[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Goethe University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":411},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,67,94,134,160,185,210,232,258,296,318,342,365,387],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100565954","phase-2-isatuximab-in-adult-patients-with-cytologic-or-molecular-relapsedrefractory-cd38-positive-t-cell-acute-lymphoblastic-leukemia-100565954",false,"NCT06648889","Isatuximab in Adult Patients With Cytologic or Molecular Relapsed\u002FRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia","A Multicenter, Single-arm Phase II Study to Assess the Safety, Tolerability, and Efficacy of Isatuximab in Adult Patients With Cytologic or Molecular Relapsed\u002FRefractory CD38 Positive T-cell Acute Lymphoblastic Leukemia (GMALL-Isatuximab)","Inclusion Criteria:\n\n\\- Patients with CD38 positive T-ALL fitting either to the definitions for cohort 1 or cohort 2:\n\nCohort 1: In relapse or with primary refractory disease defined as ≥5% blasts in bone marrow after at least three chemotherapy cycles (induction I-II, consolidation I) with the following additional specifications:\n\n* early relapse within 12 months from first achievement of CR or\n* late relapse later than 12 months from first achievement of CR or\n* primary refractory disease without any CR or\n* any relapse after stem cell transplantation or\n* any refractory relapse, defined as no response to at least one salvage therapy or\n* any second or later relapse and\n* Availability of patient material with blast cells (bone marrow or peripheral blood) for central MRD assessment or availability of respective predefined marker.\n\nCohort 2: In complete hematological remission (defined as less than 5% blasts in bone marrow and no evidence of extramedullary disease) after at least three chemotherapy cycles (induction I-II, consolidation I)\n\n* Detection of quantifiable MRD at a level of ≥10-4, either as molecular failure without prior achievement of molecular remission or molecular relapse after prior achievement of molecular remission\n* MRD assay at the central reference lab with at least one marker a minimum sensitivity of 10-4\n* MRD detection for study inclusion after an interval of at least 2 weeks from last systemic chemotherapy including antibody therapy\n* (in patients without clonal molecular MRD marker, MRD testing can be based on flow-cytometry established in reference laboratory)\n\nECOG status:\n\n* Cohort 1: 0-2\n* Cohort 2: 0-1\n\nAge ≥ 18 years Evidence of a personally signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n\nRegeneration from last chemotherapy defined as follows:\n\nCohort 1:\n\n* Platelets ≥10.000\u002FuL (platelet transfusion allowed)\n* Hemoglobin ≥ 7.5 g\u002Fdl (red blood cell transfusion allowed)\n\nCohort 2:\n\n* Neutrophils ≥1.000\u002FuL\n* Platelets ≥50.000\u002FuL\n* Hemoglobin ≥9 g\u002Fdl\n\nAdequate liver function defined as follows:\n\n* Bilirubin ≤ 1.5 ULN (unless Gilbert Meulengracht disease or classified as result of liver infiltration by investigator)\n* AST and ALT ≤ 2.5 x ULN (unless classified as result of liver infiltration by investigator)\n\nAdequate renal function defined as follows:\n\n* Serum creatinine ≤ 2 x ULN\n* Any serum creatinine level associated with a calculated creatinine clearance ≤ 40 mL\u002Fmin\n* Negative pregnancy test in women of childbearing potential (WOCBP)\n* WOCBP must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously.\n* Men who are sexually active with a WOCBP must agree to use a barrier method of contraception\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* Extramedullary involvement except for non-bulky (\\\u003C7.5 cm) lymph node involvement, splenomegaly, or hepatomegaly\n* Patients who have received prior antileukemic immunotherapy within 2 weeks prior to start of Isatuximab treatment\n* Patients who have received treatment for leukemia with chemotherapy as follows:\n\nCohort 1:\n\n* Patients who have received treatment for leukemia with chemotherapy within 2 weeks prior to start of Isatuximab treatment (exception: pre-phase therapy with 5-7 days of Dexamethasone, 3 days of Cyclophosphamide; intrathecal prophylaxis)\n* Patients who are candidates for a treatment with Nelarabine\n\nCohort 2:\n\n* Any chemotherapy or antibody therapy after the MRD assay leading to study inclusion (exception: intrathecal prophylaxis)\n* Patients must have recovered from acute non-hematologic toxicity from previous therapies to ≤ grade I unless signs or symptoms are correlated to leukemia involvement\n* Prior SCT ≤ 3 months from start of study treatment\n* Acute GvHD ≥ grade II or active chronic GvHD requiring systemic treatment\n* Any systemic GvHD prophylaxis or treatment within 2 weeks from start of study treatment\n* Known HIV positivity, known hepatitis B surface antigen positivity or known history of hepatitis C\n* Unstable or severe uncontrolled medical condition e.g. unstable cardiac function or unstable pulmonary condition\n* Treatment with an investigational agent within 4 weeks from start of study treatment (safety follow-up period of respective study)\n* Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been treated with radiation or surgery; patients with previous malignancies are eligible if they have been disease free for ≥ 2 years and do not require any antitumor therapy.\n* Evidence of uncontrolled current serious active infection or recent history (within 4 months) of deep tissue infections such as fasciitis or osteomyelitis\n* Known allergies, hypersensitivity, or intolerance to boron or Mannitol, corticosteroids, mAb (including Isatuximab) or human proteins, or their excipients (refer to respective Summary of Product Characteristics), or known sensitivity to mammalian-derived products.\n* Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator\n* Pregnant or breastfeeding females\n* Vaccination with live attenuated vaccines within 4 weeks of first study agent administration.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the patient inappropriate for entry into this study","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The planned trial offers treatment cohorts for patients with full cytologic relapse (R\u002FR ALL - Cohort 1), as well as for patients with molecular failure\u002Frelapse (MRD+ ALL - Cohort 2). Basically, the study aims to develop data for optimization of first-line therapy of T-ALL, either by modification of standard induction with Isatuximab or by establishing a post-induction therapy for eradication of MRD and thereby evaluates in parallel two different strategies.",[26],"T-ALL",[28],"R\u002FR or MRD CD38-positive T-ALL","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2024-10-22",{"date":37,"type":20},"2028-08",{"name":39,"class":40},"Goethe University","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100630533","phase-4-dynamic-networks-in-depression-treatment-mechanisms-of-change-in-pharmacological-psychological-and-combined-treatment-of-depression-100630533","NCT07488910","Dynamic Networks in Depression Treatment: Mechanisms of Change in Pharmacological, Psychological and Combined Treatment of Depression","Veränderungen Dynamischer Symptom-Netzwerke Unter Pharmakologischer, Psychotherapeutischer Und Kombinierter Behandlung Bei Depression (DYNDET)","DYNDET","Inclusion Criteria:\n\n1. Depressive disorder (mild to moderate symptom severity)\n2. 18-65 years\n3. must own a smartphone with internet access\n\nExclusion Criteria:\n\n1. severe depressive episode\n2. acute suicidality,\n3. bipolar disorder,\n4. substance use disorder\n5. psychotic depression\n6. severe medical or neurological illness\n7. insufficient german language skills\n8. concurrent psychotherapeutic treatment\n9. conditions that may interfere with fMRI","65 Years",{"count":51,"type":20},90,[53],"PHASE4","This study investigates how antidepressant pharmacotherapy, cognitive-behavioral therapy, or their combination modulate the temporal dynamics and connectivity of depressive symptom networks. Using intensive longitudinal ecological momentary assessment data, the trial examines treatment-specific changes in symptom interactions.\n\nBy applying network-based analytic approaches, the study aims to elucidate differential and potentially complementary mechanisms of change across treatment modalities. Findings may contribute to more informed and individualized treatment strategies for major depressive disorder.",[56],"Depression - Major Depressive Disorder","NOT_YET_RECRUITING","2026-03-18",{"date":60,"type":33},"2026-03-23",{"date":62,"type":20},"2026-02",{"date":64,"type":20},"2028-01",{"name":39,"class":40},3,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100625454","dynamic-network-response-to-tms-treatment-100625454","NCT07422844","Dynamic Network Response to TMS Treatment","Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression","Inclusion Criteria:\n\n* Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.\n* Men and women will be included in a balanced ratio.\n* German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.\n\nExclusion Criteria:\n\n* Patients younger than 18 or older than 70 will be excluded\n* Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.\n* Further exclusion criteria for participation are acute or chronic neurological diseases.\n* Patients who are pregnant will not be included in the study.\n* As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.","70 Years",{"count":76,"type":20},100,"OBSERVATIONAL","This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment.\n\nAdditionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment.\n\nPatients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.",[80],"MDD",[82,83,84],"TMS","Brain Networks","Symptom Networks","2026-02-13",{"date":87,"type":33},"2026-02-20",{"date":89,"type":33},"2025-11-24",{"date":91,"type":20},"2031-12-31",{"name":39,"class":40},1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100597907","effects-of-frontopolar-tms-in-alcohol-craving-100597907","NCT07064590","Effects of Frontopolar TMS in Alcohol Craving","Investigation of Frontopolar Transcranial Magnetic Stimulation on Correlates of Craving in Alcohol Addiction","TMS-SUD","Inclusion Criteria:\n\n* adults aged 18-65\n* ICD-10 diagnosis of alcohol dependence\n* Ability to give consent\n* Sinus rhythm in ECG\n\nExclusion Criteria:\n\n* Current psychotic symptoms in patients with psychotic disorders (F20, F23, F10.5)\n* Contraindication against TMS or MRI\n* Severe neurological disorders such as epilepsy, stroke, neuroinflammatory disorders (e.g., multiple sclerosis). A history of seizures only in the context of alcohol withdrawal does not represent a contraindication, unless the seizure happened in the last 3 weeks before study inclusion.\n* Acute withdrawal symptoms (CIWA-Ar \\> 5)",{"count":103,"type":20},34,[105],"NA","The goal of this interventional study is to learn if continuous theta burst stimulation (cTBS) applied over the left frontopolar cortex can reduce psychological, physiological, and neurobiological markers of alcohol craving in patients with alcohol dependence (AD).\n\nThe main questions it aims to answer are:\n\n* Does cTBS over the left frontopolar cortex reduce psychological and physiological measures of alcohol craving in individuals with AD?\n* Are baseline structural and functional brain connectivity patterns associated with individual differences in cTBS-induced changes in craving?\n\nThe participants will:\n\n* Receive cTBS over the left frontopolar cortex using an accelerated protocol comprising 15 TMS-sessions on five consecutive days\n* Undergo psychological and physiological assessments of alcohol craving before and after the TMS intervention\n* Complete magnetic resonance imaging (MRI) sessions to assess baseline brain structural and functional connectivity\n\nThis study aims to advance the understanding of the neurophysiological mechanisms underlying craving in AD and the identification of potential biomarkers for predicting psychological and physiological craving reductions.",[108],"Alcohol Addiction",[110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"frontopolar transcranial magnetic stimulation (TMS)","craving","alcohol addiction","addiction treatment","virtual reality (VR)","magnetic resonance imaging (MRI)","Continuous Theta Burst Stimulation (cTBS)","neuromodulation","structural and functional brain connectivity","connectome","neurophysiological craving markers","prediction","physiological craving markers","psychological craving markers","Neuronavigation","2026-01-19",{"date":127,"type":33},"2026-01-22",{"date":129,"type":33},"2025-05-16",{"date":131,"type":20},"2027-05",{"name":39,"class":40},2,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":150,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":93},"100605345","urolithin-a-in-patients-with-previously-untreated-solid-tumors-receiving-immune-checkpoint-inhibitors-100605345","NCT07161310","Urolithin A in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors","A Randomized Study of Urolithin A vs. Placebo in Patients With Previously Untreated Solid Tumors Receiving Immune Checkpoint Inhibitors","MitoCancer","Inclusion Criteria:\n\n1. Newly diagnosed solid cancer without previous systemic anticancer treatment\n2. Planned single agent or double agent immune checkpoint inhibitor therapy as first-line standard-of-care treatment either with or without chemotherapy. Of note, patients receiving neoadjuvant therapy are eligible\n3. Age ≥ 18 years\n4. Life-expectancy ≥ 3 months\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n6. Patient is willing and able to comply with the protocol for the duration of the study, including hospital visits and scheduled follow-up visits and examinations\n7. Female patients of childbearing potential (WOCBP) are only eligible if using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:\n\n   * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n   * Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n   * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n\nExclusion Criteria:\n\n1. Patients who currently receive or have received cytostatic chemotherapy, glucocorticoids, or immune modulatory agents (including low-dose methotrexate, TNF alpha inhibitors, calcineurin inhibitors, interleukin inhibitors, etc.) during the last 3 months are not eligible. Of note, topical glucocorticoid treatments and hormone replacement therapy is acceptable\n2. Patients who currently take or plan to take mitochondrial supplements like coenzyme q10, NAD+ boosters (e.g. nicotineamide riboside, nicotineamine mononucleotide), or L-carnitine\n3. Patients who have received radiotherapy to the mediastinum or to other areas with anticipated strong irradiation of a large blood vessel by the judgement of the investigator are not eligible\n4. Patients with known HIV infection are not eligible. Testing is not mandatory\n5. Patients with a history of solid organ or hematopoietic cell transplantation6. Any medical condition that in the opinion of the investigators would compromise the study outcome or the safety of the patient",{"count":143,"type":20},45,[105],"The aim of this clinical study is to learn more about the effects of urolithin A (MitoPure®) on the immune system of cancer patients receiving immune checkpoint inhibitor-based therapies. Any effects will be compared with patients who take a placebo instead of urolithin A (MitoPure®).",[147,148,149],"Solid Cancer","Non-Small Cell Lung Cancer","Melanoma",[151],"immune checkpoint inhibitor (ICI)","2026-01-07",{"date":154,"type":33},"2026-01-08",{"date":156,"type":33},"2026-01-02",{"date":158,"type":20},"2027-03",{"name":39,"class":40},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":170,"studyType":77,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},"100276031","gmall-registry-and-collection-of-biomaterial-prospective-data-collection-regarding-diagnosis-treatment-and-outcome-of-adult-acute-lymphoblastic-leukemia-all-patients-and-related-diseases-associated-with-a-prospective-collection-of-biomaterial-100276031","NCT02872987","GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","GMALLregistry","Inclusion Criteria:\n\n* Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols\n* Other Types of Leukemia (NK Cell Lymphoma\u002FLeukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols\n* Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols\n* Age minimum 18 yrs",{"count":169,"type":20},10000,"15 Years","The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.",[173,174,175],"Acute Lymphoblastic Leukemia","Leukemia","Non-Hodgkin's Lymphoma","2025-11-27",{"date":178,"type":33},"2025-12-05",{"date":180,"type":4},"2009-02",{"date":182,"type":20},"2035-12",{"name":39,"class":40},152,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":93},"100593578","robot-assisted-cystectomies-with-regard-to-blood-loss-pain-and-transfusions-100593578","NCT07008261","Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions.","Prospective Evaluation of Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusion Requirements.","Inclusion Criteria:\n\n* planned radical cystectomy\n\nExclusion Criteria:\n\n* ASA classification V\n* Previously known coagulation disorder",{"count":193,"type":20},60,"What influence does robot-assisted surgical treatment in the sense of a radical cystectomy and possibly bladder reconstruction have on blood loss, pain and transfusion requirements? We intend to conduct a corresponding prospective observational study at a tertiary centre.",[196,197,198,199,200,201],"Transfusions","Cystectomy","Blood Loss Requiring Transfusion","Anaemia","Anaemia Postoperative","Pain, Postoperative","2025-08-25",{"date":204,"type":33},"2025-09-02",{"date":206,"type":33},"2025-08-01",{"date":208,"type":20},"2027-12-31",{"name":39,"class":40},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":218,"minAge":17,"maxAge":49,"enrollmentInfo":219,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":93},"100531602","epidural--evaluation-of-preexisting-information-regarding-neuroaxial-procedures-for-labour-analgesia-100531602","NCT06201936","EPIDURAL- Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia","Evaluation of Preexisting Information Regarding Neuroaxial Procedures for Labour Analgesia","EPIDURAL","Inclusion Criteria:\n\n* Pregnant women prior to delivery\n\nExclusion Criteria:\n\n* Women under 18 years of age","FEMALE",{"count":220,"type":20},1000,"The aim of this research project is to anonymously survey pregnant patients before the anaesthesiological consultation about their prior knowledge of planned neuroaxial procedures in the context of childbirth by conducting an online survey and to evaluate the sources of that information.",[223],"Neuroaxial Analgesia Procedures","2025-05-05",{"date":226,"type":33},"2025-05-07",{"date":228,"type":33},"2025-03-01",{"date":230,"type":20},"2026-11-01",{"name":39,"class":40},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100520786","phase-2-randomized-trial-in-adult-de-novo-ph-positive-all-with-chemotherapy-imatinib-or-ponatinib-blinatumomab-and-sct-100520786","NCT06061094","Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT","A Multicentre, Randomized Trial in Adults With de Novo Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia to Assess the Efficacy of Ponatinib Versus Imatinib in Combination With Low-intensity Chemotherapy, to Compare End of Therapy With Indication for SCT Versus TKI, Blinatumomab and Chemotherapy in Optimal Responders and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE)","GMALL-EVOLVE","Inclusion Criteria:\n\n* Male or female patients \\>= 18 years, \\\u003C=65 years\n* Philadelphia chromosome or BCR-ABL1 positive ALL\n* Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib)\n* ECOG performance status ≤2\n* Signed written inform consent\n* Molecular evaluation for BCR-ABL1 performed\n* Negative pregnancy test in women of childbearing potential\n* Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%).\n* Normal serum levels \\> LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication\n* Serum lipase ≤ 1.5 x ULN. For serum lipase \\> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis\n* Normal QTcF interval ≤450 ms for males and ≤470 ms for females\n* Signed and dated written informed consent is available\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions\n* Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab\n* Patient previously treated with tyrosine kinase inhibitors\n* Nursing women\n* Known impaired cardiac function, including any of the following: as detailed in protocol\n* Symptomatic peripheral vascular disease\n* Any history of ischemic stroke or transient ischemic attacks (TIAs)\n* Uncontrolled hypertriglyceridaemia\n* History or presence of clinically relevant CNS pathology as detailed in protocol\n* History or active relevant autoimmune disease\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C\n* History of pancreatitis within 6 months previous to start of treatment within the trial\n* Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study\n* Inadequate hepatic functions defined as ASAT or ALAT \\> 2,5 times the institutional upper limit of normal or \\> 5 times ULN if considered due to leukemia\n* Total bilirubin \\> 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert \u002F M. Meulengracht\n* Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections\n* Inability to understand and\u002For unwillingness to sign a written informed consent",{"count":241,"type":20},220,[23],"The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation.\n\nThe EVOLVE trial aims to answer three questions challenging the current SoC:\n\nUse of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).\n\nIn MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II).\n\nIn MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).",[245],"Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[245,247,248],"Tyrosinekinase Inhibitors","Blinatumomab","2025-04-25",{"date":251,"type":33},"2025-04-29",{"date":253,"type":33},"2023-07-14",{"date":255,"type":20},"2029-07-01",{"name":39,"class":40},85,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":266,"targetDuration":268,"studyType":77,"phases":4,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":93},"100583658","cohort-of-the-specialist-network-infectious-diseases-100583658","NCT06879184","Cohort of the Specialist Network Infectious Diseases","Master Study Protocol for the Cohort of the Specialist Network Infectious Diseases (SNID)","SNID","Inclusion Criteria:\n\n* Fulfillment of all inclusion and no exclusion criteria for at least one module\n* Ability to perform all baseline visit data and biosample collections according to the study requirements no later than 48 hours (with an additional 48-hour period for weekends) after fulfilling all study and specific module inclusion and exclusion criteria\n* Signed informed consent form from all patients capable of giving consent and understanding all contents of the informed consent\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\nThere are no generic exclusion criteria in the master study protocol.",{"count":267,"type":20},15000,"2 Weeks","This observational study aims to collect standardized clinical data and biosamples from adults in university hospitals across Germany. The main goals are to create a cohort that combines clinical data, pathogen samples, and biosamples, with consent for future research. A pre-screening program tracks infection-related hospitalizations, helping detect pathogen changes early and respond quickly. Participants will be recruited if they have respiratory, bloodstream, gastrointestinal, emerging, or central nervous system infections. Data and biosamples will be collected at the start and end of the hospital stay, with additional visits if needed.",[271],"Infectious Diseases and Manifestations",[273,274,275,276,277,278,279,280,281,282,283,284,285,286,287],"infectious diseases","master study protocol","prospective","prescreening","infection-related hospitalizations","respiratory","bloodstream","gastrointestinal","emerging infections","central nervous system","infrastructure","biosamples","Germany","pandemic preparedness","sentinel","2025-03-13",{"date":290,"type":33},"2025-03-17",{"date":292,"type":20},"2025-03-20",{"date":294,"type":20},"2030-06-30",{"name":39,"class":40},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":317},"100460882","phase-2-additional-chemotherapy-for-egfrm-patients-with-the-continued-presence-of-plasma-ctdna-egfrm-at-week-3-after-start-of-osimertinib-1st-line-treatment-pace-lung-100460882","NCT05281406","Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)","Inclusion Criteria:\n\nPre-Screening Phase\n\n1. Provision of written informed consent for the pre-screening phase.\n2. Age ≥ 18 years\n3. Histologically confirmed stage IIIB or IV NSCLC\n4. Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.\n5. Planned treatment with osimertinib 80mg\u002Fd 1st-line as SoC or ongoing treatment for a maximum of 28 days\n6. Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial osimertinib treatment\n7. Previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease, except for osimertinib for a maximum of 28 days (see above)\n8. At least one measurable site of disease as defined by RECISTv1.1 criteria\n9. Female subjects of childbearing potential (WOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Further information in Appendix 20.7 (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods)\n10. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n    * Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n    * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n\nTreatment Phase\n\n1. Provision of informed consent for the screening and treatment phase prior to any study specific procedures, including screening evaluations that are not SoC.\n2. Persistent mEGFR ctDNA signal 21 to 28 days after osimertinib initiation for advanced of metastatic ex19del or L858R EGFR mutation positive NSCLC as assessed by a liquid biopsy during the pre-screening phase of the trial in the central laboratory.\n3. ECOG performance status 0-2.\n4. The 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.\n5. Osimertinib no longer than 10 weeks before start of chemotherapy in the treatment phase\n\nExclusion Criteria:\n\nPre-Screening Phase\n\n1. History of another primary malignancy. Exceptions are:\n\n   * Malignancy treated with curative intent and with no known active disease ≥6 months before the first dose of IMP, and of low potential risk for recurrence\n   * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   * Adequately treated carcinoma in situ without evidence of disease\n2. History of leptomeningeal carcinomatosis\n3. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study\n4. Previous enrolment in the present study.\n\nTreatment Phase\n\n1. Symptomatic CNS metastases. \\[Patients with asymptomatic brain metastases may be included.\\]\n2. History of leptomeningeal carcinomatosis\n3. Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior) (Appendix 20.5). All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4.\n4. Osimertinib had to be withheld or administered at reduced dosage for toxicity management for more than 7 days or persistent unresolved toxicities which preclude study treatment.\n5. Any unresolved toxicities other than osimertinib from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy.\n6. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib. History of hypersensitivity to any of the chemotherapy drugs used.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n9. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value\n   2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n   3. Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\u002Fplasma potassium \\\u003C LLN; Serum\u002Fplasma magnesium \\\u003C LLN; Serum\u002Fplasma calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes. \\[Note: Electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia) can be corrected to be within normal ranges prior to first dose. No more than two re-tests may be performed in order to meet this criterion.\\]\n10. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n11. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count below lower limit of normal (\\\u003CLLN) \\*\n    2. Platelet count below lower limit of normal (\\\u003CLLN) \\*\n    3. Hemoglobin \\\u003C90 g\u002FL \\*\n\n       \\* The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted.\n    4. Alanine aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    5. Aspartate aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    6. Total bilirubin \\>1.5 times ULN if no liver metastases or \\>3 times ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinaemia\\] or liver metastases;\n    7. Serum creatinine \\>1.5 times ULN concurrent with creatinine clearance \\\u003C60 mL\u002Fmin \\[calculated by Cockcroft and Gault equation\\]-confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n    8. INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before chemotherapy \\[Subjects under therapeutic anticoagulation are permitted.\\]\n12. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n13. Women who are pregnant or breast-feeding\n14. Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 4 months (male patients) or 6 weeks (female patients) after the last dose of osimertinib and 6 months after the last dose of chemotherapy.\n15. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \\[§ 40 Abs. 1 S. 3 Nr. 3a AMG\\].\n16. Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.\n17. Any chemotherapy, biologic, or hormonal therapy for cancer treatment used concurrently or within 6 months prior to first dose of study treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n18. Major surgery (as defined by the Investigator) within 4 weeks prior to starting the study; patients must have recovered from effects of preceding major surgery. Note: Local non-major surgery for palliative intent (e.g., surgery of isolated lesions) is acceptable",{"count":303,"type":20},50,[23],"PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.",[307,308],"NSCLC Stage IIIB","NSCLC Stage IV","2025-02-20",{"date":311,"type":33},"2025-02-21",{"date":313,"type":33},"2021-11-12",{"date":315,"type":20},"2026-11",{"name":39,"class":40},16,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":325,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":93},"100564281","expected-and-actual-preterm-birth-and-parental-distress-impact-on-childrens-mental-health-100564281","NCT06627140","Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health","Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum","Children and their parents must have participated in the previous study. Inclusion criteria of the previous study regarding the parents were:\n\n* Pregnant women and their partners from the 24th week of gestation on\n* 18 years of age\n\nExclusion criteria of the previous study were:\n\n* Psychiatric, mainly psychotic diseases\n* Drug abuse\n* Severe neurological disorders\n* Stillbirth",true,{"count":327,"type":20},250,"The purpose of the present study is the assessment of the mental health and cognitive development of children 6-11 years after premature or term birth. Impairments in children's' mental health are assessed focusing different disorders or problems (ADHD, Autism traits, Affective disorders, oppositional-aggressive behavior) and using both questionnaires and a clinical interview. Risk and protective factors will be analyzed, e.g., threat and\u002For actual premature birth compared to term birth, parents' mental health, positive coping, personality traits and social support in the peripartum period and afterwards, as well as medical parameters. The potential interaction of premature birth, medical complications, parental distress and children's mental health will be taken into consideration.",[330,331,332,333],"Preterm Birth","Psychological Distress","Mental Health","Cognitive Functioning","2024-10-02",{"date":336,"type":33},"2024-10-04",{"date":338,"type":33},"2024-07-08",{"date":340,"type":20},"2024-12-20",{"name":39,"class":40},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":350,"targetDuration":4,"studyType":21,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":93},"100555861","process-based-therapy-for-difficult-to-treat-anxiety-disorders-and-depression-100555861","NCT06517589","Process-based Therapy for Difficult-to-treat Anxiety Disorders and Depression","Process-based Therapy vs. Routine-CBT for Difficult-to-treat Anxiety Disorders and Depression","PBTRAND","Inclusion Criteria:\n\n* A primary DSM-5 diagnosis of depressive or anxiety disorder\n* At least two unsuccessful attempts of pharmacological or psychological treatment according to the German guidelines for the treatment of depression or anxiety disorders (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)\n* Age 18-65 years\n* Sufficient knowledge of the German language\n* Participating patients are not required to discontinue medication, but to keep medication constant over the treatment period\n\nExclusion Criteria:\n\n* Increased suicidality\n* Substance abuse or dependency\n* Borderline personality disorder\n* Pervasive developmental disorder\n* Psychotic disorder\n* Eating disorder\n* Bipolar disorder\n* Severe physical illness",{"count":351,"type":20},80,[105],"The aim of this study is to test the relative efficacy of Process-based Therapy compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat anxiety disorders and depression.",[355,356],"Depression","Anxiety Disorder","2024-07-28",{"date":359,"type":33},"2024-07-30",{"date":361,"type":33},"2024-01-29",{"date":363,"type":20},"2025-07-30",{"name":39,"class":40},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":373,"targetDuration":375,"studyType":77,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":133},"100539356","main-image-registry-100539356","NCT06302777","MAIN-IMAGE Registry","Multifactorial Analysis of Coronary Artery Plaques Using INtracoronary IMAGing for Exploration of Atherosclerotic Determinants and Progression - the MAIN-IMAGE Registry","MAIN-IMAGE","Inclusion Criteria:\n\npatients undergoing pre-intervention optical coherence tomography imaging\n\nExclusion Criteria:\n\n\\-",{"count":374,"type":20},500,"3 Years","All comers registry with patients with chronic coronary syndrome or acute coronary syndrome who underwent intracoronary imaging during cardiac catherization. The aim is to identify plaque characteristics on OCT or IVUS that are associated with adverse cardiac events including myocardial infarction and atherosclerotic progression.",[378],"Coronary Artery Disease","2024-03-04",{"date":381,"type":33},"2024-03-12",{"date":383,"type":33},"2023-09-26",{"date":385,"type":20},"2031-09-26",{"name":39,"class":40},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":394,"targetDuration":396,"studyType":77,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":93},"100279037","german-pediatric-hemophilia-research-database-100279037","NCT02912143","German Pediatric Hemophilia Research Database","GEPHARD","Inclusion Criteria:\n\n* hemophilia A or B\n* FVIII\u002FFIX \\\u003C1% to 25%\n* informed consent\n\nExclusion Criteria:\n\n* no consent",{"count":395,"type":20},800,"10 Years","The German Pediatric Hemophilia Research Database will collect data on the prophylactic and therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL) and living circumstances in newly diagnosed children with hemophilia.",[399,400,401,402],"Hemophilia A","Hemophilia B","Children","Drug Specific Antibodies","2023-03-06",{"date":405,"type":33},"2023-03-08",{"date":407,"type":4},"2017-01-01",{"date":409,"type":20},"2028-12-31",{"name":39,"class":40},""]