[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universität Duisburg-Essen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":350},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,50,85,110,137,164,207,237,264,296,326],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100642389","evaluation-of-an-exercise-intervention-during-intensive-medical-treatment-in-pediatric-oncology-100642389",false,"NCT07647471","Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology.","Evaluation of an Exercise Intervention During Intensive Medical Treatment in Pediatric Oncology (Evaluation BEwegungs- Und sPorttherapeutischer Interventionen Unter Medizinischer Therapie in Der Pädiatrischen Onkologie)","BEPPO","Inclusion Criteria:\n\n* Patients aged ≥3 and ≤18 years\n* Oncological diagnosis with curative treatment intent\n* ≤6 weeks since cancer diagnosis (diagnosis can be initial, secondary or relapse diagnosis)\n* Information and consent procedures feasible in German, English or with using local site resources (e.g., interpreters or multilingual staff)\n* Communication with the patient is possible in German, English or with using local site resources (e.g., interpreters or multilingual staff) during the assessments and intervention\n* Patients insured by German statutory health insurers\n\nExclusion Criteria:\n\n* Patients aged \\\u003C3 and \\>18 years\n* No active medical oncological treatment (e.g., watch-and-wait strategy, surgery without ongoing oncological acute treatment at a pediatric oncology center)\n* Medical limitations that do not allow implementation of the study protocol\n* Life expectancy \\\u003C 6 months\n* Patients not insured by German statutory health insurers (e.g., Privatly insured patients, self-paying patients)","ALL","3 Years","18 Years",{"count":21,"type":22},346,"ESTIMATED","INTERVENTIONAL",[25],"NA","The BEPPO study is a Germany-wide clinical trial investigating whether a structured exercise program can improve physical and mental health in children and adolescents undergoing cancer treatment. Although exercise is known to support recovery and well-being, it is not yet a standard part of pediatric oncology care. The study aims to generate evidence to support the integration of exercise into routine treatment.\n\nA total of 346 patients aged 3 to 18 years are recruited across 13 pediatric oncology centers in Germany. Participants are randomly assigned to either an exercise intervention group or a standard care control group.\n\nChildren in the intervention group take part in a 6-month individualized exercise program with 3-5 sessions per week. The program is delivered across different settings, including inpatient hospital care, outpatient treatment, and home-based training supported by telemedicine. This ensures continuous support throughout the course of medical treatment.\n\nIn addition to supervised exercise sessions, participants receive four structured counseling sessions. These sessions aim to strengthen motivation, address individual barriers to participation, and support long-term engagement in physical activity. The counseling also helps build a strong therapeutic relationship and promotes adherence to the program.\n\nThe exercise intervention is based on established principles of sports science but is individually adapted to each patient's health status, treatment phase, and personal preferences. Each training session follows a structured plan with specific goals, while also considering individual physical and psychological conditions to ensure safety, feasibility, and effectiveness.\n\nThe main objective of the BEPPO study is to improve physical performance, particularly leg strength, which is the primary endpoint. Secondary outcomes include endurance, functional mobility, balance, physical activity levels, fatigue, quality of life, mental well-being, frailty, and treatment-related symptoms and side effects.\n\nIn addition to clinical effectiveness, the study also evaluates how well the intervention can be implemented in routine healthcare settings. This includes assessing adherence, feasibility, and potential barriers and facilitators for integrating exercise into standard care. A health economic evaluation is also conducted in collaboration with health insurance providers to determine cost implications.\n\nOverall, the BEPPO study aims to provide robust scientific evidence on the benefits and feasibility of structured exercise during pediatric cancer treatment. The long-term goal is to establish exercise as a standard component of supportive care in pediatric oncology, improving both short- and long-term outcomes for patients.",[28],"Pediatric Cancer Patients",[30,31,32,33,34,35,36],"Knee extensor strength","Quality of Life","Fatigue","Health economics","Implementation","Physical activity","Exercise","NOT_YET_RECRUITING","2026-06-09",{"date":40,"type":41},"2026-06-15","ACTUAL",{"date":43,"type":22},"2026-07-01",{"date":45,"type":22},"2028-12-31",{"name":47,"class":48},"Universität Duisburg-Essen","OTHER",13,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100421226","phase-2-cardiorespiratory-fitness-in-children-and-adolescents-after-cancer-treatment-100421226","NCT04765020","Cardiorespiratory Fitness in Children and Adolescents After Cancer Treatment.","Effects of a Physical Activity Program On Cardiorespiratory Fitness in Children and Adolescents folloWing Acute cancER Treatment: a Randomized Controlled Trial","POWER","Inclusion Criteria:\n\n* Children and adolescents between 7 and 23 years of age\n* Completion of acute cancer treatment and receiving follow-up care in Krefeld (Helios Hospital Krefeld)\n* 6 weeks post cancer-treatment\n* Signed informed consent (Parents and Patient)\n\nExclusion Criteria:\n\n* \\\u003C7 years of age, \\>23 years of age\n* Medical condition that limits participation in one of the study arms\n* Inability to follow the training-protocol\n* Inability to carry out the spiroergometry on a cycle ergometer","7 Years","23 Years",{"count":61,"type":22},56,[63,64],"PHASE2","PHASE3","The POWER-study is a two-arm exercise intervention study for pediatric patients following acute cancer treatment. This clinical trial will investigate the effects of a 12-week moderate to high-intensity exercise program on cardiorespiratory fitness in children and adolescents beginning 6 weeks after completion of acute cancer treatment.",[67],"All Types of Pediatric Cancer",[69,70,71,72,73,74],"exercise","cardiorespiratory fitness","pediatric oncology","child health","physical activity","immune function","RECRUITING","2026-05-12",{"date":78,"type":41},"2026-05-15",{"date":80,"type":41},"2021-06-21",{"date":82,"type":22},"2028-06",{"name":47,"class":48},1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":84},"100342237","mind-body-medicine-for-patients-with-malignant-hematological-diseases-100342237","NCT03735992","Mind-body Medicine for Patients With Malignant Hematological Diseases","Mind-body Medicine as a Supportive Strategy for Patients With Malignant Hematological Diseases: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with malignant hematological diseases in complete remission after primary chemotherapy and\u002For radiation\n* Physical and mental ability to attent 8 of 11 group units\n\nExclusion Criteria:\n\n* Chemotherapy, radiation, or rehabilitation programm during the study period\n* Pregnancy\n* Participation in other studies with behavioral interventions during the study period",{"count":93,"type":22},94,[25],"This randomized controlled trial aims to investigate the effectiveness of a mind-body group program as a supprtivemanagement strategy for fatigue in patients with malignant hematological diseases.",[97],"Hematologic Neoplasms",[97,99,32,100,101],"Supportive Therapy","Mind-body medicine","Complementary and alternative medicine","2026-04-10",{"date":104,"type":41},"2026-04-15",{"date":106,"type":41},"2017-09-06",{"date":108,"type":22},"2026-12-31",{"name":47,"class":48},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100232534","hypoglossal-acupuncture-for-dysgeusia-in-patients-undergoing-chemotherapy-100232534","NCT02304913","Hypoglossal Acupuncture for Dysgeusia in Patients Undergoing Chemotherapy","Hypoglossal Acupuncture for Dysgeusia in Gynecologic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial","OralAcu","Inclusion Criteria:\n\n* Initial treatment with platinum-containing or taxane-based CTX (regardless of the the length of the CTX cycle)\n* Senological, gynecological or internistic tumors\n* Phantogeusia (on average ≥4 NRS)\n* Willingness to participate in the study and written informed consent\n\nExclusion Criteria:\n\n* Severe stomatitis\n* Dysgeusia before the CTX based on neurological diseases, diabetes, or the ingestion of drugs with taste disorders as side effects\n* Leucopenia\u002Fneutropenia\n* Intake of anticoagulants\n* Smoking\n* Severe physical or mental comorbidity (due to which the patient is unable to participate in the study)\n* Participation in other CAM treatments within the integrative oncology care\n* Participation in other studies on the effectiveness of interventions for oral complications",{"count":119,"type":22},75,[25],"This randomized controlled trial aims to investigate hypoglossal acupuncture in comparison to sham acupuncture and standard medical treatment (dietary recommendations) in the treatment of dysgeusia in cancer patients undergoing chemotherapy.",[123,124,125,126,127],"Acupuncture","Taste Disorders","Dysgeusia","Chemotherapy","Cancer","2026-04-09",{"date":130,"type":41},"2026-04-14",{"date":132,"type":41},"2015-01-01",{"date":134,"type":22},"2027-12-31",{"name":47,"class":48},3,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":84},"100591794","reducing-symptom-burden-through-physical-exercise-in-melanoma-patients-100591794","NCT06985056","Reducing Symptom Burden Through Physical Exercise in Melanoma Patients","Reducing Symptom Burden Through Physical Exercise in Melanoma Patients Under Immuno- or Targeted Therapy","RESPECT","Inclusion Criteria:\n\n* patients ≥ 18 years with malignant melanoma (Stage IIb - IV) receiving adjuvant or palliative immunotherapy or targeted therapy\n* patients with ECOG level 0-2\n* patients already on the same treatment protocol for at least 3 months and no more than 9 months\n* sufficient knowledge of German\n* completed and signed written consent form and completed medical history form\n* medical clearance for the exercise program and performance diagnostics\n* ability to participate in the exercise program\n* willingness to visit the study hospital for training sessions and examinations\n\nExclusion Criteria:\n\n* confirmation of contraindications for physical exercise by the attending physician (e.g. fracture risk in the case of bone metastases)\n* untreated, symptomatic, known brain metastases\n* severe neurological or cardiac impairment according to ACSM criteria\n* confirmation of respiratory insufficiency by the attending physician\n* life expectancy less than 3 months\n* physical or mental conditions that would not allow implementation of the exercise program or study protocol\n* excessive physical activity (i.e. \\>150 minutes\u002Fweek of moderate to intense physical activity and systematic intense strength\u002Fendurance training at least twice a week for one hour)",{"count":146,"type":22},104,[25],"The aim of the clinical trial is to determine whether regular exercise can reduce fatigue in adult patients with stage IIb-IV melanoma undergoing immunotherapy or targeted therapy. Additionally, we will investigate whether a supervised exercise program improves patients' quality of life, cognitive skills, and physical fitness compared to a control group without structured exercise. We will also examine other health outcomes and various blood parameters, such as interleukins and metabolites, to understand how regular activity can affect metabolism and immune function.\n\nAfter the initial assessment at the clinic, patients will be randomly assigned to two groups. Those in the intervention group will participate in a 12-week exercise program, which includes a 60-minute personalized and supervised online training session twice a week. In weeks 3, 6, and 9, one training session will be held at the clinic. Furthermore, patients in the intervention group are encouraged to complete a self-administered 20-minute exercise session once a week. The control group will not receive a supervised exercise program. Following the 12-week intervention period, another assessment will be conducted at the clinic. All patients will then enter a 6-week follow-up phase, during which neither group will receive supervised exercise training. After this follow-up phase, a final assessment of all outcomes will take place at the clinic.",[150],"Malignant Melanoma",[36,32,152,153,154,155,31],"Physical Activity","Checkpoint Inhibitors","BRAF\u002FMEK Inhibitors","Melanoma","2026-03-26",{"date":158,"type":41},"2026-03-27",{"date":160,"type":41},"2025-08-18",{"date":162,"type":22},"2027-11",{"name":47,"class":48},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":23,"phases":174,"briefSummary":175,"conditions":176,"keywords":181,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":84},"100612571","strengthening-health-literacy-in-healthcare-workers-through-mind-body-medicine-and-nutrition-100612571","NCT07255313","Strengthening Health Literacy in Healthcare Workers Through Mind Body Medicine and Nutrition","Strengthening Psycho-physiological and Psycho-emotional Competencies in Healthcare Workers Through Mind Body Medicine and Nutrition: A Randomized Controlled Trial","SOULFOOD","Inclusion Criteria:\n\n* Age 18 years and older\n* Employees of University Medicine Essen\n* Moderate resilience of ≤ 144 points on the RS-25\n* Willingness to practice at home and keep a practice diary\n\nExclusion Criteria:\n\n* Insufficient German language skills\n* Pregnancy and breastfeeding\n* Severe comorbid mental disorders (e.g., substance use disorder, major depression) or other severe comorbid somatic diseases (e.g., oncological disease without remission, severe pre-existing cardiovascular disease, organ failure, other severe neurological disorders)\n* Planned or ongoing pension application (e.g., disability pension, occupational disability, reduced earning capacity, severe disability)\n* Concurrent participation in other clinical intervention studies",{"count":173,"type":22},252,[25],"This is a randomized controlled trial aiming to develop and evaluate a workplace health program to improve stress resilience and mental well-being among healthcare workers at University Medicine Essen using a participatory research design (including a steering committee composed of hospital staff, needs assessment through focus groups, and pilot testing). The intervention combines mind-body medicine techniques, complementary medicine self-care strategies, and psycho-biotic nutrition. If successful, the program will be integrated into routine workplace health management and serve as a model for other healthcare institutions.",[177,178,179,180],"Stress Resilience","Stress","Burnout","Burnout Syndrome",[182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198],"stress resilience","work health promotion","burnout prevention","mental well-being","occupational stress","healthcare workers","Mind-Body Medicine","complementary medicine","nutrition","employee health","participatory research","randomized controlled trial","workplace intervention","self-care strategies","occupational health management","Self-Efficacy and Stress Resistance","nutrition and mental health","2025-12-07",{"date":201,"type":41},"2025-12-15",{"date":203,"type":41},"2025-12-01",{"date":205,"type":22},"2027-08-31",{"name":47,"class":48},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":218,"phases":4,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":84},"100613934","a-comprehensive-multinational-gist-registry-100613934","NCT07273045","A Comprehensive, Multinational GIST Registry","reGISTry - a Comprehensive, Multinational GIST Registry","reGISTTry","Inclusion Criteria:\n\n* Diagnosis of a gastrointestinal stromal tumor (GIST)\n* Verbal and written informed consent for participation in the study with planned prospective data collection\n* Physical and mental ability to provide informed consent\n\nExclusion Criteria:\n\n* Severe neurological or psychological illness that impairs the ability to give informed consent",{"count":216,"type":22},1000,"20 Years","OBSERVATIONAL","Patients diagnosed with a gastrointestinal stromal tumor (GIST), a rare type of tumor in the digestive tractparticipate in this scientific research study, known as a registry study, to help improve understanding and treatment of GIST.\n\nThis study collects medical information and biological samples-such as blood or tumor tissue-from patients. It does not involve new treatments, medications, or medical procedures. The patient's regular medical care will continue as usual, and participation will not require extra appointments or tests.\n\nThe study aims to learn more about how GIST behaves, especially in rare forms such as SDH-deficient or NF1-associated tumors. While targeted drugs are available for many patients, some tumors return or become resistant to treatment. By gathering data from many patients, researchers hope to better understand these challenges, identify risk factors for worse outcomes, and help design future studies and treatments-especially for rare types of GIST.\n\nIf the patient agrees to participate, information will be collected from their medical records, scans (such as CT or MRI), and doctor visits. They may be asked to complete optional questionnaires about their health and quality of life. If they consent, small blood samples (up to 50 ml) may be collected during routine check-ups. If surgery is needed, a small part of the tumor tissue may be stored for research. Other samples-such as saliva, stool, urine, or spinal fluid-may also be collected if they are taken during normal care, to study how bacteria in the body might affect the disease and treatment.\n\nParticipation is completely voluntary. The patient can choose to join or not, and can withdraw at any time without affecting their care or relationship with their doctor. Even if they do not agree to provide biological samples, they can still take part in the study by sharing medical data and scan results.",[221,222],"Gastrointenstinal Stromal Tumor (GIST)","GIST - Gastrointestinal Stromal Tumor",[224,225,226,227,228],"GIST","KIT","SDH-Deficiency","NF1","register","2025-11-26",{"date":231,"type":41},"2025-12-09",{"date":233,"type":22},"2026-01-01",{"date":235,"type":22},"2056-01-01",{"name":47,"class":48},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":218,"phases":4,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100601325","resistance-profiling-using-functional-imaging-and-next-generation-sequencing-in-refractory-gastrointestinal-stomal-tumors-gist-100601325","NCT07109024","Resistance Profiling Using Functional Imaging and Next Generation Sequencing in Refractory Gastrointestinal Stomal Tumors (GIST)","Pilot Diagnostic Feasibility Trial of Resistance Profiling Using Functional Imaging and Next Generation Sequencing of Refractory GIST","PATHFINDERS","Inclusion Criteria:\n\n* Advanced gastrointestinal stromal tumors history of exposure and progression or intolerance to imatinib, sunitinib, regorafenib and ripretinib\n* Clinical indication for PET-CT and tumor biopsy (optional) (sarcoma center tumorboard protocol)\n* Age 18 years and older\n* FFPE tumor tissue available\n* Previous imaging studies available (CT\u002FMRI\u002FPET Abdomen, ideally at baseline, best response and progression)\n* ECOG ≤ 2\n* Progressing tumor lesion(s) of which one is accessible for biopsy\n\nExclusion Criteria:\n\n* contraindication for systemic TKI treatment\n* contraindication for contrast-enhanced both CT and MRI imaging.\n* GIST without KIT or PDGFRA mutations\n* pregnant or breastfeeding women\n* patient that - to the investigator's discretion - are not able or willing to comply with the provided protocol and visit schemes",{"count":246,"type":22},40,"Gastrointestinal stromal tumors (GIST) are the most common malignant sarcomas of the gastrointestinal tract. Inhibitors of the mutated driver proteins KIT and PDGFRA can temporarily control disseminated GIST disease but cannot cure it. Recently, the investigators were able to elucidate the two main resistance mechanisms-the coexistence of ATP-binding pocket (AP) and activation loop (AL) mutations, as well as AP\u002FAL combination mutations. Determining these resistance factors requires methods that are not yet established in routine clinical practice. The investigators hypothesize that identifying these factors and creating resistance profiles in the context of the anatomical location of metastatic lesions can open up new, clinically relevant therapeutic options, including local therapies. The aim of this project is to evaluate the practicability of these methods in everyday clinical use. An AI-supported image analysis and specialized molecular methods will be combined into a comprehensive resistance profile and will be provided to the treating physicians to potentially guide treatment decisions.",[249],"Gastrointestinal Stromal Tumor (GIST)",[224,251,252,253,254],"Resistance","Ripretinib","Progression","Imaging","2025-08-13",{"date":257,"type":41},"2025-08-19",{"date":259,"type":22},"2025-09-01",{"date":261,"type":22},"2031-03",{"name":47,"class":48},2,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":23,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":84},"100571401","impact-of-diet-and-lifestyle-modification-on-the-intestinal-barrier-integrity-in-crohns-disease-100571401","NCT06719778","Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease","Prospective Interventional Study to Evaluate the Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease","LeakyDiet","Inclusion Criteria:\n\n* age more than 18 years\n* Crohn's Disease for at least 6 months (date of initial diagnosis)\n* with suspected food-induced symptoms or irritable bowel syndrome-like symptoms (fulfils IBS-Rom-IV criteria) for at least 3 months with moderate to severe symptom severity\n* stable IBD-specific medication dosage for at least 3 months \\[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\\].\n* inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment\n* clinical indication and performance of an initial esophagogastroduodenoscopy with confocal laser endomicroscopy with detection of a food-induced intestinal barrier disorder\n* signed informed consent form\n\nExclusion Criteria:\n\n* severe flare of Crohn's disease\n* artificial intestinal outlet\n* IgE-mediated type 1 allergy to CLE-tested foods (egg white, soy, milk, yeast, wheat)\n* macroscopic inflammation of the duodenum (detected via endoscopy)\n* pregnancy or breastfeeding\n* chronic alcohol or drug abuse\n* treatment with antibiotics within one month before the start of the study\n* Acute or chronic infectious, inflammatory or autoimmune intestinal diseases (such as coeliac disease, Whipples disease, lambliasis, eosinophilia, ulcerative colitis, infectious enterocolitis) or other organs (such as chronic hepatitis, autoimmune hepatitis, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)\n* malignant diseases affecting internal organs within the last 5 years (such as colorectal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, breast cancer)\n* severe mental disorders that impair the participant's ability to understand or follow the study protocol (e.g. uncontrolled schizophrenia, severe bipolar disorder, severe depression)\n* inability to give written consent or follow study protocols\n* participation in another therapeutic study within the last 30 days (except health services research)",{"count":273,"type":22},30,[25],"The goal of this prospective interventional study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms.\n\nThe main questions the study aims to answer are:\n\n* whether a food-induced intestinal barrier disorder in Crohn's disease patients can be detected by endoscopy using confocal laser endomicroscopy (CLE) and a causal relationship with certain foods can be established.\n* whether a change in diet or a targeted elimination diet can restore the defective integrity of the intestinal barrier detected by CLE.\n* to examine whether a targeted avoidance of a food that was identified by CLE to trigger intestinal barrier disruption leads to a relevant improvement in symptoms, quality of life and disease activity in patients with Crohn's disease.\n\nParticipants will undergo a two-stage nutritional therapy concept based on a two-week inpatient integrative medicinal lifestyle modification program that comprises nutritional therapy, stress management strategies, mind-body medicine, herbal medicine and exercise:\n\n* Initially, participants learn how to employ the comprehensive lifestyle modification concept and receive nutritional training on a mostly vegetarian Mediterranean wholefood diet.\n* In a first stabilization phase, lasting for 3 months, participants independently apply the taught Mediterranean diet and use strategies from the comprehensive lifestyle modification program.\n* In a second elimination phase, lasting for another 3 months, participants additionally avoid the particular food that was identified by CLE to induce an intestinal barrier defect.\n\nCrohn's disease patients will:\n\n* initially receive a clinically indicated endoscopy with CLE and food challenge to examine whether a food-induced intestinal barrier disorder is present\n* return to the clinic for an optional endoscopy with CLE and food challenge after the first (stabilization) phase as well as the second (elimination) phase\n* answer questionnaires at study start as well as after the first and the second study phase to analyze their quality of life, the severity of their symptoms and their disease activity\n* give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during regular inpatient sampling at study start as well as after the first and the second study phase\n* document their intake of food and their symptoms in an App-based diary throughout the study participation",[277],"Crohn's Disease",[279,280,281,282,283,284,285,286,190,287],"integrative medicine","lifestyle modification","intestinal barrier","Mediterranean diet","inflammatory bowel disease","Confocal Laser Endomicroscopy","Crohn Disease","microbiome","irritable bowel","2024-12-11",{"date":290,"type":41},"2024-12-16",{"date":292,"type":41},"2024-08-01",{"date":294,"type":22},"2027-04",{"name":47,"class":48},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":311,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":84},"100569773","wild-blueberries-in-colitis-100569773","NCT06698601","Wild Blueberries in Colitis","Impact of Wild Blueberries (Vaccinium Myrtillus) on the Intestinal Barrier, Microbiome and Inflammation in Chronic Colitis - a Prospective Randomized Crossover Study","BlueVantage","Inclusion Criteria:\n\n* age \\> 18 years\n* diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC) with mild to moderate colitis for at least 6 months (CD: Harvey-Bradshaw-Index Score 5-16; UC: Partial Mayo Score 2-6)\n* stable IBD-specific medication dosage for at least 3 months \\[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\\]\n* inpatient admission to the Department for Internal and Integrative Medicine at the Sozialstiftung Bamberg, Germany for regular treatment\n* clinical indication and performance of an initial colonoscopy with confocal laser endomicroscopy (CLE)\n* signed informed consent form\n\nExclusion Criteria:\n\n* IBD without inflammation of the colon (e.g. Crohn's Disease without colitis)\n* active flare of IBD\n* CRP ≥ 100 mg\u002Fl\n* artificial bowel outlet in front of the colon (ileostomy)\n* high regular consumption of blueberries (≥ 300 g cultivated blueberries or ≥ 150 g wild blueberries per week) or administration of blueberry therapy in the last 3 months\n* participation in another therapeutic study within the last 30 days\n* Known intolerance to blueberries or their ingredients such as contained anthocyanins or fructose (e.g. fructose malabsorption)\n* presence of known serious infectious diseases e.g. of the liver such as HIV, hepatitis B and C infection",{"count":305,"type":22},60,[25],"The goal of this exploratory, prospective, monocentric randomized crossover study is to investigate the influence of a blueberry-rich diet compared to a blueberry-poor diet on the microbiome, the intestinal barrier and the inflammatory process in IBD patients with chronic colitis.\n\nThe main question the study aims to answer is:\n\n* Does a diet rich in blueberries compared to a diet low in blueberries have an influence on disease activity, intestinal inflammation and symptoms in IBD patients with chronic colitis?\n\nUlcerative Colitis (UC) and Crohn's disease (MC) patients are recruited during an inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg, Germany. During their routine inpatient stay, patients are treated by an interdisciplinary team using a comprehensive multimodal integrative inpatient therapy concept that combines conventional medicine with a wide range of integrative non-pharmacological treatments, phytotherapy, lifestyle-modification and nutritional therapy. During this time, it is verified whether the patients can participate in the study.\n\nThe study consists of two study arms, which are conducted in a cross-over design:\n\n* Intervention arm: in this study arm, participants receive 12 weeks of blueberry therapy in addition to the regular two weeks of inpatient care at the Clinic for Internal and Integrative Medicine in Bamberg. The blueberry therapy includes drinking around 35 g of blueberry powder stirred into water once a day for 12 weeks.\n* Control arm: in this study arm, participants receive the standard therapy (integrative medical therapy concept described above) during the regular two-week hospital stay. There is no additional blueberry intake.\n\nDue to the crossover study design, all participants undergo both study arms. This means that each participant takes the supplementary blueberry powder (intervention) for a period of 3 months and the control therapy for 3 months. The order in which the participants receive the forms of therapy is determined randomly. Thus, half of the study participants start the supplementary blueberry intake directly after the inpatient stay, the second half three months later (cross-over principle).\n\nUC and MC patients will:\n\n* initially receive a clinically indicated colonoscopy with confocal laser endomicroscopy (CLE) during their routine inpatient stay at the Clinic for Internal and Integrative Medicine in Bamberg\n* return to the clinic for an optional sigmoidoscopy with CLE after 12 and 24 weeks\n* answer questionnaires at study start as well as after 12 and 24 weeks to analyze their quality of life, the severity of their symptoms and their disease activity\n* give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during the colonoscopy\u002Fsigmoidoscopy at study start as well as after 12 and 24 weeks\n* document their intake of blueberry powder as well as their symptoms and stool frequencies in a diary throughout the study participation",[309,310],"Ulcerative Colitis (UC)","Crohn Disease (CD)",[312,313,279,281,283,314,315,316,190,286,317,318],"ulcerative colitis","crohn disease","confocal laser endomicroscopy","wild blueberry","bilberry","inflammation","chronic colitis","2024-11-26",{"date":321,"type":41},"2024-11-27",{"date":323,"type":41},"2024-09-24",{"date":294,"type":22},{"name":47,"class":48},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":84},"100559212","functionality-of-albumin-in-the-context-of-hemodialysis-100559212","NCT06561191","Functionality of Albumin in the Context of Hemodialysis","Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment","FACED","Inclusion Criteria:\n\n* 18 years or older at least 3 month of hemodialysis treatment (3x\u002Fweek) with constant dialysis treatment regimen\n\nExclusion Criteria:\n\n* Age ≤ 18 years\n\n  * Less than three months of regular (3x\u002Fweek) hemodialysis treatments or less than 3 treatments\u002Fweek\n  * Acute or chronic liver disease (Child stage A or higher or fulfillment of the of the Kings College criteria)\n  * Infusion of commercial human albumin (e.g. in the context of ascites drainage) in the last three months prior to study inclusion\n  * Acute or severe chronic infections\n  * Acute tumor disease",{"count":335,"type":22},50,[25],"Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.\n\nThe aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.\n\nOur own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.\n\nPrevious results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.",[339,340,341,342],"Albumin","Dialysis","Redox State","Uremic; Toxemia","2024-08-17",{"date":345,"type":41},"2024-08-19",{"date":292,"type":41},{"date":348,"type":22},"2025-12",{"name":47,"class":48},""]