<?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>IRCT2013062613783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-31</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Determining efficacy of smoke cessation  on tuberculosis  treatment</public_title>
      <acronym></acronym>
      <scientific_title>Determining efficacy of smoke cessation program on quit Rate, immunological response and treatment outcome in new pulmonary tuberculosis patients: a clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>240</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13562</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>tuberculosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group (cessation consultation and pharmacotherapy ): smokers  patients with pulmonary tuberculosis who are under Tb DOTS   Treatment  that recieve smoke cessation program consultation and pharmacotherapy . Cessation consultation consist of advice , assist  and  arrange .Four  counseling sessions will be held during the first two weeks .patients will also receive sustain release Bupropion  -150 mg- BD for nine weeks which will be free of charge for them. Intervention 2: Intervention groups(Brief advice counseling): smokers  patients with pulmonary tuberculosis who are under Tb DOTS   Treatment that receive smoking cessation brief advice for three minute. This group will get a short brief advice; strongly and clearly  advice  to quit smoking, given the benefits of cessation and linking it with their current disease status by trained physician during their TB treatment in the first visit. Intervention 3: Smoker Control Groups: smoker patients with pulmonary tuberculosis which are under Tb Treatment and  age and sex of them are matched with intervention group. They do not receive any intervention. Intervention 4: Non Smoker Control Groups: Non smoker patients with pulmonary tuberculosis which are under Tb Treatment and age and sex of them are matched with intervention group. They do not receive any intervention.</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>Mahshid Aryanpur</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital -Daar Abad-Niavaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955841452</zip>
        <telephone>+98 21 2610 9508</telephone>
        <email>mahshidaryanpur@yahoo.com</email>
        <affiliation>National Research Institute of Tuberculosis and Lung Disease</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. MohammadReza Masjedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Masih Daneshvari Hospital -Daar Abad-Niavaran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955841452</zip>
        <telephone>+1 9552126109508</telephone>
        <email>mrmasjedi@gmail.com</email>
        <affiliation>National Research Institute of Tuberculosis and Lung Disease</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: current manufactured cigarette smokers will be diagnosed with active pulmonary TB: either sputum smear-positive or smear-negative, based on classification from WHO treatment guidelines; classify under treatment Category I (new TB cases) ; patients of both sexes, aged 18 years and above; speaking the Persian language. &#13;
Exclusion criteria: having extra pulmonary TB only (involving CNS, pericardium, adrenal etc) ; they have multi-drug resistant tuberculosis at diagnosis ; they are living with or newly diagnosed with HIV/AIDS ;  they are active IV drug abuser  ; they are classified as Category II (relapse, treatment failure, and treatment after default) or Category III (chronic TB) ;they fulfill the eligibility criteria, but unwilling to participate in the study or unable to understand the contents of the informed consent form.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A15</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Respiratory tuberculosis, bacteriologically and histologically confirmed</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group (cessation consultation and pharmacotherapy ): smokers  patients with pulmonary tuberculosis who are under Tb DOTS   Treatment  that recieve smoke cessation program consultation and pharmacotherapy . Cessation consultation consist of advice , assist  and  arrange .Four  counseling sessions will be held during the first two weeks .patients will also receive sustain release Bupropion  -150 mg- BD for nine weeks which will be free of charge for them.</i_keyword>
      <i_keyword>Intervention groups(Brief advice counseling): smokers  patients with pulmonary tuberculosis who are under Tb DOTS   Treatment that receive smoking cessation brief advice for three minute. This group will get a short brief advice; strongly and clearly  advice  to quit smoking, given the benefits of cessation and linking it with their current disease status by trained physician during their TB treatment in the first visit.</i_keyword>
      <i_keyword>Smoker Control Groups: smoker patients with pulmonary tuberculosis which are under Tb Treatment and  age and sex of them are matched with intervention group. They do not receive any intervention.</i_keyword>
      <i_keyword>Non Smoker Control Groups: Non smoker patients with pulmonary tuberculosis which are under Tb Treatment and age and sex of them are matched with intervention group. They do not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Tuberculosis treatment outcome. Timepoint: 2,4,6 months. Method of measurement: sputum smear.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Smoke cessation. Timepoint: 2-4-6 months. Method of measurement: urine cotenine test.</sec_outcome>
      <sec_outcome>Immunologic response(phagocytes capacity uptake and IL-8 amount). Timepoint: 3 months. Method of measurement: flow cytometry.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-30</approval_date>
        <contact_name>National Research Institute of Tuberculosis  and lung disease</contact_name>
        <contact_address>Masih Daneshvari Hospital-Daar abad- Niavaran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
