title: Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy

summary: Open-label study to evaluate the safety and efficacy of Ixazomib in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma (MM). The patient population will consist of adult men and women up to 65 years, who have a confirmed diagnosis of MM who meet eligibility criteria.

lead_sponsor: University Hospital, Toulouse


title: Treatment Adherence in Patients With Rheumatoid Arthritis Previously Treated With Oral or Injectable Methotrexate and Requiring a New Treatment With Injectable Methotrexate

acronym: APRim

summary: The aim of this study is to evaluate, at 6 months, the rate of patients whose adherence to injectable MTX remained strong or improved according to patient-reported outcome.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Nordic Pharma SAS

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Grant/Funding Number

title: Impact of Susceptibility Testing Directly on the Deep Respiratory Samples of Patients Suspected Pneumonia Ventilator ( VAP ) Late ( > 5 Days) in Intensive Care Unit on the Adequacy of Antibiotic Treatment to Carbapenems Sparing on Day 1

summary:
Inappropriate antibiotic therapy in ventilator-associated pneumonia (VAP) is associated with increased mortality. The international guidelines recommend using broad spectrum antimicrobials especially in patients who received previous antimicrobials, with risk factors of muti-drug resistant (MDR) VAP or after 5 days of mechanical ventilation. Using broad-spectrum antibiotics for 48h until the results of conventional cultures and antimicrobial susceptibility testing (AST) are available, may promote the emergence of drug-resistant bacteria. Exposure to imipenem, as short as 1 to 3 days, is associated with a 5-fold increase in the risk of imipenem resistance in the gut microbiota of ICU patients (Armand-Lefevre AAC 2013). Performing AST directly on clinical respiratory samples would hasten the process by at least 24h.

The diagnostic performance of a rapid method combining mass spectrometry and direct AST [DAST] are previously analyzed, and compared it with the conventional method (mass spectrometry with conventional AST [CAST]) and its potential impact was assessed on antimicrobial use in 85 patients (Le DORZE M et al - Clin. Microbiol. Infect. 2015).

The results produced by the dast were useable in 85,9% of the cases and the sensitivity and negative predictive values of DAST were 100% for all antibiotics tested, except gentamicin (97.1% [95%CI = 93.3-101] and 97.4% [93.7-101], respectively) and amikacin (88.9% [81.7-96.1] and 96.4% [92.1-100.7], respectively), compared with CAST. Specificity and positive predictive values ranged from 82.9 (74.2-91.5) to 100%, and from 86.4 (78.5-94.2) to 100%, respectively. If results had been reported to the clinicians, that DAST would have saved carbapenem prescription in 17 cases (22%) and would have allowed immediate narrow spectrum antimicrobials in 35/85 (41.2%) cases. But, the benefit of DAST was based on a simulation and should be now tested in a randomized fashion. This project is a prospective multicenter study. The hypothesis is that, DAST compared to CAST, would increase the number of adequate antimicrobial therapy within 24 hours in case of late VAP (> 5 days under mechanical ventilation) with Gram negative bacilli (GNB) in IC patients while sparing carbapenems (imipenem and meropenem). The primary objective is to determine the impact of a strategy using DAST on the rate of day1 adequate therapy without carbapenems in case of late VAP due to GNB.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Determination of Carcinogens Nicotine in Electronic Cigarettes Users

acronym: CANICE

summary:
Multicenter, national study, non-randomized , controlled, comparative with 4 independent groups (20 participants in each group). There are 3 experimental groups ("smocker", "nicotine replacement therapy" an "electronic cigarette") and 1 control group ("without nicotine").

The main objective of the study is to compare the level of urinary NNN in the electronic cigarette users versus the nicotine replacement therapy (patch) users.

design_allocation: Non-Randomized

primary_purpose: Prevention

ipd_sharing: No

intervention_type: Procedure


title: Ultrasound-guided Caudal or Interlaminar Injection? A Comparative Study of Epidural Corticosteroid Injections in the Treatment of Lumbar Disk Herniation-related Sciatica

acronym: HiatUS

summary: An open-label randomized trial to compare the efficacy of ultrasound-guided caudal and interlaminar corticosteroid injections for the treatment of lumbar disk herniation-related sciatica.

status: Withdrawn

primary_purpose: Treatment

lead_sponsor: University Hospital, Caen


title: Outcomes of Critically Ill Patients With Severe Acute Kidney Injury Requiring Renal Replacement Therapy

acronym: PROVEER

summary: This study assess the vital status, renal function and renal recovery of patients admitted to intensive care unit and requiring renal replacement therapy for acute kidney failure. Patient follow up is up to 3 years after ICU admission when possible.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest


title: Observatoire Brestois Des Néoplasies Myéloprolifératives

acronym: OBENE

summary:
All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study.

Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis.

This is a not interventional study. Alive patients need to sign a non-opposition consent form.

Patients will be followed until last news (death, change of reference centre...).

status: Recruiting

time_perspective: Cross-Sectional

ReferenceType: result

ReferenceCitation: Delluc A, Lacut K, Pan-Petesch B, Galinat H, Lippert E, Ianotto JC. Statin exposure and thrombosis risk in patients with myeloproliferative neoplasms. Thromb Res. 2018 Jul;167:57-59. doi: 10.1016/j.thromres.2018.05.014. Epub 2018 May 16.

family: Delluc

full_name: Aurélien Delluc

given: Aurélien

sequence: first

family: Lacut

full_name: Karine Lacut

given: Karine

sequence: additional

family: Pan-Petesch

full_name: Brigitte Pan-Petesch

given: Brigitte

family: Galinat

full_name: Hubert Galinat

given: Hubert

family: Lippert

full_name: Eric Lippert

given: Eric

family: Ianotto

full_name: Jean-Christophe Ianotto

given: Jean-Christophe

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Thrombosis Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Mollard LM, Chauveau A, Boyer-Perrard F, Douet-Guilbert N, Houot R, Quintin-Roué I, Couturier MA, Dagorne A, Malou M, Le Calloch R, Luycx O, Thepot S, Hunault M, Guillerm G, Berthou C, Ugo V, Lippert É, Ianotto JC. Outcome of Ph negative myeloproliferative neoplasms transforming to accelerated or leukemic phase. Leuk Lymphoma. 2018 Dec;59(12):2812-2820. doi: 10.1080/10428194.2018.1441408. Epub 2018 Apr 4.

name: Service d’Hématologie Clinique, Institut de Cancéro-Hématologie, CHRU de Brest, Brest, France;

family: Mollard

full_name: Lise-Marie Mollard

given: Lise-Marie

name: Laboratoire d’Hématologie, CHRU de Brest, Brest, France;

family: Chauveau

full_name: Aurélie Chauveau

given: Aurélie

name: Service des Maladies du Sang, CHU d’Angers, Brest, France;

family: Boyer-Perrard

full_name: Françoise Boyer-Perrard

given: Françoise

name: Laboratoire de Cytogénétique, CHRU de Brest, Brest, France;

family: Douet-Guilbert

full_name: Nathalie Douet-Guilbert

given: Nathalie

name: Laboratoire d’Anatomo-Pathologie, CHRU Brest, Brest, France;

family: Houot

full_name: Roch Houot

given: Roch

name: Service d’Hématologie Clinique, CHU de Rennes, Brest, France;

family: Quintin-Roué

full_name: Isabelle Quintin-Roué

given: Isabelle

name: Service d’Hématologie Clinique, CH de Saint-Brieuc, Brest, France;

family: Couturier

full_name: Marie-Anne Couturier

given: Marie-Anne

name: Service d’Hématologie Clinique, CH de Morlaix, Brest, France;

family: Dagorne

full_name: Anaig Dagorne

given: Anaig

name: Service de Médecine Interne, CH de Quimper, Brest, France;

family: Malou

full_name: Mohamed Malou

given: Mohamed

name: Service d’Hématologie, CH de Lorient, Brest, France;

family: Le Calloch

full_name: Ronan Le Calloch

given: Ronan

name: Laboratoire d’Hématologie, CHU d’Angers, Brest, France

family: Luycx

full_name: Odile Luycx

given: Odile

family: Thepot

full_name: Sylvain Thepot

given: Sylvain

family: Hunault

full_name: Mathilde Hunault

given: Mathilde

family: Guillerm

full_name: Gaelle Guillerm

given: Gaelle

family: Berthou

full_name: Christian Berthou

given: Christian

ReferenceCitation: Mansier O, Luque Paz D, Ianotto JC, Le Bris Y, Chauveau A, Boyer F, Conejero C, Fitoussi O, Riou J, Adiko D, Touati M, Chauzeix J, Viallard JF, Béné MC, Giraudier S, Ugo V, Lippert E. Clinical and biological characterization of MPN patients harboring two driver mutations, a French intergroup of myeloproliferative neoplasms (FIM) study. Am J Hematol. 2018 Aug;93(4):E84-E86. doi: 10.1002/ajh.25014. Epub 2018 Jan 12.

name: UFR Sciences de la Vie et de la Santé; Université de Bordeaux; Bordeaux France

name: CHU de Bordeaux, Laboratoire d'Hématologie; Bordeaux France

name: INSERM U1218, ACTION, Université de Bordeaux; Bordeaux France

name: Université Angers, UFR Santé; Angers France

name: CHU d'Angers, Laboratoire d'Hématologie; Angers France

name: CRCINA, INSERM, Université d'Angers; Angers France

name: Fédération Hospitalo-Universitaire ‘Grand Ouest Against Leukemia’ (FHU GOAL); Angers France

name: CHU de Brest, Service d'Hématologie Clinique; Brest France

name: CHU de Nantes, Laboratoire d'Hématologie; Nantes France

name: CHU de Brest, Laboratoire d'Hématologie; Brest France

name: Université de Bretagne Occidentale, UFR Médecine; Brest France

name: CHU d'Angers, Service des Maladies du Sang; Angers France

name: AP-HP, CHU Henri Mondor, Laboratoire d'Hématologie; Créteil France

name: Polyclinique Bordeaux Nord Aquitaine, Service d'hémato-oncologie; Bordeaux France

name: INSERM 1066 MINT, Université d'Angers; Angers France

name: Service de Médecine-Hématologie; CH Robert Boulin; Libourne France

name: CHU de Limoges, Service d'Hématologie; Limoges France

name: CHU de Limoges, Laboratoire d'Hématologie, CRBS; Limoges France

name: Service de Médecine Interne-Maladies Infectieuses; CHU de Bordeaux; Pessac France

ReferenceCitation: Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and associated with an increased risk of complications in patients with polycythemia vera or essential thrombocythemia (OUEST study). Haematologica. 2018 Apr;103(4):607-613. doi: 10.3324/haematol.2017.180448. Epub 2017 Dec 15.

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-α2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.

ReferenceCitation: Mahé K, Delluc A, Chauveau A, Castellant P, Mottier D, Dalbies F, Berthou C, Guillerm G, Lippert E, Ianotto JC. Incidence and impact of atrial arrhythmias on thrombotic events in MPNs. Ann Hematol. 2018 Jan;97(1):101-107. doi: 10.1007/s00277-017-3164-x. Epub 2017 Nov 21.

ReferenceCitation: Ianotto JC, Couturier MA, Galinat H, Mottier D, Berthou C, Guillerm G, Lippert E, Delluc A. Administration of direct oral anticoagulants in patients with myeloproliferative neoplasms. Int J Hematol. 2017 Oct;106(4):517-521. doi: 10.1007/s12185-017-2282-5. Epub 2017 Jun 16.

ReferenceCitation: Le Clech L, Sakka M, Meskar A, Kerspern H, Eveillard JR, Berthou C, Buors C, Lippert E, Guillerm G, Quintin-Roué I, Carré JL, Ianotto JC. The presence of monoclonal gammopathy in Ph-negative myeloproliferative neoplasms is associated with a detrimental effect on outcomes. Leuk Lymphoma. 2017 Nov;58(11):2582-2587. doi: 10.1080/10428194.2017.1312380. Epub 2017 May 9.

name: Service d’Hématologie, Institut de Cancéro-Hématologie, CHRU de Brest, Brest, France;

name: Laboratoire de Biochimie, CHRU de Brest, Brest, France;

name: Laboratoire d’Anatomo-Pathologie, CHRU de Brest, Brest, France

ReferenceCitation: Le Gall-Ianotto C, Brenaut E, Gouillou M, Lacut K, Nowak E, Tempescul A, Berthou C, Ugo V, Carré JL, Misery L, Ianotto JC. Clinical characteristics of aquagenic pruritus in patients with myeloproliferative neoplasms. Br J Dermatol. 2017 Jan;176(1):255-258. doi: 10.1111/bjd.14809. Epub 2016 Dec 22.

name: Laboratory of Neurosciences of Brest University of Brest Brest France

name: Department of Dermatology University Hospital of Brest Brest France

name: CIC INSERM 0502 University Hospital of Brest Brest France

name: Department of Haematology University Hospital of Brest Brest France

name: Laboratory of Haematology University Hospital of Angers Angers France

name: Laboratory of Biochemistry University Hospital of Brest Brest France


title: Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth: a Randomized, Multicentre, Double Blind Placebo-controlled Non Inferiority Trial

acronym: BETADOSE

summary:
Extensive animal studies have indicated that antenatal betamethasone exposure results in altered developmental trajectories of several fetal systems. Follow up of a randomized controlled trial has shown that antenatal betamethasone exposure might result in insulin resistance 30 years later. Furthermore, animal studies and randomized trials in Humans have clearly demonstrated that betamethasone-induced growth alterations were dose-related.

In ewes, a 50% reduced dose regimen resulted in maximal improvement in preterm lamb lung function, similar to those obtained after a full dose.

Our hypothesis is that antenatal betamethasone after a 50% dose reduction, justified by the potential long term effects of this drug, is not inferior to a full dose to promote fetal lung maturation in Humans.

ReferenceType: derived

ReferenceCitation: Schmitz T, Alberti C, Ursino M, Baud O, Aupiais C; BETADOSE study group and the GROG (Groupe de Recherche en Gynécologie Obstétrique). Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE). BMC Pregnancy Childbirth. 2019 Feb 12;19(1):67. doi: 10.1186/s12884-019-2206-x.

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

name: for the BETADOSE study group and the GROG (Groupe de Recherche en Gynécologie Obstétrique)

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Ursino

full_name: Moreno Ursino

given: Moreno

family: Baud

full_name: Olivier Baud

given: Olivier

family: Aupiais

full_name: Camille Aupiais

given: Camille

currency_apc_doaj: GBP

journal_name: BMC Pregnancy and Childbirth

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

repository_institution: University of Geneva - Archive ouverte UNIGE

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
unige.ch

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

intervention_type: Drug


title: Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)

acronym: MAV-IRM

summary:
In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic).

This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Opthalmologique A de Rothschild

status_simplified: Ongoing


summary:
Cone beam computed tomography (CBCT), is a recent medical imaging technique where the X-rays are divergent, forming a cone.

As a result, this technique is less irradiating that the scanner. The purpose of this exploratory study is to compare the performance of the scanner and the cone beam in the detection of anatomical structures of the ear.

primary_purpose: Diagnostic

location_facility: Fondation Ophtalmologique A de Rothschild

intervention_type: Device


acronym: DIMAVE

summary: This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of the Diagnostic Performance of Electrical Impedance Tomography (EIT) to Detect Situations at Risk of Lesions Induced by Conventional Mechanical Ventilation in Acute Respiratory Distress Syndrome (ARDS)

summary:
Acute respiratory distress syndrome remains a serious condition, with a mortality rate of between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and pulmonary lesions induced by mechanical ventilation. It is therefore now established that the respirator settings influence patient prognosis. However, around 30% of patients with ARDS ventilated with these settings supposedly protective continue to present signs of pulmonary hyperinflation on tomodensitometry, suggesting an additional reduction in the tidal volume could be required in certain patients. Electrical impedance tomography (EIT) is a new imaging technique that gathers functional pulmonary information at bedside.

This technique also allows a regional analysis, allowing the complexity of the spatial distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a reliable method to detect at-risk situations of lesions induced by mechanical ventilation among patients with ARDS.

lead_sponsor: Hospices Civils de Lyon


acronym: ESPOIR

summary: This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.

status: Terminated


title: Use of Dried Blood Spot for Clinical Mass Spectrometry Analysis

acronym: BUVAMASS

summary: Dried Blood Spot or DBS is a collection of blood capillary drops spotted and dried on to a filter paper used for different bioanalysis. In comparison to conventional blood testing, DBS offers practical, analytical, clinical and financial advantages. This less invasive sampling is already used in infectious diseases screening and is useful for persons with poor venous (babies, drug users or elderly). Mass-spectrometry-based analyses allow protein quantification on very low amount of blood sample. In the project we combine the two approaches to measure on DBS blood proteins with clinical relevance -including many FDA approves biomarkers). The detection of the relevant clinical analytes will be validated on available patient samples in accordance with the clinical norm ISO15189 and the requirement for CE IVD marking. This will allow commercial developments (kits, protocols...) realized with the industrial partner Spot-to-lab

lead_sponsor: University Hospital, Montpellier

intervention_type: Biological


title: Neuronal Excitability of Hyperpolarization-activated Cyclic Nucleotide-gated (HCN1) Channel Mutations in Dravet Syndrome

acronym: EXCIDRAH

summary: This study addresses the changes in the axonal excitability parameters. It will compare these changes in patients with early infantile epileptic encephalopathy with HCN1 channel mutation and in control patients, with and without epilepsy.


title: Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia

acronym: SERC

summary: Case-control comparison of clinical population, interventional and single-center research.

lead_sponsor: Versailles Hospital

intervention_type: Behavioral


title: Prevention of Dental Caries in Primary Molars on Sealants

acronym: sealants

summary: Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.

ReferenceCitation: Chabadel O, Véronneau J, Montal S, Tramini P, Moulis E. Effectiveness of pit and fissure sealants on primary molars: A 2-yr split-mouth randomized clinical trial. Eur J Oral Sci. 2021 Feb;129(1):e12758. doi: 10.1111/eos.12758. Epub 2020 Dec 30.

name: Department of Paediatric Dentistry Hospital and University of Montpellier Montpellier France

family: Chabadel

full_name: Olivier Chabadel

name: Department of Dental Public Health University of McGill Montreal QC Canada

family: Véronneau

full_name: Jacques Véronneau

given: Jacques

name: Department of Prosthodontics Hospital and University of Montpellier Montpellier France

family: Montal

full_name: Sylvie Montal

given: Sylvie

name: Department of Dental Public Health Hospital and University of Montpellier Montpellier France

family: Tramini

full_name: Paul Tramini

given: Paul

family: Moulis

full_name: Estelle Moulis

given: Estelle

journal_name: European Journal of Oral Sciences

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effectiveness of pit and fissure sealants on primary molars: A 2‐yr split‐mouth randomized clinical trial


acronym: EPIGETBO III

summary: The aim of this study estimate VTE incidence. Investigators prospectively record all cases of symptomatic pulmonary embolism (PE) and deep vein thrombosis (DVT) of the lower limbs diagnosed between March 1, 2013 and February 28, 2014 in hospitals and in the community.


title: Search for Risk Factors of Conversion From Local to General Sedation in Emergency Endovascular Therapy for Acute Stroke

acronym: AMAS

summary:
Thrombectomy is now the standard of care of revascularization in acute ischaemic stroke. Data tend to show that final neurologic outcome is superior if the thrombectomy procedure was performed under conscious sedation.

The Rothschild Foundation is a high output centre with more than 400 thrombectomy procedures every year.

We report a rate of 5% of these procedures requiring general anesthesia despite conscious sedation being the standard of care. This study aims to identify clinical factors associated with a risk of conversion of a conscious sedation to a general anesthesia.


title: Efficacity and Safety of Metformin XR in CKD Stage 1 to 3

acronym: METXR/CKD

summary: There is limited data availability on effect of Metformin XR on 24-h plasma glucose, and there is no available data in chronic kidney disease (CKD). The planned study aims to provide data on glucose plasma level in relation to metformin plasma level in Diabetes Type II patients.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of the Effect of a Complex Inflammatory Milieu Induced by BCG Treatment in Urines of Patients With Non-muscle-invasive Bladder Cancer on the Xpert® Bladder Cancer Assay

acronym: CEPHEID

summary: Intravesical BCG immunotherapy is used after transurethral resection (TUR) for the prevention of recurrence of NMIBC. BCG treatment is usually started a few weeks after TUR and is given once a week for 6 weeks. It stimulates immune responses that can destroy bladder cancer cells (acute and chronic induced inflammations) and as a consequence causes side effects. The investigators postulate that Xpert® test might be used to demonstrate the presence of residual (after TURB) or recurrent (during adjuvant treatment) disease at the time of intravesical treatment, which could be of very significant impact in the management of this complex situation.Urines of BCG treated patients are rich in immune system elements (cytokines, lymphocytes,…), this complex inflammatory milieu of urines may interfere with urinary biomarkers. This study will allow assessing the effect of the complex inflammatory milieu induced by BCG treatment in urines of patients with NMIBC on the Xpert® Bladder cancer assay.

lead_sponsor: Institut Claudius Regaud


type: Other Identifier

title: Does Non Coeliac Gluten Sensitivity (NCGS) Exist in Children? A Double-Blind Randomized Placebo-Controlled Trial

summary:
Irritable Bowel syndrome (IBS) is a very frequent condition in children. Its management is difficult, often resulting in a persistence of chronical abdominal pain.

In adults, many patients affected by IBS improve under a gluten-free diet, even in the absence of Celiac Disease (CD) or wheat allergy. This condition is called Non Coeliac Gluten Sensitivity (NCGS). However, it is still not clear how to diagnose and manage NCGS, and the pathophysiological mechanisms also remain elusive.

The aim of this study is to determine if NCGS exists in children with IBS and to identify the clinical, serological, and histological characteristics, which could distinguish patients with NCGS from conventional IBS and CD patients.

This is a prospective cohort study in a population of children affected by a moderate to severe IBS for more than 6 months. All children had a Gluten Free Diet (GFD) for 6 weeks. Then, children who improved under GFD were randomized in two groups for a double-blind placebo-controled trial. One group had a reintroduction of gluten followed by a wash-out period, then a placebo reintroduction, whereas the other group had the placebo first, then the wash-out and the gluten reintroduction.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Dietary Supplement


title: Réseau, Epidémiologie, Information, Néphrologie (Network Epidemiology Information Nephrology)

acronym: REIN

summary: The rein registry collects case record data from patients with end stage renal disease followed in French Guiana. This allows to generate incidence and rates for terminal renal disease, mortality rates for each territory. The regional data are pooled in order to get national statistics for end stage renal disease and transplantation activity in order to adapt prevention to the main causes of renal failure and treatment and care infrastructure.

lead_sponsor: Centre Hospitalier de Cayenne


title: Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study

acronym: ADTCR

summary:
The research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT.

ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh improvements in cancer-specific outcomes against potential increased risks for cardiovascular diseases. The potential for harm from ADT should be more precisely defined according to the type of ADT. Those potential risks underscore the importance of better understanding benefits of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually deviant behavior.

lead_sponsor: Rennes University Hospital


title: Evaluation of Energy Balance During Aquatic Cycling Exercise in Premenopausal Women: Effect of Body Composition Status

summary: Exercise training on an immersible ergocycle is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. Commercial tagline highlight beneficial effect of this activity on weight management. However there are poor information concerning the energy response induced by this activity. The aim of this project is to investigate energetic response (energy expenditure and food intake) of a single bout of cycling exercise in water vs on dryland in normal weight and overweight premenopausal women.

ReferenceType: background

ReferenceCitation: Bréchat PH, Wolf JP, Simon-Rigaud ML, Bréchat N, Kantelip JP, Berthelay S, Regnard J. Influence of immersion on respiratory requirements during 30-min cycling exercise. Eur Respir J. 1999 Apr;13(4):860-6.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean

acronym: EpiConCES

summary:
The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.

The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.


title: Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Elective Pediatric Anesthetized Patient?

acronym: PEDIFLUID

summary: To predict fluid responsiveness in anesthetized pediatric patient is not an easy task although anesthesia provider has to deal with this question on their daily practices. Today, very few parameters can help anesthesia provider to predict fluid responsiveness in the pediatric anesthetized patient. Therefore anesthesia provider are let with fluid challenge with high volume of fluid boluses to see if patient were fluid responsive or not. This could lead to fluid overload and it's associated morbidity. We would like to investigate if the cardiac output response to a mini fluid challenge of 3 ml/kg in 2 minutes would be predictive of the response to an usual fluid challenge of 15 ml/kg in 10 minutes in elective pediatric anesthetized patients.

ReferenceCitation: Brandstrup B, Tønnesen H, Beier-Holgersen R, Hjortsø E, Ørding H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8.

ReferenceCitation: Desgranges FP, Desebbe O, Pereira de Souza Neto E, Raphael D, Chassard D. Respiratory variation in aortic blood flow peak velocity to predict fluid responsiveness in mechanically ventilated children: a systematic review and meta-analysis. Paediatr Anaesth. 2016 Jan;26(1):37-47. doi: 10.1111/pan.12803. Epub 2015 Nov 6. Review.

ReferenceCitation: Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e. Review.

ReferenceCitation: Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.

ReferenceCitation: Tibby SM, Hatherill M, Durward A, Murdoch IA. Are transoesophageal Doppler parameters a reliable guide to paediatric haemodynamic status and fluid management? Intensive Care Med. 2001 Jan;27(1):201-5.

ReferenceCitation: Pereira de Souza Neto E, Grousson S, Duflo F, Ducreux C, Joly H, Convert J, Mottolese C, Dailler F, Cannesson M. Predicting fluid responsiveness in mechanically ventilated children under general anaesthesia using dynamic parameters and transthoracic echocardiography. Br J Anaesth. 2011 Jun;106(6):856-64. doi: 10.1093/bja/aer090. Epub 2011 Apr 26.

ReferenceCitation: Weber T, Wagner T, Neumann K, Deusch E. Low predictability of three different noninvasive methods to determine fluid responsiveness in critically ill children. Pediatr Crit Care Med. 2015 Mar;16(3):e89-94. doi: 10.1097/PCC.0000000000000364.

ReferenceCitation: Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.

ReferenceCitation: Tibby SM, Hatherill M, Murdoch IA. Use of transesophageal Doppler ultrasonography in ventilated pediatric patients: derivation of cardiac output. Crit Care Med. 2000 Jun;28(6):2045-50.


title: The Effect of When Medication is Taken on Nutritional Status in Hospitalized Patients Older Than 65 Years

summary:
Polypathology in elderly subjects requires polypharmacy but even though the efficacy of a medication and digestive tolerance are ensured, the medication can be taken a long time from meals to reduce its side-effects. Despite numerous studies that have investigated links between medication and malnutrition, none have assessed the influence of the time the drug is taken on the evolution of the nutritional status of elderly hospitalized persons. So as to identify the best nutritional criterion in hospitalized persons, a retrospective pilot study will be conducted in about thirty patients. Their medication will be recorded and their nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI), albumin, prealbumin levels, weight and the Mini Nutritional Assessment (MNA) short form.

This preliminary study will allow us to choose the best nutritional criterion to compare the impact of two strategies for taking medication (post prandial versus pre-prandial) on improving the nutritional status of malnourished elderly hospitalized patients taking multiple drugs.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of 3D Rotational Angiography After EVAR

acronym: EVAR

summary: This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.

study_start_date_type: Anticipated

lead_sponsor: University Hospital, Lille

intervention_type: Radiation


title: Primary Prevention of Sudden Cardiac Death in Real Life: Differences With the Pivotal Studies and Their Consequences

acronym: PREV-DEATH

summary: The efficacy of implantable cardioverter-defibrillators (ICD) in primary prevention of sudden cardiac death (SCD) is well demonstrated but pivotal studies have been published more than 10 years ago and implantation's conditions tend to change.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord: Building a Conceptual Framework Based on the Perceptions and Behaviors of Patients and Professionals Involved

acronym: QUALIPREPS

summary: The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.

lead_sponsor: Nantes University Hospital


acronym: EXCYCLOTORSION

summary:
The paralysis of the fourth cranial nerve (paralysis IV), commonly known as the superior oblique muscle (SO) paralysis, represents half of vertical strabismus. The diagnosis of SO paralysis and of its congenital or acquired etiology, are based on a range of clinical findings. The three main clinical diagnostic elements are the hypertropia in paralyzed side which increases in adducted position, the positivity of Bielschowsky head tilt test and the twisting of the eye fundus. These criteria are always considered together and are interdependent. The diagnostic value and the sensitivity of each of these signs is not defined. Brain and orbital Magnetic Resonance Imaging (MRI) allowed a better understanding of the physiopathology of a number of oculomotor disorders.

For this reason, MRI constitute a reference for the SO palsy. The atrophy of the SO muscle is qualitatively determined by the asymmetry of muscle volume on two contiguous coronal MRI.

The diagnostic value of various clinical signs observed in SO paralysis (sensitivity, specificity) remains unknown.


acronym: STICOB

summary:
Cervical dystonia (CD) is a syndrome characterized by sustained and/or phasic involuntary neck muscle activity causing abnormal head postures and movements. It is the most frequent form of adult focal dystonia. The distribution of dystonic muscles is unique for each patient, explaining the variety of patterns encountered.

The therapeutic management of CD is essentially local and symptomatic: Botulinum Neurotoxin injections and/or specific retraining therapy programmes. Therefore, analyzing the characteristics of abnormal head movements and identifying the dystonic muscles are the key points of these treatments.

To a better understanding of the posture and movement disorders of head and neck, we wish to establish a three-dimensional (3-D) computer model of cervical spine movements of ten healthy subjects built from images obtained with the "Cone Beam " system. Then we will compare the cervical posture and movements for each of ten CD patients matched in age and genre to the computer model. Comparison with patients' images in the axial plane reconstructed by computer with the 3-D computer model will lead to the description of various patterns of CD. Analysis of the musculoskeletal disturbances in CD should be a help to improve the localization of Botulinum Neurotoxin injection sites as well as retraining programmes.

location_facility: Fondation Ophtalmique Adolphe de Rothschild


title: The Impact of Parkinson's Disease on Internal Preactivation of Sensory Effects of Intention-based Actions. A Subliminal Priming Study

acronym: DYNIDEO

summary: The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.


acronym: PCT

summary:
Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.

The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.

Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Is Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring During Spontaneous Breathing Trials Useful to Predict Extubation Failure in Mechanically Ventilated Patients in the ICU?

summary: Difficult weaning from ventilation and extubation failure are major issues in intensive care, concerning 30% and 12% of patients respectively. These can be partly explained by the lack of accuracy of spontaneous breathing trial (SBT) failure criteria to predict extubation failure. The investigators performed a pilot study to evaluate transcutaneous carbon dioxide pressure (tcPCO2) monitoring during SBTs. The results showed that the difference between maximum and initial tcPCO2 (or ΔtcPCO2) was significantly higher in the group of patients who failed SBTs according to the usual criteria. Moreover, the results suggested that ΔtcPCO2 could be an accurate and early criterion for SBT failure. The size of the study could not examine ΔtcPCO2 regarding extubation failure. Therefore, the main objective of this study is to determine if Δ tcPCO2 during SBTs is associated with extubation failure.


title: Evaluation of the Effectiveness of a SPA Therapy to "Neyrac-les-Bains" to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.

summary:
Low back pain is considered to be chronic if it has been present for longer than three months.

This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.

The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.

The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to "Neyrac-les-Bains".

ReferenceCitation: Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston RJ. The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain. 2007 Oct;131(3):293-301. doi: 10.1016/j.pain.2007.01.012. Epub 2007 Feb 20.

ReferenceCitation: Forestier R, Desfour H, Tessier JM, Françon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.

family: Forestier

full_name: R. Forestier

given: R.

family: Desfour

full_name: H. Desfour

given: H.

family: Tessier

full_name: J.-M. Tessier

family: Francon

full_name: A. Francon

given: A.

family: Foote

full_name: A. M. Foote

given: A. M.

family: Genty

full_name: C. Genty

given: C.

family: Rolland

full_name: C. Rolland

family: Roques

full_name: C.-F. Roques

family: Bosson

full_name: J.-L. Bosson

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

version: submittedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Pittler MH, Karagülle MZ, Karagülle M, Ernst E. Spa therapy and balneotherapy for treating low back pain: meta-analysis of randomized trials. Rheumatology (Oxford). 2006 Jul;45(7):880-4. Epub 2006 Jan 31. Review.

ReferenceCitation: Koes BW, van Tulder MW, Thomas S. Diagnosis and treatment of low back pain. BMJ. 2006 Jun 17;332(7555):1430-4. Review.

ReferenceCitation: Loney PL, Stratford PW. The prevalence of low back pain in adults: a methodological review of the literature. Phys Ther. 1999 Apr;79(4):384-96. Review.


title: Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient: a Randomized, Controlled Pilot Study

acronym: VEINVIEW

summary: Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole.


title: A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

acronym: BIOKID

summary: Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents) are one of the main causes of mortality in the general population. The recruitment of macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are rarely followed by clinical events, but can progress to complicated atheromatoses (calcification, rupture) resulting in the occurrence of various clinical events such as myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes immunogenic and induces anti-LDLox antibody production that could be markers of progression of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE) such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are generated. In order to measure the level of markers in the blood, researchers developed a series of immunologic levels in vitro, using specific antibodies directed against well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36 (sCD36) was recently identified. In this study, only healthy volunteers were recruited in order to be able to establish normal serum ranges of different immunologic biomarkers.

primary_purpose: Basic Science


title: Study of the Influence of the Expression of the Calcium-sensitive Receptor (CaSR) by Monocytes in the Synovial Liquid on Structural Alterations in Patients Diagnosed With Rheumatoid Arthritis in the Previous Two Years

acronym: CASPER

summary: Rheumatoid arthritis (RA) is the most frequent form of chronic inflammatory rheumatism in adults. The erosive damage influences the functional prognosis in patients with RA. At present, there are no sufficiently sensitive and specific predictive markers of erosive damage.


title: Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early Phase Meningeal Hemorrhage Due to a Ruptured Aneurysm a Prognostic 6-month Mortality Factor?

acronym: GAINE

summary: Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).


title: Does Postural Support During Echocardiography Modify Hemodynamic Features and Discomfort Induced by the Examination in Very Premature Neonates?

summary:
Experimental nociceptive stimulation of the fetus and neonate induces pulmonary artery vasoconstriction. The investigators assessed whether echocardiography for Ductus arteriosus screening may generate this hemodynamic response and whether postural support would be able to modulate it.

Study design

Prospective, single center, randomized study in less than 29 weeks of gestation neonates, with a post natal age < 48 hours, and requiring invasive mechanical ventilation.

Crossover design with order of echocardiographies determined by computer randomization: in one group ultrasounds are performed with postural support, than standard conditions, in the other, ultrasounds are performed in standard conditions than with postural support.

The objective of the study is to assess the ratio of the acceleration time/ejection time of pulmonary arterial flow.

The others objectives are to assess echocardiographic-Doppler features (ductus arteriosus shunt pattern, pulmonary flow pattern, estimated systolic pulmonary arterial pressure, right and left ventricular functions using tissue Doppler imaging and speckle-tracking echocardiography), pain assessment with a clinical scale and heart rate variability analysis.


title: Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.

summary:
A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.

The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.

primary_purpose: Screening

lead_sponsor: Hôpital Armand Trousseau

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Evolution of Oxidative Stress in Coronary Patients With Moderate Sleep Apnea Syndrome After Treatment With Continuous Positive Airway Pressure

acronym: CardioX SAS

summary:
Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases.

Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population.

The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.


title: Study of Sensitization to Potato in Patients Consulting at the Allergy Unit in Montpellier

summary: Patients consulting in the Allergy Unit of the Arnaud de Villeneuve Hospital for whatever suspicion of allergy were asked to participate in the study. Besides a standard battery of respiratory allergens, native raw and cooked potato were tested by means of the prick to prick method, using a metal lancet.


title: Study of Myocardial Function by Speckle Tracking After Cancer Treatment With Anthracyclines in Childhood

acronym: SPECKLEANTHRA

summary: The main goal of this study is to compare the values of echocardiographic parameters obtained by Speckle Traking analysis on myocardial function among patients under 18 years treated with anthracyclines in childhood, with healthy age and sex mached volunteers.


title: Longitudinal Study of Behavioral Changes, Economic and Sociological After CAncer

acronym: ELCCA-II

summary:
Generally, French studies concerned with the quality of life of cancer patients focus on the period of treatment (up to 2 years post diagnosis). However, studies about quality of life "after" cancer are relatively rare (= long-term quality of life, or from 5 years post diagnosis). These studies mainly concern the most common cancers (breast and prostate).

Or changes in quality of life after treatment could be different depending on the type of cancer. In addition, there is a significant influence of sociodemographic variables on the quality of life in remission.

Similarly using remote diagnostics, quality of life questionnaires related to health, must be reassessed because too often developed for situations in process.

Based on these findings, "ELCCA II" study proposes to study for five years, the evolution of the impacts of two types of cancer (breast and melanoma) on quality of life (overall and related to the subjective health), socioeconomic status, and behavioral and emotional dimensions (post-traumatic development, coping, anxiety-depression) of those treated.

status: Active, not recruiting

lead_sponsor: Institut Cancerologie de l'Ouest


title: Paris Visual Learning Test (PVLT): a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients

acronym: valid-PVLT

summary:
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory function.

Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization.

The main objective of the present study is to assess the validity of PVLT by comparing MS patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.


title: Optical Coherence Pachymetry (OCP) to Evaluate Central Corneal Ablation Depth in Myopic Femtosecond Laser in Situ Keratomileusis (LASIK)

acronym: PACO

summary: Prospective study aiming to measure central ablation depth during excimer laser surgery in myopic patients operated with femtosecond laser assisted LASIK with intraoperative OCP, before and after laser ablation. This measurement will be compared with pre and 1 month postoperative topography differential pachymetric measurements.


title: Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke

acronym: HEMOLYSE

summary:
Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue.

Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders.

Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.


title: Study of Gene Polymorphisms Involved in the Metabolism and Action of Vitamin D in Amyotrophic Lateral Sclerosis

summary: This is a case-control study performed on a biological collection. The polymorphisms present on a pre-defined list of genes will be studied for 400 Amyotrophic Lateral Sclerosis (sporadic type) DNA samples and 400 control DNA samples.

ReferenceCitation: Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. Review.

ReferenceCitation: Bender PL. Genetic family history assessment. AACN Clin Issues. 1998 Nov;9(4):483-90; quiz 615-7. Review.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Montpellier - Hôpital Gui de Chauliac


title: Implementation and Evaluation of a Social Journey Accompanied for Women With Breast Cancer Diagnosis

acronym: EPARS-SEIN

summary: Evaluate and compare the return to work rate at 12 months

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

location_facility: Institut réginal du Cancer de Montpellier


title: Setting up a Warehouse of Physiological Data and Biomedical Signals in Adult Intensive Care

acronym: REASTOC

summary: The aim of this study is the establishment of a warehouse physiological data and biomedical signal in intensive care adult patients in acute situations from particular records from the Philips Intellivue MP70 monitor.

ReferenceCitation: L'Her E, Nazir S, Pateau V, Visvikis D. Accuracy of noncontact surface imaging for tidal volume and respiratory rate measurements in the ICU. J Clin Monit Comput. 2021 Apr 22. doi: 10.1007/s10877-021-00708-x. [Epub ahead of print]

family: L’Her

full_name: Erwan L’Her

given: Erwan

family: Nazir

full_name: Souha Nazir

given: Souha

family: Pateau

full_name: Victoire Pateau

given: Victoire

family: Visvikis

full_name: Dimitris Visvikis

given: Dimitris

journal_name: Journal of Clinical Monitoring and Computing

ReferenceCitation: L'Her E, N'Guyen QT, Pateau V, Bodenes L, Lellouche F. Photoplethysmographic determination of the respiratory rate in acutely ill patients: validation of a new algorithm and implementation into a biomedical device. Ann Intensive Care. 2019 Jan 21;9(1):11. doi: 10.1186/s13613-019-0485-z.

family: N’Guyen

full_name: Quang-Thang N’Guyen

given: Quang-Thang

family: Bodenes

full_name: Laetitia Bodenes

given: Laetitia

family: Lellouche

full_name: François Lellouche

given: François

journal_name: Annals of Intensive Care

ipd_sharing: Yes

ipd_sharing_description: Ananymized warehouse platform will be shared to other researchers all over the world

lead_sponsor: University Hospital, Brest


title: Etude de l'Observance thérapeutique et Des Effets Secondaires Des Traitements Chez Les Patients traités Pour Polyglobulie de Vaquez et thrombocytémie Essentielle

acronym: OUEST

summary: Patients treated with oral or sub-cutaneous drugs for polycythemia vera or essential thrombocythemia completed an unique paper questionnaire in order to describe their observance, the side effects and their own appreciation of the taken drug.

ReferenceCitation: Le Calloch R, Lacut K, Le Gall-Ianotto C, Nowak E, Abiven M, Tempescul A, Dalbies F, Eveillard JR, Ugo V, Giraudier S, Guillerm G, Lippert E, Berthou C, Ianotto JC. Non-adherence to treatment with cytoreductive and/or antithrombotic drugs is frequent and associated with an increased risk of complications in patients with polycythemia vera or essential thrombocythemia (OUEST study). Haematologica. 2018 Apr;103(4):607-613. doi: 10.3324/haematol.2017.180448. Epub 2017 Dec 15.

family: Le Calloch

full_name: Ronan Le Calloch

given: Ronan

family: Lacut

full_name: Karine Lacut

given: Karine

family: Le Gall-Ianotto

full_name: Christelle Le Gall-Ianotto

given: Christelle

family: Nowak

full_name: Emmanuel Nowak

given: Emmanuel

family: Abiven

full_name: Morgane Abiven

given: Morgane

family: Tempescul

full_name: Adrian Tempescul

given: Adrian

family: Dalbies

full_name: Florence Dalbies

given: Florence

family: Eveillard

full_name: Jean-Richard Eveillard

given: Jean-Richard

family: Ugo

full_name: Valérie Ugo

given: Valérie

family: Giraudier

full_name: Stéphane Giraudier

given: Stéphane

family: Guillerm

full_name: Gaëlle Guillerm

given: Gaëlle

family: Lippert

full_name: Eric Lippert

given: Eric

family: Berthou

full_name: Christian Berthou

given: Christian

family: Ianotto

full_name: Jean-Christophe Ianotto

given: Jean-Christophe

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

publisher_dissemination: Ferrata Storti Foundation (Haematologica)


title: An Innovative Controlled Ovarian Hyperstimulation (COH) Protocol That Combines Large Oocyte Availability and Physiologic Estrogenic Environment for Good Prognosis In Vitro Fertilization and Embryo Transfer (IVF-ET) Patients

acronym: NATOS

summary:
To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian Stimulation) that dissociates E2 production from multiple follicle development.

The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis IVF-ET population, the physiological E2 environment resulting from NATOS significantly improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Registry Identifier

acronym: EXPRET

summary:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy characterized by an inflammatory multifocal segmental demyelination. Due to the clinical heterogeneity of this condition and the lack of specific marker that can reliably identify all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors predicting the evolution or the prognosis of the disease. Current treatments are the intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the most commonly used. Responses of the patients to the treatments are variable. Thus, it is necessary to identify predictive markers of the therapeutic response of CIDP patients treated by IVIg.

Several potential biomarkers have been proposed recently, but none of them has yet been validated as a predictive criterion for therapeutic response. It is therefore necessary to continue to investigate several biological parameters to identify a reliable biological marker.

In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the axonal loss by a precise count of functional motor units. This method, more sensitive than the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX might be a good tool to better characterize the patients and to follow the course of CIDP. It also might be a new sensitive and reliable marker predictive of the therapeutic response.

Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular diseases. A recent study on CIDP patients reported a significant decrease of the muscle Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical parameters. The use of advances MRI techniques could allow characterizing the structure and composition of muscle and nerve tissues of CIDP patients. It could also be a mean for identifying potential new markers, largely unexplored until now, that might be sensitive to disease course and/or IVIg response.

The objective of this study is to identify predictive markers of the treatment response of CIDP patients receiving IVIg.

This is a prospective observational exploratory study of a cohort of 30 CIDP patients treated with IVIg and followed-up during one year.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia

acronym: MUSICATOP

summary: The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.

primary_purpose: Supportive Care

ReferenceCitation: Guerrier G, Bernabei F, Lehmann M, Pellegrini M, Giannaccare G, Rothschild PR. Efficacy of Preoperative Music Intervention on Pain and Anxiety in Patients Undergoing Cataract Surgery. Front Pharmacol. 2021 Sep 30;12:748296. doi: 10.3389/fphar.2021.748296. eCollection 2021.

family: Guerrier

full_name: Gilles Guerrier

given: Gilles

family: Bernabei

full_name: Federico Bernabei

given: Federico

family: Lehmann

full_name: Mathieu Lehmann

given: Mathieu

family: Pellegrini

full_name: Marco Pellegrini

given: Marco

family: Giannaccare

full_name: Giuseppe Giannaccare

given: Giuseppe

family: Rothschild

full_name: Pierre-Raphaël Rothschild

given: Pierre-Raphaël

currency_apc_doaj: USD

journal_name: Frontiers in Pharmacology

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

repositories:
HAL
PubMed Central

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

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Guerrier G, Abdoul H, Jilet L, Rothschild PR, Baillard C. Efficacy of a Web App-Based Music Intervention During Cataract Surgery: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):1007-1013. doi: 10.1001/jamaophthalmol.2021.2767.

name: Department of Anesthesia and Intensive Care, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France

name: INSERM U1138 Team 17, Centre de Recherche des Cordeliers (CRC), Paris, France

name: Unité de Recherche Clinique-Centre d’Investigation Clinique Paris Descartes Necker/Cochin, Hôpital Tarnier, Paris, France

family: Abdoul

full_name: Hendy Abdoul

given: Hendy

family: Jilet

full_name: Lea Jilet

given: Lea

name: Department of Ophthalmology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France

family: Baillard

full_name: Christophe Baillard

given: Christophe

journal_name: JAMA Ophthalmology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Efficacy of a Web App–Based Music Intervention During Cataract Surgery


acronym: CTCVADS

summary:
The dissemination of individual tumor cells is a common phenomenon in solid cancers. Detection of tumor cells in peripheral blood circulating tumor cells (CTC) in nonmetastatic situation is of high prognostic significance.

The objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .

lead_sponsor: Institut de Cancérologie de Lorraine


title: Impact of Dietetics Education Focused on Prevention of Malnutrition, on Reducing Morbidity and Improving Life Quality of Patients With Chronic Heart Failure (CHF): A Randomized Controlled Multicenter Clinical Trial

acronym: NUTRICOEUR

summary: The intervention tested in this research project aims to reduce the unplanned hospitalizations in CHF patients by preventing the malnutrition using a personalized dietetic education program. This new program provides concrete solutions to patients by offering balanced menu ideas, adapted to their tastes and social-cultural habits, and a panel of recipes easy to make, inexpensive and tasty (despite the lack of salt). This new educational program should improve the dietary behavior of patients and reinforce the importance of dietary guidance in support of the CHF.

ReferenceCitation: Nicol SM, Carroll DL, Homeyer CM, Zamagni CM. The identification of malnutrition in heart failure patients. Eur J Cardiovasc Nurs. 2002 Jun;1(2):139-47.

ReferenceCitation: Arcand J, Floras V, Ahmed M, Al-Hesayen A, Ivanov J, Allard JP, Newton GE. Nutritional inadequacies in patients with stable heart failure. J Am Diet Assoc. 2009 Nov;109(11):1909-13. doi: 10.1016/j.jada.2009.08.011.

ReferenceCitation: Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. Erratum in: Arch Intern Med. 2008 Mar 24;168(6):567.

ReferenceCitation: Beck CA, Shah S. Research on health-related quality of life and cardiac conditions. Home Healthc Nurse. 2012 Jan;30(1):54-60. doi: 10.1097/NHH.0b013e31823aa740.

ReferenceCitation: Ferrante D, Varini S, Macchia A, Soifer S, Badra R, Nul D, Grancelli H, Doval H; GESICA Investigators. Long-term results after a telephone intervention in chronic heart failure: DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure) follow-up. J Am Coll Cardiol. 2010 Jul 27;56(5):372-8. doi: 10.1016/j.jacc.2010.03.049.


title: Impact of Surgery on the Treatment of Supratentorial Malignant Gliomas in Subjects Aged 70 and Over

acronym: CSA

summary: The objective of this study is to evaluate the efficacy and safety of surgical resection in elderly patients 70 years or older with a supratentorial glioblastoma de novo. The sensitivity of Magnetic Resonance Spectroscopy with perfusion sequences in the diagnosis of malignant glioma in the elderly will also be studied.


title: The Role of the Coagulation Pathways in Recurrent Angioedema

acronym: Angiocoag

summary: Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups with isolated wheals, isolated angioedema, combination of both and hereditary angioedema in terms of coagulation pathways.

lead_sponsor: University Hospital, Montpellier


title: Immune Thrombocytopenia in Pregnancy: Evolution and Prognostic Factors According to a Prospective Observational Comparative Multicenter National French Study

acronym: TIGRO

summary:
The pregnancy may activate flares of certain autoimmune diseases such as lupus. The influence of pregnancy on the evolution of ITP was never studied while this pathology affects firstly women old enough to procreate. Also, the influence of ITP on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. The realization of a prospective study to answer these questions is necessary to allow us to inform better the patients affected by ITP and to define better in this context the strategy of supervision of the mother, the foetus and the newborn. The highlighting of risk factors of ITP flare or obstetric or neonatal complications will indeed allow the implementation of prevention measures.

The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.

ReferenceCitation: Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

ReferenceCitation: Fujimura K, Harada Y, Fujimoto T, Kuramoto A, Ikeda Y, Akatsuka J, Dan K, Omine M, Mizoguchi H. Nationwide study of idiopathic thrombocytopenic purpura in pregnant women and the clinical influence on neonates. Int J Hematol. 2002 May;75(4):426-33.

ReferenceCitation: Webert KE, Mittal R, Sigouin C, Heddle NM, Kelton JG. A retrospective 11-year analysis of obstetric patients with idiopathic thrombocytopenic purpura. Blood. 2003 Dec 15;102(13):4306-11. Epub 2003 Aug 28. Review.

ReferenceCitation: Valat AS, Caulier MT, Devos P, Rugeri L, Wibaut B, Vaast P, Puech F, Bauters F, Jude B. Relationships between severe neonatal thrombocytopenia and maternal characteristics in pregnancies associated with autoimmune thrombocytopenia. Br J Haematol. 1998 Nov;103(2):397-401.

ReferenceCitation: Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21. Review.


title: Evaluation of the Prevalence of Germs Slow Growth in the Intervertebral Disc (IVD) During Spinal Surgery: a Single-center Prospective Observational Study

acronym: DISCO-PROP

summary:
Low back pain is one of the most frequent reasons for consultation in rheumatology. There is a strong correlation between low back pain, and the presence of a type of Modic 1 signal on MRI.

The anomaly Modic 1 results in a hypointense signal T1-weighted images and hyperintense on T2-weighted sequences (including T2 STIR and / or Fat Sat) and contrast enhancement of the endplates after gadolinium injection; it corresponds to a replacement of normal cancellous bone of fibrovascular tissue.

The origin of this inflammatory process Modic 1 into the vertebra is still unknown.

infectious hypothesis was raised, including contamination by germs called "slow-growth" such as Propionibacterium acnes (PA).

Many studies interesting Bacteriological analysis of disc material found the presence of bacteria (prevalence between 0 and 54%).

A recent clinical trial evaluating the efficacy of antibiotic treatment compared to placebo in low back pain with Modic 1; a show effectiveness of this treatment on the different clinical parameters evaluated.

However skin contamination is not formally excluded, particularly in patients previously infiltrated (including epidural).

Our hypothesis is that the slow-growing bacteria are not involved in Modic 1 type of disc disease, and the possible presence of PA or other slow-growing bacteria in samples obtained discal posterior approach would be related to intraoperative contamination or during preoperative spinal infiltrations The main objective is to assess the prevalence of germs slow growth in the intervertebral disc in the spinal surgery by anterior disc disease in type 1 Modic.


title: Systematic Screening With Electrocardiogram for Unknown Atrial Fibrillation in 65 Years Old and Above People in Nursing Home

summary: Atrial fibrillation is the most common arrhythmia. Some studies shown that systematic screening with electrocardiogram could improve atrial fibrillation detection. No studies are available in nursing home. The goal of this study is to screen atrial fibrillation in patients who live in nursing home.


acronym: COCOBE

summary:
Objective: To evaluate the diagnostic concordance between multislice computed tomography (MSCT) and cone beam computed tomography (CBCT) in the early postoperative assessment of patients after cochlear implantation.

Study Design: Prospective, randomized, single-center, interventional, pilot study on the diagnostic performance of a medical device.

Setting: Tertiary referral center. Patients: Patients aged over 18 years requiring a CT scan after cochlear implant surgery.

Interventions: Nine patients were implanted with electrode arrays from three different manufacturers, including one bilateral. High-resolution MSCT and CBCT were then performed, and 2 experienced radiologists blinded to the imaging modality evaluated the randomized images, twice.

ReferenceCitation: Razafindranaly V, Truy E, Pialat JB, Martinon A, Bourhis M, Boublay N, Faure F, Ltaïef-Boudrigua A. Cone Beam CT Versus Multislice CT: Radiologic Diagnostic Agreement in the Postoperative Assessment of Cochlear Implantation. Otol Neurotol. 2016 Oct;37(9):1246-54. doi: 10.1097/MAO.0000000000001165.

family: Razafindranaly

full_name: Victor Razafindranaly

given: Victor

family: Truy

full_name: Eric Truy

family: Pialat

full_name: Jean-Baptiste Pialat

given: Jean-Baptiste

family: Martinon

full_name: Amanda Martinon

given: Amanda

family: Bourhis

full_name: Magali Bourhis

given: Magali

family: Boublay

full_name: Nawele Boublay

given: Nawele

family: Faure

full_name: Frédéric Faure

given: Frédéric

family: Ltaïef-Boudrigua

full_name: Aïcha Ltaïef-Boudrigua

given: Aïcha

journal_name: Otology & Neurotology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Cone Beam CT Versus Multislice CT

lead_sponsor: Hospices Civils de Lyon

location_facility: Service imagerie pavillon B, Hopital E. Herriot


title: Next Generation Sequencing (NGS) Application for HLA Typing of Donors and Recipients of Hematopoietic Stem Cells

acronym: NGS HLA

summary: The objective of this study is to realize the typing of all HLA loci and validate this technique with continued optimization of next-generation sequencing technology (NGS).


title: Assessment of the Follow-up of Osteoporotic Patients by a Physician-pharmacist Collaboration

acronym: SIOUX

summary: The purpose of this study is to evaluate the follow-up of the osteoporotic patient by a physician-pharmacist collaboration.


title: Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy

acronym: EROD

summary: The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.

ipd_sharing_description: Data are not planned to be shared


title: Impact of Dedicated Hygienist Staff on the Occurrence of Intensive Care Unit -Aquired Bloodstream Infections

acronym: BacterHy

summary: The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.

location_facility: Hopital Nord Assistance Publique Hôpitaux de Marseille


title: Description of the Appearance of Brown Fat in Scanner

acronym: BAT

summary: The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.


title: 3-months Success Rate of Direct Pulp Capping With Biodentine®

acronym: CPDB

summary: Biodentine® is a most recent material for direct pulp capping. The aim of this study is to determine the 3 months success rate (defined as clinical and radiographic successes together) of direct pulp capping realized with Biodentine®.


acronym: MERCURE

summary:
Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy of the basement membrane or following corneal trauma. This syndrome is characterized by recurrent episodes of ocular pain more or less associated with localized separations between the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage abnormalities between these two corneal layers. This could be the result of an increased expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the basement membrane.

The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3 in the RCE syndrome.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


acronym: KERMIT

summary: Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.


title: Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

acronym: ECHO-RCF

summary: This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.

acronym: AMOS

summary: The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)


title: The Influence of Duration of Fluid Abstinence on Hypotension During General Anaesthesia Induction for Traumatic Hip Surgery in the Elderly

acronym: JEÛNE PREOP

summary: This study aims to determine if prolonged fasting represents an independent risk factor for hypotension during induction of general anesthesia in the elderly.


title: The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia

acronym: PTIREG

summary: The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.


title: Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS

acronym: BronchioIUS

summary: The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

lead_sponsor: University Hospital, Toulouse

location_facility: Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique


acronym: GENEPHY

summary: Brain somatic mutations in genes belonging to the mTOR pathway are well recognized in malformations of the cortical development, such as focal cortical dysplasia or hemimegalencephaly. The present study aims to search for brain somatic mutations in paired blood-brain samples from children undergoing epilepsy surgery at the Rothschild Foundation, Paris. Patients and their parents will be recruited to identify genetic abnormalities both in lymphocytic and cortical DNA.

location_facility: Fondation Ophtalmologique Adolphe de Rothschld

intervention_type: Genetic


title: Strut Coverage With SYNERGY Stents and Bioresorbable Vascular Scaffold in Acute Myocardial Infarction: An Intracoronary Optical Coherence Tomography Randomized Study

acronym: COVER-AMI

summary: To assess strut coverage in patients presenting an acute myocardial infarction and treated either with the SYNERGY stent or the Bioresorbable Vascular Scaffold, through a parallel group design.


title: Research of Thymix Dysgenesis in Prenatal Examination of Deletion 22q11 Syndrome

summary: 22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease


title: Are Standard Precautions as Efficient as Contact Additional Precautions Against the Transmission of Multi-drug Resistant Bacteria in Intensive Care Unit ?

acronym: PSBMR

summary: The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.


title: Pilot Study of Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, and Freezing Oocyte or Embryo Prior Chemotherapy for Breast Cancer

acronym: PRESAGE

summary:
The rates of patients with spontaneous pregnancies reported after breast cancer is between 3 and 7%, particularly because of these treatments.

Therefore, it is essential to anticipate this problem by proposing the use of fertility preservation techniques for these young patients prior to any gonadotoxic treatment.

PRESAGE study offers to patients fewer than 40, to preserve their fertility before neoadjuvant or adjuvant chemotherapy for invasive breast cancer.

The aim of this study is to evaluate the feasibility of ovarian stimulation emergency order not to delay the start of treatment. This stimulation combined gonadotropin and tamoxifen followed by an oocyte retrieval. The patient may receive an oocyte vitrification and / or embryonic.

This procedure is already done in many countries, and by some French teams, by combining tamoxifen or letrozole to the classic gonadotropin stimulation.


title: Medico-economical Evaluation of Patient-hotel in Urology

acronym: HOTELAMBU

summary:
This is a medico-economic study of outpatient surgery paired with a night stay in a patient-hotel, compared with a conventional hospitalization for three types of urological surgeries.

The aim is to show that those two strategies are not different in term of adverse effects or rehospitalization, and that the patient-hotel provide a better quality of life at a reduced cost, in order to generate savings for the paying agent: the Healthcare insurance.

primary_purpose: Health Services Research

location_facility: Service d'Urologie du Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit

acronym: ProReSHA

summary:
This prospective, observational study aim to identify :

Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)

location_facility: Service de réanimation polyvalente neurologique Hôpital Neurologique HCL


title: Urethral Sensory Profile: a New Technique to Evaluate Urethral Sensation Prospective Evaluation in Patients With or Without Neurological Disorders

summary: This is a routine evaluation of urethral sensation during urodynamic studies. The record has been realized retrospectively. The investigators propose a new way to represent urethral sensation, in a simple and non-invasive way.

lead_sponsor: Groupe de Recherche Clinique en Neuro-Urologie


title: Anesthesia Feasibility Study With the CONCERT-CL® Station: Administration of Hypnotic in Closed Loop and Administration of Morphine in TCI Mode, at Constant Concentration, After Initial Calibration With a Pupillometer

acronym: CONCERT

summary:
This is a feasibility study of anesthesia in closed loop with the CONCERT-CL® station, on the effect of the hypnotic agent, measured by the bispectral index of the electroencephalogram, to maintain the hypnosis level within the recommended limits for general anesthesia. The analgesic agent is administered in "Target-Controlled Infusion = TCI" and analgesia evaluated by pupillometry.

This is a prospective, open, non-controlled, non-randomized, monocentric study. The main objective is to study the potential contribution of the system in the conduct of anaesthesia, as decision support, for the administration of the hypnotic agent.

Secondary objectives will include hemodynamic stability, and the average concentrations of opioid and hypnotic anesthetic agents evaluated from the pharmacokinetic model.

The study will involve surgical patients scheduled for surgery under general anesthesia for more than 1 (one) hour.


title: Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia

acronym: HYPOPSY

summary: Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.


title: Psycho-behavioral Disorders in Frontotemporal Lobar Degeneration: Validation of a Quantification and Follow-up Scale

acronym: DAPHNE

summary: Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a quantification and follow-up scale specifically dedicated to patients with FTD in current clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper orality, Negligence and loss of Empathy.


acronym: CRIVO

summary: Refractive surgery includes interventions to correct refractive errors, using a medical device such as a laser or an implant (intraocular lenses) or surgical instruments. The study distinguishes corneal interventions, carried on the surface of the eye, and intraocular interventions, performed on the lens or in the anterior or posterior chamber of the eye. The number of procedures in refractive surgery is growing significantly. They seem to offer satisfactory visual results but a number of issues remains unresolved. In order to get emmetropia, refractive surgery corrects optical defects by decreasing aberrations of lower orders (ie spherical refractive error and astigmatism). This increases high-order aberrations (the most common is a bright halo on the edge of the image). The cutting of the flap to the surface of the cornea in the case of LASIK increases high-order aberrations, which have the effect of reducing post-surgical visual performance (ie visual acuity and contrast sensitivity) and can't be corrected by glasses, while the adaptation of contact lenses on a post-operative cornea is more complex. It is therefore necessary to limit these post-surgical aberrations and to identify their possible sources. Indeed, some authors have provided insight into the effects of some high-order aberrations, but the influence of several factors characterizing the preoperative eye on refractive surgery are still unknown, such as pupillary diameter, depth of the anterior chamber, Intra Ocular Pressure or astigmatism.


title: In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man

acronym: VISECA

summary:
Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing's syndrome.

The investigators speculate that:

acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
that there is a circadian rhythm of the ECS driven by the rythm of plasma cortisol

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'Endocrinologie, Hopital Haut-Leveque


acronym: IMO

summary:
This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.

This is a feasibility study with a limited number of patients.