<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200914048711N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-03</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Lycopene on the expression level of Mir-210, Antioxidant factors and apolipoproteins in patients with ischemic heart failure referring to Isfahan Chamran hospital: A randomized Clinical Trial</public_title>
      <acronym>Miracle</acronym>
      <scientific_title>The effect of Lycopene on the expression level of Mir-210, Antioxidant factors and apolipoproteins in patients with ischemic heart failure referring to Isfahan Chamran hospital: A randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53805</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number tables have been used in statistics for tasks such as selected random samples. This was much more effective than manually selecting the random samples.  

If carefully prepared, the filtering and testing processes remove any noticeable bias or asymmetry from the hardware-generated original numbers so that such tables provide the most "reliable" random numbers available to the casual user.

Note that any published (or otherwise accessible) random data table is unsuitable for cryptographic purposes since the accessibility of the numbers makes them effectively predictable, and hence their effect on a cryptosystem is also predictable. By way of contrast, genuinely random numbers that are only accessible to the intended encoder and decoder allow literally unbreakable encryption of a similar or lesser amount of meaningful data (using a simple exclusive OR operation) in a method known as the one-time pad, which has often insurmountable problems that are barriers to implementing this method correctly, Blinding description: Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes. The terms blind and masking are synonymous; both terms describe methods that heslp to ensure that individuals do not know which treatment or intervention is being administered. The purpose of triple-blinding procedures is to reduce assessment bias and to increase the accuracy and objectivity of clinical outcomes.</study_design>
      <phase>3</phase>
      <hc_freetext>Congestive heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Lycopene, one 25 mg tablet daily, for 60 days, 21st Century company, made in USA, contains 25 mg of lycopene and 170 mg of calcium carbonate. Intervention 2: Control group: Placebo, One tablet daily for 60 days,.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some of the data related to the main outcome will be shared.

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Optimization of this study to help patients

Where to obtain:
Laila Rejali: 
lailarejali@yahoo.com
Dr.Hashem Nayeri:
hnaieri@gmail.com

How to obtain:
Official letter to Leila Rejali and Dr. Hashem Nayeri

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Laila Rejali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Blvd, Basij Blvd, Falavarjan</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8451731167</zip>
        <telephone>+98 31 3742 0134</telephone>
        <email>lailarejali@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hashem Nayeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Blvd, Basij Blvd, Falavarjan</address>
        <city>Falavarjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8451731167</zip>
        <telephone>+98 31 3742 0134</telephone>
        <email>hnaieri@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ischemic heart failure
Age: 40 -70 years olds
Ejection Fraction:  20 - 40</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients with cancer, nephrotic diseases, diabetes, autoimmune diseases, organ transplantation, immunosuppressive drugs, bronchial diseases, stroke, arrhythmia, late surgery, active viral infection, active internal hemorrage, anemia with Hb&lt;10g/dl
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Lycopene, one 25 mg tablet daily, for 60 days, 21st Century company, made in USA, contains 25 mg of lycopene and 170 mg of calcium carbonate</i_keyword>
      <i_keyword>Control group: Placebo, One tablet daily for 60 days,</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart function. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Echocardiogram.</prim_outcome>
      <prim_outcome>Lipid profile. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Auto analyzer biochemistry.</prim_outcome>
      <prim_outcome>Total antioxidant capacity. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Assay kit, Spectrophotometer.</prim_outcome>
      <prim_outcome>Paraoxonase enzyme activity assay. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Assay kit, Spectrophotometer.</prim_outcome>
      <prim_outcome>Arylesterase enzyme activity assay. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Assay kit, Spectrophotometer.</prim_outcome>
      <prim_outcome>LDL separation from plasma. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Ultracentrifuge.</prim_outcome>
      <prim_outcome>Assessment of LDL oxidation. Timepoint: Before of intervention, 60 days after of intervention. Method of measurement: Cuso4, Spectrophotometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Owner</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-08</approval_date>
        <contact_name>Ethics committee of Islamic Azad University of Falavarjan</contact_name>
        <contact_address>Falavarjan, University square, University Blvd Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
