression analysis.

RESULTS: Twelve MRONJ patients were used as cases and 32 controls were matched. After adjustment for potential confounders, injectable bisphosphonates (aOR = 24.5; 95% CI = 1.05, 575.0; P < 0.05) were significantly associated with the development of MRONJ.

CONCLUSION: High-dose bisphosphonates may be a risk factor for the development of MRONJ. Patients who use these products require careful prophylactic dental treatment against inflammatory diseases, and dentists and physicians should maintain close communication.

PMID:37245962 | DOI:10.2334/josnusd.23-0096

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Nevin Manimala Statistics

Unsupervised learning

Am J Orthod Dentofacial Orthop. 2023 Jun;163(6):877-882. doi: 10.1016/j.ajodo.2023.04.001.

NO ABSTRACT

PMID:37245896 | DOI:10.1016/j.ajodo.2023.04.001

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Nevin Manimala Statistics

Rate-limiting recovery processes in neurotransmission under sustained stimulation

Math Biosci. 2023 May 26:109023. doi: 10.1016/j.mbs.2023.109023. Online ahead of print.

ABSTRACT

At active zones of chemical synapses, an arriving electric signal induces the fusion of vesicles with the presynaptic membrane, thereby releasing neurotransmitters into the synaptic cleft. After a fusion event, both the release site and the vesicle undergo a recovery process before becoming available for reuse again. Of central interest is the question which of the two restoration steps acts as the limiting factor during neurotransmission under high-frequency sustained stimulation. In order to investigate this problem, we introduce a non-linear reaction network which involves explicit recovery steps for both the vesicles and the release sites, and includes the induced time-dependent output current. The associated reaction dynamics are formulated by means of ordinary differential equations (ODEs), as well as via the associated stochastic jump process. While the stochastic jump model describes the dynamics at a single active zone, the average over many active zones is close to the ODE solution and shares its periodic structure. The reason for this can be traced back to the insight that recovery dynamics of vesicles and release sites are statistically almost independent. A sensitivity analysis on the recovery rates based on the ODE formulation reveals that neither the vesicle nor the release site recovery step can be identified as the essential rate-limiting step but that the rate-limiting feature changes over the course of stimulation. Under sustained stimulation, the dynamics given by the ODEs exhibit transient changes leading from an initial depression of the postsynaptic response to an asymptotic periodic orbit, while the individual trajectories of the stochastic jump model lack the oscillatory behavior and asymptotic periodicity of the ODE-solution.

PMID:37245846 | DOI:10.1016/j.mbs.2023.109023

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Nevin Manimala Statistics

Static and dynamic source identification of trace elements in river and soil environments under anthropogenic activities in the Haraz plain, Northern Iran

Sci Total Environ. 2023 May 26:164432. doi: 10.1016/j.scitotenv.2023.164432. Online ahead of print.

ABSTRACT

Unsustainable human activities have disrupted the natural cycle of trace elements, causing the accumulation of chemical pollutants and making it challenging to determine their sources due to interwoven natural and human-induced processes. A novel approach was introduced for identifying the sources and for quantifying the contribution of trace elements discharge from rivers to soils. We integrated fingerprinting techniques, soil and sediment geochemical data, geographically weighted regression model (GWR) and soil quality indices. The FingerPro package and the state-of-the-art tracer selection techniques including the conservative index (CI) and consensus ranking (CR) were used to quantify the relative contribution of different upland sub-watersheds in trace element discharge soil. Our analysis revealed that off-site sources (upland watersheds) and in-site sources (land use) both play an important role in transferring trace elements to the Haraz plain (northern Iran). The unmixing model’s results suggest that the Haraz sub-watersheds exhibit a higher contribution to trace elements transfer in the Haraz plain, and therefore, require greater attention in terms of implementing soil and water conservation strategies. However, it is noteworthy that the Babolroud (adjacent to Haraz) exhibited a better performance of the model. A spatial correlation between certain heavy metals, such as As and Cu, and rice cultivation existed. Additionally, we found a significant spatial correlation between Pb and residential areas, particularly in the Amol region. Our result highlights the importance of using advanced spatial statistical techniques, such as GWR, to identify subtle but critical associations between environmental variables and sources of pollution. The methodology used comprehensively identifies dynamic trace element sourcing at the watershed scale, allowing for pollutant source identification and practical strategies for soil and water quality control. Tracer selection techniques (CI and CR) based on conservatives and consensus improve unmixing model accuracy and flexibility for precise fingerprinting.

PMID:37245832 | DOI:10.1016/j.scitotenv.2023.164432

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Nevin Manimala Statistics

Monitoring influenza and respiratory syncytial virus in wastewater. Beyond COVID-19

Sci Total Environ. 2023 May 26:164495. doi: 10.1016/j.scitotenv.2023.164495. Online ahead of print.

ABSTRACT

Wastewater-based surveillance can be a valuable tool to monitor viral circulation and serve as an early warning system. For respiratory viruses that share similar clinical symptoms, namely SARS-CoV-2, influenza, and respiratory syncytial virus (RSV), identification in wastewater may allow differentiation between seasonal outbreaks and COVID-19 peaks. In this study, to monitor these viruses as well as standard indicators of fecal contamination, a weekly sampling campaign was carried out for 15 months (from September 2021 to November 2022) in two wastewater treatment plants that serve the entire population of Barcelona (Spain). Samples were concentrated by the aluminum hydroxide adsorption-precipitation method and then analyzed by RNA extraction and RT-qPCR. All samples were positive for SARS-CoV-2, while the positivity rates for influenza virus and RSV were significantly lower (10.65 % for influenza A (IAV), 0.82 % for influenza B (IBV), 37.70 % for RSV-A and 34.43 % for RSV-B). Gene copy concentrations of SARS-CoV-2 were often approximately 1 to 2 logarithmic units higher compared to the other respiratory viruses. Clear peaks of IAV H3:N2 in February and March 2022 and RSV in winter 2021 were observed, which matched the chronological incidence of infections recorded in the Catalan Government clinical database. In conclusion, the data obtained from wastewater surveillance provided new information on the abundance of respiratory viruses in the Barcelona area and correlated favorably with clinical data.

PMID:37245831 | DOI:10.1016/j.scitotenv.2023.164495

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Nevin Manimala Statistics

Assessing farmer’s exposure to pesticides and the risk for non-communicable diseases: A biomonitoring study

Sci Total Environ. 2023 May 26:164429. doi: 10.1016/j.scitotenv.2023.164429. Online ahead of print.

ABSTRACT

This cross-sectional study aimed to assess the adverse effects of pesticide use in humans, such as non-communicable diseases, using acetylcholinesterase (AChE) and pesticide concentrations in blood samples. A total of 353 samples (290 exposed and 63 control) were collected from participants with >20 years of experience in agricultural pesticide use. The pesticide and AChE concentrations were determined using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) and Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Various health risks from pesticide exposure were assessed, including dizziness or headache, tension, anxiety, confusion, loss of appetite, loss of balance, concentration difficulties, irritability, anger, and depression. These risks may be influenced by the duration and intensity of exposure, the type of pesticide, and environmental factors in the affected areas. A total of 26 pesticides were detected in the blood samples from the exposed population, including 16 insecticides, three fungicides, and seven herbicides. Pesticide concentrations ranged from 0.20 to 12.12 ng/mL, and were statistically significant between the case and control groups (p < 0,05, p < 0.01, and p < 0.001). A correlation analysis was performed to determine statistically significance between pesticide concentration and symptoms of non-communicable diseases, such as Alzheimer’s, Parkinson’s, obesity, and diabetes. The estimated AChE levels in exposed and control blood samples were 21.58 ± 2.31 and 24.13 ± 1.08 U/mL, respectively (mean ± SD). The AChE levels were significantly lower in exposed samples than in controls (p < 0.001), which is considered to be an effect of long-term pesticide exposure, and is the cause of Alzheimer’s disease (p < 0.001), Parkinson’s disease (p < 0.001), and obesity (p < 0.05). Chronic exposure to pesticides and low levels of AChE are somewhat related to non-communicable diseases.

PMID:37245816 | DOI:10.1016/j.scitotenv.2023.164429

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Nevin Manimala Statistics

Linking between ambient pollution and metals concentration in blood. Nationwide study based on the national blood banking system

Sci Total Environ. 2023 May 26:164434. doi: 10.1016/j.scitotenv.2023.164434. Online ahead of print.

ABSTRACT

This study was aimed to describe the chemical traces of air pollution in blood of residents and evaluate the association between ambient pollution and its dose absorbed internally by a human body. The national Magen David Adom Blood Services blood donation collection platform and the National Public Health Laboratory’s testing services were utilized to conduct a human biomonitoring study among blood donors in Israel. The donors’ residential addresses and donations sites’ locations were geocoded and merged with the levels of pollutants recorded by the nearby monitoring stations. Pollutants included nitrogen dioxide (NO2), sulfate dioxide (SO2), ozone (O3), carbon monoxide (CO) and particulate matter of size <10 and 2.5 μm in diameter (PM10 & PM2.5). Metal concentrations were statistically analyzed by ratio t-test and a lognormal regression, and adjusted to age, gender and smoking (defined based on Cadmium values). The findings indicate an independent positive association between pollutants and metals’ concentrations in blood. Specifically, an increase in interquartile range (IQR) of NO2 was associated with 9.5 % increase in As in blood. The increase in one IQR of PM10 and SO2 was associated with an increase in Pb, of 16.6 % and 12.4 %, respectively. SO2 was also adversely associated with Cd concentrations, by increasing its levels by 5.7 %. The donors’ proximity to quarries was related to the Pb blood levels higher 1.47 times compared to donors without quarries close to their residence (p-value = 0.013). To conclude, ambient pollution levels are associated with internal metals’ concentrations, reaffirming the link between the two in the pathological pathway from air pollution to morbidity.

PMID:37245805 | DOI:10.1016/j.scitotenv.2023.164434