title: Comparing a Diuretic Vascular Filling in the Initial Management of Acute Pulmonary Embolism With Right Ventricular Dysfunction Normotensive

summary:
Pulmonary embolism (PE) is a serious disease with frequent intra hospital mortality remains high. If anticoagulation is perfectly codified, the remainder of the initial management has been less studied.

In particular, the "conditioning" Initial often involves systematic plasma volume of 250 to 500 cc, by analogy to other situations. But this treatment option is not based on factual data. In the right ventricular dysfunction that often accompany severe EP, volume expansion may instead be harmful, according to the law of Frank Starling. A retrospective study has recently shown a benefit of diuretic therapy in patients hospitalized for severe normotensive EP.

The proposed study is interventional, prospective, multicenter, randomized, require to include 60 patients.

The main objective of the study is the comparison of the troponin normalization period Ic (biomarker of right ventricular dysfunction) in patients hospitalized in the initial phase of a serious normotensive EP, between the 2 groups diuretic and filling Vascular.

The primary endpoint is the time in hours standardization of troponin Ic.

The secondary endpoints will be:

the period of normalization of Brain Natriuretic Peptide (BNP)
changes in echocardiographic parameters of right ventricular dysfunction
a composite endpoint: cardiovascular death / cardiogenic shock / use of amines / use of thrombolysis.

ReferenceCitation: Ferrari E, Sartre B, Labbaoui M, Heme N, Asarisi F, Redjimi N, Fourrier E, Squara F, Bun S, Berkane N, Breittmayer JP, Doyen D, Moceri P. Diuretics Versus Volume Expansion in the Initial Management of Acute Intermediate High-Risk Pulmonary Embolism. Lung. 2022 Apr;200(2):179-185. doi: 10.1007/s00408-022-00530-5. Epub 2022 Apr 5.


type: Other Identifier

title: Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

summary: Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Comparison of Two Methods of Preoxygenation Before Oro Tracheal Intubation in the Hypoxemic Patient in Intensive Care Unit : Non Invasive Ventilation (NIV) + High Flow Nasal Cannula Oxygen Versus NIV Alone : a Randomized Controlled Study

acronym: OPTINIV

summary: Tracheal intubation is a challenging procedure in Intensive Care Unit (ICU), associated with severe life threatening complications. To decrease these complications, preoxygenation is recommended. Non invasive ventilation (NIV) increase effectiveness of preoxygenation, applying a positive end expiratory pressure (PEEP). High-flow nasal cannula oxygen (HFNC) improves oxygenation by increasing end-expiratory lung volume and has a potential of apneic oxygenation. The association of NIV and HFNC for preoxygenation in hypoxemic ICU patients has never been evaluated. The aim of this study is to determine if HFNC combined to NIV could have therapeutic advantages over NIV alone for preoxygenation in the ICU patients intubated for hypoxemic acute respiratory failure.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Other

ReferenceType: background

ReferenceCitation: De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRéa Network for the Frida-Réa Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

ReferenceCitation: Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61.

ReferenceCitation: De Jong A, Jung B, Jaber S. Intubation in the ICU: we could improve our practice. Crit Care. 2014 Mar 18;18(2):209. doi: 10.1186/cc13776. Review.

ReferenceCitation: De Jong A, Futier E, Millot A, Coisel Y, Jung B, Chanques G, Baillard C, Jaber S. How to preoxygenate in operative room: healthy subjects and situations "at risk". Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):457-61. doi: 10.1016/j.annfar.2014.08.001. Epub 2014 Aug 29. Review.

ReferenceCitation: Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. Epub 2006 Apr 20.

ReferenceCitation: Jaber S, Michelet P, Chanques G. Role of non-invasive ventilation (NIV) in the perioperative period. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):253-65. Review.

ReferenceCitation: Vourc'h M, Asfar P, Volteau C, Bachoumas K, Clavieras N, Egreteau PY, Asehnoune K, Mercat A, Reignier J, Jaber S, Prat G, Roquilly A, Brule N, Villers D, Bretonniere C, Guitton C. High-flow nasal cannula oxygen during endotracheal intubation in hypoxemic patients: a randomized controlled clinical trial. Intensive Care Med. 2015 Sep;41(9):1538-48. doi: 10.1007/s00134-015-3796-z. Epub 2015 Apr 14.

ReferenceCitation: Miguel-Montanes R, Hajage D, Messika J, Bertrand F, Gaudry S, Rafat C, Labbé V, Dufour N, Jean-Baptiste S, Bedet A, Dreyfuss D, Ricard JD. Use of high-flow nasal cannula oxygen therapy to prevent desaturation during tracheal intubation of intensive care patients with mild-to-moderate hypoxemia. Crit Care Med. 2015 Mar;43(3):574-83. doi: 10.1097/CCM.0000000000000743.

ReferenceCitation: Chanques G, Riboulet F, Molinari N, Carr J, Jung B, Prades A, Galia F, Futier E, Constantin JM, Jaber S. Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study. Minerva Anestesiol. 2013 Dec;79(12):1344-55. Epub 2013 Jul 15.

ReferenceCitation: Chanques G, Jaber S. [Unexpected progress of an old intensive care therapy, oxygen: towards more comfort and less mechanical ventilation…]. Rev Mal Respir. 2013 Oct;30(8):605-8. doi: 10.1016/j.rmr.2013.07.006. Epub 2013 Aug 27. French.

ReferenceCitation: Hedenstierna G, Rothen HU. Atelectasis formation during anesthesia: causes and measures to prevent it. J Clin Monit Comput. 2000;16(5-6):329-35. Review.

ReferenceCitation: Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. Epub 2005 Aug 16. Review.

ReferenceCitation: Kolettas A, Grosomanidis V, Kolettas V, Zarogoulidis P, Tsakiridis K, Katsikogiannis N, Tsiouda T, Kiougioumtzi I, Machairiotis N, Drylis G, Kesisis G, Beleveslis T, Zarogoulidis K. Influence of apnoeic oxygenation in respiratory and circulatory system under general anaesthesia. J Thorac Dis. 2014 Mar;6 Suppl 1:S116-45. doi: 10.3978/j.issn.2072-1439.2014.01.17. Review.

ReferenceCitation: Engström J, Hedenstierna G, Larsson A. Pharyngeal oxygen administration increases the time to serious desaturation at intubation in acute lung injury: an experimental study. Crit Care. 2010;14(3):R93. doi: 10.1186/cc9027. Epub 2010 May 24.

ReferenceCitation: Griesdale DE, Bosma TL, Kurth T, Isac G, Chittock DR. Complications of endotracheal intubation in the critically ill. Intensive Care Med. 2008 Oct;34(10):1835-42. doi: 10.1007/s00134-008-1205-6. Epub 2008 Jul 5.

ReferenceCitation: Jaber S, Jung B, Corne P, Sebbane M, Muller L, Chanques G, Verzilli D, Jonquet O, Eledjam JJ, Lefrant JY. An intervention to decrease complications related to endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Intensive Care Med. 2010 Feb;36(2):248-55. doi: 10.1007/s00134-009-1717-8. Epub 2009 Nov 17.

ReferenceCitation: De Jong A, Clavieras N, Conseil M, Coisel Y, Moury PH, Pouzeratte Y, Cisse M, Belafia F, Jung B, Chanques G, Molinari N, Jaber S. Implementation of a combo videolaryngoscope for intubation in critically ill patients: a before-after comparative study. Intensive Care Med. 2013 Dec;39(12):2144-52. doi: 10.1007/s00134-013-3099-1. Epub 2013 Sep 18.

ReferenceCitation: Jung B, Clavieras N, Nougaret S, Molinari N, Roquilly A, Cisse M, Carr J, Chanques G, Asehnoune K, Jaber S. Effects of etomidate on complications related to intubation and on mortality in septic shock patients treated with hydrocortisone: a propensity score analysis. Crit Care. 2012 Nov 21;16(6):R224. doi: 10.1186/cc11871.

ReferenceCitation: Futier E, Constantin JM, Pelosi P, Chanques G, Massone A, Petit A, Kwiatkowski F, Bazin JE, Jaber S. Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study. Anesthesiology. 2011 Jun;114(6):1354-63. doi: 10.1097/ALN.0b013e31821811ba.

ReferenceCitation: Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

ReferenceCitation: Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b.

ReferenceCitation: De Jong A, Molinari N, Conseil M, Coisel Y, Pouzeratte Y, Belafia F, Jung B, Chanques G, Jaber S. Video laryngoscopy versus direct laryngoscopy for orotracheal intubation in the intensive care unit: a systematic review and meta-analysis. Intensive Care Med. 2014 May;40(5):629-39. doi: 10.1007/s00134-014-3236-5. Epub 2014 Feb 21. Review.

ReferenceCitation: Jaber S, De Jong A, Castagnoli A, Futier E, Chanques G. Non-invasive ventilation after surgery. Ann Fr Anesth Reanim. 2014 Jul-Aug;33(7-8):487-91. doi: 10.1016/j.annfar.2014.07.742. Epub 2014 Aug 29. Review.

ReferenceCitation: Bourgain JL, Jaber S. [Preoxygenation: conditions of success]. Ann Fr Anesth Reanim. 2010 Mar;29(3):187-8. doi: 10.1016/j.annfar.2009.12.027. Epub 2010 Jan 27. French.

ReferenceCitation: De Jong A, Baranwal AK, Jaber S. Predictors of difficult intubation in ICU: are children and adults alike? Intensive Care Med. 2014 Nov;40(11):1769-71. doi: 10.1007/s00134-014-3429-y. Epub 2014 Aug 28.

ReferenceCitation: De Jong A, Jaber S. [Intubation in intensive care medicine: we could improve our practices!]. Ann Fr Anesth Reanim. 2014 May;33(5):293-4. doi: 10.1016/j.annfar.2014.03.017. Epub 2014 May 9. French.

ReferenceCitation: Mort TC. Preoxygenation in critically ill patients requiring emergency tracheal intubation. Crit Care Med. 2005 Nov;33(11):2672-5.

ReferenceCitation: Mort TC, Waberski BH, Clive J. Extending the preoxygenation period from 4 to 8 mins in critically ill patients undergoing emergency intubation. Crit Care Med. 2009 Jan;37(1):68-71. doi: 10.1097/CCM.0b013e318192845e.

ReferenceType: derived

ReferenceCitation: Jaber S, Molinari N, De Jong A. New method of preoxygenation for orotracheal intubation in patients with hypoxaemic acute respiratory failure in the intensive care unit, non-invasive ventilation combined with apnoeic oxygenation by high flow nasal oxygen: the randomised OPTINIV study protocol. BMJ Open. 2016 Aug 12;6(8):e011298. doi: 10.1136/bmjopen-2016-011298.

lead_sponsor: University Hospital, Montpellier

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi


title: Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

acronym: PROSPER

summary:
This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease.
MR Perfusion Imaging will be assess in both cochlea as well
Primary auditory brain pathways will be evaluated through MR diffusion imaging

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Grenoble

intervention_type: Drug

status_simplified: Unknown


type: Other Grant/Funding Number

title: Using MRI for a Non-invasive Evaluation of Portal Pressure

acronym: ENIP

summary: The objective of this research is to study the correlation between the portosystemic pressure gradient and azygos blood flow measured by MRI.

primary_purpose: Basic Science

ReferenceCitation: Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2. Review.

ReferenceCitation: Bosch J, Abraldes JG, Berzigotti A, García-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1. Review.

ReferenceCitation: Thabut D, Moreau R, Lebrec D. Noninvasive assessment of portal hypertension in patients with cirrhosis. Hepatology. 2011 Feb;53(2):683-94. doi: 10.1002/hep.24129. Review.

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: Identification of Volatile Organic Compounds in Exhaled Air During Exacerbation of Chronic Obstructive Pulmonary Disease

acronym: LAVOLEX

summary:
Exacerbations of the disease are a hallmark of Chronic Obstructive Pulmonary Disease (COPD), affecting the decline of pulmonary function, quality of life and increasing morbidity. The use of validated biomarkers could help to identify the etiology of exacerbation and to prescribe antibiotherapy when indicated.

The analysis of exhaled air allows measuring different volatile organic compounds (VOC) which reflect local or systemic inflammation and oxidative stress. The relationship between the presence of some of these compounds and the exacerbation of COPD has never been studied.

The aim of this study is to identify a cluster of VOC in COPD patients during an acute exacerbation of the disease, compared to a stable condition (3 months after discharge). Investigators also will seek for a relationship between VOC and the etiology of exacerbation (bacterial, viral, inflammatory).

study_type: Observational

time_perspective: Prospective

intervention_type: Other


title: Factors Influencing the Choice of Anesthesia (Spinal Anesthesia or Short General Anesthesia) in Outpatient Surgery

acronym: BAG

summary: The purpose of this study is to describe, in real-life conditions, the factors influencing the choice of anesthesia (spinal anesthesia or short general anesthesia) in outpatient surgery.

time_perspective: Cross-Sectional

ReferenceCitation: Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Factors Determining the Choice of Spinal Versus General Anesthesia in Patients Undergoing Ambulatory Surgery: Results of a Multicenter Observational Study. Adv Ther. 2020 Jan;37(1):527-540. doi: 10.1007/s12325-019-01171-6. Epub 2019 Dec 11.

lead_sponsor: Nordic Pharma SAS

lead_sponsor_type: industriel


title: Overuse of Antidepressant in Patients With Alzheimer Disease and Associated Disorders : An Observational Study

acronym: OVADAD

summary:
Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population.

Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in prescription duration) Main objective: to assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in prescription duration) in patients aged 70 years and over with ADAD.

Secondary objectives:

To assess the prevalence of AD prescribed for a non validated indication
To assess the prevalence of AD prescribed with excess in prescription duration
To assess the prevalence of psychotropic coprescription and notably the prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health
To assess factors associated to AD overuse Method: A transversal monocentric study in the geriatric day Bretonneau unit will be performed. Study will be proposed to all eligible patients (with non-opposition of the patient or of his legal representative to the collection of his personal data). Included people will have no supplementary clinical or complementary investigations. The geriatrician in charge will have to systematically collect the indication and the history of the AD treatment. At the end of the evaluation performed in the geriatric day unit, the geriatrician will have to conclude to the AD overuse or not associated with off label prescription. Doubtful case will be examined by a validation committee.

Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and dementia according to DSMIV criteria, whatever its level and antidepressant prescription.

Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant (data from French Health Insurance), the number of eligible patients consulting in the geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their personal data and if the overuse of AD is near 50%, precision of the result will be 12.8% (95%CI bilateral).

Duration of inclusion: 6 months Duration of patient's participation: one day

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Integration of Three-dimensional Echocardiography and Fluoroscopy Imaging During the Percutaneous Closure of intAtrial Septal Defects in Children: CIA-3D-navigator.

summary:
The interventional catheterization allows the percutaneous treatment of congenital heart diseases as the atrial septal defect (ASD). The examination is guided by the X-rays with stochastic side effects worrying at the child's. The software "Echonavigator" allows to merge the ultrasound image and fluoroscopic. This innovative software facilitates the procedures and reduce the irradiation time in some adult procedures.

The aim of this study was to validate the image fusion in children.

primary_purpose: Health Services Research

ReferenceCitation: RUBIO-ALVAREZ V, LIMON R, SONI J. [Intracardiac valvulotomy by means of a catheter]. Arch Inst Cardiol Mex. 1953 Apr;23(2):183-92. Undetermined Language.

ReferenceCitation: Rashkind WJ, Miller WW. Creation of an atrial septal defect without thoracotomy. A palliative approach to complete transposition of the great arteries. JAMA. 1966 Jun 13;196(11):991-2.

ReferenceCitation: Porstmann W, Wierny L, Warnke H. Closure of persistent ductus arteriosus without thoracotomy. Ger Med Mon. 1967 Jun;12(6):259-61.

ReferenceCitation: King TD, Thompson SL, Steiner C, Mills NL. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA. 1976 Jun 7;235(23):2506-9.

ReferenceCitation: Van Aerschot I, Boudjemline Y. [Interventional cardiac catheterization in children]. Arch Pediatr. 2012 Jan;19(1):96-102. doi: 10.1016/j.arcped.2011.06.022. Epub 2011 Oct 29. French.


title: Modification in Cortical Activation by Functional Magnetic Resonance Imaging (fMRI) in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

acronym: PlainteIMF

summary: This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.

status: Withdrawn

study_completion_date_type: Anticipated

design_allocation: Non-Randomized


title: Impact of Pneumothorax Duration Before Treatment on the Success of Needle Exsufflation

summary: Monocentric observational study of needle exsufflation for pneumothorax in the ICU.

ReferenceCitation: MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986.

ReferenceType: result

ReferenceCitation: Andrivet P, Djedaini K, Teboul JL, Brochard L, Dreyfuss D. Spontaneous pneumothorax. Comparison of thoracic drainage vs immediate or delayed needle aspiration. Chest. 1995 Aug;108(2):335-9.

ReferenceCitation: Vuillard C, Dib F, Achamlal J, Gaudry S, Roux D, Chemouny M, Javaud N, Dreyfuss D, Ricard JD, Messika J. Longer symptom onset to aspiration time predicts success of needle aspiration in primary spontaneous pneumothorax. Thorax. 2019 Aug;74(8):780-786. doi: 10.1136/thoraxjnl-2019-213168. Epub 2019 Jun 12.

lead_sponsor: Hôpital Louis Mourier


title: Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study

acronym: PECTUS

summary:
The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated.

Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods.

Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography.

Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.

status: Unknown status

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No


title: Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation

acronym: PACT

summary:
The renal transplant patient is at high cardiovascular risk compared to the general population. The cardiovascular mortality represents one of the most important causes of late graft loss. Cardiovascular risk prediction tools applied to the general population, however, are caught failing on the population of kidney transplant and tend to underestimate the actual risk.

Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is directly related to the target organ (heart, kidney, brain). Central blood pressure could be a cardiovascular risk factor more robust and powerful than brachial blood pressure.

Central blood pressure may in part explain the increased risk of cardiovascular disease in the population of kidney transplant patients. A cohort of 250 kidney transplant patients will be constituted with a measure of concomitant central hemodynamic monitoring to the annual review will be conducted. The main objective of this study is to describe the central blood pressure measured by oscillometric method in renal transplanted population.


title: Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study

acronym: SLA

summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.

The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.

Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force


title: Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy

acronym: RICART

summary: Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT restores contraction coordination between different regions of the left ventricle, which yields a significant improvement in LV systolic function, symptoms, exercise tolerance and quality of life. In the longer term, treatment with resynchronization induces a reverse remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the benefit, some (up to 40% depending on the response criteria of CRT) do not experience significant improvement (nonresponders). Echocardiography and imaging have not so far demonstrated their added value to optimize delivery of CRT. Monocentric promising work on limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering CRT evolves and new probes with four poles stimulation of the left ventricle are now used. The objective of this research is to validate new sequences of ultrasound processing estimating the CRT. These tools are based on usual echocardiographic examination of patients

lead_sponsor: Rennes University Hospital


title: Autonomic Nervous System (ANS) Analysis According to Different Renal Function Stage in Immunoglobin A (IgA) Nephropathy

summary:
The estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. Conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure.

The measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. The investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases.

The aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease.

The renal disease studied will be IgA nephropathy (IgNA). IgNA is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at list 1+) by immunofluorescence.


title: Development of Stimulator Pneumatic for Realization of Evoked Potential Allodynic/Somatosensory

acronym: STIMEA

summary:
The stimuli used in the evoked potentials are electrical or laser. They are started and synchronized with the collection of the EEG by signals TTL (transistor-transistor logic). Investigators propose to validate a pneumatic stimulator delivering the compressed air sync with the EEG. It has two advantages over existing stimuli: Is capable of inducing in patients an allodynic response, excessive, painful, in response to a stimulation painless rarely obtained with laser or electrical stimuli. Therefore, the pneumatic stimulation is a means to study allodynic evoked potentials unknown to date.

It must be possible with a single stimulator to explore non-painful sensations and allodynic sensation , compare them with one device. The differences are the abnormal responses. This validation assumes evoked potential recording 1. somatosensory (low stimulation) then 2. allodynic (only in patients). The study therefore provides for the registration 100 potential for each of these two modalities in patients and only for the painless pneumatic modality in volunteers.


acronym: BLOC-TAP

title: Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection

type: EudraCT Number

source: euctr

summary:
The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.

So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.

Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.

This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.


title: Efficacy of Deep Haptic Massage in Fibromyalgia : Preliminary Study

acronym: FEM

summary:
Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown etiology, characterized by generalized body pain, hyperalgesia and other functional and emotional comorbidities. Women are predominantly affected. Long term prognosis of FMS might be severe by its physical and psychological consequences. The etiology of FMS remains unknown but recent studies suggest a disorder of central pain modulation, neurotransmitters, sympatho-adrenal and hypothalamic-pituitary-adrenal system and peripheral muscles issues. Indeed, muscular abnormalities with a decrease of ATP and micro vascularization have been reported, inducing muscle weakness and local biochemical changes that participate to pain hyper sensitivity. Treatment of FMS is only symptomatic, often difficult, associating pharmacological and non-pharmacological therapies. Massages are largely used in FMS and are included in chronic pain management recommendations.

Massages are recognized as haptic when the hands of the practitioner move on the skin of the patient; haptic massage is superficial if the pressure applied on the skin is similar to the weight of the hand and it's a deep haptic massage when the pressure applied is over the weight of the hand, allowing reaching deep muscle structure. Deep haptic massages are largely used for athlete to improve muscle recovery and treat tendinitis. All massages evaluate in FMS are superficial haptic massage; they are recognized as efficient on pain, anxiety and depression if they are performed at least on 5 weeks but these effects are transient et remain to be optimized. The efficacy of deep haptic massage has not been evaluated in pathological conditions. The investigators hypothesize that, in FMS patients, deep intramuscular maneuvers may solicit sensitive receptors, stimulating large caliber fibers A lemniscal conveyed by the way that bypass chronic pain information carried by the C fibers of the extra-lemniscal pathway: this is the "Gate Control" theory for inhibiting pain information.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation by HR-pQCT of Bone Microarchitecture Changes in Patients With Rheumatoid Arthritis Under Anti-TNF Therapy.

summary:
Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and is characterized by chronic inflammation of the joints leading to their destruction, resulting in a major loss of function.

The investigators propose a pilot study for studying changes in bone microarchitecture with High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural parameters in subchondral area near an inflammatory joint during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).


title: Impact of Pre- Antiretroviral Therapy (ART) Blood Cluster of Differentiation (CD)4+ T Cell Level on the Rectal Reservoir in Long-term HIV-1 Treated Men

acronym: VIRECT

summary: Although combined antiretroviral therapy (cART) has dramatically improved quality of life and lifespan of HIV infected individuals, it still fails to eliminate viral reservoirs. The Gut Associated Lymphoid Tissue (GALT) is the largest reservoir of HIV-1, as it harbors most of HIV target cells as activated memory Cluster of differentiation (CD)4+/CCR5+ T cells. Intestinal T and B cells express α4β7 integrin, a gut mucosal homing receptor which binds to gp120 HIV-1 envelope facilitating the infection of intestinal T cells and the early establishment of the gut HIV reservoir. Intensive viral replication in the GALT leads to an early impairment of mucosal immunity, due to the severe CD4+ T cells depletion, that could be also explained by a lack of recruitment in the gut. Among T cells, interleukin-(IL-)17 secreting CD4+ T cells (Th17) are particularly depleted during HIV infection. This depletion could be associated with HIV progression since these cells play a crucial role in the maintenance of mucosal immunity. A dysbalance of the Th17/Treg ratio may reflect the loss of the intestinal epithelial barrier integrity. These damages are responsible for an increase in microbial translocation, which is associated with immune activation and progression to AIDS. Several recent studies have shown that cART initiation during acute or early HIV-1 infection reduces HIV DNA reservoir size and improves immune reconstitution in blood. Post-treatment controllers, who started long-term cART early after HIV infection, have very low levels of HIV DNA in peripheral blood mononuclear cells, similarly to elite controllers. Unlike most HIV-infected individuals, they maintain an undetectable plasmatic viral load after several years of cART interruption, suggesting that a weak reservoir is a prerequisite to achieve a functional cure. By extrapolation, it could be hypothesized that the gut viral reservoir is also decreased and that mucosal immunity is restored when cART is initiated during primary phase of infection. The gut viral reservoir begins to form within the first days after HIV exposure, and grows during acute HIV infection. Similarly, intestinal T cells are depleted very early after infection, due to high viral replication, host immune response and bystander effects. Most studies also concluded that long-term and optimal treatment can't fully restore mucosal immunity. These observations led us to study the impact of time of cART start on the size of viral reservoir and on immune reconstitution in the gut. For this, we analyzed the virological and immunological characteristics of the rectal HIV reservoir of long-term treated patients regarding their blood CD4+ T cells count at the time of cART initiation.


title: Monocentric Study Evaluating Bone Microarchitecture by High Resolution Quantitative Computerized Tomography (HR-pQCT) in Young Adults and Adolescents Who Developed Anorexia Nervosa (AN) in Peri or Prepubertal Period.

acronym: AMOS

summary:
The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces starvation, stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development. These consequences are initially reversible following food intake return but can lead to a more irreversible status with low height, osteoporosis and high fracture risk. The onset of the disease more and more early in life, with the first stages of puberty suggest that these consequences will be even more severe as bone resistance will be damaged by more profound effects on bone growth as well. It is therefore critical to evaluate these bone metabolism alterations in order to better manage these patients.

At every age and in every clinical circumstance either physiologic or pathologic, high resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of bone microarchitecture that is more informative than the global quantitative assessment given by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical fracture risk.

Here, we propose to measure cortical parameters, such as cortical thickness which plays a key role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had developed AN as early as the during the first stages of puberty but no longer present, compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will also be studied. In an exploratory phase, we will evaluate these bone microarchitectural parameters together with bone biological turnover markers and markers of sexual maturation in adolescents or young adults 20 years-old or less, undernourished and currently managed for AN.


title: Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum

acronym: FIDUCOR

summary: The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.

lead_sponsor: Institut Paoli-Calmettes


acronym: COCYCOX

summary:
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.

The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.

lead_sponsor: University Hospital, Caen

location_facility: Département d'orthopédie traumatologie, CHu de Caen


title: Genome Study in Constitutional Thinness

acronym: GENOSCANN

summary:
Constitutional thinness (CT) is a recently defined entity as a differential diagnosis of anorexia nervosa (AN), considered to be the most frequent cause of low body mass index (BMI) in young women. CT subjects present no AN psychiatric traits, preserved menses, no biological signs of undernutrition and balanced energy metabolism despite a Body Mass Index (BMI) <17 kg / m².

CT familial aggregation, low body mass without a hormonal explanation, and specific appetite regulation profile suggest a specific genetic profile in these subjects.

Objective: A family linkage study in order to identify genes involved in the constitutional thinness phenotype by using genome wide scan (GWAS) techniques Studied population: Fifty families including at least one well phenotyped CT index case (grade 2 or 3 of thinness according WHO classification). Blood or saliva is sampled for DNA extraction.

Perspectives: Revealing eventual abnormalities could lead to a more precise diagnosis of constitutional thinness and new hypothesis in understanding extreme bodyweight mechanisms.


acronym: TMS HALLU

summary:
Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.

Fifteen subjects will be included after collection and signed their informed consent.

The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0).

Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.


title: Pilot Study Immunomonitoring NK Cells in Patients With Myeloid Malignancies

summary:
This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.

the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.

lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.

It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.


title: Double-blind Randomized Prospective Phase III Study of a Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment of the Postoperative Pain From Hospital to Home

summary:
The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements.

Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure.

Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy.

The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner).

Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients after mastectomy.


title: Safety Profile of IntRAvenous Lidocaine Use in Coelioscopic Bariatric Surgery

acronym: SPIRAL

summary:
Intravenous lidocaine is efficient for management of post operative pain in abdominal surgery. As previously published in literature the investigators use it during bariatric surgery.

Nevertheless plasmatic concentration of lidocaine is unknown in this population, despite a widespread use.

Investigators propose in this work to bring an objective proof that administration of lidocaine based on a modified body weight is safe.

Intravenous administration concerned the peri operative period. A total of six samples are taken for each patient.

Investigators get approbation of local ethic committee for this work.

ReferenceCitation: Carabalona JF, Delwarde B, Duclos A, Le Goff MC, Moulsma M, Citterio-Quentin A, Bouffard Y, Rimmelé T. Serum Concentrations of Lidocaine During Bariatric Surgery. Anesth Analg. 2020 Jan;130(1):e5-e8. doi: 10.1213/ANE.0000000000003905.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Département d'anesthésie réanimation

intervention_type: Biological


acronym: IQSCINTIMYOC

summary:
Cardiological examination is one of the major directions in nuclear medicine for detection of myocardial ischemia in patients with suspected coronary artery disease. In Caen, they constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4 minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To date, apart from the work on heart ghosts and one publication in abstract form in 2009, no other study have been published.

The goal of the study is to study the technical performance of the innovative technology IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .


acronym: TEP-READ

summary:
In patients with heart failure, the drive to the effort has demonstrated its safety and its interest. Patients with heart failure, endothelium-dependent peripheral vasodilatation is impaired by decreased activity of endothelial NO synthase. The rehabilitation training significantly improves peripheral endothelial function, and this improvement is correlated to the increase in exercise capacity. The impact on coronary endothelial function remains poorly documented, especially in non-ischemic dilated heart disease.

The main objective of this study is to investigate the effectiveness of cardiac rehabilitation on the restoration of coronary endothelial function in cardiac failure patient evaluated with Tomography Positron Emission 15O-H2O.

ReferenceCitation: Legallois D, Belin A, Nesterov SV, Milliez P, Parienti JJ, Knuuti J, Abbas A, Tirel O, Agostini D, Manrique A. Cardiac rehabilitation improves coronary endothelial function in patients with heart failure due to dilated cardiomyopathy: A positron emission tomography study. Eur J Prev Cardiol. 2016 Jan;23(2):129-36. doi: 10.1177/2047487314565739. Epub 2014 Dec 18.

ReferenceCitation: Tuffier S, Legallois D, Belin A, Joubert M, Bailliez A, Redonnet M, Agostini D, Manrique A. Assessment of endothelial function and myocardial flow reserve using (15)O-water PET without attenuation correction. Eur J Nucl Med Mol Imaging. 2016 Feb;43(2):288-295. doi: 10.1007/s00259-015-3163-x. Epub 2015 Aug 18.


summary:
Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships.

The main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.

primary_purpose: Supportive Care


title: Effect of Inhibitors of the Proton Pump on Intestinal Transporters and Their Impact on the Pharmacokinetics of Dabigatran - Mechanistic and Clinical Approach -BIPP Study

acronym: BIPP

summary:
Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these circumstances the risk / benefit of dabigatran could be improved by combining it with gastric protectors such as inhibitor drugs proton pump (IPP).

Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy subjects.


title: Association Between Serum Periostin Levels and Cortical Porosity in Patients With Secondary Hyperparathyroidism

summary:
Based on the evidence that periostin is specifically involved in intra-cortical remodeling control, our working hypothesis is that assessment of its concentration in the serum would be helpful in identifying patients with severe cortical porosity, a critical parameter in bone fragility. Periostin expression by osteoblasts and osteocytes is part of the bone cortical response to anabolic stimuli such as mechanical strain or intermittent increase in parathyroid hormone. However, it remains unknown whether this expression may participate as well to mechanisms that will lead to exaggerated intra-cortical remodeling and subsequent bone loss.

In rare clinical situations in which trans-iliac bone biopsies will be necessary to better understand their bone status in addition to densitometry and biological bone markers assessment, specific analyses using immune-staining techniques will be performed on the bone sample. Data from routine follow-up every six months will be also collected in this specific sub-group.

High resolution peripheral quantitative computerized tomography (HR-pQCT) gives the opportunity of performing a virtual bone biopsy providing information on trabecular and cortical microarchitecture in vivo. These microarchitectural parameters allow a more accurate evaluation of the alteration of the bone structure and therefore of the fracture risk as compared to current tools used in clinical practice such as densitometry. However, the availability of such HRpQCT facilities is limited and there is on-going development on the best way of measuring porosity for example. The definition of a biological profile including key proteins such as periostin and sclerostin involved in porosity mechanisms is therefore of great interest. A better understanding of the relationship between bone matrix components and parathyroid hormone effects also appears as critical. Follow-up of routine evaluation parameters reflecting bone status in a subgroup of specific patients could also provide new and additional information.


title: Evaluation of Performances of Soluble Fibrin Assay in Exclusion of Pulmonary Embolism and Deep Venous Thrombosis

acronym: FSET

summary: The purpose of the study is to evaluate the performances of Soluble Fibrin assay for exclusion of Pulmonary Embolism and Deep Venous Thrombosis. Secondary objectives are to determine the threshold value from the ROC curves, the possible interest in the positive diagnosis of Venous Thromboembolism (VTE), and to verify the absence of influence of age on the SF results.

ReferenceCitation: Mirshahi S, Soria C, Kouchakji B, Kierzek G, Borg JY, Varin R, Chidiac J, Drouet L, Mirshahi M, Soria J. New combinational assay using soluble fibrin and d-dimer determinations: a promising strategy for identifying patients with suspected venous thromboembolism. PLoS One. 2014 Mar 24;9(3):e92379. doi: 10.1371/journal.pone.0092379. eCollection 2014.

lead_sponsor: Diagnostica Stago R&D

location_facility: Internal Medecine Unit - Adults Pole and Hematology Laboratory Hôpital Louis Mourier (AP-HP)


title: Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke

summary:
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea.

Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population.

Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.

primary_purpose: Prevention


acronym: CECOT

summary:
Corneal topography allows the measure of the radii of curvature and of the thickness of the cornea. It is essential for diagnosis in ophthalmology and allows to highlight corneal irregularities such as a keratoconus, or too thin corneas which are a contra-indication for laser refractive surgery.

Several types of corneal topographers are commercially available. Some as the Orbscan(r), operate by analyzing the image of the patterns of a Placido disk associated with a light slit, allowing the collection of thousands of points of the anterior and posterior surface of the cornea. More recent systems such as the Pentacam(r) are based on automatic rotary cameras which capture images of the whole anterior segment of the eye. The aim of this study is to compare two topographs, the Pentacam(r) and the Orbscan(r) and, more specifically, the central corneal pachymetry measurements measured pre- and postoperatively.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation ophtalmique Adolphe de Rothschild


title: Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

acronym: HIVOL

summary:
Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR.

Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.


acronym:
DARH

 DARH

title: Evaluation of the Impact of Renal Function on the Pharmacokinetics of Hydroxyurea (SIKLOS ®) in Normal-renal Function, Hyperfiltrating and Renal Failure Sickle Cell Disease Patients (DARH)

lead_sponsor: ADDMEDICA SASA

location_facility: Centre de Référence des Syndromes Drépanocytaires Majeurs, Hôpital Henri-Mondor

summary: The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.


acronym: IMPRO

summary: Investigators propose in this study to evaluate prospective memory (MP) in all its complexity as well as the processes, cognitive and brain, the underlying. Specifically, investigators propose to evaluate the evolution of the MP during normal aging and Alzheimer's disease (AD) to identify the cognitive and brain processes underlying this development. To do this, this study will have to include healthy subjects, 18 to 95 years, patients with Mild Cognitive Impairment (MCI) and patients with probable AD. All participants will undergo a series of examinations, both neuropsychological and brain imaging.


title: Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)

acronym: CESTO

summary: This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.

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


acronym: BPCTréa

summary: Investigators propose to conduct a prospective, randomized, controlled, multicenter assessing the interests of an antibiotic protocol guided by serum procalcitonin (PCT) on morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD) hospitalized in intensive care unit (ICU) for acute exacerbation with or without associated pneumonia. The main objective is to show in patients hospitalized in intensive care for acute exacerbation of COPD with or without pneumonia, safety, defined as a lack of difference in mortality at 3 months, an antibiotic strategy guided by the PCT in the ICU.


title: Aspirin With a Novel Twice-a-day Administration in Diabetic Patients With Acute Coronary Syndrome to Minimize Recurrence of Acute Ischemic Events or New Urgent Revascularization

acronym: ANDAMAN

summary: To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.

status: Recruiting

location_facility: Department of Cardiology - Lariboisiere Hospital

status_simplified: Ongoing


type: Registry Identifier

title: New Diagnostic Strategy in Hypertrophic Cardiomyopathy Including a New Genetic Approach: A Multicentric Prospective Study

acronym: HYPERGEN

summary:
Hypertrophic cardiomyopathy (HCM) is an autosomal dominant disease characterized by unexplained hypertrophy of the left ventricle, often with predominant involvement of the interventricular septum, and characterized by myocyte disarray and fibrosis.

HCM is the most common familial heart disease with strong genetic heterogeneity, demonstrated over the past 20 years. Mutations in 11 or more genes encoding proteins of the cardiac sarcomere are responsible for (or associated with) HCM.

However, 30-40% of sporadic and familial cases of HCM are still genetically unlabelled. In addition, secondary HCM caused by Fabry's disease or amyloidosis, may mimic primary HCM and may be under diagnosed. This may result in a delay in accurate diagnosis and instauration of specific treatment, with possible clinical consequences for the patients.

For these reasons, we decided to apply a new diagnostic strategy for patients with newly diagnosed HCM, including the whole exome sequencing (WES) technology.

If correctly applied, this new technology has the potential to strongly reduce the diagnostic wavering leading to earlier diagnosis and genetic counseling in sarcomeric HCM and rarer forms of secondary HCM including Fabry's disease and amyloidosis, and also specific therapy set-up in secondary forms of HCM. It should also allow identifying new genes responsible for HCM.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction

summary:
Crohn's disease is a chronic inflammation of all or part of the digestive tract, " from the mouth to the anus ". .

Cell therapy is a new and promising approach for the treatment of inflammatory disease including Crohn's disease and fistulas.

Adipose tissue seems to be an ideal source for cell therapy. This is a prospective, open, non-comparative, single center, phase I-II clinical trial. It will involve 10 patients and will be conducted over a period of 28 month.

This protocol is designed to evaluate, in patients with Crohn's disease and fistula-in-ano refractory to conventional medical and surgical treatment, the safety and efficacy of local microinjection of autologous adipose tissue and SVF from microaspirate .

The main objective is to assess tolerance and security. The secondary objective is to evaluate the effectiveness of this technique

ReferenceCitation: Philandrianos C, Serrero M, Grimaud F, Magalon J, Visée C, Velier M, Francois P, Orsoni P, Magalon G, Grimaud JC, Desjeux A, Véran J, Sabatier F. First clinical case report of local microinjection of autologous fat and adipose-derived stromal vascular fraction for perianal fistula in Crohn's disease. Stem Cell Res Ther. 2018 Jan 10;9(1):4. doi: 10.1186/s13287-017-0736-6.

location_facility: Assistance Publique Hopitaux de Marseille


title: Non Invasive Measurements of Intracranial Pressure in Patients With Malignant Glioma

acronym: GMaPIC

summary:
In patients at risk of increased intracranial pressure (ICP), ICP measurements require invasive transducers, usually with insertion of a catheter into the cranium, or through a spinal tap. These invasive modalities involve risks and pain and they can be done only in specialized care units, with a high associated cost.

A novel method for detecting changes in ICP has developed recently. The auditory hair cells emit sounds and electric signals in response to sound, which can be easily detected and measured non-invasively with the help of a microphone probe placed in the external ear canal or regular electrodes. Indeed, the cochlear aqueduct connects the cerebrospinal fluid (CSF) spaces to the inner ear in such a way that ICP and inner-ear fluid pressure equalize within seconds.

A symptom of intracranial pressure (ICP) was observed in glioma patient due to a combination of causes: the inflammatory reaction around the tumor, the mass effect of the tumor, secondary vascular changes, a change in the flow of CSF.

The evaluation of intracranial hypertension by increased ICP (invasive) is not used in the monitoring of intracranial tumors. It is then detected by using routine clinical signs, in combination with a standard imaging method (MRI), but still subjective.

The measurement of noninvasive ICP could allow earlier detection of relapse, and evaluate whether the increase in ICP precedes tumor clinical worsening and / or imaging.

lead_sponsor: Centre Jean Perrin


title: Comparison of Corneal Stromal Tissue Consumption Values Estimated When Programming the Intervention Versus the Values Measured by Pre and Postoperative Topography

acronym: LATAC

summary:
In refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. The posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. A minimum thickness of more or less 300 microns is universally accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.

With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. The ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. The latter is currently the method of reference to assess the corneal thickness.


title: Atrial Fibrillation General Long Term Registry

acronym: AFGenLT

summary: Given the advances in Atrial Fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management was undertaken (as part of the ESC Euro Heart Survey programme), and a new registry was needed.

lead_sponsor: European Society of Cardiology


acronym: DYMCO

summary:
To understand the cardiovascular reactions of the human body to changing conditions of gravity is an important aim of space science. In this context, cardiac output (CO) is a key value to estimate the human cardiovascular system.

The main objective of this experiment is to determine the effects of parabolic flight on intravascular volume, and how these changes modulate the complex haemodynamics induced by the parabolas.


acronym: ITEMS

summary:
Multiple sclerosis (MS) is an inflammatory disease of the central nervous system responsible for physical disability but can also cause cognitive disturbances annoying social and professional life of patients with the disease. Various studies have shown that there was a breach of episodic memory, working memory, attention and executive functions regardless of the form of disease, disability or duration of disease progression.

The main objective of this study is to investigate the influence of emotional components and executive processes on the components retrograde and anterograde episodic memory (thanks to an original paradigm based on the emotional valence of the memory) in MS patients

location_facility: Department of Neurologie, Caen Hospital University

intervention_type: Behavioral


acronym: VITAD

summary: The vitamin D deficiency (25OHD) is very common and affects about 80% of the population of French osteoporotic women over 50 years [5]. It contributes significantly to bone fragility and consequently the risk of fracture. To remedy this deficit, it is necessary to provide a suitable and sustainable supplementation. Changes in vitamin D deficiency ranging from undetectable to a 25OHD value very close to 30ng / ml lead to differences in therapeutic regimens, specific to each clinician in the absence of precise data in the literature. No consensus on supplementation dosages and methods have been proposed so far. Also, given the frequency of vitamin D deficiency including osteoporosis observed in the population, it became necessary to establish a single, uniform regimen for all patients with osteoporosis


summary:
All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.


acronym: AUDIOSELF

summary:
The investigators objective is twofold. Investigators propose to study how the vestibular and auditory information interact in the construction of coherence between the staff and extrapersonal space.

Furthermore, investigators want to investigate whether, even in the absence of gravity, the auditory spatial information allocentric provide a framework for spatial reference.


title: A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LEO 90100 Aerosol Foam Compared to Betesil® Medicated Plaster in the Treatment of Psoriasis Vulgaris

lead_sponsor: LEO Pharma

ReferenceCitation: Queille-Roussel C, Rosen M, Clonier F, Nørremark K, Lacour JP. Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis. Clin Drug Investig. 2017 Apr;37(4):355-361. doi: 10.1007/s40261-016-0489-5.

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

summary: The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster


title: A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted Agents

acronym: MATCH-R

summary:
This is a prospective study to identify molecular mechanisms of acquired resistance to targeted therapies in patients with unresectable or metastatic cancer.

This is a protocol to study clinical characteristics and biopsy tissue of patients with oncogene-driven cancer who have had previous clinical response to targeted therapy and subsequently experience progression of disease. The tissues and other specimens will be used to carry out laboratory studies to explore the molecular basis of acquired resistance to targeted therapies.

ReferenceCitation: Martin-Romano P, Colmet-Daage L, Morel D, Baldini C, Verlingue L, Bahleda R, Gazzah A, Champiat S, Varga A, Michot JM, Ngo-Camus M, Nicotra C, Marabelle A, Soria JC, Rouleau E, Lacroix L, Hollebecque A, Massard C, Postel-Vinay S. Epigenetic gene alterations in metastatic solid tumours: results from the prospective precision medicine MOSCATO and MATCH-R trials. Eur J Cancer. 2022 Sep;173:133-145. doi: 10.1016/j.ejca.2022.06.014. Epub 2022 Jul 21.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Gustave Roussy Cancer Campus Grand Paris


acronym: O-Mel-Sora

summary:
The objective of the study is to determine the efficacy and toxicity of sorafenib in metastatic uveal melanoma.

The main objective is to determine the non-tumor progression rate 24 weeks after initiation of treatment with sorafenib at a dose of 800 mg / day


title: Prospective Clinical and Biologic Study of Secondary Cutaneous Effects in Targeted Cancer Therapies

acronym: SKINTARGET

summary: The aim of the study is to do a descriptive analysis of the cutaneous toxicity observed in patients treated using targeted therapies in order to have a better understanding of the skin pathophysiology.


acronym: POSTURGRAV

summary: The scientific goal of this experiment is to evaluate changes in balance control in response to microgravity during reactive balance tasks. For that purpose, kinematic and neuromuscular parameters under microgravity are compared to normal gravity conditions. To induce postural responses among the test subjects, an electromagnetic maneuverable postural platform will be used in order to randomly elicit perturbations. Postural reactions will be quantified by means of mechanical and electromyographic data. In Addition, peripheral nerve stimulation will be used to assess the spinal excitability by means of H-reflex recordings. H-reflex measurements were chosen as they allow reliable information about inhibitory and facilitatory mechanisms taking place at the spinal level.


acronym: BrainDTI

summary:
Weightlessness profoundly modifies many physiological systems and especially the nervous system and the vestibular system. The changes in the nervous system are based in part on brain plasticity mechanisms, that is to say on modifications of neurons and their connections. They are the source of some of the behavioral response observed in the parabolic flight or in astronauts. For example, it is commonly observed that in the second and third days of parabolic flight campaigns with 3 flights, fewer participants are prone to motion sickness during the first day. Similarly, during their first trip into space, astronauts suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness - while this proportion is much lower in the second trip.

The hypothesis of this study is that short-term weightlessness as well as changes in the level of gravity experienced during parabolic flights, induce neuroplascity phenomena in brain regions involved in the integration of vestibular, visual and proprioceptive.

The goal is to objectify these plasticity phenomena, and assess their changes over time, using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging - DTI) will visualize nerve bundles and their journey in the brain. The total duration of this review will be about ¾ hour.

The results of this study will be compared with those of an ongoing study of 12 astronauts who have the same MRI scans taken before and after a trip to the International Space Station. Investigators can then evaluate the effect of duration of exposure to weightlessness on the phenomena of neuroplasticity.


summary:
From previous parabolic flight campaigns completed by our research group investigators gathered data showing important changes in neuro-endocrine and also immunological changes. This experiment now will complete the data set-up obtained during the MARS500 study on how these respective individuals will re-act to highly physically and emotionally challenging situations during a parabolic flight.

This add-on experiment to MARS500 will enable answering to the following questions i) if the stress response systems - when compared for two conditions but in the same individuals - do react uniformly and ii) if those subjects prone to have adequate stress response pattern will show gradually less immune modulation effects.

The understanding of the complex interactions of stress and immunity under chronic and acute stress conditions might help to enable adequate health and immune monitoring and might as well suggest suitable countermeasures for the prevention of the unwanted immunological effects during long-term confinement and space missions.


acronym: AUTOCARD

summary:
As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.

Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.


acronym: VITADCOG

summary:
Every year, nearly 30% of people aged over 65 fall at least once and about 15% fall at least twice. These falls can have serious consequences that are a significant threat to the independence and well-being of older people. From an economic perspective, the cost of medical care related to falls and resulting injuries is very high and continue to grow with the aging of the population. Therefore falls prevention is a public health priority.

Many data suggest that cognitive, common disorders in the elderly, is a major risk factor for falls and the elderly often have difficulty managing their parallel postural stability and other situations requiring attentional resources. Furthermore, the data used to evoke a role of vitamin D in the risk of falls in the elderly. Indeed, vitamin D has beneficial effects on muscle and on the human brain and several recent studies have shown the existence of positive relationship between serum 25 hydroxyvitamin D and cognitive function. These different actions may explain the beneficial effect of vitamin D supplementation on the risk of falling for practicing daily oral doses of vitamin D in the range of 700-1000 IU.

Our goal in this study is to confirm the existence of a link between vitamin D status and some areas of cognitive functions, and analyze the roles played by vitamin D deficiency and cognitive impairment in the occurrence of falls. The study will also seek the existence of a threshold level of 25-hydroxyvitamin D below which may arise cognitive disorders. The prospective follow-up of patients for 2 years will study the effect of correcting the vitamin D deficiency (initial correction and regular supplementation) on cognitive function, balance, walking and the occurrence of falls.

The study will be conducted in 150 subjects aged 50 years and over and fell in 150 subjects aged 50 and over at risk of falling. These patients will be enrolled in the Emergency Services, Orthopedics, Geriatrics, and Rheumatology of the University Hospital of Caen. All subjects will receive a dose of 25 hydroxyvitamin D, a comprehensive study of cognitive function, tests of balance and walking and assessment of activities of daily living and depression. All the examinations and tests will be carried out during the same half day. According to current recommendations, it will be prescribed a treatment with Vitamin D to subjects with a lowered rate of 25 hydroxyvitamin D (<30 ng / ml) to normalize the rate and will be advised doctors to prescribe regular supplementation vitamin D in order to maintain it in the standard rate (30 to 80 ng / ml). The effect of the correction of hypovitaminosis D, confirmed by controlling the rate of 25 hydroxyvitamin D, on cognitive functions, balance and walking will be analyzed 3 months and 9 months. During the two years following their inclusion in the study, subjects will be contacted by a phone call every 3 months during which will be recorded any falls they have been victims, as well as changes to their drug treatments, particularly case of regular intake of vitamin D supplementation.

If our hypothesis were true, it would be appropriate to consider a new approach to prevention of fractures involving the correction of vitamin D deficiency, cognitive rehabilitation and cognitive-motor drive in subjects with cognitive impairment.


acronym: DROITDEVANT

summary: The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.


title: Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

acronym: TORS

summary: Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. The da Vinci device had the FDA approval and the CE mark in 2009 for transoral surgery of head and neck cancers, using previous generations of da Vinci. The last generation da Vinci Xi has received the FDA approval for laparoscopic surgery in april 2014 and the CE mark in june 2014 but has not been evaluated yet in transoral surgery. The objective of our study is therefore to study the feasibility of this transoral robotic surgery for head and neck cancers, using the da Vinci Xi.


summary:
3-D Ballistocardiography (BCG) recording was performed in microgravity during the Spacelab D2 missions on a single astronaut. The results from this experiment have been published in the literature: the influence of respiration have been demonstrated and the signal processing methodology for the reconstruction of the displacement in one cardiac cycle have been developed. A 3D-BCG sensor has been developed and a collaboration to perform a sustained microgravity experiment onboard the Russian segment of ISS has been initiated. To be integrated in the PNEUMOCARD device, this new sensor needs to be tested in microgravity before implemented on ISS.

The aim of the present parabolic flight study is to serve as a feasibility demonstrator and test bed in order to evaluate the feasibility of 3D-BCG in sustained microgravity and to test whether the sensitivity of the developed 3D-BCG sensor is appropriate


title: Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer

acronym: FIBROP

summary:
Merge the data of ultrasound with that of the anatomical and functional MRI is necessary since the high dose rate Curietherapy is carried out under ultrasound guidance. The investigators will recruit prostate cancer patients to evaluate the quality of the data, their sensitivity to exam conditions (patient position, volume of endorectal probe, gold grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from different sources with the purpose of estimating the opportunities of integration treatment plan for Curietherapy broadband.

The nuclear magnetic resonance imaging provides precise anatomical study, but also provides access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context, involving close collaboration between clinicians, medical physicists, and physicists of the teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).


acronym: CORTICOG

summary:
Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. However, the studies on this subject during space missions short or long term could not determine how these cognitive dysfunction resulted from a direct effect of weightlessness or a stress-related effect.

Analysis of electro-encephalography (EEG) using a standardized mapping method is used to study the changes of operation of the cerebral cortex as the near infrared spectroscopy (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a relatively simple and economical method for studying brain changes in an environment where the normal brain imaging techniques can not be used.

The main objective of this experiment is to evaluate the alterations in brain cortical activity and brain oxygenation level induced by micro- and hypergravity conditions.


title: A Phase I Trial Assessing Adalimumab (Humira®), a Tumor Necrosis Factor α Inhibitor Combined to Chemotherapy and Radiotherapy in Patients With Anaplastic Thyroid Cancers

acronym: TAM-RT

summary: The hypothesis is that the particular richness of ATC's microenvironment in TAMs creates a unique opportunity for using Tumor Necrosis Factor blockade during chemotherapy and radiotherapy in order to counteract tumor resistance to therapy.


title: Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis: a Prospective Non-Interventional Approach Across Europe (NISSC) for the Autoimmune Diseases Working Party of the EBMT

acronym: NISSC

summary: The purpose of this study is to assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study protocols used across Europe in various EBMT centres through the careful recording and analysis of routinely collected clinical and biological data.

ReferenceCitation: Henes J, Oliveira MC, Labopin M, Badoglio M, Scherer HU, Del Papa N, Daikeler T, Schmalzing M, Schroers R, Martin T, Pugnet G, Simoes B, Michonneau D, Marijt EWA, Lioure B, Olivier Bay J, Snowden JA, Rovira M, Huynh A, Onida F, Kanz L, Marjanovic Z, Farge D. Autologous stem cell transplantation for progressive systemic sclerosis: a prospective non-interventional study from the European Society for Blood and Marrow Transplantation Autoimmune Disease Working Party. Haematologica. 2021 Feb 1;106(2):375-383. doi: 10.3324/haematol.2019.230128.


acronym: ADRECARD

summary:
Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.

The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.


title: Stimulus-response Associations in Parkinson's Disease Patients

acronym: SRlearning

summary:
In a computerized experiment, visual stimuli will be presented to the parkinson's disease patients and to the controls. They will respond to each image by acting on the keyboard in a specific manner. Each participant will repeat that task 384 times per session. A break will be inserted every 12 tests so that participants can rest.

The experiment consists of three sessions. Each image will be presented three times. For the first two presentations it is assumed that a link will be created between the image and the task, and the image and action. In the third presentation, the same task and the same action will be maintained or will be swapped. In this way, It can be checked whether associations thus generated will affect the performance of the participants when tasks and actions will be incongruent.

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Preliminary Study of the Interest of Diffusion-weighted Magnetic Resonance Imaging in the Early Detection of Differentiated Thyroid Carcinoma Cervical Recurrence. Comparison with18F-FDG PET/CT

acronym: THYRIRMTEP

summary: The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.

lead_sponsor: Centre Henri Becquerel


title: Role of a Simple Mechanical Device of Pressure Control in the Balloon of the Endotracheal Tube to Prevent Ventilator-acquired Pneumonia

acronym: PAV-PROTECT

summary:
Hypothesis: Nosten® device is able to reduce the time of underinflated balloon and removes excess pressure. This device may thus reduce the risk of ventilator-acquired pneumonia (VAP) and early tracheal lesions resulting from intubation with decreased discomfort, morbidity, and nursing workload.

The main objective of the investigators is to show that Nosten® device is more effective than monitoring and manual inflation of the balloon of the tracheal tube to prevent VAP occurrence.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Réanimation Médical et Toxicologique


title: Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome

acronym: ECHOCARPE

summary: The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.


title: Penetration and Compartimentation of HIV in Genital Mucosa

summary: Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial cells, Langerhans cells) and antibodies may also play a critical role. The investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Molecular Imaging of Inflammation With 18F-PBR06 to Identify Unstable Carotid Plaques in Patients With Stroke

acronym: PLAQINSTEP

summary: Evaluating an innovative molecular imaging technique to visualize inflammation of the atherosclerotic plaque in patients with a recent ischemic stroke (<15 days) with carotid stenosis> 50%, by performing a Positron emission tomography-computed tomography (PET-CT) with PBR06 18F, a tracer for Translocator protein (TPSO).

ReferenceCitation: Schollhammer R, Lepreux S, Barthe N, Vimont D, Rullier A, Sibon I, Berard X, Zhang A, Kimura Y, Fujita M, Innis RB, Zanotti-Fregonara P, Morgat C. In vitro and pilot in vivo imaging of 18 kDa translocator protein (TSPO) in inflammatory vascular disease. EJNMMI Res. 2021 May 5;11(1):45. doi: 10.1186/s13550-021-00786-7.

lead_sponsor: University Hospital, Bordeaux


title: A Phase-1, Open-label, Two Group, Fixed-Sequence Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers

summary: This is an open-label, two-group, fixed-sequence study to evaluate the effect of ACH-3102 and Simeprevir on AL-335 pharmacokinetics in healthy volunteers.

ReferenceCitation: Valade E, Valenzuela B, Kakuda TN, Westland C, McClure MW, Ouwerkerk-Mahadevan S, Perez-Ruixo JJ, Ackaert O. Characterizing the Pharmacokinetic Interaction Between Simeprevir and Odalasvir in Healthy Volunteers Using a Population Modeling Approach. AAPS J. 2018 Oct 22;20(6):111. doi: 10.1208/s12248-018-0271-0.

ReferenceCitation: Kakuda TN, McClure MW, Westland C, Vuong J, Homery MC, Poizat G, Viguerie L, Denot C, Patat A, Zhang Q, Hui J, Apelian D, Smith DB, Chanda SM, Fry J. Pharmacokinetics, safety, and tolerability of the 2- and 3-direct-acting antiviral combination of AL-335, odalasvir, and simeprevir in healthy subjects. Pharmacol Res Perspect. 2018 Apr 30;6(3):e00395. doi: 10.1002/prp2.395. eCollection 2018 Jun.

lead_sponsor: Alios Biopharma Inc.


title: Prospective Follow-up Study of Patients Undergoing Knee Ligament Surgery

acronym: FAST

summary: In this study we will examine patients who have undergone anterior cruciate and/or posterior cruciate ligament and/or multi ligaments reconstruction to determine the rate of re-injury, contralateral tear and functional outcomes at least two years after surgery.

ReferenceCitation: Lefevre N, Klouche S, de Pamphilis O, Devaux C, Herman S, Bohu Y. Postoperative discomfort after outpatient anterior cruciate ligament reconstruction: a prospective comparative study. Orthop Traumatol Surg Res. 2015 Apr;101(2):163-6. doi: 10.1016/j.otsr.2014.07.036. Epub 2015 Feb 7.

ReferenceCitation: Lefevre N, Bohu Y, de Pamphilis O, Klouche S, Devaux C, Herman S. Outpatient surgery feasibility in anterior cruciate ligament reconstruction: a prospective comparative assessment. Orthop Traumatol Surg Res. 2014 Sep;100(5):521-6. doi: 10.1016/j.otsr.2014.03.024. Epub 2014 Jul 28.

ReferenceCitation: Bohu Y, Klouche S, Lefevre N, Webster K, Herman S. Translation, cross-cultural adaptation and validation of the French version of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1192-6. doi: 10.1007/s00167-014-2942-4. Epub 2014 Mar 28.

ReferenceCitation: Lefevre N, Naouri JF, Bohu Y, Klouche S, Herman S. Sensitivity and specificity of bell-hammer tear as an indirect sign of partial anterior cruciate ligament rupture on magnetic resonance imaging. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1112-8. doi: 10.1007/s00167-013-2511-2. Epub 2013 Apr 21.

ReferenceCitation: Lefevre N, Bohu Y, Naouri JF, Klouche S, Herman S. Validity of GNRB® arthrometer compared to Telos™ in the assessment of partial anterior cruciate ligament tears. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):285-90. doi: 10.1007/s00167-013-2384-4. Epub 2013 Jan 22.

ReferenceCitation: Sadeqi M, Klouche S, Bohu Y, Herman S, Lefevre N, Gerometta A. Progression of the Psychological ACL-RSI Score and Return to Sport After Anterior Cruciate Ligament Reconstruction: A Prospective 2-Year Follow-up Study From the French Prospective Anterior Cruciate Ligament Reconstruction Cohort Study (FAST). Orthop J Sports Med. 2018 Dec 17;6(12):2325967118812819. doi: 10.1177/2325967118812819. eCollection 2018 Dec.

ReferenceCitation: Bohu Y, Klouche S, Herman S, de Pamphilis O, Gerometta A, Lefevre N. Professional Athletes Are Not at a Higher Risk of Infections After Anterior Cruciate Ligament Reconstruction: Incidence of Septic Arthritis, Additional Costs, and Clinical Outcomes From the French Prospective Anterior Cruciate Ligament Study (FAST) Cohort. Am J Sports Med. 2019 Jan;47(1):104-111. doi: 10.1177/0363546518810527. Epub 2018 Nov 27.

ReferenceCitation: Raoul T, Klouche S, Guerrier B, El-Hariri B, Herman S, Gerometta A, Lefevre N, Bohu Y. Are athletes able to resume sport at six-month mean follow-up after anterior cruciate ligament reconstruction? Prospective functional and psychological assessment from the French Anterior Cruciate Ligament Study (FAST) cohort. Knee. 2019 Jan;26(1):155-164. doi: 10.1016/j.knee.2018.11.006. Epub 2018 Nov 22.

ReferenceCitation: Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.

ReferenceCitation: Lefevre N, Klouche S, Mirouse G, Herman S, Gerometta A, Bohu Y. Return to Sport After Primary and Revision Anterior Cruciate Ligament Reconstruction: A Prospective Comparative Study of 552 Patients From the FAST Cohort. Am J Sports Med. 2017 Jan;45(1):34-41. doi: 10.1177/0363546516660075. Epub 2016 Aug 20.

ReferenceCitation: Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Traumatol Arthrosc. 2020 Aug;28(8):2578-2585. doi: 10.1007/s00167-020-05879-9. Epub 2020 Feb 5. Erratum in: Knee Surg Sports Traumatol Arthrosc. 2020 Mar 6;:.

lead_sponsor: Fonds de Dotation pour la Recherche Clinique en Orthopédie et Pathologie du Sport

location_facility: Centre Médico-Chirurgical Paris V (CMCV)