Clinical trials: sponsored by Rennes University Hospital
Heterozygous Familial Hypercholesterolemia
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
The main goal of the STEATO-FH study is to determine the prevalence of liver steatosis within the Heterozygous Familial Hypercholesterolemia patient population.
- Trial name
- STEATO-FH (NCT06634160)
- Testing
- Fibroscan, Sample collection
- Where
- 3 sites in France
- Volunteers
- 200 people
- Sponsor
- Nantes University Hospital
Mycobacterium; Xenopi, Lung Diseases
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection
Treatment of Mycobacterium xenopi (MX) lung disease is not-well- tolerated and concerned a growing number of patients, especially with chronic pulmonary diseases or immunosuppression.
- Trial name
- AKAPI (NCT06585020)
- Testing
- Arikayce, standard treatment
- Where
- France
- Volunteers
- 190 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Pneumothorax Spontaneous Primary
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
The management of large spontaneous pneumothorax is not consensual. Current practice involves placement of a Fuhrman catheter connected to a one-way valve, with outpatient monitoring in pneumology consultation.
- Trial name
- PNEUM-AMBU (NCT03691480)
- Testing
- Fuhrman catheter insertion, Three-way stopcock open, Manual aspiration
- Where
- 5 sites in France
- Volunteers
- 148 people
- Sponsor
- Rennes University Hospital
Pain Management, Analgesia
Comparison of a Comfort Scale and a Numerical Pain Scale on Opioid Consumption After Surgery
The objective is to show that the use of therapeutic communication tools, in this case a comfort scale, a low cost and simple to implement method, can reduce pain and therefore the consumption of opioids in the postoperative care…
- Trial name
- COMFORT (NCT05234216)
- Testing
- Informed consent, Surgery, Comfort scale
- Where
- 29 sites in France, Lebanon
- Volunteers
- 885 people
- Sponsor
- Rennes University Hospital
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
Arrhythmogenic Right Ventricular Cardiomyopathy
Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)
Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological…
- Trial name
- CA2VD (NCT05024708)
- Testing
- Cardiac exercises and tests
- Where
- France
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Rennes University Hospital
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
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
The aim of this study is to assess the impact of non-invasive prenatal testing right after an early isolated miscarriage on mental health and on the patient's subsequent care in the year following the miscarriage
- Trial name
- GRACE (NCT07639333)
- Testing
- Non invasive prenatal test
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Rennes University Hospital
Hyperphagia
fNIRS-based Neurofeedback Intervention for Cognitive Control Improvement in Emotional Overeating
Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one.
- Trial name
- Cemov (NCT05200182)
- Testing
- Neurofeedback with functional near infra-red spectroscopy, oral microbiota collection, Questionnaires
- Where
- France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Rennes University Hospital
Diabetic Foot Ulcer
Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
Gram-positive cocci, particularly Staphylococcus aureus and coagulase-negative staphylococci (SCoN), are the bacteria most frequently isolated from diabetic foot ulcers. Although studies have been carried out on the role of S.
- Trial name
- PETTENK-OS (NCT06688084)
- Testing
- Molecular epidemiology of the collection, Study of the resistome of the S. pettenkoferi population, Study of the virulome of the S. pettenkoferi population
- Where
- France
- Volunteers
- 230 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Cerebral Palsy, Hemiparesis; Poststroke/CVA
Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
The aim of this pilot study is to evaluate muscular activity during a single session of surface electromyography controlled exergame (muscle activation, number of contraction…) in cerebral palsy kids, hemiparetic adults and…
- Conditions
- Cerebral Palsy, Hemiparesis; Poststroke/CVA, Healthy (Controls)
- Trial name
- CONTRACTIV-1S (NCT07838688)
- Testing
- Surface electromyography (sEMG)-controlled rehabilitation game
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Rennes University Hospital
Amputation of Lower Extremity, All Causes
Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)
In lower limb amputation, prosthetic gait has been shown to be particularly energy-intensive. While energy expenditure has been the focus of many studies in adult amputees, this area of research is less developed for paediatric…
- Trial name
- MAPEDE (NCT07076602)
- Testing
- Gait and energy expenditure
- Where
- 8 sites in France
- Volunteers
- 48 people
- Sponsor
- Rennes University Hospital
Heart Failure
RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure
The RADIATE-HF study is a prospective, interventional, single-center, open-label, non-randomized study conducted at the Rennes University Hospital.
- Trial name
- RADIATE-HF (NCT07770230)
- Testing
- Low-dose cardiac radiation therapy (5 Gy)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Rennes University Hospital
Multiple Sclerosis (MS)
Comparing the Safety and Benefit of Natalizumab (Tysabri®) At-home Infusion vs At-hospital Infusion in Multiple Sclerosis
At-home use of Natalizumab in multiple sclerosis (MS) patients has been temporarily granted by French security agency of medicines and Health products (ANSM).
- Trial name
- Tys at Home (NCT04777539)
- Testing
- At-home natalizumab treated MS patient
- Where
- 21 sites in France
- Volunteers
- 283 people
- Sponsor
- Nantes University Hospital
Concussion, Brain, Sports-related Concussion
Ecological Test Standardization for Concussion Assessment in Football Players
Concussion is a major concern in the sports world. It represents an immediate and transient alteration of neurological functions due to a direct or indirect trauma, with or without loss of consciousness.
- Conditions
- Concussion, Brain, Sports-related Concussion, Football Players, Traumatic Brain Injury, Mild
- Trial name
- COMOFOOT (NCT07431320)
- Testing
- Ecological Dual-Task Cognitive Assessment, Visuospatial Working Memory Ecological Test
- Where
- France
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de Kerpape
Weaning Mechanical Ventilation
Airway Occlusion Pressure Derived Parameters During Spotaneous Breathing Trial for Predicting Extubation Failure
Weaning from invasive mechanical ventilation (IMV) is a critical stage of the intensive care unit (ICU) stay. Premature IMV discontinuation may expose patients to substantial cardiopulmonary stress, whereas prolonged weaning…
- Trial name
- Weaning-POP (NCT07786519)
- Where
- 4 sites in France
- Volunteers
- 225 people
- Sponsor
- Rennes University Hospital
Sudden Cardiac Arrest, Sudden Cardiac Death
Sudden Cardiac Arrest Related to Sport in Young and Value of the Genetic Assessment: a French Prospective Register
The increased risk of sudden cardiac arrest (SCA) or sudden cardiac death (SCD) related to vigorous physical activity is well-documented.
- Trial name
- RESOUDRE (NCT06642168)
- Testing
- Whole exome sequencing to detect myocardial genetic mutations (SCA group only)
- Where
- 26 sites in France
- Volunteers
- 80 people
- Sponsor
- Rennes University Hospital
Chronic Insomnia
Evaluation of the Efficacy of E2R Hypnotherapy in the Management of Chronic Insomnia in Primary Care (HypERR)
In France, the treatment of chronic insomnia relies mainly on hypnotic drugs in routine care, despite the high level of iatrogenicity.
- Trial name
- HypERR (NCT06898099)
- Testing
- "Standard care" control group (without hypnosis), Experimental group: "E2R hypnosis"
- Where
- 35 sites in France
- Volunteers
- 136 people
- Sponsor
- Rennes University Hospital
HCM - Hypertrophic Cardiomyopathy
Stratification, Management, and Guidance of Hypertrophic Cardiomyopathy Patients Using Hybrid Digital Twin Solutions
The goal of SMASH-HCM is to develop a digital twin or virtual model of the heart and vascular system with sympathetic nerve control that integrates multi-scale and multi-organ spatiotemporal biophysical data from a multitude of…
- Trial name
- SMASH-HCM (NCT07131371)
- Where
- Finland
- Volunteers
- 2,500 people
- Sponsor
- Tampere University