title: Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS

acronym: BronchioIUS

summary: The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

lead_sponsor: University Hospital, Toulouse

location_facility: Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique


acronym: GENEPHY

summary:
Brain somatic mutations in genes belonging to the mTOR signaling pathway are a frequent cause of cortical malformations, including focal cortical dysplasia or hemimegalencephaly.

The present study aims to search for brain somatic mutations in paired blood-brain samples and perform functional validation in children with drug-resistant focal epilepsy

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique Adolphe de Rothschld

intervention_type: Genetic

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study

acronym: COVER-AMI

summary: To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Research of Thymix Dysgenesis in Prenatal Examination of Deletion 22q11 Syndrome

summary: 22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease

time_perspective: Prospective

ipd_sharing: Yes

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Are Standard Precautions as Efficient as Contact Additional Precautions Against the Transmission of Multi-drug Resistant Bacteria in Intensive Care Unit ?

acronym: PSBMR

summary: The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

acronym: PRESAGE

summary:
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.

Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.

PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.

The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.

This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Institut Cancerologie de l'Ouest

intervention_type: Drug

status_simplified: Unknown


title: Medico-economical Evaluation of Patient-hotel in Urology

acronym: HOTELAMBU

summary:
This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.

The aim is to show that those two strategies are not different in term of adverse effects or rehospitalization, and that the patient-hotel provide a better quality of life at a reduced cost, in order to generate savings for the paying agent: the Healthcare insurance.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

intervention_type: Other


title: A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit

acronym: ProReSHA

summary:
This prospective, observational study aim to identify :

Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

location_facility: Service de réanimation polyvalente neurologique Hôpital Neurologique HCL


title: Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders

summary: This is a routine evaluation of urethral sensation during urodynamic studies. The record has been realized retrospectively. The investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

lead_sponsor: Groupe de Recherche Clinique en Neuro-Urologie


title: Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer

acronym: CONCERT

summary:
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.

This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.

Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.

The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.


title: Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia

acronym: HYPOPSY

summary: Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital


title: Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale

acronym: DAPHNE

summary: Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a quantification and follow-up scale specifically dedicated to patients with FTD in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper orality, Negligence and loss of Empathy.


acronym: CRIVO

summary: Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man

acronym: VISECA

summary:
Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome.

The investigators speculate that:

acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Endocrinologie, Hopital Haut-Leveque


acronym: IMO

summary:
This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.

This is a feasibility study with a limited number of patients.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Evaluation of Mirus™ for Sedation in Resuscitation

acronym: MIRUS

summary:
Current recommendations for the conduct of sédationanalgésie ICU encourage the use of the lightest possible sedation strategies, avoiding the administration of benzodiazepines source of longer durations of ventilation and ICU stay of syndrome cessation, mental confusion. Among the proposed alternatives, administration of halogenated volatile agents (sevoflurane) in resuscitation is interesting because their favorable pharmacokinetic even after prolonged administration: no tachyphylaxis, rapid clearance, no withdrawal syndrome.

There are two suitable delivery devices sevoflurane in intensive care, both with CE marking. The device Mirus ™ (Pall Medical, Fribourg, Switzerland) is the newest and it is easy to use and reliable. The objective of this study was to evaluate the use of Mirus ™ device in trauma resuscitation and cardiovascular resuscitation.

Specifically, it will use this modality in case of failure with conventional sedation products (propofol, midazolam): maximum permissible doses, sedation weaning failure due to severe agitation.

ReferenceType: background

ReferenceCitation: Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. Review.

ReferenceCitation: Kong KL, Willatts SM, Prys-Roberts C. Isoflurane compared with midazolam for sedation in the intensive care unit. BMJ. 1989 May 13;298(6683):1277-80.

ReferenceCitation: Sackey PV, Martling CR, Carlswärd C, Sundin O, Radell PJ. Short- and long-term follow-up of intensive care unit patients after sedation with isoflurane and midazolam--a pilot study. Crit Care Med. 2008 Mar;36(3):801-6. doi: 10.1097/CCM.0B013E3181652FEE.

ReferenceCitation: Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6.

ReferenceCitation: Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S. Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med. 2011 Jun;37(6):933-41. doi: 10.1007/s00134-011-2187-3. Epub 2011 Mar 29.

ReferenceCitation: Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN. Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med. 2008 Sep;34(9):1683-9. doi: 10.1007/s00134-008-1157-x. Epub 2008 May 24.

ReferenceCitation: Hellström J, Öwall A, Bergström J, Sackey PV. Cardiac outcome after sevoflurane versus propofol sedation following coronary bypass surgery: a pilot study. Acta Anaesthesiol Scand. 2011 Apr;55(4):460-7. doi: 10.1111/j.1399-6576.2011.02405.x. Epub 2011 Feb 22.

ReferenceCitation: Soukup J, Schärff K, Kubosch K, Pohl C, Bomplitz M, Kompardt J. State of the art: sedation concepts with volatile anesthetics in critically Ill patients. J Crit Care. 2009 Dec;24(4):535-44. doi: 10.1016/j.jcrc.2009.01.003. Epub 2009 Mar 27. Review.

ReferenceCitation: Perbet S, Bourdeaux D, Sautou V, Pereira B, Chabanne R, Constantin JM, Chopineau J, Bazin JE. A pharmacokinetic study of 48-hour sevoflurane inhalation using a disposable delivery system (AnaConDa®) in ICU patients. Minerva Anestesiol. 2014 Jun;80(6):655-65. Epub 2013 Nov 13.

ReferenceCitation: Chabanne R, Perbet S, Futier E, Ben Said NA, Jaber S, Bazin JE, Pereira B, Constantin JM. Impact of the anesthetic conserving device on respiratory parameters and work of breathing in critically ill patients under light sedation with sevoflurane. Anesthesiology. 2014 Oct;121(4):808-16. doi: 10.1097/ALN.0000000000000394.

ReferenceCitation: Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90.

ReferenceCitation: Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4.

ReferenceCitation: Bomberg H, Glas M, Groesdonk VH, Bellgardt M, Schwarz J, Volk T, Meiser A. A novel device for target controlled administration and reflection of desflurane--the Mirus™. Anaesthesia. 2014 Nov;69(11):1241-50. doi: 10.1111/anae.12798. Epub 2014 Jul 9.

lead_sponsor: University Hospital, Grenoble


title: Concordance Study of Molecular Biology Analysis for Para-aortic Nodes in the Ultra-staging of Advanced Cervical Cancers (GYNOSNA)

acronym: GYNOSNA

summary:
The para-aortic lymph node involvement in the advanced stage of cervical cancer is a poor prognostic factor for overall survival. Concomitant chemo-radiotherapy has become the standard treatment for advanced cervical cancer. In case of para-aortic lymph node involvement, an extension of radiotherapy fields is recommended.

A prospective multicentre study shown that the survival rate of patients with node ≤ 5 mm and which benefited from the expansion of radiotherapy fields was identical to the survival of pN0 patients.

However, due to a specific disease, this technique should not be performed in all patients. It is necessary to reliably select patients with retroperitoneal lymph node involvement. For this, it is recommended that prior to the concurrent chemo-radiotherapy, nodal staging surgery with a definitive histological analysis.

So we propose to use molecular diagnostic test OSNA (One Step Nucleic Acid Amplification) to improve lymph node metastasis detection sensitivity to achieve ultra-staging compared to conventional histology.

intervention_type: Procedure


title: Randomised, Evaluation-blinded, Crossover, Controlled Study Assessing the Antispastic Efficacy and Safety of Dynamic Night Hand Splinting in Adults With Post-stroke Hemiplegia Treated by Botulimum Toxin (Dysport®) - (a Pilot Study)

acronym: ORTHOX

summary:
Upper limb spasticity is currently mainly managed with local toxin treatments. Recent studies suggested combining botulinum toxin injections with splinting to optimise rehabilitation in spastic patients. However, one study focused exclusively on lower limb spasticity, the second on elbow flexor hypertonia, and the last on wrist and finger spasticity in children.

A study was performed in adult patients with upper limb spasticity treated with botulinum toxin injections used as primary objective the tolerance for dynamic splinting. The authors noted that the need for botulinum toxin was reduced in 2 patients out of 6. No study has been conducted to date on the splinting + toxin combination in adults.

Another study showed that stretching sessions over 2 weeks of a muscle just given botulinum toxin helped improve the toxin's efficacy 2, 6 and 12 weeks after the injection. For this reason, rehabilitation teams routinely prescribe 10 sessions of physiotherapy for 15 days after botulinum treatment.

Based on this principle, we hypothesise that dynamic night splinting applied just after botulinum toxin treatment may also increase the toxin's efficacy. We chose a dynamic splint providing continuous stretching of the wrist and fingers in extension whilst allowing active flexion. Night splinting is thought to promote optimal functional use of the paretic upper limb during the day and thus prevent learned non-use, which could worsen the spasticity.

Each patient will receive treatment cycles, whose results will be compared, so that each patient will act as his/her own control. The evaluation will be based on the Tardieu scale chosen for its greater inter-individual reproducibility and greater reliability to measure spasticity.

The degree of extension of wrist and fingers provided by the splint will be adjusted to the patient's clinical condition with the elastic tensioners. The purpose of the splint is to maintain the stretch beyond the Tardieu spasticity angle at fast speed (V3) without reaching maximum extension, which could be harmful.

This protocol is designed to determine whether dynamic night hand splinting combined with botulinum toxin injections will improve botulinum antispastic efficacy in adults with brain damage.

lead_sponsor: CHU de Reims


title: Intensive Care Unit and Secondary and Primary Immune Deficiency

acronym: ICUSPID

summary: Primary immune deficiencies (PID) are characterized by a failure of the immune system that is not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300 different inherited rare disorders were described. The occurrence of PID in adult is rare and diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are based only on expert recommendations and do not include comprehensive symptoms of PIDs. Recurrent infections, more aggressive, are the most common mode of revelation of the PID. Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID. The objective of this study was to evaluate the occurrence of unknown PID in adult admitted in critical care unit and to determinate if the investigation of PID in patients with severe infections or HLS should be routinely performed in MCIU.

lead_sponsor: University Hospital, Caen


title: Pre-emptive Immunomodulation After Allogeneic Stem Cell Transplantation in AML

acronym: IMODLAM

summary:
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is now an effective treatment of Acute Myeloid Leukemia (AML). After allo-HSCT, relapses are the major cause of mortality and occur in about 30% of cases. The occurrence of relapses is important during the first three months post-allogeneic transplant, then gradually decreases during the first year post-allograft and then becomes weaker. After relapse, therapeutic options include the reduction of immunosuppression, the administration of donor lymphocytes (DLI), chemotherapy or a new transplant. The performance is influenced by the early introduction of treatment whose effectiveness is related to the importance of tumor burden. Immunomodulation of preemptive strategies have recently been established by decreasing immunosuppression and achieve DLIs in patients with a high risk of relapse, before the occurrence of relapse.

The aim of this study is to evaluate the incidence of relapse following the recommendations of post-allogeneic transplant immunomodulation of the French society of bone marrow transplantation.

intervention_type: Biological


title: Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab

acronym: TENOR-IMMUNO

summary: Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

ReferenceCitation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.

lead_sponsor: University Hospital, Brest


title: CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

acronym: CYRUS II

summary:
Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.

The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.

status: Withdrawn


title: Basic Auditory Processing and Acoustico-verbal Hallucinations: a Pathophysiological Study

acronym: AUDISCHIZ

summary: Schizophrenia is a severe psychiatric disorder that affects approximately 1% of the population worldwide. Although pathophysiology of this disease remains unclear, a growing interest is emerging for low-level sensory function, acknowledging that deficits in early stages of sensory processing are related to higher-order cognitive disturbances in schizophrenia. In the field of auditory processing, symptoms as auditory-hallucinations were found correlated with disabilities to discriminate psychoacoustic parameters of sounds.

primary_purpose: Basic Science

lead_sponsor: Hôpital le Vinatier


title: Mapping the Lumbar Spine Marrow Adiposity

acronym: FATFRAC

summary: The objective of this study is to describe the change in the percentage of fat in the lumbar spine.


title: An Open-label Study to Assess the Potential for Pre-systemic Inhibition of Cytochrome P450 3A4 (CYP3A) by Idebenone in Healthy Male Subjects Using Midazolam as a Substrate

summary: This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers

lead_sponsor: Santhera Pharmaceuticals


title: French Adaptation of the CCST (California Card Sorting Task). Comparison of 3 Packages to CCST With Multiple Sclerosis (MS) Patients

summary: Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.


title: tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression

summary:
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.

Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.

primary_purpose: Prevention


title: Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

acronym: REVOIR

summary: This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.


acronym: COAG

summary: When focal epilepsies become drug-resistant, it could be eligible for cortical surgical resection. Therefore, an invasive EEG monitoring with depth electrodes is often needed during presurgical evaluation. Some of these children can have access to thermocoagulation inside the ictal onset zone, at the end of the monitoring and before to remove the electrodes. These thermocoagulations can disorganize the epileptogenic network thanks to millimetric cortical lesions around the electrodes. The aim is to stop or at least, to reduce the seizure frequency for few weeks or months. This could be a benefit for the child, and also a confirmation of the ictal onset zone and guide the surgeon. This technique is currently used in adult population for years, but remains very rare in children.


acronym: SILOG

summary: The study aims at searching for a genotype-phenotype correlation in patients with a genetic pathology of the ocular surface, in order to identify genetic abnormalities associated with the most severe clinical situations.


acronym: KEOPS

summary:
This study aims to:

describe the monitoring of patients treated for spinal disorders.
create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.
obtain a cohort of patients in the comprehensive range of spinal pathologies.
standardize data collection in this cohort with similar national projects.


title: Creation and Evaluation of a Auto-administered Questionnaire by Screening of Disorder of the Haemostasis in Preoperative

acronym: HEMOSTASE

summary: The main objective of this study is to determine the capacity of a questionnaire to predict a normal balance sheet of haemostasis.


acronym: KELOIDS SCARS

summary: Treatment of keloids scars is difficult and controversial. These keloids have a functional and aesthetic impact. A lot of treatment are described with a lot of relapses and aggravation. Authors report outcomes of the treatment with shaving and cryosurgery


title: Cluster-randomized Controlled Study Evaluating the Impact of a Call Center Providing Standardized Pediatric Advices Based on the Number of Unscheduled and Medically Unjustified Consultations

acronym: PLATEL-EVAL

summary:
In order to show that tailored pediatric counselling by telephone can reduce the number of unscheduled and medically unjustified physicians visits in emergency structures, a randomized controlled study is conducted. It compares the proportion of cases which used the emergency services or unscheduled consultation according to whether they received (or not) nurses' telephone advices from the platform. Indeed, our hypothesis is that the presence of nurses responding at the Reception and Control Calls Center inside the Emergency Medical Services (in french : Service d'Aide Médicale d'Urgence SAMU) - whose role is to deliver appropriate advice to people calling for benign pathologies they see as urgent and to answer questions following specific recommendations - will reduce the number of unplanned and medically unjustified consultations in medical emergency structures.

This platform was set-up in order to show it may be a solution in response to the growing demand for pediatric care from the population, helping to reduce overcrowding in emergency care facilities. Indeed, promoting home care or only if necessary scheduled consultation reinforces the conduct to have when facing a pathology from their child. It will also help by reducing unjustified use of emergency structures, improving not only the users' reception conditions who actually require support in these structures with less waiting time, but also the working conditions for employees who perform there.

study_start_date_type: Anticipated


type: Other Identifier

title: Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

acronym: QUAFI

summary: Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p < 0.05 will be considered as significant.

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Combination of Multiparametric MRI and Electrophysiology for the Development of New Biomarkers in Spinal Cord Diseases

summary:
The spinal cord is a common site for the development of several neurodegenerative neurological disorders (spinal muscular atrophy or SMA, amyotrophic lateral sclerosis or ALS, X-linked spinal bulbar muscular atrophy or SBMA). In different proportions, these diseases involve axonal loss in large funiculi of the spinal white matter, their demyelination, and loss of ventral horn motor neurons or motoneurones of the spinal gray matter. The lack of specific biomarkers of these macro and microscopic spinal damages, makes it difficult the differential diagnosis and monitoring of these diseases.

Techniques to explore non-invasively the human central nervous system, such as magnetic resonance imaging (MRI) and electrophysiology, are potential tools to extract specific biomarkers of spinal damages. However, imaging techniques are still poorly developed at spinal level for technical (specific antennas), anatomical (size of the spinal cord, vertebrae) and physiological reasons (cardio-respiratory movements). However, recent advances in the field of spinal cord imaging allowed to extract quantitative data on neuron loss, axonal degeneration and demyelination in different spinal pathologies whether degenerative (ALS or SMA) or traumatic (SCI). Correlations were found with clinical data, and in ALS patients, the changes in MRI metrics over time paralleled the functional deterioration. The electrophysiological techniques are used since a long time, leading to a good knowledge of the neurophysiology of human spinal cord. In addition, electrophysiology indirectly provides data at a microscopic scale, providing information on the excitability of spinal neural networks and giving an estimate of the amount of functional neurons.

By combining these techniques for the investigation of human spinal cord in vivo, the goal is to extract new biomarkers using as study models, diseases of the spinal cord affecting differentially the white and the gray matter (SMA, SBMA and ALS).

At first, new methods of diffusion MRI and modelling will be performed in healthy subjects to assess the axonal density and diameter of the fibers in the white matter. The anatomical imaging T2 will measure the geometrical parameters of the spinal cord such as its surface and/or volume at a given vertebral level. Thanks to imaging, we will construct via methods of segmentation and image processing, an atlas of the spinal cord that will allow to locate spatially spinal atrophy in patients. After this phase of validation, A study of patients will be conducted using these new MRI techniques, in addition to those already developed in the laboratory. The contribution of electrophysiology will be to assess more accurately the microscopic damage. Quantitative data from imaging and electrophysiology will be correlated with clinical data in order to extract the most relevant biomarkers.

This project has thus a methodological interest by proposing the development of new methods to assess the human spinal cord, at both macro and microscopic levels. These methods are based on the development of the techniques developed at spinal level and which are already applicable to human pathologies. The original combination of imaging and electrophysiology will also enable us to further analyze the human spinal cord, both anatomically and functionally. This project has an important clinical value for the extraction of biomarkers in diseases where there is an unmet need for diagnosis, monitoring, prognosis and evaluation of new therapies.

lead_sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale


title: Effects of Inverted Vision on Pointing and Grasping in Parabolic Flight

acronym: SpaceInVision

summary:
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

Spatial orientation perception is a critical subsystem that is used by the central nervous system in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that spatial orientation is altered by the transitions in gravito-inertial force levels (Clément 2011; Clément & Reschke 2008), transitions corresponding to mission phases particularly critical for crew safety and mission success. Accurate perception of self-in-space motion and self-motion relative to other objects is critical for successful operations that involve motor control e.g. doing an extra-vehicule activity or piloting the spacecraft. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical operations and control capabilities. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion The hypothesis is that alteration in sensorimotor performance induced by inverted vision is gravity depend: maximum alteration during hypergravity, intermediary alteration during normal gravity, minimal alteration during weightlessness.


title: Early Abduction Splintage on Stable Hips in Infants With Developmental Dysplasia of the Hip : Improvement or Overtreatment ?

acronym: BBH

summary: The aim of this study is to prove the improvement of pubo-femoral distance by early abduction splintage in one-month-old infants with developmental dysplasia of the hip (with a clinical stable hip but an abnormal hip ultrasonography).

ReferenceType: derived

ReferenceCitation: Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10:CD012717. doi: 10.1002/14651858.CD012717.pub2. Review.


title: Does Abatacept Induce Regulatory B Cells in Patients With Rheumatoid Arthritis

summary: Abatacept disrupts T-cell coactivation signals in rheumatoid arthritis (RA). Its potential effects on B cells are not well described. This study will assess the effects of abatacept therapy on the phenotype and function of peripheral blood B cells in patients with RA.


title: Comparison of 2 Techniques of Invasive Mini Surgery: Coelioscopy Mini-trocar and Monotrocar in the Adnexa no Carcinologic Surgery : Forward-looking Observational Study.

acronym: ANTATROC

summary:
The advantages of the celioscopy mini--trocar and monotrocar technical are recognized.

There is however no forward-looking or retrospective study comparing the microcomputed-celioscopy (use of microphone) - trocar of 3mm of diameter in access celioscopic pluri--trocar) in the celioscopy monotrocar ( a single intra-umbilical section) in gynecological surgery.

The objective of this preliminary study is to compare both surgical care in terms of morbidity died operating, in adnexa surgeries.

lead_sponsor: Institut Paoli-Calmettes


summary: High frequency percussive ventilation (HFPV) is a high frequency ventilation mode in which high frequency pulses accumulate to generate a low frequency tidal volume at a controlled airway pressure. Previous studies have suggested a protective effect of HFPV on lung injury. The goal of our study is to compare, in early ARDS patients, the effects of conventional mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment and distension evaluated by CT-scan

primary_purpose: Supportive Care

location_facility: Assistance Publique-Hôpitaux de Marseille


summary:
Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.

Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.

This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).

location_facility: Assistance Publique Hopitaux de Marseille


acronym: NCVG

summary: The main objective of this study is to clarify prospectively prognosis of patients newly diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival of the following events: death, heart transplantation or hospitalization for cardiovascular complications). In a second time, prognosis factors will be identify in these patients with LVNC.

location_facility: Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone


title: Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study

summary:
Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.

The investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.

The questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.

location_facility: Service de Neurologie C, Hôpital Neurologique, HCL


acronym: MUCEM

summary: Local excision for early rectal cancer has proven its feasibility and oncological safety. Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas respectively. Two procedures are currently performed in these early cancers as well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It consists of a full-thickness excision. The second procedure is a recently introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the subgroup of European series. Though very promising, the role of ESD remains controversial in malignant lesions with few published reports. There are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. So far, only one retrospective single-center study including 63 patients has compared TEM and ESD in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing TEM and ESD for any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal cancer and rectal adenomas for short- and long-term outcomes.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn

acronym: TRIPAIN

summary: The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).

ipd_sharing_description: All collected data that underlie results in a publication


title: Management of Bleeding and Coagulopathy in Trauma and Compliance to European Trauma Guidelines

acronym: APP

summary: This cohort study describes the epidemiology of trauma patients and their management in a French academic trauma center. It also aims to determine what recommendations from the European trauma guidelines is applied in routine.


title: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia: Neuropsychological and Neurophysiological Study of Changes in Emotional Experiences

acronym: KALISS

summary: Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.

location_facility: Centre Hospitalier Régional Universitaire de Brest


title: Study of Biological Determinants of Bleeding Postpartum : Predictive Role in the Number of Immature Platelets

acronym: HPP-IPF

summary:
At the entry of the delivery room, a standard blood analysis will be performed (Blood count, PT, aPTT, Fibrinogen, and D-Dimer) for each women (if they are agree), according to the center's practices.

The percentage of the immature platelets is a an additional parameter on the hemogram.

The clinical assessments (recorded in medical records) and biological values will be used to determine if there is a correlation between these data and the occurrence of postpartum hemorrhage.


title: Assessment of the Usual Choice for a First-line Treatment in Case of Atrial Fibrillation : Comparison Between Cardiology Department and Geriatric Unit.

acronym: ACFA

summary: In order to evaluate the implementation for the recommendations about the patient care for atrial fibrillation in aged patients, a non-interventional study is performed retrospectively by comparing two approach of the focus in Cardiology Department and in Geriatric unit.


title: Association Between Asthma and Food Allergy in Children and Adults

acronym: AAAli

summary:
Prevalences of food allergies and asthma increased in the population during the last decades. These two pathologies, responsible for a real burden, are often associated and are to be considered as comorbidities; this aspect is more and more studied in the literature and many authors tried to find a link between diets and asthma. The narrow link between these two atopic pathologies and the fact that food allergy can come along with respiratory symptoms also in patients without history of asthma must be better understood, considered into the management of food allergy. The main objective of this study is to study the prevalence of signs and/or symptoms suggestive of bronchial hyperreactivity, during an oral food challenge (OFC) in patients older than 5 years. The secondary objective is to study the risk factors to develop asthma during a food allergy reaction.

This historical-prospective single center study , was realized in the Allergy Unit of the University Hospital of Montpellier. All the patients having been hospitalized for a positive OFC between January, 2001 and January, 2016 were included. The diagnosis of asthma was established according to the recommended international clinical and physiological criteria. Prevalence of bronchial hyperreactivity during OFC among those with positive OFC, was calculated. The search for risk factors was made by a logistic regression univariate then multivariate, completed by a decision tree.

lead_sponsor: University Hospital, Montpellier


title: Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year

acronym: TRACH

summary: To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.


title: Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)

acronym: NKT-CSP/MICI

summary:
Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.

Based, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone.

lead_sponsor: University Hospital, Lille


title: Transverse Abdominis Plane Block for Anterior Approach Spine Surgery: A Prospective Randomized Study

acronym: TAP ALIF

summary: Therapeutic, prospective, randomized, double blind, placebo-controlled, in intention to treat, monocentric study to evaluate the analgesic efficacy of a bilateral TAP block after spine surgery with 24 hours morphine consumption

lead_sponsor: Rennes University Hospital


title: Creation of a Prospective and Retrospective Breast Cancer Database

summary:
In order to accelerate border crossing between basic research and clinical research in breast cancer, it is necessary to easily use clinical and biological data. That is the reason why it is very important to create a clinical, biological and pathologic beast cancer database, mainly prospective but also retrospective. All data are from patients treated in Toulouse Centre.

The scientific community will easily have access to clinical and biological informations through a centralized, structured database , leading to optimize patients with breast cancer treatment.

lead_sponsor: Institut Claudius Regaud


title: In Vitro Fertilization (IVF) Outcome After Bariatric Surgery: a Multicentric Case-control Study.

summary: This case-control study compares IVF results and live birth rates in women undergoing IVF with a history of bariatric surgery as compared to 2 age-matched control groups composed of (A) non-operated women matched on cases' post-operative BMI (controls 1) and (B) non-operated severely obese women (controls 2).

time_perspective: Other

ReferenceCitation: Grzegorczyk-Martin V, Fréour T, De Bantel Finet A, Bonnet E, Merzouk M, Roset J, Roger V, Cédrin-Durnerin I, Wainer R, Avril C, Landais P. IVF outcomes in patients with a history of bariatric surgery: a multicenter retrospective cohort study. Hum Reprod. 2020 Dec 1;35(12):2755-2762. doi: 10.1093/humrep/deaa208.

lead_sponsor: Clinique Mathilde


acronym: Painkiller

summary:
Pain is a common problem encountered in about 60 % of critically ill patients who can communicate. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

Pain management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Music therapy is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the analgesic effect of music therapy in critically ill patients during potentially painful nursing procedures.

ReferenceCitation: Jacq G, Melot K, Bezou M, Foucault L, Courau-Courtois J, Cavelot S, Lang A, Bedos JP, Le-Boeuf D, Boussard JM, Legriel S. Music for pain relief during bed bathing of mechanically ventilated patients: A pilot study. PLoS One. 2018 Nov 14;13(11):e0207174. doi: 10.1371/journal.pone.0207174. eCollection 2018.

lead_sponsor: Versailles Hospital


title: Rituximab in Hairy Cell Leukemia: a Multicenter Retrospective Study

acronym: RITUX-LEUKEMIA

summary:
Hairy-cell leukemia is a rare and indolent lymphoid disorder, representing 2% of all cases of lymphoid leukemias. Treatment of hairy-cell leukemia relies mainly on the purine analogs, cladribine and pentostatin, which have shown similar efficacy and constitute the gold standard of care either as front-line therapy or for relapsed patients.

However, despite the remarkable response rates obtained with purine analogs therapy, some patients will eventually relapse and the efficacy of these agents seems to decrease at each line of treatment. The addition of new molecules to purine analogs may improve the response rates and prevent relapse.

Rituximab is a chimeric IgG1 kappa-type monoclonal antibody directed against the CD20 molecule. It was first used in relapsed patients with hairy-cell leukemia more than 10 years ago and several series of patients treated with rituximab as monotherapy were published in the following decade, reporting response rates ranging from 25% to 80%.

ReferenceCitation: Leclerc M, Suarez F, Noël MP, Vekhoff A, Troussard X, Claisse JF, Thieblemont C, Maloisel F, Beguin Y, Tamburini J, Barbe C, Delmer A. Rituximab therapy for hairy cell leukemia: a retrospective study of 41 cases. Ann Hematol. 2015 Jan;94(1):89-95. doi: 10.1007/s00277-014-2175-0. Epub 2014 Sep 7.


title: Clinical and Histological Features of Head and Neck Melanoma

acronym: head neck-mel

summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

ReferenceCitation: Dabouz F, Barbe C, Lesage C, Le Clainche A, Arnoult G, Hibon E, Bernard P, Grange F. Clinical and histological features of head and neck melanoma: a population-based study in France. Br J Dermatol. 2015 Mar;172(3):707-15. doi: 10.1111/bjd.13489. Epub 2015 Feb 11.


title: Work-related Respiratory Symptoms in Champagne Vineyard Workers

acronym: VIN-ALLERGO

summary: Work related asthma and rhinitis are frequent diseases with a significant morbidity and a social and economic impact. Farmers are highly exposed to various inhaled agents such as organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to pollen allergy, especially gramineae pollen. They can also be related to the use of pesticides or exposure to mites .

ReferenceCitation: Perotin JM, Barbe C, Nguyen KL, Fontaine JF, Gabignon Y, Nardi J, Launois C, Lebargy F, Lavaud F, Deslee G. Work-related respiratory symptoms in Champagne vineyard workers. Eur Ann Allergy Clin Immunol. 2015 Sep;47(5):140-4.


title: Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

summary:
The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically.

This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.


summary: The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.


title: Study of Predictors of Response to Anti Epilepsy in Epilepsy

acronym: RESISTANT

summary: Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. However, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome P450 and less generalised adverse events. However, their metabolism could be more complexe (i.e. the less known Uridine 5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.


acronym: CARSKIN

title: Phase II Study of Pembrolizumab (MK-3475) as First Line Single Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

lead_sponsor: Assistance Publique - Hôpitaux de Paris

type: EudraCT Number

source: euctr

ReferenceCitation: Maubec E, Boubaya M, Petrow P, Beylot-Barry M, Basset-Seguin N, Deschamps L, Grob JJ, Dréno B, Scheer-Senyarich I, Bloch-Queyrat C, Leccia MT, Stefan A, Saiag P, Grange F, Meyer N, de Quatrebarbes J, Dinulescu M, Legoupil D, Machet L, Dereure O, Zehou O, Montaudié H, Wierzbicka-Hainaut E, Le Corre Y, Mansard S, Guégan S, Arnault JP, Dalac S, Aubin F, Alloux C, Lopez I, Cherbal S, Tibi A, Lévy V; Groupe de Cancérologie Cutanée30. Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. J Clin Oncol. 2020 Sep 10;38(26):3051-3061. doi: 10.1200/JCO.19.03357. Epub 2020 Jul 30.

summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab in patient with locally advanced or metastatic squamous cell carcinoma of the skin


title: Detection of Somatic Mutations on Cell-free Circulating DNA in Potentially Aggressive Cutaneous Lymphomas

acronym: MATULILA

summary: To evaluate the possibility of detecting cell-free circulating tumoral DNA in potentially aggressive primary cutaneous lymphomas, the investigator opted to search a representative tumor sample mutation in the blood of these patients, by digital PCR. Patients with mycosis fungoides, primary cutaneous T-cell lymphoma helper follicular phenotype and primary cutaneous diffuse large B-cell lymphoma, leg-type will be included and 4 blood samples will be collected during 12 months.

lead_sponsor: University Hospital, Bordeaux

location_facility: University Hospital of Bordeaux - Hospital Saint André


title: Validation Study of the Accuracy of E/e' in Estimating Left Ventricular Filling Pressure

acronym: EUROFILLING

summary: The non-invasive estimation of left ventricular end diastolic pressure (LVeDP) is a main goal for performing an echocardiography in the routine clinical practice. Conflicting evidence exists about mitral E/e' ratio reliability for predicting high LVeDP


title: Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist

acronym: TARIFF

summary: The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.


title: Analysis of Immune Response In Bacterial Infection of Obese Subject

acronym: ARIIBO

summary: Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude


title: Single-center, Open-label, Phase 1 Study Consisting of a Single-dose Pilot Phase and a Randomized, Two-way Crossover, Single-dose Main Phase to Investigate the Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Male Subjects

summary: The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

ReferenceType: result

ReferenceCitation: Kaufmann P, Hurst N, Astruc B, Dingemanse J. Absolute oral bioavailability of selexipag, a novel oral prostacyclin IP receptor agonist. Eur J Clin Pharmacol. 2017 Feb;73(2):151-156. doi: 10.1007/s00228-016-2164-4. Epub 2016 Nov 24.

lead_sponsor: Actelion


acronym: Shortystrap

summary: The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.


title: Effectiveness Study of Finger Individuation Training by Finger Force Manipulandum (FFM) Compared to Conventional Rehabilitation for Patients With Writer's Cramp

acronym: FIDEX

summary: Writer's cramp (WC) is a focal dystonia characterized by abnormal movements and postures during writing. Limited finger independence during writing manifests as difficulty suppressing unwanted activations of neighbouring non task-relevant fingers. WC patients also have difficulty in fine control of grip force. However, some previous studies indicate positive effects of individual finger movement training in WC although these studies lacked enhanced visual feedback of activations in 'stationary' fingers. The investigators have recently developed the Finger Force Manipulandum which quantifies the forces applied by the fingers in different tasks. This method is sensitive for detection and quantification of small unwanted contractions in non-active ('stationary') fingers. Forces in 'stationary' fingers can be displayed on-line providing enhanced feedback on independence of finger movements. The aim of this study is to test the effectiveness of finger individuation training using the FFM to improve symptoms in WC patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild


acronym: LabyDys

summary:
Writer's cramp (WC) is a task specific dystonia that occurs from the moment patient starts writing. It leads to partial or complete inability to use the hand only during the handwriting gesture. It is characterized by the appearance of cramps or spasms of certain muscles of the hand and/or forearm.

Clinical scales currently use for the assessment of WC fail to accurately reflect changes in the characteristics of handwriting in response to treatments (Botulinum Neurotoxin injections and / or retraining therapy).

The Zigzag Tracking Task (ZZTT), easy to use in current practice provides useful information in terms of speed and precision of handwriting gesture. This timed handwriting test is to follow with a pen a zigzag path beset with obstacles to avoid. It permits to evaluate the time in seconds required to carry out the zigzag path and count the number of errors (output path and contacts with obstacles). The investigators propose to validate the ZZTT for the assessment of the handwriting gesture of WC.

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: Neonatal Hypoxic Ischemic Encephalopathy : Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells

acronym: NEOSTEM

summary:
Neonatal hypoxic-ischaemic encephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss.

Currently, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions.

Cord blood stem cells are a promising treatment for the near future.

The primary objective of this study is to test the safety and feasibility of a curative treatment with autologous cord blood stem cell in neonatal hypoxic-ischaemic encephalopathy.

The secondary objectives are to test the efficacy of this curative treatment with cell with neurogenic potential on the prevention of neurologic sequelae, as well as to test the optimum timing of cell preparation administration


summary:
Clinical assessment of motor and sensory deficits is still today largely based on tests that do not permit any precise quantification. However, robotic technologies, coupled with neuroimaging techniques constitute new tools to assess sensorimotor functions that could allow to conceive neurorehabilitation protocols better adapted to the neurological impairment of each patient and to her/his specific recovery profile.

The goal of this project is to contribute identifying the factors that determine functional recovery in stroke patients presenting upper-limb motor deficits. Here, we will focus our research on two factors that contribute in a complementary way to motor control: 1) the processing of proprioceptive informations, and 2) the processing of movement-execution errors. In this purpose, we will combine psychophysical methods that allow to precisely quantify sensorimotor deficits with functional and anatomical neuroimaging techniques. More specifically, we will exploit experimental protocols that have been developed in basic research, that use a robotic exoskeleton coupled with a virtual reality device, to precisely quantify motor and proprioceptive deficits in stroke patients. Then, we will link these behavioral data to electroencephalographic (EEG) signals recorded during a motor adaptation task, as well as to anatomical data, namely conventional magnetic resonance imaging (MRI) completed by diffusion tensor images (DTI) in order to achieve a finer description of the cerebral lesions.

The present study will include two experimental parts, respectively centered on the proprioceptive deficits (Part 1) and the anomalies in the processing of movement-execution errors (Part 2).

Proprioceptive deficits in stroke patients : We will test the hypothesis that, when present, deficits in kinaesthesia and troubles in unconscious proprioception contribute substantially to motor deficits in stroke patients ; with as a corollary hypothesis, that deficits in " proprioception for action " are more determinant than deficits in the conscious sense of position (classically tested in clinics). In this purpose, we will collect three sets of behavioral data, in chronic stroke patients and healthy control participants, respectively intended to assess a) motor deficits, b) troubles in conscious sense of position, and c) deficits in "proprioception for action". To better document the neuronatomical substrates of these different types of deficits. In this purpose, we will link the obtained behavioral data with the results of detailed analyses of the lesions of the tested stroke patients.

Anomalies in the processing of movement-execution errors in stroke patients : We will assess movement-execution error processing in stroke patients, in order to test the idea that anomalies in error processing might contribute to motor deficits in stroke patients. In this purpose, we will record an electrophysiological correlate (ERP) of movement-error processing during a motor adaptation task. We will analyse the relation between the modulation of this ERP and motor performance. We will also examine the relation between these two sets of data (behavioral and electrophysiological) and the behavioral data collected during the first part of the study (Proprioceptive deficits). This will provide us with insight into the relationship between proprioceptive deficits and cinematic error processing. As in the first part of the study, we will link the observed electrophysiological and behavioral anomalies with the results of a detailed analysis of the anatomical lesions of the tested patients.


summary: The level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor. Because of a high level of risk of developing an Obstructive Sleep Apnea Syndrome (OSAS), an accurate evaluation of the prevalence, of the risk factors and of the impact on quality of life is important in order to propose preventive and therapeutic solutions to these patients.

location_facility: Service d'ORL et de Chirurgie Cervico-Faciale - Hôpital de la Timone, AP-HM

intervention_type: Radiation


title: Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

acronym: IMPRIM

summary: Open-label, non-randomized, prospective, single center, observational, translational study


title: Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy

summary: Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.

lead_sponsor: Hospices Civils de Lyon


acronym: CQFD

summary:
End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of graft availability. Being under dialysis requires a recourse to pluri-weekly magazine of health care system, impacting negatively patient's quality of life (QoL) and their entourage, at a psychological, physical and social level.

Although further studies have assessed QoL in ESRD grafted children, a lack of information exists concerning patients' QoL during dialysis before graft. In addition, some limits could be listed, these studies have small samples, 50 patients at all, and only clinical determinants are studied. A larger clinical research assessing children's QoL studying individual and populational factors is necessary.

The aim of the study is to assess the influence of individual and populational determinants on children's QoL with ESRD, treated by dialysis.

Material & Method An exhaustive inclusion of patient with ESRD treated by dialysis will be realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders, ii) younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one of the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and the 31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be signed by patient and their mainly caregiver.

Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and VSP-A. In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment (IPPA), optimism (Y-LOT) measures and socio-demographic data will be collected. Self-administered questionnaires will be used for assessing caregivers' Qol (SF36), anxiety (STAI-Y), coping (BriefCope situational format), health care system satisfaction (Care quality scale) and burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by caregivers will be assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition, socio-demographic data, urban environment and economic environment will be collected. Clinical data will be collected by health professionals.

Results expected A sample of 136 children with ESRD is expected for identifying individual and populational factors which could influence chronic dialysed children QoL, in order to propose adjustments to optimize these patients quality of life.

intervention_type: Behavioral


title: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

acronym: EPIDEMYOSITIS

summary:
Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.

Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.

lead_sponsor: University Hospital, Rouen


acronym: ASTEQ

summary: The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.


title: Variations of High Sensitivity Troponin T in Neonates

acronym: TnTc-us

summary: Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.

ReferenceCitation: Lefèvre G. [Troponins: biological and clinical aspects]. Ann Biol Clin (Paris). 2000 Jan-Feb;58(1):39-48. Review. French.

ReferenceCitation: Adamcová M. Troponins in children and neonates. Acta Paediatr. 2003 Dec;92(12):1373-5.

ReferenceCitation: Fortunato G, Carandente Giarrusso P, Martinelli P, Sglavo G, Vassallo M, Tomeo L, Rea M, Paladini D. Cardiac troponin T and amino-terminal pro-natriuretic peptide concentrations in fetuses in the second trimester and in healthy neonates. Clin Chem Lab Med. 2006;44(7):834-6.

ReferenceCitation: Nomura RM, Ortigosa C, Fiorelli LR, Liao AW, Zugaib M. Gender-specific differences in fetal cardiac troponin T in pregnancies complicated by placental insufficiency. Gend Med. 2011 Jun;8(3):202-8. doi: 10.1016/j.genm.2011.05.001.

lead_sponsor: Centre Hospitalier René Dubos


title: Modulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral Sclerosis

acronym: LymphoEnergy

summary:
Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development.

The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

PBMC and platelets will be stored for future analyses.


title: Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System

acronym: EFEL

summary:
The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.

Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.

The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.


title: Enhancing Social Interaction With an AlterEgo Artificial Agent

acronym: ALTEREGO

summary:
The objective of AlterEgo is the creation of an interactive cognitive architecture, implementable in various artificial agents, allowing a continuous interaction with patients suffering from social disorders, by virtue of changes in behavioural (robot-based) as well as morphological (avatar-based) properties of that agent. The project includes research in fundamental and clinical neurosciences, interaction modeling, development of new computer-vision techniques and human-robot interfaces, as well as evaluation of the scenarios with patients before, during, and after training sessions. At the end of the project, the investigators will produce a new avatar-based clinical method able to enhance social interaction of patients.

The first challenge of this project is to create an avatar alter ego of a patient. Based on recent work in social robotics and neurosciences, the investigators hypothesize that if patients face artificial agents morphologically and behaviourally similar to them, they will increase their social interaction. The second challenge is to transform the morphology and the behaviour of the similar artificial agent into that of a healthy and different agent. The investigators assume that the smooth and continuous behavioural shift from similar/unhealthy to complementary/healthy social behaviour will lead to a better social rehabilitation. AlterEgo opens the door to a new generation of social artificial agents in service robotics. AlterEgo is an interdisciplinary project at the interaction of Social Motor Neurosciences (UM1), Robotics (EPFL), Complex Systems Dynamics (UOB), Computer Vision (DFKI), and Psychiatry (CHU).

This project includes a set of experiments that started in april 2014 and will terminate in september 2016 before undergoing a randomised clinical research.

location_facility: Service Universitaire de psychiatrie adulte, University Hospital of Montpellier


title: Study of the Association Between Genetic Markers (Endothelial Lipase and Aldose Reductase) and Proliferative Diabetic Retinopathy

acronym: REDIAGEN

summary:
Type 2 Diabetes (TD2) is the leading cause of new cases of preventable blindness in these countries (and the gold-standard treatment, laser photocoagulation has proven to be effective in preventing vision loss at the end stage of eye disease due to proliferative diabetic retinopathy (PDR) that occurs in 3 to 6 % of the cases.Therefore, the ongoing search for predictive factors of sight threatening stages of diabetic retinopathy has become more important.

Previous studies that have examined candidate predictive factors for diabetic eye disease have mostly focused on systemic risk factors leading to PDR. Among various clinical parameters, increased HbA1c % levels, uncontrolled blood pressure, diabetes duration, neuropathy and elevated triglycerides have been associated with PDR.

Some genetic factors may also account for the development of PDR and are prospectively considered in this study .

lead_sponsor: CHU de Reims


summary:
ECMO (extra-corporeal membrane oxygenation) is a blood oxygenation technical and purification of carbon dioxide by means of an extracorporeal circulation using a pump (identical to those used in cardiac surgery) and a membrane permitting gas exchange. This technique is used for almost 40 years in the acute respiratory distress syndrome (ARDS) but benefited from many technology improvements over the past 10 years.

The circuit is now fully pre-heparin, not imposing obtaining activated partial thromboplastin time (aPTT) high. Centrifugal pumps limit the risk of intravascular hemolysis. The multi-perforated drainage cannula in place in femoral vein or jugular no longer need to maintain hypervolaemia to ensure sufficient flow.

The membrane ensuring gas exchange is now polymethylpentene. This hollow fiber system ensures the gas exchange.

In light of recent technical improvements, manufacturers indicate that the membranes can be used for 3 weeks. However, after a few days of use, fibrinoplaquettaires microthrombi form at the ECMO circuit, up from cannulas up to the oxygenator, decreasing membrane efficiency and imposing more early changes of the circuit. This hypercoagulable state was revealed through the study of classical plasma markers of coagulation. There is not so far from reliable predictive marker of thrombus formation, indicating a need to change the circuit.

The production of microparticles (MPs) is a characteristic of cells subjected to an activation or apoptosis. MPs are membrane Smaller fragments released into the extracellular milieu after rupture of the asymmetry of the distribution of membrane phospholipids and characterized by the presence of phosphatidylserine (PhtdSer) on their surface, as well as various antigens expressed by their cells of origin. The PhtdSer is a pro-coagulating surface on which are going to assemble the enzymes responsible for the formation of thrombin and increases proportionally the TF activity ultimately leading to fibrin polymerization in the vessels.

The vesiculation phenomenon exists in healthy subjects. In human pathology, many examples emphasize the fundamental role of MP in clotting or thrombosis. The PM generating fault is associated with bleeding disorders (Scott syndrome, dysvésiculation syndrome). Conversely, high circulating levels of MP are found in many thrombotic diseases (myocardial infarction, diabetes, antiphospholipid antibody syndrome, preeclampsia ...). Platelet and intense monocyte endothelial activation, observed in sepsis and severe trauma, is accompanied by the generation of procoagulant MP carriers of tissue factor (TF). These MP diffuse into the vascular compartment pathogenic potential may exacerbate inflammatory and thrombotic responses and play a leading role in triggering the DIC.

More recently, various studies have shown that the microparticles are not only activation markers or injury, but also cellular elements having a true pathogenic role. Because they contain or express on their surface various biological effector (adhesion molecules, tissue factor, inflammatory mediators or apoptogenic, growth factor ...) the microparticles are able to interact with their environment and modulate cellular very different way the properties of target cells. And platelet or leukocyte microparticles could actively participate in the thrombotic process by increasing adhesion of monocytes and endothelial cells, or by inducing endothelial procoagulant response.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Evaluation of Inter-patient Variability Size of the Nasal Cavity, Based on CT Scans

summary:
This study is part of the french research program ANR NEMRO "MICROROBOTIC NASAL ENDOSCOPY BY OPTICAL COHERENCE TOMOGRAPHY: IMPACT OF SMELL DEFICIENCY ON NEURODEGENERATIVE DISEASES." Recent studies have shown a strong correlation between the decrease in olfactory faculties of patients and the presence of neurodegenerative diseases.

This possible relationship has created a need to inspect in detail the area of the nasal cavity that houses the olfactory function.

Thus, the purpose of NEMRO project is developing a robot to explore olfactory slots of patients, with a view to extract images through non invasive imaging probe, and hoping to identify early signs of degeneration the olfactory tissue. The robot developed will thus be able to navigate in the nasal cavity of patients, and to break into the olfactory slots, which will host the imaging phase.

The purpose of this study is therefore to collect data on the usual path of instruments (endoscope, for example) in this area, and future potential pathway of the robot. This collection made from Computed Tomography (CT) scans will define the clinical geometry of the target area and provide precisely the dimensional constraints needed to build the NEMRO robot .

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial

acronym: FUSAC

summary:
After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms.

Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.

status: Active, not recruiting

location_facility: Fondation Opthalmologique A de Rothschild


title: Assessment of Patients' Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke

acronym: AVC-endovasc

summary:
This trial aims at collecting standardized data concerning the early neurological clinical recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.

Although this outcome is a major issue of patients' prognosis, it is rarely collected at this stage of their follow-up.


title: Long Term Follow-up After Embolization of Brain Arteriovenous Malformations

acronym: MAV-endovasc

summary: The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients.

ReferenceCitation: Baharvahdat H, Blanc R, Fahed R, Pooyan A, Mowla A, Escalard S, Delvoye F, Desilles JP, Redjem H, Ciccio G, Smajda S, Hamdani M, Mazighi M, Piotin M. Endovascular treatment as the main approach for Spetzler-Martin grade III brain arteriovenous malformations. J Neurointerv Surg. 2021 Mar;13(3):241-246. doi: 10.1136/neurintsurg-2020-016450. Epub 2020 Sep 28.

ReferenceCitation: Baharvahdat H, Blanc R, Fahed R, Smajda S, Ciccio G, Desilles JP, Redjem H, Escalard S, Mazighi M, Chauvet D, Robert T, Sasannejad P, Piotin M. Endovascular Treatment for Low-Grade (Spetzler-Martin I-II) Brain Arteriovenous Malformations. AJNR Am J Neuroradiol. 2019 Apr;40(4):668-672. doi: 10.3174/ajnr.A5988. Epub 2019 Feb 21.


title: Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain

acronym: ANENDOVASC

summary:
The time-frame and the follow-up elements after embolization of brain aneurysm are not standardized. Therefore, few reliable follow-up data are available for these patients.

This study aims at collecting standardized long term data for these patients, in order to assess the occurence of aneurysm recanalization and particularly those requiring another intervention on the aneurysm.


title: Assessing the Interest of Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

acronym: FAP-ECHO

summary: Using ultrasound to guide vascular catheterism in children is highly recommended for central venous access. It has been proven that central venous line is inserted faster, with fewer attempts and complications. Its interest in central arterial line insertion is less obvious. It seems to have benefits in adults, both for radial and femoral arterial insertion. But there is no study assessing the interest of ultrasound guided arterial puncture in children,.


title: Treatment of Ptosis to Muscular Dystrophy Oculopharyngeal by Myoblast Autologous Graft

acronym: TTT-PT-DOP

summary:
Interventional , multicenter , comparative study. One eye receiving the cells and the contralateral eye as a negative control . If effectiveness following review of the primary endpoint and the advice of an independent expert committee , the experimental treatment will be offered to the patient to the contralateral eyelid.

Objective is to restore muscle function levator muscle of the upper eyelid by providing a registry of autologous myoblasts from a non- clinically affected muscle .

lead_sponsor: University Hospital, Caen


summary:
The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.


title: Cohort Study to Assess Electronic-caps Defined Adherence Patterns - Virological Outcome Relationship Amongst HIV-1 Infected Subjects Receiving Dolutegravir-Based Antiretroviral Therapy)

acronym: DOLUTECAPS

summary:
The main assumption is that the dolutegravir can get virologic suppression to suboptimal adherence levels (between 80 and 95%, and after treatment interruptions) where other molecules are not capable, due to their pharmacokinetic/pharmacodynamic (pardonnance).

While the investigators goal is not to compare molecules (study with one arm) in terms of forgiveness, the results of this cohort in terms of forgiveness could be compared to other cohorts available.


summary: The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.

lead_sponsor: ONIRIS


title: Evaluation of the Benefits of a Program of Prehabilitation: Pilot Study

acronym: PrehabPilote

summary: The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". In the present pilot trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be evaluated.

lead_sponsor: Hopital Foch


type: Registry Identifier

title: ORI2 : ORI for hyperOxia Reduction in ICU

summary:
Recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. This could be related to pulmonary lesions (including notably atelectasis) but also to increased tissue damage and organ dysfunctions, secondary to increased/induced oxidative stress. At last higher FiO2 led to "over-consumption" of oxygen and therefore to additional costs. Usually, FiO2 and oxygen flows are modified according to the monitoring of SpO2. But, it has also been recognized that modifying FiO2 (and oxygen flows) according to SpO2 monitoring is not routinely (or easily) done. Indeed, nurses (and doctors) are reluctant to reduce oxygen flows when everything appear under control.

The ORI (Oxygen Reserve Index) is an index measured using non-invasive SpO2 sensors (Rainbow sensors- MASIMO) that evaluates non-invasively PaO2 (partial pressure of oxygen). An ORI ≤0 indicates that PaO2 is less than 100 mmHg. When ORI increases (i.e. ORI≥0.01) PaO2 is higher than 100 mmHg. This index increases up to 1. ORI between 0.01 and 1 indicates that PaO2 is probably between 100 and 200 mmHg. Thus, monitoring critically ill patients using the ORI, may help identifying when PaO2 is high and when FiO2 (or oxygen flows in non-intubated patients) may be reduced. This could help reducing the time with hyperoxia (i.e. PaO2 ≥100 mmHg or ≥80 mmHg).

The purpose of this feasibility study is to evaluate if the use of ORI can help to decrease length of moderate hyperoxia (PaO2>100mmHg) in critically ill patients, in comparison with monitoring the SpO2 only.

ReferenceCitation: Lasocki S, Brochant A, Leger M, Gaillard T, Lemarié P, Gergaud S, Dupré P. ORI monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORI(2) study. Intensive Care Med. 2019 Nov;45(11):1661-1662. doi: 10.1007/s00134-019-05732-9. Epub 2019 Aug 13.

lead_sponsor: University Hospital, Angers


title: Evaluation of Doppler Flow From the Femoral Artery as a Reflection of Cardiac Flow in a Vascular Fluid Test

acronym: RER D

summary:
In order to identify the responding patients with vascular filling test, this research aims to compare the performance of the increased flow in the femoral artery to the performance of the blood pressure increase.

The reference measurement will increase cardiac output measured by ultrasound.

lead_sponsor: Nantes University Hospital


title: Conditional Imaging Prescription Strategy as an Alternative to Systematic Unenhanced Computed Tomography for Exploration of Acute Uncomplicated Renal Colic With Lower Radiation Exposure

acronym: IMAGENCO

summary:
Prospective single centre study aiming at validating a conditional imaging strategy for diagnosis of suspected kidney stone.

Consecutive Emergency department patients referred to the medical imaging department for exploration of a suspected acute uncomplicated renal colic will undergo the following interventions : systematic plain abdominal Xray, systematic ultrasonography and systematic unenhanced CT (with a reduced dose scan), in addition to clinical examination and assessment of body mass index and the Sex, Timing, Origin, Nausea, Erythrocytes (STONE) clinical prediction score for symptomatic stone.

Patients will be followed up at 1 month to record the need for urologic intervention and its type.

The performances of different conditional imaging strategy for the diagnosis of suspected renal colic will be assessed retrospectively. The conditional strategies tested will be based on the patient's stone score and BMI and targeted use of combined plain X-ray and ultrasonography and/or unenhanced CT.

The reference diagnosis for renal colic will be made according to the finding of a ureteral stone or indirect signs of urolithiasis at unenhanced CT.

lead_sponsor: University Hospital, Montpellier


title: Study of Predictive Factors of Chemoresistance in Ovarian Cancer

acronym: FaCliBioCCo

summary: Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but most often a recurrence occurred in the first 18 months. Early recurrence signs chemoresistance and palliative treatment. The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.

lead_sponsor: Rennes University Hospital


title: Functional Magnetic Resonance and Diffusion Tensor Imaging in the Preoperative Assessment of Dystonia

acronym: IRMF-DIFF

summary:
The aim of this study is to evaluate the organization of the motor circuit in a group of patients suffering from dystonia compared with a group of healthy controls. Deep Brain stimulation is a functional neurosurgery technique consisting in neuromodulation of the motor circuit that has been applied to dystonia. The efficiency of this technique depends on the relative preservation of the function and the structure of the motor network .

The assessment of neuronal circuit by advanced techniques of functional neuroimaging in this study might contribute to expand our understanding of the abnormalities in motor circuit activation and the integrity of CNS structure underlying dystonia. This study might contribute therefore to the refinement of Deep brain stimulation indications and techniques in complex dystonia syndromes