[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396485":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":37,"overallOfficials":37,"centralContacts":37,"locations":47,"responsibleParty":68,"collaborators":37,"id":72,"slug":37,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":37,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":37,"enrollmentInfo":80,"targetDuration":37,"studyType":83,"phases":37,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":50,"whyStopped":37,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Gentofte, Copenhagen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mortality","All-cause mortality","30 days",{"measure":10,"description":11,"timeFrame":14},"90 days",[16,19,22,25,28,31,34],{"measure":17,"description":18,"timeFrame":12},"Biomarker levels","Blood biomarker level",{"measure":20,"description":21,"timeFrame":12},"LTOT","Change in oxygen need",{"measure":23,"description":24,"timeFrame":12},"QoL","Score of patient reported quality of life assessed by questionnaires",{"measure":26,"description":27,"timeFrame":12},"Respiratory support","Need for non-invasive or invasive respiratory support, including oxygen, CPAP, NIV and intubation",{"measure":29,"description":30,"timeFrame":12},"Decline in functional level","Decrease in functional level, e.g. moved to nursing home, hospice or other",{"measure":32,"description":33,"timeFrame":12},"Treatment during hospitalization","Treatment administered for respiratory worsening",{"measure":35,"description":36,"timeFrame":14},"Treatment after hospitalization","Treatment administered after discharge",null,{"allocation":37,"interventionModel":37,"interventionModelDescription":37,"primaryPurpose":37,"observationalModel":39,"timePerspective":40,"maskingInfo":37},"COHORT","PROSPECTIVE","The aim of this study is to investigate the diagnostic and prognostic value of clinical and blood biomarkers during exacerbations, or other increase in respiratory symptoms requiring hospital admission in patients with IPF.\n\nPatients that are already included in the PFBIO-cohort (NCT02755441) and who are admitted to hospital with an increase in respiratory symptoms, are also included in PFBIO-EXA.\n\nPatients are recruited within 24 hrs. from hospital admission with respiratory worsening, where clinical data, and blood samples are collected. The blood samples are investigated for the same blood biomarkers as PFBIO.\n\nPatient related outcomes are also collected, including quality-of-life questionnaires and outcomes of the exacerbations.","Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.",[44],{"label":45,"type":37,"description":46,"interventionNames":37},"PFBIO-EXA","All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort.",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Herlev and Gentofte Hospital","RECRUITING","Hellerup","Copenhagen","2900","Denmark","DK",{"type":57,"coordinates":58},"Point",[59,60],12.57093,55.73204,{"lat":60,"lon":59},[63],{"name":64,"role":65,"phone":66,"phoneExt":37,"email":67},"Nils Hoyer, MD PhD","CONTACT","+45 38674200","nils.hoyer@regionh.dk",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Nils Hoyer","Principal Investigator","100396485",false,"NCT04442711","Cohort of IPF Patients Experiencing an Exacerbation","Pulmonary Fibrosis Biomarkers During Exacerbation","Inclusion Criteria:\n\n* Admitted with an increase in respiratory symptoms\n* Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA\n* Age at least 18 years\n\nExclusion Criteria:\n\n* Unable to provide informed consent","ALL","18 Years",{"count":81,"type":82},50,"ESTIMATED","OBSERVATIONAL","Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years.\n\nIn the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.",[86],"Idiopathic Pulmonary Fibrosis",[88,89,90,91,92,93],"Exacerbation","Hospitalization","Biomarkers","Outcome","Prognosis","Diagnosis","2023-12-21",{"date":96,"type":97},"2023-12-22","ACTUAL",{"date":99,"type":97},"2020-06-13",{"date":101,"type":82},"2028-12-31",{"name":5,"class":6},1]