xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974332</url>
    </required_header>
    <id_info>
      <org_study_id>Beni-Suefu</org_study_id>
      <nct_id>NCT05974332</nct_id>
    </id_info>
    <brief_title>Oncostatin M in Ulcerative Colitis Patients</brief_title>
    <official_title>Serum Oncostatin M in Ulcerative Colitis Patients and Its Relation to Severity and Acute Exacerbation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea,&#xD;
        bloody stools, and abdominal pain with repeated relapses and remissions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation&#xD;
        can facilitate subsequent prognostication. On the basis of these considerations, achievement&#xD;
        of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD&#xD;
        using endoscopy is extremely important. However, endoscopic examinations are associated with&#xD;
        problems such as physical burden to the patient, cost, and risk of complications.&#xD;
  &#xD;
        Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately&#xD;
        reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal&#xD;
        immunochemical occult blood test (FIT) are being widely used in clinical practice.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Identify if oncostatin M is a good marker</measure>
      <time_frame>6 months</time_frame>
      <description>Diagnosis of Ulcerative colitis and follow up</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">99</enrollment>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>Ulcerative colitis Patients</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>45 apparently healthy subjects as controls who were not UC</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Oncostatin M</intervention_name>
      <description>Test to diagnosis of Ulcerative colitis</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Ulcerative colitis Patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients aged &gt;18 years and &lt;80 years, of both gender who diagnosed to have UC and&#xD;
               given the consent for participation in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1- Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or&#xD;
               tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus&#xD;
               erythematous&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>mohamed gamal mohamed abdel aleem</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colitis</mesh_term>
      <mesh_term>Colitis, Ulcerative</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oncostatin M</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974332
  org study id: Beni-Suefu
  nct id: NCT05974332
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea,
        bloody stools, and abdominal pain with repeated relapses and remissions.
  Evaluation of UC activity is important, and endoscopic evaluations of mucosal inflammation
        can facilitate subsequent prognostication. On the basis of these considerations, achievement
        of mucosal healing is important in inflammatory bowel disease (IBD), and evaluation of IBD
        using endoscopy is extremely important. However, endoscopic examinations are associated with
        problems such as physical burden to the patient, cost, and risk of complications.
  
        Thus, to avoid the need for frequent endoscopy, noninvasive biomarkers that accurately
        reflect the endoscopic activity of UC have emerged, and fecal calprotectin (FC) and the fecal
        immunochemical occult blood test (FIT) are being widely used in clinical practice.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: Single (Participant)
  measure: Identify if oncostatin M is a good marker
  time frame: 6 months
  description: Diagnosis of Ulcerative colitis and follow up
  arm group label: Ulcerative colitis Patients
  arm group type: Active Comparator
  description: 45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding
  arm group label: Control
  arm group type: Active Comparator
  description: 45 apparently healthy subjects as controls who were not UC
  intervention type: Diagnostic Test
  intervention name: Oncostatin M
  description: Test to diagnosis of Ulcerative colitis
  arm group label: Control
  arm group label: Ulcerative colitis Patients
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: mohamed gamal mohamed abdel aleem
  investigator title: Doctor
  mesh term: Colitis
  mesh term: Colitis, Ulcerative
  mesh term: Ulcer
  mesh term: Oncostatin M