Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a complex metabolic disorder that increases the risk for cardiovascular disease in patients with type 2 diabetes mellitus (T2DM). Global longitudinal strain (GLS) is an indicator of left ventricular (LV) mechanics and can detect subclinical myocardial dysfunction. We compared the effects of pioglitazone and empagliflozin on GLS in patients with T2DM and NAFLD without established atherosclerotic cardiovascular disease. METHODS: This study was a 24-week randomized, single-blind, and parallel-group (1: 1 ratio) clinical trial. Seventy-three participants with T2DM (being treated with metformin) and NAFLD but without established atherosclerotic cardiovascular disease (ASCVD) were randomized to empagliflozin or pioglitazone. Liver steatosis and fibrosis were measured using transient elastography, and GLS was measured by echocardiography. The primary endpoint was the change in GLS from baseline to week 24. Secondary end points include changes in controlled attenuation parameter (CAP) and Liver stiffness measure (LSM). RESULTS: In this study, GLS improved by 1.56 ± 2.34% (P < 0.01) in the pioglitazone group and 1.06 ± 1.83% (P < 0.01) in the empagliflozin group without a significant difference between the two groups (P = 0.31). At baseline, GLS was inversely associated with the severity of liver fibrosis: r = - 0.311, P = 0.007. LSM in the pioglitazone and empagliflozin group [(-0.73 ± 1.59) and (-1.11 ± 1.33)] kpa (P < 0.01) decreased significantly. It was without substantial difference between the two groups (P = 0.26). Empagliflozin and pioglitazone both improved controlled attenuation parameter. The improvement was more critical in the empagliflozin group: -48.22 + 35.02 dB/m vs. -25.67 + 41.50 dB/m, P = 0.01. CONCLUSION: Subclinical cardiac dysfunction is highly important in patients with T2DM and with NAFLD. Empagliflozin and Pioglitazone improve LV mechanics and fibrosis in patients without established ASCVD. This has a prognostic importance on cardiovascular outcomes in high-risk patients with T2DM. Moreover, empagliflozin ameliorates liver steatosis more effectively them pioglitazone. This study can serve as a start point hypothesis for the future. Further studies are needed to explore the concept in larger populations. TRIAL REGISTRATION: This trial was registered in the Iranian Registry of Clinical Trials (IRCT): "A Comparison between the Effect of Empagliflozin and Pioglitazone on Echocardiographic Indices in Patients with Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease" IRCT20190122042450N5, 29 November 2020. https://www.irct.ir/search/result?query=IRCT20190122042450N5 .

Non-alcoholic fatty liver disease and compromised endothelial function in people with type 2 diabetes.

INTRODUCTION: Nonalcoholic fatty liver disease (NAFLD) frequently coexists with type 2 diabetes mellitus (T2DM) and synergistically contributes to the development of atherosclerosis. Flow-mediated dilation (FMD) is a commonly used noninvasive test for assessing endothelial function. The main objective of this study was to explore FMD in patients with T2DM with and without NAFLD. METHODS: In this cross-sectional study, conducted on people with T2DM, NAFLD was defined as controlled attenuation parameter (CAP) score > 302 dB/m. Endothelial dysfunction was detected when arterial FMD of brachial artery was equal or less than 0.7%. Regression analyses were applied to assess factors associated with impaired FMD. RESULT: A total of 147 patients (72 with NAFLD and 75 without NAFLD) were included in the final analysis. Patients with NAFLD were more likely to develop FMD ≤ 7% (77.8% vs. 58.7%, P = 0.01). In multivariate analysis, NAFLD (OR = 2.581, 95% CI (1.18-5.62), P = 0.017) and hypertension (HTN) (OR = 3.114, 95% CI (1.31-7.35), P = 0.010) were associated with an increased risk of impaired FMD. However, female sex was associated with a decreased risk of impaired FMD (OR = 0.371, 95% CI (0.15-0.87), P = 0.024). CONCLUSION: NAFLD is associated with endothelial dysfunction in people with T2DM. This risk is comparable with the risk imposed by HTN, highlighting the importance of screening and management of NAFLD in these patients.

The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.

BACKGROUND AND AIM: Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis. METHOD: We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m2 from 13 centers in Iran. Patients were treated for 12 weeks with a single daily pill containing 400-mg sofosbuvir and 60-mg daclatasvir. Patients with cirrhosis were treated for 24 weeks. Response to treatment was evaluated 12 weeks after end of treatment (sustained viral response [SVR]). ClinicalTrials.gov identifier: NCT03063879. RESULTS: A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. CONCLUSIONS: The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.

Metabolic Syndrome Is Associated with Health-Related Quality of Life in Suspected Patients with Nonalcoholic Steatohepatitis.

OBJECTIVE: This study was designed to examine the effect of metabolic syndrome (MetS) on health-related quality of life (HRQOL) in patients with suspected nonalcoholic steatohepatitis (NASH). SUBJECTS AND METHODS: Three hundred thirty-two patients (236 males and 96 females) with suspected NASH from the Amol cohort study were included in this study. MetS was diagnosed based on Adult Treatment Panel III criteria and HRQOL was measured using the 12-Item Short-Form Health Survey (SF-12) questionnaire (with 8 subscales and 2 summary components). A multivariable linear regression model was used to assess the independent effect of MetS on HRQOL. RESULTS: The mean age of the study population was 42 ± 13 years (range 18-82). The prevalence of MetS was 43.4% (n = 144) and the mean scores on the Physical Component Summary (PCS) and the Mental Component Summary were 72.4 ± 20.86 and 42.7 ± 12.42, respectively. The multivariable linear regression model showed that MetS was negatively associated with 4 subscales of HRQOL that included: role limitations due to physical problems (RP) (B = -14.05, p = 0.004), bodily pain (BP) (B = -7.37, p = 0.02), vitality (VT) (B = -7.72, p = 0.022), and role limitations due to emotional problems (RE) (B = -12.67, p = 0.005) after adjustment for other variables. Also, MetS had a borderline association with the general health and mental health subscales and the PCS (p < 0.1). CONCLUSION: In this study, there was a strong association between MetS and 4 subscales (RP, BP, VT, and RE) of HRQOL in patients with suspected NASH; this could be considered as a part of health policy to improve general health.

Identifying the pattern of unhealthy dietary habits among an Iranian population: A latent class analysis.

Background: An unhealthy diet is one of the most important risk factors for chronic diseases. The goal of this study was to use the latent class analysis (LCA) modeling to define unhealthy diet habits among an Iranian population. Methods: This cross-sectional study was conducted within the framework of Amol (North of Iran) cohort health study (Phase 1). The participants aged 10 to 90 years. All participants provided written informed consent. Latent class analysis was used to classify the participants of the study. All analyses were conducted by PROC LCA in SAS 9.2 software. Significance level was set at 0.05. Results: The mean age of the participants was 42.58±17.23 years. Four classes of individuals with different diet habits were identified using LCA modeling: class 1: individuals with healthy diet patterns (92.6%); class 2: individuals with slightly unhealthy diet habits (6.3%); class 3: individuals with relatively unhealthy diet habits (0.8%); and class 4: individuals with unhealthy diet habits (0.2%). Being female and alcohol consumption increased the odds of membership in latent classes 2,3, and 4 compared to class 1. Physical activity decreased the odds of membership in classes 3 and 4 compared to class 1. Conclusion: Overall, almost more than 7.4% of all participants had some degree of unhealthy dietary habits, and some variables acted as risk factors for membership in risky classes. Therefore, focusing on these variables may help design and execute effective preventive interventions in groups with unhealthy dietary habits.

Pattern of body mass index, chronic diseases, and physical component of quality of life in a population in North of Iran: A latent class analysis.

Background: Due to the rise of non-communicable diseases (NCDs) and lifestyle changes, this study aimed at determining the subclasses of Iranian adults based on body mass index, some NCDs, and status of physical component of quality of life. Methods: A total of 5207 participants of Amol cohort study were studied in this study. Latent class analysis (LCA) was used to determine the best model with the minimum AIC or BIC. Results: We decided that the 6 latent classes model was the best model. The first class described 35.1% of the participants and was characterized by individuals with no disease status. The sixth class described 0.7% of the individuals and was characterized by individuals exhibiting high probability of body mass index (BMI) equal or more than 25, kidney inadequacy, hypertension, and moderate physical component of quality of life status. Conclusion: This study showed the pattern of body mass index, chronic diseases, and physical component of quality of life. Our findings demonstrated that some risk factors and non-communicable diseases tend to accumulate in some classes, especially classes 5 and 6, and thus the risk of developing these diseases rises along with increase in their clustering abilities. These results point out the critical importance of designing specific preventive interventional programs for these stratums of individuals.

Application of the short form of quality of life instrument version 2 in a large population of Tehran.

Background: Quality of life (QoL) is now considered as a key indicator in health studies. Therefore, this study was conducted to evaluate QoL in the general population of Tehran (capital of Iran) using SF-12v2 questionnaire and determine some factors associated with it. Methods: This was part of a large population-based cross sectional study conducted in Tehran, Iran, in 2011. Participants were selected from all districts of Tehran using multistage cluster random sampling method. Data were collected using the Iranian version of the SF12v2 questionnaire. Linear regression model was used to assess the independent effect of surveyed variables of the study population on their QoL. P< 0.05 was considered statistically significant. Results: Overall, 30 809 individuals over the age of 20 from 22 urban districts were included in this study and evaluated by SF-12v2 questionnaire. The mean age of the study population was 44.5±15.9, and most of them were female (19 967 (64.8%)). The total mean score of SF-12v2 was 60.4 and the lowest and highest mean scores were observed in GH (46.9±26.5) and MH subscales (64.1±24.7), respectively. It was also observed that District 3 of Tehran had the highest mean score (65.2±18.7) in the total QoL and District 12 had the lowest mean score (56.6±18.7), respectively. The results of multiple linear regression model showed that sex, age, education, household size, presence of chronic disease in family, having insurance, smoking, and marital status were significantly related to most subscales and two summary components of QoL. Conclusion: The results of this study showed that the surveyed population of Tehran had a relatively moderate QoL, but it changed from district to district. It was also observed that age and education of the study population were important variables in relation to QoL.

Is household food insecurity a determinant of weight status in patients with type 2 diabetes in rural areas?

Background: There is mixed evidence about food insecurity and overweight/obesity coexisting, however it is unclear about association between food insecurity and weight status in people with type 2 diabetes. Therefore, the aim of this study was to evaluate the relationship between food insecurity and weight status in individuals with type 2 diabetes in rural areas in Iran. Methods: 1847 patients with type 2 diabetes who were residence in rural areas completed Household Food Security Scale (six-item short questionnaire). Logistic regression model was applied to assess the independent effect of food insecurity on weight status. Results: Mean age of the study population was 62.6±11.8 years, and the majority of them were female (70.4%). Most of the study population (70.4%) had unhealthy weight status. Food insecurity affected more than 46% (n=852) of the households of the study population. According to weight status, more than 40% (n=565) of overweight and obese subjects and 60% (n=18) of underweight subjects lived in households with food insecurity. The results of multiple logistic regression model showed that food insecurity was not an independent significant predictor of overweight or obesity in patients with type 2 diabetes. However, low food security (LFS) was an independent significant predictor for underweight in patients with type 2 diabetes (OR=2.35, P=0.041). Conclusion: It is concluded that food insecurity was frequent in all levels of weight status of patients with type 2 diabetes in rural regions. However this association observed in underweight individuals but there was no significant overall relationship between household food insecurity and in overweight and obesity in this group of patients.

Serum Alkaline Phosphate Level Associates with Metabolic Syndrome Components Regardless of Non-Alcoholic Fatty Liver; A Population-Based Study in Northern Iran.

Background: Serum alkaline phosphatase (ALP) is an indicator of hepatobiliary disorders, such as metabolic syndrome (MetS). To assess the association between serum ALP levels and MetS, with or without non-alcoholic fatty liver disease (NAFLD), in a cohort study in northern Iran. Methods: Data from approximately 5257 subjects aged more than 18 years participating in the Amol cohort were used. We extracted the required data and investigated the correlation between liver enzyme levels and MetS. Multiple logistic regression analyses based on the serum ALP quartiles were performed. Results: Of them, 2860 were male with a mean age of 42.11±16.1 years. A positive linear trend was observed between serum ALP levels and the number of MetS components in both sexes. In both sexes, systolic blood pressure, waist circumferences, and high-density lipoprotein (HDL) had a significant association with ALP. After adjusting for age, both sexes with NAFLD showed an increased risk of developing MetS. The risk of NAFLD increased in individuals with>2nd quartile of ALP. Furthermore, higher ALP levels were associated with an increased risk of MetS in males (1.1014 [0.782-1.315]) and females (1.441 [1.085-1.913]). Conclusion: There is a significant association between serum ALP levels and MetS, independent of fatty liver changes, suggesting that this marker can be considered as a feasible predictor of MetS.

Household Food Insecurity and Associated Factors among Iranian Patients with Esophageal and Gastric Cancers.

Background: Household food insecurity (HFI) which has still been one of the major global public health issues is related to adverse health outcomes in individuals. Therefore, this study aimed to determine the prevalence of HFI and its associated factors in Iranian patients with esophageal and gastric cancers. Methods: The data of this cross-sectional study was obtained from 315 patients with esophageal and gastric cancers who were selected from a gastrointestinal cancer-based cohort study conducted in Firoozgar hospital, in Tehran. Food insecurity (FI) was measured using the Iranian version of the HFI questionnaire that was completed by a trained interviewer. The multivariable logistic regression model was used to determine the independent association of each factor with HFI. A P value lower than 0.05 was considered statistically significant. Results: The mean±SD of participants' age was 63.2±12.6 years and 65.4% were men. Most of the patients (75.8%) suffered from gastric cancer and 24.2% from esophageal cancer. The overall prevalence of FI among participants' households was 35.2%. There was an independent significant association between wealth index (WI) and HFI after the use of the multivariable logistic regression model, in such a way that the odds of FI in the poorest, poor, moderate, and rich patients' households were respectively, 6.41, 5.05, 2.74 and 2.04 times higher compared with the richest households. Conclusion: More than a third of participants' households struggled with FI, which was found to have a higher prevalence in loweconomic households. Therefore, health policymakers should intervene in food-insecure households by developing, establishing, and implementing strategies and control programs to improve affordable food access.

Proposing Novel Data Analytics Method for Anatomical Landmark Identification from Endoscopic Video Frames.

BACKGROUND: The anatomical landmarks contain the characteristics that are used to guide the gastroenterologists during the endoscopy. The expert can also ensure the completion of examination with the help of the anatomical landmarks. Automatic detection of anatomical landmarks in endoscopic video frames can be helpful for guiding the physicians during screening the gastrointestinal tract (GI). METHOD: This study presents an automatic novel method for anatomical landmark detection of GI tract from endoscopic video frames based on semisupervised deep convolutional neural network (CNN) and compares the results with supervised CNN model. We consider the anatomical landmarks from Kvasir dataset that includes 500 images for each class of Z-line, pylorus, and cecum. The resolution of these images varies from 750 × 576 up to 1920 × 1072 pixels. RESULT: Experimental results show that the supervised CNN has highly desirable performance with accuracy of 100%. Also, our proposed semisupervised CNN can compete with a slight difference similar to the CNN model. Our proposed semisupervised model trained using 1, 5, 10, and 20 percent of training data records as labeled training dataset has the average accuracy of 83%, 98%, 99%, and 99%, respectively. CONCLUSION: The main advantage of our proposed method is achieving the high accuracy with small amount of labeled data without spending time for labeling more data. The strength of our proposed method saves the required labor, cost, and time for data labeling.

Concurrent Collagenous Gastritis and Collagenous Colitis: A Case Presentation and Review of the Literature.

Collagenous gastritis is a rare gastrointestinal condition, and its presence with collagenous colitis may be an exception. We describe a 31-year-old man with simultaneous collagenous gastritis and collagenous colitis. The patient initially presented with dyspepsia, anemia, and weight loss. Endoscopy assessment revealed irregular gastric atrophy with the normal colon. Gastric biopsies illustrated increased thickness and subepithelial collagen band.

Acute liver failure after vaccination against of COVID-19; a case report and review literature.

BACKGROUND: Vaccination against COVID-19 remains as a main root of COVID-19 prevention. Few vaccines have been launched for this purpose recently with different side effects. Thrombotic events have been reported as a rare side effect after ChAdox1nCOV-19 vaccination that may cause death of recipient. CASE PRESENTATION: We report a case of hepatic artery occlusion after the first dose vaccination by ChAdOx1nCov-19. The patient was a health care worker, aged 34-year old. Past medical history was unremarkable and had not used heparin. Over the next couple of days after the vaccination, he reported headache, nausea, and dizziness as well as abdominal pain. His general status and the laboratories studies deteriorate quickly by increasing liver enzymes and severe coagulopathy. Clinically he had presented acute hepatic failure. He had been received blood products, prednisolone pulse along with broad antibiotics without benefit. He died on the sixth day. CONCLUSIONS: Thrombotic events after vaccination is very rare but can develop in main arteries with lethal outcome. This event may mimic autoimmune thrombosis clinically.

Association between Melatonin Value and Interleukins1B, -18, and -33 Levels in Patients with Different Stages of Non-Alcoholic Fatty Liver Disease.

BACKGROUND: Interaction between immune modulators and inflammatory factors is considered as one of the main underlying pathologies of non-alcoholic fatty liver disease (NAFLD). Hence we aimed to assess the association between these cytokines and melatonin. METHODS: We enrolled adult patients diagnosed with fatty liver by ultrasonography in a crosssectional study. All of them underwent Fibroscan evaluation. The subjects who met the inclusion and exclusion criteria for NAFLD were involved. A normal group who did not have NAFLD, viral or non-viral hepatitis, and without a history of pancreatobiliary surgery, bariatric surgery, and intake of any medication that influence the liver was also selected. The participants were categorized into the three following groups: 1) fibrosis>9.1 kPa and steatosis>290 dbm, 2) fibrosis: 6-9.0 kPa and steatosis 240-290 dbm, and 3) normal group with fibrosis<6.0 kPa and steatosis<240 dbm. Laboratory assessment and a questionnaire including demographic, anthropometric, laboratories, and clinical data were completed for each of them. RESULTS: Totally 97 subjects were enrolled in the present study. The mean age of the subjects was 42.2±11.3 years. 60% of them (59 patients) were female. Serum levels of melatonin, interleukin (IL)-1B, IL-18, and IL-33 increased according to the advancing of NAFLD state. Based on multiple linear regression model, melatonin was significantly associated with IL-1B (ß=2.8, P<0.001,95% CI=1.41-4.19), IL-18 (ß=0.018, P=0.0005, 95% CI=0.006-0.03), and IL-33 (ß=0.31, P=0.045, 95% CI=0.008-0.62) after adjustment for other variables. CONCLUSION: Melatonin level has a strong association with these cytokines. This linkage probably influences on the development and progression of NAFLD. Therefore it can be hypothesized that the therapeutic approach that affects this process may have a significant impact.

A randomized triple-blind controlled clinical trial evaluation of sitagliptin in the treatment of patients with non-alcoholic fatty liver diseases without diabetes.

The current study aimed to evaluate the efficacy of sitagliptin vs. placebo in treating non-alcoholic fatty liver disease (NAFLD). In a triple-blind randomized clinical trial, we assigned 120 eligible subjects with NAFLD to receive daily dosing of 50 mg sitagliptin (n = 60) or the placebo (n = 60) for 56 weeks and lifestyle modification in both groups. Laboratory and anthropometric outcomes were measured, and liver stiffness was assessed using a fibroscan. The primary outcome measures were changes from baseline in fibrosis scores and liver transferases. Out of 120 patients randomized into sitagliptin and placebo groups, 76 patients completed the trial, of whom 44 were in the sitagliptin and 32 in the placebo groups. Patients receiving sitagliptin showed a significant decrease in the fibrosis scores (P = 0.001). The reductions in the alanine aminotransferase (AST) (P = 0.036) and aspartate AST (P < 0.001) levels were also statistically significant. The effect of sitagliptin in reducing fibrosis scores was significantly greater in normal-weight and overweight individuals than in obese individuals (p = 0.036, and p = 0.018, respectively), whereas the effects of sitagliptin on AST levels were greater among overweight/obese patients (p = 0.028, and p = 0.016, respectively). Sitagliptin reduced fibrosis scores and liver enzymes in NAFLD patients after 56 weeks of therapy. The changes in fibrosis scores were more prominent in patients with normal weight and overweight than obese patients, whereas the effects on AST levels were greater among overweight/obese patients. Other randomized trials with larger sample sizes and longer treatment durations may be required before precise results can be reached. Clinical Trial Registration: [https://www.irct.ir/trial/46140], identifier [IRCT20140430017505N2].

Different Effects of Aerobic Exercise and Diaphragmatic Breathing on Lower Esophageal Sphincter Pressure and Quality of Life in Patients with Reflux: A Comparative Study.

BACKGROUND Gastroesophageal reflux disease (GERD) is a worldwide disorder with an increasing prevalence. The quality of life (QOL) of the patients may be influenced by reflux disease. Diaphragmatic breathing (DB), as well as aerobic exercise (AE), may improve the symptoms of reflux disease, although it remains a controversial issue. The aim of this study was to compare the effects of AE and DB on QOL and lower esophageal sphincter (LES) pressure of patients with moderate to severe reflux. METHODS This was a case-control study that was conducted for 8 weeks among patients with moderate to severe GERD. The block randomization method was designed to randomize patients into three groups (AE, DB, and control) to achieve equal sample sizes. The control group received omeprazole 20 mg once daily. The other groups, in addition to omeprazole, received AE and DB. QOL and LES pressure were measured before and after the study by Questionary and Manometry method, respectively. RESULTS 75 patients were enrolled in this study. Positive effects of DB on LES pressure was approved (p = 0.001). DB had significantly more effects on QOL than aerobic exercise (p = 0.003). AE can significantly improve QOL in patients (p = 0.02) but no significant change in LES pressure (p = 0.38). There was no change in the control group for both variables. CONCLUSION AE had no effects on LES pressure but can improve QOL of the patients. DB had more effects on QOL than AE, so injured or disable patients with reflux who cannot do AE, can benefit from DB to improve their reflux symptoms.

Characterization of biliary microbiota dysbiosis in extrahepatic cholangiocarcinoma.

Extrahepatic cholangiocarcinoma (CCA) accounts for 3% of digestive cancers. The role of biliary microbiota as an environment-related modulator has been scarcely investigated in CCA, and the putative impact of associated diseases has not been yet assessed. We characterized the biliary microbiota in CCA patients in order to identify a specific CCA-related dysbiosis. The biliary effluents were collected through an endoscopic retrograde pancreatic cholangiography (ERCP) examination involving 28 CCA and 47 patients with gallstones, herein considered as controls. The biliary effluents were submitted to bacterial DNA extraction and 16S rRNA sequencing, using Illumina technology. Overall, 32% of CCA and 22% of controls displayed another associated disease, such as diabetes, pancreatitis, inflammatory bowel disease, or primary sclerosing cholangitis. Such associated diseases were considered in the comparisons that were made. Principal coordinate analysis (PCoA) detected a significant disparity of biliary microbiota composition between CCA patients and controls without an associated disease. Amongst the most abundant phyla, Proteobacteria did not significantly differ between CCA patients and controls, whereas Firmicutes levels were lower and Bacteroidetes higher in CCAs' biliary microbiota than in the controls' microbiota. The most abundant genera were Enterococcus, Streptococcus, Bacteroides, Klebsiella, and Pyramidobacter in CCA's biliary microbiota. Additionally, levels of Bacteroides, Geobacillus, Meiothermus, and Anoxybacillus genera were significantly higher in CCA patients' biliary microbiota, without an associated disease, in comparison with controls. A specific CCA-related dysbiosis was identified as compared to controls independently from associated diseases. This suggests that a microorganism community may be involved in CCA pathogenesis.

Clinical features of pregnant women in Iran who died due to COVID-19.

BACKGROUND: To evaluate the clinical presentation of pregnant women in Iran who died due to COVID-19. METHODS: Data were evaluated of pregnant women who died following a laboratory diagnosis of COVID-19. The data were obtained from electronic medical records. Additionally, a questionnaire was completed for each patient, including demographic, clinical, laboratorial, imaging, and treatment data. In case of missing information, a member of the research team contacted the first-degree relatives via phone. RESULTS: Of 32 pregnant women who tested positive for COVID-19, 15 were enrolled into the study (mean age 30.0 ± 5.0 years). The mean time from first symptoms to death was 12 ± 7.0 days. Pre-existing comorbidities were seen in six patients. The main presentations at admission were fatigue and coughing, but most of the women had a fever below 38 °C. Increased white blood cell count and neutrophils were noticeable. A significant drop of saturation of O2 with ground glass and consolidation seen in both lungs were prominent. The most common complications were acute respiratory distress syndrome followed by respiratory failure. CONCLUSION: Computed tomography findings, O2 pressure, and regular blood assessment may be considered suitable indicators for the surveillance of patients.

Are Serum Levels of Nuclear Factor Kappa B and Forkhead Box Protein P3 in Patients with Non-Alcoholic Fatty Liver Disease Related to Severity of Fibrosis?

BACKGROUND Inflammation has a significant impact on the development and progression of fatty liver diseases.In this study, we aimed to investigate the relation between serum levels of nuclear factor kappa B (NFkB) and Forkhead box protein P3 (FOXP3)with fibrosis severity among patients with non-alcoholic fatty liver disease(NAFLD). METHODS In a prospective study, the patients suspicios of havingfatty liver were enrolled. The exclusion criteria lack of viral hepatitis, autoimmune hepatitis, Wilson's or other known liver diseases,history of liver or biliary surgery,bariatric surgery, and medications that influence liver metabolism. The participantsunderwent liver fibroscan. According to liver fibrosis, the patients weredivided into two groups; 1)fibrosis less than 7.2 KP,2)advanced NAFLD, fibrosis ≥7.3 KP. A10 cc fasting blood sample was taken from each patient for laboratory assessments.The variables between the two groups were compared using Chi-square or Fisher's exact test.The independence of cytokines was assessed by a logistic regression test. RESULTS Totally 90 patients were enrolled.The mean age was 42.21 ± 11 years. Of them, 50 and 47 participants were allocated to groups 1 and 2, respectively. In the univariate analysis, we revealed asignificant difference between age, body mass index (BMI), fasting blood glucose, liver enzymes, total cholesterol, andtriglyceride levels. Also, there was a significant difference betweenthe levels of NFKB and FOXP3 in group one compared with group two of the participants,as FOXP3(9.17 ± 10.0 vs. 18.63 ± 12.9; p < 0.001) and NFKB (1.70 ± 1.70; p < 0.01). After excluding the confounding factors, we observed a significant association between fibrosis level and cytokine levels in logistic regression. CONCLUSION Serum levels of NFKB and FOXP3 increased by advancing liver fibrosis in patients with NAFLD.This is an independent association. The identification of intermediary regulatory factors would be necessary.