acronym: TG-MLD

intervention_type: Genetic

title: A Phase I/II, Open Labeled, Monocentric Study of Direct Intracranial Administration of a Replication Deficient Adeno-associated Virus Gene Transfer Vector Serotype rh.10 Expressing the Human ARSA cDNA to Children With Metachromatic Leukodystrophy.

ReferenceCitation: Piguet F, Sondhi D, Piraud M, Fouquet F, Hackett NR, Ahouansou O, Vanier MT, Bieche I, Aubourg P, Crystal RG, Cartier N, Sevin C. Correction of brain oligodendrocytes by AAVrh.10 intracerebral gene therapy in metachromatic leukodystrophy mice. Hum Gene Ther. 2012 Aug;23(8):903-14. doi: 10.1089/hum.2012.015. Epub 2012 Jul 23.

ReferenceCitation: Sondhi D, Johnson L, Purpura K, Monette S, Souweidane MM, Kaplitt MG, Kosofsky B, Yohay K, Ballon D, Dyke J, Kaminksy SM, Hackett NR, Crystal RG. Long-term expression and safety of administration of AAVrh.10hCLN2 to the brain of rats and nonhuman primates for the treatment of late infantile neuronal ceroid lipofuscinosis. Hum Gene Ther Methods. 2012 Oct;23(5):324-35. doi: 10.1089/hgtb.2012.120. Epub 2012 Nov 6.

ReferenceCitation: Colle MA, Piguet F, Bertrand L, Raoul S, Bieche I, Dubreil L, Sloothaak D, Bouquet C, Moullier P, Aubourg P, Cherel Y, Cartier N, Sevin C. Efficient intracerebral delivery of AAV5 vector encoding human ARSA in non-human primate. Hum Mol Genet. 2010 Jan 1;19(1):147-58. doi: 10.1093/hmg/ddp475.

ReferenceCitation: i Dali C, Hanson LG, Barton NW, Fogh J, Nair N, Lund AM. Brain N-acetylaspartate levels correlate with motor function in metachromatic leukodystrophy. Neurology. 2010 Nov 23;75(21):1896-903. doi: 10.1212/WNL.0b013e3181feb217.

ReferenceCitation: Zerah M, Piguet F, Colle MA, Raoul S, Deschamps JY, Deniaud J, Gautier B, Toulgoat F, Bieche I, Laurendeau I, Sondhi D, Souweidane MM, Cartier-Lacave N, Moullier P, Crystal RG, Roujeau T, Sevin C, Aubourg P. Intracerebral Gene Therapy Using AAVrh.10-hARSA Recombinant Vector to Treat Patients with Early-Onset Forms of Metachromatic Leukodystrophy: Preclinical Feasibility and Safety Assessments in Nonhuman Primates. Hum Gene Ther Clin Dev. 2015 Jun;26(2):113-24. doi: 10.1089/humc.2014.139. Epub 2015 Apr 28.

summary:
The objective of this open-label, single arm, monocentric, phase I/II clinical study is to assess safety and efficacy of ARSA gene transfer in the brain of children affected with early onset forms of Metachromatic Leukodystrophy (MLD). For this purpose, an adeno-associated virus serotype rh.10 (AAVrh.10) vector will be used to transfer the ARSA cDNA coding for Arylsulfatase A (ARSA) enzyme into the brain of children. Five patients with early onset form of MLD, age ranging from 6 months to 4 years, will be included in this protocol and will be followed during 24 months.

Patients will be selected at presymptomatic or early stage of their disease, following clinical, neuropsychological and brain imaging criteria.

Twelve simultaneous injections of the investigational medicinal product will be performed in the white matter of both brain hemispheres, through 6 image-guided tracks, with 2 deposits per track.

A low dose (1x10EXP12 vg total) will be administered to the first 2 patients, while the last 3 will receive a higher dose (4x10EXP12 vg total).

Safety and efficiency will be evaluated based on clinical, neuropsychological, radiological, electrophysiological and biological parameters.


type: Registry Identifier

title: Discovery of the Risk Factors Associated to the Development of Vasospasm Following a Sub-arachnoid Aneurismal Hemorrhage Via Genomic Studies Including Genetic and Transcriptomic

summary:
Rational: The main danger with intracranial aneurism is its rupture conjugated with subarachnoid hemorrhage (SAH) occurrence. SAH is a severe pathology leading not only to neurological but also extra cerebral disorders. The major cause of morbidity and mortality when developing a SAH is the secondary development of a delayed cerebral ischemia consecutive to a prolonged vasospasm of cerebral arteries. The understanding of the pathophysiological mechanisms of SAH complication, such as vasospasm which is the more frequent, is essential.

Vasospasm is defined as a reversible shrinking of an artery lumen diameter in the subarachnoid space, beginning generally between 4 and 12 days after the hemorrhage. Such a vasospasm could have a huge clinical impact leading to delayed neurological ischemic deficiency in 17 to 40 % of cases. Up to day, mechanisms involved in vasospasm occurrence are not well described.

Disposing of well-established genetics and transcriptomics databases along with cerebral ischemia and inflammation is essential to unravel the mechanisms leading to vasospasm occurrence on SAH patients. It will enable researchers to better comprehend SAH pathology and elaborate an efficient and individualized therapeutic strategy to SAH acute phase in order to reduce the risk of vasospasm occurrence.

Aims: 1) Constitute DNA and RNA Biobank via blood proofing oh SAH patients 2) Constitute a database grouping clinical and biological data 3) Look for genetic and transcriptomic early markers via genomic approaches 4) Correlate these different markers with vasospasm occurrence and clinical evolution of the patients

Study: Patients inclusion will be done following their admission (D1) in the " unité de réanimation neurochirurgicale" of Pitié-Salpètrière Hospital. After obtaining of the informed consent, blood proofing will be realized daily during 12 days: one daily 2.5ml tube for the transcriptomic study and a single 10ml EDTA tube for genetic analyses. Clinical and biological follow-up will be performed as usual.

200 patients will be initially included during 2 to 3 years for the transcriptomic study of which 1/3 will develop vasospastic complication. The transcriptomic study will thus be performed by comparing patients developing or not developing this complication

Expected Results: Unravel vasospasm early genetic markers.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Pulcrano-Nicolas AS, Proust C, Clarençon F, Jacquens A, Perret C, Roux M, Shotar E, Thibord F, Puybasset L, Garnier S, Degos V, Trégouët DA. Whole-Blood miRNA Sequencing Profiling for Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage. Stroke. 2018 Sep;49(9):2220-2223. doi: 10.1161/STROKEAHA.118.021101.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Neuro-anesthesia intensive care unit, Pitié-Salpétrière hospital

lead_sponsor_type: academique

status_simplified: Completed


title: Non Invasive IDentification of Gliomas With IDH1 Mutation by Free Plasmatic DNA Analysis, 2-hydroxyglutarate Dosage in the Urines and 2-hydroxyglutarate Detection by Brain SPEctro-MRI: Diagnostic and Follow-up Application (IDASPE)

acronym: IDASPE

summary:
The recurrent mutation IDH1Arg132His leads to the cellular accumulation of D-2-hydroxyglutarate (2-HG), thus representing a diagnostic marker (this change is almost specific for gliomas) and prognostic (mutated gliomas have longer survival) of interest.

The main objective is to identify the patients with IDH1 mutated glioma by three complementary approaches -genetic (identification of IDH1 mutation in plasmatic DNA), biochemical (2-HG dosage in the urine of patients) and radiological (2-HG

location_facility: GH Pitié-Salpêtrière, 47 Bd de l'Hopital,


title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.

summary: Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.


title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.

summary: Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.


title: L'Apathie Dans la schizophrénie: étude Neuropsychologique et Anatomique

summary:
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is a core component of negative symptoms. It has been suggested that the physiopathology of apathy is not a single entity but may be multiple, depending on which specific process or macrofunction is disrupted during completion of GDB. In line with this notion, Levy and Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing: 'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been associated with executive dysfunction, functional impairment and poor outcome. However, the neurobiological underpinnings of apathy in schizophrenia are poorly understood.

Primary objective: confirm that chronic schizophrenic patients are apathic compared to healthy volunteers

Secondary objectives:

investigate if apathy is related to a particular aspect of the disease (i.e. negative, positive symptomatology and/or deficit form)
investigate if apathy correlates with executive dysfunction
investigate if apathy is associated with a specific mechanism using an experimental task specially designed to investigate the different mechanism (i.e. 'a-motivation', 'cognitive inertia', and 'uncoupling')
investigate if there is a volumetric abnormality affecting the executive system in apathic schizophrenic patients
link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits according to a specific subtype of apathy in the apathic schizophrenic group

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

enrollment_type: Anticipated

location_facility: INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière

status_simplified: Unknown


title: Methodological Study of Synaptic Plasticity Imaging With Diffusion MRI

summary: Diffusion MRI employed in functional imaging has the potential to probe directly brain activation instead of blood changes like the BOLD technique. The researchers investigated these rapid synaptic plasticity changes with visual activation followed by BOLD and diffusion functional MRI as well as anatomical (venography, tractography by diffusion) features in young and aged subjects.

time_perspective: Retrospective


title: Social Interactions: Ocular Explorations and Pupillometry in Autism

acronym: ISEOP

summary:
The primary objective of this work will first to characterize in typical childhood, visual exploratory behavior and pupillary response associated with salience of human social stimuli (faces and body movements), and then to evaluate these markers in children with autism.

The second objective of this work will be to achieve in a population of children with autism a longitudinal evaluation of these markers during development and therapeutics.


title: Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.

summary:
The purpose of this study is to compare, in healthy women, the adipose tissue composition between abdomen and thigh and then determine whether differences exist independently of the state of obesity.

The findings of this study may help to explain the mechanism contributing to a beneficial role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on cardiovascular and metabolic dysfunctions.

study_type: Interventional

primary_purpose: Basic Science

location_facility: Centre d'Investigation Clinique, CHU Purpan

intervention_type: Procedure


title: Analyse Fonctionnelle Par Imagerie Dynamique de l'épithélium Respiratoire Chez Des Nourrissons Atteints de Mucoviscidose

summary: Cystic fibrosis (CF) is characterized by airway inflammation and infection leading to progressive destruction of lungs. One of the most important abnormalities in CF is an abnormal processing of the mutated CFTR protein through the endoplasmic reticulum that causes abnormal location or even absence of the protein at the apical plasma membrane of airway epithelial cells. This abnormality results in a marked dehydration of the airway surface fluid, decreased mucus transport and airway obstruction. Nevertheless, the events that occur very early during the progression of the disease at the airway level in infants are not known. At cellular level, it has also been reported that the CFTR expression and localization could be related to the differentiation state of the airway epithelium. Furthermore, it has been reported that gap junctions could be involved in dysregulate inflammation process. In CF infants, many answers are still lacking. For a better understanding of the early stages of cystic fibrosis, it is of major interest to study respiratory epithelial cells obtained as early as possible. In 15 CF infants and 15 control infants, a nasal brushing will be performed by means of a soft sterile cytology brush. Samples will be used for cytological and functional studies: ciliary beating frequency, cAMP-dependent chloride efflux, potassium efflux, tight and gap junctions functionalities. These studies will be done in basal conditions and will be repeated after activation of the nasal epithelial cells by the bacteria, such as Staphylococcus aureus, which can be found very early in the course of CF disease.

ReferenceType: result

ReferenceCitation: Mosler K, Coraux C, Fragaki K, Zahm JM, Bajolet O, Bessaci-Kabouya K, Puchelle E, Abély M, Mauran P. Feasibility of nasal epithelial brushing for the study of airway epithelial functions in CF infants. J Cyst Fibros. 2008 Jan;7(1):44-53. Epub 2007 Jun 5.


title: Spatio-temporal Dynamic of the Relationship Between Spatial Attention and Visual Awareness

summary:
The tight relationship between attention and conscious perception makes them difficult to study in isolation and has led many scientists to closely link these two processes. However, while some authors argue that conscious perception cannot occurs without attention, magnetoencephalography (MEG) and fMRI studies had shown that attention and consciousness are two distinct brain processes.

If endogenously triggered attention and consciousness are dissociated, it has been proposed that orienting of exogenous attention is a necessary, though not sufficient, antecedent of conscious perception.

In the present study we used MEG to explore the neural correlates of exogenous attention and consciousness during visual processing.


title: Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.

acronym: ELECTRE

summary: The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.

design_allocation: Randomized

location_facility: Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière

intervention_type: Device


type: EudraCT Number

title: Evaluation de la Spironolactone Dans le Traitement Des choriorétinites séreuses Centrales Non résolutives à Trois Mois

summary:
The objective of the study is to evaluate the effect of spironolactone on 16 patients presenting with chronic non-resolutive central serous chorioretinitis (CSCR) and to evaluate whether spironolactone can resolve sub retinal fluid in these patients.

CSCR is a major cause of visual loss in the young population. It is characterized by sub retinal fluid under the retina and retinal pigment epithelial detachments. The exact causes of the disease remain unknown but a choroidopathy has been suggested. Moreover, corticotherapy and stress are known risk factors of CSCR.

Our preclinical studies have demonstrated that the mineralocorticoid pathway could be involved in the control of choroidal blood flow.

The investigators propose to evaluate the mineralocorticoid receptors antagonist spironolactone in the treatment of CSCR.

Criteria of efficacy Endpoint: reduction of subretinal fluid ≥ 40 microns Secondary endpoint: visual acuity gain ≥ 15 EDTRS letters

primary_purpose: Treatment

intervention_type: Drug


title: Observational, Follow-up Study of Adaptive Optics Retinal Imaging in Controls and During Retinal or General Diseases

acronym: iPhot

summary: Using an adaptive optics imaging device, retinal structures are observed in healthy and diseased subjects.

ReferenceCitation: Paques M, Meimon S, Rossant F, Rosenbaum D, Mrejen S, Sennlaub F, Grieve K. Adaptive optics ophthalmoscopy: Application to age-related macular degeneration and vascular diseases. Prog Retin Eye Res. 2018 Sep;66:1-16. doi: 10.1016/j.preteyeres.2018.07.001. Epub 2018 Jul 17. Review.

ReferenceCitation: Miloudi C, Rossant F, Bloch I, Chaumette C, Leseigneur A, Sahel JA, Meimon S, Mrejen S, Paques M. The Negative Cone Mosaic: A New Manifestation of the Optical Stiles-Crawford Effect in Normal Eyes. Invest Ophthalmol Vis Sci. 2015 Nov;56(12):7043-50. doi: 10.1167/iovs.15-17022.

ReferenceCitation: Jacob J, Krivosic V, Paques M, Tadayoni R, Gaudric A. CONE DENSITY LOSS ON ADAPTIVE OPTICS IN EARLY MACULAR TELANGIECTASIA TYPE 2. Retina. 2016 Mar;36(3):545-51. doi: 10.1097/IAE.0000000000000737.

ReferenceCitation: Paques M, Miloudi C, Kulcsar C, Leseigneur A, Chaumette C, Koch E. High-resolution imaging of gunn's dots. Retina. 2015 Jan;35(1):120-4. doi: 10.1097/IAE.0000000000000269.

ReferenceCitation: Errera MH, Coisy S, Fardeau C, Sahel JA, Kallel S, Westcott M, Bodaghi B, Paques M. Retinal vasculitis imaging by adaptive optics. Ophthalmology. 2014 Jun;121(6):1311-2.e2. doi: 10.1016/j.ophtha.2013.12.036. Epub 2014 Feb 25.

ReferenceCitation: Koch E, Rosenbaum D, Brolly A, Sahel JA, Chaumet-Riffaud P, Girerd X, Rossant F, Paques M. Morphometric analysis of small arteries in the human retina using adaptive optics imaging: relationship with blood pressure and focal vascular changes. J Hypertens. 2014 Apr;32(4):890-8. doi: 10.1097/HJH.0000000000000095.

ReferenceCitation: Gocho K, Sarda V, Falah S, Sahel JA, Sennlaub F, Benchaboune M, Ullern M, Paques M. Adaptive optics imaging of geographic atrophy. Invest Ophthalmol Vis Sci. 2013 May 1;54(5):3673-80. doi: 10.1167/iovs.12-10672.


title: Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.

summary: Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Athanasiou A, Tardivon A, Tanter M, Sigal-Zafrani B, Bercoff J, Deffieux T, Gennisson JL, Fink M, Neuenschwander S. Breast lesions: quantitative elastography with supersonic shear imaging--preliminary results. Radiology. 2010 Jul;256(1):297-303. doi: 10.1148/radiol.10090385. Epub 2010 May 26.


title: Accelerated Aging of the Cells of Visceral Adipose Tissue in Morbid Obese Subjects: Involvement in Diseases Associated With Obesity (Viellissement accéléré Des Cellules du Tissu Adipeux viscéral Chez Les obèses Morbides: Implication Dans Les Pathologies associées à l'obésité)

acronym: SENAPID

summary:
Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases.

The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells).

This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.


title: Evaluation de l'efficacité de la Galantamine Versus Placebo associée à Une Revalidation Neuropsychologique Chez Des Patients présentant un Trouble Cognitif après un Premier Infarctus cérébral : étude en Neuroimagerie Fonctionnelle

acronym: COGICRehab

summary:
The investigators would like to conduct a double blind placebo-controlled prospective study to show the impact of a treatment combining a specific cognitive rehabilitation program and acetylcholinesterase inhibitors on executive function of young patients 3 months after a first symptomatic stroke. The secondary objectives will be to assess cognitive changes performance (executive but also non trained functions such as memory) before and after treatments and treatment effect on activity of daily living and on quality of life.

The main objective of this study is to show the impact of this combined treatment on brain activation maps in VCI-ND patients in the post-acute phase (3 months) after a stroke. Treatment effect will be assessed by functional MRI (fMRI) while patients will be performing a specific executive task.

The investigators hypothesize that the specific rehabilitation associated with acetylcholinestrase inhibitors treatment will focalize cerebral activation observed in fMRI, improve executive functions specifically, improve non trained cognitive functions (generalization effect).

location_facility: Service de Neurologie, CHU Toulouse Purpan


title: EG-VEGF (Endocrine Gland-derived Vascular Endothelial Growth Factor) in Normal and Pathological Pregnancies: Potential Marker of Pre-eclampsia and / or Intrauterine Growth Restriction

acronym: EGEVE

summary: The purpose of this study is to assess the potential prognostic value of seric concentrations of EG-VEGF for Pre-eclampsia and/or intrauterine growth restriction and will allow checking whether plasma levels of EG-VEGF at 14-18 weeks of gestation could be proposed as prognostic marker for preeclampsia.

primary_purpose: Other

ReferenceCitation: Hoffmann P, Feige JJ, Alfaidy N. Placental expression of EG-VEGF and its receptors PKR1 (prokineticin receptor-1) and PKR2 throughout mouse gestation. Placenta. 2007 Oct;28(10):1049-58. Epub 2007 May 25.

ReferenceCitation: Hoffmann P, Feige JJ, Alfaidy N. Expression and oxygen regulation of endocrine gland-derived vascular endothelial growth factor/prokineticin-1 and its receptors in human placenta during early pregnancy. Endocrinology. 2006 Apr;147(4):1675-84. Epub 2005 Dec 29.

ReferenceCitation: Hoffmann P, Saoudi Y, Benharouga M, Graham CH, Schaal JP, Mazouni C, Feige JJ, Alfaidy N. Role of EG-VEGF in human placentation: Physiological and pathological implications. J Cell Mol Med. 2009 Aug;13(8B):2224-2235. doi: 10.1111/j.1582-4934.2008.00554.x.

location_facility: Clinical investigation center of the Grenoble University Hospital

intervention_type: Other


status: Terminated

primary_purpose: Prevention

acronym: EVAD

intervention_type: Biological

title: Randomised, Multicentric, Phase ii Study of the Immunogenicity of a "Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency

source: euctr

location_facility: Service d'Immunologie Clinique Hôpital Henri Mondor

summary: The main objective of this study is to evaluate and to compare the specific antibody response to a " prime-boost " vaccine strategy combining the seven valence pneumococcal conjugate vaccine (PnCj) prime at W0 followed by the administration of the pneumococcal capsular polysaccharide vaccine (PPS) boost at W4, to the administration of the pneumococcal capsular polysaccharide vaccine (PPS) alone at W4 in patients with common variable immunodeficiency.


title: Effect of Curcumin on Iron Metabolism in Healthy Volunteer

acronym: CURHEP

summary: The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.

ReferenceCitation: Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Détivaud L, Leroyer P, Brissot P, Loréal O. Natural and synthetic STAT3 inhibitors reduce hepcidin expression in differentiated mouse hepatocytes expressing the active phosphorylated STAT3 form. J Mol Med (Berl). 2010 May;88(5):477-86. doi: 10.1007/s00109-009-0588-3. Epub 2010 Feb 19.

ReferenceCitation: Loréal O, Haziza-Pigeon C, Troadec MB, Detivaud L, Turlin B, Courselaud B, Ilyin G, Brissot P. Hepcidin in iron metabolism. Curr Protein Pept Sci. 2005 Jun;6(3):279-91. Review.

ReferenceCitation: Verga Falzacappa MV, Vujic Spasic M, Kessler R, Stolte J, Hentze MW, Muckenthaler MU. STAT3 mediates hepatic hepcidin expression and its inflammatory stimulation. Blood. 2007 Jan 1;109(1):353-8. Epub 2006 Aug 31.

ReferenceCitation: Sharma RA, Euden SA, Platton SL, Cooke DN, Shafayat A, Hewitt HR, Marczylo TH, Morgan B, Hemingway D, Plummer SM, Pirmohamed M, Gescher AJ, Steward WP. Phase I clinical trial of oral curcumin: biomarkers of systemic activity and compliance. Clin Cancer Res. 2004 Oct 15;10(20):6847-54.

ReferenceCitation: Vareed SK, Kakarala M, Ruffin MT, Crowell JA, Normolle DP, Djuric Z, Brenner DE. Pharmacokinetics of curcumin conjugate metabolites in healthy human subjects. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1411-7. doi: 10.1158/1055-9965.EPI-07-2693.

location_facility: Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou


title: Evaluation and Comparison of Cerebral Activities Modifications Associated With Two Different Cognitive and Behavioral Therapies for Obsessive Compulsive Disorder Patients

acronym: TOC TOC

summary:
Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and compulsions are the two manifestations of this disease. Obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety.

OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops.

Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference treatments : medication and Cognitive and Behavioral Therapy (CBT).

Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They are randomised in two groups : one proposing a "reference CBT", the other associate CBT to a new psychopedagogic task developed by the investigators team.

Clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity, patients and relatives quality of life are also assessed.

design_allocation: Non-Randomized

intervention_type: Behavioral


title: Structural and Functional Connectivity in Partial Epilepsies Studied With MRI and MEG

summary:
Surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies.

SEEG is considered the criterion standard to localize the epileptogenic zone (EZ) but the procedure is risky with a limited spatial sampling. The development of non-invasive neuroimaging alternatives is thus an important goal to improve EZ delineation and optimize SEEG procedures.

The main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. The investigators wish to explore this network using diffusion tensor MRI to study structural connectivity and MEG/FMRI to study functional connectivity. The investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process.

The investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.

ReferenceCitation: Chavez M, Valencia M, Navarro V, Latora V, Martinerie J. Functional modularity of background activities in normal and epileptic brain networks. Phys Rev Lett. 2010 Mar 19;104(11):118701. Epub 2010 Mar 18.


title: Long-term Outcome and Lung Capacity in Survivors of ARDS Due to Influenza A (H1N1) v2009 The RESPIFLU Study

acronym: RESPIFLU

summary:
Influenza A (H1N1) v2009 infection was responsible throughout the world of viral pneumonia and severe pulmonary edema requiring rescue therapeutics such as extracorporeal oxygenation. To date, no data exist on the outcome of patients having developed acute respiratory distress syndrome (ARDS) due to influenza A (H1N1) v2009, and in particular in patients with very severe lung injury requiring extracorporeal oxygenation. Although data exist on long-term outcome of survivors of ARDS, the patients included in the observational studies were heterogeneous with various underlying disease. Moreover, no study compared the outcome of survivors of ARDS according to the need or not of extracorporeal oxygenation. We therefore conducted this prospective case-control study to compare the long term pulmonary and extra pulmonary function in 2 groups of patients, one with severe ARDS due to H1N1 requiring extracorporeal oxygenation (case), and the second with ARDS due to H1N1 but without need for extracorporeal oxygenation (control). Eighteen case patients with inclusion and without non-inclusion criteria were selected from our national registry, and 32 controls (with inclusion and exclusion criteria) were matched on age, sex, and body mass index. All 48 patients will be contacted and asked to participate. Patients will be evaluate at least 9 months after ICU discharge, looking for health-related quality of life, measured by the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), post traumatic stress disorder, assessed by the Impact of Event Scale Anxiety, and depression, assessed by the Hospital and Depression Score. Pulmonary function testing, including VO2 max test on a static bike will be performed. Muscle weakness will be clinically evaluated by the medical council research (MRC) test, with an additional electromyography if the result of the test was <48/60. A CT-scan will be performed, looking for lung abnormalities (fibrosis...). Albumin and prealbumin will be measured to evaluate the nutritional status.

Primary outcome measurement is carbon monoxide diffusion capacity. The primary hypothesis is that patients with extracorporeal oxygenation will have a carbon monoxide diffusion capacity lower than patients without extracorporeal oxygenation (15% difference between groups). Inclusion of 13 patients in the case group and 26 patients in the control group will allow testing this hypothesis with a statistical power of 80% (standard deviation 15%). Secondary outcome measures will be the quality of life, the presence or not of post-traumatic stress disorders, of anxiety and/or depression, the results of pulmonary function testing, of the CT-scan, and of muscle testing. All results will be compared in patients with and without extracorporeal oxygenation.

ReferenceCitation: Luyt CE, Combes A, Becquemin MH, Beigelman-Aubry C, Hatem S, Brun AL, Zraik N, Carrat F, Grenier PA, Richard JM, Mercat A, Brochard L, Brun-Buisson C, Chastre J; REVA Study Group. Long-term outcomes of pandemic 2009 influenza A(H1N1)-associated severe ARDS. Chest. 2012 Sep;142(3):583-592. doi: 10.1378/chest.11-2196.


title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island

summary: Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.

ReferenceCitation: Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Régnier C, Boyer MC, Cogne M, Bakiri F, Schwager JC, Favier F. Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island. Diabetes Metab. 2012 Feb;38(1):46-53. doi: 10.1016/j.diabet.2011.07.002. Epub 2011 Oct 24.


title: Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile

summary: The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.


type: Other Identifier

title: Intracavernous Bone Marrow Stem-cell Injection for Post Prostatectomy Erectile Dysfunction

acronym: INSTIN

summary:
Erectile dysfunction is a frequent adverse event after radical prostatectomy for prostate cancer.

It is the consequence of penile vascular damage, mainly arterial insufficiency and venous leakage associated with fibrosis of the corpus cavernous. Apoptosis of penile cells, including mesenchymal cells, smooth muscle cells and endothelial is believed to play an important role in the pathophysiology of post prostatectomy erectile dysfunction.

Bone marrow mononucleated cells (BMMNC) contain different cell types that may replace the damaged penile cells after radical prostatectomy. These are mainly: mesenchymal stem cells, endothelial progenitor cells and hematopoietic stem cell. Intracavernous injection of BMMNC may therefore find application in the treatment of post prostatectomy erectile dysfunction.

The aims of this phase I-II study is to test the safety of autologous intracavernous BMMNC injection and to evaluate benefit for the patient concerning recovery of natural erection. Patients with penile vascular abnormality (echo-doppler) and localized prostate cancer (considered as cured by radical prostatectomy) will be included in this study.

Four different doses of BMMNC will be tested.

ReferenceCitation: Yiou R, Hamidou L, Birebent B, Bitari D, Le Corvoisier P, Contremoulins I, Rodriguez AM, Augustin D, Roudot-Thoraval F, de la Taille A, Rouard H. Intracavernous Injections of Bone Marrow Mononucleated Cells for Postradical Prostatectomy Erectile Dysfunction: Final Results of the INSTIN Clinical Trial. Eur Urol Focus. 2017 Dec;3(6):643-645. doi: 10.1016/j.euf.2017.06.009. Epub 2017 Jun 24.

ReferenceCitation: Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871.

location_facility: CHU Henri Mondor-Albert Chenevier-Centre Intercommunal de Créteil


title: High Field MR Imaging (7T and 3T) of the Brainstem, the Deep Nuclei and Their Connections in the Parkinsonian Syndromes. Applications to Prognosis, Pathophysiology and Improvement of Therapeutic Strategies

acronym: Nucleipark

summary:
To date except for the larger striato-pallidal complex, there are no reliable imaging markers of small deep nuclei. Major improvement of the spatial resolution resulting from the use of ultra-high field MRI systems offers new perspectives of imaging of these deep structures.

We will use the new contrast mechanisms available in data acquired with ultra-high field MR systems (7T) as well as the most recent high angular diffusion imaging techniques in order to characterize the cytoarchitectonics of the deep brain structures and brainstem lesions in parkinsonian syndromes (with special interest in substantia nigra (SN) pathology and nigro-striatal fiber pathways; subthalamic nucleus (STN), red nucleus (RN), oculomotor structures (involved in PSP); pedonculo-pontine nucleus (involved in gait and posture control disorders) and the locus sub-coeruleus area (implicated in sleep disorders) The optimized MR sequences at 7T will be adapted and validated at 3T (on a more clinically oriented MRI approach).

The clinical goal of the project (via the characterization of deep brain structures) is the detection of new neuroimaging markers of neuronal lesions in PD. These biomarkers will be used to create a diagnostic tool at early stage of the disease that could be correlated to clinical signs such as gait disorders and help to identify predictive factors. In addition, this could contribute to establish an adequate therapeutic strategy (as for example with deep brain stimulation).


title: Effect of a Receptor Antagonist of Endothelin 1 (Sitaxsentan, Thelin) on Bronchial Remodeling in Severe Asthma With Fixed Bronchial Obstruction

acronym: Sitax

summary:
Introduction. Despite adequate steroid therapy, a subpopulation of approximately 10% of asthmatics develops severe persistent airflow obstruction. It is now widely agreed that the latter is the consequence of a remodeling process of the airways, characterized by an increase in airway smooth muscle mass, mucus gland hypertrophy, increased thickness of the subepithelial basement membrane, extracellular matrix protein deposition, angiogenesis, fibroblast and myofibroblast accumulation. These phenomena are responsible for airway wall thickening and for decreased airway caliber leading to persistent airflow obstruction.

Endothelin-1 (ET-1) is a small peptide, synthesized in the lung by airway epithelial and smooth muscle cells, as well as inflammatory cells. ET-1 induces bronchoconstriction, mediates eosinophils recruitment during allergic inflammation and contributes to airway remodeling by inducing fibroblasts and smooth muscle cells differentiation and proliferation. In a recent work from Inserm Unit 700, it has been shown that ET-1 was overexpressed in epithelial cells from severe asthmatic patients as compared to patients with less severe disease, and that ET-1 expression was strongly correlated with airway obstruction (measured by FEV1) and on bronchial biopsies with airway smooth muscle areas. In another study, we have shown that a polymorphism of the receptor for ET-1 was strongly associated with the degree of airway obstruction in a population of asthmatic patients. All these data suggest that inhibition of the ET-1 pathway could be a potential therapeutic option in patients with steroids refractory asthma and irreversible airway obstruction. Bosentan, a specific inhibitor of ET-1 receptors which is actually used in patients with pulmonary hypertension, improves survival and inhibits vascular remodeling.

Aim and strategy. To study the impact on airway remodeling and clinical status of an antagonist of the endothelin receptors (Sitaxentan 100mg/day) over a 12-month period, in a prospective randomised placebo-controlled trial involving two parallel groups of 25 severe asthmatic patients with irreversible airflow obstruction (FEV1≤ 70% of predicted) . Various hallmarks of airway remodeling will be analyzed on bronchial biopsy specimens by immunohistochemistry and morphometry. These findings will be correlated with the results of pulmonary function tests. Twenty-five patients will be included in each group. Remodeling will be measured on bronchial biopsies performed during fiberoptic bronchoscopy at inclusion and after one year, by assessing smooth muscle area, submucosal fibroblasts count and basement membrane thickness. Every 3 months, bronchial obstruction (FEV1), clinical status, asthma exacerbations, steroids use, need for emergency care, asthma symptoms and quality of life will be assessed. Evaluation of airway inflammation will be assessed every 3 months by exhaled NO and induced sputum cytology.

This proof of concept study will validate ET-1 as a new molecular target for treating airway remodeling in patients with severe asthma.

location_facility: Clinical Investigation center 07, Hopital Bichat


title: Prospective Study of Individuals at Risk for Spinocerebellar Ataxia Type 1, Type 2, Type 3, Type 6 and Type 7 (SCA1, SCA2, SCA3, SCA6, SCA7)

acronym: RISCA

summary:
The spinocerebellar ataxias (SCAs) are a clinically and genetically heterogeneous group of autosomal dominantly inherited progressive ataxia disorders. It is estimated that there are 30,000 individuals in the European Community that directly descend from individuals affected by a SCA disorder and thus carry a 50% risk of having inherited an SCA mutation. These at risk individuals provide a unique research opportunity to prospectively study the presymptomatic phase of SCA disorders and to identify the earliest and most sensitive clinical signs and biological markers that herald the onset of the illness. This information is of critical importance for the development of future therapeutic interventions aimed at postponing the clinical onset of ataxia.

We therefore propose to perform a prospective observational study of individuals at risk for the most common SCA disorders, SCA1, SCA2, SCA3 and SCA6 (RISCA). It is our aim to answer the following questions: (1) What is the incidence of disease manifestation in mutation carriers? (2) Which clinical signs precede the onset of manifest ataxia in SCA1, SCA2, SCA3 and SCA6? (3) What are the prevalence and incidence of preceding signs? (4) Are the prevalence and incidence of preceding signs affected by genotype, gender, age, estimated time until disease manifestation and repeat length? (5) Does the presence of certain preceding signs predict the manifestation of ataxia ? (6) Are there MRI alterations that precede the onset of ataxia? It is planned to enroll 480 study participants and to follow them at regular intervals over six years. At each visit, study participants are asked in a structured interview for a number of predefined clinical signs that potentially precede the onset of ataxia. In addition, the following self-assessment scales will be applied: Pittsburgh Sleep Quality Index (PSQI), Diagnostic Criteria for Restless Legs Syndrome, Patient´s Health Questionnaire (PHQ-9). All study participants will undergo a physical examination including the Scale for the Assessment and Rating of Ataxia (SARA). Study participants will further perform the SCA Functional Composite (SCA-FC) which is a comprehensive measure of functional capacity based on results in quantitative tests related to gait (8m timed walk), speech (PATA rate) and hand function (9 hole pegboard). In a subset of study participants, we will record eye movements and obtain volumetric MRIs. The study will also be used to collect and store blood and urine samples for proteomic and gene expression studies.

RISCA is conducted by the Ataxia Study Group (ASG). It relies on the network structure created by the EUROSCA project.

ReferenceCitation: Wilke C, Mengel D, Schöls L, Hengel H, Rakowicz M, Klockgether T, Durr A, Filla A, Melegh B, Schüle R, Reetz K, Jacobi H, Synofzik M. Levels of Neurofilament Light at the Preataxic and Ataxic Stages of Spinocerebellar Ataxia Type 1. Neurology. 2022 May 17;98(20):e1985-e1996. doi: 10.1212/WNL.0000000000200257. Epub 2022 Mar 9.

ReferenceCitation: Jacobi H, du Montcel ST, Romanzetti S, Harmuth F, Mariotti C, Nanetti L, Rakowicz M, Makowicz G, Durr A, Monin ML, Filla A, Roca A, Schöls L, Hengel H, Infante J, Kang JS, Timmann D, Casali C, Masciullo M, Baliko L, Melegh B, Nachbauer W, Bürk-Gergs K, Schulz JB, Riess O, Reetz K, Klockgether T. Conversion of individuals at risk for spinocerebellar ataxia types 1, 2, 3, and 6 to manifest ataxia (RISCA): a longitudinal cohort study. Lancet Neurol. 2020 Sep;19(9):738-747. doi: 10.1016/S1474-4422(20)30235-0.

ReferenceCitation: Tezenas du Montcel S, Durr A, Rakowicz M, Nanetti L, Charles P, Sulek A, Mariotti C, Rola R, Schols L, Bauer P, Dufaure-Garé I, Jacobi H, Forlani S, Schmitz-Hübsch T, Filla A, Timmann D, van de Warrenburg BP, Marelli C, Kang JS, Giunti P, Cook A, Baliko L, Melegh B, Boesch S, Szymanski S, Berciano J, Infante J, Buerk K, Masciullo M, Di Fabio R, Depondt C, Ratka S, Stevanin G, Klockgether T, Brice A, Golmard JL. Prediction of the age at onset in spinocerebellar ataxia type 1, 2, 3 and 6. J Med Genet. 2014 Jul;51(7):479-86. doi: 10.1136/jmedgenet-2013-102200. Epub 2014 Apr 29. Erratum in: J Med Genet. 2014 Sep;51(9):613. Bela, Melegh [corrected to Melegh, Béla].

ReferenceCitation: Jacobi H, Reetz K, du Montcel ST, Bauer P, Mariotti C, Nanetti L, Rakowicz M, Sulek A, Durr A, Charles P, Filla A, Antenora A, Schöls L, Schicks J, Infante J, Kang JS, Timmann D, Di Fabio R, Masciullo M, Baliko L, Melegh B, Boesch S, Bürk K, Peltz A, Schulz JB, Dufaure-Garé I, Klockgether T. Biological and clinical characteristics of individuals at risk for spinocerebellar ataxia types 1, 2, 3, and 6 in the longitudinal RISCA study: analysis of baseline data. Lancet Neurol. 2013 Jul;12(7):650-8. doi: 10.1016/S1474-4422(13)70104-2. Epub 2013 May 22. Erratum in: Lancet Neurol. 2013 Jul;12(7):630.


title: Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction

acronym: IBLOMAVED

summary: The diagnosis of asymptomatic left ventricular dysfunction is difficult in general practice since it requires transthoracic cardiac echocardiography that is generally performed in specialized services. Although blood BNP levels monitoring can be of some help in heart failure diagnosis is is mostly a late biomarker that is secreted upon heart stretch and has many limitations. Therefore the aim of this study is to identify new specific blood biomarkers that would help for asymptomatic left ventricular dysfunction diagnosis in large populations with cardiovascular risk.

ReferenceCitation: Koukoui F, Desmoulin F, Galinier M, Barutaut M, Caubère C, Evaristi MF, Murat G, De Boer R, Berry M, Smih F, Rouet P. The prognostic value of plasma galectin-3 in chronic heart failure patients is maintained when treated with mineralocorticoid receptor antagonists. PLoS One. 2015 Mar 18;10(3):e0119160. doi: 10.1371/journal.pone.0119160. eCollection 2015.

location_facility: Hospital from Toulouse Rangueil, Pr Galinier department (Cardiology A)


title: Specific Vaccine Therapy in Chronic Hepatitis B Using a Naked DNA: Phase I Study Using a GMO

summary: The purpose of this study was to investigate whether HBV-DNA vaccination is safe and could restore immune responses in patients with chronic hepatitis B non responder to available therapies.

ReferenceCitation: Mancini-Bourgine M, Fontaine H, Scott-Algara D, Pol S, Bréchot C, Michel ML. Induction or expansion of T-cell responses by a hepatitis B DNA vaccine administered to chronic HBV carriers. Hepatology. 2004 Oct;40(4):874-82.

ReferenceCitation: Mancini-Bourgine M, Fontaine H, Bréchot C, Pol S, Michel ML. Immunogenicity of a hepatitis B DNA vaccine administered to chronic HBV carriers. Vaccine. 2006 May 22;24(21):4482-9. Epub 2005 Aug 18.

ReferenceCitation: Scott-Algara D, Mancini-Bourgine M, Fontaine H, Pol S, Michel ML. Changes to the natural killer cell repertoire after therapeutic hepatitis B DNA vaccination. PLoS One. 2010 Jan 18;5(1):e8761. doi: 10.1371/journal.pone.0008761.

location_facility: Service d'Hepatologie, Hopital Necker Enfants Malades


title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

summary: The aim of this study is to compare two different preparation

ReferenceCitation: Lyrenäs S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78.

ReferenceCitation: Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5.

ReferenceCitation: El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30.

location_facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital


title: The SU.VI.MAX Study. A Randomized, Placebo-controlled Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.

summary: It has been suggested that a low dietary intake of antioxidant vitamins and minerals increases the incidence rate of cardiovascular disease and cancer. To date, however, the published results of randomized, placebo-controlled trials of supplements containing antioxidant nutrients have not provided clear evidence of a beneficial effect. We tested the efficacy of nutritional doses of supplementation with a combination of antioxidant vitamins and minerals in reducing the incidence of cancer and ischemic cardiovascular disease in the general population.

ReferenceCitation: Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, Roussel AM, Favier A, Briançon S. The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals. Arch Intern Med. 2004 Nov 22;164(21):2335-42. Erratum in: Arch Intern Med. 2005 Feb 14;165(3):286.

ReferenceCitation: Andreeva VA, Péneau S, Julia C, Shivappa N, Hébert JR, Wirth MD, Touvier M, Hercberg S, Galan P, Kesse-Guyot E. The inflammatory potential of the diet is prospectively associated with subjective hearing loss. Eur J Nutr. 2021 Oct;60(7):3669-3678. doi: 10.1007/s00394-021-02531-1. Epub 2021 Mar 18.

ReferenceCitation: Lécuyer L, Dalle C, Micheau P, Pétéra M, Centeno D, Lyan B, Lagree M, Galan P, Hercberg S, Rossary A, Demidem A, Vasson MP, Partula V, Deschasaux M, Srour B, Latino-Martel P, Druesne-Pecollo N, Kesse-Guyot E, Durand S, Pujos-Guillot E, Manach C, Touvier M. Untargeted plasma metabolomic profiles associated with overall diet in women from the SU.VI.MAX cohort. Eur J Nutr. 2020 Dec;59(8):3425-3439. doi: 10.1007/s00394-020-02177-5. Epub 2020 Jan 11.

ReferenceCitation: Lécuyer L, Dalle C, Lyan B, Demidem A, Rossary A, Vasson MP, Petera M, Lagree M, Ferreira T, Centeno D, Galan P, Hercberg S, Deschasaux M, Partula V, Srour B, Latino-Martel P, Kesse-Guyot E, Druesne-Pecollo N, Durand S, Pujos-Guillot E, Touvier M. Plasma Metabolomic Signatures Associated with Long-term Breast Cancer Risk in the SU.VI.MAX Prospective Cohort. Cancer Epidemiol Biomarkers Prev. 2019 Aug;28(8):1300-1307. doi: 10.1158/1055-9965.EPI-19-0154. Epub 2019 Jun 4.

ReferenceCitation: Assmann KE, Adjibade M, Hercberg S, Galan P, Kesse-Guyot E. Unsaturated Fatty Acid Intakes During Midlife Are Positively Associated with Later Cognitive Function in Older Adults with Modulating Effects of Antioxidant Supplementation. J Nutr. 2018 Dec 1;148(12):1938-1945. doi: 10.1093/jn/nxy206.

ReferenceCitation: Wiernik E, Lemogne C, Fezeu L, Arnault N, Hercberg S, Kesse-Guyot E, Galan P. Association Between Alexithymia and Risk of Incident Cardiovascular Diseases in the SUpplémentation en VItamines et Minéraux AntioXydants (SU.VI.MAX) Cohort. Psychosom Med. 2018 Jun;80(5):460-467. doi: 10.1097/PSY.0000000000000592.

ReferenceCitation: Assmann KE, Adjibade M, Shivappa N, Hébert JR, Wirth MD, Touvier M, Akbaraly T, Hercberg S, Galan P, Julia C, Kesse-Guyot E. The Inflammatory Potential of the Diet at Midlife Is Associated with Later Healthy Aging in French Adults. J Nutr. 2018 Mar 1;148(3):437-444. doi: 10.1093/jn/nxx061.

ReferenceCitation: Ruhunuhewa I, Adjibade M, Andreeva VA, Galan P, Hercberg S, Assmann KE, Kesse-Guyot E. Prospective association between body mass index at midlife and healthy aging among French adults. Obesity (Silver Spring). 2017 Jul;25(7):1254-1262. doi: 10.1002/oby.21853. Epub 2017 May 11.

ReferenceCitation: Adjibade M, Andreeva VA, Lemogne C, Touvier M, Shivappa N, Hébert JR, Wirth MD, Hercberg S, Galan P, Julia C, Assmann KE, Kesse-Guyot E. The Inflammatory Potential of the Diet Is Associated with Depressive Symptoms in Different Subgroups of the General Population. J Nutr. 2017 May;147(5):879-887. doi: 10.3945/jn.116.245167. Epub 2017 Mar 29.

ReferenceCitation: Walker V, Perret-Guillaume C, Kesse-Guyot E, Agrinier N, Hercberg S, Galan P, Assmann KE, Briançon S, Rotonda C. Effect of Multimorbidity on Health-Related Quality of Life in Adults Aged 55 Years or Older: Results from the SU.VI.MAX 2 Cohort. PLoS One. 2016 Dec 29;11(12):e0169282. doi: 10.1371/journal.pone.0169282. eCollection 2016.

ReferenceCitation: Kesse-Guyot E, Assmann KE, Andreeva VA, Touvier M, Neufcourt L, Shivappa N, Hébert JR, Wirth MD, Hercberg S, Galan P, Julia C. Long-term association between the dietary inflammatory index and cognitive functioning: findings from the SU.VI.MAX study. Eur J Nutr. 2017 Jun;56(4):1647-1655. doi: 10.1007/s00394-016-1211-3. Epub 2016 Apr 7.

ReferenceCitation: Adriouch S, Julia C, Kesse-Guyot E, Méjean C, Ducrot P, Péneau S, Donnenfeld M, Deschasaux M, Menai M, Hercberg S, Touvier M, Fezeu LK. Prospective association between a dietary quality index based on a nutrient profiling system and cardiovascular disease risk. Eur J Prev Cardiol. 2016 Oct;23(15):1669-76. doi: 10.1177/2047487316640659. Epub 2016 Mar 21.

ReferenceCitation: Graffouillère L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hébert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. The Dietary Inflammatory Index Is Associated with Prostate Cancer Risk in French Middle-Aged Adults in a Prospective Study. J Nutr. 2016 Apr 1;146(4):785-791. Epub 2016 Mar 9.

ReferenceCitation: Graffouillère L, Deschasaux M, Mariotti F, Neufcourt L, Shivappa N, Hébert JR, Wirth MD, Latino-Martel P, Hercberg S, Galan P, Julia C, Kesse-Guyot E, Touvier M. Prospective association between the Dietary Inflammatory Index and mortality: modulation by antioxidant supplementation in the SU.VI.MAX randomized controlled trial. Am J Clin Nutr. 2016 Mar;103(3):878-85. doi: 10.3945/ajcn.115.126243. Epub 2016 Feb 10.

ReferenceCitation: Deschasaux M, Souberbielle JC, Latino-Martel P, Sutton A, Charnaux N, Druesne-Pecollo N, Galan P, Hercberg S, Le Clerc S, Kesse-Guyot E, Ezzedine K, Touvier M. Weight Status and Alcohol Intake Modify the Association between Vitamin D and Breast Cancer Risk. J Nutr. 2016 Mar;146(3):576-85. doi: 10.3945/jn.115.221481. Epub 2016 Jan 27.

ReferenceCitation: Kesse-Guyot E, Assmann KE, Andreeva VA, Ferry M, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Consumption of Dairy Products and Cognitive Functioning: Findings from the SU.VI.MAX 2 Study. J Nutr Health Aging. 2016 Feb;20(2):128-37. doi: 10.1007/s12603-015-0593-x.

ReferenceCitation: Deschasaux M, Souberbielle JC, Latino-Martel P, Sutton A, Charnaux N, Druesne-Pecollo N, Galan P, Hercberg S, Le Clerc S, Kesse-Guyot E, Ezzedine K, Touvier M. Prospective associations between vitamin D status, vitamin D-related gene polymorphisms, and risk of tobacco-related cancers. Am J Clin Nutr. 2015 Nov;102(5):1207-15. doi: 10.3945/ajcn.115.110510. Epub 2015 Oct 7.

ReferenceCitation: Kesse-Guyot E, Lassale C, Assmann KE, Andreeva VA, Julia C, Blacher J, Fezeu L, Hercberg S, Galan P. Are different vascular risk scores calculated at midlife uniformly associated with subsequent poor cognitive performance? Atherosclerosis. 2015 Nov;243(1):286-92. doi: 10.1016/j.atherosclerosis.2015.09.023. Epub 2015 Sep 21.

ReferenceCitation: Donnenfeld M, Deschasaux M, Latino-Martel P, Diallo A, Galan P, Hercberg S, Ezzedine K, Touvier M. Prospective association between dietary folate intake and skin cancer risk: results from the Supplémentation en Vitamines et Minéraux Antioxydants cohort. Am J Clin Nutr. 2015 Aug;102(2):471-8. doi: 10.3945/ajcn.115.109041. Epub 2015 Jul 8.

ReferenceCitation: Chhim AS, Fassier P, Latino-Martel P, Druesne-Pecollo N, Zelek L, Duverger L, Hercberg S, Galan P, Deschasaux M, Touvier M. Prospective association between alcohol intake and hormone-dependent cancer risk: modulation by dietary fiber intake. Am J Clin Nutr. 2015 Jul;102(1):182-9. doi: 10.3945/ajcn.114.098418. Epub 2015 May 20.

ReferenceCitation: Kesse-Guyot E, Andreeva VA, Touvier M, Jeandel C, Ferry M, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Overall and abdominal adiposity in midlife and subsequent cognitive function. J Nutr Health Aging. 2015 Feb;19(2):183-9. doi: 10.1007/s12603-014-0508-2.

ReferenceCitation: Deschasaux M, Pouchieu C, His M, Hercberg S, Latino-Martel P, Touvier M. Dietary total and insoluble fiber intakes are inversely associated with prostate cancer risk. J Nutr. 2014 Apr;144(4):504-10. doi: 10.3945/jn.113.189670. Epub 2014 Feb 19.

ReferenceCitation: Touvier M, Deschasaux M, Montourcy M, Sutton A, Charnaux N, Kesse-Guyot E, Fezeu LK, Latino-Martel P, Druesne-Pecollo N, Malvy D, Galan P, Hercberg S, Ezzedine K, Souberbielle JC. Interpretation of plasma PTH concentrations according to 25OHD status, gender, age, weight status, and calcium intake: importance of the reference values. J Clin Endocrinol Metab. 2014 Apr;99(4):1196-203. doi: 10.1210/jc.2013-3349. Epub 2014 Feb 14.

ReferenceCitation: Andreeva VA, Galan P, Arnaud J, Julia C, Hercberg S, Kesse-Guyot E. Midlife iron status is inversely associated with subsequent cognitive performance, particularly in perimenopausal women. J Nutr. 2013 Dec;143(12):1974-81. doi: 10.3945/jn.113.177089. Epub 2013 Oct 2.

ReferenceCitation: Julia C, Touvier M, Meunier N, Papet I, Galan P, Hercberg S, Kesse-Guyot E. Intakes of PUFAs were inversely associated with plasma C-reactive protein 12 years later in a middle-aged population with vitamin E intake as an effect modifier. J Nutr. 2013 Nov;143(11):1760-6. doi: 10.3945/jn.113.180943. Epub 2013 Sep 11.

ReferenceCitation: Kesse-Guyot E, Andreeva VA, Jeandel C, Ferry M, Touvier M, Hercberg S, Galan P. Alcohol consumption in midlife and cognitive performance assessed 13 years later in the SU.VI.MAX 2 cohort. PLoS One. 2012;7(12):e52311. doi: 10.1371/journal.pone.0052311. Epub 2012 Dec 19.

ReferenceCitation: Kesse-Guyot E, Andreeva VA, Lassale C, Ferry M, Jeandel C, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Mediterranean diet and cognitive function: a French study. Am J Clin Nutr. 2013 Feb;97(2):369-76. doi: 10.3945/ajcn.112.047993. Epub 2013 Jan 2.

ReferenceCitation: Kesse-Guyot E, Charreire H, Andreeva VA, Touvier M, Hercberg S, Galan P, Oppert JM. Cross-sectional and longitudinal associations of different sedentary behaviors with cognitive performance in older adults. PLoS One. 2012;7(10):e47831. doi: 10.1371/journal.pone.0047831. Epub 2012 Oct 17.

ReferenceCitation: Kesse-Guyot E, Ahluwalia N, Lassale C, Hercberg S, Fezeu L, Lairon D. Adherence to Mediterranean diet reduces the risk of metabolic syndrome: a 6-year prospective study. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):677-83. doi: 10.1016/j.numecd.2012.02.005. Epub 2012 May 25.

ReferenceCitation: Touvier M, Kesse-Guyot E, Andreeva VA, Fezeu L, Charnaux N, Sutton A, Druesne-Pecollo N, Hercberg S, Galan P, Zelek L, Latino-Martel P, Czernichow S. Modulation of the association between plasma intercellular adhesion molecule-1 and cancer risk by n-3 PUFA intake: a nested case-control study. Am J Clin Nutr. 2012 Apr;95(4):944-50. doi: 10.3945/ajcn.111.027805. Epub 2012 Feb 29.

ReferenceCitation: Briançon S, Boini S, Bertrais S, Guillemin F, Galan P, Hercberg S. Long-term antioxidant supplementation has no effect on health-related quality of life: the randomized, double-blind, placebo-controlled, primary prevention SU.VI.MAX trial. Int J Epidemiol. 2011 Dec;40(6):1605-16. doi: 10.1093/ije/dyr161.

ReferenceCitation: Péneau S, Galan P, Jeandel C, Ferry M, Andreeva V, Hercberg S, Kesse-Guyot E; SU.VI.MAX 2 Research Group. Fruit and vegetable intake and cognitive function in the SU.VI.MAX 2 prospective study. Am J Clin Nutr. 2011 Nov;94(5):1295-303. doi: 10.3945/ajcn.111.014712. Epub 2011 Sep 28.

ReferenceCitation: Kesse-Guyot E, Fezeu L, Jeandel C, Ferry M, Andreeva V, Amieva H, Hercberg S, Galan P. French adults' cognitive performance after daily supplementation with antioxidant vitamins and minerals at nutritional doses: a post hoc analysis of the Supplementation in Vitamins and Mineral Antioxidants (SU.VI.MAX) trial. Am J Clin Nutr. 2011 Sep;94(3):892-9. doi: 10.3945/ajcn.110.007815. Epub 2011 Jul 20.

ReferenceCitation: Pérez-Jiménez J, Fezeu L, Touvier M, Arnault N, Manach C, Hercberg S, Galan P, Scalbert A. Dietary intake of 337 polyphenols in French adults. Am J Clin Nutr. 2011 Jun;93(6):1220-8. doi: 10.3945/ajcn.110.007096. Epub 2011 Apr 13.

ReferenceCitation: Kesse-Guyot E, Amieva H, Castetbon K, Henegar A, Ferry M, Jeandel C, Hercberg S, Galan P; SU.VI.MAX 2 Research Group. Adherence to nutritional recommendations and subsequent cognitive performance: findings from the prospective Supplementation with Antioxidant Vitamins and Minerals 2 (SU.VI.MAX 2) study. Am J Clin Nutr. 2011 Jan;93(1):200-10. doi: 10.3945/ajcn.2010.29761. Epub 2010 Nov 24.

ReferenceCitation: Ezzedine K, Latreille J, Kesse-Guyot E, Galan P, Hercberg S, Guinot C, Malvy D. Incidence of skin cancers during 5-year follow-up after stopping antioxidant vitamins and mineral supplementation. Eur J Cancer. 2010 Dec;46(18):3316-22. doi: 10.1016/j.ejca.2010.06.008. Epub 2010 Jul 6.

ReferenceCitation: Kesse-Guyot E, Vergnaud AC, Fezeu L, Zureik M, Blacher J, Péneau S, Hercberg S, Galan P, Czernichow S. Associations between dietary patterns and arterial stiffness, carotid artery intima-media thickness and atherosclerosis. Eur J Cardiovasc Prev Rehabil. 2010 Dec;17(6):718-24. doi: 10.1097/HJR.0b013e32833a197f.

ReferenceCitation: Phillips CM, Goumidi L, Bertrais S, Field MR, Cupples LA, Ordovas JM, Defoort C, Lovegrove JA, Drevon CA, Gibney MJ, Blaak EE, Kiec-Wilk B, Karlstrom B, Lopez-Miranda J, McManus R, Hercberg S, Lairon D, Planells R, Roche HM. Gene-nutrient interactions with dietary fat modulate the association between genetic variation of the ACSL1 gene and metabolic syndrome. J Lipid Res. 2010 Jul;51(7):1793-800. doi: 10.1194/jlr.M003046. Epub 2010 Feb 22.

ReferenceCitation: Phillips CM, Goumidi L, Bertrais S, Ferguson JF, Field MR, Kelly ED, Peloso GM, Cupples LA, Shen J, Ordovas JM, McManus R, Hercberg S, Portugal H, Lairon D, Planells R, Roche HM. Complement component 3 polymorphisms interact with polyunsaturated fatty acids to modulate risk of metabolic syndrome. Am J Clin Nutr. 2009 Dec;90(6):1665-73. doi: 10.3945/ajcn.2009.28101. Epub 2009 Oct 14.

ReferenceCitation: Czernichow S, Vergnaud AC, Galan P, Arnaud J, Favier A, Faure H, Huxley R, Hercberg S, Ahluwalia N. Effects of long-term antioxidant supplementation and association of serum antioxidant concentrations with risk of metabolic syndrome in adults. Am J Clin Nutr. 2009 Aug;90(2):329-35. doi: 10.3945/ajcn.2009.27635. Epub 2009 Jun 2.


title: A Single-blinded, Monocentric, Randomized Pilot Study, to Evaluate the Yellow Laser PHOTOLASE PLV-585nm Versus the Reference Green Laser (KTP Excel V 532 nm) in the Treatment of Erythematotelangiectatic Rosacea

acronym: ROSAPHOTOLASE

summary:
Rosacea is a frequent dermatological condition, with a chronic and disturbing evolution that is characterized by redness, permanent erythema associated with telangiectasia (visible and permanent dilatation of the small vessels). It frequently affects men and women with fair skin and can have significant psycho-emotional consequences.

To counteract the unaesthetic appearance of redness and eliminate telangiectasia, the use of the laser is proposed to the patient.

This study is a single center prospective, randomized, controlled split face study to compare 532nm KTP laser versus 585 nm PLV Laser in terms of improvement of the symptoms in the treatment of Erythematotelangiectatic Rosacea 20 subjects will receive up to 3 laser treatments at day 0, month 2 and 4 and will be followed at month 6 and 12.

lead_sponsor: University Hospital, Lille


acronym: BOREAL

summary: This study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.

lead_sponsor: Allergan

location_facility:
CL Mutualiste Chirurgicale
CH Mulhouse
CHU de Rouen
CHU Besancon
CH Châlons-en-Champagne
Hôpital Civil / Nouvel Hôpital Civil
CHU Angers
CH Belfort
CHU Bordeaux
CHI E.Durkheim Plateau de La Justice
CHU Toulouse
CL Toulouse Lautrec
SIH Privas La Voulte
CH de la Conception (APHM)
CH Mont de Marsan
CL Saint Augustin
CH Colmar
CH Lyon Sud (HCL)
CH Tenon (APHP)
CHU de Rennes
CH Renee Sabran Hyeres (HCL)
CH Annecy
CH de Saintonge (Saintes)
CHU Tours
CH Bicêtre (APHP)
CH Raymond Poincare (APHP)
CL de L'Alliance Saint Cyr/Loire
CH Hopale Ctre Calot/Helio
CHU Clermont Ferrand
CH de Cahors
GH de la Rochelle Ré-Aunis
CH Avranches Granville
GH Saint Joseph
CH Bagnols Sur Ceze
CHU Nimes
CH de Pontoise
CL Mutualiste Porte de L'Orient
Polyclinique Les Bleuets
USLD de Lusignan
CH Saint-Avold
Clinique de l'Ormeau Pyrénées
CHU Montpellier
CH Angouleme
CH Le Mans
CH Foch
CHU Limoges
Site D'Aix En Provence
CL Beau Soleil
CHU Dijon
CHU Mondor (APHP)

lead_sponsor_type: industriel


title: Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)

acronym: MELANIS

summary: This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).

time_perspective: Other

lead_sponsor: Hoffmann-La Roche

location_facility: CENTRE HOSPITALIER ANNECY-GENEVOIS; Dematologie

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Pole de Cancerologie Prive Strasbourgeois

location_facility: Hia Sainte Anne; Medecine Interne Oncologie

location_facility: Centre Hospitalier Le Mans; Dermatologie

location_facility: CHU Rouen - CH C. Nicolle - Clinique dermatologique

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie


title: Prospective Study : Podocyturia as Predictive Factor for Pre-eclampsia

summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. Preventive treatment using aspirin could be administrated in early pregnancy. We hypothesized that podocyturia could be an early indicator of preeclampsia. This is a prospective, non-interventional, monocentric study.

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of obstetrics, Femme Mère Enfant Hospital, Lyon, France


title: Prospective Study : Association Between Pococyturia and Pre-eclampsia Severity

summary: Pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. Twenty four hours proteinuria is a key element to define pre-eclampsia severity but is delaying the result by 24 hours and constraining for the patient. A simple and rapid indicator for severe preeclampsia would help clinicians to make appropriate decision in patient management. We hypothesized that urinary podocyturia is correlated to preeclampsia severity. This is a prospective, non-interventional, monocentric study.

status: Recruiting

status_simplified: Ongoing


title: Antioxidants Supplementation Associated With Pulmonary Rehabilitation is it Effective on Muscle Dysfunction and Signaling Pathways Involved in the Myopathy of COPD?

summary: On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits

ReferenceCitation: Gouzi F, Maury J, Héraud N, Molinari N, Bertet H, Ayoub B, Blaquière M, Bughin F, De Rigal P, Poulain M, Pincemail J, Cristol JP, Laoudj-Chenivesse D, Mercier J, Préfaut C, Pomiès P, Hayot M. Additional Effects of Nutritional Antioxidant Supplementation on Peripheral Muscle during Pulmonary Rehabilitation in COPD Patients: A Randomized Controlled Trial. Oxid Med Cell Longev. 2019 Apr 17;2019:5496346. doi: 10.1155/2019/5496346. eCollection 2019.

lead_sponsor: University Hospital, Montpellier

location_facility:
University Hospital of Montpellier
Clinique du souffle la vallonie

intervention_type: Dietary Supplement


title: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

acronym: HYDRAMUC

summary: Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.

status: Active, not recruiting

lead_sponsor: Laboratoires IPRAD

location_facility: Institut de Cancerologie de Lorraine - Site 004


title: Clinical Trial on the Effect of Bezafibrate in the Muscular Form of Carnitine Palmitoyltransferase 2 Deficiency

summary: The purpose of this study is to determine whether bezafibrate is effective in the treatment of the muscular adult form of carnitine palmitoyltransferase 2 deficiency

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effect of Prone Position on the Use of Non-invasive and Invasive Ventilation in Infants With Moderate to Severe Acute Bronchiolitis

acronym: PROPOSITIS

summary:
Acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in France). Between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support.

Non-invasive ventilation, in particular the nasal Continuous Positive Airway Pressure (nCPAP), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. Nowadays, this technique is considered as the gold standard in the pediatric intensive care units (PICU) in France. High Flow Nasal Cannula (HFNC) has been proposed as an alternative to the nCPAP because of its better tolerance and simplicity of implementation. However, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the PICU.

In a physiological study (NCT02602678, article published), it has been demonstrated that prone position (PP) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis.

Investigators hypothesize that prone position, during High Flow Nasal Cannula (HFNC), would significantly reduce the use of non-invasive ventilation (nCPAP and others) or invasive ventilation, as compared to supine position during HFNC, in infants with moderate to severe viral bronchiolitis.

location_facility: CRHU Nancy Réanimation Pédiatrique Spécialisée

location_facility: CHU GRENOBLE Service de réanimation pédiatrique Hôpital Couple Enfant

location_facility: CH CHAMBERY Unité de surveillance continue pédiatrique

location_facility: CHU de Caen, Service de réanimation et surveillance continue pédiatrique

location_facility: CHU SAINT-ETIENNE Service de réanimation pédiatrique

location_facility: Hôpital Necker Enfant Malade, Paris Service de Réanimation et surveillance continue médicochirurgicales

location_facility: Réanimation pédiatrique et unité de surveillance continue - Hôpital Femme Mère Enfant - Hospices Civils de Lyon

location_facility: CH VILLEFRANCHE Service de pédiatrie néonatologie

location_facility: CHU Nantes Unité de surveillance continue pédiatrique Hôpital mère-enfant

location_facility: CHU MONTPELLIER Service de réanimation pédiatrique

location_facility: Hôpital d'Enfants CHU de Dijon Service de réanimation pédiatrique

location_facility: CHU LENVAL NICE Service de réanimation pédiatrique

location_facility: CH ANNECY GENEVOIS Unité de surveillance continue pédiatrique


title: TIPS (With Coated Stents) OR PARACENTESIS + ALBUMIN ADMINISTRATION FOR THE TREATMENT OF REFRACTORY ASCITES IN PATIENTS WITH CIRRHOSIS : A RANDOMIZED TRIAL COMPARING SURVIVAL, QUALITY OF LIFE AND NUTRITIONAL STATUS

summary: The main end point of the study is to assess survival in cirrhotic patients with refractory ascites treated by TIPS (using PTFE covered stents) vs patients treated by paracentesis + albumin infusion.

ReferenceCitation: Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Péron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75.

ReferenceCitation: Bureau C, Thabut D, Oberti F, Dharancy S, Carbonell N, Bouvier A, Mathurin P, Otal P, Cabarrou P, Péron JM, Vinel JP. Transjugular Intrahepatic Portosystemic Shunts With Covered Stents Increase Transplant-Free Survival of Patients With Cirrhosis and Recurrent Ascites. Gastroenterology. 2017 Jan;152(1):157-163. doi: 10.1053/j.gastro.2016.09.016. Epub 2016 Sep 20. Erratum in: Gastroenterology. 2017 Sep;153(3):870.

lead_sponsor: University Hospital, Toulouse

location_facility: Service d'Hépato-Gastro-Entérologie, Hôpital Purpan


title: Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.

summary: This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).

ReferenceCitation: Jeanne M, Delecroix M, De Jonckheere J, Keribedj A, Logier R, Tavernier B. Variations of the analgesia nociception index during propofol anesthesia for total knee replacement. Clin J Pain. 2014 Dec;30(12):1084-8. doi: 10.1097/AJP.0000000000000083.

ReferenceCitation: Jeanne M, Clément C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

ReferenceCitation: De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909.

ReferenceCitation: Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82.

location_facility: CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro

location_facility: Hôpital maritime de Zuydcoote, Service de SSR Enfant

location_facility: Centre de Réadaptation Fonctionnelle Marc Sautelet


title: Complications of Jugular and Femoral Venous Catheterization in Critically Ill Patients Requiring Hemodialysis: A Randomized Controlled Trial

acronym: CATHEDIA

summary: The purpose of this study is to determine whether a jugular route leads to a lower rate of complications as compared with a femoral route for catheterization in patients admitted in several intensive care units in France who develop acute renal failure requiring hemodiafiltration or hemodialysis.

ReferenceCitation: Parienti JJ, Thirion M, Mégarbane B, Souweine B, Ouchikhe A, Polito A, Forel JM, Marqué S, Misset B, Airapetian N, Daurel C, Mira JP, Ramakers M, du Cheyron D, Le Coutour X, Daubin C, Charbonneau P; Members of the Cathedia Study Group. Femoral vs jugular venous catheterization and risk of nosocomial events in adults requiring acute renal replacement therapy: a randomized controlled trial. JAMA. 2008 May 28;299(20):2413-22. doi: 10.1001/jama.299.20.2413.

ReferenceCitation: Parienti JJ, Mégarbane B, Fischer MO, Lautrette A, Gazui N, Marin N, Hanouz JL, Ramakers M, Daubin C, Mira JP, Charbonneau P, du Cheyron D; Cathedia Study Group. Catheter dysfunction and dialysis performance according to vascular access among 736 critically ill adults requiring renal replacement therapy: a randomized controlled study. Crit Care Med. 2010 Apr;38(4):1118-25. doi: 10.1097/CCM.0b013e3181d454b3.

ReferenceCitation: Parienti JJ, Dugué AE, Daurel C, Mira JP, Mégarbane B, Mermel LA, Daubin C, du Cheyron D; Members of the Cathedia Study Group. Continuous renal replacement therapy may increase the risk of catheter infection. Clin J Am Soc Nephrol. 2010 Aug;5(8):1489-96. doi: 10.2215/CJN.02130310. Epub 2010 Jun 17.

ReferenceCitation: Dugué AE, Levesque SP, Fischer MO, Souweine B, Mira JP, Megarbane B, Daubin C, du Cheyron D, Parienti JJ; Cathedia Study Group. Vascular access sites for acute renal replacement in intensive care units. Clin J Am Soc Nephrol. 2012 Jan;7(1):70-7. doi: 10.2215/CJN.06570711. Epub 2011 Nov 10.

ReferenceCitation: Parienti JJ, Deryckère S, Mégarbane B, Valette X, Seguin A, Sauneuf B, Mira JP, Souweine B, Cattoir V, Daubin C, du Cheyron D; Cathedia Study Group. Quasi-experimental study of sodium citrate locks and the risk of acute hemodialysis catheter infection among critically ill patients. Antimicrob Agents Chemother. 2014 Oct;58(10):5666-72. doi: 10.1128/AAC.03079-14. Epub 2014 Jun 30.

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Mégarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

ReferenceCitation: Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9:CD013330. doi: 10.1002/14651858.CD013330.pub2. Review.

lead_sponsor: University Hospital, Caen

location_facility: Medical and nephrologic Intensive Care Unit, CHU Amien Sud

location_facility: Medical Intensive Care Unit, CHU de Caen


title: An International Multicenter Phase II Randomised Trial Evaluating and Comparing Two Intensification Treatment Strategies for Metastatic Neuroblastoma Patients With a Poor Response to Induction Chemotherapy

acronym: VERITAS

summary: The main objective is to evaluate the efficacy of two intensified consolidation strategies in very-high risk neuroblastoma (VHR-NBL) patients in terms of event-free survival from randomisation date. This evaluation will follow a hierarchical testing procedure: each experimental treatment will be first evaluated as a single-arm phase 2 study, and in case of positive conclusion, the relative efficacy of both arms will then be evaluated comparatively.

ipd_sharing: Yes

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Austria Netherlands France

location_facility:
Princess Maxima Center
Gustave Roussy
Medizinische Universität Innsbruck
St. Anna Kinderspital GmbH

intervention_type: Radiation


title: Identification of Genetic Modifying Factors in Striated Muscle Laminopathies

acronym: LMNAModifier

summary:
Mutations in the LMNA gene, which codes for lamins A and C, proteins of the nuclear lamina, are responsible for a wide spectrum of pathologies, including a group specifically affecting striated skeletal and cardiac muscles, with cardiac involvement being life-threatening. At the skeletal muscle level, a wide phenotypic spectrum has been described, ranging from severe forms of congenital muscular dystrophy to less severe forms of limb-girdle muscular dystrophy. The great clinical variability of striated muscle laminopathies, both inter- and intra-familial, can be observed in the age of onset, severity of signs and progression of muscle and heart involvement. To date, more than 400 LMNA mutations have been associated with striated muscle laminopathies (www.umd.be/LMNA/), highlighting strong clinical and genetic heterogeneity. A few recurrent mutations linked to a difference in severity have been identified. However, these genotype-phenotype relationships and the rare cases of digenism reported do not explain all the clinical variability of laminopathies. Therefore, there are probably other factors of severity than the causative mutation, called "modifier genes".

Identification of such modifier genes has been initiated by studying a large family with significant clinical variability in the age of onset of muscle signs. A segregation analysis within this family identified 2 potential modifier loci. High-throughput sequencing restricted to these 2 regions according to phenotypic subgroups did not led to meaningful results so far. In addition, an international retrospective study of the natural history of early muscle laminopathies has allowed the investigators to highlight a strong inter-family clinical variability in patients carrying recurrent mutations. The investigators thus have strong preliminary data that could allow them to identify modifying genetic factors in a cohort of patients carrying a mutation in the LMNA gene.

In order to identify these factors that modulate the clinical severity of laminopathies, the investigators wish to collect biological material (muscle and/or skin biopsies) from patients carrying a mutation in the LMNA gene. The study of this biological material using multi OMICs technics will allow the investigators to identify and functionally validate the action of these modifying genes.

OMIICs is a set of techniques for characterising biological molecules using high-throughput approaches such as DNA sequencing, RNA sequencing and/or chromatin conformation (ATACseq...), proteins.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Granger B, Gueneau L, Drouin-Garraud V, Pedergnana V, Gagnon F, Ben Yaou R, Tezenas du Montcel S, Bonne G. Modifier locus of the skeletal muscle involvement in Emery-Dreifuss muscular dystrophy. Hum Genet. 2011 Feb;129(2):149-59. doi: 10.1007/s00439-010-0909-1. Epub 2010 Nov 10.

ReferenceCitation: Ben Yaou R, Yun P, Dabaj I, Norato G, Donkervoort S, Xiong H, Nascimento A, Maggi L, Sarkozy A, Monges S, Bertoli M, Komaki H, Mayer M, Mercuri E, Zanoteli E, Castiglioni C, Marini-Bettolo C, D'Amico A, Deconinck N, Desguerre I, Erazo-Torricelli R, Gurgel-Giannetti J, Ishiyama A, Kleinsteuber KS, Lagrue E, Laugel V, Mercier S, Messina S, Politano L, Ryan MM, Sabouraud P, Schara U, Siciliano G, Vercelli L, Voit T, Yoon G, Alvarez R, Muntoni F, Pierson TM, Gómez-Andrés D, Reghan Foley A, Quijano-Roy S, Bönnemann CG, Bonne G. International retrospective natural history study of LMNA-related congenital muscular dystrophy. Brain Commun. 2021 Apr 11;3(3):fcab075. doi: 10.1093/braincomms/fcab075. eCollection 2021 Jul.

location_facility: Laboratoire d'Explorations Fonctionnelles - Centre de Référence Maladies Neuromusculaires Rares, CHU Nantes

location_facility: Service de Génétique médicale, CHU Rennes

location_facility: Service de cardiologie & Service de Neurophysiologie - CHU de Rouen

location_facility: Service de Neuropédiatrie, Centre de Référence Maladies Neuromusculaires, CHU de Montpellier

location_facility: Centre de référence maladies neuromusculaires, Hôpital Femme Mère Enfant, CHU Lyon

location_facility: Service de Neurologie, Réanimation Pédiatriques, Hôpital Raymond Poincaré, Hôpitaux Universitaires, Paris-Ile-de-France-Ouest

location_facility: Centre de référence maladies neuromusculaires, Institut de myologie, Hôpital Pitié-Salpêtrière

location_facility: Centre de référence pour les maladies cardiaques héréditaires


title: Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)

summary:
Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome…). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.

The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.

location_facility: Exploration Fonctionnelle Digestive, Hôpital Edouard Herriot, Lyon, France


title: International Validation of a Sexual Quality of Life Questionnaire Specific to HIV and Hepatitis C Infections (PROQOL-SexLife)

acronym: SexLife

summary: To develop and validate a specific questionnaire of sexual quality of life in several languages and cultures (France, Brazil, Australia) allowing a meaningful and comprehensive assessment of the sexuality of patients infected with HIV and HCV; Propose reference scoring for sub-populations.

ReferenceCitation: WHO | Sexual health [Internet]. WHO. Available from: http://www.who.int/topics/sexual_health/en/

ReferenceCitation: Koole O, Noestlinger C, Colebunders R. Quality of life in HIV clinical trials: why sexual health must not be ignored. PLoS Clin Trials. 2007 Mar 2;2(3):e8.

ReferenceCitation: Marcellin F, Préau M, Ravaux I, Dellamonica P, Spire B, Carrieri MP. Self-reported fatigue and depressive symptoms as main indicators of the quality of life (QOL) of patients living with HIV and Hepatitis C: implications for clinical management and future research. HIV Clin Trials. 2007 Sep-Oct;8(5):320-7.

ReferenceCitation: Sandfort TG, Collier KL, Grossberg R. Addressing sexual problems in HIV primary care: experiences from patients. Arch Sex Behav. 2013 Oct;42(7):1357-68. doi: 10.1007/s10508-012-0009-5. Epub 2012 Sep 11.

ReferenceCitation: Meystre-Agustoni G, Jeannin A, de Heller K, Pécoud A, Bodenmann P, Dubois-Arber F. Talking about sexuality with the physician: are patients receiving what they wish? Swiss Med Wkly. 2011 Mar 8;141:w13178. doi: 10.4414/smw.2011.13178. eCollection 2011.

ReferenceCitation: Dyer K, das Nair R. Why don't healthcare professionals talk about sex? A systematic review of recent qualitative studies conducted in the United kingdom. J Sex Med. 2013 Nov;10(11):2658-70. doi: 10.1111/j.1743-6109.2012.02856.x. Epub 2012 Jul 30. Review.

ReferenceCitation: Soykan A, Boztaş H, Idilman R, Ozel ET, Tüzün AE, Ozden A, Ozden A, Kumbasar H. Sexual dysfunctions in HCV patients and its correlations with psychological and biological variables. Int J Impot Res. 2005 Mar-Apr;17(2):175-9.

ipd_sharing: Undecided

lead_sponsor: University Paris 7 - Denis Diderot

location_country: Australia Canada Brazil France

location_facility: Centre Hépato -Biliaire de l'Hôpital Paul Brousse