[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heidelberg University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":398},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,49,74,102,139,166,188,218,241,278,301,328,353,378],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100201063","international-pediatric-peritoneal-biobank-100201063",false,"NCT01893710","International (Pediatric) Peritoneal Biobank","Inclusion Criteria\n\n* Age 0 to 90 years\n* CKD 5D, peritoneal dialysis and\n* Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)\n* Patients post PD and post Tx\n* Oral and written consent\n* Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively\n\nExclusion Criteria:\n\n* Abdominal adhesions, malformation and inflammation beyond PD induced changes\n* Patients with disseminated tumour disease\n* Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk\n* Pregnancy\n* Preterm babies (below 37 weeks of gestational age)\n* Serum hemoglobin \\\u003C 10 g\u002Fdl in newborns and \\\u003C 8 g\u002Fdl in children and adults",true,"ALL","1 Day","90 Years",{"count":20,"type":21},500,"ESTIMATED","2 Years","OBSERVATIONAL","Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.\n\nAn international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.\n\n3\u002F2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.",[26,27,28,29],"Kidney Failure, Chronic","Peritoneal Dialysis Complication","Transplantation","Healthy",[31,32,33,34,35],"peritoneal dialysis","parietal peritoneum","omentum","chronic kidney disease","vasculopathy","RECRUITING","2026-04-29",{"date":39,"type":40},"2026-04-30","ACTUAL",{"date":42,"type":40},"2011-02-01",{"date":44,"type":21},"2028-12-31",{"name":46,"class":47},"Heidelberg University","OTHER",26,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100442767","phase-3-early-stage-follicular-lymphoma-and-radiotherapy-plus-anti-cd20-antibody-100442767","NCT05045664","Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody","FORTplus","Inclusion Criteria:\n\n* • Centrally reviewed CD20-positive follicular lymphoma grade 1\u002F2 or 3a based on WHO classification (2008)\n\n  * Untreated (radiation-, chemo- or immunotherapy) nodal follicular lymphoma (including involvement of Waldeyer´s ring)\n  * Age: ≥18 years\n  * ECOG: 0-2\n  * Stage: clinical stage I or II (Ann Arbor classification) based on FDG-PET Staging\n  * Risk profile: Largest diameter of the lymphoma ≤ 7 cm (sectional images)\n  * Written informed consent and willingness to cooperate during the course of the trial\n  * Adequate bone marrow capacity: ANC ≥ 1.5 x 103\u002Fml, thrombocytes ≥ 100000 x 10 3\u002Fml, hemoglobin ≥ 10 g\u002FdL\n  * Capability to understand the intention and the consequences of the clinical trial\n  * Adequate contraception for men and women of child-bearing age during therapy and 18 months thereafter\n\nExclusion Criteria:\n\n* Extra nodal manifestation of follicular lymphoma\n* Secondary cancer in the patient's medical history (exclusion: basalioma, spinalioma, melanoma in situ, bladder cancer T1a, non-metastasized solid tumor in constant remission, which was diagnosed \\>3 years ago)\n* Serious disease interfering with a regular therapy according to the study protocol, e.g: congenital or acquired immune-deficiency syndromes, active infections including viral hepatitis, uncontrolled concomitant diseases including significant cardiovascular or pulmonary disease\n* Severe psychiatric disease\n* Pregnancy \u002F lactation\n* Known hypersensitivity against Obinutuzumab or Rituximab drugs with similar chemical structure or any other additive of the pharmaceutical formula of the study drug\n* Active hepatitis B infection (inactive hepatitis B infections require additional prophylactic anti-viral medication for 1 year (e.g. Lamivudin, Entecavir, Tenofovir)\n* Participation in another interventional trial or follow-up period of a competing trial which can influence the results of this current trial\n* Creatinine \\> 1.5 times the upper limit of normal (ULN) (unless creatinine clearance normal), or calculated creatinine clearance \\\u003C 40 mL\u002Fmin\n* AST or ALT \\> 2.5 × ULN\n* Total bilirubin ≥ 1.5 × ULN\n* INR \\> 1.5 × ULN\n* PTT or aPTT \\> 1.5 × the ULN","18 Years",{"count":58,"type":21},100,"INTERVENTIONAL",[61],"PHASE3","The MIR study proved the effect of Rituximab in combination with a localized irradiation given in a standard dose. Together with the TROG 99.03 trial, this led to the recommendation of using this combined approach in early stage nodal follicular lymphoma. The GAZAI study is currently looking for the effect of a low dose radiotherapy of 2x2 Gy in combination with Obinutuzumab. The combination seems to show a high CR rate based on the 50% of the patients. This is in contrast to the FORT trial, which showed an inferiority of the 4 Gy dose compared to the standard dose (24 Gy) in terms of response and progression free survival.\n\nThe goal of the FORTplus trial is to prove (1) the non-inferiority of LDRT (4Gy) in a combined approach with an anti-CD20-antibody. In case of non-inferiority, a possible (2) superiority of the Obinutuzumab + LDRT should be tested against Rituximab + standard dose using the same test set.\n\nThe radiation dose can significantly be reduced to 16% of the standard dose if (1) is confirmed. Knowing the data of the FORT trial, this would have a significant influence on the treatment of the disease worldwide even if the difference in the CR rate at week 18 is not as high as currently in the historical comparison expected.",[64],"Early Stage Follicular Lymphoma WHO Grade 1\u002F2 or 3a","2026-04-27",{"date":67,"type":40},"2026-04-28",{"date":69,"type":40},"2022-07-06",{"date":71,"type":21},"2030-06-30",{"name":46,"class":47},12,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100588608","colorectal-resections-in-patients-with-retroperitoneal-sarcoma-100588608","NCT06943612","Colorectal Resections in Patients With Retroperitoneal Sarcoma","Colorectal Resections and Reconstructions in Patients With Retroperitoneal Sarcoma: Evaluation of Surgical Strategies and Postoperative Quality of Life","COLOSARC-Q","Inclusion Criteria:\n\n* Histological confirmation with evidence of a retroperitoneal sarcoma\n* Tumor resection with colorectal resection\n* Surgery in a DKG-certified sarcoma center or hospital that meets certification-equivalent criteria\n* Age 18 years or older\n* Written consent\n\nExclusion Criteria:\n\n* Absence of consent",{"count":83,"type":21},120,"COLOSARC-Q is a multicenter study with the objective of providing an up-to-date assessment of colorectal resections and reconstruction techniques in the context of multivisceral resections for retroperitoneal sarcomas, as well as colorectal surgery-associated complications and their impact on patients' quality of life.\n\nIn multivisceral resections involving the colon and rectum, the primary aim is to achieve complete resection and preserve organ function. However, multivisceral resections have a high risk of perioperative morbidity including anastomotic leakage. The proposed project aims to determine the number of primary anastomoses, their insufficiency rates, and the fraction of patients with primary and secondary stomas. In addition, the patients' quality of life after multivisceral sarcoma resection is to be recorded using standardized surveys.\n\nThe analysis has the potential to facilitate intraoperative decision-making for colorectal resections in the context of multivisceral resections.",[86,87],"Sarcoma, Soft Tissue","Retroperitoneal Sarcoma",[89,87,90,91,92],"Soft tissue sarcoma","Sarcoma Surgery","Stoma","Colorectal resection","2025-12-04",{"date":95,"type":40},"2025-12-12",{"date":97,"type":40},"2025-01-27",{"date":99,"type":21},"2026-03",{"name":46,"class":47},13,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":59,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100603386","digital-home-based-physical-activity-promotion-for-older-adults-after-total-hip-arthroplasty-100603386","NCT07135843","Digital Home-Based Physical Activity Promotion for Older Adults After Total Hip Arthroplasty","iPATH - Digital Home-Based Training for Physical Activity Promotion in Older Adults After Total Hip Arthroplasty: A Randomized Controlled Trial","iPATH","Inclusion Criteria:\n\n* Age ≥65 years\n* Coxarthrosis with indication for total hip arthroplasty\n* Residence within a radius of ≤50 km from Heidelberg\n* Ability to walk ≥10 m (with\u002Fwithout walking aid)\n* Access to the internet (Wi-Fi) at home\n* Written informed consent\n\nExclusion Criteria:\n\n* Insufficient German language skills\n* Insufficient hearing to communicate via (video) telephone\n* Insufficient vision to recognize study materials\n* Contralateral coxarthrosis with indication for total hip arthroplasty\n* Severe medical condition illnesses that compromise physical fitness (heart failure classified as New York Heart Association \\[NYHA\\] class ≥3, heart valve defects associated with syncope, cardiac arrhythmia with dizziness, chronic obstructive pulmonary disease \\[COPD\\] with oxygen therapy, cancer with chemotherapy and\u002For radiation, Parkinson's disease with rollator use \\[Hoehn \\& Yahr stage ≥4\\])\n* Living in a nursing home\n* Planned major medical procedure within the next 6 months with inpatient hospital stay (e.g., further surgery)\n* Simultaneous participation in another competing study\n* Cognitive impairment (6-item Cognitive Impairment Test \\[6CIT\\] score \\>7 points)","65 Years",{"count":112,"type":21},213,[114],"NA","The goal of this clinical trial is to evaluate the efficacy of a 12-week digital home-based intervention program, consisting of a tablet-based exercise program with or without personal coaching, to promote physical activity (PA) in older adults after total hip arthroplasty (THA). The main question it aims to answer is:\n\n• Does the combination of the digital exercise program and personal coaching lead to higher PA six months after THA compared to usual care among older adults?\n\nSecondary questions are:\n\n* Does the digital exercise program alone lead to higher PA compared to usual care?\n* Does the digital exercise program combined with personal coaching lead to higher PA compared to the exercise program alone?\n\nParticipants' PA will be objectively measured with a body-fixed sensor at 1 week before THA (T1), 6 weeks after THA (T2), and 6 months (i.e. after THA (T3). After the postoperative assessment at T2, participants will be randomly assigned to one of three groups:\n\n* 12-week tablet-based exercise program at home with virtual personal coaching for physical activity promotion\n* 12-week tablet-based exercise program at home\n* Usual care (control group, no additional intervention)",[117,118],"Total Hip Arthroplasty (THA)","Older Adults (65 Years and Older)",[120,121,122,123,124,125,126,127,128,129],"Total Hip Arthroplasty","Physical Activity","Older Adults","Digital Intervention","Physical Exercise","Coaching","Patient Education","Postoperative Care","Ambulatory Monitoring","Behavior Change","2025-08-29",{"date":132,"type":40},"2025-09-02",{"date":134,"type":21},"2025-09",{"date":136,"type":21},"2028-01",{"name":46,"class":47},1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":15,"sex":147,"minAge":56,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":138},"100601115","hyperspectral-imaging-for-prediction-of-preeclampsia-100601115","NCT07106294","Hyperspectral Imaging for Prediction of Preeclampsia","Systematic Evaluation of Hyperspectral Analysis as a Predictive Marker of Preeclampsia","HIPPA","Inclusion Criteria:\n\n* singleton pregnancies\n* age ≥ 18 years\n* patient's ability to provide consent\n* written informed consent\n* women scheduled for a routine ultrasound scan in first or second trimester\n\nExclusion Criteria:\n\n* lack of consent\n* language barrier\n* severe fetal chromosomal\u002Fgenetic\u002Fstructural anomalies known at study enrollment\n* smoking in the last two hours before measurement\n* diagnosis of preeclampsia at study enrollment","FEMALE",{"count":149,"type":21},1430,"Preeclampsia is a hypertensive pregnancy disorder that can quickly lead to serious, potentially life-threatening outcomes for both the mother and the fetus. Typical features of preeclampsia are by endothelial and microvascular dysfunctionsNotably, such impairments in endothelial function may precede preeclampsia diagnosis and canpersist for years postpartum. In clinical practice, however, no predictive methods have yet been established that specifically reflect endothelial dysfunction in the context of preeclampsia.\n\nHyperspectral imaging represents a new and non-invasive imaging modality that allows contact-free visualization of peripheral microcirculatory dynamics and tissue perfusion. Despite its growing use in other medical fields, this technology has not yet been systematically studied to determine its predictive potential in preeclampsia.\n\nThe HIPPA project (Systematic Evaluation of Hyperspectral Analysis for Prediction of Preeclampsia) is a prospective observational study to evaluate the applicability of hyperspectral imaging as a new tool for prediction of preeclampsia.",[152,153],"Preeclampsia (PE) Risk","Preeclampsia",[155,156,157,158],"preeclampsia","hyperspectral imaging","EASIX","endothelial dysfunction","2025-08-24",{"date":130,"type":40},{"date":162,"type":40},"2025-08-21",{"date":164,"type":21},"2027-07-01",{"name":46,"class":47},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":15,"sex":147,"minAge":56,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":138},"100586215","endothelial-dysfunction-for-prognosis-in-patients-with-preeclampsia-100586215","NCT06912477","Endothelial Dysfunction for Prognosis In Patients With preeClampSia","Systematic Evaluation of Endothelial Dysfunction as a Prognostic Marker for Outcomes in Women With Preeclampsia","EPICS","Inclusion Criteria:\n\n* singleton pregnancies\n* Age ≥ 18 years\n* Patient's ability to provide consent\n* written informed consent\n\nExclusion Criteria:\n\n* Lack of consent\n* Language barrier\n* Dark to very dark skin type\n* Severe fetal chromosomal\u002Fgenetic\u002Fstructural anomalies\n* Laboratory changes in LDH, creatinine, or platelets due to other causes (e.g., isolated thrombocytopenia, e.g., immune thrombocytopenia, carcinoma)",{"count":175,"type":21},385,"Preeclampsia is a pregnancy-specific hypertensive disorder and can progress rapidly to severe adverse outcomes affecting both the mother and the fetus. Endothelial and microcirculatory dysfunction mediate systemic preeclampsia-related organ dysfunctions. Changes in endothelial and vascular function in preeclampsia have been demonstrated through reduced flow-mediated vasodilation as a result of reduced availability of nitric oxide, which potentially persists up to several years postpartum. Hyperspectral imaging is a new innovative technology that allows to assess the peripheral microcirculation and perfusion non-invasively and contactless, but has never been evaluated in the context of preeclampsia before.\n\nThis EPICS project (Endothelial dysfunction for Prognosis In patients with preeClampSia) is a prospective observational study and aims to investigate hyperspectral imaging as a new potential diagnostic and prognostic marker in preeclampsia.",[178,179],"Preeclampsia (PE)","Hypertensive Disorder of Pregnancy",[155,156,158],"2025-05-08",{"date":183,"type":40},"2025-05-11",{"date":181,"type":40},{"date":186,"type":21},"2027-07",{"name":46,"class":47},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":15,"sex":16,"minAge":56,"maxAge":110,"enrollmentInfo":195,"targetDuration":4,"studyType":59,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":138},"100539999","effectiveness-of-an-ecological-momentary-emotion-regulation-intervention-100539999","NCT06311136","Effectiveness of an Ecological Momentary Emotion Regulation Intervention","Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial","Inclusion Criteria:\n\n* Online consent for participation\n* Adequate proficiency in the German language, encompassing both reading and comprehension skills\n* Ownership of a smartphone, compatible with either Android or iOS operating systems, and access to the Internet\n\nFor individuals in the clinical group with current depressive disorders:\n\n* Currently meeting the DSM-5 criteria for a mild or moderate major depressive episode, or persistent depressive disorder\n\nExclusion Criteria:\n\n* Current severe substance use disorder\n* Acute suicidality\n* Current severe major depressive episode\n* Lifetime bipolar disorder\n* Lifetime psychotic disorders\n\nFor the control group, additional exclusion criteria include:\n\n* Meeting the DSM-5 criteria for a major depressive episode within the last 12 months\n* History of severe major depressive episodes\n* Recurrent depressive disorder\n* History of persistent depressive disorder\n* Current treatment (psychotherapy, pharmacotherapy) for depressive symptoms",{"count":196,"type":21},200,[114],"This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.\n\nParticipants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.\n\nOutcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).\n\nA second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice.",[200,201,29],"Depressive Disorder, Major","Persistent Depressive Disorder",[203,204,205,206,207,208,209],"Emotion Beliefs","Emotional Regulation","Positive Emotions","Affective Symptoms","Ecological Momentary Assessment","Internet-Based Intervention","Depression","2025-03-24",{"date":212,"type":40},"2025-03-27",{"date":214,"type":40},"2024-01-12",{"date":216,"type":21},"2025-08",{"name":46,"class":47},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":226,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":59,"phases":229,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},"100356760","phase-2-a-study-to-evaluate-safety-and-efficacy-of-subcutaneous-administration-of-anakinra-in-patients-with-cf-100356760","NCT03925194","A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF","A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis","ANAKIN","Inclusion Criteria:\n\n1. Age ≥ 18 years (1st cohort). If justified by interim analysis, 18 \\> age ≥ 12 years (2nd cohort),\n2. Informed consent of the patient (if applicable) and\u002For all legal guardians,\n3. Sufficient fluency of patient and\u002For his\u002Fher representative in German language to comply with study-specific procedures (e.g. to complete required quality of life questionnaires),\n4. Confirmed diagnosis of cystic fibrosis, fulfilling at least one of the following three criteria:\n\n   1. sweat chloride ≥ 60mEq\u002FL,\n   2. two CF causing mutations in the CFTR gene,\n   3. alterations of transepithelial potential difference of nasal or rectal epithelia typical for CF,\n5. FEV1 ≥ 50 % pred. at screening,\n6. LCI2.5 ≥ 7.05 at screening,\n7. Ability to perform reproducible multiple breath washout and spirometry,\n8. Oxyhaemoglobin saturation of ≥ 90% on room air at screening,\n9. No changes in the medication for cystic fibrosis lung disease for at least 4 weeks prior to the first administration of the IMP of each treatment period (in case of medication changes in Period 1 and\u002For the washout phase the wash-out may be extended for up to 12 weeks in order to fulfill this criterion),\n10. Adequate bone marrow function assessed on the basis of: neutrophils \\>1.5 x 109\u002FL, platelets \\>100 x 109\u002FL, hemoglobin \\>9.0 g\u002FdL,\n11. Adequate liver function assessed on the basis of: GGT, ASAT, and ALAT \\\u003C3 x upper limit of normal (ULN),\n12. Adequate blood clotting assessed on the basis of: aPTT \\\u003C39 sec., INR \\\u003C1.2,\n13. Negative serology for HIV (anti-HIV 1\u002F2 IgG\u002FIgM and p24-Ag), HBV (anti-HBs quantitative and anti-HBc IgG\u002FIgM) and HCV (anti-HCV IgG), negative Interferon-gamma release assay,\n14. Negative Beta-HCG blood\u002Furine test in women of childbearing potential (of childbearing potential are females who have experienced menarche and are not permanently sterile or postmenopausal (postmenopausal: 12 consecutive months with no menses without an alternative medical cause)),\n15. Use of adequate contraception in sexually active female subjects (sexual abstinence, hormonal contraceptives or intrauterine device).\n\nExclusion Criteria:\n\n1. Expected non-compliance, i.e. inability or unwillingness to comply with study-specific procedures,\n2. Known allergy to anakinra or any ingredient of the pharmaceutical formulation of Kineret®,\n3. Planned immunization with attenuated (live) vaccine(s) during the treatment with the IMP or completed immunization with attenuated (live) vaccine(s) within 4 weeks prior to the first administration of the IMP,\n4. Renal failure (creatinine in serum above ULN),\n5. History of tuberculosis or repeated detection of non-tuberculous mycobacteria from airway samples in the last 12 months before start of each treatment period,\n6. History of detection of Burkholderia cenocepacia species in the last 12 months before start of each treatment period,\n7. Colonization with multi-resistant Staphylococcus aureus (MRSA) and\u002For 4-multi-resistant gram negative (MRGN) Pseudomonas aeruginosa is only an exclusion criterion if the treating physician judges that this is an increased risk for the patient,\n8. Acute bronchopulmonary exacerbation (defined by modified Fuchs criteria (1) (see Appendix 1), modification includes all ways of application of an antibiotic (e.g., oral, i.v., inhaled)) within 14 days prior to the screening and before start of each treatment period,\n9. Signs of other active infection within 14 days prior to the screening and before start of each treatment period (clinical symptoms (e.g. burning sensation while urinating, skin, wound or dental infection) and\u002For fever and\u002For deterioration of infection-specific laboratory parameters beyond changes driven by the underlying disease),\n10. Immunosuppressive treatment due to organ transplantation, rheumatic or autoimmune diseases as well as treatment with Anakinra in the last 3 months before Day 1 of Period 1,\n11. Participation in another interventional trial within the last 30 days prior to screening,\n12. Current oral corticosteroid use,\n13. Current oxygen supplementation,\n14. Current treatment with etanercept,\n15. Medical history of lung transplantation,\n16. Pregnant or nursing females (females of childbearing potential must have a negative pregnancy test at Screening),\n17. Known hypersensitivity to hypertonic saline (used for induction of sputum).","12 Years",{"count":228,"type":21},52,[230],"PHASE2","OBJECTIVES\n\nPrimary:\n\nTo evaluate efficacy of treatment with anakinra in subjects with CF who are ≥ 12 years of age by means of lung clearance index (LCI).\n\nSecondary To evaluate safety and tolerability of treatment with anakinra as well as to investigate further effects of anakinra on lung function and quality of life (QOL) in subjects with CF.",[233],"Cystic Fibrosis, 10011762",{"date":212,"type":40},{"date":236,"type":40},"2022-12-01",{"date":238,"type":21},"2026-12-01",{"name":46,"class":47},3,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":59,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":277,"locationsCount":138},"100560732","exploring-the-effects-of-exercise-on-memory-and-cognition-in-parkinsons-disease-100560732","NCT06580977","Exploring the Effects of Exercise on Memory and Cognition in Parkinson´s Disease","EMCo","Inclusion Criteria:\n\n* Diagnosed Parkinson's disease\n* Disease stage ≤3 on the Hoehn \\& Yahr scale\n* Age ranging from 50 - 80 years\n* Naive to the memory tasks (primary outcomes)\n* Ability to stand and walk at least 10 meters independently\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Significant level of cognitive impairment (i.e., Montreal Cognitive Assessment \\\u003C21)\n* Deep brain stimulation or brain pacemaker\n* Diagnosed psychiatric illness\n* Known clinically relevant neurological, internal or orthopedic conditions besides Parkinsonism that would interfere with the exercise paradigm\n* Exceeding the recommended level of cardiovascular exercise for older adults (i.e., cardiovascular exercise done ≥150 min per week of moderate-intensity or ≥75 min per week of vigorous-intensity)","50 Years","80 Years",{"count":251,"type":21},60,[114],"The study aims to assess the effects of cardiovascular (aerobic) training on memory formation and cognitive function in people with Parkinson's disease. Participants will be randomly allocated to one of two groups either performing cardiovascular training (experimental group) or stretching (control group) for twelve weeks, three times a week. The primary aim is to examine whether moderate-intense cardiovascular training (MICT) improves procedural memory formation (primary outcome) compared to stretching. Secondary outcomes include episodic memory formation, cognitive function, cardiorespiratory fitness, sleep quality, and brain-derived neurotrophic factor (BDNF) blood concentration levels.",[255],"Parkinson Disease",[257,258,259,260,261,262,263,264,265,266,267,268,269,270],"Parkinson's Disease","rehabilitation","cardiovascular training","aerobic exercise","neuroplasticity","memory","encoding","consolidation","motor learning","acquisition","retention","cognition","sleep","brain-derived neurotrophic factor","2024-08-28",{"date":273,"type":40},"2024-08-30",{"date":275,"type":40},"2024-02-27",{"date":186,"type":21},{"name":46,"class":47},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":110,"enrollmentInfo":286,"targetDuration":4,"studyType":59,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":300},"100517494","mentalization-based-treatment-versus-bona-fide-treatment-for-patients-with-borderline-personality-disorder-in-germany-100517494","NCT06018272","Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany","Mentalisierungsbasierte Therapie Versus Bona-fide-Therapie für Patient:Innen Mit Borderline-Persönlichkeitsstörung in Deutschland (MaGnet): Eine Prospektive, Multizentrische Randomisiert-kontrollierte Studie Mentalization-based Treatment Versus Bona-fide Treatment for Patients With Borderline Personality Disorder in Germany (MAGNET): a Prospective, Multi-centre Randomized Controlled Trial","MAGNET","Inclusion Criteria:\n\n* Borderline Personality Disorder\n* non-suicidal self injury or suicide attempts in the past two years as indicated by the IPDE item \"repeated suicidal behaviours, gestures, threats or self-harm\", one of which has occurred in the past six months\n\nExclusion Criteria:\n\n* acute substance use disorder (exception: cannabis dependency)\n* diagnosis of schizophrenia or schizotypal personality disorder\n* bipolar I disorder (DSM-5)\n* cognitive impairment (IQ\\\u003C80) or evidence of organic brain disorder\n* BMI\\\u003C16.5\n* serious medical condition that will require hospitalization within the next year (e.g. cancer)\n* no sufficient German language abilities",{"count":287,"type":21},304,[114],"Background: Borderline Personality Disorder (BPD) is a serious mental disorder. Mentalization-based treatment (MBT) is one evidence-based treatment for individuals with BPD. Specifically, MBT has been highlighted for its effectiveness in reduction of suicidal and non-suicidal self-injury (NSSI). Yet, randomized-controlled trials (RCT) on MBT in outpatient settings compared with bona fide treatment (BFT) are still scarce and none has been conducted in Germany. The primary objective of this RCT is to investigate whether outpatient MBT is more effective in the reduction of crisis events (incidences of NSSI and suicide attempts) compared with BFT (namely psychodynamic or cognitive-behavioural psychotherapy) in Germany. Secondary, MBT's efficacy will be investigated with regard to cost-effectiveness, general and interpersonal functioning, BPD and general symptom severity, social adjustment, quality of life, reduction in psychotropic medication and therapy retention. Additionally, moderator as well as common and treatment specific mediator variables will be investigated.\n\nStudy Design\u002F Study Population\u002F Methods: Across 5 study sites in Germany, 304 individuals of all genders from age 18 to 65 with a BPD diagnosis and NSSI or suicide attempts in the past will be asked to participate in the study for two years. In the first year, patients will receive either MBT or BFT (psychodynamic or cognitive behavioural psychotherapy) and will take part in continuous scientific assessments. Scientific assessments will continue after therapy completion up to a 12-moth follow up. As primary outcome, crisis events will be assessed via ecological momentary assessment (EMA) four times a week once per month during the first year and once every three months in the second year. Number of crisis events up to 2 years post randomization will be compared between treatment arms using a log-linear regression model following an intention-to-treat approach. Secondary outcomes, such as borderline and general symptom severity, will be assessed at several timepoints. A within-trial cost-effectiveness analysis (CEA) will be conducted with a societal perspective.\n\nClinical Trial Rationale: This study investigates efficacy of MBT as BPD specific treatment in an outpatient setting compared with BFT in Germany. Results of this study can address a treatment gap in the German healthcare system, and inform about health economic aspects of BPD treatment as well as mechanisms of psychotherapeutic change.",[291],"Borderline Personality Disorder","2024-05-08",{"date":294,"type":40},"2024-05-10",{"date":296,"type":40},"2024-02-28",{"date":298,"type":21},"2028-03-31",{"name":46,"class":47},5,{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":249,"enrollmentInfo":308,"targetDuration":4,"studyType":59,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":138},"100378962","phase-2-adenoid-cystic-carcinoma-and-carbon-ion-only-irradiation-100378962","NCT04214366","Adenoid Cystic Carcinoma and Carbon Ion Only Irradiation","ACCO","Inclusion Criteria:\n\n* Histologically confirmed adenoid cystic carcinoma in the head and neck area\n* Indication for irradiation:\n* non-operable or\n* R1\u002FR2 resected or\n* perineural sheat invasion (Pn+) or\n* pT3\u002FpT4\n* Informed consent\n* KI \\> 60% or ECOG 0\u002F1 (minimum: self-sufficiency, normal activity or work not possible)\n* Age 18-80 years\n\nExclusion Criteria:\n\n* rejection of the study by the patient\n* Patient is not able to consent\n* Stage IV (distant metastases), except lung metastases \\\u003C 1cm\n* lymph node involvement (clinical or pathological)\n* Previous radiotherapy in the head and neck area\n* Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)\n* Contraindication to MR imaging\n* Simultaneous participation in another clinical study that could influence the outcome of this study or the other study\n* Pregnancy",{"count":309,"type":21},314,[230],"Adenoid cystic tumors are rare tumors of the head and neck region. Despite their slow growth, re-irradiation is often necessary due to the high metastatic risk. Patients are usually irradiated with photons or, as here at the Heidelberg University Hospital, with a combination of carbon ions and photons. So far, there is no data from Europe available for the sole irradiation with carbon ions. The present ACCO (Adenoid Cystic Carcinoma and Carbon ion Only irradiation) study, a prospective, open-label, phase II, single-arm, investigator-initiated study, will therefore investigate the sole radiotherapy of carbon ions in this tumor entity. Irradiation is applied - significantly shorter than the combination therapy - in about 4 weeks (22 fractions); patients are followed up for further 5 years after the start of therapy. Carbon ions alone are expected to increase local tumor control rates from 60% to 70% after 5 years (primary objective criterion of this study). In order to reject the null hypothesis with a power of 80% and a significance level of 5%, 175 patients are included (including a drop-out rate of 15%). Secondary objective criteria are progression-free survival, overall survival, acute and late toxicity, and quality of life.",[313],"Adenoid Cystic Carcinoma",[315,316,317,318,319],"carbon ion","heavy ion","salivary gland tumor","ACC","Radiation therapy","2023-11-29",{"date":322,"type":40},"2023-11-30",{"date":324,"type":40},"2019-12-01",{"date":326,"type":21},"2032-12-01",{"name":46,"class":47},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100229890","longitudinal-observational-study-on-the-course-of-cystic-fibrosis-lung-disease-in-patients-following-newborn-screening-100229890","NCT02270476","Longitudinal Observational Study on the Course of Cystic Fibrosis Lung Disease in Patients Following Newborn Screening","TRACK-CF","Inclusion Criteria:\n\n1. Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted criteria is fulfilled: i) sweat chloride ≥ 60mEq\u002FL and\u002For ii) 2 CF-causing mutations in the CFTR gene and\u002For iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium.\n2. Age and mode of diagnosis:\n\n   * Early diagnosed (ED): Initial diagnosis following CF-NBS or for other reasons in the first 4 months of life (in preterms corrected age of 4 months) after January 1st, 2006. Other reasons could be prenatal diagnostics, meconium ileus or positive family history.\n   * Late diagnosed (LD): Diagnosed after the fourth month of life due to clinical symptoms; initial diagnosis after January 1st, 2006.\n\nExclusion Criteria:\n\nAll patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure.\n\nFurther exclusion criteria are:\n\n1. Preterms \\\u003C30th week of gestation\n2. Longer period of mechanical ventilation in first 3 months of life\n3. A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol\n4. Previous major surgery except for meconium ileus or atresia of the intestine\n5. Other major organ dysfunction, excluding pancreatic or hepatic dysfunction or another condition due to CF\n6. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by investigator\n7. Chronic lung disease other than CF (e.g. bronchopulmonary dysplasia)\n8. History of adverse reaction to medication for sedation or known claustrophobia\n\nCriteria, which lead to a displacement of the procedures in sedation until the child has recovered: - Clinically significant upper airway obstruction as determined by investigator (e.g.\n\nsevere laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnoea)\n\n\\- Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy",{"count":196,"type":21},"The purpose of this study is to further characterize early CF lung disease in newborns, infants and toddlers with cystic fibrosis (CF).",[338],"Cystic Fibrosis Lung Disease",[340,341,342,343,344],"Cystic Fibrosis","Infant","Toddler","Children","Newborn screening","2023-11-28",{"date":320,"type":40},{"date":348,"type":4},"2011-12",{"date":350,"type":21},"2030-12",{"name":46,"class":47},4,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":59,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":368,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":377},"100474925","training-in-hfpef-ph-100474925","NCT05464238","Training in HFpEF-PH","Implementation, Safety, Tolerability and Effect of Exercise and Respiratory Training on 6-minute Walking Distance in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF): a Randomized Controlled Multicenter Trial in European Countries.","TRAIN HFpEF","Inclusion Criteria:\n\n1. Female and male patients ≥18 years\n2. WHO\u002FNYHA functional class II - IV\n3. PH with HFpEF diagnosed by right heart catheterisation showing:\n\n   mean pulmonary arterial pressure (mPAP) ≥25mmHg at rest; pulmonary arterial wedge pressure (PAWP) ≥15mmHg at rest or LVEDP ≥16mmHg and\u002For PAWP≥25 mmHg during exercise, and\n4. Preserved left ventricular ejection fraction ≥50%\n5. Patients receiving optimized therapy including intensified treatment with diuretics and who have been stable for 1 month before entering the study.\n6. Except for diuretics, medical treatment should not be changed during the study period.\n7. Able to understand and willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n1. Pre-capillary pulmonary hypertension (Group I; Group III; Group IV; Group V according to PH guidelines)\n2. Congenital or acquired severe valvular diseases (severe aortic stenosis or insufficiency, severe mitral valve stenosis or insufficiency)\n3. Pregnancy or lactation\n4. Walking disability\n5. Subject who participates in an interventional study during the course of this study\n6. Severe lung disease: FEV1\u002FFVC \\\u003C0.5 and total lung capacity \\\u003C60% of the normal value\n7. Active myocarditis, unstable angina pectoris, exercise induced ventricular arrhythmias, active liver disease, porphyria or elevations of serum transaminases \\>3 x ULN (upper limit of normal) or bilirubin \\>1.5 x ULN\n8. Haemoglobin concentration less than 75% of the lower limit of normal\n9. Systolic blood pressure \\\u003C85 mmHg\n10. History or suspicion of inability to cooperate adequately.",{"count":362,"type":21},90,[114],"Exercise interventions alone or as a component of a comprehensive cardiac rehabilitation program for patients with heart failure (HFrEF and HFpEF) have already shown to reduce the risk of hospitalisations due to HF and improved exercise capacity and health-related quality of life. Two meta-analyses have confirmed the beneficial effects in cardiorespiratory fitness and quality of life. The effects of exercise training on systolic and diastolic function remain inconclusive. Due to the positive results of exercise training in HFpEF, cardiac rehabilitation is recommended (Class I, level A) to be integrated into the overall provision of HF care. However, none of these studies focused on concomitant PH in HFpEF.\n\nExercise training in patients with pulmonary hypertension has already shown to improve exercise capacity, quality of life and peak oxygen consumption, which was confirmed by three meta-analyses and a Cochrane review. Though different diagnostic subgroups have already been enrolled in PH exercise training studies, they mainly included pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. Data on combined PH and HFpEF is still lacking.\n\nAs recently pointed out by Arena et al. there may thus be an exercise training volume\u002Fintensity which may be detrimental to the RV in patients with HF and concomitant PH.\n\nThis study is sought to investigate whether a specialized training program is safe and tolerable and may improve exercise capacity, quality of life, hemodynamics, diastolic dysfunction and biomarkers in patients with PH and HFpEF.",[366,367],"Pulmonary Hypertension Due to Left Heart Disease","Heart Failure With Preserved Ejection Fraction","NOT_YET_RECRUITING","2022-09-14",{"date":371,"type":40},"2022-09-16",{"date":373,"type":21},"2023-02-01",{"date":375,"type":21},"2026-12",{"name":46,"class":47},2,{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":15,"sex":16,"minAge":56,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":138},"100287519","heidelberg-study-on-diabetes-and-complications-100287519","NCT03022721","Heidelberg Study on Diabetes and Complications","HEIST-DiC","Inclusion Criteria Age between 18 and 75 years Persons with manifest diabetes mellitus type 1 or type 2 and diagnosis according to DDG guidelines 2011, that is HbA1c of 6,5 percent or higher after exclusion of false values, more than 200 mg per dl two hours after glucose in the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice Healthy persons without diabetes or impairment of glucose metabolism in the oGTT according to DDG guidelines 2011 fasting plasma glucose less than 100 mg per dl and 2 hour plasma glucose less than 140 mg per dl Pre diabetics with impaired fasting glucose between 100 mg per dl and 125 mg per dl, or impaired glucose tolerance with 2 hour glucose values between 140 and 199 mg per dl in the oGTT, all values from venous plasma\n\nExclusion Criteria General exclusion criteria Secondary types of Diabetes, ADA criteria type 3 B H Current pregnancy Acute infections or fever Immune suppressant therapy Severe psychiatric diseases requiring treatment, including personality disorders, schizophrenia, depression Known alcohol or drug dependency Severe heart NYHA stadium IV, kidney, or liver insufficiency Non diabetic liver disease, for example PBC, PSC, Wilsons disease, hemochromatosis, autoimmune hepatitis severe peripheral artery disease stadium IV non diabetic glomerulopathy Cancer or other malignant diseases within the last 5 years Infectious diseases like hepatitis B, C, E, or HIV Other severe autoimmune diseases Current participation in an interventional study Anemia or disorders of bone marrow Exclusion criteria for MRI Pacemaker or ICD Metallic and magnetic implants, for example mechanic cardiac valves replacements, joint prostheses, clips after vascular surgery, middle or inner ear implants, recent tooth implants, penile implants Waist circumference more than 135 cm Claustrophobia Allergies against MRI contrast Impaired kidney function with a GFR less than 65 ml per min\n\nExclusion criteria for clamp study Past history of deep vein thrombosis or pulmonary embolism Routine laboratory test results less than 80 percent below lower reference value of Ferritin, iron, leucocytes, hemoglobin, hematocrite, RBC, platelets, blood alcohol Level\n\nExclusion criteria for bioimpedance measurement Pacemaker or ICD\n\nExclusion criteria for lung function testing Ignoring or non understanding of the instructions Body weight more than 160 kg","75 Years",{"count":20,"type":21},"The prospective observational study entitled \"Heidelberg Study on Diabetes and Complications\" is designed to Monitor the presence and development of diabetic complications in type 1 and type 2 diabetic patients, as well as pre-diabetics. Mail Goal is to detect new metabolic mechanisms or new risk factors for the development of diabetic complications in order to identify risk-subgroups. Non-diabetic controls will be enrolled for reference and comparison.",[389],"Diabetes Complications","2017-01-12",{"date":392,"type":21},"2017-01-16",{"date":394,"type":4},"2016-09",{"date":396,"type":21},"2028-09",{"name":46,"class":47},""]