[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital Tuebingen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":615},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,83,0,25,[9,51,74,106,136,149,179,203,221,249,272,296,322,344,368,395,416,444,472,493,519,539,555,571,588],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053255",false,"NCT07151378","Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease","INITIATE-LECIG","Inclusion Criteria:\n\n* Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures. 2. Able to adhere to the study visit schedule and other protocol requirements. 3. Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during the study (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner2, sexual abstinence3).\n\n  1. For the purpose of this document, a female is considered of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. For the purpose of this document, a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy\n  2. Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success\n  3. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 4. All subjects must agree not to share medication. 5. Diagnosis of Idiopathic PD, inclusive of familial PD and genetic forms of L-Dopa responsive PD Age 18 - 75 years 7. Age at Parkinson's disease onset before 65 years 8. Disease duration ≥ 5 years 9. Oral medication constant for four weeks prior to baseline visit 10. Oral treatment with L-Dopa and non-ergot dopamine agonist(s) (any preparation, any dosage) 11. Presence of dopaminergic motor fluctuations based on patient history 12. Presence of dopaminergic neuropsychiatric (affective) fluctuations based on patient history 13. Presence of behavioural hyperdopaminergic syndrome including clinically relevant neuropsychiatric behavioural abnormalities according Ardouin Behavioural Scale Section 1, hypomanic symptoms, psychosis + Section 4 hyperdopaminergic behaviours (score ≥ 3), eventually further accompanied by impulse control disorders, a\u002Fo dopamine dysregulation, syndrome, a\u002Fo hallucination - psychosis spectrum; in case symptoms of the hallucination\u002Fpsychosis or hypomania-mania spectrum are present, retained insight is mandatory at the time of study enrolment\n\nExclusion Criteria:\n\n* 1.Women during pregnancy and lactation. 2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 3. Participation in other clinical trials or observation period of competing trials over the past three months 4. Patients suffering from cognitive impairment (MoCA \\\u003C 21) will be excluded for the major reason to obtain valid Ardouin assessments that will be hampered in case cognitive impairment (and therefore insight) is too severe 5. Acute paranoid psychosis without retained insight (however impulse control disorder or dopamine dysregulation syndrome are not an exclusion criterion; illusions or (pseudo)-hallucinations are not an exclusion criterion as long as there is no endangerment of the patients themselves or other persons owing to clinical judgement; patients may be eligible after remission of psychosis\u002Fsuicidality) 6. Severe depression according to ICD-10 criteria; however, affective fluctuations with intermittent depressive symptoms (reversed by dopaminergic medication) are not an exclusion criterion 7. Active suicidality without self-distancing (however, suicidal ideation\u002Fthoughts or passive wishes of being dead are not an exclusion criterion as long as the patient is credibly distancing from it). 8. General contraindications for intestinal L-Dopa therapy (according to Lecigon® Fachinformation) 9. Gastrointestinal contraindications against PEG-J tube placement 10. Tremor-dominant PD without dopaminergic response fluctuationt Pre-existing device assisted therapy (DAT) immediately before study enrolment including with DBS, LCIG\u002FLECIG, or subcutaneous therapy with apomorphine or foslevodopa; if patient terminated pre-existing subcutaneous therapy, the patient will be eligible after having received oral dopamine replacement therapy for at least 3 months 12. Malignancy in a non-remitted stage","ALL","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the \"hyperdopaminergic symptoms\" corresponding to section 3 of the \"Ardouin Behavioural Scale\" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.",[27],"PARKINSON DISEASE (Disorder)",[29,30,31,32,33,34,35,36,37],"LECIG","device assisted therapy","motor and non-motor fluctuations","dopaminergic complications","impulse control disorder","levodopa seeking","dopamine dysregulation syndrom","dopamine agonist","intestinal levodopa","RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":42},"2025-10-27",{"date":46,"type":21},"2030-09-22",{"name":48,"class":49},"University Hospital Tuebingen","OTHER",7,{"id":52,"slug":4,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100538474","NCT06291311","Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants","Treatment of Infections of the Cervix Uteri With High- and Low-risk Variants of the Human Papillomavirus Using Non-invasive Physical Plasma","Inclusion Criteria:\n\n* Inclusion criteria for NIPP treatment\n\n  * Age ≥ 18 years\n  * mRNA or DNA-based virus detection by smear (also external findings)\n  * Clearly visible transformation zone of the cervix and margins of the lesions corresponding to T1\u002FT2\n  * Written informed consent to participate in the study\n* Inclusion criteria for control group\n\n  * Age ≥ 18 years\n  * Swab-based mRNA or DNA-based virus detection (also external findings)\n  * Clearly visible transformation zone of the cervix corresponding to T1\u002FT2\n  * Written informed consent to participate in the study\n\nExclusion criteria:\n\nThe following exclusion criteria apply to both groups of patients (NIPP treatment and control group).\n\n* Transformation zone not fully visible\n* Evidence of invasive disease\n* Serious cardiovascular diseases","FEMALE",{"count":59,"type":21},50,"OBSERVATIONAL","This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen.",[63,64],"HPV Infection","Cervical Cancer","2026-06-25",{"date":67,"type":42},"2026-06-30",{"date":69,"type":42},"2023-12-27",{"date":71,"type":21},"2026-12",{"name":48,"class":49},1,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100642906","NCT07644754","Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng\u002Fml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases","RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease","RIALTO","Inclusion Criteria:\n\n* Prostate adenocarcinoma\n* de novo metastasized prostate cancer (at least 4 osseous metastases +\u002F- lymphonodal metastases)\n* first-line combined antihormonal therapy (ADT + ARPI) for six months\n* PSA \\> 0,2 ng\u002Fml after six months of combined ADT\u002FARPI therapy\n* multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)\n* \\\u003C16 osseous\u002Flymphnodal metastases on response assessment imaging (PSMA-PET\u002FCT) after six months of combined antihormonal therapy\n\nExclusion Criteria:\n\n* neuroendocrine histology\n* visceral metastases (M1c)\n* prior radiotherapy to the pelvis\n* PSA \\\u003C 0,2 ng\u002Fml after 6 months of combined antihormonal therapy\n* prior prostatectomy\n* contraindication against PSMA-PET\u002FCT and\u002For radiotherapy to the prostate\u002Fmetastases\n* HIFU or TUR-P within 6 months of study treatment\n* other active malignancy two years prior to study inclusion (except skin cancer in remission)\n* relevant GU\u002FGI condition (active fistula or other)\n* known tumor predisposition syndrome","MALE","85 Years",{"count":84,"type":21},27,[86],"NA","The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (\\>0,2 ng\u002Fml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.\n\nThe main questions it aims to answer are:\n\n• Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.\n\nParticipants will:\n\n* Continue taking combined androgen-deprivation therapy\n* Receive a total of three PSMA-PET\u002FCT scans\n* Receive radiotherapy to the prostate and PET-positive metastases\n* Visit the clinic every three months for 36 months\n* Complete quality of life questionnaires at every visit",[89,90,91],"Prostate Cancer","Prostate Cancer Metastatic Disease","Prostate Cancer Metastatic to Bone",[93,94,95,96],"mHSPC","insufficient PSA-response to dual antihormonal treatment","local therapy","radiotherapy","NOT_YET_RECRUITING","2026-06-08",{"date":100,"type":42},"2026-06-12",{"date":102,"type":21},"2026-07",{"date":104,"type":21},"2031-02",{"name":48,"class":49},{"id":107,"slug":4,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":16,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":73},"100588268","NCT06939192","E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families","E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach","NeoUp2","Inclusion Criteria:\n\n* Premature babies born at the UKT,\n* Gestational age 28-34 weeks,\n* Mother: age ≥ 18 years,\n* agreement to participate in this study and signing of a consent form,\n* sufficient knowledge of German,\n* internet access\n\nExclusion Criteria:\n\n* Premature babies \\\u003C 28th or \\>34th week of pregnancy,\n* at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,\n* at least one of the children has serious congenital diseases or suffers from malformations,\n* Mother: Lack of access to a smartphone\u002Ftablet,\n* no internet access,\n* insufficient knowledge of German",true,"28 Weeks","34 Weeks",{"count":117,"type":21},120,[86],"The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.",[121],"Preterm Birth",[123,124,125,126,127],"Preterm birth","E-health","Risk factors","Protective factors","Prevention","2026-06-04",{"date":130,"type":42},"2026-06-09",{"date":132,"type":42},"2024-01-31",{"date":134,"type":21},"2027-12-31",{"name":48,"class":49},{"id":137,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":25,"conditions":140,"keywords":141,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":147,"locationsCount":148},"100604581",{"count":20,"type":21},[24],[27],[29,30,31,32,33,34,35,36,37],"2026-05-20",{"date":144,"type":42},"2026-05-22",{"date":44,"type":42},{"date":46,"type":21},{"name":48,"class":49},4,{"id":150,"slug":4,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100506179","NCT05871021","Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma","A Phase IIa, Open-label, Multicenter Study of Radiochemotherapy With Isotoxic Dose Escalation and Protective VEGF Inhibition Using Bevacizumab in the Treatment of Patients With First Diagnosis of IDH Wild-type, MGMT Unmethylated Glioblastoma","PRIDE","Inclusion Criteria:\n\n* IDH wild-type, MGMT unmethylated glioblastoma patients\n* Informed consent\n* Age ≥18 and ≤70 years, smoking or non-smoking, of any ethnic origin\n* ECOG 0-2\n* Neutrophil counts \\>1500\u002Fµl, Platelet counts \\>100.000\u002Fµl, Hemoglobin \\> 8 g\u002Fdl, Serum creatinine \\\u003C1.5-fold upper limit of normal (ULN), Bilirubin, AST or ALT \\\u003C2.5-fold ULN unless attributed to anticonvulsants, Alkaline phosphatase \\\u003C2.5-fold ULN\n* Adequate contraception\n* Serum creatinine ≤ 1.5 x ULN AND patients with urine dipstick for proteinuria \\\u003C 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should show urine protein to creatinine ratio ≤ 1\n\nExclusion Criteria:\n\n* Evidence of significant hemorrhage on postoperative MRI of the brain. Patients with asymptomatic, minor hemosiderin deposition, resolving postsurgical hemorrhagic changes, or punctate intratumoral hemorrhage (e.g., related to biopsy or surgery) are not excluded\n* Subjects on any drug suspected to interfere with bevacizumab at the time of study inclusion\n* Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)\n* Known hypersensitivity to any component of the investigational drugs or excipients (allergy to or other intolerability of bevacizumab or excipients)\n* Any other significant medical illness or medically significant laboratory finding that would, in the investigator's judgement, make the patient inappropriate for this study, or would increase the risk associated with the patients' participation in the study\n* Incapability to undergo MRI\n* Prior treatment with bevacizumab for any indication\n* Contraindication and\u002For hypersensitivity to bevacizumab or its excipients. For details check the Summary of Product Characteristics Aybintio®\n* Significant cardiovascular disease defined as congestive heart failure (NYHA Class II, III, IV), unstable angina pectoris, or myocardial infarction within 6 months prior to enrolment\n* Inadequately controlled hypertension (defined as a blood pressure of \\> 150 mmHg systolic and\u002For \\>100 mmHg diastolic on medication), or any prior history of hypertensive crisis or hypertensive encephalopathy\n* History of clinically significant cerebrovascular events within 6 months prior to enrolment. This includes ischemic stroke or transient ischemic attack. Small, clinically silent perioperative ischemic changes are not exclusionary.\n* Significant vascular disease (e.g. aortic aneurysm, aortic dissection or recent peripheral arterial thrombosis) within 6 months prior to enrolment\n* Evidence or history of recurrent thromboembolism (\\> 1 episode of deep venous thrombosis \u002F peripheral embolism) during the past 2 years\n* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)\n* Chronic daily intake of aspirin \\> 325 mg\u002Fday or clopidogrel \\> 75 mg \u002Fday\n* History of intracranial abscess within 6 months prior to inclusion\n* History of abdominal or tracheo-oesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrolment\n* History of ≥ grade 2 hemoptysis according to NCI-CTC criteria within 1 month prior to inclusion\n* Serious non-healing wound, ulcer or bone fracture","70 Years",{"count":158,"type":21},146,[160],"PHASE2","Glioblastoma is the most aggressive brain tumor and often recurs locally despite intensive treatment. Standard chemoradiotherapy with 60 Gy may not be sufficient to control the tumor, and dose escalation seems to be warranted, but causes more toxicity. To address this, the multicentric PRIDE trial employs two cycles of bevacizumab to achieve dose escalation isotoxically. The goal is improved survival without significantly increasing side effects. The study uses a simultaneous integrated boost with a total dose of 75 Gy in 2.5 Gy per fraction.",[163],"Glioblastoma",[165,166,167,168,169],"Dose escalation","bevacizumab","VEGF inhibition","FET PET","VMAT","2026-05-15",{"date":172,"type":42},"2026-05-18",{"date":174,"type":42},"2024-04-10",{"date":176,"type":21},"2028-07-10",{"name":48,"class":49},9,{"id":180,"slug":4,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":148},"100485384","NCT05600374","Brain-Oscillation-Synchronized Stimulation to Enhance Motor Recovery in Early Subacute Stroke","Boss-Stroke","Inclusion Criteria:\n\nSubjects meeting all of the following criteria will be considered for admission to the trial:\n\n1. Age ≥ 18 years at the time of signing the informed consent.\n2. Cerebral ischemia identified by brain imaging (cerebral MRI or CT) occurred 1-14 days ago.\n3. Subject understands and voluntarily signs an informed consent document prior to any study related assessments\u002Fprocedures.\n4. Stroke has resulted in a new arm-\u002Fhand motor deficit with ≤ 50 points in the FMA-UE.\n5. Presence of motor evoked potentials (MEPs) in the paretic hand. MEPs has to be obtained in the resting muscle\n\n   o If no MEPs can be obtained, MEP search procedure can be repeated later up to 14 days after stroke onset.\n6. ● μ-oscillation (8-12 Hz) is recordable by EEG in the ipsilesional sensorimotor cortex with a sufficient signal-to-noise ratio of at least 3 dB\n7. ● Subject is able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following criteria will not be included in the trial:\n\n1. Hemorrhagic stroke (this refers to primary intracerebral hemorrhage only; hemorrhagic transformation of ischemic infarcts is not an exclusion criterion)\n2. Estimated life expectancy \\\u003C 12 months\n3. Presence of intracranial ferromagnetic metal (extracranial stents ≥10 cm away from the TMS coil are acceptable) in accordance with current safety guidelines \\[18\\]\n4. Intraocular metal, cochlear implants\n5. If TMS might interact with sensors of active implants (e.g., intra-cardiac defibrillators).\n6. If a cranial bone gap affects currents induced by TMS (such as after craniotomy).\n7. History of seizures or epilepsy.\n8. Treatment intervention can't be started within 14 days after onset of stroke.\n9. Women during pregnancy and lactation.\n10. Participation in other studies if they are MDR or AMG studies or there is otherwise a high risk of insurance law issues intervening between two studies. In case of uncertainty, competing insurances must be contacted prior to participation\n11. persistent addiction disorder (except for nicotine dependence)\n12. CNS malignoma\n13. If there is any concern by the investigator regarding the safe participation of the subject in the study or for any other reason the investigator considers the subject inappropriate for participation in the study.\n14. The ability to consent for patients who are unable to speak will be assessed on the basis of the NIHS-Score by an independent physician (details see chapter 21 and appendix).",{"count":186,"type":21},144,[86],"We will investigate the therapeutic efficacy of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) in the early subacute phase after ischemic stroke to improve upper limb motor rehabilitation. We hypothesize that synchronization of rTMS with the phase of the ongoing sensorimotor oscillation indicating high corticospinal excitability leads to significantly stronger improvement of paretic upper limb motor function than the same rTMS protocol non-synchronized to the ongoing sensorimotor oscillation or sham stimulation.",[190],"Ischemic Stroke, Acute",[192,193,194,195],"Oscillation","motor recovery","Transcranial magnetic stimulation","EEG-synchronized","2026-05-14",{"date":170,"type":42},{"date":199,"type":42},"2023-02-06",{"date":201,"type":21},"2028-02-28",{"name":48,"class":49},{"id":204,"slug":4,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":73},"100581058","NCT06845371","MELODY Registry Follow-Up Study","Inclusion Criteria:\n\n* previous inclusion in the MELODY Registry\n\nExclusion Criteria:\n\n* none",{"count":209,"type":21},845,"Extension of the MELODY Registry, to assess longterm follow-up clinical results of Melody valve implantation after its commercialization in Europe \u002F OUS",[212],"Congenital Heart Disease (CHD)","2026-04-28",{"date":215,"type":42},"2026-05-04",{"date":217,"type":42},"2026-04-01",{"date":219,"type":21},"2027-08-01",{"name":48,"class":49},{"id":222,"slug":4,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":226,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":148},"100523316","NCT06094101","Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)","Prospective Phase I\u002FII Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment","PerVision","Inclusion Criteria, definition of partial remission plus (PRplus)\n\n* Screening Stage 1:\n\n  * Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.\n  * Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER (Register study Molecularly Aided Stratification for Tumor Eradication) or HEROES-AYA networks (Heterogeneity, evolution and resistance of fusion-driven sarcomas in AYA) or similar evaluation.\n* Screening stage 2:\n\n  * Design and production of the patient-individual vaccine cocktail was successful\n  * Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and\u002For maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed. Definition of PRplus: Partial remission(plus) implicates that all remaining tumor residua including all metastases have received local therapy by this time point: Either surgical removal or local irradiation. The assessment of which therapy modality and, in the case of irradiation, which radiation dose is selected, lies with the treating physician. Whether PRplus is achieved will be decided finally by the investigator after review of the patient records.\n\nExclusion Criteria:\n\n* Ejection fraction \\\u003C 25%\n* Creatinine-clearance \\\u003C 40ml\u002Fmin\n* Bilirubin \\> 4mg\u002Fdl\n* Alanine aminotransferase (ALT) \\> 400 units (U)\u002Fl and\u002For aspartate aminotransferase (AST) \\> 400 U\u002Fl\n* Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen\u002Fantibody or nucleic acid tests \\[NAT\\]) and CD4-positive cells \\\u003C 500\u002Fμl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\]) and hepatitis B NAT test \\> 2000 IU\u002Fml). Hepatitis C virus: positive for heavy chain only antibody \\[HCAb\\] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)\n* Subjects with a known hypersensitivity \u002F allergy to any component of the study drugs.\n* Subjects who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).\n* Subjects with a prior haematopoietic stem cell transplantation \u002F prior organ transplantation.\n* Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.\n* Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence functionality and activity of T cells, such as steroids (more than 0,5 mg\u002Fkg body weight prednisolone-equivalent), calcineurin-inhibitors, mofetil mycophenolate, sirolimus, everolimus, and cytotoxic medication. Those drugs should be avoided until 28 days after third\u002Ffinal vaccination but may be given after discussion with the principal investigator. Application of tyrosine kinase inhibitors is permitted during the trial (only stage 2).\n* Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.\n* Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy\u002Fleucoencephalopathy (\\> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).\n* Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment\n* Pregnant females\n* Female subjects of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior to Screening stage 2 visit to 180 days after the last vaccination.\n* Male subjects of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.\n* Not willing and\u002For not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.\n* History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may include but is not limited to: history of central nervous system or cardiovascular disease, history of relevant drug allergies, history of psychiatric disorder, history or present of clinically significant pathology.\n* Karnofsky performance status of \\\u003C 70% for subjects ≥ 16 years of age, Lansky performance status of \\\u003C 70% for subjects \\\u003C 16 years of age\n* Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the \"frontline and relapsed rhabdomyosarcoma study\"( (FaR-RMS) after completion of the maintenance therapy (EudraCT-2018-000515-24)). Commonly used drugs as per standard or phase III-trials are permitted.","2 Years","40 Years",{"count":231,"type":21},30,[233,160],"PHASE1","The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.\n\nThis approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.\n\nIt is an interventional, multicenter, open-label, phase I\u002FII feasibility and early proof of concept study evaluating a personalized peptide vaccine.\n\nPrimary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.",[236,237,238],"Ewing Sarcoma","Rhabdomyosarcoma","Synovial Sarcoma",[240,241,242],"metastasized fusion-driven sarcoma","clinical study","phase I\u002FII",{"date":215,"type":42},{"date":245,"type":42},"2023-09-19",{"date":247,"type":21},"2027-09",{"name":48,"class":49},{"id":250,"slug":4,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":73},"100418680","NCT04731857","Diagnostic Value of Exome\u002F Genome Sequencing, Conventional Methods in Rare Diseases and Familial Tumor Syndromes","Diagnostic Value of Exome and Genome Sequencing as Well as Conventional Methods in Rare Diseases and Familial Tumor Syndromes","EXGEFATU","Inclusion Criteria:\n\n* Patient with genetic disease or\n* Family members\n* Genetic analysis between 10\u002F2016 and 12\u002F2020 at the Institute for Medical Genetics and Applied Genomics at the University Hospital Tübingen\n\nExclusion Criteria:\n\n\\- None",{"count":257,"type":21},12000,"For the retrospective data analysis, patients with genetic diseases of any age and, if available, other family members, for whom genetic analyzes were carried out between 10\u002F2016 and 12\u002F2020, should be included. This equates to approximately 13,000 records, minus combined analyzes in the same patient, an estimated 12,000 individuals.",[260,261],"Rare Diseases","Genetic Predisposition",[260,261,263,264,265,266],"Next Generation Sequencing (NGS)","Polygenic risk scores (PRSs)","Repeat-Expansion","Genetic variation",{"date":215,"type":42},{"date":269,"type":42},"2021-02-18",{"date":104,"type":21},{"name":48,"class":49},{"id":273,"slug":4,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},"100409100","NCT04607096","Intermittent Fasting to Improve Insulin Secretion","IFIS","Inclusion Criteria:\n\n* Body mass index (BMI) between 25 - 40 kg\u002Fm²\n* Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures.\n* Subjects with prediabetes (IFG and\u002For IGT, HbA1c 5,4 % - 6,4 %, subphenotype cluster 3 or 5) or\n* Subjects with type 2 diabetes mellitus (diagnosed \\\u003C5 years prior to screening), HbA1c 6.0% - 9.5%, not receiving insulin or thiazolidinediones, and with an appropriate washout period for all other antidiabetic medications)\n\nExclusion Criteria:\n\n* Subjects with diabetes mellitus type 1 (GAD-, IA2-AB positive)\n* Women during pregnancy and lactation\n* Treamtent with any medication effecting on glucose metabolism like anti-diabetic drugs or steroids\n* Subjects with a haemoglobin (Hb) ≤ 11.5 g\u002Fdl (for males) and Hb ≤ 10.5 g\u002Fdl (for females) at screening\n* Any pancreatic disease\n* Medical history of cancer and\u002For treatment for cancer within the last 5 years.\n* Known current presence or history of severe neurological or psychiatric diseases, schizophrenia, bipolar disorder\n* Known history of bariatric surgery\n* Severe liver or kidney diseases (Alanine Aminotransferase (ALT \\[SGPT\\]), Aspartate Aminotransferase (AST \\[SGOT\\]) above 3 x upper limit of normal (ULN) or Glomerular Filtration Rate (eGFR) ≤ 60 ml\u002Fmin (MDRD formula)\n* Systemic infection (CRP \\> 1 mg\u002Fdl)\n* Severe diabetic complications like chronic kidney disease (CKD), proliferating retinopathy or symptomatic cardiovascular disease\n* Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.\n* Persons with limited temperature sensation and \u002F or elevated sensitivity to warming of the body\n* Persons with a hearing disorder or a increased sensitivity for loud noises\n* Claustrophobia\n* Participation in other clinical trials or observation period of competing trials up to 30 days prior to this study\n* Refusal to get informed of unexpected detected pathological findings",{"count":279,"type":21},200,[86],"Type 2 diabetes (T2D) mellitus is a challenge for health care systems as the numbers increases constantly. In 2014, 422 million people had been living with diabetes worldwide. The absolute numbers of people with prediabetes have also grown substantially over 25 years worldwide. In Germany, about 10% of the population has T2D and another 21 % of the population has prediabetes.Overall, 16% of all deaths in Germany are attributable to type 2 diabetes. Macro- and microvascular complications of diabetes imply a significant threat for the patients and are already present in the prediabetic state. Short term and long term complications, the burden of treatment, and reduced quality of life are major burdens of the disease. Accumulating data indicate that currently recommended therapeutic diet regimens in patients with obesity and diabetes are not sustainable on the long term. Novel concepts are therefore urgently needed.\n\nT2D occurs when insulin secretion from pancreatic beta-cells cannot sufficiently be increased to compensate for insulin resistance. Causes of beta-cell dysfunction are heterogeneous. In addition, the most important determinants of diabetes remission are the extend of weight loss and restoration of beta-cell function. In the course of diabetes progression, the inability to recover insulin secretion might identify the state of no return to normal glucose tolerance. It is therefore crucial to improve insulin secretion in treatment and prevention of diabetes. Up to now lifestyle intervention trials in prediabetes or pharmacological intervention trials in diabetes did not show improvement of insulin secretion after intervention. However, one recent small human trial shows that intermittent fasting (early time restricted fasting) is able to improve insulin secretion.Currently, there are no trials that examine the effect of intermittent fasting in individuals with a broad range of impaired glucose metabolism (from prediabetes to diabetes). Recently novel subtypes of diabetes and prediabetes with high risk for the early manifestation of diabetes complications have been identified. Currently, prevention strategies for this high risk individuals have not been examined yet. We will study for the first time the effectiveness of 4 weeks intermittent fasting on changes in insulin secretion capacity in subphenotypes of diabetes and in prediabetes.",[283,284,285,286],"PreDiabetes","Diabetes type2","Intermittent Fasting","Insulin Secretion","2026-04-20",{"date":289,"type":42},"2026-04-21",{"date":291,"type":42},"2021-04-08",{"date":293,"type":21},"2027-03-01",{"name":48,"class":49},8,{"id":297,"slug":4,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":81,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":178},"100622057","NCT07378670","DEfeating PEnile CAncer-2","Robot-assisted vs. Open Inguinal Lymphadenectomy for Penile Cancer - a Prospective Randomized Trial With a Supporting Translational Program","DEPECA-2","Inclusion Criteria:\n\n* 1\\. Patient has provided written informed consent.\n* 2\\. Male patient ≥ 18 years at time of signing the informed consent form.\n* 3\\. Patient has histologically proven penile squamous cell carcinoma.\n* 4\\. Patient has indication for prophylactic (intermediate or high-risk primary tumor and cN0) or therapeutic (cN1\u002F2) inguinal lymphadenectomy, i.e.:\n\n  * pT1a, G2, cN0 OR\n  * pT1b- pT3, any G, cN0 OR\n  * pT1-pT3, any G, cN1-2\n* 5\\. Patients has adequate hepatic, renal and bone marrow function:\n\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Absolute neutrophil count ≥ 1.5 x 109 \u002FL\n  * Platelets ≥ 100 x 109 \u002FL\n  * International normalized ratio (INR) \u002F activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants. Anticoagulation is accepted according to the surgeon's practice.\n* 6\\. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.\n* 7\\. Performance status of the patient is judged by the treating physician as appropriate to undergo surgery.\n\nExclusion Criteria:\n\n* 1\\. Patients has inguinal bulky disease ≥ 4 cm (determined by ultrasound or cross-sectional imaging).\n* 2\\. Patient has distant metastases.\n* 3\\. Patient receives or is scheduled for neoadjuvant chemotherapy for PeCa.\n* 4\\. Patient received previous major inguinal surgery (transabdominal laparoscopic inguinal hernia repair is permitted), lymph node resection or radiotherapy in the groin or pelvic area.\n* 5\\. Patient participates in competing trials affecting the effects of the surgery or outcome measures.\n* 6\\. Patient has addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences.\n* 7\\. Patient has any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.\n* 8\\. Patient has been incarcerated or involuntarily institutionalized by court order or by the authorities.\n* 9\\. Patient is unable to consent because he does not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.",{"count":304,"type":21},80,[86],"Open inguinal lymphadenectomy (O-ILAD) is the current standard of care for invasive staging and simultaneously the curative approach for patients with PeCa and elevated risk for or clinically detectable lymphatic disease in the groin. The high rate of complications of this surgical procedure, which are often mutilating and associated with a long-term convalescence, leads to a critical delay in initiation of adjuvant systemic therapy. Being in apprehension of these postsurgical adversities, physicians are often reluctant with indicating this procedure, thus depriving their patients of the vital prognosis-relevant care. In the sum, these obstacles inevitably result in inferior oncologic outcomes. Aiming to decrease postsurgical detrimental sequelae, several attempts to modify radicality of the technique, including inter alia a radioguided approach of sentinel lymph node resection, have been presented in the last decades. Unfortunately, utilization of the sentinel lymph node technique outside of a few highly specialized referral centers is prone to a significant false negativity, while other approaches are associated with inconsistent oncological and perioperative outcomes, hence precluding a general breakthrough in the surgical management of the groin lymph nodes. Thus, a high unmet medical need exists for the establishment of an approach with the lowest possible rate of complications and at the same time the optimal oncological safety.\n\nIn this context, preliminary evidence from small sample studies points to a promising potential of minimally invasive surgery to be further tested in the setting of inguinal lymphadenectomy. A recent retrospective single-center report on robot-assisted inguinal lymphadenectomy (R-ILAD) showed that the rate of major complications was only as low as 2%. On the contrary, the rate of major complications in our own and other O-ILAD series was approx. 30%.\n\nDEPECA-2 is a prospective randomized multicenter trial, in which R-ILAD will be tested vs. O-ILAD on the 1b level of evidence for the first time. The scientific value of the project is significantly substantiated by a comprehensive translational research program, which includes inflammatory and oncologic biomarker research, as well as functional validation in preclinical models. The results of this trial will foster further optimization of outcomes in the surgical management of PeCa.",[308,309],"Penile Cancer","Penile Neoplasms Malignant",[311,312,313],"robotic inguinal lymph node dissection","inguinal lymphadenectomy","surgical outcome","2026-04-11",{"date":316,"type":42},"2026-04-15",{"date":318,"type":42},"2026-04-10",{"date":320,"type":21},"2031-11-30",{"name":48,"class":49},{"id":323,"slug":4,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":329,"studyType":60,"phases":4,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":50},"100527303","NCT06146010","Non Interventional German Leptomeningeal Disease Register","Deutsches Meningeosis Neoplastica Register","Inclusion Criteria:\n\n* Patients with leptomeningeal disease\n* Written consent of the patient or legal guardian.\n* Capacity to give consent or legal guardianship\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Lack of informed consent from the patient\n* Lack of capacity to consent on the part of the person concerned or lack of legal guardianship\n* Age \\\u003C 18 years",{"count":59,"type":21},"5 Years","The planned multicenter register is intended to create a database in the form of a cancer register on the incidence and course of disease in Germany of leptomeningeal disease, the therapeutic measures administered in the real world and the complications.",[332,333],"Meningeal Neoplasms","Leptomeningeal Disease",[335],"Meningeosis Neoplastica","2026-04-02",{"date":338,"type":42},"2026-04-08",{"date":340,"type":42},"2024-06-26",{"date":342,"type":21},"2029-12",{"name":48,"class":49},{"id":345,"slug":4,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":113,"sex":57,"minAge":17,"maxAge":229,"enrollmentInfo":349,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":73},"100526102","NCT06130371","Stress, Inflammation and Neuroimaging in Major Depressive Disorder as Compared to Premenstrual Dysphoric Disorder","Inclusion Criteria:\n\n* Women,\n* age between 18 and 40 years (no menopausal women),\n* regular menstrual cycles (25-31 days),\n* normal body mass index (18-35 kg\u002Fm2),\n* German language fluency\n\nExclusion Criteria:\n\n* any neurological or mental disease (only for healthy participants)\n* hormonal, metabolic or chronical diseases\n* pregnancy\n* women who gave birth or were breastfeeding within the last year\n* women with any kind of steroid hormonal treatment\n* oral contraceptive treatment in the last three months\n* psychotropic treatment, only if regular\n* engagement in competitive sports\n* shift work",{"count":350,"type":21},75,"Premenstrual dysphoric disorder (PMDD) is a sex-specific depressive disorder where depressive symptom severity drastically changes in relation to menstrual cycle phase. It is characterized by late luteal phase symptoms of affective lability, irritability, depressed mood, and anxiety. A lot remains unclear and further studies are needed in order to improve the understanding of PMDD and to differentiate it from major depressive disorder (MDD). To date, and in contrast to MDD, the neural correlates of PMDD have been sparsely and poorly investigated. The aim of this study is therefore to investigate the neural correlates of PMDD as compared to MDD and to relate them to stress reactivity. Therefore, three groups of naturally cycling women will be investigated and compared, namely (1) women with MDD, (2) women with PMDD, and (3) healthy control women.\n\nStress and HPA axis activity are assumed to play a crucial role in the development of many mental disorders, including MDD. How stress reactivity and HPA axis activity are connected to PMDD still needs to be investigated. Furthermore, the HPA axis can affect or suppress the activity of the hypothalamic-pituitary-gonadal (HPG) axis, which is involved mainly in the reproductive, but also the immune system, making it an important candidate for the investigation of sex-specific differences in stress reactivity.\n\nThere are sex-specific differences in stress reactivity, but also in the prevalence of stress-related diseases. Women are twice as likely to suffer from depression than men and the first onset of MDD usually peaks during the reproductive years. As to why these differences exist, a recent theory suggests that ovarian hormone fluctuations function as modulators of women's susceptibility to stress and that altered reactivity to stressors during different cycle phases plays a role in the etiology of depressive disorders. This hypothesis extends the Social Signal Transduction Theory of Depression which first and foremost relates depression to inflammation. They postulate a critical role of cytokines for understanding the pathogenesis of depression. Therefore, ovarian hormone fluctuations, but also inflammation in regard to MDD and PMDD and stress reactivity will be investigated in this study.",[353,354],"MDD","PMDD",[353,354,356,357,358,359,360],"Stress","Inflammation","Cytokines","fMRI","MIST","2026-03-31",{"date":363,"type":42},"2026-04-07",{"date":365,"type":42},"2024-01-04",{"date":102,"type":21},{"name":48,"class":49},{"id":369,"slug":4,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":113,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":374,"targetDuration":376,"studyType":60,"phases":4,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":394},"100552397","NCT06472557","Spinocerebellar Ataxia Type 27B Natural History Study (SCA27B-NHS)","Inclusion Criteria:\n\n* SCA27B: genetic diagnosis of ≥250 uninterrupted GAA repeat expansions in FGF14\n* SCA27B risk subject: asymptomatic first-degree relative of SCA27B participant with known or unknown carrier status\n* Unrelated healthy controls: no signs or history of neurological or psychiatric disease AND\n* Written informed consent AND\n* Participants are willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* SCA27B: Missing informed consent\n* SCA27B risk subjects: Missing informed consent\n* Unrelated healthy controls: Missing informed consent, or concurrent neurological, orthopedic, or other diseases interfering with the motor assessments","99 Years",{"count":375,"type":21},300,"24 Months","This international, multi-center, multi-modal, and prospective observational cohort study aims to validate trial outcomes for capturing disease progression in Spinocerebellar Ataxia Type 27B (SCA27B), with combined multi-modal capture of clinical outcome assessments, digital-motor assessments, and molecular biomarkers.",[379],"Spinocerebellar Ataxia Type 27B",[381,382,383,384,385],"ataxia","SCA27B","FGF14","Natural History Study","Outcome Validation","2026-03-30",{"date":388,"type":42},"2026-04-06",{"date":390,"type":42},"2024-06-04",{"date":392,"type":21},"2028-12-31",{"name":48,"class":49},5,{"id":396,"slug":4,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":406,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":415,"locationsCount":73},"100549213","NCT06431087","Effect of a Mindfulnes Program \"Healthy Under Stress\" on Stress: A Prospective Intervention Study","Effect of a Mindfulnes Program \"Healthy Under Stress\" on Stress and Stress-associated Parameters: A Prospective Intervention Study","Inclusion Criteria:\n\n* Employees, patients and family members of the Robert-Bosch-Krankenhaus (RBK) and Bosch Health Campus of all specialties.\n* Informed consent.\n\nExclusion Criteria:\n\n* Physical or mental condition which, in the opinion of the investigator does not allow the patient to participate in the study.\n* Participation in other clinical studies with behavioral, psychological or complementary medical interventions.\n* Insufficient knowledge of the German language.",{"count":117,"type":21},[86],"Stress describes a state of worry and mental tension that results from an imbalance between demands and coping strategies, as well as the disruption of physiological homeostasis. It represents an important ability to adapt to environmental factors, and chronically has negative psychological and physical consequences. The mind-body medical program \"Healthy in Stress\" according to Esch aims to strengthen the individual's ability to deal with stress through comprehensive training. The main target parameter is stress reduction, measured using the Perceived Stress Scale (PSS).",[405],"Subjective Stress",[407,408],"Mindfulness","Healthy Lifestyle","2026-03-11",{"date":411,"type":42},"2026-03-12",{"date":413,"type":42},"2024-07-08",{"date":201,"type":21},{"name":48,"class":49},{"id":417,"slug":4,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":425,"conditions":426,"keywords":429,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100614200","NCT07276503","Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study","Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery","MO-FA2-(TB)","Inclusion Criteria:\n\n* Elective cardiac surgery Heart valve surgery, bypass surgery with CPB\n* Length of stay in ICU \\> 48 hours\n* Age ≥18 years\n* Fluent German language skills\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Lack of capacity to give consent\n* Emergency\n* Readmission to intensive care unit\n* OPCAB surgery, microsurgical procedure",{"count":424,"type":21},100,"Basics (state of scientific knowledge):\n\nDelirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers.\n\nIn cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis.\n\nBoth current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium.\n\nObjectives of the study:\n\nVerification of the predictive score \"MO-FA2-(TB)\" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints\n\nCategories examined in the score:\n\nMemory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time\n\nStudy duration (for individual subjects):\n\npostoperative intensive care stay up to and including day 10\n\nStudy population Patients who have to undergo cardiac surgery with CPB\n\nInclusion criteria:\n\nElective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU \\> 48 hours Age ≥18 years Fluent German language skills\n\nExclusion criteria:\n\nAge \\\u003C18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure\n\nRecruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay \\>48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10\n\nTreatment data collected:\n\nPreoperative data, including ejection fraction, aids, abuse, scores collected (\"4AT test\" for rapid assessment of delirium and cognitive impairment, \"MO-FA2-(TB)\", \"geriatric check\" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis\n\nNumber of cases: Approx. 100 patients\n\nMethodology Monocentric, observation",[427,428],"Emergence Delirium","Postoperative Delirium",[430,431,432,433,434,435,421],"predicitve","delirium","postoperative","valve surgery","bypass surgery","Score","2026-03-05",{"date":438,"type":42},"2026-03-06",{"date":440,"type":21},"2026-03-09",{"date":442,"type":21},"2028-05-30",{"name":48,"class":49},{"id":445,"slug":4,"hasResults":11,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":16,"minAge":451,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":73},"100624571","NCT07411365","Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI","Efficacy of Dual-task Telerehabilitation to Prevent Worsening in Activities of Daily Living in People With Parkinson's Disease at High Risk for Dementia: A Proof-of-concept Study","HomeFitPD","Inclusion Criteria:\n\n* PD diagnosis confirmed by a neurologist\n* PD diagnosis at least for one year\n* Age between 51-80 years\n* German as their mother tongue\n* Diagnosis of PD-MCI according to the Level II criteria of the Movement Disorder Society\n* Cognitive ADL impairment as defined by the FAQ quotient\n* An informant who has given consent to provide information about the participant's activities of daily living (ADLs) and who lives in the participant's home.\n* Access to a WIFI Network at home\n* Unimpaired or corrected vision and hearing\n* Appropriate text comprehension and reading ability\n* Ability to communicate well with the investigator, to understand and comply with the requirements of the study\n* Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care\n\nExclusion Criteria:\n\n* Diagnosis of PDD\n* Intake of anti-dementia drugs\n* Deep brain stimulation\n* History of brain disease other than PD (e.g. head trauma, stroke, encephalitis) also including muscular diseases (e.g. myestenia gravis or myopathy)\n* Pre-existing condition that limits limb movement (e.g. muscular injuries, knee and hip disorders\n* severe cardiovascular diseases with heart failure\n* severe respiratory diseases (e.g. asthma and lung disease)\n* severe other accompanying illnesses with impairment of lung function\n* renal insufficiency\n* acute stage of infectious disease\n* acute stage of cancer\n* other disease with pronounced physical weakness\n* History of brain disease other than PD, e.g., head trauma, stroke, encephalitis\n* Alcohol, medication, or drug dependency or abuse (except for nicotine)\n* Signs of severe depression indicated by either the 15 item version Geriatric Depression Scale (≥ 5 points)\n* Acute psychosis\n* Any disability or issues that may prevent the subject from completing the informed consent form or other study requirements\n* Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study\n* Participation in any clinical investigation of a new compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations","51 Years","80 Years",{"count":454,"type":21},42,[86],"Telerehabilitation is a promising tool for treating and preventing further disease progression in Parkinson's disease (PD) \\[1, 2\\]. First studies in people with PD (PwPD) verified the feasibility of home-based digital cognitive training \\[3-7\\]. Progression in cognitive impairment and the onset and worsening of problems with complex everyday tasks are hallmarks of the prodromal phase of Parkinson's disease dementia (PDD). Consequently, the risk of PDD conversion is dramatically increased for PwPD with both mild cognitive impairment (PD-MCI) and complex activities of daily living (ADL) problems related to cognitive impairment \\[8\\]. Therefore, this group may be a promising target group for interventions, as they are at risk for serious and rapidly progressive cognitive deterioration.\n\nPwPD with PD-MCI show deficits in motor-cognition \\[9\\] and attentional-control, both of which affect ADL \\[10\\]. Dual-task cognitive trainings (DCT) shows great potential to lower down the disease process \\[11, 12\\], but so far no home-based DCT with the primary endpoint of complex ADL and cognition has been conducted in PwPD. We adapted an on-site DCT to improve both physical and cognitive function in PwPD \\[13\\]. The training will be conducted as a telerehabilitation training in PwPD with PD-MCI and cognitive ADL impairment, identified with the Functional Activities Questionnaire (FAQ). Of PwPD with PD-MCI who have more cognitive rather than motor associated ADL dysfunction (reflected by a value of the FAQ quotient \\> 1.008), nearly 50% develop dementia (PDD) within three years \\[8\\].\n\nIn our single-center randomized, controlled non-pharmacological intervention, 42 PwPD with PD-MCI and FAQ quotient \\>1.008 will be assessed with pre-(T0) and post(T1), 6-months (T2) and 12-month follow-up (T3) testing. After 1:1 randomization to either the experimental DCT or the control motor training (CMT), both groups will leg-cycle safely in a comfortable chair on a bicycle ergometer, 3 times a week for 30 minutes. While cycling, the DCT group will additionally perform digital cognitive training on a tablet, covering attention, working memory and executive function. The cognitive training will automatically adapt to performance levels and is remotely accessible. The training is aimed to enhance cognition as well as ADL and to prevent its further decline, with an emphasis on maintaining ADLs in the prodromal stage of Parkinson's disease dementia (PDD).",[27,458],"Mild Cognitive Impairment (MCI)",[460,461,462,463],"Dual task training","Parkinson's disease","Activities of daily living function","Hometraining","2026-02-16",{"date":466,"type":42},"2026-02-19",{"date":468,"type":21},"2026-03-01",{"date":470,"type":21},"2027-08-31",{"name":48,"class":49},{"id":473,"slug":4,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":73},"100618919","NCT07337876","Organ Preservation in Rectal Cancer by Dose Escalated MR Guided Adaptive Radiotherapy","MARS","Inclusion Criteria:\n\n* Patients with histologically confirmed diagnosis of rectal cancer localized between dentate line and 12 cm from the anocutaneous line\n* Any MRI staged rectal cancer meeting the following criteria\n* cT1-cT3 and\n* cN0 -cN1 and\n* cM0\n* Inclusion of UICC Stage I tumors only if unsuitable for endoscopic resection or if primary surgery would require permanent colostomy or deep anastomosis with expected poor organ function.\n* Tumor affects less than 70% of the rectal circumference.\n* Maximum longitudinal extension of the tumor less than 8 cm on MRI\n* MR-Staging requirements: High-resolution, thin-sliced (i.e.\n\n  ≤3mm) magnetic resonance imaging (MRI) of the pelvis.\n* Cross-sectional imaging of the abdomen and chest to exclude distant metastases.\n* Aged at least 18 years. No upper age limit.\n* WHO\u002FECOG Performance Status ≤ 1\n* Adequate hematological, hepatic, renal and metabolic function parameters\n* Informed consent of the patient\n\nExclusion Criteria:\n\n* Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy\n* Distant metastases\n* Preexisting fecal incontinence for solid stool\n* Prior antineoplastic therapy for rectal cancer\n* Prior radiotherapy of the pelvic region\n* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.\n* Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).\n* Other concomitant antineoplastic therapy\n* Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active,uncontrolled infections, active, disseminated coagulation disorder\n* Other primary tumors with an estimated life expectancy of less than three years\n* Contraindications for treatment with 5-Fluorouracil or Capecitabine\n* Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).",{"count":424,"type":21},[160],"This study is testing whether radiation delivered with MRI guidance using a so-called MR-linac in distal rectal cancer can result in a high rate of organ preservation. Patients will receive radiotherapy together with standard chemotherapy.",[482],"Rectal Cancer",[484],"organ preservation","2026-02-14",{"date":487,"type":42},"2026-02-17",{"date":489,"type":42},"2026-01-07",{"date":491,"type":21},"2029-01",{"name":48,"class":49},{"id":494,"slug":4,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":500,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100576738","NCT06789198","Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA","FusionVAC22_02: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Oncogenic Driver Fusion","FusionVAC22_02","Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written informed consent document.\n* Histologically confirmed Fibrolamellar hepatocellular carcinoma (FL-HCC) or other malignant disease in an adjuvant setting, defined as:\n\n  * Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based NGS or RT-PCR\n  * Achievement of complete remission (CR) according to RECIST1.1 by any of the following therapeutic measures:\n* surgical procedures,\n* radiotherapy,\n* local therapeutic measures (e.g. TACE, SIRT, etc.)\n* systemic treatment (e.g. chemotherapy)\n* Age ≥ 12 years. Note: Subjects aged ≥ 12 years but \\\u003C 18 are eligible to enroll only after 6 adult patients have been enrolled in the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Adequate laboratory values for\n\n  * Absolute Lymphocyte Count \\> 500 \u002Fµl\n  * Platelets \\> 50.000 \u002Fµl\n  * Creatinine clearance GFR \\> 30 ml\u002Fmin\n  * Alanine aminotransferase (ALT) and aminotransferase (AST) ≤ 5 times upper limit range\n  * Bilirubin ≤ 3 mg\u002Fdl\n* Negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion.\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential who are sexually active must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last dose of the vaccination\n* For FCBP two negative pregnancy tests (sensitivity of at least 25 mIU\u002FmL) prior to first application of the study drug (vaccination at visit V1), one at screening and the other one at visit V1 prior (\\\u003C 24h) to first vaccination.\n* Postmenopausal or evidence of non-child-bearing status.\n* Be willing to minimize blood and body fluid exposure after vaccination until end of study\n\n  * Refrain from sperm or ovary egg donation\n  * Refrain from blood donation\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Concurrent or previous treatment within 14 days in another interventional clinical trial with an investigational anti-cancer treatment.\n* Concurrent treatment with any of the following therapeutic measures:\n\n  * surgical procedures,\n  * radiotherapy,\n  * local therapeutic measures (e.g. TACE, SIRT, etc.)\n  * systemic treatment (e.g. chemotherapy)\n* Concurrent or previous treatment within 6 months with an anti-cancer vaccine treatment.\n* Any live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment\n* Known sensitivity to or history of allergic reactions to investigational drug.\n* Active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (\\> 10 mg per day) or immunosuppressive agents (Please note, patients after liver transplantation requiring immunosupressants are allowed).\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","12 Years",{"count":502,"type":21},20,[233],"The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript as adjuvant treatment",[506],"Fibrolamellar Hepatocellular Carcinoma (FLC)",[508,509],"DNAJB1-PRKACA fusion transcript","Fibrolamellar hepatocellular carcinoma (FL-HCC)","2026-02-09",{"date":512,"type":42},"2026-02-12",{"date":514,"type":42},"2025-07-08",{"date":516,"type":21},"2028-11",{"name":48,"class":49},2,{"id":520,"slug":4,"hasResults":11,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":73},"100509557","NCT05914974","Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","ICK-Gyn: Immunotherapy-related CRP Kinetics in Metastatic Gynecological Malignancies","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven metastatic gynecological malignancies irrespective of therapy line\n* patients with advanced or metastatic gynecological malignancies must fulfill treatment requirements for ICI therapy in the experimental group\n* planned ICI therapy in combination with palliative chemotherapy in the experimental group\n* patients with advanced or metastatic gynecological malignancies that undergo chemotherapy without ICIs in the first therapy line in the control group\n* written informed consent into ICK-Gyn\n\nExclusion Criteria:\n\n* missing indication for ICI therapy in the experimental group\n* any ICI therapy before inclusion into the trial\n* patients with advanced or metastatic endometrial or cervical cancer in the second or higher therapy line without indication to ICI therapy\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)",{"count":117,"type":21},"ICK-Gyn is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in advanced or metastatic gynecological malignancies under immune checkpoint inhibitor (ICI) therapy on the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).",[528,64,529,530,531],"Gynecological Malignancies","Endometrial Cancer","Ovarian Cancer","Vulvar Cancer",{"date":533,"type":42},"2026-02-10",{"date":535,"type":42},"2023-09-11",{"date":537,"type":21},"2035-04",{"name":48,"class":49},{"id":540,"slug":4,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":550,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":73},"100509556","NCT05914961","Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer","ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line\n* ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)\n* patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group\n* planned ICI therapy in combination with chemotherapy in the experimental group\n* written informed consent into ICK-breast\n\nExclusion Criteria:\n\n* ER-positive or PR-positive\n* HER2-positive (IHC 2+, FISH pos or IHC 3+)\n* any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients\n* any ICI therapy before inclusion into the trial\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)",{"count":546,"type":21},225,"ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.",[549],"TNBC - Triple-Negative Breast Cancer",{"date":512,"type":42},{"date":552,"type":42},"2024-06-01",{"date":537,"type":21},{"name":48,"class":49},{"id":556,"slug":4,"hasResults":11,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":570,"locationsCount":73},"100506740","NCT05878314","Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer","Impact of Preoperative Endocrine Therapy, Menstrual Cycle, PAM50 Assessment and Ki67 Dynamics on Adjuvant Treatment Decisions in Hormone Receptor-positive and HER2-negative Patients With Early Breast Cancer","Inclusion Criteria:\n\n* women ≥ 18 years of age\n* histologically proven unilateral primary non-metastatic invasive breast cancer\n* Estrogen receptor (ER)-\u002F or Progesterone receptor (PR)- positive and HER2-negative\n* Ki67 from core biopsy is available\n* no lymph-node involvement by clinical evaluation and ultrasound (cN0)\n* not amendable to neoadjuvant chemotherapy\n* surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg\n* planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks\n* written informed consent\n\nExclusion Criteria:\n\n* ER-negative and PR-negative\n* HER2-positive\n* bilateral breast cancer\n* preexisting cancer disease within the last 10 years\n* preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)\n* any systemic breast cancer therapy before inclusion into the trial\n* indication for neoadjuvant chemotherapy\n* any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery\n* locally advanced, inoperable or metastatic breast cancer\n* pregnant or lactating patients\n* inadequate general condition (not fit for chemotherapy)\n* hormonal contraception within 6 months before inclusion",{"count":562,"type":21},504,"PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.",[565],"Hormone Receptor Positive HER-2 Negative Breast Cancer",{"date":533,"type":42},{"date":568,"type":42},"2023-04-25",{"date":537,"type":21},{"name":48,"class":49},{"id":572,"slug":4,"hasResults":11,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":73},"100623466","NCT07397000","AI-Based Real-Time Detection of Surgical Smoke Using Endoscopic Data","Development of AI-Based Approaches for Automated Real-Time Detection of Surgical Smoke Using Endoscopic Image and Video Data","Inclusion Criteria:\n\n* \\- Age ≥ 18 years\n* Written consent after receiving information\n* Indication for surgical treatment using HF surgery\n\nExclusion Criteria:\n\n* \\- Expected lack of compliance by the patient or inability of the patient to understand the meaning and purpose of the clinical trial\n* Lack of patient consent\n* S-Pilot cannot be used",{"count":231,"type":21},"The goal of this observational, prospective monocentric pilot study is to generate a pilot dataset to train a computer-assisted model for automatic, intraoperative detection of surgical smoke gas.\n\nWomen with indications for laparoscopic evaluation requiring the use of HF surgery (expecting the formation of smoke gas) and a smoke evacuation system (Karl Storz S-Pilot) are employed.",[580],"Detection of Surgical Smoke Gas Using AI","2026-02-02",{"date":510,"type":42},{"date":584,"type":42},"2024-02-21",{"date":586,"type":21},"2026-08",{"name":48,"class":49},{"id":589,"slug":4,"hasResults":11,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":595,"targetDuration":4,"studyType":22,"phases":597,"briefSummary":598,"conditions":599,"keywords":603,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":73},"100589390","NCT06953791","Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients","Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Standard of Care or an Adapted Crohn's Disease Exclusion Diet With Partial Enteral Nutrition in Adult Patients","CONSISTENT","Inclusion Criteria:\n\n* Must be ≥ 18 years at the time of signing the informed consent.\n* Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy\n* Patients with a Crohn's disease activity index (CDAI) of ≥ 150\n* Patients will not be excluded if they have received 5ASA or an immunomodulator for \\> 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy\n* Understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures\n* Able to adhere to the study visit schedule and other protocol requirements\n* All subjects must agree to refrain from donating blood while on study drugs\n* All subjects must agree not to share medication.\n* Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment\n\nExclusion Criteria:\n\n* Patients with with minimal disease activity (CDAI \\\u003C150) or severe disease (CDAI \\>450)\n* Patients who have received corticosteroids of any kind in the previous 4 weeks\n* Patients who have started an immunomodulator in the previous 8 weeks\n* Any current biological or small molecule treatment\n* Isolated large bowel disease iinvolving the recto-sigmoid or descending colon\n* Patients with penetrating disease (abscess or fistula)\n* Active perianal disease\n* Fixed stricture or small bowel obstruction\n* Normal fecal calprotectin\n* Active extraintestinal disease (e.g. joint disease)\n* Patients who have undergone an intestinal resection\n* Sclerosing cholangitis\n* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.\n* Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.",{"count":596,"type":21},52,[160],"Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects. Exclusive enteral nutrition (EEN) is a recommended first-line treatment for pediatric CD, proving more effective than oral corticosteroids without side effects. However, EEN demands strict adherence, making it challenging for patients, particularly adults.\n\nIn 2019, Levine et al. found that a combination of a specific diet (CD exclusion diet, CDED) and partial enteral nutrition (PEN) was as effective as EEN in inducing remission in pediatric patients, with better tolerance and adherence. CDED focuses on whole foods and aims to minimize harmful dietary components affecting the gut.\n\nIn clinical practice, an adapted CDED (aCDED) has been used to provide more food choices, but it lacks validation in clinical trials. An aCDED that considers regional and seasonal food variations could enhance patient adherence and align with modern dietary preferences.\n\nThis study aims to compare the quality of life during a flare up of Crohn's disease treated with standard of care or an adapted Crohn's disease exclusion diet with partial enteral nutrition in adult patients.",[600,601,602],"Crohn Disease","Nutrition Assessment","Diet Therapy",[604,605,606,607],"Nutrition","crohn disease","diet therapy","consistent",{"date":609,"type":42},"2026-02-05",{"date":611,"type":42},"2026-02-01",{"date":613,"type":21},"2028-02-01",{"name":48,"class":49},""]