title: Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)

acronym: HyperVOPTICA

summary:
The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to measure optical aberrations in hyperopic eyes.

The study hypotheses are the:

Ability to measure optical aberrations in hypermetropia.
Knowledge of optical aberrations of the eye hyperopic.
To adapt therapeutic management in optical aberrations measured.

ReferenceCitation: Fernández EJ, Manzanera S, Piers P, Artal P. Adaptive optics visual simulator. J Refract Surg. 2002 Sep-Oct;18(5):S634-8.

ReferenceCitation: Piers PA, Fernandez EJ, Manzanera S, Norrby S, Artal P. Adaptive optics simulation of intraocular lenses with modified spherical aberration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4601-10.

ReferenceCitation: Piers PA, Manzanera S, Prieto PM, Gorceix N, Artal P. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007 Oct;33(10):1721-6.

ReferenceCitation: Manzanera S, Prieto PM, Ayala DB, Lindacher JM, Artal P. Liquid crystal Adaptive Optics Visual Simulator: Application to testing and design of ophthalmic optical elements. Opt Express. 2007 Nov 26;15(24):16177-88.

ReferenceCitation: Villegas EA, Alcón E, Artal P. Optical quality of the eye in subjects with normal and excellent visual acuity. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4688-96. doi: 10.1167/iovs.08-2316. Epub 2008 Jun 14.

ReferenceCitation: Fernández EJ, Prieto PM, Artal P. Wave-aberration control with a liquid crystal on silicon (LCOS) spatial phase modulator. Opt Express. 2009 Jun 22;17(13):11013-25.

ReferenceCitation: Fernández EJ, Prieto PM, Artal P. Binocular adaptive optics visual simulator. Opt Lett. 2009 Sep 1;34(17):2628-30. doi: 10.1364/OL.34.002628.

ReferenceCitation: Pérez GM, Manzanera S, Artal P. Impact of scattering and spherical aberration in contrast sensitivity. J Vis. 2009 Mar 25;9(3):19.1-10. doi: 10.1167/9.3.19.

ReferenceCitation: Bueno JM, Acosta E, Schwarz C, Artal P. Wavefront measurements of phase plates combining a point-diffraction interferometer and a Hartmann-Shack sensor. Appl Opt. 2010 Jan 20;49(3):450-6. doi: 10.1364/AO.49.000450.


title: Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients

summary: Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.

acronym: IPRA

summary: The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.

lead_sponsor: Rennes University Hospital

location_facility: Service d'Endocrinologie-Diabétologie - CHU de Rennes - Hôpital Sud


title: Automated Administration of Fluid Administration Thanks to Hemodynamic Parameters and Cardiac Output During General Anesthesia

summary: The investigators want to test during anesthesia the feasibility of a closed-loop automated fluid replacement system using cardiac output monitoring as the input value.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Hopital Foch

intervention_type: Device

status_simplified: Unknown


title: Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.

acronym: ValApPhI

summary: The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Besleaga T, Blum M, Briot R, Vovc V, Moldovanu I, Calabrese P. Individuality of breathing during volitional moderate hyperventilation. Eur J Appl Physiol. 2016 Jan;116(1):217-25. doi: 10.1007/s00421-015-3260-3. Epub 2015 Sep 23.

family: Besleaga

full_name: Tudor Besleaga

given: Tudor

sequence: first

family: Blum

full_name: Michaël Blum

given: Michaël

sequence: additional

family: Briot

full_name: Raphaël Briot

given: Raphaël

family: Vovc

full_name: Victor Vovc

given: Victor

family: Moldovanu

full_name: Ion Moldovanu

given: Ion

family: Calabrese

full_name: Pascale Calabrese

given: Pascale

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Applied Physiology

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Grenoble


title: Syndrome and Aspiration Pneumonia in Intensive Care

acronym: SPIRE

summary:
Inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of ICU stay increased. However, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known.

The aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Departemental Vendee


title: FUnctional Testing Underlying Coronary REvascularisation.

acronym: FUTURE

summary:
The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients.

The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated.

The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up.

Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.

primary_purpose: Diagnostic

ReferenceCitation: Rioufol G, Dérimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle É, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefèvre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Dérimay

full_name: François Dérimay

given: François

family: Roubille

full_name: François Roubille

family: Perret

full_name: Thibault Perret

given: Thibault

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Angoulvant

full_name: Denis Angoulvant

given: Denis

family: Cottin

full_name: Yves Cottin

given: Yves

family: Meunier

full_name: Ludovic Meunier

given: Ludovic

family: Cetran

full_name: Laura Cetran

given: Laura

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Harbaoui

full_name: Brahim Harbaoui

given: Brahim

family: Wiedemann

full_name: Jean-Yves Wiedemann

given: Jean-Yves

family: Van Belle

full_name: Éric Van Belle

given: Éric

family: Pouillot

full_name: Christophe Pouillot

given: Christophe

family: Noirclerc

full_name: Nathalie Noirclerc

given: Nathalie

family: Morelle

full_name: Jean-François Morelle

given: Jean-François

family: Soto

full_name: François-Xavier Soto

given: François-Xavier

family: Caussin

full_name: Christophe Caussin

family: Bertrand

full_name: Bernard Bertrand

given: Bernard

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Dupouy

full_name: Patrick Dupouy

given: Patrick

family: Lesault

full_name: Pierre-François Lesault

given: Pierre-François

family: Albert

full_name: Franck Albert

given: Franck

journal_name: Journal of the American College of Cardiology

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

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


title: Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study

acronym: FLARIOC

summary:
The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.

Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:

ease of use
lack of invasiveness
absence of ionizing radiation to the patient and the operating staff
performed prior to any dissection (prior to "critical view of safety")

Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.

The study requires a 2-month patient participation.

ReferenceType: result

ReferenceCitation: Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400.

family: Diana

full_name: Michele Diana

given: Michele

family: Soler

full_name: Luc Soler

given: Luc

family: Agnus

full_name: Vincent Agnus

given: Vincent

family: D’Urso

full_name: Antonio D’Urso

given: Antonio

family: Vix

full_name: Michel Vix

given: Michel

family: Dallemagne

full_name: Bernard Dallemagne

family: Faucher

full_name: Vanina Faucher

given: Vanina

family: Roy

full_name: Catherine Roy

given: Catherine

family: Mutter

full_name: Didier Mutter

given: Didier

family: Marescaux

full_name: Jacques Marescaux

given: Jacques

family: Pessaux

full_name: Patrick Pessaux

journal_name: Annals of Surgery

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil


title: Clinical Utility of Contrast-enhanced Intraoperative Ultrasound in Surgery of Colorectal Liver Metastases. Phase II Clinical Trial.

acronym: ULIIS

summary:
Hypothesis: Use of contrast ultrasound showed interesting results, which can increase ultrasonography sensitivity performed during surgery in the evaluation of operable liver metastases.

This study is a two-stage phase II multicenter study (Simon's two-stage).

ReferenceCitation: Desolneux G, Isambert M, Mathoulin-Pelissier S, Dupré A, Rivoire M, Cattena V, Palussière J, Dinart D, Bellera C, Evrard S. Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study. Eur J Surg Oncol. 2019 Jul;45(7):1212-1218. doi: 10.1016/j.ejso.2019.03.002. Epub 2019 Mar 10.

family: Desolneux

full_name: G. Desolneux

given: G.

family: Isambert

full_name: M. Isambert

given: M.

family: Mathoulin-Pelissier

full_name: S. Mathoulin-Pelissier

given: S.

family: Dupré

full_name: A. Dupré

given: A.

family: Rivoire

full_name: M. Rivoire

family: Cattena

full_name: V. Cattena

given: V.

family: Palussière

full_name: J. Palussière

given: J.

family: Dinart

full_name: D. Dinart

given: D.

family: Bellera

full_name: C. Bellera

given: C.

family: Evrard

full_name: S. Evrard

journal_name: European Journal of Surgical Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Institut Bergonié

lead_sponsor_type: industriel


title: Evaluation of Endoscopic Submucosal Dissection (ESD) Efficacy

acronym: DISSECMUC

summary:
Superficial rectal tumors could be removed by ESD with two major advantages showed by the literature: high rate of monobloc resection and R0 resection. Hence, recurrence rate was lower than ERM therapy. This technique is actually performed routinely in Japan and experience is limited in Europe, with few data in the literature.

This study is suggested to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.

Follow-up is one year. For lesion with invasive carcinoma (vessel and lymphatic involvement, undifferentiated, free margin less than 1 mm), a surgical resection is performed.

All the patients have an endoscopic control 3 months after ESD (rectosigmoidoscopy with biopsies):

For complete resection, an endoscopic control was performed at 1 year.
For incomplete resection, another endoscopic therapy was attempted (EMR) an endoscopic control was performed at 1 year.

At one year, patient with incomplete resection have a surgical resection.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Gastroenterology Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure


title: Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue

acronym: MTM

summary:
Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.

The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project

ReferenceType: background

ReferenceCitation: Abdel-Galil K, Mitchell D. Postoperative monitoring of microsurgical free-tissue transfers for head and neck reconstruction: a systematic review of current techniques--part II. Invasive techniques. Br J Oral Maxillofac Surg. 2009 Sep;47(6):438-42. doi: 10.1016/j.bjoms.2008.12.002. Epub 2009 Jan 19. Review.

ReferenceCitation: Benacquista T, Kasabian AK, Karp NS. The fate of lower extremities with failed free flaps. Plast Reconstr Surg. 1996 Oct;98(5):834-40; discussion 841-2.

ReferenceCitation: Birke-Sørensen H, Toft G, Bengaard J. Pure muscle transfers can be monitored by use of microdialysis. J Reconstr Microsurg. 2010 Nov;26(9):623-30. doi: 10.1055/s-0030-1267382. Epub 2010 Oct 6.

ReferenceCitation: Bøgehøj M, Emmeluth C, Overgaard S. Blood flow and microdialysis in the human femoral head. Acta Orthop. 2007 Feb;78(1):56-62.

ReferenceCitation: Brix M, Muret P, Ricbourg B, Humbert P. [Monitoring free flaps with cutaneous microdialysis: preliminary study in oral cavity reconstruction]. Rev Stomatol Chir Maxillofac. 2006 Dec;107(6):460-4. French.

ReferenceCitation: Bui DT, Cordeiro PG, Hu QY, Disa JJ, Pusic A, Mehrara BJ. Free flap reexploration: indications, treatment, and outcomes in 1193 free flaps. Plast Reconstr Surg. 2007 Jun;119(7):2092-2100. doi: 10.1097/01.prs.0000260598.24376.e1.

ReferenceCitation: Delgado JM, DeFeudis FV, Roth RH, Ryugo DK, Mitruka BM. Dialytrode for long term intracerebral perfusion in awake monkeys. Arch Int Pharmacodyn Ther. 1972;198(1):9-21.

ReferenceCitation: Ferguson REH Jr, Yu P. Techniques of monitoring buried fasciocutaneous free flaps. Plast Reconstr Surg. 2009 Feb;123(2):525-532. doi: 10.1097/PRS.0b013e318196b9a3.

ReferenceCitation: Hölzle F, Rau A, Loeffelbein DJ, Mücke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.

ReferenceCitation: Jallali N, Ridha H, Butler PE. Postoperative monitoring of free flaps in UK plastic surgery units. Microsurgery. 2005;25(6):469-72.

ReferenceCitation: Jyränki J, Suominen S, Vuola J, Bäck L. Microdialysis in clinical practice: monitoring intraoral free flaps. Ann Plast Surg. 2006 Apr;56(4):387-93.

ReferenceCitation: Laure B, Sury F, Bayol JC, Goga D. [Microdialysis: experience in postoperative monitoring of 30 free flaps]. Ann Chir Plast Esthet. 2009 Feb;54(1):29-36. doi: 10.1016/j.anplas.2008.05.008. Epub 2008 Nov 29. French.

ReferenceCitation: Mourouzis C, Anand R, Bowden JR, Brennan PA. Microdialysis: use in the assessment of a buried bone-only fibular free flap. Plast Reconstr Surg. 2007 Oct;120(5):1363-1366. doi: 10.1097/01.prs.0000279555.75241.4c.

ReferenceCitation: Röjdmark J, Blomqvist L, Malm M, Adams-Ray B, Ungerstedt U. Metabolism in myocutaneous flaps studied by in situ microdialysis. Scand J Plast Reconstr Surg Hand Surg. 1998 Mar;32(1):27-34.

ReferenceCitation: Setälä L, Papp A, Romppanen EL, Mustonen P, Berg L, Härmä M. Microdialysis detects postoperative perfusion failure in microvascular flaps. J Reconstr Microsurg. 2006 Feb;22(2):87-96.

ReferenceCitation: Setälä LP, Korvenoja EM, Härmä MA, Alhava EM, Uusaro AV, Tenhunen JJ. Glucose, lactate, and pyruvate response in an experimental model of microvascular flap ischemia and reperfusion: a microdialysis study. Microsurgery. 2004;24(3):223-31.

ReferenceCitation: Smit JM, Zeebregts CJ, Acosta R, Werker PMN. Advancements in free flap monitoring in the last decade: a critical review. Plast Reconstr Surg. 2010 Jan;125(1):177-185. doi: 10.1097/PRS.0b013e3181c49580. Review.

ReferenceCitation: Stolle LB, Arpi M, Jørgensen PH, Riegels-Nielsen P, Keller J. In situ gentamicin concentrations in cortical bone: an experimental study using microdialysis in bone. Acta Orthop Scand. 2003 Oct;74(5):611-6.

ReferenceCitation: Ungerstedt U, Rostami E. Microdialysis in neurointensive care. Curr Pharm Des. 2004;10(18):2145-52. Review.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells

acronym: ARTHROSTEM

summary: Articular cartilage can be the seat of many diseases including osteoarthritis and traumatic defaults. The cartilage has no intrinsic ability to repair resulting at long term in function loss in the joints. Currently available treatments are not satisfactory in the long term, the use of mesenchymal stem cells appears to be promising due to their ability to multipotency and immunomodulation properties. This project aims to determine the most appropriate source for regenerative medicine of cartilage stem cells from tissue taken during arthroplasty in patients with osteoarthritis. These cells will be tested for different chondrogenic markers. The success of this project will consider the implementation of a strategy for regenerative medicine in bone and joint diseases.

primary_purpose: Other

lead_sponsor: Nantes University Hospital


title: Phase I Dose Escalation Trial of Efavirenz for Patients With Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.

acronym: ESCALE

summary:
Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in order to determine the maximum tolerated dose to improve therapeutic effect.

This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic cancer) and non-Hodgkin lymphoma (NHL).

Main objective is to determine the safety profile, and particularly the maximum tolerated dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer) or NHL in therapeutic failure.

Secondary objectives are:

Evaluate efavirenz pharmacokinetics at 2, 4 and 12 weeks;
Evaluate objective response at 12 weeks;
Evaluate progression free survival at 6 months;
Assess biological progression-free survival at 6 months (prostate tumours only).

Primary Endpoint

Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz and will be defined as follows:

Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia, nausea and vomiting, regardless of grade),
Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days,
Score ≥ 19 HAD during treatment. Secondary Criteria
Solid tumors: response and progression defined by RECIST v1.1 [Eisenhauer EA et al. EJC 2009).
Non-Hodgkin lymphomas: Response and progression defined according to Cheson criteria [Cheson BD et al. JCO 1999]
Biological progression (particular case of prostate tumors): defined according to Scher [Scher HI et al. JCO 2008] Statistical Considerations This is a Phase I dose escalation strategy using the method CRML, described by O'Quigley and Shen [O'Quigley et al. Biometrics 1996] and commonly used in Phase I trials in oncology.
Maximum number of eligible and evaluable subjects is 30.
Six dose levels are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000 mg.
The risk of dose limiting toxicities maximum allowed is 25%.

study_start_date_type: Actual

intervention_type: Drug


title: Coaching of Difficult Diabetic Patients by a Care Coordinating Team After Hospital Discharge

acronym: SORTIDIAB

summary: One third of the costs of medical care for people with diabetes are related to hospitalization." Difficult" diabetic patient, i.e. those with very high HbA1c, patients > 75y, those with diabetic foot ulcers, or those with a recent cardiovascular event have a high rate of readmission when discharged at home after an initial hospitalization related to diabetes or its complications. The objective of the study is to test if a coaching with a care coordinating team after hospital discharge would decrease diabetes-related rehospitalization rate compared with usual care.

primary_purpose: Supportive Care

location_facility: Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital

intervention_type: Behavioral


title: Malignant Progression of Anal Intra-epithelial Neoplasia in a Cohort of Patients

summary: Evaluation of the 3-years anal carcinoma (AC) incidence in patient with anal AIN3 lesions, and factors associated with this AC. A retrospective cohort study will be conducted (2000-2013) followed by a prospective cohort study (starting in 2013) with new diagnoses of anal AIN3 lesion. The main outcome is histology proven AC. The 3-years incidence rate of AC will be calculated. Factors associated with AC will be estimated using a multivariate Cox regression model.

lead_sponsor: French Society of Coloproctology

location_facility: Service d'Hépato-gastro-entérologie, Hôpital Bichat, 46 rue Henri Huchard


type: EudraCT Number

title: Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

acronym: Loop-NVPO

summary: The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

primary_purpose: Prevention

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

family: Liu

full_name: Ngai Liu

given: Ngai

family: Chazot

full_name: Thierry Chazot

given: Thierry

family: Hamada

full_name: Sophie Hamada

given: Sophie

family: Landais

full_name: Alain Landais

given: Alain

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Dussaussoy

full_name: Corinne Dussaussoy

given: Corinne

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: Anesthesia & Analgesia

title: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index

ReferenceCitation: Song JW, Park EY, Lee JG, Park YS, Kang BC, Shim YH. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011 Apr;66(4):263-7. doi: 10.1111/j.1365-2044.2011.06648.x.

ReferenceCitation: Bataille A, Letourneulx JF, Charmeau A, Lemedioni P, Léger P, Chazot T, Le Guen M, Diemunsch P, Fischler M, Liu N. Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study. Eur J Anaesthesiol. 2016 Dec;33(12):898-905.


title: PAZOPANIB Efficacy and Tolerance in Desmoids Tumors : Phase 2 Clinical Trial

acronym: DESMOPAZ

summary:
Desmoids tumors are benign soft tissues tumors characterized by aggressiveness and potential local recurrence. There is a female predominance with a sex ratio of 2/1 and median age at diagnosis is about 30 years.

Only a complete surgical excision is recommended in desmoids tumors. Some forms of desmoid tumors are recurrent and/or symptomatic and are not accessible to a conservative surgical treatment. In these clinical situations, only a medical treatment may achieve tumor control and quality of life maintenance. Place of systemic treatments in the management of desmoids tumors is poorly evaluated. Regarding chemotherapy, methotrexate and vinblastine protocol is actually the best evaluated combination, which allowed observing objective response rate between 40 and 75%. Toxicity was mainly marked by the risk of haematological toxicity.

Pazopanib is an inhibitor of multi-target tyrosine kinase, in oral form, with selective type receptors -1, -2 and -3 of VEGF receptors on the PDGFA and B, and c-Kit. It is currently under clinical development in humans in the treatment of several tumor types.

ReferenceCitation: Toulmonde M, Pulido M, Ray-Coquard I, Andre T, Isambert N, Chevreau C, Penel N, Bompas E, Saada E, Bertucci F, Lebbe C, Le Cesne A, Soulie P, Piperno-Neumann S, Sweet S, Cecchi F, Hembrough T, Bellera C, Kind M, Crombe A, Lucchesi C, Le Loarer F, Blay JY, Italiano A. Pazopanib or methotrexate-vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study. Lancet Oncol. 2019 Sep;20(9):1263-1272. doi: 10.1016/S1470-2045(19)30276-1. Epub 2019 Jul 19.

family: Toulmonde

full_name: Maud Toulmonde

given: Maud

family: Pulido

full_name: Marina Pulido

given: Marina

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Andre

full_name: Thierry Andre

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Penel

full_name: Nicolas Penel

family: Bompas

full_name: Emmanuelle Bompas

given: Emmanuelle

family: Saada

full_name: Esma Saada

given: Esma

family: Bertucci

full_name: François Bertucci

given: François

family: Lebbe

full_name: Celeste Lebbe

given: Celeste

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Soulie

full_name: Patrick Soulie

given: Patrick

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

family: Sweet

full_name: Stephen Sweet

given: Stephen

family: Cecchi

full_name: Fabiola Cecchi

given: Fabiola

family: Hembrough

full_name: Todd Hembrough

given: Todd

full_name: Carine Bellera

given: Carine

family: Kind

full_name: Michèle Kind

given: Michèle

family: Crombe

full_name: Amandine Crombe

given: Amandine

family: Lucchesi

full_name: Carlo Lucchesi

given: Carlo

family: Le Loarer

full_name: François Le Loarer

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

title: Pazopanib or methotrexate–vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study


title: Conscious Sedation With Midazolam in Dentally Anxious Patients: Effect of the Administration Route (Oral Versus Intravenous Administration)

summary:
Use lay language.

To compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route

ReferenceCitation: Collado V, Faulks D, Nicolas E, Hennequin M. Conscious sedation procedures using intravenous midazolam for dental care in patients with different cognitive profiles: a prospective study of effectiveness and safety. PLoS One. 2013 Aug 5;8(8):e71240. doi: 10.1371/journal.pone.0071240. Print 2013.

family: Collado

full_name: Valérie Collado

given: Valérie

family: Faulks

full_name: Denise Faulks

given: Denise

family: Nicolas

full_name: Emmanuel Nicolas

given: Emmanuel

family: Hennequin

full_name: Martine Hennequin

given: Martine

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Conscious Sedation Procedures Using Intravenous Midazolam for Dental Care in Patients with Different Cognitive Profiles: A Prospective Study of Effectiveness and Safety

lead_sponsor: University Hospital, Clermont-Ferrand


title: Comparison of Biomarkers of Stress in Emergency Physicians Working a 24-hour Shift or a 14-hour Night Shift - the JOBSTRESS Randomized Trial

acronym: JOBSTRESS

summary: A stressful state can lead to symptoms of mental exhaustion, physical fatigue, medical errors, and also increase coronary heart disease. Emergency physicians subjectively complain of stress related to changes in work shifts. Several potential biomarkers of stress have been described, but never investigated in emergency physician, who may represent a good model of stress due to the complex interplay between stress (life-and-death emergencies, which is the defining characteristic of their job), lack of sleep and fatigue due to repeated changes in shifts.The aim of this study was to compare biomarkers in emergency physicians working a 24-hour shift (24hS) or a 14-hour night shift (14hS), and in those working a control day (clerical work on return from leave). We also followed these markers three days following each shift (D3/24hS and D3/14hS).

primary_purpose: Screening

ReferenceCitation: Dutheil F, Marhar F, Boudet G, Perrier C, Naughton G, Chamoux A, Huguet P, Mermillod M, Saâdaoui F, Moustafa F, Schmidt J. Maximal tachycardia and high cardiac strain during night shifts of emergency physicians. Int Arch Occup Environ Health. 2017 Aug;90(6):467-480. doi: 10.1007/s00420-017-1211-5. Epub 2017 Mar 7.

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

family: Marhar

full_name: Fouad Marhar

given: Fouad

family: Boudet

full_name: Gil Boudet

given: Gil

family: Perrier

full_name: Christophe Perrier

given: Christophe

family: Naughton

full_name: Geraldine Naughton

given: Geraldine

family: Chamoux

full_name: Alain Chamoux

given: Alain

family: Huguet

full_name: Pascal Huguet

given: Pascal

family: Mermillod

full_name: Martial Mermillod

given: Martial

family: Saâdaoui

full_name: Foued Saâdaoui

given: Foued

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

journal_name: International Archives of Occupational and Environmental Health


title: Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study

summary:
Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the most effective possible tool for hemostasis allows a bleeding decrease during liver transection and thus could reduce postoperative morbidity.

In the past decade, the improvement of techniques of transection of the hepatic parenchyma was one of the most important factors to ensure the hepatectomy safety. But the clinical performances of these technological innovations (ultrasound dissectors, monopolar radiofrequency probes and dissection devices using pressurized water) remain still unclear.

The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology of "transcollation" combining a source of radiofrequency associated with a conductive liquid (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks of electric arc and overheating met with conventional electrosurgery. This device allows the coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These clinical benefits could be translated by an improvement of the direct and indirect costs associated to the surgery. However the Aquamantys® technology has not been scientifically validated in the context of the hepatic surgery, and this technology is expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment in a generator (Aquamantys Pump Generator®).

Consequently, it is essential to realize a study measuring the clinical and medical economic impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.


title: Randomized and Single Blind Study Comparing Remifentanil Sedation Versus Propofol for Performing Bronchial Fibroscopies Under Intravenous Anesthesia

acronym: REVPRO

summary: The purpose of this study is to determine whether the use of Target-Controlled Infusion (TCI) of Remifentanil can deliver better conditions for performing bronchial fibroscopy with spontaneous ventilation (decrease the duration of cough) compared to the use of TCI of Propofol.

location_facility: Hôpital Saint-Louis - Anesthésie Réanimation


title: Efficacy of Facial Block for Outpatient Rhinoplasty Analgesia

acronym: FABLORA

summary: A bilateral facial block (infraorbital and infratrochlear) will be performed immediately after intubation in patients undergoing outpatient rhinoplasty with 2.5% levobupivacaine (intervention group) or saline as control. Intravenous saline or morphine will be administered at the end of surgery in intervention or control groups, respectively. In case of pain in post-anesthesia care unit (numerical pain score >3 on a 0-10 scale), both groups will receive intravenous morphine titration. The total perioperative morphine consumption (intraoperative and in post-anesthesia care unit) will be compared between groups. Pain intensity, presence of nausea/vomiting and patient's satisfaction will be compared between groups.

lead_sponsor: Hospices Civils de Lyon


summary: The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.

lead_sponsor: Poitiers University Hospital


title: A Prospective, Single Center, Single-blinded, Randomized Study, of the Angel of Water™ for Colon Cleansing as Preparation for Colonoscopy

summary:
The aim of this study is to demonstrate the efficacy of the hydrocolonic lavage method in order to prepare the colon prior to performing a colonoscopy, by comparison the hydrotherapy to standard preparation solution.

Hypothesis: Colon cleansing by hydrotherapy is as good as colon cleansing by standard preparation solution.

lead_sponsor: novoGI

location_facility: Department of Hepato-Gastroenterology, Nouvel Hopital Civil


title: Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties

acronym: EMDOGAIM

summary: The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus in Adults Patients

acronym: LORACLOFT

summary: The main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus in adult patients.

location_facility: Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière


title: Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus.

acronym: IONTO-CXL

summary:
The primary purpose of the protocol is to compare the current standard CXL with iontophoretic CXL to provide evidence in relation to the efficacy and safety in progressive keratoconus.

Corneal collagen crosslinking (CXL) is the first surgical procedure that appears to halt the progression of keratoconus. In the current standard CXL, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. The epithelium debridement can cause severe pain, infection and stromal haze. The study hypothesis is that iontophorese CXL is as effective as standard CXL to stabilize a progressive keratoconus.

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ReferenceCitation: Behar-Cohen FF, El Aouni A, Gautier S, David G, Davis J, Chapon P, Parel JM. Transscleral Coulomb-controlled iontophoresis of methylprednisolone into the rabbit eye: influence of duration of treatment, current intensity and drug concentration on ocular tissue and fluid levels. Exp Eye Res. 2002 Jan;74(1):51-9.

ReferenceCitation: Eljarrat-Binstock E, Orucov F, Frucht-Pery J, Pe'er J, Domb AJ. Methylprednisolone delivery to the back of the eye using hydrogel iontophoresis. J Ocul Pharmacol Ther. 2008 Jun;24(3):344-50. doi: 10.1089/jop.2007.0097.

ReferenceCitation: Patane MA, Cohen A, From S, Torkildsen G, Welch D, Ousler GW 3rd. Ocular iontophoresis of EGP-437 (dexamethasone phosphate) in dry eye patients: results of a randomized clinical trial. Clin Ophthalmol. 2011;5:633-43. doi: 10.2147/OPTH.S19349. Epub 2011 May 15.

ReferenceCitation: Cohen AE, Assang C, Patane MA, From S, Korenfeld M; Avion Study Investigators. Evaluation of dexamethasone phosphate delivered by ocular iontophoresis for treating noninfectious anterior uveitis. Ophthalmology. 2012 Jan;119(1):66-73. doi: 10.1016/j.ophtha.2011.07.006. Epub 2011 Nov 23.

ReferenceCitation: Wollensak G, Spoerl E, Wilsch M, Seiler T. Endothelial cell damage after riboflavin-ultraviolet-A treatment in the rabbit. J Cataract Refract Surg. 2003 Sep;29(9):1786-90.

ReferenceCitation: Spoerl E, Seiler T. Techniques for stiffening the cornea. J Refract Surg. 1999 Nov-Dec;15(6):711-3.

ReferenceCitation: Chien YW, Banga AK. Iontophoretic (transdermal) delivery of drugs: overview of historical development. J Pharm Sci. 1989 May;78(5):353-4. Review.

ReferenceCitation: Reinhart WJ, Musch DC, Jacobs DS, Lee WB, Kaufman SC, Shtein RM. Deep anterior lamellar keratoplasty as an alternative to penetrating keratoplasty a report by the american academy of ophthalmology. Ophthalmology. 2011 Jan;118(1):209-18. doi: 10.1016/j.ophtha.2010.11.002. Review.

ReferenceCitation: Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.

ReferenceCitation: Asri D, Touboul D, Fournié P, Malet F, Garra C, Gallois A, Malecaze F, Colin J. Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Reference Center for Keratoconus. J Cataract Refract Surg. 2011 Dec;37(12):2137-43. doi: 10.1016/j.jcrs.2011.08.026.

ReferenceCitation: Vimalin J, Gupta N, Jambulingam M, Padmanabhan P, Madhavan HN. The effect of riboflavin-UV-A treatment on corneal limbal epithelial cells--a study on human cadaver eyes. Cornea. 2012 Sep;31(9):1052-9. doi: 10.1097/ICO.0b013e3182498902.

ReferenceCitation: Touboul D, Robinet-Perrin A, Fournié P, Malecaze F. [Efficacy of corneal cross-linking for the treatment of keratoconus]. J Fr Ophtalmol. 2016 Mar;39(3):308-14. doi: 10.1016/j.jfo.2015.12.002. Epub 2016 Mar 16. Review. French.

family: Touboul

full_name: D. Touboul

given: D.

family: Robinet-Perrin

full_name: A. Robinet-Perrin

given: A.

family: Fournié

full_name: P. Fournié

given: P.

family: Malecaze

full_name: F. Malecaze

given: F.

title: Efficacité du cross-linking du collagène cornéen pour le traitement du kératocône


title: Study of the Role of Acid Sensing Ion Channels (ASICs) in Human Inflammatory Pain

summary: In recent years, ion channels have emerged as new therapeutic targets for pain. Among these channels, ASICs (Acid Sensing Ion Channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. Indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification. ASIC are excitatory ion channels that are expressed in neurons, including nociceptive sensory neurons. In humans, the use of amiloride, a nonspecific inhibitor of ASICs, has demonstrated their role in the perception of pain induced by subcutaneous injections of acidic solutions. ASICs thus appear as new candidates capable of mediating pain in humans. A growing number of data suggests that, in addition to protons, ASICs may also be activated by one or more endogenous compounds produced during inflammation. The purpose of this research project is to identify these compounds by testing the effects of human inflammatory exudates on ASICs activity. The discovery of such compounds would definitely validate ASICs as novel therapeutic targets for pain treatment in humans


title: Effects of Regular Perdialytic Physical Activity on the Peripheral Microcirculation in Chronic Hemodialysis Patients

acronym: ACTIVDIAL

summary: Chronic kidney disease (CKD) is associated with high level of peripheral arterial disease (PAD). This could lead wounds, infections then amputations or deaths by impairment of the peripheral cutaneous perfusion. Medical therapies are presently unable to cure, but only slow down these disorders. Impact of exercise and lower extremity PAD rehabilitation is decreased by the significant inactivity of the chronic hemodialysis patients. Recently, many studies have shown several various favorable effects of the perdialytic physical activity. There is currently no data about effects of the perdialytic activity on the lower extremity perfusion. The aim of this clinical study is to show the impact of three months perdialytic cycling on the microcirculation, in chronic hemodialysis patients. Primary outcome will be the increase of cutaneous perfusion, assessed by measuring transcutaneous oxygen pressure (tcPO2) on about twenty patients.


title: Rehabilitation Protocol for Disorders on Hand Sensitivity in Multiple Sclerosis Patients.

acronym: FINGER

summary:
Sensory disorders in patients with multiple sclerosis are among the most common symptoms encountered.

A functional impairment based on sensory disorders of the hand. The hand is a sensory organ that transmits the cerebral cortex protopathic sensitive information, proprioceptive or epicritiques. The view-hand association plays an important role in the understanding of the environment. Its exploratory use remains an essential and voluntary basis. The process of recognition of the object passes through manipulation, but operates instantaneously. The brain is able to do a quick summary of the information it receives to determine the nature of the manipulated object. The exploration takes a posteriori, the brain can then determine the details component object (texture, shape, composition, temperature and weight).

Neurophysiological mechanisms that would explain the analgesic effects of transcutaneous electrical nerve stimulation (TENS) are not fully understood. Several theories underlying its use as a neuromodulator of pain. The gate control theory has led to the development of TENS devices. Recruitment of myelinated, large caliber, by the TENS electrodes afferent fibers increases the control exerted on spinal level, thereby inhibiting the action of afferent fibers of small caliber related to nociception. This stimulation strengthens the blocking of "gate" at the corresponding cell bodies of spinothalamic tract and reduces the transmission of nociceptive impulses to the spinal cord dorsal horn. This is segmental presynaptic inhibition depends on the area and stimulated.

The objective of this study is to improve the quality of life through improved sensitivity disorders of the hand in patients with MS, thanks to reeducation of the hand.


title: Evaluation of MRI Sequences in Hepatic Overload.

summary: MRI, without any contrast injection, allows a non-invasive evaluation and quantification of hepatic overloads, especially iron (liver iron content LIC) and fat (steatosis) overloads, but in certain clinical circumstances, cases require to improve performances. The aim of the study is to add to MRI scans which currently must be performed innovative sequences appropriate for the clinical question to overall appreciate on a varied range of patients their quality, their robustness, their relative performance and, for patients having a biopsy, their accuracy.


title: IN UTERO SMOKING AND PREMATURE CELLULAR SENESCENCE

summary:
Actually, there is an increasing number of arguments for a premature origin of chronic adult's diseases, as the chronic obstructive pulmonary disease (COPD). Several factors interacting with the foetal or postnatal lung growth are associated with early and long-lasting respiratory functional changes susceptible to contribute very significantly to the arisen of a COPD in the adulthood. It is possible that these situations reflect phenomena of premature cellular senescence, recently involved in the physiopathology of the COPD. An in utero exposition to cigarette smoking is one of these situations, because it is known to induce, not only functional respiratory changes, but also multiple diseases in the child which could testify of cellular ageing phenomena.

Our project aims to demonstrate that in utero smoking is associated with markers of premature cellular senescence in newborn children

The study will be driven in human newborn child's, with comparison of the length of the telomeres in circulating lymphocytes (umbilical blood is collected), according to the exposure in in utero smoking and also according to the degree of hypotrophy. This study will be a pilot study completed by an animal experimental study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Genetic


title: French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)

acronym: PC-QOL

summary:
Cough is one of the most common reasons for consultation. Even if cough is a non-specific symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.

Objective : The aim of the study is to validate the French version of the PC-QoL, a parent-proxy QoL chronic cough specific questionnaire.

Methods : Linguistic validation will be performed using backward/forward translation guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in 150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire and two cough-related measures (visual analogue score, verbal category descriptive). Clinical data (medical history, physical examination) will be collected. Children QoL will be assessed using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and sensitivity to change, parents will be retested 7 and 21 days later. Content validity, construct's validity, external validity and instrument's reliability will be explored.


title: Prospective Longitudinal 1-year Study of the Correlation Between Cognitive Functioning in Patients With Clinically Isolated Syndrome Suggestive of Multiple Sclerosis and Disconnection in the Brain Assessed by MRI:"SCI-COG" Study

acronym: SCI-COG

summary: Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.

ReferenceCitation: Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupé P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27.

family: Moroso

full_name: Amandine Moroso

given: Amandine

family: Ruet

full_name: Aurélie Ruet

given: Aurélie

family: Lamargue-Hamel

full_name: Delphine Lamargue-Hamel

given: Delphine

family: Munsch

full_name: Fanny Munsch

given: Fanny

family: Deloire

full_name: Mathilde Deloire

given: Mathilde

family: Coupé

full_name: Pierrick Coupé

given: Pierrick

family: Ouallet

full_name: Jean-Christophe Ouallet

given: Jean-Christophe

family: Planche

full_name: Vincent Planche

given: Vincent

family: Moscufo

full_name: Nicolas Moscufo

given: Nicolas

family: Meier

full_name: Dominik S Meier

given: Dominik S

family: Tourdias

full_name: Thomas Tourdias

given: Thomas

family: Guttmann

full_name: Charles R G Guttmann

given: Charles R G

family: Dousset

full_name: Vincent Dousset

family: Brochet

full_name: Bruno Brochet

given: Bruno

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_host_type: repository

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

repository_normalized: HAL

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Bordeaux


title: Multimodal Approach of Undernutrition in Chronic Heart Failure : a Controlled, Randomized Trial

acronym: NUTRICARD

summary:
The treatment of chronic heart failure (CHF) is a key challenge in public health. Despite medical advances, 1-year mortality of NYHA III-IV CHF is 28%. Undernutrition is an independent risk factor for mortality and complications. Up-to-date, interventional studies involving nutrition are scarce in CHF. Academic societies are recommending the use of oral nutritional supplements (ONS) in case of weight loss, without defining the modalities. ONS could improve nutritional status in undernourished CHF patients, but solely administered, have a limited impact on undernutrition, physical performance and prognosis. A multimodal approach integrating physical exercise, nutritional intakes, polyunsaturated n-3 fatty acids (n-3 PUFA), and anabolizing hormones, has to be privileged. A recent trial has shown the clinical benefits of such an approach in patients with chronic respiratory insufficiency (CRI), who have similar nutritional and muscular characteristics.

Exercise rehabilitation is well validated in CHF patients, but has never been validated in case of undernutrition. Exercise rehabilitation allows improving exercise capacity, quality of life and cardiovascular outcomes including mortality.

N-3 PUFA supplementation improves muscle strength and endurance in CRI patients. n-3 PUFA supplementation decreases by 30% cardiovascular mortality of CHF patients. n-3 PUFA could be useful for CHF patients rehabilitation.

Androgenopenia is a prognostic factor in CHF. Androgen substitution improves significantly muscle strength, walking endurance and quality of life. In the context of a multimodal approach, Androgen substitution together with exercise rehabilitation and ONS could have a beneficial effect on muscle mass, strength and endurance of CHF patients, as already described in CRI, elderly and HIV patients.

The study hypotheses that a 3-month multimodal approach associating exercise rehabilitation, androgen substitution, n-3 PUFAs and ONS improves exercise capacity of undernourished CHF patients.


title: Position of Children During Urine Collection: Evaluation Study

acronym: PUCES

summary: Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.

lead_sponsor: University Hospital, Limoges


title: Evaluation of Adrenocortical Functions by Insulin Tolerance Test and Sodium Depletion in Women With Nonclassical Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency in Comparison With Healthy Volunteers.

summary:
The risk of adrenal insufficiency in patients with nonclassical congenital adrenal hyperplasia due to 21-hydroxylase deficiency is not well documented. Indication of cortisol replacement therapy in situation of acute stress or at long term is thus controversial. The mineralocorticoid reserve of these patients has never been evaluated.

Hypothesis: The glucocorticoid and mineralocorticoid function of the adrenal glands in women with nonclassical 21-hydroxylase deficiency is comparable with the adrenal functions of healthy age- sexe- and BMI-matched subjects.

ReferenceCitation: Kamenický P, Blanchard A, Lamaziere A, Piedvache C, Donadille B, Duranteau L, Bry H, Gautier JF, Salenave S, Raffin-Sanson ML, Genc S, Pietri L, Christin-Maitre S, Thomas J, Lorthioir A, Azizi M, Chanson P, Le Bouc Y, Brailly-Tabard S, Young J. Cortisol and Aldosterone Responses to Hypoglycemia and Na Depletion in Women With Non-Classic 21-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2020 Jan 1;105(1). pii: dgz005. doi: 10.1210/clinem/dgz005.

name: Service d’Endocrinologie et des Maladies de la Reproduction, Hôpital de Bicêtre, Assistance Publique-Hôpitaux de Paris (AP-HP), Le Kremlin-Bicêtre, France

name: Univ Paris-Sud, Université Paris-Saclay, Le Kremlin-Bicêtre, France

name: Institut National de la Santé et de la Recherche Médicale (Inserm) UMR_S1185, Le Kremlin Bicêtre, France

family: Kamenický

full_name: Peter Kamenický

given: Peter

name: Centre d’Investigation Clinique, Hôpital Européen Georges Pompidou, AP-HP, Paris, France

family: Blanchard

full_name: Anne Blanchard

given: Anne

name: Plateforme de Métabolomique, Peptidomique et de Dosage de Médicaments, Hôpital Saint-Antoine, AP-HP, Paris, France

family: Lamaziere

full_name: Antonin Lamaziere

given: Antonin

name: Unité de Recherche Clinique, Hôpital de Bicêtre, AP-HP, Le Kremlin-Bicêtre, France

family: Piedvache

full_name: Céline Piedvache

given: Céline

name: Service d’Endocrinologie et des Maladies de la Reproduction, Hôpital Saint-Antoine, AP-HP, Paris, France

family: Donadille

full_name: Bruno Donadille

name: UF de Gynécologie Adolescente et Jeune Adulte, Hôpital de Bicêtre, AP-HP, Le Kremlin-Bicêtre, France

family: Duranteau

full_name: Lise Duranteau

given: Lise

family: Bry

full_name: Hélène Bry

given: Hélène

name: Centre Universitaire de Diabétologie et de ses Complications, Hôpital Lariboisière, AP-HP, Paris, France

family: Gautier

full_name: Jean-François Gautier

given: Jean-François

family: Salenave

full_name: Sylvie Salenave

given: Sylvie

name: Service d’Endocrinologie, Hôpital Ambroise Parré, Boulogne-Billancourt, France

family: Raffin-Sanson

full_name: Marie-Laure Raffin-Sanson

given: Marie-Laure

name: Service d’Endocrinologie, Hôpital Jean Bernard, Valenciennes Cedex, France

family: Genc

full_name: Seray Genc

given: Seray

name: Service d’Endocrinologie, Hôpital Saint-Joseph, Paris, France

family: Pietri

full_name: Laurence Pietri

given: Laurence

family: Christin-Maitre

full_name: Sophie Christin-Maitre

given: Sophie

family: Thomas

full_name: Julien Thomas

given: Julien

name: Unité d’Hypertension, Hôpital Européen Georges Pompidou, AP-HP, Paris, France

family: Lorthioir

full_name: Aurelien Lorthioir

given: Aurelien

family: Azizi

full_name: Michel Azizi

given: Michel

family: Chanson

full_name: Philippe Chanson

given: Philippe

family: Le Bouc

full_name: Yves Le Bouc

given: Yves

name: Service de Génétique Moléculaire, Pharmacogénétique et Hormonologie, Hôpital de Bicêtre, AP-HP, Le Kremlin-Bicêtre, France

family: Brailly-Tabard

full_name: Sylvie Brailly-Tabard

family: Young

full_name: Jacques Young

given: Jacques

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society


title: Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment

acronym: PRESH

summary: Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.


title: Does Type II Diabetes Influence Prognosis and Left Ventricular Remodeling in Patients With Aortic Valve Stenosis Referred for Aortic Valve Replacement ?

acronym: DIAPASON

summary:
This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.

The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.

The secondary objectives are :

assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.

The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: FOCAL CORTICAL ATROPHY AFTER MYOCARDIAL INTERNAL CAPSULE: CORRELATION FRACTION ANISOTROPY BEAM PYRAMID AND DISABILITY

acronym: ACFI

summary:
Primary purpose of the trial is to demonstrate the arisen of focal cortical atrophy, localized in the ipsilateral primary motor area, measured in mm, three months after infarction of internal capsule.

The patient is compared to himself between day zero to ten and three months.

The study hypotheses are:

A focal cortical atrophy of the ipsilesional primary motor area occurs after cerebral infarction of the internal capsule. It is measurable accurately and reproducibly by MRI at three months. Other brain areas within the voluntary motor system will also be explored (supplementary motor area, pre motor area).
This atrophy is correlated with achievement of pyramidal tract, assessed by the fractional anisotropy of its fibers.
This atrophy is correlated with disability at three months, assessed by Rankin score.

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ReferenceCitation: Wang LE, Fink GR, Diekhoff S, Rehme AK, Eickhoff SB, Grefkes C. Noradrenergic enhancement improves motor network connectivity in stroke patients. Ann Neurol. 2011 Feb;69(2):375-88. doi: 10.1002/ana.22237. Epub 2010 Dec 28.

ReferenceCitation: Xue R, van Zijl PC, Crain BJ, Solaiyappan M, Mori S. In vivo three-dimensional reconstruction of rat brain axonal projections by diffusion tensor imaging. Magn Reson Med. 1999 Dec;42(6):1123-7.

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ReferenceCitation: Yang Q, Tress BM, Barber PA, Desmond PM, Darby DG, Gerraty RP, Li T, Davis SM. Serial study of apparent diffusion coefficient and anisotropy in patients with acute stroke. Stroke. 1999 Nov;30(11):2382-90.

ReferenceCitation: Zhu LL, Lindenberg R, Alexander MP, Schlaug G. Lesion load of the corticospinal tract predicts motor impairment in chronic stroke. Stroke. 2010 May;41(5):910-5. doi: 10.1161/STROKEAHA.109.577023. Epub 2010 Apr 8.

lead_sponsor: University Hospital, Toulouse


title: Neutrophils Function and Identification of Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener's Granulomatosis).

acronym: NeutroVasc

summary:
Anti-neutrophil cytoplasm antibodies (ANCA)-associated vasculitis are rare diseases characterized by inflammation of blood vessels. Among the numerous cell types that play a role in vasculitis, one of the key actors is the neutrophil. Neutrophils are equipped with very powerful molecules that they use to destroy the invading microbes. Therefore, the mechanisms controlling neutrophil activation should be tightly controlled. If that is not the case, neutrophils may destroy the tissues of the host. This is what happens during chronic inflammation in vasculitis. Autoantibodies directed against neutrophils, ANCA, produced thus demonstrating that neutrophils are also targets of the immune system in these diseases. In addition, molecular studies provided evidence that genes normally silenced in mature neutrophils under normal conditions can be re-expressed in neutrophils from patients with ANCA-associated vasculitis thus strongly suggesting a profound deregulation of neutrophil functions in these conditions. Notably, the investigators have preliminary data showing that neutrophils from patients with granulomatosis with polyangiitis (GPA, formerly Wegener's granulomatosis), an ANCA-associated vasculitis, interfere with the normal phase of resolution of inflammation.

The objective of the investigators' study is to understand the mechanisms underlying this increased activation state and determine if neutrophils could be used to define prognostic markers by clinicians to optimize patients' care. Therefore, the investigators plan to study the expression of proteins implicated in GPA pathophysiology at the membrane of neutrophils when they undergo apoptosis. The investigators will also study the deregulation of protein expression in neutrophils. This point will be the molecular translation of neutrophil deregulation. This technique is powerful and well adapted to identify by mass spectrometry the proteins that will be differentially expressed between the control and the disease state. After identification of proteins differentially expressed in patients with GPA, the investigators will further investigate whether their expression is modulated during the disease course and/or modified by the treatment.

The investigators believe that understanding these neutrophil perturbations can lead to better monitoring of disease activity. Ultimately, the investigators may propose more targeted anti-inflammatory therapies which would be better tolerated by patients. the investigators also can identify new markers for disease activity which allow clinicians to define a better therapeutic strategy.

ReferenceCitation: Millet A, Martin KR, Bonnefoy F, Saas P, Mocek J, Alkan M, Terrier B, Kerstein A, Tamassia N, Satyanarayanan SK, Ariel A, Ribeil JA, Guillevin L, Cassatella MA, Mueller A, Thieblemont N, Lamprecht P, Mouthon L, Perruche S, Witko-Sarsat V. Proteinase 3 on apoptotic cells disrupts immune silencing in autoimmune vasculitis. J Clin Invest. 2015 Nov 2;125(11):4107-21. doi: 10.1172/JCI78182. Epub 2015 Oct 5.

apc_source: openAPC

family: Millet

full_name: Arnaud Millet

given: Arnaud

family: Martin

full_name: Katherine R. Martin

given: Katherine R.

family: Bonnefoy

full_name: Francis Bonnefoy

given: Francis

family: Saas

full_name: Philippe Saas

family: Mocek

full_name: Julie Mocek

given: Julie

family: Alkan

full_name: Manal Alkan

given: Manal

family: Terrier

full_name: Benjamin Terrier

given: Benjamin

family: Kerstein

full_name: Anja Kerstein

given: Anja

family: Tamassia

full_name: Nicola Tamassia

given: Nicola

family: Satyanarayanan

full_name: Senthil Kumaran Satyanarayanan

given: Senthil Kumaran

family: Ariel

full_name: Amiram Ariel

given: Amiram

family: Ribeil

full_name: Jean-Antoine Ribeil

given: Jean-Antoine

family: Guillevin

full_name: Loïc Guillevin

given: Loïc

family: Cassatella

full_name: Marco A. Cassatella

given: Marco A.

family: Mueller

full_name: Antje Mueller

given: Antje

family: Thieblemont

full_name: Nathalie Thieblemont

given: Nathalie

family: Lamprecht

full_name: Peter Lamprecht

given: Peter

family: Mouthon

full_name: Luc Mouthon

given: Luc

family: Perruche

full_name: Sylvain Perruche

given: Sylvain

family: Witko-Sarsat

full_name: Véronique Witko-Sarsat

given: Véronique

journal_name: Journal of Clinical Investigation

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: American Society for Clinical Investigation


type: Registry Identifier

title: Effect of Acute Preoperative Stress Assessed With Salivary Amylase on the Severity of Maternal Hypotension After Spinal Anesthesia for Planned Cesarean Section

acronym: SAS

summary: Spinal anesthesia is the technique of choice for planned cesarean section. It is associated with a high frequency of maternal hypotension. Hyperactivity of the sympathetic system assessed with the LF/HF ratio (heart rate variability analysis) predicts the severity of maternal hypotension after spinal anesthesia. Increased LF/HF ratio may be explained by maternal stress that can be measured with salivary amylase. The goal of this study is to assess the relationship between salivary amylase and severity of maternal hypotension after spinal anesthesia for planned cesarean section.

time_perspective: Retrospective


title: Evaluation of Palliative and Supportive Care for Spinal Muscular Atrophy (SMA) Type 1 Patients

summary: The purpose of this study is to evaluate the quality of supportive and palliative care for SMA type 1 patients.

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ReferenceCitation: Kaufmann P, Greiss C, Brown J. Survival in SMA type 1. Neuromuscul Disord. 2009 Jan;19(1):76; author reply 76. doi: 10.1016/j.nmd.2008.10.010. Epub 2008 Dec 12.

ReferenceCitation: Roper H, Quinlivan R; Workshop Participants. Implementation of "the consensus statement for the standard of care in spinal muscular atrophy" when applied to infants with severe type 1 SMA in the UK. Arch Dis Child. 2010 Oct;95(10):845-9. doi: 10.1136/adc.2009.166512. Epub 2009 Oct 8. Review.

ReferenceCitation: Hully M, Barnerias C, Chabalier D, Le Guen S, Germa V, Deladriere E, Vanhulle C, Cuisset JM, Chabrol B, Cances C, Vuillerot C, Espil C, Mayer M, Nougues MC, Sabouraud P, Lefranc J, Laugel V, Rivier F, Louvier UW, Durigneux J, Napuri S, Sarret C, Renouil M, Masurel A, Viallard ML, Desguerre I. Palliative Care in SMA Type 1: A Prospective Multicenter French Study Based on Parents' Reports. Front Pediatr. 2020 Feb 18;8:4. doi: 10.3389/fped.2020.00004. eCollection 2020.

family: Hully

full_name: Marie Hully

given: Marie

family: Barnerias

full_name: Christine Barnerias

given: Christine

family: Chabalier

full_name: Delphine Chabalier

given: Delphine

family: Le Guen

full_name: Sophie Le Guen

given: Sophie

family: Germa

full_name: Virginie Germa

given: Virginie

family: Deladriere

full_name: Elodie Deladriere

given: Elodie

family: Vanhulle

full_name: Catherine Vanhulle

given: Catherine

family: Cuisset

full_name: Jean-Marie Cuisset

given: Jean-Marie

family: Chabrol

full_name: Brigitte Chabrol

given: Brigitte

family: Cances

full_name: Claude Cances

given: Claude

family: Vuillerot

full_name: Carole Vuillerot

given: Carole

family: Espil

full_name: Caroline Espil

given: Caroline

family: Mayer

full_name: Michele Mayer

given: Michele

family: Nougues

full_name: Marie-Christine Nougues

given: Marie-Christine

family: Sabouraud

full_name: Pascal Sabouraud

given: Pascal

family: Lefranc

full_name: Jeremie Lefranc

given: Jeremie

family: Laugel

full_name: Vincent Laugel

given: Vincent

family: Rivier

full_name: Francois Rivier

given: Francois

family: Louvier

full_name: Ulrike Walther Louvier

given: Ulrike Walther

family: Durigneux

full_name: Julien Durigneux

given: Julien

family: Napuri

full_name: Sylvia Napuri

given: Sylvia

family: Sarret

full_name: Catherine Sarret

family: Renouil

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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

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


title: Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

acronym: BiRDS

summary:
The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.

The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.

lead_sponsor: University Hospital, Angers

location_facility: Medical Intensive Care Unit, University Hospital of Angers