Reference range of testosterone and dehydroepiandrosterone sulfate levels in women during reproductive age in the Iranian population.

Backgrounds: To determine the average cutoff values of serum-free and total testosterone (FT, TT) and dehydroepiandrosterone sulfate (DHEAS) among healthy premenopausal women. Materials and Methods: Participants were women aged 18-55 years without signs and symptoms of hyperandrogenism (n = 489). Participants if Ferriman-Gallwey (FG) scores between 6 and 8 were considered a group located in the upper spectrum related to the normal hirsutism score (n = 30). DHEAS, TT, and FT levels were compared between different populations. Upper limits of 97.5 and 95 and lower limits of 5 and 2.5 percentiles were calculated to provide the reference intervals for DHEA, TT, and FT in the total sample and in the population with FG 6-8. Results: In the total population, the mean ± standard deviation (SD) serum FT, TT, and DHEAS levels were 1.40 ± 0.63 pg/mL, 0.42 ± 0.17 ng/mL, and 1.5 ± 0.97 µg/ml, respectively. The cutoff values of FT at 1.35 and TT at 0.49 were obtained for differentiating the patients with FG 6-8 scores from the normal population, with the corresponding specificity of 0.60, the sensitivity of 0.67, and area under the ROC curve (AUC) (confidence interval 95%) of 0.63 (0.52-0.73), P = 0.01 and 0.68 (0.58-0.78) P = 0.001, respectively. Conclusions: In our study, the mean ± SD serum FT level was 1.40 ± 0.63 pg/mL, the TT level was 0.42 ± 0.17 ng/mL, and the DHEAS level was 1.5 ± 0.97 µg/ml, in premenopausal women between 18 and 49 years of age. Furthermore, in a population with FG 6-8 score, a cutoff value of FT at 1.35 and TT at 0.49 was obtained. Although the irregular menstrual cycle did not change the reference range when compared with the normal group.

Urinary iodine excretion after using povidone iodine or chlorhexidine gluconate for topical disinfectant in patients undergoing thyroidectomy due to thyroid carcinoma: When to do radio active iodine therapy?

Background: Povidone Iodine (PI) is the most frequent antiseptic used as a topical disinfectant in surgery. It has been reported high transcutaneous iodine absorption due to topical PI usage, but there is a lack of data in periods of excess iodine depletion. Materials and Methods: This is a cross-sectional study designed to assess serial urinary iodine concentration (UIC) after topical administration of PI to evaluate the transcutaneous iodine absorption and the proper iodine depletion time for safe administration of Radio Active Iodine (RAI) therapy as ablative or adjuvant therapy. Results: Thirty-seven patients with papillary thyroid carcinoma undergoing total thyroidectomy were assigned to the PI group (n = 20) or chlorhexidine gluconate (CHG) group (n = 17). In the PI group, the UIC levels rose to a maximum of 2 times in the 4th week after administration and returned to pre-operative levels in the 8th week after. In the CHG group, there was a decrease in UIC levels due to a low iodine diet (LID) with a significant P-value of 0.001, <0.001, and 0.001 in the 2nd, 4th, and 8th weeks follow up respectively compared to the PI group. The urinary excretion of excess iodine lasts about 8 weeks after total thyroidectomy until iodine levels turn back to pre-operative values. Conclusion: If the thyroidectomy was prepared with PI, RAI is better to be performed 6-8 weeks after surgery rather than the standard prescription of 4 weeks.

The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND: Thyroid cancer is a very damaging disease. The most common treatment for this disease includes thyroidectomy and then using radioactive iodine (RAI). RAI has many side effects, including a decrease in salivary secretions, followed by dry mouth and oral and dental injuries, as well as increased inflammation and oxidative stress. Selenium can be effective in these patients by improving inflammation and oxidative stress and by modulating salivary secretions. So far, only one clinical trial has investigated the effect of selenium on thyroid cancer patients treated with radioiodine therapy (RIT) conducted on 16 patients; considering the importance of this issue, to show the potential efficacy of selenium in these patients, more high-quality trials with a larger sample size are warranted. METHODS: This is a parallel double-blind randomized controlled clinical trial that includes 60 patients aged 20 to 65 years with papillary thyroid cancer (PTC) treated with RAI and will be conducted in Seyyed al-Shohada Center, an academic center for referral of patients to receive iodine, Isfahan, Iran. Thirty patients will receive 200 µg of selenium for 10 days (3 days before to 6 days after RAI treatment) and another 30 patients will receive a placebo for the same period. Sonographic findings of major salivary glands, salivary secretions, and sense of taste will be evaluated before and 6 months after 10-day supplementation. DISCUSSION: Due to its anti-inflammatory and antioxidant effects, as well as improving salivary secretions, selenium may improve the symptoms of thyroid cancer treated with radioactive iodine. In past studies, selenium consumption has not reduced the therapeutic effects of radiation therapy, and at a dose of 300 to 500 µg/day, it has not had any significant side effects in many types of cancer under radiation therapy. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20201129049534N6 . Registered on 16 September 2021.

The effect of curcumin-piperine on cardiometabolic, inflammatory and oxidative stress factors and macular vascular density in optical coherence tomography angiography (OCTA) in patients with non-proliferative diabetic retinopathy: Study protocol for a randomized, double-blind controlled trial.

Objective: Curcumin is a safe phytochemical with antioxidant, anti-inflammatory, antidiabetic, and lipid-lowering effects. This study aims to investigate the efficacy of curcumin-piperine in non-proliferative diabetic retinopathy. Materials and Methods: In this double-blind randomized trial, 60 diabetic retinopathy patients after meeting the inclusion criteria will be randomly assigned to two groups of curcumin-piperine supplementation (1000 mg per day for 12 weeks) or receiving placebo. The density of small blood vessels in the retina by optical coherence tomography angiography (OCTA), fasting blood glucose, triglyceride, renal indices (blood urea nitrogen and creatinine), high-sensitivity C-reactive protein, total antioxidant capacity, total oxidant status, body mass index, waist circumference, and weight will be measured. Conclusion: If the beneficial effects of curcumin on diabetic retinopathy are observed, this safe, this natural and inexpensive herbal supplement can be considered a therapeutic solution in these patients.

The association of exposure to air pollution with changes in plasma glucose indices, and incidence of diabetes and prediabetes: A prospective cohort of first-degree relatives of patients with type 2 diabetes.

Background: Increasing incidence rates of diabetes related to air pollution have been reported in high-income countries. However, few studies evaluated air pollution effect on plasma glucose indices, in addition to diabetes and prediabetes incidence in developing countries. This study investigated the association between exposure to common air pollutants and the changes plasma glucose indices over time. The incidence of type 2 diabetes (T2D) and prediabetes in future were also examined in association with exposure to air pollution. Materials and Methods: A total of 3828 first-degree relatives of patients with T2D who were prediabetes or had normal glucose tolerance (NGT) were enrolled in this study. Cox regression was used to assess the relationships between particulate matter (PM2.5 and PM10), nitrogen monoxide (NO), nitrogen dioxide, nitric oxides, sulfur dioxide (SO2), and ozone exposure and the incidence of T2D and prediabetes. We also applied a linear mixed model to assess the association between exposure to these air pollutants and changes in plasma glucose indices over time. Results: Air pollutants showed a significant positive association with changes in fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and 2 h oral glucose tolerance (OGTT) in participants with NGT and prediabetes. The maximum increase in plasma glucose indices was associated with NO concentration. Our study also showed exposure to all air pollutants except SO2 was significantly associated with an increased risk of developing T2D and prediabetes (Hazard ratio > 1, P < 0.001). Conclusion: According to our results, exposure to air pollution increases the risk of T2D and prediabetes incidence in our population. The exposure to air pollutants was also associated with increasing trend in FPG, HbA1c, and OGTT levels in both groups of NGT and prediabetic participants.

Association of RASis and HMG-CoA reductase inhibitors with clinical manifestations in coronavirus disease 2019 patients: Results from the Khorshid Coronavirus Disease Cohort Study.

Background: Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEinhs) may deteriorate or improve the clinical manifestations in severe acute respiratory syndrome coronavirus 2 infection. A comparative, cross-sectional study was conducted to evaluate the association of ARBs/ACEinhs and hydroxy-3-methyl-glutaryl-CoA reductase inhibitors (HMGRis) with clinical outcomes in coronavirus disease 2019 (COVID-19). Materials and Methods: From April 4 to June 2, 2020, 659 patients were categorized according to whether they were taking ARB, ACEinh, or HMGRi drugs or none of them. Demographic variables, clinical and laboratory tests, chest computed tomography findings, and intensive care unit-related data were analyzed and compared between the groups. Results: The ARB, ACEinh, and HMGRi groups significantly had lower heart rate (P < 0.05). Furthermore, a lower percent of O2 saturation (89.34 ± 7.17% vs. 84.25 ± 7.00%; P = 0.04) was observed in the ACEis group than non-ACEinhs. Mortality rate and the number of intubated patients were lower in patients taking ARBs, ACEinhs, and HMGRis, although these differences failed to reach statistical significance. Conclusion: Our findings present clinical data on the association between ARBs, ACEinhs, and HMGRis and outcomes in hospitalized, hypertensive COVID-19 patients, implying that ARBs/ACEinhs are not associated with the severity or mortality of COVID-19 in such patients.

The effect of a low renal acid load diet on blood pressure, lipid profile, and blood glucose indices in patients with type 2 diabetes: a randomized clinical trial.

BACKGROUND: Observational studies have reported that dietary renal acid load has an important role in insulin resistance and metabolic factors. The aim of the present study was to assess the effect of a low renal acid load diet (LRALD) on blood pressure, lipid profile, and blood glucose indices in patients with type 2 diabetes. METHODS: In this parallel randomized clinical trial, 80 patients with type 2 diabetes were randomly assigned to the LRALD (n = 40) or control (n = 40) groups, for 12 weeks. Both groups received a balanced diet and a list of nutritional recommendations based on healthy eating behaviors. In the LRALD group, food items with low renal acid load were prescribed. Primary outcomes including: fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting serum insulin, quantitative insulin sensitivity check index (QUICKI), homeostatic model assessment for insulin resistance (HOMA) and secondary outcomes including: weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), triglyceride (TG), total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL). were measured at baseline and end of the study. The present trial was registered at IRCT.ir (IRCT20130903014551N5). RESULTS: Seventy subjects completed the study (n = 35 in control group and n = 36 in LRALD). Weight (P < 0.001), body mass index (P < 0.001), FBG (P < 0.001), HbA1c (P < 0.001), SBP (P = 0.004), and TG (P = 0.049) were reduced and HDL (P = 0.002) was increased in both groups, compared with baseline. After adjusting for baseline values, DBP (P = 0.047) was reduced in the LRALD group compared with control group. Results had no changes after using intention to treat analysis. CONCLUSION: A LRALD may decrease DBP in type 2 diabetic patients. However, it elicited no significant effect on lipid profile compared with a healthy diet. TRIAL REGISTRATION: This randomized clinical trial was registered at IRCT.ir (IRCT20130903014551N5).

Antidiabetic effects of Eryngium billardieri hydrosol in the treatment of type 2 diabetic patients: A double-blind randomized clinical trial.

Objective: Medicinal plants with fewer side effects and low cost than synthetic medicines are increasingly advised to treat diseases. The present study aimed to identify Eryngium billardieri compounds and evaluate the plant's effects on hyperglycemic and hyperlipidemia indices, and liver, and kidney function. Materials and Methods: Following identification of Eryngium billardieri using GC/MS method, 72 participants were randomly divided into two groups (n=36 per group), receiving oral hypoglycemic medication (metformin) with or without 50 ml hydrosol twice a day for three months as intervention and placebo control, respectively. Body mass index (BMI), systolic and diastolic blood pressure, fasting blood sugar (FBS), glycosylated hemoglobin (HbA1c), total cholesterol, triglyceride, HDL-C, and LDL-C levels were measured at the beginning and end of the experiment. Also, aspartate transaminase, alanine transaminase, blood urea nitrogen, and creatinine levels were measured to assess adverse effects on liver and kidney functions. Results: The main components were terpenes with 46.69% of the total ingredients of E. billardieri essential oil. Other prominent compounds identified included octanoic acid (12.14 %) and isoxazole (6.72 %). Intergroup changes in blood parameters showed that E. billardieri hydrosol for three months could significantly reduce HbA1C and blood cholesterol levels but did not affect other measured parameters. Also, there were no adverse effects on kidney or liver function. Conclusion: The present findings showed that the consumption of 50 ml of E. billardieri hydrosol as a complementary treatment in diabetic patients reduced HbA1C and cholesterol levels without adverse effects on the liver or kidneys functions.

A comparative study of the effects of multimedia training materials on mini CEX scores of internal medicine residents in Isfahan University of Medical Sciences.

BACKGROUND: Role of multimedia training materials on Mini-CEX scores of internal medicine residents. We aimed to assess the effect of multi multimedia training materials on Mini-CEX scores of internal medicine residents of Isfahan University of Medical Sciences. SETTINGS AND DESIGN: A quasi-experimental action research study on 1st, 2nd, and 3rd-year internal medicine residents were implemented. MATERIALS AND METHODS: The Mini-CEX test measures students' performance in six core skills necessary for medical practice. Mini-CEX scores of 135 internal medicine residents in 2017-2018 were compared before and after the training with prepared multimedia materials. We used repeated measured ANOVA and Mann-Whitney U test to compare the distribution of Mini-CEX scores across corresponding groups. Analysis was done using the SPSS software version 23 (IBM SPSS Statistics for Windows. Armonk, NY, USA: IBM Corp). RESULTS: The median Mini-CEX score (IQR) of students in preintervention and postintervention groups were 16.14 (5.19) and 19.62 (3.13), respectively. Findings of this study showed a significant increase in mini-CEX scores of the groups who used the multimedia learning material compared to those who did not use it (P < 0.001). CONCLUSIONS: Multimedia learning resources demonstrated a promising influence on internal residents' mini-CEX scores in this study. They demonstrate significantly greater performance after using multimedia learning materials compared to their same-year residents who did not benefit from it. This demonstrates the favorable effect of multimedia on the acquisition of practical skills such as obtaining a history or performing a physical examination.

Lived Experiences of Diabetes Team and Patients about Diabetes Care System after Redesigning Delivery System and Supporting Self-Management in Iran: A Qualitative Research.

Background: Diabetes as a chronic disease requires a change in the paradigm of treatment and health care system based on acute illnesses to chronic conditions. Chronic Care Model has been designed to address this need. This study aimed to explore the lived experiences of the diabetes team and diabetic patients regarding the health care system after redesigning delivery system and supporting self-management based on the Chronic Care Model in Iran. Methods: Research was conducted with a qualitative descriptive approach in one of the Isfahan city clinics in 2018. The participants were diabetes team (composed of diabetes physician, nurse, assistant nurse and dean of the clinic) and 17 type- 2 diabetic patients who were selected through purposive sampling. Data collection was performed through semi-structured interviews and then were analyzed using content analysis with an inductive approach. Results: The findings of this study were composed of the following two main categories: (1) educational function change, including the sub-categories of evidence-based nurse education and patients' demand to ongoing participation in the training classes; and (2) treatment and care method upgrade, including the sub-categories of nurse's role change in a team approach, continuity in cares and upgrading patients' self-care behaviors. Conclusions: Delivery system redesign and diabetes self-management support based on Chronic Care Model changed organizational structure and performance of the diabetes care system. It also reformed the structure of treatment providers from a vertical and hierarchical form to a team arrangement. Nurse's educational function became evidence-based and patients' self-care behaviors upgraded.

The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial.

BACKGROUND: COVID-19 pandemic has made the disease a major global problem by creating a significant burden on health, economic, and social status. To date, there are no effective and approved medications for this disease. Curcumin as an anti-inflammatory agent can have a positive effect on the control of COVID-19 complications. This study aimed to assess the efficacy of curcumin-piperine supplementation on clinical symptoms, duration, severity, and inflammatory factors in patients with COVID-19. METHODS: Forty-six outpatients with COVID-19 disease were randomly allocated to receive two capsules of curcumin-piperine; each capsule contained 500 mg curcumin plus 5 mg piperine or placebo for 14 days. RESULTS: Mean changes in complete blood count, liver enzymes, blood glucose levels, lipid parameters, kidney function, and c-reactive protein (CRP) were not significantly different between the two groups. There was a significant improvement in health status, including dry cough, sputum cough, ague, sore throat, weakness, muscular pain, headache, and dyspnea at week 2 in both curcumin-piperine and placebo groups (P value < 0.05); however, the improvement in weakness was more in the curcumin-piperine group than with placebo group (P value 025). CONCLUSION: The present study results showed that curcumin-piperine co-supplementation in outpatients with COVID-19 could significantly reduce weakness. However, in this study, curcumin-piperine co-supplementation could not significantly affect the other indices, including biochemical and clinical indices. TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT20121216011763N46 . 2020-10-31.

The most prominent problems of diabetes education in Iran: A qualitative content analysis.

BACKGROUND: Education in vulnerable communities can be a health affordable strategy to promote patient empowerment. Recognition and understanding the problems of diabetes education are of significance to overcome the barriers and advance the educational and care services to control diabetes and promotion of society health. The aim of this study was to explore participants' perspectives, experiences, and preferences, regarding diabetes education problems. MATERIALS AND METHODS: This descriptive, qualitative study was conducted from March 2016 to September 2017. The participants were 23 people including nine patients with diabetes and their family members and 14 members of diabetes healthcare team (physicians, nurses, and nutritionists). The data were collected through individual semi-structured interviews and analyzed through conventional content analysis approach proposed by Graneheim and Lundman. Some main categories and subcategories emerged. RESULTS: Three main categories showed the most prominent problems of diabetes education, namely, inadequate infrastructure for diabetes education, insufficient defined and de facto position for the role of diabetes nurse educator, and the failure in patient-oriented team approach in diabetes education. CONCLUSION: This article addresses the most important problems of diabetes education. The fundamental strategy to overcome these problems seems to be the planning and management of diabetes education as a high priority in the noncommunicable disease management policies of the Ministry of Health and Medical Education.

The Renoprotective Effect of Linagliptin in Type 2 Diabetic Patients with Severely Increased Albuminuria.

INTRODUCTION: Previous studies have suggested that linagliptin may represent renoprotective effects besides its anti-hyperglycemic properties in patients with type 2 diabetes. However, there is a lack of decisive evidence to support this assumption. This study aimed to address the effect of linagliptin in type 2 diabetic patients with severely increased albuminuria. METHODS: In this randomized double-blind, placebo-controlled clinical trial, type 2 diabetic patients with severely increased albuminuria (albuminuria ≥ 300 mg/24 h) were enrolled. Patients were randomized to linagliptin (5 mg/d) and placebo based on a computer-generated list of random numbers. Biochemical (fasting blood sugar (FBS) (mg/dL), hemoglobin A1c (HbA1c) (%), proteinuria (mg/24h), blood urea nitrogen (BUN) (mg/dL), serum creatinine (mg/dL)) and clinical variables (weight (kg), systolic, and diastolic blood pressure (mmHg)) were measured at baseline and 3 and 6 months post intervention. RESULTS: At baseline, no statistically significant difference was detected in demographic characteristics between the two groups (P > .05). A significant decrease was observed in proteinuria, FBS, weight, SBP, and DBP in the intervention group after 6 months (Ptime < .05), however; none of the clinical and biochemical variables showed a significant difference between groups after 6 months (Pgroup > .05). CONCLUSION: Linagliptin may serve as a renoprotective therapeutic option in diabetic patients with severely increased albuminuria due to its role in proteinuria reduction. Results of this study can be used for future large-scale, long-term studies investigating the renoprotective effects of linagliptin in patients with diabetic nephropathy. DOI: 10.52547/ijkd.6110.

Hemoperfusion in patients with severe COVID-19 respiratory failure, lifesaving or not?

BACKGROUND: The new coronavirus outbreak quickly filled hospital beds and stunned the world. Intensive care is required for 5% of patients, and the mortality rate for critically ill patients is 49%. The "cytokine storm" is considered as the main cause of pathogenesis for coronavirus disease-19 (COVID-19)-related respiratory failure, hemoperfusion may be a modality for treatment of disease. MATERIALS AND METHODS: Thirty-seven an patients with positive real-time polymerase chain reaction for SARStions2 in an upper respiratory tract sample or typical chest computed tomography lesion were eligible for this case-control study. Patients meeting the criteria for hemoperfusion including clinical and laboratory indices, were evaluated for outcomes such as hospitalization length and mortality. Patients were divided into three groups, i.e., patients who received hemoperfusion without a need for mechanical ventilation (MV), patients who received hemoperfusion before MV, and patients who received hemoperfusion after MV. RESULTS: Among 37 patients with COVID-19 respiratory failure, 32% were female with a mean age of 55.54 (standard deviation 14.1) years. There was no statistically significant difference between the three groups in terms of length of hospital stay and intensive care unit (ICU) stay (P-tayns: 0.593 and 0.243, respectively, confidence interval [CI]: 95%). Heart rate, respiratory rate, PaO2/FIO2, high-sensitivity C-reactive protein, and ferritin significantly improved after the application of hemoperfusion in all groups (P < 0.05, CI: 95%). CONCLUSION: It seems that applying hemoperfusion in the inflammatory phase of the disease, especially before the intubation, reduce the need for MV. However, hemoperfusion does not have any impacts on the duration of hospital and ICU stay.

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial.

OBJECTIVES: This study aims to investigate the efficacy of curcumin-piperine co-supplementation on oxidative stress factors, clinical symptoms, and mortality rate in patients with coronavirus (COVID-19) admitted to the intensive care unit (ICU). TRIAL DESIGN: This study is a randomized, placebo-controlled, double-blind, parallel-arm clinical trial. PARTICIPANTS: The study participants will be recruited from patients admitted to the ICU of Al-Zahra hospital with a definitive diagnosis of COVID-19. The inclusion criteria are aged between 20 and 75 years, confirmation of COVID-19 based on the PCR test, and admitted to the ICU. The exclusion criteria include the present use of parenteral nutrition support, a history of underlying diseases such as congenital disorders, immune diseases, renal and hepatic insufficiency, and pancreatitis, a history of sensitivity to herbal remedies such as turmeric and pepper, and regular use of anticoagulant drugs such as warfarin. This study will be performed in the Al-Zahra hospital, an academic hospital affiliated with Isfahan University of Medical Sciences, Isfahan, Iran. INTERVENTION AND COMPARATOR: Sixty eligible patients will be randomly assigned, in a 1:1 ratio, to receive curcumin-piperine capsules (three capsules/day; each capsules containing 500 mg curcumin plus 5 mg piperine; in total 1500 mg curcumin and 15 mg piperine/daily) for seven days (n=30) or matching placebo capsules (three capsules/day; each capsules containing 505 mg maltodextrin; totally 1515 mg, maltodextrin/ daily) for same duration (n=30). Capsules will be administered after oral or enteral feeding at 9, 15 and 21 o'clock. MAIN OUTCOMES: The primary outcome is the time from initiation of supplementation (curcumin-piperine or placebo) to normalization of fever, respiratory rate, and blood oxygen saturation. The secondary outcomes are the mortality rate, length of stay in ICU, temperature, levels of blood oxygen saturation, ventilator dependency, respiratory rate, levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), levels of liver markers (ALT, AST, LDH), and levels of kidney function markers (BUN, Creatinine). FOLLOW UP: All of the parameters will be assessed at baseline and end of the study (7 days intervention). In addition, the rate of mortality will be collected after 4 weeks (28 days' mortality in the ICU, 4 weeks follow up). RANDOMISATION: Eligible patients will be randomly assigned to either the intervention group (Curcumin-piperine) or the control group (Placebo). Randomization sequences will be generated using an electronic table of random numbers to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the stratified block randomization method. Stratification was conducted according to sex (male and female), with a block size of four. The allocation sequences will be prepared by an independent statistician and will be kept inside sealed, opaque, and consecutively numbered envelopes. Participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. BLINDING (MASKING): This study is a double-blind clinical trial (participants, investigators, nurses, and physicians). The curcumin-piperine and placebo supplements will be similar in the terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labeling, and packaging. All participants, investigators, nurses, and physicians will be unaware of the trial-group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is estimated at 60 participants, including 30 patients in the intervention group and 30 patients in the placebo group. TRIAL STATUS: The protocol is Version 2, registered on May 13, 2021. Recruitment began May 20, 2021, and is anticipated to be completed by September 20, 2021. TRIAL REGISTRATION: This trial has been registered in Iranian Registry of Clinical Trials (IRCT) with the title of "Evaluation of the effect of curcumin-piperine supplementation in patients with coronavirus admitted to the intensive care unit (ICU): a double-blind clinical trial study". IRCT registration number is IRCT20121216011763N52 . The registration date was May 13, 2021. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (File 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

The Effects of Berberis integerrima Fruit Extract on Glycemic Control Parameters in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial.

BACKGROUND: Berberis integerrima Bunge fruits have been utilized in traditional medicine to control diabetes mellitus (DM). However, no clinical survey has been done in this regard. This study was conducted to clinically evaluate the effects of fruit extract of this plant in improving glycemic control indices in patients with type 2 DM (T2DM). METHODS: In a randomized controlled clinical trial, patients with T2DM who met the inclusion criteria were randomly divided into two groups of drug (Berberis) and control to receive the extract solution 5 ml twice daily (equivalent to 1000 mg of dry extract) with standard treatment (metformin) or only standard treatment, respectively, for 8 weeks. Before and after the intervention, fasting blood sugar (FBS), serum glycosylated hemoglobin (HbA1c), serum insulin, the homeostasis assessment model for insulin resistance (HOMA-IR), body mass index (BMI), and systolic and diastolic blood pressure were determined and compared between the two groups. RESULTS: During the study, 30 and 35 patients in the drug and control groups, respectively, completed the study. Although no significant changes occurred in any parameter within each group, postintervention FBS (117.5 [107-128.8] versus 134 [120-142], P = 0.001) and HbA1c (7 [6.4-7.7] versus 7.5 [6.8-7.9], P = 0.045) were significantly lower in the drug group than in the control one. In terms of other parameters, there were no significant differences between the groups. CONCLUSION: Consumption of B. integerrima Bunge fruit extract at a dosage of 1000 mg daily decreases FBS and HbA1c but does not affect HOMA-IR in patients with type 2 diabetes mellitus.

Effect of Curcumin on Glycemic Control in Patients with Type 2 Diabetes: A Systematic Review of Randomized Clinical Trials.

Type 2 diabetes mellitus (T2DM) is a chronic metabolic condition, which carries considerable morbidity and mortality. There is growing evidence that curcumin could modulate glucose homeostasis and improve vascular risk in patients with T2DM. The aim of this systematic review was to study the effect of curcumin on glycemic indices in patients with diabetes. A comprehensive search was conducted in PubMed, Scopus, Embase, and Google Scholar up to March 5, 2020, to identify randomized control trials investigating the effect of curcumin supplementation on glycemic indices including fasting blood glucose (FBS), hemoglobin A1c (HbA1C), and the homeostatic model assessment for insulin resistance (HOMA-IR). Eleven articles comprising 1131 individuals with T2DM were included in the study. Treatment with curcumin significantly reduced the level of FBS and HbA1c in 8 and 7 studies, respectively. HOMA-IR was evaluated in five studies, and this was reduced significantly by curcumin supplementation in three of those studies. Patients who took curcumin supplementation over longer periods (≥12 weeks) showed a significant reduction in glycemic indices. The current systematic review showed that curcumin can improve glycemic control in patients with T2DM. However, further studies are required to determine the optimum conditions for these effects of curcumin, particularly regarding readouts of insulin resistance.

Designing, implementation, and evaluation of internship comprehensive system for assessment and monitoring.

BACKGROUND: During the past decade, the benefits of using portfolios, especially electronic portfolios, were recognized. Due to the lack of using portfolios and especially electronic portfolio in the clinical evaluations of internship training in medical schools of Iran, this study has designed, implemented, and evaluated a comprehensive system for monitoring and evaluating the activities of interns. MATERIALS AND METHODS: This study was a software development study in the three phases of design, implementation, and evaluation. All stages of the project were carried out in the Isfahan University of Medical Sciences during 2019-2020. The software design phase was performed using the Rapid Application Development Methodology (RAD model). In the implementation phase, it was used as a pilot study in the internal department of the medical school. System evaluation was performed using a combination of quantitative and qualitative methods. Data were analyzed using the content analysis for qualitative data and descriptive statistical analysis using the SPSS software for quantitative data. RESULTS: In the educational standards survey, in 10 items, the percentage of choosing "perfectly fit" and "fit" was above 90% (high quality). In the technical standards questionnaire, out of 35 items related to software technical quality, eight items were of acceptable quality and 27 of them were partially acceptable. In the Student Satisfaction Questionnaire, in 9 items, interns' satisfaction with the system was high or very high, and in either case, there was little or no dissatisfaction or satisfaction. CONCLUSIONS: Positive educational effects can be used in all clinical settings if modification and improvement of the software continues, with slight modifications.

Cardiogenic Shock and Guillain-Barré Syndrome as the First Manifestations of Pheochromocytoma.

Febrile congestive heart failure is a rare first manifestation of pheochromocytoma. Herein, the case of a 31-year-old female with febrile congestive heart failure and subsequent cardiogenic shock is presented. After intensive care unit (ICU) admission and further evaluating the right adrenal mass observed in abdominal ultrasonography, the diagnosis of pheochromocytoma was confirmed. Then, she was scheduled for the right adrenalectomy. Before surgery, she complained of acute-onset progressive muscle weakness in the lower limbs, followed by the upper limbs. After further investigation, she was diagnosed with Guillain-Barré syndrome and treated with intravenous immunoglobulin (IVIG). She recovered well after the right adrenalectomy, and during the subsequent 18 months, the follow-up did not reveal any complications, and left ventricular function recovered to normal.

Restrictors of the effectiveness of diabetes self-management education: A qualitative content analysis.

BACKGROUND: A key step for improving the effectiveness of diabetes self-management education (DSME) is to identify its restrictors. OBJECTIVES: The aim of this study was to explore the restrictors of the effectiveness of DSME. METHODS: This descriptive qualitative study was conducted in March 2016-2017. Participants were 16 DSME providers (viz., physicians, nurses, nutritionists, and psychologists) and nine DSME receivers (viz., patients and their family members) - 25 in total. Semi-structured interviews were held for data collection. Interviews were transcribed word by word and analyzed through conventional content analysis approach proposed by Graneheim and Lundman. RESULTS: The restrictors of the effectiveness of DSME were categorized into three main categories and 11 subcategories, namely patients' limited welcoming of DSME classes (allocating limited time for participation in DSME classes, inadequate knowledge about diabetes mellitus [DM] importance, inappropriate educational environment, and financial problems), unfavorable adherence to treatments: serious challenge (inattention to educations, poor motivation for adherence to medical recommendations, and inattention to the psychological aspects of DM), and the difficulty of adult education (the difficulty of changing health-related attitudes and behaviors, mere information delivery during education, adults' physical and perceptual limitations, and diabetes educators' limited competence in adult education). CONCLUSION: The findings of the present study provide an in-depth understanding about the restrictors of the effectiveness of DSME. DM management authorities and policymakers can use these findings to develop strategies for improving the effectiveness of DSME.