[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Erlangen-Nürnberg Medical School\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":646},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,40,0,25,[9,46,94,117,142,163,185,207,229,248,270,291,319,348,370,399,422,448,475,504,527,548,573,592,617],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100641363","phase-2-efficacy-and-safety-of-sp16-in-preventing-acute-kidney-injury-in-at-risk-subjects-with-chronic-kidney-disease-undergoing-elective-cardiac-surgery-using-the-heart-lung-machine-100641363",false,"NCT07661940","Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine","Efficacy and Safety of SP16 in Preventing Acute Kidney Injury in At-risk Subjects With Chronic Kidney Disease Undergoing Elective Cardiac Surgery Using the Heart-lung-machine: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial (EASE-AKI)","EASE-AKI","Inclusion Criteria:\n\n* Individual aged ≥18 years.\n* Male or female.\n* Scheduled for CABG OR aortic valve surgery (aortic valve replacement or repair alone, with or without aortic root repair) OR mitral valve surgery OR aortic\u002Fmitral valve surgery combined with CABG.\n* Use of the CPB during surgical intervention expected.\n* Written informed consent obtained from the participant.\n* Understanding of study procedures and willingness to abide by all procedures during the course of the clinical trial.\n* CKD Stage 2-3b with eGFR ≤90 and ≥30 ml\u002Fmin\u002F1.73 m2 (according to 2021 CKD-EPI equation) known for ≥ 3 months prior to enrollment\n* BMI ≥19 kg\u002Fm² to ≤40 kg\u002Fm².\n* Contraceptive measures:\n\nFemale participants must fulfil at least one of the following criteria of highly effective contraception (according to CTFG recommendations v1.2) during and up to 3 months after the end of study participation:\n\n* Menopause (at least 12 months of natural amenorrhoea or 6 months of amenorrhoea with serum FSH \\>40 mU\u002Fml) OR\n* Condition after bilateral ovariectomy or hysterectomy for at least 6 weeks prior to the screening appointment (Visit 1a, Day 54 to -2) OR\n* Regular, correct and reliable use of a contraceptive method with an error rate ≤1% per year:\n\n  1. Inhibition of ovulation by estrogen and progesterone combination preparations (oral, intravaginal, or transdermal) or\n  2. Inhibition of ovulation by progesterone monopreparations (oral, per injectionem \\[depot injections\\], or implant) or\n  3. Intrauterine device, hormone coil OR\n* Bilateral tubal ligation OR\n* Vasectomy of all partners OR\n* Sexual abstinence.\n\nMale participants must fulfill at least one of the following contraceptive criteria during and up to 3 months after the end of participation in the study:\n\n* Vasectomy OR\n* Regular, correct, and reliable use of condoms\n\nExclusion Criteria:\n\n* CKD stages 4-5 with eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2 pre-surgery as determined by CKD EPI.\n* Previous cardiac surgery.\n* Person has a kidney transplant or another solid organ transplant.\n* Person is scheduled for intermittent or continuous renal replacement therapy (dialysis).\n* Known diagnosis of dementia or other clinical signs of mental illness that will prevent full understanding.\n* Known diagnosis of severe COPD (Gold 3) and\u002For FEV1 \\\u003C 1 l\u002Fs.\n* Heart failure with severity of symptoms according to NYHA IV.\n* Heart failure with impaired cardiac pump function (LVEF \\\u003C35%).\n* Acute onset or ongoing sepsis - sepsis is defined as the presence of a confirmed or putative infection, along with a dysregulated systemic immune reaction leading to organ dysfunction.\n* Clinical signs of a currently active infection including endocarditis requiring antibiotic treatment.\n* Clinical signs of an acute viral infection.\n* Serious underlying disease(s) or very poor general medical condition, so that in the investigator's judgment the person is not expected to survive ICU or hospital stay.\n* Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.\n* Administration of iodinated contrast agent within 24 hours prior to cardiac surgery\n* Recent (discontinued in the last 14 days before V1a or V1b) or current treatment with immunosuppressive drugs, including, but not limited to, high dose corticosteroids \\[\\> 1 mg\u002Fkg of prednisone equivalent\\], tumour necrosis factor alpha blockers, or ciclosporin.\n* Current regular use of anti inflammatory drugs such as NSAID, with discontinuation not possible. (however, if these medications are discontinued in the last 10 days before V2, the participant is eligible to participate). ASA up to 100 mg per day is allowed.\n* Systemic corticosteroid therapy (any dose).\n* Known active chronic inflammatory disease (including, but not limited to, rheumatoid arthritis or systemic lupus erythematosus).\n* Known allergy to SP16 or to other ingredients of the IMP.\n* Person who is not willing to use highly effective contraceptive measures (according to CTFG recommendations v1.2).\n* Pregnant women.\n* Breastfeeding women.\n* Current participation in another interventional clinical study (register studies or non-interventional, observational studies excluded).\n* Employee or direct relative of an employee of the study site, the CRO, or the Sponsor.","ALL","18 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This clinical study investigates the safety and potential effectiveness of the investigational drug SP16 in preventing acute kidney injury in patients with pre-existing chronic kidney disease who are undergoing cardiac surgery involving the use of cardiopulmonary bypass (heart-lung machine).\n\nSP16 is an investigational medicinal product that has not yet been approved for clinical use. To date, it has been studied in 28 individuals. The sponsor aims to evaluate whether SP16 can safely reduce or prevent kidney damage associated with the inflammatory and ischemia-reperfusion processes that may occur during cardiac surgery with cardiopulmonary bypass.\n\nParticipation in the study extends over a period of slightly more than five months. Screening procedures are performed within approximately seven weeks to two days before the scheduled surgery to determine eligibility for participation. During the hospitalization for cardiac surgery, which is expected to last approximately 10 days, a total of 11 study visits are conducted. Follow-up assessments include a telephone contact approximately one month after hospital discharge and a final on-site study visit approximately three months after discharge.\n\nThis is a randomized, double-blind, placebo-controlled clinical trial. Participants are randomly assigned to receive either SP16 or a placebo, which contains no active ingredient. Neither the participants nor the investigators know which treatment has been assigned during the study period.\n\nBased on previous preclinical and early clinical findings, SP16 may have the potential to reduce or mitigate kidney injury caused by the use of the heart-lung machine during cardiac surgery. However, since the efficacy of SP16 has not yet been proven, no clinical benefit can be guaranteed. Participants receiving placebo are not expected to derive a direct therapeutic benefit from study treatment.",[28],"AKI - Acute Kidney Injury",[30,31,32],"AKI","cardiac surgery","CKD","NOT_YET_RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":22},"2026-06-18",{"date":41,"type":22},"2029-05",{"name":43,"class":44},"University of Erlangen-Nürnberg Medical School","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":66,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100643710","effects-of-dietary-supplementation-with-omega3-fatty-acids-fish-oil-and-progressive-resistance-training-on-skeletal-muscle-status-in-gynaecological-gastrointestinal-and-urological-cancer-patients-100643710","NCT07643558","Effects of Dietary Supplementation With omega3-fatty Acids (Fish Oil) and Progressive Resistance Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal and Urological Cancer Patients","SUPPORT-Study = Effects of a Dietary SUPPlementation With Omega3-fatty Acids\u002F Fish Oil and Progressive Resistence Training on Skeletal Muscle Status in Gynaecological, Gastrointestinal, and Urological Cancer Patients","SUPPORT","Inclusion Criteria:\n\n* Patients with malignant tumors undergoing curative or palliative treatment, including breast, ovarian, esophageal, pancreatic, gastric, colon, rectal, and prostate cancer, across all UICC stages\n* Women and men aged 18 years or older\n* ECOG performance status 0-2\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Bone metastases or skeletal involvement associated with a high risk of fracture\n* Pregnant or breastfeeding women\n* Patients with psychiatric disorders that raise concerns regarding decision-making capacity or ability to provide informed consent\n* Participation in other exercise and\u002For nutritional intervention studies within the previous 3 months\n* Current use of fish oil supplements\n* Severe cardiovascular disease, NYHA class IV",{"count":55,"type":22},288,[57],"NA","Cancer cachexia is a common and prognostically relevant complication of advanced malignancies, characterized by systemic inflammation, increased catabolism, and reduced nutritional intake, leading to a progressive loss of skeletal muscle mass, physical performance, and quality of life. Muscle wasting negatively affects the tolerability and efficacy of oncological therapies and exacerbates distressing symptoms such as fatigue. Consequently, international guidelines recommend combined nutritional and exercise interventions as key components of supportive cancer care. However, due to treatment-related limitations, conventional exercise programs are often difficult to implement, highlighting the need for feasible, time-efficient, and individually adaptable training concepts suitable for daily life.\n\nIn addition, adequate protein-rich nutrition is essential and may be supported by targeted nutritional supplementation. Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), have demonstrated anti-inflammatory effects and beneficial influences on nutritional status, quality of life, and potentially skeletal muscle mass.\n\nThe aim of the present project is to investigate, in a randomized, placebo-controlled trial, whether the combination of progressive resistance training (twice-weekly TheraBand-based exercise) and omega-3 supplementation (daily intake of 2 g EPA and 1 g DHA administered as fish oil capsules) can improve muscle status, physical performance, and patient-relevant outcomes such as quality of life, appetite, and fatigue in cancer patients at high risk of developing cancer cachexia.",[60,61,62,63,64,65],"Cancer Cachexia","Omega 3","Resistance Training","Cancer","Muscle Wasting","Systemic Inflammation",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Resistance training","Progressive resistance exercise","Exercise therapy","Supportive cancer care","Nutritional intervention","Protein-rich nutrition","Nutritional supplementation","Omega-3 fatty acids","Eicosapentaenoic acid (EPA)","Docosahexaenoic acid (DHA)","Fish oil supplementation","Physical performance","Quality of life","Fatigue","Appetite","Patient-reported outcomes","Randomized placebo-controlled trial","Cachexia risk","RECRUITING","2026-06-08",{"date":88,"type":37},"2026-06-11",{"date":90,"type":37},"2026-01-01",{"date":92,"type":22},"2029-10",{"name":43,"class":44},{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":45},"100559182","phase-4-dapagliflozin-on-renal-morphology-and-renal-perfusion-in-patients-one-year-after-kidney-transplantation-100559182","NCT06560801","Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation","Randomized Clinical Study to Analyse the Effects of Dapagliflozin on Renal Morphology and Renal Perfusion in Patients With Impaired Renal Function One Year After Kidney Transplantation","Inclusion Criteria:\n\n* Female and male patients aged between 18 and 75 years\n* Patients with renal transplant having a stable eGFR, who are in stable condition, 9 months after transplantation, irrespective of their diabetes status\n* Females of child bearing potential must be using adequate contraceptive precautions\n* Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit\n* Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus.\n* HbA1c \\> 10%\n* Use of SGLT-2 inhibitor within the past 2 months\n* Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion.\n* eGFR \\\u003C25 ml\u002Fmin\u002F1.73m² (CKD-EPI Formula).\n* Uncontrolled arterial hypertension (RR \\> 180\u002F110 mmHg).\n* Congestive heart failure (CHF) NYHA stage IV.\n* Recurrent urinary tract infections (bacterial or fungal)\n* Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmacokinetics of the drug.\n* Significant laboratory abnormalities such as SGOT or SGPT levels more than 5 x above the upper limit of normal range.\n* Antihypertensives are allowed but should be kept stable throughout the study period.\n* Statins and other antihyperlipidemic drugs are allowed but should be kept stable throughout the study period.\n* Drug or alcohol abusus\n* Pregnant or breast-feeding patients\n* Patients with contraindications to MRI","75 Years",{"count":103,"type":22},48,[105],"PHASE4","The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study.\n\nThe objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).",[108],"Chronic Kidney Diseases","2026-04-29",{"date":111,"type":37},"2026-05-06",{"date":113,"type":37},"2023-07-28",{"date":115,"type":22},"2026-12-31",{"name":43,"class":44},{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":128,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":45},"100624485","mpn-childhood-registry-100624485","NCT07410247","MPN Childhood Registry","The Myeloproliferative Neoplasms (MPN) Childhood Registry and Biobank","Inclusion Criteria:\n\n* Newly diagnosed PV, ET, PMF or pHES\n* Age \\\u003C 18 years (up to 17 years and 365 days) at the day of diagnosis\n* Patient treated in a participating center\n* Written informed consent to registry participation\n\nExclusion Criteria:\n\no Secondary polycythemia, thrombocytosis, myelofibrosis or HES with underlying reasons other than PV, ET, PMF or pHES","0 Years","17 Years",{"count":127,"type":22},500,"15 Years","OBSERVATIONAL","Myeloproliferative neoplasms (MPNs) are caused by defects in blood cell production. This leads to an overproduction of mature cells, such as red blood cells or platelets. As a result, clinical symptoms and complications can develop. Circulatory disorders and resulting pain symptoms, such as headaches, are the most prominent. Furthermore, blood clotting disorders can occur, leading to vascular occlusions or bleeding. Over a longer period, bone marrow transformation into fibrous tissue or the development of acute leukemia can occur, resulting in even more serious complications.\n\nIn the vast majority of cases, MPNs are diagnosed in older adults. These diagnoses are extremely rare in children and adolescents. Therefore, clinical and genetic characteristics, treatment options, and outcomes in pediatric patients with MPNs are insufficiently described, and only limited data are available for standardizing diagnostic and therapeutic approaches for MPNs in childhood and adolescence. Recommendations and guidelines from the adult field, which have largely been adopted and applied to children and adolescents, do not adequately address the specific needs of patients in childhood and adolescence. To gain more insights into MPN during this early, vulnerable phase of life, we have established a nationwide registry in Germany that systematically collects data from children and adolescents with MPN.\n\nThe registry focuses particularly on the scientific analysis of the biological characteristics and differences of MPN in children and adolescents compared to adults.",[132],"Childhood Myeloproliferative Neoplasms",[132],"2026-04-27",{"date":136,"type":37},"2026-05-01",{"date":138,"type":37},"2023-01-01",{"date":140,"type":22},"2037-12-31",{"name":43,"class":44},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":149,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":45},"100590623","establishment-and-evaluation-of-standardized-clinical-biological-and-imaging-parameters-to-assess-the-response-of-ldrt-in-heel-spur-with-plantar-fasciitis-100590623","NCT06969820","Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis","HEALSPUR","Inclusion Criteria:\n\n* Age \\> 39 years\n* Typical clinical picture of plantar fasciitis for at least 3 months without associated trauma, other musculoskeletal co-morbidities or degenerative joint disease\n* Patients with first-time application of LDRT to the affected joint\n* Willingness to cooperate and accessibility of patients, especially geographical proximity, for treatment and follow-up\n* Patients for whom LDRT is indicated independently of the study\n* Karnofsky Index \\>70%\n\nExclusion Criteria:\n\n* Achillodynia (\"dorsal\" calcaneal spur)\n* Previous trauma to the foot (fracture, tendon rupture)\n* Musculoskeletal comorbidities of the foot\n* Acute infections\u002Fopen wounds in the area of the tendon to be examined or other relevant damage to the tendon to be examined\n* Local steroid injections into the tendon prior to the study\n* Rheumatic or vascular diseases, lymphedema\n* Patients with tumors\n* Individuals of childbearing potential who do not use adequate contraceptive measures consistently during therapy\n* Persistent drug, medication or alcohol abuse\n* Patients who have already undergone radiotherapy for the treatment of cancer\n* Patients with an increased risk of an MRI examination, including the presence of metal implants, pacemakers or claustrophobia","40 Years",{"count":151,"type":22},35,"The clinical picture of calcaneal spur with plantar fasciitis is a debilitating disease that is difficult to treat with conservative and interventional measures. Radiotherapy has shown very good therapeutic results in retrospective data, which need to be clinically confirmed both subjectively and in terms of image morphology in a prospective approach.\n\nPrimary objective of the study:\n\nTo demonstrate a clinical benefit of LDRT: improvement of pain, functionality and quality of life after LDRT",[154],"Calcaneal Spur","2026-03-24",{"date":157,"type":37},"2026-03-30",{"date":159,"type":22},"2026-06-01",{"date":161,"type":22},"2028-04-30",{"name":43,"class":44},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100519721","immune-biomarker-study-for-salivary-gland-carcinoma-100519721","NCT06047236","Immune Biomarker Study for Salivary Gland Carcinoma","ImmoGlandula","Inclusion Criteria:\n\n1. Observational group\n\n   * Initial diagnosis of a primary salivary gland carcinoma in the head and neck region (no squamous cell carcinomas)\n   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired\n2. Control group 1\n\n   * Initial diagnosis of a benign salivary gland tumor in the head and neck region\n   * Specimen collection from the center of the tumor when the primary tumor is sufficiently large without that the pathological assessment is impaired\n3. Control group 2\n\n   * functional diseases of the nose or ear (patients with the indication for functional ear surgery and rhinoplasty)\n   * Specimen collection with sufficiently large resectate during a functional nose surgery\n\nfor all groups:\n\n* Willingness of patients to collect blood, saliva and stool and consent to the preservation of all samples for study purposes.\n* Age ≥ 18 years\n* sufficient cognitive ability of the patients to understand the purpose of the study and to understand the purpose of the study and agree to it\n\nExclusion Criteria:\n\n* Distant metastasis at the time of diagnosis and simultaneous second cancers, i.e. at study inclusion\n* Malignancy in the last 5 years regardless of location (except basal cell carcinoma or cis of the uterine cervix)\n* Carcinomas for which specimen collection is not possible or likely without compromising the compromise the pathological evaluation\n* Persistent drug or medication abuse\n* Patients who are unable or unwilling to comply with protocol and to be treated\n* Patients who are represented by a legal guardian\n* Patients who are not suitable for participation in the study due to a language barrier",{"count":171,"type":22},300,"Salivary gland carcinomas (SGC) are rare tumors. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically, and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it challenging to recruit a high number of patients for individual entities in clinical studies, leading to the pooling of patients with different histological subtypes to achieve sufficient participants. The different histological subtypes of SGC exhibit significant differences in their clinicopathological features, including grading, occurrence, and outcome. SGCs usually are stratified into low-, intermediate-, or high-grade tumors. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. To integrate IT as a therapeutic option for SGC and to facilitate informed therapeutic decisions based on tumor (immune) biology, predictive and prognostic immunological biomarkers are indispensable. In this prospective study, 500 patients will be enrolled, distributed across three arms. The observational cohort includes patients with malignant salivary gland tumors, whereas patients with benign tumors of a salivary gland are grouped in the control group 1. In the control cohort, two patients do not have a salivary gland tumor but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status of the tumor tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analyzed before and after surgery and after the adjuvant and definitive chemoradiotherapy (CRT), if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modeling approaches will be applied to identify interactions between local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.",[174,175],"Salivary Gland Tumor","Benign Salivary Gland Tumor","2026-03-13",{"date":178,"type":37},"2026-03-16",{"date":180,"type":37},"2024-01-08",{"date":182,"type":22},"2031-09-30",{"name":43,"class":44},2,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":45},"100629008","characterization-of-renal-microvascular-alterations-in-patients-with-active-urinary-sediment-andor-proteinuria-using-ultrasound-localization-microscopy-100629008","NCT07469059","Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and\u002For Proteinuria Using Ultrasound Localization Microscopy","VARIOUS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Evidence of active urinary sediment and\u002For proteinuria \\>1 g\u002Fg creatinine\n* Indication for kidney biopsy as part of study-independent diagnostics\n* Written informed consent\n\nExclusion Criteria:\n\n* Known allergic disposition to SonoVue®\n* Contraindication to the use of SonoVue®\n* Pregnancy\n* Breastfeeding mothers",{"count":193,"type":22},30,"The goal of this study is the non-invasive visualization and quantification of renal microvascular dynamics in adult kidneys with proteinuria and\u002For active sediment.",[196],"Nephritis",[198,199],"kidney","ultrasound localization microscopy (ULM)","2026-03-12",{"date":176,"type":37},{"date":203,"type":37},"2025-09-18",{"date":205,"type":22},"2028-09",{"name":43,"class":44},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":45},"100588919","immune-biomarker-study-for-cisplatin-ineligible-patients-receiving-chemoradiotherapy-with-docetaxel-100588919","NCT06947668","Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel","DoIT_Neck","Inclusion Criteria:\n\n* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated\n* Patients who are cisplatin-unfit for chemotherapy, defined as:\n\n  * ECOG 2\n  * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases\n  * Calculated creatinine clearance of ≤50ml\u002Fmin\n  * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \\\u003C 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml\u002Fmin due to increased body weight, uncontrolled hypertension\n  * Poor nutritional status BMI \\\u003C 16kg\u002Fm²\n  * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.\n  * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes\n  * Age ≥ 18 years\n  * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it\n\nExclusion Criteria:\n\n* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion\n* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)\n* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment\n* Persistent drug or medication abuse\n* Patients who are unwilling or unable to comply with the protocol and receive treatment\n* Patients who are unsuitable for participation in the study due to a language barrier",{"count":215,"type":22},250,"Analysis of tumor tissue (which is already available in pathology) and collection of saliva\u002Fstool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.",[218,219,220,221],"Squamous Cell Carcinoma of Oropharynx","Squamous Cell Carcinoma of the Hypopharynx","Larynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","2026-03-11",{"date":200,"type":37},{"date":225,"type":37},"2025-05-01",{"date":227,"type":22},"2030-12-31",{"name":43,"class":44},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":235,"enrollmentInfo":236,"targetDuration":238,"studyType":129,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":45},"100551754","prospective-registry-study-on-the-implementation-of-simultaneous-postoperative-radiochemotherapy-for-salivary-gland-carcinomas-of-the-head-and-neck-region-100551754","NCT06464198","Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region","Inclusion Criteria:\n\n* Salivary gland carcinomas of the major and minor salivary glands of the head and neck region\n* High-grade histology\n* Successful oncological resection with curative intent\n* pT3-4 or pN1-3 or Pn1(perineural sheath infiltration) or pT1-2 with scarce or positive resection margin\n* cM0\n* Indication for postoperative combined radiochemotherapy (guideline-compliant radiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg\u002Fm² KOF d1 and cisplatin 33mg\u002Fm² KOF d1-3, q d22 or paclitaxel 135mg\u002Fm² KOF d1, carboplatin AUC 1.5 KOF d1-3 or paclitaxel 50mg\u002Fm² KOF, carboplatin AUC2 d1,8,15, q d22 or paclitaxel 50mg\u002Fm²KOF and cisplatin 30mg\u002Fm² KOF d1,8,15, q d22, 4 cycles each).\n* Patient age ≥18 years\n* WHO performance score ≤ 1\n* Signed patient information\u002Fconsent form\n\nExclusion Criteria:\n\n* Distant metastases\n* Other cancer in the last 5 years prior to study inclusion (with the exception of: adequately treated skin cancer (except melanoma) or lentigo maligno or adequately treated carcinoma in situ, in each case without evidence of active disease).\n* Previous chemotherapy or radiotherapy for salivary gland carcinoma\n* Previous radiotherapy in the head and neck area\n* Pre-existing uncontrolled disease that constitutes a contraindication to simultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardial infarction within the last 6 months before the start of therapy, congestive heart failure, heart disease with New York Heart Association (NYHA) III or IV classification, active and therapy-resistant infection, pre-existing or concomitant immunodeficiency syndrome)\n* Pregnancy and breastfeeding\n* Fertile patients who cannot ensure effective contraception during and up to six months after combination therapy","99 Years",{"count":237,"type":22},100,"5 Years","This is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in Erlangen and elsewhere. The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.",[241],"Locally Advanced Salivary Gland Carcinoma",{"date":176,"type":37},{"date":244,"type":37},"2024-06-01",{"date":246,"type":22},"2037-06",{"name":43,"class":44},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":45},"100518430","phase-2-de-intensification-of-postoperative-radiotherapy-in-patients-with-squamous-cell-carcinoma-of-the-head-and-neck-100518430","NCT06030440","De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck","DIREKHT2","Inclusion Criteria:\n\n1. Histologically proven squamous cell carcinoma of the oral cavity\u002Flarynx\u002Foro-or hypopharynx (except glottis cancer (pT1\u002F2pN0))\n2. Surgery of primary tumor and neck dissection performed according to predefined surgical standard\n3. Indication for postoperative radio(chemo)therapy\n4. No lymph node metastases \\> 6cm\n5. Lymph node metastases in not more than 3 lymph node level\n6. No distant metastases (cM0)\n7. Age ≥ 18 years, no upper age limit\n8. Eastern Cooperative Oncology Group (ECOG) ≤ 2\n9. Patients who understood protocol contents and are able to behave according to protocol\n10. Signed study-specific consent form prior to therapy\n11. Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)\n\nExclusion Criteria:\n\n1. macroscopic incomplete resection R2\n2. Distant metastases (cM1)\n3. Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)\n4. Lymph node metastases in \\> 3 lymph node level\n5. pregnant or lactating\u002Fnursing women\n6. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment\n7. Any condition potentially hampering compliance with the study protocol and follow-up schedule\n8. On-treatment participation on other clinical therapeutic trials\n9. Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant\u002Finduction))\n10. Patients who have contraindication for MRI and CT with contrast agent (both)\n11. Prior (\\> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage\n12. History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease",{"count":256,"type":22},508,[25,258],"PHASE3","This randomized, prospective, multicenter phase II\u002FIII trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.",[261,262,219,263],"Squamous Cell Carcinoma of the Oral Cavity","Squamous Cell Carcinoma of the Larynx","Squamous Cell Carcinoma of the Oropharynx",{"date":176,"type":37},{"date":266,"type":37},"2024-01-26",{"date":268,"type":22},"2033-09",{"name":43,"class":44},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":45},"100552427","non-invasive-evaluation-of-graft-condition-in-adult-patients-with-kidney-transplant-using-ultrasound-localization-microscopy-and-multispectral-optoacoustic-tomography-100552427","NCT06472947","Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography","ESTIMATOR","Inclusion Criteria:\n\n* kidney transplant\n* indication for biopsy set in clinical routine\n* minimum 18 years of age\n* written consent\n\nExclusion Criteria:\n\n* allergy against contrast agents\u002F SonoVue\n* tatoos in examined areas\n* contraindication against SonoVue\n* pregnant women\n* breast feeding women",{"count":278,"type":22},10,"In this study, the condition of the kidney transplant in adults is to be assessed non-invasively using Multispectral Optoacoustic Tomography and Ultrasound Localization Microscopy (ULM). ULM imaging can be performed in a 2-dimensional and a 3-dimensional way (2D and 3D ULM). Therefore, \"ULM\" in the following texts and measures will refer to 2D and 3D ULM.\n\nNew, non-invasive markers that allow conclusions to be drawn about the condition of the transplant should reduce the need for invasive diagnostic procedures in the future.",[281,282],"Kidney Transplant","Kidney Biopsy","2026-03-02",{"date":285,"type":37},"2026-03-04",{"date":287,"type":37},"2024-06-18",{"date":289,"type":22},"2028-01-18",{"name":43,"class":44},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":298,"sex":18,"minAge":19,"maxAge":101,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":45},"100620595","octa-in-cardiovascular-disease-and-healthy-controls-100620595","NCT07359664","OCTA in Cardiovascular Disease and Healthy Controls","Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group","Inclusion Criteria for patients with cardiovascular disease:\n\n* cardiovascular disease defined as one or more of the following: arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure\n\nInclusion Criteria for healthy individuals:\n\n* BMI 18-29.9 kg\u002Fm2\n* Non-smoker\n* Good general health, as determined by study personnel based on assessments of previous visits, including anamnesis, vital signs, physical examination and clinical laboratory parameters.\n\nExclusion criteria for patients with cardiovascular disease:\n\n* Active ophthalmological (retinal) disease resulting in impaired visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).\n\nExclusion criteria for healthy individuals:\n\n* Active ophthalmological (retinal) disease with reduced visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).\n* clinically relevant deviation in physical examination, vital signs, or laboratory parameters (based on the physician's clinical judgement).\n* a clinically relevant history of cardiovascular disease or any other previously known cardiovascular disease\n* History of clinically relevant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine or other diseases\n* office blood pressure above or equal to 140\u002F90 mmHg\n* Office heart rate outside of the following range: 50-99 bpm\n* regular intake of any medication for the treatment of cardiovascular diseases (e.g. antihypertensive or antidiabetic medication) within one month before study inclusion\n* alcohol or drug abuse",true,{"count":300,"type":22},64,[57],"This prospective clinical study will involve the non-invasive assessment of retinal vessels using OCTA (Cirrus OCT 6000 AngioPlex) and scanning laser Doppler flowmetry (SLDF) in patients with cardiovascular disease and healthy individuals. The study will be conducted at the Clinical Research Centre (CRC), Department of Nephrology and Hypertension at the University of Erlangen-Nuremberg.",[304,305],"Patients With Cardiovascular Disease","Healthy Participants",[307,308,309,310],"arterial hypertension","type 2 diabetes mellitus","chronic kidney disease","heart failure","2026-01-15",{"date":313,"type":37},"2026-01-22",{"date":315,"type":37},"2025-12-01",{"date":317,"type":22},"2027-03",{"name":43,"class":44},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":45},"100367659","flexi-band-resistance-training-versus-ems-exercise-in-patients-with-the-diagnosis-of-malignant-diseases-100367659","NCT04067167","Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases","Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases","FREEDOM","Inclusion Criteria:\n\n* malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation\n* ongoing or planned curative or palliative anti-cancer therapy\n* ECOG-Status 0-2\n\nExclusion Criteria:\n\n* simultaneous participation in other nutritional or exercise intervention Trials\n* bone metastases with high fracture risk\n* cardiovascular disease\n* use of anabolic medications\n* epilepsy\n* severe neurological or rheumatic diseases\n* skin lesions in the area of electrodes\n* energy active metals in body\n* pregnancy\n* acute vein thrombosis",{"count":237,"type":22},[57],"The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.",[63,60,331,332],"Inflammation","Muscular Atrophy",[63,334,335,67,336,337,338,339,340],"Cachexia","Muscular strength","Body composition","Muscle mass","Physical exercise","Nutrition","whole-body electromyostimulation",{"date":342,"type":37},"2026-01-20",{"date":344,"type":37},"2019-05-01",{"date":346,"type":22},"2026-06-30",{"name":43,"class":44},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":355,"maxAge":125,"enrollmentInfo":356,"targetDuration":4,"studyType":23,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":45},"100617073","evaluation-of-acute-and-chronic-nephrotoxicity-in-acute-lymphatic-leukemia-patients-using-ultrasound-localization-microscopy-100617073","NCT07313878","Evaluation of Acute and Chronic Nephrotoxicity in Acute Lymphatic Leukemia Patients Using Ultrasound Localization Microscopy","HEALED","Inclusion Criteria:\n\n* Diagnosed acute lymphatic leukemia\n* From 3 years to \\\u003C 18 years\n* completed oncological treatment or treatment day \\\u003C 50 according to therapy protocol and no administration of CPM before first examination.\n\nExclusion Criteria:\n\n* Known allergic disposition to SonoVue \u002F other contrast agents\n* Tattoo in the area of the examination field\n* Pregnancy\n* Breastfeeding mothers\n* Contraindication for the use of Sonovue\n* Critical condition\n* Known clinically evident renal impairment","3 Years",{"count":193,"type":22},[57],"With increasing survival rates in pediatric oncology, reports of long-term side effects persisting decades after treatment are also rising. Clinically evident nephropathies occur in about 5.5% of survivors more than five years after therapy. Chemotherapeutic agents such as ifosfamide, cisplatin, and carboplatin, as well as kidney-directed treatments like radiation, surgery, or stem cell transplantation, increase this risk. Acute kidney injury has also been described in association with cyclophosphamide and high-dose methotrexate, which are used in the treatment of acute lymphoblastic leukemia (ALL). Studies show a high prevalence of albuminuria (around 14.5% of childhood cancer survivors), an early marker of kidney damage, while standard parameters like creatinine often become abnormal only at later stages.\n\nLeukemia survivors suffer from vascular late effects caused by persistent endothelial damage triggered by cancer therapies such as anthracyclines, cyclophosphamide, and asparaginase, which increase inflammation and thrombosis risk. These vascular changes may also contribute to kidney injury.\n\nULM is a high-resolution ultrasound technique that uses microbubbles to visualize the microvasculature and resolve dynamic blood flow changes with a resolution beyond the diffraction limit. ULM is independent of kidney or liver function, has been applied in various organs, and was recently used for the first time to visualize glomeruli-the smallest functional units of the kidney-in humans. This method enables early detection of glomerular injury as a consequence of vascular damage, even before albuminuria appears, potentially allowing earlier adaptation of follow-up and initiation of treatment.\n\nThis pilot project focuses on survivors of ALL, as they are the largest and best studied pediatric cancer patient group also regarding late effects and, therefore, a sufficient number of individuals can be expected for his monocentric approach. Vascular functional impairment of the kidney could be detected at an early stage and the follow-up structures and measures such as the early use of nephroprotective drugs could be adapted.",[360,361],"Acute Lymphoblastic Leukaemias (ALL)","Long Term Follow-Up","2025-12-22",{"date":364,"type":37},"2026-01-02",{"date":366,"type":37},"2025-11-19",{"date":368,"type":22},"2026-11-30",{"name":43,"class":44},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":377,"minAge":19,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":380,"conditions":381,"keywords":386,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":398},"100603087","immune-biomarkers-in-prostate-cancer-patients-treated-with-brachytherapy-100603087","NCT07131956","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)","Inclusion Criteria Arm 1:\n\n* Primary treatment with I-125 seeds or HDR-BT\n* No previous treatment for prostate cancer\n* Age ≥ 18 years\n\nInclusion Criteria Arm 2:\n\n* HDR- or PDR-BT\n* No radiation therapy within three months before salvage treatment\n* Complete documentation available on previous treatment for prostate cancer\n* No history of prostatectomy\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Pre-existent auto-immune disease\n* patients under bloodthinning medication\n* substance abuse","MALE",{"count":379,"type":22},200,"Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.",[382,383,384,385],"Prostate Cancer (Diagnosis)","Prostate Cancer Patients Who Have Brachytherapy Seed Implant","Prostate Cancer Patients Treated by Radiotherapy","Prostate Cancer Recurrent",[387,388,389],"Immune-profiling in prostate cancer patients","brachytherapy for prostate cancer","interstitial brachytherapy for prostate cancer","2025-11-17",{"date":392,"type":37},"2025-11-18",{"date":394,"type":22},"2025-12",{"date":396,"type":22},"2028-07-31",{"name":43,"class":44},3,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":235,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":45},"100558844","effect-of-renal-denervation-on-bood-pressure-in-patients-on-hemodialysis-100558844","NCT06556407","Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis","Effect of Renal Denervation on Blood Pressure in Patients With Treatment Resistant Hypertension, End-stage Chronic Kidney Disease and Hemodialysis","RDN-HD","Inclusion Criteria:\n\n* Uncontrolled treatment resistant hypertension (despite intake of 3 different classes of antihypertensive medications) confirmed by 24-h ambulatory blood pressure according to current guidelines (ESH 2023) (office blood pressure ≥ 140\u002F and\u002F or ≥ 90 mmHg and ambulatory blood pressure ≥ 130\u002F and\u002For ≥ 80 mmHg\n* end-stage renal disease on chronic hemodialysis\n* Stable hemodialysis regime for at least 3 months based on the decision of the treating physician\n* Patient is adhering to a stable drug regimen without changes for a minimum of 4 weeks.\n* Individual is ≥ 18 years of age, male and female patients are included.\n\nExclusion Criteria:\n\n* Episodes of sustained systolic and\u002For diastolic hypotension according to 24-h ambulatory blood pressure or dialysis protocols which in the eyes of the treating physician would interfere with a safe renal denervation treatment of the patient\n* Known hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which in the eyes of the interventionalist would interfere with safe catheter placement\n* Prior renal denervation procedure\n* Anatomic or functional solitary kidney, kidney transplantation\n* Severe atherosclerotic disease or artery calcification preventing the assessment of reliable BP measurements\n* Endocrine hypertension other than obstructive sleep apnea\n* Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 3 months of the screening visit\n* Acute episode of systemic and renal disease requiring uptitration of any immunosuppressive drug regimen within the last 3 months\n* Subject is pregnant, nursing, or intends to become pregnant\n* Enrollment in another interventional research protocol.\n* Any condition that, at the discretion of the investigator, would preclude participation in the study (e.g. non-adherence)",{"count":408,"type":22},12,[57],"The RDN-HD Study is a prospective, single-center feasibility study. All patients included will undergo endovascular ultrasound-based RDN (no sham group, no blinding). The purpose of the RDN-HD Study is to demonstrate that ultrasound-based RDN is safe in patients with TRH and ESRD hemodialysis and reduces 24-h ambulatory BP.",[412,413],"Treatment Resistant Hypertension","Chronic Hemodialysis","2025-09-22",{"date":416,"type":37},"2025-09-26",{"date":418,"type":37},"2024-03-04",{"date":420,"type":22},"2026-12-01",{"name":43,"class":44},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":430,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":45},"100586926","ultrasound-localization-microscopy-in-patient-with-congenital-anomalies-of-the-kidney-and-urinary-tract-cakut-100586926","NCT06921733","Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)","Non-invasive Evaluation of Kidneys in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) Using Ultrasound Localization Microscopy","Search_CAKUT","Inclusion Criteria:\n\nMinimum Age 1 Month Maximum Age 6 Years Indication for MAG3 Scintigraphy of the Kidney Congenital Anomalies of the Kidney and Urinary Tract Obstruction Diagnosis Availability of the qualified examiner Consent of the parents\u002Flegal guardians\n\nExclusion Criteria:\n\nLack of consent of at least one parent","0 Months","6 Years",{"count":433,"type":22},20,"This clinical study aims to non-invasively visualize perfusion and microvascularization, as well as individual glomeruli, using Ultrasound Localization Microscopy (ULM) and CEUS in patients with congenital anomalies of the kidney and urinary tract (CAKUT).",[436,437,438,439],"Congenital Anomalies of Kidney and Urinary Tract","Lower Urinary Tract Obstruction, Congenital","Ureteropelvic Junction Obstruction","Hydronephrosis Congenital","2025-09-16",{"date":442,"type":37},"2025-09-17",{"date":444,"type":37},"2025-05-13",{"date":446,"type":22},"2027-12-01",{"name":43,"class":44},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":457,"conditions":458,"keywords":466,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":45},"100431035","clinical-benefit-and-biomarker-analysis-of-combination-of-pd-1pd-l1-immune-checkpoint-inhibitors-and-radiotherapy-100431035","NCT04892849","Clinical Benefit and Biomarker Analysis of Combination of PD-1\u002FPD-L1 Immune Checkpoint Inhibitors and Radiotherapy","Clinical Benefit and Biomarker Analysis of Combination of PD-1\u002FPD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors","ST-ICI02","Inclusion Criteria:\n\n* Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or \"other solid tumour\"\n* Indication for system therapy with a PD-1\u002FPD-L1 inhibitor according to clinical standards\n* Patients without or with radiation of one or more metastases\n* Age at least 18 years\n\nExclusion Criteria:\n\n* Melanoma patients\n* Fertile patients who refuse effective contraception during study treatment\n* Persistent drug and\u002For alcohol abuse\n* Patients not able or willing to behave according to study protocol\n* Patients in care\n* Patients that are not able to speak German\n* Patients which are imprisoned according to legal or governmental order\n\nBoth gender are included into the study, a maximum age was not defined.",{"count":379,"type":22},"Inhibitors of the programmed cell death protein 1 (PD-1)\u002FPD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1\u002FPD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and \"other solid tumors\" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin \\[depending on the current drug approval\\]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects",[459,460,461,462,463,464,465],"HNSCC","NSCLC","Esophageal Cancer","Urothelial Carcinoma","Renal Cell Carcinoma","Squamous Cell Carcinoma of the Skin","Small Cell Bronchial Carcinomas",[467,468],"Immunotherapy","Radiotherapy","2025-09-10",{"date":442,"type":37},{"date":472,"type":37},"2021-04-30",{"date":227,"type":22},{"name":43,"class":44},{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":298,"sex":18,"minAge":483,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":493,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":184},"100550929","transfer-effects-of-stationary-bicycle-perturbation-training-on-older-adults-cycling-skills-100550929","NCT06453473","Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills","The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial","BiPerAge","Inclusion Criteria:\n\n* Ability and willingness to provide informed consent and accept randomization to either study arm\n* Ability to come to cycle course testing locations\n* ≥3 errors in pre-test of cycle course\n\nExclusion Criteria:\n\n* Severe diseases e.g. ischemic heart disease which restricts exercise, chronic obstructive pulmonary disease (COPD), uncontrolled blood pressure, manifest osteoporosis or any other disease leading to increased fracture risks\n* A period less than one year after hip or knee replacement surgery or after fractures of the lower extremities\n* Amputation of a lower limb\n* Neurological diseases or 6-month after a stroke\n* Inability to ambulate independently\n* Severe visual impairments (blindness), non-compensable hearing\n* Cognitive impairment, scoring less than 24 on the MMSE (Mini-Mental State Examination), inability to understand and follow instructions\n* Participation in another intervention trial at the same time or within the previous 6 months","65 Years","100 Years",{"count":486,"type":22},127,[57],"The Israeli research group of this trial has developed the Perturbation Stationary Bicycle Robotics (PerStBiRo) system that can challenge balance while sitting. With this system, unexpected perturbations can be provided under controlled and safe conditions. Within the BiPerAge-project it will be evaluated if 20 training sessions (20 minutes each) on the PerStBiRo system will lead to transfer effects on safe cycling skills of community-dwelling older adults (age 65 years and older). The ability to cycle safely will be tested prior and after the training period using a cycling course, which consists of variant tasks requiring motor and cognitive skills.",[490,491,492],"Older Adults","Exercise Training","Bicycling",[492,494,495,496],"Perturbation","Balance control","Falls","2025-09-09",{"date":440,"type":37},{"date":500,"type":37},"2025-03-12",{"date":502,"type":22},"2027-03-31",{"name":43,"class":44},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":298,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":524,"leadSponsor":526,"locationsCount":4},"100602321","multispectral-optoacoustic-imaging-for-the-detection-of-inflammation-and-damage-of-peripheral-nerves-in-guillain-barr-syndrome-and-chronic-inflammatory-demyelinating-polyneuropathy-100602321","NCT07121985","Multispectral Optoacoustic Imaging for the Detection of Inflammation and Damage of Peripheral Nerves in Guillain-Barré Syndrome and Chronic Inflammatory Demyelinating Polyneuropathy","MIND","Inclusion Criteria Patient Cohort(s):\n\n* Established diagnosis or suspected CIDP or GBS\n* Age: 18 years or older\n* Written informed consent provided by participant\n\nInclusion Criteria Control Cohort:\n\n* Written informed consent provided by participant\n* Age: 18 years or older\n* No pre-existing conditions that may affect peripheral nerves (e.g., diabetes, traumatic nerve injuries, etc.)\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding mothers\n* Cardiopulmonary instability\n* Tattoo in the examination area\n* Subcutaneous fat tissue \\> 3 cm",{"count":193,"type":22},"The aim of this study is to assess disease activity in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Guillain-Barré Syndrome (GBS) using multispectral optoacoustic tomography (MSOT).\n\nThe currently available diagnostic procedures for CIDP and GBS do not allow for a clear distinction between remission and active disease and show limitations in sensitivity and specificity during acute diagnostics. This can lead to delayed diagnosis, which is crucial for timely initiation of therapy and, consequently, for a better prognosis. Long-term therapy management is also challenging, as objective parameters for assessing therapeutic success are largely lacking.\n\nMSOT can detect inflammation through the measurement of hemoglobin, a method that our research group has already successfully demonstrated in patients with chronic inflammatory bowel diseases (Knieling, NEJM 2017). The use of MSOT could therefore also be applied to nerve inflammation, allowing for earlier detection of inflammation and nerve damage and contributing to timely treatment of patients.\n\nFor nerve imaging, a CE-certified MSOT device from iThera Medical is available at the Pediatric Clinic in Erlangen. In addition, a non-CE-certified device with lower laser power is available, which can be used for bedside examinations.\n\nThe arm nerves will be examined in three cohorts, which will be compared with each other and with standard diagnostics (blood tests, electrophysiology, conventional ultrasound).\n\nEach cohort will include ten healthy control subjects, ten patients with CIDP, and ten patients with GBS.",[514,515],"CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","Guillain-Barré Syndrome (GBS)",[517,518,519],"MSOT","PAI","Nerve Ultrasound","2025-08-06",{"date":522,"type":37},"2025-08-14",{"date":520,"type":22},{"date":525,"type":22},"2027-08-06",{"name":43,"class":44},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":298,"sex":18,"minAge":534,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":45},"100594620","multispectral-optoacoustic-tomography-for-advanced-imaging-of-centronuclear-myopathy-100594620","NCT07021820","Multispectral Optoacoustic Tomography for Advanced Imaging of Centronuclear Myopathy","MOSAIC","CNM arm:\n\nInclusion Criteria: diagnosed CNM; minimum of 2 years of age\n\nExclusion Criteria:\n\n* Pregnancy\n* Nursing mothers\n* Tattoo in the area of the examination field\n* Subcutaneous fatty tissue \\> 3 cm\n\nHV:\n\nInclusion criteria: minimum of 2 years of age\n\nExclusion criteria:\n\n* any signs\u002Fhistory of muscle diseases\n* Pregnancy\n* Nursing mothers\n* Tattoo in the area of the examination field\n* Subcutaneous fatty tissue \\> 3 cm","2 Years",{"count":5,"type":22},"Twenty patients with centronuclear myopathy and twenty age- and sex-matched, muscle-healthy controls will undergo diagnostic examination. Study participants will undergo physical examination, clinical and functional testing, and multispectral optoacoustic tomography (MSOT) scanning at predefined muscle sites (paraspinal muscles, trapezius muscle, deltoid muscle, forearm flexors, quadriceps muscle, adductor muscles, ischiocrural muscles, triceps surae muscle, and tibialis anterior).",[538],"Centronuclear Myopathy",[517,540,532],"centronuclear myopathy","2025-06-11",{"date":543,"type":37},"2025-06-15",{"date":545,"type":37},"2025-05-29",{"date":115,"type":22},{"name":43,"class":44},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":298,"sex":556,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":45},"100590073","predicting-cancer-risk-with-digital-and-molecular-markers-100590073","NCT06962670","Predicting Cancer Risk With Digital and Molecular Markers","Digital and Molecular Detection of Markers for Disease Risk Prediction, Improvement of Diagnostic Detection Accuracy and Implementation for Preventive Measures of Cancer - A Combined Case-control and Cohort Study","PräDigt","Inclusion Criteria:\n\n1. Biological adult (at least 18 years old) women\n2. Written informed consent for study participation and processing of personal data\n3. Own smartphone that can run the BayPass mobile application and willingness to use said smartphone for study purposes\n\n   Additional inclusion criterion for case group:\n4. Pre-existing or current diagnosis of at least one of the following oncological diseases: breast cancer, lung cancer, colorectal cancer, gynecologic cancer (incl. ovarian cancer, endometrial cancer, cervical cancer, fallopian tube cancer, vaginal cancer and vulvar cancer)\n\nExclusion Criteria:\n\n1. Known infection with HIV (Human Immunodeficiency Virus), HepA (Hepatitis A), HepB (Hepatitis B), HepC (Hepatitis C) or active SARS-CoV2 (Severe acute respiratory syndrome coronavirus type 2) infection\n2. Acute severe or potentially life-threatening illness, except those specified in inclusion criterion #4","FEMALE",{"count":558,"type":22},1250,[57],"The goal of this study is to identify new markers to predict the risk of developing cancer, primarily breast cancer. For this purpose, researchers will compare data obtained from cancer patients and healthy individuals. If characteristic differences are identified, e.g. in biomarkers, life style or family history, this may indicate a person's increased risk of developing cancer.",[562,563,564,565],"Breast Cancer","Lung Cancer","Colorectal Cancer","Gynecologic Cancer","2025-04-29",{"date":568,"type":37},"2025-05-08",{"date":570,"type":37},"2024-09-14",{"date":394,"type":22},{"name":43,"class":44},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":23,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":45},"100544313","app-based-recording-and-optimization-of-the-nutritional-status-in-patients-with-head-and-neck-tumors-during-and-after-radiochemotherapy-100544313","NCT06367257","App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy","Inclusion Criteria:\n\n* Patients with squamous cell carcinoma in the head and neck region, who receive a postsurgical or definitive radio(chemo)therapy\n* Patients who have a smartphone on which the Emento app can be installed\n* Minimum age 18 years\n\nExclusion Criteria:\n\n* Patients who are represented by a legal guardian\n* Patients who are not suitable for participation in the study due to a language barrier",{"count":580,"type":22},148,[57],"Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition.",[584],"Squamous Cell Carcinoma of Head and Neck","2025-04-07",{"date":587,"type":37},"2025-04-10",{"date":589,"type":37},"2024-02-29",{"date":346,"type":22},{"name":43,"class":44},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":45},"100519187","smart-and-fit-for-kidney-transplantation-100519187","NCT06040281","Smart and Fit for Kidney Transplantation","The Effects of an Interdisciplinary Treatment Approach in ESRD Patients: a Randomised Controlled Trial","S&F4NTx","Inclusion Criteria:\n\n* Patients must be on dialysis\n* Patients ≥ 18 years of age\n* Patients who own a smartphone\n* Patients must be willing to undergo inpatient rehabilitation within the project period\n* signed informed consent and data protection regulation\n\nExclusion Criteria:\n\n* Patients who are not psychologically or physically able to take part in exercise promotion measures and\u002For nutritional counselling as well as psychological offers\n* Patients who have already participated in a similar project",{"count":379,"type":22},[57],"This study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). The aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.",[604],"Chronic Kidney Disease Requiring Chronic Dialysis",[606,607,608],"Transplantation","Prehabilitation","Exercise and Nutritional Support","2025-03-25",{"date":611,"type":37},"2025-03-30",{"date":613,"type":37},"2023-09-18",{"date":615,"type":22},"2026-03-31",{"name":43,"class":44},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":298,"sex":18,"minAge":19,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":632,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":45},"100584124","effects-of-intermittent-fasting-and-exercise-on-inflammation-metabolism-and-the-microbiome-in-metabolic-syndrome-100584124","NCT06885255","Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome","Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study","FIT","Inclusion Criteria:\n\n* Written consent to participate in the study.\n* Persons aged 18 years and older.\n* Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.\n\nExclusion Criteria:\n\n* Pregnant or nursing individuals.\n* Cardiovascular diseases or orthopedic restrictions that prevent exercise.\n* Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).\n* Body weight greater than 200 kg (maximum capacity of training equipment).\n* Individuals with mental illnesses that may impair their ability to understand or participate in the study.","80 Years",{"count":215,"type":22},[57],"The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is:\n\nDoes intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome?\n\nParticipants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.",[630,631],"Metabolic Syndrome","Obesity and Obesity-related Medical Conditions",[633,634,635,636,637],"obesity","metabolic syndrome","high-intensity interval training","inflammation","intermittent fasting","2025-03-17",{"date":640,"type":37},"2025-03-20",{"date":642,"type":37},"2023-06-01",{"date":644,"type":22},"2026-03",{"name":43,"class":44},""]