<?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>IRCT20220215054023N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-04-27</date_registration>
      <primary_sponsor>Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</primary_sponsor>
      <public_title>Effectiveness of Thalidomide in Transfusion Dependent Thalassemia patients</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Thalidomide in Transfusion Dependent Thalassemia patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>55</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61970</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Beta thalassemia is genetic disorder which is caused by insertions and deletions in chromosome number 11. The disease is treated by blood transfusions which leads to iron over load and demand for chelation therapy. Some patients do not respond to this treatment and suffer from complications. Although treatment with hydroxyurea has leads to improved conditions by reducing transfusion demand, but some patients do not respond to this treatment. Hence, other treatment modalities which induce fetal hemoglobin are being explored. The aim of this study is to see the effectiveness of thalidomide in treating beta thalassemia patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients diagnosed with beta thalassemia diagnosed according to clinical characteristics and hemoglobin electrophoresis were included in this study according to the selection criteria. At the time of treatment the patients will interviewed and tested for pre-treatment variables which include hemoglobin levels, transfusion rate. All the patients will then be given 2-5mg/kg thalidomide for 6 months as prescribed by the consultant and these variables will be tested again. Response rate will be tested on the basis of operational definition. The principal investigator will follow up with all the patients and see post-treatment results. Drug used in the study is Capsule Thalido(Thalidomide) with strength 50mg and 100mg will ne given as 2-5mg/kg in once daily dose for 6 months manufactured by ATCO laboratories. Intervention 2: Control group: This group will not receive any type of treatment as assigned to interventional group. Effectiveness will be measured in interventional group only.</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:
Effectiveness of Thalidomide in Transfusion Dependent Thalassemia Patients
This study will be conducted at Department of Pediatrics, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan. This study will be conducted after approval from Ethical Review Board (ERB) of Sheikh Zayed Hospital and University of Health Sciences, Lahore. Performa, attached with the synopsis, will be filled by the principle investigator. Patients diagnosed with beta thalassemia diagnosed according to clinical characteristics and hemoglobin electrophoresis were included in this study according to the selection criteria. At the time of treatment the patients will interviewed and tested for pre-treatment variables which include hemoglobin levels and transfusion rate. All the patients will then be given 2-5mg/kg thalidomide for 6 months as prescribed by the consultant hematologist and these variables will be tested again. Response rate will be tested on the basis of operational definition. The principal investigator will follow up with all the patients and see post-treatment results.

When:
Starting 6 months after publication

To whom:
For people working in academic institutions

Conditions:
This data will de used for research purposes and also improve the treatment of beta thalassemia

Where to obtain:
Contact the relevant person via phone number, email addresses or postal

How to obtain:
Just contact the relevant person via phone number, email addresses or postal to request to access data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Prof. Dr. Muhammad Saleem Laghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics(unit 2), Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</address>
        <city>Rahim Yar Khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 333 8808633</telephone>
        <email>profdrmsaleem@szmc.edu.pk</email>
        <affiliation>Department of Pediatrics (unit 2), Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Prof. Dr. Muhammad Saleem Laghari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Pediatrics (unit 2), Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</address>
        <city>Rahim Yar Khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 333 8808633</telephone>
        <email>profdrmsaleem@szmc.edu.pk</email>
        <affiliation>Department of Pediatrics (unit 2), Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Beta thalassemia patients are diagnosed by clinical characteristics and by hemoglobin electrophoresis
Age 2 years to 15 years
Both Gender</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients already undergoing treatment for induction of HbF
Patients with liver, renal, cardiac, pulmonary, neurological deficits or history of thrombotic episodes
Patients not giving consent to treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D56.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Beta thalassemia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients diagnosed with beta thalassemia diagnosed according to clinical characteristics and hemoglobin electrophoresis were included in this study according to the selection criteria. At the time of treatment the patients will interviewed and tested for pre-treatment variables which include hemoglobin levels, transfusion rate. All the patients will then be given 2-5mg/kg thalidomide for 6 months as prescribed by the consultant and these variables will be tested again. Response rate will be tested on the basis of operational definition. The principal investigator will follow up with all the patients and see post-treatment results. Drug used in the study is Capsule Thalido(Thalidomide) with strength 50mg and 100mg will ne given as 2-5mg/kg in once daily dose for 6 months manufactured by ATCO laboratories</i_keyword>
      <i_keyword>Control group: This group will not receive any type of treatment as assigned to interventional group. Effectiveness will be measured in interventional group only</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Response to treatment. Timepoint: before intervention and after 6 months after intervention. Method of measurement: become transfusion free after treatment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Number of transfusion and hemoglobin level. Timepoint: before intervention and after 6 months of intervention. Method of measurement: number of transfusion and hemoglobin level.</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>Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-04</approval_date>
        <contact_name>Institutional Review Board Sheikh Zayed Medical College/Hospital, Rahim Yar Khan</contact_name>
        <contact_address>Sheikh Zayed Medical College/Hospital, Rahim Yar Khan Rahim Yar Khan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
