[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Bonn\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":389},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,39,57,92,121,154,177,217,249,285,321,343,368],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100538322","ai4hope-pilot-study-1-digital-toolkit-assessment-100538322",false,"NCT06289322","AI4HOPE Pilot Study 1 Digital Toolkit Assessment","AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose and Endurance in Palliative Care for Dementia: Pilot Study 1 Digital Toolkit Assessment","AI4HOPE1","Inclusion Criteria:\n\n* Mild to moderate dementia of any type\n* Montrea Cognitive Assessment (MoCA) score of 16-25\n* Living at home, or in residential or nursing home care\n* Receiving adequate social support\n\nExclusion Criteria:\n\n* Moderate\u002Fsevere cognitive impairment (MoCA \\\u003C 16)\n* No cognitive impairment (MoCA \\>25)\n* Inpatient or acute hospital treatment\n* Infectious diseases or lokal skin conditons preventing the use of wearable body sensors","ALL",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia.",[26],"Dementia","NOT_YET_RECRUITING","2026-02-02",{"date":30,"type":31},"2026-02-05","ACTUAL",{"date":33,"type":20},"2026-02",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"University of Bonn","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100538538","ai4hope-pilot-study-2-digital-dementia-care-planning-100538538","NCT06292143","AI4HOPE Pilot Study 2 Digital Dementia Care Planning","AI4HOPE - Artificial Intelligence Based Health, Optimism, Purpose, and Endurance in Palliative Care Ofr Dementia: Pilot Study 2 Digital Dementia Care Planning","AI4HOPE2","Inclusion Criteria:\n\n* Mild or moderate dementia of any type\n* Montreal Cognitive Assessment (MoCA) score of 16-25\n* Living at home, or in residential or nursing home care\n* Receiving adequate social support\n\nExclusion Criteria:\n\n* Moderate\u002Fsevere cognitive impairment (MoCA \\\u003C 16)\n* No cognitive impairment (MoCA \\>25)\n* Inpatient or acute hospital treatment\n* Infectious diseases or lokal skin conditions preventing the use of wearable body sensors",{"count":19,"type":20},[23],"This pilot study will test a digital care planning decision support system for patients with dementia.",[26],"2026-01-29",{"date":28,"type":31},{"date":33,"type":20},{"date":55,"type":20},"2027-12",{"name":37,"class":38},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100618014","phase-4-a-clincial-study-testing-tirzepatide-on-reproductive-function-and-metabolic-health-in-women-with-pcos-who-are-overweight-or-obese-100618014","NCT07326111","A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese","A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction","PERIODS","General Inclusion Criteria\n\n* Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial\n* Subjects\n\n  * motivated, capable, and willing to self-inject IMP, as required for this protocol.\n  * motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, includ-ing, but not limited to lifestyle, dietary and exercise advice.\n  * motivated, capable, and willing to complete trial diaries and required questionnaires.\n\nIndication-specific Inclusion Criteria\n\n* Females aged 18 - 45 years of childbearing potential\n* At least 3 years post-menarche and premenopausal\n* BMI ≥ 27 kg\u002Fm²\n* Previous diagnosis of PCOS, defined by Rotterdam criteria\n* Oligomenorrhea or secondary amenorrhea with irregular periods (defined as cycle length less than 21 or more than 35 days or \\\u003C 8 cycles per year); within the last 10 years (if currently receiving hormonal contraceptive treatment) OR over the last year in the absence of hormonal contraceptive treatment\n* Biochemical signs of hyperandrogenism with total testosterone in upper 95th Percentile AND free androgen index (FAI) \\> ULN and\u002For clinical signs of hyperandrogenism\n* Hormonal contraceptive naïve or not on hormonal contraceptives six months prior to screening, willing to be without hormonal contraceptives for the duration of the clinical trial and to perform safe alternate contraception (barrier methods) during the 72-week IMP intake period and 30 days after the last dose of IMP\n\nGeneral Exclusion Criteria\n\n* Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial\n* Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial\n\n  * Note: Patients with depression or other psychiatric disorder whose disease state is considered stable and expected to remain stable throughout the course of the clinical trial, in the opinion of the investigator, may be considered for inclusion.\n  * Note: Subjects with a lifetime suicidal event cannot be considered for inclusion\n* Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga-tional product, up to 30 days after last IMP intake in that clinical trial\n* Known or persistent abuse of medication, drugs or alcohol\n* History of an active or untreated malignancy or being in remission from a clinically significant malig-nancy for less than 5 years\n\n  o Excluding basal- or squamous-cell skin cancer or in situ carcinomas of the cervix\n* Prior diagnosis of severe renal impairment or measured as estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² during screening\n* Acute or chronic hepatitis, signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or alanine aminotransferase (ALT) level \\> 3.0 X the upper limit of normal, as deter-mined by the laboratory during screening\n* History of gastric emptying abnormality (e.g., gastroparesis, gastric outlet obstruction or chronic de-pendence on drugs that significantly affect gastric emptying)\n* Current (positive pregnancy test, e.g., ß-HCG test in urine \u002F serum) or planned pregnancy during the 72-week treatment period from randomization, or nursing women\n\nIndication-specific Exclusion Criteria\n\n* Prior diagnosis of diabetes mellitus other forms than type 2\n\n  o Note: Excluding prior history of gestational diabetes\n* In case of diabetes mellitus type 2, exclusion of subjects\n\n  * on DPP-4 inhibitors, GLP-1R agonist and\u002For a dual\u002Ftriple incretin agonist (up to 6 months prior to screening)\n  * on sulfonylureas or insulin (basal and\u002For bolus)\n  * with uncontrolled diabetes (HbA1c \\> 8.5%)\n  * with non-proliferative diabetic retinopathy requiring acute treatment\n  * with diabetic maculopathy\n  * Note: use of metformin or SGLT-2-inhibitor (if needed for glycemic control in type-2-diabetes) is allowed\n* Current or prior treatment (up to 6 months prior to screening) with GLP-1R agonist or a dual incretin agonist for obesity or other indications\n* Use of inositol formulations (up to 6 months prior to screening)\n* Congenital adrenal hyperplasia (CAH, classic and non-classic forms)\n* Thyroid, pituitary, and\u002For adrenal disease (if not appropriately treated)\n\n  o Note: Excluding stable disease and\u002For stable drug dose 12 weeks before screening\n* Hyperprolactinaemia\n* Known history of benign intrauterine lesions\n* Hysterectomy\n* Known history of hypersensitivity against tirzepatide or excipients\n* Known history of hypersensitivity against medroxyprogesterone acetate or dydrogesterone or any other ingredients of the Auxiliary Medicinal Products\n* Known personal or family history of medullary thyroid cancer or subjects with Multiple Endocrine Ne-oplasia syndrome type 2 (MEN 2)\n* Elevated calcitonin levels as determined by the laboratory during screening\n\n  * ≥ 20 ng\u002FL, if eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2\n  * ≥ 35 ng\u002FL, if eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* Known secondary cause of obesity (i.e., Cushing syndrome) or monogenetic or syndromic forms of obesity (i.e., melanocortin 4 receptor deficiency or Prader Willi Syndrome)\n* Known history of acute or chronic pancreatitis\n* Previous or planned bariatric surgery or endoscopic and\u002For device-based therapy for obesity\n\n  o Note: excluding liposuction or abdominoplasty if performed \\> 1 year prior to screening\n* Vaginal bleeding of unknown cause\n* Known thromboembolic events or active thrombophlebitis","FEMALE","18 Years","45 Years",{"count":69,"type":20},198,[71],"PHASE4","This clinical study examines whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. Tirzepatide is already approved for the treatment of diabetes and obesity, but its effects on ovarian dysfunction in PCOS are not yet known. Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner.\n\nThe goal of the study is to demonstrate that tirzepatide, at the maximum tolerated dose, is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS.\n\nAll participants will have a screening visit, followed by 72 weeks of treatment. Treatment includes a 20-week dose-escalation period and a 52-week maintenance period. Lower doses may be used if side effects occur, and the highest tolerated dose will be continued through the maintenance phase. A 4-week safety follow-up will take place after treatment, and long-term follow-up will continue for one year. The study will take place at five clinical trial sites in Germany.",[74,75],"Polycystic Ovary Syndrome (PCOS)","Obesity & Overweight",[77,78,79,80,81],"pcos","tirzepatide","obesity","reproductive health","polycystic ovary syndrome","RECRUITING","2025-12-23",{"date":85,"type":31},"2026-01-08",{"date":87,"type":31},"2025-12-09",{"date":89,"type":20},"2029-12",{"name":37,"class":38},2,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":17,"minAge":66,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":119,"locationsCount":120},"100608172","tvns-motivation-and-insulin-sensitivity-100608172","NCT07198100","tVNS, Motivation, and Insulin Sensitivity","Acute Effects of Non-invasive Vagus Nerve Stimulation on Motivation and Its Dependency on Insulin Sensitivity in Patients With Depression and Controls","Inclusion criteria:\n\n* Participants with depression (DSM-5 diagnosis) or participants without depression (no DSM-5 diagnosis, lifetime)\n* BMI between 18.5 and 40 kg\u002Fm²\n* Age between 18 and 60 years\n* Legally valid informed consent\n\nExclusion criteria:\n\nThe following diagnoses in medical history:\n\n* Brain injury\n* Schizophrenia\n* Bipolar disorder\n* Severe substance use disorder\n* Coronary heart disease\n* Stroke\n* Epilepsy\n* Chronic inflammatory diseases (e.g., rheumatoid arthritis, Crohn's disease, etc.)\n* Type I diabetes\n\nThe following diagnoses within 12 months prior to the experiment:\n\n* Obsessive-compulsive disorder\n* Somatic symptom disorder\n* Eating disorder\n\nThe following diagnoses in medical history for control participants:\n\n* Depression\n* Anxiety disorders (except specific phobias)\n\nGenerally:\n\n* Contraindications for MRI (e.g., metal implants, claustrophobia) or taVNS (e.g., piercings, sore or diseased skin on the outer right ear)\n* Pregnant and breastfeeding women will not be included\n* Unclear capacity to consent\n* Stomach surgeries affecting body weight (e.g., bypass surgeries)",true,"60 Years",{"count":102,"type":20},120,[23],"Disturbances in energy metabolism significantly increase the risk of developing major depressive disorder (MDD), especially in individuals with type 2 diabetes. Insulin sensitivity may particularly impair reward anticipation and motivational processes, contributing to anhedonia, a core symptom of depression. Preclinical and clinical studies highlight the vagus nerve as a critical pathway mediating metabolic signals between the body and the brain, influencing motivational and affective states.\n\nThe present study aims to evaluate whether acute transcutaneous auricular vagus nerve stimulation (taVNS) improves motivation and mood and whether individual differences in insulin sensitivity modulate these improvements.\n\nThe investigators plan to recruit 60 patients with MDD and 60 control participants matched for age, sex, and body mass index (BMI), covering a wide BMI range (up to 40 kg\u002Fm²) and insulin sensitivity (including patients with type 2 diabetes). Participants will undergo comprehensive metabolic assessments, behavioral testing of reward anticipation, motivation, consummation, and learning, and ecological momentary assessments (EMA) coupled with continuous glucose monitoring to assess real-world motivational behavior and glucose dynamics. Furthermore, participants will undergo two neuroimaging sessions, involving both task-free and task-based functional MRI, during concurrent taVNS or sham stimulation, implemented in a randomized, single-blinded, crossover design.\n\nThis study hypothesizes that individuals with lower insulin sensitivity, particularly those with MDD and pronounced anhedonic symptoms, will show greater motivational and neural responsiveness to taVNS.\n\nH1A. Individuals with depression (vs. controls) and higher anhedonia show greater deficits in reward-related behavior and lower insulin sensitivity.\n\nH1B. Across all participants, reduced reward-related behavior and higher anhedonia are associated with lower insulin sensitivity.\n\nH2A. tVNS (vs. sham) increases motivation for rewards, brain responses to rewards, and body-brain interactions across participants.\n\nH2B. These tVNS-induced effects are particularly pronounced in individuals with depression and stronger anhedonia who show reductions in these domains.\n\nH3A. Greater tVNS-induced effects (behavioral, neural, body-brain) are associated with lower insulin sensitivity.",[106],"Major Depressive Disorder (MDD)",[108,109,110,111,112],"tVNS","motivation","insulin-sensitivity","depression","diabetes","2025-12-17",{"date":115,"type":31},"2025-12-24",{"date":117,"type":31},"2025-10-10",{"date":55,"type":20},{"name":37,"class":38},1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":99,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":120},"100604475","clinical-assessment-for-rheumatologic-disease---research-and-advancement-in-safety-and-efficacy-100604475","NCT07150000","Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy","CARe RAiSE","Inclusion Criteria:\n\n* Participants aged ≥ 18 years\n* Signed written informed consent to participate voluntarily in the study.\n* Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:\n* Rheumatoid arthritis (RA)\n* Psoriatic arthritis (PsA)\n* Axial spondyloarthritis (axSpA)\n* Giant cell arteritis (GCA)\n* Connective tissue diseases, including:\n\n  1. Systemic lupus erythematosus (SLE)\n  2. Systemic sclerosis (SSc)\n  3. Mixed connective tissue disease (MCTD)\n  4. Idiopathic inflammatory myopathies (IIM)\n* ANCA-associated vasculitides (AAV), including:\n\n  1. Microscopic polyangiitis (MPA)\n  2. Granulomatosis with polyangiitis (GPA)\n  3. Eosinophilic granulomatosis with polyangiitis (EGPA)\n* Autoinflammatory diseases, including\n\n  1. Familial Mediterranean fever (FMF)\n  2. Cryopyrin-associated periodic syndromes (CAPS)\n  3. TNF receptor-associated periodic syndrome (TRAPS)\n  4. Adult-onset Still's disease (AOSD)\n\n     Exclusion Criteria:\n* Refusal to participate in the study or inability to provide informed consent.\n\nInclusion Criteria - Healthy Control Group:\n\n* Participants aged ≥ 18 years (capable of providing informed consent).\n* Signed written informed consent to participate voluntarily in the study.\n\nExclusion Criteria - Healthy Control Group:\n\n\\- Presence of a known or active rheumatologic disease.",{"count":102,"type":20},"OBSERVATIONAL","The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.\n\nDespite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.\n\nThe assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.\n\nThrough this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.",[133,134,135,136,137,138,139,140,141,142,143,144,145],"Rheumatic Diseases","Rheumatoid Arthritis (RA)","Giant Cell Arteritis (GCA)","Psoriatic Arthritis (PsA)","Axial Spondylarthritis (axSpA)","Polymyalgia Rheumatica (PMR)","ANCA Associated Vasculitis (AAV)","Connective Tissue Disease (CTD)","Systemic Sclerosis (SSc)","Systemic Lupus Erthematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Autoinflammatory Disease","Gout Arthritis","2025-08-24",{"date":148,"type":31},"2025-09-02",{"date":150,"type":31},"2025-04-01",{"date":152,"type":20},"2028-12",{"name":37,"class":38},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":120},"100564753","fast-and-accurate-breast-cancer-diagnosis-using-nanopore-sequencing-in-tanzania-fast-abcd-sequencing-100564753","NCT06633276","Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)","Nanopore Sequencing for Accelerating Breast Cancer Diagnosis in Tanzania: A Prospective Observational Study","Inclusion Criteria:\n\n* Patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection after specialist consultation as per institutional guidelines\n* Excess fresh tumor sample\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patients who have already commenced therapy for BC (except for treatment other than biomedicine, e.g. herbal medicines)",{"count":162,"type":20},100,"This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania. It aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. By enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.",[165],"Breast Cancer Invasive",[167,168],"Nanopore sequencing","breast cancer","2025-05-08",{"date":171,"type":31},"2025-05-14",{"date":173,"type":20},"2025-05",{"date":175,"type":20},"2026-05",{"name":37,"class":38},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":99,"sex":185,"minAge":186,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":189,"conditions":190,"keywords":199,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":120},"100569575","aylo---autoimmunity-and-loss-of-y-100569575","NCT06696027","AYLo - AutoimmunitY and Loss of y","Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases","AYLo","Inclusion Criteria:\n\n* Male\n* \\> 50 years\n* Diagnosis of arthritis (RA, PsA), collagen diseases (SLE, systemic sclerosis, Sjögren's syndrome, mixed connective tissue diseases), vasculitis (eGPA, GPA, MPA, IgG4-related disease, GCA, PMR), sarcoidosis, COPD, ILD or asthma bronchiale confirmed by the treating physician.\n\nExclusion Criteria:\n\n* Female\n* \\\u003C 50 years\n\nInclusion Criteria (Healthy controls):\n\n* Male\n* \\> 50 years\n\nExclusion Criteria (Healthy controls):\n\n* Female\n* \\\u003C 50 years\n* autoimmune, rheumatological diease\n* pulmonary precondition","MALE","50 Years",{"count":188,"type":20},500,"The AYLo study (AutoimmunitY and Loss of y - Investigating the Role of Hematopoietic Mutations and Mosaic Mutation in the Y Chromosome in Autoimmune Rheumatologic Diseases) aims to systematically investigate hematopoietic mutations, such as hematopoietic (mosaic) loss of the Y chromosome (mLOY), focusing on their underlying causes, pathophysiological significance, patterns of manifestation, and impact on disease progression in autoimmune, rheumatologic disorders. This research seeks to bridge existing knowledge gaps by exploring how such mutations influence immune homeostasis, cellular function, and susceptibility to inflammation-driven pathologies.\n\nThrough the integration of advanced immunological profiling, the study aspires to uncover key mechanisms that drive the initiation, progression, and complications of autoimmune rheumatic diseases. These analyses will combine single nucleotide polymorphisms (SNP) arrays, multiplex assays, transcriptomics, and flow cytometry staining of peripheral blood mononuclear cells to delineate the interplay between hematopoietic mutations and immune dysregulation.\n\nA further objective is the development of a multimodal framework for disease-specific characterization, enabling precise mapping of mutation-driven phenotypes across diverse autoimmune conditions. This framework will incorporate clinical, molecular, and imaging data.\n\nAdditionally, the AYLo study aims to explore the potential role of mLOY and other hematopoietic mutations as biomarkers for disease stratification, prognosis, and therapeutic response. The findings may open avenues for personalized treatment approaches, leveraging the molecular insights to inform targeted interventions and improve patient outcomes in autoimmune rheumatic disorders.\n\nBy integrating translational and basic science approaches, this study has the potential to redefine current paradigms in autoimmune disease research and therapy.",[135,138,139,191,192,134,136,193,194,195,196,197,198],"Idiopathic Inflammatory Myopathies","IgG4-Related Diseases","Connective Tissue Disease","Sarcoidosis","Interstitial Lung Disease Due to Systemic Disease (Disorder)","Interstitial Lung Disease (ILD)","Asthma Bronchiale","COPD",[200,201,202,203,204,205,191,192,206,207,193,194,208],"Autoimmune Diseases","Vasculitis","Large Vessel Vasculitis","Giant Cell Arteritis","Polymyalgia Rheumatica","ANCA Associated Vasculitis","Rheumatoid Arthritis","Psoriatic Arthritis","Interstitial Lung Disease","2025-04-07",{"date":211,"type":31},"2025-04-10",{"date":213,"type":31},"2024-11-15",{"date":215,"type":20},"2026-07",{"name":37,"class":38},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":99,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":120},"100551442","assessing-biomarker-in-giant-cell-arteritis-and-polymyalgia-rheumatic-100551442","NCT06460142","Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic","Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica: A Comprehensive Analysis of Clinical, Laboratory, and Imaging Profiles","GCAIO","Inclusion Criteria:\n\n* Informed Consent: Participants (\\>18 years) must provide written informed consent to voluntarily participate in the study.\n* Confirmed Diagnosis: Diagnosis of GCA or PMR confirmed by the treating physician and fulfilling expanded ACR-EULAR classification criteria. Patients must have been either newly diagnosed within the last three days or have experienced a disease flare within the same timeframe.\n\nExclusion Criteria:\n\n* Severe Renal Insufficiency: Chronic glomerular filtration rate (GFR) less than 30 mL\u002Fmin.\n* Other Medical Conditions Requiring Glucocorticoids: Presence of medical conditions other than GCA or PMR that necessitate continuous or intermittent treatment with oral or parenteral glucocorticoids.\n* Other Inflammatory Rheumatic Diseases: Patients with other inflammatory rheumatic diseases.",{"count":162,"type":20},"The GCAIO study is an innovative, multimodal research initiative designed to enhance the understanding, diagnosis, and management of giant cell arteritis (GCA) and frequently associated polymyalgia rheumatica (PMR). This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed immunological profiling.\n\nThe study focuses on three primary objectives: (1) Identifying and analyzing cytokine profiles and immune cell phenotypes, employing techniques like flow cytometry, enzyme-linked immunosorbent assays (ELISA), and next-generation sequencing to predict disease activity and therapeutic responses. (2) Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies, including MRI, optical coherence tomography angiography (OCTA), and ultrasound. These modalities aim to improve the detection of neuro-ophthalmological, cardiac, and aortic complications in GCA, potentially offering more precise monitoring and earlier diagnosis. (3) Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies, thus improving patient outcomes.",[203,204],[203,204,201,229,230,231,232,233,234,235,236,237,238,239,240,241,242],"Inflammatory Disorders","Clinical Biomarkers","Predictive Biomarkers","Disease Activity Monitoring","Therapeutic Response","Diagnostic Imaging Techniques","Aortic Imaging","Magnetic Resonance Imaging (MRI)","Vascular Ultrasound","Optical Coherence Tomography Angiography (OCT-A)","Transcriptome Analysis","Vascular-adhesion protein 1","Positron emission tomography-computed tomography (PET\u002FCT)","Siglec-9",{"date":211,"type":31},{"date":245,"type":31},"2023-09-01",{"date":247,"type":20},"2027-09-30",{"name":37,"class":38},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":257,"targetDuration":259,"studyType":130,"phases":4,"briefSummary":260,"conditions":261,"keywords":269,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":120},"100578173","a-longitudinal-observational-study-to-evaluate-the-efficacy-of-movement-and-implement-concrete-movement-recommendations-with-the-help-of-mobility-tracking-with-smartwatches-in-subjects-with-axial-spondyloarthritis-100578173","NCT06807853","A LONGITUDINAL OBSERVATIONAL STUDY to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS with the HELP of MOBILITY TRACKING with SMARTWATCHES in SUBJECTS with AXIAL SPONDYLOARTHRITIS","SYMPTOM-ACCESSMENT in SUBJECTS with AXIAL SPONDYLOARTHRITIS with PATIENT-REPORTED OUTCOMES and MOBILITY TRACKING with SMARTWATCHES VIA SPECIALLY PROGRAMMED STUDY-APP to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS","SPARTAKUS","Inclusion Criteria:\n\n* Patients with Axial Spondyloarthritis\n* Patients do must have an own iPhone due to software reasons\n* do must be willing and able to wear a Smartwatch\n* do must be able to regularly fill out the PROs at home\n\nExclusion Criteria:\n\n* no iphone\n* no physical or mental Ability to wear a Smartwatch\n* no physical or mental Ability to regularly fill out the PROs at home",{"count":258,"type":20},50,"6 Months","Axial spondyloarthritis (axSpa) is a chronic inflammatoric autoimmune disease of the back with a prevalence around 1,4% (1) . In patients decreased function and decreased quality of life as well as chronic pain are strong burdens . Despite modern treatments like biological agents just 25% of the patients are at remission (2) . Besides the pharmacological treatment physical activity is known to be very important to gain disease control. A low physical activity is related to a higher disease activity and a high physical activity to better disease control. Until now there is no structured capture of the daily movements of patients with axial spondylarthritis in clinical practice. Our goal is to analyse the relationship between movement and disease activity and to implement concrete recommendations for movement in patients with axSpa.\n\nThe primary objective of the study is to investigate which type, frequency and intensity of movement are helpful in gaining and remaining disease control in patients with axSpa.\n\nMethods This monocentric longitudinal study recordes movement, sport and physical parameters like heart frequency and heart rate variability through an observational period of 6 month via smartwatch. Meanwhile we record disease activity, pain and functional outcomes with regular surveys every two weeks. Patients in every phase of disease are eligible for inclusion, but they do must have an own iPhone due to software reasons. Data is collected in a specially programmed study-app. Fifty participants will be included in this study. Until now we have 24 patients included since april 2024. Patients come to clinic every 3 month as this is our standard in outclinic patients. We than do anamnesis and a physical examination. After the study period of 6 month we transmit the mobility and disease-related data of the surveys of the patients mobile device to our system.\n\nThe primary endpoint is to find exact recommendations for concrete movement in patients with axSpa.\n\nSo this is the first study that wants to give concrete recommendations for movement in patients with axSpa with the help of mobility tracking with smartwatches. This could help to prevent flares and also to recover quicker from a flare.\n\n1. López-Medina und Moltó, \"Update on the epidemiology, risk factors, and disease outcomes of axial spondyloarthritis\".\n2. Pina Vegas u. a., \"Factors associated with remission at 5-year follow-up in recent-onset axial spondyloarthritis: results from the DESIR cohort\".",[262,263,264,265,266,267,268],"Axial Spondyloarthritis","Axial Spondyloarthritis (AxSpA)","Axial Spondylarthritis (r-axSpA)","Axial Spondyloarthopathy","Axial Spondyloarthritis and Ankylosing Spondylitis","Axial Spondyloarthritis, Non-Radiographic","Axial and Peripheral Spondyloarthritis",[270,271,272,273,274,275,276],"Mobility Tracking","Patient-Reported Outcomes (PROs)","Disease Activity","Smartwatch","Study-App","Mobile Device","Movement Recommedations","2025-02-13",{"date":279,"type":31},"2025-02-18",{"date":281,"type":31},"2024-04-01",{"date":283,"type":20},"2025-11",{"name":37,"class":38},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":120},"100560218","characteristics-of-hypophosphatasia-in-adult-patients-in-rheumatology-and-their-value-in-developing-an-algorithm-to-hpp-diagnosis---the-cohir-multi-center-study-100560218","NCT06574282","Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study","The COHIR Multi-center Study - a Non-interventional, Prospective, Multi-center Investigation With Exploratory Data Analysis to Assess the Proportion of Patients With Hypophosphatasia Presenting at the Department of Rheumatology and Establishment of an Algorithm to HPP Diagnosis.","COHIRnational","Inclusion Criteria:\n\n* Written informed consent\n* Age \\> 18 years\n* Clinical suspicion of hypophosphatasia\n* Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening\n\nExclusion Criteria:\n\n* Failure to meet the inclusion criteria listed above",{"count":294,"type":20},720,"Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis",[297],"Hypophosphatasia",[297,299,300,301,302,303,304,305,306,307,308,309,310,311,312],"Hypophosphatasemia","Musculoskeletal complaints","Genetic disorder","Rare disease","Alkaline phosphatase gene","ALP","ALPL gene","Rheumatology","COHIR study","COHIR multi-center study","COHIRnational study","Prevalence","Diagnostic Algorithm","Metabolic bone diseases","2025-02-05",{"date":315,"type":31},"2025-02-10",{"date":317,"type":31},"2024-08-25",{"date":319,"type":20},"2027-09",{"name":37,"class":38},{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":17,"minAge":186,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":21,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":120},"100569954","effects-of-a-legume-rich-diet-in-the-context-of-the-planetary-health-diet-compared-to-a-western-oriented-dietary-pattern-in-participants-with-increased-cardiometabolic-risk-100569954","NCT06700954","Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Participants with Increased Cardiometabolic Risk","Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases","LeguPlan_2","Inclusion Criteria:\n\n* written informed consent\n* Non-smoking\n* BMI: 27 - 34,9 kg\u002Fm2\n* Waist circumference (women ≥ 80 cm, men ≥ 94 cm)\n* Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg\n* At least one of the following criteria:\n* Fasting triglycerides in serum: ≥ 150 mg\u002FdL\n* Fasting LDL cholesterol in serum ≥160 mg\u002FdL\n* Fasting HDL-Cholesterol in serum: women \\\u003C 50 mg\u002Fdl, men \\\u003C 40 mg\u002FdL\n* Fasting glucose in plasma: ≥ 100 mg\u002FdL\n* CRP in serum 0,2-3 mg\u002FdL\n\nExclusion Criteria:\n\n* food intolerances and allergies (especially legumes)\n* Smoking\n* malabsorption syndromes\n* thyroid diseases\n* impaired renal function\n* chronic liver disease\n* heart failure\n* myocardial infarction\n* insulin-dependent diabetes mellitus\n* chronic inflammatory diseases\n* tumors\n* anemia\n* immunosuppression\n* intake of supplements (e.g., fish oil)\n* Participation in another study\n* other exclusion criteria at the discretion of the physician\u002F investigator","75 Years",{"count":162,"type":20},[23],"The aim of the study is to systematically investigate the effects of a diet enriched with legumes in a dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires.",[334],"Cardiovascular Diseases","2024-11-19",{"date":337,"type":31},"2024-11-22",{"date":339,"type":20},"2025-01-06",{"date":341,"type":20},"2025-12-31",{"name":37,"class":38},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":99,"sex":17,"minAge":66,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":120},"100554143","bioavailability-of-human-milk-oligosaccharides-in-healthy-adults-100554143","NCT06495255","Bioavailability of Human Milk Oligosaccharides in Healthy Adults","Inclusion Criteria:\n\n* Age: 18-40 Years\n* Non-smoker\n* Normal weight (BMI 18.5-25.0 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Impaired insulin sensitivity\u002Fglucose tolerance\n* Underweight or overweight\u002Fobesity\n* Regular intake of nutritional supplements\n* Alcohol, drug or medication abuse\n* Pregnancy and breastfeeding\n* Hypo- and hypertension\n* Epilepsy\n* known hepatitis B, hepatitis C, HIV infection\n* Malabsorption and maldigestion syndrome\n* Type 1 or type 2 diabetes mellitus\n* Other metabolic diseases\n* Chronic inflammatory diseases\n* Other chronic diseases\n* Psychiatric illnesses\n* Participation in another study","40 Years",{"count":351,"type":20},10,[23],"Human milk oligosaccharides (HMOs) have been associated with beneficial health outcomes in breastfed infants, therefore they were investigated intensively within recent years. HMOs support the establishment of a \"balanced\" intestinal microbiome by acting as both a prebiotic and as a specific antimicrobial. In vitro work has demonstrated that HMOs are resistant to hydrolysis by salivary, pancreatic, and brush-border enzymes, as well as to low gastric pH values enzymes. Consequently, HMOs are mostly resistant to digestion and reach the colon unmodified, where they are available for selective utilisation by certain bacteria. Microbial utilisation results in the formation of microbial metabolites, which are associated with local and systemic effects. Simultaneously, HMOs have bacteriostatic effects and directly limit the growth of potential pathogens. Moreover, they serve as antiadhesives, mimicking intestinal epithelial cell surface receptors to which pathogenic microbes attach, thus acting as a decoy receptor. Additionally, it is suggested that HMOs exert effects independent of the microbiome, by modulating cell recognition and cell signalling. These include interactions with immune cells, thereby modulating the development and responses of the immune system, the maturation of the intestinal glycocalyx, and the promotion of neurodevelopment and cognitive functions. A prerequisite for systemic effects is that HMOs are absorbed and can enter the blood circulation, thus making them potentially available at the systemic level. In order to understand the underlying mechanisms for HMO-mediated, microbe-independent effects, information regarding absorption, metabolisation, and excretion is needed and will be investigated in this study.",[355],"Healthy",[357,358,359],"absorption","excretion","metabolic markers","2024-07-02",{"date":362,"type":31},"2024-07-10",{"date":364,"type":31},"2024-05-14",{"date":366,"type":20},"2026-03-31",{"name":37,"class":38},{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":99,"sex":17,"minAge":66,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":91},"100537533","investigation-of-the-influence-of-the-human-microbiome-on-giant-cell-arteritis-100537533","NCT06279065","Investigation of the Influence of the Human Microbiome on Giant Cell Arteritis","Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis","GCA-Biom","Inclusion Criteria:\n\n• Diagnosis of Giant cell arteritis (only in one arm)\n\nExclusion Criteria:\n\n* chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B\u002FC\n* acute infection with usage of antibiotics less then 90 days before screening\n* major gastro-intestinal surgery \\\u003C5 years from screening\n* gastro-intestinal bleeding \\\u003C90 days before screening\n* inflammatory bowel disease (confirmed bioptically)\n* bulimia or anorexia nervosa\n* adipositas (body mass index ≥ 40)\n* intake of high dosage of probiotics (\\>10\\^9 colony forming units per day) \\\u003C90 days before screening\n* not controlled Diabetes mellitus\n* Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)\n* known abuse of alcohol oder drugs.",{"count":258,"type":20},"The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.",[203],[380],"microbiome","2024-05-07",{"date":383,"type":31},"2024-05-09",{"date":385,"type":31},"2024-02-29",{"date":387,"type":20},"2028-02",{"name":37,"class":38},""]