Polypill for prevention of cardiovascular disease in an Urban Iranian population with special focus on nonalcoholic steatohepatitis: A pragmatic randomized controlled trial within a cohort (PolyIran - Liver) – Study protocol

Background: Cardiovascular disease (CVD) is among the most common causes of mortality in all populations. Nonalcoholic steatohepatitis is a common finding in patients with CVD. Prevention of CVD in individual patients typically requires periodic clinical evaluation, as well as diagnosis and management of risk factors such as hypertension and hyperlipidemia. However, this is resource consuming and hard to implement, especially in developing countries. We designed a study to investigate the effects of a simpler strategy: a fixed-dose combination pill consisting of aspirin, valsartan, atorvastatin and hydrochlorthiazide (PolyPill) in an unselected group of persons aged over 50 years. Design: The PolyIran-Liver study was performed in Gonbad city as an open label pragmatic randomized controlled trial nested within the Golestan Cohort Study. We randomly selected 2,400 cohort study participants aged above 50 years, randomly assigned them to intervention or usual care and invited them to participate in an additional measurement study (if they met the eligibility criteria) to measure liver related outcomes. Those agreeing and randomized to the intervention arm were offered a daily single dose of PolyPill. We will follow participants for 5 years. The primary outcome is major cardiovascular events, secondary outcomes include all-cause mortality and liver related outcomes: liver stiffness and liver enzyme levels. Cardiovascular outcomes and mortality will be determined from the cohort study and liver-related outcomes in those consenting to follow up. Analysis will be by allocated group. Trial Status: Between October and December 2011, 1,320 intervention and 1,080 control participants were invited to participate in the additional measurement study. For all these participants, the major cardiovascular events will be determined using blind assessment of outcomes through the cohort study. In the intervention and control arms, 875 (66%) and 721 (67%) respectively, met the eligibility criteria and agreed to participate in the additional measurement study. Liver related outcomes will be measured in these participants. Of the 1,320 participants randomized to the intervention, 787 (60%) accepted the PolyPill. Conclusion: The PolyIran-liver urban study will provide us with important information on the effectiveness of PolyPill on major cardiovascular events, all-cause mortality and liver related outcomes. (ClinicalTrials.gov ID: NCT01245608). © 2015, Academy of Medical Sciences of I.R. Iran. All rights reserved

Differentiation between Pancreatic Ductal Adenocarcinoma and Normal Pancreatic Tissue for Treatment Response Assessment using Multi-Scale Texture Analysis of CT Images

Background: Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent type of pancreas cancer with a high mortality rate and its staging is highly dependent on the extent of involvement between the tumor and surrounding vessels, facilitating treatment response assessment in PDAC. Objective: This study aims at detecting and visualizing the tumor region and the surrounding vessels in PDAC CT scan since, despite the tumors in other abdominal organs, clear detection of PDAC is highly difficult. Material and Methods: This retrospective study consists of three stages: 1) a patch-based algorithm for differentiation between tumor region and healthy tissue using multi-scale texture analysis along with L1-SVM (Support Vector Machine) classifier, 2) a voting-based approach, developed on a standard logistic function, to mitigate false detections, and 3) 3D visualization of the tumor and the surrounding vessels using ITK-SNAP software. Results: The results demonstrate that multi-scale texture analysis strikes a balance between recall and precision in tumor and healthy tissue differentiation with an overall accuracy of 0.78±0.12 and a sensitivity of 0.90±0.09 in PDAC. Conclusion: Multi-scale texture analysis using statistical and wavelet-based features along with L1-SVM can be employed to differentiate between healthy and pancreatic tissues. Besides, 3D visualization of the tumor region and surrounding vessels can facilitate the assessment of treatment response in PDAC. However, the 3D visualization software must be further developed for integrating with clinical applications

The prevalence of hepatitis B surface antigen and anti-hepatitis B core antibody in Iran: A population-based study

Background: Hepatitis B virus infection is a very common cause of chronic liver disease worldwide. It is estimated that 3 of Iranians are chronically infected with hepatitis B virus. Current population-based studies on both rural and urban prevalence of hepatitis B virus infection in Iran are sparse with results that do not always agree. We performed this study to find the prevalence of hepatitis B surface antigen, anti-hepatitis B core antibody, and associated factors in the general population of three provinces of Iran. Methods: We randomly selected 6,583 subjects from three provinces in Iran, namely Tehran, Golestan, and Hormozgan. The subjects were aged between 18 and 65 years. Serum samples were tested for hepatitis B surface antigen and anti-hepatitis B core antibody. Various risk factors were recorded and multivariate analysis was performed. Results: The prevalence of hepatitis B surface antigen and anti-hepatitis B core antibody in Iran was 2.6 and 16.4, respectively. Predictors of hepatitis B surface antigen or anti-hepatitis B core antibody in multivariate analysis included older age, not having high-school diploma, living in a rural area, and liver disease in a family member. We did not find any significant differences between males and females. Conclusion: In spite of nationwide vaccination of newborns against hepatitis B virus since 1992, hepatitis B virus infection remains a very common cause of chronic liver disease in Iran which should be dealt with for at least the next 30-50 years

Clinical Utilization of the FilmArray Meningitis/Encephalitis (ME) Multiplex Polymerase Chain Reaction (PCR) Assay

Objective: To assess the clinical utilization and performance of the FilmArray® Meningitis/Encephalitis (ME) multiplex polymerase chain reaction (PCR) panel in a hospital setting.Background: Rapid diagnosis and treatment of central nervous system (CNS) infections are critical to reduce morbidity and mortality. The ME panel is a Food and Drug Administration (FDA) approved rapid multiplex PCR assay that targets 14 bacteria, viruses, and fungi. Previous studies show an overall agreement of 93–99% between the ME panel and conventional diagnostic testing. However, few studies have evaluated the clinical implementation of the ME assay, which is available for routine use at our institution.Methods: We performed a single center retrospective chart review of inpatients who underwent ME panel testing from August 2016 to May 2017. Clinical, radiologic, and laboratory data were reviewed to determine the clinical significance of results. Indication for lumbar puncture (LP), time to results of the ME panel, and duration of antimicrobial therapy were evaluated.Results: Seven hundred and five inpatients underwent ME testing, of whom 480 (68.1%) had clinical suspicion for CNS infection with 416 (59.0%) receiving empiric antimicrobial treatment for CNS infection. The median time-to-result of the ME panel was 1.5 h (IQR, 1.4–1.7). Overall agreement between the ME panel results and clinico-laboratory assessment was 98.2%. Forty-five patients tested positive by ME, of which 12 (26.6%) were determined likely to be clinically insignificant.Conclusions: Routine availability of the ME panel led to overutilization of diagnostic test ordering, as demonstrated by the fact that over one-third of ME panel tests performed were ordered for patients with little or no suspicion for CNS infection. The median time from LP to ME panel result was 1.5 h (IQR, 1.4–1.7). The ME panel's rapid turn-around time contributed to the overuse of the test. Approximately one-quarter of positive ME results were deemed clinically insignificant, though the impact of these positive results requires additional evaluation. Twenty-four and forty-eight hours after the ME panel resulted, 68 and 25% of patients started on empiric therapy remained on antibiotics, respectively. The median time from diagnosis to discontinuation and/or narrowing of antibiotic coverage was 25.6 h (IQR, 3.6–42.5). Further consideration of the appropriate indications for use of the ME panel in clinical settings is required

CovidCTNet: an open-source deep learning approach to diagnose covid-19 using small cohort of CT images

Coronavirus disease 2019 (Covid-19) is highly contagious with limited treatment options. Early and accurate diagnosis of Covid-19 is crucial in reducing the spread of the disease and its accompanied mortality. Currently, detection by reverse transcriptase-polymerase chain reaction (RT-PCR) is the gold standard of outpatient and inpatient detection of Covid-19. RT-PCR is a rapid method; however, its accuracy in detection is only ~70�75. Another approved strategy is computed tomography (CT) imaging. CT imaging has a much higher sensitivity of ~80�98, but similar accuracy of 70. To enhance the accuracy of CT imaging detection, we developed an open-source framework, CovidCTNet, composed of a set of deep learning algorithms that accurately differentiates Covid-19 from community-acquired pneumonia (CAP) and other lung diseases. CovidCTNet increases the accuracy of CT imaging detection to 95 compared to radiologists (70). CovidCTNet is designed to work with heterogeneous and small sample sizes independent of the CT imaging hardware. To facilitate the detection of Covid-19 globally and assist radiologists and physicians in the screening process, we are releasing all algorithms and model parameter details as open-source. Open-source sharing of CovidCTNet enables developers to rapidly improve and optimize services while preserving user privacy and data ownership. © 2021, The Author(s)

Diagnostic Accuracy of Age and Alarm Symptoms for Upper GI Malignancy in Patients with Dyspepsia in a GI Clinic: A 7-Year Cross-Sectional Study

<div><h3>Objectives</h3><p>We investigated whether using demographic characteristics and alarm symptoms can accurately predict cancer in patients with dyspepsia in Iran, where upper GI cancers and <em>H. pylori</em> infection are common.</p> <h3>Methods</h3><p>All consecutive patients referred to a tertiary gastroenterology clinic in Tehran, Iran, from 2002 to 2009 were invited to participate in this study. Each patient completed a standard questionnaire and underwent upper gastrointestinal endoscopy. Alarm symptoms included in the questionnaire were weight loss, dysphagia, GI bleeding, and persistent vomiting. We used logistic regression models to estimate the diagnostic value of each variable in combination with other ones, and to develop a risk-prediction model.</p> <h3>Results</h3><p>A total of 2,847 patients with dyspepsia participated in this study, of whom 87 (3.1%) had upper GI malignancy. Patients reporting at least one of the alarm symptoms constituted 66.7% of cancer patients compared to 38.9% in patients without cancer (p<0.001). Esophageal or gastric cancers in patients with dyspepsia was associated with older age, being male, and symptoms of weight loss and vomiting. Each single predictor had low sensitivity and specificity. Using a combination of age, alarm symptoms, and smoking, we built a risk-prediction model that distinguished between high-risk and low-risk individuals with an area under the ROC curve of 0.85 and acceptable calibration.</p> <h3>Conclusions</h3><p>None of the predictors demonstrated high diagnostic accuracy. While our risk-prediction model had reasonable accuracy, some cancer cases would have remained undiagnosed. Therefore, where available, low cost endoscopy may be preferable for dyspeptic older patient or those with history of weight loss.</p> </div

Potential MR enterography features to differentiate primary small intestinal lymphoma from Crohn disease

OBJECTIVE. The purpose of this study was to assess the MR enterographic features of primary small intestinal lymphoma (PSIL) and compare them with active Crohn disease (CD) presenting with severe (≥ 10 mm) mural thickening of the small bowel. MATERIALS AND METHODS. This retrospective study included 15 patients with pathologically proven PSIL and 15 patients with active inflammatory CD with severe mural thickening. Various morphologic, enhancement, and diffusion parameters were compared between the two groups at MR enterography. The ratios of the upstream to involved luminal diameter and mural thickness to luminal diameter in the involved segment were calculated. An attempt was made to define a predictive model (morphologic score) for discriminating PSIL from CD with severe mural thickening. RESULTS. Patients with PSIL were more likely than those with CD to have unifocal disease (66.7% vs 20.0%, p = 0.025), circumferential involvement (86.7% vs 26.7%, p &lt; 0.001), luminal dilatation (60.0% vs 7.0%, p = 0.005), and an attenuated fold pattern (53.3% vs none, p &lt; 0.001). They were less likely to have serosal surface involvement (40.0% vs 100%, p = 0.001) and mesenteric fat infiltration (33.3% vs 100%, p &lt; 0.001). Median upstream to involved luminal diameter ratio (1.5 vs 9.6, p &lt; 0.001) and mural thickness to involved luminal diameter ratio (1.1 vs 4.3, p = 0.044) were significantly lower in patients with PSIL than in those with CD with severe mural thickening. No significant difference was observed in enhancement and diffusion measures. Morphologic score was based on the presence of luminal dilatation, unifocal involvement, mesenteric fat infiltration, and luminal stricture, yielding accuracy of 98% for differentiation between PSIL and CD with severe mural thickening. CONCLUSION. Morphologic features seen at MR enterography rather than enhancement or diffusion parameters may be valuable for differentiation of PSIL from active CD with severe mural thickening with significantly lower ratios of upstream to involved luminal diameter and mural thickness to involved luminal diameter in PSIL

Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trial

AIMS: Individuals with non-alcoholic steatohepatitis or elevated liver enzymes have increased cardiovascular mortality but are often excluded from prevention trials. We investigated the effectiveness of fixed-dose combination therapy for the prevention of major cardiovascular events (MCVE) among individuals with and without presumed non-alcoholic steatohepatitis (pNASH). METHODS AND RESULTS: Two thousand four hundred participants over 50 were randomized into the intervention and control groups. Consent was obtained post-randomization. Consenting participants in the intervention group were given a pill containing aspirin, atorvastatin, hydrochlorothiazide, and valsartan (polypill). Participants were followed for 5 years. Presumed non-alcoholic steatohepatitis was diagnosed by ultrasonography and elevated liver enzymes. The primary outcome was MCVE. ClinicalTrials.gov: NCT01245608. Among the originally randomized population, 138 of 1249 in the intervention group (11.0) and 137 of 1017 controls (13.5) had MCVE during the 5-year follow-up unadjusted risk ratio (RR) 0.83, 95% confidence interval (CI) 0.66-1.03. Of the 1508 participants who consented to additional measurements and treatment, 63 of 787 (8.0%) intervention group participants and 86 of 721 (11.9%) controls had MCVE (adjusted RR 0.61, 95% CI 0.44-0.83). Although the adjusted relative risk of MCVE in participants with pNASH (0.35, 95% CI 0.17-0.74) was under half that for participants without pNASH (0.73, 95% CI 0.49-1.00), the difference did not reach statistical significance. There was no change in liver enzymes in participants taking polypill but among those with pNASH, there was a significant decrease after 60 months of follow-up (intragroup -12.0 IU/L, 95% CI -14.2 to -9.6). CONCLUSION: Among patients consenting to receive fixed-dose combination therapy, polypill is safe and effective for the prevention of MCVE, even among participants with fatty liver and increased liver enzymes. © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. All rights reserved. For permissions, please e-mail: [email protected]