[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536800":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Comenius University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heart-rate variability (HRV) biofeedback intervention + standard of care","EXPERIMENTAL","Deep paced breathing with the HRV monitoring performed three times a day for seven minutes during three months with standard of care.",[13],"Other: HRV biofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","NO_INTERVENTION","Gemcitabine 1000 mg\u002Fm2 + Cisplatin 70 mg\u002Fm2 day 1 (new course day 22) or Methotrexate 30 mg\u002Fm2 day 1, Doxorubicin 30 mg\u002Fm2 day 2, Vinblastine 3 mg\u002Fm2 day 2, Cisplatin 70 mg\u002Fm2 day 2 with Pegfilgrastim 6 mg s.c. day 4 (new course day 15) up to 4 courses followed by radical cystectomy or irradiation with cisplatin 70 mg\u002Fm2 weekly.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"HRV biofeedback","Daily deep paced breathing 3-times (minimum 7 minutes each) for 3 months",[9],[25],"physiologic",[27],{"name":28,"affiliation":29,"role":30},"Patrik Palacka","Faculty of Medicine, Comenius University in Bratislava","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Luba Hunáková","CONTACT","+421290119943","luba.hunakova@fmed.uniba.sk",[38],{"facility":39,"status":40,"city":41,"state":18,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"National Cancer Institute","RECRUITING","Bratislava","83310","Slovakia","SK",{"type":46,"coordinates":47},"Point",[48,49],17.10674,48.14816,{"lat":49,"lon":48},[52,55],{"name":53,"role":34,"phone":18,"phoneExt":18,"email":54},"Katarina Rejlekova","katarina.rejlekova@nou.sk",{"name":28,"role":30,"phone":18,"phoneExt":18,"email":18},{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100536800","stress-reducing-intervention-in-urothelial-carcinoma-100536800",false,"NCT06269536","Stress-reducing Intervention in Urothelial Carcinoma","A Study on Therapeutic Potential of Stress-reducing Intervention in Patients With Urothelial Carcinoma","Inclusion criteria:\n\n1. Patients older than 18 years.\n2. Evidence of muscle-infiltrating urothelial bladder carcinoma (including variants) by biopsy.\n3. No prior chemotherapy.\n4. No previous malignancy, except for basal-cell carcinoma of the skin within last 5 years.\n5. Adequate renal functions: measured or calculated (by Cockcroft formula) creatinine clearance \\> 60 ml\u002Fmin.\n6. Absolute granulocytes count 1,500\u002Fmm3 or higher, platelets 100,000\u002Fmm3 or higher, bilirubin 1.5x the upper limit of normal value and lower.\n7. Adequate liver functions.\n8. Basic computer skills.\n9. Signed informed consent.\n\nExclusion criteria:\n\n1. Diabetes mellitus with symptomatic neuropathy.\n2. Using antiarrhythmic drugs, opiates and\u002For antidepressants.\n3. Implanted permanent pacemaker (PPM).\n4. Human Immunodeficiency Virus (HIV) infection.\n5. Not fitting inclusion criteria.","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone.",[75],"Bladder Cancer",[77,78,79,80,81,82,83,84,85,86,87],"Muscle-Infiltrating Urothelial Carcinoma","Neoadjuvant Chemotherapy","Standard of Care","Heart-Rate Variability","Biofeedback Intervention","Inflammation","Quality of Life","Cognitive Functions","Salivary Cortisol Slopes","Circadian Rhythms","Sleep Quality","2024-02-13",{"date":90,"type":91},"2024-02-21","ACTUAL",{"date":93,"type":69},"2024-02-15",{"date":95,"type":69},"2029-02-15",{"name":5,"class":6},1]