[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bielefeld University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":147},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,78,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640267","intensive-neurofeedback-protocol-for-children-with-adhd-a-proof-of-concept-study-comparing-iapf-personalized-and-standard-theta-beta-ratio-training-100640267",false,"NCT07595783","Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training","Inclusion Criteria:\n\n* Children aged 6-13 years. Confirmed ADHD diagnosis (ICD 10: F90.0, F90.1, or F98.8)\n* German-speaking children with normal or corrected vision.\n\nExclusion Criteria:\n\n* Children with neurological disorders (e.g., Epilepsy)\n* Children without an ADHD diagnosis\n* Caregivers with inability to provide informed consent or complete questionnaires\n* Participation in neurofeedback that was conducted in the year prior to the intended participation or is still ongoing.\n\nThe intake of medication or psychotherapeutic treatments and ICD-10 diagnosis are queried at T1, T2 and T3. These are recorded as control variables and are not exclusion criteria. The medication intake was kept constant during the NF training.","ALL","6 Years","13 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The first aim of this clinical trial is to test the feasibility and signal validity of a new approach to neurofeedback training (NF) using intensive EEG-based theta-beta NF for children with ADHD in the context of NF camps during school holidays. The second aim is to compare the efficacy of two neurofeedback protocols in reducing ADHD symptoms. Previous study results highlight that children with ADHD frequently show increased Theta-Beta-Ratios (TBR) in the qEEG, probably associated with attention difficulties, which may be ameliorated following neurofeedback training. However, the current state of research shows heterogenous findings regarding the efficacy of standard TBR NF for children with ADHD. Further study results suggest that personalized NF training protocols, based on the individual alpha peak frequency (iAPF), may be more effective in reducing ADHD symptoms than standardized ones.\n\nTherefore, in this proof-of-concept study of children with ADHD a standard TBR NF protocol is compared with an iAPF-personalized TBR NF (iAPF-TBR NF) protocol (based on the previously obtained iAPF). The study is designed as a randomized controlled intervention trial (RCT) with three assessment points (pre \\[T1\\], post \\[T2\\] and 6-month follow-up \\[T3\\]). Primary endpoints include the reduction of ADHD symptoms assessed by parent-, teacher- and self-report questionnaires. Furthermore, it is hypothesized that NF training is associated with better performance in a sustained attention and executive function test and a reduced TBR in qEEG, particularly following iAPF-TBR NF.\n\nThe main questions are:\n\n* Is it feasible to train groups of up to 12 children with two sessions NF per day for an eight-day-period during their school holidays?\n* Does iAPF-TBR NF provide a valid neuromodulatory signal compared to the standard-TBR-NF protocol? Do the frequency boundaries demonstrate spectral stability across the 16 training sessions?\n* Does the personalized iAPF-TBR NF training reduce ADHD symptoms measured immediately after the training more than standard-TBR-NF training? (comparison T2-T1)\n* Does the personalized iAPF-TBR NF training reduce ADHD symptoms measured 6 months after the NF training more than standard TBR-NF training? (comparison T3-T1)\n* Does the reduction in ADHD symptoms measured immediately after the NF-training persist until the 6-month follow-up? Do possible differences between iAPF-TBR NF training and standard TBR NF training remain? (comparison T3-T2)\n\nPost-hoc analyses of the courses are carried out. In addition, selectivity analyses will be carried out for clinical subgroups (e.g. different ADHD profiles)",[26,27,28,29,30],"ADHD","Inattention","Hyperactivity","Impulsivity","Executive Dysfunction",[32,26,33],"EEG-neurofeedback","children","RECRUITING","2026-05-12",{"date":37,"type":38},"2026-05-19","ACTUAL",{"date":40,"type":38},"2024-07-09",{"date":42,"type":20},"2026-12-31",{"name":44,"class":45},"Bielefeld University","OTHER",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100382562","phase-3-neorad-breast-cancer-study-100382562","NCT04261244","NeoRad Breast Cancer Study","Preoperative Radiotherapy Versus Postoperative Radiotherapy After Neoadjuvant Chemotherapy (\"NeoRad\") in High-risk Breast Cancer: a Prospektiv, Randomized, International Multicenter Phase III Trial","NeoRad","Inclusion Criteria:\n\n* Histologically proven invasive, unilateral breast cancer\n* Indication for radiotherapy\n* Indication for neoadjuvant chemotherapy (+\u002F- antibody treatment or other targeted therapies) in accordance with national and international guidelines\n* Female\n* Informed consent for the trial signed by the patient\n* Hormone receptor and HER2 status: no restrictions\n* All grades G1-G3\n* Age ≥ 18 years at the time of informed consent\n* Performance status ≤ 2\n* No pre-existing conditions that prohibit therapy\n\nExclusion Criteria:\n\n* Neoadjuvant treatment solely with endocrine therapy\n* Bilateral breast cancer\n* Pregnancy or lactation\n* Prior radiotherapy of the thorax\n* Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans\n* Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies, such as farmer's lung, severe lung emphysema, COPD °III)\n* Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker, and\u002For implanted defibrillator\n* Malignoma except basalioma or in-situ-carcinomas in complete response\n* Distant metastasis\n* Plexopathies of the arm of the treated side\n* Stiffness of the shoulder of the arm of the side of the breast cancer of any origin (e.g. following a road accident)\n* Lymph edema ≥°II of the arm at the side of the breast cancer\n* Other medical conditions that prohibit the neoadjuvant radiotherapy (i.e. Expected non-compliance, etc.)\n* Male patients\n* Patients who have previously been assessed for chemotherapy response","FEMALE","18 Years",{"count":58,"type":20},1826,[60],"PHASE3","The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT.",[63],"Breast Cancer",[65,66,67,68],"neoadjuvant chemotherapy","preoperative radiotherapy","capsular contraction","immediate reconstruction","2025-05-05",{"date":71,"type":38},"2025-05-07",{"date":73,"type":38},"2024-02-01",{"date":75,"type":20},"2034-03-31",{"name":44,"class":45},16,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":56,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":113,"locationsCount":114},"100585068","act-for-mental-health-in-neurological-disorders-100585068","NCT06897553","ACT for Mental Health in Neurological Disorders","Acceptance and Commitment Therapy- Based Group Therapy for Mental Health in Neurological Disorders","Inclusion Criteria:\n\n* Value above a cut-off of the DASS-21 subscales (depression \\> 10, anxiety \\> 6, and stress \\> 10)\n* Sufficient cognition and language ability (clinical rating)\n* Sufficient therapy motivation (clinical rating)\n\nExclusion Criteria:\n\n* Behavioral disorders (e.g., high irritability or apathy in clinical rating)\n* Other severe mental disorder (dementia, psychosis, personality disorders, intellectual disability)\n* Simultaneous psychotherapy or neuropsychological therapy",{"count":86,"type":20},44,[23],"The goal of this clinical trial is to examine the efficacy of this manual for mental health in people with mixed neurological disorders, including post-COVID. These conditions are often associated with cognitive impairment, which may hamper the effects of psychoterapy. Executive functioning and especially the ability to abstract thinking may be useful for individuals using Acceptance and Commitment Therapy. Therefore, the main questions research questions are:\n\n* Is this intervention effective in improving mental health?\n* Do executive functions predict the extent of social participation and mental health at the end of therapy? Participants will take part in 8 weekly group therapy sessions of 100 minutes each.",[90,91,92,93,94,95,96],"Neurological Disorders","Mental Health","Executive Function (Cognition)","Depression\u002FAnxiety","Stress","Brain Injury","Post-COVID",[98,99,100,101,102,103,104,105,106,96],"Acceptance and Commitment Therapy (ACT)","group therapy","neurological disorders","brain injury","anxiety","stress","depression","executive functioning","abstraction ability","2025-03-25",{"date":109,"type":38},"2025-03-27",{"date":111,"type":38},"2024-12-01",{"date":42,"type":20},{"name":44,"class":45},1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":15,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":114},"100516210","preventing-physical-and-emotional-violence-by-teachers-in-public-schools-in-pakistan-100516210","NCT06001554","Preventing Physical and Emotional Violence by Teachers in Public Schools in Pakistan","Improving Adolescent Student Mental Health and Quality of Life Through a Reduction in Physical and Emotional Violence by Teachers in Pakistan: A Cluster Randomized Controlled Trial","ICC-T_Pak","General:\n\nInclusion Criteria:\n\nAll: Written informed consent (if underaged by parents (written) \\& minors themselves (written) Students: Enrollment in selected secondary school Teachers: All teachers employed at the selected schools\n\nSchools:\n\nPublic secondary schools Day schools At least 30 students in selected class\u002Fstream\n\nExclusion criteria:\n\nStudents and teachers:\n\nAcute drug or alcohol intoxication Acute psychotic disorder","11 Years","62 Years",{"count":126,"type":20},2100,[23],"Violence has severe and long-lasting negative consequences for children and adolescents' well-being and psychosocial functioning, thereby also hampering communities and societies' economic growth. Studies show high prevalence rates of violence by teachers against children in Pakistan. In addition to legal and structural factors (e. g. stressful working conditions for teachers), attitudes favoring violence against children as an effective and acceptable discipline method and the lack of access to alternative non-violent strategies are likely to contribute to teachers' ongoing use of violence against children.\n\nNotwithstanding, there are currently very few school-level interventions to reduce violence by teachers that a) have been scientifically evaluated and b) that focus both on changing attitudes towards violence and on equipping teachers with non-violent discipline strategies.\n\nThus, the present study tests the effectiveness of the preventative intervention Interaction Competencies with Children - for Teachers (ICC-T) in secondary schools in Pakistan. Previous studies have provided initial evidence on the feasibility to implement teacher violence interventions in secondary schools in Pakistan. This study aims to provide first evidence for the effectiveness of ICC-T to reduce violence and to improve children's functioning (i.e. mental health, well-being, academic performance) in Pakistan.",[130],"Violence",[132,133,134,135,136,137,138],"school violence","teacher violence","teachers","intervention","students","public schools","secondary schools","2024-04-08",{"date":141,"type":38},"2024-04-09",{"date":143,"type":38},"2023-09-15",{"date":145,"type":20},"2026-12",{"name":44,"class":45},""]