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/NCT05967494</url>
    </required_header>
    <id_info>
      <org_study_id>84606875</org_study_id>
      <nct_id>NCT05967494</nct_id>
    </id_info>
    <brief_title>Discovering Trends in Chronic Fatigue Syndrome Patients' Clinical Study Experiences</brief_title>
    <official_title>Assessing Patient Engagement and Understanding in Chronic Fatigue Syndrome Clinical Trials</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Power Life Sciences Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Power Life Sciences Inc.</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>
        The study seeks to delve into the firsthand experiences of patients diagnosed with chronic&#xD;
        fatigue syndrome who partake in a separate clinical trial featuring a specific medical&#xD;
        intervention. The primary emphasis will be on meticulously tracking the rates of trial&#xD;
        completion and withdrawal among these individuals.&#xD;
  &#xD;
        The data collected from this study will help improve future outcomes for all chronic fatigue&#xD;
        syndrome patients as well as those in under-represented demographic groups.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2024</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of patients who decide to join in a chronic fatigue syndrome clinical trial</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of chronic fatigue syndrome patients who remain in clinical trial until completion</measure>
      <time_frame>12 months</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Chronic Fatigue Syndrome</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with chronic fatigue syndrome who are actively considering enrolling in a clinical&#xD;
          study, but have not yet completed enrollment and randomization.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signed Written Informed Consent&#xD;
  &#xD;
            -  Aged ≥ 18 years old&#xD;
  &#xD;
            -  No prior treatment for chronic fatigue syndrome&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant is actively receiving study therapy in another&#xD;
  &#xD;
            -  Inability to provide written informed consent&#xD;
  &#xD;
            -  Women of childbearing potential without a negative pregnancy test; or women who are&#xD;
               lactating.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael B Gill</last_name>
      <role>Study Director</role>
      <affiliation>Power Life Sciences Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael B Gill</last_name>
      <phone>(415) 900-4227</phone>
      <email>bask@withpower.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Power Life Sciences</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94107</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael B Gill</last_name>
        <phone>415-900-4227</phone>
        <email>https://www.withpower.com/contact-us@withpower.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Meng XD, Guo HR, Zhang QY, Li X, Chen Y, Li MY, Zhuo XM, Wang MJ, Shan K, Gong YN, Li NC, Chen B, Chen ZL, Guo Y. The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial. Complement Ther Clin Pract. 2020 Aug;40:101210. doi: 10.1016/j.ctcp.2020.101210. Epub 2020 Jun 20.</citation>
      <PMID>32891286</PMID>
    </reference>
    <reference>
      <citation>Kim DY, Lee JS, Park SY, Kim SJ, Son CG. Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). J Transl Med. 2020 Jan 6;18(1):7. doi: 10.1186/s12967-019-02196-9. Erratum In: J Transl Med. 2020 Dec 23;18(1):492.</citation>
      <PMID>31906979</PMID>
    </reference>
    <reference>
      <citation>Galeoto G, Sansoni J, Valenti D, Mollica R, Valente D, Parente M, Servadio A. The effect of physiotherapy on fatigue and physical functioning in chronic fatigue syndrome patients: A systematic review. Clin Ter. 2018 Jul-Aug;169(4):e184-e188. doi: 10.7417/T.2018.2076.</citation>
      <PMID>30151552</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic Fatigue Syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fatigue</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 21, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT05967494/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05967494
  org study id: 84606875
  nct id: NCT05967494
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study seeks to delve into the firsthand experiences of patients diagnosed with chronic
        fatigue syndrome who partake in a separate clinical trial featuring a specific medical
        intervention. The primary emphasis will be on meticulously tracking the rates of trial
        completion and withdrawal among these individuals.
  
        The data collected from this study will help improve future outcomes for all chronic fatigue
        syndrome patients as well as those in under-represented demographic groups.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Rate of patients who decide to join in a chronic fatigue syndrome clinical trial
  time frame: 3 months
  measure: Number of chronic fatigue syndrome patients who remain in clinical trial until completion
  time frame: 12 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael B Gill
  role: Study Director
  affiliation: Power Life Sciences Inc.
  last name: Michael B Gill
  phone: (415) 900-4227
  email: bask@withpower.com
  facility: 
  contact: 
  country: United States
  citation: Meng XD, Guo HR, Zhang QY, Li X, Chen Y, Li MY, Zhuo XM, Wang MJ, Shan K, Gong YN, Li NC, Chen B, Chen ZL, Guo Y. The effectiveness of cupping therapy on chronic fatigue syndrome: A single-blind randomized controlled trial. Complement Ther Clin Pract. 2020 Aug;40:101210. doi: 10.1016/j.ctcp.2020.101210. Epub 2020 Jun 20.
  PMID: 32891286
  citation: Kim DY, Lee JS, Park SY, Kim SJ, Son CG. Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). J Transl Med. 2020 Jan 6;18(1):7. doi: 10.1186/s12967-019-02196-9. Erratum In: J Transl Med. 2020 Dec 23;18(1):492.
  PMID: 31906979
  citation: Galeoto G, Sansoni J, Valenti D, Mollica R, Valente D, Parente M, Servadio A. The effect of physiotherapy on fatigue and physical functioning in chronic fatigue syndrome patients: A systematic review. Clin Ter. 2018 Jul-Aug;169(4):e184-e188. doi: 10.7417/T.2018.2076.
  PMID: 30151552
  responsible party type: Sponsor
  mesh term: Fatigue Syndrome, Chronic
  mesh term: Syndrome
  mesh term: Fatigue
  sharing ipd: Undecided
  provided document: 