Tehran

Researchers are evaluating a new multi-component score called the Readiness for EXtubation score (REXs) to predict when ICU patients on invasive mechanical ventilation are ready for extubation. Extubation readiness is determined through clinical criteria including improvement in underlying conditions, hemodynamic stability, and adequate respiratory effort. The study addresses the challenge of safely removing patients from mechanical ventilation by improving prediction of extubation success, defined as not needing invasive support within 48 hours after tube removal. The study involves screening ICU patients on invasive mechanical ventilation daily to collect various clinical data including ventilation parameters, blood gases, respiratory muscle strength, cough ability, sedation levels, heart rate, hemoglobin, and nutrition status. These data will be anonymously recorded in an electronic case report form. The REXs score will be developed and analyzed based on these parameters to predict extubation readiness. The target enrollment is about 470 patients to account for a 10% dropout rate. Participants will be monitored throughout the weaning process with assessments such as spontaneous breathing trials, arterial blood gas measurements, ventilator settings, and sedation scores. The primary outcome is extubation failure within 48 hours after extubation. Statistical analyses will evaluate associations between clinical variables and extubation outcomes, and the REXs score's predictive ability will be examined. Data collection, monitoring, and safety evaluations will occur during patients' ICU stay until hospital discharge or death.

This research aims to improve understanding of rare autoinflammatory diseases (AID), which cause repeated inflammatory episodes without infection or cancer. The study focuses on hereditary periodic syndromes (monogenic AID) caused by gene mutations, as well as related polygenic or multifactorial AID like Behcet's disease, Still disease, Schnitzler's disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, spondyloarthritis, and Castleman disease. The goal is to gather detailed clinical and therapeutic data to expand knowledge of these rare conditions, which are often difficult to diagnose outside specialized centers. Participants will be enrolled in the AIDA international registry, which uses a secure online platform to collect retrospective and prospective information. Data collected include demographics, genetics, clinical features, laboratory and radiologic results, treatments, and socioeconomic impact. The registry covers multiple specific AID types and will track patients over at least 10 years through routine clinical visits usually every 3-6 months. The platform supports data sharing and analysis to identify disease patterns, treatment responses, and long-term outcomes. During the study, patients' medical records will be regularly updated with clinical and laboratory data. Researchers will analyze changes in patient numbers and disease characteristics over time. The registry also aims to foster international collaboration, improve early diagnosis, assess quality of life and socioeconomic effects, and support future research and clinical trials. Patient data privacy is maintained by using pseudonyms and complying with data protection laws throughout the study.

Benign prostatic hyperplasia (BPH) is a common condition affecting men, especially as they age, with up to 90% of men experiencing it by age 80. This research aims to create an ongoing international registry to collect and analyze demographic and clinical data from men with BPH who receive either medical therapy or surgical treatments. The registry helps track treatment patterns and outcomes worldwide to better understand the effectiveness and complications related to various BPH treatments. The registry collects detailed baseline information including patient-reported symptoms, sexual health, quality of life, urinary flow, and laboratory values such as prostate-specific antigen and testosterone. It also records any complications like bleeding, infections, incontinence, strictures, ejaculation issues, and erectile dysfunction. This data is gathered over a three-year period with no set endpoint, allowing for long-term follow-up and analysis of real-world treatment results. Participants provide medical records which are securely stored and accessed only by authorized users. The study monitors symptoms using standardized scores and quality of life measures, along with clinical tests such as post-void residual urine volume. Regular audits ensure data accuracy, and the registry’s technology supports future integration with patient portals and electronic medical records. The study duration is planned for at least three years, with possible extensions to continue follow-up and research.

Researchers are investigating whether a shorter course of radiotherapy given at higher doses per session (hypofractionated chemoradiotherapy) is as effective and safe as the conventional longer treatment for women with cervical cancer. This study focuses on patients with uterine cervix cancer stages IB to IIIC and aims to compare clinical response and toxicity between the two treatments in a phase 2 trial setting. Participants will be randomly assigned to one of two groups: the hypofractionation group receiving external beam radiotherapy (EBRT) at a total dose of 40 Gy delivered in 15 fractions over 3 weeks along with 3 weekly doses of cisplatin chemotherapy, or the standard group receiving EBRT at 45 Gy over 25 fractions in 5 weeks with 5 weekly cisplatin doses. After EBRT, all patients will undergo high-dose-rate brachytherapy consisting of 28 Gy delivered in 4 weekly sessions starting one week after EBRT completion. Throughout the study, patients will be assessed for early and late side effects using standardized criteria at the end of brachytherapy, and then at 3 months, 6 months, 1 year, and 3 years post-treatment. Clinical response will be monitored using dynamic contrast-enhanced pelvic MRI scans at 3 months, 1 year, and 3 years after brachytherapy. Primary outcomes include early toxicity and early treatment response measured 3 months after treatment ends.

Researchers are evaluating the effects of different aspirin formulations and a hybrid strategy to reduce the harmful impact of air pollution on patients with atherosclerotic cardiovascular disease (ASCVD). This study compares enteric-coated aspirin to plain low-dose aspirin (81 mg) and assesses a combined intervention including educational materials, pollution alerts via text messages, recommendations to stay indoors or wear KN-95 masks on polluted days, and advice to consume citrus fruits. The trial is designed as a multicenter randomized controlled study with a 2x2 factorial design to inform clinical practice on aspirin use and pollution mitigation for cardiovascular health. Participants will be randomly assigned to receive either enteric-coated or plain aspirin daily in a double-blind manner. Additionally, they will be randomized openly to either receive the hybrid pollution mitigation strategy or continue usual care. The hybrid strategy involves a one-page educational flashcard, text message alerts on high pollution days, encouragement to reduce outdoor exposure or wear facemasks, and advice to eat citrus fruits. The study is conducted in teaching hospitals in Tehran province, Iran, with follow-up planned for up to 30 months. During the study, participants will be monitored for cardiovascular events such as ischemic stroke, myocardial infarction, acute limb events, and cardiovascular death. Researchers will evaluate the safety and effectiveness of aspirin formulations and the hybrid pollution strategy through clinical assessments and outcome adjudication by a blinded committee. The trial aims to enroll thousands of patients, with detailed tracking of adherence, adverse events, and clinical outcomes over a median follow-up of two years.

Researchers are evaluating the best protein intake strategy to improve nutritional and clinical outcomes while reducing complications and death in critically ill patients at risk for refeeding syndrome (RS). This trial includes ICU patients who are identified as at risk for RS based on the 2020 ASPEN guidelines. The study aims to test the hypothesis that higher protein intake lowers the chance of developing refeeding syndrome and improves outcomes such as survival and hospital stay length. Participants will be randomly assigned to either a high-protein group or a standard-protein group. Both groups will receive nutritional support starting with low calorie intake, carefully increased over time. The high-protein group targets 2 grams of protein per kilogram of body weight daily, while the standard group targets 1.3 grams per kilogram. Whey protein powder may be added if needed to meet protein goals, but will be stopped if kidney function worsens. All patients will receive thiamine and multivitamin-mineral supplements daily for one week. The intervention lasts 14 days with a minimum of 5 days. Throughout the study, patients will be monitored for signs of refeeding syndrome and other clinical outcomes like infections, organ failure, and mortality up to 45 days after admission. Daily blood tests will measure key electrolytes and kidney function for one week. Scores for nutrition risk and organ failure will be calculated at admission and before feeding. This detailed monitoring helps assess the safety and effects of different protein levels during critical illness treatment.

This research investigates the effects of two types of fat components in total parenteral nutrition (TPN) on children and adolescents aged 2 to 18 years with acute leukemia undergoing hematopoietic stem cell transplantation (HSCT). The study aims to compare SMOF lipid and Intralipid to determine which better supports successful engraftment, reduces complications after surgery, and lowers malnutrition risk during HSCT. Participants are randomly assigned to receive either TPN containing SMOF lipid or TPN containing Intralipid as their fat component. Before the transplant, blood samples are collected to measure biochemical markers such as cholesterol, blood sugar, proteins, and inflammatory markers. Nutritional intake and appetite are also monitored. After transplantation, similar tests are repeated on days 15 and 30, while clinical outcomes including graft-versus-host disease, infections, bleeding, cholestasis, hospital stay, and mortality are tracked. During the study, researchers closely observe the time to neutrophil and platelet engraftment, oral intake ability, and overall nutrition status alongside TPN usage. Data collection includes biochemical, hematologic, and anthropometric assessments. The goal is to evaluate which lipid formulation leads to better graft success and fewer complications, with study participation lasting through the immediate post-transplant period up to day 35 for engraftment measurement.

Researchers are collecting detailed information about patients with venous thromboembolism (VTE), which includes blood clots in veins such as deep-vein thrombosis and pulmonary embolism. The project aims to improve doctors' understanding of VTE, especially in patients often excluded from clinical trials, like pregnant women, elderly individuals, cancer patients, and those with other complex health issues. The goal is to reduce deaths, clot recurrence, bleeding problems, and artery-related events by sharing this knowledge widely. The study involves gathering extensive data on each patient's health status, treatments, and outcomes during the first three months of therapy. This registry is available online to help doctors quickly find information on patients with similar medical profiles and make informed decisions about managing high-risk individuals. There are no specific interventions being tested; instead, the focus is on collecting real-world patient data. Participants provide informed consent and are followed for at least three years to monitor for new clot events and complications. Researchers track recurrences of VTE, bleeding episodes, and deaths, aiming to create tools that predict which patients are most at risk for problems. This ongoing data collection supports improving care and guiding treatment decisions for diverse patient groups over time.

Researchers are investigating treatments for patients with unresectable or borderline resectable liver metastases from colorectal cancer who have not yet received chemotherapy for their metastatic disease. This Phase 3 trial aims to compare the effects of irinotecan-loaded drug-eluting beads (DEBIRI) combined with systemic chemotherapy versus systemic chemotherapy alone. The goal is to determine whether these treatments can shrink tumors enough to make surgery possible, improving patient outcomes. Participants will be randomly assigned to one of two groups: the treatment group receiving DEBIRI plus systemic chemotherapy and possibly targeted therapy, or the control group receiving systemic chemotherapy alone with possible targeted therapy. The treatment schedule includes chemotherapy on days 0 and 14, and DEBIRI on days 7 and 21 for those in the treatment group, with at least two DEBIRI doses planned unless side effects prevent further treatment. Targeted therapies are tailored based on tumor biology and patient health, and treatment response will be assessed using MRI or CT scans within 1 to 3 months after starting treatment. Throughout the study, patients will be closely monitored with imaging reviewed by blinded radiologists to evaluate tumor response according to RECIST criteria. The main outcome is the proportion of patients who become eligible for surgery after treatment, assessed at a three-month multidisciplinary team meeting. Secondary outcomes include treatment safety, side effects, progression-free survival, and overall survival. The study enrollment period is from September 2024 to September 2026, and participants will be followed during and after treatment to assess these outcomes.

Polycystic Ovary Syndrome (PCOS) is a common hormonal disorder affecting women of reproductive age, often linked to problems like insulin resistance, abnormal lipid levels, and hormonal imbalances that can cause infertility and excessive hair growth. Many current treatments do not fully address these underlying metabolic and hormonal issues. This trial investigates the combined effects of magnesium and L-carnitine supplements on blood sugar control, lipid levels, and hirsutism in women with PCOS diagnosed by the Rotterdam criteria, aiming to find better management options. Participants will be randomly divided into three groups for 12 weeks: one group will take 500 mg of magnesium daily in two doses, another will take 1000 mg of L-carnitine daily plus 500 mg of magnesium daily, and the last group will receive placebo capsules matching both supplements. The study is triple-blind, meaning neither participants nor researchers know who receives which treatment during the trial. Throughout the study, participants' physical activity and dietary intake will be assessed using questionnaires and 24-hour dietary recalls. Measurements such as body mass index, waist circumference, blood pressure, fasting blood sugar, lipid profile, hemoglobin A1c, insulin levels, insulin resistance, and hirsutism scores will be collected at the start and end of the study. Compliance will be checked by counting remaining capsules, and participants consuming less than 90% of their capsules will be excluded from the analysis. The primary outcome is the change in fasting blood sugar after 12 weeks.