title: Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery

acronym: CAVIT

summary: In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de RENNES


title: Clinical Evaluation Of An X-Ray Bone Densitometer: Use Of DXA Technology For Precise Assessment Of Body Composition In Humans

summary:
The main objectives of this study are:

to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic QDR 4500 A by Hologic inc.
to assess the concordance of body composition measures between two bone densitometry devices: the STRATOS by Diagnostic Medical Systems (DMS) and the Hologic HORIZON A by Hologic inc.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Diagnostic Medical Systems

location_facility: Centre Hospitalier Universitaire de Montpellier

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


type: Other Identifier

title: A Phase 1, Single-center, Open-label, 2-period, Single Sequence Drug-drug Interaction Study to Evaluate the Effects of Multiple-dose Rifampicin on the Pharmacokinetics and Pharmacodynamics of Single Dose Sotagliflozin in Healthy Male and Female Subjects

summary:
Primary Objective:

To evaluate the effects of rifampicin on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects.

Secondary Objectives:

To assess total 24-hour urinary glucose excretion (UGE) after a dose of sotagliflozin 400 mg, alone and with rifampicin, in healthy male and female subjects.
To assess the safety and tolerability of single dose sotagliflozin with and without rifampicin in healthy male and female subjects.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

lead_sponsor: Sanofi

intervention_type: Drug

status_simplified: Completed


title: Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study

acronym: FINDOL

summary:
Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.

To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.

The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Montpellier

lead_sponsor_type: academique


title: Search of a Paradoxical Fall in Maximum Expiratory Flow After Bronchodilation in Healthy Subjects

acronym: VACUVOL

summary: There exists a physiological limitation of the expiratory flows because of the physical properties of the bronchial tree (flexible bronchial walls in a complex architecture subjected to variations of pressure and volume). For a given lung, in a given state, for each pulmonary volume there is a corresponding Maximum Expiratory Flow (MEF). In healthy subject, the bronchial smooth muscles have a basal tonicity which is not negligible. If the tonicity is increased, this generally leads to a reduction in MEF. If it is decreased, MEF rather tends to increase, there are healthy individuals for whom the inhibition of the contraction of the bronchial smooth muscles by inhalation of bronchodilatator leads to a reduction in the MEF: this is called "paradoxical effect". When this reduction exists, it appears it occurs at low pulmonary volumes (approximately 50% for a volume of less than 25% of the CV). Under this circumstance, it seems that the basal tonicity of the bronchial smooth muscles would fight against the expiratory collapse of the bronchi, and this would happen especially for distal bronchi, for low pulmonary volume and for forceful expiration. The existence of such a phenomenon would be in favour of a "stiffening" role of the bronchial smooth muscles. The bronchial smooth muscles would not be only harmful cells causing of the asthma attacks.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: "ART REGISTRY : Rheumatoid Arthritis and Anti-TNF"

acronym: ART

summary:
Rheumatoid arthritis (RA) is a complex and multifactorial autoimmune disease. The biological treatments that are currently available for the treatment of RA are the TNF-alpha inhibitors. Tumor necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. The anti-TNFs were the first to enter the market, and they revolutionised the prognoses of patients with RA. They remain the most common first-line biotherapy and are the most used at this time.

The French Society of Rheumatologists intends to coordinate a prospective national registry study for this follow-up.

This registry will include 1500 RA patients from the start of treatment with anti-TNF-α and then followed for 5 years, regardless of the therapeutic modifications occurring thereafter.

This registry is an observational, multicentre, longitudinal, prospective registry study The objectives of this registry is to contribute 1) to evaluate the therapeutic management of patients; and 2) to improve this therapeutic management.

status: Recruiting

study_type: Observational

time_perspective: Prospective

intervention_type: Other

status_simplified: Ongoing


title: Exploration of the Mechanism of Movement Improvement During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RBD) in Parkinson's Disease Using Near-infrared Spectroscopy (NIRS)

acronym: NIRS-RBD

summary: The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's disease and to explore the neuronal network involved in this improvement using NIRS.

primary_purpose: Other

lead_sponsor: Clinique Beau Soleil


title: Deductive Reasoning and Math Learning Difficulty: an fMRI Study in Children

summary: Most studies to date that have examined the factors underlying math achievement in children have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic numerical knowledge and recent behavioral studies suggest a relationship between math and deductive reasoning skills. The goal of this study is to determine the neural mediators of this relationship using functional magnetic resonance imaging. The investigators will ask children from 8 to 14 to complete a standardized math achievement test, and measure their brain activity while they process deductive arguments. The investigators will then correlate brain activity during reasoning to individual math skills to identify the brain regions in which activity during reasoning is modulated by math skill.

lead_sponsor: Hospices Civils de Lyon


title: Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation After an Acute Coronary Syndrome (REHABDIAB [REHABilitation for Coronary Disease and DIABetes])

acronym: REHABDIAB

summary: Because prevalence of glucose metabolism disorders is high in patients with coronary disease, the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after an acute coronary syndrome (ACS). However, there are some concerns about its performance in clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in comparison with its real application in the whole French population.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Study of Olfaction / Vision Interactions in Expert and Novice Populations

summary: The aim of this research project is to better understand the reciprocal influence of visual and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the importance of olfacto-visual learning in expert situations, the degree of expertise in olfaction will also be considered. In addition, the investigators will try to better understand the differences between expert and non-expert populations in olfaction through different levels of approach: sensory, genetic and cerebral. To achieve this, the investigators will use psychophysical tests, genetic analyzes and a non-invasive technique, functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects - novices or experts in olfaction - in response to different visual and olfactory stimuli.


title: Sleep Inertia and Functional Connectivity Between Brain Regions at Awakening : a Functional Magnetic Resonance Imaging (fMRI) Study

summary: The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.


title: Neural Correlates of Multimodal Face/Voice Processing in a Gender Task.

acronym: Face-Voice

summary: Bayesian models of perception represent a promising approach to describe information processing by the brain. Predictive coding hypothesizes a process in which top-down expectations are continuously compared across multiple hierarchical levels with bottom-up sensory inputs and the differences or error signals are propagated in a bottom-up direction. The investigators hypothesize that strong expectations, are best investigated in expert processes such as face and voice recognition in humans. Individuals in complex social systems need to extract socially relevant information in a fast and efficient manner; hence, the majority of humans constitute face, voice and gender experts. Nevertheless, linking such combined abilities to brain activity with regards to the predictive coding hypothesis has not been attempted.Our results suggest asymmetric contributions of visual and auditory signals to the gender classification task. This sensitive psychophysical procedure is implemented in a decoding approach using fMRI and multi-voxel pattern analysis (MVPA). The investigators plan to test whether cortical areas implicated in processing auditory and visual gender signals show similar asymmetries.

ReferenceType: background

ReferenceCitation: Gerardin P, Kourtzi Z, Mamassian P. Prior knowledge of illumination for 3D perception in the human brain. Proc Natl Acad Sci U S A. 2010 Sep 14;107(37):16309-14. doi: 10.1073/pnas.1006285107. Epub 2010 Aug 30.

ReferenceCitation: Wacongne C, Changeux JP, Dehaene S. A neuronal model of predictive coding accounting for the mismatch negativity. J Neurosci. 2012 Mar 14;32(11):3665-78. doi: 10.1523/JNEUROSCI.5003-11.2012.

ReferenceCitation: Pegado F, Comerlato E, Ventura F, Jobert A, Nakamura K, Buiatti M, Ventura P, Dehaene-Lambertz G, Kolinsky R, Morais J, Braga LW, Cohen L, Dehaene S. Timing the impact of literacy on visual processing. Proc Natl Acad Sci U S A. 2014 Dec 9;111(49):E5233-42. doi: 10.1073/pnas.1417347111. Epub 2014 Nov 24.

ReferenceCitation: Markov NT, Ercsey-Ravasz M, Van Essen DC, Knoblauch K, Toroczkai Z, Kennedy H. Cortical high-density counterstream architectures. Science. 2013 Nov 1;342(6158):1238406. doi: 10.1126/science.1238406. Review.

ReferenceCitation: Charrier C, Knoblauch K, Maloney LT, Bovik AC, Moorthy AK. Optimizing multiscale SSIM for compression via MLDS. IEEE Trans Image Process. 2012 Dec;21(12):4682-94. doi: 10.1109/TIP.2012.2210723. Epub 2012 Jul 30.

ReferenceCitation: Gerardin P, Devinck F, Dojat M, Knoblauch K. Contributions of contour frequency, amplitude, and luminance to the watercolor effect estimated by conjoint measurement. J Vis. 2014 Apr 10;14(4). pii: 9. doi: 10.1167/14.4.9.


title: Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation

acronym: AiRehab

summary: Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients

ReferenceType: derived

ReferenceCitation: Prieur G, Medrinal C, Combret Y, Dupuis Lozeron E, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Borel JC, Reychler G. Nasal high flow does not improve exercise tolerance in COPD patients recovering from acute exacerbation: A randomized crossover study. Respirology. 2019 Nov;24(11):1088-1094. doi: 10.1111/resp.13664. Epub 2019 Aug 6.

name: Institut de Recherche Expérimentale et Clinique (IREC), Pôle de Pneumologie, ORL and Dermatologie, Groupe de Recherche en Kinésithérapie RespiratoireUniversité Catholique de Louvain Brussels Belgium

name: Institute for Research and Innovation in Biomedicine (IRIB)Normandie University, UNIROUEN Rouen France

name: Pulmonology DepartmentGroupe Hospitalier du Havre Montivilliers France

name: Pulmonary Rehabilitation DepartmentGroupe Hospitalier du Havre Montivilliers France

family: Prieur

full_name: Guillaume Prieur

given: Guillaume

sequence: first

family: Medrinal

full_name: Clement Medrinal

given: Clement

sequence: additional

name: Physiotherapy DepartmentGroupe Hospitalier du Havre Montivilliers France

family: Combret

full_name: Yann Combret

given: Yann

name: Division of Clinical EpidemiologyGeneva University Hospitals Geneva Switzerland

family: Dupuis Lozeron

full_name: Elise Dupuis Lozeron

given: Elise

name: ADIR AssociationRouen University Hospital Rouen France

family: Bonnevie

full_name: Tristan Bonnevie

given: Tristan

family: Gravier

full_name: Francis‐Edouard Gravier

given: Francis‐Edouard

family: Quieffin

full_name: Jean Quieffin

given: Jean

family: Lamia

full_name: Bouchra Lamia

given: Bouchra

name: Association AGIR à dom, Research and Development Meylan France

family: Borel

full_name: Jean‐Christian Borel

given: Jean‐Christian

name: Service de PneumologieCliniques Universitaires Saint‐Luc Brussels Belgium

family: Reychler

full_name: Gregory Reychler

given: Gregory

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Respirology

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Prieur G, Medrinal C, Combret Y, Quesada AR, Prieur F, Quieffin J, Borel JC, Reychler G. Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial. BMJ Open Respir Res. 2017 Aug 16;4(1):e000191. doi: 10.1136/bmjresp-2017-000191. eCollection 2017.

family: Quesada

full_name: Aurora Robledo Quesada

given: Aurora Robledo

full_name: Fabrice Prieur

given: Fabrice

full_name: Jean Christian Borel

given: Jean Christian

currency_apc_doaj: GBP


title: Prospective Study Evaluating the Feasibility of Fiducial Markers Placement Under Echoendoscopy (EUS) Guidance for Patients With Esophageal or Rectal Cancer With an Indication of Radiotherapy

acronym: FIDECHO

summary:
It is a multicenter prospective observational study including consecutive patients with esophageal tumor or rectum with indication for radiotherapy

The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance. The evaluation criteria are:

Success rate evaluation of the placement of two markers : one in the upper part of the tumor and one in the lower part. Success of the procedure will be evaluated by the endoscopist at the end of the procedure. Pictures of the markers will objectify the good placement of the markers.
Complications (early within 24 hours and late complications) such as pain, bleeding, perforation, infection, migration of the markers
The length of the procedure
The costs (procedure, hospitalization)
The clinical efficacy, by studying the decrease of the estimated target volume, the decrease of the dose delivered to the healthy tissue and the improvement of positioning of the irradiation beams by the radiotherapy technician
The presence of the markers at the end of the radiotherapy

lead_sponsor: Société Française d'Endoscopie Digestive


title: Impact of the Choice of Glomerular Filtration Rate-Estimating Equations on Plasmatic Concentrations of Direct Oral Anticoagulants in Elderly Patients With Atrial Fibrillation

acronym: REINACO

summary: Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.


title: Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung

acronym: HYPERSENS

summary: This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).

ReferenceCitation: Rouzet A, Reboux G, Dalphin JC, Gondouin A, De Vuyst P, Balliau T, Millon L, Valot B, Roussel S. An immunoproteomic approach revealed antigenic proteins enhancing serodiagnosis performance of bird fancier's lung. J Immunol Methods. 2017 Nov;450:58-65. doi: 10.1016/j.jim.2017.07.012. Epub 2017 Jul 29.

family: Rouzet

full_name: Adeline Rouzet

given: Adeline

family: Reboux

full_name: Gabriel Reboux

given: Gabriel

family: Dalphin

full_name: Jean-Charles Dalphin

given: Jean-Charles

family: Gondouin

full_name: Anne Gondouin

given: Anne

family: De Vuyst

full_name: Paul De Vuyst

given: Paul

family: Balliau

full_name: Thierry Balliau

given: Thierry

family: Millon

full_name: Laurence Millon

given: Laurence

family: Valot

full_name: Benoit Valot

given: Benoit

family: Roussel

full_name: Sandrine Roussel

given: Sandrine

bso_classification: Biology (fond.)

journal_name: Journal of Immunological Methods

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire


title: Simultaneous Assessments of Serotonin and Kynurenine Pathways Parameters in Patients Shortly (Less Than 4 Hours and a Half) After the Onset of a Cerebral Infarction

summary:
Single-center, prospective, descriptive and biomedical research with controls, without health product.

Depression is the second risk factor for stroke as tobacco smoking following hypertension. Peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects.

The aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3 months after the cerebral infarction.

primary_purpose: Prevention

lead_sponsor: Versailles Hospital


title: Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2

summary: The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

primary_purpose: Supportive Care

lead_sponsor: Centre Jean Perrin


title: Oxygenation of Paravertebral Muscles During Exercise in Chronic Low Back Pain Patients

acronym: OXYLOM

summary:
The study evaluate paraspinal aerobic metabolism of chronic low back pain patients and healthy people during an original and standardized isokinetic protocol.

The aim of this study is to determine a potential alteration of muscular aerobic metabolism in low back pain patients, in order to establish the underlying cause of pain and muscular fatigability characterizing low back pain patients. Then, the aim is to determine if functional rehabilitation program can improve it.

the unit of care have access to metabolic adaptations in measuring the muscular oxygenation and the pulmonary oxygen consumption, using near infrared spectroscopy and gas analyser.

lead_sponsor: University Hospital, Lille


type: EudraCT Number

title: Assessment of Fetal and Maternal Sufentanil Pharmacokinetics After Intra-amniotic Injection

summary:
The fetus may be exposed during pregnancy to nociceptive stimuli because of fetal pathology (e.g., malformation) or a diagnostic or therapeutic procedure.

To date, there is very little data and no consensus on fetal analgesia. The aim of the investigators study is to evaluate the pharmacokinetics of Sufentanil after intra amniotic injection.


title: Alarm Relay Bracelet for Simplification and Security Respiratory Assistance at Home: Evaluation of the Nocturnal Awakening Capability in Ventilated Patients and Healthy Volunteers

acronym: BRASSARD

summary: As part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).

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

location_facility: Service des pathologies du sommeil - GH Pitié-Salpêtrière


title: Comparison of Devices Evaluating Fractional Flow Reserve in Coronary Arteries : FRACTIONAL FLOW RESERVE - DEVICE STUDY (FFR-DS)

acronym: FFR-DS

summary: The aim of the study is to compare different devices available to measure fractional flow reserve (FFR) in coronary arteries.

lead_sponsor: University Hospital, Caen


title: Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies

acronym: GREFEXII

summary: The role of disorders of socio-emotional processes in cerebral diseases such as Alzheimer's disease, frontal temporal dementia, Parkinson's disease, Huntington's disease, traumatic brain injury, stroke, focal lesions, has been recognized recently. Social cognition refers to a large group of emotional and cognitive abilities regulating inter-individuals relationships and it includes mainly theory of mind, emotional information processing and empathy. However, assessment of socio-emotional processes is still largely based on experimental tests that are not validated for clinical purpose. In addition their long duration of administration is not adapted to clinical examination. Finally these tests have not been standardized and normalized in French-speaking population.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Behavioral


title: Prevalence and Persistence of Human Papillomavirus (HPV) and of Cervical Dysplasia in a Cohort of Women With Cystic Fibrosis

acronym: MUCOHPV

summary:
Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV), with several intermediate steps between HPV infection and cervical cancer. Cervical screening with pap smear test and HPV vaccination are effective preventions. A high frequency of HPV carriage and of cervical dysplasia have been described in transplanted women.

The majority of women with cystic fibrosis reach adulthood and some will face transplantation. Particular attention should therefore be paid to cervical screening. However, low adherence to screening recommendations was noted. In addition, preliminary data has found a high frequency of abnormal smears and of inflammatory aspect of the cervix in women with cystic fibrosis.

Objectives of the study The main objective of the study is to determine the prevalence of HPV carriage in a cohort of women with cystic fibrosis

The secondary objectives are:

To study the factors associated with the prevalence of HPV (transplantation, smoking, age at first intercourse, number of sexual partners in the year, contraception, gravidity and parity, HPV vaccination)

To describe and to compare with data in the general population, in hospital-based population, (and with data in transplanted population for transplanted women)

the prevalence of HPV (and of different genotypes) infection, of cervical dysplasia, of vulvar/vaginal/cervical condylomatosis
the rate of HPV persistence (> 12 months), the mean time of HPV clearance; rates of spontaneous regression / persistence / worsening of cervical dysplasia

Study design:

The study will last 24 months. Includable patients are adult women, transplanted or not, followed at Lyon CRCM. Included women will attend a consultation with a gynaecologist. Pap smear test (liquid phase cytology) and genomic DNA microarray assay enabling the detection of 35 different HPV genotypes will be performed.

Patients with an initial abnormal pap smear or a positive HPV test will be monitored:

In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will be renewed every 6 months during the study period
In case of an abnormal smear:

Atypical squamous cells of undetermined significance (ASC-US) : the attitude will depend on the result of the HPV test Atypical squamous cells - cannot exclude HSI L (ASC-H), Low-grade squamous intraepithelial lesion (LSIL), High-grade squamous intraepithelial lesion (HSIL), Atypical glandular cell of undetermined significance (AGUS) , Atypical glandular cells (AGC) , Adenoma carcinoma in situ (AIS), carcinoma: a colposcopy will be systematically performed

Expected results This study will help to determine the frequency of HPV infection and the pathogenic power of HPV in non-transplanted and in transplanted women with cystic fibrosis This data will help to sensitize health professionals on the importance of gynecological care and regular cervical screening, and on the importance of HPV vaccination.

In case of a high frequency of genital diseases linked to HPV, recommendations on gynecological monitoring procedures for women with cystic fibrosis could evolve.

primary_purpose: Screening

location_facility: Service de Gynécologie oncologique - Centre Hospitalier Lyon Sud

intervention_type: Procedure


title: Performance of a Minor Head Trauma Clinical Decision Rule Dedicated to Children Younger Than Two Years: A National Prospective Multicenter Study

acronym: PELICAN

summary: The purpose of this study is to validate a clinical decision rule for the management of minor head trauma in infants aged less than two years, constructed with the intention of minimizing the rate of computed tomography scans ordering.

ReferenceCitation: Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308.

ReferenceCitation: Schonfeld D, Bressan S, Da Dalt L, Henien MN, Winnett JA, Nigrovic LE. Pediatric Emergency Care Applied Research Network head injury clinical prediction rules are reliable in practice. Arch Dis Child. 2014 May;99(5):427-31. doi: 10.1136/archdischild-2013-305004. Epub 2014 Jan 15.

ReferenceCitation: Bressan S, Romanato S, Mion T, Zanconato S, Da Dalt L. Implementation of adapted PECARN decision rule for children with minor head injury in the pediatric emergency department. Acad Emerg Med. 2012 Jul;19(7):801-7. doi: 10.1111/j.1553-2712.2012.01384.x. Epub 2012 Jun 22.

ReferenceCitation: Osmond MH, Klassen TP, Wells GA, Correll R, Jarvis A, Joubert G, Bailey B, Chauvin-Kimoff L, Pusic M, McConnell D, Nijssen-Jordan C, Silver N, Taylor B, Stiell IG; Pediatric Emergency Research Canada (PERC) Head Injury Study Group. CATCH: a clinical decision rule for the use of computed tomography in children with minor head injury. CMAJ. 2010 Mar 9;182(4):341-8. doi: 10.1503/cmaj.091421. Epub 2010 Feb 8.

ReferenceCitation: Rogers AJ, Maher CO, Schunk JE, Quayle K, Jacobs E, Lichenstein R, Powell E, Miskin M, Dayan P, Holmes JF, Kuppermann N; Pediatric Emergency Care Applied Research Network. Incidental findings in children with blunt head trauma evaluated with cranial CT scans. Pediatrics. 2013 Aug;132(2):e356-63. doi: 10.1542/peds.2013-0299. Epub 2013 Jul 22.

ReferenceCitation: Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de González A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.

ReferenceCitation: Greenes DS, Schutzman SA. Clinical indicators of intracranial injury in head-injured infants. Pediatrics. 1999 Oct;104(4 Pt 1):861-7.

ReferenceCitation: Palchak MJ, Holmes JF, Vance CW, Gelber RE, Schauer BA, Harrison MJ, Willis-Shore J, Wootton-Gorges SL, Derlet RW, Kuppermann N. A decision rule for identifying children at low risk for brain injuries after blunt head trauma. Ann Emerg Med. 2003 Oct;42(4):492-506.

ReferenceCitation: Jehlé E, Honnart D, Grasleguen C, et al. Comité de pilotage. Minor head injury (Glasgow Coma Score 13 to 15): triage, assessment, investigation and early management of minor head injury in infants, children and adults. Ann Fr Med Urg 2012;2:199-214

location_facility: Pediatric Emergency Department - Necker-Enfants malades Hospital -


title: Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients

acronym: UMACHAPA

summary:
Physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA) among those patients could improve their tolerance to the treatment, and thereby their quality of life. APA could be beneficial to patients with curable disease as well as patients undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle mass could lead to a survival benefit. However, APA is not established in daily practice and has not yet been evaluated in a chemotherapy ambulatory care unit.

Primary aim of the study is to assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip strength in patients beginning chemotherapy or targeted therapy for a digestive, lung, hematological or dermatological cancer, of any stage.

lead_sponsor: CHU de Reims


title: Neuromuscular Fatigue Aetiology Comparison Between Prepubertal Boys and Adults

acronym: LENGTH-FATIG

summary:
Potential factors involved in neuromuscular fatigue were classified into two categories: 1) central factors involving the central nervous system and neural pathways, and 2) peripheral factors occurring within the muscle beyond the neuromuscular junction. In adults, it has been shown that peripheral factors contribute to a large part of the fatigue induced by repeated maximal contractions. However in children, central factors could account for the development of fatigue to a greater extent. Force-generating capacity and musculotendinous stiffness could be two of the discriminatory factors accounting for the differences in the neuromuscular fatigue between children and adults.

Force production capacity and musculotendinous stiffness vary as function of muscle length. Naturally, they could differ depending on the muscle groups studied. The main aim of the present protocol is to compare the effect of knee extensors and ankle plantarflexors length on the development and aetiology of neuromuscular fatigue, in children and adults. The investigators formulated the hypotheses that at short muscle length force and low musculotendinous stiffness, differences in force between children and adults would be reduced. Thus neuromuscular fatigue development and aetiology would be similar between both groups. The results of the present protocol will allow to better understanding of the aetiology of neuromuscular fatigue in children and help improving training or rehabilitation programs.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes

acronym: Smartguard

summary:
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.

The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen


title: Validation of Alveolar Probe-based Confocal Laser Endomicroscopy Descriptors in Diffuse Parenchymal Lung Diseases : A Multicentric Prospective Study

acronym: Microsemio-PI

summary:
Diffuse parenchymal lung diseases (DPLD) include a variety of respiratory conditions that affect either the pulmonary interstitium or the alveolar space . The etiological diagnosis of DPLD is often challenging, because of the large number of pathological entities involved, which share close clinical and radiological presentations. High resolution Chest CT, a key diagnostic procedure in DPLD, is subject to significant inter-observer analysis variations, so that the diagnosis sometimes requires a surgical or transbronchial lung biopsy sampling. This invasive procedure is not devoid of morbidity and may be impossible to perform in fragile patients. Therefore, the definite diagnosis of DPLD is usually achieved following a multi-disciplinary expert consensus, based on careful medical history, chest CT and bronchoalveolar lavage examinations.

Alveolar probe-based confocal laser endomicroscopy (pCLE) is a mini invasive endoscopic technique that allows distal lung microscopic imaging in vivo, during a flexible bronchoscopy performed under topical anaesthesia. Since 2006, Alveolar pCLE has been used in a monocentric clinical trial at the Rouen University Hospital in more than 200 patients and healthy volunteers. This allowed the first pCLE in-vivo description of normal pulmonary acinus, and confirmed the safety of the technique.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Rouen


title: Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology

summary: This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic

ReferenceCitation: Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094. Review.

ReferenceCitation: Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11.

lead_sponsor: Hospital Nord

location_facility: Departement anesthesie reanimation hopital nord


title: Evaluation of the Impact of Bioimpedance Analysis in Patients With Cardiac Implantable Electronic Devices

summary: There are an increase number of patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) worldwide. The current medical practice guidelines warn on performing bioimpedance analysis (BIA) in this group of patients to avoid any electromagnetic interference. These recommendations restrict the use of BIA in many patients with heart failure in whom BIA might be of great interest in detecting peripheral congestion and in guidance of treatment. However, it is not well known whether BIA can affect the function of cardiac devices. Investigators aimed to test the incidence of electromagnetic interference between BIA and CIEDs.

ReferenceCitation: Chabin X, Taghli-Lamallem O, Mulliez A, Bordachar P, Jean F, Futier E, Massoullié G, Andonache M, Souteyrand G, Ploux S, Boirie Y, Richard R, Citron B, Lusson JR, Godet T, Pereira B, Motreff P, Clerfond G, Eschalier R. Bioimpedance analysis is safe in patients with implanted cardiac electronic devices. Clin Nutr. 2019 Apr;38(2):806-811. doi: 10.1016/j.clnu.2018.02.029. Epub 2018 Mar 2.

family: Chabin

full_name: Xavier Chabin

given: Xavier

family: Taghli-Lamallem

full_name: Ouarda Taghli-Lamallem

given: Ouarda

family: Mulliez

full_name: Aurélien Mulliez

given: Aurélien

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

family: Jean

full_name: Frédéric Jean

given: Frédéric

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Massoullié

full_name: Grégoire Massoullié

given: Grégoire

family: Andonache

full_name: Marius Andonache

given: Marius

family: Souteyrand

full_name: Géraud Souteyrand

given: Géraud

family: Ploux

full_name: Sylvain Ploux

given: Sylvain

family: Boirie

full_name: Yves Boirie

given: Yves

family: Richard

full_name: Ruddy Richard

given: Ruddy

family: Citron

full_name: Bernard Citron

given: Bernard

family: Lusson

full_name: Jean-R. Lusson

given: Jean-R.

family: Godet

full_name: Thomas Godet

given: Thomas

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Clerfond

full_name: Guillaume Clerfond

given: Guillaume

family: Eschalier

full_name: Romain Eschalier

given: Romain

journal_name: Clinical Nutrition


title: Are LXRs Involved in Regulation of Human Oocyte Meiosis Resumption?

summary: Previous studies in animal model showed clearly that lipid homeostasis influence oocyte meiosis resumption. However Liver X Receptors pathway has never been investigated in human ovocyte


title: Resectable Pancreatic Adenocarcinoma Neo-Adjuvant FOLF(IRIN)OX-based CHEmotherapy - A Multicenter, Randomised Phase II Trial (PANACHE01-PRODIGE48 Study)

summary:
In patients with resectable pancreatic duct adenocarcinoma (PDAC), curative surgery followed by adjuvant chemotherapy is currently the standard of care. However, the long-term results are still poor, with median disease-free and overall survival of 14 months and 23 months. The corresponding 5-year overall survival rate is 20%.

Chemotherapy before surgery (neoadjuvant chemotherapy) allows identification of patients with rapidly progressive metastatic disease at time of preoperative restaging (surgery is then avoided in these patients), and may increase the rate of free margin resection (R0) and reduce the risk of local recurrence.

Even though single-agent gemcitabine and 5-FU have been validated in adjuvant and metastatic settings, the objective response was low (at around 10%), whereas combination chemotherapy exceeds a response rate of 30% in advanced disease. In metastatic PDAC, palliative FOLFIRINOX chemotherapy has been demonstrated to be effective (in terms of response rates and progression-free survival) and well tolerated. Interestingly, the response rate is increased by using more than two chemotherapeutic agents in advanced pancreatic cancer, justifying the use of an alternative neoadjuvant FOLFOX-based chemotherapy arm.

PANACHE-01 is an open, non-comparative, randomised, multicentre Phase II study designed to assess the safety and efficacy of two modes of neo-adjuvant chemotherapy (FOLFIRINOX & FOLFOX) relative to the current reference treatment (surgery and then adjuvant chemotherapy) for resectable PDAC.

Patients with immediately resectable PDAC (definition based on the NCCN's (American National Comprehensive Cancer Network 2014) latest guidelines) will be randomised to either pancreatectomy and adjuvant chemotherapy or 4 cycles of neoadjuvant chemotherapy with either FOLFOX or FOLFIRINOX. The patients in the neoadjuvant chemotherapy arms will receive postoperative chemotherapy for 4 months (8 cycles).

ReferenceCitation: Schwarz L, Vernerey D, Bachet JB, Tuech JJ, Portales F, Michel P, Cunha AS. Resectable pancreatic adenocarcinoma neo-adjuvant FOLF(IRIN)OX-based chemotherapy - a multicenter, non-comparative, randomized, phase II trial (PANACHE01-PRODIGE48 study). BMC Cancer. 2018 Jul 24;18(1):762. doi: 10.1186/s12885-018-4663-4. Erratum in: BMC Cancer. 2020 Mar 3;20(1):168.

family: Schwarz

full_name: Lilian Schwarz

given: Lilian

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Portales

full_name: Fabienne Portales

given: Fabienne

family: Michel

full_name: Pierre Michel

family: Cunha

full_name: Antonio Sa Cunha

given: Antonio Sa

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Prospective Efficacy and Tolerance Data Collection in 34 to 36 Weeks Preterm Neonates Treated by High Flow Nasal Cannula for Respiratory Distress Syndrom

acronym: PRIMAIR

summary:
The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (RDS).

The secondary objective is to evaluate the safety of HFNC in this indication.

lead_sponsor: University Hospital, Montpellier


title: Effect of Choice on Food Pleasure Using fMRI

acronym: PLEASIN

summary: Previous studies have suggested that consumers who can choose what to eat could find food more pleasant, and consume more of that food, than when in absence of choice. However cognitive mechanisms that could explain the effect of choice have not been investigated. The study consists in a fMRI experiment intended to observe the effect of the presence of choice on brain activity following consumption of a fruit-flavored drink, compared to the brain activity when the same drink is consumed without choice. It is suggested that consumers will appreciate drinks they chose better, and that the activity in gustatory and reward regions will change accordingly to changes in declared food pleasure.


title: Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.

summary: The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


type: Other Grant/Funding Number

title: Impact of Gender and Pubertal Status on Human Plasmacytoid Dendritic Cells - PLASMACYTOKID Study

summary: Differences in pDCs function related to gender have been demonstrated in adults but have never been addressed in children. Yet, differences in immune responses related to gender also exist in children, both in responses to pathogens and susceptibility to autoimmune diseases. The investigators suppose that these differences are partly linked to difference in pDCs functions. This study aim is to compare pDCs functions in children based on gender and pubertal status. This study will be performed in healthy children, boys with Klinefelter syndrome and girls with Turner syndrome.

lead_sponsor: University Hospital, Toulouse

intervention_type: Biological


title: Follow-up of Myocardial T1 Relaxation Time in Patients With Anderson Fabry Disease (AFD): Impact of Treatment by Agalsidase Alpha (Replagal®)

summary:
Anderson Fabry disease (AFD) is an X-linked lysosomal storage disorder caused by a deficiency of the enzyme alpha-galactosidase. AFD can involve various organs and lead to a series of clinical abnormalities. Left ventricular hypertrophy in middle-aged men is one of its life threatening complications. It was shown that pending the absence of myocardial replacement fibrosis, substitution therapy could improve myocardial morphology and function as well as exercise capacity. Today, there is no available marker of the efficacy of the treatment on the heart morphology and function.

The T1 time (or longitudinal relaxation time) is one of the major components of the image formation in Magnetic Resonance Imaging (along with T2 time and proton density). Several techniques have been described to assess the myocardial T1-time.

One of them called MOLLI (Modified Look Locker Inversion Recovery), was made available in research centres by the Siemens company. In a study published in 2013, Sado et al. showed in a series of various conditions (hypertension, AFD, hypertrophic cardiomyopathy, AL amyloidosis, aortic stenosis and healthy volunteers) that a septal T1 below a threshold of 940ms could discriminate AFD patients. No overlap was shown with other conditions in this study. Our experience with T1 mapping supports that finding (even though our threshold could be slightly different), and we could recently detect by MRI a number of AFD patients, some of them with hypertrophy, some others without hypertrophy. The effect of Replagal® on the T1 relaxation time remains unknown.

The purpose of that study was to follow-up the heart morphology, function and myocardial T1 relaxation time in a population of treated/untreated patients.


title: " Effect of Affordance of Objects on the Memory: Study in Transcranial Magnetic Stimulation " (SIMULANG-TMS)

acronym: SIMULANG-TMS

summary: The purpose of this study is determine the involvement of motor system in the memory of manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial magnetic stimulation to see whether this stimulation will affect memory of manipulable objects.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre de Recherche Clinique (CRC) - CHSA


title: Assessment of Optical Spectroscopy's Diagnosis Accuracy When Non-invasively and Automatically Classifying Skin Lesions in One of the Following Histological Classes: Healthy, Actinic Keratosis, in Situ Carcinoma and Invasive Carcinoma.

acronym: SPETROLIVE

summary:
Actinic keratosis are of utmost medical and economical interest because of their high prevalence (20 % of 60 year-old people and older in the Northern hemisphere) and their important cosmetic impact as such actinic keratosis mostly appear on photo-exposed skin sites. The surgeon in charge of such lesions' removal (i) some actinic keratosis adjoining carcinoma to be resected therefore causing the problem of functional areas damaging (eyelids, lips, etc.) or (ii) numerous actinic keratosis localized away from carcinoma (photo-carcinogenesis field) faces the issue of clinical evaluation of such lesions: which ones will spontaneously regress (it is supposed to be the case for 20 % of such lesions);which ones will remain and which ones will develop into invasive carcinomas ?

A non-invasive, non-traumatic, automated and real-time help for the clinical diagnosis orientation of such skin lesions could help improving diagnosis accuracy of the medical practitioner's visual inspection:

In terms of sensitivity in order to potentially decrease the number of actinic keratosis evolving towards invasive carcinoma,
In terms of specificity in order to potentially decrease useless resections and reduce resection margins and therefore reduce scars surface.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep

acronym: STIMENPHASE

summary: This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.

lead_sponsor: Dreem

location_facility: Centre du Sommeil et de la Vigilance, Hotel-Dieu de Paris


title: Use of New Technologies for the Follow-up in Adolescent Obesity

acronym: MHI

summary: The purpose of this study is to evaluate the efficacy of a distance follow-up on body mass index decrease at 15 months compared to traditional management in obese adolescents.

ReferenceCitation: O'Malley G, Clarke M, Burls A, Murphy S, Murphy N, Perry IJ. A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. Trials. 2014 Jan 31;15:43. doi: 10.1186/1745-6215-15-43.

ReferenceCitation: Turner T, Spruijt-Metz D, Wen CK, Hingle MD. Prevention and treatment of pediatric obesity using mobile and wireless technologies: a systematic review. Pediatr Obes. 2015 Dec;10(6):403-9. doi: 10.1111/ijpo.12002. Epub 2015 Jan 12. Review.

ReferenceCitation: Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226. Erratum in: Obesity (Silver Spring). 2016 Feb;24(2):536. Bennett, G B [Corrected to Bennett, G G].

ReferenceCitation: Pretlow RA, Stock CM, Allison S, Roeger L. Treatment of child/adolescent obesity using the addiction model: a smartphone app pilot study. Child Obes. 2015 Jun;11(3):248-59. doi: 10.1089/chi.2014.0124. Epub 2015 Mar 11.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: MICRO-RNAs OF NEUTROPHILS IN RENAL ANCA-ASSOCIATED VASCULITIS

acronym: MINERVA

summary: Activation of neutrophils by ANCA ("Anti-Neutrophil Cytoplasm Antibodies") and subsequent microvascular endothelial cell damage is the main feature of ANCA-associated vasculitis (AAV), a severe autoimmune disease that often targets the kidney. There is no specific treatment for AAV to date and 25% of patients with renal damage evolve towards end-stage renal disease, requiring dialysis and kidney transplantation. In addition, there is no reliable biological marker of the disease activity available, which makes the diagnostic, follow-up and treatment of patients difficult. Therefore, the identification of new therapeutic targets and non-invasive biomarkers constitutes a major clinical challenge to improve AAV patients care and to ameliorate their renal outcome.

lead_sponsor: Nantes University Hospital


title: Evaluation of the Efficacy of the Sequencing Method by Gene-panel, Compared to the Reference Sanger Method, on Patients With Primary Immuno-deficiencies, and Who Need a Genetic Diagnosis.

acronym: Génétique-DIH

summary: In order to accelerate the identification of genes responsibles of PID, and to improve the diagnosis of PID, the research team would like to validate a rapid and targeted method of high-throughput sequencing, on 301 genes, known to be involved in PID.

lead_sponsor: Imagine Institute


title: Phenomenological Approach of Epilepsy in Patients With Epilepsy and Their Relatives for Risk Prevention

summary:
Rationale : Persons with epilepsy have a greater risk of incurring accidental injury and a higher mortality risk than the general population.

The main objective of the study is to understand life experience of the disease or risks associated with epilepsy in patients with epilepsy, relatives of patients and bereaved families.

Study design: Qualitative study (study based on interviews) Population: Three groups will be interviewed: bereaved families, patients with epilepsy and relatives of patient. Bereaved family: relatives who contact the French sentinel network "Réseau Sentinelle Mortalité Epilepsie" (RSME) notifying an epilepsy-related death (regardless the cause of the death and the timeframe between death and interview). Patients with epilepsy: patients having a secure diagnostic of epilepsy from 15 years old to 65 years old. Relatives of patients with epilepsy: spouse/husband or parents invited by a patient with epilepsy to participate to the interview who consent to participate.

Method: Semi structured in-depth interviews will be conducted by an experienced qualitative psychologist in face to face, at home, at the hospital or at any other place (depending on the choice of the participants). The interview topic guide will be centered on participants'personal experience. Interviews will be digitally recorded and will be transcribed by a secretary.

The results of this study will be integrated in educational therapeutic programs regarding prevention of risks related to epilepsy.


title: Causes of Death in Follicular Lymphoma: a Single Center Retrospective Analysis

summary: Background.Although the life expectancy of patients with FL has recently increased, notably since the introduction of rituximab in combination with chemotherapy, little is known regarding the precise causes of patients death. Patients and methods'. This study describes the different causes of death in FL patients among followed since 2000 at Lyon University Hospital, centre Léon Bérard and Mayo Clinic. The causes of death will be classified as related to lymphoma progression, treatment-related toxicity (including TRM and secondary myelodysplastic syndrome/acute myeloid leukemia), secondary neoplasias, or other.

time_perspective: Retrospective

lead_sponsor: Hospices Civils de Lyon


lead_sponsor: Hybrigenics Corporation

source: euctr

title: Phase 2 Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study

summary: To assess the efficacy of inecalcitol in combination with imatinib in CML patients with molecular residual disease on imatinib monotherapy.


title: Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates

acronym: DISSO

summary: Background: Adverse childhood experience have been described in sexual offenders but the link with the offence need to be further investigated. Investigators postulate that one of the clinical moderating factors could be dissociative experience, a consequence of these early adverse experiences reactivated during the offence. The purpose of the study is to estimate the prevalence of clinical dissociation during the offence in a male adult population referred to our center for a sexual offence and to explore its correlations with epidemiological and clinical data (personal, legal history, psychiatric comorbidities), clinical trauma and dissociation, prognosis estimates.

primary_purpose: Health Services Research

lead_sponsor: Hôpital le Vinatier


title: ACCeptation and Qualitative Evaluation of Phone-delivered Intervention To Prevent Suicide Reattempt

acronym: ACCEPT-S

summary: Background: Previous suicide attempt is known to be a strong risk factor for repetition and repetition is common within the first year after an episode of deliberate self-harm (DSH). There has been growing interest in brief interventions for this population that are focused on maintaining long-term contact and/or offering re-engagement with services when needed. Despite telephone-delivered interventions have shown promising results in suicide reattempt prevention, subjective impact of such brief contact interventions and effectiveness mechanisms have never been evaluated.


title: Endoscopic Sleeve Gastroplasty

acronym: Endosleeve

summary:
The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.

The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.

ReferenceCitation: Lopez-Nava G, Galvão MP, da Bautista-Castaño I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

ReferenceCitation: Lopez-Nava G, Galvão MP, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.

ReferenceCitation: Lopez-Nava G, Galvao M, Bautista-Castaño I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.

ReferenceCitation: Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

ReferenceCitation: Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg


title: Impact of Neutrophil Extracellular Traps (NET) on Thrombolysis in Acute Phase of Cerebral Ischemia

acronym: THINK

summary:
Cerebral infarcts represent a major cause of morbidity/mortality in spite of therapeutics for a premature recanalisation (intravenous recombinant tissue plasminogen activator (rt-PA) and thrombectomy). Thrombolysis failure by the administration of rt-PA is frequent, in particular in proximal occlusion. Experimental studies suggest that neutrophils could play an important role in the thrombus development via the organization of a network (NET) within the thrombus. Targeting this network of NET could, in addition to the fibrinolysis, increase the rate of recanalisation and thus improve the neurological prognostic after a cerebral infarct.

The aim of the research is to Study of the biochemical and histological composition of the stemming thrombi of cerebral thrombectomies with in vitro analysis of the sensibility in the thrombolysis induced by rt-PA +/- Desoxyribonuclease I (DNase I).

lead_sponsor: Hopital Foch


title: Cardiac Structure and Function in Acromegalic Patients: A Cardiac Magnetic Resonance Imaging Study

acronym: ACROCOEUR

summary:
In this study, the investigators will evaluate the cardiac structure and function, focusing on the myocardial water content and interstitial fibrosis, in patients with active acromegaly in comparison with 1) healthy volunteers, 2) the same acromegalic patients that have received efficient therapy.

The investigators hypothesize that the myocardial water content in acromegaly is increased as these patients present with sodium and water retention and that this myocardial water infiltration will improve with efficient treatment of the disease. They will thus assess using CMRI, this parameter by measuring the myocardial transverse relaxation time (T2), reflecting water content in the myocardium.


title: Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction

summary: The aim of the study is to estimate the contribution of abdominal imaging by magnetic resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction associated to the atrial fibrillation in the cerebral infarction.

ReferenceCitation: Slaoui T, Klein IF, Guidoux C, Cabrejo L, Meseguer E, Abboud H, Lavalllée PC, Mazighi M, Labreuche J, Amarenco P. Prevalence of subdiaphragmatic visceral infarction in cardioembolic stroke. Neurology. 2010 Mar 30;74(13):1030-2. doi: 10.1212/WNL.0b013e3181d76aaa. Epub 2010 Mar 3.

ReferenceCitation: Abboud H, Labreuche J, Gongora-Riverra F, Jaramillo A, Duyckaerts C, Steg PG, Hauw JJ, Amarenco P. Prevalence and determinants of subdiaphragmatic visceral infarction in patients with fatal stroke. Stroke. 2007 May;38(5):1442-6. Epub 2007 Mar 22.

ReferenceCitation: Flint AC, Tayal AH. The search for paroxysmal atrial fibrillation in cryptogenic stroke: leave no stone unturned. Neurology. 2013 Apr 23;80(17):1542-3. doi: 10.1212/WNL.0b013e31828f1938. Epub 2013 Mar 27.

ReferenceCitation: White H, Boden-Albala B, Wang C, Elkind MS, Rundek T, Wright CB, Sacco RL. Ischemic stroke subtype incidence among whites, blacks, and Hispanics: the Northern Manhattan Study. Circulation. 2005 Mar 15;111(10):1327-31.


title: P75NTR, Diagnostic Biomarker for Alzheimer's Disease: Quantification Study in Cerebrospinal Fluid

summary: This research will be achieved by the assessment of p75NTR-ECD expression (total and linked to different species of Aβ (Aβ1-40 and Aβ-1-42)) within the cerebrospinal fluid (CSF) of patients with AD dementia, mild cognitive impairment (MCI) due to AD, frontotemporal dementia and non-neurodegenerative dementia.


title: Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans

acronym: SERODOM

summary: Previous studies have already revealed the involvement of the serotoninergic system in the social behavior process. For example, more serotonin (5HT) was found in dominant male adult monkeys. Little is known about the serotoninergic implication in human's social behavior. The project aims to clarify the role of the serotoninergic system in social behavior in relation to the process of social hierarchical information. In order to determine how serotoninergic system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us to measure the brain activity and the serotoninergic transporter occupancy (using the [C11]-DASB) at the same time. The current study aims to investigate whether serotonin transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection of social dominance in facial expressions or other measures of social information processing. Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and neuropsychological questionnaires will give at the investigator more information and allow to investigate whether performance on social information processing is modulated by personality trait and genotype.


title: Prognostic Value of Dominant Hand Held Dynamometry in Mechanical Ventilation Weaning: a Prospective, Multicenter Study

acronym: GRIPWEAN

summary: The purpose of this study is to test the association between ICU acquired weakness as evaluated by dominant handheld dynamometry (handgrip) and the mechanical ventilation weaning outcome

ReferenceCitation: Cottereau G, Messika J, Megarbane B, Guérin L, da Silva D, Bornstain C, Santos M, Ricard JD, Sztrymf B. Handgrip strength to predict extubation outcome: a prospective multicenter trial. Ann Intensive Care. 2021 Oct 2;11(1):144. doi: 10.1186/s13613-021-00932-3.

family: Cottereau

full_name: Guillaume Cottereau

family: Messika

full_name: Jonathan Messika

given: Jonathan

family: Megarbane

full_name: Bruno Megarbane

family: Guérin

full_name: Laurent Guérin

given: Laurent

family: da Silva

full_name: Daniel da Silva

given: Daniel

family: Bornstain

full_name: Caroline Bornstain

given: Caroline

family: Santos

full_name: Matilde Santos

given: Matilde

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Sztrymf

full_name: Benjamin Sztrymf

given: Benjamin

journal_name: Annals of Intensive Care


type: Registry Identifier

title: Transposition of Internal Limiting Membrane in the Treatment of Macular Holes. A Descriptive Pilot Study

acronym: ILMT

summary:
Macular hole is an infrequent retinal pathology (2 to 4/1000) which most often affects people aged over 60, and twice common in women than men.

The vast majority of cases are idiopathic. Without treatment, the macular hole evolves through a series of stages until the extension of the diameter (up to 500 microns and higher values). With a fully developed macular hole, patients complain of metamorphopsia and decreased visual acuity.

This pathology has clearly benefited from advances in microsurgery and better understanding of its pathophysiology. Macular hole treatment has evolved to include small-gauge pars plana vitrectomy with or without internal limiting membrane (ILM) peeling and placement of intraocular gas tamponade.

The postoperative closure rate is close to 80%, but strongly depends on the initial characteristics of the hole, its diameter remaining the main prognostic factor. Thus for macular holes <400 microns, the closure rate is close to 92% dropping to 56% for macular holes above 400 microns. In case of surgical failure, one or more reoperations can be proposed, but with a lower closure rate.

The quest for a surgical technique presenting a greater success rate is a common goal to all retinologists.

Here the investigators propose a new surgical technique, derived from the FLAP method, and consisting of an inner limiting membrane transposition.

The objective of this study is to evaluate the feasibility of a new surgical technique for the treatment of macular holes already operated but without macular hole closure, allowing these patients a new therapeutic alternative. The success of this technique will be confirmed by detecting postoperatively the presence of the transposed internal limiting membrane into the foveal region.

lead_sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace


title: KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN

acronym: PAPCLEAR

summary: Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear within a few months or years. There infections are much less studies than chronic infections, even though they represent the main reservoir for the virus. The goal of this project is to decipher the kinetics of the virus and of the host immune response in acute HPV genital infections in your women. This will be performed by following women longitudinally and regularly in order to measure variations in virus load, immune cell count, cytokine concentration and antibody titers. The investigators will also investigate the interaction between these kinetics and host genetics and host vaginal microbiota

ReferenceCitation: Selinger C, Rahmoun M, Murall CL, Bernat C, Boué V, Bonneau M, Graf C, Grasset S, Groc S, Reynes J, Hirtz C, Jacobs N, Alizon S. Cytokine response following perturbation of the cervicovaginal milieu during HPV genital infection. Immunol Res. 2021 Jun;69(3):255-263. doi: 10.1007/s12026-021-09196-2. Epub 2021 Apr 30.

family: Selinger

full_name: Christian Selinger

given: Christian

family: Rahmoun

full_name: Massilva Rahmoun

given: Massilva

family: Murall

full_name: Carmen Lia Murall

given: Carmen Lia

family: Bernat

full_name: Claire Bernat

given: Claire

family: Boué

full_name: Vanina Boué

given: Vanina

family: Bonneau

full_name: Marine Bonneau

given: Marine

family: Graf

full_name: Christelle Graf

given: Christelle

family: Grasset

full_name: Sophie Grasset

given: Sophie

family: Groc

full_name: Soraya Groc

given: Soraya

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Hirtz

full_name: Christophe Hirtz

given: Christophe

family: Jacobs

full_name: Nathalie Jacobs

given: Nathalie

family: Alizon

full_name: Samuel Alizon

given: Samuel

journal_name: Immunologic Research

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

version: submittedVersion

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

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

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories: HAL medRxiv

ReferenceCitation: Murall CL, Rahmoun M, Selinger C, Baldellou M, Bernat C, Bonneau M, Boué V, Buisson M, Christophe G, D'Auria G, Taroni F, Foulongne V, Froissart R, Graf C, Grasset S, Groc S, Hirtz C, Jaussent A, Lajoie J, Lorcy F, Picot E, Picot MC, Ravel J, Reynes J, Rousset T, Seddiki A, Teirlinck M, Tribout V, Tuaillon É, Waterboer T, Jacobs N, Bravo IG, Segondy M, Boulle N, Alizon S. Natural history, dynamics, and ecology of human papillomaviruses in genital infections of young women: protocol of the PAPCLEAR cohort study. BMJ Open. 2019 Jun 11;9(6):e025129. doi: 10.1136/bmjopen-2018-025129.

full_name: Carmen Lía Murall

given: Carmen Lía

family: Baldellou

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

repository_institution: University of Liège - Open Repository and Bibliography


title: Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen

acronym: SATISFYDG

summary:
This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals.

This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.

lead_sponsor: University Hospital, Caen


title: Multicentric Prospective Study Assessing the Efficiency of Preoperative Reversible Selective Portal Vein Embolization in Patients Requiring Major Hepatic Resection

acronym: EMBORES

summary: The aim of this study is to prospectively evaluate the tolerance and efficiency of a new technique of preoperative selective portal vein embolization (PVE) in patients requiring major hepatic resection.

status: Active, not recruiting


title: French Prospective Randomised Double Blind Study, on Aspirin Versus Placebo in Resected Colon Cancer With PI3K Mutation

acronym: ASPIK French

summary: Four retrospective studies were recently published on efficacy of aspirin in patients with surgically resected colon cancer. Two of these studies strongly suggested that aspirin used in low doses (100 mg/d) after surgical resection of colorectal cancer with PI3K mutation could act as a targeted therapy with a major protective effect on the risk of recurrence. The other two studies did not confirm the benefit of aspirin in this situation. These four retrospective studies provide an insufficient level of evidence to demonstrate the benefit of low-dose aspirin as adjuvant to surgery for colorectal cancer. Therefore, it is necessary as recommended in the conclusion of these studies and meta-analyses to perform a randomised prospective study to validate these data.

lead_sponsor: University Hospital, Rouen


title: Prediction of the Answer to the Treatment by Biotherapies for Naive Spondyloarthritis Disease During 6 Months by Combinatorial Analysis of Serum Biomarkers

acronym: PRESA

summary:
The aim of this trial is the caracterisation of a predicting algorithm of the answering response for patients with etanercept treatment in spondyloarthritis disease.

This algorithm will help to target patients patients who have a risk / benefit important for etanercept treatment.

ReferenceCitation: Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17. Review.

ReferenceCitation: Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. Epub 2004 Jun 8. Review.

ReferenceCitation: Kristensen LE, Saxne T, Nilsson JA, Geborek P. Impact of concomitant DMARD therapy on adherence to treatment with etanercept and infliximab in rheumatoid arthritis. Results from a six-year observational study in southern Sweden. Arthritis Res Ther. 2006;8(6):R174.

lead_sponsor: University Hospital, Grenoble


title: Diagnostic Accuracy of Circulating Tumor Cells (CTCs) and Onco-exosome Quantification in the Diagnosis of Pancreatic Cancer - PANC-CTC

acronym: PANC-CTC

summary: The proposal aims at determining whether liquid biopsy approaches are valid in the diagnosis of pancreatic cancer. Step1 will test 3 CTC isolation methods and analyse by flow cytometry the presence of onco-exosomes in the culture media of pancreatic cell lines. Step 2 will examine the diagnostic accuracy of these blood tumor elements for the diagnosis of cancer of patients with PDAC suspicion or recent diagnosis and their value for disease monitoring.

lead_sponsor: University Hospital, Bordeaux


title: Right Ventricular Dysfunction Incidence After Major Lung Resection, a Prospective Study.

acronym: RESECHO

summary: This study aims to describe incidence of right ventricular dysfunction after major lung resection with echocardiography criteria.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Validation of a Predictive Score of Acute Chest Syndrome

summary:
Vaso-Occlusive Crisis (VOC), the most common manifestation of sickle cell disease (SCD), is the first cause of death, particularly when complicated by an acute chest syndrome (ACS).

The PRESEV score could help the physicians to better manage VOC and could be used for future therapeutic trials. This predictive score of secondary ACS has to be validated in a multicenter international study.

lead_sponsor: Soutien aux Actions contre les Maladies du Globule Rouge


title: Detection of Annexin A2 in Systemic Lupus Erythematosus

acronym: ANLUP

summary:
There is substantial clinical and biological intra and inter-patient variability in SLE. Vascular, renal and neurologic deficiency can be organ-threatening or even life-threatening, leading to increased morbidity and mortality.

Thus, biomarkers of disease activity and prognosis are required for regular follow-up of SLE patients.

Implication of Toll-like Receptors (TLRs) in SLE has been extensively studied in mice models and humans. Self nuclear antigens bind to TLRs which are located on the surface of dendritic cells, B-cells, and endothelial cells, leading to production of pro-inflammatory cytokines and pathologic autoantibodies involved in organ dysfunction of SLE patients. Moreover, TLR expression in SLE is significantly higher and significantly correlated with disease activity.

Annexin A2 (ANXA2) is a member of the annexins superfamily which exists as a monomer or heterotetramer and is implicated in several biological processes. Most notably, it binds to ẞ2GP1/anti-ẞ2GP1 antibodies and mediates endothelial cell activation via a TLR4 signaling pathway, highlighting its key role in Antiphospholipid Syndrome (APS) frequently associated with SLE.

ANXA2 is also involved in the physiopathology of SLE. Anti-DNA autoantibodies can bind with ANXA2 expressed on mesangial cells in lupus nephritis. Besides, a french study carried out in Amiens' University Hospital showed that vascular lesions in lupus nephritis were associated with a significant increase in vascular expression of ANXA2.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy

acronym: MUCO-DUO

summary:
Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.

All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.

Hundred and twenty patients will be included and followed 2 years after mucosectomy.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Validation of Thermometric Cardiac Imaging by MRI

acronym: VAIMTH-IRM

summary:
Radiofrequency ablation is the primary treatment for atrial and ventricular arrhythmias resistant to medication. However, the absence of assessment of injury creation during radiofrequency application is an important issue. One of the objectives of the Institut Hospitalo-Universitaire (IHU) Liryc (l'Institut de Rythmologie et Modélisation Cardiaque) is to improve ablation procedures by radiofrequency of cardiac arrhythmias. This is based on thermometric imaging by Magnetic Resonance Imaging (MRI) which allows a real time visualization of tissue temperature in all the myocardium with sufficient spatial and temporal resolution to characterize the induced thermal lesion. Today, investigators have developed and validated a new method for cardiac thermometry, associating rapid MRI acquisition technique (4 to 5 slices per heart beat) with online image reconstruction and correction algorithms against residual motion, magnetic susceptibility, drift of the magnetic field, etc... Recent preclinical studies showed a precision of 1°Celsius in the myocardium, largely sufficient to characterize a thermal treatment induced by radiofrequency where typical temperature rises of 40°C are observed during ablation. Temporal evolution of the temperature in each pixel provides access to calculation of the accumulated thermal dose that is a relevant indicator of the induced necrosis.

This imaging method must now be evaluated in humans in order to test its robustness under real conditions (presence of arrhythmias, corpulent patients, etc…) and to optimize acquisition parameters and image processing. The aim of this research is thus to obtain specific MRI sequence of images of patients, on which will be evaluated the different algorithms of reconstruction and processing for temperature imaging. This study is a mandatory step in the perspective of future clinical treatments of cardiac arrhythmia under MRI.


title: Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC

acronym: PIC

summary:
Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids remains controversy. Some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies were retrospective, non randomised studies including various underlying disease and severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult to interpret all the results.

The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


lead_sponsor: Centre d'Investigation Clinique et Technologique 805

acronym: FEDEX

title: FEcal Transplant, a Hope to Eradicate Colonization of Patient Harboring eXtreme Drug Resistant Bacteria?

summary: Our trial try to eradicate digestive tract colonization of patient harboring Extreme Drug Resistant (XDR) bacteria by performing a fecal transplantation.


title: A Comparative Pilot Study in an Infectious Disease Department Assessing the Impact of Medication Reconciliation at Discharge Associated With a Patient's Counseling Session, Both Provided by a Pharmacist, on Patient's Care After Discharge

acronym: CONCIVILLE

summary: Patient's discharge from hospital is associated with iatrogenic events for 12 to 17% of patients. This risk may be linked with discontinuity of care between hospital physicians and Primary Care Physician (PCP). The investigators aim to assess in this study the impact of medication reconciliation at discharge associated with a patient's counseling session, both provided by a pharmacist, on patient's care after discharge. To demonstrate the interest of medication reconciliation at discharge we expect a reduction by 15% of the number of prescription changes not maintained by the PCP after discharge.


title: Representations, Strategies and Identity Redefinition in the Recovery Process: Exploratory Study

acronym: EPR

summary:
In the recent context of deinstitutionalization and longitudinal studies pointing to a large number of positive long-term outcommes for people affected by a psychiatric disorder (schizophrenia, bipolar disorder, eating disorder, severe personality disorder, etc.), the possibility of overcoming the consequences of a psychiatric pathology emerges as a solid fact. Therefore, the existence of this possibility calls for the identification of the determinants underlying of the various outcomes over time of those affected by a severe psychiatric disorder, in particular those likely to underpin the most positive developments.

While it is well known from a medical point of view that certain dimensions affect the prognosis of persons affected by a severe psychiatric disorder (such as the persistence of negative symptoms or cognitive disorders in schizophrenic disorders), prognosis from a purely medical perspective (and putting aside the role of the person and his environment) seems to be able to account only for a modest proportion of the prognosis of people affected by a serious psychiatric disorder.

It is this fact that has gradually led to the emergence of complementary models capable of enriching the understanding of the determinants of the future of people affected by a severe psychiatric disorder, in particular models inviting to separate "becoming of the person" from the " psychiatric disorder "to take into account the" personal role of the person "in his or her own healing. This perspective is the "recovery" perspective.

Recovery process is defined as a personal trajectory which includes the person's experiences and the reactions of his / her environment following the installation of a psychiatric disorder, which can support a mode of release of the status of "psychiatric patient". Recovery thus implies an "approach underpinned by the understanding of the human response to pathology" (Noiseux) and, one might add, of its environment.

However, while these studies point to a number of crucial dimensions involved in the recovery of a severe psychiatric disorder, one of the important limitations of these studies is the distance from any psychopathological consideration, thus setting aside the possibility of specific processes of recovery depending of the pathology. The identification of recurrent experiential logics specific to the various psychiatric disorders therefore appears to be an important field of investigation. It would potentially be able to guide the development of new therapeutic devices based on the recovery model.


title: Visuospatial Attention and Eye Movement Behaviour in Patients With Alzheimer's Disease When Searching in Realistic Scenes and a Natural Setting: Exploring Perceptual and Cognitive Mechanisms and Their Relationships With IADLs

acronym: ARVA-MA

summary: The aim is to understand which components of attentional deployment and selection are impaired in AD during searching in realistic scenes on a computer screen (Experiment 1) and in a natural setting (Experiment 2).The investigators will also examine how deficits in visual exploration may be related to impairments in semantic, long-term memory (LTM) and working memory (WM) representations by manipulating the semantic consistency between the target and its visual surroundings, and the type of target cue (abstract vs. precise), respectively. Perceptual saliency of target and distractor objects will be also manipulated in Expt.1, In Expt.2, in order to determine how deficits in visual exploration may be involved in the IADL deficits shown by AD patients, participants at each trial will be required to search in a natural settings different types of targets and then to perform an IADL using five objects, among which one of the searched targets. Measures analysed: for the search tasks (Expt. 1 and 2): eye movements in different search phases, accuracy and response times; for IADLs tasks (Expt. 2): eye movements during action planning and execution, motor efficiency (number and types of action performed), time to terminate the activity. Compared to controls, the investigators expect that AD patients will have reduced ability using scene semantic LTM in order to locate the objects, greater attentional capture from highly salient features and greater search performance impairment when higher WM resources are required (abstract target cues). The investigators also expect that their performance at IADLs will be less efficient and, in particular, less organized than control, with reduced advantage of eye guidance.

ReferenceCitation: Ramzaoui H, Faure S, Spotorno S. Top-down and bottom-up guidance in normal aging during scene search. Psychol Aging. 2021 Jun;36(4):433-451. doi: 10.1037/pag0000485.

family: Ramzaoui

full_name: Hanane Ramzaoui

given: Hanane

family: Faure

full_name: Sylvane Faure

given: Sylvane

family: Spotorno

full_name: Sara Spotorno

given: Sara

bso_classification: Social sciences

journal_name: Psychology and Aging

repository_institution: Keele University - Keele Research Repository

version: acceptedVersion

publisher: American Psychological Association (APA)

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Study of Differences in Skeletal Muscle Energy Metabolism Alterations in Women With Weight Loss and Ovarian and/or Endometrial Cancer Based on the Body Mass Index

acronym: METERMUS-IMC

summary: the aim is to study skeletal muscle metabolism alterations métaboliques associated with weight loss in women with ovarian and/or endometrial cancer according to BMI.

lead_sponsor: University Hospital, Tours

location_facility: Gynecology Department, University Teaching Hospital, Tours


title: MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma

acronym: DepiSCARRH

summary: The purpose of this study is to assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).

lead_sponsor: Institut Curie


title: Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism Noninvasive Comparative Study in Humans of the Respective Cardiovascular Effects of Hyperaldosteronism and Hypertension by Magnetic Resonance Imaging

acronym: COEURALDO

summary: Animal models have demonstrated the role of aldosterone in left ventricular remodeling involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It is accepted that patients with primary aldosteronism have a higher prevalence of LV hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has been demonstrated between aldosterone and heart failure as well as the benefit of the administration of an anti -aldosterone drug to lower mortality in this population , regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in humans has been associated with inflammation, fibrosis and aortic stiffness . However, primary aldosteronism is generally associated with so-called secondary hypertension . Chronic hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI hyperaldosteronism on the heart.

time_perspective: Cross-Sectional

ReferenceCitation: Redheuil A, Blanchard A, Pereira H, Raissouni Z, Lorthioir A, Soulat G, Vargas-Poussou R, Amar L, Paul JL, Helley D, Azizi M, Kachenoura N, Mousseaux E. Aldosterone-Related Myocardial Extracellular Matrix Expansion in Hypertension in Humans: A Proof-of-Concept Study by Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2020 Oct;13(10):2149-2159. doi: 10.1016/j.jcmg.2020.06.026. Epub 2020 Sep 16.

family: Redheuil

full_name: Alban Redheuil

given: Alban

family: Blanchard

full_name: Anne Blanchard

given: Anne

family: Pereira

full_name: Helena Pereira

given: Helena

family: Raissouni

full_name: Zainab Raissouni

given: Zainab

family: Lorthioir

full_name: Aurelien Lorthioir

given: Aurelien

family: Soulat

full_name: Gilles Soulat

given: Gilles

family: Vargas-Poussou

full_name: Rosa Vargas-Poussou

given: Rosa

family: Amar

full_name: Laurence Amar

given: Laurence

family: Paul

full_name: Jean-Louis Paul

given: Jean-Louis

family: Helley

full_name: Dominique Helley

given: Dominique

family: Azizi

full_name: Michel Azizi

given: Michel

family: Kachenoura

full_name: Nadjia Kachenoura

given: Nadjia

family: Mousseaux

full_name: Elie Mousseaux

given: Elie

journal_name: JACC: Cardiovascular Imaging

location_facility: Centre d\'investigation Clinique, hopital Europeen George Pompidou


title: Establish a Concordance Between the Mismatch Negativity Amplitude and a Score of Logatoms Discrimination, Both Highlighting Capacities of Auditory Discrimination, in Adult Cochlear Implant Users

acronym: EVODA-ICMN

summary: A cochlear implant is a device for the rehabilitation of severe to profound hearing loss. Despite the standardization of surgical procedures and rehabilitation, speech discrimination performance varied significantly in cochlear implant users and could be improved by early individualized cares. However, there is no objective method yet to evaluate phonemes discrimination, especially in infants, which account for more than half of the indications for implantation. In electroencephalography (EEG), it is possible to highlight the discrimination of auditory stimuli studying the wave of MisMatch Negativity (MMN). In this work, this study propose to use the MMN as an objective vocal audiometry method to evaluate the ability to discriminate phonemes, the smallest units of oral language, in adult cochlear implant users.


title: Exploratory Study to Evaluate the Safety and Efficacy of CD10367 in Subjects With Psoriasis

summary:
This is an exploratory, single-centre, investigator blinded, randomized, controlled, intra-individual study, involving subjects with psoriasis vulgaris.

The objective is to evaluate, in a modified Dumas-Scholtz psoriasis mini-zone test, the safety and efficacy of CD10367 solution at 1% and 3% after a 3-week treatment period of once daily application.

lead_sponsor: Galderma R&D


title: Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer

acronym: FOSTINE

summary: The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.