<?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>IRCT20230214057416N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-02</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of prescribing diuretics and the inclined position with the head down for the removal of lower calices stones during extracorporeal shock wave lithotripsy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of prescribing diuretics and the inclined position with the head down for the removal of lower calices stones during extracorporeal shock wave lithotripsy in patients who referred to the Stone Crushing Center</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>148</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68873</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: . We use the permuted block randomization method to balance the number of detected samples. For this purpose, we use the site https://www.sealedenvelope.com/simple-randomiser/v1/lists for block randomization and get the following results:
Your list
Seed: 500000000000000000
Block sizes: 4
Actual list length: 52
block identifier, block size, sequence within block, treatment
•	1, 4, 1, Group A
•	1, 4, 2, Group B
•	1, 4, 3, Group B
•	1, 4, 4, Group A
•	2, 4, 1, Group A
•	2, 4, 2, Group A
•	2, 4, 3, Group B
•	2, 4, 4, Group B
•	3, 4, 1, Group B
•	3, 4, 2, Group A
•	3, 4, 3, Group A
•	3, 4, 4, Group B
•	4, 4, 1, Group A
•	4, 4, 2, Group B
•	4, 4, 3, Group B
•	4, 4, 4, Group A
•	5, 4, 1, Group B
•	5, 4, 2, Group A
•	5, 4, 3, Group B
•	5, 4, 4, Group A
•	6, 4, 1, Group A
•	6, 4, 2, Group A
•	6, 4, 3, Group B
•	6, 4, 4, Group B
•	7, 4, 1, Group A
•	7, 4, 2, Group B
•	7, 4, 3, Group A
•	7, 4, 4, Group B
•	8, 4, 1, Group A
•	8, 4, 2, Group B
•	8, 4, 3, Group A
•	8, 4, 4, Group B
•	9, 4, 1, Group A
•	9, 4, 2, Group B
•	9, 4, 3, Group A
•	9, 4, 4, Group B
•	10, 4, 1, Group B
•	10, 4, 2, Group B
•	10, 4, 3, Group A
•	10, 4, 4, Group A
•	11, 4, 1, Group A
•	11, 4, 2, Group A
•	11, 4, 3, Group B
•	11, 4, 4, Group B
•	12, 4, 1, Group A
•	12, 4, 2, Group B
•	12, 4, 3, Group A
•	12, 4, 4, Group B
•	13, 4, 1, Group B
•	13, 4, 2, Group B
•	13, 4, 3, Group A
•	13, 4, 4, Group A

And then we can use coin toss to choose between A and B. Also, a questionnaire has been designed to record information, which includes three parts before the operation, during the operation and after the operation, which are included in the appendices.</study_design>
      <phase>3</phase>
      <hc_freetext>lower calices stones.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: prescribing diuretics and the inclined position with the head down. Intervention 2: Control group: Injection of normal saline without diuretics and without head down position.</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:
All information except personal information can be shared.

When:
since 1403

To whom:
Researchers working in academic and scientific institutions

Conditions:
All people who need the results of this research, including doctors, researchers, students of medical sciences, etc.

Where to obtain:
The Researcher ( Darya Rezaei ) drrezaei98@gmail.com

How to obtain:
Sending an email and replying to her/him at least 1 week later

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Darya Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>16 Azar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461884513</zip>
        <telephone>+98 21 6640 5357</telephone>
        <email>drrezaei98@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Darya Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>16 azar</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1461884513</zip>
        <telephone>+98 21 6640 5357</telephone>
        <email>drrezaei98@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 60 years
Patients diagnosed with lower calyx stones</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>anatomical abnormality in urinary system
Uncorrected coagulation problem
Untreated urinary tract infection or urosepsis
Previous urological surgery
Obstruction of the urinary tract distal to the stone
Unilateral and simultaneous kidney and ureter stones
Kidney failure (urine creatinine more than 1.8)
Having a cardiovascular disease such as having a pacemaker
tumore in areas exposed to shock
Aneurysms
BMI&gt;40  Kg/m2
Skeletal problems such as inability to take certain positions
History of having allergy diuretics
pregnancy
single kidney
hypotention
uncontrolled HTN
history of CNS disease
history of brain tumors
history of ICP rise</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: prescribing diuretics and the inclined position with the head down</i_keyword>
      <i_keyword>Control group: Injection of normal saline without diuretics and without head down position</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Removal of lower calices stones. Timepoint: After two weeks of ESWL. Method of measurement: questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-15</approval_date>
        <contact_name>Research Ethics Committees of Sina Hospital</contact_name>
        <contact_address>Tehran - Imam Khomeini St. - Hassan Abad Square - Sina Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
