<?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>IRCT2014052515975N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-06-17</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences, Semnan, Iran</primary_sponsor>
      <public_title>Effects of acute stress on declarative memory reconsolidation across menstrual cycle</public_title>
      <acronym></acronym>
      <scientific_title>Effects of acute stress on declarative memory reconsolidation across menstrual cycle in healthy women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15085</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress.</hc_freetext>
      <i_freetext>Intervention 1: In stress condition, participants expose to the socially evaluated cold pressor test (SECPT). Subjects will ask to immerse their right hand up to and including the wrist into ice water (0-2 C). Subjects would be asking to remain immersed for 3 min, but tell that they are free to pull out at any time without penalty. During hand immersion they will videotaping, ask to look into the video camera and tell that these video recordings would be analyzed later for facial expression. The SECPT has been shown to elicit significant increases in cortisol and autonomic activity. In the control condition, individuals immerse their right hand up to and including the wrist for 3 min into warm water (35—37 ºC). They are not videotape. Intervention 2: Memory Task. Day1: Learning; On day 1, participants learn 30 pictures include ten positive pictures (such as Ice cream), ten negative pictures (example Injury) and ten neutral pictures(glass). Day2: Reactivation; On day 2, participants in reactivation group would be asked to remind the pictures they had learned on the previous day. In no reactivation group, participants reading newspaper. Immediately, they are challenging with Stress or Control. Day3: Retrieval and Recognition; On day 3, participants would be asked to write down the pictures they had learned on day 1. Cued recall will be assessed immediately after free recall. After 2 months, participants return for days 4, 5, and 6, during which the same procedures with the alternate condition (Stress or Control).</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>Dr. Mohsen Pourazizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of medicine, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1335 4359</telephone>
        <email>m.pourazizi@yahoo.com ; m.pourazizi@sem-ums.ac.ir</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Ali Rashidy-Pour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Laboratory of Learning and Memory, Physiology Research Center, Semnan University of Medical Sciences, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 1335 4359</telephone>
        <email>rashidy-pour@sem-ums.ac.ir</email>
        <affiliation>Physiology Research Center, Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria:  Age between 18 and 25 years; Body mass index (BMI) between 19 and 26 kg/m2; No smoking; No addiction to narcotic substance and alcohol; No reported history of disease or psychiatric problems; No medication intake; No use of psychotropic drugs; No history of disease or abnormal laboratory test; Not being in stressful situations; Having a positive mood (According to PANAS); Naturally cycling with menstrual cycles between 24 and 32 days; Consent to participate in the study.&#13;
Exclusion Criteria: Being in stressful situations or disease  during study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>25 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z73.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In stress condition, participants expose to the socially evaluated cold pressor test (SECPT). Subjects will ask to immerse their right hand up to and including the wrist into ice water (0-2 C). Subjects would be asking to remain immersed for 3 min, but tell that they are free to pull out at any time without penalty. During hand immersion they will videotaping, ask to look into the video camera and tell that these video recordings would be analyzed later for facial expression. The SECPT has been shown to elicit significant increases in cortisol and autonomic activity. In the control condition, individuals immerse their right hand up to and including the wrist for 3 min into warm water (35—37 ºC). They are not videotape.</i_keyword>
      <i_keyword>Memory Task. Day1: Learning; On day 1, participants learn 30 pictures include ten positive pictures (such as Ice cream), ten negative pictures (example Injury) and ten neutral pictures(glass). Day2: Reactivation; On day 2, participants in reactivation group would be asked to remind the pictures they had learned on the previous day. In no reactivation group, participants reading newspaper. Immediately, they are challenging with Stress or Control. Day3: Retrieval and Recognition; On day 3, participants would be asked to write down the pictures they had learned on day 1. Cued recall will be assessed immediately after free recall. After 2 months, participants return for days 4, 5, and 6, during which the same procedures with the alternate condition (Stress or Control).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Memory retrieval. Timepoint: Day 3. Method of measurement: Number of recalled pictures.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Salivary cortisol level. Timepoint: S1: Day 2, Before SECPT or Control     condition (Base); S2: Day 2, 10 minutes after SECPT or Control ; S3: Day 2, 25 minutes after SECPT or Control; S4: Day 2, 60 minutes after SECPT or Control;  S5: Day 3, Before retrieval test. Method of measurement: Immunoassay- IBL kit (IBL Immuno Biological Laboratories, Hamburg, Germany).</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>Semnan University of Medical Sciences, Semnan, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-11-27</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences, Semnan, Iran Semnan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
