Clinical trials: sponsored by University Hospital, Rouen
Healthy Conditions
Role of Endothelin-1 in Flow-mediated Dilatation
Endothelial dysfunction of conduit arteries contributes to the increased morbidity and cardiovascular mortality in patients with essential hypertension and appears increasingly as an independent therapeutic target.
- Trial name
- Endothelin (NCT02086253)
- Testing
- BQ-788 and/or BQ-123
- Where
- France
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Neisseria Meningitidis
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 in Patients Having to be Vaccinated MenBVac® (Extension EFFIVAC)
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against…
- Trial name
- Exten Effivac (NCT01621945)
- Testing
- MenBvac
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Vaccination
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against…
- Trial name
- EFFIVAC (NCT01054053)
- Testing
- MenBVac Vaccination
- Where
- France
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Obesity
Evaluation of Liver Fibrosis Following Surgical-induced Weight Loss
Obesity is a frequent disease with an increased prevalence, estimated to 12.4% in France (OBEPI study 2006). Non alcoholic fatty liver disease (NAFLD) and non alcoholic steatohepatitis (NASH) both complicate morbid obesity and…
- Trial name
- FIBROTEST (NCT01469962)
- Testing
- Surgical procedure
- Where
- France
- Volunteers
- 255 people
- Sponsor
- University Hospital, Rouen
Mental Health Disorder
Overview of the Mental Health of Adolescents in Therapeutci, Educational and Pedagogical Facilities in France
Assess the prevalence of various psychiatric disorders in adolescents aged 12 to 16 receiving support from therapeutic, educational and pedagogical institutes.
- Trial name
- PsyPreDi (NCT06489912)
- Testing
- WAIS IV
- Where
- 2 sites in France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Severe Forms of Mucous Membrane Pemphigoid
Randomized Clinical Trial Comparing the Safety and Efficacy of Rituximab Versus Oral Cyclophosphamide in Severe Forms of Mucous Membrane Pemphigoid
Mucous membrane pemphigoid (MMP) describes a group of chronic auto-immune bullous diseases (AIBD) of the basement membrane zone (BMZ), characterized by predominant or exclusive mucosal involvement, including oral…
- Trial name
- RITUX-MMP (NCT03295383)
- Testing
- Rituximab 1g IV, Cyclophosphamide 50Mg Oral Tablet
- Where
- 27 sites in France
- Volunteers
- 92 people
- Sponsor
- University Hospital, Rouen
Monoclonal Gammopathy of Undetermined Significance, Myeloma Multiple
Determine the Frequency of Variants in the GBA/PSAP Genes in Patients With MM or MGUS
No effective specific treatment is currently available for the management of Multiple Myeloma (MM) and Monoclonal Gammopathy of Undetermined Significance (MGUS).
- Trial name
- GAMY (NCT06559033)
- Testing
- Evaluation of the presence and number of mutated alleles of the GBA/PSAP genes in patients with MM or MGUS
- Where
- 2 sites in France
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Vascular Complications
Prospective Exploration of Vascular Complications Associated With the Use of Immune Checkpoint Inhibitors
The development of immune checkpoint inhibitors (ICIs) has revolutionized the management of many oncological diseases, and their use continues to increase.
- Trial name
- ICI-Vasc (NCT07535944)
- Testing
- Evaluation of the vascular impact of ICIs (Immune Checkpoint Inhibitors)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Rouen
Male Infertility
Relationship Between Sperm Head Vacuoles and Sperm DNA Alterations in Infertile Men
In men presenting sperm alterations, the selection of genetically undamaged spermatozoa need to be improved in order to increase the success of assisted reproduction treatments.
- Trial name
- VATES (NCT02006446)
- Testing
- Sperm Samples
- Where
- 2 sites in France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Ehlers-Danlos Syndrome (EDS)
Impact of Ehlers-Danlos Syndrome on Gynaecological Health
Dysmenorrhea is a common problem in gynaecology, significantly impacting patients' quality of life. Ehlers-Danlos syndrome (EDS) is associated with joint hypermobility, tissue fragility and chronic pain.
- Trial name
- GYNESED (NCT07151274)
- Where
- France
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Aneurysm Aortic
Evaluation of the Efficacy of Ischemic Preconditioning to Protect Against Acute Kidney Injury After Open Surgery for Juxtarenal Abdominal Aortic Aneurysm
Juxta-renal abdominal aortic aneurysms (AAA) are challenging to treat with standard endovascular techniques (EVAR) due to their proximity to the renal arteries.
- Trial name
- EPAKI (NCT07441564)
- Testing
- patients with aortic clamping with preconditioning, patients with aortic clamping without preconditioning
- Where
- 7 sites in France
- Volunteers
- 206 people
- Sponsor
- University Hospital, Rouen
Pancreaticoduodenectomy, Antibiotherapy
Postoperative Anti-infective Strategy Following Pancreaticoduodenectomy in Patients With Preoperative Biliary Stent
The main objective of the study is to compare 2 broad-spectrum antibiotic (Piperacillin / Tazobactam) treatment modalities, following pancreaticoduodenectomy in patients with preoperative biliary stent, to demonstrate the…
- Trial name
- FRENCH24 ANIS (NCT06123169)
- Testing
- Antibioprophylaxis (Piperacillin-tazobactam), 5 days Antibiotherapy (Piperacillin-tazobactam)
- Where
- France
- Volunteers
- 326 people
- Sponsor
- University Hospital, Rouen
Lung Surgery
Impact of Reventilation After One-Lung Ventilation in Thoracic Surgery (OLVREEXP)
Lung cancer is a common disease, and more than 8,000 patients in France undergo lobectomy or pulmonary segmentectomy each year. This surgery remains associated with significant postoperative pulmonary complications, whose…
- Trial name
- OLVREEXP (NCT07247500)
- Testing
- Bipulmonary Reventilation using the accessory circuit, Bipulmonary Reventilation under controlled ventilation
- Where
- 5 sites in France
- Volunteers
- 350 people
- Sponsor
- University Hospital, Rouen
Elderly, Frail
Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score at 2-year Follow-up
"Healthy ageing" is not limited to the absence of disease, but implies the "development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being": (for example : the ability to walk, go out…
- Trial name
- FRAPA (NCT06560723)
- Testing
- Quality of life test
- Where
- 4 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Rouen
Kidney Diseases
Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>
Kidney transplantation is the standard treatment for patients with end-stage renal failure. However, anticalcineurin inhibitors, the most widely used immunosuppressants, are involved in the occurrence of cardiovascular events, a…
- Trial name
- BELAFENDO (NCT06291077)
- Testing
- Belatacept, anticalcineurins
- Where
- France
- Volunteers
- 44 people
- Sponsor
- University Hospital, Rouen
Kidney Transplant Rejection
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)
Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs)…
- Trial name
- BELA-M-R (NCT06291103)
- Testing
- Conversion to Belatacep, Standard of care treatment (SOC regimen) with Tacrolimus
- Where
- France
- Volunteers
- 290 people
- Sponsor
- University Hospital, Rouen
Kidney Diseases
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and is caused by mutations in the PKD1 or PKD2 genes, which encode polycystins 1 and 2.
- Trial name
- ETERNAL-PKD (NCT06291116)
- Testing
- standard care + rotigotine at 4 mg/24h for 24 months., standard care for 24 months.
- Where
- 4 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Rouen
Thrombotic Microangiopathies
Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies
The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.
- Trial name
- GEMECULI (NCT05702996)
- Testing
- Eculizumab administration
- Where
- 2 sites in France
- Sponsor
- University Hospital, Rouen
Metastatic Colon Cancer
De-scalation or swItch of Treatment According to Circulating tuMOr DNA Variation After 2 Cycles of Doublet Chemotherapy Plus Targeted Agent in Metastatic Unresectable Colorectal Cancer
Background : In unresectable mCRC, a de-escalation strategy using maintenance or chemotherapy (CT) discontinuation in selected cases is considered as a valid option in non-progressive patients after a first-line induction of…
- Trial name
- DIAMOND (NCT06446557)
- Testing
- treatment adaptation guided by ctDNA variation, standard management
- Where
- France
- Volunteers
- 408 people
- Sponsor
- University Hospital, Rouen
Lung Injury
Functional Residual Capacity and Alveolar Recruitment in Single-lung Ventilation: a Randomized Study
In thoracic surgery, the incidence of postoperative pulmonary complications is higher than for other surgeries. Indeed, thoracic surgery has the specificity of being carried out with single-lung ventilation and is thus a source…
- Trial name
- OLVEELV (NCT06446544)
- Testing
- VPFE monitoring with intraoperative alveolar recruitment maneuvers.
- Where
- France
- Volunteers
- 44 people
- Sponsor
- University Hospital, Rouen