acronym: IRON KID

title: Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child

location_facility:
University Hospital of Montpellier
University Hospital of Angers

summary: Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .


title: Impact of a Personalized Video in Oral Hygiene Motivation

acronym: GOPERIO

summary: Impact of a personalized video in oral hygiene motivation: The study hypothesis is that the use of a personalized oral hygiene video, made available to the patient via a cloud-based system, in conjunction with a text-based two-way recall system will increase patient compliance, hence leading to improvement or oral hygiene.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Garyga V, Pochelu F, Thivichon-Prince B, Aouini W, Santamaria J, Lambert F, Maucort-Boulch D, Gueyffier F, Gritsch K, Grosgogeat B. GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial. Trials. 2019 Dec 10;20(1):699. doi: 10.1186/s13063-019-3738-0.

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_country: France Belgium

location_facility: Hospices Civils de Lyon - Service de Consultations et de Traitements Dentaires

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

acronym: ExplorASI

summary: The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.

status: Completed

study_completion_date_type: Actual

primary_purpose: Other

enrollment_type: Actual

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

location_facility:
Hopital Raymond Poincare
Nicolas ROCHE, Md PhD

lead_sponsor_type: industriel

status_simplified: Completed


title: Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4: Efficacy and Tolerability of Grazoprevir 100mg/Elbasvir 50mg During 8 Weeks

acronym: SAHIV

summary: The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Gambotti L, Batisse D, Colin-de-Verdiere N, Delaroque-Astagneau E, Desenclos JC, Dominguez S, Dupont C, Duval X, Gervais A, Ghosn J, Larsen C, Pol S, Serpaggi J, Simon A, Valantin MA, Velter A; Acute hepatitis C collaborating group. Acute hepatitis C infection in HIV positive men who have sex with men in Paris, France, 2001-2004. Euro Surveill. 2005 May;10(5):115-7.

ReferenceCitation: Fierer DS, Dieterich DT, Fiel MI, Branch AD, Marks KM, Fusco DN, Hsu R, Smith DM, Fierer J. Rapid progression to decompensated cirrhosis, liver transplant, and death in HIV-infected men after primary hepatitis C virus infection. Clin Infect Dis. 2013 Apr;56(7):1038-43. doi: 10.1093/cid/cis1206. Epub 2012 Dec 21.

ReferenceCitation: European AIDS Treatment Network (NEAT) Acute Hepatitis C Infection Consensus Panel. Acute hepatitis C in HIV-infected individuals: recommendations from the European AIDS Treatment Network (NEAT) consensus conference. AIDS. 2011 Feb 20;25(4):399-409. doi: 10.1097/QAD.0b013e328343443b.

ReferenceCitation: Rockstroh JK, Nelson M, Katlama C, Lalezari J, Mallolas J, Bloch M, Matthews GV, Saag MS, Zamor PJ, Orkin C, Gress J, Klopfer S, Shaughnessy M, Wahl J, Nguyen BY, Barr E, Platt HL, Robertson MN, Sulkowski M. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomised, open-label trial. Lancet HIV. 2015 Aug;2(8):e319-27. doi: 10.1016/S2352-3018(15)00114-9. Epub 2015 Jul 9. Erratum in: Lancet HIV. 2015 Aug;2(8):e316. Lancet HIV. 2015 Oct;2(10):e416.

ipd_sharing: Yes

ipd_sharing_description: All data are available as IPD. An official request must be made to the Principal Investigator. The request will be reviewed by the Scientific Committee. If approved, data will be exchanged according to European Union General Data Protection Regulation.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility:
CHU de Nice
CHU de Lyon
Hôpital La Pitié-Salpêtrière
Hôpital Tenon
Hôpital Bichat
Hôpital Saint-Antoine

intervention_type: Drug


type: Other Identifier

title: Boosting Reward-based Attention Through VEstibular STimulation

acronym: BRAVEST

summary:
The exploration of space is more effective when intrinsically rewarding elements are located in the visual scene. Thus, rewards could be exploited as a novel rehabilitation approach to various attentional disorders. The first part of the project aims to characterize these effects at the behavioural level. The interventional part consists then in the administration of Caloric Vestibular Stimulation (CVS), which by means of injection of a small quantity of water in the external ear activates the vestibular organs and subsequently vestibular-related brain areas. Among the observed brain activations, the possibility to reach cingulate areas appears particularly interesting because it foreshadows the possibility to further enhance attentional capture by rewards.

CVS will be delivered to patients with brain lesion of the right hemisphere, engaged in cancellation tasks requiring the processing of targets of different nature (e.g. monetary or neutral). The main prediction is that CVS administration would enhance spatial exploration in terms of center of gravity of the cancellation and improved accuracy as a function of the type of target processed (e.g. its value).

status: Recruiting

design_allocation: Non-Randomized

primary_purpose: Basic Science

location_facility: CRNL, équipe IMPACT (CNRS UMR5292, INSERM U1028)

location_facility: Service de médecine et réadaptation neurologique, Hôpital Henry Gabrielle

intervention_type: Procedure

status_simplified: Ongoing


type: Registry Identifier

title: Study to Elucidate the Association of the Renin-angiotensin System and Right Ventricular Function in Mechanically Ventilated Patients

summary: The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7) levels are associated with right ventricular (RV) dysfunction in mechanically ventilated subjects. It is also designed to further characterize the subject population for severity of RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS) peptides and markers of RV function, as measured by echocardiography, in subjects requiring acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they will be evaluated over three days period using standard of care investigations, including trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE) echocardiography. The maximum total duration of this study for subjects is 28 days.

status: Terminated

primary_purpose: Diagnostic

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline


title: Randomized Double Blind Placebo-controlled Clinical Study : Effect of IBSIUM on the Improvement of Gastro-intestinal Disorders Associated to the Irritable Bowel Syndrome (IBS) With C Phenotype (Predominant-constipation)

acronym: IBS-GO

summary: The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).

ReferenceCitation: Mourey F, Decherf A, Jeanne JF, Clément-Ziza M, Grisoni ML, Machuron F, Legrain-Raspaud S, Bourreille A, Desreumaux P. Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation. World J Gastroenterol. 2022 Jun 14;28(22):2509-2522. doi: 10.3748/wjg.v28.i22.2509.

lead_sponsor: Lesaffre International

location_facility:
General pratices
Créabio Rhône Alpes
Institut Pasteur de Lille
Biofortis Mérieux NutriSciences
Eurofins Optimed

intervention_type: Dietary Supplement


title: Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)

acronym: RADICAL

summary:
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis

Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre Gf Leclerc
CHRU de Besançon

intervention_type: Radiation


type: Other Grant/Funding Number

title: CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

acronym: CORAIL

summary: The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital d'Instruction des Armées Robert Picqué

location_facility: Hôpital européen Georges Pompidou - APHP

intervention_type: Device


title: Evaluation of Efficacy of Two Therapeutic Strategies for Cervical Maturation Before Medical Termination: Mechanical Plus Medicinal Maturation vs Medicinal Maturation Alone

acronym: IMEGYN

summary: Reducing the time patients spend in the labor and delivery room saves money and reduces patient discomfort as well and reducing complications. We will compare two methods for inducing cervical maturation in order to shorten the time taken between administration of drugs and delivery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU Nimes
CHU de Montpellier


title: Analysis of Inhaled Corticoid Prescriptions in General Medicine

acronym: COMEGE

summary:
Chronic obstructive pulmonary disease (COPD) and asthma are frequent and disabling pathologies. The general practitioner is often at the front line vis-a-vis screening, diagnosis and treatment of these pathologies. There are currently many treatments available, in particular inhaled corticosteroids, and although the recommendations for management appear to be well codified in theory, the adaptation of drug therapy remains complex in general practice.

The prescription of inhaled corticosteroids, often initiated during a general medicine consultation, is not simple. The aim of this study is to analyze the relevance of the prescription of inhaled corticosteroids in primary care and to identify the criteria necessary for the prescription of inhaled corticosteroids available in general practice.

The main objective of our study is to evaluate the rate of consultations where all the elements required for guiding the prescription of an inhaled corticoid are available.

The secondary objectives are:

Identify other factors associated with decision-making
Identify the causes of inhaled corticosteroid stopping (de-prescription)

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Montpellier


title: Impact of Early Low-Calorie Low-Protein Versus Standard-Calorie Standard-Protein Feeding on Outcomes of Ventilated Adults With Shock: a Randomised, Controlled, Multicentre, Open-label, Parallel-group Study (NUTRIREA-3)

summary: Among critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.

primary_purpose: Supportive Care

ReferenceCitation: Reignier J, Le Gouge A, Lascarrou JB, Annane D, Argaud L, Hourmant Y, Asfar P, Badie J, Nay MA, Botoc NV, Brisard L, Bui HN, Chatellier D, Chauvelot L, Combes A, Cracco C, Darmon M, Das V, Debarre M, Delbove A, Devaquet J, Voicu S, Aissaoui-Balanant N, Dumont LM, Oziel J, Gontier O, Groyer S, Guidet B, Jaber S, Lambiotte F, Leroy C, Letocart P, Madeux B, Maizel J, Martinet O, Martino F, Mercier E, Mira JP, Nseir S, Picard W, Piton G, Plantefeve G, Quenot JP, Renault A, Guérin L, Richecoeur J, Rigaud JP, Schneider F, Silva D, Sirodot M, Souweine B, Reizine F, Tamion F, Terzi N, Thévenin D, Thiéry G, Thieulot-Rolin N, Timsit JF, Tinturier F, Tirot P, Vanderlinden T, Vinatier I, Vinsonneau C, Maugars D, Giraudeau B. Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). BMJ Open. 2021 May 11;11(5):e045041. doi: 10.1136/bmjopen-2020-045041.

lead_sponsor: Nantes University Hospital

location_country: France Guadeloupe

location_facility: Hôpital de Hautepierre CHU de Strasbourg

location_facility: Centre Hospitalier Bretagne Atlantique - Vannes Auray


type: EudraCT Number

title: Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

acronym: CHLOVIS

summary: Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU de Rouen
CHU de Nimes
CHU de Caen
Ch St Joseph St Luc
CHU de Strasbourg
CHU de Clermont-Ferrand
CHU de Toulouse
CHU de Lille
CHU de Montpellier
CH la Rochelle
CH d'Annecy
CH d'Avignon
CH de Chartres
CH d'Aix en Provence
CHU de Bordeaux
CHU de Reims
CHU d'Amiens
CH de Périgueux
CHU d'Angers
CHU de Grenoble
CHU de Dijon
CHU de Brest
CHU de Saint-Etienne
AP-HM


title: Experience of Chronic (Non-malignant) Musculoskeletal Pain of French Adolescent and Young Adult: a Qualitative Research With Their Physicians and Non-medical Practitioners

acronym: DMS-AJA

summary:
The purpose of this study is to explore the perspectives of health professionals on chronic (non-malignant) musculoskeletal pain in adolescence and young adulthood. The prevalence of this pain symptom is rising for ten years, and most of the time the diagnosis is complex. Health professionals have to differentiate between the continuing activity of a somatic problem, some painful sequelae, a low threshold for the perception of pain, and psychological symptoms with somatic expression. Diagnosis in this case takes time, and is a matter of trained specialists. No protocol exists to assess the sub-clinical symptoms which will be used to help doing this complex task.

This qualitative study will elicit the perspectives of trained specialists on this diagnosis: how do they deal with these patients? What signs and symptoms helps them? The results will present their clinical experiences. The overall goal is to construct the first chronic musculoskeletal pain multidimensional scale that will help the practitioners with this complex diagnosis.

ReferenceCitation: Goodman JE, McGrath PJ. The epidemiology of pain in children and adolescents: a review. Pain. 1991 Sep;46(3):247-264. doi: 10.1016/0304-3959(91)90108-A. Review.

ReferenceCitation: De Inocencio J. Epidemiology of musculoskeletal pain in primary care. Arch Dis Child. 2004 May;89(5):431-4.

ReferenceCitation: Anthony KK, Schanberg LE. Pediatric pain syndromes and management of pain in children and adolescents with rheumatic disease. Pediatr Clin North Am. 2005 Apr;52(2):611-39, vii. Review.

ReferenceCitation: Petty RE, Southwood TR, Manners P, Baum J, Glass DN, Goldenberg J, He X, Maldonado-Cocco J, Orozco-Alcala J, Prieur AM, Suarez-Almazor ME, Woo P; International League of Associations for Rheumatology. International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001. J Rheumatol. 2004 Feb;31(2):390-2.

ReferenceCitation: Jaremko JL, Liu L, Winn NJ, Ellsworth JE, Lambert RG. Diagnostic utility of magnetic resonance imaging and radiography in juvenile spondyloarthritis: evaluation of the sacroiliac joints in controls and affected subjects. J Rheumatol. 2014 May;41(5):963-70. doi: 10.3899/jrheum.131064. Epub 2014 Mar 15.

ReferenceCitation: Bell DS, Bell KM, Cheney PR. Primary juvenile fibromyalgia syndrome and chronic fatigue syndrome in adolescents. Clin Infect Dis. 1994 Jan;18 Suppl 1:S21-3.

ReferenceCitation: McGhee JL, Burks FN, Sheckels JL, Jarvis JN. Identifying children with chronic arthritis based on chief complaints: absence of predictive value for musculoskeletal pain as an indicator of rheumatic disease in children. Pediatrics. 2002 Aug;110(2 Pt 1):354-9.

ReferenceCitation: Sherry DD, McGuire T, Mellins E, Salmonson K, Wallace CA, Nepom B. Psychosomatic musculoskeletal pain in childhood: clinical and psychological analyses of 100 children. Pediatrics. 1991 Dec;88(6):1093-9.

ReferenceCitation: Kashikar-Zuck S, Goldschneider KR, Powers SW, Vaught MH, Hershey AD. Depression and functional disability in chronic pediatric pain. Clin J Pain. 2001 Dec;17(4):341-9.

ReferenceCitation: - Lachal J, Speranza M, Schmitt A, Spodenkiewicz M, Falissard B, Moro MR, Revah-Levy A. Depression in adolescent from qualitative research to measurement. Adolescent Psychiatry 2012,2(4):296-308.

ReferenceCitation: - Smith J. Interpretative phenomenological analysis. In: Qualitative Psychology: A Practical Guide to Research Methods. 2e éd. Sage Publications Ltd; 2008.

ReferenceCitation: Taïeb O, Bricou O, Baubet T, Gaboulaud V, Gal B, Mouthon L, Dhote R, Guillevin L, Rose Moro M. Patients' beliefs about the causes of systemic lupus erythematosus. Rheumatology (Oxford). 2010 Mar;49(3):592-9. doi: 10.1093/rheumatology/kep430. Epub 2009 Dec 29.

ReferenceCitation: Smith JA, Michie S, Stephenson M, Quarrell O. Risk Perception and Decision-making Processes in Candidates for Genetic Testing for Huntington's Disease: An Interpretative Phenomenological Analysis. J Health Psychol. 2002 Mar;7(2):131-44. doi: 10.1177/1359105302007002398.

ReferenceCitation: Chapman E, Smith JA. Interpretative phenomenological analysis and the new genetics. J Health Psychol. 2002 Mar;7(2):125-30. doi: 10.1177/1359105302007002397.

ReferenceCitation: Lefèvre H, Loisel A, Meunier BB, Deslandre C, Lemoine N, Moro MR, Quartier P, Lachal J. Chronic idiopathic musculoskeletal pain in youth: a qualitative study. Pediatr Rheumatol Online J. 2019 Dec 27;17(1):86. doi: 10.1186/s12969-019-0389-3.

location_facility:
Cochin hospital
Necker Hospital


title: Evaluation of a Video-ludic Re-education of the Paretic Upper Limb in Chronic Hemipartic Patients Post Cerebral Vascular Accident

acronym: ERGOTACT

summary: The aim of this randomized controlled study with stroke patients is to demonstrate that a re-education with interactive table with instrumented objects delivering sensory feedback and serious game improve certain motor functions of the paretic upper limb than rehabilitation based on a standardized self-rehabilitation program.


title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.

acronym: POEMS

summary:
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology.

The investigators propose a phase II multicentre protocol, based on the use of lenalidomide combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or resistant or in relapse.

Patients who can be treated by local radiation or intensive treatment with stem cell support will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the Len-Dex combination (Group 2).

A biological study is coupled with this clinical protocol in order to define the best biological markers predicting clinical responses, to better understand the POEMS pathophysiological mechanisms and to set up a bank of samples which can be used to study this rare pathology.

lead_sponsor: University Hospital, Limoges

location_facility:
CHU de Caen
CHU de Nantes
Hospices Civil de Lyon
CHU d'Angers
Pitié Salpétrière
Centre Léon Bérard
CHU de Toulouse
Hôpital Necker
CHU de Limoges
CHU de Lille
Hôpital Saint-Louis


title: Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty

acronym: PUC-INTEVO

summary: Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
Clinique de La Baie
CHRU de Brest


title: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceCitation: Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: CHU La Réunion, site de Saint Denis de la Réunion

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise


title: Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning

acronym: EFES

summary:
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients.

This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance.

By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hôpital Pellegrin
Hôpital Haut-Lévêque

intervention_type: Diagnostic Test


title: A Randomized Open-label Phase II Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

acronym: OLYMPE

summary:
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor.

Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway.

LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).

lead_sponsor: Centre Francois Baclesse

location_facility:
Institut Bergonié
Institut Paoli Calmettes
Centre Jean Perrin
Institut Curie
Institut de Cancérologie de l'Ouest
Hôpital St Louis, AP-HP
Centre Léon Bérard
Centre Georges-François Leclerc
Hegp, Ap-Hp
Institut Gustave Roussy
Centre Henri Becquerel
Institut Claudius Regaud
Centre Eugène Marquis
Centre François Baclesse


title: The 4th Month Oral Consultation at Pregnant Women : Investigation Carried in Pregnant Women and Health Care Professionals of Nantes and Brest

summary: Epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. Indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. Also, non-treatment of caries and periodontal disease can lead to acute pain and stress. This may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. As part of the prevention of complications of pregnancy associated with oral diseases, the National Agency for Accreditation and Evaluation in Health (ANAES) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. This study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. On the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.

time_perspective: Prospective

location_facility:
Nantes University Hospital
Brest University Hospital


title: SPPLAASH Study : a Randomized Study Aiming at Evaluating the Incidence of Post Lumbar Puncture Headache (PLPH) With the Use of Atraumatic Needles in Hematology

acronym: SPPLAASH

summary: Lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. Post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. Some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. In this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.

location_facility:
Centre Léon Bérard
CHU de Saint-Etienne


title: IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma

summary: Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.

ReferenceType: result

ReferenceCitation: Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chretien ML, Rigaudeau S, Dib M, Nicolas-Virelizier E, Escoffre-Barbe M, Belhadj K, Mariette C, Stoppa AM, Araujo C, Doyen C, Fontan J, Kolb B, Garderet L, Brechignac S, Malfuson JV, Jaccard A, Lenain P, Borel C, Hebraud B, Benbrahim O, Dorvaux V, Manier S, Augeul-Meunier K, Vekemans MC, Randriamalala E, Chaoui D, Caers J, Chaleteix C, Benboubker L, Vincent L, Glaisner S, Zunic P, Slama B, Eveillard JR, Humbrecht-Kraut C, Morel V, Mineur P, Eisenmann JC, Demarquette H, Richez V, Vignon M, Caillot D, Facon T, Moreau P, Colin AL, Olivier P, Wuilleme S, Avet-Loiseau H, Corre J, Attal M. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study. Blood. 2022 May 5;139(18):2747-2757. doi: 10.1182/blood.2021014635.

lead_sponsor: University Hospital, Toulouse

location_facility: Centre Hospitalier de Versailles-Hôpital André Mignot

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth


title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

acronym: COG-ANGIO

summary: Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

location_facility:
Centre François BACLESSE
CHU
Hôpital Georges Pompidou
Institut Gustave Roussy
Centre Henri Becquerel


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy (MTM)

acronym: MTM

summary: This is a prospective, non-interventional, longitudinal study of the natural history and function of approximately 60 patients with MTM from the United States, Canada and Europe. The duration of the study, including the enrollment period, will be 36 months. Data from the study will be used to characterize the disease course of MTM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

ReferenceCitation: Herman GE, Finegold M, Zhao W, de Gouyon B, Metzenberg A. Medical complications in long-term survivors with X-linked myotubular myopathy. J Pediatr. 1999 Feb;134(2):206-14.

ReferenceCitation: Jungbluth H, Sewry CA, Buj-Bello A, Kristiansen M, Ørstavik KH, Kelsey A, Manzur AY, Mercuri E, Wallgren-Pettersson C, Muntoni F. Early and severe presentation of X-linked myotubular myopathy in a girl with skewed X-inactivation. Neuromuscul Disord. 2003 Jan;13(1):55-9.

ReferenceCitation: McEntagart M, Parsons G, Buj-Bello A, Biancalana V, Fenton I, Little M, Krawczak M, Thomas N, Herman G, Clarke A, Wallgren-Pettersson C. Genotype-phenotype correlations in X-linked myotubular myopathy. Neuromuscul Disord. 2002 Dec;12(10):939-46.

ReferenceCitation: Jungbluth H, Wallgren-Pettersson C, Laporte J. Centronuclear (myotubular) myopathy. Orphanet J Rare Dis. 2008 Sep 25;3:26. doi: 10.1186/1750-1172-3-26. Review.

ReferenceCitation: Annoussamy M, Lilien C, Gidaro T, Gargaun E, Chê V, Schara U, Gangfuß A, D'Amico A, Dowling JJ, Darras BT, Daron A, Hernandez A, de Lattre C, Arnal JM, Mayer M, Cuisset JM, Vuillerot C, Fontaine S, Bellance R, Biancalana V, Buj-Bello A, Hogrel JY, Landy H, Servais L. X-linked myotubular myopathy: A prospective international natural history study. Neurology. 2019 Apr 16;92(16):e1852-e1867. doi: 10.1212/WNL.0000000000007319. Epub 2019 Mar 22.

lead_sponsor: Valerion Therapeutics, LLC

location_country:
Spain
Italy
Canada
United States
France
Belgium
Germany

location_facility: Hôpital Femme Mère Enfant, CHU Lyon Escale

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hospital for Sick Children, 555 University Avenue

location_facility: Institut de Myologie, GH Pitié Salpêtrière, Bâtiment Babinski

location_facility: Boston Children's Hospital, 300 Longwood Avenue


title: Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.

acronym: DEQOLAGE

summary:
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.

The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.

location_facility:
Hôpital Saint Louis
Hôpital Henri Mondor
CHRU Nancy


title: Asthma Attack in the Emergency Department : Reasons Of This Attendance

acronym: AERO

summary:
Objective: Identify modifiable factors that may affect asthma control and the use of emergency room to define customized interventions for the management of asthma prior to emergency room.

Emergency department attendance is always a sign of poor balance or control of asthma. In spite of a decrease in the number of deaths that has been halved in 20 years and hospitalization due to asthmatic disease, the use of emergency center for this disease has not decreased. We now know that the passage through emergencies and hospitalization for aggravation of asthma is in itself a factor of mortality. Acting on the determinants of poor balance or control of asthma is essential to further reduce the mortality and morbidity of asthma.

lead_sponsor: Olivier CHASSANY

location_facility: Service d'accueil des urgences Hôpital Beaujon

location_facility: Service d'acceuil des urgences hôpital Bichat- Claude Bernard


title: Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases

acronym: PembroMetaRT

summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie Strasbourg-Europe

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Hopital Nord Franche Comté - Site de Mittan


title: Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients

acronym: MADECCS

summary: This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.

lead_sponsor: Centre Hospitalier St Anne

location_facility: Service de Médecine Physique et Rédaptation

location_facility: Centre de Recherche Clinique (CRC) - CHSA


title: Strain Analysis as a Right Ventricle Contractility Marker

summary: The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hopital Saint Joseph Saint Luc
Hôpital de la Croix Rousse


title: Assessment of Biomarkers Initially Identified in Whole Blood by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans

acronym: BMS-LyTrans

summary: Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.

time_perspective: Other

lead_sponsor: Rennes University Hospital

location_facility: Bordeaux University Hospital ( Haut-Lévêque Hospital)


title: Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) on Coronary Microcirculation's Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction (STE and NSTE-ACS): Assessment by Index of Microcirculatory Resistance (IMR)

acronym: GUARDIANCORY

summary:
NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention (PCI) worldwide. PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon. Distal embolization lead to coronary microcirculation lesions. This complication is related to poor prognosis.

MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve, which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction.

Index of microcirculatory resistance (IMR) is a validated method to assess coronary microcirculation.

Accordingly, the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI, compared with a bare metal stent (BMS) and drug eluting stent (DES) in patients with NSTE-ACS, assessed by Index of microcirculatory resistance.

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29.

ReferenceCitation: Silen W, Machen TE, Forte JG. Acid-base balance in amphibian gastric mucosa. Am J Physiol. 1975 Sep;229(3):721-30.

ReferenceCitation: Pride YB, Mohanavelu S, Zorkun C, Kunadian V, Giugliano RP, Newby LK, Braunwald E, Califf RM, Harrington RA, Gibson CM; EARLY ACS Investigators. Association between angiographic complications and clinical outcomes among patients with acute coronary syndrome undergoing percutaneous coronary intervention: an EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome) angiographic substudy. JACC Cardiovasc Interv. 2012 Sep;5(9):927-35. doi: 10.1016/j.jcin.2012.05.007.

ReferenceCitation: Gibson CM, Kirtane AJ, Morrow DA, Palabrica TM, Murphy SA, Stone PH, Scirica BM, Jennings LK, Herrmann HC, Cohen DJ, McCabe CH, Braunwald E; TIMI Study Group. Association between thrombolysis in myocardial infarction myocardial perfusion grade, biomarkers, and clinical outcomes among patients with moderate- to high-risk acute coronary syndromes: observations from the randomized trial to evaluate the relative PROTECTion against post-PCI microvascular dysfunction and post-PCI ischemia among antiplatelet and antithrombotic agents-Thrombolysis In Myocardial Infarction 30 (PROTECT-TIMI 30). Am Heart J. 2006 Oct;152(4):756-61.

ReferenceCitation: Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, Antman EM, Braunwald E; TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001 May 29;103(21):2550-4.

ReferenceCitation: De Bruyne B, Pijls NH, Smith L, Wievegg M, Heyndrickx GR. Coronary thermodilution to assess flow reserve: experimental validation. Circulation. 2001 Oct 23;104(17):2003-6.

ReferenceCitation: Steg PG, Dabbous OH, Feldman LJ, Cohen-Solal A, Aumont MC, López-Sendón J, Budaj A, Goldberg RJ, Klein W, Anderson FA Jr; Global Registry of Acute Coronary Events Investigators. Determinants and prognostic impact of heart failure complicating acute coronary syndromes: observations from the Global Registry of Acute Coronary Events (GRACE). Circulation. 2004 Feb 3;109(4):494-9. Epub 2004 Jan 26.

ReferenceCitation: Cuisset T, Hamilos M, Melikian N, Wyffels E, Sarma J, Sarno G, Barbato E, Bartunek J, Wijns W, De Bruyne B. Direct stenting for stable angina pectoris is associated with reduced periprocedural microcirculatory injury compared with stenting after pre-dilation. J Am Coll Cardiol. 2008 Mar 18;51(11):1060-5. doi: 10.1016/j.jacc.2007.11.059.

ReferenceCitation: Holm J, Häggendal E, Lundberg D, Scherstén T, Stenberg K, Wetterqvist H. Effect of lumbar sympathetic blockade and chlorpromazine-induced adrenergic alpha-receptor blockade on skin temperature in peripheral arterial diseases. J Cardiovasc Surg (Torino). 1976 Jan-Feb;17(1):69-71.

ReferenceCitation: Aarnoudse W, Fearon WF, Manoharan G, Geven M, van de Vosse F, Rutten M, De Bruyne B, Pijls NH. Epicardial stenosis severity does not affect minimal microcirculatory resistance. Circulation. 2004 Oct 12;110(15):2137-42. Epub 2004 Oct 4.

ReferenceCitation: Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006.

ReferenceCitation: Henriques JP, Zijlstra F, Ottervanger JP, de Boer MJ, van 't Hof AW, Hoorntje JC, Suryapranata H. Incidence and clinical significance of distal embolization during primary angioplasty for acute myocardial infarction. Eur Heart J. 2002 Jul;23(14):1112-7.

ReferenceCitation: Kaul P, Ezekowitz JA, Armstrong PW, Leung BK, Savu A, Welsh RC, Quan H, Knudtson ML, McAlister FA. Incidence of heart failure and mortality after acute coronary syndromes. Am Heart J. 2013 Mar;165(3):379-85.e2. doi: 10.1016/j.ahj.2012.12.005. Epub 2013 Jan 22.

ReferenceCitation: Ng MK, Yeung AC, Fearon WF. Invasive assessment of the coronary microcirculation: superior reproducibility and less hemodynamic dependence of index of microcirculatory resistance compared with coronary flow reserve. Circulation. 2006 May 2;113(17):2054-61. Epub 2006 Apr 24.

ReferenceCitation: Fearon WF, Balsam LB, Farouque HM, Caffarelli AD, Robbins RC, Fitzgerald PJ, Yock PG, Yeung AC. Novel index for invasively assessing the coronary microcirculation. Circulation. 2003 Jul 1;107(25):3129-32. Epub 2003 Jun 23. Erratum in: Circulation. 2003 Dec 23;108(25):3165.

ReferenceCitation: Akdeniz C, Umman S, Nisanci Y, Umman B, Bugra Z, Aslanger EK, Kaplan A, Yilmaz A, Teker E, Güz G, Polat N, Sezer M. Percutaneous coronary intervention increases microvascular resistance in patients with non-ST-elevation acute coronary syndrome. EuroIntervention. 2013 Jun 22;9(2):228-34. doi: 10.4244/EIJV9I2A38.

ReferenceCitation: Fearon WF, Shah M, Ng M, Brinton T, Wilson A, Tremmel JA, Schnittger I, Lee DP, Vagelos RH, Fitzgerald PJ, Yock PG, Yeung AC. Predictive value of the index of microcirculatory resistance in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2008 Feb 5;51(5):560-5. doi: 10.1016/j.jacc.2007.08.062.

ReferenceCitation: Napodano M, Ramondo A, Tarantini G, Peluso D, Compagno S, Fraccaro C, Frigo AC, Razzolini R, Iliceto S. Predictors and time-related impact of distal embolization during primary angioplasty. Eur Heart J. 2009 Feb;30(3):305-13. doi: 10.1093/eurheartj/ehn594. Epub 2009 Jan 19.

ReferenceCitation: Fearon WF, Low AF, Yong AS, McGeoch R, Berry C, Shah MG, Ho MY, Kim HS, Loh JP, Oldroyd KG. Prognostic value of the Index of Microcirculatory Resistance measured after primary percutaneous coronary intervention. Circulation. 2013 Jun 18;127(24):2436-41. doi: 10.1161/CIRCULATIONAHA.112.000298. Epub 2013 May 16.

ReferenceCitation: Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyła R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004.

ReferenceCitation: Jolly SS, Cairns JA, Yusuf S, Meeks B, Pogue J, Rokoss MJ, Kedev S, Thabane L, Stankovic G, Moreno R, Gershlick A, Chowdhary S, Lavi S, Niemelä K, Steg PG, Bernat I, Xu Y, Cantor WJ, Overgaard CB, Naber CK, Cheema AN, Welsh RC, Bertrand OF, Avezum A, Bhindi R, Pancholy S, Rao SV, Natarajan MK, ten Berg JM, Shestakovska O, Gao P, Widimsky P, Džavík V; TOTAL Investigators. Randomized trial of primary PCI with or without routine manual thrombectomy. N Engl J Med. 2015 Apr 9;372(15):1389-98. doi: 10.1056/NEJMoa1415098. Epub 2015 Mar 16.

ReferenceCitation: Napodano M, Dariol G, Al Mamary AH, Marra MP, Tarantini G, D'Amico G, Frigo AC, Buja P, Razzolini R, Iliceto S. Thrombus burden and myocardial damage during primary percutaneous coronary intervention. Am J Cardiol. 2014 May 1;113(9):1449-56. doi: 10.1016/j.amjcard.2014.01.423. Epub 2014 Feb 12.

ReferenceCitation: Layland J, Carrick D, McEntegart M, Ahmed N, Payne A, McClure J, Sood A, McGeoch R, MacIsaac A, Whitbourn R, Wilson A, Oldroyd K, Berry C. Vasodilatory capacity of the coronary microcirculation is preserved in selected patients with non-ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv. 2013 Jun;6(3):231-6. doi: 10.1161/CIRCINTERVENTIONS.112.000180. Epub 2013 Jun 11.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital Grenoble
Annecy Hospital


title: Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.

acronym: TRAMUNE

summary: A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.

status: Active, not recruiting

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Léon Bérard


title: French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

summary: The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

lead_sponsor: French Cardiology Society

location_facility: Institut Hospitalier Jacques Cartier-ICPS


title: Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department

summary: The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

ReferenceCitation: McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.

ReferenceCitation: White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5.

lead_sponsor: Centre Hospitalier le Mans

location_facility:
Centre Hospitalier Universitaire Angers
Centre Hospitalier Le Mans


title: A Phase I/IIa Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC)

summary: This is a study to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

lead_sponsor: Transgene

location_facility:
Site No 0102
Site No 0101

intervention_type: Biological


title: A Multicentre, Controlled, Randomised, Single-blind, Two-armed Trial Evaluating the Visual Performance, Quality of Vision and Subjective Outcomes After Bilateral Implantation of MINI WELL Ready® or FineVision® in Patients With Cataract Surgery.

summary: Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial

lead_sponsor: SIFI SpA

location_facility:
Clinique Juge
Ophtalmologie Hôpital Morvan


title: Predictive Signature of Benralizumab Response

acronym: BENRAPRED

summary:
The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients.

This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility: Assistance Publique des Hôpitaux de Marseille


title: FRench Acute Cerebral Multimodal Imaging to Select Patient for MEchanical Thrombectomy

acronym: FRAME

summary: FRench Acute cerebral multimodal imaging to select patient for MEchanical thrombectomy is a prospective multi-center study to determine if multimodal imaging could identify patients who may and those who may not benefit from an endovascular clot removal procedure within 6 hours after stroke onset.

ReferenceCitation: Fontaine L, Sibon I, Raposo N, Albucher JF, Mazighi M, Rousseau V, Darcourt J, Thalamas C, Drif A, Sommet A, Viguier A, Guenego A, Januel AC, Calvière L, Menegon P, Bonneville F, Tourdias T, Albers GW, Cognard C, Olivot JM; FRAME Investigators*. ASCOD Phenotyping of Stroke With Anterior Large Vessel Occlusion Treated by Mechanical Thrombectomy. Stroke. 2021 Dec;52(12):e769-e772. doi: 10.1161/STROKEAHA.121.035282. Epub 2021 Oct 27.

location_facility:
University hospital Toulouse
U H Bordeaux


title: Efficiency of a Tight Monitoring by a Nurse Practitioner of Rheumatoid Arthritis (RA) Patients in Remission (or Low Disease Activity) Under Rituximab to Detect Early Relapse of the Disease

acronym: SIERRA

summary:
Rheumatoid arthritis (RA) is a progressive disease that affects mainly small and medium joints and, in the absence of appropriate background therapy, leads to progressive joint destruction, functional, psychological, social and occupational repercussions.

Several biomedicine treat this pathology, including rituximab (RTX). It is recommended to evaluate the therapeutic response to RTX and re-administer it from the 24th week when the goal of remission has not been achieved. However, the optimal modality for reprocessing remains to be determined.

To this end, different approaches have been explored, such as lymphocyte typing or ultrasound monitoring. The pace of these examinations, however, remains wide and their cost is not negligible. This is why we propose here to explore the track of a tight follow-up nurse DAS28.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up.

The hypothesis is that a tight nursing follow-up can detect the symptomatic recovery earlier than the current medical follow-up

lead_sponsor: University Hospital, Rouen

location_facility:
Caen University Hospital
Rouen University Hospital


title: The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation

acronym: RENALIFE

summary: When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

primary_purpose: Health Services Research

ReferenceCitation: Faucher Q, Alarcan H, Sauvage FL, Forestier L, Miquelestorena-Standley E, Nadal-Desbarats L, Arnion H, Venhard JC, Brichart N, Bruyère F, Marquet P, Barin-Le Guellec C. Perfusate Metabolomics Content and Expression of Tubular Transporters During Human Kidney Graft Preservation by Hypothermic Machine Perfusion. Transplantation. 2022 Sep 1;106(9):1831-1843. doi: 10.1097/TP.0000000000004129. Epub 2022 Apr 20.

lead_sponsor: University Hospital, Tours

location_facility:
Urology CHRU-TOURS
CHR-ORLEANS Service d'Urologie


title: Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient

acronym: DAME

summary: Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint-Etienne
Clinique Mutualiste Saint Etienne


title: Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

summary: Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.

ReferenceCitation: Bleuzen A, Huang C, Olar M, Tchuenbou J, Tranquart F. Diagnostic accuracy of contrast-enhanced ultrasound in focal lesions of the liver using cadence contrast pulse sequencing. Ultraschall Med. 2006 Feb;27(1):40-8.

ReferenceCitation: Forsberg F, Ro RJ, Potoczek M, Liu JB, Merritt CR, James KM, Dicker AP, Nazarian LN. Assessment of angiogenesis: implications for ultrasound imaging. Ultrasonics. 2004 Apr;42(1-9):325-30.

ReferenceCitation: Broillet A, Hantson J, Ruegg C, Messager T, Schneider M. Assessment of microvascular perfusion changes in a rat breast tumor model using SonoVue to monitor the effects of different anti-angiogenic therapies. Acad Radiol. 2005 May;12 Suppl 1:S28-33.

ReferenceCitation: Niermann KJ, Fleischer AC, Donnelly EF, Schueneman AJ, Geng L, Hallahan DE. Sonographic depiction of changes of tumor vascularity in response to various therapies. Ultrasound Q. 2005 Jun;21(2):61-7; quiz 149, 153-4.

ReferenceCitation: Preda A, Novikov V, Möglich M, Turetschek K, Shames DM, Brasch RC, Cavagna FM, Roberts TP. MRI monitoring of Avastin antiangiogenesis therapy using B22956/1, a new blood pool contrast agent, in an experimental model of human cancer. J Magn Reson Imaging. 2004 Nov;20(5):865-73.

ReferenceCitation: Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005 Feb 1;65(3):671-80.

ReferenceCitation: Zondor SD, Medina PJ. Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1258-64. Epub 2004 Jun 8. Review.

ReferenceCitation: Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42.

ReferenceCitation: Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

location_facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris


acronym: ARAMIS

title: Anakinra Versus Placebo Double Blind Randomized Controlled Trial for the Treatment of Acute MyocarditIS

lead_sponsor: Assistance Publique - Hôpitaux de Paris

source: euctr

location_facility: ACTION Study Group - Department of Cardiology - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

location_facility: Department of internal medicine - Pitié Salpétrière Hospital, 47 Bd de l'Hopital

summary:
There is no specific treatment of acute myocarditis, especially during the inflammatory period. Interleukin (IL) is specifically involved during this period and play a role in myocardial oedema. ANAKINRA, an IL-1β Blocker, is a new treatment that has never been evaluated in myocarditis. The benefit for the patient could be important with a reduction of heart failure and ventricular arrhythmias.

Hypothesis : ANAKINRA in addition to standard therapy for treatment of Acute Myocarditis is superior to standard therapy based on an association of beta-blockers and Angiotensin-Converting-Enzyme inhibitor (ACE).


title: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)

summary: The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

ReferenceCitation: Reignier J, Boisramé-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guérin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thévenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

ReferenceCitation: Brisard L, Le Gouge A, Lascarrou JB, Dupont H, Asfar P, Sirodot M, Piton G, Bui HN, Gontier O, Hssain AA, Gaudry S, Rigaud JP, Quenot JP, Maxime V, Schwebel C, Thévenin D, Nseir S, Parmentier E, El Kalioubie A, Jourdain M, Leray V, Rolin N, Bellec F, Das V, Ganster F, Guitton C, Asehnoune K, Bretagnol A, Anguel N, Mira JP, Canet E, Guidet B, Djibre M, Misset B, Robert R, Martino F, Letocart P, Silva D, Darmon M, Botoc V, Herbrecht JE, Meziani F, Devaquet J, Mercier E, Richecoeur J, Martin S, Gréau E, Giraudeau B, Reignier J. Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2). Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: CHU de Strasbourg - Hôpital de Hautepierre

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil


title: Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial

acronym: EOMEC/CP

summary:
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.

In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.

This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.

lead_sponsor: Lille Catholic University

location_facility:
IEM Christian Dabbadie
IEM Ellen Poidatz
IEM Vent de Bise
IEM Sévigné


title: Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.

acronym: InterfaceVent

summary:
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.

The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.

The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.

ReferenceCitation: Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.

ReferenceCitation: Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire de Montpellier


title: Impact of Preoperative 4-week Supplementation With Omega-3 Polyunsaturated Fatty Acids on Liver Volume and Steatosis to Facilitate Bariatric Surgery in Morbdly Obese Patients : the " Omegaobese Study ".

acronym: Omegobese

summary:
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the hiatal region during bariatric surgery. The doctors made a preliminary prospective study that showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on ultrasounds.

The aim of this study is to determine whether a 4-week preoperative course with omega-3 without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume and its fat content, rendering thus surgery easier.

The primary end point is the reduction of the volume of the left liver lobe as measured by magnetic resonance imaging.

Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver injuries during surgery, and duration of surgery, the evolution of liver tests as well as the correlation between preoperative MRI data and intraoperative liver biopsy for the quantification of liver steatosis.

Study design: This is an interventional, prospective, multicentric, randomized, double blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients in 12 months.

Study time schedule: At the time of the enrollment visit two visits are scheduled, the first before the beginning of the study and the last at the end. Surgery is scheduled no more than 7 days after the end of the treatment. At time of these two visits a clinical examination is performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein) and a MRI to evaluate the volume and the fat content of the liver. At time of surgery duration of surgery and any eventual liver injury are recorded and a liver biopsy is performed.

The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a reduction in the volume of the left liver lobe of 20 %.

Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in a significant reduction of liver volume and steatosis before bariatric surgery, it may be recommended as a systematic preoperative treatment.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - Chirurgie Digestive- Hôpital Archet

location_facility: CHU de Montpellier - Chirurgie digestive


title: Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.

summary: Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

lead_sponsor: DTAMedical SAS

location_facility:
Hôpital de la Conception
CHU Henri Mondor
CHU de Nantes Centre des Brûlés
Hôpital La Timone


title: Validation of Radio-induced Damage Biomarkers : BIOM-DRI Study

acronym: BIOM-DRI

summary: The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage.

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care

acronym: CLOSEAP+

summary:
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.

A wide acceptance of the Artificial Pancreas (AP) usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice.

The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored Home Healthcare Provider (HHP) service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled T2D needing home nursing care for their daily insulin treatment versus usual care.

lead_sponsor: Air Liquide Santé International

location_facility:
CHU Nantes
CHU Strasbourg
CHU Caen
Hopital Européen de Marseille
CHU Rouen
CHU Toulouse
APHP Lariboisière
CHRU Nancy-Hôpitaux de Brabois
CHRU Brest
CHU Amiens


title: Home Telemonitoring of Resting Spontaneous Breathing in Severe Asthma: a Pilot Study

acronym: AsthmaDom

summary: Asthma exacerbations account for a significant morbidity and disproportionate health care costs. However, there is no currently available biomarker or lung function parameter that can accurately predict the risk of future exacerbations. The current work aims at evaluating the resting ventilatory flow by applying a new technique called anharmonic morphological analysis of the respiratory signals (AMARS). We hypothesize that monitoring AMARS is potentially able to detect an increased risk of asthma exacerbations.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Bordeaux University Hospital
Grenoble University Hospital


title: Efficacy and Safety of Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness

acronym: HAROSA IV

summary:
The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS.

The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period.

status: Withdrawn

lead_sponsor: Bioprojet

location_facility: Laboratoire du sommeil Clinique de Physiologie, Sommeil et Exercice Pôle Thorax et Vaisseaux CHU de Grenoble

location_facility: Hôpital Gui de Chauliac, CHU Montpellier, Unité des Troubles du Sommeil et de l'Eveil


title: Prediction of Pain During Old People Care Measured by Skin Conductance

acronym: DOLOAGE

summary:
The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and simple of employment, for old people able to answer to a digital scale of pain intensity.

The main objective is to develop and to validate a model of prediction of the pain in old subject at the time of the care, using the measure of variation of the skin conductance.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Maison Médicale Jeanne Garnier


title: Evaluation de l'Impact d'un Mode de supplémentation en Vitamine D (Dose séquentielle vs Dose Quotidienne) Sur l'Incidence de l'Hypercalciurie Chez Des Enfants Des départements du Gard et de l'Hérault agés de 2 à 6 Ans. Etude contrôlée randomisée en 2 Groupes parallèles

acronym: DonneDVit

summary: Recommendations for vitamin D supplementation for children between 2 and 6 years offer strong sequential doses of vitamin D: 2 times 100 000 units in spaced winter period of 3 months. Data from the literature show a further increase in the incidence of oxalo-calcium stones in children and adolescents associated with hypercalciuria with training Randall plates, essential step lithogenesis calcium oxalate. Knowing the links between vitamin D and urinary calcium excretion, these data lead to the question of increased sensitivity in some children with vitamin D, sensitivity could explain these situations with hypercalciuria increase the gallstone risk. This increased sensitivity to vitamin D may unmask particularly if inputs of high doses of vitamin responsible then a transient hypercalciuria with development of microcrystals.


title: Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters

acronym: EDGE

summary: The objective of this research is to study the sphincter activity during ejaculation in patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this purpose, using a catheter the protocol plans to measure the sphincter pressures during ejaculation. Moreover, cardiovascular parameters will be measured continuously during the ejaculatory test.

location_facility:
Centre Bouffard Vercelli
Centre Calvé


title: Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study

lead_sponsor: Guerbet

location_facility:
Hôpital Beaujon
CHU Angers

summary: This study is an exploratory study aiming to collect data about diagnosis efficacy (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology analysis. The standard of reference for diagnosis will be given by the site according to their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site and/or the more recent AFP results available). 10 additional subjects will be included to explore the diagnostic efficacy for HCC at half dose of P03277.


title: Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer

acronym: Phi-Bra

summary:
Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography.

The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature.

The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification).

The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography.

The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Radiologie, Hôpital de la Croix-Rousse

location_facility: Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse


title: Development and Validation of a CT-based Diagnostic Models Using Artificial Intelligence for Detection of Small Bowel Obstruction

summary:
Small bowel obstruction (SBO) is a common non-traumatic surgical emergency. All guidelines recommend computed tomography (CT) as the first-line imaging test for patients with suspected SBO. The objectives of CT are multiple: (i) to confirm or refute the diagnosis of GI obstruction, defined as distension of the digestive tracts greater than 25 mm, and, when SBO is present, (ii) to confirm the mechanism (mechanical vs. functional), (iii) to localize the site of obstruction, i.e., the transition zone (TZ), (iv) to identify the cause, and (v) to look for complications such as strangulation or perforation, influencing management.

Given the exponential increase in the number of scans being performed, especially in the setting of emergency management, methods to assist the radiologist would be useful to:

Sort the scans performed, allowing prioritization of the analysis of scans with a higher probability of pathology (occlusion in our case)
Help the radiologist to diagnose occlusion and its type (functional or mechanical), and to identify signs of severity.
To help the emergency physician and the digestive surgeon to make a decision on the management of the disease (surgical or medical).

Machine learning has developed rapidly over the last decades, first thanks to the increase in data storage capacities, then thanks to the arrival of parallel processing hardware based on graphic processing units, in the context of radiological diagnostic assistance. Consequently, the number of studies on deep neural networks in medical imaging is increasing rapidly. However, few teams focus on SBO. The only published classification models have been produced for standard abdominal radiographs. No studies have used CT or 3D models, apart from our preliminary study on ZTs, despite the recognized advantages of CT for the diagnosis of SBO and the likely contribution of 3D models, which may be comparable to that of multiplanar reconstruction for the analysis of images in multiple planes of space.

ReferenceCitation: Ten Broek RPG, Krielen P, Di Saverio S, Coccolini F, Biffl WL, Ansaloni L, Velmahos GC, Sartelli M, Fraga GP, Kelly MD, Moore FA, Peitzman AB, Leppaniemi A, Moore EE, Jeekel J, Kluger Y, Sugrue M, Balogh ZJ, Bendinelli C, Civil I, Coimbra R, De Moya M, Ferrada P, Inaba K, Ivatury R, Latifi R, Kashuk JL, Kirkpatrick AW, Maier R, Rizoli S, Sakakushev B, Scalea T, Søreide K, Weber D, Wani I, Abu-Zidan FM, De'Angelis N, Piscioneri F, Galante JM, Catena F, van Goor H. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2017 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2018 Jun 19;13:24. doi: 10.1186/s13017-018-0185-2. eCollection 2018. Review.

ReferenceCitation: Expert Panel on Gastrointestinal Imaging, Chang KJ, Marin D, Kim DH, Fowler KJ, Camacho MA, Cash BD, Garcia EM, Hatten BW, Kambadakone AR, Levy AD, Liu PS, Moreno C, Peterson CM, Pietryga JA, Siegel A, Weinstein S, Carucci LR. ACR Appropriateness Criteria® Suspected Small-Bowel Obstruction. J Am Coll Radiol. 2020 May;17(5S):S305-S314. doi: 10.1016/j.jacr.2020.01.025.

ReferenceCitation: Frager D, Medwid SW, Baer JW, Mollinelli B, Friedman M. CT of small-bowel obstruction: value in establishing the diagnosis and determining the degree and cause. AJR Am J Roentgenol. 1994 Jan;162(1):37-41.

ReferenceCitation: Montagnon E, Cerny M, Cadrin-Chênevert A, Hamilton V, Derennes T, Ilinca A, Vandenbroucke-Menu F, Turcotte S, Kadoury S, Tang A. Deep learning workflow in radiology: a primer. Insights Imaging. 2020 Feb 10;11(1):22. doi: 10.1186/s13244-019-0832-5. Review.

ReferenceCitation: Cheng PM, Tejura TK, Tran KN, Whang G. Detection of high-grade small bowel obstruction on conventional radiography with convolutional neural networks. Abdom Radiol (NY). 2018 May;43(5):1120-1127. doi: 10.1007/s00261-017-1294-1.

ReferenceCitation: Kim DH, Wit H, Thurston M, Long M, Maskell GF, Strugnell MJ, Shetty D, Smith IM, Hollings NP. An artificial intelligence deep learning model for identification of small bowel obstruction on plain abdominal radiographs. Br J Radiol. 2021 Jun 1;94(1122):20201407. doi: 10.1259/bjr.20201407. Epub 2021 Apr 27.

ReferenceCitation: Vanderbecq Q, Ardon R, De Reviers A, Ruppli C, Dallongeville A, Boulay-Coletta I, D'Assignies G, Zins M. Adhesion-related small bowel obstruction: deep learning for automatic transition-zone detection by CT. Insights Imaging. 2022 Jan 24;13(1):13. doi: 10.1186/s13244-021-01150-y.

ReferenceCitation: Hodel J, Zins M, Desmottes L, Boulay-Coletta I, Jullès MC, Nakache JP, Rodallec M. Location of the transition zone in CT of small-bowel obstruction: added value of multiplanar reformations. Abdom Imaging. 2009 Jan-Feb;34(1):35-41. doi: 10.1007/s00261-007-9348-4.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Central for Visual Computing - OPIS Inria group


title: Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery. First-in-human Study

acronym: ODYSSEE

summary:
Pedicle screw malposition is a common problem for spine surgeons. A poorly placed screw can lead to potentially serious complications (hemorrhage, paralysis) in the short- or medium-term. Accurate images during surgery facilitates preoperative planning and aids the placement of pedicle screws.

Surgical navigation covers all techniques and equipment (hardware and software) needed to perform a computer-assisted procedure with 3D image visualization of the surgical act.

Surgical navigation systems have been on the market for about 15 years. Surgical navigation increases the accuracy of pedicle screw placement. Many technologies are available, but they are expensive and often require extensive instrumentation.

The PYTHEAS® ODYSSEE angular assistance system has many advantages over more widely used systems. Indeed, this system provides surgeons with the necessary information to correctly insert pedicle screws during posterior spondylodesis procedures for the treatment of deformity, osteoarthritis (degenerative spine) and trauma.

Compared to competing solutions, the purpose of this device is to reduce pedicle screw malpositioning while offering minimal radiation exposure and the least possible impact on the conventional surgical workflow. It is a lightweight, efficient and easy-to-use medical device with 2-step functionality: 1) Surgical planning of pedicle screws based on a preoperative scan; 2) Angular assistance tool during surgery.

The study investigators wish to evaluate the performance and safety of the PYTHEAS® ODYSSEE medical device (not CE marked) as well as its usability in a pilot study of first use in humans.

Without a navigation system, the literature reports that on average 9 to 10% of perforations are incorrectly positioned by the "free hand" method. With the PYTHEAS® ODYSSEE angular assistance device, the study hypothesis is that this rate will be 5%, i.e. a 50% improvement.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Nimes
Hôpital Saint Joseph


title: Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

acronym: KLOTHO

summary: The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

location_facility:
Hôpital Foch
AH-HP Hôpital Necker enfants malades


title: Characterization of Neuromuscular Involvement in Late Adolescent and Adult Cystinosis Patients

acronym: Cystinose

summary:
The primary objective of the study is to evaluate the change in motor function of patients with cystinosis.

The secondary objectives of the study:

assessment of the respiratory function;
assessment of the muscle function;
assessment of swallowing disorders;
assessment radiologically of the muscular efficiency;
assessment of lean mass / fat mass ratio;
assessment of sleeping disorders;
annual assessment of evolution of above functions.

All patients will be examined by experienced neuromuscular specialist (Pr Pascal Laforêt) and pulmonologist specialized in neuromuscular disorders (Pr Hélène Prigent). All evaluations will be performed in Raymond-Poincaré hospital (Teaching hospital of Assistance Publique - Hopitaux de Paris (APHP) and University of Paris-Saclay) neuromuscular center, coordinated by Pr Pascal Laforêt.

location_facility: Neurology Department, Raymond-Poincaré hospital, APHP

location_facility: Department of Nephrology and Transplantation Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte, Necker-Enfants Malades University Hospital, APHP


title: Prospective Non-interventional, Prospective Multicenter Study of VEGA System® Prosthesis in the Total Knee Arthroplasty

summary: This post-market clinical follow-up study intends to investigate long-term functionality of the VEGA System®. The design of the VEGA System® is meant to provide the patient with more knee mobility compared to their pre-operative state.The endpoint is the revision of at least one of the prosthesis components

lead_sponsor: BBraun Medical SAS

location_facility: Hôpital Lariboisière- Service de Chirurgie Orthopédique et Traumatologie

location_facility: Hôpital Privé des Bonnettes-Service de Chirurgie Orthopédique et Traumatologie


title: Integrative Study of Vestibular Pathology With Analysis of Postural, Neurosensory, and Cognitive Disorders: Search for New Markers on the Causes and Consequences of Vertigo

summary:
Exploratory posturological, neurosensory, cognitive, emotional, personality and general evaluations (quality of life).

The investigators will characterize a sensory profile quantified by one or more scores from a multi-parameter baysian approach. Each parameter and these scores will be correlated to the type of vestibular damage and its recovery in order to establish diagnostic, prognostic and therapeutic follow-up markers.

lead_sponsor: University Hospital, Caen

location_facility:
Caen University Hospital
Frédéric Xavier


title: Perceived Impact of Art Therapy in Patients With Cystic Fibrosis (Adolescents, Adults and Transplanted Not Transplanted) and in Professional Interdisciplinary Teams Taking Care of Them.

acronym: MUCO-ART-PLUS

summary:
Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.

Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling

lead_sponsor: Nantes University Hospital

location_facility:
Foch Hospital
Nantes University Hospital


summary: The objective of the study is to estimate the reliability of the determination of the cardiac output measured by the ECOM™ device. This study will be performed with the latest version of the software which should give better results than those published previously. Two techniques of measure of the cardiac output will be compared: the reference measure by trans-esophageal echography and the bioimpedance used by the ECOM™. monitor.

location_facility:
Centre Chirurgical Marie-Lannelongue
Institut Mutualiste Montsouris


acronym: OSCILLOREVERS

summary:
Limitation of expiratory flows is considered as the main determiner of dynamic distension and dyspnoea in chronic obstructive pulmonary disease (COPD). The analysis of proximal and distal resistances should allow to better appreciate the functional impact.

This study should also allow to specify the best parameters in respiratory functional explorations useful for the follow-up in COPD and to specify the relevance of functional indications other than the forced expiration volume at 1 second (FEV1) or the functional residual capacity (FRC) to estimate in a more relevant way the clinical improve with the increase of the therapeutic load (increase of posology, association of two bronchodilatators, addition of an anti-inflammatory drug, thus etc…) at already handled patients suffering from a persistent dyspnoea insufficiently relieved.

location_facility:
Hôpital Foch
CHRU


title: Pilot Study to Assess Performance and Safety of SULFEX 13081.22 Nasal Spray in Patients With Dry or Irritated Nose

summary: As the medical device is CE marked, the objective of this study is to provide performance and safety data on SULFEX 13081.22 nasal spray as close as possible to the routine care.

lead_sponsor: Church & Dwight Company, Inc.

location_facility:
Pharmacie Lair
Pharmacie Plaisance