Clinical trials: sponsored by University Hospital, Lille
Multiple Sclerosis
Switch to Ofatumumab and Level of Immunoglobulins
This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG…
- Trial name
- SOLI (NCT07625800)
- Testing
- ofatumumab
- Where
- France
- Volunteers
- 115 people
- Sponsor
- University Hospital, Lille
Prolymphocytic Leukemia, T-cell Leukemia
Observatory of Prolymphocytic Leukemia T
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course.
- Trial name
- T-PLL (NCT04411043)
- Testing
- Molecular caracterization
- Where
- France
- Volunteers
- 50 people
- Sponsor
- French Innovative Leukemia Organisation
Cardiac Arrest
Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
Among patients admitted after an out-of-hospital cardiac arrest (OHCA) in intensive care unit (ICU), almost two thirds of patients will develop in the first hours a post-cardiac arrest (CA) shock.
- Trial name
- VICEPAC (NCT05817851)
- Testing
- Vitamin C (Laroscorbine) + Vitamin B1 (Bevitine), standard treatment
- Where
- 14 sites in France
- Volunteers
- 65 people
- Sponsor
- Centre Hospitalier de Bethune
Hepatocellular Carcinoma
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection.
- Trial name
- KARCHER-1 (NCT04587739)
- Testing
- Surgery with Neoadjuvant stereotactic body radiation therapy
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Lille
Breast Cancer, Liver Cancer
Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers
The European Society for Medical Oncology (ESMO) strongly recommends to develop multigene sequencing in the framework of molecular screening programmes, in order to improve access to innovative drugs and to accelerate clinical…
- Conditions
- Breast Cancer, Liver Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- ESCAT (NCT06958224)
- Testing
- Large and early multigene sequencing
- Where
- France
- Volunteers
- 360 people
- Sponsor
- University Hospital, Lille
Medical Imaging
Defining Dosimetric Reference Levels in Computed Tomography Spectral Scanning
Spectral computed tomography or dual-energy CT imaging can overcome the limitations of conventional CT in differentiating between two materials with equivalent total attenuation.
- Trial name
- NR Spectral (NCT07305103)
- Testing
- Spectral ComputedTomography
- Where
- France
- Volunteers
- 9,600 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Critically-ill Patients
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Antimicrobial resistance AMR is an emerging global threat to human health, and intensive care units (ICUs) are a 'hot spot' for the emergence and diffusion of multidrug-resistant (MDR) bacteria.
- Trial name
- TANGERINE (NCT06652126)
- Testing
- Microbiological examinations.
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Lille
Splenomegaly, Splenectomy
Study of the Prevalence of Acid Sphingomyelinase Deficiency/Niemann Pick AB and B Disease in Patients With Diffuse Interstitial Lung Disease
The goal of this clinical trial is to optimise and facilitate screening for Acid SphingoMyelinase Deficiency (ASMD) disease, by evaluating acid sphingomyelinase activity and, where appropriate, LysoSM levels in a cohort of 200…
- Conditions
- Splenomegaly, Splenectomy, Thrombopenia, Interstitial Lung Disease (ILD)
- Trial name
- Niemann-PID (NCT06869499)
- Testing
- Blood sampling for dosage
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Wladimir MAUHIN, Dr
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
To assess the efficacy of administrating daily caspofungin aerosols versus placebo for seven days, in adjunction of conventional systemic antifungal therapy during curative treatment of Pneumocystis pneumonia, on the clinical…
- Conditions
- Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection, Pneumocystis Infections
- Trial name
- CaspoNEB (NCT06892951)
- Testing
- Caspofungin Acetate 50 MG, Physiologic saline
- Where
- 3 sites in France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Tours
Disorder Related to Renal Transplantation, Diabetes
Prevention of Diabetes After Transplantation by Vildagliptin in the Early Post-transplant Period
Post-transplant diabetes affects 15 to 20% of renal transplant patients and contributes to increased morbidity and reduced survival of transplants and patients.
- Trial name
- PRODIG (NCT02849899)
- Testing
- Vildagliptin
- Where
- France
- Volunteers
- 47 people
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Endometriosis, Chronic Pain
Perioperative Yoga Therapy and Endometriosis Surgery
YOGENDOCHIR is a multicentre, prospective, randomised, controlled, parallel-group study involving 188 adult women scheduled to undergo surgery for endometriosis.
- Conditions
- Endometriosis, Chronic Pain, Impairment of Quality of Life
- Trial name
- YOGENDOCHIR (NCT07765680)
- Testing
- Standard surgical management for endometriosis, Structured perioperative yogatherapy programme plus standard surgical management
- Where
- 4 sites in France
- Volunteers
- 188 people
- Sponsor
- University Hospital, Lille
Hypersensitivity, Food, Legumes Allergy
Observational Study of IgE-Mediated Leguminous Allergies in a Pediatric Population
Prospective, monocentric, observational study with standard care follow-up during 5 years or until the patient reaches the age of 18.
- Trial name
- FabALL (NCT07811141)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Lille
Fluid Challenge, Hemodynamic Monitoring
Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness.
In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge…
- Trial name
- TIDALEC (NCT04535115)
- Testing
- Starting LRM (Lung Recruitment Maneuver), Starting VtC (Tidal Volume Challenge)
- Where
- France
- Volunteers
- 160 people
- Sponsor
- University Hospital, Lille
Schizophrenia, Hallucinations, Auditory
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations.
- Conditions
- Schizophrenia, Hallucinations, Auditory, Hallucinations, Visual
- Trial name
- INTRUDE (NCT04798131)
- Testing
- Active neurofeedback procedure
- Where
- France
- Volunteers
- 84 people
- Sponsor
- University Hospital, Lille
Frailty, Septic Shock
Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock.
The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14)…
- Trial name
- Woodstock (NCT05928767)
- Where
- 5 sites in France
- Volunteers
- 200 people
- Sponsor
- Centre Hospitalier de Lens
Intermittent Fasting, Septic Shock
Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit
This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.
- Conditions
- Intermittent Fasting, Septic Shock, Organ Failure, Multiple
- Trial name
- ENNUT-CI (NCT06330610)
- Testing
- Intermittent enteral nutrition
- Where
- France
- Volunteers
- 174 people
- Sponsor
- University Hospital, Rouen
Delirium in the Intensive Care Unit
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours.
- Trial name
- PEDIADEX (NCT07542990)
- Testing
- Dexmedetomidine, Midazolam
- Where
- 7 sites in France
- Volunteers
- 266 people
- Sponsor
- University Hospital, Tours
Multiple Myeloma
Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma
The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an…
- Trial name
- IFM2021-01 (NCT05572229)
- Testing
- Teclistamab, Daratumumab, Lenalidomide
- Where
- 22 sites in France
- Volunteers
- 74 people
- Sponsor
- University Hospital, Lille
Glioblastoma
Impact of Fluorescence-Guided Resection and Chemoradiotherapy on the Systemic Immune Response in Glioblastoma: A Kinetic Analysis of Immune Biomarkers.
The immune system plays a critical role in cancer progression and antitumor responses. Glioblastoma is an aggressive and incurable brain tumor characterized by a highly immunosuppressive microenvironment.
- Trial name
- SHAM INDYGO/DO (NCT07568782)
- Testing
- Fluorescence-guided resection (FGR)
- Where
- France
- Volunteers
- 17 people
- Sponsor
- University Hospital, Lille
Multiple Myeloma
Compare Lenalidomide and Subcutaneous Daratumumab vs Lenalidomide and Dexamethasone in Frail Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
This is a Phase 3, randomized (study drug assigned by chance), open-label (participants and researchers are aware about the treatment, participants are receiving), active-controlled (study in which the experimental treatment or…
- Trial name
- IFM2017_03 (NCT03993912)
- Testing
- Daratumumab SC in combination with Lenalidomide, Lenalidomide PO (25mg), Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
- Where
- 23 sites in France
- Volunteers
- 294 people
- Sponsor
- University Hospital, Lille