<?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>IRCT20240503061640N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-20</date_registration>
      <primary_sponsor>Combined Military Hospital</primary_sponsor>
      <public_title>Post total thyroidectomy hypocalcemia in toxic MNG and effect of post operative intravenous calcium gluconate in its incidence</public_title>
      <acronym></acronym>
      <scientific_title>Post total thyroidectomy hypocalcemia in toxic MNG and effect of post operative intravenous calcium gluconate in its incidence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>65</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/76800</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: I used computer generated software SPSS version 23 for randomization. First the sample size was randomized into two groups by using SPSS. Then subjects were assign to each group accordingly, Blinding description: Participants were told that they will given post op intravenous calcium gluconate 1 gram 10 ml in 100 ml of infusion as a single dose, or given 10 ml of IV normal saline in 100 ml infusion as a placebo.
After informed written consent Patient will be given either medicine post operative.
Patient will be told that they will not know which medicine is given to them.
As color of both medicine are same, so Patient will not be know which medicine is given.
Medicine will be given by resident surgery.</study_design>
      <phase>3</phase>
      <hc_freetext>Toxic Multinodular goiter and Hypocalcemia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative calcium supplements as single dose intravenous calcium gluconate 1g in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours. Intervention 2: Control group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative normal saline 10 ml as single dose in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours.</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:
POST TOTAL THYROIDECTOMY HYPOCALCEMIA IN TOXIC MNG AND EFFECT OF POST OPERATIVE INTRAVENOUS CALCIUM GLUCONATE IN ITS INCIDENCE

When:
In January 2025

To whom:
Only available for people working in academic institute

Conditions:
whereisdrahsan@yahoo.com

Where to obtain:
whereisdrahsan@yahoo.com

How to obtain:
Through email ID

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Muhammad Ahsan Mustafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahawalpur cantt</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 333 3396180</telephone>
        <email>whereisdrahsan@yahoo.com</email>
        <affiliation>Combined Military Hospital Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Muhammad Ahsan Mustafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahawalpur cantt</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>+92 333 3396180</telephone>
        <email>whereisdrahsan@yahoo.com</email>
        <affiliation>Combined Military Hospital Bahawalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient who are with toxic multinodular goiter.
Patient who underwent total thyroidectomy.
Patient whose pre op calcium level were normal.
Pateint who did not have any parathyroid disease.
Patient who give consent for study research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient who are not with toxic multinodular goiter.
Patient who have solitary thyroid nodule, hypothyroid, diffuse goiter, thyroid carcinoma and recurrent thyroid swelling.
Patient who didn't give consent for study research.
Pateint who were not followed.
Patient whose pre op calcium were not normal.
Patient who were taking pre op calcium supplements.
Patient who have parathyroid disease.
Pateint who underwent lobectomy and isthmusectomy
Patient having any allegy to calcium gluconate.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative calcium supplements as single dose intravenous calcium gluconate 1g in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours.</i_keyword>
      <i_keyword>Control group: In this group participants pre operative calcium level will be checked by laboratory calcium testing machine. Then total thyroidectomy will be done for toxic MNG. After surgery patient will be given post operative normal saline 10 ml as single dose in 100 ml infusion (in 6 hours). Then post operative calcium levels will be checked after 12, 24 and 48 hours.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post total thyroidectomy hypocalcemia. Timepoint: Before and After 12 hours, 24 hours and 48 hour of intervention. Method of measurement: Use laboratory calcium testing machine for measuring calcium level.</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>Combined Military Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-01</approval_date>
        <contact_name>Ethical Committee CMH Bahawalpur</contact_name>
        <contact_address>CMH Bahawalpur cantt Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
