Comparative Analysis of Mortality Rates among Morbidly Obese Individuals: A Study of Patients Undergoing Bariatric Surgery, Nonsurgical Morbidly Obese Individuals, and the General Population.

INTRODUCTION: Mortality decreases following bariatric surgery. We explored the extent of the reduction and whether or not it reaches the general population level in a large cohort of patients with obesity. This study aimed to compare all-cause mortality between patients with obesity who undergo bariatric surgery and those who do not, with the general Iranian population during the same period. METHOD: Data from Iran's National Obesity Surgery Database were used to establish a large cohort of patients registered between 2009 and 2019. The current vital status of the patients was determined by utilizing post-surgery follow-up data for those who underwent the operation. For patients without a surgery record, a predefined checklist was filled out through telephone interviews. Death data from the National General Registrar's office were obtained for all cohort members. RESULTS: Of 13,313 cohort members, 12,915 were eligible for analysis. The median age at the first visit was 38 years, and 78% were women. 6,190 patients (47.9%) underwent bariatric surgery, and 6,725 patients (52.1%) were not yet operated on at the time of analysis. We observed 139 deaths during 53,880 person-years follow-ups. The median follow-ups for operated-on and not operated-on groups were 4 and 4.8 years. The mortality rates among nonoperated patients were 2.89 times higher (standardized mortality ratio [SMR] = 2.89, 95% CI: 2.36-3.53) than those in the general population, while in operated patients, the mortality rate decreased to 1.82 as high (SMR = 1.82, 95% CI: 1.34-2.46). CONCLUSION: The risk of death has been diminished in the operated-on group. It still remains considerably higher than the risk in the general population.

The 15-year national trends of urinary cancers incidence among Iranian men and women; 2005-2020.

BACKGROUND: Urinary tract cancers including bladder, kidney, ureter, and pelvis are a common malignancy worldwide with high mortality ratio. Aimed to investigate the prevalence of these cancers, we conducted this study. METHODS: In this study, all the information related to ICD10 codes, gender, age and province of residence of individuals were obtained from the data of Iran's cancer registry by the Ministry of Health, Medicine and Medical Education and demographic evidence for each sub-country from the reports of Statistics Center of Iran (SCI). Also, the data of two Iranian national survey studies CASPIAN-III, IV, and V (information related to the care and prevention of non-communicable diseases (NCD) in childhood and adolescence) and STEPs (including information on NCD in adults over 18 years old) were used. The data was analyzed using Poisson regression with mixed effects to estimate the incidence of cancers. RESULTS: Bladder and kidney neoplasm are the most common cancers of the urinary system in Iran. The prevalence of bladder cancer has increased from 5.82 to 11.50 per 100,000 individuals. The increasing trend is growing faster in men compared with women. The incidence of kidney neoplasm has increased over the years (2.03 in 2005 vs. 7.02 in 2020 per 100,000). Having a higher incidence ratio compared with bladder cancer, kidney cancer is responsible for 35.06% of all urinary cancers in 2020 compared with 23.71% in 2005. Both neoplasms of the ureter and renal pelvis were recorded rarely and with lower incidence in both sexes during this period. CONCLUSION: Considering the increasing trend in the incidence of urinary neoplasms in Iran during these years, the advantage of focusing on the risk of urinary cancers is highlighted. Therefore, investigating the prevalence and incidence of urinary cancers to plan and manage these cancers will result in prevention and reduction of the disease burden on the Iranian society. Future studies in this field can help in the prevention and well-timed diagnosis of these cancers.

The levels and trends of cancer incidence in the elderly population at national and sub-national scales in Iran from 1990 to 2016.

BACKGROUND: Cancer is most commonly associated with aging. It is necessary to gain a better understanding of cancer's trend and distribution among elderlies and provide comprehensive cancer care for this population. AIMS: The aim of the current study was to show the trends in cancer incidence focusing on the population aged 60+ from 1990 to 2016 in Iran. MATERIAL AND RESULTS: We used the dataset of the Iran Cancer Registry to estimate cancer incidences by sex, age, province, and year. In order to account for incomplete data we used a two-stage spatiotemporal model along with random intercept mixed effect models. We calculated annual age-standardized incidence rates (ASIRs) for age groups 60+ and 5-interval age groups. There was an increasing trend of 25.3% to 936.9% (95% uncertainty interval: 769.6-1141.8) in ASIR in the elderly in 2016. ASIR of all cancers were 889.7 (731.3-1083.6) in women and 988.1 (811.1-1205) in men in 2016, per 100 000 respectively, which had an increasing trend comparing 1990. Skin, breast, and stomach cancers in women and prostate, skin, and stomach cancers in men were the most common types in 2016. All the most incident cancer subtypes underwent an increasing trend in both sexes, except for the bladder, esophageal, and skin cancers which almost had a similar level in 1990 and 2016. Most provinces had an increasing trend in ASIR in all cancers combined from 1990 to 2016 except Zanjan with a decreasing trend. CONCLUSION: Regarding the persistent increasing trend of most elderly cancers' incidence, this is crucial for policymakers to establish preventive plans, determine proper resource allocation, and develop specific treatments for elderly cancer patients.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine (FAKHRAVAC®) in healthy adults aged 18-55 years: Randomized, double-blind, placebo-controlled, phase I clinical trial.

Background: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity. Methods and findings: In this double-blind, placebo-controlled, phase I trial, we randomly assigned 135 healthy adults between 18 and 55 to receive vaccine strengths of 5 or 10 µg/dose or placebo (adjuvant only) in 0-14 or 0-21 schedules. This trial was conducted in a single center in a community setting. The safety outcomes in this study were reactogenicity, local and systemic adverse reactions, abnormal laboratory findings, and Medically Attended Adverse Events (MAAE). Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.The most frequent local adverse reaction was tenderness (28.9%), and the most frequent systemic adverse reaction was headache (9.6%). All adverse reactions were mild, occurred at a similar incidence in all six groups, and were resolved within a few days. In the 10-µg/dose vaccine group, the geometric mean ratio for neutralizing antibody titers at two weeks after the second injection compared to the placebo group was 9.03 (95% CI: 3.89-20.95) in the 0-14 schedule and 11.77 (95% CI: 2.77-49.94) in the 0-21 schedule. The corresponding figures for the 5-µg/dose group were 2.74 (1.2-6.28) and 5.2 (1.63-16.55). The highest seroconversion rate (four-fold increase) was related to the 10-µg/dose group (71% and 67% in the 0-14 and 0-21 schedules, respectively). Conclusions: FAKHRAVAC® is safe and induces a strong humoral immune response to the SARS-CoV-2 virus at 10-µg/dose vaccine strength in adults aged 18-55. This vaccine strength was used for further assessment in the phase II trial.Trial registrationThis study is registered with https://www.irct.ir; IRCT20210206050259N1.

Weight Reduction Percentile Charts: 2-Year Follow-up Results of OAGB and RYGB Post Bariatric Surgery.

PURPOSE: Using a single percentile chart provides us with high standards for the evaluation and accurate investigation of sufficient weight loss after bariatric surgery, counseling, and treating patients in an evidence-based way. Creating percentile charts of weight loss for gastric bypass is the aim of this study. MATERIALS AND METHODS: This retrospective study was based on data from patients who underwent RYGB or OAGB from February 2008 to February 2020. The lambda-mu-sigma (LMS) method was used to estimate the reduction in body mass index (BMI) and six other metrics measured throughout post-operative follow-up. Percentile charts for various metrics have been presented for the first 2 years' post-surgery. We applied a bootstrap sampling method to evaluate percentile validity. RESULTS: We recruited 2579 and 1943 patients who underwent OAGB (75% female) and RYGB (84% female) and were between the ages of 18 and 70 years. The preoperative BMI of patients in the OAGB group was higher than in the RYGB group. Concerning RYGB weight reduction results, the maximum percentage of excess weight loss (%EWL) occurs 18 months after surgery and is steady at 24 months. Far above 50%, EWL is achieved after 6 months. OAGB weight loss follows the same trend as RYGB; at 6 months, the %EWL values are slightly higher than RYGB. CONCLUSIONS: We present the first bariatric weight loss percentile chart for OAGB. It allows evaluation of sufficient and insufficient weight loss at any post-operative point in a visual aspect. Furthermore, it predicts prospective outcomes and guides patient monitoring.

Did the COVID-19 pandemic change the weight reduction in patients with obesity after bariatric surgery?

BACKGROUND: The COVID-19 pandemic has significantly impacted healthcare services worldwide, including bariatric surgery. There is a concern that the pandemic-induced stay-at-home orders and social restrictions may negatively affect weight reduction outcomes post-bariatric surgery. This study aimed to examine the impact of the COVID-19 on weight loss up to six months after three types of bariatric surgeries including One-Anastomosis Gastric Bypass (OAGB), RY Gastric Bypass (RYGB), and Sleeve Gastrectomy (SG) before and two time periods during the COVID-19 pandemic. METHODS: We conducted a retrospective study using data from a comprehensive database of bariatric surgery patients in Iran. We recruited 882 patients who underwent bariatric surgery from the initiation of COVID-19 to 6 months before public vaccination (Time period 3); among them, 311 patients underwent surgery in the first six months of the pandemic (Time period 2). These patients were compared with 1368 ones in the control group who completed their 6 months follow-up before the pandemic. The study compared the BMI reduction, excess weight loss (EWL), and total weight loss (TWL) outcomes between these groups using Generalized Estimating Equations (GEE) with gamma distribution to adjust for factors that were unevenly distributed across the groups. RESULTS: The age of participants in time periods 2 and 3 had a mean (standard deviation) of 38.97 (10.99) and 38.84 (10.71), respectively. In all groups, the majority of patients were females, accounting for 76.02%, 71.06%, and 75.74% for the control group and time periods 2 and 3, respectively. There was no significant difference between the groups in terms of weight reduction, as measured by BMI reduction, EWL, and TWL (related P values: 0.283, 0.465 and 0.169). Regression analysis indicated that higher baseline BMI values were associated with greater BMI reduction (0.04, 95% CI: 0.03-0.05), but this did not translate to higher EWL or TWL. Males showed greater BMI reduction (0.33, 95% CI: 0.18-0.49) and EWL (1.58, 95% CI: 0.79-2.37) than females, while females achieved higher TWL compared to males. Among different types of surgery, the OAGB resulted in more weight reduction among patients in the study. CONCLUSION: In conclusion, our study reveals that bariatric surgery remains effective for weight reduction during the first 6 months of the pandemic in Iran. Implementation of pandemic protocols ensures comparable efficacy to non-pandemic times. However, caution is needed in generalizing results beyond our specific context due to study limitations. Further research is essential to comprehensively assess the pandemic's broader impact on bariatric surgery outcomes under varying conditions.

Child mortality inequalities and socioeconomic determinants of health in Iran, 2016-2018.

Measuring health inequalities is essential to inform policy making and for monitoring implementation to reduce avoidable and unfair differences in health status. We conducted a geospatial analysis of child mortality in Iran using death records from the Ministry of Health and Medical Education from 2016 to 2018 stratified by sex, age, province, and district, and household expenditure and income survey data from the Statistical Center of Iran collected in 2017. We applied multilevel mixed-effect models and detected significant inequality in child mortality and the impact of socioeconomic factors, especially household income. We advocate for using mortality rate for young children (< 5 years old) as an indicator for assessing the impact of interventions to reduce inequalities among various socioeconomic groups. We also recommend to design and implement comprehensive and longitudinal data collection systems for accurate, regular, and specific monitoring of health inequalities.

A Bayesian latent class extension of naive Bayesian classifier and its application to the classification of gastric cancer patients.

BACKGROUND: The Naive Bayes (NB) classifier is a powerful supervised algorithm widely used in Machine Learning (ML). However, its effectiveness relies on a strict assumption of conditional independence, which is often violated in real-world scenarios. To address this limitation, various studies have explored extensions of NB that tackle the issue of non-conditional independence in the data. These approaches can be broadly categorized into two main categories: feature selection and structure expansion. In this particular study, we propose a novel approach to enhancing NB by introducing a latent variable as the parent of the attributes. We define this latent variable using a flexible technique called Bayesian Latent Class Analysis (BLCA). As a result, our final model combines the strengths of NB and BLCA, giving rise to what we refer to as NB-BLCA. By incorporating the latent variable, we aim to capture complex dependencies among the attributes and improve the overall performance of the classifier. METHODS: Both Expectation-Maximization (EM) algorithm and the Gibbs sampling approach were offered for parameter learning. A simulation study was conducted to evaluate the classification of the model in comparison with the ordinary NB model. In addition, real-world data related to 976 Gastric Cancer (GC) and 1189 Non-ulcer dyspepsia (NUD) patients was used to show the model's performance in an actual application. The validity of models was evaluated using the 10-fold cross-validation. RESULTS: The presented model was superior to ordinary NB in all the simulation scenarios according to higher classification sensitivity and specificity in test data. The NB-BLCA model using Gibbs sampling accuracy was 87.77 (95% CI: 84.87-90.29). This index was estimated at 77.22 (95% CI: 73.64-80.53) and 74.71 (95% CI: 71.02-78.15) for the NB-BLCA model using the EM algorithm and ordinary NB classifier, respectively. CONCLUSIONS: When considering the modification of the NB classifier, incorporating a latent component into the model offers numerous advantages, particularly within medical and health-related contexts. By doing so, the researchers can bypass the extensive search algorithm and structure learning required in the local learning and structure extension approach. The inclusion of latent class variables allows for the integration of all attributes during model construction. Consequently, the NB-BLCA model serves as a suitable alternative to conventional NB classifiers when the assumption of independence is violated, especially in domains pertaining to health and medicine.

Safety and efficacy of the FAKHRAVAC compared with BBIBP-Corv2 against SARS-CoV-2 in adults: a non-inferiority multi-center trial.

BACKGROUND: We compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial. METHOD: We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference) because of slow recruitment. The adult population received 0.5 ml (10 µg per dose) intramuscular injections of Fakhravac or BBIBP-Corv-2 vaccines 21 days apart. The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A 10% non-inferiority margin to the reported 72.8% efficacy of BBIBP-Corv2 was assumed. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals. RESULT: We enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) rates in the BBIBP-Corv2 (2.57, 95% CI 1.33-4.49) and Fakhravac (2.25, 95% CI 1.72-2.89) groups; none of which were related to the vaccines received. We recorded 9815 Medically Attendant Adverse Events (MAAE), 736 of which were categorized as somehow related. The rate of related MAAE in the Fakhravac was similar to the BBIBP-Corv2 groups (0.31 and 0.26 per 1000 person-day) in the randomized and considerably higher (0.24 and 0.07 per 1000 person-day) in the non-randomized arms. We observed 129 (35% of the 365 required by target sample size) events of PCR + symptomatic Covid-19 during four months of active follow-up in the randomized arm, demonstrating that those receiving the Fakhravac vaccine were significantly less likely (HR = 0.69; 95% CI 0.49-0.98) to be diagnosed with PCR + symptomatic Covid-19 compared with those receiving BBIBP-Corv2 vaccine. After adjusting for type I error using the O'Brien Fleming method, the Fakhravac vaccine was non-inferior to the BBIBP-Corv2 (assuming a 10% non-inferiority margin to the reported 72.8% BBIBP-Corv2 vaccine efficacy; HR < 1.35) (One-way test: HR = 0.66; 99.8% CI 0.38-1.15). In the non-randomized arm, the results were inconclusive (HR = 1.23; 95% CI 0.96-1.61). We observed 5 cases of hospitalized Covid-19 in the randomized arm, none of which occurred in the Fakhravac vaccine group. Those receiving the Fakhravac vaccine were four times less likely to go to the hospital because of a Covid-19 diagnosis (HR = 0.24; 95% CI 0.10-0.60). The vaccine efficacy of the Fakhravac vaccine is estimated to be 81.5% (95% CI 81-82.4%). CONCLUSION: Fakhravac inactivated SARS-CoV-2 vaccine has comparable safety and efficacy to the BBIBP-Corv2 vaccine. Trial registration This study was registered with the Iranian Registry of Clinical Trials ( www.irct.ir : IRCT20210206050259N3).

The 15-year national trends of endocrine cancers incidence among Iranian men and women; 2005-2020.

Cancer is one of the important health problems in Iran, which is considered as the third cause of death. Endocrine cancers are rare but mostly curable. Thyroid cancer, the most common endocrine tumors, includes about one percent of malignant cancer. In this study, we examined the 15-year national trend of endocrine cancer incidence in Iranian men and women. The data in each province were evaluated based on age, gender, and cancer type according to International Classification of Disease Codes version 10 (ICD-10) from 2005 to 2020 in Iran. All data were obtained from the reports of the Statistics Center of Iran (SCI), 6 phases of the step-by-step approach to monitoring the risk factors of chronic diseases over 18 years old (STEPs), and 3 periods of the CASPIAN study (survey of non-communicable diseases in childhood and adolescence). Statistical analyzes and graph generation were done using R statistical software. Poisson regression with mixed effects was used for data modeling and incidence rate estimation. The incidence of thyroid gland malignancy is higher in women than in men. On the other hand, the incidence of adrenal gland cancer is slightly higher in men than in women. The same pattern is observed for other endocrine neoplasms and related structures. The incidence rate of these types of cancers has generally increased from 2005 to 2020 in Iran. This increase is more in women than in men. In addition, in the middle of the country, there is a strong region in terms of the occurrence of these types of cancers. The incidence rate in these provinces is relatively higher for both sexes and all studied periods. We conducted a study to observe the changing trends for various types of endocrine cancers over 15 years in men and women. Considering the increasing trend of thyroid cancers in Iran, therefore, creating essential policies for the management of these types of cancers for prevention, rapid diagnosis, and, timely treatment is particularly important.

Mode of delivery and maternal vitamin D deficiency: an optimized intelligent Bayesian network algorithm analysis of a stratified randomized controlled field trial.

This study aimed to elucidate the algorithm of various influential factors relating to the association between 25-hydroxyvitamin D (25(OH)D) concentration at delivery and mode of delivery. The investigation constituted a secondary analysis using data collected as part of the Khuzestan Vitamin D Deficiency Screening Program in Pregnancy, which is a stratified randomized vitamin D supplementation-controlled trial comprising 1649 eligible pregnant women. The Bayesian Network (BN) method was utilized to determine the association algorithm between diverse influential factors associated with maternal vitamin D and mode of delivery. The optimized intelligent BN algorithm revealed that women presenting with moderate (35.67%; 95% CI: 33.36-37.96) and severe vitamin D deficiency (47.22%; 95% CI: 44.81-49.63) at delivery were more likely to undergo cesarean section than those presenting with normal concentrations of this nutritional hormone (18.62%; 95% CI: 16.74-20.5). The occurrence probabilities of preeclampsia in mothers with normal, moderate, and severe vitamin D deficiency at delivery were (1.5%; 95% CI: 0.92-2.09), (14.01%; 95% CI: 12.33-15.68), and (26.81%; 95% CI: 24.67-28.95), respectively. Additionally, mothers with moderate (11.81%; 95% CI: 10.25-13.36) and severe (27.86%; 95% CI: 25.69-30.02) vitamin D deficiency exhibited a higher probability of preterm delivery in comparison to those presenting with normal concentrations (1.12%; 95% CI: 0.62-1.63). This study demonstrated that the vitamin D status of pregnant women at delivery could directly affect the mode of delivery and indirectly through maternal complications, such as preeclampsia and preterm delivery, leading to a higher occurrence probability of cesarean section.

Clear cell carcinoma of the ovary and venous thromboembolism: a systematic review and meta-analysis.

OBJECTIVES: As the second most common subtype of Epithelial ovarian cancers (EOCs), ovarian clear cell carcinoma (OCCC) is associated with a high rate of cancer-associated thrombosis. Previous studies revealed the wide range prevalence (6-42%) of venous thromboembolism (VTE) among OCCC patients. This study aimed to determine the prevalence of VTE among OCCC patients as well as factors affecting it. METHODS: PubMed, Scopus, Embase, and Cochrane Library databases were searched up to December 12th, 2022. Studies reporting venous thromboembolic events in women with clear cell carcinoma of the ovary were included. Demographic data, clinical, and paraclinical features of the patients were independently extracted by two reviewers. RESULTS: Out of the 2254 records, 43 studies were processed for final review. The qualified studies involved 573 VTE cases among 2965 patients with OCCC. The pooled prevalence of VTE among OCCC patients was 21.32% (95%CI=(17.38-25.87)). Most VTE events were reported in Japanese women (26.15%), followed by Americans (24.41%) and UK (21.57%), and Chinese (13.61%) women. VTE was more common in patients with advanced stages (37.79%) compared to those with early stages of the disease (16.54%). CONCLUSIONS: Ovarian clear cell carcinoma is associated with a high rate of cancer-associated thrombosis. VTE events in OCCC patients were higher in advanced stages and Japanese women.

Chronic Obstructive Pulmonary Disease: Novel Genes Detection with Penalized Logistic Regression.

OBJECTIVE: This study aimed to introduce novel techniques for identifying the genes associated with developing chronic obstructive pulmonary disease (COPD) and to prioritize COPD candidate genes using regression methods. MATERIALS AND METHODS: This is a secondary analysis of the data from an experimental study. We used penalized logistic regressions with three different types of penalties included least absolute shrinkage and selection operator (LASSO), minimax concave penalty (MCP), and smoothly clipped absolute deviation (SCAD). The models were trained using genome-wide expression profiling to define gene networks relevant to the COPD stages. A 10-fold cross-validation scheme was used to evaluate the performance of the methods. In addition, we validate our results by the external validity approach. We reported the sensitivity, specificity, and area under curve (AUC) of the models. RESULTS: There were 21, 22, and 18 significantly associated genes for LASSO, SCAD, and MCP models, respectively. The most statistically conservative method (detecting less significant features) was MCP detected 18 genes that were all detected by the other two approaches. The most appropriate approach was a SCAD penalized logistic regression (AUC= 96.26, sensitivity= 94.2, specificity= 86.96). In this study, we have a common panel of 18 genes in all three models that show a significant positive and negative correlation with COPD, in which RNF130, STX6, PLCB1, CACNA1G, LARP4B, LOC100507634, SLC38A2, and STIM2 showed the odds ratio (OR) more than 1. However, there was a slight difference between penalized methods. CONCLUSION: Regularization solves the serious dimensionality problem in using this kind of regression. More exploration of how these genes affect the outcome and mechanism is possible more quickly in this manner. The regression-based approaches we present could apply to overcoming this issue.

The 15-year national trends of genital cancer incidence among Iranian men and women; 2005-2020.

BACKGROUND: Cancer is a major health problem and cause of mortality worldwide. Despite the prevalence of other cancers in males and females, genital cancers are especially important because of their psychological effects on individuals. Currently, cervical cancer, corpus uteri neoplasm, and ovarian cancer are the most common gynecological cancers in Iran. Prostate cancer has increased in Iranian men in the last decade. Therefore, this study aimed to investigate the 15-year national trend in the incidence of genital cancers in the Iranian population. METHODS: In this study, we used Iranian cancer registration data collected by the Ministry of Health and Medical Education, demographic information from the reports of the Statistics Center of Iran, STEPs (STEPwise approach to non-communicable diseases risk factor surveillance), and Caspian (childhood and adolescence surveillance and prevention of adult non-communicable disease). A list of potential auxiliary variables and secondary variables at all levels of the province-age-sex were evaluated during the years. We used mixed-effects Poisson regression to model the data and calculate the incidence of each cancer. RESULTS: Our results show an enhancement in the outbreak of all types of male cancers, but the most important are prostate (11.46 in 2005 to 25.67 in 2020 per 100,000 males) and testicular cancers (2.39 in 2005 to 5.05 per 100,000 males). As for female cancers, there has been an increase in ovarian and corpus uteri neoplasm incidence with 6.69 and 4.14 incidences per 100,000 females in 2020, making them the most occurring female genital neoplasms. While the occurrence of cervical cancer has decreased over the years (4.65 in 2005 to 3.24 in 2020). In general, the incidence of genital cancers in men and women has amplified in the last 15 years. CONCLUSIONS: Our study examined the trend of change for each malignant genital neoplasm for 15 years in Iranian men and women in each province. Considering the growing trend of the elderly population in Iran, patient awareness and early screening are essential in reducing mortality and costs imposed on patients and the health care system.

Phase II randomized, double blind, placebo controlled, clinical trial of safety and immunogenicity of an inactivated SARS-CoV-2 vaccine FAKHRAVAC in adults aged 18-70 years.

BACKGROUND: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. METHODS: We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. RESULTS: Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32-3.12, N:309) and (GMR = 5.51, 95% CI 3.94-8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5-4.47, N:142). CONCLUSIONS: FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18-70. A phase III trial is needed to assess the clinical efficacy. TRIAL REGISTRATION: Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).

Evaluation of pregnancy outcomes in mothers with COVID-19 infection: a systematic review and meta-analysis.

Pregnant women are one of the endangered groups who need special attention in the COVID-19 epidemic. We conducted a systematic review and summarised the studies that reported adverse pregnancy outcomes in pregnant women with COVID-19 infection. A literature search was performed in PubMed and Scopus up to 1 September 2022, for retrieving original articles published in the English language assessing the association between COVID-19 infection and adverse pregnancy outcomes. Finally, in this review study, of 1790 articles obtained in the initial search, 141 eligible studies including 1,843,278 pregnant women were reviewed. We also performed a meta-analysis of a total of 74 cohort and case-control studies. In this meta-analysis, both fixed and random effect models were used. Publication bias was also assessed by Egger's test and the trim and fill method was conducted in case of a significant result, to adjust the bias. The result of the meta-analysis showed that the pooled prevalence of preterm delivery, maternal mortality, NICU admission and neonatal death in the group with COVID-19 infection was significantly more than those without COVID-19 infection (p<.01). A meta-regression was conducted using the income level of countries. COVID-19 infection during pregnancy may cause adverse pregnancy outcomes including of preterm delivery, maternal mortality, NICU admission and neonatal death. Pregnancy loss and SARS-CoV2 positive neonates in Lower middle income are higher than in High income. Vertical transmission from mother to foetus may occur, but its immediate and long-term effects on the newborn are unclear.

Idiopathic hirsutism and dyslipidemia: A systematic review, meta-analysis, and meta-regressions.

BACKGROUND: Despite existing several kinds of studies on idiopathic hirsutism (IH) and its association with metabolic disturbances, a limited number of studies have assessed lipid profiles in patients with IH with conflicting and inconclusive results. This study aimed to evaluate the lipid profiles in women with IH, compared to those of polycystic ovary syndrome (PCOS) and healthy controls. MATERIALS AND METHODS: For this systematic review and meta-analysis, PubMed, Scopus, and EMBASE databases were searched to obtain studies published from inception to July 2021 investigating the lipid parameters, including triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) in women with IH, compared to control groups. A meta-regression and subgroup analysis were conducted to explore heterogeneity sources. Publication bias was assessed by the Egger test. RESULTS: Of 209 studies retrieved through searching databases and other sources, a total of 12 studies including 3913 participants were included for the meta-analysis. This meta-analysis showed higher standardized mean difference (SMD) of TC (SMD: 0.09 mg/dl; 95% CI: 0.001, 0.18) and lower SMD of HDL-C (SMD: -0.10 mg/dl; 95% CI: -0.18, -0.02) in women with IH, compared to those of the healthy controls, whereas there were no significant differences in the SMDs of TG and LDL-C between the study groups. This study also revealed no difference in the levels of lipid profiles of women with IH in comparison with PCOS patients, except for TG (SMD: -0.24 mg/dl; 95% CI: -0.46, -0.02). The results of subgroup analysis based on the study design revealed no significant differences in the SMD of lipid parameters between women with IH and healthy controls. We also found no significant difference in the levels of lipid profiles of women with IH versus PCOS patients, except for HDL-C in the subgroup of case-control studies (SMD: 0.18 mg/dl; 95% CI: 0.01, 0.34). CONCLUSION: This study demonstrated that the majority of lipid parameters were not significantly different in women with IH, compared to those of healthy and PCOS controls.

Determinants of Patient's Adherence to the Predefined Follow-up Visits After Bariatric Surgery.

INTRODUCTION: Multidisciplinary care after bariatric surgery is essential for long-term safety and optimal weight loss. However, many patients do not participate in routine postoperative follow-ups. We have explored the determinants of patients' adherence to scheduled follow-up visits after bariatric surgery. METHOD: A retrospective cohort study was performed on patients who underwent bariatric surgery from 2009 to 2019. Cohort participants with a proportion of attendance above the median were compared with those below the median in the first-year post-operation and the period after that. We assumed that the contribution of each predefined session to the overall attendance at eligible sessions is not equal. We weighted each predefined session by the proportion of attendance of all cohort members scheduled for that session. We then calculated the proportion of attendance for each individual at each period. Discriminatory logistic regression was used to identify factors separating adherers from non-adherers. RESULTS: We followed 5245 patients who underwent bariatric surgery for up to 10 years. The median follow-up was 2 years. Patients with the following characteristics were more likely to comply with the postoperative attendance schedule: female sex, older age, higher body mass index at the first visit, non-smoker, readmission after surgery, being operated in a general hospital, and one-anastomosis gastric bypass (OAGB) or Roux-en-Y gastric bypass (RYGB) surgery type. Comorbidities did not significantly affect patients' adherence to the predefined follow-up schedules. CONCLUSION: Younger male smokers are more likely non-adherers. Patients with comorbidities are not at an increased risk of missing predefined postoperative follow-up visits.

A Representative Percentile Chart for Prediction of Weight Loss Trend after Sleeve Gastrectomy.

INTRODUCTION: It could be valuable for surgeons and patients to use one chart in different groups and evaluate weight loss during the post-surgery period. METHODS: This retrospective study used the Iran National Obesity Surgery Database. Patients with clinically severe obesity aged 18-70 undergoing sleeve gastrectomy participated in this study. Body mass index (BMI) reduction and 5 other metrics measured over the study period were modeled using lambda-mu-sigma method. Our data were split into the train (70%) and test (30%) sets. RESULTS: In this study, 1,258 patients (75% female) met the eligibility criteria to participate. Mean age and initial BMI were 36.87 ± 10.51 and 42.74 (40.37-46.36), respectively. Percentile charts for various metrics have been presented for the first 2 years after surgery. CONCLUSIONS: For sleeve surgery, all metrics are acceptable for clinical applications. Using the statistical view, BMI reduction is the most acceptable metric according to the lowest bias values and its variation between all the metrics.

Various screening and diagnosis approaches for gestational diabetes mellitus and adverse pregnancy outcomes: a secondary analysis of a randomized non-inferiority field trial.

INTRODUCTION: We evaluate which screening and diagnostic approach resulted in the greatest reduction in adverse pregnancy outcomes due to increased treatment. RESEARCH DESIGN AND METHODS: This study presents a secondary analysis of a randomized community non-inferiority trial conducted among pregnant women participating in the GULF Study in Iran. A total of 35 430 pregnant women were randomly assigned to one of the five prespecified gestational diabetes mellitus (GDM) screening protocols. The screening methods included fasting plasma glucose (FPG) in the first trimester and either a one-step or a two-step screening method in the second trimester of pregnancy. According to the results, participants were classified into 6 groups (1) First-trimester FPG: 100-126 mg/dL, GDM diagnosed at first trimester; (2) First trimester FPG: 92-99.9 mg/dL, GDM diagnosed at first trimester; (3) First trimester FPG: 92-99.9 mg/dL, GDM diagnosed at second trimester; (4) First trimester FPG: 92-99.9 mg/dL, healthy at second trimester; (5) First trimester FPG<92 mg/dL, GDM diagnosed at second trimester; (6) First trimester FPG<92 mg/dL, healthy at second trimester. For our analysis, we initially used group 6, as the reference and repeated the analysis using group 2, as the reference group. The main outcome of the study was major adverse maternal and neonatal outcomes. RESULTS: Macrosomia and primary caesarean section occurred in 9.8% and 21.0% in group 1, 7.8% and 19.8% in group 2, 5.4% and 18.6% in group 3, 6.6% and 21.5% in group 4, 8.3% and 24.0% in group 5, and 5.4% and 20.0% in group 6, respectively. Compared with group 6 as the reference, there was a significant increase in the adjusted risk of neonatal intensive care unit (NICU) admission in groups 1, 3, and 5 and an increased risk of macrosomia in groups 1, 2, and 5. Compared with group 2 as the reference, there was a significant decrease in the adjusted risk of macrosomia in group 3, a decreased risk of NICU admission in group 6, and an increased risk of hyperglycemia in group 3. CONCLUSIONS: We conclude that screening approaches for GDM reduced the risk of adverse pregnancy outcomes to the same or near the same risk level of healthy pregnant women, except for the risk of NICU admission that increased significantly in groups diagnosed with GDM compared with healthy pregnant women. Individuals with slight increase in FPG (92-100 mg/dL) at first trimester, who were diagnosed as GDM, had an even increased risk of macrosomia in comparison to those group of women with FPG 92-100 mg/dL in the first trimester, who were not diagnosed with GDM, and developed GDM in second trimester TRIAL REGISTRATION: IRCT138707081281N1 (registered: February 15, 2017).