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
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
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
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
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
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
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
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Transfusion Related Complication, Anemia
- Trial name
- ICONE (NCT05699005)
- Testing
- Packed Red Blood Cells (PRBCs)
- Where
- 4 sites in France
- Volunteers
- 236 people
- Sponsor
- University Hospital, Lille
Esophageal Cancer, Esophagectomy
PAravertebral CaTheter Versus Epidural Analgesia in Totally Minimally Invasive Esophagectomies
Esophageal cancer ranks as the seventh leading cause of cancer globally, with 604,100 new cases, and the sixth leading cause of cancer-related deaths worldwide.
- Conditions
- Esophageal Cancer, Esophagectomy, Multimodal Analgesia, Minimally Invasive Surgery
- Trial name
- PACEMIE (NCT07434739)
- Testing
- paravertebral catheter analgesia, Epidural group
- Where
- France
- Volunteers
- 506 people
- Sponsor
- University Hospital, Lille
Low Cardiac Output Syndrome Bypass Children
Performance of Carbon Dioxide (CO2)-Derived Parameters in Predicting Low Cardiac Output Syndrome
In congenital cardiac intensive care, low cardiac output syndrome (LCOS) after surgery is defined by a decrease in cardiac output due to cardiac dysfunction.
- Trial name
- GAP-CO2 (NCT07770386)
- Where
- France
- Volunteers
- 306 people
- Sponsor
- University Hospital, Lille
Intracerebral Haemorrhage, ICH
Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI
Intracerebral haemorrhage is the type of stroke with the highest mortality rate, estimated at 40% in the acute phase. Among survivors, half will experience functional disability.
- Trial name
- TIPITCH-7T (NCT07789990)
- Testing
- Sodium tissue concentration will be measured in perihematomal oedema
- Volunteers
- 48 people
- Sponsor
- University Hospital, Lille
Classic Congenital Adrenal Hyperplasia, 21-Hydroxylase Deficiency
Pediatric Congenital Adrenal Hyperplasia Management: Regret and Long-term Outcomes
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises.
- Trial name
- CAH - REC (NCT07781267)
- Testing
- questionnaire
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Lille
Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired
Impact of a Strategy Based on Bacterial DNA Detection to Optimize Antibiotics in Immunocompromised Patients With Hospital-acquired Pneumonia Requiring Mechanical Ventilation
RESPIRE is a randomized, unblinded, controlled study to measure the impact of a strategy based on a PCR test on the adjustment of antimicrobial therapy in immunocompromised patients suspected with ventilator-associated or…
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Hospital-Acquired, Immunodeficiency
- Trial name
- RESPIRE (NCT05405491)
- Testing
- PCR based strategy, Standard care
- Where
- France
- Volunteers
- 31 people
- Sponsor
- University Hospital, Lille
Hepatocellular Carcinoma, Liver Transplant
PET TDM FDG-Choline as a Decision-making Tool for Routine Care on the Liver Transplant List for HCC
HCC is the most common malignant liver tumor for which liver transplantation is one of the pivotal curative treatments. The best possible selection of patients who are candidates for transplantation is essential in the current…
- Trial name
- TEP CARE (NCT04792801)
- Testing
- PET TDM FDG-Choline
- Where
- 2 sites in France
- Volunteers
- 108 people
- Sponsor
- University Hospital, Lille
Sarcopenia, Pancreatic Cancer
Preoperative Prehabilitation for Sarcopenic Patients Prior to Pancreatic Surgery for Cancer
Major digestive surgery is associated with a significant rate of postoperative complications. To improve postoperative outcome, efforts are focused on postoperative course leading to the concept of rehabilitation.
- Trial name
- PSOAS (NCT04469504)
- Testing
- Prehabilitation program, Oral Impact
- Where
- France
- Volunteers
- 6 people
- Sponsor
- University Hospital, Lille
Critical Illness, Anesthesia
Evaluation of Glycemic Variability (GLAIVE)
This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU.
- Trial name
- GLAIVE (NCT02812927)
- Testing
- Edelvaiss Multiline-8, Standard infusion line
- Where
- France
- Volunteers
- 172 people
- Sponsor
- University Hospital, Lille