<?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>IRCT20210118050072N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-18</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Cinnopar on reducing the complications of femoral neck fractures in people aged 40 to 60 years old</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Cinnopar on reducing the complications of femoral neck fractures in people aged 40 to 60 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54019</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple randomization. Random unit: individual. Randomization tool: random number table. How to randomize a random sequence: first, we predetermine the table numbers to read (up, down, left and right). The even or odd numbers are in the control group or the case group. Then we put them on one of the numbers and in one moves in predetermined directions and records numbers and assigns them to different groups. Concealment: using opaque envelopes sealed with a random sequence. First the random sequence is specified with a table of random numbers and then a number of envelopes are prepared and each random sequence is recorded on a card and the cards are inside the envelope. The letters are placed in order and finally pasted in envelopes and placed inside a box, and after each patient's visit, one of the envelopes is opened in order, the assigned group of the participant is revealed.</study_design>
      <phase>3</phase>
      <hc_freetext>femoral neck fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: people with femoral neck fractures in the ages of 40 to 60 years referred to the orthopedic ward of Golestan and Imam Khomeini hospitals in Ahvaz after division by simple randomization method who are in the intervention group in addition to the usual treatments for femoral neck fractures including surgery and internal fixation, anticoagulants, antibiotics treated with Cinnopar at a dose of 20 micrograms per day for one month. Then they are visited in the third, sixth and third month after the operation. Intervention 2: Control group: people with femoral neck fractures in the age of 40 to 60 years referred to the orthopedic ward of Golestan and Imam Khomeini hospitals in Ahvaz after being divided by simple randomization method who are in the control group treated with common femoral neck fractures including surgery and internal fixation, anticoagulants, antibiotics and then visit in the third, sixth and third week after surgery.</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:
At the end of the study, all data can be shared after unidentified individuals and will be available through the registration of information and the results in the relevant scientific sites

When:
From the year 1400

To whom:
Researchers working in academic institutions, physicians and medical students at different levels

Conditions:
Orthopedic specialists can access the results of our studies by email or in person or by phone in order to choose an adjunct method for better healing of femoral neck fractures and to reduce the complications caused by these fractures.

Where to obtain:
Mojtaba Jafarzade 09173917359

How to obtain:
Making a phone call, if the requested person is identified, they will be provided with prompt information

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mojtaba Jafarzade Jahromi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Motahari hospital, Motahari Ave.</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7415713548</zip>
        <telephone>+98 71 5433 1137</telephone>
        <email>mojtaba.jafarzade@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad fakoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam khomeini hospital, Azadegan Ave.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673111</zip>
        <telephone>+98 61 3222 2922</telephone>
        <email>dr_m_fakoor@hotmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient consent to participate in the study
Patients with femoral neck fractures in the ages of 40-60 years old</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smocking
Alcohol consumption
Patients with a history of diabetes, chronic hypertension, rheumatoid arthritis, calcium metabolism disorders, cancer, Paget's disease and chronic renal failure 
Corticosteroids and PPI user
Patients with very high or very low weight</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S72.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of unspecified part of neck of femur</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: people with femoral neck fractures in the ages of 40 to 60 years referred to the orthopedic ward of Golestan and Imam Khomeini hospitals in Ahvaz after division by simple randomization method who are in the intervention group in addition to the usual treatments for femoral neck fractures including surgery and internal fixation, anticoagulants, antibiotics treated with Cinnopar at a dose of 20 micrograms per day for one month. Then they are visited in the third, sixth and third month after the operation.</i_keyword>
      <i_keyword>Control group: people with femoral neck fractures in the age of 40 to 60 years referred to the orthopedic ward of Golestan and Imam Khomeini hospitals in Ahvaz after being divided by simple randomization method who are in the control group treated with common femoral neck fractures including surgery and internal fixation, anticoagulants, antibiotics and then visit in the third, sixth and third week after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Non- union. Timepoint: X_ray at first, after 3 weeks, after 3 months and after 6 months. Method of measurement: X-ray.</prim_outcome>
      <prim_outcome>Time to return to activity. Timepoint: 6 weeks and 3 months. Method of measurement: The patient walks independently and without pain and performs normal activities.</prim_outcome>
      <prim_outcome>Reduce pain. Timepoint: After 3 months. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Fixation failure. Timepoint: 2 weeks, 6 weeks, 3 months post operation. Method of measurement: x ray.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-16</approval_date>
        <contact_name>Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Ahvaz, Farvardin St., Golestan Hospital Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
