<?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>IRCT2012072410380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-18</date_registration>
      <primary_sponsor>National Nutrition and Food Research Institute</primary_sponsor>
      <public_title>Identification of rheological properties of desirable foodstuffs for Iranian dysphagic patients</public_title>
      <acronym></acronym>
      <scientific_title>Identification and modification of rheological properties of beverages, desserts, and food in patients with esophagus cancer dysphagia and assessment of the rheological modification on improving nutritional indices and quality of life in these patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/10890</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>dysphagia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group uses the rheologically modified foodstuffs, along with common diet (one product from each item). Intervention 2: control group: there isnt any intervention&#13;
they use their conventional diet.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azizollaah Zargaraan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21 4467 3175</telephone>
        <email>aziz.zargaran@gmail.com ; zargaraan@sbmu.ac.ir</email>
        <affiliation>National Nutrition and Food Technology Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. M.A Mohammadifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1981619573</zip>
        <telephone>+98 21223690658</telephone>
        <email>mohamdif@ut.ac.ir</email>
        <affiliation>National Nutrition and Food Technology Research Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients who have esophageal dysphagia (from esophageous cancer); patients are in the second phase of esophageous cancer (starting chemotrapy).  Exclusion criteria: the tendency of samples to exclude from study.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Difficulty in swallowing</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group uses the rheologically modified foodstuffs, along with common diet (one product from each item)</i_keyword>
      <i_keyword>control group: there isnt any intervention&#13;
they use their conventional diet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of body weight loss(%BWL). Timepoint: at the start and 3 monthes after intervention. Method of measurement: scale.</prim_outcome>
      <prim_outcome>Triceps(TSF) and subscapular skin fold(SSF). Timepoint: at the start and 3 monthes after intervention. Method of measurement: caliper.</prim_outcome>
      <prim_outcome>Mid arm circumference(MAC). Timepoint: at the start and 3 monthes after intervention. Method of measurement: Tape Measure.</prim_outcome>
      <prim_outcome>Arm muscle circumference(AMC). Timepoint: at the start and 3 monthes after intervention. Method of measurement: Tape Measure.</prim_outcome>
      <prim_outcome>Serum Total Proteins. Timepoint: at the start and 3 monthes after intervention. Method of measurement: Electrophoresis.</prim_outcome>
      <prim_outcome>Serum C-reactive protein. Timepoint: at the start and 3 monthes after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Albumin. Timepoint: at the start and 3 monthes after intervention. Method of measurement: Elisa.</prim_outcome>
      <prim_outcome>Transferrin. Timepoint: at the start and 3 monthes after intervention. Method of measurement: Electrophoresis.</prim_outcome>
      <prim_outcome>Pre-Albumin. Timepoint: at the start and 3 monthes after intervention. Method of measurement: Electrophoresis.</prim_outcome>
      <prim_outcome>Hematocrit. Timepoint: at the start and 3 monthes after intervention. Method of measurement: coagulation.</prim_outcome>
      <prim_outcome>Total Lymphocyte. Timepoint: at the start and 3 monthes after intervention. Method of measurement: microscopic.</prim_outcome>
      <prim_outcome>Prognostic Nutritional Index (PNI). Timepoint: at the start and 3 monthes after intervention. Method of measurement: 158 - 16.6(Alb) - 0.78(Ts) - 0.20(Trn) - 5.8(DH).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Appetite. Timepoint: at the start and 3 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Energy intake. Timepoint: at the start and 3 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Micronutrient intake. Timepoint: at the start and 3 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Macronutrient intake. Timepoint: at the start and 3 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: at the start and 3 month after intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Enjoyment from foodstuffs. Timepoint: 3 month after intervention. Method of measurement: vas.</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>National Nutrition and Food Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-12-02</approval_date>
        <contact_name>National Nutrition and Food Technology Research Institute</contact_name>
        <contact_address>No. 7, West Arghavan St., Farahzadi Blvd., Shahrake Qods (west), Tehran, Iran. Zip Code: 1981619573, P.O.Box: 19395-4741 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
