title: Analysis of Sympathetic Activity in Willis-Ekbom Disease

acronym: MIBG-RLS

summary:
Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are often associated with micro-arousals that contribute to sleep fragmentation and repeated increases of blood pressure and heart rate throughout the night, thus representing an increased risk for hypertension and cardiovascular diseases (CVD).

Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational, cross-sectional or longitudinal population-based studies on the association between RLS and CVD and hypertension showed controversial results.

While the pathophysiology of RLS is yet to be elucidated and is likely multifactorial, one theory involves a reduction in dopaminergic outflow to the preganglionic sympathetic neurons in the dorsal horn of the spinal cord. Dopamine inhibits preganglionic sympathetic neurons, therefore a reduction in dopamine may in turn increase sympathetic outflow.

Based on this notion, the investigators hypothesize an increase of sympathetic autonomic activity in Willis-Ekbom disease responsible for the recurrent increase in blood pressure and heart rate during sleep, which may play a role in increasing the risk of cardiovascular diseases.

The aim of this study is to analyze the autonomic nervous activity in patients with WED compared to healthy volunteers controls. The investigators will measure primarily the cardiac sympathetic activity by the 123I-metaiodobenzylguanidine (123I-MIBG) scintigraphy and secondarily the sympathetic nerve activity by the plasmatic pro inflammatory biomarkers and urinary catecholamine levels and the circadian variation of blood pressure and heart rate as assessed by the 24-hour ambulatory blood pressure monitoring.

lead_sponsor: University Hospital, Montpellier


title: Progression of Carotid Atherosclerosis and Vascular Events in People With Diabetes: A Prospective Cohort Study

acronym: PROCAVE-D

summary: Diabetes is a risk factor for carotid atherosclerotic whose progression is associated with an increased risk of vascular events. Investigators assessed prospectively by arterial duplex ultrasonography the progression of carotid atherosclerosis in a cohort of people with diabetes to assess the importance of progression and to analyze the impact of this progression on vascular events. The main hypothesis is that people with carotid atherosclerosis progression are at higher risk of vascular events than those without any progression.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Vouillarmet J, Marsot C, Maucort-Boulch D, Riche B, Helfre M, Grange C. Vascular Events and Carotid Atherosclerosis: A 5-Year Prospective Cohort Study in Patients with Type 2 Diabetes and a Contemporary Cardiovascular Prevention Treatment. J Diabetes Res. 2019 Dec 22;2019:9059761. doi: 10.1155/2019/9059761. eCollection 2019.

apc_source: openAPC

name: Hospices Civils de Lyon, Department of Endocrinology, Diabetes and Nutrition, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

family: Vouillarmet

full_name: Julien Vouillarmet

given: Julien

sequence: first

family: Marsot

full_name: Charlotte Marsot

given: Charlotte

sequence: additional

name: Department of Biostatistics, Hospices Civil de Lyon, Lyon, France

name: CNRS, UMR 5558, Laboratoire Biostatistiques Sante, Pierre-Bénite, France

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Riche

full_name: Benjamin Riche

given: Benjamin

name: Hospices Civils de Lyon, Department of Vascular Medicine, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

family: Helfre

full_name: Marjorie Helfre

given: Marjorie

family: Grange

full_name: Claire Grange

given: Claire

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Diabetes Research

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Hindawi - Hindawi

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_institution:
Hindawi - Hindawi
PubMed Central - Europe PMC

publisher: Hindawi Limited

publisher_dissemination: Hindawi

publisher_group: Hindawi

publisher_normalized: Hindawi

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Endocrinologie, Diabète et Maladie de la Nutrition, GH Sud, Hospices Civils de Lyon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Multicentre, Randomized, Multi-arm Trial Comparing the Efficacy and Safety of Adalimumab, Anakinra and Tocilizumab in Subjects With Non-infectious Refractory Uveitis RUBI: Refractory Uveitis BIotherapies

acronym: RUBI

summary:
RUBI, is the first prospective randomized, head to head study, comparing Adalimumab to either anakinra, or tocilizumab in refractory Non Infectious Uveitis (NIU). There is no firm evidence or randomized controlled trials directly addressing the best biologic agent in severe and refractory NIU. NIU can cause devastating visual loss and up to 20% of legal blindness. Corticosteroids and immunosuppressants failed to demonstrate sustainable remission over 70 % of refractory/relapsing severe uveitis. The incidence of blindness in NIU has been dramatically reduced in the recent years with the use of biologics, raising the question of whether these compounds should be used earlier in the treatment of severe non infectious uveitis. Contrasting with immunosuppressors, biotherapies act rapidly and are highly effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma.

Despite a strong rationale, these compounds are not yet approved in uveitis, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug

status_simplified: Unknown


title: Interest of elastoFRM With Force Measure by MRI on Patients With Hepatocellular Cancer

acronym: FORCE

summary:
FORCE project aims to measure actives forces of malignant tumor by magnetic resonance force (FRM). Two main forces are considered as key indicators of therapeutic response and metastatic potential: interstitial force and traction force at the interface cell/tumor. Biomarkers of these forces will be developped using direct images of magnetic resonance force (FRM). Efficiency of these non-invasive biomarkers will be evaluated through their capacity to predict tumoral environment invasion, notably micro-vascular invasion, and therapeutical results in Hepatocellular Cancer (HCC).

Principal criteria will be

micro-vascular invasion assessed by pathological examination of surgical pieces (gold standard).
interstitial force and traction force at the cell/tumor interface assessed by FRM.

Population of patients will be divided in three groups. A first group will be constituted of 20 volunteer patients coming for abdominal MRI with no known hepatic disease, in order to determine the feasibility of FRM. A second group will be constituted of 60 patients with resectable HCC eligible for surgery. This group will enable to evaluate the tumoral environment invasion. Third group will be constituted of 50 patients with HCC eligible for transplant with transcatheter arterial chemoembolization (TACE) treatment as pending treatment before transplant. This groups will enable to evaluate the efficiency of TACE through the necrosis percentage in treated HCC.

Inclusion of patients will occur during 24 months for a total study duration of 36 months.

All patients will have MRI as usual care. FRM is performed during MRI with the use of a specific medical device and therefore corresponds to an additional procedure of the research.

Moreover, patients in group 2 and 3 will be asked to participate to an ancillary study consisting in circulating tumoral cells (CTC) measurement. If they accept, a blood sample will be collected just before the MRI in order to evaluate the correlation between CTC and micro-vascular invasion.

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Diagnostic

ipd_sharing: Undecided

intervention_type: Radiation

status_simplified: Ongoing


type: Other Identifier

title: Per-oral Endoscopy Pyloromyotomy (G-POEM) in the Treatment of Refractory Diabetic Gastroparesis : Prospective Evaluation of Efficacy

acronym: G-POEM

summary: The objective of the study is to document the clinical efficacy and complications of endoscopic pyloromyotomy in patients with refractory gastroparesis (diabetic, post-operative and idiopathic), compared to Botulinic toxin injection intra-pyloric the results of which are close to the placebo.

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Gastro-entérologie, Hôpital Nord ,Assistance Publique Hôpitaux de Marseille

intervention_type: Procedure


title: Assessment of White Blood Cell SPECT/CT in Monitoring Antibiotic Treatment in Patients With Diabetic Foot Osteomyelitis

summary: Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was associated with recurrence in 70% of cases. The aim of our study was to evaluate prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic therapy.

ReferenceCitation: Vouillarmet J, Tordo J, Moret M, Michon P, Morelec I. 99mTc-white blood cell SPECT/CT to assess diabetic foot osteomyelitis remission: contribution of semi-quantitative scoring system. Nucl Med Commun. 2021 Jul 1;42(7):713-718. doi: 10.1097/MNM.0000000000001390.

family: Tordo

full_name: Jeremie Tordo

given: Jeremie

family: Moret

full_name: Myriam Moret

given: Myriam

family: Michon

full_name: Paul Michon

given: Paul

family: Morelec

full_name: Isabelle Morelec

given: Isabelle

journal_name: Nuclear Medicine Communications

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Vouillarmet J, Moret M, Morelec I, Michon P, Dubreuil J. Application of white blood cell SPECT/CT to predict remission after a 6 or 12 week course of antibiotic treatment for diabetic foot osteomyelitis. Diabetologia. 2017 Dec;60(12):2486-2494. doi: 10.1007/s00125-017-4417-x. Epub 2017 Sep 2.

family: Dubreuil

full_name: Julien Dubreuil

journal_name: Diabetologia

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility: Service d'Endocrinologie-Diabétologie-Maladies de la nutrition, GH Sud, Hospices Civils de Lyon


title: Generation of Powerful Biological Tools - Fibroblast or Inducible Pluripotent Bone Marrow Cells - for Understanding the Pathophysiology of Chronic Granulomatous Disease.

acronym: FIBRO CGD

summary:
Chronic granulomatous disease (CGD) is a rare genetic disease of innate immune due to the malfunction of phagocytic cells unable to destroy pathogens during infection. The four genes implicated are CYBB, CYBA, NCFA and NCF2 respectively encoding Nox2, p22phox, p47phox and p67phox. Nox2 analogs have recently been discovered in cells other than phagocytes. So the question arises on physiopathological impact of the absence of theses proteins not only in phagocytes but also in other cells types such as fibroblasts or neurons.

The principal objective is thus to study the impact of protein deficits Nox2 and p22phox, in the pathophysiology of neurons from inducible pluripotent bone marrow cells (iPSC).

For this purpose, a collection was built of fibroblasts and keratinocytes from patients with different forms of CGD to get iPSC similar to embryonic marrow cells and differentiable into several cell types (neurons, phagocytes).

status: Terminated

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: O'Neill S, Brault J, Stasia MJ, Knaus UG. Genetic disorders coupled to ROS deficiency. Redox Biol. 2015 Dec;6:135-156. doi: 10.1016/j.redox.2015.07.009. Epub 2015 Jul 17. Review.

ReferenceCitation: Bedard K, Krause KH. The NOX family of ROS-generating NADPH oxidases: physiology and pathophysiology. Physiol Rev. 2007 Jan;87(1):245-313. Review.

ReferenceCitation: Nakano Y, Longo-Guess CM, Bergstrom DE, Nauseef WM, Jones SM, Bánfi B. Mutation of the Cyba gene encoding p22phox causes vestibular and immune defects in mice. J Clin Invest. 2008 Mar;118(3):1176-85. doi: 10.1172/JCI33835.

ReferenceCitation: Schiavone S, Sorce S, Dubois-Dauphin M, Jaquet V, Colaianna M, Zotti M, Cuomo V, Trabace L, Krause KH. Involvement of NOX2 in the development of behavioral and pathologic alterations in isolated rats. Biol Psychiatry. 2009 Aug 15;66(4):384-92. doi: 10.1016/j.biopsych.2009.04.033. Epub 2009 Jun 26.

ReferenceCitation: Brault J, Goutagny E, Telugu N, Shao K, Baquié M, Satre V, Coutton C, Grunwald D, Brion JP, Barlogis V, Stephan JL, Plantaz D, Hescheler J, Krause KH, Sarić T, Stasia MJ. Optimized Generation of Functional Neutrophils and Macrophages from Patient-Specific Induced Pluripotent Stem Cells: Ex Vivo Models of X(0)-Linked, AR22(0)- and AR47(0)- Chronic Granulomatous Diseases. Biores Open Access. 2014 Dec 1;3(6):311-26. doi: 10.1089/biores.2014.0045.

lead_sponsor: University Hospital, Grenoble


title: High Fidelity Simulation Performance After a Potential Optimization Training for Anesthesiologist Resident: a Randomized Controlled Trial.

acronym: TOP

summary: Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.

primary_purpose: Other

lead_sponsor: Claude Bernard University

intervention_type: Behavioral


summary:
The aim of this study is

1) To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital

time_perspective: Cross-Sectional

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of Safety and Efficency of Custom-made Corpectomy Implants: UNiD 3D VBR

summary:
Multicenter study allowing to include the first sixty patients implanted with a custom-made corpectomy implant (UNiD 3D VBR): 30 patient implanted in cervical region and 30 patients implanted in thoracolumbar region.

The main objective is to confirm feasibilty and safety of patient-specific implants for one or multi-level corpectomy and fusion.

This study was approved in March 2016 allowing to include retrospectivley all patients since the first implantation in January 2015 and prospectively all patients after the approval.

lead_sponsor: Medicrea International

intervention_type: Device

lead_sponsor_type: industriel


title: Nutritional Intake of "Finger-food" on Elderly People in Seniors's Resident

acronym: FIFO

summary:
The undernourishment and the prevention of its risk at the elderly person in seniors's resident represent a major issue in public health. The diagnosis of undernourishment and its risk are systematically recommended in these structures where the nutrition of these people is a problem because often inappropriate for their capacities of prehension and consequently for their nutritional needs. One of the solutions to remedy can be found in the " finger-food ".

The study FIFO ("Finger-Food") suggests verifying the hypothesis which the finger-food would allow to increase the nutritional intake of the resident who have disorders of the prehension and\or requiring a nutritional stimulation and\or require an help to the preparation of the meal.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Impact of Muscular Training Program on Body Composition of Overweight and Obese Teenagers: classi201c Cycling Exercise in Concentric Versus Eccentric

acronym: TEXTOO

summary:
Nowadays, eccentric exercise can be realized in a dynamic way with an ergocycle which permits eccentric (ECC) lower limbs contractions at a defined power output. With this type of ergometer, O2 consumption (VO2) in ECC is three fold lower than in concentric (CON) for the same power output. Consequently, ECC program could be used in chronic disorders with limited capacities, such as obesity.

The investigators hypothesis that an eccentric training program, as it will induce higher mechanical constraints, would improve body composition, especially by reducing fat mass. This effect could be explained by an increased rest energy expenditure and a better improvement in biological parameters (particularly lipid profile and insulin-resistance) after ECC training (versus CON training).

This study aims to compare the modification of fat mass after an ECC program versus a CON program at the same VO2.. The secondary goal is to assess the physiological mechanisms involved in the modification of body composition.

ReferenceCitation: Julian V, Thivel D, Miguet M, Brengues C, Pereira B, Courteix D, Richard R, Duclos M. Bone response to eccentric versus concentric cycling in adolescents with obesity. Obes Res Clin Pract. 2020 Nov - Dec;14(6):554-560. doi: 10.1016/j.orcp.2020.10.002. Epub 2020 Oct 26.

family: Julian

full_name: Valérie Julian

given: Valérie

family: Thivel

full_name: David Thivel

given: David

family: Miguet

full_name: Maud Miguet

given: Maud

family: Brengues

full_name: Chloé Brengues

given: Chloé

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Courteix

full_name: Daniel Courteix

given: Daniel

family: Richard

full_name: Ruddy Richard

given: Ruddy

family: Duclos

full_name: Martine Duclos

given: Martine

journal_name: Obesity Research & Clinical Practice

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

evidence: open (author manuscript)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand


title: Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation

acronym: BETACTIV

summary: Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.


type: EudraCT Number

title: Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.

acronym: LYRORL

summary:
Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of referred otalgia involves several non adjacent nerve territories as those of head, neck or ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.

Four cranial nerves participate in the sensory innervation of the external ear: the trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there are important interindividual anatomical variations.

The relationship between referred otalgia and probable nerve damage has been described. In he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic component.

In the literature, the curative treatment of referred otalgia is the cancer treatment. However, the high intensity of referred otalgia leads the patients to a large consumption of analgesics in particular of opioids. These latter are particularly adapted for pain resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage channels in the central nervous system. its effectiveness has been demonstrated for the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the bone marrow but also the postoperative pain when the molecule is administered after the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or three daily doses.

The purpose of this study was to evaluate the activity of pregabalin administered orally for three weeks after the anesthesia consultation on the intensity of the pain of referred otalgia and on its neuropathic component.

lead_sponsor: University Hospital, Lille


title: Discordance Dans l'évaluation d'Activité de la Polyarthrite Rhumatoide

acronym: DIAPO

summary:
Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).

The objectives of this study were:

to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity

to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.

Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline

Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.

Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.


title: Genetic Susceptibility and Biomarkers in Listeriosis (MONALISA-GENBIO)

acronym: MONALISAGENBIO

summary:
Listeriosis is a rare, severe foodborne infection caused by the bacterium Listeria monocytogenes (Lm). It manifests as septicemia, central nervous system (CNS) infection and maternal-fetal (MF) infection. Its associated overall mortality is very high, above of 30%. A better knowledge on the factors involved in its occurrence and in clinical manifestations is therefore needed to improve outcome.

A number of frequent acquired risk factors for listeriosis have been identified, such as pregnancy, diabetes, cancer, HIV infection, and immunosuppressive therapies. However, no genetic study on host susceptibility to listeriosis in humans has been performed so far, in the absence of prospective collection of patients' samples. Also, listeriosis diagnosis is based on Lm culture from clinical samples. This method lacks sensitivity, and the contribution of biomarkers to listeriosis diagnosis and prognosis has not been evaluated.

The Multicentric Observational NAtional Analysis of Listeriosis and Listeria (MONALISA), is the first national case-control prospective study on listeriosis. It is implemented since 2009 and enrolls all culture-proven cases declared to the NRCL: and collects for each patient clinical and biological data and biological samples. Controls with comparable background and presentation are also included. 818 cases have been included (427 S, 252 CNS and 107 MN) over 3.5 years, along with 456 controls.

The aim of the study is to identify human genetic susceptibility factors to listeriosis, biomarkers to improve its diagnosis and prognosis (survival or death), and thereby help improve management of patients with listeriosis.

Samples from the completed cohort will be analyzed : SNPs genotyping and exam sequencing; biomarkers a identification in serum and plasma of patients and controls by simultaneous multi-analyte and metabolomic profiling.

time_perspective: Retrospective

lead_sponsor: Institut Pasteur

location_facility: Institut Pasteur, Unité de Biologie des Infections


title: GALIG Gene Expression in Parkinson's Disease

acronym: GALIGPARK

summary: Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements), and non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates in the brainstem and extends progressively through the entire cortex. The processes leading to cell death are poorly understood. Pathological cells exhibit abnormal deposits, called Lewy bodies, which contain numerous proteins. A major constituent of these protein deposits is alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular Biophysics of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein interacts with Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin could thus be a factor regulating α-synuclein activity or aggregation. It is postulated that the level of expression of the GALIG gene is different in Parkinson's disease patients compared with control subjects.

ReferenceCitation: Alieva AKh, Filatova EV, Karabanov AV, Illarioshkin SN, Slominsky PA, Shadrina MI. Potential Biomarkers of the Earliest Clinical Stages of Parkinson's Disease. Parkinsons Dis. 2015;2015:294396. doi: 10.1155/2015/294396. Epub 2015 Sep 21.

ReferenceCitation: Pinho R, Guedes LC, Soreq L, Lobo PP, Mestre T, Coelho M, Rosa MM, Gonçalves N, Wales P, Mendes T, Gerhardt E, Fahlbusch C, Bonifati V, Bonin M, Miltenberger-Miltényi G, Borovecki F, Soreq H, Ferreira JJ, F Outeiro T. Gene Expression Differences in Peripheral Blood of Parkinson's Disease Patients with Distinct Progression Profiles. PLoS One. 2016 Jun 20;11(6):e0157852. doi: 10.1371/journal.pone.0157852. eCollection 2016. Erratum in: PLoS One. 2017 Dec 28;12 (12 ):e0190552.

ReferenceCitation: Scherzer CR, Eklund AC, Morse LJ, Liao Z, Locascio JJ, Fefer D, Schwarzschild MA, Schlossmacher MG, Hauser MA, Vance JM, Sudarsky LR, Standaert DG, Growdon JH, Jensen RV, Gullans SR. Molecular markers of early Parkinson's disease based on gene expression in blood. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):955-60. Epub 2007 Jan 10.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Suprapubic Versus Transurethral Catheterization After Rectal Resection With Low Anastomosis for Cancer in Males

summary: The urpose of this study is to compare the urinary tract infection rate on the four postoperative day between the 2 groups of patients who have undergone total mesorectal excision for cancer and low anastomosis, with either suprapubic or transurethral catheterization.

ReferenceCitation: Shah EF, Huddy SP. A prospective study of genito-urinary dysfunction after surgery for colorectal cancer. Colorectal Dis. 2001 Mar;3(2):122-5.

ReferenceCitation: Sterk P, Shekarriz B, Günter S, Nolde J, Keller R, Bruch HP, Shekarriz H. Voiding and sexual dysfunction after deep rectal resection and total mesorectal excision: prospective study on 52 patients. Int J Colorectal Dis. 2005 Sep;20(5):423-7. Epub 2005 Apr 22.

ReferenceCitation: Branagan GW, Moran BJ. Published evidence favors the use of suprapubic catheters in pelvic colorectal surgery. Dis Colon Rectum. 2002 Aug;45(8):1104-8.

ReferenceCitation: Lee SY, Kang SB, Kim DW, Oh HK, Ihn MH. Risk factors and preventive measures for acute urinary retention after rectal cancer surgery. World J Surg. 2015 Jan;39(1):275-82. doi: 10.1007/s00268-014-2767-9.

ReferenceCitation: Platt R, Polk BF, Murdock B, Rosner B. Mortality associated with nosocomial urinary-tract infection. N Engl J Med. 1982 Sep 9;307(11):637-42.

ReferenceCitation: Tambyah PA, Oon J. Catheter-associated urinary tract infection. Curr Opin Infect Dis. 2012 Aug;25(4):365-70. doi: 10.1097/QCO.0b013e32835565cc. Review.

ReferenceCitation: Rasmussen OV, Korner B, Møller-Sørensen P, Kronborg O. Suprapubic versus urethral bladder drainage following surgery for rectal cancer. Acta Chir Scand. 1977;143(6):371-4.

ReferenceCitation: Shapiro J, Hoffmann J, Jersky J. A comparison of suprapubic and transurethral drainage for postoperative urinary retention in general surgical patients. Acta Chir Scand. 1982;148(4):323-7.

ReferenceCitation: Sethia KK, Selkon JB, Berry AR, Turner CM, Kettlewell MG, Gough MH. Prospective randomized controlled trial of urethral versus suprapubic catheterization. Br J Surg. 1987 Jul;74(7):624-5.

ReferenceCitation: Piergiovanni M, Tschantz P. [Urinary catheterization: transurethral or suprapubic approach?]. Helv Chir Acta. 1991 Jul;58(1-2):201-5. French.

ReferenceCitation: O'Kelly TJ, Mathew A, Ross S, Munro A. Optimum method for urinary drainage in major abdominal surgery: a prospective randomized trial of suprapubic versus urethral catheterization. Br J Surg. 1995 Oct;82(10):1367-8.

ReferenceCitation: Ratnaval CD, Renwick P, Farouk R, Monson JR, Lee PW. Suprapubic versus transurethral catheterisation of males undergoing pelvic colorectal surgery. Int J Colorectal Dis. 1996;11(4):177-9.

ReferenceCitation: Perrin LC, Penfold C, McLeish A. A prospective randomized controlled trial comparing suprapubic with urethral catheterization in rectal surgery. Aust N Z J Surg. 1997 Aug;67(8):554-6.

ReferenceCitation: Baan AH, Vermeulen H, van der Meulen J, Bossuyt P, Olszyna D, Gouma DJ. The effect of suprapubic catheterization versus transurethral catheterization after abdominal surgery on urinary tract infection: a randomized controlled trial. Dig Surg. 2003;20(4):290-5. Epub 2003 Jun 5.

ReferenceCitation: McPhail MJ, Abu-Hilal M, Johnson CD. A meta-analysis comparing suprapubic and transurethral catheterization for bladder drainage after abdominal surgery. Br J Surg. 2006 Sep;93(9):1038-44. Review.

ReferenceCitation: Niël-Weise BS, van den Broek PJ. Urinary catheter policies for short-term bladder drainage in adults. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD004203. Review. Update in: Cochrane Database Syst Rev. 2015;12:CD004203.

ReferenceCitation: Healy EF, Walsh CA, Cotter AM, Walsh SR. Suprapubic compared with transurethral bladder catheterization for gynecologic surgery: a systematic review and meta-analysis. Obstet Gynecol. 2012 Sep;120(3):678-87. doi: 10.1097/AOG.0b013e3182657f0d. Review.


title: French National Investigation About Student's Sleep Perturbations Before Simulation Session.

acronym: Simsleep

summary:
High fidelity simulation provide educational skills but the simulation of critical events could eventually provide anxiety among participants.

The anxiety could raise before the simulation session and affect the perceived quality of sleep the night prior to the simulation session. The lack of sleep would eventually affect both participation and memorization during the simulation session. The investigators would like to investigate with a survey how much participants had their sleep affected before the simulation session.


title: A Phase 1 Study of MONALIZUMAB (IPH2201), a Humanized Anti CD94/NKG2A Monoclonal Antibody (Mab) Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation (SCT) Prepared With a Reduced Intensity Conditioning

acronym: PIRAT

summary: This study will determine the Maximal Tolerated Dose if any and the recommended dose for phase 2 of monalizumab, a monoclonal antibody directed against the CD94/NKG2A receptor, after allogenic stem cell transplantation. All patients will receive one single intravenous administration of one of the four doses of monalizumab.

ReferenceCitation: Ruggeri L, Urbani E, André P, Mancusi A, Tosti A, Topini F, Bléry M, Animobono L, Romagné F, Wagtmann N, Velardi A. Effects of anti-NKG2A antibody administration on leukemia and normal hematopoietic cells. Haematologica. 2016 May;101(5):626-33. doi: 10.3324/haematol.2015.135301. Epub 2015 Dec 31.

ReferenceCitation: Godal R, Bachanova V, Gleason M, McCullar V, Yun GH, Cooley S, Verneris MR, McGlave PB, Miller JS. Natural killer cell killing of acute myelogenous leukemia and acute lymphoblastic leukemia blasts by killer cell immunoglobulin-like receptor-negative natural killer cells after NKG2A and LIR-1 blockade. Biol Blood Marrow Transplant. 2010 May;16(5):612-21. doi: 10.1016/j.bbmt.2010.01.019. Epub 2010 Feb 6.

ReferenceCitation: Rathmann S, Glatzel S, Schönberg K, Uhrberg M, Follo M, Schulz-Huotari C, Kaymer M, Veelken H, Finke J, Fisch P. Expansion of NKG2A-LIR1- natural killer cells in HLA-matched, killer cell immunoglobulin-like receptors/HLA-ligand mismatched patients following hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2010 Apr;16(4):469-81. doi: 10.1016/j.bbmt.2009.12.008. Epub 2010 Jan 4.

ReferenceCitation: Pical-Izard C, Crocchiolo R, Granjeaud S, Kochbati E, Just-Landi S, Chabannon C, Frassati C, Picard C, Blaise D, Olive D, Fauriat C. Reconstitution of natural killer cells in HLA-matched HSCT after reduced-intensity conditioning: impact on clinical outcome. Biol Blood Marrow Transplant. 2015 Mar;21(3):429-39. doi: 10.1016/j.bbmt.2014.11.681. Epub 2015 Jan 9.

lead_sponsor: Institut Paoli-Calmettes


title: Monocentric, Prospective Study Assessing the Feasibility to Use Resting Energy Expenditure by Indirect Calorimetry as Prognostic Marker of Tumoral Response to 1st Line Chemotherapy in Patients Suffering From Metastatic Pancreatic Cancer

acronym: EnergiePancrea

summary: The purpose of this study is to determine whether evolution of resting energetic expenditure is a predictive marker of tumoral response for patients suffering from metastatic pancreatic cancer and treated with 1st line of chemotherapy.

lead_sponsor: Center Eugene Marquis


title: Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot

acronym: GS-OROPHARYNX

summary: Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a 99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along with the other lymph nodes of the selective group II and III recess. Sentinel lymph node staging alone and complete dissection with routine anatomical pathology will be compared If this technique is reliable it will make a therapeutic de-escalation in the treatment of small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node is free from metastasis and also to better choose the treatment in case of lymph node involvement

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


summary:
Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed.

Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied.

The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

ReferenceCitation: Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Dupuis Lozeron E, Frenoy E, Contal O, Lamia B. Comparison of exercise intensity during four early rehabilitation techniques in sedated and ventilated patients in ICU: a randomised cross-over trial. Crit Care. 2018 Apr 27;22(1):110. doi: 10.1186/s13054-018-2030-0.

family: Medrinal

full_name: Clément Medrinal

given: Clément

family: Combret

full_name: Yann Combret

given: Yann

family: Prieur

full_name: Guillaume Prieur

given: Guillaume

family: Robledo Quesada

full_name: Aurora Robledo Quesada

given: Aurora

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis Edouard Gravier

given: Francis Edouard

family: Dupuis Lozeron

full_name: Elise Dupuis Lozeron

given: Elise

family: Frenoy

full_name: Eric Frenoy

given: Eric

family: Contal

full_name: Olivier Contal

given: Olivier

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

currency_apc_doaj: GBP

journal_name: Critical Care

repository_institution: HES-SO (https://www.hes-so.ch/) - ArODES

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Medrinal C, Combret Y, Prieur G, Robledo Quesada A, Bonnevie T, Gravier FE, Frenoy É, Contal O, Lamia B. Effects of different early rehabilitation techniques on haemodynamic and metabolic parameters in sedated patients: protocol for a randomised, single-bind, cross-over trial. BMJ Open Respir Res. 2017 Jan 30;4(1):e000173. doi: 10.1136/bmjresp-2016-000173. eCollection 2017.


title: Prognostic and Predictive Biomarkers in Ovarian Cancers

acronym: OvBIOMark

summary: The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.


title: TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

acronym: TrOma

summary: The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.

lead_sponsor: University of Paris 5 - Rene Descartes


title: Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen

acronym: FIPALLOC

summary:
Traditionally known for their role in haemostasis, platelets have also an immune role.

Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.

Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Pilot Study of Evaluation of the Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

acronym: SALVADS-Fluo

summary:
Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins.

Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer.

The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area.

The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.

ReferenceCitation: Cortese S, Kerrien E, Yakavets I, Meilender R, Mastronicola R, Renard S, Leroux A, Bezdetnaya L, Dolivet G. ICG-induced NIR fluorescence mapping in patients with head & neck tumors after the previous radiotherapy. Photodiagnosis Photodyn Ther. 2020 Sep;31:101838. doi: 10.1016/j.pdpdt.2020.101838. Epub 2020 May 30.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Descriptive Analysis of Morphological Aspects of Nerve by Ultra-high Frequency Ultrasound (30-50MHZ) in Demyelinating Neuropathies: Inflammatory Demyelinating Polyneuropathy Chronic (IPDC), Neuropathy Multifocal Motor Block of Conducting (NMMBC) and Neuropathy With Antibody A MAG

acronym: EchoNerf

summary:
The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a promising growing field (1). Non-invasive and painless, ultrasound provides additional data electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently in several studies. However the limited resolution of current ultrasound images do not allow detailed study of the internal structure of the nerves which could later help deepen knowledge in this innovative field and can better understand the pathophysiological mechanism of the evolution of these pathologies .

To do this, the investigators have available a UHF ultrasound in the ultrasound department of the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive analysis study, pilot, mono-centric, multi and prospective on patients followed in the center with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects matched by age and sex. All the patients and controls in this study will receive a briefing and must sign an informed consent.

They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound system that will allow the assessment of anatomical structures of nerve (size, structure, vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared with the data obtained with the EMG and clinical scores obtained using clinical rating scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of neuropathy at the EMG examination.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Intestinal Metagenome of Undernourished in Patients

acronym: INT-METAVOSA

summary: The objective of this trial is to evaluate gut microbiota changes in undernourished patients with anorexia nervosa under enteral nutrition.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells

acronym: ANOPEC 3

summary: The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Biological


title: Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.

summary:
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.

In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


type: Registry Identifier

title: Impact of Different DAV132 Dose Regimens (From 2 to 22.5 g/Day During 7 Days, Bid and Tid) on the Fecal Moxifloxacin Concentrations and the Intestinal Microbiota of Healthy Volunteers Treated With Moxifloxacin 400 mg/Day During 5 Days

summary: The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

lead_sponsor: Da Volterra


title: Evaluation de l'Intervention Des Services de Protection Maternelle et Infantile de 11 départements français Ayant bénéficié d'un référentiel Commun d'Intervention à Domicile (Projet Panjo : Promotion de la Santé et de l'Attachement Des Nouveau-nés et de Leurs Jeunes Parents : un Outil de Renforcement Des Services de PMI)

acronym: PANJO

summary: The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.

ReferenceCitation: Saïas, T, Delawarde, C, Colson, S, Planche, M, Vallée, V, Du Roscoät, E, Bonnard, A, Bodard, J, Dugravier, R. De l'expérimentation scientifique à l'implantation dans les services publics : le projet Panjo. Revue Francophone Internationale de Recherche Infirmière, 2 : 232-241, 2016.

lead_sponsor: L'Agence des Nouvelles Interventions Sociales et de Santé


title: Determination of Normal Range Values of Thrombin Generation Parameters in Pediatrics Population Using a New Standardized Thrombin Generation Assay

acronym: TGT

summary: The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesia™" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults > 18 years old).

lead_sponsor: CHU de Reims


title: Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia

summary: Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy

summary: The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy.


title: An Open Single-center, Phase I Proof of Concept Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy With Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients With a First Clinical Episode Highly Suggestive of Multiple Sclerosis

acronym: MS and EBV-CTL

summary: The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood. Indeed MS is a multifactorial disease involving genetic and environmental factors and Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV infection and the immunological mechanisms underlying MS is not clear. Robust sero-epidemiological evidences support an association between EBV infection and MS, and immunological data suggest an altered/deficient immune response against this virus. In healthy individuals EBV produces a persistent infection that is tightly controlled by the immune system. In patients with MS, cellular and humoral immune studies demonstrate an altered response against the virus with a T-cell abnormal reactivity against the EBV-infected autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear Antigen-1, and in the case of children, an increased EBV shedding, demonstrating frequent EBV reactivations. Thus, it has been proposed, that patients with MS present a partially inefficient control of the EBV infection. Some experimental data support the hypothesis suggesting that the presence of autoreactive EBV-B cells in the meninges of patients, probably due to an insufficient clearance of these cells by the immune system, lead to the infiltration of autoreactive T cells. Another hypothesis also suggests a deficient control of the virus, in that case during the inactive phase of the disease. Together, the above data and hypotheses lead to the notion that an immune intervention capable of restoring the host-EBV balance could be beneficial to MS patients In this project, we will assess the feasibility and safety of autologous transfer of several amounts of CD8 T cells directed against autologous EBV transformed B cell lines, in order to finally restore an efficient control of EBV in MS patients. The main objective of the project is to test the feasibility and safety of the process, while efficacy parameters will be also assessed in secondary objectives.

lead_sponsor: Nantes University Hospital


acronym: WEAN SLEEP 2

summary: The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.

lead_sponsor: Poitiers University Hospital


title: Genetic Study of Familial Forms of Non-atopic Asthma

acronym: GANA

summary:
The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory drugs (NSAIDs), a sinonasal polyposis and eosinophilia.

Unlike allergic asthma, this form does not today demonstrated its genetic character. However, the existence of familial forms of asthma in this region Pays de La Loire led us to hypothesize the existence of genetic variations can explain some familial forms of non-atopic asthma. Corresponding genes may be relevant to understanding the pathophysiological pathways involved in the more common sporadic forms.

The investigators propose a study combining genetic linkage analysis and complete sequencing exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The clinical stage essential for mutation identification is to identify and recruit large families with members affected by non-atopic asthma and ensure accurate phenotyping of all individuals recruited over several generations.

The aim of this study is to create a cohort of families who have more members within them non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family linkage study will then reveal the presence or absence of genetic variations associated with intrinsic asthma.

location_facility: CHU de Nantes - Service de Pneumologie - HGRL

intervention_type: Genetic


title: Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

acronym: EvAd

summary: There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

primary_purpose: Supportive Care


title: Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

summary: The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

lead_sponsor: BBraun Medical SAS


title: Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life

summary: We aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

ReferenceCitation: Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.

family: Werner

full_name: Oscar Werner

given: Oscar

family: Bredy

full_name: Charlene Bredy

given: Charlene

family: Lavastre

full_name: Kathleen Lavastre

given: Kathleen

family: Guillaumont

full_name: Sophie Guillaumont

given: Sophie

family: De La Villeon

full_name: Gregoire De La Villeon

given: Gregoire

family: Vincenti

full_name: Marie Vincenti

given: Marie

family: Gerl

full_name: Cristelle Gerl

given: Cristelle

family: Dulac

full_name: Yves Dulac

given: Yves

family: Souletie

full_name: Nathalie Souletie

given: Nathalie

family: Acar

full_name: Philippe Acar

given: Philippe

family: Pages

full_name: Laurence Pages

given: Laurence

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Bourrel

full_name: Gerard Bourrel

given: Gerard

family: Oude Engberink

full_name: Agnes Oude Engberink

given: Agnes

family: Million

full_name: Elodie Million

given: Elodie

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

family: Amedro

full_name: Pascal Amedro

given: Pascal

journal_name: Health and Quality of Life Outcomes

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

evidence: oa repository (via OAI-PMH title and first author match)

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital


title: Development and Evaluation of a Care Protocol for Caregivers and Parents of Children Recently Gastrostomised

acronym: Gastrostomy

summary: The aim of the study is to improve care practice related to gastrostomy management. This a before-after study, aimed at evaluating knowledge of care givers, families and patients about gastrostomy management. The intervention includes 1) A training in a care protocol for hospital care givers, and 2) A booklet for patients, families, and outpatient care givers. The evaluation criterion is a questionnaire to assess knowledge of hospital care givers, patients, families, and outpatient care givers.

lead_sponsor: Hospices Civils de Lyon


title: Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

summary:
Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases.

Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells.

Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.


title: Relevance and Possible Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients.A Prospective, Monocentric, Observational Study

acronym: FR-REA

summary:
In ICU setting, a large number of medical devices are attached to patients, generating numerous alarm signals. Several studies have demonstrated that most of these alarms are not clinically relevant and tend to lower the attentiveness of healthcare professional and, in turn, lower patient safety.The aim of the study is to assess the relevance of respiratory rate alarm on a monitoring device in non-ventilated ICU patients.

The investigator primary hypothesis is that this alarm is potentially useless. If this hypothesis is confirmed, a second interventional trial will be conducted on the impact of this alarm removal.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Search for New Genetic Causes of Hypercalcemia by Massively Parallel Sequencing of a Genes Panel

acronym: HyCaGene

summary:
Hypercalcemia, whether chronic or acute, exposes the patient to potentially serious complications (arrhythmias, nephrolithiasis, nephrocalcinosis, ...). Prevention relies primarily on effective etiological necessary for taking matched load. Under the French reference center for rare disorders of calcium and phosphorus, the investigators looked for mutations in the coding sequence of the CYP24A1 gene (encoding the enzyme responsible for the breakdown of vitamin D), among patients with hypercalcemia without hyperparathyroidism with hypersensitivity to vitamin D. However, only 25% of these patients have a genetic anomaly suggesting the involvement of other genes (Molin et al. 2015). Recently our team, combined with Kaufmann et al. (2014 JCEM) validated the interest of the determination of metabolites of vitamin D by liquid chromatography-tandem mass spectrometry (LC-MS / MS), as biological pre-screening stage for patients with hypercalcemia.

The objective of this project is to complement the molecular and biochemical studies of patients without mutation of the coding sequence of CYP24A1, in a gene candidate approach using massively parallel sequencing (MPS) which allows to study a panel of gene potentially involved in disorder of metabolism of calcium and phosphorus. Highlighted variations will be tested in silico, and if possible in vitro. The investigators will also use LC-MS / MS to evaluate in vivo the effects of these variations on the metabolism of vitamin D, to develop a genotype / phenotype correlation.

The work carried out within the Genetics Department Caen University Hospital in collaboration with physicians of the rare disease reference center of the metabolism of calcium and phosphorus should identify new genetic mechanisms underlying hypercalcemia. At the time of development of personalized medicine, it will adapt the therapy in patients at risk for metabolic complications and / or kidney following administration of vitamin D and finally to offer genetic counseling.

time_perspective: Other

ipd_sharing: Yes

ipd_sharing_description: The data will be communicated to the referent physician of the patient.

lead_sponsor: University Hospital, Caen


title: Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events

acronym: EHPAGE

summary: The Réseau QualiSanté (risk management network) hardly works on risk management in nursing homes. A model to help nursing homes managers to structure and analyze adverse events has been constructed by a working group of health professionals in the Réseau QualiSanté. Several questions appeared: is the model able to increase patient safety culture of professionals working in nursing homes? How to characterize adverse events in nursing homes? How frequent are they? The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The project combines quantitative data (questionnaire) and qualitative data (interviews).

ReferenceCitation: Teigné D, Mabileau G, Anthoine E, Lucas M, Leclère B, Moret L, Terrien N. Transcultural adaptation and psychometric study of the French version of the nursing home survey on patient safety culture questionnaire. BMC Health Serv Res. 2019 Jul 15;19(1):490. doi: 10.1186/s12913-019-4333-5.

family: Teigné

full_name: Delphine Teigné

given: Delphine

family: Mabileau

full_name: Guillaume Mabileau

given: Guillaume

family: Anthoine

full_name: Emmanuelle Anthoine

given: Emmanuelle

family: Lucas

full_name: Marion Lucas

given: Marion

family: Leclère

full_name: Brice Leclère

given: Brice

family: Moret

full_name: Leila Moret

given: Leila

family: Terrien

full_name: Noémie Terrien

given: Noémie

journal_name: BMC Health Services Research

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repositories:
HAL
PubMed Central


title: Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System

acronym: TELE-REHAB

summary:
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.

The feasibility is assessed using the patient's satisfaction and it ease of use.

The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.

ReferenceCitation: Bonnevie T, Gravier FE, Elkins M, Dupuis J, Prieur G, Combret Y, Viacroze C, Debeaumont D, Robleda-Quesada A, Quieffin J, Lamia B, Patout M, Cuvelier A, Muir JF, Medrinal C, Tardif C. People undertaking pulmonary rehabilitation are willing and able to provide accurate data via a remote pulse oximetry system: a multicentre observational study. J Physiother. 2019 Jan;65(1):28-36. doi: 10.1016/j.jphys.2018.11.002. Epub 2018 Dec 17.

apc_source: doaj

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis-Edouard Gravier

given: Francis-Edouard

family: Elkins

full_name: Mark Elkins

given: Mark

family: Dupuis

full_name: Johan Dupuis

given: Johan

family: Prieur

full_name: Guillaume Prieur

family: Combret

full_name: Yann Combret

given: Yann

family: Viacroze

full_name: Catherine Viacroze

given: Catherine

family: Debeaumont

full_name: David Debeaumont

given: David

family: Robleda-Quesada

full_name: Aurora Robleda-Quesada

given: Aurora

family: Quieffin

full_name: Jean Quieffin

given: Jean

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

family: Patout

full_name: Maxime Patout

given: Maxime

family: Cuvelier

full_name: Antoine Cuvelier

given: Antoine

family: Muir

full_name: Jean-François Muir

given: Jean-François

family: Medrinal

full_name: Clement Medrinal

given: Clement

family: Tardif

full_name: Catherine Tardif

currency_apc_doaj: EUR

journal_name: Journal of Physiotherapy

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: ADIR Association


title: Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition

summary: Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS.

location_facility: Service de Neurologie C Hôpital " Pierre Wertheimer "


title: Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study

summary: The goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.

lead_sponsor: St Joseph University, Beirut, Lebanon


title: Study of the Frequency and of the Regulatory Function of Positive T Lymphocytes Dual CD4CD8aa (DP8a) Specific to a Bacteria of the Intestinal Microbiota (Faecalibacterium Prausnitzii) in Atopic Dermatitis, Asthma and Allergic Rhinitis

acronym: Prévall-DP

summary:
The prevalence of allergic diseases (atopic dermatitis, asthma, rhinitis, conjunctivitis and food allergy) has increased dramatically in industrialized countries over the last 20-30 years.

Allergic diseases are present especially in children and young adults, but all age groups are affected, with variations across countries and age. To propose new therapies, the investigators must first understand the physiopathology.

Since their discovery the regulatory T cells have continued to be the subject of work to understand their role in maintaining immune homeostasis in the human body but also their involvement in autoimmune diseases, inflammatory diseases, transplants of solid organs or fluids and allergic diseases.

It was identified two broad classes of regulatory T cells:

T cells = natural regulators acquisition of a phenotype and a regulatory function right out of the thymus ( CD25 + / CD127 + low / FoxP3 +).
T cells induced regulators = acquisition of a phenotype and a regulatory function on the periphery depending on the cytokine micro-environment.

Phenotypic characterization of these is less obvious and even more so than during the last ten years several induced regulatory T cell populations have been described ( eg, Tr1 ).

A new subpopulation of T cells induced in patients with inflammatory bowel disease recently identified have a particular phenotype as bearing the CD4 and CD8 double marking with a regulatory phenotype.

These regulatory T cells are also induced a specific of a commensal intestinal bacterium (Faecalibacterium prausnitzii).

Regarding allergies, it has been widely demonstrated a relationship between changes of the intestinal microbiota and the occurrence of allergic diseases.

The investigators would therefore propose a cross-sectional study, single-center, controlled, single blinded to study the role of T cells called double positive induced regulators DP8 to compare the frequency and the regulatory function of specific DP8 of Faecalibacterium prausnitzii in atopic dermatitis, asthma and allergic rhinitis compared to control samples.


title: Mastectomy in Ambulatory Breast Surgery

acronym: MASTAMBU

summary: This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population

summary:
Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.

We chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.

lead_sponsor: University Hospital, Montpellier


acronym: PSYEDUC

summary:
The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program.

Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the hospital and relating to patients, health and territories.

ReferenceCitation: Misdrahi D, Petit M, Blanc O, Bayle F, Llorca PM. The influence of therapeutic alliance and insight on medication adherence in schizophrenia. Nord J Psychiatry. 2012 Feb;66(1):49-54. doi: 10.3109/08039488.2011.598556. Epub 2011 Aug 10.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux


title: Study of RNA and Heat Shock Protein (HSP) Derived Biomarkers in Radiation-induced Fibrosis in Patients Treated for Breast Cancer.

acronym: SPLICI-Rad

summary: The purpose of this study is to seeking a molecular signature of pathological radiation induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two groups of patients distinguished by their individual radiosensitivity. The signature will integrate recent insights in terms of alternative splicing of mRNAs and level of expression of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each group each expression patterns of candidate HSP proteins potentially predictive of pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on cell culture will be characterized.


title: A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

acronym: REACH

summary: The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.

ReferenceCitation: Tao Y, Aupérin A, Sun X, Sire C, Martin L, Coutte A, Lafond C, Miroir J, Liem X, Rolland F, Even C, Nguyen F, Saada E, Maillard A, Colin-Batailhou N, Thariat J, Guigay J, Bourhis J. Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH). Eur J Cancer. 2020 Dec;141:21-29. doi: 10.1016/j.ejca.2020.09.008. Epub 2020 Oct 24.

family: Tao

full_name: Yungan Tao

given: Yungan

family: Aupérin

full_name: Anne Aupérin

given: Anne

family: Sun

full_name: Xushan Sun

given: Xushan

family: Sire

full_name: Christian Sire

given: Christian

family: Martin

full_name: Laurent Martin

given: Laurent

family: Coutte

full_name: Alexandre Coutte

given: Alexandre

family: Lafond

full_name: Cedrik Lafond

given: Cedrik

family: Miroir

full_name: Jessica Miroir

given: Jessica

family: Liem

full_name: Xavier Liem

given: Xavier

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Even

full_name: Caroline Even

given: Caroline

family: Nguyen

full_name: France Nguyen

given: France

family: Saada

full_name: Esma Saada

given: Esma

family: Maillard

full_name: Aline Maillard

given: Aline

family: Colin-Batailhou

full_name: Natacha Colin-Batailhou

given: Natacha

family: Thariat

full_name: Juliette Thariat

given: Juliette

family: Guigay

full_name: Joël Guigay

given: Joël

family: Bourhis

full_name: Jean Bourhis

journal_name: European Journal of Cancer

evidence: open (via crossref license)

title: Avelumab–cetuximab–radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH)

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou


title: Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone

summary: Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.

ReferenceCitation: Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.

family: Sabourdin

full_name: Nada Sabourdin

given: Nada

family: Meniolle

full_name: Fleur Meniolle

given: Fleur

family: Chemam

full_name: Sarah Chemam

given: Sarah

family: Rigouzzo

full_name: Agnes Rigouzzo

given: Agnes

family: Hamza

full_name: Jamil Hamza

given: Jamil

family: Louvet

full_name: Nicolas Louvet

given: Nicolas

family: Constant

full_name: Isabelle Constant

given: Isabelle

journal_name: Anesthesia & Analgesia

evidence: open (via free article)

lead_sponsor: Hôpital Armand Trousseau

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients

acronym: OptiPOP

summary:
In case of sepsis, the therapeutic success is strongly influenced by the choice of anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is therefore critical to achieve adequate AI concentration as quickly as possible.

This protocol aims to define a common framework to studies conducted jointly by the Antimicrobial Stewardship Team and the Pharmacology department of Cochin hospital for various AI in a range of specific study populations (intensive care unit patients, neutropenic patients…).

These studies will use mathematical modeling methodologies to investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets. The effects of covariates on PK and PD parameters will be investigated to better explain the between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital

acronym: SIC

summary: The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition


acronym: BABY MILK

summary:
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).

lead_sponsor: Institut Pasteur de Lille


title: Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

acronym: GASVERT

summary:
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera


title: Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : "ASA-test. A New Tool for the Screening of Aspirin Treatment")

acronym: FirstAMOS

summary: prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

lead_sponsor: University Hospital, Angers


acronym: TolTwiCare

summary:
The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.

The proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.

The comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.

location_facility: CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale


title: Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.

acronym: EDUCONSULT

summary: To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.


title: Sleep Quality and Risk of Intubation in Intensive Care Units Patients With Hypoxemic Acute Respiratory Failure

acronym: HIGH SLEEP

summary: The aim of the study is to evaluate the impact of sleep quality on intubation rate in intensive care units patients with acute respiratory failure


title: Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

acronym: PEDIACHROII

summary:
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.

The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

ReferenceType: result

ReferenceCitation: Batoz H, Semjen F, Bordes-Demolis M, Bénard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.

family: Batoz

full_name: H Batoz

given: H

family: Semjen

full_name: F Semjen

given: F

family: Bordes-Demolis

full_name: M Bordes-Demolis

given: M

family: Bénard

full_name: A Bénard

given: A

family: Nouette-Gaulain

full_name: K Nouette-Gaulain

given: K

journal_name: British Journal of Anaesthesia

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre hospitalier Universitaire de Bordeaux


title: Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level

acronym: CAPANOX

summary:
The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility.

Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.

lead_sponsor: Centre Hospitalier St Anne


acronym: PHAS

summary:
Proximal hamstring rupture is a rare injury, which may be immediately diagnosed.

In 1996, Sallay showed that functional results of surgical repair were better than those of conservative treatment. Surgery is now the rule. The main aim of this study is to obtain a more detailed and quantified description of the postoperative outcomes.

ReferenceCitation: Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Returning to sports after surgical repair of acute proximal hamstring ruptures. Knee Surg Sports Traumatol Arthrosc. 2013 Mar;21(3):534-9. doi: 10.1007/s00167-012-2204-2. Epub 2012 Sep 13.

family: Lefevre

full_name: N. Lefevre

given: N.

family: Bohu

full_name: Y. Bohu

given: Y.

family: Naouri

full_name: J. F. Naouri

given: J. F.

family: Klouche

full_name: S. Klouche

given: S.

family: Herman

full_name: S. Herman

journal_name: Knee Surgery, Sports Traumatology, Arthroscopy

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Lefevre N, Bohu Y, Klouche S, Herman S. Surgical technique for repair of acute proximal hamstring tears. Orthop Traumatol Surg Res. 2013 Apr;99(2):235-40. doi: 10.1016/j.otsr.2012.05.006. Epub 2012 Aug 25.

journal_name: Orthopaedics & Traumatology: Surgery & Research

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

lead_sponsor: Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport


title: A Phase II Study to Assess the Efficacy of the Anti-PD-L1 Antibody Atezolizumab (MPDL3280A) Administered With Stereotactic Ablative Radiotherapy (SABR) in Patients With Metastatic Tumours

summary:
Although it is usually described as an immunosuppressive modality and not thought of as immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity, which enhances tumour control both locally and distantly. Importantly, IR effects exceed the classical cytocidal properties by also causing phenotypic changes in the fraction of surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination. However, not all IR-induced modifications of the tumour and its microenvironment favor immune rejection. The tumour microenvironment is populated by various types of inhibitory immune cells including Tregs, alternatively activated macrophages, and myeloid-derived suppression cells (MDSCs), which suppress T cell activation and promote tumour outgrowth. Chiang et al. showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia present in irradiated tumours. IR then may also induced responses that are inadequate to maintain antitumuor immunity.

Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for the rational design of combination therapy with immune modulators and radiotherapy. Deng et al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR. Moreover, administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T cell-dependent mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1 synergistically reduced the local accumulation of tumour-infiltrating MDSCs, which suppress T cells and alter the tumour immune microenvironment. Finally, activation of cytotoxic T cells with combination therapy mediated the reduction of MDSCs in tumours through the cytotoxic actions of TNF. Sagiv-Barfi et al, also demonstrated in 5 patients receiving atezolizumab and radiation therapy, at least stabilization of systemic progression in all patients and a RECIST partial response at systemic sites in 1 patient. Transient, grade 1-2 inflammatory adverse events (fevers, flu-like symptoms) occurred with no serious immune-related toxicities. Abscopal out-field effects of irradiation has also been described in addition to a reduction in circulating MDSCs in a melanoma patient treated with the anti CTLA-4 ipilimumab and radiotherapy.

Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for patients with solid tumour, with durable remissions and a low toxicity profile. Many non-randomised studies have shown that SBRT for oligometastases is safe and effective, with local control rates of about 80%. Importantly, these studies also suggest that the natural history of the disease is changing, with 2-5 year progression-free survival of about 20%. For colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates ranged from 67 to 91%. Moreover, abscopal reponses in the setting of immune checkpoints inhibitors and radiotherapy combinations have been made in the setting of metastatic disease event in patients with extensive tumor burden. The goal of SABR is to deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly, the dose and fractionation employed modulate RT ability to synergize with immunotherapy. Vanpouille-Box et al, showed that immune response genes were differentially expressed in irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated SABR acting as a "in situ tumour vaccine".

As hypofractionated SABR may, in addition to its good local control, increase the effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the tolerability of the combination of anti-PD-L1 antibody with SABR.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


acronym: HONEY

summary: The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.

lead_sponsor: Lesaffre International

intervention_type: Dietary Supplement


title: Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago

acronym: IMESCUT

summary: The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.

lead_sponsor: Hopital Foch


title: Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)

acronym: RugbyCom

summary: This study assess the putative persistence of neural damage using resting state fMRI after concussion in rugby player once they have clinically recovered. The hypothesis is that despite a clinical recovery (absence of symptoms; neurological and neuropsychological examination returned to normal) connectivity map obtained using resting state fMRI are significantly different from a group of control subjects.

ReferenceCitation: Smits M, Houston GC, Dippel DW, Wielopolski PA, Vernooij MW, Koudstaal PJ, Hunink MG, van der Lugt A. Microstructural brain injury in post-concussion syndrome after minor head injury. Neuroradiology. 2011 Aug;53(8):553-63. doi: 10.1007/s00234-010-0774-6. Epub 2010 Oct 6.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?

summary: The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and dynamic electromyography recordings, will be studied in children with bilateral spastic cerebral palsy during level walking, and before and after a training on a treadmill with a sloped surface (7°). Data will be compared with those obtained in a sample of typically developing (TD) children (controls)

lead_sponsor: Nantes University Hospital


title: Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.

acronym: UGV

summary: This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)

lead_sponsor: University Hospital, Brest


title: Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints

acronym: COGMED

summary:
Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

The impact of this program on compliance, quality of life, and memory complaints will be evaluated.

The investigator will measure whether there is a correlation between working memory and overall performances.

Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.


title: Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax

summary: The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.

lead_sponsor: Alcon, a Novartis Company


title: A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

summary:
The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.


title: Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

acronym: Echo-CRT

summary: The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

ReferenceCitation: Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Maréchaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.

family: Appert

full_name: Ludovic Appert

given: Ludovic

family: Menet

full_name: Aymeric Menet

given: Aymeric

family: Altes

full_name: Alexandre Altes

given: Alexandre

family: Ennezat

full_name: Pierre Vladimir Ennezat

given: Pierre Vladimir

family: Bardet-Bouchery

full_name: Hélène Bardet-Bouchery

given: Hélène

family: Binda

full_name: Camille Binda

given: Camille

family: Guyomar

full_name: Yves Guyomar

given: Yves

family: Delelis

full_name: François Delelis

given: François

family: Castel

full_name: Anne-Laure Castel

given: Anne-Laure

family: Le Goffic

full_name: Caroline Le Goffic

given: Caroline

family: Guerbaai

full_name: Raphaelle-Ashley Guerbaai

given: Raphaelle-Ashley

family: Graux

full_name: Pierre Graux

given: Pierre

family: Tribouilloy

full_name: Christophe Tribouilloy

given: Christophe

family: Maréchaux

full_name: Sylvestre Maréchaux

given: Sylvestre

journal_name: Canadian Journal of Cardiology

lead_sponsor: Lille Catholic University

location_facility: Hospitals of Lille Catholic University (GHICL)