title: EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)

acronym: TEP-GVH

summary:
Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.

PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.

Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.

The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.

lead_sponsor: University Hospital, Caen


title: Patients With Alzheimer Disease, Spouse Carers and Risk of Institutionalization: a Prospective Observational Cohort Study of Dyads (AID Study)

summary: The primary objective of AID study is to identify the medico-neuropsychological, socio-economic and environmental baseline characteristics of dyads associated with the institutionalization of AD patients.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Angers

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Features Emotional Responses in Adults With Autism: Comparison With Bipolar Disorder

acronym: REMBAU

summary: The objective of this study is to identify the specific characteristics of Autism Spectrum Disorder (ASD) in emotional response profiles and shared with Bipolar Disorder (BD) characteristics.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours

status_simplified: Ongoing


type: Registry Identifier

title: Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children

summary: A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


title: Analysis of the Individual Variation of the Carbohydrate Amount at Each Meal in Children and Adolescents With Type 1 Diabetes Using the Carbohydrate Counting Method

summary: The total amount of carbohydrates (CHO) at meal consumed strongly predicts the glycemic response in children and adolescents with type 1 diabetes. Carbohydrate counting is a technique to adapt a dose of rapid acting insulin to the carbohydrate content of a meal. Thanks to this flexible insuline therapy, the glycemic control and the quality of life tend to improve. Carbohydrate counting is a recommended technique in the adult diabetic population. There is little data on the use of this methode in youth with diabetes. There are no studies on the change of carbohydrates content at meals in children and adolescents with diabetes practicing counting carbs, while it is the main interest of this technique. The aim of this study is to assess how children and adolescents with type 1 diabetes use the possibility to change their carbohydrate amount at each main meal when they use the counting carb method. The investigators hypothesize that children vary their amount of CHO greatly. This is an argument for using this technique in pediatrics

primary_purpose: Other

lead_sponsor: Fondation Lenval

lead_sponsor_type: industriel


title: Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program

summary: The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to make the teenager to self manage their disease and its treatment. Based on social cognitive theory Bandura, the effects of educational activities for TVE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence of teenager and a better quality of life. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the ETP program, are not sufficiently documented.

status: Unknown status

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

status_simplified: Unknown


type: EudraCT Number

title: Topical Timolol Benefit in Venous Ulcers

acronym: EETUV

summary:
Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their management. At the origin of high health costs and strong repercussions on quality of life for patients, they require long management and may be subject to possible complications.

In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks.

Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous ulcers with topical timolol.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Active Prevention of MSDs (Musculoskeletal Disorders, Upper and Spine Members) in the Context of Computer Screen Work

acronym: I-Preventive

summary: Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment.

ReferenceType: derived

ReferenceCitation: Lanhers C, Pereira B, Garde G, Maublant C, Dutheil F, Coudeyre E. Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial. BMJ Open. 2016 Sep 22;6(9):e011304. doi: 10.1136/bmjopen-2016-011304.

family: Lanhers

full_name: C Lanhers

given: C

sequence: first

family: Pereira

full_name: B Pereira

given: B

sequence: additional

family: Garde

full_name: G Garde

given: G

family: Maublant

full_name: C Maublant

family: Dutheil

full_name: F Dutheil

given: F

family: Coudeyre

full_name: E Coudeyre

given: E

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Evaluation of ‘I-Preventive’: a digital preventive tool for musculoskeletal disorders in computer workers—a pilot cluster randomised trial

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Evaluation Program of the Benefit of the Coordination of the Course of the Elderly Patient in Health Establishment - Pilot Study.

acronym: PROCOPES

summary:
The large share of chronic diseases correlated with an aging population calls to develop necessary coordination between the hospital and non-hospital (professional of the city, home ...) to create new complementarities.

Since July 2013, the Nantes University Hospital experiences the establishment of a coordinator route patient in Gerontology. The evaluation program of the benefit of coordinating the course in elderly patients in health establishment (PROCOPES) must allow to prove the efficiency of the intervention of a coordinator route patient, following elderly patients in complex situations, both within the hospital and outside the hospital (home, nursing home,...). The objective of PROCOPES is to show the added value of an innovative position that can make the link between the hospital and the city on deemed complex situations.The pilot study results present a strong interest for health care settings, nursing home and in the world of research. It will also permit to have preliminary data for bigest studies.

lead_sponsor: Nantes University Hospital


title: Suture Care in the Pediatric Emergency Department: a Randomized Trial Comparing the Analgesic Efficacy of Hypnosis Versus MEOPA

acronym: Hypno-Mo

summary:
This is a therapeutic, randomized, single center, two parallel-arm trial comparing pain control via "MEOPA" (equimolar mixture of nitrous oxide and oxygen) in one arm versus "Hypnosis + MEOPA if needed" in the second arm.

The primary objective is to compare the two study arms in terms of efficacity for pain control according to the FLACC (Face Legs Activity Cry Consolability Observational Tool) behavioural scale.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau


title: Evaluation of Myocardial Function by Two Dimensional Speckle Tracking Echocardiography in Children With Duchenne Muscular Dystrophy Versus Healthy Children: a Comparative Transversal Multicenter Study

summary: Compare systolic function of left ventricle (LV) and right ventricle (VD) by 2D strain evaluation in Duchenne muscular dystrophy children versus a control group.

ReferenceType: background

ReferenceCitation: Amedro P, Vincenti M, De La Villeon G, Lavastre K, Barrea C, Guillaumont S, Bredy C, Gamon L, Meli AC, Cazorla O, Fauconnier J, Meyer P, Rivier F, Adda J, Mura T, Lacampagne A. Speckle-Tracking Echocardiography in Children With Duchenne Muscular Dystrophy: A Prospective Multicenter Controlled Cross-Sectional Study. J Am Soc Echocardiogr. 2019 Mar;32(3):412-422. doi: 10.1016/j.echo.2018.10.017. Epub 2019 Jan 21.

lead_sponsor: University Hospital, Montpellier

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


title: Multimodal Therapeutic Approach by Exercise, Oral Nutritional Supplementation, Omega 3 and Androgen in Undernourished Maintenance Hemodialysis Patients (AMERICANO)

acronym: AMERICANO

summary: The aim of the study is to evaluate a 3 months integrated multimodal therapeutic approach including exercise training program with ergocycle during dialysis sessions, oral nutritional supplementation, omega 3 and androgen, on effort tolerance and quality of life of under-nourish maintenance hemodialysis Chronic Kidney Disease (CKD) patient.

primary_purpose: Prevention

ReferenceCitation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5:CD012616. doi: 10.1002/14651858.CD012616.pub2.

name: Integrated Renal Service; Eastern Health; Box Hill Australia

family: Mah

full_name: Jia Yee Mah

given: Jia Yee

family: Choy

full_name: Suet Wan Choy

given: Suet Wan

name: Eastern Health Clinical School; Monash University; Box Hill Australia

family: Roberts

full_name: Matthew A Roberts

given: Matthew A

name: Department of Dietetics/Renal; Eastern Health; Box Hill Australia

family: Desai

full_name: Anne Marie Desai

given: Anne Marie

family: Corken

full_name: Melissa Corken

given: Melissa

name: Department of Epidemiology and Preventive Medicine; Monash University; Clayton Australia

family: Gwini

full_name: Stella M Gwini

given: Stella M

family: McMahon

full_name: Lawrence P McMahon

given: Lawrence P

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley


intervention_type: Drug

lead_sponsor: LEO Pharma

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

source: euctr

title: A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris

summary: The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.


title: Prospective Prediction of Cocaine Relapse After Inpatient Cessation by Combining Functional Imaging and Neuropsychological Biomarkers With Craving and Impulsivity Measures

acronym: QUIT-COC

summary: Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated with relapse to cocaine use.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Psychiatrie, Hôpital Fernand Widal

intervention_type: Procedure


title: Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome

acronym: OXYDV

summary:
Hypoxemia may be refractory to protective ventilation during the acute respiratory distress syndrome (ARDS), justifying the use of other therapies that improved oxygenation and decreased mortality, including prone position (PP).

During ARDS, the majority of patients are responders to PP with increased PaO2 due to homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and intra-abdominal pressure, hemodynamic parameters are not changed.

Besides the fact that the PP improves systemic oxygenation is it the same on cerebral oxygenation? No study has investigated the cerebral oxygenation during PP in patients with ARDS. The cerebral oxygenation may be altered due to the position of the patient and high levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for cognitive impairment when patients awake.

NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information on cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for the management of resuscitation in Intensive Care Unit (ICU) patients. This study is to investigate cerebral oxygenation during prone position in the investigators' patients of ICU.

lead_sponsor: Centre Hospitalier Bretagne Atlantique


title: Evaluation of Breathing, Sleep and the Effects of Continuous Positive Airway Pressure During Wakefulness in Children With Heart Failure

acronym: IC-E-PPC

summary:
Adult patients with heart failure (HF) have an increased work of breathing and are at increased risk for obstructive and/or central apnea during sleep. Noninvasive continuous positive airway pressure (CPAP) has proved its efficacy in decreasing the work of breathing and improving sleep-disordered breathing in these patients.

The aim of the study is to analyze the work of breathing and objective and subjective sleep quality in children with HF and to evaluate the ability of noninvasive CPAP to decrease the work of breathing and improve cardiac output during wakefulness.

location_facility: Necker - Enfants Malades Hospital (Assistance Publique des Hopitaux de Paris)


acronym: NOCaPH

title: Role of the Nitric Oxide (NO) in Pre-oxygenation Before Anesthetic Induction in Patients With a Pulmonary Hypertension in Cardiac Surgery. Pilot Study of Feasibility

summary:
The pulmonary hypertension (HTP) due to a left heart disease or a hypoxemiant lung disease is frequent in cardiac surgery. The HTP represents an independent risk factor of morbidity and mortality in cardiac surgery, entering to the criteria of Euroscore evaluation (European System for Cardiac Operative Risk Evaluation).

An acute perioperative hemodynamic decompensation of these patients is frequent. Perioperative hemodynamic modifications, hypoxemia, hypercapnia, sympathetic stimulation, increase pulmonary vascular resistances (RVP) and might provoke right ventricular failure.

The anesthetic induction and the beginning of mechanical ventilation are the most sensible times due to the risk of hemodynamic decompensation. The suppression of the sympathetic tonus which is consequence of the anesthetic induction, decrease the systemic vascular resistances and lead to decrease of blood pressure. In return, the anesthetic induction is associated with an increase of pulmonary vascular resistances, resulting in increase of the postcharge and the work of the right ventricle (VD). These systemic and pulmonary hemodynamic modifications can lead to equalization, or even an inversion of the systemic and pulmonary pressures. As consequence, a hemodynamic collapse or even a heart arrest can arise.

The patients suffering from HTP are hypoxemic. They have very limited oxygen reserves due to decrease of the functional residual capacity (CRF). The apnea period, which follows the anesthetic induction, is often associated with a fast desaturation, even if a good pre-oxygenation was performed before. This desaturation causes an increase of the pulmonary vascular resistances with the hemodynamic consequences previously mentioned. A risk of hypoxic heart arrest is also present.

Nitric Oxide (NO) is an endogenous mediator produced from the vascular endothelium. The NO is a powerful vasodilator and is used in intensive care in inhaled way as selective pulmonary vasodilator (iNO). NO decreases the RVP, the shunt effect and improves the oxygenation by optimization of ventilation-perfusion ratio. The short lifetime of iNO (6sec approximately) allows a fast metabolism without inducing any undesirable effects such as the systemic hypotension.

No studies, until now, have investigated the use of iNO in pre-oxygenation before anesthetic induction in cardiac surgery.

We hope to demonstrate that iNO used in oxygenation before anesthetic induction will have a beneficial effect on the respiratory and cardiovascular parameters.

Our objective is to estimate the feasibility and the tolerance of iNO before anesthetic induction of the patients with a moderate or severe HTP programmed for cardiac surgery with extracorporeal circulation. The effect will be estimated in terms of efficiency (hemodynamic and respiratory optimization).


title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Effect of Saccharomyces Cerevisiae on Improving the Effectiveness of Conventional Treatment of Vulvo-vaginal Candidiasis

summary: This study aims to evaluate the effect of a specific strain of Saccharomyces cerevisiae on improving the effectiveness of conventional treatment of vulvo-vaginal candidiasis. This is a randomized, double-blind, placebo-controlled study.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Lesaffre International

intervention_type: Dietary Supplement


title: CogStim, a Pilot Study : Cognitive Rehabilitation Management of HIV-1 Mild Cognitively Impaired Patients Controlled With Antiretroviral Therapy

acronym: CogStim

summary:
Despite undetectable plasma viral load under treatment, about 30% of HIV infected patients show asymptomatic neurocognitive impairment or minor cognitive disorder. These symptoms impact the compliance of the treatment, though its performance and daily life quality. To this day, no therapy tested has proved its efficiency, including the strategy of the antiretroviral therapy (cART) optimization according to the Cerebral Penetration effectiveness Score (CPE).

Description of the study: an open prospective comparative monocentric pilote study, randomised in three groups which investigates the efficiency of a 6 months-cognitive rehabilitation program on improving asymptomatic or minor cognitive disorder for undetectable HIV+ patients. This study gathers HIV-1 patients undetectable under stable cART with a good cerebral penetration who develop asymptomatic or minor cognitive disorders connected to HIV infection. Those who have severe psychiatric disorder or who are on medication that could interfere with psychometrical tests will be excluded.

Main Objective: to compare the impact of a cognitive rehabilitation program over a 6 months period on the evolution of minor cognitive disorders and asymptomatic patients to a control group and a group treated with psychological support.

location_facility: Assistance Publique Hopitaux de Marseille


title: Usefulness of Protoarray®Microarray for Identifying Biomarkers in Idiopathic Juvenile Arthritis Antinuclear Antibodies Positive.

summary: Juvenile idiopathic arthritis (JIA) is the most common form of arthritis in children. The etiology is unknown. Several types of arthritis fall under the JIA heading. Oligoarticular JIA with antinuclear antibodies affects about half of all children. There 's no specific markers. Our purpose is to identify new markers in this pathology. The ProtoArray®Human Protein Microarray allows rapid and efficient detection of protein interaction using a suitable protein or small molecule probe. The investigators hope so detect novel potential autoantigen biomarkers specific in JIA.

location_facility: Cardiology paediatric consultation, Arnaud de Villeneuve Hospital


title: Perioperative Hemodynamic Optimization Using the Photoplethysmography in Colorectal Surgery : A Randomized Controlled Study

summary: The purpose of this study is to determine whether hemodynamic optimization with photoplethysmography (ClearSight, Edwards Lifesciences, Irvine, CA) during colorectal surgery could decrease the incidence of perioperative complications.

ReferenceCitation: Fischer MO, Fiant AL, Boutros M, Flais F, Filipov T, Debroczi S, Pasqualini L, Rhanem T, Gérard JL, Guittet L, Hanouz JL, Alves A, Parienti JJ; PANEX3 study group. Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 22;17:159. doi: 10.1186/s13063-016-1278-4.

family: Fischer

full_name: Marc-Olivier Fischer

given: Marc-Olivier

family: Fiant

full_name: Anne-Lise Fiant

given: Anne-Lise

family: Boutros

full_name: Mariam Boutros

given: Mariam

family: Flais

full_name: Frédéric Flais

given: Frédéric

family: Filipov

full_name: Tzetan Filipov

given: Tzetan

family: Debroczi

full_name: Stéphane Debroczi

given: Stéphane

family: Pasqualini

full_name: Léa Pasqualini

given: Léa

family: Rhanem

full_name: Toufiq Rhanem

given: Toufiq

family: Gérard

full_name: Jean-Louis Gérard

given: Jean-Louis

family: Guittet

full_name: Lydia Guittet

given: Lydia

family: Hanouz

full_name: Jean-Luc Hanouz

given: Jean-Luc

family: Alves

full_name: Arnaud Alves

given: Arnaud

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

journal_name: Trials

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

intervention_type: Device


title: Randomized, Multicenter, Double-blind, Vancomycin-controlled Study to Evaluate the Efficacy of Ethanol Lock Solution for the Curative Treatment of Implantable Venous Access Port Infection Due to Coagulase-negative Staphylococci

acronym: Etha-LOCK

summary: Implantable venous access port infections are mainly due to coagulase negative staphylococci and may be managed by antibiotic lock therapy with retention of the port. Most of the time a vancomycin lock is used. Experimental data show that vancomycin may be poorly effective in eradicating the staphylococcal biofilm in the port. Another disadvantage of Vancomycin-containing lock solution is the occurrence of resistant organisms and the risk of catheter occlusion. Ethanol-containing lock solution is highly effective in vitro and does not expose to the risk of emergence resistance.


title: Early Onset Immunotherapy by Intravenous Immunoglobulin in Well-characterized Onconeural-antibody-positive Paraneoplastic Neurological Syndromes

acronym: IaSON

summary: Paraneoplastic Neurological Syndromes (PNS) are rare remote effects of cancer, not directly attributed to mass lesions, metastases, infections, ischemia, coagulopathy, metabolic disruptions or tumour treatment. Currently, PNS treatment is mostly limited to tumour treatment. Because of an initial inflammatory stage early in the evolution of the PNS several immunotherapy modalities have been tried. Intravenous human immunoglobulins could be expected to provide a stabilization or even improvement of PNS, if administered early enough to prevent permanent neuronal damage.

ReferenceCitation: Berzero G, Karantoni E, Dehais C, Ducray F, Thomas L, Picard G, Rogemond V, Candelier G, Camdessanché JP, Antoine JC, De Seze J, Liou-Schischmanoff A, Honnorat J, Delattre JY, Psimaras D. Early intravenous immunoglobulin treatment in paraneoplastic neurological syndromes with onconeural antibodies. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):789-792. doi: 10.1136/jnnp-2017-316904. Epub 2017 Oct 30.

family: Berzero

full_name: Giulia Berzero

given: Giulia

family: Karantoni

full_name: Evgenia Karantoni

given: Evgenia

family: Dehais

full_name: Caroline Dehais

given: Caroline

family: Ducray

full_name: François Ducray

given: François

family: Thomas

full_name: Laure Thomas

given: Laure

family: Picard

full_name: Géraldine Picard

given: Géraldine

family: Rogemond

full_name: Véronique Rogemond

given: Véronique

family: Candelier

full_name: Gaëlle Candelier

given: Gaëlle

family: Camdessanché

full_name: Jean-Philippe Camdessanché

given: Jean-Philippe

family: Antoine

full_name: Jean-Christophe Antoine

given: Jean-Christophe

family: De Seze

full_name: Jérôme De Seze

given: Jérôme

family: Liou-Schischmanoff

full_name: Amélie Liou-Schischmanoff

given: Amélie

family: Honnorat

full_name: Jérôme Honnorat

family: Delattre

full_name: Jean-Yves Delattre

given: Jean-Yves

family: Psimaras

full_name: Dimitri Psimaras

given: Dimitri

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries


title: Transcranial Direct Current Stimulation as an add-on Treatment in SSRI-resistant Obsessive Compulsive Disorder : a Randomized Clinical Trial

acronym: TDCSTOC

summary: The purpose of this study is to determine whether tDCS is effective as an add-on treatment in SSRI-resistant patients with obsessive and compulsive disorder

ipd_sharing: No

lead_sponsor: Hôpital le Vinatier


title: ETUDE DU MICROBIOTE DES RHINOSINUSITES CHRONIQUES DIFFICILES A TRAITER PAR METAGENOMIQUE ET CULTUROMIQUE

summary:
To analyse and describe sinus microbiota, during hard to treat (or refractory) rhinosinusitis, using culturomic and metagenomic methods (i.e. to culture on many different medium of culture to grow hard to cultivate bacteria + to sequence and analyse all DNA contained in samples).

Samples are middle meatus swabs or pus aspiration, done during usually patient following.

primary_purpose: Screening

lead_sponsor: Institut Hospitalo-Universitaire Méditerranée Infection

location_facility: Service ORL et de Chirurgie Cervico - Faciale/ AP-HM


title: Operative Hysteroscopy for Fibroma by Classic Resection Versus Morcellation: a Ramdomised Study

summary: Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.


title: Evaluation of the Efficiency of a Therapeutic Education Program in Standardized Thermal Cure for Fibromyalgia Patients

acronym: FiETT

summary: The study evaluates the efficiency, in terms of quality of life improvement, of a patient's therapeutic education program (ETP), based on long term commitment in adapted physical activities carried out during a standardized thermal cure (CTS) for fibromyalgia among patients continuing regular drug treatment or not

ReferenceCitation: Diatchenko L, Nackley AG, Slade GD, Fillingim RB, Maixner W. Idiopathic pain disorders--pathways of vulnerability. Pain. 2006 Aug;123(3):226-230. doi: 10.1016/j.pain.2006.04.015. Epub 2006 Jun 13. Review.

ReferenceCitation: Branco JC, Saraiva F et al. Fibromyalgia Syndrom : A european epidemiological survey. Abstract Sat 0452 Eular 2005

ReferenceCitation: Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28.

ReferenceCitation: Haute Autorité de Santé. Le syndrome fibromyalgique de l'adulte. Rapport d'orientation. Juillet 2010. 124p

ReferenceCitation: Laroche F. Actualités de la fibromyalgie. Rev Rhum 2009;76:529-36.

ReferenceCitation: Boureau F. Modèles théoriques cognitifs et comportementaux de la douleur chronique Doul et Analg 1999 ; 4 : 265-72

ReferenceCitation: Vlaeyen JWS. Place du concept de " peur de bouger " (ré) apparition du " mal " dans l'analyse et la réhabilitation comportementale des lombalgiques chroniques. Doul et Analg, 1999 ; 4 :281-8

ReferenceCitation: Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. Review.

ReferenceCitation: Bannwarth B, Blotman F, Le Lay K, Boussetta S, Caubère JP, André E, Taïeb C. Prévalence of fibromyalgia : a large-scale european survey : results in France Eular 2008, Paris, THU0392

ReferenceCitation: Maugars Y, Lamotte M, De Vos C C, Girard L, Caubère JP, André E, Le Lay K, Taïeb C. Fibromyalgia : the avoied cost of the non-diagnosed patient in France. Eular 2008, Paris, THU0386

ReferenceCitation: Boureau F. in Pratique du Traitement de la Douleur. Doin ed. 1988, 402p

ReferenceCitation: Weigent DA, Bradley LA, Blalock JE, Alarcón GS. Current concepts in the pathophysiology of abnormal pain perception in fibromyalgia. Am J Med Sci. 1998 Jun;315(6):405-12. Review.

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ReferenceCitation: Grille OPTIMON évaluant le risque patient dans les études de recherche clinique institutionnelles

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lead_sponsor: Association Francaise pour la Recherche Thermale


title: Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers

acronym: BIPPED

summary: The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

ReferenceCitation: Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. Review.

lead_sponsor: University Hospital, Grenoble


title: Exploration by NMR Spectroscopy of the Choline Concentrations in the Insular Cortex of Patients Suffering of Neuropathic Pain Induced by Oxaliplatin

acronym: INSULOX

summary:
Neurotoxic chemotherapy, including oxaliplatin, are responsible for very disabling neuropathic pain that can last for months or even years after the end of chemotherapy. Currently, there is no effective neuroprotective treatment to prevent or relieve this pain. The only strategy is the reduction of oxaliplatin doses or premature discontinuation of therapy, with the risk of burdening the prognosis for remission. Thus, a better understanding of the pathophysiology of these iatrogenic neuropathies appears necessary in order to discover new potential therapeutic targets.

Preclinical works were able to demonstrate important metabolic changes in certain brain structures in an animal model of oxaliplatin-induced neuropathy. A significant increase of choline concentration has been found in the posterior insular cortex of neuropathic animals compared with control animals. Furthermore, the concentrations of choline were positively correlated to nociceptive thresholds. Thus, neuropathic pain induced by oxaliplatin would involve the posterior insular cortex and would be associated with an increase in choline concentration at this level. Clinical translation of these preclinical results is feasible in practice since choline concentration can be determined in the brain by non-invasive magnetic resonance spectroscopy.


title: Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)

acronym: LymphoSeq

summary: This is a prospective descriptive monocentric study whose purpose is to describe the clonal evolution of the mutational pattern in cfDNA of a cohort of patients with Diffuse Large B-Cell Non-Hodgkin Lymphomas (DLBCL) before, during and after standard treatment

ReferenceCitation: Camus V, Sarafan-Vasseur N, Bohers E, Dubois S, Mareschal S, Bertrand P, Viailly PJ, Ruminy P, Maingonnat C, Lemasle E, Stamatoullas A, Picquenot JM, Cornic M, Beaussire L, Bastard C, Frebourg T, Tilly H, Jardin F. Digital PCR for quantification of recurrent and potentially actionable somatic mutations in circulating free DNA from patients with diffuse large B-cell lymphoma. Leuk Lymphoma. 2016 Sep;57(9):2171-9. doi: 10.3109/10428194.2016.1139703. Epub 2016 Feb 17.

family: Camus

full_name: Vincent Camus

given: Vincent

family: Sarafan-Vasseur

full_name: Nasrin Sarafan-Vasseur

given: Nasrin

family: Bohers

full_name: Elodie Bohers

given: Elodie

family: Dubois

full_name: Sydney Dubois

given: Sydney

family: Mareschal

full_name: Sylvain Mareschal

given: Sylvain

family: Bertrand

full_name: Philippe Bertrand

given: Philippe

family: Viailly

full_name: Pierre-Julien Viailly

given: Pierre-Julien

family: Ruminy

full_name: Philippe Ruminy

family: Maingonnat

full_name: Catherine Maingonnat

given: Catherine

family: Lemasle

full_name: Emilie Lemasle

given: Emilie

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

family: Picquenot

full_name: Jean-Michel Picquenot

given: Jean-Michel

family: Cornic

full_name: Marie Cornic

given: Marie

family: Beaussire

full_name: Ludivine Beaussire

given: Ludivine

family: Bastard

full_name: Christian Bastard

given: Christian

family: Frebourg

full_name: Thierry Frebourg

given: Thierry

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Centre Henri Becquerel


title: A Single-Sequence, 2-Period, Open-Label Study of a Novel Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet Dosed for 3 Days to Investigate the Effect on Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men

summary: The purpose of this study is to demonstrate that the intestinal absorption of calcium from a novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg) and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.

primary_purpose: Basic Science

lead_sponsor: Takeda


title: Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

acronym: TEA-NIRS

summary: Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.

lead_sponsor: University Hospital, Caen


title: Study of Validation of Measurements of the Movement of Stiff Treated Teeth and Orthodontic Corticotomy

acronym: OBS

summary: Codify the treatment of teeth by stiff Corticotomy technique. Evaluate the duration of treatment and tooth movement.


title: Building a Population Pharmacokinetic Model of Tacrolimus in Paediatric Liver Transplant Patients

acronym: TACTHEP

summary: Tacrolimus is the cornerstone immunosuppressant in children with liver transplantation, its use is complicated by its narrow therapeutic index and variable pharmacokinetics. This study is designed to assess the posology of tacrolimus in post-transplantation in the month after liver transplantation to obtain a therapeutic target between 10-15 ng/mL and the impact of biological and genetic factors on the pharmacokinetic parameters in paediatric liver transplant recipients.


title: Microglial Activation Role In ALS (MARIA)

acronym: MARIA

summary:
Neuroinflammation, characterized in particular by microglia activation, is an essential component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. An experimental radiopharmaceutical specific of TSPO expression, namely [18F]DPA714, allow to quantify this microglial activation using Positon Emission Tomography (PET) imaging.

The purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 ALS patients:

in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (CSF).
in vivo: [18F]DPA714 PET imaging. These assays will be performed in the framework of the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.

study_start_date_type: Anticipated

status: Withdrawn

ReferenceType: result

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family: Corcia

full_name: P. Corcia

given: P.

family: Valdmanis

full_name: P. Valdmanis

family: Millecamps

full_name: S. Millecamps

given: S.

family: Lionnet

full_name: C. Lionnet

given: C.

family: Blasco

full_name: H. Blasco

given: H.

family: Mouzat

full_name: K. Mouzat

given: K.

family: Daoud

full_name: H. Daoud

family: Belzil

full_name: V. Belzil

given: V.

family: Morales

full_name: R. Morales

given: R.

family: Pageot

full_name: N. Pageot

given: N.

family: Danel-Brunaud

full_name: V. Danel-Brunaud

family: Vandenberghe

full_name: N. Vandenberghe

family: Pradat

full_name: P. F. Pradat

given: P. F.

family: Couratier

full_name: P. Couratier

family: Salachas

full_name: F. Salachas

given: F.

family: Lumbroso

full_name: S. Lumbroso

family: Rouleau

full_name: G. A. Rouleau

given: G. A.

family: Meininger

full_name: V. Meininger

family: Camu

full_name: W. Camu

given: W.

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Blasco H, Corcia P, Moreau C, Veau S, Fournier C, Vourc'h P, Emond P, Gordon P, Pradat PF, Praline J, Devos D, Nadal-Desbarats L, Andres CR. 1H-NMR-based metabolomic profiling of CSF in early amyotrophic lateral sclerosis. PLoS One. 2010 Oct 8;5(10):e13223. doi: 10.1371/journal.pone.0013223.

full_name: Hélène Blasco

given: Hélène

full_name: Philippe Corcia

title: 1H-NMR-Based Metabolomic Profiling of CSF in Early Amyotrophic Lateral Sclerosis

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

ReferenceCitation: Corcia P, Ingre C, Blasco H, Press R, Praline J, Antar C, Veyrat-Durebex C, Guettard YO, Camu W, Andersen PM, Vourc'h P, Andres CR. Homozygous SMN2 deletion is a protective factor in the Swedish ALS population. Eur J Hum Genet. 2012 May;20(5):588-91. doi: 10.1038/ejhg.2011.255. Epub 2012 Jan 25.

ReferenceCitation: Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. 2012;7(12):e52941. doi: 10.1371/journal.pone.0052941. Epub 2012 Dec 31.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repositories:
PubMed Central
Zenodo
pdfs.semanticscholar.org

title: Molecular Imaging of Microglial Activation in Amyotrophic Lateral Sclerosis


title: Evaluation Des rééducations Neuropsychologiques Des Troubles de l'Inhibition Chez l'Enfant Avec un TDAH

acronym: ERNTITDAH

summary: This research aims to assess the cognitives rehabilitations in attention deficit disorder (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive factors for rehabilitative to improve the inhibition of disorders in ADHD.

lead_sponsor: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône


title: A Novel BCI-controlled Pneumatic Glove System for Neurorehabilitation Post-stroke

acronym: BCI-stroke

summary: The goal is to evaluate the potential of a EEG based BCI (Brain-Computer-Interface) connected to a non-invasive pneumatic glove for rehabilitation of hand-movements post-stroke.


acronym: THIC Cu

title: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo

summary:
Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.

Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.


acronym: PANCREADOGREL

location_facility: Service d'oncologie digestive - Institut Sainte Catherine

title: A Phase III Multi-centre Double-blind Placebo Controlled Study Analysing the Efficacy and Safety of Daily Administration of a P2Y12 Inhibitor (Clopidogrel) for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

summary:
Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor.

In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma.

The aim of the study is;

to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients
to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study)


title: Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®

acronym: EVOSKIN

summary: Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

lead_sponsor: University Hospital, Limoges


title: Identification of the Mechanisms of Action of Intravenous Immunoglobulins in CIDP by Analysis of the Genetic Expression Profile in Blood Mononuclear Cells

acronym: PHARMACOPID

summary: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is an immune-mediated disorder of peripheral nerves. Intravenous immunoglobulins (IVIg) are a first line therapy for CIDP. The investigators used a transcriptomic approach to compare the gene expression profiles in the peripheral blood of patients having a CIDP or autoimmune diseases, before and after IVIg treatment, in order to identify their mechanism of action in this condition, to lead to a better understanding of CIDP pathophysiology, and potentially determine factors associated with the response to the treatment.


acronym: GICAC

summary: In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction

lead_sponsor: CHU de Reims


title: Study of Circulating Microparticles in Giant Cell Arteritis

acronym: MicroGiant

summary: To demonstrate that microparticles (MPs), having a powerful procoagulant potential, are in larger amounts in the blood of patients with histologically proven giant cell arteritis (GCA), compared with patients matched for age, sex and with or without inflammatory syndrome.

location_facility: Centre Hospitalier Universitaire Côte de Nacre


title: Combination of Everolimus and Octreotide LAR in Aggressive Recurrent Meningiomas.

acronym: CEVOREM

summary: To determine if combination of everolimus and octreotide exert an anti-tumoral activity in recurrent and/or aggressive meningiomas growth with limited adverse effects.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents

summary: This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

primary_purpose: Health Services Research

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hôpitaux pediatriques CHU de Nice Fondation Lenval


title: Diagnostic Value of PCR Genetic Amplification and Mannan Antigenemia Coupled With Antimannan Antibodies in Intensive Care Patients With Suspected Invasive Candidiasis

acronym: EMPIRICAND

summary:
The study consists in taking 4 tubes of blood at different times over a period of 10 days, via a catheter (central venous or arterial catheter) already in place in the usual therapeutic management. These samples will make it possible to measure blood levels of certain markers specific to invasive candidiasis. PCR will be used to quantify fungal load precisely, that is to say the quantity of yeast present in the blood and to monitor this quantity over time.

These samples will be transferred to a specialized unit and stored for a maximum of three years for use at the end of the study.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Biological


title: Evolution of Albumin on AOA1 Patients Supplemented With Coenzyme Q10

summary:
We propose a study on Ataxia with oculomotor apraxia type 1 (AOA1) in which Coenzyme Q10 (CoQ10) deficit has been observed. Main objectives of the study are :

To monitor evolution of albumin in patients affected with AOA1 while supplemented with CoQ10 ;
To measure with clinical scales and biological markers efficacy of supplementation on disease evolution.

AOA1 is characterised by Hypoalbuminemia. Disease duration is negatively correlated with albumin level. This study aims to understand mechanisms of the disease and our hypothesis is that correction or stabilization of albumin level with CoQ10 supplementation could impact disease evolution. The study is planned from 1 to 2 years supplementation. The CoQ10 is classified as a food supplement and has already been tested in other neurological conditions.


title: Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)

summary: This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.


title: Anosognosia Evaluation After Cranocerebral Trauma Moderate to Severe

acronym: ANOSOGNOSIA

summary:
This study is conducted over 18 months. The main objective of this study is to test and compare the relevance and reliability of different tools for measuring the anosognosia.

Secondary objectives are :

identify the relevant test who are able to evaluate more specially the cognitive processes involved in anosognosia
explore the links between the anosognosia manifestations and the psychological manifestations

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: MRI for the Etiological Diagnosis of Orbital Tumours

acronym: MEDORT

summary:
Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

The MRI assessment performed routinely in a patient with an orbital mass includes morphological sequences T1, T2 fat suppression, T1 injected fat suppression, diffusion. This exploration requires, regardless of the performed research, a contrast agent injection (0.1 mg / kg weight of Gadobutrol®).

In this research protocol, during the injection of the contrast agent performed during the MRI assessment performed routinely, a DCE perfusion sequence, which consists of a repeated acquisition at short intervals of a volume gradient echo T1, will be added. This acquisition will be preceded by two short series for calibration. The post treatment will include parametric permeability cards (Ktrans) and plasmatic volume (Vp), evaluating one or more regions of interest in the tumor, normal lacrimal glands, jaw muscles and nasal mucosa being the reference. It will also be added a magnetic susceptibility EPI sequence type. All the qualitative parameters (T1, T2, T1 injected, distribution, low signal intensity in susceptibility) and quantitative (Ktrans, Vp, relative intensity enhancement, apparent diffusion coefficient) parameters will be collected.

The result of the pathological exam of the biopsy or of the surgical specimen, which is the gold-standard, will be collected.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Study About Contamination of Testicle Tissue by RT-PCR in Children With Solid Tumors

acronym: TESTIMAR

summary: For prepubertal patients, cryopreservation of testicular tissue is the only option available to preserve their fertility before cancer treatment. But testicular autograft raises the issue of the risk of reintroduction of potentially malignant cells. The aim of our study is to develop a specific and sensitive method for residual disease detection in the testicular tissue from patients treated for a solid tumor during infancy, whose fertility may have been compromised by treatments and who benefited of testicular tissue cryopreservation.

ReferenceCitation: Chaput L, Grèze V, Halle P, Radosevic-Robin N, Pereira B, Véronèse L, Lejeune H, Durand P, Martin G, Sanfilippo S, Canis M, Kanold J, Tchirkov A, Brugnon F. Sensitive and Specific Detection of Ewing Sarcoma Minimal Residual Disease in Ovarian and Testicular Tissues in an In Vitro Model. Cancers (Basel). 2019 Nov 17;11(11). pii: E1807. doi: 10.3390/cancers11111807.

family: Chaput

full_name: Laure Chaput

given: Laure

family: Grèze

full_name: Victoria Grèze

given: Victoria

family: Halle

full_name: Pascale Halle

given: Pascale

family: Radosevic-Robin

full_name: Nina Radosevic-Robin

given: Nina

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Véronèse

full_name: Lauren Véronèse

given: Lauren

family: Lejeune

full_name: Hervé Lejeune

family: Durand

full_name: Philippe Durand

given: Philippe

family: Martin

full_name: Guillaume Martin

given: Guillaume

family: Sanfilippo

full_name: Sandra Sanfilippo

given: Sandra

family: Canis

full_name: Michel Canis

given: Michel

family: Kanold

full_name: Justyna Kanold

given: Justyna

family: Tchirkov

full_name: Andrei Tchirkov

given: Andrei

family: Brugnon

full_name: Florence Brugnon

given: Florence

currency_apc_doaj: CHF

journal_name: Cancers

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

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


title: Research a New Predictive Marker of Intraventricular Hemorrhage in Very Preterm Infants: HEMO PREMA Study

acronym: HEMO PREMA

summary:
The most frequent complications in premature infants are neurological complications: intracranial hemorrhages and white matter lesions. In Epipage 2 study the incidence of severe intraventricular hemorrhages remains stable. Severe hemorrhages are associated with neurological sequelae.

A recent study in humans and in animals shows the role of the complex formed by plasminogen activator (t-PA) and its inhibitor (PAI-1) in the induction of vascular fragility via stromelysin (MMP-3). FIBRINAT study in Rouen University Hospital showed a rate of complex t-PA-PAI1 probably very high in preterm infants. An other factor maturation PDGF-C induced by t-PA is associated with the vascular embrittlement. Among the few genetic factors associated with cerebral palsy include 2 SNP of PAI-1 gene and one SNP in the gene of endothelial NO synthase.

The hypothesis is that a high rate of the complex t-PA-PAI-1 in cord blood could be a high risk of intracranial hemorrhage in preterm infants and provide predictive of their occurrence. The rates of MMP-3, PDGF-C and PAI-1 free in cord blood, and the polymorphism of PAI-1 gene and eNOS could separately or associated with the main criterion to identify predictive of hemorrhages.

The main objective is to search a rate difference of the complex t-PA-PAI-1 in cord blood of preterm infants (before 30 weeks of gestation) that would predict intracranial hemorrhage coming in the first days of life.

The secondary objectives are

Evaluate potential marker risk of high levels of MMP-3, PAI-1 free, and PDGF-CC

Search in both groups the presence of alleles -675G4 / G5 and 11053 (G / T) of the PAI-1 gene and -922 (A / G) of the eNOS gene.

120 preterm infants will be included before 30 weeks of gestation with precise inclusion and exclusion criteria during a period of 3 years.

Patients will be divided into two groups according to whether they will or not showed intracranial hemorrhage (detected by ultrasound J5-J7).

The complex rate tPA-PAI-1, PAI-1 free, MMP-3 and PDGF-C will be measured. The comparison between the two groups will be carried out using statistical tests. Comparison of the presence of the alleles -675 4G and 11053T the PAI-1 gene or -922G eNOS gene between the two groups will be performed.

The demonstration of this hypothesis would permit to identify children from birth in whom the immediate implementation of preventive treatment of bleeding is desirable.

lead_sponsor: University Hospital, Rouen


title: Impact of the Introduction of a New Qualitative Composition of the Evening Meal on the Feeding Behavior of Institutionalized Residents of a Long-term Care Unit: a Randomized, Single Center Study

acronym: IRCAR

summary: The main objective of this study was to evaluate and compare 6-month calorie intakes between a group of patients receiving a standard dinner and a group of patients whose evening meal is "improved"; compliance will be assessed on a food card with 5 levels of consumption: no (0%), 25%, 50%, 75%, all (100%). This per patient per meal food card will be prepared 3 days per month for 6 months and will, from the total calorie intake of each dish, estimate calorie intake ingested per day on all meals of the day.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Centre de Gérontologie de Serre Cavalier


title: Impact of a Written Document on Post Traumatic Stress Disorder (PTSD) Diagnosed in Family Members After Withholding and Withdrawing Life-sustaining Therapies in the Intensive Care Unit

acronym: LATA

summary:
Relatives of patients in situation of withholding and withdrawing life-sustaining therapies often show post traumatic stress disorder (PTSD) (60%)[1]. This number is even greater when family members are active in this decision (81%) or when communication is not optimal between medical team and family members.

There are several ways to assist families of patients in intensive care units [2], amongst them the use of a written document to explain the environment, therapies and possible outcomes.

Here the investigators want to test the impact of a written document in the context of end-of-life conference in intensive care units. Specifically, this research addresses wether such written support could decrease 3-months post-traumatic stress disorder, anxiety and depression exhibited by the closest family member or the patient representative.

ReferenceCitation: Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larché J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. Epub 2005 Jan 21.

ReferenceCitation: Schmidt M, Azoulay E. Having a loved one in the ICU: the forgotten family. Curr Opin Crit Care. 2012 Oct;18(5):540-7. doi: 10.1097/MCC.0b013e328357f141. Review.

ReferenceCitation: Robin S, Labarriere C, Sechaud G, Dessertaine G, Bosson JL, Payen JF. Information Pamphlet Given to Relatives During the End-of-Life Decision in the ICU: An Assessor-Blinded, Randomized Controlled Trial. Chest. 2021 Jun;159(6):2301-2308. doi: 10.1016/j.chest.2021.01.072. Epub 2021 Feb 5.

family: Robin

full_name: Sylvaine Robin

given: Sylvaine

family: Labarriere

full_name: Cyrielle Labarriere

given: Cyrielle

family: Sechaud

full_name: Guillaume Sechaud

family: Dessertaine

full_name: Geraldine Dessertaine

given: Geraldine

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Payen

full_name: Jean-Francois Payen

given: Jean-Francois

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility: Anesthesiology and Critical Care Depratment, Grenoble University Hospital


title: Psychiatric Disorders and Electrophysiological Markers

acronym: ERPs-PSY

summary:
Schizophrenia is considered as the most frequent and the most severe chronic psychotic disorder. Its evolutionary modes and its clinical symptomatology remain particularly heterogeneous. Moreover, the brain processes involved in schizophrenia are still far from being clearly understood. Current empirical studies provide a mean duration comprised between 1 and 3 years without any specific diagnosis or treatment. These diagnosis issues are partly based on difficulties in the early distinction between schizophrenia and bipolar affective disorders (BD).

These results emphasize the necessity of new early indices (or endophenotypes). Such markers are intended to be more specific than classical clinical manifestations. In other words, they have to be absent among patients with differential diagnosis, such as BD. Among other possible early indices, several electrophysiological disturbances have been explored.

Our study is designed to mainly describe the N400 component among patients with schizophrenia or BD. This component is classically interpreted as indexing the integration the meaning of a linguistic stimulus in its preceding context. Our main hypothesis aims to show a specific alteration of N400 component among patients with schizophrenia when compared to participants with BD.

The second aim of this study concerns the exploration of four other event related potentials (ERPs) among patients with schizophrenia or BD:

the P50 component, involved in early sensory gating processes,
the P300 component, thought to reflect attentional resource allocation and working memory updating of stimulus context,
the P600 component, elicited during same paradigms than N400, and reflecting their syntactic congruity.
the CNV (Contingent Negative Variation), reflecting processes of motor anticipation

Regarding to their potential 'endophenotypes' status, our aim consists in comparing the N400 and three other ERPs among patients with schizophrenia or bipolar affective disorder. Since the schizophrenic specificity of such ERPs alterations still remains rarely studied, we also propose to describe the possible relations between these ERPs results and clinical scores observed among patients.

location_facility: Assistance Publique Hôpitaux de Marseille


title: Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease

acronym: ECOTRACH

summary: Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.


title: Hypothalamus Connectivity in Chronic and Episodic Migraine in Headache-free Period: A Resting State Functional Magnetic Resonance Imaging Study

acronym: HYPOTHAMIG

summary: The purpose is to compare, using functional magnetic resonance imagery in resting-state, the connectivity of the hypothalamus in 2 groups of migraineurs. The first group is composed of chronic migraineurs, studied outside a migraine attack and is compared to gender- and age- matched episodic migraineurs with very few attacks per month and studied in the attack-free period. The primary outcome will be the connectivity index of the hypothalamus to brainstem areas activated during migraine attacks and to the trigeminal-cervical complex.

ReferenceCitation: Denuelle M, Fabre N. Functional neuroimaging of migraine. Rev Neurol (Paris). 2013 May;169(5):380-9. doi: 10.1016/j.neurol.2013.02.002. Epub 2013 Apr 18. Review.

ReferenceCitation: Lerebours F, Boulanouar K, Barège M, Denuelle M, Bonneville F, Payoux P, Larrue V, Fabre N. Functional connectivity of hypothalamus in chronic migraine with medication overuse. Cephalalgia. 2019 Jun;39(7):892-899. doi: 10.1177/0333102419833087. Epub 2019 Mar 5.

name: Department of Neurology, University Hospital of Toulouse, Toulouse, France

family: Lerebours

full_name: Fleur Lerebours

given: Fleur

name: UMR 1214, Toulouse NeuroImaging center, Toulouse, France

family: Boulanouar

full_name: Kader Boulanouar

given: Kader

family: Barège

full_name: Michèle Barège

given: Michèle

family: Denuelle

full_name: Marie Denuelle

given: Marie

name: Department of Radiology, University Hospital of Toulouse, Toulouse, France

family: Bonneville

full_name: Fabrice Bonneville

given: Fabrice

family: Payoux

full_name: Pierre Payoux

given: Pierre

family: Larrue

full_name: Vincent Larrue

given: Vincent

family: Fabre

full_name: Nelly Fabre

given: Nelly

journal_name: Cephalalgia

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: University Hospital, Toulouse


title: Impact of the Paramedic Announced Consultation on the Use of Patient Care With Cancer and Treated With Chemotherapy

acronym: ANNONCEP

summary:
The project aims primarily to measure the expected paramedic consultation announcement benefits for the patient, at different levels. It will measure improvements in the management of patients treated with chemotherapy. Indeed, paramedical consultation ad aims to provide a better understanding of the disease and treatment incurred, which should lead to the implementation of joint strategies between the healthcare team and the patient to prevent the effects of and treatment of the disease by the patient and caregivers.

This improvement is to promote the fair treatment by reducing patient anxiety and / or carers and involving them in the management of their disease. In this context, it is shown a profit of paramedical consultation for the patient, it will work, based on the recommendations of the Cancer Plan, strengthen the need to routinely offer paramedic Ad consultation.

This work should also help measure the impact of ad paramedical consultation on optimizing care consumption off-line therapy and to assess the associated costs.

For patients who received paramedic ad or not consultation, it will therefore be of particular compare intercurrent hospitalizations, commuting structure of care, the number of consultations with the doctor, the reports of cure, additional biological monitoring or other health care consumption.

With the participation of several centers in the fight against cancer, this study will provide valuable information on the practice of paramedical consultation ad in several tumor sites.

It will objectify the benefit provided by the Medical device announcement for both patients and the organization and use of care prerequisite to encourage better integration of this device in the course of patient care, the consultation paramedical ad remaining poorly understood by many health professionals.

lead_sponsor: Centre Francois Baclesse


title: Reliability of Kinematic Analysis in Assessment and Rehabilitation of the Upper Arm of Stroke Patients Following a Cerebral Vascular Accident, Hemiparetic Subjects

summary: Reproducibility assessment of a quantitative measure of the amount of trunk compensation by kinematic analysis in a grasping task in stroke patients.This "maladaptive trunk compensation" is suspected to be underlined by "arm non-use" in some patients, since this abnormal movement impairs the ability of patients to correctly flex their shoulder and extend their elbow during grasping.

ReferenceCitation: Bakhti KKA, Laffont I, Muthalib M, Froger J, Mottet D. Kinect-based assessment of proximal arm non-use after a stroke. J Neuroeng Rehabil. 2018 Nov 14;15(1):104. doi: 10.1186/s12984-018-0451-2.

family: Bakhti

full_name: K. K. A. Bakhti

given: K. K. A.

family: Laffont

full_name: I. Laffont

given: I.

family: Muthalib

full_name: M. Muthalib

given: M.

family: Froger

full_name: J. Froger

given: J.

family: Mottet

full_name: D. Mottet

given: D.

journal_name: Journal of NeuroEngineering and Rehabilitation

lead_sponsor: University Hospital, Montpellier


title: Genetic Analysis of Childhood Obesity

acronym: OSV

summary: Identify news genetic causes of different type of obesity (syndromic, familial or isolated obesity) by highlighting new mutations or new implied genes

lead_sponsor: Lille Catholic University


title: Renal Resistive Index Compared With NephroCheckTM to Predict Postoperative Acute Renal Failure in Patients Undergoing Cardiac Surgery.

summary:
Postoperative acute renal failure is a frequent complication after cardiac surgery. The current practice cannot predict Acute Kidney Injuries (AKI) early enough to reduce a significant kidney assault and prevent an organic dysfunction leading to cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that, both sonographic criteria, such as the Renal Resistive Index (IRR) and urinary biomarkers can predict AKI promptly. These urinary biomarkers are the 'tissue inhibitor of metalloproteinases' (TIMP-2) and the 'insulin-like growth factor binding protein' (IGFBP7). These two proteins are sought noninvasively, directly in the urine, within the same test called 'NephroCheckTM'. These markers, ultrasonographic and biologic, have the advantage of being easy to perform, accessible and seem to have both high sensitivity and specificity to predict AKI promptly after cardiac surgery. Thus, the IRR and the NephroCheckTM test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI. However, so far, no study has compared these markers yet.

Therefore, the aim of this prospective observational study will be to compare the effectiveness of the IRR with the NephroCheckTM to predict AKI promptly after cardiac surgery. The secondary outcome will be to determine the threshold of these markers from which patients will be likely to develop AKI

lead_sponsor: University Hospital, Bordeaux


title: Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover, Proof-of-mechanism Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Adult Patients With Cystic Fibrosis Homozygous for the F508del Mutation

acronym: MIGLUSTAT-CF

summary: The purpose of this study is to demonstrate that Miglustat restores the function of the cystic fibrosis transmembrane conductance regulator (CFTR) in adult patients with cystic fibrosis homozygous for the F508del mutation.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance publique-Hôpitaux de Paris, Hôpital Cochin


title: Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery

acronym: COSINUS

summary: This study compares the morphological concordance between CT (computed tomography) and cone beam in sinus on 26 validated items. CT and cone beam is performed on each patient. Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of the ionizing radiations is lower with the cone beam.

intervention_type: Radiation


title: Evaluation of the Clinical and Electrophysiological Responses of the Brainstem in Patients With Alteration of Consciousness in Relation or Not With Sedation: Prognostic Study of Brain Reflexes

acronym: PRORETRO

summary:
Severe diseases in intensive care unit (ICU) patients are associated with a high mortality rate which nevertheless remains difficult to predict. Recently, the abolition of some brainstem reflexes at clinical examination of ICU patients within the first 24 hours after has been shown of prognostic value in ICU patients requiring sedation. Early abolition of the cough reflex was associated with an increase in mortality and that of the oculocephalic reflex was predictive of coma or delirium after sedation has been stopped. A dysfunction of the brainstem may account for these results and be present in other patient subpopulations, particularly those who do not receive iv sedation or the brain injured patients, who were eluded from the previous study. This dysfunction could take place in the muti-organ failure characteristic of the severe ICU patient. On the other hand, a preliminary study performed on somatosensory evoked potentials has shown that a latency of the P14 wave greater than 16 ms between day 1 and day 3 after admission was associated with death at 28 days. The primary goal of this project is to confirm this hypothesis. By studying the clinical and electrophysiological responses of the brainstem in ICU patients, with or without brain injury, with alteration of consciousness in relation or not with sedation. The other objectives are to determine the correlations between neurophysiological clinical neurological, or neuroradiological data with delirium occurrence.

The main objective of this study is to determine, in ICU patients with or without brain injury and with alteration of consciousness in relation or not with sedation, if abolition of the cough reflex at Day 1 after admission is predictive of mortality at 28 days, independent from cause for admission and severity.


title: Therapeutic Effects of Maternal Melatonin Administration on Brain Injury and White Matter Disease in Very Preterm Infants

acronym: PREMELIP

summary:
Neurocognitive sequelae observed in preterm represent a major health problem for which there is no preventive treatment approved to date. These effects are the result of a multifactorial brain damage occurring in developing prenatal and perinatal period. Melatonin, the principal hormone secreted by the pineal gland has neuroprotective properties in various experimental animal models of perinatal brain damage level. This hormone readily crosses the placental barrier, its antenatal administration would have a neuroprotective effect in the case of preventive preterm birth before 28 weeks of amenorrhea.

The objective of this study determine the dose of melatonin administered parenterally in prenatal maternal in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) with statistical spatial analysis (TBSS) to the theoretical term of 40 weeks in children born prematurely.


title: "Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22

acronym: Famirea 22

summary:
After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.

Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.

ReferenceCitation: Kentish-Barnes N, Chevret S, Champigneulle B, Thirion M, Souppart V, Gilbert M, Lesieur O, Renault A, Garrouste-Orgeas M, Argaud L, Venot M, Demoule A, Guisset O, Vinatier I, Troché G, Massot J, Jaber S, Bornstain C, Gaday V, Robert R, Rigaud JP, Cinotti R, Adda M, Thomas F, Calvet L, Galon M, Cohen-Solal Z, Cariou A, Azoulay E; Famirea Study Group. Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial. Intensive Care Med. 2017 Apr;43(4):473-484. doi: 10.1007/s00134-016-4669-9. Epub 2017 Feb 14.

family: Kentish-Barnes

full_name: Nancy Kentish-Barnes

given: Nancy

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Champigneulle

full_name: Benoît Champigneulle

given: Benoît

family: Thirion

full_name: Marina Thirion

given: Marina

family: Souppart

full_name: Virginie Souppart

given: Virginie

family: Gilbert

full_name: Marion Gilbert

given: Marion

family: Lesieur

full_name: Olivier Lesieur

given: Olivier

family: Renault

full_name: Anne Renault

given: Anne

family: Garrouste-Orgeas

full_name: Maïté Garrouste-Orgeas

given: Maïté

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Venot

full_name: Marion Venot

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Guisset

full_name: Olivier Guisset

family: Vinatier

full_name: Isabelle Vinatier

given: Isabelle

family: Troché

full_name: Gilles Troché

given: Gilles

family: Massot

full_name: Julien Massot

given: Julien

family: Jaber

full_name: Samir Jaber

given: Samir

family: Bornstain

full_name: Caroline Bornstain

given: Caroline

family: Gaday

full_name: Véronique Gaday

given: Véronique

family: Robert

full_name: René Robert

given: René

family: Rigaud

full_name: Jean-Philippe Rigaud

given: Jean-Philippe

family: Cinotti

full_name: Raphaël Cinotti

given: Raphaël

family: Adda

full_name: Mélanie Adda

given: Mélanie

ReferenceCitation: Kentish-Barnes N, Chevret S, Azoulay E. Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial. Trials. 2016 Feb 20;17(1):102. doi: 10.1186/s13063-016-1212-9.