title: The FGF/FGFR Signalling Pathway: a Novel Therapeutic Target in Liposarcomas

acronym: FILIPO

summary:
Liposarcomas are the most common type of soft tissue sarcomas (STS). Among liposarcomas, well-differentiated liposarcoma (WDLPS)/dedifferentiated liposarcoma (DDLPS) are the most frequent types. WDLPS are composed mostly of mature fat whereas DDLPS contain both a WDLPS component and a non-lipomatous sarcoma component mostly of high grade. More than 50% of DDLPS will relapse locally. A significant proportion of patients will remain with a non-resectable disease that will metastasize in 20% of cases. Standard chemotherapy is poorly efficient and alternative options are so far limited. Identification of new therapeutic targets is urgent and mandatory. the recent preliminary results as well as data from the literature led us to hypothesize that the FGF (Fibroblast Growth factor)/FGFR pathway is involved in liposarcomagenesis and might therefore be a novel relevant therapeutic target in WDLPS/DDLPS.

Description of the project The project associates 4 teams with a longstanding collaboration : 3 teams fom Nice (Nice University Hospital/IRCAN, Nice University Hospital, Comprehensive Cancer Center Centre Antoine Lacassagne and one team from Bordeaux (Comprehensive Cancer Center Institut Bergonié). These 4 teams are experts in the clinics, pathology and molecular genetics of sarcomas as well as in biostatistics.

Expression studies on the role of the syndecan-1 (SDC1)/FGFR pathway in WDLPS/DDLPS tumorigenesis

The recent studies provide original results that may have a direct application in treatments of liposarcomas. They suggest that SDC1 -an effector of the FGF/FGFR pathway- might be involved in DDLPS tumorigenesis. Staff will analyse:

The pattern of expression and localisation of syndecans, FGFs and FGFRs in WDLPS/DDLPS both in a large collection of 249 primary tumors and in our in-house panel of high quality and validated human WDLPS/DDLPS cell lines.
The prognostic value of SDC1, FGF2 and FGF18 expression by correlation to the patient clinical outcomes

Fonctional studies of the role of the SDC1/FGFR pathway in WDLPS/DDLPS tumorigenesis. We will analyse:

The effects of modulating SDC1, FGFR expression in WDLPS and DDLPS cells on cell proliferation, cell cycle, apoptosis and on their capacity to differentiate in adipocytes.
The sensitivity of WDLPS and DDLPS cells to the FGFR inhibitor JNJ-427556493 as a single agent or in combination with other antagonists.
The mechanisms of sensitivity and resistance to JNJ-427556493 by phosphoproteomic analysis of WDLPS and DDLPS cells before and after JNJ-427556493 treatment.
The involvement of SDC1 in the dedifferentiation process of liposarcoma. Expected results staff expect to demonstrate the relevance of the SDC1/FGFR pathway in liposarcomas. We also expect to link drug activity to genomics and proteomics data. This will allow the characterization of the activity of FGFR inhibitors and the identification of powerful preclinical biomarkers of drug activity and mechanisms of resistance in DDLPS. The availability of xenograft models will allow us to validate our in vitro findings in the in vivo setting with the ultimate goal to improve patient management.

The availability of an early clinical trial unit in Institut Bergonié, managed by A. Italiano, will give the immediate opportunity to transfer our data to the management of metastatic liposarcoma patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

appel_a_projets: PRTK

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CTRE HOSPITALIER UNIVERSITAIRE DE NICE

type_etablissement: CHUR

acronyme: FILIPO

titre: La voie de signalisation cellulaire FGF/FGFR : une nouvelle cible thérapeutique dans les liposarcomes

discipline_principale: cancer

nom_porteur: PEDEUTOUR

prenom_porteur: Florence


type: Other Identifier

title: Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome

acronym: COVAP

summary: Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Compliance to Oral Nutritional Supplements (ONS) in Undernourished Frail Older Adults Living at Home.

acronym: OFraDDom

summary:
In this study, patients are supposed to take Fortimel® Protein, an Oral Nutritional Supplement (ONS) recommended in case of malnutrition once daily during the study period.

Three visits will be planned for each patient enrolled in the study (baseline visit, visits of follow-up at 4 weeks and 12 weeks). Phone calls will be regularly organized during one month or three months according to the duration of supplementation.

The primary purpose of the OFraDDom study is to assess the compliance with ONS (respect by the patient of the physician's prescription) at the end of the first month.

Data regarding the beneficial effects of ONS, or compliance with ONS in frail elderly population, are very limited. The study could complete knowledge about oral nutritional supplementation in the undernourished frail elderly people and help to demonstrate that oral nutritional supplements have benefits on nutritional status and physical performances in frail elderly people.

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Nutricia, Inc.

location_facility: Toulouse University Hospital (CHU de Toulouse)

intervention_type: Dietary Supplement


title: Metabolic Signatures Resulting From Acute (Postprandial) Ingestion of Yoghurt or Milk in Humans: Effect of Age

acronym: FermentoMilk

summary:
Despite the fact that dairy products are greatly consumed, it remains today very difficult to determine with a classical blood biochemical test whether a person has ingested a fresh fermented dairy product or just milk, while their biological, metabolic and health impacts may be different.

The metabolic footprint left by the consumption of these products could be modified by the age of the consumer. Indeed, in the elderly, the processes of digestion, assimilation and metabolism are known to be altered /different compared to healthy adults. Thus, different metabolic signatures in the elderly could appear as the result of a less effective use and metabolism of the nutrients ingested. This could further also result in different or altered biological effects on dairy products.

design_allocation: Randomized

primary_purpose: Basic Science

ipd_sharing_description: The identified individual participant data for all outcome measures will be made available, only after joined consent of promotor and investigator. Data use and transfer to a third party will be performed according to the agreement signed as part of the grant funded by CNIEL.

lead_sponsor: Sergio Polakof

collaborators: Centre de Recherche en Nutrition Humaine d'Auvergne

collaborators: Agroscope Liebefeld-Posieux Research Station ALP

intervention_type: Other

lead_sponsor_type: industriel


title: Primary Headache and Psychological Factors, Mental Functioning and Attachment Modalities.

acronym: CEPRIVA

summary:
The World Health Organization (WHO) ranks headache among the top 20 causes of disability in the world.

Primary headaches (with no known organic cause) account for 90% of these conditions. INSERM estimates that 15% of the general population is concerned. WHO estimates that 1.7-4% of the global adult population is affected by headache for at least 15 days a month. Headaches are disabling, for patients (pain, suffering, fatigue, unavailability ...) but also for society (socio-economic cost as frequent work stoppages and drug costs). They are a public health problem.

In 2002, the High Authority of Health published its recommendations for the diagnosis and management of migraine patients. In addition, the French Society for Migraine and Headache Studies updated these recommendations in 2013. They are focused on the medical management offered by doctors and pharmacists. However, the professionals in daily contact with the subjects know that the dimension psychic plays an important role in the etiology of headaches.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Health Services Research

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

status_simplified: Unknown


title: Description of Chronic Pain in Emergencies Room and Medical Care Modalities

acronym: CHRODOLURG

summary: The rate of patients with chronic pain (CP) is 40% in patients with acute pain in emergency department (ED). Patients with CP come more frequently to ED than patients without CP. Reasons for their visit to ED are often in relation with this CP. Few studies have been interested to management modalities of these patients in ED. The investigators are going to realize a prospective observational study in one center. The hypothesis is that patients with chronic pain are less satisfied of ED management that patients without CP.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Pellegrin - Service des urgences adultes


title: CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology

acronym: CAP'ONCO

summary:
This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes:

A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist)
Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops
An information booklet "Prepare the work return" The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

primary_purpose: Supportive Care

lead_sponsor: Institut Bergonié


title: Development and Progression of Carcinoid Heart Disease in a Cohort of Adult Patients With Neuroendocrine Tumors Carcinoid Heart Disease (CHD): An Observational French Multi-Centre Cohort Study CRUSOE - NETs (CaRdiac UltraSonic OutcomEs - NETs)

acronym: CRUSOE-NETs

summary:
Carcinoid Heart Disease (CHD) is a rare form of heart disease, occurring in over 50% of the patients with carcinoid syndrome. Pathophysiology, prognostic factors of development of Carcinoid Heart Disease and progression of disease remain unclear.

This observational multicenter cohort study is designed to study the occurrence of Carcinoid Heart Disease in patients with differentiated carcinoid tumors, to describe numerous factors influencing the occurrence, severity, progression and long-term survival of patients with Carcinoid Heart Disease. Basic informations and detailed diagnosis informations (oncological and cardiac parameters), are collected by professional doctors. Clinical outcomes (onset of Carcinoid Heart Disease, cardiac surgery, related death) will be followed up every year or every six/three months if clinically indicated.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard HERRIOT, Institut du Cancer - Hospices Civils de Lyon

status_simplified: Ongoing


title: Comparison of Standard Opioid Prescription Versus Prescription Guided by Pharmacogenetic Analysis in Patients With Non-cancerous Chronic Pain.

acronym: AlgoPGx

summary: The investigators hypothesize that opioid prescription guided by patient pharmacogenetic profile will diminish opioid-associated undesirable effects by 50% and improve medication compliance.

status: Withdrawn

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

acronym: COMP-RMS

summary: The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )

time_perspective: Retrospective

lead_sponsor: Nantes University Hospital


title: Sensitivity to Acute Middle Cerebral or Intracranial Carotid Artery Occlusion in MIGrainers - SAMCO-MIG

acronym: SAMCO-MIG

summary: Sensitivity to Acute Middle cerebral or intracranial Carotid artery Occlusion in MIGrainers (SMCO-MIG) is a prospective multi-center study to determine if migraine induces a faster infarct growth as assessed by initial multimodal imaging.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU de Montpellier - Neurology Departement

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU MONTPELLIER

type_etablissement: CH

acronyme: SAMCO-MIG

titre: Vulnérabilité à l'ischémie aiguë par occlusion de l'artère cérébrale moyenne ou de la carotide interne intracrânienne chez les migraineux Sensitivity to Acute Middle cerebral or intracranial Carotid Artery Occlusion in MIGraineurs

discipline_principale: neurologie

nom_porteur: DUCROS

prenom_porteur: Anne


intervention_type: Drug

lead_sponsor: UniQure Biopharma B.V.

summary: This is an open-label, phase I/II study of intra-cerebral administration of adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from Sanfilippo type B syndrome.

ReferenceType: derived

ReferenceCitation: Gougeon ML, Poirier-Beaudouin B, Ausseil J, Zerah M, Artaud C, Heard JM, Deiva K, Tardieu M. Cell-Mediated Immunity to NAGLU Transgene Following Intracerebral Gene Therapy in Children With Mucopolysaccharidosis Type IIIB Syndrome. Front Immunol. 2021 May 10;12:655478. doi: 10.3389/fimmu.2021.655478. eCollection 2021.

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: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

sponsor_collaborators:
UniQure Biopharma B.V.
Venn Life Sciences
Institut Pasteur

title: Protocol AMT110-CD-001: A Phase I/II, Open-label, Study of Intracerebral Administration of Adeno-associated Viral Vector Containing the Human Alpha-N-acetylglucosaminidase cDNA in Children With Sanfilippo Type B Syndrome

source: euctr

collaborators:
Venn Life Sciences
Institut Pasteur


title: BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

acronym: BIVOLUTX

summary: Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

ReferenceCitation: Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ipd_sharing_description: Mutual ananymized database. Substudies anticipated.

lead_sponsor: Clinique Pasteur


title: Bacteriological Link Between Upper and Lower Airways in Cystic Fibrosis and Primary Ciliary Dyskinesia

acronym: BAVASI

summary: Cytobacteriological examination of sputum and bacteriological sampling in the middle meatus.

ReferenceType: background

ReferenceCitation: Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7. doi: 10.1128/JCM.41.9.4424-4427.2003.

ReferenceCitation: Frederiksen B, Lanng S, Koch C, Hoiby N. Improved survival in the Danish center-treated cystic fibrosis patients: results of aggressive treatment. Pediatr Pulmonol. 1996 Mar;21(3):153-8. doi: 10.1002/(SICI)1099-0496(199603)21:33.0.CO;2-R.

ReferenceCitation: Berkhout MC, van Rooden CJ, Rijntjes E, Fokkens WJ, el Bouazzaoui LH, Heijerman HG. Sinonasal manifestations of cystic fibrosis: a correlation between genotype and phenotype? J Cyst Fibros. 2014 Jul;13(4):442-8. doi: 10.1016/j.jcf.2013.10.011. Epub 2013 Nov 5.

ReferenceCitation: Berkhout MC, Klerx-Melis F, Fokkens WJ, Nuijsink M, van Aalderen WM, Heijerman HG. CT-abnormalities, bacteriology and symptoms of sinonasal disease in children with Cystic Fibrosis. J Cyst Fibros. 2016 Nov;15(6):816-824. doi: 10.1016/j.jcf.2016.03.004. Epub 2016 Apr 3.

ReferenceCitation: Jelsbak L, Johansen HK, Frost AL, Thogersen R, Thomsen LE, Ciofu O, Yang L, Haagensen JA, Hoiby N, Molin S. Molecular epidemiology and dynamics of Pseudomonas aeruginosa populations in lungs of cystic fibrosis patients. Infect Immun. 2007 May;75(5):2214-24. doi: 10.1128/IAI.01282-06. Epub 2007 Jan 29.

ReferenceCitation: Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

ReferenceCitation: Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.

ReferenceCitation: Aanaes K, Johansen HK, Poulsen SS, Pressler T, Buchwald C, Hoiby N. Secretory IgA as a diagnostic tool for Pseudomonas aeruginosa respiratory colonization. J Cyst Fibros. 2013 Jan;12(1):81-7. doi: 10.1016/j.jcf.2012.07.001. Epub 2012 Jul 20. Erratum In: J Cyst Fibros. 2013 Dec;12(6):830.

ReferenceCitation: Fischer N, Hentschel J, Markert UR, Keller PM, Pletz MW, Mainz JG. Non-invasive assessment of upper and lower airway infection and inflammation in CF patients. Pediatr Pulmonol. 2014 Nov;49(11):1065-75. doi: 10.1002/ppul.22982. Epub 2014 Jan 25.

ReferenceCitation: Aanaes K. Bacterial sinusitis can be a focus for initial lung colonisation and chronic lung infection in patients with cystic fibrosis. J Cyst Fibros. 2013 Sep;12 Suppl 2:S1-20. doi: 10.1016/S1569-1993(13)00150-1.

ReferenceCitation: Magnin ML, Cros P, Beydon N, Mahloul M, Tamalet A, Escudier E, Clement A, Le Pointe HD, Blanchon S. Longitudinal lung function and structural changes in children with primary ciliary dyskinesia. Pediatr Pulmonol. 2012 Aug;47(8):816-25. doi: 10.1002/ppul.22577. Epub 2012 May 8.

ReferenceCitation: Alanin MC, Nielsen KG, von Buchwald C, Skov M, Aanaes K, Hoiby N, Johansen HK. A longitudinal study of lung bacterial pathogens in patients with primary ciliary dyskinesia. Clin Microbiol Infect. 2015 Dec;21(12):1093.e1-7. doi: 10.1016/j.cmi.2015.08.020. Epub 2015 Sep 2.

ReferenceCitation: Alanin MC, Johansen HK, Aanaes K, Hoiby N, Pressler T, Skov M, Nielsen KG, von Buchwald C. Simultaneous sinus and lung infections in patients with primary ciliary dyskinesia. Acta Otolaryngol. 2015 Jan;135(1):58-63. doi: 10.3109/00016489.2014.962185. Epub 2014 Nov 5.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Diagnostic Test


title: Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home

acronym: EzyGain

summary: Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the training work of walking in everyday life compared to a conventional care.

status: Terminated

location_facility: Service de Médecine Physique et de Réadaptation - Hôpital F.Widal


title: Characterization of Behavioral Disorders and 24 H-melatonin Level in Adults With Smith Magenis Syndrome

acronym: SMS-adults

summary: Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an inversion of the nychtemeral secretion of melatonin. This inversion have been described in children with SMS. However its evolution during adulthood remains unknown. The aim of this study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize medication in adults with SMS

primary_purpose: Screening

lead_sponsor: Hôpital le Vinatier

sponsor_collaborators:
Hôpital le Vinatier
Hospices Civils de Lyon

intervention_type: Biological


type: Registry Identifier

title: Métabolismes Des caroténoïdes Dans la lumière du Tube Digestif de l'Homme Sain

acronym: CarotenoiDig

summary: Consumption of foods containing carotenoids, as well as vitamin E, have been associated with lower risk of developing a number of chronic diseases. While the parent compounds have largely been assumed to exert protective antioxidant effects, more recent work has suggested that metabolites may be bioactive. Very little attention has been given to the metabolism of these compounds during the digestive process. Our primary aim is to conduct a postprandial feeding study in healthy men to determine the stability of carotenoids and vitamin E during digestion, and to identify the primary metabolites produced in various compartments of the upper gastrointestinal tract and blood during digestion. Targeted metabolites will be identified and quantitated using high-performance liquid chromatography-tandem mass spectrometry methods previously developed. In addition, a non-targeted metabolomics approach will be used to identify non-predicted metabolites in the samples. A better understanding of carotenoid and vitamin E stability and metabolism during digestion will provide greater insight into how these compounds may confer protection against chronic disease.

ReferenceCitation: Kopec RE, Caris-Veyrat C, Nowicki M, Gleize B, Carail M, Borel P. Production of asymmetric oxidative metabolites of [13C]-beta-carotene during digestion in the gastrointestinal lumen of healthy men. Am J Clin Nutr. 2018 Oct 1;108(4):803-813. doi: 10.1093/ajcn/nqy183.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories_concat: HAL

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

collaborators:
Aix Marseille Université
Hôpital de la Conception

location_facility: Centre d'Investigation Clinique de la Hôpital Conception


title: Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.

acronym: MUCO-OS

summary:
The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.

Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.

Finally the action of CFTR modulators on these bone cells will be tested.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose


title: 2D Strain of Right Ventricle in Peroperative Cardiac Surgery : Evaluation of Early Signs of RV Dysfunction

summary:
Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

TEE is performed for each patient of cardiac surgery during the operation time .

This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

location_facility: Hôpital Arnaud de Villeneuve réanimation

intervention_type: Procedure


summary: Neurofibromatosis type 1 (NF1) is one of the most common autosomal dominant genetic disorders. The aim of our study was to evaluate post-traumatic stress disorder (PTSD) in patients and their families following the disclosure of sporadic NF1. Diagnosis of NF1 was retained according to NIH criteria, familial forms were excluded. The French version of the Impact of Event Scale-Revised was used for the diagnosis of PTSD.

lead_sponsor: University Hospital, Brest


title: Elderly Appropriate Treatment in Primary Care (EAT)

acronym: TAPAGE

summary: The general practitioner (GP) is confronted, for a part of his clientele, with the management of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five major consequences: increasing the number of inappropriate treatments, increasing the risk of potentially dangerous drug interactions, increasing the risk of contraindications associated with several concomitant pathologies, decreasing adherence to treatments by patients and the increased cost of care. Drug misuse in the elderly is particularly common, due to the age-related physiological changes and physiological alterations, with the consequent increase in the risk of adverse events, particularly hospitalizations. Several tools have been proposed to decrease morbimortality in elderly patients with polypharmacy. The studies concluded that the STOPP/START tool was the most structured, sensitive and had the most appropriate use format for clinical practice. However, there are currently no ambulatory studies demonstrating the impact of prescription revision with STOPP/START on the morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness of an intervention targeting GPs to decrease morbimortality in elderly patients with polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in systematic medication review by GP with STOPP/START. In both groups, patient morbimortality will be measured at the end of the study.

ReferenceCitation: O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16. Erratum In: Age Ageing. 2018 May 1;47(3):489.

ReferenceCitation: Dalleur O, Spinewine A, Henrard S, Losseau C, Speybroeck N, Boland B. Inappropriate prescribing and related hospital admissions in frail older persons according to the STOPP and START criteria. Drugs Aging. 2012 Oct;29(10):829-37. doi: 10.1007/s40266-012-0016-1.

ReferenceCitation: Gallagher PF, O'Connor MN, O'Mahony D. Prevention of potentially inappropriate prescribing for elderly patients: a randomized controlled trial using STOPP/START criteria. Clin Pharmacol Ther. 2011 Jun;89(6):845-54. doi: 10.1038/clpt.2011.44. Epub 2011 Apr 20.

ReferenceCitation: Dalleur O, Boland B, Losseau C, Henrard S, Wouters D, Speybroeck N, Degryse JM, Spinewine A. Reduction of potentially inappropriate medications using the STOPP criteria in frail older inpatients: a randomised controlled study. Drugs Aging. 2014 Apr;31(4):291-8. doi: 10.1007/s40266-014-0157-5.

ReferenceCitation: Frely A, Chazard E, Pansu A, Beuscart JB, Puisieux F. Impact of acute geriatric care in elderly patients according to the Screening Tool of Older Persons' Prescriptions/Screening Tool to Alert doctors to Right Treatment criteria in northern France. Geriatr Gerontol Int. 2016 Feb;16(2):272-8. doi: 10.1111/ggi.12474. Epub 2015 Mar 21.

collaborators: CNGE : Collège National des Généralistes Enseignants

collaborators: RMG : Institut de Recherche en Médecine Générale

location_facility: Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)


title: Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

acronym: COLORI

summary: Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer


title: Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors

acronym: PrediCTTro

summary:
Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.

The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .

To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.

The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.

The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.

location_facility: Centre Français de Référence des Maladies Trophoblastiques


title: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study

acronym: DEBIB

summary:
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).

PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.

ipd_sharing_description: NC


title: Analyse de la Prise en Charge et de l'Orientation Des Patients de 75 Ans et Plus Consultant Pour Chute Aux Urgences du CHU Angers : données de l'évaluation Initiale et du Recueil de données effectué un an après Leur Passage Aux Urgences

acronym: OREGoN

summary:
The fall is a complex process associated with high morbidity and mortality, with an institutionalization rate of up to 40% and a major socio-economic impact.

The prevalence of falls increases with age. In fact, it is estimated that one-third of people over 65 and 50% of those over 80 living at home fall at least once a year, half of whom fall repeatedly.

For all these reasons, the fall is a frequent reason for emergency consultation, and is an integral part of geriatric syndromes at risk of early readmission.

The care of the elderly patient has been the subject of good practice recommendations by the Health Authority (HAS) in 2009, with the aim of referring patients to specialized geriatric care. Among these recommendations is the need to look for signs of geriatric severity of falls.

To our knowledge, few studies have investigated the applicability of HAS recommendations with the practice of emergencies; this study is part of a project to improve practices.

- Hypothesis : Due to the fast pace of emergency medicine, the complexity of elderly patients and the inherent limitations of the care system, we hypothesize that few serious fallers are included in the geriatric pathway after admission to the emergency room (ER).

lead_sponsor: University Hospital, Angers


title: Coupling Between Saccadic Adaptation and Visuospatial Perception Process: MRI Study in Humans

summary:
Accurate execution of our directed behaviors in the immediate environment allows the vast majority of our daily activities. Through the movements of our eyes and different parts of our body, we perceive, explore and act on our environment and can exchange and communicate with others. The mechanisms of sensorimotor adaptation of saccades (saccadic adaptation) contribute on the one hand to maintain the accuracy of saccades in the short, medium and long term, by opposing the deleterious effects of various physiological changes (development, aging), pathological or environmental (optical corrections).

The aim of this study is to identify neuronal structures and networks involved in saccadic adaptation through the study of brain metabolic activation (BOLD) during the development of the adaptation of reactive saccades. The study will be organized in a single session with 3 runs. Each run include 4 blocks: 3 include the double-step target paradigm RND, U+, U-) and one without target jump (STA). The 'U+'/ 'U-'blocks include saccadic trials with forward/backward displacement of the target during a targeting saccade, the 'RND' block include saccadic trials with random target jump (forward or backward) and the 'STA' block are trials without displacement of the target. Each subject will make 12 repetitions of the 4 blocks.

intervention_type: Behavioral


title: Clinical and Electrophysiological Characterization of Essential Tremor in Children and Adolescents

summary: Essential tremor (TE) is the most common abnormal movement of the adult. His diagnosis is based on a bundle of clinical arguments (Movement Disorders Society, 1998). Well characterized in the adult, little data is available concerning child. The objective of this work is (1) to define the demographic and clinical characteristics of the TE of children and adolescents, (2) to determine the electrophysiological characteristics in the child, (3) evaluate the functional impact of TE, and assess the functional impact of TE, and assess the current management modalities of TE in children and adolescent.


acronym: SCLERODERMIE

summary:
Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).


title: Outpatient Orthognathic Surgery: "AMBOST" a One Year Prospective Study

acronym: AMBOST

summary: The aim of this prospective and observational study is to describe the conditions of orthognathic procedures performed in Toulouse Teaching Hospital over a one-year period, the outpatient-to-inpatient shifts rate and the whole outpatient rate among the whole orthognathic procedures done. The investigator also wants to identify factors associated with an outpatient-to-inpatient shift, and factors associated with the duration of hospitalization.

lead_sponsor: University Hospital, Toulouse


title: Development and Evaluation of Hygie, a New Serious Game for Continuing Medical Education of General Practitioners: a Randomized Trial

summary: We produced a prototype video game called Hygie on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva). We then carried out a randomized trial comparing the learning provided by a week of access to the game versus source articles, in a population of clinical supervisors (CS) from 13 French departments of general practice.

ReferenceCitation: Jaunay LB, Zerr P, Peguin L, Renouard L, Ivanoff AS, Picard H, Griffith J, Chassany O, Duracinsky M. Development and Evaluation of a New Serious Game for Continuing Medical Education of General Practitioners (Hygie): Double-Blinded Randomized Controlled Trial. J Med Internet Res. 2019 Nov 20;21(11):e12669. doi: 10.2196/12669.

repositories_concat: PubMed Central

publisher_dissemination: JMIR Publications

ipd_sharing: Yes

ipd_sharing_description: all collected IPD

lead_sponsor: Hygie


title: Lung Cancer and Idiopathic Pulmonary Fibrosis : Pathological and Molecular Characterization

acronym: K-FPI

summary: Retrospective inclusion of lung cancers developed in a context of idiopathic pulmonary fibrosis, diagnosed and / or treated in participating centers. The cases are recovered retrospectively from the records of the pulmonology and pathology departments of our various partners.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

acronyme: K-FPI-

titre: Cancer et Fibrose Pulmonaire : du patient vers la paillasse

nom_porteur: CAZES

prenom_porteur: Aurélie


title: Interaction Between Diaphragm and Cardiac Function During Weaning From Mechanical Ventilation

acronym: I-DISCO

summary: Weaning failure is associated with prolonged duration of mechanical ventilation that itself can worsen patient's prognosis. Therefore, identification of the causes and mechanisms leading to weaning failure is important in daily practice. While diaphragm dysfunction and pulmonary edema are two main causes of weaning failure, there are currently no data that quantify their respective contribution neither their potential co-existence. During weaning from mechanical ventilation, heart and lung interaction plays a major role. As a key factor, diaphragm function is therefore certainly involved in the occurrence of weaning-induced pulmonary edema. However, both phenomenons diaphragm dysfunction and weaning induced pulmonary edema have not been simultaneously investigated so far. This current project aims at exploring the relationship between diaphragm dysfunction and pulmonary in patients experiencing weaning failure. The objectives are 1) to quantify the respective contribution and co-existence of diaphragm dysfunction and weaning induced pulmonary edema and 2) to investigate the role of diaphragm function in the occurrence of weaning induced pulmonary edema.

primary_purpose: Diagnostic


title: Patient Outcomes After an Hospitalization in the Specialized Cognitive-behavioral Unit (UCC) of Toulon

acronym: UCC

summary: The purpose of the study is to assess the mortality of patient discharged from the specialized cognitive-behavioral unit (UCC) of Toulon.

ReferenceCitation: Walsh JS, Welch HG, Larson EB. Survival of outpatients with Alzheimer-type dementia. Ann Intern Med. 1990 Sep 15;113(6):429-34. doi: 10.7326/0003-4819-113-6-429.

ReferenceCitation: Molsa PK, Marttila RJ, Rinne UK. Survival and cause of death in Alzheimer's disease and multi-infarct dementia. Acta Neurol Scand. 1986 Aug;74(2):103-7. doi: 10.1111/j.1600-0404.1986.tb04634.x.

ReferenceCitation: Edland SD, Rocca WA, Petersen RC, Cha RH, Kokmen E. Dementia and Alzheimer disease incidence rates do not vary by sex in Rochester, Minn. Arch Neurol. 2002 Oct;59(10):1589-93. doi: 10.1001/archneur.59.10.1589.

ReferenceCitation: Fitzpatrick AL, Kuller LH, Lopez OL, Kawas CH, Jagust W. Survival following dementia onset: Alzheimer's disease and vascular dementia. J Neurol Sci. 2005 Mar 15;229-230:43-9. doi: 10.1016/j.jns.2004.11.022. Epub 2004 Dec 23.

ReferenceCitation: Lee M, Chodosh J. Dementia and life expectancy: what do we know? J Am Med Dir Assoc. 2009 Sep;10(7):466-71. doi: 10.1016/j.jamda.2009.03.014. Epub 2009 Jun 27.

ReferenceCitation: Mitchell SL, Kiely DK, Hamel MB, Park PS, Morris JN, Fries BE. Estimating prognosis for nursing home residents with advanced dementia. JAMA. 2004 Jun 9;291(22):2734-40. doi: 10.1001/jama.291.22.2734.

ReferenceCitation: Mitchell SL, Miller SC, Teno JM, Davis RB, Shaffer ML. The advanced dementia prognostic tool: a risk score to estimate survival in nursing home residents with advanced dementia. J Pain Symptom Manage. 2010 Nov;40(5):639-51. doi: 10.1016/j.jpainsymman.2010.02.014.

ReferenceCitation: Mitchell SL, Miller SC, Teno JM, Kiely DK, Davis RB, Shaffer ML. Prediction of 6-month survival of nursing home residents with advanced dementia using ADEPT vs hospice eligibility guidelines. JAMA. 2010 Nov 3;304(17):1929-35. doi: 10.1001/jama.2010.1572.

ipd_sharing_description: There is no plan to share IPD

sponsor_collaborators: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal de Toulon La-Seyne-sur-Mer


title: Interest of High Fidelity Simulation Training Beginning as Part of the Procedure Tracheobronchial Aspiration

acronym: SIMREAL

summary: The aim of this study is to compare a control group (Practical Work Group) with a High fidelity Stimulation group about competences and reasoning clinic.


title: Infiltrations of OnaBotulinum Toxin A in Resistant Depression: Comparison of Two Facial Injection Sites at Three Months.

acronym: OnaDEP

summary: The aim of the study is to evaluate in adult subjects with resistant depression the effect of an injection of botulinum toxin in the corrugator and procerus muscles, in comparison to the infiltration of the crow's feet area, in addition to the current antidepressant treatment.

lead_sponsor: Centre Hospitalier Esquirol


title: Place of Jugular Ultrasound in the Evaluation of the Volemia by a Clinician Doctor in Routine Care (JUVIA)

acronym: JUVIA

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

ReferenceType: result

ReferenceCitation: Henriot B, Scanff A, Sebillot M, Lautredoux F, Jego P. Jugular vein ultrasound for estimating changes in blood volume: a new tool for all physicians. Intern Emerg Med. 2021 Oct;16(7):2005-2007. doi: 10.1007/s11739-021-02792-y. Epub 2021 Jul 1. No abstract available.

oa_host_type: closed

publisher_dissemination: Springer-Nature

lead_sponsor: Rennes University Hospital


title: Randomized, Double-blind, Controlled and Parallel Study of the Effect of a New Nutritional Solution to Improve Intestinal Permeability in Celiac Patients

acronym: Protalsafe

summary: Celiac disease (or gluten intolerance) is recognized as one of the most common chronic diseases: prevalence of 1 in 100 to 1/300 people in Europe and the United States. To date, the treatment consists of a total elimination of any source of gluten from the diet. This eviction generates many daily constraints that would explain that more than 50% of patients do not follow this diet correctly. Hidden sources of gluten in a number of foods also carry the burden of this difficulty in effective exclusion. The objective of the ProtAlSafe study is to develop an innovative nutritional approach in the form of a dietary supplement to improve quality of life of patients. The product is not intended to replace a strict gluten-free diet but to propose a nutritional approach in the form of a dietary supplement to improve quality of life of patients. The expected benefits for people consuming the test product are an overall improvement in quality of life and an improvement in biological markers (intestinal permeability, chronic inflammation, etc.) associated with celiac disease.

lead_sponsor: Société Guaranteed Gluten Free (GGF)

collaborators: Association Française des Intolérants au Gluten (AFDIAG)


title: Heritability of Polycystic Ovary Syndrome: Role of Antimullerian Hormone, Steroids and Leptin

acronym: HERITOPK

summary:
Polycystic ovary syndrome (PCOS) is the most common cause of ovulation disorders and affects 10 to 15% of women. Despite its frequency, its physiopathology remains unknown.

In women, Anti-Müllerian hormone (AMH) is secreted by granulosa cells located in the ovaries within the follicles. Compared to control women, serum AMH level is higher in PCOS women and could play a role in its pathophysiology. The severity of the PCOS phenotype is correlated with the production of AMH.

It is currently described in the literature that daughters of women with PCOS have a 50% risk of developing PCOS, but no genetic cause of transmission is known. In mice (article in press), pregnant females injected with AMH give birth to offspring with PCOS symptoms. The AMH could thus also play a role in the heritability of PCOS in women. Our team demonstrated that AMH, in its active cleaved form, had a direct central action on the hypothalamus by increasing the pulsatility of GnRH, inducing LH hypersecretion. The hypothesis is that AMH remains higher in pregnant women with PCOS and may affect the fetus by altering fetal and maternal hypothalamic secretions or by modifying placental steroid production.

Leptin has a role in reproduction, through its receptors located at the central (hypothalamus) and peripheral (granulosa cells) levels. In excessively high serum concentration, as observed in obesity, it would lead to a dysregulation of GnRH secretion, an alteration of ovarian steroidogenesis and a dysregulation of folliculogenesis.

Will be compare leptin levels in first trimester patients with and without PCOS to look for possible correlations between AMH and leptin and eliminate possible bias.

lead_sponsor: University Hospital, Lille

intervention_type: Genetic


title: Neural Bases of the Check Process

acronym: Check

summary:
Effective exploration of the environment, check for information to improve one's own performance, are fundamental abilities of human cognition. These abilities are dependent on the process of cognitive control.

However, they are clearly impaired and uncontrollable in certain behavioral disorders such as obsessive-compulsive disorder (OCD). Compulsive checks of these patients, spontaneously associated with a feeling of intense uncertainty, suggest disturbances of evaluative and metacognitive functions. However, no biological observations have yet been able to feed these hypotheses.

The evaluation of decisions and actions involves the middle cingulate cortex (MCC) (which belongs to a cortico-subcortical network structurally and functionally altered in OCD patients). Cingulotomy has long been used as a therapy in severe OCD, with However, the precise part of the cingulate cortex that contributes to check (and its pathological forms) remains to be discovered.

The purpose of this research campaign is to determine, through functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) in healthy human subjects:

the location and role of the MCC region involved in normal check decision processes,
determine the identity of the entire network involved

lead_sponsor: Hospices Civils de Lyon


type: EudraCT Number

title: Whole Brain Connectivity Changes Induced by Traumatic Coma: Combined Structural, Functional and Neuroinflammatory Approaches

summary: To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).

design_allocation: Non-Randomized

ReferenceCitation: Laureys S, Owen AM, Schiff ND. Brain function in coma, vegetative state, and related disorders. Lancet Neurol. 2004 Sep;3(9):537-46. doi: 10.1016/S1474-4422(04)00852-X.

ReferenceCitation: Schiff ND. Recovery of consciousness after brain injury: a mesocircuit hypothesis. Trends Neurosci. 2010 Jan;33(1):1-9. doi: 10.1016/j.tins.2009.11.002. Epub 2009 Dec 1.

ReferenceCitation: Silva S, de Pasquale F, Vuillaume C, Riu B, Loubinoux I, Geeraerts T, Seguin T, Bounes V, Fourcade O, Demonet JF, Peran P. Disruption of posteromedial large-scale neural communication predicts recovery from coma. Neurology. 2015 Dec 8;85(23):2036-44. doi: 10.1212/WNL.0000000000002196. Epub 2015 Nov 11.

ReferenceCitation: Chauveau F, Van Camp N, Dolle F, Kuhnast B, Hinnen F, Damont A, Boutin H, James M, Kassiou M, Tavitian B. Comparative evaluation of the translocator protein radioligands 11C-DPA-713, 18F-DPA-714, and 11C-PK11195 in a rat model of acute neuroinflammation. J Nucl Med. 2009 Mar;50(3):468-76. doi: 10.2967/jnumed.108.058669. Epub 2009 Feb 17.

ReferenceCitation: Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

ReferenceCitation: Mattia GM, Sarton B, Villain E, Vinour H, Ferre F, Buffieres W, Le Lann MV, Franceries X, Peran P, Silva S. Multimodal MRI-Based Whole-Brain Assessment in Patients In Anoxoischemic Coma by Using 3D Convolutional Neural Networks. Neurocrit Care. 2022 Aug;37(Suppl 2):303-312. doi: 10.1007/s12028-022-01525-z. Epub 2022 Jul 25.


title: Collection of Biological Resources During Medical Care of Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase for an Epigenetic Study of Leukemic Stem Cells

acronym: EPIK

summary: Primary objective : To identify epigenetic dysregulations of in vivo TKI-resisting CML cells Hypothesis : An epigenetic dysregulation is involved in the in vivo survival of a CML cell subclone despite the use of TKIs

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Institut Bergonié Bordeaux, hematology department

collaborators: CHU Saint-Etienne, hematology department

collaborators: Institut Universitaire du Cancer de Toulouse - Oncopole, hematology department

collaborators: AP-HP Hôpital Henri-Mondor, hematology department


title: SelfEPO - Therapeutic Education of Chronic Renal or Renal Transplant Patient in the Management of EPO Injections

acronym: SELFEPO

summary:
In chronic kidney disease, ESAs (Erythropoiesis-stimulating agents) are used to treat anemia. This anemia is due to decreased renal production of erythropoietin (EPO), a hormone that stimulates the production of red blood cells in the bone marrow. Treatment of anemia increases survival, decreases morbidity and improves quality of life and exercise tolerance.

Self-administration of ASE has been encouraged for many years, notably with pens for injection, but only few patients are educated in the injection technique.

The investigators therefore wish to lead a study in the Nephrology department of Rennes University Hospital to educate the patient, or his or her spouse, on ESA injections during hospitalization, in order to empower the patient in his care, and with the second aim of reducing the costs of chronic renal insufficiency.


acronym: CYST-HD

summary: The purpose of this project is to study Huntington's disease by metabolomic approach.

title: Metabolomic Study in Huntington's Disease


title: Patients With Ocular Neuropathic Pain: Description of Pain and Impact on Their Quality of Life

acronym: QUALVIDON

summary:
Some patients with dry eye may have severe disabling neuropathic pain. They describe spontaneous pain, dysesthesia, hyperalgesia or even allodynia. It is classical to note an important discordance between the high intensity of the symptoms and the poverty of the clinical signs. These pains are often unrecognized and therefore often not sufficiently treated. A significant impact on patient's quality of life may occur. The concept of ocular neuropathic pain being relatively recent, few studies have focused on the subject at present. Our study aims to shed light on these pains in patients consulting for dry eyes at the Ophthalmological Foundation A. de Rothschild.

The objective of our study is to describe precisely the characteristics of neuropathic eye pain and the visual, general and psychological repercussions in these patients.

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtamologique A. de Rothschild


title: Voluntary Drug Poisoning by Psychoactive Molecules: Identify Cognitive Markers Predictive of a Preserved Memory of Care in Psychiatric Emergencies

acronym: IMG-COG

summary: To identify in patients admitted for Voluntary drug poisoning (IMV) by psychoactive substances, T1 predictors of T2 recall of psychiatric interview and care project.


title: Arnold Chiari Malformation: the Otological Assessment as an Objective Criteria for Surgical Treatment

acronym: MCoto

summary: The aim of this study is to compare the value of multifrequency tympanometry between patients with surgical indication of treatment for a Chiari type I malformation and healthy volunteers.

lead_sponsor: University Hospital, Bordeaux


title: Coronary Artery Disease and Coronary Microvascular Disease in Cardiomyopathies Registry

summary: Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

status: Recruiting

lead_sponsor: University Hospital, Grenoble

collaborators: Groupe Hospitalier Mutualiste de Grenoble


title: Mechanical Ventilation Weaning Prediction Improved by Diaphragmatic Ultrasound Associated With the Rapid Shallow Breathing Index

acronym: CODEX

summary:
The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm.

Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD.

The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.

ReferenceCitation: Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.

ReferenceCitation: DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

ReferenceCitation: Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

ReferenceCitation: Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

ReferenceCitation: Forgiarini LA Junior, Esquinas AM. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2016 Jul-Aug;42(4):306. doi: 10.1590/S1806-37562016000000099. No abstract available.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Dynamic Arterial Elastance: an Indirect Marker of the Critical Capillary Pressure at the Microcirculatory Level (POEME)

acronym: POEME

summary: The measurement of dynamic arterial elastance (Eadyn) was proposed as a marker of vascular tone. It is calculated by the ratio of the respiratory variation of the pulse pressure and the respiratory variation of stroke volume. Despite several clinical studies, no study has really focused on the physiological significance of Eadyn. No study demonstrates at present, if this index is a reflect of macrocirculatory parameters (systemic resistances, blood pressure, arterial elastance, ventricular elastance, ventriculo-arterial coupling) or microcirculatory tone in the capillaries and small arterioles (critical capillary pressure or capillary resistance). the physicians don't know which variables are associated with this index. the hypothesis is that Eadyn is an indirect reflect of capillary pressure (PCC).

ReferenceCitation: Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation

acronym: GAVI

summary: The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies (ART) center of Toulouse.


title: Study of Natural Killer Immunity During Infections With CMV or AdV After Allogeneic Hematopoietic Stem Cells

acronym: Allo-NK-CMV

summary: NK cells are lymphocytes who play a role in the control of viral infections , tumor and fœtal tolerance. They belong to innate immune cells but they have a link with adaptative immunity. Indeed, after some viral infections such as CMV, Chikungunya, B hepatitis etc, a subset of NKG2C+ NK cells expands and can transfer, in murine models, a " memory " that can better control CMV infections. CMV reactivation is a major cause of morbidity and mortality after allogeneic hematopoietic ste cell transplantation in humans. The aim of this prospective study is to evaluate the role of NK cells, in particular NKG2C+ NK cells in the control of CMV but also Adenovirus after allo HSCT. Peripheral NK cells from 30 and 10 patients who reactivated respectively CMV and AdV are prospectively studied (extensive phenotyping and functional studies before and after administration of anti viral drugs) and compared with 30 allotransplanted patients who didn't reactivate CMV in a pair analysis, and 30 healthy donors serologically + for CMV.


title: Intraabdominal Hypertension After Kidney Transplantation : Incidence and Associated Factors

acronym: KITIV

summary:
Intraabdominal hypertension (IAH) is a frequent and severe condition affecting intensive care patients. Gold standard for estimation of intraabdominal pressure is intravesical pressure (IVP) measurement. IVP measurement is recommended in patients presenting IAH risk factor(s). Acute kidney injury is the most frequent and described complication of IAH condition.

Patients undergoing kidney transplantation have several risk factors to develop IAH. Nevertheless, to our knowledge, IAH incidence, associated factors and impact on renal function recovery remains unknown.

We aim to study IAH incidence, associated factors and impact on renal function recovery in post kidney transplantation period.

ReferenceCitation: Dupont V, Debrumetz A, Leguillou A, Morland D, Wynckel A, Colosio C, Mokri L, Schvartz B, Vuiblet V, Larre S, Barbe C, Rieu P. Intra-abdominal hypertension in early post-kidney transplantation period is associated with impaired graft function. Nephrol Dial Transplant. 2020 Sep 1;35(9):1619-1628. doi: 10.1093/ndt/gfaa104.

publisher_dissemination: Oxford University Press

lead_sponsor: CHU de Reims


title: Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates: Double Filtration PlasmaPheresis (DFPP) vs Large Plasma Volume Specific ImmunoAdsorption

acronym: DADI

summary:
Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. However, breaking the ABO barrier is possible only with a preconditioning regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of apheresis are available. To date, two main techniques used in clinical setting are the Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP permits the depletion of the selective plasma fraction containing Immunoglobulins, while limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a major loss in essential plasma components. To date, no randomized study comparing DFPP and SIA exist. SIA is less often used because of its high cost. However, in order to reduce the number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A large part of the difference in the cost is related to the apheresis technique.

Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP and SIA to desensitize ABO incompatible kidney transplant candidates.

location_facility: University Hospital Toulouse (Hospital Rangueil)


title: Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples

acronym: ARMED NEO

summary: In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers. These are now integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. The ARMED project (2012-2015) funded by the ANSM, whose goal was to prioritizing the risk linked to the migration of these plasticizers from MDs, has shown that TOTM and DEHT present the best benefit / risk ratio due to lower migration and cytotoxicity. Nevertheless, it is important to evaluate the level of exposure of neonatal intensive care patients, due to the multi exposure to MD made of PVC, the frequent use of intravenous route and the vulnerability of this at-risk population to the metabolites of these plasticizers.


title: TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma - A Phase Ib Clinical Study

acronym: TICIMEL

summary: This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.

ReferenceCitation: Montfort A, Filleron T, Virazels M, Dufau C, Milhes J, Pages C, Olivier P, Ayyoub M, Mounier M, Lusque A, Brayer S, Delord JP, Andrieu-Abadie N, Levade T, Colacios C, Segui B, Meyer N. Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial. Clin Cancer Res. 2021 Feb 15;27(4):1037-1047. doi: 10.1158/1078-0432.CCR-20-3449. Epub 2020 Dec 3.

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Institut Claudius Regaud

intervention_type: Combination Product


title: Phenotypic and Functional Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis, a Pilot Study.

acronym: CATERLIS

summary:
In rheumatoid arthritis (RA) the clinical response to anti-TNFα is related to an increase in the number or in the function of Treg lymphocytes in the peripheral blood of patients. This observation suggests the central role of Tregs in homeostasis of the immune response during RA.

In the literature the Tregs frequency and phenotype in the peripheral blood are well documented, however the analyses done on the Tregs in inflamed environment are still fragmentary or disparate.

In this project Tregs phenotype as well as expression of several transcripts will be analysed in order to better characterize the Treg cell subsets within the synovial fluid. Moreover, the local inflammatory cytokines (TNF, IL-6 and IL-1) may affect both the phenotype and the suppressive function of these Tregs and a comparison between peripheral and tissue Tregs will allow us to better understand the cause of functional loss.

Outcomes:

Primary outcome: Identification and characterization of the Tregs subpopulation present in the synovial fluid for RA patients suffering an episode of acute arthritis.

Secondary outcomes: compare the phenotypic and expression profile of the Tregs present in the synovial fluid with the Tregs present in the peripheral blood of RA patients suffering from an episode of acute arthritis.

lead_sponsor: University Hospital, Montpellier


title: MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin

acronym: MISOBOLD

summary: This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.

sponsor_collaborators:
University Hospital, Bordeaux
Cancéropôle GSO and GIRCI SOOM (API-K)


title: The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma

acronym: BIGHPANC

summary: The primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I to IV) of pancreatic adenocarcinoma lesion.

status: Active, not recruiting

lead_sponsor: Centre Leon Berard


title: Does the Urine Concentration of TIMP2*IGFBP7 Can Distinguish Patients Who Will Present Transient or Persistent Acute Kidney Injury During Septic Shock? A Retrospective Analysis. BIOCHECK

acronym: BIOCHECK

summary: Patients with septic shock in the intensive care unit have a high risk to develop acute kidney injury (AKI) and AKI is an independent risk factor of mortality. Given the absence of validated pharmacological treatments for limiting the progression of AKI or for accelerating recovery from AKI, early intervention and the restoration of the glomerular filtration rate (GFR) in this context of septic shock might improve the patients' prognosis. One major challenge is to determine whether or not the AKI is reversible (return to normal function KDIGO 0 within 72 hours). In this retrospective study the investigators will analyze all patients admitted for a septic shock in three French ICUs between the 1st january 2014 and 01st January 2017 who developed an AKI (KDIGO ≥1) at admission and who had a determination of the urine concentration of TIMP2*IGFBP7 at admission. The investigators will determine the best threshold of TIMP2*IGFBP7 to distinguish the population of patients who will return to normal kidney function within 72 hours (KDIGO 0).

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Clinical and Molecular Characterization of Cerebral Proliferative Vasculopathy

acronym: VPCA

summary:
As principal objective, the study aims to:

Describe the spectrum and evaluate the frequency of angiodysplasia of the nevrax;
Establish the physiopathological basis of Fowler's syndrome;
Identify FLVCR2 partners and the signaling pathways involved;
Test new candidate genes: GPR124 and possible partners of FLVCR2.

As second objective, the study aims to:

perform phenotype / genotype correlation if necessary;
and propose a prenatal diagnosis in families with identified mutations.

time_perspective: Other

ReferenceCitation: Thomas S, Encha-Razavi F, Devisme L, Etchevers H, Bessieres-Grattagliano B, Goudefroye G, Elkhartoufi N, Pateau E, Ichkou A, Bonniere M, Marcorelle P, Parent P, Manouvrier S, Holder M, Laquerriere A, Loeuillet L, Roume J, Martinovic J, Mougou-Zerelli S, Gonzales M, Meyer V, Wessner M, Feysot CB, Nitschke P, Leticee N, Munnich A, Lyonnet S, Wookey P, Gyapay G, Foliguet B, Vekemans M, Attie-Bitach T. High-throughput sequencing of a 4.1 Mb linkage interval reveals FLVCR2 deletions and mutations in lethal cerebral vasculopathy. Hum Mutat. 2010 Oct;31(10):1134-41. doi: 10.1002/humu.21329.


title: Evaluation of Indirect Measurement of Respiratory Quotient in Non-cardiac Major Surgery as a Predictor of Anaerobic Metabolism (The BAR Study) Indirect Respiratory Quotient as a Predictor of Anaerobic Metabolism

summary: Demonstrate the ability of the RQ, measured indirectly from the anesthesia ventilator, to predict the occurrence of anaerobic metabolism in patients operated of major non-cardiac surgical operation in the operating room

ReferenceCitation: Bar S, Grenez C, Nguyen M, de Broca B, Bernard E, Abou-Arab O, Bouhemad B, Lorne E, Guinot PG. Predicting postoperative complications with the respiratory exchange ratio after high-risk noncardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2020 Nov;37(11):1050-1057. doi: 10.1097/EJA.0000000000001111.


title: Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.

acronym: OXMNM

summary:
Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.

The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.

lead_sponsor: University Hospital, Tours


title: Neuropsychological Management of Multiple Sclerosis: Benefits of a Computerised Semi-autonomous At-home Cognitive Rehabilitation Programme

acronym: SEPIA

summary:
Multiple sclerosis (MS) is a central nervous system inflammatory disease that causes a chronic and progressive physical handicap. Though primarily considered as a motor disease, it may, in 40 to 65% of cases, cause cognitive function deficits, concerning mainly attention, information processing speed, executive functions and memory. The impairment of these various functions may significantly impair the patients' social, professional and family lives. As such, the presence of cognitive difficulties is more frequently associated with the onset of anxio-depressive psychiatric symptoms and with reduced quality of life to the extent that it can be estimated via psychometric scales, or by a more qualitative approach. Recent research has focused, not on demonstrating the existence of cognitive disorders in MS, but rather on attempting to reduce their daily impact through cognitive rehabilitation programmes. While encouraging, the available results are relatively discordant and further work is required to demonstrate the actual efficacy of such programmes applied to daily life and of their long-term effects.

The main objective of this work is to evaluate, in patients suffering from MS and presenting with cognitive disorders and/or with complaints, the effect of an innovative computerised, semi-autonomous at-home cognitive rehabilitation programme, following care, on quality of life. The secondary objective is to estimate the improvement, or even stabilisation over time, of patients' cognitive performance and psycho-affective sphere.

In this randomised trial, the investigators plan to include 40 patients suffering from the RR and SP forms of MS, distributed to two groups paired by age, gender and socio-cultural level, one of which will benefit from computerised management, along with at-home support from a psychologist, while the other receives only the support.

This work is expected to provide two types of benefits. Firstly, to enable patients to better understand their cognitive function via daily management and as such to improve their quality of life and self-esteem. Secondly, to eventually allow more appropriate patient management by combining the quasi-systematic use of this programme with follow-up consultations with referring practitioners (neurologists, psychologists, etc.).

lead_sponsor: University Hospital, Caen


title: Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia

acronym: CroyAid-SCZ

summary:
Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.


title: Predictive Factors for Failure or Success of Endoscopic Treatment of Superficial Colorectal Tumors

acronym: REC

summary: To evaluate the long-term complete remission rate (> 12 months) after endoscopic treatment of early neoplastic colorectal lesions.

ReferenceCitation: Dixon MF. Gastrointestinal epithelial neoplasia: Vienna revisited. Gut. 2002 Jul;51(1):130-1. doi: 10.1136/gut.51.1.130.

ReferenceCitation: Repici A, Pellicano R, Strangio G, Danese S, Fagoonee S, Malesci A. Endoscopic mucosal resection for early colorectal neoplasia: pathologic basis, procedures, and outcomes. Dis Colon Rectum. 2009 Aug;52(8):1502-15. doi: 10.1007/DCR.0b013e3181a74d9b.

ReferenceCitation: Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub 2014 Jul 1.

ReferenceCitation: Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

oa_colors: green other

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher_dissemination: Georg Thieme

ReferenceCitation: Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.

lead_sponsor: Institut Paoli-Calmettes


title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

acronym: QUALIPRO

summary: This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.

lead_sponsor: Centre Oscar Lambret

collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation


title: Posterior Reversible Encephalopathy Syndrome in the Critically Ill Patients

summary: Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview

lead_sponsor: Ictal Group

sponsor_collaborators:
Ictal Group
Versailles Hospital

location_facility: Intensive Care Unit - Versailles Hospital


title: Unicentric Retrospective Analysis of a Cohort of 602 Young Adult and Adolescent Patients (AJA), Aged 15 to 30 Years, With Haematological Malignancies, and Managed Between 2000 and 2016

acronym: HEMAJA

summary: Unicentric retrospective analysis of a cohort of 602 young adult and adolescent patients, aged 15 to 30 years, with haematological malignancies, and managed between 2000 and 2016


title: Itch and Pain Characteristics in Skin Carcinomas

acronym: PRURITCC

summary: The objective of this study is to have better knowledge about sensations of patients with skin carcinomas and to have data about characteristics of pain and pruritus . All patients presenting with a suspicions lesion for skin carcinomas will be included and will respond to a questionnaire. Demographics data, and histological data about skin carcinomas will be collected.

lead_sponsor: University Hospital, Brest


title: Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH

acronym: AMETHYST

summary:
Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.

sponsor_collaborators:
University Hospital, Caen
Amiens University Hospital


title: Hypnosis as a Therapeutic Tool in Patients With Reccurent Cystitis

acronym: HYPNOCYST

summary:
Half of the women present an episode of cystitis once in their lives. A recurrence occurs in about 20% to 30% of the patients, and half of these patients will make more than 4 episodes per year, defining recurrent cystitis (CR).

Complications such as pyelonephritis are rare (less than 0.5% of patients in the absence of underlying complication), however, CRs are responsible for a significant impact on women but also on society. Pain is at the forefront, but also the fear of not managing pollakiuria, with its social exclusion. The impact on sexuality is major. The medical circuit imposed on the patients is long and arduous. The clinical assessment sometimes reveals favorable factors, variable in pre- or post-menopause, but in the majority of cases, no explanatory cause can resolve the problem and some authors suggest resignation as a classic reaction to this problem. The only study on psychological disorders associated with recurrent cystitis suggests patients who are much more anxious than the average of female.

Hypnotherapy is an old technique, used for care in Western societies for at least two hundred years. By the word, the practitioner induces in the patient a particular state of consciousness characterized by an indifference on the outside and a hyper suggestibility. This "hypnotic" state of consciousness can be used to amplify the patient's internal resources to fight against anxiety and pain, and to eliminate symptoms.

The physiological mechanisms at work in hypnosis are the subject of recent studies becoming more and more precise. The results of these studies made it possible to objectify changes in cerebral functioning related to hypnotic trance.

A report by Inserm of 2015 confirms the effectiveness of this practice in hypnosedation, hypnoanalgesia and hypnotherapy, particularly in irritable bowel syndrome, although the methodology to be used in its evaluation is difficult and subjective. The principal investigator hypothesizes that the symptoms presented in recurrent cystitis (pain, anxiety) can be improved by hypnotherapy, and that thus the prognosis of this pathology can be totally modified.

In the absence of any study published in the literature, the investigator propose an intervention pilot study with minimal risks and constraints monocentric prospective non-randomized prospectively in 15 patients.

The main objective of this project is to demonstrate that hypnotherapy improves the psycho-emotional parameters of patients suffering from recurrent cystitis after 3 hypnosis sessions combined with home exercises performed by the patient. The evaluation will be carried out during the last session of hypnosis.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Early Identification of Patients in Surgical Intensive Care With a Risk of Acute Respiratory Distress Following Visceral Surgery: Prognostic Value of Pulmonary Extravascular Water Revealed by Pulmonary Ultrasound.

acronym: ODR

summary:
Today there are few studies in the literature involving patients in an ICU following major visceral surgery. There are thus few results about the prognostic value of pulmonary extravascular water in this population of patients, but also the prognostic value of pulmonary extravascular water measured at the bedside using pulmonary ultrasound.

In addition, pulmonary ultrasound will be combined with echocardiography to measure left ventricular function (LVEF) and to study the profile of the mitral valve to assess filling pressure in patients with immediate post-operative ventilation. This will make it possible to distinguish between increases in pulmonary extravascular water associated with high filling pressure and increased pulmonary water associated with low filling pressure: characteristic of lesional oedema.

The aim of this study is to determine the prognostic value of extravascular pulmonary water (PEVW) diagnosed using pulmonary ultrasound in patients admitted to an ICU following scheduled or emergency visceral surgery in the onset of acute respiratory distress requiring invasive mechanical ventilation, or prolonged post-operative intubation, or non-invasive.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

acronym: DHA

summary: Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


title: Clinical Evaluation of a Brain Computer Interfaces (BCI)-Based Training of Attention in Children With Attention Deficit Hyperactivity Disorder (ADHD)

acronym: MyB

summary:
This project aims to assess the evolution of symptoms in ADHD children from 8 to 17 years, with various types of attention training.

Different groups A, B and C will be evaluated: the first with Neurofeedback training, the second with a similar training but not indexed on brain activity and the third without training.

30 patients will be randomly assigned to groups A and B according to a ratio 2:1.

Others patients who meet the same criteria but for logistical reasons cannot comply with the training constraints will be assigned to group C.

Children included in groups A and B will participate in training sessions (Neurofeedback and control training, respectively) as well as in four evaluation sessions. Children in group C will only participate in evaluation sessions (baseline control group).

Patients of groups A and B will be followed over 6 months: 4 months of training and a follow-up evaluation 2 months after training.

Patients of group C will be followed each 2 months for 6 months. This study uses electro-encephalography measures, serious video game, neuropsychological tests and questionnaires.

It also uses actigraphy measures to evaluate sleep quality.

lead_sponsor: Hospices Civils de Lyon


title: Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance

acronym: PRECOG

summary: The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of gestation.

ReferenceCitation: Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. doi: 10.1210/jc.2003-030528.

ReferenceCitation: Sibiude J, Guibourdenche J, Dionne MD, Le Ray C, Anselem O, Serreau R, Goffinet F, Tsatsaris V. Placental growth factor for the prediction of adverse outcomes in patients with suspected preeclampsia or intrauterine growth restriction. PLoS One. 2012;7(11):e50208. doi: 10.1371/journal.pone.0050208. Epub 2012 Nov 28.

ReferenceCitation: Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM CESP1018


title: A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients

summary: The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).

ReferenceCitation: Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.

lead_sponsor: Mondelēz International, Inc.

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe


title: Pilot Study Evaluating a Perioperative E-follow-up Protocol in Patients With Ambulatory Surgery for Breast Cancer

acronym: PITCA

summary:
This is a monocentric, prospective cohort study evaluating the feasibility of a perioperative e-follow-up protocol in patients with ambulatory surgery for breast cancer.

This protocol will be based on:

A coordinated ambulatory follow-up performed by a dedicated nurse
An electronic follow-up tool used in pre- and post-surgery

Patients will be followed 8 days before the surgery until 30 days after the surgery of breast cancer.


title: Effects at 12 Weeks of Transcranial Direct Current Stimulation on the Cognitions of People Presenting Early Alzheimer's Disease (tDCS-AD)

acronym: tDCS-AD

summary:
TDCS is a rapidly expanding technique, used to treat cognitive difficulties associated with many pathologies (Parkinson's disease, rehabilitation after head trauma, etc.), but which remains of the field of research.

Its use remains very experimental, and concerns the exploration of cognitions, in healthy and diseased subjects. There are not many studies on the elderly subject with Alzheimer's disease, nor do they document the medium- and long-term effect (more than one month), nor the effect on geriatric parameters such as Fragility indices and the risk of falls, especially at home. These characteristics are decisive because they define the level of autonomy.

The investigators therefore wish to study the effect of a 2-week treatment with tDCS (tDCS active) versus placebo (2-week tDCS group) for a three-month period.

lead_sponsor: Benjamin CALVET


title: Fatigue After Stroke

acronym: Fatigue AVC

summary:
Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.


title: Evaluation of the Detection of B D Glucan in Peritonitis Fluid in Intensive Care Unit (ICU) Patients With Peritonitis for the Diagnosis of Fungal Peritonitis, Compared to Routine Microbiology Diagnosis Method. The PERICAND Study

acronym: PERICAND

summary:
Invasive candidiasis has a high mortality rate, around 40%. Outcome remains tightly linked to the time of treatment administration. Routine microbiological techniques give results too lately to allow prompt antifungal therapy initiation (at least 48 hours). It is important to develop diagnostic tools to initiate antifungal therapy as early as possible.

The B D glucan detection, one of the major components of the candida cell wall, can be useful for a early diagnosis.

There are several techniques on the market for the detection of glucan. In Europe and America, the most used is Fungitell (Associated of Cape Cod, Inc).

There is several studies about the use of such kits for fungemia. A number of studies are reporting evidences of a early diagnosis.

But, in medical literature, there isn't study focused on the detection of B D glucan in peritoneal fluid for Candida peritonitis diagnosis.


title: Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.

acronym: PUC NAVIO

summary:
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.

Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.

The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.

The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith & Nephew).

The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.

sponsor_collaborators:
Hospices Civils de Lyon
Smith & Nephew, Inc.


title: Effect of a Combined Language Therapy (Linguistic/Communication) on Aphasia After Stroke in Acute Phase: A Prospective, Controlled, Monocentric Pilot Study

acronym: ORACLE

summary: Linguistic training is traditionally the gold standard for rehabilitation of aphasia after stroke and efficacy criteria count early stage, intensity as well as personalized treatment. To date, no clear evidence showed a specific effect of any therapy in the acute phase of aphasia after stroke. This study aims to compare the effect of a combined therapy (linguistic/communication) versus a linguistic therapy on communication performance in patients in the acute phase of aphasia after a first stroke.

ReferenceCitation: Galletta EE, Barrett AM. Impairment and Functional Interventions for Aphasia: Having it All. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):114-120. doi: 10.1007/s40141-014-0050-5.

ReferenceCitation: Bhogal SK, Teasell R, Speechley M. Intensity of aphasia therapy, impact on recovery. Stroke. 2003 Apr;34(4):987-93. doi: 10.1161/01.STR.0000062343.64383.D0. Epub 2003 Mar 20.

ReferenceCitation: Tippett DC, Niparko JK, Hillis AE. Aphasia: Current Concepts in Theory and Practice. J Neurol Transl Neurosci. 2014 Jan;2(1):1042.

ReferenceCitation: Jorm AF, Jacomb PA. The Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): socio-demographic correlates, reliability, validity and some norms. Psychol Med. 1989 Nov;19(4):1015-22. doi: 10.1017/s0033291700005742.

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