[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital Schleswig-Holstein\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":616},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,41,67,96,125,153,177,203,231,252,275,297,326,355,378,403,429,460,480,508,532,559,586],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641576","phase-4-efficacy-of-top-down-therapy-with-mirikizumab-versus-standard-of-care-with-azathioprine-in-patients-with-newly-diagnosed-moderate-to-severe-crohns-disease-100641576",false,"NCT07659353","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed, Moderate-to-severe Crohn's Disease: A 52-week, Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Given written informed consent prior to any study-specific procedures.\n2. Willing and able to complete the scheduled study assessments, including ileocolonoscopy and daily Diary entry.\n3. Willing to comply with contraception requirements (as specified in Section 7.7 Contraception requirements).\n4. Age 18-75 years.\n5. Naïve to thiopurines (azathioprine or 6-mercaptopurine) and methotrexate.\n6. Naïve to advanced therapies (targeted biologic or small-molecule therapies) for Crohn's disease or any other disease.\n7. Early disease: Crohn's disease diagnosed per DGVS\u002FECCO criteria ≤12 months and ≥4 weeks before Week 0 (randomization).\n8. Prior 5-aminosalicylate (5-ASA) and\u002For oral glucocorticoid therapy with inadequate response, loss of response, or intolerance to the agent(s) received.\n9. If receiving systemic GC at screening start: cumulative systemic GC exposure prior to screening start should be ≤8 weeks, and prednisolone ≤20 mg\u002Fday (or equivalent) should be stable for ≥2 weeks before screening colonoscopy.\n10. Oral budesonide must be discontinued ≥2 weeks before screening colonoscopy. A switch to prednisolone is permitted. Oral mesalamine must be discontinued ≥2 weeks before screening colonoscopy.\n11. Evidence of active Crohn's disease at enrollment, defined as all of the following:\n\n    1. CDAI 220-500 at screening and Week 0; and\n    2. CRP \\> ULN and\u002For fecal calprotectin \\>250 μg\u002Fg measured during screening (Week -8 to Week 0); and\n    3. Endoscopic activity on screening ileocolonoscopy (Week -8 to Week 0)\n12. No actively draining fistula at screening and baseline.\n13. No prior CD-related surgery\n\nExclusion Criteria:\n\n1. Acute severe\u002Ffulminant Crohn's disease requiring immediate inpatient management or urgent surgery at screening (e.g., obstructive complication with imminent surgery, perforation, draining fistula, uncontrolled sepsis\u002Fabscess, toxic megacolon).\n2. Oral and rectal 5-ASA or rectal steroids treatment within 2 weeks prior to screening colonoscopy.\n3. History of malignancy, except for non-melanoma skin cancer that has been successfully treated and considered cured at screening.\n4. Planned or foreseeable surgery at or before randomization (Week 0).\n5. Known thiopurine methyltransferase deficiency or known inherited mutated nudix hydrolase 15 (NUDT15) gene.\n6. Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n7. Diagnosis inconsistent with Crohn's disease, including ulcerative colitis, indeterminate colitis, microscopic colitis, or other non-CD inflammatory enteropathies.\n8. Clinically important active infection, including but not limited to hepatitis B, hepatitis C, HIV\u002FAIDS, or active tuberculosis (TB).\n9. Detectable hepatitis B virus (HBV) DNA or hepatitis C virus (HCV) RNA at screening.\n10. Latent TB.\n11. Planned receipt of live or live-attenuated vaccines (including Bacillus Calmette-Guerin, BCG) during screening or the study.\n12. Systemic mycoses or parasitosis.\n13. Unstable or uncontrolled illness that could increase risk or confound efficacy assessment, including but not limited to cerebro-cardiovascular, respiratory, gastrointestinal (other than CD), hepatic, renal, endocrine, hematologic, neurological disorders, or active malignancy.\n14. Known systemic hypersensitivity to any study drug or any excipient, or prior acute systemic hypersensitivity to monoclonal antibodies that, in the investigator's judgment, precludes mirikizumab therapy.\n15. Women who are pregnant, lactating or planning pregnancy\n16. Employee of Lilly or any of the organizations involved with this study or study site personnel directly affiliated with this study and\u002For their immediate families.\n17. Participation in another interventional clinical trial involving an investigational product or nonapproved use of a drug within the 12 weeks before screening, or concurrent enrollment in any other clinical study or any other type of medical research judged not to be scientifically or medically compatible with this trial.\n18. Unwilling or unable to comply with eDiary\u002Fdata-capture requirements or other study procedures for the duration of the study.\n19. Committed to an institution by judicial or administrative order.","ALL","18 Years","75 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The choice of drug therapy for Crohn's disease depends on several factors, such as the severity of the condition, the sections of the bowel affected, or the patient's previous treatment history. Conventional therapy consists of a short course of corticosteroid treatment followed by azathioprine therapy. Alternatively, there are so-called advanced therapies using biologics (biotechnologically produced protein substances such as antibodies), for example mirikizumab. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the standard therapy of azathioprine in combination with corticosteroids. Following an inclusion phase, patients will be randomly assigned to either treatment with mirikizumab or azathioprine + corticosteroids. Patients in the azathioprine arm may switch to mirikizumab therapy at three time points from week 24 onwards if they do not respond adequately to azathioprine therapy. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 13 doses of mirikizumab. This includes initially 900 mg intravenously every 4 weeks followed by 300 mg subcutaneously. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.",[27],"Chrohn's Disease","NOT_YET_RECRUITING","2026-06-15",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":21},"2026-08-01",{"date":36,"type":21},"2029-03-31",{"name":38,"class":39},"University Hospital Schleswig-Holstein","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100553633","phase-2-efficacy-and-safety-of-oral-controlled-ileocolonic-release-nicotinamide-cicr-nam-in-patients-with-mild-to-moderately-active-ulcerative-colitis-100553633","NCT06488625","Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) in Patients With Mild to Moderately Active Ulcerative Colitis","A Phase II\u002FIII, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-Ileocolonic-Release Nicotinamide (CICR-NAM) for Induction and Maintenance Therapy in Patients With Mild to Moderately Active Ulcerative Colitis","Inclusion Criteria:\n\nGeneral:\n\n1. Male and female patients with UC and 18 to 80 years of age (at the time of signing the informed consent).\n2. Ability to understand and comply with the protocol.\n3. Signed written informed consent.\n\n   Disease-specific:\n4. Documented diagnosis of UC, with a minimum disease duration of 3 months prior to screening and ≥ 1 relapse, clinically defined using established criteria within the last 12 months.\n5. Histology supportive for the diagnosis of UC.\n6. Mild to moderate disease activity (at screening): modified Mayo score (mMS) 4-7 RB ≥ 1, endoscopic score ES ≥1 and SF ≥ 1.\n7. RHI \\> 4 (at screening endoscopy).\n8. Disease extent \\>15 cm from the anal verge (at screening endoscopy).\n9. Elevated level(s) of C-reactive protein (CRP) and\u002For faecal calprotectin during the screening period (levels above the reference range, measured by local laboratories).\n10. Full colonoscopy with no signs of malignancy either during screening or within one year before screening.\n\n    Medication:\n11. In the case of no oral 5-ASA therapy within the last 2 weeks before entry into screening with informed consent, any prior oral 5-ASA therapy is permitted and the patient is not allowed to receive 5-ASA during the study. In the case of oral 5-ASA therapy within 2 weeks before entry into screening with informed consent, the 5-ASA therapy should have been ongoing for \\> 3 months, should not be increased ≥ 4 weeks before screening endoscopy and should remain stable for ≥ 1 week before screening endoscopy at the maximum dose according to label or lower. This 5-ASA baseline medication must be kept stable in the induction period and may be reduced (but not increased again) in the maintenance period. In cases in which 5-ASA is dosed higher than the approved dose, the dose will be adjusted to the maximum approved dose at the time of randomization.\n\nExclusion Criteria:\n\nGeneral health and UC:\n\n1. Diagnosis of CD, microscopic colitis, ischaemic colitis, radiation colitis or indeterminate colitis.\n2. Infectious colitis, diverticulitis or segmental colitis associated with diverticulosis (SCAD) within the last 6 months before screening.\n3. Current or past diagnosis of complex fistulae, intra-abdominal or peritoneal abscesses, strictures with obstructive symptoms.\n4. Severe UC disease activity (modified Mayo score \\>7).\n5. Severe extraintestinal manifestations of UC requiring special treatment.\n6. Steroid-dependent or steroid-refractory UC.\n7. Foreseeable need for hospitalisation.\n8. Previous colonic surgery, except for appendectomy.\n9. Stools positive for enteric pathogens; Clostridium difficile toxin (CDT)-positive infection; indications for other relevant infections including cytomegalovirus colitis, each at screening.\n10. Current or history of colon carcinoma, high grade colonic dysplasia or other malignancies except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin.\n11. Moderate to severe anaemia (haemoglobin \\\u003C9 g\u002FdL) at screening.\n12. Moderate to severe renal impairment (glomerular filtration rate \\\u003C60) at screening.\n13. Relevant bleeding or thrombotic disorders.\n14. Alcohol or drug abuse within the last 2 years.\n\n    Medications:\n15. Rectal topical 5-ASA and\u002For rectal budesonide therapy (enemas, foams or suppositories) ≤ 2 weeks prior to screening endoscopy (up to 3 single doses allowed).\n16. Use of oral corticosteroids and\u002For oral budesonide ≤ 4 weeks prior to screening endoscopy.\n17. Previous use of immunosuppressants, Janus kinase inhibitors, sphingoside-1-phosphate receptor modulators or biologics.\n18. Use of antibiotics for the treatment of UC or probiotic medication within 6 weeks prior to screening endoscopy.\n19. Any need of parenteral therapies for the therapy of UC (except iron infusions).\n20. Known hypersensitivity towards any component of the CICR-NAM or placebo tablets.\n\n    Regulatory requirements\n21. Participation in a clinical trial within 4 weeks prior to screening for this trial or intake of an investigational medicinal product (IMP) within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer if necessary in the investigator's discretion).\n22. Patients under legal supervision or guardianship, including patients, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n23. Patients who are dependent on the investigator or the sponsor.\n\n    Other:\n24. Pregnant or breastfeeding women.\n25. Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP.\n26. Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP.\n27. Indications that the patient may be unable to comply with the trial procedures, e.g. language barriers precluding adequate understanding or cooperation.\n28. Any circumstances or medical conditions which could contradict a trial participation and lead the investigator to assess the patient as unsuitable for trial participation for any other reason.","80 Years",{"count":50,"type":21},459,[52,53],"PHASE2","PHASE3","Double-blind, randomised, placebo-controlled phase II \u002F III trial evaluating efficacy and safety of two different doses (2 g\u002Fd or 3 g\u002Fd) of oral controlled-ileocolonic-release nicotinamide (CICR-NAM) compared to placebo in patients with ulcerative colitis (UC).\n\nThe intended therapeutic use of CICR-NAM is to improve intestinal inflammation in adults with UC by topically increasing nicotinamide supply in the ileocolonic region and thus favourably influencing the composition of intestinal microbiota",[56],"Ulcerative Colitis, Unspecified","RECRUITING","2026-06-08",{"date":60,"type":32},"2026-06-11",{"date":62,"type":32},"2024-09-12",{"date":64,"type":21},"2027-12",{"name":38,"class":39},26,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100637984","impact-of-a-reminder-app-on-physical-activity-during-radiation-therapy-for-lung-cancer-100637984","NCT07627022","Impact of a Reminder App on Physical Activity During Radiation Therapy for Lung Cancer","APPAREL","Inclusion Criteria:\n\n1. Histologically proven lung cancer\n2. Treatment with ≥50 Gy of conventionally fractionated radiation therapy\n3. Possession of and ability to use a smart phone plus a step counter\n4. Age ≥18 years\n5. Written informed consent\n6. Capacity of the patient to consent\n\nExclusion Criteria:\n\n1\\. Expected non-compliance",{"count":75,"type":21},32,[77],"NA","The primary objective of this prospective randomized trial is to explore whether the use of a smart phone-based reminder application is associated with a change in physical activity during radiation therapy in patients with lung cancer. The primary endpoint focuses on the within-patient change in physical activity between Week 1 and Week 5, with comparison between treatment groups to assess potential differences attributable to the intervention.\n\nSecondary objectives include the exploratory assessment of patient satisfaction with the reminder app, its impact on the use and perception of digital health technology.\n\nA total of 28 evaluable patients in the Full Analysis Set (approximately 14 per treatment arm) are required to detect a clinically relevant difference corresponding to a probability of superiority of approximately 0.65 with 80% power at a two-sided significance level of 0.05. Assuming that approximately 10% of patients will not be evaluable for the primary endpoint, a total of 32 patients will be randomized.",[80],"Lung Cancer",[82,83,84,85,86],"Lung cancer","Radiotherapy","Physical activity","Step counts","Reminder app","2026-05-31",{"date":89,"type":32},"2026-06-04",{"date":91,"type":21},"2026-07-01",{"date":93,"type":21},"2027-02-15",{"name":38,"class":39},7,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":104,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":40},"100638721","chemotherapy-induced-peripheral-neuropathy---additional-evaluation-in-breast-cancer-survivors-100638721","NCT07604441","Chemotherapy-Induced Peripheral Neuropathy - Additional Evaluation in Breast Cancer Survivors","Chemotherapy-induced Peripheral Neuropathy - Additional Evaluation of a Self-administered Scoring System for Breast Cancer Survivors","NEURO-BREAC-02","Inclusion Criteria:\n\n1. Histologically proven breast cancer\n2. Previous treatment with taxane-based chemotherapy followed by adjuvant radiotherapy\n3. Mild or no CIPN according to the Total Neuropathy Score\n4. Female gender\n5. Age ≥18 years\n6. Written informed consent\n7. Capacity of the patient to consent\n\nExclusion Criteria:\n\n1. Disease-related skin disorders of the lower extremities (e.g., related to skin infections, bullous dermatoses, dermatitis, papulo-squamous skin disorders, or urticaria\u002Ferythema)\n2. Pregnancy, Lactation\n3. Expected non-compliance","FEMALE",{"count":106,"type":21},28,[77],"The main goal of this trial is to identify the optimal cut-off score of a Scoring System to discriminate between mild chemotherapy-induced peripheral neuropathy (CIPN) and no CIPN in breast cancer survivors previously treated with taxane-based chemotherapy and adjuvant radiotherapy.",[110],"Breast Cancer",[112,113,114,115,116],"Breast cancer","Chemotherapy","Taxanes","Chemotherapy-induced peripheral neuropathy","Scoring system","2026-05-17",{"date":119,"type":32},"2026-05-22",{"date":121,"type":21},"2026-06-01",{"date":123,"type":21},"2026-08-31",{"name":38,"class":39},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100586374","hypofractionated-radiosurgery-for-localised-prostate-cancer-hypostat-iii-100586374","NCT06914544","Hypofractionated Radiosurgery for Localised Prostate Cancer (HYPOSTAT-III)","HYPOSTAT-III","Inclusion Criteria:\n\n* Localised, histopathologically confirmed Prostate Cancer (cT1-T2c N0 M0)\n* Gleason-grade ≤7, ISUP Grade Group 1-3\n* Guideline-based staging\n* Age ≥ 18 years\n* PSA \\\u003C 20 ng\u002Fml\n* Volume of the prostate \\\u003C 80 cm³\n* IPSS-Score ≤ 12\n* Written informed consent\n\nExclusion Criteria:\n\n* History of prior pelvic radiotherapy\n* Previous transurethral resection, laser enucleation or prostate ablation\n* Contraindication to MRI or Fiducial marker implantation (e.g. gold allergy)\n* Relevant comorbidity thought to adversely affect treatment compliance\n* Legal incapacity or lack of informed consent","MALE",{"count":134,"type":21},175,[77],"Hypofractionated radiosurgery with 5 fractions is considered standard of care for localized prostate cancer. The investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 3 fractions in patients with localised prostate cancer under the hypothesis that the ratio of patients with late GU and GI toxicity ≥ grade 2 after 1 year amounts to 8.4% and 1.3% and is significant lower than 16.4% and 5.7% currently.",[138],"Prostate Cancer",[138,140,141,142,143],"SBRT","CyberKnife","Radiosurgery","HYPOSTAT","2026-04-28",{"date":146,"type":32},"2026-04-29",{"date":148,"type":32},"2025-12-10",{"date":150,"type":21},"2029-12-31",{"name":38,"class":39},6,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100614988","phase-2-efficacy-and-safety-of-oral-controlled-release-nicotinic-acid-cir-na-for-the-remission-of-prediabetes-concept-100614988","NCT07286747","Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)","A Phase II, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) for Inducing Remission in Subjects With Prediabetes","CONCEPT","Inclusion Criteria:\n\n1. Male and female participants ≥ 18 to \\\u003C 80 years of age (at the time of signing the informed consent).\n2. Body mass index ≥ 20 kg\u002Fm².\n3. Ability to understand and comply with the protocol.\n4. Signed written informed consent.\n5. Diagnosed prediabetes according to the current EASD\u002FDDG guidelines. Prediabetes is present if at least one value is in the prediabetes range, but no value is in the T2DM range.\n6. Subgroup-specific: MASLD fibrosis score ≥ -1.455.\n\nExclusion Criteria:\n\n1. Presence or a history of type 2 diabetes mellitus according to the current EASD\u002FDDG guidelines.\n2. Participants with relevant medical conditions (based on evaluation of medical history and screening assessments), unstable and uncontrolled underlying diseases, e.g., hypothyroidism, asthma, COPD or arterial hypertension, can be excluded per judgment of the Investigator.\n3. Renal impairment (glomerular filtration rate \\\u003C60 ml\u002Fmin\u002F1.73).\n4. Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase \\[\\> 3-fold compared to normal range\\]).\n5. Current infection with hepatitis B or C.\n6. Clinically relevant abnormal findings in medical history or screening assessments which, in the opinion of the Investigator, may put the participant at risk when participating in the trial or provide difficulties in interpreting the trial data.\n7. Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin.\n8. Alcohol or drug abuse within the last 2 years at the discretion of the Investigator.\n9. Subgroup-specific: Any circumstances which could contradict MRI and MRS imaging. For details, see Informed Consent Form (ICF) for additional examinations.\n10. Regular use of any prescribed or over-the-counter medication, food supplements or herbal preparations, which cannot be terminated 3 weeks before baseline and during the full duration of the trial. Pain medication (e.g., ibuprofen or paracetamol), topical allergy medicines, hormone replacement therapies and oral contraceptives according to label are allowed. Medications in stable doses for controlling stable underlying diseases (see exclusion criterion 2) are also allowed per judgment of the Investigator.\n11. Use of antibiotics (systemic or gut-acting \\[non-absorbed\\]) within 8 weeks prior to the first dose of IMP.\n12. Long term use of higher doses of proton pump inhibitors, targeted H2-receptor antagonists or antacid formulations (i.e., doses equivalent to \\> 40 mg pantoprazole per day).\n13. Known hypersensitivity towards any component of the CIR-NA or placebo tablets.\n14. Participation in a clinical trial (as defined in the clinical trial regulation (CTR)), currently or within 4 weeks prior to screening for this trial or intake of an IMP within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer, if necessary, at the Investigator's discretion).\n15. Participants under legal supervision or guardianship, including participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n16. Participants who are dependent on the Investigator or the Sponsor.\n17. Pregnant or breastfeeding women.\n18. Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP.\n19. Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP.\n20. Any other circumstances or medical conditions which could contradict a trial participation and lead the Investigator to assess the participant as unsuitable for trial participation.","79 Years",{"count":163,"type":21},390,[52],"The goal of this clinical trial is to prevent the change from prediabetes (a pre-stage of type 2 diabetes mellitus (T2DM)) to T2DM in participants with prediabetes using oral CIR-NA (a nicotinic acid formulation that is designed to be released after reaching the ileum) which targeted the gut microbiota. The main questions it aims to answer are:\n\n1. Is CIR-NA effective and does it prevent the change from prediabetes to T2DM?\n2. Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes?\n\nResearchers will compare CIR-NA to a placebo (a look-alike substance that contains no drug) in terms of an extended safety evaluation including safety laboratory assessments, physical examination, vital signs and 12-lead ECG.\n\nParticipants will:\n\nTake CIR-NA or a placebo every day for 26-weeks. Visit the clinic at week 1 and subsequently once every 4 weeks for checkups and tests.\n\nReceive standardized lifestyle recommendations regarding nutrition and physical activity during the intervention.",[167],"Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","2026-03-26",{"date":170,"type":32},"2026-04-01",{"date":172,"type":32},"2026-03-03",{"date":174,"type":21},"2028-12-31",{"name":38,"class":39},2,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":176},"100627143","intervention-with-tralokinumab-in-patients-with-moderate-to-severe-atopic-dermatitis-with-genital-impact-100627143","NCT07444801","Intervention With Tralokinumab in Patients With Moderate-to-severe Atopic Dermatitis With Genital Impact","AD Genital","Inclusion Criteria:\n\n* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give written, signed and dated informed consent before any study related activity is performed.\n* Subjects must be at least 18 years of age at time of enrollment.\n* Subjects starting treatment with tralokinumab and for whom the clinical decision has been made independent of the study according to licensed product specifications and treatment guidelines prior to participation in the study.\n* Subjects diagnosed with moderate-to-severe AD and genital involvement eligible for systemic therapy according to the local label.\n\nExclusion Criteria:\n\n* Exclusion criteria will comply with the licensed specifications for tralokinumab.\n* Subjects incapable of giving full informed consent.\n* Current participation in another study with any investigational products (noninterventional or registries are allowed).\n* Currently pregnant or nursing women will be excluded from this study.\n* Subjects without genital involvement",{"count":185,"type":21},30,"OBSERVATIONAL","Hypothesis: Treatment with tralokinumab in patients with moderate-to-severe AD involving the genital region is expected to lead to significant improvements in PROs and clinical disease severity. These improvements will be assessed using genital-specific scoring systems, validated PRO instruments, and non-invasive imaging techniques, including optical coherence tomography (OCT), confocal microscopy, or line-field optical coherence tomography (LC-OCT). Objectives: To investigate improvements in genital scores and PROs in patients with moderate-to-severe AD involving the genital region during treatment with tralokinumab in routine clinical care. Clinical assessment of genital AD severity will be conducted using genital-specific scoring systems (e.g., Genital-Numerical Rating Scale (g-NRS), Genital-Investigator Global Assessment (g-IGA)), validated PRO instruments (e.g., Patient Oriented Eczema Measure (POEM), Atopic Dermatitis Control Tool (ADCT)), and non-invasive imaging techniques (e.g., confocal microscopy, OCT, LC-OCT)",[189],"Atopic Dermatitis (Moderate-to-severe) Involving the Genital Region",[191,192,193,194,195],"atopic dermatits","Moderate-to-Severe Atopic Dermatitis","Genital Atopic Dermatitis","Tralokinumab","Non-Interventional Study","2026-02-24",{"date":172,"type":32},{"date":199,"type":32},"2025-10-20",{"date":201,"type":21},"2028-06-30",{"name":38,"class":39},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":228,"leadSponsor":230,"locationsCount":4},"100615807","prevention-in-pd-study-100615807","NCT07297407","Prevention-in-PD-Study","PREVENTION-IN-PD - Development of a Multidomain Lifestyle Intervention Study for Prodromal and Clinical Parkinson's Disease","Inclusion Criteria:\n\n* All participants: ability to perform informed consent; age 30-85\n* RBD group: polysomnographic proven diagnosis of isolated REM sleep behavior disorder (iRBD)\n* PD group: early to moderate disease (Hoehn \\& Yahr stage 1-2.5), diagnosis according to the Movement Disorder Society diagnostic criteria for clinical Parkinson's Disease\n* Agreement to participate in group sessions and online meetings\n\nExclusion Criteria:\n\n* dementia (Mini Mental Score, MMSE \\\u003C 19 points) (MMSE is specifically chosen here to avoid too frequent repetitions of the MoCA, which is used as an outcome parameter for the interventional trial)\n* physical inability to perform exercise training or other trainings as judged by a physician\n* manifest (severe) depression (Beck Depression Inventory, BDI-II \\> 29 points)\n* participation in other interventional trials\n* other significant diseases of the central nervous system\n* Planned change in medication within the following 6 months","30 Years","85 Years",{"count":213,"type":21},99,[77],"The goal of this clinical trial (feasibility study) is to learn if a multimodal lifestyle program can improve adherence to recommended lifestyle changes in people with REM Sleep Behavior Disroder (RBD) or Parkinson's disease (PD).\n\nThe main question it aims to answer is if individuals with RBD oder PD can follow a combined lifestyle program over six months Participants will take part in a six-month intervention program that includes: Physical training, Mediterranean diet counseling, Sleep counseling and cognitive training.\n\nThe program will be supported by psychoeducation, skills training, and personalization to make it practical and motivating.",[217],"Parkinson's Disease (PD)",[219,220,221,222,223],"lifestyle","exercise","nutrition","cognitive training","sleep","2025-12-16",{"date":226,"type":32},"2025-12-22",{"date":170,"type":21},{"date":229,"type":21},"2027-09",{"name":38,"class":39},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":40},"100611078","phase-4-efficacy-of-top-down-therapy-with-mirikizumab-versus-standard-of-care-with-azathioprine-in-patients-with-newly-diagnosed-moderate-to-severe-ulcerative-colitis-100611078","NCT07235904","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis","Efficacy of Top-down Therapy With Mirikizumab Versus Standard of Care With Azathioprine in Patients With Newly Diagnosed Moderate-to-severe Ulcerative Colitis: A 52-week, Multicenter, Open-label, Randomized Controlled Trial","MIRACLE","Inclusion Criteria:\n\n1. Have given written informed consent prior to any study-specific procedures being completed.\n2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.\n3. Are willing to comply with contraception requirements (as specified in section 7.7)\n4. Age between 18 and 75 years.\n5. Naïve to azathioprine and its metabolite 6-MP\n6. Naïve to advanced therapies.\n7. Early disease (duration \\\u003C 12 months since first diagnosis).\n8. Patients with active ulcerative colitis (UC) for whom a previous therapy with 5-aminosalicylic acid (5-ASA) or steroids have not worked well enough, have stopped working, or have caused unacceptable side effects.\n9. The steroid oral therapy must have been stable for at least two weeks before baseline and may consist of prednisone ≤20 mg\u002Fday (or equivalent) per os.\n10. The oral 5-ASA therapy must have been ongoing for at least 8 weeks and dose must be stable for at least 2 weeks before baseline.\n11. Modified Mayo score (mMS) 5-9.\n12. Endoscopic Mayo (eMayo) score ≥2 (local).\n13. Robarts Histopathology Index (RHI) \\>4 (central)\n14. Elevated CRP (above the upper limit of normal) or Fcal (above 250 ug\u002Fg stool).\n15. Disease localization involving at least the rectum and sigmoid colon (\\>15 cm).\n\nExclusion Criteria:\n\n1. Fulminant ulcerative colitis patients who do not respond to steroid treatment or requiring \\>20 mg of prednisolone (or equivalent) at baseline and\u002For fulfilling the criteria for severe UC (requirement of hospitalization) .\n2. Patients with complex UC who have required cyclosporine and tacrolimus for previous treatment\n3. Treatment with MTX within 8 weeks before baseline\n4. Rectal 5-ASA or rectal steroids treatment within 2 weeks prior to baseline\n5. History of malignancy, except for non-melanoma skin cancer.\n6. Planned or foreseeable surgery at the time of inclusion.\n7. Known thiopurine methyltransferase deficiency.\n8. Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n9. Diagnosis of Crohn's disease.\n10. Have been diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV\u002FAIDS, and active tuberculosis (TB).\n11. Have detectable hepatitis B virus (HBV) DNA. or hepatitis C virus (HCV) RNA\n12. Have been diagnosed with latent TB and are not willing to comply with completing TB treatment as appropriate.\n13. Intend to receive a Bacillus Calmette-Guerin (BCG) vaccination or live attenuated vaccine(s) during the study.\n14. Have been diagnosed with systemic mycoses and parasitosis\n15. Have an unstable or uncontrolled illness, including, but not limited to, cerebrocardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic or neurological disorders or malignancy that would potentially affect patient safety within the study or confound efficacy assessment.\n16. Have a known systemic hypersensitivity to any component of this investigational product or has experienced an acute systemic hypersensitivity event with previous study drug administration, that precludes mirikizumab therapy.\n17. Women who are pregnant, lactating or planning pregnancy\n18. Became a Lilly employee or employee of any of the organizations involved with this study or study site personnel directly affiliated with this study and\u002For their immediate families.\n19. Have participated in another clinical trial involving an investigational product or nonapproved use of a drug during the last twelve weeks before screening or are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.\n20. Are unwilling or unable to comply with the use of a data collection device to directly record data from the patient daily for the duration of Study MIRACLE or are unable to complete other study procedures.\n21. Have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities",{"count":240,"type":21},300,[24],"The MIRACLE trial is for patients who have been newly diagnosed with moderate to severe ulcerative colitis in the last 12 months and who have not responded adequately to treatment with mesalazine and prednisolone alone. The standard drug therapy for ulcerative colitis begins with mesalazine (+cortisone) and, if the response is insufficient, continues with azathioprine (+cortisone). Only in the next step are biologics (biotechnologically produced protein substances such as antibodies) such as mirikizumab used as needed. Recent studies have now shown that earlier treatment with mirikizumab without prior treatment with azathioprine may be more effective in the long term, and there are indications that this may result in fewer side effects. This study aims to investigate whether direct, early treatment with mirikizumab is more effective than the usual initiation of standard therapy with azathioprine, whereby these patients can then switch to mirikizumab at predetermined times during the course of the study from week 24 onwards if they have a defined disease activity despite the previous azathioprine treatment. The study consists of an initial treatment period of 12 weeks (induction therapy) and a maintenance therapy period of 40 weeks. Patients in the mirikizumab arm receive 12 doses of mirikizumab. This includes initially 300 mg intravenously every 4 weeks at the trial site, followed by 200 mg subcutaneously via two subcutaneous injections of 100 mg each, administered independently at home. In the azathioprine arm patients receive daily administration of azathioprine tablets in combination with a steroid. Assignment to one of the two treatment options is randomised with equal probability for each of the treatment options.",[244],"Ulcerative Colitis (UC)","2025-12-08",{"date":224,"type":32},{"date":248,"type":32},"2025-12-05",{"date":250,"type":21},"2028-10",{"name":38,"class":39},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":48,"enrollmentInfo":260,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":40},"100515996","influence-of-glucose-on-metabolism-and-clinical-symptoms-of-patients-with-parkinsons-disease-100515996","NCT05998772","Influence of Glucose on Metabolism and Clinical Symptoms of Patients With Parkinson's Disease","PaGlu","Inclusion Criteria:\n\n* Diagnosis of Parkinson's Disease, stage Hoehn \\& Yahr 1.5-3\n* Ability to pause antiparkinsonian medication in the morning without relevant impairment\n* Capacity to give consent (determined in doubt by two independent neurologists, MOCA ≥18) and written informed consent.\n* Patients are between 50 and 80 years of age, with exceptions for a maximum of 5 additional patients enrolled per group\n* For stratification into patients with and without sweet craving, a 3-day dietary protocol should be completed once by the patients\n* Group I: increased hunger for sweets.\n* Group II: no increased hunger for sweets.\n\nFor the stratification into patients with and without increased hunger for sweets, participants are asked to answer the following questions:\n\n1. Do you have sudden attacks of cravings for sweets?\n2. Would you say that your consumption of sweet food has increased in recent years?\n3. Would you describe your consumption of sugary food as increased or excessive?\n\nIf one of the questions is answered with yes, participants will be assigned to group I, if all questions are answered with no, participants will be assigned to group II.\n\nExclusion Criteria:\n\n* Other significant neurological diseases primarily affecting the central nervous system (e.g., multiple sclerosis)\n* Diagnosis of diabetes mellitus or prediabetes\n* Use of medications that affect glucose metabolism, such as antidiabetics, glucocorticoids, ciclosporin, tacrolimus, sirolimus, beta-blockers, thiazide diuretics, beta-2 adrenoreceptor agonists, theophylline, Clozapine, olanzapine, paliperidone, quetiapine, risperidone, tricyclic antidepressants, mirtazapine, mianserin, carbamazepine, gabapentin, pregabalin, valproic acid, lithium, antiretroviral drugs, statins\n* cardiac or brain pacemakers","50 Years",{"count":261,"type":21},50,"Many patients with Parkinson's Disease (PD) report an increased consumption of fast-acting sugars. This tendency to consume sweet, high-sugar foods occurs in some patients even before the onset of cardinal motor symptoms. Some recent studies have demonstrated that PD patients have an increased consumption of fast-acting carbohydrates compared to healthy controls. However, the reason for this change in eating behavior has not yet been adequately explained. It is discussed that the increased sugar intake leads to an increased dopamine release in the brain via an increase in insulin and thus to an improvement in clinical symptoms. This study investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels as well as motor and non-motor symptoms in patients with PD using an oral glucose tolerance test and a placebo oral glucose tolerance test in a crossover design.",[264,265,266],"Parkinson Disease","Nutritional and Metabolic Diseases","Sugar Intake","2025-09-16",{"date":269,"type":32},"2025-09-22",{"date":271,"type":32},"2023-09-01",{"date":273,"type":21},"2025-12",{"name":38,"class":39},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":282,"sex":16,"minAge":259,"maxAge":283,"enrollmentInfo":284,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":296,"locationsCount":40},"100418148","prodromal-alpha-synuclein-screening-in-parkinsons-disease-study-100418148","NCT04724941","Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study","PASS-PD","Inclusion Criteria:\n\n* Age between 50 and 99\n\nExclusion Criteria:\n\n* Presence of clinical PD at the time of study inclusion\n* Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis)\n* other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment\n* in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)",true,"99 Years",{"count":285,"type":21},2000,"The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.",[264],[289,290,291],"Prodromal","Alpha-Synuclein","Risk disclosure",{"date":269,"type":32},{"date":294,"type":32},"2021-06-01",{"date":64,"type":21},{"name":38,"class":39},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":104,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":307,"studyType":186,"phases":4,"briefSummary":308,"conditions":309,"keywords":314,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":40},"100604578","pilot-project-renal-and-cardiovascular-tertiary-prevention-in-preeclampsia-100604578","NCT07151339","Pilot Project Renal and Cardiovascular Tertiary Prevention in Preeclampsia","Pilotprojekt Renale Und kardiovaskuläre Tertiärprävention Nach Präeklampsie","EagleEye3P","Inclusion Criteria:\n\n* older than 18 yrs\n* diagnosed preeclampsia, HELLP syndrome or kidney disease durig pregnancy\n\nExclusion Criteria:\n\n* unable for informed consent",{"count":306,"type":21},100,"12 Months","Tertiary prevention program for women with preeclampsia, HELLP syndrome, kidney disease and pregnancy or associated conditions, including founding of a biobank. (Observational study since no interference with regular path of treatment suggested in national and international guidelines)",[310,311,312,313],"Preeclampsia","HELLP Syndrome","Eclampsia","Kidney Disease",[315,316,317],"cardiovascular prevention","preeclampsia","pregnancy","2025-08-28",{"date":320,"type":32},"2025-09-03",{"date":322,"type":32},"2024-11-01",{"date":324,"type":21},"2030-11",{"name":38,"class":39},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":282,"sex":16,"minAge":332,"maxAge":48,"enrollmentInfo":333,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":335,"conditions":336,"keywords":345,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":40},"100510571","determinants-of-chronic-inflammatory-skin-disease-trajectories-100510571","NCT05928169","Determinants of Chronic Inflammatory Skin Disease Trajectories","Inclusion Criteria:\n\n* dermatologist-diagnosed inflammatory skin disease\n* informed consent\n\nExclusion Criteria:\n\n* subject and\u002For the legal guardians are not able to give written informed consent\n* pregnant and breastfeeding women\n* concurrent participation in a clinical trial\n* use of systemic immunosuppressive therapy or phototherapy during the last 4 weeks or receipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months\n* treatment of the target skin areas with topical corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection","0 Years",{"count":334,"type":21},1000,"Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. There are currently no reliable markers that could predict or delineate patient subgroups to support patient management. The aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.",[337,338,339,340,341,342,343,344],"Atopic Dermatitis","Psoriasis","Lichen Planus","Alopecia Areata","Hidradenitis Suppurativa","Prurigo Nodularis","Cutaneous Lupus","Rosacea",[346],"Inflammatory Skin Diseases","2025-07-17",{"date":349,"type":32},"2025-07-22",{"date":351,"type":32},"2023-05-01",{"date":353,"type":21},"2032-12-31",{"name":38,"class":39},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":282,"sex":16,"minAge":332,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":40},"100313496","disease-trajectories-and-anti-cytokine-response-signatures-in-atopic-dermatitis-and-psoriasis-100313496","NCT03361215","Disease Trajectories and Anti-cytokine Response Signatures in Atopic Dermatitis and Psoriasis","Disease Trajectories in Atopic Dermatitis and Psoriasis","DiTrAP","Inclusion Criteria:\n\n* Patients with a clinical diagnosis of atopic dermatitis, psoriasis or autoimmune skin disease\n* Written informed consent obtained from the subject\n\nExclusion Criteria:\n\n* Patients who decline participation\n\nIn patients\\\u003C18 years of age no biopsies will be taken","100 Years",{"count":334,"type":21},"The clinical study investigates the long-term course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis) and the impact of tarheted therapies on the clinical and molecular level. For this purpose, patients are asked to take part in regular examinations and data collections, and to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). Blood samples are used to analyze inflammation messengers. Punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression. Tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer that will be used to examine mRNA and protein expression. The skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. Overall, the study will help to monitor the disease course clinically and on the molecular level in participating patients for at least ten years and to collect information about the impact of various external factors including treatments. The study has no effect on the therapies of the disease, it serves only the accompanying data collection",[337,338,367],"Healthy",[369,370,371],"Disease progression","Disease course","Immunological characterization",{"date":349,"type":32},{"date":374,"type":32},"2015-03-16",{"date":376,"type":21},"2030-12-31",{"name":38,"class":39},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":402},"100566328","reminder-app-to-optimize-bladder-filling-during-radiotherapy-for-prostate-cancer-100566328","NCT06653751","Reminder App to Optimize Bladder Filling During Radiotherapy for Prostate Cancer","A REminder App to Optimize Bladder FILLing During Radiotherapy of Patients With Prostate CAncer","REFILL-PAC","Inclusion Criteria:\n\n1. Histologically proven high-risk prostate cancer\n2. Indication for definitive normo-fractionated radiotherapy\n3. Possession of a smart phone and the ability to use it\n4. Bladder volume at CT-simulation \\\u003C200 ml\n5. Male gender\n6. Age ≥18 years\n7. Written informed consent\n8. Capacity of the patient to contract\n\nExclusion Criteria:\n\n1. Radiotherapy of pelvic lymph nodes\n2. Expected non-compliance",{"count":106,"type":21},[77],"The primary goal of this study is to assess the impact of an app that reminds patients irradiated for high-risk prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \\\u003C200 ml during the radiotherapy course and to demonstrate that this number is lower than without using an app (historical control group).",[390],"Prostate Cancer Patients Treated by Radiotherapy",[392,83,393],"High-risk prostate cancer","Mobile application","2025-06-17",{"date":396,"type":32},"2025-06-22",{"date":398,"type":21},"2025-07-01",{"date":400,"type":21},"2026-10-31",{"name":38,"class":39},5,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":4},"100592474","physical-activity-during-chemo--andor-immunotherapy-for-lung-cancer-100592474","NCT06993896","Physical Activity During Chemo- and\u002For Immunotherapy for Lung Cancer","Assessment of Physical Activity During Chemo- and\u002For Immunotherapy for Lung Cancer","APACHIE-01","Inclusion Criteria:\n\n1. Histologically proven non-small cell lung cancer\n2. Indication for chemo- and\u002For immunotherapy\n3. Possession of and ability to use a smart phone that includes a step counter\n4. Willingness to wear the smart phone close to the body at any time\n5. Age ≥18 years\n6. Written informed consent\n7. Capacity of the patient to consent\n\nExclusion Criteria:\n\n1. Small-cell lung cancer\n2. Karnofsky performance score \\\u003C60\n3. Thoracic surgery within 3 months prior to chemo- and\u002For immunotherapy\n4. Expected Non-Compliance",{"count":412,"type":21},38,"The main goal of this trial is to describe the pattern of physical activity in patients with non-small cell lung cancer during chemo- and\u002For immunotherapy, to evaluate potential predictors of those patterns and to assess potential correlations with patient reported outcomes (pain-, distress-, and fatigue scores). To reach this goal, this trial will be first trial in which the mean number of steps per week performed at baseline and during each week of chemo- and or immunotherapy will be collected in a standardized prospective way. The trial is exploratory in nature with the aim to generate scientific hypotheses to be investigated in future clinical trials.",[415],"Lung Cancer (NSCLC)",[417,418,419,420],"lung cancer","chemotherapy","immunotherapy","physical activity","2025-05-27",{"date":423,"type":32},"2025-05-29",{"date":425,"type":21},"2025-06-16",{"date":427,"type":21},"2025-12-31",{"name":38,"class":39},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":40},"100583280","metabolic-phenotyping-for-personalized-obesity-therapy-100583280","NCT06874270","Metabolic Phenotyping for Personalized Obesity Therapy","Establishment of a Specific Metabolic Phenotyping for the Personalization of Obesity Therapy in Morbidly Obese Individuals","Inclusion Criteria:\n\n* Morbid obesity (BMI \\> 40 kg\u002Fm²)\n* Currently undergoing a multimodal obesity therapy program at the Department of Internal Medicine I at the University Hospital Schleswig-Holstein (UKSH), Campus Kiel\n\nExclusion Criteria:\n\n* Type 1 or Type 2 diabetes mellitus, or fasting blood glucose \\>125 mg\u002FdL, or HbA1c \\>6.5%\n* Conditions affecting appetite or energy expenditure (e.g., Cushing's syndrome, uncontrolled hyper-\u002Fhypothyroidism, diabetes mellitus)\n* Gastrointestinal diseases that may impair nutrient absorption (e.g., inflammatory bowel disease, malabsorption syndromes, peptic ulcers)\n* Psychiatric disorders that influence eating behavior (e.g., active depression, anorexia nervosa, bulimia nervosa, borderline personality disorder)\n* Acute, unstable cardiovascular disease requiring hospitalization within the last 6 months (e.g., stent implantation)\n* Cancer requiring treatment within the past 5 years\n* Chronic kidney disease at Stage IV or worse according to NKF criteria\n* Active infectious disease (e.g., HIV, hepatitis)\n* Active nicotine use\n* Drug use (e.g., amphetamines, cocaine, heroin, marijuana)\n* Regular intense physical activity (≥1 hour of sport per day)\n* Non-MRI-compatible metallic implants (e.g., joint replacements, metal plates)\n* Pregnancy or breastfeeding\n* Use of weight-loss medications\n* Clinically relevant claustrophobia\n* Any other condition not specified above that, in the judgment of the investigator, could interfere with study participation or compromise patient safety","70 Years",{"count":438,"type":21},80,"This study aims to develop a simple, clinically applicable method for metabolic phenotyping to personalize obesity therapy in morbidly obese individuals. The underlying concept is that the way a person's resting metabolic rate (RMR) responds to a 24-hour fast can help distinguish between two metabolic phenotypes. Individuals with a \"thrifty\" metabolism show a significant drop in RMR during fasting, which may make them less responsive to conventional weight loss interventions. In contrast, those with a \"spendthrift\" metabolism exhibit little to no drop-or even a slight increase-in RMR, suggesting they may lose weight more readily.\n\nThe trial is designed as a prospective, single-center, longitudinal cohort study involving 20 morbidly obese patients (BMI \\>40 kg\u002Fm²) who are already participating in a multimodal obesity therapy program. The study is divided into three phases. In the baseline phase, participants undergo comprehensive screening, which includes physical examinations, blood tests, and body composition assessments. RMR is measured using indirect calorimetry both before and after a 24-hour fasting period, and a device (Lumen™) is used to assess whether the body is primarily burning carbohydrates or fats.\n\nAfter the fasting measurements, participants perform a low-protein meal test by consuming a specially calibrated chocolate beverage. Their RMR is then monitored at several time points to determine the energy required for digestion. Following this, the study moves into the very-low-calorie diet (VLCD) phase, where participants consume approximately 800 kcal per day using formula meals tailored to meet their nutritional needs despite the calorie restriction. During this 12-week phase, changes in body weight, composition, and metabolic parameters are closely monitored.\n\nThe final phase of the study is a 12-week weight maintenance period, during which the focus is on sustaining the achieved weight loss. In addition to RMR and dietary assessments, advanced techniques such as metabolomics are employed. Blood, urine, and saliva samples are collected to analyze metabolic profiles and identify potential hormonal biomarkers-such as leptin, FGF21, and adrenaline-that could further differentiate the \"thrifty\" and \"spendthrift\" phenotypes. Body composition is also assessed using methods like bioimpedance analysis (BIA), quantitative magnetic resonance imaging (qMR), and air displacement plethysmography (BodPod).\n\nBy correlating the changes in RMR with metabolic and hormonal markers, the study tests the hypothesis that individuals with a marked RMR decrease during fasting (the \"thrifty\" phenotype) may experience less weight loss during a hypocaloric diet compared to those with minimal RMR change (the \"spendthrift\" phenotype). If validated, this approach could allow clinicians to predict weight loss outcomes more accurately and tailor obesity treatments to the individual's unique metabolic profile.",[441],"Obesity and Overweight",[443,444,445,446,447,448,449,450,451],"obesity","metabolic phenotype","thrifty","spendthrift","weight loss","indirect calorimetry","fasting","meal test","VLCD","2025-03-07",{"date":454,"type":32},"2025-03-13",{"date":456,"type":32},"2023-09-15",{"date":458,"type":21},"2027-09-30",{"name":38,"class":39},{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":282,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":467,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":40},"100582243","how-metabolism-affects-weight-loss-and-gain-100582243","NCT06860776","How Metabolism Affects Weight Loss and Gain","Pilot Study on the Analysis of the Metabolic Phenotype in Individuals With Difficulties in Losing and Gaining Weight","Inclusion Criteria:\n\n* Group 1 (Lean): BMI 18.5-22.0 kg\u002Fm², reporting difficulty gaining weight\n* Group 2 (Obese): BMI \\>30 kg\u002Fm², reporting difficulty losing weight\n* Healthy status as determined by medical history, physical examination, and laboratory tests\n* Stable weight (less than 5% fluctuation) over the past 6 months\n\nExclusion Criteria:\n\n* Prediabetes (HbA1c \\>5.6% or fasting blood glucose \\>100 mg\u002FdL) or diabetes mellitus\n* Conditions affecting appetite or energy expenditure (e.g., Cushing's syndrome, uncontrolled hyper-\u002Fhypothyroidism)\n* Gastrointestinal disorders that impact nutrient absorption (e.g., inflammatory bowel disease, malabsorption syndromes, ulcers)\n* Psychiatric conditions influencing eating behavior (e.g., active depression, anorexia nervosa, bulimia nervosa, borderline personality disorder)\n* Acute, unstable cardiovascular disease requiring hospitalization within the last 6 months (e.g., stent placement)\n* Cancer that required treatment in the past 5 years\n* Chronic kidney disease (Stage IV or higher, per NKF criteria)\n* Active infectious disease (e.g., HIV, hepatitis)\n* Current nicotine use or nicotine use within the last month prior to screening\n* Illicit drug use (e.g., amphetamines, cocaine, heroin, marijuana)\n* Regular high-intensity physical activity (≥1 hour\u002Fday)\n* Non-MRI-compatible metallic implants (e.g., artificial joints, metal plates)\n* Pregnancy or breastfeeding\n* Use of weight-loss medications\n* Clinically significant claustrophobia\n* Any other condition not mentioned above that, in the opinion of the investigator, could interfere with study participation or compromise patient safety",{"count":468,"type":21},20,"This study examines why some individuals with obesity have difficulty losing weight, whereas some lean individuals struggle to gain weight. The investigators will measure how the human body uses energy during a fasting period and after consumption of a specially designed, low-protein meal. By comparing these responses, the investigators aim to identify different \"metabolic phenotypes\" that affect weight control. Findings from this research may lead to more personalized treatments for managing weight. Participation in this study involves simple tests and basic body measurements.",[441],[443,444,445,446,472,449,448],"diet-induced thermogenesis",{"date":474,"type":32},"2025-03-12",{"date":476,"type":32},"2024-09-16",{"date":478,"type":21},"2025-08-01",{"name":38,"class":39},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":493,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":507},"100576347","a-reminder-app-to-optimize-bladder-filling-in-patients-with-prostate-cancer-receiving-hypo-fractionated-radiotherapy-100576347","NCT06784115","A Reminder App to Optimize Bladder Filling in Patients with Prostate Cancer Receiving HYPO-fractionated Radiotherapy","A REminder App to Optimize Bladder FILLing in Patients with ProstAte Cancer Receiving HYPO-fractionated Radiotherapy","REFILLPAC-HYPO","Inclusion Criteria:\n\n1. Histologically proven prostate cancer\n2. Indication for definitive HF-RT\n3. Possession of and ability to use a smartphone\n4. Bladder volume at CT-simulation \\\u003C200 ml\n5. Male gender\n6. Age ≥18 years\n7. Written informed consent\n8. Capacity of the patient to contract\n\nExclusion Criteria:\n\n1. Radiotherapy of pelvic lymph nodes\n2. Expected non-compliance",{"count":489,"type":21},27,[77],"The primary goal of this study is to assess the impact of an app that reminds patients treated with hypofractionated radiotherapy (HF-RT) for prostate cancer to drink water prior to each radiotherapy session on the number of bladder volumes \\\u003C200 ml during the HF-RT course and to demonstrate that this number is lower than without using an app (historical control group).",[390],[494,495,496,497,498],"prostate cancer","radiotherapy","hypofractionation","mobile application","bladder filling","2025-01-17",{"date":501,"type":32},"2025-01-20",{"date":503,"type":21},"2025-02-15",{"date":505,"type":21},"2027-01-31",{"name":38,"class":39},4,{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":104,"minAge":17,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":402},"100553237","dermatitis-during-adjuvant-irradiation-for-breast-cancer-100553237","NCT06483477","Dermatitis During Adjuvant Irradiation for BREAst Cancer:","Dermatitis During Adjuvant Irradiation for BREAst Cancer: Grade ≥2 Radiation Dermatitis in Breast Cancer Patients with or Without a Mobile Application (Reminder-App)","DAI-BREAC","Inclusion Criteria:\n\n1. Histologically proven invasive breast cancer\n2. Indication for adjuvant hypo-fractionated radiotherapy\n3. Possession of and ability to use a smartphone\n4. Female gender\n5. Age ≥18 years\n6. Written informed consent\n7. Capacity of the patient to contract\n\nExclusion Criteria:\n\n1. Pregnancy, Lactation\n2. Expected non-compliance",{"count":517,"type":21},268,[77],"In the randomized DAI-BREAC trial, a reminder app will be prospectively tested that reminds breast cancer patients four times each day to perform the required skin care. This will likely contribute to the reduction of grade ≥2 radiation dermatitis in these patients. A total of 268 patients will be randomized to receive standard skin care supported by a reminder app (Arm A) or standard skin care alone (Arm B). Stratification will be done using the three factors treatment volume, radiation boost, and at least one risk factor of dermatitis. Secondary aims include pain (radiation fields), patient satisfaction with the reminder app (Arm A only), impact of the app on the use of health technology (Arm A only), and benefit from support by staff members of the treating Department of Radiation Oncology and\u002For the UKSH academy regarding the use of the app (Arm A only).",[521],"Breast Cancer Female",[112,83,523,393],"Dermatitis","2025-01-14",{"date":526,"type":32},"2025-01-16",{"date":528,"type":32},"2024-12-23",{"date":530,"type":21},"2026-09-30",{"name":38,"class":39},{"id":533,"slug":534,"hasResults":11,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":539,"targetDuration":4,"studyType":22,"phases":541,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":40},"100409401","phase-2-video-supervised-motor-and-awareness-training-in-writers-cramp-100409401","NCT04611009","Video-supervised Motor and Awareness Training in Writer's Cramp","Treatment Effect and Relevance on Daily Life of a Video-supervised Sensorimotor Training Program and Its Influence on the Pathophysiology in Writer's Cramp","Inclusion Criteria:\n\n* Right handed idiopathic WC according to standardized criteria (simple and complex WC, any dystonic posture (including flexion, extension, pronation, supination))\n* able to participate in video-calls\n\nExclusion Criteria:\n\n* Additional neurological or psychiatric diseases\n* left-handed patients\n* last botulinum toxin treatment \\\u003C3 months, remaining weakness from the last injection\n* concomitant use of anticholinergics or sedating medication\n\nExclusion criteria for MRI:\n\n* Cardiac pacemaker, electronic or metal implants\n* pregnancy or suspected pregnancy\n* severe ametropia, anxiety in small rooms",{"count":540,"type":21},54,[52],"Writer's cramp is the most common task-specific dystonia. It is characterized by involuntary co-contraction of antagonistic muscles during writing. This disabling condition may force patients to give up their occupation. In this study the efficacy of a twelve months long-term training in patients with writer's cramp will be investigated. Two different programs will be offered: The first one will consist of a sensorimotor, the second one of an awareness training. All patients will benefit from video-based supervision with the aim to establish a practice-oriented therapeutic approach that will be available to all patients independently of their home location. The treatment effect will be measured primary with the patient-centered Canadian Occupational Performance Measure (COPM) and secondary with clinical scales to assess the clinical efficacy and everyday constraints. Writing will be assessed with a computer-based kinematic writing analysis. To evaluate the influence on the brain network, several functional magnetic resonance imaging (fMRI) evaluations will be performed. This project is of minimal risk without negative side effects from the training. The risks for the MRI experiment are equal to a non-contrast standard MRI investigation.",[544],"Writer's Cramp",[546,547,548,549,550],"dystonia","training","kinematic writing analysis","COPM","functional magnetic resonance imaging","2024-12-09",{"date":553,"type":32},"2024-12-10",{"date":555,"type":32},"2020-06-26",{"date":557,"type":21},"2027-01-01",{"name":38,"class":39},{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":567,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":577,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":507},"100523580","phase-2-improvement-of-quality-of-life-by-cannabinoids-in-oncologic-patients-100523580","NCT06097533","Improvement of Quality of Life by Cannabinoids in Oncologic Patients","Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)","BELCANTO","Inclusion Criteria:\n\n* ≥25 years old and legally competent\n* Palliative oncological therapy\n* ECOG status 1, 2 or 3, incapacitated for work\n* ESAS TSDS \\> or equals 16\n* Nutritional Risk Screening \\> or equals 3\n* Pain numerical rating scale \\> or equals 4\n* informed consent\n* for WOCBP:\n\n  * Negative pregnancy test\n  * Reliable contraception (Pearl Index \\\u003C 1%)\n\nExclusion Criteria:\n\n* nausea \\> or equals grade 3 (CTCAE) or vomiting \\> or equals grade 2 (CTCAE) in the preceding week\n* Inability to understand and complete the questionnaires\n* Cannabis use in the last 6 weeks\n* Alcohol addiction\n* Pregnancy\u002Flactation\n* Contraindications or intolerance to the study medication (esp. psychosis)\n* Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)\n* Any other condition as judged by the investigator, e.g. non-compliance","25 Years",{"count":569,"type":21},170,[52],"The goal is to explore whether the application of cannabis extract Avextra 10\u002F10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.",[573,574,575,576],"Medical Oncology","Palliative Care","Quality of Life","Cannabinoids",[565],"2024-10-23",{"date":580,"type":32},"2024-10-26",{"date":582,"type":32},"2024-04-08",{"date":584,"type":21},"2026-11-30",{"name":38,"class":39},{"id":587,"slug":588,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":595,"conditions":596,"keywords":598,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":614,"locationsCount":615},"100414666","covidom-longterm-morbidity-of-sars-cov-2-infection-and-covid-19-disease---consequences-for-health-status-and-quality-of-life-100414666","NCT04679584","COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life","COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life (NAPKON-POP)","NAPKON-POP","Inclusion Criteria:\n\n* PCR-confirmed SARS-CoV-2 infection\n* living in one of the target areas\n* age at least 18 years\n* written informed consent\n\nExclusion Criteria:\n\n* Acute SARS-CoV-2 infection or reinfection",{"count":285,"type":21},"COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system\n\nAssessment of SARS-CoV-2-longterm morbidity and sequels on the population level:\n\nIn order to identify and treat these sequels in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequels on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals.\n\nWithin the COVIDOM study we will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.",[597],"COVID-19",[599,597,600,601,602,575,603,604,605,606,607],"SARS-CoV-2","COVID","Corona","longterm morbidity","longterm consequences","Chronic impairment","Chronic dysfunction","Chronicity","Sequels","2020-12-18",{"date":610,"type":32},"2020-12-22",{"date":612,"type":32},"2020-11-16",{"date":376,"type":21},{"name":38,"class":39},3,""]