Iranian Registry Of Clinical Trials Research Articles

Amlodipine Therapy in β-Thalassemia Patients: A Systematic Review and Meta-Analysis on Ferritin Levels and Liver MRI T2*

Background and aim: We conducted a review to determine the efficacy of amlodipine alongside iron chelators on serum ferritin levels and liver T2-weighted magnetic resonance imaging (MRI T2*) in β-thalassemia patients. Methods: Systematic search was conducted in multiple databases, including Web of Science, PubMed, Scopus, Embase, Cochrane Library, ClinicalTrials.gov, the Iranian Registry of Clinical Trials (IRCT), ProQuest, OpenGrey, and Web of Science Conference Proceedings Citation Index. The search was closed in January 2023. Primary outcomes were comprised of liver MRI T2* (millisecond (msec)) and serum ferritin levels (ng/mL). Results: Seven studies (n = 227) were included in the study. The pooled Cohen’s d for serum ferritin was estimated at −0.46, 95% confidence interval (CI) −1.11 to 0.19 and p = 0.16 (I2 86.23%, p < 0.0001). The pooled mean difference for serum ferritin was −366.44 ng/mL, 95% CI −844.94 to 112.05, and p = 0.13 (I2 81.63%, p < 0.0001). After a meta-regression based on the length of using amlodipine, a coefficient for the mean difference was also −23.23 ng/mL and 95% CI −155.21 to 108.75. The coefficient obtained from a meta-regression as per the amlodipine dose at 5 mg/day than 2.5 to 5 mg/day anchored at −323.49 ng/mL and 95% CI −826.14 to 1473.12. A meta-regression according to the baseline values of serum ferritin discovered a coefficient of 1.25 ng/mL and 95% CI 0.15 to 2.35. Based on two included studies (n = 96), the overall Cohen’s d for liver MRI T2* was 2.069, 95% CI −0.896 to 5.035, and p = 0.17 (I2 96.31%, p< 0.0001). The synthesized mean difference for liver MRI T2* was 8.76 msec, 95% CI −4.16 to 21.67, and p = 0.18 (I2 98.38%, p < 0.000). Conclusion: At a very low level of evidence, probably using amlodipine at a dose of 2.5 to 5 mg a day, up to a year, alongside iron chelators slightly decreases serum ferritin levels in iron-overloaded thalassemia cases by nearly 366 ng/mL (23 ng/mL per month). The liver MRI T2* might also rise to 8.76 msec upon co-therapy with amlodipine.

Effects of brief cognitive behavioral therapy on mental health in substance-related disorder: a randomized controlled trial

Background & objectivesPopulation and aging are major contributing factors influencing the increase in substance use disorder (SUD), which in itself affects mental health, particularly anxiety and depression. Cognitive behavioral therapy (CBT) and pharmacotherapy co-treatment are considered the gold standard for the treatment of SUD. Thus, the present study has been carried out to investigate the efficacy of brief CBT on the general health of opioid users.MethodsA randomized controlled trial (RCT) was conducted with forty opioid users whose addiction was dully confirmed by a psychiatrist at the drop-in center of the Ahvaz Jundishapur University of Medical Sciences. The patients were then randomly divided into two equal groups (n = 20). The control group was treated solely using methadone maintenance therapy (MMT); however, the intervention group underwent four sessions of CBT in addition to MMT. The general health questionnaire (GHQ) consisting of 28 items (Goldberg, 1979) was applied to both groups at the beginning and end of the study. The collected data was analyzed using IBM SPSS ver. 26, and data analysis was carried out using chi-square, t-test, Mann-Whitney, and Poisson regression model. P < 0.05 was statistically significant for all the aforementioned tests.ResultsThe mean age for the control and intervention groups were 37.95 ± 7.64 and 43.85 ± 9.92, respectively (p = 0.042). There was no statistically significant difference in terms of gender and levels of education (p = 0.311 and p = 0.540). Both groups differed statistically regarding marital status and occupation (p = 0.025 and 0.002). There was no significant statistical difference in all subclasses and the total scores of GHQ-28 for both groups, except for anxiety and insomnia in the intervention group (p = 0.038). After applying a Likert scale with a 23-point cut-off score, there was no statistically significant difference in terms of psychosis after intervention in the intervention group (p = 0.077).ConclusionThe results of the current study show that brief CBT is effective on psychiatric health, especially anxiety and sleep disorders, whereas brief CBT fails to affect the patient’s depression, somatic symptoms, and social dysfunction.Trial registrationThe Iranian Registry of Clinical Trials (IRCT) approved the study design (IRCT registration number: IRCT20190929044917N1, registration date: 13/01/2020).

The efficacy of phase I cardiac rehabilitation training based on augmented reality on the self-efficacy of patients undergoing coronary artery bypass graft surgery: A randomized clinical trial

BackgroundOpen-heart surgery is considered one of the primary treatments for severe coronary artery stenosis, but it comes with its own set of complications. However, these complications can be reduced through the implementation of proper cardiac rehabilitation during phase I. This study aimed to examine the impact of phase I cardiac rehabilitation training, using augmented reality, on the self-efficacy of cardiac management in patients undergoing coronary artery bypass grafting.MethodologyThis randomized clinical trial study involved 60 patients who were admitted to the Cardiac Surgery Intensive Care Unit at Ghaem Hospital in Mashhad. The software used in this study consisted of various videos and educational images demonstrating physical exercises for cardiac rehabilitation. The software was developed to train the patients in the intervention group on the rehabilitation program, starting from their admission to the Intensive Care Unit until their discharge from the hospital. The collected data were analyzed using statistical tests such as independent t-test, Mann-Whitney test, paired t-test, chi-square test, as well as descriptive indicators. Cohen’s d was also used to evaluate the magnitude of the effect size.ResultsThe findings of this study revealed that the total mean score for cardiovascular management self-efficacy significantly increased during the transfer to the Intensive Care Unit and at the time of discharge. Notably, the increase observed in the intervention group was significantly greater than that of the control group (P < 0.001).ConclusionThe results of this study indicated that implementing early rehabilitation programs, using innovative educational technology like augmented reality, enhanced the self-efficacy of patients undergoing coronary artery bypass grafting. These findings suggest that such programs can be effectively employed as educational tools throughout different stages of cardiac rehabilitation.Trial RegistrationThis study was registered in the Iranian Registry of Clinical Trials (no. IRCT20200203046361N1) on 16/02/2020.

A structured laughter yoga therapy program on patients with chemotherapy-induced nausea and vomiting: A randomized clinical trial

ObjetiveChemotherapy is a prevalent cancer treatment, often accompanied by debilitating side effects such as nausea and vomiting. This study explores the potential effectiveness of laughter yoga, a combination of exercise and voluntary laughter, in alleviating chemotherapy-induced nausea and vomiting. MethodsThis two-group randomized clinical trial was conducted on 69 cancer patients undergoing chemotherapy at the Reza Chemotherapy and Oncology Center, Mashhad, Iran, in 2018. Patients were randomly divided into intervention and control groups. Both groups received routine self-care training, with the addition of four 20-min to 30-min laughter yoga sessions held immediately before one of their chemotherapy appointments for the intervention group only. Nausea and vomiting were assessed using the Morrow Assessment of Nausea and Emesis questionnaire at two stages, before and after the intervention. Data were analyzed with Chi-square, Independent-t, Mann–Whitney, Wilcoxon, and McNemar tests using Statistical Package for the Social Sciences (SPSS). ResultsThe mean age of patients in the intervention group was 49.0 ± 9.6 years, while in the control group, it was 45.2 ± 12.6 years. The intragroup comparison showed a statistically significant decrease in the severity and duration of nausea in the intervention group and a statistically significant increase in the severity and duration of nausea in the control group from pre-test to post-test (P < 0.05). The intergroup comparison showed no statistically significant difference between the two groups in terms of vomiting conditions. ConclusionsLaughter yoga demonstrates promise in improving chemotherapy-induced nausea, suggesting its potential recommendation for managing this distressing side effect. Further research is warranted to explore its broader application in cancer care. Trial registrationThis study (No. IRCT20180429039463N1) was registered in the Iranian Registry of Clinical Trials on 21/08/2018.

Designing a new physical activity calorie equivalent food label and comparing its effect on caloric choices to that of the traffic light label among mothers: a mixed-method study.

We designed a new type of 'physical activity calorie equivalent' (PACE) food label in Iran to compare its effect with that of the traffic light food label (TLL) on caloric choices. Mixed-method study. Mothers of school children between the ages of 6-12 years. In the qualitative phase, 10 focus group discussions (FGDs) were conducted with various groups of mothers, and two FGDs were conducted with food science and nutrition experts to design a new PACE label. In the quantitative phase, 496 mothers were randomly assigned to five groups: (1) no nutrition label, (2) current TLL, (3) current TLL + educational brochure, (4) PACE label, and (5) PACE label + brochure. Samples of dairy products, beverages, cakes, and biscuits were presented. ANOVA and multiple linear regressions were applied to examine the association between label types and calories of the selected products as our main outcome. The mothers' perspectives were classified into two sub-themes, the PACE label's facilitators and barriers. The new PACE label's characteristics were divided into two subcategories: (a) appearance, and (b) nutritional information, including 14 codes. In the quantitative section, mean calories of the selected foods were lowest in the TLL + brochure group (831.77 kcal; 95% CI: 794.23-869.32), and highest in the PACE label group (971.61; 95% CI: 926.37-1016.84). The new PACE label was a combination of PACE, TLL, and warning labels. It did not significantly affect lower caloric choice, however, the TLL + brochure option was effective in choosing foods with fewer calories.Clinical trial registration: The study was registered in the Iranian Registry of Clinical Trials 23 (IRCT20181002041201N1).

Effects of a Workplace mHealth Intervention for Smoking Behaviour: A Quasi Experimental Study Protocol

Introduction: Tobacco smoking causes various chronic diseases and adds costs to healthcare systems. The current smoking cessation interventions mostly target smokers who are ready to quit and are reactive in recruitment. Recently, mobile phones have become a new tool for promoting smoking cessation. The aim of this paper is to present a study protocol on a quasi-experimental study investigating the effects of a workplace mHealth intervention for smoking behaviour. Methods: A quasi-experimental study will be conducted among employees in an academic institution in Malaysia. The intervention group will receive a theory based WhaSTOP module via WhatsApp and will be compared with the control group (receive usual care). The primary outcomes are stage movement and the number of cigarettes per day. The secondary outcomes include knowledge of smoking, quit attempt, nicotine dependence, 7-day point prevalence of smoking abstinence, and the Transtheoretical Model constructs. A generalised estimating equation analysis will be performed to determine the effects of the intervention. Discussion: This protocol will provide a novel method to proactively approach smokers regardless of readiness to quit and to guide them through the stages of change so that they will be ready to take action to quit. This research will also provide insight into whether the intervention can be utilised as an additional tool for smokers at the workplace to quit smoking. Trial Registration: The trial was registered with the Iranian Registry of Clinical Trials (Registry Number IRCT20220415054539N1).

Combination of metformin and double antibiotic paste for the regeneration of non-vital immature teeth: a preliminary randomized clinical study

BackgroundThe present study aimed to investigate whether incorporating metformin in double antibiotic paste (DAP) can promote the regeneration process of non-vital immature teeth.MethodsOut of 32 pediatric patients undergoing regenerative endodontic procedures (REPs), 6 cases with a follow-up period of less than 12 months or lack of documentation were excluded then the remaining 26 were analyzed. 15 cases received DAP, and 11 cases received a DAP + metformin as the intra-canal medicament, kept for an average of 23 days. During 18 months of follow-up, clinical and radiographic examinations were performed to evaluate the treatment outcomes based on the resolution of apical periodontitis, root development, and the occurrence of intracanal calcification. The chi-square test was used for the statistical analysis (P < 0.05).ResultsAll patients demonstrated resolution of apical periodontitis; however, complete apical closure was only seen in 50% of the patients. The rate of apical closure and root length was significantly higher in the DAP + metformin group (P = 0.047), although the two groups were not significantly different in terms of root width (P = 0.184). Canal obliteration was seen in 15% of cases, all of which were in the DAP group.ConclusionsAccording to the present findings, metformin could promote root development in the regeneration process when incorporated in DAP.Trial registrationThis clinical trial was registered on the Iranian Registry of Clinical Trials (IRCT20200120046197N1) on 26.2.2021.

The effect of donepezil hydrochloride on post-COVID memory impairment: A randomized controlled trial

BackgroundPost-Coronavirus Disease (COVID-19) condition, known as “post-COVID syndrome,” is associated with a range of complications persisting even after recovery. Among these complications, cognitive dysfunction, including memory impairment, has been relatively common observed, impacting executive function and quality of life. To date, no approved treatment exists for this specific complication. Therefore, the present clinical trial aimed to investigate the impact of Donepezil Hydrochloride on post-COVID memory impairment. MethodsA randomized, controlled trial (Approval ID: IRCT20210816052203N1) was conducted, enrolling 25 patients with post-COVID memory impairment. Participants with a history of hospitalization were randomly assigned to either the drug group (n = 10) or the control group (n = 15). Memory indices were assessed at baseline, one month, and three months later using the Wechsler Memory Scale-Revised test. SPSS software and appropriate statistical tests were employed for data analysis. ResultsThe statistical analysis revealed no significant difference in WMS-R subtest and index scores between the drug and control groups at the 4-week and 12-week follow-up periods. However, within the drug group, there was a notable increase in the visual reproduction I and verbal paired associates II subtests during the specified time intervals. ConclusionWhile donepezil 5 mg did not exhibit a significant overall increase in memory scales compared to the control group over time, our findings suggest that this medication may exert a positive effect on specific memory subtests. Further research and exploration are warranted to better understand the potential benefits of donepezil in managing post-COVID-related memory impairment. Trial registrationThe study was approved by the Research Ethics Committee of Aja University of Medical Sciences (Approval ID: IR.AJAUMS.REC.1400.125) and registered in the Iranian Registry of Clinical Trials (IRCT) (Approval ID: IRCT20210816052203N1).

Post-chemo-radiotherapy response and pseudo-progression evaluation on glioma cell types by multi-parametric magnetic resonance imaging: a prospective study

BackgroundWe focused on Differentiated pseudoprogression (PPN) of progression (PN) and the response to radiotherapy (RT) or chemoradiotherapy (CRT) using diffusion and metabolic imaging.MethodsSeventy-five patients with glioma were included in this prospective study (approved by the Iranian Registry of Clinical Trials (IRCT) (IRCT20230904059352N1) in September 2023). Contrast-enhanced lesion volume (CELV), non-enhanced lesion volume (NELV), necrotic tumor volume (NTV), and quantitative values ​​of apparent diffusion coefficient (ADC) and magnetic resonance spectroscopy (Cho/Cr, Cho/NAA and NAA/Cr) were calculated by a neuroradiologist using a semi-automatic method. All patients were followed at one and six months after CRT.ResultsThe results of the study showed statistically significant changes before and six months after RT-CRT for M-CELV in all glioma types (\U0001d45d < 0.05). In glioma cell types, the changes in M-ADC, M-Cho/Cr, and Cho/NAA indices for PN were incremental and greater for PPN patients. M-NAA/Cr ratio decreased after six months which was significant only on PN for GBM, and Epn (\U0001d45d < 0.05). A significant difference was observed between diffusion indices, metabolic ratios, and CELV changes after six months in all types (\U0001d45d < 0.05). None of the patients were suspected PPN one month after treatment. The DWI/ADC indices had higher sensitivity and specificity (98.25% and 96.57%, respectively).ConclusionThe results of the present study showed that ADC values and Cho/Cr and Cho/NAA ratios can be used to differentiate between patients with PPN and PN, although ADC is more sensitive and specific.

The effect of letrozole as an adjunct in GnRH-antagonist protocol on IVF/ICSI outcome in women with endometriosis: a randomized clinical trial

BackgroundTo evaluate the effect of adding letrozole to the antagonist ovarian stimulation protocol (COS) on in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcome in endometriosis patients.MethodsThis randomized clinical trial was carried out in the department of infertility treatment at Arash Women’s Hospital from May 2019 to May 2021. The eligible women with normal ovarian reserve tests who had endometriosis diagnosis and underwent IVF/ICSI cycles were evaluated. A flexible regimen of GnRH-antagonist protocol was used for COS. In the experimental (n = 34), the patients received 5 mg letrozole daily for the first 5 days in combination with 150 IU of recombinant follicle-stimulating hormone (rFSH). In the control group (n = 30), the patients received only the same dose of rFSH. The treatment cycle was compared between groups.ResultsAnalysis of demographic characteristics, severity of endometriosis, and baseline hormonal tests of patients showed that the two groups were similar and comparable. The means of total used gonadotropins ampoules and serum E2 level on oocyte trigger day in the letrozole group were significantly lower than those of in the control group (P = 0.03 and P = 0.004, respectively). No statistically significant difference in terms of the total number of retrieved and MII oocytes as well as the total numbers of obtained and top-quality embryos, and cryopreserved embryos was found.ConclusionThe co-treatment of letrozole with gonadotropins during the antagonist protocol was associated with a reduction in the total dose of gonadotropins, although it had no effect on the oocyte or embryo yield in patients with endometriosis.Trial registrationThe study was registered in the Iranian Registry of Clinical Trials on 2018 -07-13 (IRCT20150310021420N4 at www.irct.ir, registered while recruiting).

The effect of hemodialysis with cool dialysate on nausea in hemodialysis patients: A randomized clinical trial.

Experiencing nausea leads to decreased self-esteem and social isolation in hemodialysis patients and affects all aspects of their quality of life. Nausea and vomiting make hemodialysis unpleasant for patients leading to premature termination of hemodialysis. Therefore, based on this necessity, the present study was conducted to determine the effect of hemodialysis with cool dialysate on nausea in hemodialysis patients. In this clinical trial, 60 eligible patients receiving hemodialysis were randomly assigned to the control (30 participants) and intervention (30 participants) groups. In the control group, the patients received standard hemodialysis (37°C) for three sessions. Simultaneously, patients in the intervention group received hemodialysis with a cold solution (of 36°C) for three sessions. The patients' nausea and shivering rates were measured using the visual analog scale and the shivering standard assessment scale, respectively. Both groups were evaluated before and after 1 week of intervention. The study did not include blinding. The trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the number IRCT20200530047597N1. The present study was financially supported by Kermanshah University of Medical Sciences, Kermanshah, Iran (no. 990220). Data were analyzed using SPSS-25 software. The independent t test showed no statistically significant difference between the two control and experimental groups regarding the nausea rate in the three evaluation times (p < 0.05). Nevertheless, nausea severity decreased significantly after the intervention in the two groups. However, the rate of nausea in the intervention group with cold solution decreased more compared to the control group. Moreover, no patient in the intervention group experienced shivering during hemodialysis with a cool dialysate. According to the results of this study, it can be stated that the use of cold hemodialysis to control nausea in patients undergoing hemodialysis requires further studies and can be recommended as a nonpharmacological treatment to manage the treatment costs in case of efficiency.

Improving the mental health of working women with work-life conflict: A protocol development for an explanatory mixed method study

BACKGROUND: Today, one problem facing working women is the conflict between work and life, and the resultant stress has a great impact on their mental health. A well-known model for stress management is Lazarus and Folkman's model. The primary goal of the present study is to improve working women's mental health through stress management. MATERIALS AND METHODS: The present study employs a mixed approach and is conducted in 4 phases. The target population is women working in Birjand University (South Khorasan province/Eastern Iran). The first step is to describe the research population of a cross-sectional study. The measurement instrument used is Carlson's standard work-life conflict measurement questionnaire. The sample size in this step is 319. The second step is to conduct a qualitative study by interviewing working women with work and life conflict. The sampling will continue until data saturation and then the data will be analyzed through a content analysis. The third step will be the development of a questionnaire based on Lazarus and Folkman's model using the information obtained from the qualitative step. This questionnaire will be then validated in the target research population. Moreover, an exploratory factor analysis, a confirmatory factor analysis and a reliability test will be run. The last step is to carry out an educational intervention to measure the effect of the intervention on stress management and general health in working women with work and life conflict. The measurement instruments used in this step are Cohen's Perceived Stress Questionnaire, General Health Questionnaire, and a researcher-made stress management questionnaire. CONCLUSION: It seems that the educational intervention of stress management with educational content designed based on the needs of the audience, can be effective in controlling and managing the stress caused by women's work-life conflict. TRIAL REGISTRATION: IRCT (IRCT20210918052508N1) from the Iranian Registry of Clinical Trials in 2021-09-21.

Positive imagery in depressive suicidal patients: A randomized controlled trial of the effect of viewing loved ones’ photos on mood states and suicidal ideation

According to research, it has been suggested that individuals who are affected by depression could potentially engage in the creation and experience emotional advantages relating to positive events directed towards the past or future, with the condition that they are provided with suitable mental imagery techniques. The main aim of this study was to assess the impact of utilizing positive imagery, specifically through the utilization of photographs featuring loved ones, on mood states and suicidal ideation among individuals diagnosed with depression and exhibiting suicidal tendencies. This randomized, double-blind, controlled crossover trial was conducted among 78 hospitalized depressive patients at three psychiatric services between April and August 2019. The patients participated in four individual picture-viewing sessions on four consecutive days. The four categories of pictures were included: loved ones, neutral faces of strangers, natural landscapes, and optical illusions. Directly prior to and immediately following the observation of the visual stimuli (photographs), the Brunel Mood Scale (BRUMS) and the Beck Scale for Suicide Ideation (BSSI) were completed by the patients. Repeated measures ANOVAs conducted in this study revealed a significant main effect of time on ratings of tension, depression, fatigue, vigor, calmness, and happiness (P values < 0.001). Additionally, statistically significant interactions were identified between picture category and time in relation to the variables of tension, depression, fatigue, vigor, calmness, and happiness (P values < 0.001). The analysis did not reveal a significant main effect of time on ratings of anger, confusion, and suicidal ideation (P values > 0.05). Likewise, the interaction between picture category and time did not yield significant results for the variables of anger, confusion, and suicidal ideation (P values > 0.05). The positive imagery procedure using the presentation of loved ones’ photos showed beneficial effects on the mood states of depressed patients. The findings of this study suggest that incorporating a greater emphasis on positive imagery within the context of clinical depression may offer potential advantages. This highlights the potential for novel opportunities in the treatment of depression. Trial registrationThe study has been registered in the Iranian Registry of Clinical Trials (registration number: IRCT20180808040744N1; first registration date: December 22, 2018; website: https://en.irct.ir/trial/33186).

The effects of ginger supplementation on common gastrointestinal symptoms in patients with relapsing-remitting multiple sclerosis: a double-blind randomized placebo-controlled trial

BackgroundGastrointestinal (GI) symptoms affect more than 80% of individuals with relapsing-remitting multiple sclerosis (RRMS). Ginger is widely known for its GI relieving properties. Therefore, we investigated the effect of ginger supplementation on common GI symptoms in RRMS patients.MethodsThis study was a 12-week double-blind parallel randomized controlled trial with a 3-week run-in period. The intervention (n = 26) and control (n = 26) groups received 500 mg ginger and placebo (as corn) supplements 3 times a day along with main meals, respectively. At the beginning and end of the trial, the frequency and severity of constipation, dysphagia, abdominal pain, diarrhea, bloating, belching, flatulence, heartburn, anorexia, and nausea were assessed using the visual analogue scale ranging from 0 to 100 mm. Totally, 49 participants completed the study. However, data analysis was performed on all 52 participants based on the intention-to-treat principle.ResultsIn comparison with placebo, ginger supplementation resulted in significant or near-significant reductions in the frequency (-23.63 ± 5.36 vs. 14.81 ± 2.78, P < 0.001) and severity (-24.15 ± 5.10 vs. 11.39 ± 3.23, P < 0.001) of constipation, the frequency (-12.41 ± 3.75 vs. 3.75 ± 1.82, P < 0.001) and severity (-13.43 ± 4.91 vs. 6.88 ± 2.69, P = 0.001) of nausea, the frequency (-9.31 ± 4.44 vs. 1.56 ± 4.05, P = 0.098) and severity (-11.57 ± 5.09 vs. 3.97 ± 3.99, P = 0.047) of bloating, and the severity of abdominal pain (-5.69 ± 3.66 vs. 3.43 ± 3.26, P = 0.069).ConclusionGinger consumption can improve constipation, nausea, bloating, and abdominal pain in patients with RRMS.Trial RegistrationThis trial was prospectively registered at the Iranian Registry of Clinical Trials (www.irct.ir) under the registration number IRCT20180818040827N3 on 06/10/2021.

Novel technique for arterial reconstruction in simultaneous pancreas-kidney transplantation, a randomized clinical trial

IntroductionSimultaneous pancreas kidney (SPK) transplantation is an invaluable procedure to enhance the quality of life of insulin-dependent patients with advanced renal disease. The creation of vascular anastomoses of the donor’s pancreas vessels to the recipient’s, is of utmost importance to predict the graft outcome and surgical complications. In the study we introduce a novel technique for arterial reconstruction during SPK transplantation.MethodsConventionally, during the SPK transplantation, a so-called Y-graft is anastomosed between donor’s superior mesenteric and splenic artery to the recipient’s right iliac artery. In the study we adopted a new technique by preparing an extra extension using the donor’s carotid artery, to be anastomosed to the Y-graft and the iliac artery. In this non-blinded randomized clinical trial we compared the surgical complications and early outcomes between the 2 groups of patients with the traditional and new arterial reconstruction techniques during 3 months after transplantation.ResultsThirty adult patients were included in the study. The incidence of pancreatitis, vascular thrombosis and surgical site infection was lower in the new Y-graft and extension technique, which was not statistically significant. However, the calculated Cohen’s d index showed the medium effect of new Y-graft and extension technique on complication after SPK transplantations.ConclusionThe post-operative complications tend to be lower in the novel arterial reconstruction technique, however a study on a larger patient group is encouraged to confirm our primary results.Trial registrationThe study was registered at the Iranian Registry of Clinical Trials on 12/05/2022; IRCT 20210625051701N2; (http://www.irct.ir/).

The effectiveness of home modifications on the risk of falling in older adults with dementia: A randomized clinical trial

Introduction: This study aimed to investigate the effectiveness of modifying the home environment on falls in older adults with dementia. Methods: In this single-blind clinical trial study, 44 older adult patients with dementia who met the inclusion criteria, were included in the study and then randomly assigned to intervention ( n = 22) and control ( n = 22) groups using a balanced block randomization method. The intervention group received home modifications, while the control group did not receive any modifications. After intervention, The HOME Fall and Accident Screening Tool was used to assess falls. The ethics committee of Tehran University of Medical Sciences approved the study procedure (IR.TUMS.FNM.REC.1399.163) and this study was registered in the Iranian Registry of Clinical Trials with the code: IRCT20210106049950N1. Results: Comparing the mean fall risk scores between the two groups at the beginning of the study showed no significant difference in the risk of falling ( p = 0.6). By contrast, at the end of the study, this difference became significant between groups ( p &lt; 0.001). This comparison in the control group at the beginning and end of the study indicated no significant difference ( p = 0.32). However, it was significant in the intervention group at the beginning of the study and after modifications ( p &lt; 0.001). Conclusion: Modifications by applying changes and reforms to the home environment reduced the risk of falling in older adults with dementia.

A comparison of misoprostol with and without methylergometrine and oxytocin in outpatient medical abortion: a phase III randomized controlled trial

ObjectiveThe complications associated with miscarriages have surfaced as a major concern in maintaining women’s physical and mental health. The present study evaluated the efficacy of three medication regimes for the complete expulsion of retained intrauterine tissues in patients who underwent a miscarriage.MethodsIn this randomized clinical trial, 90 patients participated with their gestational age below 12 weeks, each having undergone a recent miscarriage. After being screened for underlying diseases and coagulative blood disorders, they were randomly allocated into three groups. For the first group, labeled as the control group, misoprostol was administered alone. In contrast, the combination of misoprostol plus methylergometrine and misoprostol plus oxytocin was prescribed for the second and third groups, respectively. Further, the data obtained were analyzed by descriptive and inferential statistics using Stata software version 14.ResultsThe mean age of participants and gestational age were 29.76 ± 5.53 years and 8.23 ± 2.29 weeks, respectively. There was no significant difference between the three treatment groups regarding the amount of bleeding after the abortion(P = 0.627). Regarding pain severity, the group that received Misoprostol plus Methylergometrine had less pain intensity than the other two groups(p = 0.004). The mean rate of RPOC expulsion was in the Misoprostol plus Oxytocin (9.68 ± 10.36) group, Misoprostol plus Methylergometrine (11.73 ± 12.86), and Misoprostol groups (19.07 ± 14.31)(p = 0.013). The success rate in outpatient medical abortion in the misoprostol plus oxytocin and misoprostol plus methylergonovine group was 93.33%, but in patients treated by misoprostol alone was 83.33%.ConclusionThe effectiveness of the drugs in the two drug groups combined with oxytocin and methylergometrine is higher than the misoprostol group alone. An outpatient approach was deemed more satisfactory against surgical maneuvers and hospitalizations by patients since family support influenced their pain coping mechanism.Trial registrationThe trial was registered in the Iranian registry of clinical trials on 04/10/2019. (https://fa.irct.ir/trial/34519; registration number: IRCT20150407021653N19).

The effects of Portulaca oleracea extract on 24-hour urine indices in patients with renal stone: A double-blind randomized placebo-controlled clinical trial

Introduction: Portulaca oleracea, or purslane, is a medicinal plant used in traditional medicine, according to its various medical properties, as well as its potential antioxidant and anti-inflammatory properties. Objectives: The present study aimed to investigate the efficacy of P. oleracea powder on 24-hour urine indices in patients with nephrolithiasis and normal kidney function. Patients and Methods: In this randomized clinical trial, eligible patients with nephrolithiasis were randomly assigned to receive P. oleracea or placebo capsules once daily for eight weeks. Twenty-four-hour urine indices, along with serum electrolytes, inflammatory and lipid components were measured, then compared between the two groups at baseline and the end of the trial. Results: A total of 54 patients, including 28 in P. oleracea and 26 in the control groups, were assigned. Their mean age was 42.2±9.8 years; there was no statistically significant difference between the mean age of the P. oleracea and placebo groups (42.1years versus 42.2 years, respectively; P&gt;0.05). After eight weeks, the mean urine citrate level in the Portulaca oleracea subjects (674.82±94.56 mg/24 h) was significantly higher than placebo group subjects (579.19±85.06 mg/24 h; P&lt;0.01). In addition, the mean urine calcium level in the P. oleracea group (176.32±27.40 mg/24 h) was significantly lower compared to the control group (194.26±25.17 mg/24 h; P=0.016). Within the groups, analysis revealed that in subjects in P. oleracea and control groups, mean serum triglyceride (TG) decreased after intervention (P=0.01 and P=0.02, respectively), as well as mean urine citrate level (P&lt;0.01, P=0.01, respectively). Conclusion: The findings show that P. oleracea may be proposed as a medicinal plant that has a preventive effect on kidney stone formation by increasing urine citrate and decreasing urine calcium level. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20170725035305N4; https://en.irct.ir/trial/42388, ethical code; IR.SBMU.MSP. REC.1398.538).

Effects of levothyroxine replacement therapy on insulin resistance in patients with untreated primary hypothyroidism

ObjectivesThis study investigated the effects of levothyroxine replacement therapy on insulin resistance, lipid profile, and thyroid function in patients with untreated primary hypothyroidism. 105 patients with hypothyroidism with indication for levothyroxine replacement were enrolled in the present study. Insulin, fasting blood glucose and lipid profile were assessed at the beginning of diagnosis and three months after levothyroxine replacement. Insulin resistance was calculated by hemostasis model assessment of insulin resistance (HOMA-IR) and quantitative insulin sensitivity check index (QUICKI).ResultsOur data revealed a significant reduction in body mass index (27.18 ± 4.27 versus 26.81 ± 4.18 kg/m2, p = 0.028), cholesterol (199.79 ± 37.61 versus 178.10 ± 32.25 mg/dl, p < 0.001), triglyceride (160.41 ± 71.86 versus 146 ± 61.11 mg/dl, p = 0.012), low density lipoprotein-cholesterol (123.54 ± 30.7 versus 107.08 ± 26.98 mg/dl, p < 0.001), fasting insulin (8.91 ± 3.92 versus 8.05 ± 2.65 mIU/l, p < 0.001), and thyroid stimulating hormone (47.47 ± 3.4 versus 2.22 ± 1.84 µIU/ml, p < 0.001) levels before and after drug intervention. However, no statistical differences were observed in HOMA-IR, QUICKI, and high density lipoprotein-cholesterol. In conclusion, in patients with untreated primary hypothyroidism, levothyroxine replacement therapy based on HOMA-IR and QUICKI did not improve insulin resistance; however, lipid profile was significantly improved following levothyroxine administration.Trial registrationThis study was registered in the Iranian Registry of Clinical Trials (IRCT) with ID number: IRCT20130610013612N10 on the date 2019-09-02.

Comparing the effect of transcutaneous electrical nerve stimulation and massage therapy on post laparoscopic shoulder pain: a randomized clinical trial

BackgroundShoulder pain is a common clinical problem after laparoscopic surgeries. The use of non-pharmacological massage and transcutaneous electrical nerve stimulation (TENS) as an adjunct to routine treatment is increasing to provide optimal pain relief. Therefore, we aimed to determine the effect of TENS and massage therapy on post laparoscopic shoulder pain (PLSP).MethodsThis study was conducted on 138 patients who underwent laparoscopic cholecystectomy. Patients were randomly divided into three groups: massage plus conventional pharmacological treatment (n = 46), TENS plus conventional pharmacological treatment (n = 46), and conventional pharmacological treatment (n = 46). Massage and TENS were performed three consecutive times after the patients regained consciousness in the inpatient wards. The intensity of Shoulder pain was evaluated using a visual analog scale before and 20 min after each treatment.ResultsBoth massage therapy and TENS led to a significant reduction in the intensity of PLPS compared to the control group in all three measured times (p < 0.001). However, no significant difference was observed between TENS and massage at any of the three-time points.ConclusionsThis study’s findings demonstrated that massage and TENS techniques could reduce PLSP.Trial registrationRegistered in the Iranian registry of clinical trials (www.irct.ir) in 05/02/2022 with the following code: IRCT20200206046395N1.