title: New Oxymetry Indices in Critical Limb Ischemia (French Original Title is "Nouveaux Indices Oxymétriques Chez Les Patients Vus Pour Suspicion d'Ischémie Critique du membrE inférieur")

acronym: NOVICE

summary:
Transcutaneous oxygen tension (TcpO2) at rest, sensitized by oxygen inhalation tests, is widely applied for the evaluation of chronic critical limb ischemia (CLI). If foot TcpO2 measurements are good prognostic factors of the risk of amputation or the probability of wound healing without amputation, they have never proven their hability to estimate the risk of death in patients with critical limb ischemia. On the one hand, studies have considered only the response observed on legs without considered the thoracic variations. On the other hand, the variability of the TcpO2 signal has never been analyzed as a prognostic factor.

The objective of the NOVICE study is therefore to assess, first, whether the variability of resting TcPO2 values at thoracic probe as well as at affected limb probe is a morbidity-mortality prognostic factor and secondly, to evaluate during the oxygen tests, if the measurement of the amplitude of the distal responses in ischemic zone compared to the response observed in thoracic probe is a prognostic factor of morbi-mortality.

lead_sponsor: University Hospital, Angers


title: Micro-environment Involvement in Muscle Alteration Induced by Copd Exacerbation

acronym: MicAMI-BPCO

summary:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strengh and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. During exacerbation, some studies have suggested an association between muscle dysfunction and modifications of inflammatory circulating factors such as CRP, TNF-alpha, IL- 6, IL8, but no exhaustive study has identified precisely one (or more) biomarker(s) that can induce this muscle wasting during the exacerbation of COPD. Our hypothesis is that the serum of exacerbated COPD patients represents a deleterious microenvironment for the muscle cells which would amplify the mechanisms of atrophy linked to hospitalization. Our team has already developed a cell culture model to study the effects of the plasma microenvironment on atrophy of cultured myotubes. The investigators have shown that the serum of COPD patients can induce muscle atrophy.

The objectives of this study are : 1/ to evaluate the effects of circulating pro-inflammatory factors on atrophy and the myogenic capacities of muscle cells; and 2/ to identify one (or more) circulating biomarker (s) that may be responsible for the muscle damage induced by the microenvironment of hospitalized patients for exacerbation of COPD. First, myotubes and myoblasts of healthy subjects will be cultivated with 9 exacerbation copd patient serum or 9 copd patient serum or 9 healthy subject serum. Myotube diameters, atrophy, inflammatory and oxidative stress markers and alteration of the myogenic capacity of satellite cells will be compared between three groups. Second, the differential expression of circulating proinflammatory molecules will be compared in the serum of the three groups. Identifying circulating factors associated with muscle weakness is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.

.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Spruit MA, Gosselink R, Troosters T, Kasran A, Gayan-Ramirez G, Bogaerts P, Bouillon R, Decramer M. Muscle force during an acute exacerbation in hospitalised patients with COPD and its relationship with CXCL8 and IGF-I. Thorax. 2003 Sep;58(9):752-6.

ReferenceCitation: Crul T, Testelmans D, Spruit MA, Troosters T, Gosselink R, Geeraerts I, Decramer M, Gayan-Ramirez G. Gene expression profiling in vastus lateralis muscle during an acute exacerbation of COPD. Cell Physiol Biochem. 2010;25(4-5):491-500. doi: 10.1159/000303054. Epub 2010 Mar 23.

ReferenceCitation: Crul T, Spruit MA, Gayan-Ramirez G, Quarck R, Gosselink R, Troosters T, Pitta F, Decramer M. Markers of inflammation and disuse in vastus lateralis of chronic obstructive pulmonary disease patients. Eur J Clin Invest. 2007 Nov;37(11):897-904. Epub 2007 Sep 20.

ReferenceCitation: Catteau M, Gouzi F, Blervaque L, Passerieux E, Blaquière M, Ayoub B, Bughin F, Mercier J, Hayot M, Pomiès P. Effects of a human microenvironment on the differentiation of human myoblasts. Biochem Biophys Res Commun. 2020 May 14;525(4):968-973. doi: 10.1016/j.bbrc.2020.03.020. Epub 2020 Mar 12.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

lead_sponsor_type: academique

status_simplified: Completed


title: Transcutaneous Oxygen Pressure of the Injured Ankle as Predictor of Postoperative Cutaneous Pain

acronym: TAC

summary: This monocentric prospective observational pilot study aims to investigate if the measurement of TcPO2 can be used as a predictor of postoperative cutaneous pain in patients with ankle surgery.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

intervention_type: Device


title: Baha Bone Conduction Implants and Magnetic Resonance Imaging

acronym: BAHA-IRM

summary: Bone conduction implants (BCI) are widely used in cases of conductive/ mixed hearing loss or single side deafness when surgical treatment or air hearing aids are not feasible. There are two types of BCI, abutments (which pass through the skin) and magnets (where a subcutaneous magnet is coupled to an external magnet). Pathologies (such as cholesteatoma) leading to the insertion of this hearing implant often require prolonged MRI follow-up. However, both the abutment and the magnet are responsible for imaging artifacts that limit its interpretation. Frequency and extent of these artifacts remain unclear in the literature. In our experience, the magnet, due to its size and composition, produces larger artifacts than the abutment. The main objective of our study is to compare MRI artifacts for each of these device types (abutment and magnet).

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Descriptive Study on the Impact of Covid-19 Lockdown on Deviant Sexual Fantasies

summary:
Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing many populations, worldwide, into confinement for their own protection. The very characteristics of this confinement and of the disease (isolation, potential severity of the illness, being psychologically unprepared for such a circumstance) have a significant impact on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning to normal life, vicarious traumas… Confinement is paradoxical in as although well-intended to protect the individual, it leads to the isolation of the individual. This paradox is destabilizing one's feelings, because when the investigators feel the need for protection and reassurance, the investigators are left alone and feel abandoned. The investigators therefore understand that this confinement framework is in essence a situation that might revive unresolved deprivation situations from the childhood. How to react in front of this upsurge in anxiety? Strategies used may include, among others, escape in the imaginary through numerical tools or others, and /or going to the actual characterized by deviant sexual behaviours. The investigators know in fact that certain moments, like anxiety, depression, boredom, psychological unrest are propicious for acting, for violent sexual offenders. The investigators therefore pay extra attention to our patients in such periods favoring these kinds of trouble.

This study will enable us to understand if the confinement associated with COVID 19 has generated anxiety that lead sexual offenders or individuals with paraphilic disorders to engage into deviant fantasies or, potentially sexual activities.

intervention_type: Behavioral


title: Etude de Cohorte Observationnelle Rétrospective SYMBOL CUP 1

summary: This is a single-center retrospective observational cohort study of consecutively operated patients who underwent primary total hip arthroplasty with a SYMBOL CUP DM HA hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of that implant at two-year follow-up.

lead_sponsor: Dedienne Sante S.A.S.

location_facility: Lyon Ortho Clinic - Clinique de la Sauvegarde


title: Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas

acronym: ICILOLA

summary:
When patients arrive in the waiting room of the MRI department, patients will be given the briefing note explaining the purpose of the study and how it is going. During the consultation, the radiologist will check the inclusion and non-inclusion criteria, and will take the time to answer all of the patient's questions about the study (or his family member by telephone if the patient does not is not in a condition to give its consent).

The MRI examination will be performed on a 3T multi-parametric MRI. If the neurological disorder presented by the patient does not require an injection as part of routine care, only a high resolution 3D T2 sequence on the nasosinus cavities and the olfactory tract, called bFFE-Xd for approximately 2 min.

If the neurological disorder presented by the patient requires an injection as part of current care, the examination will be completed with the nasosinus and olfactory 3D bFFE-Xd sequence, and the following additional sequences performed after post injection: a

3D FABIR 0.9 sequence covering the brain, dedicated to exploring the subarachnoid spaces;
a 3D T1 TSE 0.7 sequence covering the brain looking for meningeal or encephalic contrast enhancement,
FLAIR HR coronal sequence (high resolution) exploring the limbic system.
Optional: a 3D FLAIR "labyrinth" sequence in the event of hearing / balance problems; a DCE infusion sequence (T1-WI) on the olfactory tract if olfactory disorder, which will be the first sequence made at the time of injection.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


type: EudraCT Number

title: Optimizing Response to Li Treatment Through Personalized Evaluation of Individuals With Bipolar I Disorder: The R-LiNK Initiative

acronym: R-LiNK

summary:
Bipolar disorder (BD), especially BD type I, is a highly prevalent mental disorder and a is a highly prevalent mental disorder and an important factor for suicide. Lithium is the key treatment for prevention of BD relapse and has a proven suicide prevention effect. Whilst many cases become asymptomatic with lithium treatment, the majority show sub-optimal response.

The objectives of this project are to:

improve outcomes of bipolar I disorder (BDI) cases prescribed lithium through the application of stratified approaches
optimize the early prediction of lithium response using a set of multi-modal biomarkers ("blood omics", Magnetic Resonance Imaging and Li7-Magnetic Resonance Spectroscopy derived-markers)
develop a multidisciplinary multinational network of experts to undertake this and future projects on personalized diagnostics and therapeutics and
implement new, powerful technologies to characterize brain lithium distribution and the blood molecular signature of lithium in responders and non-responders.

This cutting edge approach will identify the eligibility criteria for treatment with lithium in BD in terms of response, safety and tolerability.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Drug


title: Study of Conjunctival and Retinal Blood Vessels for the Evaluation of the Load of Small Vessel Disease in Patients With Transient Ischemic Attacks (TIAs) and Minor Strokes

acronym: EVACORMA

summary:
The purpose of the study is to use a simple photography of conjunctival vessels to search for an association between conjunctival vessels abnormalities and the load of small vessel disease as quantified by MRI in patients with TIA s and minor strokes.

The artificial intelligence (AI) tools will permit to classify abnormalities of conjunctival vessels that predict the load of small vessel disease in TIAs and strokes.

study_type: Interventional

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Toulouse


title: Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in Patients With Congenital Central Hypoventilation Syndrome

acronym: DyspnOndine

summary:
Congenital central hypoventilation syndrome (CCHS) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of CO2/H+ chemosensitivity. This suggests cortical activity during awakening to maintain breathing. Cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (NIV) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. This can suggest that CCHS may be breathless at rest and this discomfort could be reduced by NIV.

The objective is to evaluate dyspnea with a multi dimensional score, MDP, in CCHS patient at rest in every day life and during 1H session of NIV.

The investigators will perform a prospective, including 20 CCHS patients. MDP scores will be measure before and after 1H-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after NIV.

The investigators expect that CCHS patients don't have rest dyspnea but NIV would improve breathing discomfort that would mean they have latent rest dyspnea.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière


title: Mediolateral Episiotomy and Prevention of Obstetric Anal Sphincter Injuries in Instrumental Delivery: a Prospective Population-based Propensity Score Study

acronym: INSTRUMODA

summary:
Literature is contradictory about the impact of mediolateral episiotomy during operative vaginal delivery in obstetric anal sphincter injuries prevention explaining the absence of international guidelines. The investigators consider that a randomized trials does not appears feasible for both ethical and practical reason and so we suggest a large national observational study.

The investigators will include all nulliparous women that underwent an operative vaginal delivery within the 72h following the delivery at more than 34 weeks of amenorrhea. The investigators will collect data about the history of pregnancy, the course of labor, the mode of delivery, maternal immediate and one-year morbidity, neonatal immediate morbidity. The investigators expect a one-year study in 129 recruiting center with 15000 included women.

The primary objective is to assess the protective effect of mediolateral episiotomy against obstetric anal sphincter injury during instrumental delivery in nulliparous women according to the type of instrument used. The secondary endpoints are to investigate the effect of mediolateral episiotomy on one-year maternal morbidity, immediate maternal morbidity. The investigators also aim to develop a clinical score to assess the absolute risk of obstetric anal sphincter injury during instrumental delivery. Finally, the investigators will investigate the impact of fetal presentation ultrasound assessment immediately before instrumental delivery on the mode of delivery.

ReferenceType: derived

ReferenceCitation: Gachon B, Schmitz T, Artzner F, Parant O, De Tayrac R, Ducarme G, Le Ray C, Pizzoferrato AC, Garabedian C, Riethmuller D, Pierre F, Ragot S, Fritel X; GROG (Groupe de Recherche en Gynécologie Obstétrique). A core outcome set development for a French national prospective study about the effect of mediolateral episiotomy on obstetric anal sphincter injury during operative vaginal delivery (INSTRUMODA). BMC Pregnancy Childbirth. 2021 Mar 25;21(1):251. doi: 10.1186/s12884-021-03603-0.

family: Gachon

full_name: Bertrand Gachon

given: Bertrand

sequence: first

name: the GROG (Groupe de Recherche en Gynécologie Obstétrique)

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

sequence: additional

family: Artzner

full_name: France Artzner

given: France

family: Parant

full_name: Olivier Parant

given: Olivier

family: De Tayrac

full_name: Renaud De Tayrac

given: Renaud

family: Ducarme

full_name: Guillaume Ducarme

given: Guillaume

family: Le Ray

full_name: Camille Le Ray

given: Camille

family: Pizzoferrato

full_name: Anne Cécile Pizzoferrato

given: Anne Cécile

family: Garabedian

full_name: Charles Garabedian

given: Charles

family: Riethmuller

full_name: Didier Riethmuller

given: Didier

family: Pierre

full_name: Fabrice Pierre

given: Fabrice

family: Ragot

full_name: Stephanie Ragot

given: Stephanie

family: Fritel

full_name: Xavier Fritel

given: Xavier

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Pregnancy and Childbirth

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Poitiers University Hospital

intervention_type: Procedure


title: Effect of " Sitting in a Chair " Versus " Conventional Semi-recumbent In-bed Position " on the Oxygenation Level for ICU Non-sedated Patients

acronym: FALCON

summary:
The positioning of the ICU patient is a daily concern of the medical and paramedical teams. Developments in emergency medicine and sedation and analgesia techniques have made it possible to reduce patient mortality. However, considered too unstable, patients were no longer mobilized outside the bed until the complete resolution of the symptoms that led to hospitalization or surgery.

Despite encouraging results for early mobilization, bed and rest remained the most widespread positioning technique worldwide with the emergence of intensive care units, mechanical ventilation and sedation/analgesia/curarization. The result is peripheral muscular amyotrophy and respiratory muscular amyotrophy, with increased length of stay and exacerbated morbidity/mortality several years after discharge from ICU.

Numerous studies have shown the value of early mobilization of the ICU patient to preserve functional and muscular capital.

However, few studies have evaluated the value of mobilizing the ICU patient from the bed in order to improve oxygenation. The lack of mobility outside the bed causes condensation of the pulmonary parenchyma at the bases and in the dorsal region when the patient is lying down or in a prolonged semi-seated position.

In awake spontaneously ventilated patients, whether intubated on ventilatory support (Pressure Support), non-invasive ventilation (NIV) or high flow nasal oxygen therapy (HFNO), the reference position is a semi-seated patient with the head of the resuscitation bed tilted at 30°. The problem with this position in the bed is that patients tend to slide toward the foot of the bed. This migration is due to gravity or the design of the ICU bed. The end result of this migration is that the inclination indicated by the bed head inclinometer does not correspond to the actual angulation between the patient's lower limbs and trunk. The patient finds himself "compressed" in the lower abdomen, which can lead to compression of the diaphragm and thus hypoventilation in the postero-caudal regions of the lungs.

Our hypothesis is that the chair position (outside the ICU bed) allows, without modification of the ventilatory parameters, to improve the alveolar ventilation and thus the oxygenation of the arterial blood, compared to the "natural" semi-seated position in the ICU bed, in patients with spontaneous ventilation (PS/NIV/HFNO).

design_allocation: Randomized

primary_purpose: Other

ReferenceCitation: Domański Z, Niezabitowski K, Latawiec-Mazurkiewicz I. [Phlebography of the spermatic vein near the unpalpable testicle]. Rofo. 1980 Sep;133(3):322-4. German.

ReferenceCitation: Castellani G, Vincenzi G, Brugnolo E. [Reliability of parapulp support in the coronal reconstruction of silver amalgam in posterior teeth]. Dent Cadmos. 1983 Jun;51(6):25-32. Italian.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Impact of Art Therapy on Alexithymia in People With Alcohol Use Disorder

acronym: ALEXART

summary: Art therapy support combined with standard care for people with an alcohol use disorder coming to a day hospital for withdrawal could be beneficial compared to standard care alone because it would improve the alexithymia of these patients, helping them to better identify their feelings and / or emotions, and improve their self-confidence, their self-esteem self and their oral communication.


title: Oncology Care Pathway's Modifications Impact During COVID-19 Pandemic : the ONCOCARE-COV Study

acronym: ONCOCARE-COV

summary: In december 2019, SARS-CoV2 and its clinical manifestations, COVID-19, appeared in China and caused a pandemic. It led decision makers to prioritize emergency and intensive care dedicated to infection management. Other conditions, such as cancer screening, diagnosis, and treatment, may have been delayed during the containment period. Consequences of this "distraction effect" are being.

lead_sponsor: CHU de Reims


title: Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition

summary: Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.

design_allocation: Non-Randomized

primary_purpose: Supportive Care

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

intervention_type: Dietary Supplement


title: Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages

acronym: SCLERO JAK

summary: The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients

time_perspective: Cross-Sectional

lead_sponsor: Rennes University Hospital


title: Hemodynamic and Respiratory Tolerance of Intermittent Hemodialysis (Acetate Free Biofiltration and Bicarbonate-based Intermittent Dialysis) in Critically Ill Patients

acronym: COOBrA

summary: Acute kidney injury (AKI) affects up to 30% of critically ill patients and is associated with increased rates of mortality. Up to 60% of patients with AKI will ultimately require renal replacement therapy (RRT). Intermittent hemodialysis (IHD) is one of the main methods of RRT worldwide. In IHD-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. To avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). However, IHD-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the CO2 release in the circulation during IHD (HCO3- <--> CO2 + H2O). Some recent studies showed that acetate free biofiltration (AFB-K), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of CO2 delivered to the patients. AFB-K may thus improve the hemodynamic and respiratory tolerance of intermittent RRT in critically ill patients.


title: Prospective Evaluation of Programmed Ventricular Stimulation Before Pulmonary Valve Replacement in Patients With Tetralogy of Fallot

summary:
Severe pulmonary regurgitation is common in patients with Tetralogy of Fallot and results in progressive right ventricular dilatation and dysfunction. Pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing.

Ventricular arrhythmias are a frequent late complication in patients with tetralogy of Fallot. The most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch.

While an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. An electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. Moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis.

At present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking.

The aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of Fallot.

lead_sponsor: Paris Cardiovascular Research Center (Inserm U970)


title: Comparison of the Effectiveness of 3 Teaching Methods in Oral Hygiene in Adolescent Orthodontic Patients: Prospective Randomized Controlled Clinical Study

acronym: MAHO

summary:
Orthodontic appliances have been shown to interfere with oral hygiene maneuvers by providing many additional sites for formation and retention of biofilm.

Its accumulation is responsible for undesirable effects such as decays and periodontal pathologies. These lower the benefit / risk ratio of orthodontic treatments. In addition, their management is not negligible at the macroeconomic level.

As such, it is more than necessary for the orthodontist to teach oral hygiene methods adapted to each of his patients fitted to limit the risk of appearance of biofilm.

primary_purpose: Prevention

ReferenceCitation: Le Fouler A, Jeanne S, Sorel O, Brézulier D. How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods. Trials. 2021 Feb 15;22(1):144. doi: 10.1186/s13063-021-05093-z.

family: Le Fouler

full_name: Alisée Le Fouler

given: Alisée

family: Jeanne

full_name: Sylvie Jeanne

given: Sylvie

family: Sorel

full_name: Olivier Sorel

family: Brézulier

full_name: Damien Brézulier

given: Damien

journal_name: Trials

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square


title: Project A4sc - An Atlas of Airways at a Single Cell Level

summary:
The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.

status: Unknown status

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice

status_simplified: Unknown


title: Catheter Ablation in Congenital Heart Disease: French National Prospective Registry

acronym: CATCH-Registry

summary:
Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population.

The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures.

Most of available studies are retrospective or include a limited number of patients.

The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.


type: Registry Identifier

title: Evaluation of a Cohort of Congenital Deep Deafness Patients and/or With Auditory Neuropathy, Looking for DFNB9

acronym: AUDIOFERLINE

summary:
Evaluation of a cohort of deaf children looking for autosomal recessive deafness-9 (DFNB9).

Clinical and audiologic evaluation of patients with known auditive neuropathy / auditory dys-synchrony (ANAD) or recently diagnosed congenital severe to profound hearing loss (HL), and assessing genetic analysis looking for DFNB9. The investigators expect to compile genotypic and phenotypic characterization of 25 children with DFNB9 within 4 years.

time_perspective: Other

ReferenceCitation: Denoyelle F, Petit C. DFNB9. Adv Otorhinolaryngol. 2002;61:142-4.

ReferenceCitation: Loundon N, Marcolla A, Roux I, Rouillon I, Denoyelle F, Feldmann D, Marlin S, Garabedian EN. Auditory neuropathy or endocochlear hearing loss? Otol Neurotol. 2005 Jul;26(4):748-54.

ReferenceCitation: Marlin S, Feldmann D, Nguyen Y, Rouillon I, Loundon N, Jonard L, Bonnet C, Couderc R, Garabedian EN, Petit C, Denoyelle F. Temperature-sensitive auditory neuropathy associated with an otoferlin mutation: Deafening fever! Biochem Biophys Res Commun. 2010 Apr 9;394(3):737-42. doi: 10.1016/j.bbrc.2010.03.062. Epub 2010 Mar 16.

ReferenceCitation: Mehl AL, Thomson V. The Colorado newborn hearing screening project, 1992-1999: on the threshold of effective population-based universal newborn hearing screening. Pediatrics. 2002 Jan;109(1):E7.

ReferenceCitation: Migliosi V, Modamio-Høybjør S, Moreno-Pelayo MA, Rodríguez-Ballesteros M, Villamar M, Tellería D, Menéndez I, Moreno F, Del Castillo I. Q829X, a novel mutation in the gene encoding otoferlin (OTOF), is frequently found in Spanish patients with prelingual non-syndromic hearing loss. J Med Genet. 2002 Jul;39(7):502-6.

ReferenceCitation: Rouillon I, Marcolla A, Roux I, Marlin S, Feldmann D, Couderc R, Jonard L, Petit C, Denoyelle F, Garabédian EN, Loundon N. Results of cochlear implantation in two children with mutations in the OTOF gene. Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):689-96. Epub 2005 Oct 13.

ReferenceCitation: Roux I, Safieddine S, Nouvian R, Grati M, Simmler MC, Bahloul A, Perfettini I, Le Gall M, Rostaing P, Hamard G, Triller A, Avan P, Moser T, Petit C. Otoferlin, defective in a human deafness form, is essential for exocytosis at the auditory ribbon synapse. Cell. 2006 Oct 20;127(2):277-89.

ReferenceCitation: Varga R, Avenarius MR, Kelley PM, Keats BJ, Berlin CI, Hood LJ, Morlet TG, Brashears SM, Starr A, Cohn ES, Smith RJ, Kimberling WJ. OTOF mutations revealed by genetic analysis of hearing loss families including a potential temperature sensitive auditory neuropathy allele. J Med Genet. 2006 Jul;43(7):576-81. Epub 2005 Dec 21.

ReferenceCitation: Yasunaga S, Grati M, Cohen-Salmon M, El-Amraoui A, Mustapha M, Salem N, El-Zir E, Loiselet J, Petit C. A mutation in OTOF, encoding otoferlin, a FER-1-like protein, causes DFNB9, a nonsyndromic form of deafness. Nat Genet. 1999 Apr;21(4):363-9.

location_facility: Unité d'Audiophonologie et d'Implantation cochléaire - Necker hospital


title: Immunologic Biomarker Profile of Cerebrospinal Fluid

acronym: BIOMOG

summary: The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Serum Neurofilaments Light Chain and GFAP (Glial Fibrillary Acidic Protein) in Atypical Idiopathic Inflammatory Demyelinating Disorders

acronym: AMIS

summary:
Idiopathic inflammatory disorders of the central nervous system include various disorders of which multiple sclerosis is the most common. Besides multiple sclerosis, other distinct disorders including for example anti-AQP4 (aquaporine-4) and anti-MOG (Myelin oligodendrocyte glycoprotein) NMOSD (Neuromyelitis optica spectrum disorder) have been well characterized and are now known to be distinct from MS.

some patient belonging to MS spectrum have recently being characterized but unusual MRI findings have mimicking inherited leukoencephalopathies and leukodystrophies.

Whether these patients with atypical phenotype represent a separate disease distinct from MS or belong to MS spectrum is not clear.

The objectives are to evaluate a series of 15 patients with atypical forms of MS using non-conventional MRI techniques and biological biomarkers (serum neurofilaments light chain) and to compare them with classical MS patients (15 relapsing remitting patients and 15 progressive patients) and 15 controls. the hypothesize is that these patients with atypical MS have a more severe neurodegenerative process.


title: Characteristics in Doppler Ultrasound of the Carotid Diaphragm Responsible for an Ischemic Stroke

acronym: DIADOP

summary:
Carotid diaphragms are a non-atheromatous arterial cause of cerebral infarction, especially in young people (≤65 years old). This anomaly is more common in the African or African-American population, although it is more and more often discovered in young Caucasians. This cause of cerebrovascular accident (CVA), known until the 1970s, was later forgotten until a recent revival of interest, probably in connection with the improvement of imagery but also by the discovery that these lesions have a high rate of recurrence in the absence of interventional care. In a Brazilian study, the carotid diaphragm was reported in 10% of patients under the age of 60.

The carotid diaphragm is a non-atheromatous overgrowth of the intima of the arterial wall. It appears in imagery in the form of an endoluminal web wider than it is tall. Its preferred seat is the carotid bulb. It is a source, by an embologenic mechanism, of cerebral infarction starting from local thrombus developed within large cerebral arteries. In histology, the lesions are different from atherosclerosis and characterized by a thickening of the intima with proliferation of loose and strewed spindle cells mainly involving the intima.

An atheromatous plaque or dissection with detachment of the intima are the two main differential diagnoses of the carotid web. However, the appearance of a diaphragm implanted on a regular wall and the absence of any other localization of atheroma distinguish the lesion of the carotid web from that of a focal atheromatous plate. In addition, the very proximal localization of the carotid web, from the emergence of the internal carotid artery, does not suggest a dissection, the localization of which is usually downstream of the bulb.

The baseline exam to detect a carotid diaphragm is a carotid angiography scan, but the abnormalities are often inconspicuous, making diagnosis difficult. We can be led in case of doubt to perform a conventional arteriography, which remains the "gold standard". The latter, dynamic examination compared to the CT scan, shows above all a stasis of blood flow in the recess created by the diaphragm, stasis at the origin of the formation of thrombi. It has been suspected that the maximum risk of infarction is upon waking, at the time of verticalization, with mobilization of the thrombus.

Therapeutically, the discovery of a symptomatic carotid diaphragm (ischemic swallowing accident) justifies radical treatment. The risk of recurrence of a patient on antithrombotic (antiplatelet or anticoagulant) being too high, it is proposed either surgery, or carotid angioplasty with stent placement. No comparative study of the 2 techniques has been carried out.

Besides radiological examinations, ultrasound is another technique for studying the cervical arteries. It is reputed to be of little contribution in the search for a carotid diaphragm, but few publications exist to date even though the cervical Doppler is often the first arterial examination carried out after an ischemic stroke. Two series reported Doppler ultrasound data in the carotid diaphragm. A recent retrospective study evaluated, in multimodal imaging [Doppler, CT scan of the Supra-Aortic Trunks (ASD) and conventional arteriography], 30 patients (60 carotids) with diaphragm or atherosclerosis. The correlation between conventional arteriography and CT angiography was perfect, but the correlation between Doppler and CT angiography for diaphragm diagnosis was moderate. In another series studying 15 diaphragms diagnosed by CT angiography, the retrospective analysis of doppler reports revealed that 40% were considered normal and 60% mentioned nonspecific hyperechoic lesions, but this work remained in the form of a presentation. at a congress. With the improvement of the technique and the resolution of the Doppler ultrasound as well as the knowledge of the particular ultrasound characteristics, it seems to us that this examination could regain a place in the diagnosis of the pathology. The carotid diaphragm is also largely unknown to vascular doctors practicing cervical Doppler ultrasound.

This descriptive study of the diagnostic contribution of the echo-doppler for a carotid diaphragm has for perspective the establishment of a prospective study of the contribution of a combined expertise angiologist-neurologist in the echo-Doppler for patients <60 years hospitalized for an ischemic stroke.

ReferenceType: result

ReferenceCitation: Haussen DC, Grossberg JA, Bouslama M, Pradilla G, Belagaje S, Bianchi N, Allen JW, Frankel M, Nogueira RG. Carotid Web (Intimal Fibromuscular Dysplasia) Has High Stroke Recurrence Risk and Is Amenable to Stenting. Stroke. 2017 Nov;48(11):3134-3137. doi: 10.1161/STROKEAHA.117.019020. Epub 2017 Oct 10.

name: From the Emory University/Grady Memorial Hospital, Atlanta, GA.

family: Haussen

full_name: Diogo C. Haussen

given: Diogo C.

family: Grossberg

full_name: Jonathan A. Grossberg

given: Jonathan A.

family: Bouslama

full_name: Mehdi Bouslama

given: Mehdi

family: Pradilla

full_name: Gustavo Pradilla

given: Gustavo

family: Belagaje

full_name: Samir Belagaje

given: Samir

family: Bianchi

full_name: Nicolas Bianchi

given: Nicolas

family: Allen

full_name: Jason W. Allen

given: Jason W.

family: Frankel

full_name: Michael Frankel

given: Michael

family: Nogueira

full_name: Raul G. Nogueira

given: Raul G.

journal_name: Stroke

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Coutinho JM, Derkatch S, Potvin AR, Tomlinson G, Casaubon LK, Silver FL, Mandell DM. Carotid artery web and ischemic stroke: A case-control study. Neurology. 2017 Jan 3;88(1):65-69. doi: 10.1212/WNL.0000000000003464. Epub 2016 Nov 18. Erratum in: Neurology. 2017 Aug 1;89(5):521.

family: Coutinho

full_name: Jonathan M. Coutinho

given: Jonathan M.

family: Derkatch

full_name: Sheldon Derkatch

given: Sheldon

family: Potvin

full_name: Alphonse R.J. Potvin

given: Alphonse R.J.

family: Tomlinson

full_name: George Tomlinson

given: George

family: Casaubon

full_name: Leanne K. Casaubon

given: Leanne K.

family: Silver

full_name: Frank L. Silver

given: Frank L.

family: Mandell

full_name: Daniel M. Mandell

given: Daniel M.

journal_name: Neurology

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

title: Carotid artery web and ischemic stroke

ReferenceCitation: Madaelil TP, Grossberg JA, Nogueira RG, Anderson A, Barreira C, Frankel M, Haussen DC. Multimodality Imaging in Carotid Web. Front Neurol. 2019 Mar 12;10:220. doi: 10.3389/fneur.2019.00220. eCollection 2019.

title: Multimodality Imaging in Carotid Web


title: Evaluation of Sexual Quality of Life in Women Less Than 51 Years Old, During Adjuvant Hormonal Therapy for Breast Cancer

summary:
Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects.

According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered.

In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods.

This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.

ReferenceCitation: Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015. Review.

ReferenceCitation: Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26. Review.

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

location_facility: Institut régional du Cancer de Montpellier


type: Other Identifier

title: Simultaneous Study of the Serum Tryptase Level of the Mother and the Child During Childbirth

acronym: TryPla

summary:
Currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. For example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. However, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. There is also no database that has defined normal values for tryptase in cord blood.

Our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Biological


title: VERARE : Effectiveness of Virtual Motor Actions for Improving Walking in Patients With Post-resuscitation Muscle Weakness

acronym: VERARE

summary:
After a hospitalization in Intensive Care Unit (ICU), approximately 50% of patients usually have a ICU-Weakness, i.e. nerves and muscles injury secondary to immobilization and to treatments which had to be used. This disease is expected to be similar or even higher in patients suffering from COVID-19 and hospitalized in ICU due to the average length of hospitalization of several weeks in this population. This condition will delay the return-to-walk of these patients, their discharge from hospitalization and may deteriorate their autonomy in daily life activities.

Virtual Reality (VR) environments are already used and have proven their worth for the assessment and rehabilitation of patients with neurological diseases. It therefore seems appropriate to offer the use of virtual environments for this type of population. VR represents a unique opportunity for the rehabilitation care of these patients, and in particular those who have been reached by COVID-19, due to the possible mismatch between the amount of motor rehabilitation to be provided and the fatigability and breathlessness at the slightest effort which seem particularly intense in this population.

The main objective of our project is to improve and to accelerate gait recovery in patients hospitalized in Physical and Rehabilitation Medicine after discharge from Resuscitation or Continuous Care Unit and in patients hospitalized in ICU and presenting ICU-weakness secondary to resuscitation, notably due to COVID-19 infection, thanks to the use of Virtual Reality tools. The VR tool will consist of virtual environments presented using a Virtual Reality headset where an avatar (double) of the patient hospitalized in Physical and Rehabilitation Medicine or in ICU will be represented, who will perform different motor tasks involving their lower limbs (ex: walking, or kicking a ball) in several different virtual environments (settings). The patient will be asked to observe actions, then to imagine carrying out their actions which will be performed by the avatar in the virtual environment, then they will be able to control the actions of the avatar using their legs thanks to sensors, then feel walking sensations through the use of haptic devices.

status: Withdrawn


title: Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial

acronym: COLO-GENIUS

summary:
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy.

The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).

lead_sponsor: Clinique Paris-Bercy


title: Prevalence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) Following Squamous Cell Carcinomas of the Oropharynx Treatment by Combined Chemoradiotherapy

acronym: COROSAS

summary: The study's aim is to determinate the prevalence of obstructive sleep apnea hypopnea syndrome after treatment by combined chemoradiotherapy in a locally advanced stages treated population of oropharyngeal cancer. Indeed, the level of knowledge about the consequences of oropharyngeal cancer treatment on sleep quality remains poor but the few studies published on the subject suggest an increased risk of development of OSAHS for these patients.


title: O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus

acronym: METABOLUPS

summary: This study aims at defining the role of O-GlcNAcylation is in the physiopathology of systemic lupus erythematosus (SLE). O-GlcNAcylation is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Service d'Immunologie et Immunogénétique


title: Assessment of Human Diaphragm Strength by Magnetic and Electric Stimulation After Ultrasonography Phrenic Nerve Tracking : a Randomized, Cross Over, Physiologic Study in Critically Ill Patients Requiring Invasive Mechanical Ventilation

acronym: SONOSTIM

summary: Development and validation of a new affordable and easy-to-use phrenic nerve stimulation tool for diaphragm strength assessment in intensive care unit

ipd_sharing: Yes

ipd_sharing_description: Individual patient data will be made available upon a reasonable request

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire Saint Eloi


title: Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index

acronym: ABIPULSE

summary:
Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical practice.

The recommended measurement was gradually replaced by colour or pulsed Doppler without validation of these techniques.

The objective of our study is to compare these two techniques (color Doppler and pulsed Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI measurement.

lead_sponsor: University Hospital, Caen


title: Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers

acronym: ECOG

summary: Acoustic overexposure can induced temporary or hearing loss. Usually hearing loss is associated with cochlear cell damages. Recently, a new pathological entity was described and called "hidden hearing loss". In animal model, the histopathology revealed a selective reduction in the number of auditory fibers, resulting in a decrease in the amplitude of wave I of the auditory brainstem response. Electrocochleography (Ecog) is a method for recording the electrical potentials of the cochlea (e.g. wave I). In clinical routine, Ecog is performed invasively with sedation or local anesthesia. Actually, a non invasive approach could be perform but it seems necessary to optimize this method and to define reference values in healthy volunteers.

intervention_type: Diagnostic Test


title: Impact of Body Mass Index on Positive End-Expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anesthesia: A Retrospective Observational Study

acronym: PEPTI

summary:
The induction of general anaesthesia is associated with a fall in lung volume due in particular to a decrease in muscle tone and the formation of denitrogenation atelectasis. Many recent studies insist on the need to apply a so-called "protective" strategy of intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena. However, the setting of PEEP remains debated and several authors agree on the need to individualize ventilatory parameters, particularly in obese patients, without describing the individualization tools.

In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to determine whether the use of this technique during general anaesthesia allows for the individualization of PEEP, and whether the value determined is correlated with the body mass index (BMI).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Methotrexate-associated Anti-TNF Alpha (Infliximab/Adalimumab) Combination Therapy: Evaluation of Efficacy and Safety Compared to Traditional Azathioprine-associated Combination Therapy in Patients With Chronic Inflammatory Bowel Disease.

acronym: MTX

summary:
The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). The benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy).

Data on the use of immunosuppressive methotrexate treatment are divergent. Indeed, a previous randomized trial suggested that the combination of anti-TNF alpha including infliximab and methotrexate was no more effective than anti-TNF alpha monotherapy in patients with Crohn's disease. However, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time.

In practice, more and more practitioners are prescribing this combination (antiTNF and MTX) in IBD patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint.

The interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.

status: Active, not recruiting


title: INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients

acronym: INSTIGO

summary: The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.

ReferenceCitation: Veyssière H, Lusho S, Molnar I, Kossai M, Bernadach M, Abrial C, Bidet Y, Radosevic-Robin N, Durando X. INSTIGO Trial: Evaluation of a Plasma Protein Profile as a Predictive Biomarker for Metastatic Relapse of Triple Negative Breast Cancer. Front Oncol. 2021 Jun 25;11:653370. doi: 10.3389/fonc.2021.653370. eCollection 2021.

family: Veyssière

full_name: Hugo Veyssière

given: Hugo

family: Lusho

full_name: Sejdi Lusho

given: Sejdi

family: Molnar

full_name: Ioana Molnar

given: Ioana

family: Kossai

full_name: Myriam Kossai

given: Myriam

family: Bernadach

full_name: Maureen Bernadach

given: Maureen

family: Abrial

full_name: Catherine Abrial

given: Catherine

family: Bidet

full_name: Yannick Bidet

given: Yannick

family: Radosevic-Robin

full_name: Nina Radosevic-Robin

given: Nina

family: Durando

full_name: Xavier Durando

given: Xavier

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

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

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

lead_sponsor: Centre Jean Perrin


title: National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

summary: The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.

lead_sponsor: University Hospital, Toulouse


title: Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study

acronym: DrainICU

summary: This prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.

primary_purpose: Treatment


title: Neutropenic Enterocolitis in Critically Ill Hematological Patients: Taxonomic and Functional Analysis of Gut Microbiota

acronym: PROFANE

summary: A prospective, single-center, cohort study to allow collecting observations of patients receiving induction chemotherapy for primary Acute Myeloid Leukemia (AML), collecting biological samples(including fecal samples for microbiota analyses, and metagenomic profiling in blood samples) and clinical outcomes (notably the occurrence of neutropenic enterocolitis), with a nested case-control analysis comparing patients with or without neutropenic enterocolitis

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis.

acronym: MUCODIABTAB

summary: Reducing tobacco consumption is a major public health objective, with the prevalence of active smoking estimated in 2017 at 26.9% of the French population aged 18 to 25. The negative impact of passive smoking on children's health and development has been demonstrated by numerous studies, especially with regard to respiratory pathologies. Parental smoking is also a risk factor for active smoking in adolescence and adulthood (with an odds ratio of 1.72 if at least one of the two parents is a smoker). It has been shown that intervention with parents can reduce the number of children exposed to passive parental smoking by about 5%.


title: Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90

acronym: HSP-HEMATO

summary: NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).


title: INTER-Regional COHORTE of Long Term Pancreatic Cancer Survivors

acronym: CaPaLong

summary: The study is particularly innovative as it will accurately analyze the microscopic characteristics of the stroma, tumor budding and mucin expression in adenocarcinomas of the pancreas, using a comparative approach of long-survivor/short-survival patients.

lead_sponsor: University Hospital, Lille


title: Influence of Breastfeeding on Gut Health in Children

acronym: PENSINE

summary: The aim of the study is to evaluate the impact of early nutrition on gut health in children. A prospective cohort of newborns will be recruited at birth and followed up to 4 years of age. Information on parent's nutritional habits and life style, breastfeeding duration and child's complementary feeding, will be collected. Cord blood cells and stools will be collected at birth, 6 months, 2 years and 4 years of age for implementing a biological collection. Gut health will be evaluated in children during the first four years of life based on fecal secretory immunoglobulin A (SIgA) and presence of digestive symptoms. Precise data on breastfeeding practices and their short- and medium-term effects on the health of the child, in particular and in an innovative way on gut health, will be obtained.

ReferenceCitation: Ley D, Beghin L, Morcel J, Flamein F, Garabedian C, Accart B, Drumez E, Labreuche J, Gottrand F, Hermann E. Impact of early life nutrition on gut health in children: a prospective clinical study. BMJ Open. 2021 Sep 6;11(9):e050432. doi: 10.1136/bmjopen-2021-050432.

family: Ley

full_name: Delphine Ley

given: Delphine

family: Beghin

full_name: Laurent Beghin

given: Laurent

family: Morcel

full_name: Jules Morcel

given: Jules

family: Flamein

full_name: Florence Flamein

given: Florence

family: Garabedian

full_name: Charles Garabedian

given: Charles

family: Accart

full_name: Bertrand Accart

given: Bertrand

family: Drumez

full_name: Elodie Drumez

given: Elodie

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Gottrand

full_name: Frederic Gottrand

given: Frederic

family: Hermann

full_name: Emmanuel Hermann

given: Emmanuel

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories:
PubMed Central
medRxiv

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: " Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"

acronym: ARONCO

summary:
The purpose of this study is to evaluate the impact of art-therapeutic management on a patient with cancer, during chemotherapy treatment, on the reduction of physical or psychological symptoms.

Art therapy is a non-drug approach that can help some patients cope with the consequences of cancer beyond the care provided.

The common psychosocial difficulties experienced by cancer patients are pain, fatigue, depression, anxiety, drowsiness. In sum, the well-being and quality of life of the patient throughout the illness.

The main objective is to evaluate the impact of art therapy, as a supportive care, on improving the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions( around 24 days between 2 sessions) , at patients with a cancer pathology using two questionnaires, one on the evaluation of symptoms (ESAS), the other on the quality of life (FACT-G).

ReferenceCitation: Schiltz L, Zimoch A. [Using arts therapies in psycho-oncology: evaluation of an exploratory study implemented in an out-patient setting]. Bull Soc Sci Med Grand Duche Luxemb. 2013;(1):48-71. French.

ReferenceCitation: Götze H, Geue K, Buttstädt M, Singer S, Schwarz R. [Art therapy for cancer patients in outpatient care. Psychological distress and coping of the participants]. Forsch Komplementmed. 2009 Feb;16(1):28-33. doi: 10.1159/000191211. Epub 2009 Jan 30. German.

ReferenceCitation: Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836. Review.

ReferenceCitation: Nainis N, Paice JA, Ratner J, Wirth JH, Lai J, Shott S. Relieving symptoms in cancer: innovative use of art therapy. J Pain Symptom Manage. 2006 Feb;31(2):162-9.

ReferenceCitation: Geue K, Goetze H, Buttstaedt M, Kleinert E, Richter D, Singer S. An overview of art therapy interventions for cancer patients and the results of research. Complement Ther Med. 2010 Jun-Aug;18(3-4):160-70. doi: 10.1016/j.ctim.2010.04.001. Epub 2010 May 15. Review.

ReferenceCitation: Bruera E, MacMillan K, Hanson J, MacDonald RN. The Edmonton staging system for cancer pain: preliminary report. Pain. 1989 May;37(2):203-209. doi: 10.1016/0304-3959(89)90131-0.

ReferenceCitation: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9.

ReferenceCitation: Wood MJ, Molassiotis A, Payne S. What research evidence is there for the use of art therapy in the management of symptoms in adults with cancer? A systematic review. Psychooncology. 2011 Feb;20(2):135-45. doi: 10.1002/pon.1722. Review.

ReferenceCitation: Lefèvre C, Ledoux M, Filbet M. Art therapy among palliative cancer patients: Aesthetic dimensions and impacts on symptoms. Palliat Support Care. 2016 Aug;14(4):376-80. doi: 10.1017/S1478951515001017. Epub 2015 Nov 20.

ReferenceCitation: Rhondali W, Lasserre E, Filbet M. Art therapy among palliative care inpatients with advanced cancer. Palliat Med. 2013 Jun;27(6):571-2. doi: 10.1177/0269216312471413.

ReferenceCitation: Conroy T, Mercier M, Bonneterre J, Luporsi E, Lefebvre JL, Lapeyre M, Puyraveau M, Schraub S. French version of FACT-G: validation and comparison with other cancer-specific instruments. Eur J Cancer. 2004 Oct;40(15):2243-52.

ReferenceCitation: Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.

ipd_sharing_description: data sharing characteristics are not yet defined

lead_sponsor: Centre Hospitalier de Perigueux


title: Comparison of Different Refraction Measurements in Adults

acronym: REFRACT

summary:
The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.

The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.

The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.

The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Development of a New Algorithm-based Classification for Glioma

acronym: TELOGNOSTIC

summary: ATRX (X-linked mental retardation and alpha-thalassaemia syndrome protein) loss and pTERT (Telomerase reverse transcriptase) mutation are diagnostic markers of gliomas. However, 4 to 28% of gliomas shows none of these alterations. The aim of this project is to propose a new test able to detect the telomeric status for every glioma. Based on this test and other markers (such as mutation of IDH1 (isocitrate dehydrogenase 1) and IDH2 (isocitrate dehydrogenase 2)), investigators propose an algorithm, able to classify the main subtypes of gliomas (astrocytoma, oligodendroglioma and glioblastoma).

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut de Pathologie Est, Biopathologie moléculaire, Hôpitaux Est, HCL


title: Study of Prognostic Factors in Patients Admitted to ICU for Stroke

acronym: REAVC

summary:
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).

The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Evaluation of Decision Capacity of ICU Patients Under Sedatives. A Prospective Observational Multicenter Study.

acronym: DexCap

summary: This prospective observational multicenter study is intended to investigate the impact of sedatives on the decision capacity of intensive care units patients.


title: Evaluation of an Enriched Speech Rehabilitation Program Combining Speech Therapy and Sensory-motor Integration in Aphasic Patients

acronym: SEMO

summary: SEMO is a multidisciplinary project (language sciences, cognitive psychology and neuropsychology, physical medicine and rehabilitation, neurology, speech-language pathology, functional neuroimaging and engineering sciences) that aims first, to test and develop a novel speech rehabilitation program designed for patients with non-fluent aphasia and, second, to better describe neural reorganization after successful recovery. To this end, the investigators will conduct a prospective monocentric cross-over study, including two cohorts of post-stroke aphasic patients and two control groups.

lead_sponsor: University Hospital, Grenoble


title: Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease

summary: Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.

lead_sponsor: Rennes University Hospital


title: Prospective Study of the 'Win Test', a New Diagnostic Tool to Assess Human Endometrial Receptivity Under Natural Cycle or Hormone Replacement Therapy

acronym: Win-Test

summary: Evaluation of endometrial receptivity is a crucial step in in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) programs. Using "Omic technologies", such as transcriptomic and proteomic analyses, the investigators previously identified a specific molecular signature of human endometrial receptivity during the embryo implantation window. After validation of this signature in fertile women and in an ex vivo model (i.e., stromal and epithelial endometrium cells),the investigatorsdeveloped a diagnostic tool called Win-Test (Window Implantation Test) to evaluate the expression level of a set of endometrial receptivity-specific genes during the implantation window by quantitative RT-PCR. Based on their expression, each endometrial biopsy sample can be classified as receptive, partially receptive or non-receptive. Then, after the identification of the right cycle day within the implantation window where endometrium is considered as receptive, a customized timing for embryo transfer with respect of the synchronization of the embryo-maternal dialogue must be performed. A prospective study to validate the relevance of the Win-Test, is a necessary step to gauge its effectiveness. In this objective, patients with multiple implantation failures will be recruited. Embryo transfers were performed in double-arm: the intervention group had a customized timing of embryo transfer according to the Win-Test strategy and recommendation, the control group had their embryos transferred in a classical timing. Pregnancy and live birth rates (LBR) were compared between groups.

ReferenceCitation: Haouzi D, Entezami F, Torre A, Innocenti C, Antoine Y, Mauries C, Vincens C, Bringer-Deutsch S, Gala A, Ferrieres-Hoa A, Ohl J, Gonzalez Marti B, Brouillet S, Hamamah S. Customized Frozen Embryo Transfer after Identification of the Receptivity Window with a Transcriptomic Approach Improves the Implantation and Live Birth Rates in Patients with Repeated Implantation Failure. Reprod Sci. 2021 Jan;28(1):69-78. doi: 10.1007/s43032-020-00252-0. Epub 2020 Jul 28.

apc_source: openAPC

family: Haouzi

full_name: Delphine Haouzi

family: Entezami

full_name: Frida Entezami

given: Frida

family: Torre

full_name: Antoine Torre

given: Antoine

family: Innocenti

full_name: Charlène Innocenti

given: Charlène

family: Antoine

full_name: Yannick Antoine

family: Mauries

full_name: Charlotte Mauries

given: Charlotte

family: Vincens

full_name: Claire Vincens

given: Claire

family: Bringer-Deutsch

full_name: Sophie Bringer-Deutsch

given: Sophie

family: Gala

full_name: Anna Gala

given: Anna

family: Ferrieres-HOA

full_name: Alice Ferrieres-HOA

given: Alice

family: Ohl

full_name: Jeanine Ohl

given: Jeanine

family: Gonzalez Marti

full_name: Beatriz Gonzalez Marti

given: Beatriz

family: Brouillet

full_name: Sophie Brouillet

family: Hamamah

full_name: Samir Hamamah

given: Samir

journal_name: Reproductive Sciences

oa_colors: green hybrid

evidence: open (via crossref license)


title: Impact of a Curriculum About Professionalism on Stress Response During a Critical Situation: a Controlled Simulation Trial in Anesthesia Residents

summary: The purpose of this study is to evaluate the impact of a curriculum about professionalism on stress response during a critical situation in anesthesiology residents. Residents in anesthesiology will complete a training program on professionalism during their first postgraduate year. They will go through a standardized simulated scenario where they have to manage an intra-hospital cardiorespiratory arrest and then meet the patient's family. Stress response will be assessed and compared to a control group that did not receive the training program.

lead_sponsor: University Grenoble Alps


title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement

acronym: CovImmune 2

summary:
This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study

summary: To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or after 7 years.


title: Registrar Performance in Laparoscopic Distal Pancreatectomy and Its Effect on Postoperative Outcomes

summary: This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.


title: Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention.

acronym: SINFONI

summary:
The aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject.

The inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.

location_facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes


title: Is Adipose Tissue a Reservoir for SARS-Cov2 Spread?

summary: Resident cells of human adipose tissue express ACE2 and DPP4, receptors for SARS-Cov2. The hypothesis is that the virus may enter and spread in fat depots.


title: Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation (NIV) Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), Phase I/IIa

acronym: MORPHEUS I/IIa

summary:
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a major source of morbidity and mortality for patients and cost to the society. In case of acute respiratory failure with hypercapnia and acidosis, Non Invasive Ventilation (NIV) is preferred as a first line treatment.

NIV failures are not uncommon, from 15% in intensive care to 25 - 30% in emergency departments. They most often occur at the start of the NIV or in the hours that follow. There are many reasons for these failure. Among these are; dyspnea, discomfort, the pain related to the exacerbation and also to the NIV are frequently noted.

The use of certain drugs with anxiolytic, hypnotic and/or analgesic properties could also be useful. Some sedatives and opioids have already been studied in this indication but without a therapeutic trial and satisfactory methodology. Among the molecules of interest, Morphine seems interesting . It's administration could reduce the ventilatory rate, intensity of dyspnea, pain and anxiety as well as dynamic hyperinflation.

The investigators believe that morphine administration will decrease the rate of early NIV failure by improving comfort (decreased dyspnea and pain) and ventilation (decreased respiratory rate and increase in tidal volume) in patients with exacerbations of COPD.

However, before considering a randomized phase III efficacy study, it is necessary to determine the optimal dose of morphine in this indication, through a phase I/II dose-finding study taking into accounts both the efficacy and toxicity of morphine.

The main objective of this study, is to determine the optimal dose of morphine administered at the initiation of NIV in patient with acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), which is defined as the maximum gain function combining the probability of dose-limiting toxicity with PaCO2.Therefore, the impact of morphine administration on the physiological parameters of NIV- COPD exacerbation patients will be assessed.

ReferenceCitation: Wedzicha JA Ers Co-Chair, Miravitlles M, Hurst JR, Calverley PM, Albert RK, Anzueto A, Criner GJ, Papi A, Rabe KF, Rigau D, Sliwinski P, Tonia T, Vestbo J, Wilson KC, Krishnan JA Ats Co-Chair. Management of COPD exacerbations: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2017 Mar 15;49(3). pii: 1600791. doi: 10.1183/13993003.00791-2016. Print 2017 Mar.

ReferenceCitation: Bounes V, Charriton-Dadone B, Levraut J, Delangue C, Carpentier F, Mary-Chalon S, Houze-Cerfon V, Sommet A, Houze-Cerfon CH, Ganetsky M. Predicting morphine related side effects in the ED: An international cohort study. Am J Emerg Med. 2017 Apr;35(4):531-535. doi: 10.1016/j.ajem.2016.11.053. Epub 2016 Nov 30.

ReferenceCitation: Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, López Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agustí A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

name: University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany

family: Vogelmeier

full_name: Claus F. Vogelmeier

given: Claus F.

name: Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania

family: Criner

full_name: Gerard J. Criner

given: Gerard J.

name: New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, New York

family: Martinez

full_name: Fernando J. Martinez

given: Fernando J.

name: University of Texas Health Science Center, San Antonio, Texas

name: South Texas Veterans Health Care System, San Antonio, Texas

family: Anzueto

full_name: Antonio Anzueto

given: Antonio

name: National Heart and Lung Institute, Imperial College, London, United Kingdom

family: Barnes

full_name: Peter J. Barnes

given: Peter J.

name: McGill University Health Centre, McGill University, Montreal, Quebec, Canada

family: Bourbeau

full_name: Jean Bourbeau

given: Jean

name: Brigham and Women’s Hospital, Boston, Massachusetts

family: Celli

full_name: Bartolome R. Celli

given: Bartolome R.

name: State Key Lab for Respiratory Disease, Guangzhou Institute of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

family: Chen

full_name: Rongchang Chen

given: Rongchang

family: Decramer

full_name: Marc Decramer

given: Marc

name: University of Modena and Reggio Emilia, Modena, Italy

family: Fabbri

full_name: Leonardo M. Fabbri

given: Leonardo M.

name: Faculty of Medicine, Flinders University, Bedford Park, South Australia, Australia

family: Frith

full_name: Peter Frith

given: Peter

name: Royal Devon and Exeter Hospital, Exeter, United Kingdom

family: Halpin

full_name: David M. G. Halpin

given: David M. G.

name: Universidad de la República, Hospital Maciel, Montevideo, Uruguay

family: López Varela

full_name: M. Victorina López Varela

given: M. Victorina

name: Hokkaido University School of Medicine, Sapporo, Japan

family: Nishimura

full_name: Masaharu Nishimura

given: Masaharu

name: Hôpital Cochin (Assistance Publique–Hôpitaux de Paris), University Paris Descartes, Paris, France

family: Roche

full_name: Nicolas Roche

given: Nicolas

name: Thorax Institute, Hospital Clinic Universitat de Barcelona, Barcelona, Spain

family: Rodriguez-Roisin

full_name: Roberto Rodriguez-Roisin

given: Roberto

name: St. Paul’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada

family: Sin

full_name: Don D. Sin

given: Don D.

name: University of Manchester, Manchester, United Kingdom

family: Singh

full_name: Dave Singh

given: Dave

name: University Hospital, Birmingham, United Kingdom; and

family: Stockley

full_name: Robert Stockley

given: Robert

family: Vestbo

full_name: Jørgen Vestbo

given: Jørgen

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

name: Hospital Clínic, Universitat de Barcelona, Centro de Investigación Biomédica en Red de Enfermedade Respiratorias, Barcelona, Spain

family: Agustí

full_name: Alvar Agustí

given: Alvar

journal_name: American Journal of Respiratory and Critical Care Medicine

ReferenceCitation: Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. Epub 2006 Apr 12. Review.

ReferenceCitation: Schmidt SA, Johansen MB, Olsen M, Xu X, Parker JM, Molfino NA, Lash TL, Sørensen HT, Christiansen CF. The impact of exacerbation frequency on mortality following acute exacerbations of COPD: a registry-based cohort study. BMJ Open. 2014 Dec 19;4(12):e006720. doi: 10.1136/bmjopen-2014-006720.

ReferenceCitation: Hartl S, Lopez-Campos JL, Pozo-Rodriguez F, Castro-Acosta A, Studnicka M, Kaiser B, Roberts CM. Risk of death and readmission of hospital-admitted COPD exacerbations: European COPD Audit. Eur Respir J. 2016 Jan;47(1):113-21. doi: 10.1183/13993003.01391-2014. Epub 2015 Oct 22.

ReferenceCitation: Mackay AJ, Hurst JR. COPD exacerbations: causes, prevention, and treatment. Med Clin North Am. 2012 Jul;96(4):789-809. doi: 10.1016/j.mcna.2012.02.008. Epub 2012 Mar 16. Review.

title: COPD Exacerbations

ReferenceCitation: Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2). pii: 1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug. Review.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

ReferenceCitation: Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017 Jul 13;7:CD004104. doi: 10.1002/14651858.CD004104.pub4. Review.

name: Monash University; Department of Physiotherapy; McMahons Road Frankston Melbourne Victoria Australia 3199

name: Monash Health; Monash Lung and Sleep; 246 Clayton Road Clayton Melbourne Victoria Australia 3168

name: Institute for Breathing and Sleep; Melbourne Victoria Australia 3084

name: The University of Adelaide; Department of Respiratory Medicine, The Queen Elizabeth Hospital; Adelaide Australia

name: The University of Adelaide; School of Medicine; Adelaide Australia

name: University of Southampton; Southampton Health Technology Assessments Centre; First Floor, Epsilon House, Enterprise Road, Southampton Science Park, Chilworth Southampton Hampshire UK SO16 7NS

name: Imperial College London; National Heart and Lung Institute; London UK

repository_institution: University of South Australia - UniSA Research Outputs Repository

ReferenceCitation: Ko BS, Ahn S, Lim KS, Kim WY, Lee YS, Lee JH. Early failure of noninvasive ventilation in chronic obstructive pulmonary disease with acute hypercapnic respiratory failure. Intern Emerg Med. 2015 Oct;10(7):855-60. doi: 10.1007/s11739-015-1293-6. Epub 2015 Sep 4.

ReferenceCitation: Maignan M, Chauny JM, Daoust R, Duc L, Mabiala-Makele P, Collomb-Muret R, Roustit M, Maindet C, Pépin JL, Viglino D. Pain during exacerbation of chronic obstructive pulmonary disease: A prospective cohort study. PLoS One. 2019 May 24;14(5):e0217370. doi: 10.1371/journal.pone.0217370. eCollection 2019.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

ReferenceCitation: Yeung WY, Reigner B, Beyer U, Diack C, Sabanés Bové D, Palermo G, Jaki T. Bayesian adaptive dose-escalation designs for simultaneously estimating the optimal and maximum safe dose based on safety and efficacy. Pharm Stat. 2017 Nov;16(6):396-413. doi: 10.1002/pst.1818. Epub 2017 Jul 9.

name: Department of Biostatistics; Hoffmann-la Roche LTD/Roche Products Limited; United Kingdom

name: Department of Clinical Pharmacology; Roche Pharma Research & Early Development, Roche Innovation Center Basel; F. Hoffmann-la Roche LTD Basel Switzerland

name: Department of Biostatistics; Hoffmann-la Roche LTD; Basel Switzerland

name: Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics; Fylde College, Lancaster University; Lancaster United Kingdom

ReferenceCitation: Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC. Erratum in: Am J Respir Crit Care Med. 2018 Mar 15;197(6):839-840.

name: Intensive Care and Burn Unit, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

name: Fattouma Bourguiba University Hospital, Monastir, Tunisia

name: Abderrahmen Mami Hospital, Ariana, Tunisia

name: Georges Pompidou European Hospital, Paris, France

name: Angers University Hospital, Angers, France

name: Institut national de la santé et de la recherche médicale, UMR 955, Université Paris Est, Créteil, France

name: Air Liquide Santé International, Medical R&D, Jouy-en-Josas, France

name: University Hospital of Geneva, Intensive Care Unit, Geneva, Switzerland

name: Li Ka Shing Institute and Keenan Research Centre, St Michael’s Hospital, Toronto, Ontario, Canada; and

name: University of Toronto, Interdepartmental Division of Critical Care Medicine, Toronto, Ontario, Canada

ReferenceCitation: Lightowler JV, Wedzicha JA, Elliott MW, Ram FS. Non-invasive positive pressure ventilation to treat respiratory failure resulting from exacerbations of chronic obstructive pulmonary disease: Cochrane systematic review and meta-analysis. BMJ. 2003 Jan 25;326(7382):185. Review.

ipd_sharing_description:
The international writing and publication rules (The Uniform Requirements for Manuscripts of the ICMJE, April 2010) will be followed. The minimum anonymized source data for performing the statistical analysis will be made public at the time of publication, with the article, or deposited in an appropriate public database. Other anonymized data may be available from the principal investigator upon reasonable request and with the consent of the sponsor.

In accordance with the French law n ° 2002-303 of March 4th, 2002, the subjects can be informed, at their request, of the overall results of the research. In this study, the investigators commit to individually communicating the overall results to each subject participating in the research by a short (popularized) summary and associated with a copy of the scientific article.

location_facility: Emergency Department of Grenoble Alpes University Hospital


title: Study of the Sars-Cov2 Neuroinvasiveness - COVID19

acronym: CORONEVRAXE

summary: Sars-Cov2 (COVID-19) may invade the CNS inducing neurological diseases such as anosmia, ageusia, encephalitis, ischemic or hemorrhagic stroke. Management of severe neurological complications in COVID-19 patients may require ventricular cerebrospinal fluid drainage and cranial decompression. During surgery, cerebrospinal fluid, meninges and brain parenchyma can be safely removed from the patient. In this study, COVID-19 patients will be evaluated first, for the presence of Sars-Cov2 in the cerebrospinal fluid and/or biopsies and second, for the consequences of Sars-Cov2 neuroinfection in terms of inflammatory and immune responses.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Impact of Barriers and Facilitators to Physical Activity in Patients With Inflammatory Arthritis and Link With Physical Activity Collected by Mobile Phone Apps: a Cross-sectional Study

acronym: ImBAIA

summary:
Background: Patients with inflammatory arthritis (IA), such as spondyloarthritis (axSpA), rheumatoid arthritis (RA) or psoriatic arthritis (PsA) are more prone to physical inactivity but derive specific benefits from regular physical activity. Barriers and facilitators to physical activity (B&F-PA) are key elements and knowledge of their correlation to physical activity is essential for developing interventions to promote physical activity that have a greater likelihood of success.

Objectives: primary objective will be to measure the correlation of these B&F-PA to physical activity collected through apps. Secondary objective will be to (I) to quantify physical activity collected through apps in IA patients and (II) to observe the link between physical activity, B&F to physical activity and adherence to treatment.

Patients and methods: This is an international, multicentric, cross-sectional study.

Patients: From the first of September to the first of February 2020, all patients with definite axSpA, RA or PsA, aged above 18 and able to walk, who have a mobile phone compatible with apps that can track steps, who agree to participate and give his oral informed consent and with ability to read and write in the language of the participating country, seen in outpatient visits in the participating centers, will be asked to participate. The planed inclusion was 200 participants.

Data collection: clinical data and information about physical activity and B&F-PA will be entered by rheumatologists during or electronically by patients at the same time point.

Questionnaire for B&F-PA: a patient reported questionnaire was recently developed for this study in 2019 based on a systematic review to identify the main B&F-PA. A list of questions was generated from the systematic review reviewed and tested for face validity by 11 experts and confronted to 20 patients with IA through a cognitive debriefing.

Physical activity: Physical activity will be measured objectively during the last 7 days by apps already installed by default on the mobile phone of participants and subjectively with the International Physical Activity Questionnaire short version (IPAQ-S).

Other outcomes: Stage of exercise behavior change and adherence to treatment will also be collected.

Planned analyses: Perceived B&F-PA will be described using frequencies. A score will be calculated for each participant representing the limitations or facilities to perform physical activity.

Analysis of the physical activity: The distribution of mean number of steps will be assessed visually for outliers. Univariate analysis will be completed between mean number of steps and gender, age, disease and stages of change. Correlation between mean number of steps and IPAQ-S score will be calculated.

Link between physical activity and barriers and facilitators: The link between B&F questionnaire score and mean number of steps will be tested using linear regression. Then multivariate regression including demographic variables, psychological status and disease characteristics will be performed.

Outcomes of the study: The expected outcomes of the ImBAIA study are a better understanding of B&F to physical activity in patients with IA and their impact to limit or to favor physical activity. We also expect to observe the level of physical activity of an IA population objectively measured with apps. Finally, a validation was expected to use questionnaire of B&F.

ReferenceCitation: Davergne T, Tekaya R, Sellam J, Tournadre A, Mitrovic S, Ruyssen-Witrand A, Hudry C, Dadoun S, Avouac J, Fautrel B, Gossec L. Influence of perceived barriers and facilitators for physical activity on physical activity levels in patients with rheumatoid arthritis or spondyloarthritis: a cross-sectional study of 150 patients. BMC Musculoskelet Disord. 2021 Oct 30;22(1):915. doi: 10.1186/s12891-021-04792-7.

family: Davergne

full_name: Thomas Davergne

given: Thomas

family: Tekaya

full_name: Rawdha Tekaya

given: Rawdha

family: Sellam

full_name: Jérémie Sellam

given: Jérémie

family: Tournadre

full_name: Anne Tournadre

given: Anne

family: Mitrovic

full_name: Stéphane Mitrovic

given: Stéphane

family: Ruyssen-Witrand

full_name: Adeline Ruyssen-Witrand

given: Adeline

family: Hudry

full_name: Christophe Hudry

given: Christophe

family: Dadoun

full_name: Sabrina Dadoun

given: Sabrina

family: Avouac

full_name: Jérôme Avouac

given: Jérôme

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Gossec

full_name: Laure Gossec

given: Laure

journal_name: BMC Musculoskeletal Disorders

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

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

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere