[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kliniken Essen-Mitte\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,68,93,120],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100616859","feasibility-of-a-lifestyle-intervention-for-women-with-triple-negative-breast-cancer-under-neoadjuvant-immunotherapy-100616859",false,"NCT07311083","Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy","Feasibility of a Lifestyle Intervention to Switch to a High-fiber, Gut-healthy Diet in Women With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy: a Randomized Controlled Trial","BallastImmun","Inclusion Criteria:\n\n* Female patients aged 18-75\n* Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy\n* Willingness to participate in the study and signed consent form\n\nExclusion Criteria:\n\n* Advanced stage of disease with metastases\n* Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study\n* Pregnancy\n* Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions\n* A diet that is incompatible with a high-fiber diet, such as the ketogenic diet\n* Abuse of drugs and\u002For alcohol\n* Inability to complete the questionnaires independently\n* Colectomy\n* Gastrointestinal stenosis\n* Fructose intolerance\n* Histamine intolerance\n* Gluten intolerance\n* Ketogenic diet\n* Unwillingness to refrain from taking probiotics for the duration of the study\n* Eating disorders\n* No laptop and\u002For camera available to participate in the online group training program","FEMALE","18 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients.\n\nStudies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved.\n\nThe aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.",[28],"Microbiome","RECRUITING","2026-05-05",{"date":32,"type":33},"2026-05-08","ACTUAL",{"date":35,"type":33},"2026-02-01",{"date":37,"type":22},"2027-07-01",{"name":39,"class":40},"Kliniken Essen-Mitte","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100548452","hemodynamic-effects-of-anesthesia-induction-100548452","NCT06421181","Hemodynamic Effects of Anesthesia Induction","KEM-HEN","Inclusion Criteria:\n\n* Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte\n* Due to the invasiveness of the planned surgery there is an indication for an arterial and central-venous line as well as an peridural catheter\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Lack of written informed consent\n* Insufficient language skills\n* Unwillingness to have pseudonymized disease data stored at the study site and lack of consent to share anonymized data as part of the clinical trial\n* American society of anaesthesiologists physical status higher as grade 3\n* congestive heart failure with a grade of 2 or higher according to the New York heart association (NYHA)\n* Ischemic cardiopathy with a grade of 2 or higher according to the Canadian cardiovascular society (CCS)\n* Known severe valve pathologies of the heart\n* Chronic kidney disease with dependency of hemodialysis\n* Atrial fibrillation ora trail flutter\n* Pulmonary hypertension",{"count":50,"type":22},30,"OBSERVATIONAL","The idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention (induction of anesthesia) in a highly controlled environment by two hemodynamic monitoring devices. The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion.\n\nBoth devices complement one another in their hemodynamic profiling ability. One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasound\u002Fechocardiography device with advanced possibilities for differential diagnostics.\n\nA second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert.",[54],"Patients Undergoing Anaesthesia Induction",[56,57,58,59,60],"Hemodynamic monitoring","Point-of-care ultrasound","Point-of-care echocardiography","Anaesthesia induction","Respiratory effects","2025-01-14",{"date":63,"type":33},"2025-01-15",{"date":61,"type":33},{"date":66,"type":22},"2026-06-30",{"name":39,"class":40},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100574871","integrative-and-complementary-therapy-for-episodic-migraine-and-tension-type-headache-100574871","NCT06764914","Integrative and Complementary Therapy for Episodic Migraine and Tension-type Headache","NAturheilkundliche Komplextherapie Bei Episodischer MIgräne Und KOpfschmerz Vom Spannungstyp","NAMIKOS","Inclusion Criteria:\n\n* Episodic migraine (\\\u003C15 headache days\u002Fmonth in the last 3 months)\n* Episodic tension headache (\\\u003C15 headache days\u002Fmonth in the last 3 months)\n* Mixed forms or parallel occurrence of both types of headache is permitted\n* Diagnosis confirmed in advance by a neurologist\n* Mandatory imaging to exclude another cause of headache before or during hospitalisation (cMRI or cCT)\n* Participation in the integrative headache supply programm oft the health insurence provider Barmer Ersatzkasse and Techniker Krankenkasse\n* Signed declaration of consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Chronic migraine (15 migraine days in the last 3 months) or chronic tension type headache\n* Medication-induced headache\u002Fpainkiller abuse (\\> 10 triptans\u002Fcombination analgesics\u002Fergotamines\u002Fopiates or \\>15 classical analgesics per month)\n* Acute severe mental illness (e.g. severe depression with suicidal tendencies)\n* Acute, severe physical illness that prevents participation in the inpatient naturopathic programme or emergency inpatient treatment of a different kind (e.g. ongoing treatment of a cancer severe acute illness of the cardiovascular system such as heart attack, stroke, acute insufficiency of other organs (kidney, liver, etc.), other severe acute neurological diseases, e.g. relapse of multiple sclerosis, uncontrolled epilepsy)\n* Pregnancy\u002Flactation period\n* Simultaneous participation in other clinical studies\n* No consent","ALL",{"count":78,"type":22},130,"This study is a monocentric uncontrolled observational study to evaluate a 12-14 day inpatient stay in an internal medicine clinic for integrative and complementary medicine for patients with episodic migraine and\u002For episodic tension headache. The aim is to investigate the extent to which a 14-day inpatient stay can influence a reduction in headache days and\u002For pain intensity, medication use, quality of life, anxiety, depression, perceived stress, general well-being, and a reduction in sick days\u002Fwork absenteeism, and prevent the chronification of migraine and may counteract the chronification of migraine or tension-type headache. In addition, patients' previous experiences with complementary naturopathic therapies, expectations and perceived benefits in everyday life will be analysed.",[81,82],"Migraine","Headache, Tension-Type",[81,82],"NOT_YET_RECRUITING","2025-01-08",{"date":87,"type":33},"2025-01-09",{"date":89,"type":22},"2025-01-01",{"date":91,"type":22},"2031-01-01",{"name":39,"class":40},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":76,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100543399","association-of-intraoperative-hemodynamic-characteristics-to-postoperative-complications-and-mortality-100543399","NCT06355362","Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality","HeCoMo","Inclusion Criteria:\n\n* Patients undergoing elective surgery with increased postoperative morbidity and\u002For increased postoperative mortality\n\nExclusion Criteria:\n\n* Patients undergoing surgery in the field of obstetrics\n* Age \\\u003C 18 years\n* Lack of written informed consent\n* Lack of language understanding\n* Unwillingness to store disease data on site and share anonymised data as part of the clinical trial",{"count":101,"type":22},1000,"Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.\n\nThe aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.\n\nIn the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.\n\nIn addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities.",[104],"High-risk Surgery",[106,107,108,109,110,111],"hemodynamic","transfusion","perioperative process quality","intensive care medicine","complications","mortality","2024-07-25",{"date":114,"type":33},"2024-07-26",{"date":116,"type":22},"2024-09-01",{"date":118,"type":22},"2025-06-30",{"name":39,"class":40},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":76,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100474788","tad-in-primary-breast-cancer-with-initially--3-suspicious-lymph-nodes-100474788","NCT05462457","TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes","Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)","SenTa2","Inclusion Criteria:\n\n* signed informed consent form\n* female\u002Fmale patient aged ≥ 18 years\n* clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed\n* invasive breast cancer confirmed by core biopsy\n* clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes\n* biopsy-proven axillary lymph node involvement\n* marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST\n* without distant metastases\n* indication for NST including chemotherapy\n* TAD + ALND planned\n* at least 7 lymph nodes (TAD + ALND) planned for histological analysis\n\nExclusion Criteria:\n\n* cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes\n* patients without indication for NST or NST \\\u003C 12 weeks\n* NST without chemotherapy\n* adjuvant\u002F neoadjuvant therapy already started prior to inclusion in the study\n* patients for whom only ALND is planned\n* ycN+ (by means of axillary ultrasound or other imaging methods)\n* recurrent breast cancer\n* larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study\n* previous radiotherapy of the breast or axilla\n* inflammatory breast cancer\n* extramammary breast cancer\n* pregnant women\n* not able to undergo surgery\n* inability to understand the purpose of the clinical study or to comply with study conditions",{"count":129,"type":22},150,"Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0\u002FTis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.\n\nThe present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.",[132,133],"Breast Cancer","Node-positive Breast Cancer",[135,136,137],"Targeted axillary dissection","TAD","False-negative rate","2023-02-13",{"date":140,"type":33},"2023-02-15",{"date":142,"type":33},"2022-03-07",{"date":144,"type":22},"2032-03",{"name":39,"class":40},""]