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<docDscr>
  <citation>
    <titlStmt>
      <titl>Comorbidities associated with peripheral neuropathic pain (PNP)</titl>
      <IDNo>FRESH-PEF111-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="PFIZER (FRANCE)" role="">Isabelle PITHOIS-MERLI</producer>
    </prodStmt>
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      <version></version>
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  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Comorbidities associated with peripheral neuropathic pain (PNP)            </titl>
      <altTitl>
                    ORBIT                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF111-en            </IDNo>
      <IDNo agency="PEF">
                    111                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF111                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Véronique MILLET                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="PFIZER (FRANCE)">
        <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
        <ExtLink title="SIREN" URI="433623550" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            PFIZER (FRANCE)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="PFIZER (FRANCE)" email="veronique.millet@pfizer.com">
                    Véronique;MILLET
                                            <ExtLink title="ROR" URI="https://ror.org/02c9yny10" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="433623550" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Neurology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c4793dfe-e80e-49dd-9fcc-a1a742de1b25"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/00a5c4f4-b7ee-41a4-bcdf-3a02e6be1660"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009462"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Chronic peripheral neuropathic pain                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Primary: - Evaluate the frequency of anxiety and mood disturbances and the degree of sleeping disorders in patients monitored for PNP Secondary: - Describe the links between the components of the PNP and the existence of anxiety, mood disturbances and the degree of sleeping disorders, - Describe the relations between the components of PNP, anxiety, sleeping disorders, mood disturbances on the one hand and the quality of life on the other hand, - Describe the relation between the components of the PNP, the existence of anxiety and mood disturbances, the degree of sleep disorders on the one hand and the current drug care of patients on the other hand.</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2006-01-01"/>
      <collDate event="end" date="2008-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">Patients &gt; 18 years, - Peripheral neuropathic pain (in relation with a lesion of the peripheral nervous system). - Intensity of the pain &gt; 3 on the NVS,  - Radiculalgia without lumbar pain or with lumbar pain of which the intensity of the pain is &lt; 3 on the NVS (intensity of the lumbar pain from 0 to 2), - Through general neurology: patient consulting for his PNP or for the etiology of this PNP, - Through home consultation: patient consulting for a PNP for the 1st or 2nd consultation.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health care consumption and services</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>195</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
