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 to be extubated. The process of liberation from mechanical ventilation involves weaning, readiness assessment, and extubation, with success defined as not needing invasive support within 48 hours. This study focuses on developing and analyzing REXs to help clinicians assess extubation readiness more accurately in critically ill patients. The study involves daily screening of ICU patients undergoing weaning from invasive mechanical ventilation. Data collected include clinical parameters such as arterial blood gases, ventilation settings, sedation and agitation scores, heart rate, hemoglobin levels, nutritional status, and cough strength, among others. Clinicians will anonymously enter data into an electronic case report form to develop and evaluate the REXs score. Patients prepared for extubation will have their readiness assessed using this score. Participants will be monitored during their ICU stay, with data collected on extubation success or failure at 24, 48, and 72 hours after extubation. Researchers will also track length of ICU and hospital stays and mortality outcomes. The study uses routine clinical data, with anonymization to protect patient confidentiality. Statistical methods will analyze associations between clinical factors and extubation outcomes to validate the REXs scores predictive ability. The total study duration extends until the end of 2026.

Researchers are investigating autoinflammatory diseases AID, which involve recurring inflammatory episodes without infection, cancer, or adaptive immune system problems. This study focuses on both monogenic hereditary periodic syndromes and polygenic or multifactorial AID, including rare conditions like Behets disease, Still disease, Schnitzlers disease, PFAPA syndrome, chronic recurrent multifocal osteomyelitis, non-infectious uveitis and scleritis, among others. The goal is to gather detailed data to improve understanding and management of these rare diseases through an international collaboration. The study uses the AIDA registry, a secure online platform for collecting demographic, genetic, clinical, laboratory, radiologic, and therapeutic information. Data are gathered retrospectively and prospectively during routine clinical visits scheduled every 3-6 months. Eleven registries focus on different AID conditions, enabling comprehensive data collection to identify clinical patterns, treatment impacts, and long-term outcomes over a period of at least 10 years. Participants provide information during their usual care visits, allowing researchers to track changes in disease activity, organ involvement, inflammatory markers, visual function, pain levels, fatigue, fertility, and socioeconomic factors. The study monitors these outcomes over multiple timepoints up to 120 months. Data privacy is ensured by pseudonymizing patient information. This registry supports multiple clinical studies and aims to enhance knowledge, awareness, and future research on autoinflammatory diseases worldwide.

Benign prostatic hyperplasia BPH is a common condition affecting many men as they age, often leading to lower urinary tract symptoms LUTS. Due to a growing and aging population, the number of men diagnosed with BPH continues to rise, making treatment for this condition one of the most performed surgical procedures in urology. This research aims to establish a global, ongoing registry that collects detailed demographic and clinical data on men undergoing medical or surgical treatments for BPH to better understand treatment patterns and outcomes worldwide. The registry records information from men aged 18 and older with a primary diagnosis of BPH and LUTS who are receiving either medication or surgical intervention. Data collected includes baseline demographics, peri-operative details, and follow-up outcomes with no actual interventions performed by the registry team. The study uses validated patient-reported outcome measures like the International Prostate Symptom Score IPSS, Sexual Health Inventory for Men SHIM, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction MSHQ-EjD, along with clinical data such as quality of life, urine flow rates, prostate-specific antigen levels, and complications related to treatment. Participants provide data over a period of three years with ongoing follow-up and no fixed end date, allowing for long-term observation of treatment effectiveness and safety. The registry also ensures data security and quality through encryption, user access controls, and regular audits. Researchers will analyze outcomes including symptom scores, quality of life, post-void residual urine, and complications like incontinence, bleeding, urinary tract infections, and erectile dysfunction, aiming to inform future BPH management and research.

Researchers are investigating treatment options for uterine cervix cancer, focusing on comparing a newer hypofractionated chemoradiotherapy approach with the conventional standard treatment. The study aims to find out if the shorter, higher-dose radiation schedule is not worse in terms of clinical response and side effects. This Phase 2 trial involves patients with cervical cancer stages IB to IIIC and is sponsored by Tehran University of Medical Sciences. Participants are randomly assigned to one of two groups. The experimental group receives external beam radiotherapy EBRT of 40 Gy delivered in 15 sessions over 3 weeks along with three weekly doses of chemotherapy drug cisplatin. The control group receives standard EBRT of 45 Gy in 25 sessions over 5 weeks with five weekly cisplatin doses. After EBRT, all patients undergo high dose rate brachytherapy consisting of 28 Gy over four weekly sessions. Throughout the study, patients are monitored for early and late side effects based on established criteria at multiple time points up to three years post-treatment. Clinical response is assessed using dynamic contrast-enhanced pelvic MRI at 3 months, 1 year, and 3 years after brachytherapy. The study also tracks progression-free survival, disease-specific survival, and overall survival over five years. Total participation includes treatment and long-term follow-up evaluations.

Researchers are evaluating the effects of two types of low-dose aspirinenteric-coated and plain formulationson patients with atherosclerotic cardiovascular diseases ASCVD. They are also studying a hybrid strategy aimed at reducing the harmful impact of air pollution on cardiovascular health. This study uses a randomized controlled trial with a 2x2 factorial design to compare these interventions and assess their clinical efficacy and safety. Participants will be assigned to receive either 81 mg enteric-coated aspirin or plain aspirin daily in a double-blind manner. Separately, they will be randomized to either a hybrid air pollution mitigation strategy, which includes educational materials, text message alerts on polluted days, recommendations to stay indoors or wear KN-95 masks when outside, and advice to consume citrus fruits, or to usual care without these interventions. The trial is conducted across multiple centers with concealed allocation and blinded outcome assessment. During the study, participants will be monitored for up to 30 months for major cardiovascular events such as ischemic stroke, myocardial infarction, acute limb events, and cardiovascular death. Researchers will collect data on these outcomes as well as bleeding events and hospitalizations. Participants will receive regular follow-ups, and all events will be reviewed by a blinded clinical events committee. The results aim to guide treatment and preventive strategies for people with ASCVD.

This clinical trial is focused on critically ill patients who are at risk for refeeding syndrome RS and are receiving supportive nutrition in an ICU setting. Researchers aim to find the best protein administration method to improve nutritional and clinical outcomes, reduce complications, and lower mortality. The study tests the hypothesis that a higher protein intake may decrease the occurrence of refeeding syndrome and improve overall patient outcomes, including shorter ICU and hospital stays. Participants are randomly assigned to either a high-protein group or a standard-protein group. Both groups receive nutritional support starting with low calorie intake that gradually increases. The high-protein group targets 2 grams of protein per kilogram of body weight per day, while the standard-protein group targets 1.3 grams per kilogram per day. Protein is gradually introduced, with whey protein powder added if needed, and the intervention lasts for 14 days with a minimum of 5 days. All patients receive daily thiamine and multivitamin-mineral supplements during the study. During the trial, patients are closely monitored with daily laboratory tests for key blood levels and organ function using scoring systems like SOFA. Researchers track the number of patients who develop refeeding syndrome within the first week, as well as secondary outcomes like infections, organ failure, length of ICU and hospital stays, and mortality up to 45 days after admission. The study involves regular assessments and careful monitoring to understand the effects of protein intake on these critically ill patients.

Researchers are comparing two types of fat components used in total parenteral nutrition TPN for children and adolescents aged 2 to 18 years with acute leukemia who are candidates for hematopoietic stem cell transplantation HSCT. The study aims to see if SMOF lipid leads to better graft success, fewer complications after surgery, and less malnutrition compared to Intralipid. This randomized trial is sponsored by Shahid Beheshti University and includes both male and female participants. Participants will be randomly assigned to receive TPN with either SMOF lipid or Intralipid as the fat component. Before transplantation and at days 15 and 30 after, blood samples will be collected to measure biochemical markers like cholesterol, blood sugar, albumin, electrolytes, inflammatory markers, and blood counts. Nutritional intake and appetite will also be assessed. Clinical outcomes such as graft engraftment, infections, bleeding, acute graft-versus-host disease, cholestasis, hospitalization, and mortality will be monitored throughout the study. During the study, participants will be closely followed with blood tests and physical measurements including mid-arm circumference and weight. Researchers will track the time to neutrophil and platelet engraftment and observe nutrition status, including oral intake and duration of parenteral nutrition. Outcomes will be collected for up to 7 weeks after transplantation, with some measures followed for up to 100 days. This comprehensive monitoring will help assess the effects of SMOF lipid versus Intralipid on transplant success and recovery.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are evaluating treatment options for patients with unresectable or borderline resectable colorectal cancer that has spread to the liver. This randomized clinical trial compares the effects of irinotecan-loaded drug-eluting beads DEBIRI combined with systemic chemotherapy versus systemic chemotherapy alone in patients who have not previously received chemotherapy for their metastatic disease. The study aims to determine whether adding DEBIRI can increase the chance of making tumors operable within three months and to assess treatment tolerability, progression-free survival, and overall survival. Participants will be randomly assigned to one of two groups. The treatment group receives systemic chemotherapy on days 0 and 14, plus DEBIRI on days 7 and 21, with at least two doses of DEBIRI unless side effects prevent further treatment. The control group receives 4 cycles of systemic chemotherapy alone. Targeted therapies may be added in both groups based on tumor biology and patient condition. Imaging with MRI or CT scans will be used to monitor tumor response after 1 to 3 months. Throughout the study, patients undergo imaging reviewed by blinded radiologists to evaluate tumor shrinkage using RECIST criteria. The primary outcome is the proportion of patients whose tumors become operable within three months, assessed by a multidisciplinary team. Secondary outcomes include treatment side effects and survival rates. Participants will be followed closely for up to one year to monitor safety and disease progression.

Polycystic Ovary Syndrome PCOS is a common hormonal disorder in women of reproductive age that can cause insulin resistance, abnormal cholesterol levels, hormonal imbalances, infertility, and excessive hair growth. This research evaluates the effects of taking magnesium and L-carnitine supplements together on blood sugar control, cholesterol levels, and hirsutism in women with PCOS. The trial is randomized, triple-blind, and placebo-controlled, involving 84 women aged 19 to 65 diagnosed by the Rotterdam criteria. Participants are assigned to one of three groups for 12 weeks one group takes magnesium supplements 500 mg daily split into two doses plus a placebo for L-carnitine another takes L-carnitine supplements 1000 mg daily plus magnesium and the third group receives placebo capsules matching both supplements. The study collects data on physical activity, diet, body measurements, blood pressure, and blood samples for glucose, insulin, cholesterol, and insulin resistance. Hirsutism is assessed using a standardized scoring method. Throughout the study, participants weight, height, waist circumference, and blood pressure are measured. Blood tests are done after fasting to measure fasting blood sugar, lipid profile, hemoglobin A1c, insulin levels, and insulin resistance using the HOMA-IR calculation. Hirsutism scores are recorded before and after the intervention. Adherence is monitored by counting remaining capsules, excluding those who consume less than 90%. The study aims to track changes in these measures from the start to 12 weeks later.