title: Study at the Man of the Profile of Chimiokines in the Anorexia Bound to the Cancerous Cachexy.

acronym: CHIMIOKINES

summary:
The syndrome of anorexia-cachexie, which accompanies numerous cancers is a major comorbidity which compromises the forecast of these patients. Several cytokines pro-inflammatory as interleukines IL1 ß, IL6 or TNFa participate in the physiopathology of this syndrome at the man and the animal. Besides, it is now established that different neuronal populations, localized in the hypothalamus, are nerve centers of the control of the appetite and the energy homéostasie. However, there is not enough evidence of a direct action of cytokines on these neurones, suggesting the participation of intermediate molecules as chimiokines, inflammatory molecules produced in reaction to an immunological stress by gliales cells and acting directly on the surrounding neurones. The implication of chimiokines in the syndrome of anorexia-cachexie associated with the cancer thus seems very likely Among these, chimiokines " Monocyte Chemoattractant Proteins 1-3 " or MCPs represent obvious candidates because they are produced by multiple tumors. Furthermore, to the mouse, the intellectual expression of MCP1 is correlated in the anorexia led by peripheral injections of a bacterial by-product, the lipopolysaccharide (LPS).

The investigators' main objective is to test at the Man's, in situation of cancer of the pancreas any confused stages, the degree of prédictivité of the chimiokine MCP1 towards the syndrome of anorexia-cachexie associated with the cancer. The investigator also suggest describing: i) the link between rate plasmatique of MCP1 and energy metabolism on one hand, physical composition on the other hand;; ii) the impact of the other chimiokines, particularly those of the family of the MCPs, on the anorexia-cachexie bound to the cancer, iii) the correlation enters their profile of expression plasmatique and the severity of the anorexia, the energy metabolism and the physical composition; iv) the same research on the other inflammatory factors plasmatiques, of nature different from chimiokines; v) the correlation between thin mass and anorexia; vi) the evolution of the chimiokines various and inflammatory factors after surgical treatment or chemotherapy with curative aim in 6 months.


type: Other Identifier

title: Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients

summary: Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Widehem R, Bory P, Greco F, Pavillard F, Chalard K, Mas A, Djanikian F, Carr J, Molinari N, Jaber S, Perrigault PF, Chanques G. Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study. Ann Intensive Care. 2021 May 4;11(1):69. doi: 10.1186/s13613-021-00857-x.

family: Widehem

full_name: Rémy Widehem

given: Rémy

sequence: first

family: Bory

full_name: Paul Bory

given: Paul

sequence: additional

family: Greco

full_name: Frédéric Greco

given: Frédéric

family: Pavillard

full_name: Frédérique Pavillard

given: Frédérique

family: Chalard

full_name: Kévin Chalard

given: Kévin

family: Mas

full_name: Alexandre Mas

given: Alexandre

family: Djanikian

full_name: Flora Djanikian

given: Flora

family: Carr

full_name: Julie Carr

given: Julie

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Jaber

full_name: Samir Jaber

given: Samir

family: Perrigault

full_name: Pierre-François Perrigault

given: Pierre-François

family: Chanques

full_name: Gerald Chanques

given: Gerald

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

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

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

version: submittedVersion

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square


title: Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

acronym: D co réa

summary: Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care).

ReferenceCitation: Bernard C, Delmas V, Duflos C, Molinari N, Garnier O, Chalard K, Jaber S, Perrigault PF, Chanques G. Assessing pain in critically ill brain-injured patients: a psychometric comparison of 3 pain scales and videopupillometry. Pain. 2019 Nov;160(11):2535-2543. doi: 10.1097/j.pain.0000000000001637.

family: Bernard

full_name: Christine Bernard

given: Christine

family: Delmas

full_name: Valentine Delmas

given: Valentine

family: Duflos

full_name: Claire Duflos

given: Claire

family: Garnier

full_name: Océane Garnier

given: Océane

full_name: Gérald Chanques

given: Gérald

journal_name: Pain

oa_host_type: repository

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

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: Undecided

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Neural Correlates of Intern Speech

acronym: INNERSPEECH

summary: The goal is to define what is the nature of intern speech, how it manifests itself, who deal with agency in intern speech and finally what is the role of intern speech in attention tasks.

status: Terminated

study_type: Interventional

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Baciu MV, Rubin C, Décorps MA, Segebarth CM. fMRI assessment of hemispheric language dominance using a simple inner speech paradigm. NMR Biomed. 1999 Aug;12(5):293-8.

ReferenceCitation: Basho S, Palmer ED, Rubio MA, Wulfeck B, Müller RA. Effects of generation mode in fMRI adaptations of semantic fluency: paced production and overt speech. Neuropsychologia. 2007 Apr 9;45(8):1697-706. Epub 2007 Jan 16.

ReferenceCitation: Bookheimer SY, Zeffiro TA, Blaxton T, Gaillard W, Theodore W. Regional cerebral blood flow during object naming and word reading. Human Brain Mapping. 1995;3:93-106.

ReferenceCitation: Clark A, Karmiloff-Smith A. The cognizer's innards: a psychological and philosophical perspective on the development of thought. Mind & Language. 1993;8:487-519.

ReferenceCitation: Conrad B, Schönle P. Speech and respiration. Arch Psychiatr Nervenkr (1970). 1979 Apr 12;226(4):251-68.

ReferenceCitation: Davis RN, Nolen-Hoeksema S. Cognitive inflexibility among ruminators and nonruminators. Cognitive Therapy and Research. 2000;24:699-711.

ReferenceCitation: Frings M, Dimitrova A, Schorn CF, Elles HG, Hein-Kropp C, Gizewski ER, Diener HC, Timmann D. Cerebellar involvement in verb generation: an fMRI study. Neurosci Lett. 2006 Nov 27;409(1):19-23. Epub 2006 Oct 12.

ReferenceCitation: Huang J, Carr TH, Cao Y. Comparing cortical activations for silent and overt speech using event-related fMRI. Hum Brain Mapp. 2002 Jan;15(1):39-53.

ReferenceCitation: Lupyan G. Extracommunicative functions of language: verbal interference causes selective categorization impairments. Psychon Bull Rev. 2009 Aug;16(4):711-8. doi: 10.3758/PBR.16.4.711. Erratum in: Psychon Bull Rev. 2009 Oct;16(5):986.

ReferenceCitation: McGuire PK, Silbersweig DA, Murray RM, David AS, Frackowiak RS, Frith CD. Functional anatomy of inner speech and auditory verbal imagery. Psychol Med. 1996 Jan;26(1):29-38.

ReferenceCitation: Morin A. Inner Speech Encyclopedia of Human Behavior. 2012;Elsevier:436-43.

ReferenceCitation: Netsell R, Ashley E, Bakker K. The Inner Speech of Persons who Stutter. Proceedings of the International Motor Speech Conference. Savannah, Georgia2010

ReferenceCitation: Olivers CN, Nieuwenhuis S. The beneficial effects of additional task load, positive affect, and instruction on the attentional blink. J Exp Psychol Hum Percept Perform. 2006 Apr;32(2):364-79.

ReferenceCitation: Owen WJ, Borowsky R, Sarty GE. FMRI of two measures of phonological processing in visual word recognition: ecological validity matters. Brain Lang. 2004 Jul-Sep;90(1-3):40-6.

ReferenceCitation: Palmer ED, Rosen HJ, Ojemann JG, Buckner RL, Kelley WM, Petersen SE. An event-related fMRI study of overt and covert word stem completion. Neuroimage. 2001 Jul;14(1 Pt 1):182-93.

ReferenceCitation: Partovi S, Konrad F, Karimi S, Rengier F, Lyo JK, Zipp L, Nennig E, Stippich C. Effects of covert and overt paradigms in clinical language fMRI. Acad Radiol. 2012 May;19(5):518-25. doi: 10.1016/j.acra.2011.12.017. Epub 2012 Jan 27.

ReferenceCitation: Rosen HJ, Ojemann JG, Ollinger JM, Petersen SE. Comparison of brain activation during word retrieval done silently and aloud using fMRI. Brain Cogn. 2000 Mar;42(2):201-17.

ReferenceCitation: Shergill SS, Bullmore ET, Brammer MJ, Williams SC, Murray RM, McGuire PK. A functional study of auditory verbal imagery. Psychol Med. 2001 Feb;31(2):241-53.

ReferenceCitation: Shuster LI, Lemieux SK. An fMRI investigation of covertly and overtly produced mono- and multisyllabic words. Brain Lang. 2005 Apr;93(1):20-31.

ReferenceCitation: Uttl B, Morin A, Faulds TJ, Hall T, Wilson JM. Sampling Inner Speech Using Text Messaging. Proceedings of the Canadian Society for Brain, Behavior, and Cognitive Science. Kingston2012. p. 287.

lead_sponsor: University Hospital, Grenoble

status_simplified: Unknown


summary:
The aim of this study is to know the difference between protein profiles (multi-analyte profile) of PH1 patients, idiopathic hypercalciuria (IH) patients and PH1 patients 'siblings. Idiopathic hypercalciuria is a less severe kidney disease that PH1, which also leads to the formation of kidney stones.

The aim is to identify patterns of discriminating markers associated with primary hyperoxaluria type 1 (PH1) that will significantly improve clinical diagnosis and prognosis.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon


title: Using Environmental Light Therapy to Improve Sleep and Neuropsychiatric Symptoms in Dementia

acronym: SOLEIL SOMMEIL

summary: Alzheimer's disease and related syndromes (AD) is a disease affecting memory but also the relationship with the environment and empower people. Patients with AD present in 90% of cases of behavioral disorders and of these behavioral disorders include agitation, apathy but also sleep disorders by circadian rhythm impairment.. No study has shown proven efficacy on the behavior of patients with AD. The main objective of the study was to assess the influence of environmental light nighttime sleep of residents.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Device


title: Clinical and Genetic Study of Familial Sarcoidosis (SARCFAM)

acronym: SARCFAM

summary:
Major impacts of air pollution are lung diseases such as granulomatous diseases and mainly sarcoidosis. Understanding the respective role of inorganic / nanoparticles and genetic background in these chronic diseases is a major challenge for the management of patients and prevention strategies. Granulomas are characterized by giant epithelioid and multinucleated cells, reflecting a severe disturbance in immunological pathways induced both by toxic exposure and genetic predisposition. Previous studies demonstrated that professional environmental context and acute exposures (the World Trade Center disaster) to micro/nanoparticles have a pathogenic impact with a sharp increase in sarcoidosis. Sarcoidosis is a multifactorial disease occurring in a genetically vulnerable context. Many gene variants have been linked to an increased odds-ratio of the disease, such BTNL2, CCDC88B, ANNEXIN A11 involved in regulation of T-cell activation and maturation pathways. We have contributed since 2008 to a national cohort (GSF, 28 centers) of ≈ 800 sarcoidosis patients with familial and sporadic presentation of the disease. This collection has been an exceptional (and worldwide unique) tool for the implementation of an exhaustive clinical database on sarcoidosis, modelling of disease evolution and identification of clinical / genetic criteria differentiating sporadic and familial forms.

The main goals of the project are:

Completion of the genetic data in order to establish a pattern of gene variants segregating with familial forms of the disease, compared to sporadic one. This will be done by WES (WHOLE EXOME) analysis on the previously collected DNA samples. The informed consent for the patients included the information about the BTNL2 gene, which has been already tested since 2008, and related genes connected to immune pathways, thus allowing a unambiguous information about the research finality of the project.
Completion of the clinical data about each patient, in cooperation with the GSF network, management of the database established since 2008. The data collected are those which are commonly detailed in the normal follow-up of the patients. The project do not include any new interventions on the patient (neither radiological or invasive tests).
Specific biological studies might be done on the white blood cells of the patients, and might need in such cases a new blood sampling, both in patients and first degree related healthy controls. Theses specific studies will be presented to an ethical committee (CCP) in order to validate the feasibility in term of 'new intervention' on the cohort. The samples collected will be at the same volume of a classical blood sampling (2*7 ml).
Any other projects, submitted to the GSF network will needed a specific registration and ethical committee validation.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Calender A, Rollat Farnier PA, Buisson A, Pinson S, Bentaher A, Lebecque S, Corvol H, Abou Taam R, Houdouin V, Bardel C, Roy P, Devouassoux G, Cottin V, Seve P, Bernaudin JF, Lim CX, Weichhart T, Valeyre D, Pacheco Y, Clement A, Nathan N; in the frame of GSF (Groupe Sarcoïdose France). Whole exome sequencing in three families segregating a pediatric case of sarcoidosis. BMC Med Genomics. 2018 Mar 6;11(1):23. doi: 10.1186/s12920-018-0338-x.

family: Calender

full_name: Alain Calender

given: Alain

family: Rollat Farnier

full_name: Pierre Antoine Rollat Farnier

given: Pierre Antoine

family: Buisson

full_name: Adrien Buisson

given: Adrien

family: Pinson

full_name: Stéphane Pinson

given: Stéphane

family: Bentaher

full_name: Abderrazzaq Bentaher

given: Abderrazzaq

family: Lebecque

full_name: Serge Lebecque

given: Serge

family: Corvol

full_name: Harriet Corvol

given: Harriet

family: Abou Taam

full_name: Rola Abou Taam

given: Rola

family: Houdouin

full_name: Véronique Houdouin

given: Véronique

family: Bardel

full_name: Claire Bardel

family: Roy

full_name: Pascal Roy

given: Pascal

family: Devouassoux

full_name: Gilles Devouassoux

given: Gilles

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Seve

full_name: Pascal Seve

family: Bernaudin

full_name: Jean-François Bernaudin

given: Jean-François

family: Lim

full_name: Clarice X. Lim

given: Clarice X.

family: Weichhart

full_name: Thomas Weichhart

given: Thomas

family: Valeyre

full_name: Dominique Valeyre

given: Dominique

family: Pacheco

full_name: Yves Pacheco

given: Yves

family: Clement

full_name: Annick Clement

given: Annick

family: Nathan

full_name: Nadia Nathan

given: Nadia

journal_name: BMC Medical Genomics

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

location_facility: Hospices Civils de Lyon / Hopital Edouard Herriot


intervention_type: Drug

lead_sponsor: UCB Biopharma S.P.R.L.

primary_purpose: Treatment

type: EudraCT Number

source: euctr

title: An Open-label Adaptive Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Radiprodil in Subjects With Drug-resistant Infantile Spasms

summary: The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

lead_sponsor_type: industriel


title: Evaluation of the Animal Intervention Used as Therapy. Impact of Animal-assisted Therapy on the Well-being in Patients With Alzheimer's Disease

acronym: ELIAUT

summary:
The animal-assisted therapy (AAT) is now considered a non-drug care and is often used in geriatrics. Many studies have shown a link between the presence of the animal and the psycho-behavioral symptoms decrease in dementia (PBSD) such as depression, anxiety or irritability that affects their quality of life and improved cognitive abilities. However, many methodological flaws in these researches exist.

The aim of the study is to evaluate the effectiveness of AAT on the well-being of patients with Alzheimer disease (AD) at the stage of Major Neuro Cognitive Disorder (NCD) at short and medium term (before care, during care (at the beginning and end of each session), 1 week after, 2 weeks and 1 month after the last session) compared to a group receiving the same stimulation without the dog's response.

Patients will be seen in groups of 4 to 6 people at 8 workshops. 2 groups will be formed: AAT group versus control group. The only difference between these two groups is the intervention of the dog at each workshop in the AAT group.

Each workshop will consist of three identical times. It will begin with a 15 minute introductory activity, the first goal will be to establish a relationship with patients (patients-patients and patients-caregivers) and a 40 minute cognitive stimulation, identical in the 2 groups, will be proposed and finally 5 minutes will be devoted to the closing of the session This study should highlight a positive effect of animal assisted therapy on the well-being, PBSD, depression, anxiety and cognitive abilities and a long-term retention of these positive effects.

design_allocation: Randomized

primary_purpose: Health Services Research

intervention_type: Behavioral


title: Precarious Elderly Patient Supported For Cancer Impact on Quality Of Life of a Domotic And Remote Assistance Approach for Elderly Patients Supported For Locally Advanced or Metastatic Cancer, Socially Isolated: Randomized, Comparative, Prospective Multi-Centre Study

acronym: PREDOMOS

summary: The objective of the PREDOMOS study is to evaluate the impact of establishing a Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance (PS-DR) on the improvement of quality of life of elderly patients, isolated or at risk of isolation, treated for locally advanced or metastatic cancer.

status: Recruiting

ReferenceCitation: Couderc AL, Nouguerède E, Baumstarck K, Loubière S, Le Caer H, Guillem O, Rousseau F, Greillier L, Norguet-Monnereau E, Cecile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Kirscher S, Diaz N, Morando C, Villani P, Auquier P, Daumas A. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial. Trials. 2019 Jan 15;20(1):54. doi: 10.1186/s13063-018-3127-0.

family: Couderc

full_name: Anne-Laure Couderc

given: Anne-Laure

family: Nouguerède

full_name: Emilie Nouguerède

given: Emilie

family: Baumstarck

full_name: Karine Baumstarck

given: Karine

family: Loubière

full_name: Sandrine Loubière

given: Sandrine

family: Le Caer

full_name: Hervé Le Caer

given: Hervé

family: Guillem

full_name: Olivier Guillem

given: Olivier

family: Rousseau

full_name: Frédérique Rousseau

given: Frédérique

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Norguet-Monnereau

full_name: Emmanuelle Norguet-Monnereau

given: Emmanuelle

family: Cecile

full_name: Maud Cecile

given: Maud

family: Boulahssass

full_name: Rabia Boulahssass

given: Rabia

full_name: Françoise Le Caer

given: Françoise

family: Tournier

full_name: Sandrine Tournier

family: Butaud

full_name: Chantal Butaud

given: Chantal

family: Guillet

full_name: Pierre Guillet

given: Pierre

family: Nahon

full_name: Sophie Nahon

given: Sophie

family: Kirscher

full_name: Sylvie Kirscher

given: Sylvie

family: Diaz

full_name: Nadine Diaz

given: Nadine

family: Morando

full_name: Claire Morando

given: Claire

family: Villani

full_name: Patrick Villani

given: Patrick

family: Auquier

full_name: Pascal Auquier

family: Daumas

full_name: Aurélie Daumas

given: Aurélie

ReferenceCitation: Crétel-Durand E, Nouguerède E, Le Caer H, Rousseau F, Retornaz F, Guillem O, Couderc AL, Greillier L, Norguet E, Cécile M, Boulahssass R, Le Caer F, Tournier S, Butaud C, Guillet P, Nahon S, Poudens L, Kirscher S, Loubière S, Diaz N, Dhorne J, Auquier P, Baumstarck K. PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial. Trials. 2017 Apr 12;18(1):174. doi: 10.1186/s13063-017-1894-7.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: A European, Multicenter, Randomized Study Comparing the Effectiveness and Safety of Mitral Valve Repair With the NeoChord DS1000 Artificial Chordae Delivery System Versus Conventional Surgery in Patients With Severe Primary Mitral Regurgitation Due to Isolated Leaflet Prolapse

acronym: MITRACHORD

summary: The main objective is to assess the effectiveness and safety of the NeoChord DS1000 repair technique as compared with conventional open-heart on-pump mitral valve surgery in patients with severe primary mitral regurgitation.

study_start_date_type: Anticipated

status: Withdrawn


title: Implementation and Evaluation of a Paediatric Nurse-driven Sedation Protocol in a Paediatric Intensive Care Unit

acronym: SEDATIDE

summary:
Management of analgesia and sedation is an integral component of the medical care of a critically-ill child. Its role is to assure comfort and safety to a patient undergoing painful cares and technical procedures; it can also be, in particular situations like acute respiratory distress syndrome or acute brain injury, a full processing treatment.

Sedation involves, most of the time, the association of an opioid and a sedative. The use of these drugs is difficult in children, because of a specific metabolism, inducing tolerance and withdrawal in case of prolonged administration.

The COMFORT-BEHAVIOR (COMFORT-B) scale is a validated, simple, reliable and reproducible score evaluating sedation and analgesia. Sedation scoring systems must be used regularly to avoid inadequate sedation.

Excessive sedation is associated with poor outcomes like prolonged mechanical ventilation, longer hospitalisation and more frequent withdrawal symptoms. Adult and paediatric data suggest that goal-directed sedation algorithms allow a more appropriate adaptation of the treatment to the patient's need and permit a reduction in the duration of mechanical ventilation.

The objective was to evaluate the impact of a nurse-driven sedation protocol in a paediatric intensive care unit on duration of mechanical ventilation, total doses and duration of medications, Paediatric Intensive Care Unit (PICU) length of stay, incidence of ventilator-associated-pneumonia and occurrence of withdrawal.

time_perspective: Retrospective

location_facility: service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel


title: Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

summary:
Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide.

The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Hadeed K, Hascoet S, Castex MP, Munzer C, Acar P, Dulac Y. Endothelial Function and Vascular Properties in Children with Sickle Cell Disease. Echocardiography. 2015 Aug;32(8):1285-90. doi: 10.1111/echo.12851. Epub 2014 Dec 3.

name: Department of Pediatric Cardiology; Children's Hospital; Toulouse France

family: Hadeed

full_name: Khaled Hadeed

given: Khaled

family: Hascoet

full_name: Sébastien Hascoet

given: Sébastien

name: Department of Pediatric Hematology; Children's Hospital; Toulouse France

family: Castex

full_name: Marie-Pierre Castex

given: Marie-Pierre

name: Department of Pediatric Clinical Research; Children's Hospital; Toulouse France

family: Munzer

full_name: Caroline Munzer

given: Caroline

family: Acar

full_name: Philippe Acar

given: Philippe

family: Dulac

full_name: Yves Dulac

given: Yves

journal_name: Echocardiography

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


type: Other Grant/Funding Number

title: Ghrelin Cellular Resistance Study in Adolescents With Idiopathic Scoliosis

summary:
Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses the process. In addition administration of melatonin to AIS patients improved the pathology. However this hypothesis has shown controversial results. Recent studies have demonstrated melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations in the cells. As modulation of cAMP is important for osteogenesis such resistance may be critical for the initiation or the development of AIS.

Gi signalization is used by several other GPCR, thus, this hormonal resistance could logically be found in other hormonal or mediator pathways. A precedent study previously focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures osteoblasts.

ReferenceCitation: Sales de Gauzy J, Gennero I, Delrous O, Salles JP, Lepage B, Accadbled F. Fasting total ghrelin levels are increased in patients with adolescent idiopathic scoliosis. Scoliosis. 2015 Nov 30;10:33. doi: 10.1186/s13013-015-0054-7. eCollection 2015.

family: Sales de Gauzy

full_name: Jérôme Sales de Gauzy

given: Jérôme

family: Gennero

full_name: Isabelle Gennero

given: Isabelle

family: Delrous

full_name: Olivier Delrous

given: Olivier

family: Salles

full_name: Jean-Pierre Salles

given: Jean-Pierre

family: Lepage

full_name: Benoit Lepage

given: Benoit

family: Accadbled

full_name: Franck Accadbled

given: Franck

journal_name: Scoliosis

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

intervention_type: Biological


title: Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis

acronym: METHOBIO

summary: The overall purpose of this trial is to assess efficacy and safety of the combination of low doses of Methotrexate (MTX) with anti Tumor Necrosis Factor (TNF) alpha to improve initial efficacy and maintenance rate of anti-TNF alpha treatment in patients with psoriasis.


title: Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

summary: The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI

ReferenceCitation: Calviere L, Nasr N, Arnaud C, Czosnyka M, Viguier A, Tissot B, Sol JC, Larrue V. Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Cerebral Blood Flow Velocities and Cerebral Autoregulation Assessment. Neurocrit Care. 2015 Oct;23(2):253-8. doi: 10.1007/s12028-015-0125-x.

family: Calviere

full_name: Lionel Calviere

given: Lionel

family: Nasr

full_name: Nathalie Nasr

given: Nathalie

family: Arnaud

full_name: Catherine Arnaud

given: Catherine

family: Czosnyka

full_name: Marek Czosnyka

given: Marek

family: Viguier

full_name: Alain Viguier

given: Alain

family: Tissot

full_name: Bernard Tissot

given: Bernard

family: Sol

full_name: Jean-Christophe Sol

given: Jean-Christophe

family: Larrue

full_name: Vincent Larrue

given: Vincent

journal_name: Neurocritical Care


title: Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases

acronym: IRM-de-FLUX

summary:
The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements data with morphological images.

Even if the anatomy of the external carotid artery is well known, data obtained through Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery.

The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.

ReferenceCitation: Balédent O, Fin L, Khuoy L, Ambarki K, Gauvin AC, Gondry-Jouet C, Meyer ME. Brain hydrodynamics study by phase-contrast magnetic resonance imaging and transcranial color doppler. J Magn Reson Imaging. 2006 Nov;24(5):995-1004.

ReferenceCitation: Cadenat H, Barthélémy R, Combelles R, Fabié M, Maneaud M. [Importance of mandibular vascularization in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1972 Jan-Feb;73(1):60-5. French.

ReferenceCitation: Castelli WA, Nasjleti CE, Díaz-Pérez R. Interruption of the arterial inferior alveolar flow and its effects on mandibular collateral circulation and dental tissues. J Dent Res. 1975 Jul-Aug;54(4):708-15.

ReferenceCitation: Combelles R, Manelfe C, Hugot B, Pasturel J, Barthelemy R, Fabie M, Cadenat H. [Selective catherization of the external carotid in stomatology]. Rev Odontostomatol Midi Fr. 1974;32(1):19-37. French.

ReferenceCitation: Dakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.

ReferenceCitation: Decorato I, Kharboutly Z, Vassallo T, Penrose J, Legallais C, Salsac AV. Numerical simulation of the fluid structure interactions in a compliant patient-specific arteriovenous fistula. Int J Numer Method Biomed Eng. 2014 Feb;30(2):143-59. doi: 10.1002/cnm.2595. Epub 2013 Nov 5.

ReferenceCitation: d'Hauthuille C, Testelin S, Moure C, Gbaguidi C, Devauchelle B. [Mandibular osteoradionecrosis. Part II: efficiency of revascularization surgery]. Rev Stomatol Chir Maxillofac. 2008 Nov;109(5):296-300. doi: 10.1016/j.stomax.2007.12.009. Epub 2008 Jun 4. French.

ReferenceCitation: Frydrychowicz A, François CJ, Turski PA. Four-dimensional phase contrast magnetic resonance angiography: potential clinical applications. Eur J Radiol. 2011 Oct;80(1):24-35. doi: 10.1016/j.ejrad.2011.01.094. Epub 2011 Feb 17.

ReferenceCitation: Gauvrit J, Trystram D, Oppenheim C, Leclerc X. [Advanced vascular imaging techniques of supra-aortic, encephalic and medullary vessels]. J Radiol. 2007 Mar;88(3 Pt 2):472-82. Review. French.

ReferenceCitation: Herment A, Lefort M, Kachenoura N, De Cesare A, Taviani V, Graves MJ, Pellot-Barakat C, Frouin F, Mousseaux E. Automated estimation of aortic strain from steady-state free-precession and phase contrast MR images. Magn Reson Med. 2011 Apr;65(4):986-93. doi: 10.1002/mrm.22678. Epub 2010 Nov 3.

ReferenceCitation: Houseman ND, Taylor GI, Pan WR. The angiosomes of the head and neck: anatomic study and clinical applications. Plast Reconstr Surg. 2000 Jun;105(7):2287-313.

ReferenceCitation: Maurits NM, Loots GE, Veldman AE. The influence of vessel wall elasticity and peripheral resistance on the carotid artery flow wave form: a CFD model compared to in vivo ultrasound measurements. J Biomech. 2007;40(2):427-36. Epub 2006 Feb 7.

ReferenceCitation: Morita S, Suzuki K, Masukawa A, Kojima S, Hirata M, Ueno E. Identification of efferent flow in the superior vena cava and azygos vein confluence using cine phase-contrast MRI: speculation of the role of the azygos arch valves. Magn Reson Imaging. 2010 Nov;28(9):1306-10. doi: 10.1016/j.mri.2010.06.005. Epub 2010 Aug 4.

ReferenceCitation: Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.

family: Mouton Paradot

full_name: Gaëlle Mouton Paradot

given: Gaëlle

family: Baledent

full_name: Olivier Baledent

family: Sallioux

full_name: Guillaume Sallioux

given: Guillaume

family: Lehmann

full_name: Pierre Lehmann

given: Pierre

family: Gondry-Jouet

full_name: Catherine Gondry-Jouet

family: Le Gars

full_name: Daniel Le Gars

given: Daniel

journal_name: Neurochirurgie

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Apport de l’IRM de flux dans les hydrocéphalies à pression normale de l’adulte : intérêt prédictif dans les indications chirurgicales

ReferenceCitation: Nayler GL, Firmin DN, Longmore DB. Blood flow imaging by cine magnetic resonance. J Comput Assist Tomogr. 1986 Sep-Oct;10(5):715-22.

ReferenceCitation: Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.

ReferenceCitation: Rebergen SA, van der Wall EE, Doornbos J, de Roos A. Magnetic resonance measurement of velocity and flow: technique, validation, and cardiovascular applications. Am Heart J. 1993 Dec;126(6):1439-56. Review.

ReferenceCitation: Saliou G, Balédent O, Lehmann P, Paradot G, Gondry-Jouet C, Bouzerar R, Devisme G, Theaudin M, Deramond H, Le Gars D, Meyer ME, Vallée JN. [Acute CSF changes in the mesencephalon aqueduct after subarachnoid hemorrhage as measured by PC-MRI]. J Neuroradiol. 2009 Mar;36(1):41-7. doi: 10.1016/j.neurad.2008.07.004. Epub 2008 Aug 12. French.

ReferenceCitation: Testelin, Sylvie, 2000. Incidence du flux microvasculaire sur le comportement des tissus transplantés. Exploration par vélocimétrie doppler laser. Université de Picardie Jules Verne-Amiens.

ReferenceCitation: Yim PJ, Tilara A, Nosher JL. The paradoxical flow hypothesis of the carotid artery: supporting evidence from phase-contrast magnetic resonance imaging. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):101-8. doi: 10.1016/j.jstrokecerebrovasdis.2007.10.004.

ReferenceCitation: Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Departement of Maxillo-Facial Surgery, Amiens University Hospital

status_simplified: Ongoing


title: Clinical Trajectory of Children and Adolescents With Disruptive Behavior Admitted to Pediatric and Psychiatric Emergencies.

acronym: TRAJECTORY

summary:
Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.

Care management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.

The main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.


title: Study of the Platelet Function During the Last Month of Pregnancy

summary:
The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment.

The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

primary_purpose: Prevention

ReferenceCitation: Valéra MC, Parant O, Cenac C, Arnaud C, Gallini A, Hamdi S, Sié P, Arnal JF, Payrastre B. Platelet Adhesion and Thrombus Formation in Whole Blood at Arterial Shear Rate at the End of Pregnancy. Am J Reprod Immunol. 2015 Dec;74(6):533-41. doi: 10.1111/aji.12433. Epub 2015 Oct 4.

name: INSERM; U1048; CHU de Toulouse and Université Toulouse 3; Toulouse Cedex 04 France

family: Valéra

full_name: Marie-Cécile Valéra

given: Marie-Cécile

name: Service de Gynécologie Obstétrique; CHU de Toulouse; Toulouse France

family: Parant

full_name: Olivier Parant

name: INSERM; U1043; CNRS; U5282 and Université Toulouse 3; CPTP; Toulouse France

family: Cenac

full_name: Claire Cenac

given: Claire

name: INSERM; U1027 and Université Toulouse 3; Toulouse France

name: Unité de soutien méthodologique à la recherche clinique; service d’épidémiologie; CHU de Toulouse; Toulouse France

family: Gallini

full_name: Adeline Gallini

given: Adeline

name: Laboratoire de Biochimie and Groupe de Recherche en Fertilité Humaine; EA 3694; CHU de Toulouse; Toulouse France

family: Hamdi

full_name: Safouane Hamdi

given: Safouane

name: Laboratoire d'Hématologie; CHU de Toulouse; Toulouse Cedex 04 France

family: Sié

full_name: Pierre Sié

family: Arnal

full_name: Jean-François Arnal

given: Jean-François

family: Payrastre

full_name: Bernard Payrastre

journal_name: American Journal of Reproductive Immunology


title: Cartography of Allodynic and Hypoasthetic Territories Associated With Neuropathic Pain Following Total Knee Arthroplasty (TKA)

acronym: CARTODOL

summary: The purpose of this study is to realize a cartography of the allodynic and hypoasthetic territories associated with a neuropathic pain appearing in patients who underwent a Total Knee Arthroplasty (TKA)


title: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

acronym: TFH and AIHA

summary:
T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of a Monitoring Device for Patients With Cancer Treated Using Oral Therapeutics

acronym: CAPRI

summary:
The emergence of oral delivery in cancer therapeutics is expected to result in an increased need for better coordination between all treatment stakeholders, mainly to ensure adequate treatment delivery to the patient. There is significant interest in the nurse navigation program's potential to improve transitions of care by improving communication between treatment stakeholders and by providing personalized organizational assistance to patients. The use of health information technology is another strategy aimed at improving cancer care coordination that can be combined with the NN program to improve remote patient follow-up. However, the potential of these two strategies combined to improve oral treatment delivery is limited by a lack of rigorous evidence of actual impact.

The investigators are conducting a large scale randomized controlled trial designed to assess the impact of a navigation program denoted CAPRI that is based on two Nurse Navigators and a web portal ensuring coordination between community and hospital as well as between patients and navigators, versus routine delivery of oral anticancer therapy. The primary research aim is to assess the impact of the program on treatment delivery for patients with metastatic cancer, as measured by Relative Dose Intensity. The trial involves a number of other outcomes, including toxic side effects, patient quality of life and patient experience . An economic evaluation adopting a societal perspective will be conducted, in order to estimate those health care resources' used. A parallel process evaluation will be conducted to describe implementation of the intervention

ReferenceCitation: Gervès-Pinquié C, Daumas-Yatim F, Lalloué B, Girault A, Ferrua M, Fourcade A, Lemare F, Dipalma M, Minvielle E. Impacts of a navigation program based on health information technology for patients receiving oral anticancer therapy: the CAPRI randomized controlled trial. BMC Health Serv Res. 2017 Feb 13;17(1):133. doi: 10.1186/s12913-017-2066-x.

family: Gervès-Pinquié

full_name: Chloé Gervès-Pinquié

given: Chloé

family: Daumas-Yatim

full_name: Fatima Daumas-Yatim

given: Fatima

family: Lalloué

full_name: Benoît Lalloué

given: Benoît

family: Girault

full_name: Anne Girault

given: Anne

family: Ferrua

full_name: Marie Ferrua

given: Marie

family: Fourcade

full_name: Aude Fourcade

given: Aude

family: Lemare

full_name: François Lemare

given: François

family: Dipalma

full_name: Mario Dipalma

given: Mario

family: Minvielle

full_name: Etienne Minvielle

given: Etienne

journal_name: BMC Health Services Research

repositories:
HAL
PubMed Central

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

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Improvement of the Etiological Diagnosis of the Pericarditis

acronym: PERICARDITE

summary: Pericardial syndrome includes pericardites acute pericardial effusion and cardiac tamponade, recurrent pericarditis squeezing chronic pericarditis. The etiologies are very numerous and can be classified as infectious, neoplastic, metabolic or systemic, toxic causes. Diagnosis is difficult, and 80% of etiologies remain classified idiopathic. In their laboratory to improve the diagnosis of this syndrome investigators have developed a strategy of systematic prescription of biological tests by kit. This prescription by 'kit' strategy proved its interest by comparison with an intuitive requirement of biological. In this study investigators want to improve the diagnostic causative of pericarditis by implementing a new diagnostic strategy. This new strategy includes (i) samples additional less invasive for the patient, the swab pharyngeal and nasal, (ii) the addition of at the outset of more effective diagnostic techniques: specific Polymerase Chain Reaction (PCR)

location_facility: Assistance Publique Hopitaux de Marseille


title: Retrospective Study on the Evaluation of Intra-disc Infiltration in the Active Disc Disease

acronym: MODIC

summary: Active discopathies or MODIC 1, are a diagnostic entity discovery with the contribution of MRI in which the first cases were described by Dr. Michael MODIC in 1988. It is characterized by a vertebral bone edema secondary to active discarthrose. Its prevalence is estimated at 6% of the general population and up to 40% of the CLBP according to studies. Following the discovery of this recent diagnostic entity, responsible for low back pain, the question of its management is debate in the medical community. Early studies demonstrate the effectiveness of corticosteroid injections in intra-disc. Other works, most recent, suggest the contrary, infectious, incriminating a pathogenic role of certain bacteria such as Propionibacterium acness or Corynebacterium propinquum recommending, in contrast, treatment with prolonged antibiotic therapy. This study will aim to assess the effectiveness of intra-disc infiltration GHPSJ carried out between 2007 and 2014. The innovation of our work will be to assess these infiltrations in various subgroups such as patients with a previous surgery of the spine or a history of scoliosis or spondylolisthesis.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Prospective Study of Technical Optimization of the Detection of KRAS Mutations, BRAF and NRAS by Next Generation Sequencing on Tumor DNA Circulating in Metastatic Colorectal Cancer.

summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin

primary_purpose: Other

lead_sponsor: Institut de Cancérologie de Lorraine


title: Study of the Strategies of Visual Perception of Social Scenes During Emotional States Induced to Subjects With an Intrusive Disorder of the Development: Pilot Study

acronym: VisioTED

summary:
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications.

The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies.

This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.


title: Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)

acronym: PRIMIMMUNO

summary: The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).

location_facility: Hospices Civils de Lyon / Hôpital de la Croix Rousse


title: Evaluation of the Effectiveness of a Diagnostic Kit in the Etiological Diagnosis of Fevers of the Traveler

summary:
Annually about 10 to 15 million international travelers from Europe visit tropical countries. Returning from a journey, fever is the cardinal symptom of many infections. This is the second reason for consultation (23%) for return from a trip, after digestive disorders (42%). Urgent evaluation must always be proposed. Although that may be the manifestation of a benign disease, fever of return can also presage a rapidly progressive and lethal disease. In 50% of cases, patients return home, after treatment and disappearance of symptoms, though the microorganism responsible for the pathology is not able to be identified. The prescription of a series of systematic biological examinations in the form of a diagnostic kit has shown its relevance and its effectiveness in improving the etiological diagnosis of endocarditis and pericardites for optimal support. In this study we propose to assess the effectiveness of the systematic prescription of a diagnostic kit 'fever of the traveler' to all patients hospitalized with a fever after returning from a trip. "Ready to use" kit brings together in a single bag (i) instructions for use, (ii) the tubes, bottles and jars for the etiological diagnosis of fever of the traveler in the usual support (iii) an additional blood tube for research of pathogens emerging.

Primary:

To assess the effectiveness of a diagnostic kit for the etiological diagnosis of fevers of travelers on the return.

Hypothesis:

Improvement of at least 15% of the etiological diagnosis of fevers of travelers on the return through the development of a diagnostic kit.

location_facility: Asssitance Publique Hopitaux de Marseille


title: Diagnostic Performances of Urine and Plasma 5-hydroxyindolacetic Acid (5HIAA) Values in Patients With Small-intestine Neuroendocrine Tumors

summary: Urinary measure of 5-hydroxyindolacetic acid (5HIAA) is an important marker for the diagnosis and follow-up of patients with small-intestine neuroendocrine tumors. Although this marker has good specificity, its sensitivity is moderate and its dosage is constraining, since it requires urine collection over 2-3 days and specific diet. Preliminary data suggested that overnight 5HIAA value may be representative of 24-hour 5HIAA value, and that plasma 5HIAA dosage could be a valuable alternative to urine 5HIAA dosage. The main objective of this study is to compare sensitivity and specificity of overnight 5HIAA value, 24-hour 5HIAA value and plasma 5HIAA value, in patients with small-intestine neuroendocrine tumors.

ReferenceCitation: de Mestier L, Savagner F, Brixi H, Do Cao C, Dominguez-Tinajero S, Roquin G, Goichot B, Hentic O, Dubreuil O, Hautefeuille V, Walter T, Cadiot G. Plasmatic and Urinary 5-Hydroxyindolacetic Acid Measurements in Patients With Midgut Neuroendocrine Tumors: A GTE Study. J Clin Endocrinol Metab. 2021 Mar 25;106(4):e1673-e1682. doi: 10.1210/clinem/dgaa924.

name: Université de Paris, Department of Gastroenterology-Pancreatology, ENETS Centre of Excellence, Hôpital Beaujon (APHP), Clichy, France

family: de Mestier

full_name: Louis de Mestier

given: Louis

name: Biochemistry and Genetic Laboratory, Federative Institute of Biology, Hôpital Purpan and Université Toulouse III Paul Sabatier, Inserm, Toulouse, France

family: Savagner

full_name: Frédérique Savagner

given: Frédérique

name: Department of Hepato-Gastroenterology and Digestive Oncology, Hôpital Robert Debré and Université Reims-Champagne-Ardenne, Reims, France

family: Brixi

full_name: Hedia Brixi

given: Hedia

name: Department of Endocrinology, Hôpital Claude Huriez, Centre Hospitalo-Universitaire de Lille, Lille, France

family: Do Cao

full_name: Christine Do Cao

given: Christine

name: Department of Onco-Hematology, Hôpitaux Catholiques de Lille, Université Catholique de Lille, Lille, France

family: Dominguez-Tinajero

full_name: Sophie Dominguez-Tinajero

given: Sophie

name: Department of Hepato-Gastroenterology and Digestive Oncology, Centre Hospitalo-Universitaire d’Angers, Angers, France

family: Roquin

full_name: Guillaume Roquin

given: Guillaume

name: Department of Internal Medicine, Endocrinology & Nutrition, Hôpital Hautepierre, Hôpitaux Universitaires, Strasbourg, France

family: Goichot

full_name: Bernard Goichot

given: Bernard

family: Hentic

full_name: Olivia Hentic

given: Olivia

name: Department of Digestive Oncology, Hôpital La Pitié Salpétrière (APHP), Paris, France

family: Dubreuil

full_name: Olivier Dubreuil

given: Olivier

name: Department of Hepato-Gastroenterology and Digestive Oncology, Centre Hospitalo-Universitaire d’Amiens, Amiens, France

family: Hautefeuille

full_name: Vincent Hautefeuille

given: Vincent

name: Department of Digestive Oncology, ENETS Centre of Excellence, Hospices Civils de Lyon, Lyon, France

family: Walter

full_name: Thomas Walter

given: Thomas

family: Cadiot

full_name: Guillaume Cadiot

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

lead_sponsor: CHU de Reims


title: Electro- Hemodynamic Activity in Children: Combined Analysis by Video -EEG Spectroscopy and Near-infrared (NIRS )

acronym: AEHCEE

summary: Epilepsy in children is a major public health issue. It is the first neurological disease of the child.


title: Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

acronym: HEV

summary:
Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.

HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.

In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.

This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.

primary_purpose: Screening


title: Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study

acronym: OptimEpi

summary:
Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination.

The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

lead_sponsor: Pierre and Marie Curie University


title: Interest of the Use of the Web Platform LICORNE (LIaison and COoRdination With a NumériquE Health Reseau) Concerning Coordination of Care for Dependant Elderly Patients

acronym: LICORNE

summary:
This project is associating partners from the public area (university hospital of Nice, Nice university) and the private area (Agfa Health Care, Radhuis, Domicalis) to create a unique medico-psycho-social shared record.

The purpose of this project is to significantly improve coordination of care, especially between hospital and home. We can expect a significant improvement in the patient's living conditions, improving its management, its security and ultimately, lower health care costs.


lead_sponsor: Assistance Publique - Hôpitaux de Paris

acronym: REOVAS

title: Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study

summary:
Phase III, comparative, multicenter, randomized, controlled, double-blind and superiority research, comparing rituximab-based regimen with conventional therapeutic strategy for the induction of remission in patients with eosinophilic granulomatosis with polyangiitis (EGPA).

Patients with newly diagnosed or relapsing EGPA will be randomized in a 1:1 ratio to receive:

Experimental therapeutic strategy based on the use of rituximab (experimental group)
Conventional therapeutic strategy based on Five-Factor Score (FFS)-assessed disease severity (comparative group)


title: Study Protocol: Reference Values for External Genitalia and Androgen Blood Level in New Born Girls

acronym: VOGE

summary:
Normal values for female external genitalia size at birth, particularly clitoris and blood level of androgens are not well known. This study's aim is to collect normal values in 180 newborn girls of 24 to 41 weeks of pregnancy, and to build genitalia growth charts according to gestational age and birth weight.

The investigators will measure clitoris, genito-anal ratio using a small plastic caliper, at birth, and their evolution until Day 3 of life (if the child is still at the hospital).

The investigators also want to establish normal values of blood testosterone, 17-hydroxyprogesterone, delta4-androstenedione, 21-deoxycortisol, 11-deoxycortisol, deoxycorticosterone, corticosterone, dehydroepiandrostenedione, and dihydrotestosterone), using samples taken for systematic post natal screening of diseases (only in new born of 35 or more weeks of birth).

This is an observational prospective study.


title: Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics

acronym: XXS SYMPA

summary: Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.

intervention_type: Dietary Supplement


title: Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftaroline in Patients With CSF Device

acronym: Ceftaroline

summary:
Ceftaroline is a piece of new cephalosporin very active on resistant staphylococci in methicillin (SEMR: Staphylococcus Epidermidis Resistant in Methicillin, SMAR: Staphylococcus Aureus Resistant in Methicillin)and/or in vancomycin ; Ceftaroline is also very active on pneumococci resistant in penicillin and/or 3rd generation of cephalosporins.

Ceftaroline was approved by the European Medicines Agency for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia.

Scientific literature describes a good efficiency in septicemy and/or SAMR endocarditis.

Besides, a study on animal shows the efficiency of ceftaroline in meningeal infections with gram-negative Bacilli.

The rationale of this study is based on the antibacterial spectra of ceftaroline that could be used for the antibacterial treatment (curative and prophylactic) of CSF shunt associated infections.

To validate this hypothesis, it is necessary to evaluate the concentration of ceftaroline in meningeal compartment after treatment.

ReferenceCitation: Chauzy A, Nadji A, Combes JC, Defrance N, Bouhemad B, Couet W, Chavanet P. Cerebrospinal fluid pharmacokinetics of ceftaroline in neurosurgical patients with an external ventricular drain. J Antimicrob Chemother. 2019 Mar 1;74(3):675-681. doi: 10.1093/jac/dky489.

name: Université de Poitiers, INSERM U1070, CHU Poitiers, Poitiers, France

family: Chauzy

full_name: Alexia Chauzy

given: Alexia

name: Neuroréanimation, Hôpital du Bocage, CHU Dijon, Dijon, France

family: Nadji

full_name: Abdelouaid Nadji

given: Abdelouaid

family: Combes

full_name: Jean-Christophe Combes

given: Jean-Christophe

family: Defrance

full_name: Nadine Defrance

given: Nadine

family: Bouhemad

full_name: Belaid Bouhemad

given: Belaid

family: Couet

full_name: William Couet

given: William

name: Département d’Infectiologie, CHU and INSERM CIC1432, Université de Bourgogne, Dijon, France

family: Chavanet

full_name: Pascal Chavanet

given: Pascal

journal_name: Journal of Antimicrobial Chemotherapy

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


acronym: CurHaTOF

summary:
Current guidelines recommend monitoring of neuromuscular blockade at the adductor pollicis by stimulation of the ulnar nerve at the wrist.

However, in certain situations (laparoscopic surgery, cranial surgery or surgical comfort, arterial catheterization), it is impossible to access the patient's wrists, delaying monitoring, antagonizing the neuromuscular block, the emergence from anesthesia and patient extubation , leading in some cases to single injections lack of control of the reversal of the patient.

To overcome these technical difficulties, a group nerve / muscle looks interesting and often easily accessible to the anesthesiologist.

The stimulation of the posterior tibial nerve can observe a response to the flexor hallucis brevis muscle and allows quick access to monitoring the reversal before the end of the intervention.

The primary outcome was to compare the speed of recovery from neuromuscular block flexor hallux versus that of the adductor pollicis.

The secondary objective was to compare the speed of installation of deep neuromuscular block flexor hallucis versus that of the adductor pollicis.

This is a prospective, exploratory, uncontrolled, single-center for routine care.

Are included all aged patients over 18 years, ASA I or II, without guardianship, having no known allergy to Atracurium, without neuromyopathy known, emergency surgery or full stomach, predictable difficult intubation .

ReferenceCitation: Le Merrer M, Frasca D, Dupuis M, Debaene B, Boisson M. A comparison between the flexor hallucis brevis and adductor pollicis muscles in atracurium-induced neuromuscular blockade using acceleromyography: A prospective observational study. Eur J Anaesthesiol. 2020 Jan;37(1):38-43. doi: 10.1097/EJA.0000000000001090.

family: Le Merrer

full_name: Maëlle Le Merrer

given: Maëlle

family: Frasca

full_name: Denis Frasca

given: Denis

family: Dupuis

full_name: Maxime Dupuis

given: Maxime

family: Debaene

full_name: Bertrand Debaene

given: Bertrand

family: Boisson

full_name: Matthieu Boisson

given: Matthieu

journal_name: European Journal of Anaesthesiology

oa_host_type: publisher

evidence: open (via free article)

lead_sponsor: Poitiers University Hospital


title: Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants

summary:
The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.

Design: Prospective, controlled, randomized, multi-center.

Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours.

Conditions of measurements:

Primary endpoint: Proportion of failure in both arms during the first 24 hours.

Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (correlated to an initial gas analysis), Report SpO2 / FiO2

Statistic: Intention to treat Analysis.

Expected number of patients: 135 per arm: 270 children.

ReferenceCitation: Milési C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.

family: Milési

full_name: Christophe Milési

given: Christophe

family: Pierre

full_name: Anne-Florence Pierre

given: Anne-Florence

family: Deho

full_name: Anna Deho

given: Anna

family: Pouyau

full_name: Robin Pouyau

given: Robin

family: Liet

full_name: Jean-Michel Liet

given: Jean-Michel

family: Guillot

full_name: Camille Guillot

given: Camille

family: Guilbert

full_name: Anne-Sophie Guilbert

given: Anne-Sophie

family: Rambaud

full_name: Jérôme Rambaud

given: Jérôme

family: Millet

full_name: Astrid Millet

given: Astrid

family: Afanetti

full_name: Mickael Afanetti

given: Mickael

family: Guichoux

full_name: Julie Guichoux

given: Julie

family: Genuini

full_name: Mathieu Genuini

given: Mathieu

family: Mansir

full_name: Thierry Mansir

given: Thierry

family: Bergounioux

full_name: Jean Bergounioux

given: Jean

family: Michel

full_name: Fabrice Michel

given: Fabrice

family: Marcoux

full_name: Marie-Odile Marcoux

given: Marie-Odile

family: Baleine

full_name: Julien Baleine

given: Julien

family: Durand

full_name: Sabine Durand

given: Sabine

full_name: Philippe Durand

given: Philippe

family: Dauger

full_name: Stéphane Dauger

given: Stéphane

family: Javouhey

full_name: Etienne Javouhey

given: Etienne

family: Leteurtre

full_name: Stéphane Leteurtre

family: Brissaud

full_name: Olivier Brissaud

ipd_sharing_description: All data will be centralized at the sponsor office for the final analysis


title: Evaluation of Clinical Perfectionism in Parkinson Disease

summary: Scientific studies show that almost half of the people with Parkinson's Disease (PD) suffer of depression and / or anxiety.


title: Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

acronym: MP-TCSP-IRMf

summary:
Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem.

Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system".

A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system.

The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD.

The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Treatment of the Osgood Schlatter Disease by Immobilization ( Ankle Cruro Resin ) Versus Sporting Rest ( Reference Treatment ) : Randomized Controlled Study

acronym: OSGOOD

summary:
The disease Osgood-Schlatter is most commonly found in sports teenager growing up apophysose accounting for 28.4% of osteochondrosis by Breck. It relates to 62% of osteochondrosis knee and affects adolescent girls between 10 and 12 and boys between 12 and 15 It is usually considered a benign pathology that cures in the majority of cases. However, in 5-10% of cases there is persistent residual pain in adulthood.

The classic complication is the avulsion fracture of the tibial tuberosity in adolescents who continued his sports without restriction.

The possible consequences are numerous including the presence of a free bone fragment at the insertion of the tendon originally described by Osgood the establishment of a genu recurvatum, a high kneecap or patella alta and an enlarged tibial tuberosity (ATT) annoying sport.

The main two treatments are complete rest from sport activity or cast immobilization.

The main objective is to compare these two technics according to the proportion of full sporting recovering at 12 months

location_facility: Department of Sport's medicine, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval


ReferenceCitation: Gallais F, Ysebaert L, Despas F, De Barros S, Dupré L, Quillet-Mary A, Protin C, Thomas F, Obéric L, Allal B, Chatelut E, White-Koning M. Population Pharmacokinetics of Ibrutinib and Its Dihydrodiol Metabolite in Patients with Lymphoid Malignancies. Clin Pharmacokinet. 2020 Sep;59(9):1171-1183. doi: 10.1007/s40262-020-00884-0.

family: Gallais

full_name: Fanny Gallais

given: Fanny

family: Ysebaert

full_name: Loïc Ysebaert

given: Loïc

family: Despas

full_name: Fabien Despas

given: Fabien

family: De Barros

full_name: Sandra De Barros

given: Sandra

family: Dupré

full_name: Loïc Dupré

family: Quillet-Mary

full_name: Anne Quillet-Mary

given: Anne

family: Protin

full_name: Caroline Protin

given: Caroline

family: Thomas

full_name: Fabienne Thomas

given: Fabienne

family: Obéric

full_name: Lucie Obéric

given: Lucie

family: Allal

full_name: Ben Allal

given: Ben

family: Chatelut

full_name: Etienne Chatelut

family: White-Koning

full_name: Mélanie White-Koning

given: Mélanie

journal_name: Clinical Pharmacokinetics

location_facility: Cancer University Institute of Toulouse Oncopole

title: Real Life Assessment of the Association and Its Determinants Between Side Effects and Plasmatic Concentrations of Two Protein Kinase Inhibitors: Ibrutinib (IMBRUVICA®) and Idelalisib (ZYDELIG®) in Hematological Malignancies Treatment.

summary:
Recently, European Medicines Agency approved ibrutinib and idelalisib to treat Chronic Lymphocytic Leukemia (CLL) and two lymphomas: Follicular Lymphoma (FL) for ibrutinib and Mantle cell lymphoma (MCL) for idelalisib.

Clinical trials for ibrutinib and idelalisib were performed with a small number of patients (300-350) and showed several side effects profiles. Since, pharmacokinetic properties of these 2 drugs highlight a interindividual variability of pharmacokinetic. The aim of this study is to determine the association between clinically significant side effects occurrence during the first year of treatment and plasma mean concentration of the steady state of ibrutinib or idelalisib at 1 month.


acronym: TARGET

location_facility: Neuro onsology unit - Groupe Hospitalier Pitié-Salpêtrière

title: A Phase I/II, Open-Label, Multicentre Study to Assess The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of AZD4547 in Patients With Relapsed/Refractory Glioma Positive for an FGFR Fusion

summary:
The investigators will look for the presence of the fusion gene in all patients operated on for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter being sought in both routine and anomalies never co-existing.

The hypothesis is that the rate of progression-free survival in grade IV gliomas and III without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients relapse before 6 months of treatment), must be with this new treatment 35% (primary endpoint).

The main objective is the evaluation of disease-free survival at 6 months.


title: INEqualities in Health Psychosocial Determinants of Neuro and Cardio-V@scuLar Disease: Identification of Novel Levers for Secondary Prevention

summary:
The aim of this study is to identify groups of subjects at risk of recurrence in secondary prevention based on Psychosocial Factors.

The aim is also to propose novel levers to reduce health inequalities in this population so as to develop new prevention strategies for neuro- and cardio-vascular health This study is based on data from questionnaires (Quality of life at work, perceived stress, perceived disease severity) and on behavior indicators (factors related to lifestyle: alcohol, smoking, obesity, sedentarity).

Biomarkers of endothelial function (ADMA) will also be assayed. It's an interventional study because of blood sample


title: Neuroinflammation, Serotonin, Impulsivity and Suicide

acronym: NISIS

summary:
Suicide is a major health problem that causes annually a million death worlwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition (personality, family history of SB…) and stressful conditions (early life adversity).

Studies show that suicide ideations could favour inflammation and that depression is associated with an elevated inflammation.

Recent evidences also suggest that inflammatory mediators play a critical role in SB.

The aim of the study is to evaluate the inflammatory markers rate on depressed patients with or without personal history of SB.

In the second part of the study, the relations between the rates of inflammatory markers and characteristics of SB, impulsivity, psychological pain, childhood abuse and gene expression of 5HT2B receptor will be investigated.

lead_sponsor: University Hospital, Montpellier


title: Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers of Inflammation

acronym: RIFIFI

summary:
An intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. The inflammatory processes involved are complex and haven't been explored in detail in human patients. This inflammatory response can increase myocardial damage following reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac death).

Cardiac MRI can assess the size of myocardial infarction and many other parameters associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction.

(However the association between biomarkers of inflammation and these imaging parameters is not known).

There is very little data correlating imaging markers of myocardial injury to the biokinetics of inflammation biomarkers.

In this study, the aim is to assess the relationship between the kinetics of specific inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2), neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20 acute mycardial infarction (AMI) patients.


title: MRI Investigations in Attention Deficit Hyperactivity Disorder (ADHD) and High Potential (HP) Children for a Better Therapeutic Approach

acronym: HP

summary:
Impulsivity and/or hyperactivity in children has become one of the main clinical symptom for consultation, among the most frequent, in general or pediatric medicine. Among the different clinical forms of instability, ADHD appears to be an especially disabling condition for the development of the child, both in psychomotor, cognitive, emotional and relational aspects. Further, a significant link between ADHD children and some children with High Potential (HP) is observed. HP children show overall ahead cognitive developments compared to children with the same age. In these children, as well as in children with ADHD, an attention vulnerability, psychomotor deficits are noted, as well as emotional and relational deficits that significantly contrasted with some of their cognitive skills. Regarding the HP, the hypothesis is that children with significantly heterogeneous results (Complex) to the Wechsler IV scales are affected by this shift, and hence, by the difficulty of a differential diagnosis with ADHD, unlike those whose intelligence quotient (IQ) results that are more homogeneous (Laminar).

The goal of this work was to study a population of 80 children aged from 8 to 12 years (20 subjects per group) to evaluate the functional and structural brain development by:

Functional magnetic resonance imaging (fMRI) acquisitions with cognitive stimulations, involving attention, working memory and semantic processing, and emotional stimulations,
fMRI acquisitions at rest (without activation),
diffusion tensor magnetic resonance imaging (DTI) acquisitions,
3D anatomic acquisitions. Identification of developmental differences in certain cortical brain areas (eg, prefrontal vs parietal), white matter fiber bundles or functional networks preferentially used by one or other of these groups, will help to better understand this disease, and to improve the differential diagnosis in order to implement a more appropriate and personalized management of the patients via new therapeutic strategies.

location_facility: Service de psychiatrie infantile, Hôpital Pierre Wertheimer, 59 Boulevard Pinel


title: Obstetric and Proctology Support of Patients With Perineums Suits. Prospective Cohort

summary:
Perineal tear grade III and IV are relatively common (1-10% of deliveries depending on the series), and are a source of potentially serious complications, even long time after delivery (especially disorders of anal continence, psychological trauma). If a number of risk factors are well described, the support arrangements at the time of delivery and the characteristics of the review Proctological remote delivery and its relationship to the clinical status of patients is little known and rarely studied.

In maternity wards of the hospital Saint Joseph Paris and Cochin-Port Royal group, patients with a diagnosis of severe perineal tear was made are taken following load with common rules, both for the immediate repair for the remote monitoring. Patients of both sites are indeed encouraged to consult in proctology consultation in Saint Joseph 4-6 months of birth.

The same support on both sites allows to consider the creation of a relatively homogeneous cohort in terms of support and consider an important recruitment. Moreover, the geographical proximity of the inclusions sites (maternity) with proctology service is likely to limit the risk of lost sight of.


title: Study of the Level of Mannose Binding Lectin (MBL) as a Predictor of the Onset of a Invasive Fungal Infection (IFI) During Chemo-induced Aplasia in Patients With Acute Leukemia (AL)

acronym: MBL INFFONG

summary: The aim of this study is to investigate levels of a protein, mannose binding lectin, in patients with acute leukemia who develop or not an invasive fungal infection.


title: Aortic Calcification and Vitamin K Antagonists

acronym: AVKAL

summary: The vitamin K antagonists (VKA) are necessary drugs of prevention and treatment of thrombo-embolic disease. The AVKAL study assesses the impact of VKA treatment on the aortic calcifications development. This is a biomedical research without health product, transversal and monocentric study which compares the aortic calcifications levels of two populations : one treated by VKA and the other which has never been treated by VKA.

ReferenceCitation: Price PA, Urist MR, Otawara Y. Matrix Gla protein, a new gamma-carboxyglutamic acid-containing protein which is associated with the organic matrix of bone. Biochem Biophys Res Commun. 1983 Dec 28;117(3):765-71.

ReferenceCitation: Schurgers LJ, Aebert H, Vermeer C, Bültmann B, Janzen J. Oral anticoagulant treatment: friend or foe in cardiovascular disease? Blood. 2004 Nov 15;104(10):3231-2. Epub 2004 Jul 20.

ReferenceCitation: Price PA, Faus SA, Williamson MK. Warfarin causes rapid calcification of the elastic lamellae in rat arteries and heart valves. Arterioscler Thromb Vasc Biol. 1998 Sep;18(9):1400-7.

ReferenceCitation: Schurgers LJ, Cranenburg EC, Vermeer C. Matrix Gla-protein: the calcification inhibitor in need of vitamin K. Thromb Haemost. 2008 Oct;100(4):593-603. Review.


title: One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery

acronym: VUPPAM

summary: Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.


title: Evaluation of Diagnostic Qualities of Lung Ultrasonography to Monitor the Position of the Intubation Probe

acronym: ECOVERA

summary:
The purpose of this study is to evaluate the diagnostic qualities of lung ultrasonography to monitor the position of the intubation probe.

The primary assessment criterion is of study the position of the intubation probe with two examinations carried out independently :

sonography
chest radiography

A correct position of the intubation probe will be considered if there is :

Highlighting of the extremity of the intubation probe in endo tracheal
Highlighting bilateral lung sliding

ReferenceCitation: Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70.

ReferenceCitation: Harris EA, Arheart KL, Penning DH. Endotracheal tube malposition within the pediatric population: a common event despite clinical evidence of correct placement. Can J Anaesth. 2008 Oct;55(10):685-90. doi: 10.1007/BF03017744.

ReferenceCitation: Schmölzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1. Review.

ReferenceCitation: Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21. Review.

ReferenceCitation: Pfeiffer P, Rudolph SS, Børglum J, Isbye DL. Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. Acta Anaesthesiol Scand. 2011 Nov;55(10):1190-5. doi: 10.1111/j.1399-6576.2011.02501.x. Epub 2011 Sep 8.

ReferenceCitation: American College of Emergency Physicians. Clinical Policies Committee. Verification of endotracheal tube placement. Ann Emerg Med. 2002 Nov;40(5):551-2.


title: Q Fever and Auto-immunity

acronym: Q Fever

summary: The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.

location_facility: Assistance Publique - Hôpitaux de Marseille


title: CoHort of STEMI Patients

acronym: STEMI

summary:
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention.

However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year.

Also, therapeutic management following international guidelines is standardized toward a "one-size fits all" therapeutic management.

In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling ….

This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine.

The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.

location_facility: Hôpital Cardiovasculaire Louis Pradel 28, Avenue du Doyen Lépine


title: Efficacity of a Standardized Hypnotic Message on Pain Experienced During the Application of a Qutenza (Capsaicin) 8% Patch in Patients With Peripheral Neuropathic Pain

acronym: ENHYZA

summary: QUTENZA® is a skin patch with a high concentration of capsaicin (8%) which is the component responsible for spicy peppers. QUTENZA® is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other analgesics. Acute pain experienced during and after the procedure can be relieved by local cooling methods and oral analgesics but the pain remains intense. The hypothesis is that hypnosis via a standardized hypnotic message would increase the local tolerance of the treatment when applying the patch QUTENZA®. To date, there are no studies that can confirm or refute this hypothesis.

ReferenceCitation: Etienne R, Laurent M, Henry A, Bioy A, Salleron J, Schohn CH, Cretineau N. Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial. BMC Complement Med Ther. 2021 May 27;21(1):154. doi: 10.1186/s12906-021-03329-8.

family: Etienne

full_name: Rémi Etienne

given: Rémi

family: Laurent

full_name: Myriam Laurent

given: Myriam

family: Henry

full_name: Aline Henry

given: Aline

family: Bioy

full_name: Antoine Bioy

given: Antoine

family: Salleron

full_name: Julia Salleron

given: Julia

family: Schohn

full_name: Cécile Huin Schohn

given: Cécile Huin

family: Cretineau

full_name: Nathalie Cretineau

given: Nathalie

journal_name: BMC Complementary Medicine and Therapies

repositories:
PubMed Central
Research Square


title: Pain in Psychiatry : Impact on Length of Hospital Stays

acronym: D-PSY

summary: For several decades, authors are interested in the existence and meaning of painful symptoms in a population of psychiatric inpatients. But, to date, studies specifically focused on the impact of pain in patient populations in psychiatric hospitals are few. More recently, a review of the literature highlights the difficulties of evaluation of pain in populations of psychiatric patients but also the complex interrelationships between painful symptoms and psychiatric diseases. The first national survey conducted among 172 health which evaluate pain and its management in the field of psychiatry concluded on the need to develop research in this area.


title: Assessment of Cystatin C as a Tubular and Glomerular Marker of Nephrotoxicity in Pediatric Oncology

acronym: CysPed

summary: Cisplatin and ifosfamide are commonly used drugs in chemotherapy. They are known to involve renal toxic threats in children given their immature kidney. This toxicity is increased especially after nephrectomy and/or concomitant radiotherapy. In pediatric oncology, the available evaluation methods of the renal function could be very restrictive to perform on children. In this study, the investigators intend to test the use of the cystatin C as an effective and reliable biological marker of renal toxicity in children treated with cisplatin and / or ifosfamide.

status: Active, not recruiting

ReferenceCitation: Lambert M, White-Koning M, Alonso M, Garnier A, Alphonsa G, Puiseux C, Munzer C, Berthier J, Malard L, Pasquet M, Chatelut E. Plasma cystatin C is a marker of renal glomerular injury in children treated with cisplatin or ifosfamide. Pediatr Blood Cancer. 2021 Jan;68(1):e28747. doi: 10.1002/pbc.28747. Epub 2020 Oct 15.

name: Cancer Research Centre of Toulouse (CRCT) Université de Toulouse, Inserm  Toulouse France

name: Institut Claudius‐Regaud, IUCT‐Oncopole  Toulouse France

family: Lambert

full_name: Marie Lambert

given: Marie

family: White‐Koning

full_name: Melanie White‐Koning

given: Melanie

name: Unité de Radiopharmacie CHU de Toulouse‐Purpan  Toulouse France

family: Alonso

full_name: Mathieu Alonso

given: Mathieu

name: Unité de Néphrologie Pédiatrique Hôpital des Enfants, CHU Purpan  Toulouse France

family: Garnier

full_name: Arnaud Garnier

given: Arnaud

name: Unité d'Hémato‐Oncologie Hôpital des Enfants, CHU  Toulouse France

family: Alphonsa

full_name: Gwennaelle Alphonsa

given: Gwennaelle

family: Puiseux

full_name: Chloé Puiseux

given: Chloé

name: URCP, Hôpital des Enfants, CHU  Toulouse France

family: Munzer

full_name: Caroline Munzer

family: Berthier

full_name: Joseph Berthier

given: Joseph

family: Malard

full_name: Laurence Malard

given: Laurence

name: CRCT, Equipe 16 IUCT‐Oncopole  Toulouse France

family: Pasquet

full_name: Marlène Pasquet

given: Marlène

given: Etienne

journal_name: Pediatric Blood & Cancer


title: Evaluation of the Impact of a Coordinating Nurse in a Personalized Care Program on Quality of Care, Coordination of the Actors and on Quality of Life for Patients With Lung Cancer. A French Randomized Monocentric Prospective Study

acronym: EVIDEC

summary:
The prognosis of patients with lung cancer is related to the stage of the diagnosis : 73% of one-year-survival rate at stage IA and only 13% one-year-survival rate at stage IV. Controlling the timelines in a care program seems crucial to improve prognosis of lung cancer.

The project aims to evaluate the impact of a coordinating nurse (CN) in a personalized care program for patients of thoracic oncology.

ReferenceCitation: Martin F, Piquet J, Orlando JP, Blanchon F, Lebas FX. [Clinical research in pneumology in French general hospitals]. Rev Mal Respir. 2014 Nov;31(9):801-3. doi: 10.1016/j.rmr.2014.10.726. Epub 2014 Nov 5. French.

ReferenceCitation: Locher C, Debieuvre D, Coëtmeur D, Goupil F, Molinier O, Collon T, Dayen C, Le Treut J, Asselain B, Martin F, Blanchon F, Grivaux M. Major changes in lung cancer over the last ten years in France: the KBP-CPHG studies. Lung Cancer. 2013 Jul;81(1):32-8. doi: 10.1016/j.lungcan.2013.03.001. Epub 2013 Mar 29.

ReferenceCitation: Grivaux M, Locher C, Bombaron P, Collon T, Coëtmeur D, Dayen C, Debieuvre D, Goupil F, Le Treut J, Martin F, Molinier O, Asselain B, Zureik M, Blanchon F. [Study KBP-2010-CPHG: inclusion of new cases of primary lung cancer diagnosed in general hospital pneumology departments between 1st January and 31 December 2010]. Rev Pneumol Clin. 2010 Dec;66(6):375-82. doi: 10.1016/j.pneumo.2010.08.001. Epub 2010 Dec 3. French.

ReferenceCitation: Leveque N, Brouchet L, Lepage B, Hermant C, Bigay-Game L, Plat G, Dahan M, Riviere D, Didier A, Mazieres J. [An analysis of treatment delays of thoracic cancers: a prospective study]. Rev Mal Respir. 2014 Mar;31(3):208-13. doi: 10.1016/j.rmr.2013.10.001. Epub 2013 Oct 28. French.

ReferenceCitation: Goldstraw P, Crowley J, Chansky K, Giroux DJ, Groome PA, Rami-Porta R, Postmus PE, Rusch V, Sobin L; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007 Aug;2(8):706-14. Erratum in: J Thorac Oncol. 2007 Oct;2(10):985.

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


title: Evaluation of Serum Procalcitonin Rate in Patients With Stage IV Non-small Cell Lung

acronym: KBPCT

summary: Treatment of a stage IV NSCLC is based on chemotherapy and requires before each session to check clinically, biologically and radiologically absence of infection. This biological evaluation is based on the CRP rate. Lots of infections may occur in this situation and could reduce by three the patient's life duration. However it is very important to make as early as possible a correct diagnosis of infection. CRP rate is classically higher for those patients even without any infection. In comparison with CRP, Procalcitonin (PCT) is well-known for its better sensibility and specificity for the infection diagnosis but has never been study in case of active cancer. The aim of this study is to evaluate the Procalcitonin basal rate for those patients suffering from NSCLC. It could be a simple and reliable method to use. So the investigators decided to include each new patient with NSCLC stage IV coming for his first-line chemotherapy without any infection sign, and to realize a Procalcitonin dosage before the start of the treatment. This sample will be analyzed at the chemical laboratory and the result will not be communicated to the patient physician. A new clinical evaluation will be realized either at the hospital or by phone at day 7 to search any sign of infection. In absence of infection, patient will be reevaluated at day 14, 21 and 30. In case of infection, a new Procalcitonin (and CRP) dosage will be performed.