Many Locations, Iran, Islamic Republic of

Pharmacological Treatment of Presbyopia

Validation of 5-Point Investigator Global Assessments for Pemphigus

This study aims to obtain statistical data regarding the inter-rater and intra-rater reliability of the IGAs, Pemphigus Disease Activity Index (PDAI) and Autoimmune Bullous Skin Disease Intensity Score (ABSIS) as well as the convergent validity of the IGAs with the PDAI and objective component of the ABSIS. Photograph sets of pemphigus lesions will be gathered from the lead site and participant sites. They will be de-identified and printed in a two hardcopy booklets; the first containing 20 photo sets and the second containing 17 new photo sets and 3 repeat photo sets. In the first part of the study, 8 dermatologists will score 20 sets of photographs of pemphigus lesions (a mixture of skin and mucosal lesions), using the IGAs for pemphigus as well as the PDAI and ABSIS. The first booklet will be mailed to dermatologists and they will use the booklet to score each photo set and will submit their scores in a confidential online survey. In the second part of the study, the second booklet will be sent to dermatologists in the same manner 4 weeks later, and each dermatologist will score the photo sets using the same scoring tools. It is estimated that each scoring session will take two hours to complete. Data gathered here will allow for calculation of inter-rater reliability and intra-rater reliability of the IGAs and convergent validity of the IGAs with PDAI and ABSIS. Later, a sub-study will occur to calculate minimal clinically important differences (MCID) for the IGAs and PDAI. This will involve scoring pemphigus severity of patients at Premier Specialists using PDAI and IGA scores and a Likert score to classify patients as improved, stable or deteriorated compared to previous visits.

Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis

Acute pancreatitis is one of the most common diagnoses made in gastroenterology wards worldwide which causes a great deal of pain and expense along with fatal complications (1). The incidence of acute pancreatitis is trending upward in the United States with $2.6 billion annual health care costs (2). While most patients present with mild and interstitial form of pancreatitis, 10-20% of patients progress to necrotizing pancreatitis that result in significant morbidity and mortality (3). Initial conservative management may be feasible in necrotizing pancreatitis (4), however the majority of patients with infected necrosis or persistent symptoms will eventually require a drainage procedure (5). Drainage procedures for necrotizing pancreatitis include open surgery, minimally invasive surgery, percutaneous drainage, and endoscopic drainage. Drainage procedures are typically postponed for several weeks until the necrotic cavity becomes walled off which is called walled off pancreatic necrosis (WOPN). In the recent years, minimally invasive approaches have largely replaced open surgical necrosectomy (6). Endoscopic drainage of walled off pancreatic necrosis involves creation of a transmural fistula between the enteral lumen and WOPN cavity with stent placement under endoscopic ultrasound (EUS) guidance. Furthermore, direct endoscopic necrosectomy can be performed through the fistula track. The best timing for endoscopic necrosectomy is not yet defined. A recent retrospective study suggested that immediate necrosectomy after stent placement results in earlier resolution of WOPN with fewer sessions of endoscopic necrosectomy (7). The aim of this study is to compare immediate vs. on-demand endoscopic necrosectomy in patients with infected WOPN who undergo EUS-guided transmural drainage of WOPN. Infected necrosis is diagnosed with one of the following criteria in patients with WOPN three weeks after onset of acute pancreatitis (8): A. Positive Gram's stain or culture from a fine-needle aspiration; B. the presence of gas within pancreatic and peripancreatic necrosis on contrast-enhanced CT scan; C. Presence of two inflammatory variables (temperature >38.5°C or elevated C-reactive protein levels or leukocyte counts) in the absence of another focus of infection (other than infected necrosis) ; D. Presence of persistent organ failure.

Effect of High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Attentional Control: an fMRI Study on Healthy Participants

NAC Effect on Infertile Women With Endometrioma

This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction. Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique.

Home Vision Therapy and Prism Prescription in Presbyopic Persons With Convergence Insufficiency

Between non-strabismic binocular vision problems, convergence insufficiency is the most common problem (6) even in people with presbyopia this problem has high prevalence. (11) The most common ocular finding in these patients is an increase in near exophoria and thus reduces person's performance in activities such as reading, computer working and near activities. (12) Despite the effectiveness of vision therapy in reducing patients' symptoms and improving visual function, the different accommodation and vergence systems in the elderly may cause different results (1) so a comprehensive study of adult patients over the age of 40 with convergence insufficiency is needed. According to our knowledge the only study in these patients was done by MH Birnbaum (13) in 1999 which had several limitations. For example, in their study, the results were classified and recorded as success and failure in functional therapy and improvement or non-improvement of asthenopia; Success in treatment was achieved when two criteria were met: 1. The criterion of asthenopia includes achieving the ability to study for at least one hour without diplopia; And the ability to study without headache, eye pain and loss of concentration at least 75% of the time 2- Achieving 3 options of functional criteria including having an appropriate near point of convergence, having appropriate near point of convergence with red lens, having low near phoria and positive fusional vergence. Another problem of this study was: not using the CISS questionnaire, which is a valid questionnaire of convergence insufficiency, and only considered success in treatment based on the two criteria, it should be mentioned that in their study the method for patients' selection did not report; On the other hand, the study was not blind, the importance of designing blind studies has been proven. Only one study by B Teitelbaum assessed prism prescription in patients over 40 years with convergence insufficiency (14) their study had two main problems, first: selected patients did not necessarily have convergence insufficiency, because the two basic criteria for convergence insufficiency (near point of convergence and positive fusion vergence) did not include in their study. Second: not using commercial progressive add lenses in patients glasses and it was unique lens with special design with limitation in base in prism prescription. Because of the effects of various factors on vision therapy including patients' motivation, lack of cooperation in eye exercise, inappropriate age and unfavorable economic conditions, (especially in developing countries like Iran) or pandemic condition like COVID19 pandemy, vision therapy may not always be possible (1-3) and clinicians may have to prescribe base in prism for these patients. On the other hand, due to the changes in accommodation and convergence system and their interaction with aging (1, 3-4) study of their responses to the two types of treatments including active vision therapy and passive base in prism therapy and comparing them are noticeable matter and solving this challenge is absolutely necessary. This study includes two phases. In the first phase, investigators will evaluate the reliability and validity of the Persian version of questionnaire for the elderly patients, this version was validated for young patients (38). Investigators will modify this questioner for presbyopic patients. For this purpose, six optometrists experienced in binocular vision will assess the questioner in two aspects: validity and reliability. The validity of the modified Persian CISS include face validity (use of meaningful words), content validity (relevancy, clarity, comprehensiveness), discriminant validity Using a 6-point Likert scale (very weak, weak, moderate, good, very good, best), face validity will be assessed according to the aspects of fluency in elderly patients' cultural acceptance in iran and a score of ≥4 for each question will be passable. Content validity will be determined based on 1-relevancy (the extent to which the question of interest can being closely connected or appropriate for characteristics of the content under study), 2-clarity (appropriateness of the selected items in terms of being coherent and intelligible in concept and writing style), and 3-comprehensiveness (the ability of the questioner to cover all domains related to the topic under study). Relevancy and clarity will be assessed item by item and for the whole items in the questioners using a 4-point Likert scale (1-undesirable, 2-relatively desirable, 3-desirable, 4-completely desirable), and the Item Content Validity Index (I-CVI) and Scale Content Validity Index (S-CVI) will be calculated for the indices. Universal agreement approach will be used to check, the I-CVI value and it will be between 0-100%, and I-CVI≥ 0.8 will be considered passable. 20 The S-CVI for relevancy and clarity will be determined by averaging all I-CVI values. Comprehensiveness will be only measured at the scale level using a 4-point Likert scale (1- incomprehensive, 2- relatively comprehensive, 3- comprehensive, and 4- totally comprehensive). Then, the reliability of the questionnaire will be assessed using test-retest reliability analysis between first and second questioner administration in a group of 50 presbyopic patients aged 40-60 with convergence insufficiency. The elderly participants will be asked to participate in a second administration of the questionnaire 7-14 days later. To assess discriminant validity, convergence insufficiency will be categorized to 3 groups of mild (PFV ≥1.50 × near exophoria), severe (PFV < near exophoria), and moderate (values in between these groups) based on the severity of clinical manifestations according to the Convergence Insufficiency Treatment Trial guideline, and the mean overall CISS score Will be compared between these three groups. Also, to evaluate the validity and reliability of the CISS questionnaire in the elderly patients and to determine the appropriate cut off point to differentiate between the normal group and the group with the problem of convergence insufficiency, a group of 50 people aged 40-60 with normal binocular vision to compare the scores will be considered to fill out the questionnaire and participants will complete the questionnaire again within 7 to 14 days. T-test will be used to compare the scores of the convergence insufficiency group and the group with normal binocular vision; The area under the ROC curve will also be used to assess the ability of CISS scores to differentiate between individuals with convergence insufficiency and individuals with normal binocular vision. Intraclass Correlation Coefficient (ICC) will be used to assess the reliability of the CISS questionnaire. In the second phase, After the initial examination and having the inclusion criteria, patients will be invited to participate in the study, all the steps and nature of the research will be explained to them and informed consent will be obtained from them. We will have two optometrists, all patients will be assigned to one of the treatment or control groups by optometrist number (1) (Zahra Kamary Rad). Before randomization, patients will be asked to complete the CISS questionnaire and submit this questionnaire to Optometrist No.1. Optometric examinations will be done by optometrist No1 (Zahra Kamary Rad) . First distance and near uncorrected visual acuity will be measured, then patients refraction will be measured by autokeratorefractometer (TOPCON, KR8800, Japan) and refraction will be repeated by retinoscope(beta 200 Heine Germany ). Subjective refraction with positive maximal lens method with maximum visual acuity will be obtained, distance heterophoria will be measured at six meters with covzer and prism bar and target two lines above the best visual acuity. The best visual acuity will be measured with near glasses at a distance of 40 cm and the cover test results are repeated three times and bracketing method will be used to determine the final result of the heterophoria measurements. The near point of convergence will be evaluated by red-green filters method. In this method the near point of convergence will be measured three times and the results will be averaged. The near point of convergence is recorded based on break and recovery point with near glasses. The amplitude of monocular accommodation will be calculated by push-up method, first in the right eye and then in the left eye. Near step PFV will be measured by base out prism bar using 20/30 column at 40 cm with patients near glasses. Near vergence facility will be evaluated by flipper prism (3 base in and 12 base out) with target two lines above the best near-corrected visual acuity. This test will be also recorded by the patient's near glasses. Stereopsis will be evaluated by the patients near glasses and red-green filters using TNO test. To check the prism adaptation, one hour after wearing the glasses, the amount of heterophoria will be measured again and the amount of change in the heterophoria is recorded as prism adaptation in percentag. Tropicamide 1% will be then dropped twice 5 minutes apart, in both eyes, and twenty minutes after the second drop refraction will be repeated; An ophthalmologist will check and confirm the health status of the eyes with a slit lamp and a +90 lens. After examining the patients by optometrist No. 1 vision therapy exercises and necessary trainings will be given to all patients by optometrist No. 2 (Saeid Abdi) In order to assign patients to each of the randomized treatment groups based on blocks classified according to age, gender and severity of convergence insufficiency. For patients in control group new near glasses as a conventional treatment with the practice of random and aimless eye movements, without convergence and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi) in Patients with base in prism prescription using sheards criterion near prismatic glasses will be prescribed and the amount of prism will be divided between two eyes; and random and aimless eye movements, without convergence and accommodation effects will be prescribed by optometrist No. 2 (Saeid Abdi). In patients in the home exercise group , near glasses will be prescribed along with a complete training of the exercises and with a form of information about how and how long to do the exercise, along with random and aimless eye movements, by optometrist No 2 (Saeid Abdi). These accommodation/ convergence training includes: Voluntary convergence, Bug on string, Eccentric Circles, Jumping vergence , Barrel card, chiastopic fusion, Brock string, push-up These exercises will be performed by the patient in a variety of ways in each session. Which will be 3 days a week for 20 minutes ( 10 minutes at noon and 10 minutes at night ) and must record these exercises for 2 month. Home exercises include eight vision therapy exercises and patients willdo two exercises each day at noon and two exercises at night. Also, each exercise will be done five minutes , so subjects have to do four different exercises every day, and in the next session participants have to do the next four exercises. Participants should register these trainings in a special form for 2 months. The total number of training sessions will be two months( 24 sessions) All prescribed glasses will be checked and used after confirmation, and patients do not know in which group categorized. Practice and use of glasses will continue for 2 months and the participants will refer for the final examination and all optometric examinations will be repeated by optometrist No. 1 It should also be noted that base in prism will be prescribed according to the sheards criterion and will be rounded upwards and this amount of prism is evenly divided between the two eye.

Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula

Assessment of the Efficacy of Vitamins A and D and γ-oryzanol-fortified Canola Oil in Adults With Type 2 Diabetes

Ninety confirmed type 2 diabetes patients aged 20-65 years old will be selected. Participants who change their usual medicine intake or make any changes in their diet and lifestyle that could alter the effectiveness of the intervention as well as those who do not use the fortified oil for three consecutive days or do not use the fortified oil for more than ten days throughout the intervention will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified canola oil with vitamins A and D and γ-oryzanol , 2. fortified canola oil with vitamins A and D, 3. fortified sunflower oil with vitamins A and D. Each participant will consume 30 g of oil every day for 2 months. At the first and last visits, dietary and laboratory assessments will be performed for all subjects. The primary outcomes are the improvement of anthropometric, inflammatory, immunity, appetite, glycemic, and lipidemic markers of adults with type 2 diabetes.

Co-transplantation of Mesenchymal Stem Cell Derived Exosomes and Autologous Mitochondria for Patients Candidate for CABG Surgery

This research will be performed as a retrospective cohort study at Tehran Heart Center. Patients will be selected from CABG candidates with severely low Ejection fraction determined by speckle echocardiography. Patients with severe co-morbidities or cerebral damage will be excluded from the study. Detailed informed consent will be taken from the patients. Patients who refuse to provide consent will receive standard treatment. Criteria Inclusion Criteria: - Patients who are a candidate for CABG due to CAD±MR - History of Q-wave MI, less than one month - Age: 35-80 - LVEF <=25% (by any imaging modality: echocardiography/SPECT/LV angiography and Cardiac MRI) - Viability study as evidenced by low-dose dobutamine stress echocardiogram and/or thallium redistribution nuclear study (at least four viable segments). Exclusion Criteria: - Severe co-morbidities (e.g., renal failure, liver failure, etc.) - Inability to provide informed consent - Cerebral Damage 1. Study groups: The standard treatment performed for all patients is revascularisation by coronary artery bypass grafting surgery. Patients will be divided into four groups based on the treatments received, in addition to the standard treatment. Mitochondrial and exosome transplantation by intracoronary and intra-myocardial injection. Study groups: 1. Intracoronary and intra-myocardial injection of exosomes (5 patients) 2. Intracoronary and intra-myocardial injection of mitochondria (5 patients) 3. Intracoronary and intra-myocardial injection of exosomes and mitochondria (5 patients) 4. Placebo (5 patients) For the patients in groups b and c, mitochondria will be extracted from a muscle tissue specimen extracted at the beginning of the surgery from pectoralis muscles exposed after sternotomy. Mitochondria will be extracted from the muscle specimen simultaneously with the surgery. When revascularisation is achieved by the bypass grafts, The extracted mitochondria will be injected into the heart muscle. A 31-gauge insulin syringe will perform injections into ten different sites in the ischemic area of the heart muscle. Besides direct injection into the heart muscle, one-third of the extracted mitochondria will be injected into the coronary sinus. Patients in groups a and b will receive the extracted exosome from MSC cells described in step 2. The extracted exosome will be injected into the coronary sinus after the placement of the Cardiopulmonary bypass. 2. Isolation and characterisation of mesenchymal stem cells from the human umbilical cord (UC-MSCs) Human umbilical cord mesenchymal stem cells are enzymatically isolated by collagenase in terms of a previous study and cultured in DMEM / F12 medium with 10% exosome-depleted FBS (GMP grade) with penicillin and streptomycin antibiotics and incubated at 37 ° C and 5% CO2. After the cell confluence reaches 80%, the conditioned medium is collected (for exosome isolation, the cells are used in passage 3). The phenotypic analysis is performed on the third passage. Surface antigens are analysed for CD90, CD105, CD73 and CD34 using flow cytometry. 3. Extraction of exosomes from UC-MSCs by ultracentrifugation and characterisation. After the cell confluence reaches 80%, the conditioned medium is collected for exosome isolation by several ultracentrifuges. In brief, after 48 h, the conditioned medium (CM) of the cells is centrifuged at 400 g for 10 min to remove cells and at 2500 g for 30 min to eliminate apoptotic bodies and debris. Afterwards, CM was centrifuged twice at 100 000 g for two h, followed by the process of suspending the exosome pellet in PBS. Surface antigens are analysed for CD9, CD63 and CD81 using western blot. Furthermore, Bradford Colorimetric Assay (BCA) kit is used to measure exosome production total protein at a wavelength of 570 nm. Dynamic light scattering (DLS) determines the size distribution of exosomes. 4. Extraction of mitochondria from US-MSCs and characterisation. 5. Short-term evaluation of the safety of clinical trial transplant mitochondria and exosome phase I: The patient will be under close monitoring after the surgery based on clinical symptoms, signs, arrhythmia, echocardiographic evaluations and lab results. 6. Short-term evaluations of the patient in terms of blood factors (cTnT, CK-MB) Creatine kinase (CK) and its isoenzyme CK-MB are critical tools for diagnosing acute myocardial infarction (AMI). The content of CK-MB relative to total CK in myocardial cells is variable; in normal myocardium, it is low and enhanced several-fold in hypoxic myocardium and heart stroke. 7. SPECT scan, Cardiac MRI and Dobutamine stress Speckle Echocardiography, before and after 2 months. The evaluation of the patient's recovery will be performed one month after the surgery. This evaluation is based on patients' signs and symptoms, Function Class assessments, Speckle and Dobutamine stress Eco, SPECT Nuclear heart Scan and Cardiac MRI imaging (CMR). Evaluations will be performed before surgery and one month after the surgery. Close Comparison will be performed between evaluation results to report possible improvements in the patient's condition. The assessed variables for follow-up evaluation include: - Ejection Fraction variables from Eco and CMR (LVEF, RVEF, Global EF) - 16 Segment viability analysis by SPECT scan and CMR - NYHA Classification assessment based on patient physical examination. 8. Data Analysis will be performed by IBM SPSS Statistics Version 25. A p-value of less than 0.05 will be assessed as significant.

The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain

The present study will be a randomized, parallel group, two-arm, double-blind, double-dummy, superiority, controlled trial with a 1:1 allocation ratio. The main objective of this study is to compare the effects of dry needling and lumbar spinal mobilization on pain intensity, functional disability, lumbar multifidus and quadratus lumborum muscles function, lumbar range of motion and pain pressure threshold in patients with chronic non-specific low back pain. After selecting individuals with chronic non-specific low back pain by non-probability purposive sampling method, patients will be randomly assigned to two groups of dry needling (for lumbar Multifidus and Quadratus lumborum muscles) plus sham mobilization (first group) and lumbar spine mobilization plus sham dry needling group (second group). In addition, participants in both treatment groups will receive routine physiotherapy (including low-power laser and core stability exercise). Both groups will be treated for 8 sessions over 4 weeks. Primary outcomes include pain and functional disability, and secondary outcomes include quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold. This study is a double-blind study in which the participants, the person evaluating the outcome, and the person analyzing the data will be blinded to the allocation of patients to the two treatment groups. All of the participants will be identified and recruited by posters and word-of-mouth from the university and the surrounding local communities. Eligible participants will be explained about the aim of the study and the examination involved in this study, and all eligible patients will sign a written informed consent before entering the study. The study will be performed in the Rehabilitation Sciences school of Iran University of Medical Sciences.