<?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>IRCT20190316043072N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-31</date_registration>
      <primary_sponsor>Karaj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aerobic exercise as auxiliary therapy on the improvement of the negative and cognitive symptoms of patients with chronic schizophrenia in a randomized clinical case-control study .</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aerobic exercise as auxiliary therapy on the improvement of the negative and cognitive symptoms of patients with chronic schizophrenia in a randomized clinical case-control study .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38383</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 50 patients were randomly assigned to control group and control group, Blinding description: Researcher and analyst are not aware of patients who are under an intervention or non-intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizopherenia disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with chronic schizophrenic disorder are randomly divided into two groups, if they have inclusion criteria. The intervention group is 25 people. In a 8-week program, 2mg of risperidone tablets are given at a dose of 6mg per day, and they are taking 3 days a week in aerobic exercises for 30 minutes per session. Intervention 2: Control group: control group of 25 people. In a 8-week program, risperidone tablets are given at a dose of 2 milligrams per day and not aerobic exercise.</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:
After publishing the article, people can access all the data without mentioning the patients' names

When:
Once the article is printed, people can access the data at any time

To whom:
Analyst / and eventually in the resulting research without the names of the sick

Conditions:
For scientific use and benefit from the results to help patients with schizophrenia disorder after the publication of the article.

Where to obtain:
After the publication and publication of the article, access to data is accessible by protecting the privacy of patients without their names.

How to obtain:
After the publication and publication of the article, access to data is accessible by protecting the privacy of patients without their names.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Atefe Zandifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Araj- Taleghani Square- North Taleghani Blvd - Administrative City- Supreme Court of Justice- Alborz University of Medical Sciences</address>
        <city>Karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 32563328026</telephone>
        <email>zandifaratefe@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Atefe Zandifar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3149779453</zip>
        <telephone>+98 32 5633 2802</telephone>
        <email>zandifaratefe@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria for DSM-V for patients with schizophrenia
The PANSS60 is the lowest score
Age 18 to 05 years old
Obtain informed consent from patient care at least 2 years after the onset of the disease
 Minimum patient score based on Negative subscore 20</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Significant neurological or organoleptic disease, cardiovascular disease and history of cardiac surgery, or any cardiovascular procedure, clinically and laboratory examinations, and case study and biographies of the family.
There is another diagnosis in axis I based on DSM-Vo IQ of less than 70 based on Clinical Clinical suspiciono Drug abuse (except nicotine and caffeine)
 An anti-psychoactive oral intake in the past week or an anti-psychoactive effect in the past montho Get the ECT in the last two weekso Having Major Depression Criteria or Top 4 Scores Based on PANSS Depression 
The desire and suicide attempt in Hamiltono Patients drinking alcohol simultaneously
Patients with a history of drug use in the last 6 months
 Women of childbearing age are not admitted without adequate prophylaxis
 CHF and liver patients 
All patients are undergoing ECG and biochemical tests for liver and kidney disease. 
All patients undergo five stages including basal and weekly visits in weeks 2- 4 and 6.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20-29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia, schizotypal and delusional disorders(F20-F29)</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: Patients with chronic schizophrenic disorder are randomly divided into two groups, if they have inclusion criteria. The intervention group is 25 people. In a 8-week program, 2mg of risperidone tablets are given at a dose of 6mg per day, and they are taking 3 days a week in aerobic exercises for 30 minutes per session.</i_keyword>
      <i_keyword>Control group: control group of 25 people. In a 8-week program, risperidone tablets are given at a dose of 2 milligrams per day and not aerobic exercise.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aerobic exercise. Timepoint: Weeks: 0, 2, 4, 6 and 8. Method of measurement: PANSS/ Brain MRI.</prim_outcome>
      <prim_outcome>Negative and cognitive symptoms. Timepoint: Weeks: 0, 2, 4, 6 and 8. Method of measurement: PANSS/ Brain MRI.</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>medical University Tehran . And Alborz University of Medical Sciences.   Considering the patients are from Roozbeh Hospital in Tehran and Imam Hossein Hospital in Alborz. According to the approval of the project in both Rosabeh and Alborz research centers</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-13</approval_date>
        <contact_name>Ethics committee of Alborz University of Medical Sciences</contact_name>
        <contact_address>North Taleghani Blvd. Taleghani Square. Karaj. Alborz.IRAN karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
