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IRCT20230903059342N6 IRCT 2026-05-30 Bagheiat-allah University of Medical Sciences Evaluation of the safety and efficacy of an optimized measles virus vaccine in patients with malignant ascites A clinical trial of the first phase of evaluating the safety and efficacy of the optimized intraperitoneal measles virus vaccine in patients with malignant ascites. 2026-06-21 anticipated 20 Pending https://irct.ir/trial/90305 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is going to be done by the method of random blocks of 6 random strings with a length of 20coincidences with a ratio of 2 to 1. This string is created by one of the online randomization software. In order to hide the randomization, the method of closed envelopes will be used. 1 Malignant ascites. Intervention group: In addition to standard treatment, patients receive the optimized measles vaccine product designed and optimized by Baqiyatallah University intraperitoneal. Simultaneously with treatment with the optimized measles vaccine, patients receive their standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ruhollah Dorostkar
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8817 0179 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences scientific Ruhollah Dorostkar
Virology Lab. Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheikh Bahai South Avenue, Mollasadra St, Vanak Sq, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8817 0179 R.dorost@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Patients with malignant ascites Patient age between 18 and 80 years Absence of pregnancy Proper functioning of liver, kidney and bone marrow The ability to understand and sign the consent form by the patient and one of these cases: the patient's spouse, parent or guardian. Complying with all protocol steps including sample submission and returning to the clinical study site for subsequent visits Absence of autoimmune diseases or diseases of the immune system 18 years 80 years Both Life-threatening acute infection Absence of any previous record that describes the doctor's treatment and orders were nor followed by patient. Using drugs that weaken the immune system Affected by any diseases that disturbs the immune system Having any previous record of organ transplantation Allergy to measles vaccine pregnancy Using other investigational treatments at the same time R18.0 Malignant ascites N/A Intervention group: In addition to standard treatment, patients receive the optimized measles vaccine product designed and optimized by Baqiyatallah University intraperitoneal. Simultaneously with treatment with the optimized measles vaccine, patients receive their standard treatments including chemotherapy and immunotherapy. In fact, the intervention is in the form of adjuvant therapy. Fever. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: Thermometer. Examining changes in the patient's heart condition. Timepoint: Examining changes in the patient's heart condition. Method of measurement: Electrocardiogram. Examining changes in the patient's breathing status. Timepoint: Hourly in the first 24 hours and then daily up to 7 days. Method of measurement: pulse oximeter. Bagheiat-allah University of Medical Sciences Approved 2025-01-19 Ethics Committee in Research of the Educational and Therapeutic Center of Baqiyatullah Al-Azam Mollasadra st, Vanak sq, Sheykh bahayi st,Tehran,Iran. Tehran Tehran Iran (Islamic Republic of)