title: Breast Reconstruction and Body Map : Assessment by Functional MRI (REMASCO)

acronym: REMASCO

summary:
Breast reconstruction is an integral part of the management of patients with breast cancer and treated by total mastectomy. The aim of breast reconstruction is to get a satisfying aesthetic and functional result (sensitivity) and that would enable the patient to appropriate the reconstructed breast. Patient satisfaction assessed subjectively by questionnaires would be better in autologous reconstructions than in reconstructions by prosthesis.

The aim of our trial is to use functional MRI (fMRI) as an objective evaluation tool to describe the brain functional changes of sensory projections after immediate or secondary breast reconstruction.

lead_sponsor: Centre Oscar Lambret


type: Other Identifier

title: Molecular Mechanisms of Senescence Predisposing to Cancer : Exploratory Analysis on Healthy Tissues Collected for Two Age Groups.

summary:
Epidemiological data show that the incidence of carcinoma, the most common cancer, is strongly linked to the age. Non Melanoma Skin Carcinomas (NMSCs) (the most frequent cancers in the elderly population) derive from keratinocytes of the basal layer of the epidermis, from differentiated keratinocytes of the more superficial layers or from stem cells of hair follicles. Unlike NMSCs, soft-tissue sarcomas, including those deriving from dermal fibroblasts, are very rare (less than 1% of all cancers). Our overall purpose is to decipher the molecular pathways activated during the aging of these tissues that may explain why they have a so different propensity to undergo a malignant transformation. Given that senescent cells accumulate in the dermis and epidermis with age, we will constitute two groups : "young skin" that we arbitrarily limit to the range ≥ 18 and ≤ 40 and "aged skin" ≥ 55.

Thus the main objective of our study is to search within 2 age groups (≥ 18 and ≤ 40 years and ≥ 55 years) the expression of senescence markers on healthy skin tissue.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ipd_sharing: No

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Completed


title: Analysis of Swallowing, Speech and Quality of Life of Patients With Stage T3-T4 Squamous Cell Carcinoma of the Oropharynx Before and After Multimodal Treatment With Curative Intent

summary:
The curative treatment and organ preservation in advanced squamous cell carcinoma of the oropharynx is multimodal. It involves induction chemotherapy and depending on the response radio-chemotherapy or surgery. The combination of these methods has important functional consequences.

The aim of this prospective pilot study is to describe swallowing, speech, but also patients' quality of life before and after therapeutic management (existing studies measuring these functions after treatment but not before).

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

lead_sponsor_type: academique

status_simplified: Unknown


type: Registry Identifier

title: Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers

acronym: Hydex

summary: The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in healthy volunteers compared to placebo.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug


title: The Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus Under Steady-state Remifentanil Analgesia

summary: A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

primary_purpose: Basic Science

ReferenceType: derived

ReferenceCitation: Sabourdin N, Peretout JB, Khalil E, Guye ML, Louvet N, Constant I. Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target-Controlled Infusion: A Crossover Randomized Pilot Study. Anesth Analg. 2018 Jan;126(1):70-77. doi: 10.1213/ANE.0000000000001802.

family: Sabourdin

full_name: Nada Sabourdin

given: Nada

sequence: first

family: Peretout

full_name: Jean-Baptiste Peretout

given: Jean-Baptiste

sequence: additional

family: Khalil

full_name: Eliane Khalil

given: Eliane

family: Guye

full_name: Marie-Laurence Guye

given: Marie-Laurence

family: Louvet

full_name: Nicolas Louvet

given: Nicolas

family: Constant

full_name: Isabelle Constant

given: Isabelle

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Influence of Depth of Hypnosis on Pupillary Reactivity to a Standardized Tetanic Stimulus in Patients Under Propofol-Remifentanil Target–Controlled Infusion

lead_sponsor: Hôpital Armand Trousseau

location_facility: Departement d'anesthesie Hopital Armand Trousseau

intervention_type: Device


title: Comparative Study, Prospective, Randomized , Assessing the Reduction of Pain Felt During Installation Intra- Uterine Device by Direct Technique. A Monocentric Study

acronym: DIRECTE

summary: Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.

primary_purpose: Prevention


title: Study of Staphylococcus Aureus Colonization of the Posterior Nasal Cavity in Patients Undergoing Otorhinolaryngologic Surgery. A Monocentric Study

summary: Staphylococcus aureus nasal carriage is a major risk factor of infection with this bacterium. Staphylococcus aureus colonization of the posterior nasal cavity is still misunderstood. This study is aimed at evaluating the relationship between Staphylococcus aureus strains colonizing the vestibulum nasi, the sphenoethmoidal recess and the nasopharynx.

primary_purpose: Screening

intervention_type: Other


title: Impact of the Absence of Nasogastric Decompression After Pancreaticoduodenectomy : A Prospective and Randomized Study

acronym: IPOD

summary:
The use of nasogastric (NG) decompression after pancreaticoduodenectomy (PD) is a current practice. NG tube is associated with a high rate of morbidity including pulmonary morbidity, delayed gastric emptying and finally an increased length of hospital stay.

The absence of NG decompression could be the corner stone of the concept of the enhanced recovery program after PD.

primary_purpose: Supportive Care

ReferenceCitation: Bergeat D, Merdrignac A, Robin F, Gaignard E, Rayar M, Meunier B, Beloeil H, Boudjema K, Laviolle B, Sulpice L. Nasogastric Decompression vs No Decompression After Pancreaticoduodenectomy: The Randomized Clinical IPOD Trial. JAMA Surg. 2020 Sep 1;155(9):e202291. doi: 10.1001/jamasurg.2020.2291. Epub 2020 Sep 16.

name: Service de Chirurgie Hépatobiliaire et Digestive, Hôpital Pontchaillou, Centre Hospitalier Universitaire (CHU Rennes), Université de Rennes 1 Centre, Rennes, France

name: UMR NuMeCan (Nutrition, Métabolismes, Cancer), INRA, ALICE, St Gilles, France

family: Bergeat

full_name: Damien Bergeat

given: Damien

family: Merdrignac

full_name: Aude Merdrignac

given: Aude

family: Robin

full_name: Fabien Robin

given: Fabien

family: Gaignard

full_name: Elodie Gaignard

given: Elodie

name: UMR NuMeCan, INSERM U1241, Rennes, France

family: Rayar

full_name: Michel Rayar

given: Michel

family: Meunier

full_name: Bernard Meunier

given: Bernard

name: INSERM, CIC1414 Centre d’Investigation Clinique de Rennes, Rennes, France

name: CHU Rennes, Pôle Anesthésie et Réanimation, Rennes, France

family: Beloeil

full_name: Hélène Beloeil

given: Hélène

family: Boudjema

full_name: Karim Boudjema

given: Karim

name: CHU Rennes, Service de Pharmacologie Clinique, Rennes, France

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Sulpice

full_name: Laurent Sulpice

given: Laurent

journal_name: JAMA Surgery

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou


title: Estimation of Pain During Epidural Analgesia During Labor - a Monocentric Study

acronym: PERIDANS

summary:
Epidural regional anesthesia is a technique to eliminate or lessen pain during obstetric labor and childbirth. It consists in establishing a catheter into the epidural space and to block the transmission of pain sensations by injecting a local anesthetic and an opioid. In 10-25% of cases the epidural does not give perfect results, causing it to test its effectiveness, which is mainly done by questioning the patient on mitigation or disappearance of pain. This collaboration of patients is sometimes limited in our care structure by the inability to assess or express the pain, mainly due to cultural differences or language barriers, which can represent up to 15% of women in our institution. This led to develop objective measures of pain techniques used at the bedside.

Pupil diameter (PD) varies under the double influence of sympathetic system (Σ), dilator of the pupil, and parasympathetic system (pΣ).

The PD increases in response to painful stimulation, in proportion to the intensity of the nociceptive stimulus. This variation of PD has been proposed as a means of evaluation of pain in patients under general anesthesia, but has been little studied in conscious subjects.

There are other permanent changes in the PD, due to constant interaction between Σ and pΣ systems. Few data have been published to date on this PD variability (PDV).


title: Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer

acronym: LYMPHOLUNG

summary: With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would allow physicians to monitor the immune status of their patient's tumor and though to evaluate the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood marker has been validated so far. The LYMPHOLUNG study investigate the concordance between blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for 2-year recurrence-free survival will also be addressed.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Rouen


title: Association Between High Faecal Calprotectin, Increased Intestinal Permeability and Visceral Hypersensitivity in Patients Suffering From Irritable Bowel Syndrome With Diarrhoea

acronym: SIIMPA

summary: Visceral hypersensitivity, low grade inflammation and increased intestinal permeability are three main pathophysiological mechanisms involved in irritable bowel syndrome. The connexion between these abnormalities is not known. We hypothesis there is a link between them in IBS with diarrhoea.

status: Recruiting

status_simplified: Ongoing


title: Brain Computer Interface: Neuroprosthetic Control of a Motorized Exoskeleton

acronym: BCI

summary: The BCI project falls within the very broad field of brain machine interfaces. Its multiple applications include the compensation of motor deficits. The subject of the present protocol is the first test of the system in man on the compensation of motor deficits by an epidural brain implant enabling an electrocorticogram (EcoG) to be recorded.

ReferenceType: background

ReferenceCitation: Benabid AL, Costecalde T, Eliseyev A, Charvet G, Verney A, Karakas S, Foerster M, Lambert A, Morinière B, Abroug N, Schaeffer MC, Moly A, Sauter-Starace F, Ratel D, Moro C, Torres-Martinez N, Langar L, Oddoux M, Polosan M, Pezzani S, Auboiroux V, Aksenova T, Mestais C, Chabardes S. An exoskeleton controlled by an epidural wireless brain-machine interface in a tetraplegic patient: a proof-of-concept demonstration. Lancet Neurol. 2019 Dec;18(12):1112-1122. doi: 10.1016/S1474-4422(19)30321-7. Epub 2019 Oct 3.

ReferenceCitation: Larzabal C, Bonnet S, Costecalde T, Auboiroux V, Charvet G, Chabardes S, Aksenova T, Sauter-Starace F. Long-term stability of the chronic epidural wireless recorder WIMAGINE in tetraplegic patients. J Neural Eng. 2021 Sep 9;18(5). doi: 10.1088/1741-2552/ac2003.

ReferenceCitation: Detection of Error Correlates in the Motor Cortex in a Long Term Clinical Trial of ECoG based Brain Computer Interface DOI: 10.5220/0010227800260034

doi: detection

ReferenceCitation: Larzabal C, Auboiroux V, Karakas S, Charvet G, Benabid AL, Chabardès S, Costecalde T, Bonnet S. The Riemannian Spatial Pattern method: mapping and clustering movement imagery using Riemannian geometry. J Neural Eng. 2021 Mar 26. doi: 10.1088/1741-2552/abf291. [Epub ahead of print]

family: Larzabal

full_name: Christelle Larzabal

given: Christelle

family: Auboiroux

full_name: Vincent Auboiroux

given: Vincent

family: Karakas

full_name: Serpil Karakas

given: Serpil

family: Charvet

full_name: Guillaume Charvet

given: Guillaume

family: Benabid

full_name: Alim-Louis Benabid

given: Alim-Louis

family: Chabardes

full_name: Stephan Chabardes

given: Stephan

family: Costecalde

full_name: Thomas Costecalde

given: Thomas

family: Bonnet

full_name: Stéphane Bonnet

given: Stéphane

bso_classification: Physical sciences, Astronomy

journal_name: Journal of Neural Engineering

publisher: IOP Publishing

publisher_dissemination: IOP Publishing

publisher_group: IOP Publishing

publisher_normalized: IOP Publishing

title: The Riemannian spatial pattern method: mapping and clustering movement imagery using Riemannian geometry

lead_sponsor: University Hospital, Grenoble


title: Changes in Echogenicity and Muscle Stiffness in Elastography After Botulinum Toxin Injection a Spastic Muscle - A Monocentric Study

summary: Muscle alterations and modifications passive biomechanical properties that occur on a spastic muscle contribute to functional disorders involved in spasticity. Botulinum toxin (TB) A is the reference treatment of the focused spasticity, and muscle source structural and biomechanical changes, very little studied in humans, especially since it is not one possibility of easily and reliably paraclinical assessment injections consequences.


acronym: COSIMH

summary: Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Angers

intervention_type: Radiation


summary:
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.

In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Reproducibility of the Measurement by 2D Ultrasound and Sonoelastometry of the Pennation Angle and Elasticity of the Medial Gastrocnemius Muscle in Children/Adolescent/Adult Cerebral Hemiplegia After Stroke

summary: Hemiplegic adults after stroke (stroke), children and adolescents with cerebral palsy (CP) have both muscles spastic and paresis. These movement disorders are likely to cause muscle changes both structural and viscoelastic involved in the alteration of neuromotor functions such as walking. Therefore, it seems interesting to study the structure of these muscles with available imaging techniques. The medial gastrocnemius muscle presents architectural characteristics which allows easy evaluation 2D ultrasound. The literature lacks data on the reproducibility of the measurement, by 2D ultrasound, of the pennation angle and muscular thickness, particularly in children. In addition, the sonoelastometry by Supersonic ShearWave Imaging (SSI) is a new technique of ultrasound, non-invasive, dynamic, which allows the calculation of the modulus of elasticity within a muscle tissue. This allows to consider new perspectives evaluation of the viscoelastic properties of the muscle. No studies have evaluated the reproducibility of this method in adults/children/ adolescent after stroke and hemiplegia.


title: Study of the Impact of Changes in Carbonemia on Microcirculation in Patients - A Monocentric Study

summary:
The microcirculatory alterations is common in circulatory failure, especially during sepsis. The severity of these changes and their sustainability are responsible of multi organ failure and ultimately death. The optimization of microcirculatory flow could be a central objective of the management of patients hospitalized in intensive care.

Microcirculation includes all blood vessels of a diameter smaller than 100 micrometer. It represents the largest heat exchange surface of the body and is involved in tissue oxygenation. Microcirculatory flow is conditioned by the macrocirculation (heart rate and blood pressure) and the state of the microcirculation (thrombosis, vasoconstriction ...). The role of the CO2 in regulating microcirculatory flow is little studied. A recent work of our team and the oldest work in the literature lead to believe that CO2 has a specific role in modulating microcirculatory flow. No study to date precisely studied the impact of changes in the microcirculatory flow carbonemia .

The hypocapnia test is carried out in a standardized manner by inhalation of a mixture enriched in CO2 7% allows a significant increase in carbonemia. Hypocapnia will in turn obtained by a calibrated voluntary hyperventilation test.

Direct visualization of microcirculation by confocal microscopy is now considered the gold standard for exploring the microcirculation.


title: Study of the Effect of the Position of the Patient's Head With Brain Lesions on Cerebral Blood Flow

summary: The position of the head of the patient influences the cerebral venous return and cerebral perfusion pressure (CPP). In our daily practice, it is almost routine to prescribe a Trendelenburg position 30 ° in all brain-damaged patients. However, this is based only on precarious bibliographic databases. It has been shown to decrease the Intracranial Pressure (ICP) in Trendelenburg position relative to the horizontal, with varying effects on PPC. Effects on sylvian objectified by Doppler velocities and cerebral oxygenation seem unaffected by changes of position of the head of the patient. But the whole of the literature on this subject has significant bias.


title: Effectiveness of Active Home Exercises for Patients With Chronic Neck Pain: a Prospective Comparative Randomized Clinical Trial

summary:
The prevalence of non-specific neck pain is 12.1 / 1000 patients / year. Their support is most often based on analgesics combined with physical therapy. More recently authors have advocated the use of self-rehabilitation, that is to say, the use by the patient himself of physiotherapy exercises to perform at home regularly. However, if there are currently many studies on the effectiveness of self-rehabilitation for low back pain, there are few data on neck pain.

In this context we have chosen to implement a prospective, randomized study, on the effectiveness of self-rehabilitation in patients with chronic neck pain.


title: Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology. A Monocentric Study

acronym: NANOPI

summary: Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.

ReferenceCitation: Forest V, Pourchez J, Pélissier C, Audignon Durand S, Vergnon JM, Fontana L. Relationship between Occupational Exposure to Airborne Nanoparticles, Nanoparticle Lung Burden and Lung Diseases. Toxics. 2021 Aug 30;9(9). pii: 204. doi: 10.3390/toxics9090204.

family: Forest

full_name: Valérie Forest

given: Valérie

family: Pourchez

full_name: Jérémie Pourchez

given: Jérémie

family: Pélissier

full_name: Carole Pélissier

given: Carole

family: Audignon Durand

full_name: Sabyne Audignon Durand

given: Sabyne

family: Vergnon

full_name: Jean-Michel Vergnon

given: Jean-Michel

family: Fontana

full_name: Luc Fontana

given: Luc

currency_apc_doaj: CHF

journal_name: Toxics

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI


title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

summary: The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.

lead_sponsor: Centre Chirurgical Marie Lannelongue


type: Other Grant/Funding Number

title: Mortality and Economic Impact of Stopping Statins in People Aged of 75 and Over: a Pragmatic Clinical Trial

acronym: SITE

summary:
In patients ≥ 75 years, there is no evidence that statins in primary prevention are associated with a decreased mortality and recent US recommendations consider statins in people only between 40 and 75 years. Moreover, statins are associated with numerous side effects impacting quality of life of those people and represent a high cost for the French healthcare system.

The aim of the present study is to evaluate cost/effectiveness ratio, in real life, of statin cessation in people ≥ 75 years treated in primary prevention.

status: Active, not recruiting

ReferenceCitation: Bonnet F, Bénard A, Poulizac P, Afonso M, Maillard A, Salvo F, Berdaï D, Salles N, Rousselot N, Marchi S, Hayes N, Joseph JP. Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial. Trials. 2020 Apr 19;21(1):342. doi: 10.1186/s13063-020-04259-5.

full_name: Fabrice Bonnet

given: Fabrice

family: Bénard

full_name: Antoine Bénard

given: Antoine

family: Poulizac

full_name: Pierre Poulizac

given: Pierre

family: Afonso

full_name: Mélanie Afonso

given: Mélanie

family: Maillard

full_name: Aline Maillard

given: Aline

family: Salvo

full_name: Francesco Salvo

given: Francesco

family: Berdaï

full_name: Driss Berdaï

given: Driss

family: Salles

full_name: Nathalie Salles

given: Nathalie

family: Rousselot

full_name: Nicolas Rousselot

given: Nicolas

family: Marchi

full_name: Sébastien Marchi

given: Sébastien

family: Hayes

full_name: Nathalie Hayes

family: Joseph

full_name: Jean-Philippe Joseph

given: Jean-Philippe

currency_apc_doaj: GBP

journal_name: Trials

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

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

repositories:
HAL
PubMed Central
Research Square
oskar-bordeaux.fr

ReferenceCitation: Bonnet F, Poulizac P, Joseph JP. Safety and efficacy of statins. Lancet. 2017 Mar 18;389(10074):1097-1098. doi: 10.1016/S0140-6736(17)30712-2.

title: Safety and efficacy of statins


title: Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear

summary:
The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.

One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).

It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.

Two factors may be involved:

The first corresponds to factors related to natural aging topics
The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.

Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.


title: Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.

acronym: DigeSTAPH

summary:
Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .

This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.


title: Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving

summary:
Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may be considered appropriately by using paradigms developed in the framework of embodied cognition theories.

In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for food in these patients, as measured by reaction time.

Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms have not yet been explored.


title: Monitoring in Intensive Care Unit of Neuromuscular Blocking Agents (NMBA) Used for Acute Respiratory Distress Syndrome (ARDS) After Cardiothoracic Surgery

acronym: CURAREA

summary:
Mortality in Acute Respiratory Distress Syndrome (ARDS) is high (40 to 60 %). Protective mechanical ventilation is the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that short-term infusion of neuromuscular blocking agents (NMBA) reduces hospital mortality. However, the mechanisms through which NMBAs could improve survival remain speculative and the dose of NMBA needed to observe a beneficial effect is still debated. In hypoxemic ventilated patients, continuous cisatracurium infusion with an objective of no response at orbicularis oculi to train-of-four (TOF) stimulation and an objective of two responses had similar effects on respiratory parameters. In their study, Papazian and colleagues used cisatracurium with an initial standard dose of 15 mg followed by a continuous infusion of 37.5mg/h, based on previous results of studies with patients monitored for paralysis. Atracurium and its stereoisomer cisatracurium are non-depolarizing neuromuscular blocking drugs, both used in anaesthesia and intensive care units.

The aim of this study was to compare in ARDS patients a dose adjustment of continuous-atracurium intravenous infusion with an end point of one or two response at orbicularis oculi to TOF stimulation, and a dose adjustment to achieve clinical goals of protective ventilation without monitoring of TOF stimulation.

ReferenceCitation: Rezaiguia-Delclaux S, Laverdure F, Genty T, Imbert A, Pilorge C, Amaru P, Sarfati C, Stéphan F. Neuromuscular Blockade Monitoring in Acute Respiratory Distress Syndrome: Randomized Controlled Trial of Clinical Assessment Alone or With Peripheral Nerve Stimulation. Anesth Analg. 2021 Apr 1;132(4):1051-1059. doi: 10.1213/ANE.0000000000005174.

family: Rezaiguia-Delclaux

full_name: Saïda Rezaiguia-Delclaux

given: Saïda

family: Laverdure

full_name: Florent Laverdure

given: Florent

family: Genty

full_name: Thibaut Genty

given: Thibaut

family: Imbert

full_name: Audrey Imbert

given: Audrey

family: Pilorge

full_name: Catherine Pilorge

given: Catherine

family: Amaru

full_name: Priscilla Amaru

given: Priscilla

family: Sarfati

full_name: Céline Sarfati

given: Céline

family: Stéphan

full_name: François Stéphan

given: François


title: Use of Specific Genetic Alteration s of Tumoral Cells Identified by NGS to Follow Peripheral Samples of Children With Metastatic and/or High Risk Solid Tumor -

acronym: NGSKids

summary: The search for genetic alterations in primary tumor by NGS techniques followed by the detection of these alterations in circulating tumor DNA and/or CTC/DTC present in peripheral samples (blood, cerebrospinal fluid, bone marrow, possibly urine) collected during several steps and after the treatment could be a tool to monitor the response during and after the treatment.

lead_sponsor: Institut Curie

intervention_type: Biological


title: Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.

acronym: BOLUS

summary: The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.

lead_sponsor: University Hospital, Brest


title: Intrathecal Rituximab in Progressive Multiple Sclerosis

acronym: EFFRITE

summary: The goal of investigators is to study the kinetics of action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in progressive MS patients. Various markers of central nervous system inflammation (osteopontin, Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at multiple time-points, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action.

ReferenceCitation: Bonnan M, Ferrari S, Bertandeau E, Demasles S, Krim E, Miquel M, Barroso B. Intrathecal rituximab therapy in multiple sclerosis: review of evidence supporting the need for future trials. Curr Drug Targets. 2014;15(13):1205-14. Review.

ReferenceCitation: Bonnan M. Intrathecal immune reset in multiple sclerosis: exploring a new concept. Med Hypotheses. 2014 Mar;82(3):300-9. doi: 10.1016/j.mehy.2013.12.015. Epub 2013 Dec 31.

lead_sponsor: Centre Hospitalier de PAU

location_facility: Centre hospitalier F. Mitterrand (CH Pau)


title: A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study

summary:
RAGE (the receptor for advanced glycation end-products) is a marker of alveolar type I cell injury and a pivotal mediator of acute inflammation and innate immunity. RAGE pathway is highly regulated; the interaction of the transmembrane receptor with its various ligands (e.g. HMGB1, S100A12) ultimately leads to NF-kB activation and RAGE upregulation itself, but precise RAGE functions and intracellular pathways remain underexplored. During ARDS, monocyte and macrophage activation could modulate alveolar inflammation and repair.

As RAGE is also expressed at the surface of monocytes/macrophages, we hypothesize that alveolar monocyte/macrophage activation may be mediated through a RAGE-TXNIP (thioredoxin interacting protein)-NLRP3/inflammasome intracellular pathway. The purpose of this observational prospective study is to compare alveolar monocyte/macrophage activation profiles (as assessed by Fluorescence-Activated Cell Sorting (FACS)) in mechanically ventilated patients with or without ARDS.

time_perspective: Cross-Sectional


summary: This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.

lead_sponsor: Poitiers University Hospital


title: Medico-economic Evaluation of the DOMOPLAIES Project by the CICAT-LR Network

acronym: DOMOPLAIES

summary: Estimate in 6 months the impact of the telemedicine on the cure rate of the chronic wounds compared with the usual care(with or without CICAT-LR Network).


title: Study on the Links Between Perception and Action in Schizophrenia, "Upside Down, Give me the Handle"

summary: In schizophrenia, dislocation of psychic functions involving a loss of contact with reality is frequently found. A fragmentation of motor and sensory perceptions could be held responsible (Fuchs, 2005). However, automatic integration between perception and action is the necessary condition to be in "relationship with the world." Affordance is the experimental link between object perception and actions potentially associated (Gibson (1977, 1979) explored by Stimulus Response Compatibility (SRC) paradigm. The existence of visual motor neurons leads us to postulate that the affordance effect can be assisted by a visuomotor priming of a hand in a position to grasp. With Tucker & Ellis sensory motor compatibility task, we study the capacity of affordance in schizophrenia, as well as the impact of perceptual motor priming on these affordance effects.


title: Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders

acronym: PHENOVIRTPSY

summary: The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

lead_sponsor: University of Bordeaux

intervention_type: Behavioral


title: Comparative Assessment of Coronary MR Angiography Vs Coronary Multislice CT After Coronary Artery Reimplantation in Children and Young Adults.

acronym: IRCADO

summary:
This is a prospective, multicentric study conducted in order to evaluate if MRI coronarography is as powerful as Cardiac Multislice CT in detection of coronary abnormalities after coronary reimpantation in children over 5 yo, teenagers and young adults who underwent coronary reimplantation in childhood.

Newborns suffering from transposition of the great vessels who underwent at neonatal age an arterial switch operation (ASO) with coronary reimplantation, may develop in time with growth, stenosis, twist or elongation of the reimplanted coronary artery, which may cause myocardial ischemia. As well, aortic root surgery such as the Ross procedure and abnomalous coronary artery from pulmonary artery (ACAPA) reimplantation may lead to the same complications. Functional ischemic tests in a combination of three minimum are positive in only 75% of the cases . Silent ischemia due to coronary abnormality is to be detected in those patients.

In those patients, coronarography was recommended to be performed at least at 7 and 15 yo, without any clinical symptoms . It has also been recommended to examine those patients at 5, 10 and 15 yo as growth is the main cause for coronary abnormality development. Cardiac CT has been proven to be as efficient as coronarography to depict coronary reimplantation abnormalities .

Due to the invasiveness of angiography and to the development of cardiac CT, in our institution, the attitude is to performed cardiac CT instead of angiography with the same frequency in our patients.

Coronaro MRI has been established as a valid technique for evaluation of coronary arteries in patients after ASO .

The aim of this study is to evaluate if non contrast 3D MR coronarography is as powerful as Cardiac Multislice CT for the depiction of coronary anomalies.

All patients, with prior ASO, Ross or ACAPA reimplantation, refereed for cardiac CT and eligible for MRI, over 5yo are included in this prospective multi centric study.

Both examinations are performed on the same day after informed consent, from the patient or from both parents if minor.

Cardiac CT is performed according to the usual protocol in our institution, and MR coronaro angiography is performed as follow: excluding any contra indication to MR, the study requires one or two maximum 3D true FISP sequence without IV contrast injection, with cardiac gating, and free breathing.

3D images are evaluated blinded to the results of cardiac CT by two senior radiologists, with at least 5 years of experience in MR and CT cardiac imaging.

Comparison of the results is consolidated afterwards. Other elements evaluated are tolerance and feasibility of the examination.

The study is designed for four years and benefits from a grant from the Assistance Publique-Hopitaux de Paris.


title: Chronic Pain After Surgical Intensive Care Admission: Incidence and Risk Factors: the DOLOCHROREA Study

acronym: DOLOCHROREA

summary:
The acute pain remains unfortunately a major health problem in intensive care patients. Several factors, such as cancer, traumatic injuries, surgery, scars, diagnostic or therapeutic procedure, could contribute to an increase in the incidence or in the intensity of acute pain. The acute pain could impact on the prognosis of intensive care patients and on the patients perception of the quality of care.

Moreover, the acute pain could lead to a long-term chronic pain syndrome. The chronic pain after intensive care admission could threaten the physical and psychological recovery after the stay in the intensive care unit (ICU).

If many studies have been conducted to improve the management of the acute pain in the ICU, only few data exist on the incidence and the risk factors of the chronic pain after a stay in a surgical intensive care.

The aim of the DOLOCHROREA study is to assess the incidence and the risk factors of 6-month chronic pain after a stay in our surgical ICU.

time_perspective: Retrospective

ReferenceCitation: Battle CE, Lovett S, Hutchings H. Chronic pain in survivors of critical illness: a retrospective analysis of incidence and risk factors. Crit Care. 2013 May 29;17(3):R101. doi: 10.1186/cc12746.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Dynamic Preload Dependence Indices in Laparoscopic Surgery

acronym: VPP Coelio

summary:
A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.

The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.

lead_sponsor: Hospices Civils de Lyon


acronym: MediSein

summary: Breast cancer are common on mediterranean basin. Epidemiological data suggest that breast cancer in young women (< 40years old) is more aggressive in the Maghreb countries comparatively to western countries. This aggressiveness could be associated with phenotypic and genotypic differences between this two populations.

intervention_type: Genetic


title: COPD in Dairy Farmers: Screening, Characterization and Constitution of a Cohort. The BALISTIC Study

acronym: BALISTIC

summary:
A pilot study from the investigators group suggests that the prevalence of chronic obstructive pulmonary disease (COPD) among dairy farmers is higher than in the general population. Most characteristics of COPD in dairy farmers (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) are largely unknown. Although immunization against organic dusts is suspected, the pathophysiology of COPD in dairy farmers is also unknown.

This study therefore aims at (i) comparing the prevalence of COPD in dairy farmers and in subjects without any occupational exposure (control arm) through a vast COPD detection program in the Franche-Comté region; (ii) comparing several characteristics (smoking habits, dyspnoea, quality of life, lung function, bronchial exhaled nitric oxide, systemic inflammation, arterial stiffness and exercise capacity) between dairy farmers with COPD and patients with COPD without any occupational exposure; (iv) identifying etiological factors of COPD in dairy farmers (comparison of exposure and specific immunoglobulin E between dairy farmers with COPD and dairy farmers with normal pulmonary function tests); and (v) constituting a cohort of COPD patients and control subjects for further longitudinal studies.

Data from selected patients (either current or former smokers) with mild COPD and from matched controls will also be analyzed in an ancillary study which objectives are to compare exercise tolerance, ventilatory constraints on tidal volume expansion and dyspnoea between asymptomatic mild COPD subjects, symptomatic mild COPD and healthy controls.

ReferenceCitation: Degano B, Bouhaddi M, Laplante JJ, Botebol M, Annesi-Maesano I, Marescaux A, Roux P, Thaon I, Wolf JP, Regnard J, Dalphin JC. [COPD in dairy farmers: screening, characterization and constitution of a cohort. The BALISTIC study]. Rev Mal Respir. 2012 Nov;29(9):1149-56. doi: 10.1016/j.rmr.2012.08.007. Epub 2012 Oct 15. French.

ReferenceCitation: Veil-Picard M, Soumagne T, Vongthilath R, Annesi-Maesano I, Guillien A, Laurent L, Andujar P, Roche N, Jouneau S, Cypriani B, Laplante JJ, Degano B, Dalphin JC. Is atopy a risk indicator of chronic obstructive pulmonary disease in dairy farmers? Respir Res. 2019 Jun 17;20(1):124. doi: 10.1186/s12931-019-1082-2.

family: Veil-Picard

full_name: Matthieu Veil-Picard

given: Matthieu

family: Soumagne

full_name: Thibaud Soumagne

given: Thibaud

family: Vongthilath

full_name: Rechana Vongthilath

given: Rechana

family: Annesi-Maesano

full_name: Isabella Annesi-Maesano

given: Isabella

family: Guillien

full_name: Alicia Guillien

given: Alicia

family: Laurent

full_name: Lucie Laurent

given: Lucie

family: Andujar

full_name: Pascal Andujar

given: Pascal

family: Roche

full_name: Nicolas Roche

family: Jouneau

full_name: Stephane Jouneau

given: Stephane

family: Cypriani

full_name: Benoit Cypriani

given: Benoit

family: Laplante

full_name: Jean-Jacques Laplante

given: Jean-Jacques

family: Degano

full_name: Bruno Degano

given: Bruno

family: Dalphin

full_name: Jean-Charles Dalphin

given: Jean-Charles

journal_name: Respiratory Research

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

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature


title: Cognitive and Communicative Development Description of Deaf Child With a Cochlear Implant.

acronym: DECCODES

summary:
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic predictors, cognitive and language to obtain optimum speech recognition with cochlear implants associated with a good communicative and language development of deaf children, the investigators intend to achieve a preliminary longitudinal study aimed to describe the cognitive, communicative and perceptive implanted deaf children.

The main objective of our study is to describe the cognitive and communicative development of deaf children implanted from the pre-implant assessment to 18 months post-implantation, by addressing the following aspects:

The psychomotor and cognitive development assessed using the Brunet-Lézine test;
The development of preverbal communication, evaluated using the Early Social Communication Scale.

lead_sponsor: University Hospital, Toulouse

location_facility: Hôpital Purpan - Pavillon Dieulafoy - Service ORL (ENT services)


title: Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease: A Phase I Safety and Efficacy Study

acronym: SpinalPark

summary: Following the so call "honey moon" period, motor symptoms of Parkinson's Disease (PD) become difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian patients restoring a decent quality of life. However, DBS need a long, complex and invasive surgery to succeed. Thus, there is a critical need to develop alternative treatments, more accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for decades to treat chronic neuropathic pains. Safety and efficacy have already been demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve locomotor activity in two different rodents' models of parkinson's disease. The purpose of this study is to determine whether thoracic SCS is safe and could induce a benefit motor parkinsonian symptoms without any impact on cognitive function and axial disability.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

acronym: DREPASOM

summary:
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.

The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.


title: Evaluation of a Combination of Blood Biomarkers for the Early Diagnosis of Mycosis Fungoides

acronym: DIAPREMYF

summary:
Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the differential diagnosis with inflammatory dermatoses is often very difficult. The histopathological diagnosis is also difficult and delayed. Therefore, it is important to develop biomarkers and/or a combination of biomarkers in order to improve the early diagnostic of MF.

In a previous trial, investigators included 490 patients in a study aiming at identifying skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This French institutional study demonstrated that the identification by PCR of a combination of 4 blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis of lymphoma in erythrodermic patients. This previously published study interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool for MF.

The aim of this study is to establishing an accurate blood diagnosis for early suspected MF by demonstrating that newly identified biomarkers or their combination [5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)] are differentially expressed by patients with MF and patients with inflammatory dermatoses closely resembling MF lesions.

Statistical analysis will establish the best combination of blood biomarkers allowing the differentiation between the two groups of patients, combination that could represent a suitable diagnostic tool for early MF.


title: Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children

acronym: OPTIMOME

summary:
Concentrations and effects of anti-infectives in critically ill 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 children. Rationalisation of anti-infectives in children is therefore desirable.

The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) > minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill children. Covariates The effects of covariates on anti-infectives 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 including 11 anti-infectives antibiotics. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were anti-infectives 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 anti-infectives exposure on patient outcome.

ReferenceCitation: Nguyen T, Oualha M, Briand C, Bendavid M, Béranger A, Benaboud S, Tréluyer JM, Zheng Y, Foissac F, Winter S, Gana I, Boujaafar S, Lopez V, Berthaud R, Demir Z, Bouazza N, Hirt D. Population Pharmacokinetics of Intravenous Ganciclovir and Oral Valganciclovir in a Pediatric Population To Optimize Dosing Regimens. Antimicrob Agents Chemother. 2021 Feb 17;65(3). pii: e02254-20. doi: 10.1128/AAC.02254-20. Print 2021 Feb 17.

name: EA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France

family: Nguyen

full_name: T. Nguyen

given: T.

name: Service de Réanimation et Surveillance Continue Médico-Chirurgicales Pédiatriques, Hôpital Necker Enfants Malades, Paris, France

family: Oualha

full_name: M. Oualha

given: M.

name: Service d’Hématologie, Immunologie et Rhumatologie Pédiatrique, Hôpital Necker Enfants Malades, Paris, France

family: Briand

full_name: C. Briand

given: C.

family: Bendavid

full_name: M. Bendavid

family: Béranger

full_name: A. Béranger

given: A.

name: Service de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France

family: Benaboud

full_name: S. Benaboud

given: S.

name: Unité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France

name: CIC-1419 Inserm, Cochin-Necker, Paris, France

family: Tréluyer

full_name: J.-M. Tréluyer

family: Zheng

full_name: Y. Zheng

given: Y.

family: Foissac

full_name: F. Foissac

given: F.

family: Winter

full_name: S. Winter

family: Gana

full_name: I. Gana

given: I.

family: Boujaafar

full_name: S. Boujaafar

name: Service de Réanimation Cardiaque Pédiatrique, Hôpital Necker Enfants Malades, Paris, France

family: Lopez

full_name: V. Lopez

given: V.

name: Service de Néphrologie Pédiatrique, Hôpital Necker Enfants Malades, Paris, France

family: Berthaud

full_name: R. Berthaud

given: R.

name: Service de Gastro-Entérologie, Hépatologie et Nutrition Pédiatriques, Hôpital Necker Enfants Malades, Paris, France

family: Demir

full_name: Z. Demir

given: Z.

family: Bouazza

full_name: N. Bouazza

given: N.

name: INSERM, U1018, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France

family: Hirt

full_name: D. Hirt

given: D.

journal_name: Antimicrobial Agents and Chemotherapy

oa_host_type: repository

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

ReferenceCitation: Abdalla S, Briand C, Oualha M, Bendavid M, Béranger A, Benaboud S, Tréluyer JM, Zheng Y, Capito C, Demir Z, Foissac F, Winter S, Gana I, Boujaafar S, Bouazza N, Hirt D. Population Pharmacokinetics of Intravenous and Oral Acyclovir and Oral Valacyclovir in Pediatric Population To Optimize Dosing Regimens. Antimicrob Agents Chemother. 2020 Nov 17;64(12). pii: e01426-20. doi: 10.1128/AAC.01426-20. Print 2020 Nov 17.

family: Abdalla

full_name: S. Abdalla

name: Service d’Hématologie, Immunologie et Rhumatologie Pédiatrique, Hôpital Necker-Enfants Malades, Paris, France

name: Service de Réanimation et Surveillance Continue Médico-Chirurgicales Pédiatriques, Hôpital Necker-Enfants Malades, Paris, France

name: Unite de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France

name: Service de Chirurgie Viscérale et Urologique Pédiatriques, Hôpital Necker-Enfants Malades, Paris, France

name: Service de Gastro-Entérologie, Hépatologie et Nutrition Pédiatriques, Hôpital Necker-Enfants Malades, Paris, France

ReferenceCitation: Béranger A, Benaboud S, Urien S, Moulin F, Bille E, Lesage F, Zheng Y, Genuini M, Gana I, Renolleau S, Hirt D, Tréluyer JM, Oualha M. Piperacillin Population Pharmacokinetics and Dosing Regimen Optimization in Critically Ill Children with Normal and Augmented Renal Clearance. Clin Pharmacokinet. 2019 Feb;58(2):223-233. doi: 10.1007/s40262-018-0682-1.

ReferenceCitation: Béranger A, Oualha M, Urien S, Genuini M, Renolleau S, Aboura R, Hirt D, Heilbronner C, Toubiana J, Tréluyer JM, Benaboud S. Population Pharmacokinetic Model to Optimize Cefotaxime Dosing Regimen in Critically Ill Children. Clin Pharmacokinet. 2018 Jul;57(7):867-875. doi: 10.1007/s40262-017-0602-9.

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


title: Pilot Study: Hepatoprotective Role of SMOFlipid® Used in Short-term Parenteral Nutrition in an Onco-Hematology Pediatric Population

acronym: SMOFPILOT

summary: Parenteral nutrition (PN) is part of supportive care in oncology Pediatric when the patient's nutritional status justifies it and enteral is impossible. In the literature, hepatotoxicity, cholestasis type, standard emulsions of soy oil-based (type Médialipide®) is described in the context of a long-term PN especially in premature infants. It results in an increase in gammaGT. The most recent use of lipid emulsions containing Omega 3 (Smoflipid), was studied in the adult population and in the preterm in the PN on short and long, with the finding of a hepatoprotection. Investigators do not find a single retrospective study about it in Pediatric Onco-Hematology. No prospective studies have been performed in the population of Onco-Hematology. The objective of this study is to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Efficacy and Tolerance of Sodium Thiosulfate Injection After Ultrasound-guided Percutaneous Irrigation of Calcific Tendinopathy of the Rotator Cuff

acronym: THIOCAL

summary: Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. US- guided needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. The goal of this procedure is to remove the calcific deposit that is believed to cause the sub-acromial impingement. However, studies have shown that complete and rapid disappearance of the calcification deposit after irrigation is rare. The treatment is thought to promote the spontaneous resorption that occurs the weeks and months after the procedure. However, due to this slow process, time to complete recovery can be long. Moreover, it has been shown an association between the amount of removed calcium and improved outcome. Therefore, there is a need to find a way to remove quickly and completely the calcific deposit after irrigation. Sodium thiosulfate has been used successfully in the treatment of calciphylaxis and subcutaneous calcification deposit. The mechanism of action involves chelation of calcium into calcium thiosulfate salts which are much more soluble than other salts of calcium. Our hypothesis is that injection of sodium thiosulfate after irrigation of the calcification will help to dissolve the calcific deposit and thus prompt the disappearance of the calcification.

ReferenceCitation: Darrieurtort-Laffite C, Bertrand-Vasseur A, Garraud T, Planche L, Le Goff B. Tolerance and effect of sodium thiosulfate in calcific tendinitis of the rotator cuff. Clin Rheumatol. 2020 Feb;39(2):561-569. doi: 10.1007/s10067-019-04793-x. Epub 2019 Nov 1.

family: Darrieurtort-Laffite

full_name: C. Darrieurtort-Laffite

family: Bertrand-Vasseur

full_name: A. Bertrand-Vasseur

family: Garraud

full_name: T. Garraud

family: Planche

full_name: L. Planche

given: L.

family: Le Goff

full_name: B. Le Goff

given: B.

journal_name: Clinical Rheumatology

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Nantes University Hospital


title: Assessment of the Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging - A Monocentric Study

summary:
Aneurysms of the thoracic ascending aorta are a serious pathology which may threatens life by rupture or dissection. Their incidence is estimated at 10.4 per 100,000 people. At present, the only parameter for assessing the risk of complication is the maximum diameter of the aneurysm. The only way to avoid a complication is a surgical replacement of the aneurysmal aorta by a prosthetic tube. This procedure is performed by sternotomy and with extracorporeal circulation and its death rate ranges between 3% and 5%. Surgical repair is indicated when the diameter of the aneurysm exceeds 5.5 cm for degenerative atheromatous aneurysms or 5 cm in a patient with genetic disorder of connective tissue (Marfan disease or Ehlers-Danlos syndrome). However, there are aneurysms with diameter greater than the surgical threshold which remain stable. Conversely, complications have been described for aneurysms less than 4.5 cm in diameter. The criterion of diameter appears therefore as inadequate to assess the risk of complication of an aneurysm of the ascending aorta.Multiple methods have been described in the literature. One of them relies on in vitro mechanical testing on healthy or aneurysmal tissue. Another method is the vivo analysis from imaging (CT, MRI or ultrasound). So far, no algorithm is robust enough for predicting the risk of complication better than the universally used criterion of diameter.

The pathophysiology of these aneurysms has also been explored from histological studies. The investigators know that the microstructure of the aortic wall of an aneurysm is deteriorated with a degradation of elastin fibers and collagen that determine to a large extent its biomechanical behavior. Histological analysis appears inseparable from biomechanical analysis.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: The Embodied Cognition: Exploratory Study of Automatic and Controlled Processes in Anorexia Nervosa. A Monocentric Study

summary: Anorexia nervosa (AN) is a common psychiatric illness, with severe prognosis (5% mortality) that has changed little over in half a century. One of the forms is the restrictive anorexia nervosa (ANR). It consists of a phobia of weight gain and food with a massive food restriction. This pathology is studied in psychology but not using the theories of embodied cognition in which "perception and action" interact through sensorimotor processes. They are the source of attitudes (unconscious) towards certain stimuli and influence our interpretation (conscious).


title: Prognosis Contribution of the 6 Minute Walk Test in Cystic Fibrosis : Prospective Multicenter Study

summary: The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a prognostic factor for cystic fibrosis patients.

ReferenceCitation: Martin C, Chapron J, Hubert D, Kanaan R, Honoré I, Paillasseur JL, Aubourg F, Dinh-Xuan AT, Dusser D, Fajac I, Burgel PR. Prognostic value of six minute walk test in cystic fibrosis adults. Respir Med. 2013 Dec;107(12):1881-7. doi: 10.1016/j.rmed.2013.10.001. Epub 2013 Oct 11.

ReferenceCitation: Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30. Review.

family: Holland

full_name: Anne E. Holland

given: Anne E.

family: Spruit

full_name: Martijn A. Spruit

given: Martijn A.

family: Troosters

full_name: Thierry Troosters

given: Thierry

family: Puhan

full_name: Milo A. Puhan

given: Milo A.

family: Pepin

full_name: Véronique Pepin

given: Véronique

family: Saey

full_name: Didier Saey

given: Didier

family: McCormack

full_name: Meredith C. McCormack

given: Meredith C.

family: Carlin

full_name: Brian W. Carlin

given: Brian W.

family: Sciurba

full_name: Frank C. Sciurba

given: Frank C.

family: Pitta

full_name: Fabio Pitta

given: Fabio

family: Wanger

full_name: Jack Wanger

given: Jack

family: MacIntyre

full_name: Neil MacIntyre

given: Neil

family: Kaminsky

full_name: David A. Kaminsky

given: David A.

family: Culver

full_name: Bruce H. Culver

given: Bruce H.

family: Revill

full_name: Susan M. Revill

given: Susan M.

family: Hernandes

full_name: Nidia A. Hernandes

given: Nidia A.

family: Andrianopoulos

full_name: Vasileios Andrianopoulos

given: Vasileios

family: Camillo

full_name: Carlos Augusto Camillo

given: Carlos Augusto

family: Mitchell

full_name: Katy E. Mitchell

given: Katy E.

family: Lee

full_name: Annemarie L. Lee

given: Annemarie L.

family: Hill

full_name: Catherine J. Hill

given: Catherine J.

family: Singh

full_name: Sally J. Singh

given: Sally J.

repository_institution: University of Hasselt - Document Server@UHasselt

ReferenceCitation: Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30. Review.


title: Effects of Reduction of the Length of Treatment by Nebulized 3% Hypertonic Saline From 72 to 24 Hours on Clinical Remission, in Children Younger Than 12 Month Hospitalized for Acute Bronchiolitis. BRONDUSAL

acronym: BRONDUSAL

summary: Efficacy/Safety of 3% hypertonic saline inhalation (24H vs 72H) to treat acute bronchiolitis in infants.

ReferenceCitation: Beal G, Barbier C, Thoret S, Rubio A, Bonnet M, Mazet R, Ego A, Pin I. Nebulized hypertonic saline 3% for 1 versus 3 days in hospitalized bronchiolitis: a blinded non-inferiority randomized controlled trial. BMC Pediatr. 2019 Nov 8;19(1):417. doi: 10.1186/s12887-019-1804-0.

family: Beal

full_name: Gaëlle Beal

given: Gaëlle

family: Barbier

full_name: Catherine Barbier

given: Catherine

family: Thoret

full_name: Sophie Thoret

given: Sophie

family: Rubio

full_name: Amandine Rubio

given: Amandine

family: Bonnet

full_name: Mathilde Bonnet

given: Mathilde

family: Mazet

full_name: Roseline Mazet

given: Roseline

family: Ego

full_name: Anne Ego

given: Anne

family: Pin

full_name: Isabelle Pin

given: Isabelle

journal_name: BMC Pediatrics

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


title: Can we Forget? Directed Forgetting and Embodied Cognition in Schizophrenia

summary: Based on the theory of embodied cognition, which focuses on the influence of sensory and motor processes on cognition, researchers propose to study the influence of the action on memorization and inhibition in patients suffering from schizophrenia, using a directed forgetting paradigm. The directed forgetting paradigm is used, composed of two lists of action verbs. The instruction "to forget" is given at the end of learning the first list (To Be Forgotten (TBF)), following a simulation of a computer bug. Therefore a second list is presented to be learned and remembered (To Be Remembered (TBR)). A recognition task is performed at the end. The action verbs had to be encoded using four conditions: action performed, mimed, imagined action, action with a contextual word, reading the action verb only. 48 schizophrenic patients were included in this study. Patients were randomized to have 10 participants per condition. 48 controls matched by age, gender, laterality and education are also included and randomized in the same modality. This study aims to show that the encoding of sensory-motor components, more than providing a context could improve the inhibitory capacities but also memory in schizophrenia, and possibly be used in remediation cognitive.


title: Assessment of the Neurovascular Microcirculatory Response in Diabetes Type 1

summary:
This study aims to see whether or not the diabetes 1 patients have a neurovascular microcirculatory dysfunction using various microvascular tests which have been previously validated.

Microvascular responses will be assessed by Laser Speckle Contrast Imaging and expressed in Laser Speckle Perfusion Units (LSPU).

ReferenceCitation: Marche P, Dubois S, Abraham P, Parot-Schinkel E, Gascoin L, Humeau-Heurtier A, Ducluzeau PH, Mahe G. Neurovascular microcirculatory vasodilation mediated by C-fibers and Transient receptor potential vanilloid-type-1 channels (TRPV 1) is impaired in type 1 diabetes. Sci Rep. 2017 Mar 13;7:44322. doi: 10.1038/srep44322.

family: Marche

full_name: P. Marche

given: P.

family: Dubois

full_name: S. Dubois

given: S.

family: Abraham

full_name: P. Abraham

family: Parot-Schinkel

full_name: E. Parot-Schinkel

given: E.

family: Gascoin

full_name: L. Gascoin

given: L.

family: Humeau-Heurtier

full_name: A. Humeau-Heurtier

given: A.

family: Ducluzeau

full_name: PH. Ducluzeau

given: PH.

family: Mahe

full_name: G. Mahe

given: G.

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Scientific Reports

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON


title: Dexmedetomidine for Non-invasive Ventilation After Chest Trauma (VENDETTA)

acronym: VENDETTA

summary:
Crossover randomized controlled double blinded trial :

The primary endpoint is the duration of Non Invasive Ventilation (NIV) session (minutes) with dexmedetomidine (DEX) or placebo.
Secondary endpoints will be the sedation level as assessed by the Richmond Agitation Sedation Scale (RASS), the number of interventions to allow the completion of NIV session, the pain intensity level as assessed by visual analogue scale, the morphine and ketamine consumption during NIV sessions, the comparison of blood gas measurements before and after NIV sessions, the reproducibility of NIV cycles. The side effects of DEX will be notified.


acronym: DROSOALLERG

summary: Allergy is a very common problem and can be a handicap in everyday life, specially when symptoms occur at work place. Some persons working with drosophila developed respiratory symptoms. Investigators tried to analyze if these manifestations could be due to a specific allergy to drosophila.


title: Reorganization of Central Auditory System After Single Sided Deafness: a Functional Magnetic Resonance Imaging Study

acronym: SSD

summary: The objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.


title: Involvement of Reactive Oxygen Species Produced by the Xanthine Oxidase in Mitochondrial Alterations in Skeletal Muscle of Type 2 Diabetic Patients

acronym: DIAXO

summary: Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.


title: Ultra-Violet Fluorescence Bronchial Cancer Location

acronym: UVFBCL

summary:
Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.

The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.

location_facility: Pneumology departement CHU Saint-Etienne


title: Attentional Capacity and Working Memory in Coronary Artery Disease Patients: Impact of the Presence of a Sleep Apnea Syndrome and Chronic Effects of Treatment With a Continuous Positive Airway Pressure System (CPAP). Etude CAPCORSAS

acronym: CAPCORSAS

summary:
The presence of Obstructive Sleep Apnea Syndrome (OSAS) has a high frequency in patients victims of a coronary artery disease (CAD) (myocardial infarction, revascularization). Unlike patients seen in a sleep Laboratory with an impact on daytime functioning, CAD apneic patients do not complain in their daytime functioning. The objective of this study is to explore whether the objective cognitive assessment measures may be a good marker of the efficacy of CPAP treatment given to non-sleepy apneic CAD patients.

Coronary patients with an AHI between 15 and 40 / h will be treated (or not) after randomization with CPAP treatment. The expected results are: CPAP apneic coronary patients should have a positive impact on cognitive performance, particularly on attention span and working memory measured by improvement in the Paced Auditory Serial Addition Test score (PASAT score).


title: Bone Microarchitectural Database Constitution From High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Device in Clinical Situation Potentially Associated With Bone Loss

acronym: DMPOs

summary:
Bone fracture occurrence is associated with an increasing of morbidity and mortality. Some factors of fracture occurrence have been highlighted. For example, some diseases or therapy are known to increased risk of bone fracture only in some patients. Accordingly, it is important for clinicians to identify patients at risk for bone fracture. Right now, various tools are available for the clinicians:

clinical exam,
bone mineral density assessed by Dual Energy X-ray Absorptiometry (DEXA),
an algorithm based on interrogation, clinical exam and bone mineral density. However, prediction of bone fracture risk needs to be improved since only 50% of bone fractures can be predicted. DEXA provides information for fracture risk estimation, but it is unable to distinguish cortical part to trabecular part. It also fails to quantify the microstructural properties that influence bone strength. Bone microarchitecture, including the cortical compartment can now be assessed in vivo by the HR-pQCT. This technique allows access to several parameters: on the one hand the volumetric bone mineral density for the whole area measured as well as cortical and trabecular regions, and on the other hand, the thickness and cortical porosity and the number of trabecular, their orientation and distribution.

Thus, the HR-pQCT allows realizing a virtual bone biopsy and provides information on cortical and trabecular bone microarchitecture. This is the only noninvasive way to assess cortical and trabecular bone microarchitecture.


title: Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease

acronym: OXYPHEN

summary:
In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.

Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.


title: Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection

acronym: PLAQUETTE

summary:
HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.

The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.


title: Scoliosis Patients Aged 10-13 Years: Monitoring of Scoliosis by the Surface Topography

acronym: SCOBIOMOD

summary:
The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography.

The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.

ReferenceCitation: de Sèze M, Cugy E. Pathogenesis of idiopathic scoliosis: a review. Ann Phys Rehabil Med. 2012 Mar;55(2):128-38. doi: 10.1016/j.rehab.2012.01.003. Epub 2012 Jan 27. Review. English, French.

ReferenceCitation: Bunnell WP. An objective criterion for scoliosis screening. J Bone Joint Surg Am. 1984 Dec;66(9):1381-7.

ReferenceCitation: Goldberg CJ, Kaliszer M, Moore DP, Fogarty EE, Dowling FE. Surface topography, Cobb angles, and cosmetic change in scoliosis. Spine (Phila Pa 1976). 2001 Feb 15;26(4):E55-63.

ReferenceCitation: Mínguez MF, Buendía M, Cibrián RM, Salvador R, Laguía M, Martín A, Gomar F. Quantifier variables of the back surface deformity obtained with a noninvasive structured light method: evaluation of their usefulness in idiopathic scoliosis diagnosis. Eur Spine J. 2007 Jan;16(1):73-82. Epub 2006 Apr 12.


title: Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive

summary:
Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains high. If anticoagulation is perfectly codified, the remainder of the initial management has been less studied.

In particular, the "conditioning" Initial often involves systematic plasma volume of 250 to 500 cc, by analogy to other situations. But this treatment option is not based on factual data. In the right ventricular dysfunction that often accompany severe EP, volume expansion may instead be harmful, according to the law of Frank Starling. A retrospective study has recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive EP.

The proposed study is interventional, prospective, multicenter, randomized, require to include 60 patients.

The main objective of the study is the comparison of the troponin normalization period Ic (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of a serious normotensive EP, between the 2 groups diuretic and filling Vascular.

The primary endpoint is the time in hours standardization of troponin Ic.

The secondary endpoints will be:

the period of normalization of Brain Natriuretic Peptide (BNP)
changes in echocardiographic parameters of right ventricular dysfunction
a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of thrombolysis.


title: Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

summary: Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.


title: Comparison of Two Methods of Preoxygenation Before Oro Tracheal Intubation in the Hypoxemic Patient in Intensive Care Unit : Non Invasive Ventilation (NIV) + High Flow Nasal Cannula Oxygen Versus NIV Alone : a Randomized Controlled Study

acronym: OPTINIV

summary: Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with severe life threatening complications. To decrease these complications, preoxygenation is recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation, applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC) improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has never been evaluated. The aim of this study is to determine if HFNC combined to NIV could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated for hypoxemic acute respiratory failure.

ReferenceCitation: De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRéa Network for the Frida-Réa Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

family: De Jong

full_name: Audrey De Jong

given: Audrey

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Terzi

full_name: Nicolas Terzi

family: Mongardon

full_name: Nicolas Mongardon

family: Arnal

full_name: Jean-Michel Arnal

given: Jean-Michel

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

family: Constantin

full_name: Jean-Michel Constantin

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Leone

full_name: Marc Leone

given: Marc

family: Papazian

full_name: Laurent Papazian

given: Laurent

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Maziers

full_name: Nicolas Maziers

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Pradel

full_name: Gael Pradel

given: Gael

family: Jung

full_name: Boris Jung

given: Boris

family: Jaber

full_name: Samir Jaber

given: Samir

journal_name: American Journal of Respiratory and Critical Care Medicine

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

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

title: Early Identification of Patients at Risk for Difficult Intubation in the Intensive Care Unit

ReferenceCitation: Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61.

ReferenceCitation: De Jong A, Jung B, Jaber S. Intubation in the ICU: we could improve our practice. Crit Care. 2014 Mar 18;18(2):209. doi: 10.1186/cc13776. Review.

ReferenceCitation: De Jong A, Futier E, Millot A, Coisel Y, Jung B, Chanques G, Baillard C, Jaber S. How to preoxygenate in operative room: healthy subjects and situations "at risk". Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):457-61. doi: 10.1016/j.annfar.2014.08.001. Epub 2014 Aug 29. Review.

ReferenceCitation: Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. Epub 2006 Apr 20.

ReferenceCitation: Jaber S, Michelet P, Chanques G. Role of non-invasive ventilation (NIV) in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):253-65. Review.

ReferenceCitation: Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

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

ReferenceCitation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbé V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.

title: Use of High-Flow Nasal Cannula Oxygen Therapy to Prevent Desaturation During Tracheal Intubation of Intensive Care Patients With Mild-to-Moderate Hypoxemia*

ReferenceCitation: Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.

ReferenceCitation: Chanques G, Jaber S. [Unexpected progress of an old intensive care therapy, oxygen: towards more comfort and less mechanical ventilation…]. Rev Mal Respir. 2013 Oct;30(8):605-8. doi: 10.1016/j.rmr.2013.07.006. Epub 2013 Aug 27. French.

ReferenceCitation: Hedenstierna G, Rothen HU. Atelectasis formation during anesthesia: causes and measures to prevent it. J Clin Monit Comput. 2000;16(5-6):329-35. Review.

ReferenceCitation: Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. Epub 2005 Aug 16. Review.

ReferenceCitation: Kolettas A, Grosomanidis V, Kolettas V, Zarogoulidis P, Tsakiridis K, Katsikogiannis N, Tsiouda T, Kiougioumtzi I, Machairiotis N, Drylis G, Kesisis G, Beleveslis T, Zarogoulidis K. Influence of apnoeic oxygenation in respiratory and circulatory system under general anaesthesia. J Thorac Dis. 2014 Mar;6 Suppl 1:S116-45. doi: 10.3978/j.issn.2072-1439.2014.01.17. Review.

ReferenceCitation: Engström J, Hedenstierna G, Larsson A. Pharyngeal oxygen administration increases the time to serious desaturation at intubation in acute lung injury: an experimental study. Crit Care. 2010;14(3):R93. doi: 10.1186/cc9027. Epub 2010 May 24.

ReferenceCitation: Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.

ReferenceCitation: Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.

ReferenceCitation: De Jong A, Clavieras N, Conseil M, Coisel Y, Moury PH, Pouzeratte Y, Cisse M, Belafia F, Jung B, Chanques G, Molinari N, Jaber S. Implementation of a combo videolaryngoscope for intubation in critically ill patients: a before-after comparative study. Intensive Care Med. 2013 Dec;39(12):2144-52. doi: 10.1007/s00134-013-3099-1. Epub 2013 Sep 18.

ReferenceCitation: Jung B, Clavieras N, Nougaret S, Molinari N, Roquilly A, Cisse M, Carr J, Chanques G, Asehnoune K, Jaber S. Effects of etomidate on complications related to intubation and on mortality in septic shock patients treated with hydrocortisone: a propensity score analysis. Crit Care. 2012 Nov 21;16(6):R224. doi: 10.1186/cc11871.

ReferenceCitation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

name: Assistant Professor of Anesthesiology and Critical Care.

name: Professor of Anesthesiology and Critical Care, Director of Surgical Intensive Care Unit, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand.

name: Professor of Anesthesiology and Critical Care, Dipartimento di Scienze Chirurgiche e Diagnostiche Integrate, Universita' degli Studi di Genova, Genova, Italy.

name: Assistant Professor of Anesthesiology and Critical Care, Head of Intensive Care Unit.

name: Research Fellow, Staff Anesthesiologist, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.

name: Statistician, Department of Statistics, Centre Jean Perrin, University Hospital of Clermont-Ferrand.

name: Professor of Anesthesiology and Critical Care, Department of Anesthesiology and Critical Care Medicine, Estaing Hospital, University Hospital of Clermont-Ferrand.

name: Professor of Anesthesiology and Critical Care, Head of Department, Department of Critical Care Medicine and Anesthesiology (SAR B), Saint Eloi Hospital, University Hospital of Montpellier, Montpellier, France.

title: Noninvasive Ventilation and Alveolar Recruitment Maneuver Improve Respiratory Function during and after Intubation of Morbidly Obese Patients

ReferenceCitation: Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

ReferenceCitation: Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b.

ReferenceCitation: De Jong A, Molinari N, Conseil M, Coisel Y, Pouzeratte Y, Belafia F, Jung B, Chanques G, Jaber S. Video laryngoscopy versus direct laryngoscopy for orotracheal intubation in the intensive care unit: a systematic review and meta-analysis. Intensive Care Med. 2014 May;40(5):629-39. doi: 10.1007/s00134-014-3236-5. Epub 2014 Feb 21. Review.

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ReferenceCitation: De Jong A, Baranwal AK, Jaber S. Predictors of difficult intubation in ICU: are children and adults alike? Intensive Care Med. 2014 Nov;40(11):1769-71. doi: 10.1007/s00134-014-3429-y. Epub 2014 Aug 28.

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

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

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi


title: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

acronym: PROSPER

summary:
This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease.
MR Perfusion Imaging will be assess in both cochlea as well
Primary auditory brain pathways will be evaluated through MR diffusion imaging


title: Using MRI for a Non-invasive Evaluation of Portal Pressure

acronym: ENIP

summary: The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.

ReferenceCitation: Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2. Review.

ReferenceCitation: Bosch J, Abraldes JG, Berzigotti A, García-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1. Review.

ReferenceCitation: Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129. Review.


title: Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease

acronym: LAVOLEX

summary:
Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.

The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.

The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).