Universitätsklinikum Hamburg-Eppendorf — Biomedical Watch V2

Traitements8programmes

Essais4liés

Publications4liées

SourceDBlocale

Traitements

8

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
AlemtuzumabThe MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.	SEP	Phase 2	Remyélinisation	Germany	À vérifier
ASPIRE-85 — Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.	Hypertension	Non applicable	À vérifier	Germany	À vérifier
Autologous Hematopoietic Stem Cell TransplantationThis is a randomized, open-label, prospective, multicenter phase III superiority study in patients with newly diagnosed stage IV extranodal NK/T-cell lymphoma. The study compares two frontline induction strategies followed by consolidation with autologous hematopoietic stem cell transplantation in patients who achieve a protocol-defined strict complete remission. Eligible participants will be randomized 1:1 to Arm A or Arm B, stratified by three-level PINK-E risk category. Arm A consists of one cycle of GELAD induction followed by three cycles of MEDA chemotherapy. Participants who achieve strict complete remission after key response assessment will proceed to autologous hematopoietic stem cell transplantation consolidation. Arm B consists of four cycles of LEAP induction with sintilimab, pegaspargase, and anlotinib. Participants who achieve strict complete remission will receive high-dose methotrexate CNS-directed consolidation followed by autologous hematopoietic stem cell transplantation consolidation if eligible. The primary endpoint is event-free survival within 24 months after randomization. Secondary endpoints include progression-free survival, overall survival, overall response rate, complete remission rate, strict complete remission rate, autologous hematopoietic stem cell transplantation completion rate, cumulative incidence of relapse, grade 3 or higher adverse events, treatment discontinuation, treatment-related mortality, and plasma EBV-DNA clearance dynamics.	Cancer, Myasthénie, SEP	Phase 2	Thérapie cellulaire	Germany	À vérifier
low energy argonplasma coagulationThe objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.	Cancer	Non applicable	À vérifier	Germany	À vérifier
AlemtuzumabThe MRI study is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination.	SEP	Phase 4	Remyélinisation		À vérifier
low energy argonplasma coagulationThe objective of this study is to investigate the feasibility for the treatment of precancerous peri-ampullary FAP polyps in the duodenum using low-thermal argonplasma.	Cancer	Non applicable	À vérifier	Germany	À vérifier
ASPIRE-85 — Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.	Hypertension	Non applicable	À vérifier	Germany	À vérifier
Autologous Hematopoietic Stem Cell TransplantationThis is a randomized, open-label, prospective, multicenter phase III superiority study in patients with newly diagnosed stage IV extranodal NK/T-cell lymphoma. The study compares two frontline induction strategies followed by consolidation with autologous hematopoietic stem cell transplantation in patients who achieve a protocol-defined strict complete remission. Eligible participants will be randomized 1:1 to Arm A or Arm B, stratified by three-level PINK-E risk category. Arm A consists of one cycle of GELAD induction followed by three cycles of MEDA chemotherapy. Participants who achieve strict complete remission after key response assessment will proceed to autologous hematopoietic stem cell transplantation consolidation. Arm B consists of four cycles of LEAP induction with sintilimab, pegaspargase, and anlotinib. Participants who achieve strict complete remission will receive high-dose methotrexate CNS-directed consolidation followed by autologous hematopoietic stem cell transplantation consolidation if eligible. The primary endpoint is event-free survival within 24 months after randomization. Secondary endpoints include progression-free survival, overall survival, overall response rate, complete remission rate, strict complete remission rate, autologous hematopoietic stem cell transplantation completion rate, cumulative incidence of relapse, grade 3 or higher adverse events, treatment discontinuation, treatment-related mortality, and plasma EBV-DNA clearance dynamics.	SEP	Phase 2	Thérapie cellulaire	Germany	À vérifier

Essais cliniques

4

Molécule	Indication / population	Phase	NCT	Titre	Statut
Autologous Hematopoietic Stem Cell Transplantation	SEP	Phase 2	NCT04971005	COAST — Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial	TERMINATED
ASPIRE-85 — Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac	Hypertension	Non applicable	NCT07713121	ASPIRE-85 — Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery	RECRUITING
low energy argonplasma coagulation	Cancer	Non applicable	NCT06435533	coldAPC — Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis	UNKNOWN
Alemtuzumab	SEP	Phase 4	NCT01395316	Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis	COMPLETED

Publications

4

Molécule	Indication / population	Titre	Journal	Date
Autologous Hematopoietic Stem Cell Transplantation		Resolution of Neuroblastoma-Related Opsoclonus-Myoclonus Ataxia Syndrome Following Tandem High-Dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation and Extensive Intravenous Immunoglobulin.	Pediatric blood & cancer
Autologous Hematopoietic Stem Cell Transplantation		Secondary poor graft function after autologous stem cell transplantation in multiple myeloma: a case-based expert review and successful rescue with secondary autologous stem cell infusion.	Hematology (Amsterdam, Netherlands)
Alemtuzumab		Lymphopenia predicts infectious complications after alemtuzumab therapy in multiple sclerosis: Real-world experience from a Brazilian cohort.	Clinical neurology and neurosurgery
Alemtuzumab		Alemtuzumab Induction via Intravenous vs. Subcutaneous Administration in Pediatric Kidney Transplantation.	Pediatric transplantation