title: Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis

acronym: RéMiFaSy

summary: Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients

summary:
Aim: to determine the effects of DHA supplementation:

on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
on redox status on cells and plasma
on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Véricel E, Colas R, Calzada C, Lê QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes

intervention_type: Dietary Supplement

lead_sponsor_type: academique

status_simplified: Completed


title: Antenatal Ultrasound Diagnosis of Periventricular Pseudocysts and Postnatal Outcome

acronym: UDiPPP

summary: The present study aims to improve the information given to the parents during the screening of periventricular pseudocysts in the Pluridisciplinary Center of Prenatal Diagnosis, with retrospective cases screened during the last 5 years in university hospital of Bordeaux.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

intervention_type: Other

status_simplified: Ongoing


title: Evaluation of Cyto-chex Tubes for the Measurement of Monocyte Expression of HLA-DR Molecules by Flow Cytometry

acronym: CHEX-DR

summary:
The expression of mHLA-DR, measured by flow cytometry, is today the reference marker to guide immunostimulatory therapies (IFN-γ) in the most severely immunocompromised patients. Nevertheless, pre-analytical constraints (storage of samples at +4°C before analysis) limit the wide use of mHLA-DR in clinical practice (problem of transporting samples to sites with a flow cytometer). Recent studies have shown that samples taken on Cyto-Chex Blood Collection Tubes (BCT) (containing a cell membrane stabilizer) were, for mHLA-DR, stable at room temperature during 72 hours after sampling. The main objective of this study is to compare the expression of mHLA-DR from samples taken simultaneously from standard tubes (EDTA) and new generation Cyto-Chex BCT tubes, to validate using Cyto Chex BCT tube in the clinical practice.

The investigators think that mHLA-DR quantification performed from Cyto-Chex BCT tubes is reliable and similar to quantification performed from EDTA tubes.

study_type: Observational

time_perspective: Prospective

intervention_type: Diagnostic Test


title: Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials

acronym: RELAXPE

summary:
Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.

The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.

The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience

primary_purpose: Supportive Care


title: Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

summary:
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.

Eligible patients are included according to a standard 3+3 design.

Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.

The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.

primary_purpose: Treatment

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Claudius Regaud
CHU Toulouse Larrey

intervention_type: Drug

lead_sponsor_type: industriel


type: Registry Identifier

title: Trisomy of Chromosome 21 Diagnosis by High Output Sequencing of Foetal Circulating DNA in Mother Blood at First Trimester of Pregnancy.

summary: Demonstrate that the High output shotgun sequencing of the foetal DNA in the maternal blood could allow a complete discrimination between the mothers of a trisomic fetus 21 or a DISOMIQUE foetus 21 from the first quarter of the pregnancy, and so to obtain a reliable alternative in invasive procedure.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Necker Enfants Malades
Chi Poissy St Germain


title: Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers (SEQUOIA)

acronym: SEQUOIA

summary: The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Basic Science

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

summary:
Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.

So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.

The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Beze S, Castellani L, Pereira B, Chiambaretta F, Durif F, Marques A. Two-year longitudinal follow-up of visual illusions and hallucinations in Parkinson's disease. J Neurol. 2022 Aug;269(8):4546-4554. doi: 10.1007/s00415-022-11074-2. Epub 2022 Mar 16.

ReferenceCitation: Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.

ReferenceCitation: Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Chu Clermont-Ferrand
CHU Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Unknown


title: Recurrent Collection By Medical Student From Sorbonne-Université in General Medicine

acronym: RCIMG

summary: The project for the recurrent collection of data from interns in general medicine is a formalized description of the consultations attended by medical students during their outpatient training. This formalization uses the International Classification of Primary Care. This project aims to create a research network between general medical interns, mainly for their thesis, which pools their observations in a database accessible to all participants.

lead_sponsor: Sorbonne University


title: Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients During Emotional Tasks and With Reference to Controls

summary: After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task

lead_sponsor: Qualissima

location_facility: Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite

location_facility: Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille


title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

acronym: OVO

summary: The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

status: Withdrawn

lead_sponsor: Breas Medical S.A.R.L.

location_facility: GH Pitié-Salpétrière - Service de pneumologie et réanimation

intervention_type: Device


title: Cardiovascular Events at One Year of Patients Hospitalized for Critical Limb Ischaemia and Aspirin Resistant Using the VerifyNow®. Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

acronym: Aspirine

summary:
Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. However, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.

Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care VerifyNow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.

lead_sponsor: University Hospital, Limoges

location_facility:
UH Toulouse
UH Bordeaux


title: Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease). A Phase III, Prospective, Multicentre, Randomized, Double-blind Controlled Study

acronym: METFORMYO

summary:
The study team hypothesize that non-diabetic patients with Myotonic dystrophy type I (DM1) will improve their symptoms, especially their motor deficit which is the main feature of the disease, because of the splicing defect correction by metformin.

The primary objective of the study is to evaluate the efficacy of metformin vs placebo, on the improvement of muscle function in patients with DM1 compared to its placebo.

As the secondary objectives, the study aims:

To evaluate the safety of metformin on patient with DM1.

To evaluate the efficacy of metformin vs placebo on:

The hand-grip strength;
The thumb-index pinch strength;
The locomotor function;
The respiratory function;
The cardiac function;
The quality of life;
The daily and social activity.

ReferenceType: background

ReferenceCitation: Bérard C, Payan C, Hodgkinson I, Fermanian J; MFM Collaborative Study Group. A motor function measure for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005 Jul;15(7):463-70.

ReferenceCitation: Landfeldt E, Nikolenko N, Jimenez-Moreno C, Cumming S, Monckton DG, Faber CG, Merkies ISJ, Gorman G, Turner C, Lochmüller H. Change over time in ability to perform activities of daily living in myotonic dystrophy type 1. J Neurol. 2020 Nov;267(11):3235-3242. doi: 10.1007/s00415-020-09970-6. Epub 2020 Jun 15.

location_facility: Neurology Department, Raymond-Poincaré hospital - APHP


title: Multidimensional Assessment of Quality of Life, Social and Professional Life and Care Utilization in Patients With Diffuse Large Cell B-cell Lymphoma Treated With CAR-T Cells

acronym: QUALITOP CAR-T

summary: Immunotherapy became in recent years a major innovation in the care of cancer patients, with unprecedented improvement in complete response and survival, particularly in hematological cancers. Since 2018, patients with relapsed or refractory lymphoma can benefit from immunotherapy based on CAR-T cells (Chimeric Antigenic Receptor - T cells), drugs derived from gene therapy and products from the patient's own T cells. The efficacy of these drugs, their development in more and more indications and in continuous earlier lines of treatment, their unprecedented adverse effects and their very high cost justify the search for predictive factors of efficacy and tolerance in order to optimize their use and benefit the greatest number of eligible patients. A better understanding of quality of life and its determinants in patients who received CAR-T cells could play a major role in predicting efficacy and tolerance. Quality of life data have indeed been deemed insufficient in phase 1-2 trials which have demonstrated the benefit of CAR-T cells in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in 3rd line of treatment or more and led to obtaining their marketing authorization. It is therefore necessary to assess the quality of life of patients treated in routine care with CAR-T cells. The European Qualitop project aims, from self-questionnaires, to explore the quality of life during the 2 years following the initiation of immunotherapy with a multidimensional approach integrating genetic factors, lifestyle habits and psychosocial determinants of patients. In this context, the Qualitop CAR-T study is a prospective non-comparative real-life study aimed at describing the multidimensional quality of life, its psychosocial determinants and drug consumption in patients with relapsed or refractory DLBCL treated with CAR -T cells.

location_facility: Service pharmaceutique, Hospices Civils de Lyon - Groupement Hospitalier Sud


title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

acronym: MASI

summary:
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.

The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.

The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

ReferenceCitation: Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6.

ReferenceCitation: Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. French.

ReferenceCitation: Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97. Review.

ReferenceCitation: Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61.

ReferenceCitation: Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.

lead_sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

location_facility: Ecole Nationale Supérieure des Arts et Metiers

intervention_type: Radiation


title: Neurotrophins Implications in Primary Sjögren Syndrome

acronym: Neuro-SGSp

summary:
Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.

location_facility:
Opthalmologie
Médecine Interne

intervention_type: Biological


title: Predictive Factors of Graft Detachment Following Dmek: Retrospective Study About 170 Cases

acronym: PDF DMEKDETACH

summary: The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

intervention_type: Procedure


title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

acronym: KILLSLEEP

summary: Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because of conflicts between physiological needs and social or professional activities, it is necessary to develop affordable countermeasure to sleepiness. In real-life driving studies, nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect of caffeine is quick but brief and varies between individuals. There is a need for more knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic light (blue light) decreases subjective sleepiness and improves performances. One objective of this project is to investigate whether blue light exposure during driving would be useful in a real driving situation when sleepiness becomes acute. Owing to the fact that our knowledge of the effects of exercise on driving is very sparse and to the absolutely need to standardize the bouts of exercise that will be applied to the subjects. One objective of the present study will be to investigate in a simulator study the effects of a bout of moderate exercise on participants driving ability when sleepiness becomes acute. Nocturnal neurobehavioral performance varies widely between individuals and only certain subjects seem significantly affected by sleep loss. It is of interest to find biological markers for sleep drive to identify vulnerable drivers to sleep deprivation or to identify responders to sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to determine individual differences (genetic, hormonal and cognitive) in the impairment of driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and coffee).

ReferenceCitation: Taillard J, Capelli A, Sagaspe P, Anund A, Akerstedt T, Philip P. In-car nocturnal blue light exposure improves motorway driving: a randomized controlled trial. PLoS One. 2012;7(10):e46750. doi: 10.1371/journal.pone.0046750. Epub 2012 Oct 19.

location_facility: CHU de Bordeaux Groupe Hospitalier Pellegrin


type: Other Identifier

title: MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

acronym: MOTIVATES

summary: To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

location_facility: Pediatric Intensive Care Unit, Raymond Poincaré Hospital, APHP


title: Repetitive Gravitationnal Changes on the Body-environment Relationship

acronym: ENACT

summary: The overall objective of this study is to better understand the relationship between the body and its environment, including cognitive performance, following repeated changes in gravity, including microgravity (0G) and modified gravity (i.e., hypergravity (1.8G) and modified gravity (Martian gravity)

lead_sponsor: University Hospital, Caen


title: Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

acronym: NAVASYNC

summary: NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hopital Paul Desbief
Fondation Hôpital Ambroise Paré


title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

acronym: IMMUTRI

summary: The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

time_perspective: Cross-Sectional

ReferenceCitation: Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.

lead_sponsor: Institut Jerome Lejeune

location_facility: Laboratoire d'Immunologie Biologique (Unité INSERM U580)


title: Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer

acronym: PROTAXY

summary: RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Jean Perrin
Institut Jean Godinot


title: Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort

acronym: RIEHO

summary: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.

location_facility: Service de Court Séjour Gériatrique, CHU DE REIMS, HOPITAL MAISON-BLANCHE


title: Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.

acronym: ATTENTIONEPIG

summary: Attentional disorders have been reported in neuropsychological studies evaluating patients suffering from generalized idiopathic epilepsy, but the data are disparate (in terms of test protocol). We aim to describe attentional and executive function disorder in IGE thanks to the Epitrack scale, validated in this specific population. Our secondary objective is to study the dynamic of cortical activity during an attentional task (the ANT), in order to describe the alteration of cortical networks in epileptic patients presenting with attentional disturbance.

lead_sponsor: University Hospital, Lille


title: Identification of Genes Involved in the Pathogenesis of Gliomas by Transcriptome Analysis

summary:
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue samples from patients with glioma or other brain tumors.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier
Clinique Gui de Chauliac


title: Study of the Effect of the Chronic Electric Stimulation of the Hypothalamus/Fornix on Memory Impairment in Alzheimer Disease.

summary:
Alzheimer's Disease (AD) is the most common cause of dementia. Today no treatment had shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.

The primary objectives of this prospective, non-controlled, pilot study are to assess the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing including classical instrument used in AD clinical trials. Changes in behavioral scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.

The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service de Neurochirurgie Hôpital Universitaire de Pasteur


primary_purpose: Prevention

acronym: Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season)

title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

lead_sponsor: Sanofi Pasteur, a Sanofi Company

source: euctr

summary:
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation.

Objectives:

To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.


title: Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

acronym: CIRCEE

summary: Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.


title: IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS

acronym: IntensVIH

summary:
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).

To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:

residual plasma replication between 0 and 50 copies/ml
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
proviral HIV DNA levels in PBMC and RL.

ReferenceCitation: Lafeuillade A, Assi A, Poggi C, Bresson-Cuquemelle C, Jullian E, Tamalet C. Failure of combined antiretroviral therapy intensification with maraviroc and raltegravir in chronically HIV-1 infected patients to reduce the viral reservoir: the IntensHIV randomized trial. AIDS Res Ther. 2014 Oct 7;11(1):33. doi: 10.1186/1742-6405-11-33. eCollection 2014.

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur mer

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie


title: Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

acronym: Mel-ImmAdj

summary: Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.

lead_sponsor: Hospices Civils de Lyon


title: Prospective Study Evaluating Postoperative Pain and Functional Recovery After Mastectomy and Immediate Breast Reconstruction by Implant: Prepectoral Versus Subpectoral Technique

acronym: DREAM-RMI

summary:
This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy.

The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each.

The main objective will be to evaluate the postoperative pain by BPI questionnaire.

The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.

acronym: ECP

summary:
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according to the following schedule:

Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.

location_facility: Centre de Santé - Etablissement Français du Sang (EFS)

location_facility: Hôpital Edouard Herriot, Service d'Hématologie


title: Age Influence on the Modifications of the Oral, Pharyngeal and Laryngeal Axis Alignment in Children Induced by Head Extension: an MRI Study

summary:
In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the most important procedure. To achieve this procedure as fast as possible and in is best conditions, the physician should choose the head posture which a priori will enable at first the best glottic visualisation during laryngoscopy, and at second will facilitate the route of the tube from the larynx to the trachea.

Tracheal intubation is a procedure used for years, and many textbooks recommendations on the best head posture for tracheal intubation in paediatrics have been made. Briefly summarized, depending on the age of the child, the head should (or not) be slightly extended, and a pillow should (or not) be positioned under the occiput. These recommendations are questionable for three majors reasons:

despite an apparent consensus, some recommendations are quite different.
none are based on anatomical nor clinical studies
if for all of them, the age of the child is considered as critical point, but children are only grossly categorized in three categories (newborn, infants and old children). And the clinician has no way, facing a child, to make his choice between dichotomic attitudes.

Actually, the responses to these questions should need rigourous clinical studies on laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology 2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring indirect but strong evidence and can be a first step leading to clinical studies. Many children need MRI study for different reasons, and it is fast and easy to get during their examination additional images of the superior airway.

In their unit, the investigators are experienced in this kind of study, as they recently published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in their study were in major part infants, so the influence of the age could not be properly analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation of head postures, and that a laryngeal mask the children, who were on general anesthesia (required for the MRI examination) were made using a laryngeal mask (as it was at this time the standard in their institution).

The investigators propose an MRI study of the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, with a prospective stratified on age study. Several modifications and improvement in the design of this study would diminished the limitations of the first study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


title: Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter

acronym: RV-CIP

summary:
The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses.

The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology).

Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication.

The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..

location_facility: Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS


title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

acronym: UVEXATE

summary: The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

status: Terminated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Avicenne - Service de Médecine Interne


title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

acronym: AUTOSOP

summary: The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving

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ReferenceCitation: Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12.

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lead_sponsor: University Hospital, Bordeaux

location_facility:
GENNPHASS - CHU de Bordeaux
AP-HP - Hôpital de l'Hôtel-Dieu


title: Evaluation of the Optimal Time of Recognition of a Cardiac Arrest Within the EMS 95

summary:
This study aims to evaluate the average time taken by the Medical Regulation Assistants (MRA) to detect a cardiac arrest during the call to the EMS as well as the factors influencing this delay.

Its main objective is to evaluate the delay, in seconds, between the call being picked up and the recognition of a cardiac arrest by the medical regulation assistant at the EMS 95

lead_sponsor: Centre Hospitalier René Dubos

location_facility: EMS department - Hospital René Dubos - Pontoise


title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology

summary:
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.

PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
Laboratoire URECA


title: Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.

summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals.

Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated .

The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg), nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.

Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %.

Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire


title: Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

acronym: Nutri-PA

summary:
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.

The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.

lead_sponsor: University Hospital, Rouen

location_facility:
Centre Hospitalier de Dieppe
UHRouen


title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

acronym: READ

summary: The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.

lead_sponsor: University Hospital, Caen

location_facility:
William Harvey Center
Centre Hospitalier de la Côte Fleurie


title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome

summary:
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.

Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.

location_facility: Service explorations fonctionnelles - Hopital La Miletrie


title: Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.

acronym: DTP

summary:
The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment duration in uncomplicated acute pyelonephritis.

Acute pyelonephritis is a common disease and the treatment duration is not found on scientific evidence. If a short treatment is equal to standard duration, it will possible to shortening antibiotherapy with ecologic and economic advantage.

location_facility:
University hospital of Garches
university hospital of TOURS


title: Evaluation of the Performance and Safety of the S360 Medical Device Software.

summary: The aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360. This clinical investigation is performed in order to demonstrate the conformity of the medical device, when operating under the normal conditions of its intended use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device regarding the Medical Device Regulation (MDR) 2017/745 (EU).

lead_sponsor: Sierra Neurovision


title: Impact of Ostracism on Prospective Memory in ADHD Children With or Without Emotional Dysregulation/ Impact de l'Ostracisme Sur la mémoire Prospective Chez Des Enfants Atteint de TDA/H Avec ou Sans dysrégulation émotionnelle.

acronym: IOM-ADHD

summary: Assess the effect of exposure to a situation of social exclusion or ostracism on the prospective memory of children with ADHD


title: Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

acronym: DARTAGNAN

summary: Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

lead_sponsor: Association Pour La Promotion A Tours De La Reanimation Medicale

location_facility: Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU

location_facility: Service de réanimation médicale. Hôpital La Source. CH Orléans


title: Effects of Parenteral L-carnitine Supplementation in Premature Neonates

acronym: CarniPrema

summary:
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarnitine esters across the inner mitochondrial membrane for Beta-oxidation and energy production. Intracellular carnitine deficiency induces an impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes from the diet and 25% from endogenous liver synthesis. In the neonatal period, more specifically in the premature, liver synthesis capacity is reduced because of immaturity of the biosynthetic pathway, and carnitine levels are related to exogenous sources. Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine levels fall during the first weeks of life, particularly in subjects requiring a prolonged exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has not been clearly demonstrated in these infants. However, most patients with primary carnitine deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency, commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter patients, carnitine supplementation improves all the symptoms.

Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be one of the factors involved in the liver disease frequently associated with prolonged parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and functions.

Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature neonates for liver, heart and muscle metabolism and functions.

Study Type: Multicentric prospective and randomised study

Subjects: Premature and very low birth weight neonates, defined by gestational age minor or equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be enrolled during 2.5 years

Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d), from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo comparator): parenteral supplementation with an equivalent volume of sterile water.

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Clocheville, University Hospital, Tours


title: Assessment of a Predictive Radiologic Score to Predict the Failure of the Non-operative Management of Adhesive Small Bowel Obstruction: a Prospective Cohort Analysis

acronym: PREDIFAIL

summary:
The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.

A radiological score has been proposed and was associated with an increased risk of failure of conservative management.

This tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.

lead_sponsor: University Hospital, Angers


title: Pharmacogenetic Investigation of Susceptibility to Liver Toxicity in Patients With Multiple Sclerosis Treated With Fingolimod

summary: To investigate whether polymorphic differences can be identified between Multiple Sclerosis patients developing elevated liver enzymes (defined as ALT, AST, GGT or bilirubinemia levels five above the upper normal limit on at least one) compared to those not developing elevated liver enzymes after exposure to fingolimod for multiple sclerosis.

ipd_sharing: Undecided


title: Light Endoscopic Robot Use in Abdominal and Urological Laparoscopic Surgery

summary:
Light Endoscopic Robot evaluation in abdominal and urological laparoscopic surgery : surgery with surgeon and robot (REL group = new treatment) versus surgery with surgeon and assistant (AO group - standard treatment)

Primary outcome measure : Number of useful hands (light endoscopic robot = one useful mechanical hand)

ReferenceCitation: Long JA, Descotes JL, Skowron O, Troccaz J, Cinquin P, Boillot B, Terrier N, Rambeaud JJ. [Use of robotics in laparoscopic urological surgery: state of the art]. Prog Urol. 2006 Feb;16(1):3-11. Review. French.

ReferenceCitation: Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc. 2002 Sep;16(9):1267-70. Epub 2002 Jun 14.

ReferenceCitation: Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL. Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013 Apr;23(4):351-5. doi: 10.1089/lap.2012.0233. Epub 2013 Mar 11.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital, Saint-Etienne
University Hospital, Grenoble


title: Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery

acronym: PARACARD

summary: Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation

acronym: CATAFABL

summary:
There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).

The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).

location_facility:
Clinique Pasteur
University Hospital


title: Open, Randomized, Parallel Group, Single Dose, Bioavailability Comparison of 3 Certolizumab Pegol Solution Formulations (Lyophilized, Liquid, Pre-filled Syringe Formulation) to Healthy Volunteers

summary: To compare the bioavailability of a single dose of certolizumab pegol solutions given subcutaneously either by one of the three formulations and to investigate safety and tolerability.

lead_sponsor: UCB Pharma


title: Improvement of Lung and Thoracic Compliance in ARDS Patients in Prone Position by Using Inflatable Air Bag

acronym: MAPIC

summary: ARDS is frequent in ICU and may lead to many complications and to death. Prone position is widely used in ADRS patients and demonstrated to decrease mortality. Regarding the chest wall compliance data are missing but the theorical response is that this compliance is decreased in a prone position mainly due to anterior chest and abdomen compression in this position which are more compliant that dorsal part of the body. As well prone position could be associated with complications as pressure ulcers. Because prone position is associated with complications, air bag were developped to decrease pressure on the chest and abdomen and to decrease pressure ulcers. Then, trying to improve chest compliance in prone position and reducing the risk of pressures ulcers could be a challenge with this system in comparison with standard care.


title: Impact of Loss-of-function Mutations of Genes Encoding Cytosolic Aminoacyl-tRNA Synthetases on Protein Translation and Responses to Cellular Stress

acronym: FIBROMARS

summary:
Mutations in the genes encoding cytosolic aminoacyl-tRNA synthetases are responsible for early-onset multisystemic diseases including to varying degrees interstitial lung disease, liver damage, neurological and digestive disorders, and systemic inflammation. These are rare and severe diseases whose pathophysiology is poorly understood.

The investigative team hypothesizes that mutations within these genes are responsible for a decrease in protein translation and lead to a cellular stress response similar to that induced by amino acid deprivation. The investigative team also hypothesizes that these alterations could be corrected by high-dose supplementation in the culture medium of the corresponding amino acid.

The main objective of the study is to precisely determine the consequences of cytosolic aminoacyl-tRNA synthetase mutations at the cell level on protein translation.


title: Ventilator-Induced Diaphragmatic Dysfunction (VIDD) in Critically Ill Patients

summary: Animal studies showed that controlled mechanical ventilation (CMV) can induce dysfunction of the diaphragm, resulting in an early-onset and progressive decrease in diaphragmatic force-generating capacity, called ventilator-induced diaphragmatic dysfunction (VIDD).

ReferenceCitation: Demoule A, Molinari N, Jung B, Prodanovic H, Chanques G, Matecki S, Mayaux J, Similowski T, Jaber S. Patterns of diaphragm function in critically ill patients receiving prolonged mechanical ventilation: a prospective longitudinal study. Ann Intensive Care. 2016 Dec;6(1):75. doi: 10.1186/s13613-016-0179-8. Epub 2016 Aug 5.

ReferenceCitation: Demoule A, Jung B, Prodanovic H, Molinari N, Chanques G, Coirault C, Matecki S, Duguet A, Similowski T, Jaber S. Diaphragm dysfunction on admission to the intensive care unit. Prevalence, risk factors, and prognostic impact-a prospective study. Am J Respir Crit Care Med. 2013 Jul 15;188(2):213-9. doi: 10.1164/rccm.201209-1668OC.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of Anesthesia and Critical Care (DAR B)


title: Treatment of Pilonidal Cyst With Holmium Laser

acronym: PILOLAS

summary: Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Bacterial Ecology of Pilonidal Cysts

acronym: PILOBAC

summary: Bacterial ecology of pilonidal cysts Single centre retrospective exploratory study of medical data contained in the medical records of patients operated on in the centre between 01/08/2020 and 30/11/2020.


title: A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children

summary:
Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.

The omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects.

lead_sponsor: Laboratoires URGO

location_facility:
Clinical Investigation Center
Hopital Cardiovasculaire Louis Pradel


title: Influence of Different Exercise Training Programs in Patients With Coronary Artery Disease on Cardiac and Respiratory Parameters

acronym: FRAXIO

summary: The benefits of cardiac rehabilitation have been clearly demonstrated. In particular exercise training is recognized to be part of modern management after coronary artery disease. However methods of prescribing exercise-training programs and the exercise intensity are difficult to determine. The objective of this randomised clinical trial is to determine whether appropriate endurance exercise training improves the ventilatory threshold, the exercise tolerance and the quality of life in patients with coronary artery disease. Patients are randomized to continuous training or aerobic interval training respectively: 80%-versus maximal-workload at the ventilatory threshold. For each patient, the intensity of exercise training is determined by a first exercise test with gas analysis using parameters of sub maximal exercise capacity such as ventilatory threshold. Others parameters of functional capacity are also considered. Duration of the rehabilitation stage is between 7 to 10 weeks. Dyspnoea assessment at maximal intensity, quality of life measurement by SF36, drugs and events are reported. Maximal exercise tests with gas exchange measurements are performed after training program and at 6 months follow-up to compare the different cardio respiratory parameters in the two groups before and after exercise training and to evaluate the more effective endurance training program.

lead_sponsor: University Hospital, Limoges


title: Neoadjuvant Treatment of Resectable or Locally Advanced Borderline Pancreatic Adenocarcinoma: Reproducibility of Tumor Measurement in CT Versus MRI

acronym: ReMeTTI

summary:
Despite important therapeutic advances, pancreatic adenocarcinoma remains one of the cancers with a high mortality rate (4th leading cause of cancer death in the US in 2021), poor prognosis (5-year overall survival rate of 10%) and increasing incidence.

Patients are often metastatic from the start or at an advanced stage at diagnosis, making curative treatment difficult to envisage. Although the gold standard of treatment for resecable pancreatic adenocarcinoma is initial surgery followed by adjuvant chemotherapy, considerable interest has emerged in a treatment strategy involving neoadjuvant therapy in patients at high risk for positive resection margins (R1) on initial imaging workup.

The assessment of response to neoadjuvant therapy is complex, especially for the evaluation of vascular invasion with a high risk of overestimating residual invasion after neoadjuvant therapy. Accurate assessment of tumor size before and after neoadjuvant treatment is therefore crucial to identify good responders (according to RECIST 1.1 criteria) and thus improve the selection of patients who can benefit from curative surgery with healthy resection margins (R0).

In clinical practice, tumor size assessment is performed by injected computed tomography (CT). The latter has certain advantages in terms of technical reproducibility, but has a number of limitations. Indeed, the delineation of the tumor mass in CT seems to be subject to a significant inter-observer variability. The same is true for vascular invasion. CT also seems to underestimate the size of the tumor compared to the anatomopathological examination of the surgical specimen. On the other hand, Magnetic Resonance Imaging (MRI) has been shown to be superior to CT in tumor detectability and diagnosis of malignancy in the presence of an indeterminate pancreatic mass. It has also been shown that tumor size, whether measured in diameter or volume, is frequently underestimated on CT compared to multiparametric MRI or pathological examination of the resection specimen.

In the latest recommendations of the National Comprehensive Cancer Network (NCCN), MRI is indicated at diagnosis in non-metastatic patients with indeterminate liver lesions on CT, or as a second-line alternative to CT for re-evaluation after neo-adjuvant therapy in patients with resectable or borderline resectable disease according to the NCCN classification. However, MRI is increasingly performed routinely in some centers, both at diagnosis and at re-evaluation after neo-adjuvant therapy. The question of which imaging modality between CT and multiparametric MRI is the most reproducible in terms of tumor size measurement becomes important, especially in the evaluation of the response to neoadjuvant therapy. A few studies have investigated the interobserver variability of tumor size measurement in CT versus MRI in the context of radiotherapy management for the delineation of an irradiation field, but to date investigators have not found any study evaluating the interobserver variability of tumor size measurement using RECIST criteria before and after neoadjuvant treatment for pancreatic adenocarcinoma.

status: Active, not recruiting

ReferenceCitation: Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. Erratum in: CA Cancer J Clin. 2021 Jul;71(4):359.

ReferenceCitation: Saad AM, Turk T, Al-Husseini MJ, Abdel-Rahman O. Trends in pancreatic adenocarcinoma incidence and mortality in the United States in the last four decades; a SEER-based study. BMC Cancer. 2018 Jun 25;18(1):688. doi: 10.1186/s12885-018-4610-4.

ReferenceCitation: Kaufmann B, Hartmann D, D'Haese JG, Stupakov P, Radenkovic D, Gloor B, Friess H. Neoadjuvant Treatment for Borderline Resectable Pancreatic Ductal Adenocarcinoma. Dig Surg. 2019;36(6):455-461. doi: 10.1159/000493466. Epub 2018 Nov 8. Review.

ReferenceCitation: Tempero MA, Malafa MP, Al-Hawary M, Behrman SW, Benson AB, Cardin DB, Chiorean EG, Chung V, Czito B, Del Chiaro M, Dillhoff M, Donahue TR, Dotan E, Ferrone CR, Fountzilas C, Hardacre J, Hawkins WG, Klute K, Ko AH, Kunstman JW, LoConte N, Lowy AM, Moravek C, Nakakura EK, Narang AK, Obando J, Polanco PM, Reddy S, Reyngold M, Scaife C, Shen J, Vollmer C, Wolff RA, Wolpin BM, Lynn B, George GV. Pancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Apr 1;19(4):439-457. doi: 10.6004/jnccn.2021.0017.

ReferenceCitation: Soloff EV, Al-Hawary MM, Desser TS, Fishman EK, Minter RM, Zins M. Imaging Assessment of Pancreatic Cancer Resectability After Neoadjuvant Therapy: AJR Expert Panel Narrative Review. AJR Am J Roentgenol. 2022 Apr;218(4):570-581. doi: 10.2214/AJR.21.26931. Epub 2021 Dec 1. Review.

ReferenceCitation: Dalah E, Moraru I, Paulson E, Erickson B, Li XA. Variability of target and normal structure delineation using multimodality imaging for radiation therapy of pancreatic cancer. Int J Radiat Oncol Biol Phys. 2014 Jul 1;89(3):633-40. doi: 10.1016/j.ijrobp.2014.02.035. Epub 2014 Apr 20.

ReferenceCitation: Legrand L, Duchatelle V, Molinié V, Boulay-Coletta I, Sibileau E, Zins M. Pancreatic adenocarcinoma: MRI conspicuity and pathologic correlations. Abdom Imaging. 2015 Jan;40(1):85-94. doi: 10.1007/s00261-014-0196-8.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: A Cohort of Acute, Ischemic and Rare Neuropathies

acronym: CAIRN

summary:
Neuropathies are defined as the clinical, electrical, biological and histological manifestations of peripheral neuron damage. They represent a heterogeneous group of disorders and are responsible for disabling sensory and motor disorders. Their diagnosis is based on a set of clinical arguments confirmed by the electromyogram. This allows to specify the site of the damage, its severity, and to follow the evolution of the disease.

To date, the diagnosis of peripheral nerve injury secondary to occlusion of arterial trunks is rarely evoked; its clinical, electromyographic and prognostic characteristics are poorly known. Indeed, the rare cases reported in the literature are from vascular specialties, with little data on neurological symptoms, neurophysiological diagnostic elements and prognosis.

However, these unrecognized and underdiagnosed neuropathies are sometimes indicative of severe vascular damage for which urgent management is necessary. Neurological symptoms should then be treated as warning signs and the correct recognition of the early ischemic vascular etiology may lead to an optimized medical management.

The objectives of this study will be to describe the clinical presentation of these neuropathies, to discuss their electrophysiological diagnostic characteristics, to compare the demographic data with those from the literature, and to evaluate the functional prognosis of these attacks. A better knowledge of this rare etiology of neuropathy would allow to better inform the patients and to optimize the diagnostic and therapeutic management.

ReferenceCitation: Siao P, Kaku M. A Clinician's Approach to Peripheral Neuropathy. Semin Neurol. 2019 Oct;39(5):519-530. doi: 10.1055/s-0039-1694747. Epub 2019 Oct 22. Review.

ReferenceCitation: Abdellaoui A, West NJ, Tomlinson MA, Thomas MH, Browning N. Lower limb paralysis from ischaemic neuropathy of the lumbosacral plexus following aorto-iliac procedures. Interact Cardiovasc Thorac Surg. 2007 Aug;6(4):501-2. Epub 2007 Apr 17.

ReferenceCitation: Abdelhamid MF, Sandler B, Awad RW. Ischaemic lumbosacral plexopathy following aorto-iliac bypass graft: case report and review of literature. Ann R Coll Surg Engl. 2007 Jul;89(5):W12-3. Review.

ReferenceCitation: Deylgat B, Wallaert P, De Smul G, Van Lysebeth L, Ceuppens H. Unilateral lower limb paralysis after aortobifemoral bypass graft for ruptured abdominal aortic aneurysm: a case report. Vasc Endovascular Surg. 2009 Dec;43(6):606-9. doi: 10.1177/1538574409345032. Epub 2009 Oct 14.

ReferenceCitation: Winston P, Bakker D. Ischemic Monomelic Neuropathy: The Case for Reintroducing a Little-Known Term. Can J Neurol Sci. 2020 Sep;47(5):697-699. doi: 10.1017/cjn.2020.88. Epub 2020 May 4.


title: Does the Therapist's Assessment of Movement Control in Low Back Pain Patients Correspond to an Objective Kinematic Modification

acronym: LOBACOM

summary:
Exercise-based treatment is part of the recommendations for good practice in the treatment of low back pain (acute, sub-acute and chronic).
The low back pain population is heterogeneous. This heterogeneity would cause the positive effects of a treatment to be canceled out by the negative effects of another part of the population.
This polymorphism has led several authors to classify low back pain into subgroups. These subgroups constitute more homogeneous clinical pictures and would facilitate the adaptation of treatments.
The recommendations of the American Physical Therapy Association suggest 5 subgroups of low back pain. One of them is "low back pain with movement coordination defect". In this subgroup, Luomajoki studied the reliability of different functional tests used in clinical practice. 6 out of 10 motion control fault tests show good reliability.
The quantified analysis of the movement of low back pain patients would make it possible to determine the sensitivity of detecting an anomaly in the 6 lumbar movement control tests.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)

acronym: TDA/H

summary: The aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity will be measured using magnetic Resonance Imaging Techniques.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Charles Perrens Hospital
University Hospital Bordeaux


title: Non Inferiority Study of Glycemic Monitoring Via myDiabby Healthcare vs Conventional Diary in Patients With Gestational Diabetes Mellitus

acronym: TELESUR-GDM

summary: The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Endocrinology department - Centre Hospitalier René Dubos


title: Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension

acronym: ETHAPE

summary: In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hôpital Antoine Beclere
Hospital Marie Lannelongue


title: Can Ultrasound Predict Success of Median Nerve Block? Relationship Between Diffusion of Local Anesthetic and Effectiveness of a Nerve Block

acronym: Echoalr

summary: Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study is to observe the local anesthetic solution diffusion after a conventional median nerve block technique using neurostimulation. The secondary objective is to compare diffusion and of block efficacy..

lead_sponsor: Hopital Foch

location_facility:
Hôpital Foch
Hôpital privé de l'Ouest Parisien


title: Multicenter Clinical Investigation for the Evaluation of Safe Use of SECURIDRAP® SELFIA®

acronym: SECURIDRAP

summary:
Interventional, multicenter, prospective and non-comparative clinical investigation carried out in 9 French establishments in order to assess the safety of the SÉCURIDRAP® SELFIA® bedding by mesasuring all the adverse events likend to its use.

Following the withdrawal from the market of the first version of the SECURIDRAP® SELFIA®, this clinical investigation is being carried out at the request and on the recommandation of the ASNM in order to assess the safety of the second version of the SECURIDRAP® SELFIA® coating.

lead_sponsor: Groupe Mulliez-Flory


title: Clinical and Radiological Outcomes of Composite Tibial and Femoral Allograft and Tantalum Cone Reconstructions in Total Knee Replacement Revision

summary:
A new surgical technique of reconstruction for bone loss in TKA revision using tantalum cone and allograft.

Study of radiological and clinical outcomes.

ipd_sharing_description: NC


title: Effectiveness of Standard Emergency Department Psychiatric Treatment Compared With Effectiveness of Standard Emergency Department Psychiatric Treatment Associated With Treatment Delivery by a Suicide Prevention Center.

summary:
Very few studies have proved the effectiveness of treatment for suicide attempt patients. Our objective is to evaluate the addition of the resources of an suicide prevention centre to standard psychiatric treatment in the Emergency Department. Consecutive suicide attempt patients in 2 Emergency departments (multicenter study) were included after standard psychiatric treatment and referral. After Written informed consent, psychological assessment (depression, suicide intention) was carried out After randomisation, control patients were given an information card describing the Suicide Prevention Center (SPC); experimental patients had a first meeting with a psychologist of the SPC.

To verify the hypothesis of a decrease in suicidal behaviors in the experimental group, an evaluation of these behaviors was carried out every month during a two year follow-up.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4:CD013668. doi: 10.1002/14651858.CD013668.pub2.

lead_sponsor: University Hospital, Toulouse

location_facility:
Laboratoire de Stress Post-Traumatique
Service d'Accueil des Urgences


title: Medico-economic Evaluation of the Prosthetic Replacement of the Lumbar and Cervical Intervertebral Disc

acronym: EVA

summary:
Until now, arthrodesis (intervertebral fusion) is the formal treatment for the lumbar and cervical degenerative disc disease : arthrodesis has been the standard surgical treatment for the patients when nonsurgical management has failed. However , it has shown out some drawbacks : pseudoarthrosis may appear in the short term, and junctional degeneration in the long term.

The replacement of the intervertebral disc by a prosthesis (arthroplasty) has been since a few years a major alternative therapeutic to the arthrodesis.: it demonstrates great functional results and less post-interventional complications. It is indicated to restore a normal function of the spine (motion is kept)and to avoid deterioration of the adjacent spinal segments over the long time.

In this clinical study, we will distinguish the cervical discal pathology and the lumbar discal pathology.

The purpose of this study is to analyze the results of the arthroplasty in terms of functional effects, quality of life, anatomical results and economical results.

location_facility: Service de Chirurgie CHU Hopital Antoine Béclère

location_facility: Service de Neurochirurgie CHU Saint-Etienne


acronym: Trans-Insulin

summary: The investigators' project has as for principal objective to understand the impact of trans fatty acids from dairy products and industrial origin on the development of insulin resistance in obese woman. Because of the different isomeric position of the double bound those trans fatty acids may have different metabolic effects.

ReferenceCitation: Chardigny JM, Malpuech-Brugère C, Dionisi F, Bauman DE, German B, Mensink RP, Combe N, Chaumont P, Barbano DM, Enjalbert F, Bezelgues JB, Cristiani I, Moulin J, Boirie Y, Golay PA, Giuffrida F, Sébédio JL, Destaillats F. Rationale and design of the TRANSFACT project phase I: a study to assess the effect of the two different dietary sources of trans fatty acids on cardiovascular risk factors in humans. Contemp Clin Trials. 2006 Aug;27(4):364-73. Epub 2006 Apr 24.

ReferenceCitation: Tardy AL, Lambert-Porcheron S, Malpuech-Brugère C, Giraudet C, Rigaudière JP, Laillet B, Leruyet P, Peyraud JL, Boirie Y, Laville M, Michalski MC, Chardigny JM, Morio B. Dairy and industrial sources of trans fat do not impair peripheral insulin sensitivity in overweight women. Am J Clin Nutr. 2009 Jul;90(1):88-94. doi: 10.3945/ajcn.2009.27515. Epub 2009 May 27.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Centre de Recherche en Nutrition Humaine Auvergne

location_facility: Centre de Recherche en Nutrition Humaine Rhônes-Alpes


title: Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects

summary:
Primary Objective:

To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).

Secondary Objective:

To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine

lead_sponsor: Sanofi Pasteur, a Sanofi Company


title: Evaluation of the Efficacy of an Anti Dandruff Shampoo Against Placebo on Dandruff and Scalp Microflora Composition After 4 Weeks of Treatment and 4 Weeks of Relapse

summary: A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota.

lead_sponsor: L'Oreal


title: Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY)

acronym: INSUREA

summary:
During hospitalization in the intensive care unit (ICU), the occurrence of a blood glucose imbalance is frequent and associated with increased mortality. These observations have resulted in the hypothesis that intensive insulin therapy designed to control blood glucose would improve the prognosis of patients admitted into the ICU. In a prospective, randomized, single center study in a surgical ICU during which the majority of patients had undergone cardiac surgery, intensive insulin therapy with the objective to maintain glycemia below 110 mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality and hospital mortality compared to a group with a glycemic objective of 200 mg/dl.

In a recent published article, the beneficial effect of intensive insulin therapy seems less obvious in a randomized single center study in a medical ICU. One of the potential factors limiting the impact of a therapeutic strategy like this one is the absence of achieving strict glycemic control for all patients on intensive insulin therapy. Additionally, the implementation of such a therapeutic strategy results in an increased risk of hypoglycemia, the consequences of which on morbidity remain unclear.

The aim of our study is to determine, in a mixed population of medical and surgical patients admitted to the ICU, requiring artificial ventilation with a expected duration above 48 hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to a conventional glycemic control (<11mmol/l) on hospital mortality.

lead_sponsor: Poissy-Saint Germain Hospital

location_facility: Medico-surgical ICU Louise Michel Hospital

location_facility: Medico-surgical ICU Poissy Saint Germain Hospital


title: Evaluation of the Antidandruff Effect of a Shampoo on Subjects With Dandruff and Slight Itching. Single-blind, Monocentric Study Realized Under Dermatological Control

summary: The aim of this study was to investigate the changes in the scalp lipids and TEWL in dandruff subjects treated by 1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo after an antidandruff treatment and after a remanence phase


title: Phase I Study of Safety and Pharmacokinetics of Pazopanib in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

summary: Subjects will be entered into cohorts of 3 for the dose escalation phase so that the maximum tolerated dose can be determined. 18 additional patients will be recruited once the maximum tolerated dose (MTD) is determined for disease assessment.

lead_sponsor: GlaxoSmithKline


title: Randomized, Monocenter, Double Blind, Placebo-controlled, Single Oral Dose, Three-way Cross Over Study, to Compare Levocetirizine and Desloratadine on Allergen-induced Wheal and Flare Reaction During 24 Hours in 18 Adult Allergic Volunteers.

summary: Compare the activity of 5 mg levocetirizine and 5 mg desloratadine on allergen-induced wheal and flare reaction.

lead_sponsor: UCB Pharma


title: Brain and Oculometric Markers of Emotional Facial Expression Recognition Deficits Associated With Autistic and Psychotic Symptoms

acronym: FERmarkers

summary: Disorders in the recognition of emotional facial expressions are part of the social cognition disorders described in several diseases. They are notably present in a quasi-systematic way in diseases associated with socio-emotional behavior disorders, such as schizophrenia and autism. They are also found in some genetic syndromes with atypical neurodevelopment. In previous studies, the investigators adopted the FPVS-EEG approach to investigate facial emotion discrimination abilities in typical and atypical developing populations. the investigatorshave shown that, in typical adults, the neural response to facial expressions emerges as emotional intensity parametrically increases. A time-domain analysis revealed three components, with the first two increasing linearly with expressive intensity, and the third (beyond 300 ms) showing categorical sensitivity to increasing expressive intensity. The investigators have already successfully extended this approach to the investigation of patients, such as those with 22q11.2 syndrome. The brain response to facial expression was reduced by approximately 36% in these patients, revealing impaired visual coding of emotional facial signals. In this study, response amplitude was associated with positive symptom severity, indicating a potential endophenotype for psychosis risk. Here, the investigators study the implementation of high-level processes and the top-down effect it should have on the response of occipitotemporal regions to identify altered brain markers in schizophrenic patients, but also in other populations with expression recognition deficits (autistic, 22q11.2, in particular). The implementation of compensatory strategies that should result in an increased exploration of the lower part of the face at the oculometric level will also be studied.

lead_sponsor: Hôpital le Vinatier

location_facility: centre de réhabilitation - Hôpital le Vinatier