[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Central Adelaide Local Health Network Incorporated\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":114},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100637138","phase-2-vaccination-response-modulation-with-a-targeted-rapamycin-protocol-study-100637138",false,"NCT07587801","Vaccination Response Modulation With a Targeted Rapamycin Protocol Study","Vaccination Response Modulation With a Targeted Rapamycin Protocol (VON TRAPP) Study","VON TRAPP","Inclusion Criteria:\n\n* End-stage kidney disease requiring in-centre haemodialysis three times per week as kidney replacement therapy\n* Aged \\>60 years\n\nExclusion Criteria:\n\n* Aged \\\u003C60 years\n* Alternative haemodialysis regimens (e.g. twice-weekly haemodialysis, second-daily home haemodialysis)\n* Recent infection (\\\u003C6 months) with proven Influenza A, Influenza B, or RSV\n* Current use of immunosuppressive medications, including:\n\n  * Oral steroid at a dose equivalent of 5 mg\u002Fday prednisolone or greater\n  * Mycophenolate mofetil\n  * Azathioprine\n  * Calcineurin inhibitors\n  * mTOR inhibitors\n* Recent use of intravenous immunosuppressive medications (\\\u003C6 months), including:\n\n  * T-cell depleting agents (e.g. anti-thymocyte globulin)\n  * B-cell depleting agents (e.g. rituximab)\n  * Cyclophosphamide\n* Has a history of problems with side-effects associated with sirolimus use including\n\n  * Angioedema\n  * Active\u002Frecent opportunistic infection\n  * Current or prior interstitial lung disease, non-infectious pneumonitis, organising pneumonia, or pulmonary fibrosis\n  * Clinically significant pleural effusion or pericardial effusion\n  * Active non-healing wounds, chronic skin ulcers, or planned major surgery\u002Fprocedures\n  * Current malignancy or recent malignancy with high recurrence risk\n  * Severe or uncontrolled hyperlipidaemia\n  * History of rhabdomyolysis\n  * Severe hepatic impairment\n* Ongoing use of strong CYP3A4\u002FP-gp inhibitors or inducers including\n\n  * Inhibitors: Ketoconazole, Voriconazole, Itraconazole, Telithromycin, Clarithromycin\n  * Inducers: Rifampicin, Rifabutin\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of sirolimus (rapamycin) or the contents of the influenza or RSV vaccine","ALL","60 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will investigate dialysis recipients' responses to important vaccines.\n\nResearch suggests that a medication commonly used by transplant recipients may improve vaccine responses. The investigators will be conducting a clinical trial to see whether a short course of low-dose Sirolimus improves the response to vaccination against respiratory syncytial virus (RSV) and influenza (flu) in patient with kidney disease over 60 years old who receive haemodialysis.",[27,28,29],"Vaccine Immune Response","Haemodialysis Patients","Older Adults",[31,32,33,34,35,36],"influenza","RSV","vaccine","haemodialysis","older adults","immunosenescence","NOT_YET_RECRUITING","2026-05-11",{"date":40,"type":41},"2026-05-14","ACTUAL",{"date":43,"type":21},"2026-05",{"date":45,"type":21},"2026-07",{"name":47,"class":48},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100536280","safety-and-immunogenicity-of-recombinant-zoster-vaccine-for-transplant-recipients-100536280","NCT06262776","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)","SIR ZOSTER","1. Population - Group 1. Healthy co-habitants (n = 30)\n\n   Inclusion criteria:\n   * Household co-habitant of transplant recipient in trial\n   * Aged \\>50 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C50 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n2. Population - Groups 2-4. Transplant recipients (n = 90)\n\n   Inclusion criteria:\n   * Organ transplant recipients\n\n     \\-- Specific immunosuppression regimen\n     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)\n     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)\n     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)\n   * Aged \\>18 years\n   * estimated GFR \\> 15 mL\u002Fmin\u002F1.73m2\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n3. Population - Group 5. Other (n = 10)\n\n   Inclusion criteria:\n   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression\n   * Aged \\>18 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n4. Population - Group 6. Dialysis group (n = 30)\n\nInclusion criteria:\n\n* Kidney failure receiving haemodialysis as kidney replacement therapy\n* Aged \\>18 years\n* Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\nExclusion criteria:\n\n* Aged \\\u003C18 years\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* No previous infection with VZV (chickenpox)\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* Current pregnancy\n* History of primary immunodeficiency or active immunosuppressive therapy","18 Years",{"count":59,"type":21},160,[61],"NA","The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:\n\n1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?\n2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.",[64,65],"Immunosuppression","Vaccine Response Impaired","RECRUITING","2026-04-06",{"date":69,"type":41},"2026-04-09",{"date":71,"type":41},"2024-03-20",{"date":73,"type":21},"2027-12",{"name":47,"class":48},1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100536114","effect-of-chitodex-gel-in-tympanoplasty-surgery-100536114","NCT06260618","Effect of Chitodex Gel in Tympanoplasty Surgery","A Single-blinded Randomised Trial Evaluating the Efficacy of Chitosan-dextran (Chitodex) Gel Versus Gelfoam Sponge Instillation Within the Middle Ear and External Auditory Canal During Tympanoplasty Surgery","Inclusion Criteria:\n\n1. Individuals who have otoscopic evidence of tympanic membrane perforation that is also confirmed by tympanometry (Defined as a Type B tympanogram, with elevated EAC volume) AND\n\n   1. The TM perforation is associated with at least 15dB of conductive hearing loss on the affected side AND\n   2. Are indicated to undergo closure of the perforation via tympanoplasty surgery\n2. OR Individuals who are indicated for ossiculoplasty due to ossicular chain disruption and its sequelae\n3. OR Individuals who are indicated for mastoidectomy for COM or its sequelae eg cholesteatoma\n4. Demonstrate healthy, dry middle ear mucosal cavities at time of surgery AND\n5. Are 18 years of age or over AND\n6. Are able to give written informed consent AND\n7. Are committed to returning for post-operative assessments at 2 and 6 weeks post-op, 3-, and 6- months post-op\n\nExclusion Criteria:\n\n1. Operative ear is the better or only hearing ear\n2. The ear has evidence of cholesteatoma or other middle ear tumour during otoscopic examination\n3. dysfunction during otoscopic and tympanometric examination\n4. Known allergy to shellfish or ciprofloxacin antibiotics\n5. Pregnant or breastfeeding\n6. Hepatitis, HIV or any blood disorders\n7. COVID-19 positive patients\n8. Contra-indications for MRI",{"count":84,"type":21},44,[61],"The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.",[88,89,90,91],"Tympanic Membrane Perforation","Tympanic Membrane Inflammation","Surgery","Otitis Media",[93,94,95,96,97,98,99,100,101,102,103,104],"tympanic membrane","surgery","single blinded","chitogel","chitosan-dextran","otitis media","gelfoam","medical device","chitodex","myringoplasty","mastoidectomy","ossiculoplasty","2024-11-11",{"date":107,"type":41},"2024-11-13",{"date":109,"type":41},"2021-11-20",{"date":111,"type":21},"2025-05-13",{"name":47,"class":48},2,""]