title: Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.

acronym: DIABLO

summary: In T1D, the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex: even with recent technologies of continuous measurement and monitoring of blood glucose (CGM), current systems are electrochemical, insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia. A new biosensor connected to the patient by microdialysis, will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump. In various daily scenarios (meals, physical exercise) the biosensor DIABLO responses will be compared to the measurements of standard CGM systems.

lead_sponsor: University Hospital, Bordeaux


title: Biological Determinants of Sputum Rheology in Chronic Airway Diseases

acronym: CADRhé

summary: The primary objective of this study is to investigate the biological determinants of sputum rheology variations.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: The general goal is to, in as much as possible, make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Due to conditions imposed by French law, data will be made available to the public upon request to the study sponsor and fulfilment of French legal requirements.

lead_sponsor: University Hospital, Montpellier

lead_sponsor_type: academique

status_simplified: Completed


title: Longitudinal Study of the Intestinal, Cutaneous and Salivary Microbiota in Children With Food-induced Enterocolitis Syndrome (SEIPA)

acronym: SEIBIOTE

summary:
Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non IgE-mediated allergy, presenting with vomiting, and may be complicated by hypovolemic shock.

The pathophysiology of FPIES is not well characterized and there is no biological marker confirming the diagnosis or predicting recovery. Gut microbiota in IgE-mediated allergy is pro-inflammatory and the addition of pro- or prebiotics can accelerate healing. Microbiota of patients with FPIES have never been studied yet.

The aim of this work is therefore to analyse longitudinally the gut microbiota of patients with FPIES, before and after healing, in order to predict the recovery from FPIES. The cutaneous and salivary microbiota will also be analysed at the same time, in order to look for a correlation between these three microbiota.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Trousseau Hospital, Service : Nutrition et Gastroentérologie Pédiatrique

status_simplified: Ongoing


title: Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation

acronym: IRM-A

summary: Bronchiolitis Obliterans Syndrome (BOS) is a major complication of Hematopoietic Stem cell Transplantation (HSCT) occurring in the context of chronic GVHD and associated with a poor prognosis. The diagnosis of BOS is based on functional (Pulmonary Functional Tests) and morphological criteria (chest CT-scan). Early diagnosis of BOS represents an unmet need and would facilitate early therapeutic interventions. Lung MRI has been recently developed with new sequences facilitating morphological and functional lung analysis in various inflammatory contexts. The goal of this study is to compare the morphological performances of chest CT-scan and MRI

study_type: Interventional

primary_purpose: Diagnostic

intervention_type: Device


title: Biological Markers of Functional Effects of Physical Activity : Aging, Immunometabolism and Frailty Project (VIF-APAS)

acronym: BIO-APAS

summary: Circulating biomarkers are promising tools for the early diagnosis of aging-associated pathologies. Inflammation and immunity are associated with the risk of sarcopenia and frailty in elderly patients. The investigators investigate the effect of an adapted physical activity program on the metabolism and function of circulating immune cells and miRNA in frail and non-frail elderly subjects. Induced immune changes are analyzed together with that of motor abilities and of frailty status.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Other


title: Effect of Endotracheal Tube Plus STYLET Versus Endotracheal Tube Alone on Successful First-Pass Orotracheal Intubation Among Critically Ill Patients: the Randomised STYLETO Study Protocol"

acronym: STYLETO

summary:
Patients admitted to Intensive Care Units (ICU) often require respiratory support. Orotracheal intubation is one of the most frequent procedures performed in ICU.When performed in emergency settings, intubation is a challenging issue as it may be associated with life-threatening complications in up to one third of cases

Using a preshaped endotracheal tube plus stylet may have potential advantages over endotracheal tube alone without stylet. The stylet is a rigid but malleable introducer which fits inside the endotracheal tube and allows for manipulation of the tube shape; usually into a hockey stick shape, to facilitate passage of the tube through the laryngeal inlet. The stylet can help to increase success of intubation in operating rooms

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Jaber S, Rolle A, Jung B, Chanques G, Bertet H, Galeazzi D, Chauveton C, Molinari N, De Jong A. Effect of endotracheal tube plus stylet versus endotracheal tube alone on successful first-attempt tracheal intubation among critically ill patients: the multicentre randomised STYLETO study protocol. BMJ Open. 2020 Oct 7;10(10):e036718. doi: 10.1136/bmjopen-2019-036718.

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi


title: Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction - Studying the Benefits of Digital Distractions in an Ambulatory Care Service

acronym: ALFA

summary:
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety.

During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control.

In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital.

In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic.

In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.

status: Unknown status

primary_purpose: Other

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Behavioral

status_simplified: Unknown


title: Evaluation of a Relationship Between Driving Pressure in Pressure Support Ventilation (PSV) and Mechanical Ventilation Weaning Time on Post-ARDS Patients

acronym: PMVS

summary: With the birth of Mechanical Ventilation in the 1950s came the ventilation induced lung injuries (VILI). Numerous works have since then shown the benefit of "protective ventilation", notably by controlling the delivered tidal volume and pressures. However, as the respiratory condition improves and the weaning is started by shifting to Pressure Support Ventilation (PSV), these parameters stop being tightly controlled. This study aims to determine whether there is a relationship between the driving pressure measured in PSV and the weaning time.


title: Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study

acronym: RECOVER

summary: A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.

design_allocation: Non-Randomized

lead_sponsor: Hospices Civils de Lyon


title: Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.

acronym: ITBA

summary: Invasive tracheobronchial aspergillosis (ITBA) is an uncommon, but severe clinical form of Invasive Pulmonary Aspergillosis (IPA) in which the fungal infection is entirely or predominantly confined to the tracheobronchial tree. In view of the limited data concerning critically ill patients admitted to the intensive care unit (ICU) with severe influenza associated with ITBA, the investigators decided to evaluate the differences between the clinical presentations of two invasive infections: ITBA and IPA without tracheobronchial involvement (No ITBA).

ReferenceCitation: Nyga R, Maizel J, Nseir S, Chouaki T, Milic I, Roger PA, Van Grunderbeeck N, Lemyze M, Totet A, Castelain S, Slama M, Dupont H, Sendid B, Zogheib E. Invasive Tracheobronchial Aspergillosis in Critically Ill Patients with Severe Influenza. A Clinical Trial. Am J Respir Crit Care Med. 2020 Sep 1;202(5):708-716. doi: 10.1164/rccm.201910-1931OC.

family: Nyga

full_name: Remy Nyga

given: Remy

sequence: first

family: Maizel

full_name: Julien Maizel

given: Julien

sequence: additional

name: Intensive Resuscitation Medicine Unit, Lille University Hospital Center

family: Nseir

full_name: Saad Nseir

given: Saad

name: Department of Medical Parasitology and Mycology

family: Chouaki

full_name: Taieb Chouaki

given: Taieb

family: Milic

full_name: Ivona Milic

given: Ivona

name: Department of Respiratory Intensive Care

family: Roger

full_name: Pierre-Alexandre Roger

given: Pierre-Alexandre

name: Department of Respiratory and Critical Care Medicine, Schaffner Hospital, Lens, France

family: Van Grunderbeeck

full_name: Nicolas Van Grunderbeeck

given: Nicolas

family: Lemyze

full_name: Malcolm Lemyze

given: Malcolm

name: UR UPJV 4294, Infectious Agents, Resistance and Chemotherapy Research Unit, University Center for Health Research, and

family: Totet

full_name: Anne Totet

given: Anne

family: Castelain

full_name: Sandrine Castelain

given: Sandrine

family: Slama

full_name: Michel Slama

given: Michel

name: Department of Anesthesiology and Critical Care Medicine, Amiens University Hospital, Amiens, France

name: Simplification of Complex Surgical Patient Care BQR Unit of Clinical Research, Picardy Jules Verne University, Amiens, France

family: Dupont

full_name: Hervé Dupont

given: Hervé

name: Laboratory of Medical Parasitology and Mycology, Regional University Hospital Center, and

name: Fungally Associated Invasive and Inflammatory Diseases Team, National Institute of Health and Medical Research U995–Lille Inflammation Research International Center, Lille University, Lille, France; and

family: Sendid

full_name: Boualem Sendid

given: Boualem

family: Zogheib

full_name: Elie Zogheib

given: Elie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Diagnostic Test


type: Other Identifier

title: Evaluation de la précision d'Une Mesure téléphonique de la fréquence Respiratoire à l'Aide d'Une Application Mobile - The OPERA Study (On the PhonE Respiratory rAte)

acronym: OPERA

summary:
Introduction. The increasing use of telephone medical advice requires the development of telemedicine tools to assess the patient's severity. Respiratory rate (RR) is a simple vital parameter and is often associated with morbidity and mortality of patients. There is no standardized measure of RR by telephone.

Objective: The investigators wanted to evaluate the RR measurement by phone using a smartphone application called RRate.

Methods. Adults who have been admitted for less than 6 hours to the emergency department after calling Center 15 and whose main reason for consultation is dyspnea will be included. Patients with non-invasive or tracheotomized ventilation will be excluded. The main objective will be to compare by Bland-Altman method the accuracy of the RRate measurement by phone to a one-minute RR measurement at patient's bedside. Secondary endpoints will evaluate the length of RR measurement according to the different methods used; measurement failure criteria; the accuracy of different measurement techniques (RRate at patient's bedside, impedancemetry, traditional measurement during 15s or 30s).

Expected Results. The accuracy of the RR measurement by RRate over the telephone should be within the limits of agreement. The measurement time should be shorter with the RRate application than with traditional methods. However, the measurement by telephone should not always be feasible in patients with mild dyspnea or with poorly audible breathing.

lead_sponsor: University Hospital, Grenoble


title: Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma in Poitiers Emergency

summary:
To study the future of traumatic brain injured patients at day 7 of their trauma

Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room.

Secondary judgment criteria:

Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP
Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, .
Become TCL patients under AAP or TAC
Number of reconsultation, rehospitalization, new imaging within 7 days after TCL

lead_sponsor: Poitiers University Hospital


title: Performance and Safety of the Composite Interference Screw Used in Anterior Cruciate Ligament Reconstructions

summary:
The evaluation of the clinical data has demonstrated the conformity of the Composite Interference Screw (CIS), with the relevant essential requirements for its use in orthopaedic applications. The Composite Interference Scres are intended for tibial and femoral ligament/graft fixation in the case or Anterior Cruciate Ligament (ACL) reconstructions. It has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. In order to improve the clinical data on the CIS, the manufacturer, Biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. In this objective, the goal of this study will be to observe the following parameters:

Objective IKDC score (clinical evaluation)
Subjective IKDS score (functional evaluation)
Safety (report of any adverse event)
Follow-up of the patient's recovery

lead_sponsor: Biomatlante

lead_sponsor_type: industriel


title: Interest of the Presepsin Assay as a Biomarker of Bacterial Infection, in the Management of Newborns and Infants Under 3 Months of Age Admitted for Fever in Pediatric Emergency Service

acronym: presepsin

summary: The purpose of this study is to validate presepsin as a biological marker for identifying bacterial fever among febrile syndromes of infants under three months of age. Clearly, our goal is to determine if this marker can help us distinguish a viral infection from a bacterial infection. Indeed, presepsin would be specific for bacterial infection, and rise earlier in the blood during infection than biological markers currently used. Such validation could improve the precocity of the therapeutic management by a better targeted antibiotic therapy, and the limitation of invasive complementary examinations (lumbar puncture), in infants for whom the fear of a bacterial infection leads to examinations and systematic treatments.

status: Terminated

ReferenceType: background

ReferenceCitation: Pugni L, Pietrasanta C, Milani S, Vener C, Ronchi A, Falbo M, Arghittu M, Mosca F. Presepsin (Soluble CD14 Subtype): Reference Ranges of a New Sepsis Marker in Term and Preterm Neonates. PLoS One. 2015 Dec 31;10(12):e0146020. doi: 10.1371/journal.pone.0146020. eCollection 2015.

ReferenceCitation: Okamura Y, Yokoi H. Development of a point-of-care assay system for measurement of presepsin (sCD14-ST). Clin Chim Acta. 2011 Nov 20;412(23-24):2157-61. doi: 10.1016/j.cca.2011.07.024. Epub 2011 Aug 3.

ReferenceCitation: Chenevier-Gobeaux C, Bardet V, Poupet H, Poyart C, Borderie D, Claessens YE. Presepsin (sCD14-ST) secretion and kinetics by peripheral blood mononuclear cells and monocytic THP-1 cell line. Ann Biol Clin (Paris). 2016 Jan-Feb;74(1):93-7. doi: 10.1684/abc.2015.1112.

ReferenceCitation: Pizzolato E, Ulla M, Galluzzo C, Lucchiari M, Manetta T, Lupia E, Mengozzi G, Battista S. Role of presepsin for the evaluation of sepsis in the emergency department. Clin Chem Lab Med. 2014 Oct;52(10):1395-400. doi: 10.1515/cclm-2014-0199. Review.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Psychometric Validation of the French Version of the Modified Edmonton Symptom Assessment Scale: The ESAS12-F.

summary:
Assessing symptoms of patients with cancer should be a priority for the physicians to improve their quality of life. The Edmonton Symptom Assessment Scale (ESAS) is a common tool, easy to complete and to analyse. Originally, it has been validated in English with 9 common symptoms. But a new version with 12 commons symptoms and some explanations has been created. This modified version has been translated in French, and the transcultural validation has been done. But the psychometreic validation has not been validated yet.

The primary objective is to validate the psychometric properties of this new version in French.

To validate the tool, we will compare the ESAS12-F to the European Organization for research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) which assesses common symptoms for patients with cancer, which is validated in French, but which is longer and more difficult to complete and to analyse. the patient will complete the ESAS 12-F and the EORTC QLQ-C30 at day 1, then the ESAS12-F at day 2, and the ESAS12-F and the EORTC QLQ-C30 at day 7.


title: Evaluation of Professional Practices in Botulinum Toxin Type A Intradetrusor Injection, at the Dose of 50 Units for the Treatment of Urinary Incontinence by Refractory Idiopathic Overactive Bladder

summary: Considering that the 2013 Hermieu's guidelines differs from the product marketing authorization delivered in November 2014, the primary endpoints is to evaluate life quality by questionnaires at the baseline time, and after two, six and twelve weeks of treatment in patients suffer from urinary incontinence by refractory idiopathic overactive bladder and treated by Botox® at the dose of 50UI (international units)

intervention_type: Drug


title: Clozapine and Haematologic Malignancies: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database

acronym: CLOZARIX

summary: Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen

location_facility: Caen University Hospital, Department of Pharmacology


title: AntiCoagulants and COGnition (ACCOG Trial): a Single-blind Randomized Controlled Trial Comparing the Neurocognitive Effects of Rivaroxaban Versus Vitamin K Antagonist

acronym: ACCOG

summary:
The purpose of this study is to compare the change of global cognitive performance after 52 weeks of intervention among participants with nonvalvular atrial fibrillation (NVAF) receiving rivaroxaban versus a vitamin K antagonist (warfarin).

The secondary objectives are to compare, among participants with NVFA receiving rivaroxaban versus warfarin :

the changes of global cognitive performance after 26 weeks of intervention
the changes of executive functions after 26 and 52 weeks of intervention
the changes of episodic memory after 26 and 52 weeks of intervention
the volumetric changes of the brain after 26 and 52 weeks of intervention
the changes of independence and autonomy after 26 and 52 weeks of intervention
the changes of serum vitamin K concentration after 26 and 52 weeks of intervention

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Angers


title: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, Regular Drivers of Electric Wheelchairs.

summary: The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

lead_sponsor: Pôle Saint Hélier


title: Evaluation of the Reproducibility of Ablation Volumes at One Month After Microwave Treatment Compared to the Manufacturer's Abacus: on the Kidney, Liver and Lung

acronym: Ablation

summary:
Microwave thermal ablation (MO) is recognized as an alternative to surgery for the local-regional treatment of primary and secondary hepatic and renal tumors and for secondary pulmonary tumors in patients at anesthetic and/or surgical risk.

Microwaves have a reputation for not producing reproducible ablation volumes with elliptical deformations and risks of over or under processing.

The Covidien manufacturer offers a microwave system that guarantees more spherical and reproducible ablations: Emprint TM ablation system with Thermosphere TM technology (thermal control, field control, wavelength control).

The investigators have 2 years of experience and therefore propose to carry out a first retrospective study, on a cohort of about fifty patients, whose objective will be to compare the volume of in vivo ablation one month after thermo-ablative treatment by microwave of a hepatic, renal or pulmonary tumour with the reference volume announced by the Covidien abacus manufacturer.

Microwave ablation, which is much less studied, is less used because of the low reproducibility of necrosis volumes.

The Covidien manufacturer offers a system that allows ablation volumes that are supposed to be reproducible, which attracted the Nîmes University Hospital during the call for tenders.

To the investigator's knowledge, there are no studies that have evaluated the actual volume of ablation by this system.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Emotional Proactive Brain Study in Adults With Autism Spectrum Condition

acronym: PREDEMAUT

summary:
This project aims:

to study behavioral and cerebral activity specificity (latency and amplitude of evoked potentials, time frequency maps and cerebral connectivity) in predictive process (top-down regulation) during visual recognition of static and dynamic stimuli in adults participants with autism spectrum conditions compared to typically developed participants.
to study the relation between predictive process and autonomous response (heart activity and electrodermal activity)
to explore potential sex differences between autistic males and females

ReferenceCitation: Bar M. The proactive brain: using analogies and associations to generate predictions. Trends Cogn Sci. 2007 Jul;11(7):280-9. Epub 2007 Jun 4. Erratum in: Trends Cogn Sci. 2007 Sep;11(9):372.

ReferenceCitation: Caplette L, Wicker B, Gosselin F. Atypical Time Course of Object Recognition in Autism Spectrum Disorder. Sci Rep. 2016 Oct 18;6:35494. doi: 10.1038/srep35494.

ReferenceCitation: Gomot M, Wicker B. A challenging, unpredictable world for people with autism spectrum disorder. Int J Psychophysiol. 2012 Feb;83(2):240-7. doi: 10.1016/j.ijpsycho.2011.09.017. Epub 2011 Oct 1. Review.

ReferenceCitation: Peyrin C, Michel CM, Schwartz S, Thut G, Seghier M, Landis T, Marendaz C, Vuilleumier P. The neural substrates and timing of top-down processes during coarse-to-fine categorization of visual scenes: a combined fMRI and ERP study. J Cogn Neurosci. 2010 Dec;22(12):2768-80. doi: 10.1162/jocn.2010.21424.

ReferenceCitation: Quintana DS, Guastella AJ, Outhred T, Hickie IB, Kemp AH. Heart rate variability is associated with emotion recognition: direct evidence for a relationship between the autonomic nervous system and social cognition. Int J Psychophysiol. 2012 Nov;86(2):168-72. doi: 10.1016/j.ijpsycho.2012.08.012. Epub 2012 Aug 30.

ReferenceCitation: Sinha P, Kjelgaard MM, Gandhi TK, Tsourides K, Cardinaux AL, Pantazis D, Diamond SP, Held RM. Autism as a disorder of prediction. Proc Natl Acad Sci U S A. 2014 Oct 21;111(42):15220-5. doi: 10.1073/pnas.1416797111. Epub 2014 Oct 6.

ReferenceCitation: Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8. Review.


title: Efficacy of Re-challenge With Immune-checkpoints Inhibitors in Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients: a Retrospective Observational Study

acronym: RE-CHALLENGE

summary: This is a multicentre, retrospective, national observational study aiming to describe clinical outcomes of advanced NSCLC patients that performed an ICP re-challenge during their history of disease. The objective of this study is to evaluate the ICP re-challenge efficacy.


title: Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity

acronym: FOOD

summary:
Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.

Free flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.

Among them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.

Malnutrition is not associated with a higher risk for free flap failure in the oral cavity.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Procedure


title: cDC1 Prognostic and Predictive Role in Non-Small-Cell Lung Cancer Patients Receiving Immune Checkpoint Inhibitors

acronym: LUNG-PREDICT

summary: The response rate of immune checkpoint inhibitors remains relatively low and the identification of the new predictive biomarkers is necessary. The rare population of cDC1 is very interesting, as its mouse counterparts is essential for the cross presentation of tumor-associated antigens, tumor immunity and response to immunotherapies. Their role in humans has not been studied. This proposal aims to study the prognostic role of cDC1 in a cohort of patients with advanced NSCLC, possibly demonstrating their positive predictive value of immune checkpoint inhibitors response.

status: Withdrawn


title: evaluatioN de la perfOrMAnce De Capteurs E-textiles

acronym: NOMADE

summary:
The NOMADE study has a dual purpose:

Test the performance of new types of sensors that are likely to integrate Bioserenity devices and will therefore improve them.
Test the performance of the sensors of Bioserenity CE devices and their advanced versions

Different EC and non-CE models of Neuronaute and Cardioskin may be tested in this study.

lead_sponsor: BioSerenity

location_facility: Institut Du Cerveau Et de La Moelle Epiniere


title: PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer

acronym: PERCEPTION

summary: The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

ReferenceCitation: Lusho S, Durando X, Bidet Y, Molnar I, Kossai M, Bernadach M, Lacrampe N, Veyssiere H, Cavaille M, Gay-Bellile M, Radosevic-Robin N, Abrial C. PERCEPTION Trial protocol: Comparison of predictive and prognostic capacities of neutrophil, lymphocyte, and platelet counts and tumor-infiltrating lymphocytes in triple negative breast cancer. Medicine (Baltimore). 2020 Dec 11;99(50):e23418. doi: 10.1097/MD.0000000000023418.

family: Lusho

full_name: Sejdi Lusho

given: Sejdi

family: Durando

full_name: Xavier Durando

given: Xavier

family: Bidet

full_name: Yannick Bidet

given: Yannick

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: Lacrampe

full_name: Nathalie Lacrampe

given: Nathalie

family: Veyssiere

full_name: Hugo Veyssiere

given: Hugo

family: Cavaille

full_name: Mathias Cavaille

given: Mathias

family: Gay-Bellile

full_name: Mathilde Gay-Bellile

given: Mathilde

family: Radosevic-Robin

full_name: Nina Radosevic-Robin

given: Nina

family: Abrial

full_name: Catherine Abrial

given: Catherine

currency_apc_doaj: USD

journal_name: Medicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: PERCEPTION Trial protocol

lead_sponsor: Centre Jean Perrin


title: Synchronized Nasal Intermittent Positive Pressure Ventilation Versus Noninvasive Neurally Adjusted Ventilatory Assist Ventilation in Extremely Premature Infants: a Randomized Crossover Trial

acronym: EASYNNEO

summary:
The aim of this study is to demonstrate a significant decrease in asynchrony with NIV-NAVA using the Servo n ventilator (Getinge, Sweden), as compared to abdominal triggered (Graseby capsule) synchronized nasal intermittent positive pressure ventilation (sNIPPV) using the Infant Flow CPAP device (Care Fusion, USA).

All of the data obtained can be used to develop a large-scale study aimed at reducing the rate of re-intubation in the study population (pilot study). In fact, the re-intubation criteria for extremely premature children are based on clinical criteria (desaturations, apnea, signs of respiratory control) and paraclinical criteria (FiO2, Potential hydrogen (pH), PCO2).

The results of this pilot study will help to develop an adapted methodology and to calculate a sample size to compare the 2 modes of NIV to the test on a clinical criterion: the rate of re-intubation after extubation, which is classically high in these patients.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration

acronym: IMMUNOSEPSIS 4

summary:
Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.

In this context, the main objectives of IMMUNOSEPSIS 4 study are:

to identify the best biomarkers for sepsis-induced immunosuppression
to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock

intervention_type: Biological


title: 4 Dimensional - Impairment of Posttraumatic Forearm Rotation Evaluated With Computed Tomography : 4D-IRECT Pilot Trial

summary: The aim of this study is to develop a 4D-CT (4 Dimensional Computed Tomography) -scan acquisition method for estimating the cause of posttraumatic impairment of the forearm. Both forearms of patients with posttraumatic impairment of one of the forearm will be scanned using a 4D-CT-scan, during forearm rotation. Rotation of impaired and healthy forearms will be analysed and compared to each other. This method is intended to allow differentiation of motion patterns reflecting an osseous impairment from those caused by soft tissue pathology in order to improve treatment choice.

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier


title: Usability Study of PARADE CONNECT Shoes, a Device to Detect Falls in Old People

acronym: EDORA

summary: This study evaluates the usability of a new remote warning system for fall in old people. This system is integrated in a shoe. Patients hospitalized in a geriatric ward but also their informal and professional caregivers will assess the usability of the device using a structured survey.


title: Reproducibility and Utility of Growth Hormone Inhibition by Oral Glucose Tolerance Test for the Diagnosis of Acromegaly

acronym: ACROTEST

summary: Prospective study of reproducibility and utility of growth hormone inhibition by oral glucose tolerance test for the diagnosis of acromegaly, in acromegalic and non-acromegalic subjects, with a randomized double-blind crossover over placebo arm in the group of acromegalic patients

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Characteristics and Prognosis of Patients With Critical Ischemia at High Risk of Amputation Managed by Endovascular Bypass: a Retrospective Study of 15 Patients

acronym: Pontage

summary:
Obliterative arterial disease of the lower limbs (AOMI) is associated with a high risk of cardiovascular events, with a linear relationship between a fall in the systolic pressure index and a risk of cardiovascular morbidity and mortality. Critical ischemia is the most severe stage of AOMI, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, as well as the patient's vital prognosis. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Consequently, the goal of management in a multidisciplinary setting is threefold: the treatment of pain, improvement of the functional prognosis and improvement of the patient's vital prognosis. Revascularization should be attempted as often as possible for the purpose of limb salvage and improvement of patient survival.

In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed at a multidisciplinary consultation meeting. The medical-radiological-surgical expertise takes into consideration the patient's terrain and comorbidities and the technical possibilities according to the arterial damage. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. foot with a lower morbidity-mortality compared to surgery, especially in the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with critical ischemia hospitalized in the vascular medicine department.

In patients with critical ischemia at high risk of major amputation and without the option of traditional endovascular or surgical revascularization, an endovascular revascularization technique for leg rescue is discussed as a last resort in multidisciplinary staff. This technique, performed by the interventional radiology team (MDP and GA), consists of an extra-anatomic endovascular femoro-popliteal bypass. We wish to describe the limb salvage rate and the preservation of autonomy in the 15 patients treated with this revascularization technique since 2013 in the vascular medicine department of the GHPSJ.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old

acronym: FCE

summary: Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.


title: Phase II Multicenter Study of Talimogene Laherparepvec in Classic or Endemic Kaposi Sarcoma - KAPVEC

acronym: KAPVEC

summary:
Kaposi Sarcoma (KS) is a lymphangioproliferation associated with human herpes virus 8 (HHV8) promoted by immunosuppression. HIV-related KS and iatrogenic posttransplantation KS are treated by immune restoration, in association with local or systemic therapies as chemotherapies if required. Conversely in classic and endemic KS, the underlying relative immunosuppression cannot be directly targeted. Treatment is poorly codified, mostly based on surgery or radiotherapy for localized KS. Most aggressive forms with visceral involvement are treated with chemotherapies or interferon, which give at best 30-60% of transient responses and may not be well tolerated in elderly patients.

Talimogene laherparepvec is the first oncolytic immunotherapy approved by the FDA, in metastatic or unresectable melanoma with injectable nodal or cutaneous lesions. It is designed to induce tumor regression of injected lesions through direct lytic effects, and of uninjected lesions through induction of systemic antitumor immunity.

In Merkel cell carcinoma (MCC), another virus-induced tumor, treatment with PD-1/PD-L1 axis inhibitors have proven efficacy, thus providing a proof of principle that immunotherapy could be effective in virus-induced tumors. Two cases of metastatic MCC successfully treated with talimogene laherparepvec were recently reported, suggesting that talimogene laherparepvec may also be an effective therapeutic option. Considering the high immunogenicity of viral epitopes in KS tumors, the role of the immune evasion in the development of KS, and the cutaneous manifestations (>90% of patients) that can be easily injected, classic and endemic KS is a good tumor model to be targeted with talimogene laherparepvec. The main objective is to assess whether talimogene laherparepvec is clinically inactive (partial+complete response probability π0<10%) or truly active (partial+complete response probability π1>40%) in classic and endemic Kaposi sarcoma.

location_facility: Service de Dermatologie Hopital Saint-Louis


type: EudraCT Number

title: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Carcinomatosis. Phase II Randomized Study - PIPAC EstoK 01

acronym: PIPAC EstoK 01

summary: Peritoneal metastasis is a common pattern in advanced gastric cancer leading to a terminal condition in a very short time. Whatever recent progress regarding systemic chemotherapy using multi drugs association median survival is limited to 6 months with altered quality of life (QoL) after 4 months for all patients. We postulated that a new innovative health technology for delivering intraperitoneal pressurized aerosol of chemotherapy (Doxorubicin and Cisplatin) during laparoscopy can transform that situation offering to double the survival with QoL preservation. Interestingly, PIPAC procedure is made to be applied repeatedly, every 4 to 6 weeks. This therapeutic strategy allows to improved Intra Peritoneal (IP) drugs impregnation and maintained Intra-Veinous (IV) chemotherapy meanwhile. The primary objective of this study is to evaluate and compare 24-month progression free-survival in patients with peritoneal carcinomatosis of gastric cancer treated either with IV chemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) or with IV chemotherapy alone, with preservation of quality of life.


title: Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

acronym: EPCHIRPRORL

summary:
The objective of the study is to analyse :

Psychic experience of ear aplasia in children ;
the modalities of their psychic functioning ;
and the psychological repercussions of the plastic reconstruction surgery


title: Effectiveness of a Short Physical Activity Program on the Level and Barriers to Physical Activity in Individuals With Coronary Artery Disease.

summary:
Coronary artery diseases (CAD) are multifactorial diseases which prognosis and risk factors are improved with increased physical activity (PA). Thus, CAD rehabilitation (CR) program is mainly based on recovering sufficient exercise capacity and promoting regular personalized PA associated to modifications in lifestyle habits to improve control of cardiovascular risk factors and health-related quality of life. However, most of patients do not achieve the recommended levels of PA which may be partly due to numerous barriers that hamper the return to a physically active lifestyle. One promising interventions strategy is so-called 'brief interventions' (BI) to increase PA in health care settings used to initiate change for an unhealthy behavior in individuals and consisting in "verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up". An 'extended brief intervention' (EBI) is similar but usually lasts more than 30 minutes and is delivered on a one-to-one or group basis and can be composed of multiple brief sessions. However, in CAD patients, the effect of such interventions on PA level and behavior remains unclear, as well as predictor patterns associated with better outcomes.

The investigators aimed to assess the effect of a 4-day PA education program with multiple EBI and exercise on the level and barriers to PA in CAD patients and characterize the profile of participants (barriers to PA) with better outcomes.


title: Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration

acronym: PREFISIT

summary: In situ fenestration (ISF) could represent an alternative in the treatment of aorto-iliac disease when usual techniques are not available. The aim of this study was to present the results of ISF in aorto-iliac disease. Data will retrospectively be analyzed. Inclusion criteria will be: a surgical abdominal aortic aneurysm (AAA) with an unsuitable anatomy for a standard endograft, aorto-iliac occlusion with narrow distal aorta (<14mm). Technically, after placement of the endograft, a transjugular intrahepatic access set was used to perform ISF. The hole was secondary enlarged using a cutting or non-compliant balloon. Finally, a kissing stent was performed to the aorto- uni-iliac into a bifurcated endograft.

location_facility: Service de Chirurgie Vasculaire, Hôpital Ambroise Paré


title: Prediction of Childhood Pulmonary Function Using Ulna Length in Children of Sub-saharian or Caribbean Ethnicity

acronym: ULNOIR

summary: Height measurement is unreliable when neuromuscular weakness or spinal deformity is present. The aim of this study was to accurately predict pulmonary function from a limb segment (ulna) measurement that is precise and reproducible. Equations are available in caucasian children but are not available in children of sub-saharian or caribbean ethnicity, which was the aim of the study. To this end, 350 black children referred for pulmonary function testing for asthma follow-up will be included.


title: Effect of Salbutamol on Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease

acronym: DrepaSympa

summary: Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.

ReferenceCitation: Bokov P, El Jurdi H, Denjoy I, Peiffer C, Medjahdi N, Holvoet L, Benkerrou M, Delclaux C. Salbutamol Worsens the Autonomic Nervous System Dysfunction of Children With Sickle Cell Disease. Front Physiol. 2020 Feb 26;11:31. doi: 10.3389/fphys.2020.00031. eCollection 2020.

family: Bokov

full_name: Plamen Bokov

given: Plamen

family: El Jurdi

full_name: Houmam El Jurdi

given: Houmam

family: Denjoy

full_name: Isabelle Denjoy

given: Isabelle

family: Peiffer

full_name: Claudine Peiffer

given: Claudine

family: Medjahdi

full_name: Noria Medjahdi

given: Noria

family: Holvoet

full_name: Laurent Holvoet

given: Laurent

family: Benkerrou

full_name: Malika Benkerrou

given: Malika

family: Delclaux

full_name: Christophe Delclaux

given: Christophe

journal_name: Frontiers in Physiology

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

repository_institution: PubMed Central - Europe PMC

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers


title: Acquisition of Resistant Enterobacteria During Oral Drug Challenge for Betalactams in Children

acronym: ARET

summary:
Direct drug provocation testing, without prior skin or in vitro testing, is the reference standard for confirming the diagnosis of drug hypersensitivity reactions in children reporting mild and delayed-onset reactions. However, optimal protocol(s) have not been standardized. Although a 2-days' provocation testing protocol is effective, increasing its duration (up to 14 days) may improve its diagnosis performance without increasing the risk of severe reactions. However, a prolonged provocation testing could increase the risk of emergence of bacterial resistances in the digestive flora. Longer duration could be associated with the emergence of extended-spectrum betalactamase producing enterobacteria. However, this point has never been confirmed.

The study will include children (0-18 years); referring for histories of mild and delayed-onset reactions to betalactams. drug provocation testing will be performed with the suspected BLs in our department, as in clinical practice. Two groups of patients will be compared: a group performing short provocation testing (arbitrary defined as lasting 1 to 4 days) and a group with prolonged drug provocation testing (arbitrary defined as lasting 5-8 days). A rectal swab will be collected for each patient before the provocation testing, a second one at the end of the provocation testing. Each sample will be analyzed to detect the presence extended-spectrum betalactamase -producing enterobacteria.


title: Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr

acronym: PASIPD-Fr

summary: The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) is a scale that has been developped and validated in English to quantify the level of physical activity for people with physical disabilities. The investigators aimed to translate and validate a French transcultural version of the PASIPD (PASIPD-Fr) through a rigourous process following international recommendations for cross-cultural translation and adaptation of questionnaires.

primary_purpose: Prevention


title: Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome: Pilot Translational an Exploratory Study

acronym: RADIOMIC-TBI

summary: We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.

intervention_type: Radiation


title: Multicentric, Randomized, Double Blind Study Under Dermatological Control for Evaluation of the Antidandruff Maintenance Effect of One Shampoo (Reference 1144628 D) Versus Its Vehicle (Reference 1144781) During 8 Weeks After a Ketoconazole-based Antifungal Treatment During 4 Weeks in Adult Subjects (Male and Female) With Light to Moderate Seborrheic Dermatitis

summary: The aim of this study was to investigate the changes in the scalp bacterial and fungal microbiota in subjects afflicted with a scalp seborrheic dermatitis (SSD) during a 2% ketoconazole-based treatment followed by a maintenance phase (1% Selenium Disulfide (SeS2)/1% salicylic acid-based shampoo versus its vehicle).

ipd_sharing_description: Antidandruff maintenance effect Comparison of the antidandruff maintenance effect, after a 4 weeks treatment with ketoconazole, of two shampoos (active versus vehicle) applied during 8 weeks i.e. up to week 12 (principal objective) and during 4 and 6 weeks i.e. at week 8 and week 10 (secondary objective).

lead_sponsor: L'Oreal


title: Therapeutic Abstention and Surveillance of Intra-epithelial Histological Lesions of High Grade Cervical CIN2 (Cervical Intraepithelial Neoplasia Grade 2). SUIVICIN

acronym: SUIVICIN

summary: This study proposes to describe and evaluate the rate of spontaneous regression of CIN2 at 2 year of follow up in women between 18 and 39 year old. This follow-up is proposed as an alternative to the treatment of reference (conization) with a possible extension to 4 years

lead_sponsor: University Hospital, Bordeaux


title: Study of Self-assessment Questionnaires Used in Hip and Knee Surgery

acronym: HIP-KNEE

summary:
Patient-reported outcome measures (PROMs) are currently used for evaluating orthopaedic procedures. Nevertheless, there is no consensus in the different studies, making them difficult to compare . The score mapping (or cross walk) is a statistical model for estimating a score associated with an unmeasured score.

Moreover , Minimal clinically important differences (MCID) is the smallest change in a treatment outcome that a patient would identify as important. The MCID is also not clearly identified for the French population for the hip and knee orthopaedic scores.

ReferenceCitation: Putman S, Preda C, Girard J, Duhamel A, Migaud H. Mapping and Crosswalk of the Oxford Hip Score and Different Versions of the Hip Disability and Osteoarthritis Outcome Score. Clin Orthop Relat Res. 2021 Jul 1;479(7):1534-1544. doi: 10.1097/CORR.0000000000001675.

family: Putman

full_name: Sophie Putman

given: Sophie

family: Preda

full_name: Cristian Preda

given: Cristian

family: Girard

full_name: Julien Girard

given: Julien

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Migaud

full_name: Henri Migaud

given: Henri

journal_name: Clinical Orthopaedics & Related Research

ReferenceCitation: Putman S, Dartus J, Migaud H, Pasquier G, Girard J, Preda C, Duhamel A. Can the minimal clinically important difference be determined in a French-speaking population with primary hip replacement using one PROM item and the Anchor strategy? Orthop Traumatol Surg Res. 2021 May;107(3):102830. doi: 10.1016/j.otsr.2021.102830. Epub 2021 Jan 29.

family: Dartus

full_name: Julien Dartus

family: Pasquier

full_name: Gilles Pasquier

given: Gilles

journal_name: Orthopaedics & Traumatology: Surgery & Research

oa_host_type: publisher

evidence: open (via free article)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University Hospital, Lille


title: Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma

acronym: PEP-C

summary: Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.

ReferenceCitation: Li G, Mallouk N, Flandrin P, Garcin A, Lambert C, Berremila SA, Habchi H, Mottet N. Presence of Urinary Exosomes for Liquid Biopsy of Clear Cell Renal Cell Carcinoma: Protocol for a Pilot Feasibility Study. JMIR Res Protoc. 2021 Jul 20;10(7):e24423. doi: 10.2196/24423.

family: Li

full_name: Guorong Li

given: Guorong

family: Mallouk

full_name: Nora Mallouk

given: Nora

family: Flandrin

full_name: Pascale Flandrin

given: Pascale

family: Garcin

full_name: Arnauld Garcin

given: Arnauld

family: Lambert

full_name: Claude Lambert

given: Claude

family: Berremila

full_name: Sid Ali Berremila

given: Sid Ali

family: Habchi

full_name: Hocine Habchi

given: Hocine

family: Mottet

full_name: Nicolas Mottet

given: Nicolas

journal_name: JMIR Research Protocols

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study

acronym: ICAX

summary: Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.


title: Agitation Follow up After Introduction of a New Patient Care Algorithm

acronym: SARA

summary: Agitation in the intensive care unit is motor hyperactivity. It is frequent (b/w 30% to 70%) and has multiple causes: pain, medical reason, delirium, medication, etc. It can be a source of complication, for the patient, and equipment pullout. International recommendations state that the agitation should be taken care of with standardized protocols to improve patient care.

ReferenceCitation: Chanques G, Jaber S, Barbotte E, Violet S, Sebbane M, Perrigault PF, Mann C, Lefrant JY, Eledjam JJ. Impact of systematic evaluation of pain and agitation in an intensive care unit. Crit Care Med. 2006 Jun;34(6):1691-9.

ReferenceCitation: Almeida TM, Azevedo LC, Nosé PM, Freitas FG, Machado FR. Risk factors for agitation in critically ill patients. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):413-419. doi: 10.5935/0103-507X.20160074. Portuguese, English.

ReferenceCitation: Jaber S, Chanques G, Altairac C, Sebbane M, Vergne C, Perrigault PF, Eledjam JJ. A prospective study of agitation in a medical-surgical ICU: incidence, risk factors, and outcomes. Chest. 2005 Oct;128(4):2749-57.

ReferenceCitation: Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. Review.

ReferenceCitation: Barr J, Fraser GL, Puntillo K, Ely EW, Gélinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72. Review.

ReferenceCitation: Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91.

ReferenceCitation: Payen JF, Bosson JL, Chanques G, Mantz J, Labarere J; DOLOREA Investigators. Pain assessment is associated with decreased duration of mechanical ventilation in the intensive care unit: a post Hoc analysis of the DOLOREA study. Anesthesiology. 2009 Dec;111(6):1308-16. doi: 10.1097/ALN.0b013e3181c0d4f0.

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2.

ReferenceCitation: Ely EW, Stephens RK, Jackson JC, Thomason JW, Truman B, Gordon S, Dittus RS, Bernard GR. Current opinions regarding the importance, diagnosis, and management of delirium in the intensive care unit: a survey of 912 healthcare professionals. Crit Care Med. 2004 Jan;32(1):106-12.

lead_sponsor: University Hospital, Grenoble


title: Validation of a Connected Patch, an Alternative to Conventional Monitoring

summary: The hypothesis is that this connected patch could be used in surgical departments to detect early a cardiovascular or respiratory complication and therefore to treat it without delay. However, it has not been validated in a hospital setting; that is the purpose of this project. This step of validating the connected monitoring object is required in different places: post-interventional surveillance room that approaches a conventional hospital room, and operating room where artifacts are numerous. Validation will be done by comparing data from General Electric's conventional monitors, with data from patches.

lead_sponsor: Hopital Foch


title: Effect of an Individualized Home-based Physical Activity Trial on Carotid Plaque Vulnerability for Asymptomatic Patients

acronym: PACAPh

summary:
Intraplaque hemorrhage (IPH) is one of the main features of the carotid plaque instability's and predictor of ischemic stroke. Benefits (on the basis on benefit/risk ratio) of the carotid endarterectomy remain unclear for stroke asymptomatic patients; thus, more and more patients with important stenosis (i.e. over 60%) detected are not operated. However, these patients need adapted therapeutic treatments to limit plaque instability and this should include physical activity (PA). Indeed, PA has been showed to decrease numerous inflammatory markers involved in atherosclerosis. It has also recently been reported on stroke asymptomatic patients that the prevalence of carotid IPH was decreased in those with higher level of PA. Magnetic Resonance Imaging (MRI) of the IPH has been shown to be the better non-invasive imaging technique to assess carotid plaque instability and in particular IPH. Here, the aim of this study is to assess the effect of an individualized home-based 6 months physical activity intervention on carotid IPH and other biomarkers of vulnerability for asymptomatic patients.

This study has been designed as a monocentric, longitudinal and interventional study. This study will involve one centre: Hopital Louis Pradel (HCL, Lyon). After inclusion tests, patients will be randomly included in the control group, or in the PA group. Patients of the PA group will have connected bracelets to measure daily count of steps. Twice a month, daily goals will be revaluated to increase or maintain the steps per day. The final goal is to reach 6 000 steps per day or increase by 30% the initial count of steps per day. Same tests will be done after 6 months of intervention for comparison.

lead_sponsor: Hospices Civils de Lyon


title: MOLecular Characterization and Treatment of THYroid Carcinoma on Struma Ovarii

acronym: MOLTHYSO

summary: Thyroid carcinoma on struma ovarii (TCSO) is a rare ovarian tumor, derivate from monodermic teratomas. It represents about 0.01% of overall ovarian tumours, and 5 to 10% of struma ovarii. The diagnosis is histologic and retrospective after pelvic surgery. Because of its rarity, the treatment of TCSO is not consensual and should be validated in multidisciplinary team involved in rare ovarian carcinoma. TCSO should be taken care of as a thyroid carcinoma, in case of relapse, with systemic treatment, as tyrosine kinase inhibitor (TKI), without any clinical trial proving this benefit. Indeed, molecular profiles and genomic expression is unknown, because of studies with few patients (less than 10) contrary to thyroid carcinomas with the TCGA genomic classification. The study purposes are the outcome of the patients after the first treatment and the comparison of the genomic profil in next generation sequencing (NGS) with TCGA thyroid carcinoma profile. Thus, the treatment could be tailored, confirming the same therapy as in thyroid carcinoma.

lead_sponsor: Institut Bergonié


title: Evolution of Diaphragm Thickness Under Veno-arterial ECMO : Observational Study

acronym: ATROPHY-ECMO

summary:
The main objective is to evaluate the evolution of the thickness of the diaphragm (during the first week of treatment) by VA ECMO in the resuscitation patients.

The comprehension of the mechanisms involved in the diaphragm ailment will identify modifiable factors that lead to muscle degradation and thus to the deterioration of patients' prognosis.


title: An Interventional Prospective Study to Test the Feasibility of an Individualized Physical Activity Program in Patients Over 65 Years of Age With Hematologic Malignancies: the OCAPI Project.

acronym: OCAPI

summary:
Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.

OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG <3, with no contraindications to PA and no history or coexistence of other primary cancer.

Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.

ReferenceCitation: Fournier B, Nicolas-Virelizier E, Russo C, Pérol O, Millet GY, Maire A, Delrieu L, Michallet AS, Assaad S, Belhabri A, Gilis L, Guillermin Y, Lebras L, Rey P, Santana C, Pretet-Flamand E, Terret C, Michallet M, Fervers B. Individualised physical activity programme in patients over 65 years with haematological malignancies (OCAPI): protocol for a single-arm feasibility trial. BMJ Open. 2021 Jun 3;11(6):e046409. doi: 10.1136/bmjopen-2020-046409.

family: Fournier

full_name: Baptiste Fournier

given: Baptiste

family: Nicolas-Virelizier

full_name: Emmanuelle Nicolas-Virelizier

given: Emmanuelle

family: Russo

full_name: Chiara Russo

given: Chiara

family: Pérol

full_name: Olivia Pérol

given: Olivia

family: Millet

full_name: Guillaume Y Millet

given: Guillaume Y

family: Maire

full_name: Aurélia Maire

given: Aurélia

family: Delrieu

full_name: Lidia Delrieu

given: Lidia

family: Michallet

full_name: Anne-Sophie Michallet

given: Anne-Sophie

family: Assaad

full_name: Souad Assaad

given: Souad

family: Belhabri

full_name: Amine Belhabri

given: Amine

family: Gilis

full_name: Lila Gilis

given: Lila

family: Guillermin

full_name: Yann Guillermin

given: Yann

family: Lebras

full_name: Laure Lebras

given: Laure

family: Rey

full_name: Philippe Rey

given: Philippe

family: Santana

full_name: Clémence Santana

given: Clémence

family: Pretet-Flamand

full_name: Emilie Pretet-Flamand

given: Emilie

family: Terret

full_name: Catherine Terret

given: Catherine

full_name: Mauricette Michallet

given: Mauricette

family: Fervers

full_name: Béatrice Fervers

given: Béatrice

currency_apc_doaj: GBP

journal_name: BMJ Open


title: Evolution of Bone Volume in the Mandibular Posterior Area After Natural Healing and Flapless Technique

summary: The aim of this study is to evaluate the bone loss after extraction. The surgery protocol is flapless, and the teeth are mandibular premolars or molars leaving sockets with 4 walls intact or at least 3 walls intact and the buccal wall at 80% . This study will include 40 patients

ipd_sharing_description: NC


title: Evaluation of Anticholinergic Load Using the ACB "Anticholinergic Cognitive Burden" Scale in Parkinson's Patients

summary:
Drugs with anticholinergic properties may cause central and peripheral side effects. Several scales have been developed to evaluate the anticholinergic effect of drugs. Numerous studies have been published, showing a link between the anticholinergic load and the occurrence of adverse effects in the elderly.

Anticholinergic Cognitive Burden is a scale that identifies the severity of adverse effects of anticholinergic drugs specifically on cognition including cognitive decline, mental confusion, mild cognitive impairment, and dementia. It was developed from reviews of the medical literature and the calculation of drug affinities for muscarinic receptors. This list of drugs was presented to a team of experts including geriatricians, psychogeriatrists geriatric nurses and pharmacists, who assigned these drugs three scores ranging from 1 to 3:

score 1: drugs with a possible anticholinergic effect on cognition demonstrated in vitro by its affinity for the muscarinic receptor or by calculation of the ASA level (anticholinergic activity of the serum), but without relevant clinical evidence of cognitive adverse effects;
scores 2 and 3: drugs whose moderate or severe anticholinergic effect on cognition has been clearly established clinically. The drugs of scores 2 or 3 are differentiated by their ability to cause confusion and their properties to penetrate or not the blood-brain barrier.

The sum of the scores of the different drugs taken by the patient determines the cumulative cognitive risk score related to anticholinergics.

This ACB scale seems to be the most relevant in Parkinsonian patients.

Parkinson's disease (PD) is described for the first time in 1817 by an English doctor who gives it his name.

Parkinson's disease is a chronic, slowly progressive condition defined by the presence of motor symptoms (resting tremor, slowness and difficulty of movement or bradykinesia, muscle rigidity, equilibrium disorders) associated with variable non-motor symptoms ( such as constipation, fatigue, depression and anxiety, sleep disorders, impaired sense of smell, cognitive disorders). Age is the main risk factor for the disease (?).

There is a significant increase in the number of cases due to the aging of the population and the improvement in life expectancy.

By 2030, the number of Parkinson's patients could increase by 56% with 1 in 120 people over 45 with the disease.

Parkinsonian patients are subjected to a higher anticholinergic load, by the therapeutics used in their pathologies (antidepressants, neuroleptics, antiparkinsonians, etc ...).

These central and peripheral anticholinergic effects may add to the symptomatology in Parkinson's patients and aggravate their pathology.

My study project aims to improve the management of elderly patients with Parkinson's disease.

Hypothesis: People involved in the management of Parkinson's patients are not always aware of the potential anticholinergic effects of drugs. Indeed, anticholinergic effects can be responsible for many hospitalizations in the elderly.

This is why we want to make an inventory of treatments in Parkinson's patients at the entrance of hospitalization by evaluating the anticholinergic load using the ACB scale and the hospitalization exit in order to know if this score changed after informing the doctors responsible


title: Quantification of Elastin Markers Synthesis in Williams-Beuren Syndrome and 7q11.23 Micro-duplication Syndrome

summary:
Introduction: Williams-Beuren syndrome is a rare genetic disorder caused by a 7q11.23 microdeletion. The phenotype associates vasculopathy (arterial stenosis, hypertension), dimorphism and intellectual disability. Microdeletion includes several genes: ELN encodes for elastin and the haplo-insufficiency (only 1 functional copy) causes vasculopathy.

The primary objective is to quantify plasma and urinary levels of elastin peptides in Williams-Beuren patients and 7q11.23 micro-duplication syndrome patients in order to correlate the levels of these markers with the number of copies of ELN gene (proportional positive relationship "gene copy number - circulating levels of markers) Materials and Methods: This prospective study will be carried out in Lyon at the "Hôpital Femme-Mère-Enfant" for 2 years. 3 groups of patients will be studied: Williams-Beuren patients (N=20), micro-duplication 7q11.23 syndrome patients (N=10) and healthy patients (N=60). Subjects will be followed for 1 day.

Clinical examination (weight, height, blood pressure) and biological sample collection (blood and urine sample) will be carry out for Williams Beuren and micro-duplication 7q11.23 patients group. A large majority of visits will be part of patients' usual care. A large part of patients are systematically seen in consultation once a year. For healthy group, only biological sample collection will be carry out. The PE concentrations will be assessed and compared between the three groups of patients.

location_facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon


title: Mastication Involvement in Postprandial Thermogenesis Via Autonomic Nervous System Activation in Normal Weight and Obese People

acronym: MASTICAL

summary:
The objective of the study is to analyze the specific role of physical properties of food and mastication in the cephalic phase reflex of thermogenesis, and the involvement of the autonomic nervous system in the implementation of this reflex.

The hypothesis of the study is that oral stimulation elicited by food properties during mastication can generate changes in the amplitude of variation of thermogenesis, and that these changes are distinct from those attributable to the thermal effect of food during digestion.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Effect of a Systematic Preventive Versus Curative Strategy of Fluid Removal on the Weaning of Mechanical Ventilation

acronym: PCT-Fluid

summary: Fluid overload is associated with a poor prognosis in critically ill patients, especially during weaning from mechanical ventilation as it may promote weaning induced pulmonary edema. Previous data suggest that early administration of diuretics ("preventive depletion") could shorten the duration of mechanical ventilation. However, this strategy may expose patients to a risk of metabolic complications. On the other hand, initiating fluid removal only in case of weaning induced pulmonary edema (curative depletion) may reduce the risk of metabolic complications, but prolong the duration of mechanical ventilation. Currently, there is no recommendation for a preventive or curative use of diuretics during weaning. There is therefore an equipoise on the timing of initiation of diuretics during weaning from mechanical ventilation.

primary_purpose: Health Services Research

ReferenceCitation: Dres M, Estellat C, Baudel JL, Beloncle F, Cousty J, Galbois A, Guérin L, Labbe V, Labro G, Lebut J, Mira JP, Prat G, Quenot JP, Dessap A; Reseau Européen de Recherche en Ventilation Artificielle (REVA) research network. Comparison of a preventive or curative strategy of fluid removal on the weaning of mechanical ventilation: a study protocol for a multicentre randomised open-label parallel-group trial. BMJ Open. 2021 Aug 16;11(8):e048286. doi: 10.1136/bmjopen-2020-048286.

family: Dres

full_name: Martin Dres

given: Martin

family: Estellat

full_name: Candice Estellat

given: Candice

family: Baudel

full_name: Jean-Luc Baudel

given: Jean-Luc

family: Beloncle

full_name: François Beloncle

given: François

family: Cousty

full_name: Julien Cousty

given: Julien

family: Galbois

full_name: Arnaud Galbois

given: Arnaud

family: Guérin

full_name: Laurent Guérin

given: Laurent

family: Labbe

full_name: Vincent Labbe

given: Vincent

family: Labro

full_name: Guylaine Labro

given: Guylaine

family: Lebut

full_name: Jordane Lebut

given: Jordane

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Prat

full_name: Gwenael Prat

given: Gwenael

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Dessap

full_name: Armand Dessap

given: Armand

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

acronym: ORTHOQOL

summary: The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.


title: Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie

acronym: DOSEMAP

summary: The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

lead_sponsor: University Hospital, Brest


title: Endoscopic Characterization of Colorectal Neoplasia With the Different Published Classifications: a Prospective Comparative Study Involving Gastroenterologists From Trainees to Experts.

summary: Endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. Different classifications have been proposed to predict histology depending on the endoscopic aspect. Thus, the aspect of the shape of the lesion is described in the Paris classification, the aspect of the mucosal pattern in Kudo's classification and the vascular pattern in Sano's one. Recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the NICE classification or even more recently the Japanese JNET classification. However, although the interest in combining the Paris, Sano and Kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. We have created a synthetic classification called CONECCT grouping the different criteria for an initial educational purpose. We have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. Nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. To validate this CONECCT classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.

lead_sponsor: Hôpital Edouard Herriot


title: Impact Study of a Rapid Diagnosis of Influenza in the Emergency Medical Service During the 2018-2019 Epidemic Season

summary:
The purpose of the study is to compare Emergency Department patients who undergo influenza and RSV PCR testing using an FDA-approved point-of-care device (Cepheid Xpert® Xpress Flu/RSV) located in the ED, to patients who undergo influenza and RSV PCR testing at the core laboratory.

The principal purpose is to determine if the time spent in the ED is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing.

ReferenceCitation: Soto M, Sampietro-Colom L, Vilella A, Pantoja E, Asenjo M, Arjona R, Hurtado JC, Trilla A, Alvarez-Martínez MJ, Mira A, Vila J, Marcos MA. Economic Impact of a New Rapid PCR Assay for Detecting Influenza Virus in an Emergency Department and Hospitalized Patients. PLoS One. 2016 Jan 20;11(1):e0146620. doi: 10.1371/journal.pone.0146620. eCollection 2016.

ReferenceCitation: Trabattoni E, Le V, Pilmis B, Pean de Ponfilly G, Caisso C, Couzigou C, Vidal B, Mizrahi A, Ganansia O, Le Monnier A, Lina B, Nguyen Van JC. Implementation of Alere i Influenza A & B point of care test for the diagnosis of influenza in an ED. Am J Emerg Med. 2018 Jun;36(6):916-921. doi: 10.1016/j.ajem.2017.10.046. Epub 2017 Oct 18.

ReferenceCitation: Brendish NJ, Malachira AK, Armstrong L, Houghton R, Aitken S, Nyimbili E, Ewings S, Lillie PJ, Clark TW. Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial. Lancet Respir Med. 2017 May;5(5):401-411. doi: 10.1016/S2213-2600(17)30120-0. Epub 2017 Apr 6.

ReferenceCitation: Ho YII, Wong AH, Lai RWM. Comparison of the Cepheid Xpert Xpress Flu/RSV Assay to in-house Flu/RSV triplex real-time RT-PCR for rapid molecular detection of Influenza A, Influenza B and Respiratory Syncytial Virus in respiratory specimens. J Med Microbiol. 2018 Nov;67(11):1576-1580. doi: 10.1099/jmm.0.000841. Epub 2018 Sep 12.

ReferenceCitation: Banerjee D, Kanwar N, Hassan F, Essmyer C, Selvarangan R. Comparison of Six Sample-to-Answer Influenza A/B and Respiratory Syncytial Virus Nucleic Acid Amplification Assays Using Respiratory Specimens from Children. J Clin Microbiol. 2018 Oct 25;56(11). pii: e00930-18. doi: 10.1128/JCM.00930-18. Print 2018 Nov.

ReferenceCitation: Bennett S, MacLean A, Gunson R. Verification of Cepheid Xpert Xpress Flu/RSV assay for use with gargle samples, sputa and endotracheal secretions. J Hosp Infect. 2019 Jan;101(1):114-115. doi: 10.1016/j.jhin.2018.07.016. Epub 2018 Jul 17.

ReferenceCitation: Popowitch EB, Miller MB. Comparison of the Xpert Flu/RSV XC and Xpress Flu/RSV Assays. J Clin Microbiol. 2018 Jul 26;56(8). pii: e00278-18. doi: 10.1128/JCM.00278-18. Print 2018 Aug.


title: Development of a Therapeutic Education Program for Patients With Metastatic Prostate Cancer Treated With New Generation Hormone Therapy: Construction and Feasibility Study

acronym: PROSTED

summary: The development of a personalized therapeutic education program dedicated to patients with metastatic prostate cancer and receiving next-generation hormone therapy would improve their knowledge of the disease, medication adherence and quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

acronym: ROSA-IC

summary: Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: The Point of View of Adolescents Who Have Undergone a Suicidal Act: What do They Expect From Their Relationship With Their Doctor?

summary: Evaluate the expectations of adolescents who have performed a suicidal act with regard to their relationship with their doctor


title: POSTOPERATIVE OPIOID-SPARING EFFECT OF INTRAOPERATIVE PAIN MONITORING USING THE ANALGESIA NOCICEPTIVE INDEX (ANI) DURING IDIOPATHIC SCOLIOSIS CORRECTION IN CHILDREN.

acronym: OpiSpANI

summary:
Anaesthesia is often performed using a balanced technique by administering both opioids and anaesthetics agents. Intraoperative opioid administration is still relying on simple parameters such as heart rate and blood pressure variations. However, many studies in both adults and children have shown the poor accuracy of those parameters in predicting pain because of their sensibility to other intraoperative events such as depth of anaesthesia and volaemic variations. Consequently, intraoperative analgesia is still inadequately managed with periods of under dosage or over dosage of opioid agents. This has been hypothesized to cause postoperative hyperalgesia related to both intraoperative pain (in case of under dosage) or to opioid agents (in case of over dosage). The main resulting effect is an increase of postoperative opioid consumption and the inadequate postoperative rehabilitation because of adverse effects of opioids.

During the last decade, many pain-monitors have been investigated. Most of these devices are relying on the determination of the sympathetic-to the parasympathetic systems balance. Among those monitors, the Analgesia Nociceptive Index (ANI) quantifies the parasympathetic system. The ANI device can produce two parameters the instantaneous ANI (ANIi), derived from 60 seconds analysis and the mean ANI (ANIm) derived from 4 minutes analysis. Studies have shown the accuracy of ANIi to detect both experimental and clinical pain in various populations. Moreover, a recent randomized controlled trial during spine surgery in adults has found ANIi to decrease the intraoperative and postoperative opioid consumption when used intraoperatively for guiding the administration of opioid agents

location_facility: Department of Anesthesiology, Robert Debre University Hospital


title: Strategy for Transfer to Emergency Head And Neck (UTEC) of Stroke Alerts With Suspicion of Large Vessel Occlusion for Mechanical Thrombectomy in the Languedoc Roussillon Region

acronym: START

summary: A mono-centre observational study with the aim of compare clinical outcome at 3 month on patients admitted with recent cerebral infarct and intracranial large vessel occlusion in the anterior circulation who are eligible for mechanical thrombectomy in three different position : Patients admitted first in the Comprehensive Stroke Center of Montpellier, those transferred after Proximity Stroke Unit or prehospital bypass for patients with high suspicion of large vessel occlusion.to the Comprehensive Stroke Center of Montpellier


title: Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial

acronym: COMPARACHILLE

summary: The importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .

lead_sponsor: Nantes University Hospital


title: Feasibility Study of the Taïso Practice in Parkinson's Disease

acronym: Taïso-Park

summary:
This is a pilot study of descriptive and analytical, prospective feasibility, monocentric, longitudinal with 6 months of bi-weekly practice of Taïso in patients with Parkinson's disease with mild to moderate postural instability.

The intervention is planned over 6 months (25 consecutive weeks) for the whole project of the patient group. Patients are included in the month before the start of the treatment of the intervention. Four standardized evaluation sessions are conducted: a first evaluation during the first week of Taiso and then every 8 weeks (2 months, 4 months and 6 months). Incident collection and fitness assessment tests are performed by the physical trainer while the balance and are performed by a physiotherapist. The quality of life assessment and the MDS-UPDRS II rating are performed during the inclusion visit and then the final study visit (within 2 weeks) after 6 months of practice) with the coordinating neurologist. An evaluation of incidents is also carried out during this end-of-study visit.

primary_purpose: Screening

lead_sponsor: University Hospital, Angers


title: Physical Activity Level and Cerebral Oxygenation During Gait in Old People

acronym: OXYSENIOR

summary:
Ageing is accompanied by a cognitive decline altering gait and increasing the risk of falling. Physical activity could reduce this cognitive decline by an improvement in the oxygen supply to the brain. At the moment, the effect of physical activity on brain oxygenation during walking in elderly has never been described. Moreover, the increase in cognitive request during a dual task could lead to an increase in the risk of falling. In this context, the investigators of Orleans's hospital want to examine the effect of the physical activity level of elderly on their brain oxygenation during walking and during a dual task.

Moreover, Parkinson' patients could display an impairment of gait and cognitive function. Attentional task and dual task situation are particularly impaired in this pathology. This is why the investigators of Orleans's hospital want to also examine cerebral activation of these patients during walking and during a dual task.

The hemodynamic cerebral activation will be studied using the near infrared spectroscopy at the level of the prefrontal cortex. This non-invasive technic allows the evaluation of the regional oxyhemoglobin and deoxyhemoglobin variations induced by cerebral activation.

ReferenceCitation: Anderton BH. Ageing of the brain. Mech Ageing Dev. 2002 Apr;123(7):811-7. Review.

ReferenceCitation: Andrés P, Van der Linden M. Age-related differences in supervisory attentional system functions. J Gerontol B Psychol Sci Soc Sci. 2000 Nov;55(6):P373-80.

ReferenceCitation: Asllani I, Habeck C, Borogovac A, Brown TR, Brickman AM, Stern Y. Separating function from structure in perfusion imaging of the aging brain. Hum Brain Mapp. 2009 Sep;30(9):2927-35. doi: 10.1002/hbm.20719.

ReferenceCitation: Azulay JP, Van Den Brand C, Mestre D, Blin O, Sangla I, Pouget J, Serratrice G. [Automatic motion analysis of gait in patients with Parkinson disease: effects of levodopa and visual stimulations]. Rev Neurol (Paris). 1996 Feb;152(2):128-34. French.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Diaphragm Ultrasound in Neuromuscular Disorders

summary:
Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.

The aims of the study are:

to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies
to assess the correlation between diaphragm ultrasound and FPT
to assess the correlation between diaphragm ultrasound and cardiac function

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: "Sleep, Rhythms and Risk of Alzheimer's Disease: a Daily Life Actigraphic Assessment and MRI Study" "SoRyMA - AMImage3"

summary:
Alterations in sleep and the sleep / wake cycle, which are particularly common in Alzheimer's disease patients, could represent an early biomarker for cognitive decline and onset of dementia . Moreover, these disturbances in activity rhythms and sleep patterns represent modifiable factors and therefore potential targets for the prevention of certain neurodegenerative disorders.

The main objective of this study will be to test the hypothesis that elderly people without major cognitive impairment who have circadian rhythm disorders of the sleep / wake cycle have structural and / or functional abnormalities in the central nervous system and more specifically of the hippocampal function which could represent a risk factor for the occurrence of cognitive impairment. Indeed, although many studies in both humans and animals suggest the existence of links between sleep alterations and age-related cognitive impairment, the causality of these observations is still not clear.

This description of the anatomical and functional substratum of sleep / wake cycle alterations occurring in an elderly population will be based on joint analysis of multimodal brain imaging (MRI) and neuropsychology actimetry data. The SoRyMA-AMImage 3 protocol will correspond to the 2nd actimetry measurement point and the 3rd MRI measurement point of a larger population-based cohort AMImage.

This project will collect data from the sleep / wake cycle (actimetry) from a sample of 100 patients included in AMI / AMImage 2 and relate them to brain imaging data (MRI). The main objective of the protocol is the evaluation of the link between changes in sleep and cycle parameters during aging and hippocampal functioning (through fMRI and neuropsychological score of hippocampal dependant tasks). The actimetry variables measured at the two follow-up (4 years apart) will make it possible to measure the degradation of the sleep and cycle parameters (through the reduction of sleep duration, sleep time, increase in sleep fragmentation and decrease in the relative amplitude of the rhythm).

This framework will provide access to a very large amount of data that can be cross-referenced with actimetry data; the longitudinal character of this data collected over a decade will also make it possible to work on the evolution of the actimetry parameters and its relationship with the cognitive and clinical evolution of the subjects. Thus, these data will make it possible to study the prognostic value of the analyzed actimetry parameters in association with very complete clinical and neuropsychological data.


title: Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure: Pilot Study

acronym: SFATI-IRC

summary: The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method will be accurate for measurement of systolic blood pressure with marked arterial stiffness as seen in patients with severe renal impairment. Also that the presence of arterial calcifications only changes the agreement between the SFATI method and the reference method (auscultatory method) if the calcifications are very severe.


title: Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients

acronym: CIMDREA

summary: the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.


title: Small Cortical Cerebellar Infarctions Are Associated With Patent Foramen Ovale in Young Cryptogenic Stroke Patients

summary: The investigator retrospectively analyzed consecutive young (<60 years) cryptogenic stroke patients with Patient Foramen Ovale (PFO) recruited between January 2016 and May 2019 in our center, and compared these patients with sex- and age-matched controls with cryptogenic stroke without PFO. Analyzed baseline characteristics: sex, age, cardiovascular risk factors, history of stroke, and cortical/subcortical localization, arterial territory, number of lesions, and lesion size of the acute symptomatic infarction, together with the ROPE score. The presence and the number of acute and chronic SCCI lesions were assessed.

ReferenceCitation: Renard D, Ion I, Ricci JE, Mura T, Thouvenot E, Wacongne A. Chronic Small Cortical Cerebellar Infarctions on MRI are Associated with Patent Foramen Ovale in Young Cryptogenic Stroke. Cerebrovasc Dis. 2020;49(1):105-109. doi: 10.1159/000505959. Epub 2020 Feb 14.

family: Renard

full_name: Dimitri Renard

given: Dimitri

family: Ion

full_name: Ioana Ion

given: Ioana

family: Ricci

full_name: Jean-Etienne Ricci

given: Jean-Etienne

family: Mura

full_name: Thibault Mura

given: Thibault

family: Thouvenot

full_name: Eric Thouvenot

given: Eric

family: Wacongne

full_name: Anne Wacongne

given: Anne

journal_name: Cerebrovascular Diseases

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG