[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507430":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":50,"locations":60,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":27,"enrollmentInfo":101,"targetDuration":27,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":63,"whyStopped":27,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose Radiation Therapy","EXPERIMENTAL","In the test group, patients receive radiotherapy with six fractions of 0.5 Gy each over a period of 3 weeks, with 2 doses applied per week (total dose 3.0 Gy). After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients from the test group receive another irradiation series with six fractions of 0.5 Gy each according to the same schedule as before (total dose 3.0 Gy and in sum with the first series 6.0 Gy).",[13],"Radiation: low dose radiotherapy (0.5 Gy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Mock Radiation Therapy","PLACEBO_COMPARATOR","In the control group, patients receive sham irradiation with six fractions of 0.0 Gy each over a period of 3 weeks, with 2 treatments per week. After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients in the control group, on the other hand, now also receive a radiotherapy with six fractions of 1.0 Gy each over a period of 3 weeks with 2 fractions per week (total dose 6.0 Gy).",[19,20],"Radiation: mock radiation treatment","Radiation: low dose radiotherapy (1.0 Gy)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","low dose radiotherapy (0.5 Gy)","12 times 0.5 Gy",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"mock radiation treatment","6 times 0.0 Gy",[15],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"low dose radiotherapy (1.0 Gy)","6 times 1.0 Gy",[15],[37,41,45,47],{"name":38,"affiliation":39,"role":40},"Oliver Ott, Prof. Dr","Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg","STUDY_DIRECTOR",{"name":42,"affiliation":43,"role":44},"Benjamin Frey, PD Dr.-Ing.","Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":39,"role":44},"Thomas Weissmann, Dr.",{"name":48,"affiliation":39,"role":49},"Rainer Fietkau, Prof. Dr.","STUDY_CHAIR",[51,56],{"name":42,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","+49 9131 85","44248","benjamin.frey@uk-erlangen.de",{"name":57,"role":52,"phone":53,"phoneExt":58,"email":59},"Anna-Jasmina Donaubauer, Dr.","44925","anna-jasmina.donaubauer@uk-erlangen.de",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Department of Radiation Oncology, Universitätsklinikum Erlangen","RECRUITING","Erlangen","Bavaria","91054","Germany","DE",{"type":70,"coordinates":71},"Point",[72,73],11.00783,49.59099,{"lat":73,"lon":72},[76,78,81,83,85],{"name":77,"role":52,"phone":53,"phoneExt":54,"email":55},"Benjamin Frey, Dr.-Ing.",{"name":79,"role":52,"phone":53,"phoneExt":80,"email":59},"Anna Donaubauer, M.Sc.","32311",{"name":82,"role":44,"phone":27,"phoneExt":27,"email":27},"Oliver J Ott, Prof. Dr.",{"name":84,"role":44,"phone":27,"phoneExt":27,"email":27},"Udo S Gaipl, Prof. Dr.",{"name":86,"role":44,"phone":27,"phoneExt":27,"email":27},"Thomas Wiessmann, M.D.",{"type":88,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[90],{"name":91,"class":6},"Johann Wolfgang Goethe University Hospital","100507430","investigation-of-the-clinical-efficacy-of-low-dose-ionizing-radiation-in-the-treatment-of-osteoarthritis-100507430",false,"NCT05887284","Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis","IMMO-LDRT02","Inclusion Criteria:\n\n* Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):\n\n  * Finger and wrist osteoarthritis\n  * Elbow arthrosis\n  * Shoulder arthrosis\n  * Knee arthrosis\n  * Ankle and foot joint arthrosis\n* First time application of low-dose radiotherapy (LDRT) of the affected joint.\n* Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care\n\nExclusion Criteria:\n\n* Patients with tumor diseases\n* People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy\n* Persistent drug, medication or alcohol abuse\n* Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.\n* Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.\n* Earlier radiation therapy for treatment of cancer","ALL","39 Years",{"count":102,"type":103},132,"ESTIMATED","INTERVENTIONAL",[106],"NA","IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.",[109,110],"Arthrosis","Osteoarthritis",[112,113],"low dose radiotherapy","LDRT","2024-02-12",{"date":116,"type":117},"2024-02-13","ACTUAL",{"date":119,"type":117},"2023-07-01",{"date":121,"type":103},"2028-12-31",{"name":5,"class":6},1]