Nantes University Hospital — Biomedical Watch V2

Traitements19programmes

Essais9liés

Publications2liées

SourceDBlocale

Traitements

19

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
colonoscopy or rectosigmoidoscopyThe aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.	Parkinson	Non applicable	À vérifier	France	À vérifier
Fludarabine, Busulfan, ThymoglobulineThe goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.	Cancer	Phase 2	Thérapie cellulaire + Ralentissement de la progression	France	À vérifier
IBEROGASTThe main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.	Parkinson	Phase 2	À vérifier	France	À vérifier
INNOVAN — Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular DystrophiesThe purpose of this research study is to determine the potential of a multiparametric ultrasound approach to non-invasively monitor disease progression and to serve as an objective outcome measure for future clinical trials in Duchenne and Becker Muscular Dystrophies. The investigators will compare the muscles of ambulatory or non-ambulatory boys/men with Duchenne and Becker Dystrophies with muscles of healthy age-matched individuals of the same age and monitor disease progression in those with muscular dystrophies over a 12-month year period. The ultrafast ultrasound technology used in this study allows the simultaneous assessment of muscle structure, mechanics and physiology, including stiffness, anisotropy, viscosity, intramuscular fat, muscle volume, and microvascular perfusion. The amount of muscle alteration measured will be related to performance in daily activities, such as walking and muscle strength, in order to identify sensitive and objective markers of disease progression.	Myopathies	À vérifier	Ralentissement de la progression	France	À vérifier
low-calorie low-proteinAmong critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.	Myopathies	Non applicable	À vérifier	France, Guadeloupe	À vérifier
PERCAM — Brain Perfusion Assessment in the Acute Phase of Migraine AuraThe aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.	Migraine	À vérifier	À vérifier	France	À vérifier
standard-calorie/standard-proteinAmong critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.	Myopathies	Non applicable	À vérifier	France, Guadeloupe	À vérifier
synovial biopsyPigmented villonodular synovitis (PVNS) is a rare joint disease caused by the proliferation of synovial tissue, leading to significant pain and joint destruction. It typically begins between the ages of 30 and 50 and significantly affects patients' functionality. The proliferation is due to somatic mutations in some fibroblastic cells within the tissue, which triggers a massive recruitment of inflammatory cells. The condition is considered a benign tumor of the synovial membrane with a major inflammatory component. Diagnosing PVNS requires synovial tissue analysis, obtained either through surgical excision or guided needle biopsy. This biopsy technique, done as an outpatient procedure, is well tolerated and helps confirm the diagnosis before treatment. Our goal is to better understand this disease and determine if the analysis of synovial tissue could serve as a useful biomarker for patient management in the context of personalized medicine.	Myopathies	Non applicable	Immunomodulation + Traitement symptomatique	France	À vérifier
Trap Myelin TestThe objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,	SEP	NA	À vérifier	France	À vérifier
Tys at Home — Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple SclerosisAt-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM). The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection. Quality of life, patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method. Data will be collected for a 12-month retrospective period and a 12-month prospective period.	SEP	À vérifier	À vérifier	France	À vérifier
Trap Myelin TestThe objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,	SEP	NA	À vérifier	France	À vérifier
INNOVAN — Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular DystrophiesThe purpose of this research study is to determine the potential of a multiparametric ultrasound approach to non-invasively monitor disease progression and to serve as an objective outcome measure for future clinical trials in Duchenne and Becker Muscular Dystrophies. The investigators will compare the muscles of ambulatory or non-ambulatory boys/men with Duchenne and Becker Dystrophies with muscles of healthy age-matched individuals of the same age and monitor disease progression in those with muscular dystrophies over a 12-month year period. The ultrafast ultrasound technology used in this study allows the simultaneous assessment of muscle structure, mechanics and physiology, including stiffness, anisotropy, viscosity, intramuscular fat, muscle volume, and microvascular perfusion. The amount of muscle alteration measured will be related to performance in daily activities, such as walking and muscle strength, in order to identify sensitive and objective markers of disease progression.	Myopathies	À vérifier	Ralentissement de la progression	France	À vérifier
PERCAM — Brain Perfusion Assessment in the Acute Phase of Migraine AuraThe aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.	Migraine	À vérifier	À vérifier	France	À vérifier
Tys at Home — Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple SclerosisAt-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM). The main objective of the study is to compare the safety of natalizumab administration at home vs at hospital based on retrospective and prospective data collection. Quality of life, patient perception of at-home natalizumab administration are also evaluated as secondary objectives as well as medico-economic assessment of the method. Data will be collected for a 12-month retrospective period and a 12-month prospective period.	SEP	À vérifier	À vérifier	France	À vérifier
colonoscopy or rectosigmoidoscopyThe aim of this project is to develop an original biomarker for Parkinson's disease (PD) and other parkinsonian syndromes (multiple system atrophy and progressive supranuclear palsy) based upon the detection of pathological alpha-synuclein species in routine colonoscopic biopsies.	Parkinson	Non applicable	À vérifier	France	À vérifier
IBEROGASTThe main objective of this study is to evaluate the efficacy of STW5 Iberogast, over a 28-day period, for the treatment of constipation in parkinsonian patients suffering from gastrointestinal disorders.	Parkinson	Phase 2	À vérifier	France	À vérifier
Fludarabine, Busulfan, ThymoglobulineThe goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.	Cancer	Phase 2	Thérapie cellulaire + Ralentissement de la progression	France	À vérifier
low-calorie low-proteinAmong critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.	Myopathies	Non applicable	À vérifier	France, Guadeloupe	À vérifier
synovial biopsyPigmented villonodular synovitis (PVNS) is a rare joint disease caused by the proliferation of synovial tissue, leading to significant pain and joint destruction. It typically begins between the ages of 30 and 50 and significantly affects patients' functionality. The proliferation is due to somatic mutations in some fibroblastic cells within the tissue, which triggers a massive recruitment of inflammatory cells. The condition is considered a benign tumor of the synovial membrane with a major inflammatory component. Diagnosing PVNS requires synovial tissue analysis, obtained either through surgical excision or guided needle biopsy. This biopsy technique, done as an outpatient procedure, is well tolerated and helps confirm the diagnosis before treatment. Our goal is to better understand this disease and determine if the analysis of synovial tissue could serve as a useful biomarker for patient management in the context of personalized medicine.	Myopathies	Non applicable	Immunomodulation + Traitement symptomatique	France	À vérifier

Essais cliniques

9

Molécule	Indication / population	Phase	NCT	Titre	Statut
synovial biopsy	Myopathies	Non applicable	NCT07503821	SYVIPRO — Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis	RECRUITING
low-calorie low-protein	Myopathies	Non applicable	NCT03573739	NUTRIREA3 — Impact of Early Low-Calorie Low-Protein Versus Standard Feeding on Outcomes of Ventilated Adults With Shock	COMPLETED
Fludarabine, Busulfan, Thymoglobuline	Cancer	Phase 2	NCT00841724	ITT 08-01 — Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies	COMPLETED
IBEROGAST	Parkinson	Phase 2	NCT02719496	PHYTOPARK — Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's Disease	COMPLETED
colonoscopy or rectosigmoidoscopy	Parkinson	Non applicable	NCT01353183	ColoBioParker — Analysis of the Enteric Nervous System Using Colonic Biopsies	COMPLETED
Tys at Home — Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis	SEP	À vérifier	NCT04777539	Tys at Home — Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis	COMPLETED
PERCAM — Brain Perfusion Assessment in the Acute Phase of Migraine Aura	Migraine	À vérifier	NCT03821584	PERCAM — Brain Perfusion Assessment in the Acute Phase of Migraine Aura	TERMINATED
INNOVAN — Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular Dystrophies	Myopathies	À vérifier	NCT07378553	INNOVAN — Multiparametric Ultrafast Ultrasound Biomarkers for Duchenne and Becker Muscular Dystrophies	RECRUITING
Trap Myelin Test	SEP	NA	NCT01723631	TRAP-Myéline — Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis	TERMINATED

Publications

2

Molécule	Indication / population	Titre	Journal	Date
Trap Myelin Test		Peptide profiling of Internet-obtained Cerebrolysin using high performance liquid chromatography - electrospray ionization ion trap and ultra high performance liquid chromatography - ion mobility - quadrupole time of flight mass spectrometry.	Drug testing and analysis
Trap Myelin Test		Reversing the Tumor Target: Establishment of a Tumor Trap.	Frontiers in pharmacology