title: Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.

acronym: ET-DIT

summary: Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.

location_facility: Médecine et santé au travail - Hôpital Cardiologique Louis Pradel - Groupement hospitalier Est


title: On the Highway to Autonomous Driving: How is Automation Changing Humans: Investigations of Drivers' Behaviors, Representations and Neural Processes

acronym: AUTODRIVE

summary:
In the context of ever-increasing automation in surface vehicles, automation impact on drivers will be investigated through three complementary research axes undertaken under simulated driving:

Axe 1 (Cognitive ergonomics), how automation is impacting driving behaviors and visual explorations? Axe 2 (Experimental psychology), how automation is impacting drivers' mental representations of their own driving abilities? Axe 3 (Neuroimaging), how automation is modifying the car driving neural network? And what are drivers' mental representations neural bases? The project tackle both applied and basic research issues using an original experimental neuro ergonomics approach. AUTODRIVE will bring original data on human-machine cooperation, mental representations, cognitive control and brain processes depending on the characteristics of the automation used over a significant period of time (six weeks) on a large sample (N=120) of experienced and inexperienced drivers.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Anticipated

lead_sponsor: Hospices Civils de Lyon

location_facility: Laboratoire d'Etude des Mécanismes Cognitifs (EMC)

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial

acronym: METOGiA

summary:
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. It is characterized by a granulomatous inflammation of the wall of large vessels, involving especially the aorta and extra-cranial branches of the external carotid, with vascular remodelling leading to ischemic manifestations such as temporal headaches, jaw claudication, scalp tenderness and visual loss. Most patients with GCA also present signs of systemic inflammation, including weight loss, fatigue and fever, together with an increased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level.

Glucocorticoids (GC) are the cornerstone of the treatment of GCA. They are very effective and are usually given for 18-24 months to avoid relapses. Therefore, most patients develop GC-related complications that cause morbidity and disability. GC sparing strategies are thus required to improve the treatment of GCA.

A 12-month treatment with tocilizumab (TCZ) has recently been shown to be effective in inducing and maintaining remission of GCA, with a dramatic GC-sparing effect. However, TCZ is an expensive drug; TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients; and importantly around 40% of patients relapse within 6 months after TCZ discontinuation, whether prescribed for 12 months or 4 months.
In association with 6 months of prednisone, 10 mg/week of methotrexate (MTX) for 24 months lowers the risk of relapse at 24 months from 84% to 45%.

Therefore, the hypothesis is that 12 months of MTX treatment (0.3 mg/Kg/week, without exceeding 20 mg/week) is not inferior to 12 months of TCZ (162 mg SC/week) in term of prevention of relapse at 18 months. The MTX strategy might be more cost effective than TCZ.

In the present study, it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial. Moreover, the economic consequences associated with the use of MTX rather than TCZ will be also assess.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other


title: Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI

acronym: RUMAJI

summary: According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma

acronym: MYELOCHOL

summary: Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.

status: Unknown status

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Mesguich C, Hulin C, Latrabe V, Asselineau J, Bordenave L, Perez P, Hindie E, Marit G. Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.

family: Mesguich

full_name: Charles Mesguich

given: Charles

sequence: first

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

sequence: additional

family: Latrabe

full_name: Valerie Latrabe

given: Valerie

family: Asselineau

full_name: Julien Asselineau

given: Julien

family: Bordenave

full_name: Laurence Bordenave

given: Laurence

family: Perez

full_name: Paul Perez

given: Paul

family: Hindie

full_name: Elif Hindie

given: Elif

family: Marit

full_name: Gerald Marit

given: Gerald

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JMIR Research Protocols

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: University Hospital, Bordeaux

location_facility: Bordeaux University Hospital - Haut-Lévêque

intervention_type: Drug

status_simplified: Unknown


title: Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock

acronym: HemodyNoOc

summary: Octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. When patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. Microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. The aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire, Amiens


type: Other Identifier

title: Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction

acronym: RECaVoLL

summary:
The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation.

The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.

Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.

It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.

There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.

location_facility: Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon


title: Interest of Cardiac Output Measurement by Thoracic Bio-reactance for Monitoring of Patients Treated for a Pulmonary Hypertension

acronym: PHREACT

summary:
Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased.

Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test.

The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.

time_perspective: Prospective

location_facility: Service d'Explorations Fonctionnelles Respiratoires, centre de compétences de l'hypertension pulmonaire Hospices Civils de Lyon, Groupement Hospitalier Est


title: Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 ml) in Healthy Volunteers

acronym: AUTOT-SPORT

summary: The purpose of this study is to evaluate if differences between samples of subjects obtained before autologous blood transfusion or samples of non-transfused subjects and samples of subjects after autologous blood transfusion can be identified. Analyses performed will focus on the morphological and biochemical parameters of red blood cells and associated microparticles. The final goal would be to find markers of autologous blood transfusion, that could be used to identify such doping practice.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Etablissement Français du Sang IDF, Hôpital de la Pitié Salpêtrière


title: Patients' Choice in Terms of Anticoagulant Therapy in Venous Thrombo- Embolism Disease. AntiCoagChoice Study

acronym: AntiCoagChoice

summary: The objective of the "anticoagchoice" study is to analyze the preferences of people suffering from phlebitis, in terms of anticoagulant, to improve adherence to these treatments, to adapt the medical prescriptions.

ReferenceCitation: Lanéelle D, Le Brun C, Mauger C, Guillaumat J, Le Pabic E, Omarjee L, Mahé G; SFMV VTE Study Group. Patient Characteristics and Preferences Regarding Anticoagulant Treatment in Venous Thromboembolic Disease. Front Cardiovasc Med. 2021 Jun 21;8:675969. doi: 10.3389/fcvm.2021.675969. eCollection 2021.

family: Lanéelle

full_name: Damien Lanéelle

given: Damien

family: Le Brun

full_name: Charles Le Brun

family: Mauger

full_name: Chadi Mauger

given: Chadi

family: Guillaumat

full_name: Jérôme Guillaumat

given: Jérôme

family: Le Pabic

full_name: Estelle Le Pabic

given: Estelle

family: Omarjee

full_name: Loukman Omarjee

given: Loukman

family: Mahé

full_name: Guillaume Mahé

given: Guillaume

journal_name: Frontiers in Cardiovascular Medicine

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Rennes University Hospital


title: Is Mental Motor Imagery Training Using "GHOST", a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion

acronym: GHOST

summary: Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.

lead_sponsor: Nantes University Hospital


title: Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer: First in Human Evaluation in Perioperative With Regard to a Control Group

acronym: EPIKARD

summary:
The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.

The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Grenoble


title: Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation

acronym: ECMO bleeding

summary: Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO


title: Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy

acronym: BE-API

summary:
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the gold standard for gait analysis. The existing 3DMA protocols consist of movements too standardized, in unimanual situations away from gestures of everyday life, or have not been validated in bimanual situations.

In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks integrated into a game scenario to have more spontaneity of movements, similar to those experienced by children in daily life. It allows the exploration of all degrees of freedom of the upper limb. Results showed an excellent acceptability and within day reliability on 20 uCP children and 20 typically developing children (TDC) for funct

ReferenceCitation: Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.

family: Cacioppo

full_name: Marine Cacioppo

given: Marine

family: Marin

full_name: Antoine Marin

given: Antoine

family: Rauscent

full_name: Hélène Rauscent

given: Hélène

family: Gaillard

full_name: Florence Gaillard

given: Florence

family: Brochard

full_name: Sylvain Brochard

given: Sylvain

family: Garlantezec

full_name: Ronan Garlantezec

given: Ronan

family: Cretual

full_name: Armel Cretual

given: Armel

family: Bonan

full_name: Isabelle Bonan

given: Isabelle

journal_name: Journal of Electromyography and Kinesiology

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: acceptedVersion

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

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier


title: Transcutaneous PCO2 Assessment During Intubation in ICU

acronym: C-TOP

summary: PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Procedure


title: Tolerance of Therapeutic Plasma Exchange Performed in the Rennes University Hospital 2011-2018

acronym: COMPLASMA

summary: To assess the indications, tolerance and side effects of therapeutic plasma exchange (TPE) performed at a University Hospital over 8 years

ReferenceCitation: Coirier V, Lesouhaitier M, Reizine F, Painvin B, Quelven Q, Maamar A, Gacouin A, Tadié JM, Le Tulzo Y, Camus C. Tolerance and complications of therapeutic plasma exchange by centrifugation: A single center experience. J Clin Apher. 2021 Nov 17. doi: 10.1002/jca.21950. [Epub ahead of print]

name: Maladies Infectieuses et Réanimation Médicale, CHU de Rennes  Rennes France

name: Faculté de Médecine Université de Rennes 1  Rennes France

family: Coirier

full_name: Valentin Coirier

given: Valentin

family: Lesouhaitier

full_name: Mathieu Lesouhaitier

given: Mathieu

family: Reizine

full_name: Florian Reizine

given: Florian

family: Painvin

full_name: Benoît Painvin

given: Benoît

family: Quelven

full_name: Quentin Quelven

given: Quentin

family: Maamar

full_name: Adel Maamar

given: Adel

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Tadié

full_name: Jean‐Marc Tadié

given: Jean‐Marc

family: Le Tulzo

full_name: Yves Le Tulzo

given: Yves

family: Camus

full_name: Christophe Camus

given: Christophe

journal_name: Journal of Clinical Apheresis

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley


title: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

acronym: SPOC

summary: Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.


title: Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality

summary:
Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.

The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies


title: Contribution of Functional MRI in Assessment of Auditory Processing Disorders

acronym: IRMf-TTA

summary:
Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). There is currently no gold standard in the literature for diagnosing APD. Investigators opened multidisciplinary consultation for the children suspected of APD. The purpose of this study is to analyze the results of the multidisciplinary assessment performed on these children (audiometry, cortical auditory brainstem response (ABR), behavioral assessment, psychometric evaluation, genetic analysis) to the results of functional MRI (fMRI) at rest and in activation. The goal is to find radiological MRI-fMRI markers in these patients that improve the diagnosis of APD.

Investigators will compare the f-MRI results between three groups of children in order to find specific radiological markers of APD :

group 1 : children diagnosed with an Auditory Processing Disorder (APD)
group 2 : children suspect of APD
group 3 : children without APD (controls)

ReferenceType: background

ReferenceCitation: Chermak GD, Bamiou DE, Vivian Iliadou V, Musiek FE. Practical guidelines to minimise language and cognitive confounds in the diagnosis of CAPD: a brief tutorial. Int J Audiol. 2017 Jul;56(7):499-506. doi: 10.1080/14992027.2017.1284351. Epub 2017 Feb 28. Review.

ReferenceCitation: Moore DR, Ferguson MA, Edmondson-Jones AM, Ratib S, Riley A. Nature of auditory processing disorder in children. Pediatrics. 2010 Aug;126(2):e382-90. doi: 10.1542/peds.2009-2826. Epub 2010 Jul 26.

ReferenceCitation: Barker MD, Kuruvilla-Mathew A, Purdy SC. Cortical Auditory-Evoked Potential and Behavioral Evidence for Differences in Auditory Processing between Good and Poor Readers. J Am Acad Audiol. 2017 Jun;28(6):534-545. doi: 10.3766/jaaa.16054.

ReferenceCitation: Tomlin D, Rance G. Maturation of the Central Auditory Nervous System in Children with Auditory Processing Disorder. Semin Hear. 2016 Feb;37(1):74-83. doi: 10.1055/s-0035-1570328.

ReferenceCitation: Sharma M, Purdy SC, Kelly AS. Comorbidity of auditory processing, language, and reading disorders. J Speech Lang Hear Res. 2009 Jun;52(3):706-22. doi: 10.1044/1092-4388(2008/07-0226). Epub 2008 Dec 8.

ReferenceCitation: de Wit E, Visser-Bochane MI, Steenbergen B, van Dijk P, van der Schans CP, Luinge MR. Characteristics of Auditory Processing Disorders: A Systematic Review. J Speech Lang Hear Res. 2016 Apr 1;59(2):384-413. doi: 10.1044/2015_JSLHR-H-15-0118. Review.

ReferenceCitation: Demanez L, Dony-Closon B, Lhonneux-Ledoux E, Demanez JP. Central auditory processing assessment: a French-speaking battery. Acta Otorhinolaryngol Belg. 2003;57(4):275-90.

ReferenceCitation: Sharma A, Kraus N, McGee TJ, Nicol TG. Developmental changes in P1 and N1 central auditory responses elicited by consonant-vowel syllables. Electroencephalogr Clin Neurophysiol. 1997 Nov;104(6):540-5.

ReferenceCitation: Sharma A, Dorman MF, Spahr AJ. Rapid development of cortical auditory evoked potentials after early cochlear implantation. Neuroreport. 2002 Jul 19;13(10):1365-8.

ReferenceCitation: Sharma A, Martin K, Roland P, Bauer P, Sweeney MH, Gilley P, Dorman M. P1 latency as a biomarker for central auditory development in children with hearing impairment. J Am Acad Audiol. 2005 Sep;16(8):564-73.

ReferenceCitation: Sharma A, Glick H, Campbell J, Biever A. CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES. Hearing Balance Commun. 2013 Sep;11(3). doi: 10.3109/21695717.2013.812378.

ReferenceCitation: Sharma M, Purdy S C, Kelly A S. The contribution of speech-evoked cortical auditory evoked potentials to the diagnosis and measurement of intervention outcomes in children with auditory processing disorder. Semin Hear. 2014;35(1):51-64

ReferenceCitation: Purdy SC, Kelly AS, Davies MG. Auditory brainstem response, middle latency response, and late cortical evoked potentials in children with learning disabilities. J Am Acad Audiol. 2002 Jul-Aug;13(7):367-82.

ReferenceCitation: Anderson S, Chandrasekaran B, Yi HG, Kraus N. Cortical-evoked potentials reflect speech-in-noise perception in children. Eur J Neurosci. 2010 Oct;32(8):1407-13. doi: 10.1111/j.1460-9568.2010.07409.x.

ReferenceCitation: Cunningham J, Nicol T, Zecker S, Kraus N. Speech-evoked neurophysiologic responses in children with learning problems: development and behavioral correlates of perception. Ear Hear. 2000 Dec;21(6):554-68.

ReferenceCitation: Punch S, Van Dun B, King A, Carter L, Pearce W. Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia. Semin Hear. 2016 Feb;37(1):36-52. doi: 10.1055/s-0035-1570331.

ReferenceCitation: Martin BA, Tremblay KL, Korczak P. Speech evoked potentials: from the laboratory to the clinic. Ear Hear. 2008 Jun;29(3):285-313. doi: 10.1097/AUD.0b013e3181662c0e. Review. Erratum in: Ear Hear. 2008 Dec;29(6):979.

ReferenceCitation: Micallef LA. Auditory Processing Disorder (APD): Progress in Diagnostics So Far. A Mini-Review on Imaging Techniques. J Int Adv Otol. 2015 Dec;11(3):257-61. doi: 10.5152/iao.2015.1009. Review.

ReferenceCitation: Owen JP, Marco EJ, Desai S, Fourie E, Harris J, Hill SS, Arnett AB, Mukherjee P. Abnormal white matter microstructure in children with sensory processing disorders. Neuroimage Clin. 2013 Jun 23;2:844-53. doi: 10.1016/j.nicl.2013.06.009. eCollection 2013.

ReferenceCitation: Kim MJ, Jeon HA, Lee KM, Son YD, Kim YB, Cho ZH. Neuroimaging features in a case of developmental central auditory processing disorder. J Neurol Sci. 2009 Feb 15;277(1-2):176-80. doi: 10.1016/j.jns.2008.10.020. Epub 2008 Dec 6.

ReferenceCitation: Belin P, Zatorre RJ, Lafaille P, Ahad P, Pike B. Voice-selective areas in human auditory cortex. Nature. 2000 Jan 20;403(6767):309-12.

ReferenceCitation: Thomsen T, Rimol LM, Ersland L, Hugdahl K. Dichotic listening reveals functional specificity in prefrontal cortex: an fMRI study. Neuroimage. 2004 Jan;21(1):211-8.

ReferenceCitation: Pluta A, Wolak T, Czajka N, Lewandowska M, Cieśla K, Rusiniak M, Grudzień D, Skarżyński H. Reduced resting-state brain activity in the default mode network in children with (central) auditory processing disorders. Behav Brain Funct. 2014 Sep 26;10(1):33. doi: 10.1186/1744-9081-10-33.

ReferenceCitation: Bartel-Friedrich S, Broecker Y, Knoergen M, Koesling S. Development of fMRI tests for children with central auditory processing disorders. In Vivo. 2010 Mar-Apr;24(2):201-9.

intervention_type: Genetic


title: National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (Intra-venous Thrombolysis and/or Endovascular Treatment: Thrombectomy, Intra-arterial Thrombolysis)

acronym: KID-CLOT

summary: The purpose of this study is to evaluate recanalization treatments use, safety and efficacy at the acute phase of arterial ischemic stroke in pediatric patients


title: Screening for Fabry Disease in Renal Transplantation

acronym: DEFYT

summary: Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

intervention_type: Diagnostic Test


title: Source Monitoring Déficit in Neuropsychiatric Population

summary: the investigators will measure source-monitoring ability in patients with several neuropsychiatric condition and in healthy controls appaired in age, sex and educational level. Source-monitoring will be measured thanks to internal- and reality-monitoring informatic tasks.The investigators hypothesized patients with fronto-temporal abnormalities would show more marked deficits than patients with only frontal abnormalities.

lead_sponsor: Hôpital le Vinatier


title: Impact of HMS Plus Device on Postoperative Blood Loss During Cardiac Surgery

acronym: POC/HMS

summary:
Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB.

HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.


title: Assessment of Clinical Competence of Medical Students: a Comparison of High-fidelity Simulation, Serious Game and Multiple-choice Questions

acronym: SIMEVAL

summary:
This study, focusing on the management of pediatric asthma exacerbations, assesses the clinical skills of medical students using three different evaluation tools: (i) the simulation game "Effic'Asthme" developed to train individuals on the management of pediatric asthma exacerbations; (ii) a multiple choice questionnaire (MCQ) on the same subject developed for the purpose of the study and (iii) high fidelity (HF)-simulation, considered as the gold-standard for its enhanced realism.

Its objective is to determine which of the simulation game or the MCQ reflects the best the clinical competence of medical students evaluated on a HF simulator.

primary_purpose: Other

ReferenceCitation: Norcini JJ, Swanson DB, Grosso LJ, Webster GD. Reliability, validity and efficiency of multiple choice question and patient management problem item formats in assessment of clinical competence. Med Educ. 1985 May;19(3):238-47.

ReferenceCitation: Drummond D, Delval P, Abdenouri S, Truchot J, Ceccaldi PF, Plaisance P, Hadchouel A, Tesnière A. Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study. Eur J Anaesthesiol. 2017 Dec;34(12):836-844. doi: 10.1097/EJA.0000000000000675.

family: Drummond

full_name: David Drummond

given: David

family: Delval

full_name: Paul Delval

given: Paul

family: Abdenouri

full_name: Sonia Abdenouri

given: Sonia

family: Truchot

full_name: Jennifer Truchot

given: Jennifer

family: Ceccaldi

full_name: Pierre-François Ceccaldi

given: Pierre-François

family: Plaisance

full_name: Patrick Plaisance

given: Patrick

family: Hadchouel

full_name: Alice Hadchouel

given: Alice

family: Tesnière

full_name: Antoine Tesnière

given: Antoine

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Adjedj J, Ducrocq G, Bouleti C, Reinhart L, Fabbro E, Elbez Y, Fischer Q, Tesniere A, Feldman L, Varenne O. Medical Student Evaluation With a Serious Game Compared to Multiple Choice Questions Assessment. JMIR Serious Games. 2017 May 16;5(2):e11. doi: 10.2196/games.7033.

ReferenceCitation: Fonteneau T, Billion E, Abdoul C, Le S, Hadchouel A, Drummond D. Simulation Game Versus Multiple Choice Questionnaire to Assess the Clinical Competence of Medical Students: Prospective Sequential Trial. J Med Internet Res. 2020 Dec 16;22(12):e23254. doi: 10.2196/23254.

family: Fonteneau

full_name: Tristan Fonteneau

given: Tristan

family: Billion

full_name: Elodie Billion

given: Elodie

family: Abdoul

full_name: Cindy Abdoul

given: Cindy

family: Le

full_name: Sebastien Le

given: Sebastien

journal_name: Journal of Medical Internet Research

ipd_sharing: Yes

ipd_sharing_description:
Participants' characteristics anonymized
Participants' correct and incorrect actions and answers when evaluated on the 3 different modalities: multiple choice questionnaire, high-fidelity simulation and simulation game

lead_sponsor: Ilumens


title: Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block

summary:
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation


title: Interest of Cognitive-behavioral Therapies Based on the CBSM (Cognitive Behavior Stress Management) for the Management of Patients Suffering From Pain Related to Cancer.

acronym: CBSM

summary: The CBSM is a program combining cognitive and behavioral therapies, relaxation provided in groups of 8 to 10 patients. This program has demonstrated benefits in stress management skills, adaptive strategies, anxiety, quality of life, social inclusion, medication adherence, depression, therapeutic alliance, and general well-being. It would also improve breast cancer survival after adjuvant therapy. This program has been put in place at the center of pain for patients with cancer pain in any stage. This study aims to evaluate the benefits of this technique on a patient population suffering from chronic pain related to cancer.

status: Terminated


title: Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift

summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


title: Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders

acronym: REQ-PRO

summary:
This research focuses on the effects of rehabilitation on balance, in patients with acquired chronic demyelinating neuropathy. Rehabilitation will be performed with or without vision.

It is planned to include 40 subjects consulting for walking instability related to sensitivity disorders.

This multicenter study will take place in Paris's area. Each participant will benefit from 20 rehabilitation sessions with a Physical Therapist and 3 assessments.

Thanks to randomization, patient will be allocated in one of the 2 following groups:

Control group, Patients will benefit from balance rehabilitation with open eyes.
Experimental group, they will perform the same exercises while keeping their eyes closed or their vision will be obstructed by a mask or disturbed by moving luminous dots projected on the environment in darkness.

ReferenceCitation: Barrois RP, Ricard D, Oudre L, Tlili L, Provost C, Vienne A, Vidal PP, Buffat S, Yelnik AP. Observational Study of 180° Turning Strategies Using Inertial Measurement Units and Fall Risk in Poststroke Hemiparetic Patients. Front Neurol. 2017 May 15;8:194. doi: 10.3389/fneur.2017.00194. eCollection 2017.

ReferenceCitation: Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8.

ReferenceCitation: Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Pérennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.

ReferenceCitation: Provost CP, Tasseel-Ponche S, Lozeron P, Piccinini G, Quintaine V, Arnulf B, Kubis N, Yelnik AP. Standing postural reaction to visual and proprioceptive stimulation in chronic acquired demyelinating polyneuropathy. J Rehabil Med. 2018 Feb 28;50(3):278-284. doi: 10.2340/16501977-2314.

ReferenceCitation: Missaoui B, Thoumie P. Balance training in ataxic neuropathies. Effects on balance and gait parameters. Gait Posture. 2013 Jul;38(3):471-6. doi: 10.1016/j.gaitpost.2013.01.017. Epub 2013 Mar 5.

ReferenceCitation: Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007 May;88(5):664-72.

location_facility: Service de Médecine Physique et de Réadaptation (MPR)


title: Population Pharmacokinetics and Dosing Regimens Optimization of Ceftazidime in Critically Ill Burn Children

acronym: CEFTAZOPTIM

summary:
Concentrations and effects of Ceftazidime in critically ill burn children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill burn children.

Optimization of Ceftazidime dosing is therefore desirable for all. The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) of Ceftazidime including PK/pharmacodynamic (PD) targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill burn children. The effects of covariates on Ceftazidime PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens.

It will be a prospective PK study. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were Ceftazidime concentrations above the MIC of the pathogen at both 50% (50% f T>MIC) and 100% (100% f T>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of Ceftazidime exposure on patient outcome.

location_facility: Hospital Necker - Enfants Malades (Public Hospitals of Paris)


title: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

acronym: BOVARY Pilot

summary: BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared

lead_sponsor: Institut de Cancérologie de Lorraine

lead_sponsor_type: industriel


title: Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital

summary: Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout

lead_sponsor: University Hospital, Clermont-Ferrand


title: Assessment of MRI Tractography for Pelvic Floor Sphincter Analysis

acronym: TractoCA

summary:
Urinary and faecal incontinences generally come from a dysfunction of the pelvic floor muscles, and more particularly the sphincters. Among other causes, they may be related to accidental trauma, obstetric or iatrogenic. On this last point, the incidence of surgical interventions on the bladder collar and on the anal canal on the prevalence of incontinences can be underlined.

MRI tractography could be an interesting tool to visualize in 3D the structure of pelvic sphincters and their lesions. It may thereby establish the link with observed dysfunctions, thus potentially providing a complement to the urological and proctographic examinations already carried out.

The objective of this study is, first, to define the sensitivity of the MRI tractography for the visualization of the pelvic sphincters architecture regardless of the gender. In a second time, it will give a description of normal and abnormal (pathological cases) tractography, as well as a descriptive post-surgery. The other interest of this study is the assessment of the information provided by pelvic sphincters tractography on a panel of various and frequently encountered situations in clinical routine at the IHU.

ReferenceCitation: Zijta FM, Froeling M, van der Paardt MP, Lakeman MM, Bipat S, van Swijndregt AD, Strijkers GJ, Nederveen AJ, Stoker J. Feasibility of diffusion tensor imaging (DTI) with fibre tractography of the normal female pelvic floor. Eur Radiol. 2011 Jun;21(6):1243-9. doi: 10.1007/s00330-010-2044-8. Epub 2011 Jan 1.

ReferenceCitation: Zijta FM, Lakeman MM, Froeling M, van der Paardt MP, Borstlap CS, Bipat S, Montauban van Swijndregt AD, Strijkers GJ, Roovers JP, Nederveen AJ, Stoker J. Evaluation of the female pelvic floor in pelvic organ prolapse using 3.0-Tesla diffusion tensor imaging and fibre tractography. Eur Radiol. 2012 Dec;22(12):2806-13. doi: 10.1007/s00330-012-2548-5. Epub 2012 Jul 14.

ReferenceCitation: Rousset P, Delmas V, Buy JN, Rahmouni A, Vadrot D, Deux JF. In vivo visualization of the levator ani muscle subdivisions using MR fiber tractography with diffusion tensor imaging. J Anat. 2012 Sep;221(3):221-8. doi: 10.1111/j.1469-7580.2012.01538.x. Epub 2012 Jul 4.

lead_sponsor: IHU Strasbourg

location_facility: Service de Radiologie et d'Echographie, NHC Strasbourg


title: Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder

acronym: DIABOLO

summary:
According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

Borderline personality disorder (BPD) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

BPD is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a BPD.

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a BPD are highly sensitive to it. Unfortunately, patient care for this disorder is limited. Pharmacological strategies didn't show any efficacy and psychotherapies, although proven effective, are difficult to set up.

As BPD is strongly related to suicidal attempts it appears to be a good model to study suicidal behavior. Thus, this study could improve knowledge in this field.

Suicidal behavior in patients receiving the standard therapy (dialectic behavioural therapy: DBT) will be compared to patients receiving dialectical behavior therapy and acceptance commitment therapy (ACT).

Clinical data reflecting how the participant is feeling will be collected as well.

status: Withdrawn

primary_purpose: Prevention

intervention_type: Behavioral


title: Dental Implants in Patients With X-linked Hypophosphatemia

acronym: IMPLANTS-XLH

summary: X-linked hypophosphatemia (XLH) is a rare genetic skeletal disease where increased phosphate wasting in the kidney leads to hypophosphatemia and prevents normal mineralization of bone and dentin, with osteomalacia as a principal manifestation. In previous works, the investigators have shown that adults with XLH present with more frequent and severe periodontitis than in the general population, and that vitamin D and phosphate supplementation improves their periodontal health, as it does for the osteomalacia. Their medical records also reveal that early implant failure is dramatically increased in these patients, when no supplementation is implemented, and standard surgical protocols followed. In contrast, the investigator's preliminary data showed that successful osseointegration was achieved with supplementation prior and after implant placement and extended healing time. Here, the investigators propose to assess the current recommendations for implant therapy in XLH patients, with 24 implants placed. The current recommendations consist of: 1) supplementation with vitamin D and phosphate for 3 months prior to implant placement and 6 months after; 2) implant healing time extended to 6 months. If osseointegration is achieved, prosthesis will be fabricated. Radiographic and clinical examination at 6, 12, 18 and 24 months after placement of the definitive restoration will evaluate the implant osseointegration, crestal bone level and peri-implant tissues health.

location_facility: Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre


title: Management of Anal Fistula of Crohn Disease

acronym: FISTUCROHN

summary: The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

time_perspective: Other


title: Oral Superoxide Dismutase (GLISODin) to Decrease Melasma Severity. A Prospective Randomized Placebo-controlled Study

acronym: Glisodin

summary: Oxidative stress has been reported to play a role in melasma pathophysiology. The objective of the study is to compare oral superoxide dismutase (GLISODin) to placebo, in combination to sunscreen to decrease melasma severity.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth _ DEXTRAFANT _ RC16_0183

acronym: DEXTRAFANT

summary: This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.

location_facility: Centre Hospitalier Universitaire de Nantes


title: A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

acronym: VIRTOPSY+

summary: The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

ReferenceCitation: Addison S, Arthurs OJ, Thayyil S. Post-mortem MRI as an alternative to non-forensic autopsy in foetuses and children: from research into clinical practice. Br J Radiol. 2014 Apr;87(1036):20130621. doi: 10.1259/bjr.20130621. Review.

ReferenceCitation: Brookes JA, Hall-Craggs MA, Sams VR, Lees WR. Non-invasive perinatal necropsy by magnetic resonance imaging. Lancet. 1996 Oct 26;348(9035):1139-41.

ReferenceCitation: Breeze AC, Jessop FA, Set PA, Whitehead AL, Cross JJ, Lomas DJ, Hackett GA, Joubert I, Lees CC. Minimally-invasive fetal autopsy using magnetic resonance imaging and percutaneous organ biopsies: clinical value and comparison to conventional autopsy. Ultrasound Obstet Gynecol. 2011 Mar;37(3):317-23. doi: 10.1002/uog.8844.

ReferenceCitation: Kang X, Cannie MM, Arthurs OJ, Segers V, Fourneau C, Bevilacqua E, Cos Sanchez T, Sebire NJ, Jani JC. Post-mortem whole-body magnetic resonance imaging of human fetuses: a comparison of 3-T vs. 1.5-T MR imaging with classical autopsy. Eur Radiol. 2017 Aug;27(8):3542-3553. doi: 10.1007/s00330-016-4725-4. Epub 2017 Jan 23.

ReferenceCitation: Cannie M, Votino C, Moerman P, Vanheste R, Segers V, Van Berkel K, Hanssens M, Kang X, Cos T, Kir M, Balepa L, Divano L, Foulon W, De Mey J, Jani J. Acceptance, reliability and confidence of diagnosis of fetal and neonatal virtuopsy compared with conventional autopsy: a prospective study. Ultrasound Obstet Gynecol. 2012 Jun;39(6):659-65. doi: 10.1002/uog.10079. Epub 2012 May 22.

ReferenceCitation: Griffiths PD, Paley MN, Whitby EH. Post-mortem MRI as an adjunct to fetal or neonatal autopsy. Lancet. 2005 Apr 2-8;365(9466):1271-3.

ReferenceCitation: Sebire NJ, Weber MA, Thayyil S, Mushtaq I, Taylor A, Chitty LS. Minimally invasive perinatal autopsies using magnetic resonance imaging and endoscopic postmortem examination ("keyhole autopsy"): feasibility and initial experience. J Matern Fetal Neonatal Med. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10.

ReferenceCitation: Woodward PJ, Sohaey R, Harris DP, Jackson GM, Klatt EC, Alexander AL, Kennedy A. Postmortem fetal MR imaging: comparison with findings at autopsy. AJR Am J Roentgenol. 1997 Jan;168(1):41-6.

ReferenceCitation: Thayyil S, Sebire NJ, Chitty LS, Wade A, Olsen O, Gunny RS, Offiah A, Saunders DE, Owens CM, Chong WK, Robertson NJ, Taylor AM. Post mortem magnetic resonance imaging in the fetus, infant and child: a comparative study with conventional autopsy (MaRIAS Protocol). BMC Pediatr. 2011 Dec 22;11:120. doi: 10.1186/1471-2431-11-120.

ReferenceCitation: D'Hondt A, Cassart M, De Maubeuge R, Soto Ares G, Rommens J, Avni EF. Postmortem fetal magnetic resonance imaging: where do we stand? Insights Imaging. 2018 Aug;9(4):591-598. doi: 10.1007/s13244-018-0627-0. Epub 2018 Jun 4. Review.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma Single-center, Interventional, Randomized, Single-blind Study (Masked Investigator) MELABLUE Study

acronym: MELABLUE

summary:
Melasma is a fairly common condition resulting in hyperpigmented macules on the face. Melasma is difficult to treat and has a significant negative impact on the patient's quality of life.

Melasma is worsen when exposed to high energy visible light (blue and violet light) of the solar spectrum. Blue light emitted by LED screens from computers, tablets, televisions and even mobile phones is currently suspected (via media channels) to induce harmful effects on the skin, including pigmentation and photoaging. These screens, however, emit much lower irradiances than those of the solar spectrum, and the probability that these irradiances impact the skin is very low.

The objective of the study is to assess the effect of blue light emitted by computer/television screens on the intensity of melasma pigmentation. To do this, it is proposed to use maximized conditions that could be encountered in normal daily life, namely a simulation of blue light exposure (420-490nm) at 20 cm from a laptop LED screen, 8 hours a day for 5 days. Since it is not proposed to expose a person for 8 hours a day, a solar simulator with appropriate filters will be used to emit a spectrum of between 420 and 490 nm with a compatible intensity for an acceptable duration of exposure (around 30 minutes a day).

Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified MASI on standardized photographs. A final evaluation visit will be performed at Day 15.

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Identification of Difficulties During a First Request for a Personal Autonomy Allowance by Beneficiaries and Identification of the Role of the Attending Physician During This Request.

acronym: IDAPA

summary: The objective of this study is to identify the difficulties when first applying for a first Resource Allocation (Personal autonomy allowance - APA) by beneficiaries and their relatives through a qualitative study and secondarily identification of the role of the attending physician during this request.

location_facility: Conseil Départemental -Pôle Solidarité Humaine


title: Impact of Channel Interaction on Cochlear Implant Performances in Noise : Influence of the Number of Maxima.

summary: The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.

location_facility: ENT and Cervico-Facial Surgery Department, Hôpital Edouard Herriot


title: Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia or Fungemia From Positive Blood Culture Bottles, Combining Fast Identification of Bacteria and Fungi and Evaluation of Bacterial Resistance to First Line Antibiotics.

acronym: HEMOFAST

summary: This study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. This assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. The clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).

ReferenceCitation: Huang TD, Melnik E, Bogaerts P, Evrard S, Glupczynski Y. Evaluation of the ePlex Blood Culture Identification Panels for Detection of Pathogens in Bloodstream Infections. J Clin Microbiol. 2019 Jan 30;57(2). pii: e01597-18. doi: 10.1128/JCM.01597-18. Print 2019 Feb.

ReferenceCitation: Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.

ReferenceCitation: Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96.

ReferenceCitation: Patel TS, Kaakeh R, Nagel JL, Newton DW, Stevenson JG. Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections. J Clin Microbiol. 2016 Dec 28;55(1):60-67. doi: 10.1128/JCM.01452-16. Print 2017 Jan.

ReferenceCitation: Maubon D, Dard C, Garnaud C, Cornet M. Profile of GenMark's ePlex® blood culture identification fungal pathogen panel. Expert Rev Mol Diagn. 2018 Feb;18(2):119-132. doi: 10.1080/14737159.2018.1420476. Epub 2017 Dec 28.

ReferenceCitation: Timbrook TT, Morton JB, McConeghy KW, Caffrey AR, Mylonakis E, LaPlante KL. The Effect of Molecular Rapid Diagnostic Testing on Clinical Outcomes in Bloodstream Infections: A Systematic Review and Meta-analysis. Clin Infect Dis. 2017 Jan 1;64(1):15-23. Epub 2016 Sep 26. Review.


title: Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)

acronym: NeoVAB

summary:
Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.

If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.

lead_sponsor: Centre Georges Francois Leclerc


title: Determination of Risk Factors of Postpartum Urinary Retention: a Retrospective Case-control Study

acronym: PAUR

summary:
Postpartum urinary retention is an uncommon complication of the vaginal delivery. Failure to diagnose it may have a real impact both on the urinary plane but also on the psychological level.

The hypothesis is that the identification of risk factors for the emergence of acute urinary retention would allow preventive management. The investigator conducted a retrospective, comparative, case-control study, including 2 groups of 96 patients who have had a vaginal delivery in the department between 2011 and 2015. The first group included patients with postpartum acute urinary retention (PAUR). The second group, control group, without PAUR, was selected randomly, respecting a 1:1 matching criteria, including the year of delivery and the age of the patient at delivery. The goal was to identify the potential risk factors of post-partum acute urinary retention in order to define a better prevention.

lead_sponsor: Hospices Civils de Lyon


title: Comparative Study of Arthrodeses in One Time by "Single Posterior Approach" and Two-stage Arthrodeses by "Double Anterior and Posterior Approach"

acronym: ARBORD

summary:
Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best possible one.

There is a great disparity in the techniques available to obtain this result: as regards the correction of the deformation itself, it is possible to resort to various types of gestures aimed at "freeing" the spine to allow the getting the correction. It may be staged or transpedicular osteotomies or previous releases (staged discectomies). Regarding the arthrodesis itself, this can be obtained by an isolated posterior graft or by a circumferential graft itself performed in a time using interbody cages PLIF type (posterior lumbar interbody fusion) or TLIF (transforaminal interbody fusion) or in two stages by a complementary anterior graft. These are heavy interventions with a high complication rate.

The choice of this or that technique is based on data from the literature and remains at the discretion of the surgeon who makes the surgical indication. However, it has never been possible to compare these different techniques in a prospective study. The few articles comparing the different techniques tend to show that there is no significant difference between the techniques with a higher complication rate for the two-step techniques. However, these are retrospective studies, with all the biases that this implies and despite these results the disparity in surgical indications remains substantial.

The objective of this work is therefore to evaluate, according to an identical protocol, the different surgical techniques for the treatment of spinal deformities associated with a fusion in order to determine the morbidity associated with each of the techniques and if this morbidity is justified by a better functional result at a minimum follow-up of two years.

status: Active, not recruiting

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial

acronym: CORTIFRENCH

summary:
Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.

A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of the Working Shift Organization on the Caregivers' Satisfaction and Quality of Life at Work, and the Performance of the Intensive Care Units.

acronym: IOTA-REA

summary:
This is a prospective, non-randomized, multicenter, observational national study, involving centers with different working shift organizations.

Participating centers are 24 French adult intensive care units with different working shift organizations (12-hours shift vs. less than 12-hours shift) in public hospitals.

Caregivers (doctors, nurses and assistant nurses) constitute the population of the study.

The duration of the study is 13 months.

The aim of this study is to evaluate the impact of the working shift organizations on:

The intensive care units operation;
The use of outside staff;
The caregivers' quality of life at work;
The caregivers' satisfaction at work;
The nursing work environment;
Psychosocial and organisational work constraints
The performance of the intensive care units;
The costs and efficiency of the working shift organizations.

location_facility: medical-surgical intensive care unit - TENON hospital (AP-HP)


title: Needle Aspiration for Large Cephalohematoma : a Retrospective Study of Complications

summary: The cephalohematoma is a common pathology of newborns. Observation is the primary treatment for the most of small uncomplicated cephalohematoma. However large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. The objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.

lead_sponsor: University Hospital, Montpellier


title: Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma

acronym: MESOTIP

summary:
MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).

MESOTIP aim to show an improvement of the overall survival in the experimental arm.

ReferenceCitation: Kim J, Bhagwandin S, Labow DM. Malignant peritoneal mesothelioma: a review. Ann Transl Med. 2017 Jun;5(11):236. doi: 10.21037/atm.2017.03.96. Review.

ReferenceCitation: Boffetta P. Epidemiology of peritoneal mesothelioma: a review. Ann Oncol. 2007 Jun;18(6):985-90. Epub 2006 Oct 9. Review.

ReferenceCitation: Bossard N, Velten M, Remontet L, Belot A, Maarouf N, Bouvier AM, Guizard AV, Tretarre B, Launoy G, Colonna M, Danzon A, Molinie F, Troussard X, Bourdon-Raverdy N, Carli PM, Jaffré A, Bessaguet C, Sauleau E, Schvartz C, Arveux P, Maynadié M, Grosclaude P, Estève J, Faivre J. Survival of cancer patients in France: a population-based study from The Association of the French Cancer Registries (FRANCIM). Eur J Cancer. 2007 Jan;43(1):149-60. Epub 2006 Nov 3.

ReferenceCitation: Alexander HR Jr, Li CY, Kennedy TJ. Current Management and Future Opportunities for Peritoneal Metastases: Peritoneal Mesothelioma. Ann Surg Oncol. 2018 Aug;25(8):2159-2164. doi: 10.1245/s10434-018-6337-5. Epub 2018 Feb 8. Review.

ReferenceCitation: Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16.

ReferenceCitation: Baratti D, Kusamura S, Cabras AD, Bertulli R, Hutanu I, Deraco M. Diffuse malignant peritoneal mesothelioma: long-term survival with complete cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC). Eur J Cancer. 2013 Oct;49(15):3140-8. doi: 10.1016/j.ejca.2013.05.027. Epub 2013 Jul 4.

ReferenceCitation: Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15. Review.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut réginal du Cancer de Montpellier


title: Comparison of Postoperative Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone: a Randomized Clinical Trial

summary:
This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.

The study design is a multicenter, doubled blinded randomized controlled trial. The comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is 1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients assess their pain for 7 days after permanent root obturation.

lead_sponsor: ACTEON Group


title: Electrophysiology of Brain Activity During Electrode Implantation in Patients Treated With Deep Brain Stimulation

acronym: LFP-DBS

summary:
Primary objective

Demonstrate functional markers derived from electrophysiological signals recorded during cognitive tests. These markers should make it possible to optimize the targeting procedures of electrode implantation sites for a better effectiveness of deep brain stimulation therapy.

Research hypotheses

The mechanisms of action of the deep brain stimulation (DBS) involve the modulation of the activity, locally and on a large scale, of functional cortical-subcortical networks showing pathological behavior beforehand. The electrophysiological measurements in response to different tasks make it possible to highlight precise dysfunctions of these neural networks, in relation with the behavioral and / or motor disorders associated with the pathologies treated by DBS.

Consequently, we hypothesize that the exploitation of electrophysiological responses during cognitive or sensorimotor tasks performed during the implantation procedure of stimulation electrodes in patients treated with DBS will allow :

To collect fundamental data to understanding the physiological functioning of basal ganglia in humans ;
To collect functional markers from the operating room in relation to the symptoms targeted by the DBS that will help in the choice of implantation site of the stimulation electrode ;
Define long-term predictive markers of DBS effects by comparing electrophysiological effects measured post-operatively and clinical scores under DBS.


title: Comparison Between the IMPACT's Score and the Clinician's Perception to Predict the Prognosis of Traumatic Brain Injury.

acronym: PREDICT-TBI

summary:
Main objective : To compare the quality of the prognostic assessment, (adverse evolution at 6 months) of severe and moderate traumatic brain injury, performed by the clinician compared to the prognosis described by the IMPACT score.

The Pitié-Salpêtrière hospital is conducting a study evaluating the clinician's prognostic assessment of severe and moderate traumatic brain injury compared to the prognosis described by the IMPACT score. The investigators compare the quality of the clinician's prognostic assessment (adverse evolution at 6 months) of severe and moderate traumatic brain injury to the prognosis described by the IMPACT score.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Réanimation neurochirurgicale, Hôpital Pitié-Salpêtrière


title: Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

summary: The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

lead_sponsor: Laboratoires Thea


type: Registry Identifier

title: A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

acronym: REHAB-MDT

summary:
The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration.

As secondary objectives, the study aims to:

demonstrate improvement of specific neuropsychological tests of working memory;
demonstrate improvement of non-specific tasks involving working memory;
assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect;
demonstrate improvement of social integration ability and quality of life;
demonstrate persistence of effects at 3 months and 6 months after the end of treatment;
demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.

location_facility: Physical medicine and rehabilitation department, Raymond Poincaré Hospital


title: Prediction for Coma Recovery in ICU With Comaweb: a Validation Study

acronym: COMASCORE

summary: The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.


intervention_type: Biological

location_facility: CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu

type: EudraCT Number

source: euctr

title: Evaluation of Immunological Response Following a Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients

summary: This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone) in splenectomised adults.


title: Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).

acronym: EstroTEPCompar

summary:
Breast cancer is a major public health issue despite therapeutic advances, it is the first cause of death cancer of women in Europe.

Several treatments may be proposed depending on the general condition of the patient, the characteristics of the initial tumor and the stage of the disease. The different treatments in metastatic relapse of hormone receptor-positive breast cancer are systemic treatments, such as hormone therapy, chemotherapy, targeted therapies, and possible supportive care, but also in some cases local treatments such as surgery and radiotherapy.

Comparative analysis of primary mammary tumors and their metastases has demonstrated the essential role of tumor heterogeneity, both in time and space, in the progression of the disease and the occurrence of resistance to treatments. Taking into account this intratumoral heterogeneity represents a major axis of improvement in the management of patients with breast cancer.

The use of innovative radiotracers such as 16α- [18F] -fluoro-17β-estradiol (FES) may allow in the future to better evaluate this tumor heterogeneity in patients with metastatic breast cancer through non-metastatic characterization. invasive different lesions. It will be possible to propose to each patient a more personalized care with possibly the administration, in addition to the systemic treatment, of a local treatment adapted to the characteristics of some secondary lesions likely to respond less well to the systemic treatment.

In this pilot study, the investigators would like to estimate the number of patients and the number of metastatic sites affected by tumor heterogeneity of estrogen receptor expression, which could benefit from specific management.

This study will concern a population of patients with first metastatic recurrence of hormone receptor-positive breast cancer initially, with at least one metastasis, who are candidates for treatment with hormone therapy.


title: Developing a Multi-scale Account of Attentional Control as the Constraining Interface Between Vision and Action (MAC-Brain).

acronym: MACBRAIN

summary: The project is dedicated to understanding the integration within the brain of signals of different natures that contribute to attentional control. The investigator will make use of standardized experimental displays involving the discrimination of a target (tilted-bar) presented together with 3 distractor items, with one stimulus in each visual quadrant. Across three fMRI experiments in healthy participants, the investigator will manipulate different types of signals that will guide the subject's attention towards one of the four quadrants: Exp 1 - task instruction & item salience; Exp 2 - probabilistic target location; Exp 3 - probabilistic reward. The investigator expects that irrespective of the nature of the control signal, activity in dorsal parietal cortex will index the currently relevant/attended location. Moreover, The investigator expects that upon changes of the most relevant location, one will observe activation of the ventral parietal cortex, plus increased inter-regional connectivity between ventral and dorsal parietal regions - again irrespective of the nature of the attention guiding signals.


title: Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies

acronym: ELEGANT

summary: Evaluation of Satisfaction & Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy

lead_sponsor: Centre Leon Berard


title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight

acronym: NATICOL

summary:
Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.

However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.

lead_sponsor: Institut Pasteur de Lille

intervention_type: Dietary Supplement


title: Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)

acronym: NODE

summary: Autoimmune encephalitis represents a group of rare and heterogeneous neurological disorders. Pathophysiological mechanisms in these diseases are still unknown. Recently, oculomotor and neurovisual disorders have been described. Cerebral areas and neuronal networks associated with these abnormalities are well described. The investigator proposes to study and describe such neuro-ophthalmological disorders in a prospective cohort of patients with a autoimmune encephalitis, to better understand the pathophysiological basis of this neurological condition.


title: Comparative Evaluation of the Effect on Blood Pressure of an Equivalent Content of Sodium in the Form of Bicarbonate of Sodium and in the Form of Sodium Chloride, on "Sensitive Sodium" Subjects

acronym: SODIVASC

summary:
Many large-scale epidemiological studies have established a link between the average consumption of table salt (sodium chloride) and blood pressure. In France a survey conducted in 2001 showed that the average consumption of salt is 9 to 10g per people / day, and health authorities considered it appropriate to reduce consumption about 20%, by limiting contributions of sodium in prepared foods, bread.

In terms of basic and clinical research, the biological effects of sodium chloride dietary intake, have been the subject of numerous studies for several decades. This work showed that all subjects do not react uniformly to sodium chloride flows, determining what the investigators call people "sodium-sensitive". For these people the sodium intake elevated blood pressure, much more marked than in subjects called "sodium-resistant."

"Sodium-sensitive" people represent 10 to 30% of the population. A marked over-representation of this phenotype was observed in patients with hypertension or a family history of hypertension.

In addition, studies conducted in animals and humans indicate that sodium intake has a different impact on biological parameters mentioned above, as is done in the form of chloride salt or bicarbonate of sodium.

Based on these factors, investigators developed a clinical trial protocol intended to highlight a possible differential effect in the biological effects of the same sodium intake (2.56 g / day) orally, depending on the nature salt.


title: Physiological and Psychological Responses to Stress in Year 6 Medical Students Faced to Ambulatory Symptomatic Patients

summary:
Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative stressors (patient's expectations about explanations) and task contingent stress due to time pressure, the necessity to take into account patient's mood, to deal with uncertainty of their own data collection and with complex clinical situations. In France, excepted for family medicine, undergraduate medical students and residents are currently not trained to perform consultations and are never exposed to ambulatory patients during training. The investigators postulate that this lack of practice may generate a significant state of stress during the first consultations and consequently modify or even impair clinical reasoning.

The primary objective of this study is to compare subjective and physiological levels of acute stress in ambulatory versus hospitalization setting in medical students confronted to a real patient with a diagnostic problem.

Measures: The French version of the Anxiety Spielberger test is administered just before and after each problem solving session.

Cortisol salivary samples are taken before and after each problem solving session. Salivary cortisol levels have been shown to be correlated to stressful situations and some personality traits but with some difference according to gender.

Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of primary appraisal to secondary appraisal according to Tomaka et al.

lead_sponsor: Nantes University Hospital


title: Impact of a Permanently Maintained Healthcare Multidisciplinary Facility Named Permanece d'Accès Aus Soins de Santé (PASS-MULTI) on Unscheduled Readmissions at 12 Months for Persons in Precarious Situations.

acronym: PASS-MULTI

summary:
Created in 1998, PASS departments are mostly intrahospital structures providing primary care to vulnerable patients.

The main objective of the project will be to measure the impact of a multidisciplinary PASS benefiting from outpatient pharmaceutical interviews on the rate of unplanned rehospitalization of patients in precarious situations.

The impact of the implementation of such a device will also be measured on other indicators of major interest in the course of care of the precarious patient: average lengths of stay, emergency room, improved continuity of treatment, quality of life of the patient related to his health, medication compliance, effective accessibility to social rights, qualitative improvement in the use of care, medico-economic efficiency of the intervention compared to existing practice.

The study will be multicenter: 6 centers spread throughout France (Marseille, Paris, Nice, Toulouse, Poitiers and Bayonne).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Prospective Study of Patients Treated for Bone and Joint Infection (BJI) Due to Staphylococcus Aureus, Aiming at Identifying Biomarkers of Diagnosis Interest in Chronic BJI

acronym: ESPRI-IOAC

summary:
There are more than one million (> 40,000 cases per year in France) of osteoarticular infections (OAI) yearly in the world. The number of these infections is constantly increasing due to an increase in life expectancy associated with an increase in prosthesis fitting, as well as an increase in comorbid factors. These are severe pathologies associated with mortality (5%) and significant morbidity (40%), responsible for functional sequelae with an individual cost (prolonged hospitalization, altered quality of life, disability) and societal (sick leave, partial disability). or total, temporary or permanent) extremely high. In addition, reinfection rates within two years of treatment are high.

The BJIs are a group of clinical entities that have in common the invasion and progressive destruction of bone and cartilage tissue by bacterial-like microorganisms.

Staphylococcus spp is the main pathogen (>50%) in BJI and is associated with particularly difficult to treat infections, with a high rate of chronicity and relapses, especially in case of implanted material.

The difficulty in managing these infections is partly linked, on the one hand, to the fact that the pathogens are in "persistent" metabolic forms and in intracellular reservoirs which make them insensitive to conventional antibiotics and, on the other hand, the absence of reliable markers of the infection and above all of its clinical resolution, which complicates clinical trials.

ESPRI-IOAC is a consortium of 4 partners (private-public) from Lyon area and which aims at:

studying the translational value of BJI preclinical models
identifying biomarkers of infection in preclinical models and at assessing them in a prospective study.

The current study is part of the global ESPRI-IOAC consortium, and represent the clinical application.

It is a prospective study of patients treated for BJI in the infectious disease department of the Hospices Civils de Lyon, La Croix-Rousse, for osteo-articular infections due to Staphylococcus aureus, or for simple mechanical revision or for cruciate ligament surgery, the objective of which is to highlight biomarkers of interest in the diagnosis of chronic BJI and, or predictive of the therapeutic response.

The translational value of the experimental models used in the BJI will also be studied.


title: Translation and Validation of the Abbey Pain Scale in Stroke Patients

acronym: ABBEY-F

summary:
Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide range of patients have communication problems after stroke that make it difficult to assess pain. Yet there is a major impact of pain on the quality of life of these patients. Some tools have been validated to assess pain in non-communicative patients, but none are specific to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating for non-communicative patients.

The objective is to validate a French version of the Abbey Pain Scale for stroke patients.

It is an observational study with longitudinal data collection. It is planned to include 120 patients from the neurology department of the Clermont-Ferrand University Hospital.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life

acronym: EXCLUFAT

summary:
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases.

Currently, only 30% of women who have undergone a mastectomy choose reconstruction.

The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics.

There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions.

Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction.

Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications.

Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients.

However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study.

The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Quality of Life Comparison in Patients With Different Types of Alopecia

acronym: RDACCQV

summary: Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients

acronym: KAPP-IMU

summary: Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.