title: Stress and Emotional Memory : Functional Neuroanatomy of Post-traumatic Stress Disorder in Adolescents

acronym: SEME

summary:
A broad group of disorders is associated with severe stress existence in children or adolescents. The most characteristic result, and one of the most serious being the state of post-traumatic stress disorder (PTSD), whose main source consists of physical or sexual violence, and to a lesser extent, accidents public road or natural disaster, whose child was the subject or witness. PTSD is associated with a deleterious effect on cognition and including the mnemonic operation. The painful reminder of the traumatic event is one of the most disabling symptoms. However, there are many other memory disorders that experimental studies gradually update. They maintain a close link with emotional regulation that disturbed you know if PTSD. However the majority of studies on emotion and cognition and their relationship with brain activity took adult subject. Work in adolescents are few on the morphological study, on rare neurobehavioral and reduced to two studies of functional neuroimaging. Contrary to what is observed in adults, morphological studies report consistently, no reduction in hippocampal volume. There is no study in the idle state. Two studies in functional MRI, the first highlighted in PTSD patients inhibition of the activity of the anterior cingulate cortex (ACC) to stimuli such as to evoke the trauma, a second reported increased activity in the prefrontal cortex Median (mPFC) in a inhibition. The objective task of our study is to evaluate the impact of psychological trauma on brain structures involved in the emotional component of the memory (amygdala, hippocampus, prefrontal cortex in particular). For this, the investigators will take in 33 adolescents, including patients with posttraumatic symptomatology and matched controls free of trauma age, several neuroimaging exams, anatomical and functional. The functional review will include some rest and another in activation during episodic memory task designed to assess the influence of self-perception on memory impairment observed in patients. The investigators will check, for each group of patients and controls, the involvement of cortical structures in relation to the regulation of emotional memory (CCA, amygdala and hippocampus). The anatomy of the hippocampus benefit specific imaging methods developed in the unit INSERM U923. Endocrine correlates of stress tests will be studied by a fully-traumatic by salivary cortisol sampling.

This research will clarify the mechanisms involved in emotional and memory impairments secondary to psychological trauma, their relationship with self (judgment and self-esteem) and studying their morphological substrates. A longer-term goal is to offer help in the diagnosis and monitoring of young patients with posttraumatic symptomatology.


acronym: D-TEP

summary:
Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.

The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.

status: Unknown status

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


acronym: FAST DOGS

summary:
The prognosis of patients with heart failure has improved due to recent breakthrough in medical treatment and cardiac resynchronization devices. However, there is no paraclinical parameter to assess response to cardiac resynchronization therapy (CRT). This is a major issue since about a third of implanted patients will not be improved by CRT. CZT SPECT allows to perform myocardial perfusion imaging in less than 4 minutes and is able to study myocardial perfusion, viability, left ventricular function, but also ventricular asynchrony.

Using low-dose dobutamine gated SPECT and CZT camera, we aimed to assess left ventricular dyssynchrony in viable segments in patients with heart failure eligible for CRT.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

location_facility: Service de Médecine Nucléaire du CHU de Caen

status_simplified: Completed


acronym: ELECTRODIAB

summary:
Type 2 diabetes is a major public health problem because of its increasing prevalence and morbidity and mortality that accompanies it. Therapeutic management of this pathology, lifestyle measures, dietary and physical activity are fundamental. Their observance is unfortunately too often insufficient, leading to a therapeutic climbing with first oral antidiabetic (OAD) then the use of insulin therapy.

Yet there is now ample evidence that physical activity improves glucose control in these patients in particular improving insulin sensitivity after a training period but also after a single session of physical activity.

Neuro-myo-electrical stimulation (NMES) is used in common clinical practice in physical therapy, patients with neurological or after orthopedic surgery in particular. In fact, this method enables improvement of volume and strength, even for denervated muscles. Recent studies have also shown the benefits of NMES in situations of cardiac or respiratory readjustments. In addition, NMES is used by top athletes supplements classical training in order to develop muscle strength or speed recovery.

Investigators propose to test the impact of bilateral quadriceps NMES on insulin sensitivity in type 2 diabetic patients treated with OAD (excluding glitazone). To do this, investigators plan to assess their insulin sensitivity by the reference method of hyperinsulinemic euglycemic clamp before surgery, after a single session of bilateral quadriceps NMES and after a sequence of daily training 6 days a quadriceps NMES bilateral.

Investigators hope to show an improvement in insulin sensitivity by this method, which would constitute an alternative to physical activity in the treatment of diabetes type 2. This procedure would be particularly interesting in diabetic subjects with type 2 counter- indications or an inability to perform a conventional physical activity.

primary_purpose: Treatment

location_facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen


title: Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients

acronym: PERVE-ARDS

summary: The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Godet T, Jabaudon M, Blondonnet R, Tremblay A, Audard J, Rieu B, Pereira B, Garcier JM, Futier E, Constantin JM. High frequency percussive ventilation increases alveolar recruitment in early acute respiratory distress syndrome: an experimental, physiological and CT scan study. Crit Care. 2018 Jan 11;22(1):3. doi: 10.1186/s13054-017-1924-6.

family: Godet

full_name: Thomas Godet

given: Thomas

sequence: first

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

sequence: additional

family: Blondonnet

full_name: Raïko Blondonnet

given: Raïko

family: Tremblay

full_name: Aymeric Tremblay

given: Aymeric

family: Audard

full_name: Jules Audard

given: Jules

family: Rieu

full_name: Benjamin Rieu

given: Benjamin

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Garcier

full_name: Jean-Marc Garcier

given: Jean-Marc

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature


title: Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer

summary: This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Ginzac A, Thivat É, Mouret-Reynier MA, Dubray-Longeras P, Van Praagh I, Passildas J, Abrial C, Kwiatkowski F, Boirie Y, Duclos M, Morio B, Gadea É, Durando X. Weight Evolution During Endocrine Therapy for Breast Cancer in Postmenopausal Patients: Effect of Initial Fat Mass Percentage and Previous Adjuvant Treatments. Clin Breast Cancer. 2018 Oct;18(5):e1093-e1102. doi: 10.1016/j.clbc.2018.06.010. Epub 2018 Jun 18.

family: Ginzac

full_name: Angeline Ginzac

given: Angeline

family: Thivat

full_name: Émilie Thivat

given: Émilie

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Dubray-Longeras

full_name: Pascale Dubray-Longeras

given: Pascale

family: Van Praagh

full_name: Isabelle Van Praagh

given: Isabelle

family: Passildas

full_name: Judith Passildas

given: Judith

family: Abrial

full_name: Catherine Abrial

given: Catherine

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Boirie

full_name: Yves Boirie

given: Yves

family: Duclos

full_name: Martine Duclos

given: Martine

family: Morio

full_name: Béatrice Morio

given: Béatrice

family: Gadea

full_name: Émilie Gadea

family: Durando

full_name: Xavier Durando

given: Xavier

journal_name: Clinical Breast Cancer

oa_host_type: repository

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

version: submittedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Jean Perrin

lead_sponsor_type: industriel


type: Other Identifier

title: Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study

summary:
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:

A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
Consumables necessary for the implementation of the dressing,
Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.

This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.

status: Terminated

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Device


title: Pilot Study: Measure of the Potential Evoked With Electroencephalography and Electrocorticography by Electric Stimulation of the Brain During the Neurosurgery Awakened of the Infiltrative Glioma of Low Grade (OMS Type II)

acronym: PE&CE

summary:
This study is about an experimental biomedical monocentric search concerning twelves patients presenting a infiltrative glioma of low rank OMS type II and realizing a surgery awakened on the site of the CHU of Montpellier.

The objective of this search is to understand exactly how the electric impulses, delivered by the neurosurgeon to make a functional mapping of the brain during the surgery awakened by tumors infiltrates of low rank, propagate in this one and to identify the nervous networks inhibited by these electric impulses.

Having verified the eligibility of the patients and having obtained their consent, they will be included in the study. Before the beginning of the surgery, the electroencephalography activity of the brain of every patient will be recorded. Before and after the surgical resection, the electrocorticography activity will be recorded.

The collected data will then be analyzed, after the operation. Analyses will try to identify what we call potential evoked by the stimulation and which are small electric waves which appear after the electric stimulation was delivered.

study_start_date_type: Actual

status: Active, not recruiting

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Berger MS, Rostomily RC. Low grade gliomas: functional mapping resection strategies, extent of resection, and outcome. J Neurooncol. 1997 Aug;34(1):85-101. Review.

ReferenceCitation: Borchers S, Himmelbach M, Logothetis N, Karnath HO. Direct electrical stimulation of human cortex - the gold standard for mapping brain functions? Nat Rev Neurosci. 2011 Nov 30;13(1):63-70. doi: 10.1038/nrn3140. Review.

ReferenceCitation: DeAngelis LM. Brain tumors. N Engl J Med. 2001 Jan 11;344(2):114-23. Review.

ReferenceCitation: Duffau H. Lessons from brain mapping in surgery for low-grade glioma: insights into associations between tumour and brain plasticity. Lancet Neurol. 2005 Aug;4(8):476-86. Review.

ReferenceCitation: Duffau H, Capelle L, Sichez N, Denvil D, Lopes M, Sichez JP, Bitar A, Fohanno D. Intraoperative mapping of the subcortical language pathways using direct stimulations. An anatomo-functional study. Brain. 2002 Jan;125(Pt 1):199-214.

ReferenceCitation: Duffau H, Lopes M, Arthuis F, Bitar A, Sichez JP, Van Effenterre R, Capelle L. Contribution of intraoperative electrical stimulations in surgery of low grade gliomas: a comparative study between two series without (1985-96) and with (1996-2003) functional mapping in the same institution. J Neurol Neurosurg Psychiatry. 2005 Jun;76(6):845-51. Review.

ReferenceCitation: Duffau H, Sichez JP, Lehéricy S. Intraoperative unmasking of brain redundant motor sites during resection of a precentral angioma: evidence using direct cortical stimulation. Ann Neurol. 2000 Jan;47(1):132-5.

ReferenceCitation: Keles GE, Lundin DA, Lamborn KR, Chang EF, Ojemann G, Berger MS. Intraoperative subcortical stimulation mapping for hemispherical perirolandic gliomas located within or adjacent to the descending motor pathways: evaluation of morbidity and assessment of functional outcome in 294 patients. J Neurosurg. 2004 Mar;100(3):369-75.

ReferenceCitation: Keller CJ, Honey CJ, Mégevand P, Entz L, Ulbert I, Mehta AD. Mapping human brain networks with cortico-cortical evoked potentials. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653). pii: 20130528. doi: 10.1098/rstb.2013.0528.

ReferenceCitation: Matsumoto R, Nair DR, LaPresto E, Bingaman W, Shibasaki H, Lüders HO. Functional connectivity in human cortical motor system: a cortico-cortical evoked potential study. Brain. 2007 Jan;130(Pt 1):181-97. Epub 2006 Oct 17.

ReferenceCitation: Matsumoto R, Nair DR, LaPresto E, Najm I, Bingaman W, Shibasaki H, Lüders HO. Functional connectivity in the human language system: a cortico-cortical evoked potential study. Brain. 2004 Oct;127(Pt 10):2316-30. Epub 2004 Jul 21.

ReferenceCitation: Szelényi A, Bello L, Duffau H, Fava E, Feigl GC, Galanda M, Neuloh G, Signorelli F, Sala F; Workgroup for Intraoperative Management in Low-Grade Glioma Surgery within the European Low-Grade Glioma Network. Intraoperative electrical stimulation in awake craniotomy: methodological aspects of current practice. Neurosurg Focus. 2010 Feb;28(2):E7. doi: 10.3171/2009.12.FOCUS09237. Review.

ReferenceCitation: Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. Review.

ReferenceCitation: Walker DG, Kaye AH. Low grade glial neoplasms. J Clin Neurosci. 2003 Jan;10(1):1-13. Review.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU de Montpellier - Service de neurochirurgie

intervention_type: Procedure

status_simplified: Ongoing


title: Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk

summary: Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.

location_facility: Department of Anesthesiology and critical care, Lapeyronie University Hospital


title: Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia

acronym: MONOCONTACT

summary: The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.


title: Double Upper Limb Allograft: Intervention and Clinical Evaluation. A Pilot Study of 5 Cases

acronym: DAMIE

summary:
The case of patients with amputation of forearm on one side and arm on the other is particularly interesting to study because in this situation of handicap greater than a double amputation in forearm. We should bring a functional benefit to the patient with the transplant of forearm and this situation allows to have the best possible control to compare the result of the transplant of arm to that of forearm because it is realized at the same patient.

Amputation of both arms deprives patients of an elbow what establishes a major factor of limitation of autonomy and makes patients totally dependent for the realization of the essential gestures of the current life requiring the prehension (dress, dressing, food, hygiene of the elimination). The various equipments are not always adaptable and usable. Psychologically, an amputation in arm is unanimously considered as an infringement very badly accepted of the physical integrity and establishes a major handicap factor of family, professional and social exclusion.

The results of this study should allow a better appreciation of indications and modalities of care of biamputed patients with at least one lesion level above the elbow.

This clinical research will determine the potential place of a reconstructive surgery as allograft in biamputed patients on the basis of functional results and assessment of disorders of the body schema perception.

status: Recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Service d'Urologie et Chirurgie de la Transplantation


acronym: ORB

summary:
There are no equivalent experiment setups to create comparable changes of gravitation such as during parabolic flights. To determine the initial orthostatic responses of the cardiovascular system under the gravitational conditions of mars and moon is an essential step for a better understanding of 1) the fundamental functions of the human cardiovascular system (basic research) 2) specific impact of partial-g on the human heart, lungs and vessels in a spaceflight-context 3) approaches for countermeasure development against orthostatic intolerance on moon and mars (applied research).

Non-invasive measurement methods will be used to achieve the cardiovascular key values of the study: stroke volume (SV) and cardiac output determination by pulse contour analysis, impedance cardiography and inert gas rebreathing, beat-to-beat finger blood pressure measurement, heart rate and heart rate variability determination by ECG. All of these methods have proven their accuracy during parabolic flights. Nevertheless pulse contour analysis and impedance cardiography are known to provide only relative SV and CO values. Thus inert gas rebreathing gives us the possibility to calibrate these stroke volumes and cardiac outputs to absolute values. Success of this procedure was shown during former parabolic flights.


acronym: DIRECT

summary:
Cardiac exploration almost systematically requires the acquisition and / or calculating function indices. The ejection fraction (LVEF) is probably based index most widely used in all cardiac exploration methods. This relatively universal overall index has very many qualities. LVEF is widely used in clinical practice through the exploration and monitoring of all heart disease.

Current progress in the management of various cardiomyopathies pass through the detection of early attacks. This testing often takes place upstream changes in LVEF that remains long normal or normalized. Sensitive indicators capable of detecting early abnormalities of regional functions are essential in addition to conventional echocardiography. Various studies have shown the contribution of these new markers in early detection of abnormalities of the cardiac function. The most widely used indicator in these studies because of its high sensitivity to analyze the movements of the heart is the tissue Doppler. Tissue Doppler however has limitations in particular its dependence on the incident angle, which makes it impossible to correct analysis of non-aligned in the axis of the ultrasonic beam components.

A new way of exploring the regional function of the heart, speckle tracking, can analyze heart deformations along the principal axes of the heart. The advantage of this technique has been shown in various pathological situations. Currently, this technique is mostly used in longitudinal and transverse view 2D imposing multiple planes cuts. 3D potential of this technique is not currently known, acquisition of 3D technology is recent (2004) and dedicated software is confidential dissemination and unvalidated.

The validated technique, 3D reference analysis of myocardial deformation is tagged MRI. In the 90s, studies have demonstrated the feasibility of this technique, the ability to access all of the myocardial deformation in space and to define normal values. The cost of the procedure, duration, limited accessibility and post-processing very time consuming limited the scope of the clinical benefits of this modality.

Echocardiography has major advantages over MRI, particularly its high availability, low cost and flexibility of use. The ability to access with MRI as the 3D deformation of the heart is a new opportunity that it is essential to validate.

The main purpose of the study is to compare the strain values obtained 3D ultrasound to those obtained by MRI tagged in a control group and a group of subjects with an anterior infarction sequela.


acronym: HopMot

summary:
Previous studies have neglected two important aspects for the China National Space Administration. First, while biomechanical models are very sensitive to the characteristics of the subjects, data have been collected on subjects with biomechanical characteristics very different from those of "typical" Chinese astronauts. Second, pure video analysis techniques and kinematic data lack the necessary acceleration information important to understanding the forces exerted during movement and control of human motion. While some studies used force and moment sensors to aid in robot torque control and human joint work estimation, investigators are unaware of any studies performed in a microgravity environment that have combined the kinetic force and moment information with acceleration measurements to enable more reliable motion tracking without the need for acceleration estimation.

This is why MICR0-G sensors and accompanying kinematic video system have been developed in order to provide for detailed analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques permits us to calculate the joint and musculoskeletal dynamics required to execute the microgravity motions, as well to provide insight into the altered movement strategies in reduced gravity as compared to 1-G locomotion.


acronym: Blindpulling

summary:
Parabolic flight is the only ground-based condition in which weightlessness (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

Cognitive function, together with good oculomotor control, eye-hand coordination, and spatial orientation perception, is a critical subsystem that is used by the CNS in the control of vehicles and other complex systems in a high-level integrative function. Evidence from space flight research demonstrates that the function of each of these subsystems is altered by the transitions in gravito-inertial force levels. These neuro-vestibular alterations, unfortunately, correspond to mission phases where physical and cognitive performance are particularly critical for crew safety and mission success. To date, there is only limited operational evidence that these alterations cause functional impacts on mission-critical vehicle (or complex system) control capabilities. However, the true operational risks will be estimable only after the investigators have filled the knowledge gaps and when the investigators can accurately assess integrated performance in off-nominal operational settings.

Accurate perception of self-in-space motion and self-motion relative to other objects are critical to piloting, driving, and remote manipulator operations. Immediately after space flight, most crewmembers have reported some degree of disorientation/perceptual illusion, often accompanied by nausea (or other symptoms of motion sickness), and frequently manifested by lack of coordination, particularly during locomotion. Despite recent, intensive training, some Shuttle landings were outside of the desired performance boundaries. Scores indicating neurovestibular dysfunction in returning astronauts generally correlated with poorer flying performances, including a lower approach and landing shorter, faster, and harder. An underestimation of distance, coupled to an overestimation of tilt magnitude or misperception of the type of motion, could be at the origin of these poorer performances.

This study should confirm that the unloading of the otoliths in weightlessness induces an alteration in the egocentric reference during space flight. Errors in egocentric localization might contribute at a higher level to the computation of misleading world-centered representations, and therefore be partly responsible for illusory sensations and motion sickness symptoms during space flight, and postural instability and oscillopsia after returning in a reduced or terrestrial gravitational force level.

Beside their fundamental implications, the results of this study have also practical implications in the design of man-machine interfaces. Changes in judgment of distance in microgravity or in reduced gravity affect crew posture and reach, display orientation, and other visual cues, which should be considered in hardware and operations design.


title: Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF Agents in the Management of Patients With Inflammatory Bowel Disease Treated With Anti-TNFalpha Biotherapy.

acronym: ATAIM

summary: Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

primary_purpose: Other

ReferenceCitation: Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8.

ReferenceCitation: Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, Dijkmans BA, Tak PP, Wolbink GJ. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007 Jul;66(7):921-6. Epub 2007 Feb 14.

ReferenceCitation: de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A, Nurmohamed MT, Dijkmans BA, Aarden LA, Wolbink GJ. Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis. 2009 Nov;68(11):1787-8. doi: 10.1136/ard.2009.109702.

ReferenceCitation: Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB, Bos JD, Wolbink GJ. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol. 2010 Feb;146(2):127-32. doi: 10.1001/archdermatol.2009.347.

ReferenceCitation: Ben-Horin S, Yavzori M, Katz L, Kopylov U, Picard O, Fudim E, Coscas D, Bar-Meir S, Goldstein I, Chowers Y. The immunogenic part of infliximab is the F(ab')2, but measuring antibodies to the intact infliximab molecule is more clinically useful. Gut. 2011 Jan;60(1):41-8. doi: 10.1136/gut.2009.201533. Epub 2010 Jun 2.

ReferenceCitation: Karmiris K, Paintaud G, Noman M, Magdelaine-Beuzelin C, Ferrante M, Degenne D, Claes K, Coopman T, Van Schuerbeek N, Van Assche G, Vermeire S, Rutgeerts P. Influence of trough serum levels and immunogenicity on long-term outcome of adalimumab therapy in Crohn's disease. Gastroenterology. 2009 Nov;137(5):1628-40. doi: 10.1053/j.gastro.2009.07.062. Epub 2009 Aug 5.

ReferenceCitation: Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013 Jan;108(1):40-7; quiz 48. doi: 10.1038/ajg.2012.363. Epub 2012 Nov 13. Review.

ReferenceCitation: Vande Casteele N, Gils A, Singh S, Ohrmund L, Hauenstein S, Rutgeerts P, Vermeire S. Antibody response to infliximab and its impact on pharmacokinetics can be transient. Am J Gastroenterol. 2013 Jun;108(6):962-71. doi: 10.1038/ajg.2013.12. Epub 2013 Feb 19.

ReferenceCitation: Steenholdt C, Svenson M, Bendtzen K, Thomsen OØ, Brynskov J, Ainsworth MA. Severe infusion reactions to infliximab: aetiology, immunogenicity and risk factors in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jul;34(1):51-8. doi: 10.1111/j.1365-2036.2011.04682.x. Epub 2011 May 3.

ReferenceCitation: Afif W, Loftus EV Jr, Faubion WA, Kane SV, Bruining DH, Hanson KA, Sandborn WJ. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010 May;105(5):1133-9. doi: 10.1038/ajg.2010.9. Epub 2010 Feb 9.

ReferenceCitation: Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, Dijkmans BA, Aarden L, Wolbink GJ. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011 Apr 13;305(14):1460-8. doi: 10.1001/jama.2011.406.

ReferenceCitation: Steenholdt C, Brynskov J, Thomsen OØ, Munck LK, Fallingborg J, Christensen LA, Pedersen G, Kjeldsen J, Jacobsen BA, Oxholm AS, Kjellberg J, Bendtzen K, Ainsworth MA. Individualised therapy is more cost-effective than dose intensification in patients with Crohn's disease who lose response to anti-TNF treatment: a randomised, controlled trial. Gut. 2014 Jun;63(6):919-27. doi: 10.1136/gutjnl-2013-305279. Epub 2013 Jul 22.

ReferenceCitation: Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.

ReferenceCitation: Paul S, Del Tedesco E, Marotte H, Rinaudo-Gaujous M, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Roblin X. Therapeutic drug monitoring of infliximab and mucosal healing in inflammatory bowel disease: a prospective study. Inflamm Bowel Dis. 2013 Nov;19(12):2568-76. doi: 10.1097/MIB.0b013e3182a77b41.

ReferenceCitation: Roblin X, Marotte H, Rinaudo M, Del Tedesco E, Moreau A, Phelip JM, Genin C, Peyrin-Biroulet L, Paul S. Association between pharmacokinetics of adalimumab and mucosal healing in patients with inflammatory bowel diseases. Clin Gastroenterol Hepatol. 2014 Jan;12(1):80-84.e2. doi: 10.1016/j.cgh.2013.07.010. Epub 2013 Jul 23.


title: Multicenter and Open Pilot Clinical Study on the Safety of a New One-piece Convex Appliance in Patients With Enterostomy

summary: This study evaluates the performance of a new 1-piece ostomy convex appliance in patients with enterostomy.

lead_sponsor: BBraun Medical SAS


acronym: E-NOSE

summary: The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.


acronym: Massper

summary:
Parabolic flight is the only ground-based condition in which free-fall (0G) can be created long enough for safely testing changes in human perception and behavior. In addition to the 0G period, parabolic flight generates equal duration periods of 1.8G, which present another unique opportunity to test the same responses to hypergravity and back to 1G.

It is well known that performance decrements occur in astronauts during and after gravity level transitions. Illusions are commonly felt in orbit as well disorientation and perceptual limitations, mainly due to both psycho-physiological changes and adaptation and lack of familiar points of reference in the space environment. Studies performed during previous space missions showed several changes occurring in different gravity conditions, pointing out, for example, that colors and shadows were misleading, the depth and distance perception were weakened, and the linear perspective was lost. Visual perception is of primary importance for spatial orientation and object recognition because the static vestibular (otolithic) and proprioceptive signals are absent when free-floating. Consequently, astronauts become increasingly dependent on vision to perceive motion and orientation. All these factors play an important role in the adaptation of humans to spaceflight that needs to be analyzed to understand the underlying mechanisms that regulate human psycho-physiological adaptive process to changing gravity. Human psycho-physiological health has to be safeguarded and possibly improved when long-term human space missions are programmed in the near future.

The primary objective of this experiment is to investigate if the SWI illusion is present in altered gravity environments. Since weight cannot be estimated in 0G, investigators have developed a procedure during which the subject is asked to estimate the objects' mass by shaking them rather than lifting them. Our results in 1G indicate that a size-mass illusion (SMI) is also present in 1G. Our hypothesis is that the previously observed alteration in 3D visual perception in 0G, particularly in the height of 3D objects, as well as the change in proprioceptive inputs, will be responsible for changes in the SMI in 0G and 1.8G compared to 1G. In a separate proposal, investigators will also propose to perform this experiment using the ESA short-arm human centrifuge (SAHC), with subjects exposed to various centrifugal force levels, to further investigate the role of proprioceptive cues in the size-mass illusion.


title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components

summary: MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

study_start_date_type: Anticipated

status: Withdrawn

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: MicroPort Orthopedics Inc.


title: Evaluation of Physiological and Biomechanical Efficiency of the PAPAW

acronym: SmartDrive

summary:
The main objective is to quantify energy expenditure when using the SmartDrive system during manual wheelchair propulsion in external conditions (slope, straight line). For this two comparisons are performed:

Comparison of energy expenditure with and without the use of a system SmartDrive 6 minute propulsion test.

Comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Observational Study of the Analgesic Effect of Treatment With rTMS in Patients Suffering From Chronic Neuropathic Pain Refractory to Conventional Treatment and Monitored and Evaluated in Consultation Multidisciplinary Chronic Pain in Lower Normandy

acronym: rTMSDOULNEURO

summary:
For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.

Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.

We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.

location_facility: Centre d'évaluation et de traitement de la douleur (CETD)


title: Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.

acronym: ELOCS

summary: This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

ReferenceCitation: Lawenda BD, Mondry TE, Johnstone PA. Lymphedema: a primer on the identification and management of a chronic condition in oncologic treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):8-24. doi: 10.3322/caac.20001. Review.

ReferenceCitation: Kärki A, Anttila H, Tasmuth T, Rautakorpi UM. Lymphoedema therapy in breast cancer patients: a systematic review on effectiveness and a survey of current practices and costs in Finland. Acta Oncol. 2009;48(6):850-9. doi: 10.1080/02841860902755251. Review.

ReferenceCitation: Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphat Res Biol. 2009;7(2):101-8. doi: 10.1089/lrb.2009.0006.

ReferenceCitation: Vignes S, Porcher R, Arrault M, Dupuy A. Long-term management of breast cancer-related lymphedema after intensive decongestive physiotherapy. Breast Cancer Res Treat. 2007 Mar;101(3):285-90. Epub 2006 Jul 7.

lead_sponsor: University Hospital, Toulouse


type: Registry Identifier

title: Evaluation of Perioperative Use of Hypnosis in Pediatric Surgery: Clinical and Medico-economic Interests

summary:
In adults, it is common to perform a number of superficial and non invasive surgeries under local anesthesia in order to limit the use of general anesthesia.

Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the patient comfort and experience. The benefit of this practice has been widely demonstrated in adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and vomiting.

In pediatric surgery, hypnosis is an effective technique for the management of preoperative anxiety. It is used by many teams in their daily practice, particularly during anesthetic induction.

For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University Hospital also offers for selected short and superficial non-invasive surgeries, an intraoperative management under hypnosis in association with ocal anesthesia as an alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted and recognized in our intraoperative surgical unit, to date, no studies have evaluated the benefits of this technique compared to general anesthesia.

The objective of the study is to compare the impact of these techniques (hypnosis vs. general anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain, nausea and vomiting, negative behavioral disorders).


title: ARTEMIS Synovial Markers in Arthritis Childhood

acronym: ARTEMIS

summary: The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.

ReferenceCitation: Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mangé A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12). pii: E1521. doi: 10.3390/cells8121521.

family: Nziza

full_name: Nadége Nziza

given: Nadége

family: Jeziorski

full_name: Eric Jeziorski

given: Eric

family: Delpont

full_name: Marion Delpont

given: Marion

family: Cren

full_name: Maïlys Cren

given: Maïlys

family: Chevassus

full_name: Hugues Chevassus

given: Hugues

family: Carbasse

full_name: Aurélia Carbasse

given: Aurélia

family: Mahe

full_name: Perrine Mahe

given: Perrine

family: Abassi

full_name: Hamouda Abassi

given: Hamouda

family: Joly-Monrigal

full_name: Pauline Joly-Monrigal

given: Pauline

family: Schordan

full_name: Eric Schordan

family: Mangé

full_name: Alain Mangé

given: Alain

family: Jorgensen

full_name: Christian Jorgensen

given: Christian

family: Apparailly

full_name: Florence Apparailly

given: Florence

family: Duroux-Richard

full_name: Isabelle Duroux-Richard

currency_apc_doaj: CHF

journal_name: Cells

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

ReferenceCitation: Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.

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


title: Treatment of Pleural Effusion by Routine Thoracic Ultrasound

acronym: ECHOPLEV

summary: The main objective of the study is to assess the cost-effectiveness ratio of two management strategies of pleurisy in adults : a strategy by systematic thoracic ultrasound versus a strategy without thoracic ultrasound.

ReferenceCitation: Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026.

ReferenceCitation: Reissig A, Copetti R, Mathis G, Mempel C, Schuler A, Zechner P, Aliberti S, Neumann R, Kroegel C, Hoyer H. Lung ultrasound in the diagnosis and follow-up of community-acquired pneumonia: a prospective, multicenter, diagnostic accuracy study. Chest. 2012 Oct;142(4):965-972. doi: 10.1378/chest.12-0364.

ReferenceCitation: Jones PW, Moyers JP, Rogers JT, Rodriguez RM, Lee YC, Light RW. Ultrasound-guided thoracentesis: is it a safer method? Chest. 2003 Feb;123(2):418-23.

ReferenceCitation: Ikezoe J, Morimoto S, Arisawa J, Takashima S, Kozuka T, Nakahara K. Percutaneous biopsy of thoracic lesions: value of sonography for needle guidance. AJR Am J Roentgenol. 1990 Jun;154(6):1181-5.

ReferenceCitation: Chen HJ, Yu YH, Tu CY, Chen CH, Hsia TC, Tsai KD, Shih CM, Hsu WH. Ultrasound in peripheral pulmonary air-fluid lesions. Color Doppler imaging as an aid in differentiating empyema and abscess. Chest. 2009 Jun;135(6):1426-1432. doi: 10.1378/chest.08-2188. Epub 2009 Mar 2.


title: Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial

acronym: PRELIG

summary:
Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning.

Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations.

The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR.

Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery.

Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Behavioral


title: Pharmacokinetics of Ertapenem Following Subcutaneous or Intravenous Infusion in Patients Aged Over 75 (PHACINERTA)

acronym: PHACINERTA

summary:
In geriatric departments, physicians are faced with two difficulties, first the increasing number of infections caused by multiresistant bacteria, especially extended spectrum β-lactamase (ESBL) producing enterobacteria strains and second, the poor venous access frequently encountered in elderly population. Giving antibiotics subcutaneously would be an interesting alternative, all the more as intramuscular injection is contraindicated in case the of anticoagulant therapy. Unfortunately, few data are available about subcutaneous (SC) administration. Ertapenem is a recent long-acting parenteral carbapenem indicated especially in the treatment of ESBL infection. Its subcutaneously administration has been tested in several studies in Intensive Care Units (ICU) and internal medicine wards with promising results regarding clinical and pharmacokinetics data.

An alternative to the IV Ertapenem administration is needed because of poor venous access and behavioural abnormalities commonly present in infected elderly population. Ertapenem is currently SC administrated in geriatric departments if no other option is available. Moreover elderly patients often present several comorbdities, polymedication, renal insufficiency, cachexia which may disturb antibiotics pharmacokinetics.

The aim of the study is to obtain pharmacokinetic data of SC and IV Ertapenem administration in elderly population, obtain PK/PD parameters adapted to time-dependent antibiotics (T%>MIC) and descriptive data of occurrence of adverse effects and evolution of signs of infection.

ReferenceCitation: Roubaud Baudron C, Legeron R, Ollivier J, Bonnet F, Greib C, Guerville F, Cazanave C, Kobeh D, Cressot V, Moneger N, Videau MN, Thiel E, Foucaud C, Lafargue A, de Thezy A, Durrieu J, Bourdel Marchasson I, Pinganaud G, Breilh D. Is the subcutaneous route an alternative for administering ertapenem to older patients? PHACINERTA study. J Antimicrob Chemother. 2019 Dec 1;74(12):3546-3554. doi: 10.1093/jac/dkz385.

name: CHU Bordeaux, Pôle de Gérontologie Clinique, F-33000 Bordeaux, France

name: Univ. Bordeaux, INSERM UMR 1053, BaRITOn, F-33000 Bordeaux, France

family: Roubaud Baudron

full_name: Claire Roubaud Baudron

given: Claire

name: CHU Bordeaux, Service Pharmacie à Usage Intérieur, département de Pharmacie Clinique, F-33000 Bordeaux, France

family: Legeron

full_name: Rachel Legeron

given: Rachel

family: Ollivier

full_name: Julien Ollivier

given: Julien

name: CHU Bordeaux, Service de Médecine Interne et Maladies Infectieuses, Hôpital Sain-André, F-33000 Bordeaux, France

family: Bonnet

full_name: Fabrice Bonnet

given: Fabrice

name: CHU Bordeaux, Service de Médecine Interne et Maladies Infectieuses, Hôpital Haut Lévêque, F-33000 Bordeaux, France

family: Greib

full_name: Carine Greib

given: Carine

family: Guerville

full_name: Florent Guerville

given: Florent

name: CHU Bordeaux, Service des Maladies Infectieuses et Tropicales, Hôpital Pellegrin, F-33000 Bordeaux, France

name: Univ. Bordeaux, INRA, USC EA 3671, Infections humaines à mycoplasmes et à chlamydiae, F-33000 Bordeaux, France

family: Cazanave

full_name: Charles Cazanave

given: Charles

family: Kobeh

full_name: David Kobeh

given: David

family: Cressot

full_name: Véronique Cressot

given: Véronique

family: Moneger

full_name: Nicolas Moneger

given: Nicolas

family: Videau

full_name: Marie-Neige Videau

given: Marie-Neige

family: Thiel

full_name: Elise Thiel

given: Elise

family: Foucaud

full_name: Carine Foucaud

family: Lafargue

full_name: Aurélie Lafargue

given: Aurélie

family: de Thezy

full_name: Albane de Thezy

given: Albane

family: Durrieu

full_name: Jessica Durrieu

given: Jessica

name: Univ. Bordeaux, CNRS UMR 5536 RMSB, F-33000 Bordeaux, France

family: Bourdel Marchasson

full_name: Isabelle Bourdel Marchasson

given: Isabelle

family: Pinganaud

full_name: Geneviève Pinganaud

given: Geneviève

name: Univ. Bordeaux, INSERM UMR 1034, Pharmacokinetics and Pharmacodynamics (PK/PD) Group, F-33000 Bordeaux, France

family: Breilh

full_name: Dominique Breilh

given: Dominique

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: University Hospital, Bordeaux

intervention_type: Drug


title: Comparaison Biochimique et Histologique Des Cartilages Nasal et Auriculaire Chez le fœtus et le Nouveau-né Porteur de Fente Labiale

acronym: CARTOON

summary:
We seek to compare biochemically and histologically the nasal cartilage and ear in the newborn cleft lip and slot carrier in order to improve the quality of care and patient comfort after surgery of cheilorhinoplasty which is the primary treatment slots .

The concentration of hyaluronic acid as well as in type 1 collagen and 3 are assayed by immunohistochemistry and study of mRNA and then they are compared according to the type of cartilage.

This comparison is done on nasal cartilage samples and atrial newborns holders of cleft lip and operated in the neonatal period.

Given the difficulty and constraint of time it takes to reach the 20 subjects of our study , we will also add to our population the stillborn babies before 25SA and newborns who die before the age of 28 days and having had an autopsy.


title: A Randomized Double-blind Clinical Trial on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Reducing Alcohol Consumption in Non-abstinent Patients With Alcohol Use Disorder

acronym: REDSTIM

summary: The study evaluates the efficacy of 1 week of tDCS (5 sessions) placebo in reducing alcohol consumption within the 24 weeks following the treatment in non-abstinent patients with alcohol use disorders versus placebo.

ReferenceCitation: Trojak B, Soudry-Faure A, Abello N, Carpentier M, Jonval L, Allard C, Sabsevari F, Blaise E, Ponavoy E, Bonin B, Meille V, Chauvet-Gelinier JC. Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):250. doi: 10.1186/s13063-016-1363-8.

family: Trojak

full_name: Benoit Trojak

given: Benoit

family: Soudry-Faure

full_name: Agnès Soudry-Faure

given: Agnès

family: Abello

full_name: Nicolas Abello

family: Carpentier

full_name: Maud Carpentier

given: Maud

family: Jonval

full_name: Lysiane Jonval

given: Lysiane

family: Allard

full_name: Coralie Allard

given: Coralie

family: Sabsevari

full_name: Foroogh Sabsevari

given: Foroogh

family: Blaise

full_name: Emilie Blaise

given: Emilie

family: Ponavoy

full_name: Eddy Ponavoy

given: Eddy

family: Bonin

full_name: Bernard Bonin

given: Bernard

family: Meille

full_name: Vincent Meille

given: Vincent

family: Chauvet-Gelinier

full_name: Jean-Christophe Chauvet-Gelinier

given: Jean-Christophe

journal_name: Trials

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Impact of Complementary Medicine Techniques (Therapeutic Touch and Hypno Analgesia) on the Term of Delivery of Patients Hospitalized for Preterm Labor (Hypnorelax)

acronym: Hypnorelax

summary:
The threat of premature birth (MAP) is the leading cause of hospitalization during pregnancy complicated by preterm delivery in 5-10% of cases in developed countries. Psychological stress that encompasses anxiety and anxiety resounding including sleep quality can be a work of preacher and premature delivery.

Preterm birth before 37 has an impact on the survival and health of the newborn. It is the leading cause of mortality and obstetric complications. It has a cost both for the newborn, the term parturient health but also the financial cost by the management before delivery and the consequences of a premature birth.

The usual management of MAP is hospitalized with tocolysis, monitoring and rest. The hospitalization and invasive procedures contribute to increasing stress. It therefore seems necessary to seek to diversify and master reputable techniques for their effectiveness on mastering stress and improving sleep quality as hypnosis and feel relaxing.

Hypnosis in obstetrics is used primarily to control pain, nausea and postpartum depression. It also reduces preoperative anxiety and during induction of anesthesia, as well as behavioral disorders during the first postoperative week. Hypnosis can play an important role in the prevention of preterm birth. In a non-randomized study, hypnosis combined with drug therapy has prolonged pregnancy of patients followed in high risk pregnancy.

The relaxing touch brings relaxation and well being. In obstetrics, it has an influence on the anti-stress hormones and plays a role in reducing pain during childbirth.

Few studies interested in hypnosis and relaxation therapies in pregnant women, especially in case of MAP. The published data relate to a small number of patients and a low level of evidence. Although there seems promising results, prospective studies are needed to conclude its effectiveness in improving the stress, pain or other parameters.

Health workers trained in these techniques could observe during their production improved sleep disorders, stress, better communication between doctor and patient. Moreover, these treatments could induce an improvement in the overall care of patients, and therefore have an impact on the continuation of pregnancy.

These findings are based on these hypothesis. There is a clinical gain the contribution of hypnosis and relaxing touch in women hospitalized for MAP before 32 weeks of gestation. This would, among other improvements in sleep disorders and stress, decrease pain, and acting on the extension of the term of pregnancy in women followed by these techniques and a decrease in hospitalizations of newborns premature neonatology and neonatal intensive care units.

primary_purpose: Prevention

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation (TAVI) Platelet Activation in TAVI

acronym: TAVI

summary: Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)


ReferenceCitation: Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group, Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Léger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.

name: Centre Hospitalier Universitaire (CHU) Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Université Clermont Auvergne, CNRS, Inserm U-1103, Clermont-Ferrand, France

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

name: CHU de Lille, Pôle Anesthésie Réanimation, Hôpital Claude Huriez, Lille, France

family: Garot

full_name: Matthias Garot

given: Matthias

name: CHU de Clermont-Ferrand, Département Anesthésie et Réanimation, Hôpital Estaing, Clermont-Ferrand, France

family: Godet

full_name: Thomas Godet

given: Thomas

name: CHU de Bordeaux, Département Anesthésie et Réanimation, Hôpital Pellegrin, Bordeaux, France

family: Biais

full_name: Matthieu Biais

given: Matthieu

name: CHU Montpellier, Département Anesthésie et Réanimation B (DAR B), Hôpital Saint-Eloi, and Inserm U-1046, Montpellier, France

family: Verzilli

full_name: Daniel Verzilli

given: Daniel

name: CHU de Bordeaux, Service Anesthésie et Réanimation, Centre Medico-chirugical Magellan, Bordeaux, France

name: Inserm, UMR 1034, Biology of Cardiovascular Diseases, Pessac, France

family: Ouattara

full_name: Alexandre Ouattara

given: Alexandre

name: CHU de Brest, Département Anesthésie et Réanimation, Hôpital La cavale Blanche, Brest, France

family: Huet

full_name: Olivier Huet

given: Olivier

family: Lescot

full_name: Thomas Lescot

family: Lebuffe

full_name: Gilles Lebuffe

given: Gilles

family: Dewitte

full_name: Antoine Dewitte

given: Antoine

family: Cadic

full_name: Anna Cadic

given: Anna

name: AP-HP, Département Anesthésie et Réanimation, Hôpital Beaujon, Clichy, Paris, France

family: Restoux

full_name: Aymeric Restoux

given: Aymeric

name: CHU de Nantes, Département Anesthésie et Réanimation, Hôpital Hôtel Dieu, Nantes, France

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

name: CHU de Nîmes, Section d’Anesthésie, Département Anesthésie et Réanimation, Nîmes, France

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

name: Institut Paoli Calmettes, Département Anesthésie et Réanimation, Marseille, France

family: Faucher

full_name: Marion Faucher

given: Marion

name: Assistance Publique Hôpitaux de Marseille (AP-HM), Service Anesthésie et Réanimation, Hôpital Timone, Marseille, France

family: Vaisse

full_name: Camille Vaisse

given: Camille

name: Centre Hospitalier de Valenciennes, Département Anesthésie et Réanimation, Valenciennes, France

family: El Amine

full_name: Younes El Amine

given: Younes

name: Université de Rennes, Inserm, INRA, CHU Rennes, CIC 1414, Numecan, Pôle Anesthésie et Réanimation, Rennes, France

family: Beloeil

full_name: Hélène Beloeil

given: Hélène

name: AP-HM, Service Anesthésie et Réanimation, Hôpital Nord, Université Aix Marseille, Marseille, France

family: Leone

full_name: Marc Leone

given: Marc

name: Hôpitaux Universitaires de Strasbourg, Service d’Anesthésie Réanimation Chirurgicale, Hôpital Hautepierre, Strasbourg, France

family: Noll

full_name: Eric Noll

given: Eric

name: Université Claude Bernard Lyon 1, Hospices Civils de Lyon, Service d’Anesthésie Réanimation, Centre Hospitalier Lyon Sud, Lyon, France

family: Piriou

full_name: Vincent Piriou

name: Département Anesthésie et Réanimation, CHU Angers, Angers, France

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

name: Biostatistics Unit, Direction de la Recherche Clinique (DRCI), CHU Clermont-Ferrand, Clermont-Ferrand, France

family: Pereira

full_name: Bruno Pereira

given: Bruno

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

ReferenceCitation: Futier E, Biais M, Godet T, Bernard L, Rolhion C, Bourdier J, Morand D, Pereira B, Jaber S; FLASH trial management committee. Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial. Trials. 2015 Dec 21;16:582. doi: 10.1186/s13063-015-1085-3.

name: for the FLASH trial management committee

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

title: Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)

summary: The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.


title: Study of Anti-glycan Antibodies Stability in Saint-Etienne IBD Cohort - A Monocentric Study

summary: Prognostic factors in Inflammatory Bowel Diseases (IBD) are currently mainly based on clinical factors (disease extension, perianal involvement, need for surgery, use of immunomodulators…). All of immunological markers (or serological) of IBD have a diagnostic role in indeterminate colitis (ulcerative colitis vs crohn's disease) but they never have been considered as predictors of IBD course in adults. Among the most used, anti-neutrophil cytoplasm antibodies (ANCA) and Anti-Saccaromyces cerevisiae antibodies (ASCA) allow the distinction between ulcerative colitis (ANCA+/ASCA-) and Crohn's disease (ANCA-/ASCA+), and their combined use has a sensitivity and a specificity of about 85%. However, 10 other antibodies have been identified and recently evaluated individually in IBD and especially in pediatric Crohn's disease: anti-ompC, anti-I2, anti-flagellins, anti-glycan (anti-laminaribioside carbohydrate antibodies (ALCA), anti-mannobioside carbohydrate antibodies (AMCA), anti-chitobioside carbohydrate antibody (ACCA), anti-chitin and anti-laminarin), anti-goblet cells and anti-C.albicans specific mannans antibodies. These complementary tests improve the reliability of the diagnosis. In a previous cross-sectional work on a cohort of 195 IBD patients, the investigator showed a prognostic role of some of anti-glycan Abs and especially a correlation with a pejorative form of the disease both in Crohn's disease than in Ulcerative Colitis (UC) and a prediction of corticodependency in IBD.


title: Cellular and Molecular Adaptations to Exercise-induced Inflammatory Response in Children With Autoimmune Diseases

acronym: AJI-APA

summary: Juvenile idiopathic arthritis (JIA) is a chronic disease characterized by persistent joint inflammation. The immune system disruption that leads to overproduction of pro-inflammatory cytokines (TNF-α, IL-1, IL-6) is a cascade of events on different levels-some molecular, some cellular, and some systemic. Our objective is to identify the mechanisms through which physical activity is liable to mediate inflammatory balance in autoimmune disease settings, and specifically in JIA patients.


title: Study of the Colonic Carriage of Staphylococcus Aureus in a Prospective Cohort of Patients Undergoing Endoscopic Screening for Digestive Cancer in the University Hospital of Saint-Etienne.

acronym: ColoStaph

summary: Epidemiological study aiming to describe the carriage (nasal, throat, groin, rectal and colonic) of S. aureus in patients without chronic digestive disease who are going to have a colonoscopy for cancer screening. The carriage will be analyzed globally and the similarity of strains isolated from each site will be analyzed using molecular tools. The aim of this study is to better estimate the digestive reservoir of S. aureus to better prevent endogenous infections due to this bacterium.


title: PRODIGE 33 - BALLAD - Phase III Trial Investigating the Potential Benefit of Adjvant Chemotherapy for Small Bowel Adenocarcinoma

acronym: BALLAD

summary:
The utility of adjuvant chemotherapy in the management of Small Bowel Adenocarcinoma (SBA) remains unproven and awaits the results of a large, global, prospective, phase III, randomised, controlled trial. Across the 830 million population of North America and Europe, there are approximately 3,000 patients with stage I-III SBA every year who would be potentially eligible for such an adjuvant chemotherapy trial.

Given the absence of good-quality and evidence-based data, it has been agreed that a trial considering adjuvant chemotherapy versus no chemotherapy was appropriate for patients with stage I-III SBA in whom the oncologist and patient feel that the benefit of adjuvant chemotherapy is uncertain. For those patients with stage I-III SBA who, with their oncologists, feel that the potential benefit of adjuvant chemotherapy is certain (and hence are not willing to accept randomisation to the 'no chemotherapy' arm), a randomisation between single agent fluoropyrimidine versus doublet fluoropyrimidine and oxaliplatin chemotherapy will be offered. Tumour stage will be used as a stratification factor. Those patients who do not consent to be randomised will be offered registration to allow collection of demographic, clinicopathological and survival data, thereby making optimal use of the rare patient population available. In addition, archival Formalin Fixed Paraffin Embedded (FFPE) tissue and contemporaneous venous blood samples will be collected from every registered patient to allow molecular profiling and future translational research. A questionnaire about underlying risk factors (e.g. Crohn's disease, coeliac disease, Lynch syndrome etc) will be completed along with the other collected data on all registered patients.

status: Not yet recruiting

ReferenceCitation: Kitahara H, Honma Y, Ueno M, Kanemitsu Y, Ohkawa S, Mizusawa J, Furuse J, Shimada Y; Colorectal Cancer Study Group and Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group. Randomized phase III trial of post-operative chemotherapy for patients with stage I/II/III small bowel adenocarcinoma (JCOG1502C, J-BALLAD). Jpn J Clin Oncol. 2019 Mar 1;49(3):287-290. doi: 10.1093/jjco/hyy188.

name: Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan

family: Kitahara

full_name: Hideaki Kitahara

given: Hideaki

name: Department of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan

family: Honma

full_name: Yoshitaka Honma

given: Yoshitaka

name: Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Kanagawa, Japan

family: Ueno

full_name: Makoto Ueno

given: Makoto

name: Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan

family: Kanemitsu

full_name: Yukihide Kanemitsu

given: Yukihide

family: Ohkawa

full_name: Shinichi Ohkawa

given: Shinichi

family: Mizusawa

full_name: Junki Mizusawa

given: Junki

name: Department of Medical Oncology, Kyorin University School of Medicine, Tokyo, Japan

family: Furuse

full_name: Junji Furuse

given: Junji

name: Clinical Oncology Division, Kochi Health Sciences Center, Kochi, Japan

family: Shimada

full_name: Yasuhiro Shimada

given: Yasuhiro

journal_name: Japanese Journal of Clinical Oncology


title: Comparaison du Pied Bionique Proprio-Foot® Versus le Pied Habituel Chez Les amputés Tibiaux

acronym: PROPRIO-FOOT

summary: Evaluate a new porosthetic device in lower limb amputees.

lead_sponsor: University Hospital, Angers


title: Natural History of Cardiac and Respiratory Function in Patients With Muscular Dystrophies on Home Mechanical Ventilation

summary: Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and respiratory function may be affected in this group of diseases. The investigators sought to analyze the long term cardiac and respiratory function in patients with muscular dystrophies recquiring home mechnaical ventilation .

time_perspective: Retrospective

ReferenceCitation: Fayssoil A, Lazarus A, Wahbi K, Ogna A, Nardi O, Lofaso F, Clair B, Orlikowski D, Annane D. Cardiac implantable electronic devices in tracheotomized muscular dystrophy patients: Safety and risks. Int J Cardiol. 2016 Nov 1;222:975-977. doi: 10.1016/j.ijcard.2016.08.040. Epub 2016 Aug 6.

family: Fayssoil

full_name: Abdallah Fayssoil

given: Abdallah

family: Lazarus

full_name: Arnaud Lazarus

given: Arnaud

family: Wahbi

full_name: Karim Wahbi

given: Karim

family: Ogna

full_name: Adam Ogna

given: Adam

family: Nardi

full_name: Olivier Nardi

given: Olivier

family: Lofaso

full_name: Frederic Lofaso

given: Frederic

family: Clair

full_name: Bernard Clair

given: Bernard

family: Orlikowski

full_name: David Orlikowski

given: David

family: Annane

full_name: Djillali Annane

given: Djillali

journal_name: International Journal of Cardiology

ReferenceCitation: Fayssoil A, Ogna A, Chaffaut C, Chevret S, Guimarães-Costa R, Leturcq F, Wahbi K, Prigent H, Lofaso F, Nardi O, Clair B, Behin A, Stojkovic T, Laforet P, Orlikowski D, Annane D. Natural History of Cardiac and Respiratory Involvement, Prognosis and Predictive Factors for Long-Term Survival in Adult Patients with Limb Girdle Muscular Dystrophies Type 2C and 2D. PLoS One. 2016 Apr 27;11(4):e0153095. doi: 10.1371/journal.pone.0153095. eCollection 2016.

family: Chaffaut

full_name: Cendrine Chaffaut

given: Cendrine

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Guimarães-Costa

full_name: Raquel Guimarães-Costa

given: Raquel

family: Leturcq

full_name: France Leturcq

given: France

family: Prigent

full_name: Helene Prigent

given: Helene

family: Behin

full_name: Anthony Behin

given: Anthony

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org


acronym: CMHStress

summary: Hypertrophic cardiomyopathy (HCM) is a primitive myocardic disease and the first of genetic cardiac diseases. The definition of HCM is an increase of the myocardial thickness of the left ventricle (LV) wall without any other causes of hypertrophy. It's characterized by an important heterogeneity of prognosis and clinical expression going from a asymptomatic state until the devastating sudden death occurring in a young person.The diagnosis of HCM is definite by a myocardial thickness greater or equal to 15mm (or 13mm if there is a familial history).This hypertrophy is often accompanied by other abnormalities detected by echocardiography: dynamic left ventricular outflow obstruction at rest or stress, mitral regurgitation …Now, the current challenge is to determine the prognosis factors of the disease that could help to identify the patients with high risk of sudden death. Some prognosis factors are knowed and used in the calculation of a new risk score. This risk score allows to estimate the risk of sudden death at 5 years and propose depending on the result, the implantation of a defibrillator for primary prevention.The physiopathological mechanism of HCM is very complex and still misunderstood. Myocardial fibrosis could be a major mechanism of the disease evolution. Indeed, fibrosis is responsible of scar areas where ventricular tachycardia may develop. Moreover, if the fibrosis is very extensive, it can be the responsible of a systolic or diastolic dysfunction of the left ventricle leading to heart failure.Myocardial ischemia caused by a microvascular dysfunction is now recognized as an important mechanism of the disease evolution. Acute ischemic events could be a trigger of malignant arrhythmia whereas chronic ischemia leads to fibrosis.Left ventricle function is long time preserved in HCM. Segmentary hypokinesia corresponding to extensive fibrosis appears at a very advanced stage of the disease. Exercice stress echocardiography permits to detect myocardial ischemia caused by microvascular dysfunction in the HCM before the fibrosis apparition. Moreover the investigators suggest to study the deformation parameters by speckle tracking or 2D strain witness of a contractile LV dysfunction before the apparition of segmentary hypokinesia.Magnetic resonance imaging (MRI) is now recognized as the more sensible technique to identify focal myocardial fibrosis resulting in areas of late gadolinium enhancement (LGE). LGE is frequent in HCM and his extension is correlated with the severity of the hypertrophy and the risk of sudden death. Myocardial ischemia is detected by hypoperfused defects in the perfusion sequences and as LGE, is correlated with the degree of hypertrophy. Some studies using stress MRI with vasodilatator agent show inductible hypoperfused areas correlated to the degree of hypertrophy. T1 mapping is a new hopeful sequence of MRI permitting to detect the diffuse and early myocardial fibrosis. Some studies show that T1 mapping values are reduced in the areas of LGE in HCM but also in areas without LGE which reflects the presence of new fibrosis.The objective of study is to compare these two imagery techniques in order to detect ischemia and fibrosis. These techniques are usually used in the diagnosis or the monitoring of the disease. The investigators propose to realize an exercise stress echocardiography to study: the segmentary kinetic of the left ventricle and the 2D strain and a stress MRI to study the LGE, the stress perfusion and the T1 mapping.Actually the investigators consider that LGE is a risk factor of the disease (although not yet involved in the calculation of the risk of sudden death) and need to be study in each MRI realized for HCM. From the same way, the investigators suggest to follow patients to determine if the abnormalities detected by these two techniques and particularly 2D strain abnormalities, stress myocardial ischemia and T1 mapping abnormalities are prognosis factors of the disease and appear more precociously than LGE.

location_facility: Hôpital Arnaud de Villeneuve - CHRU de Montpellier


title: Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction

summary:
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.

The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

location_facility: Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière


title: Perinatal Consequences of Endometriosis: Multicenter Prospective Comparative Study

acronym: ENDOBST

summary:
Endometriosis is a benign gynecological disease, characterized by the presence of endometrium-like tissue outside the uterine cavity that affect up to 10-15% of women in reproductive age worldwide, with an extensive impact on women's wellbeing and their reproductive life. Endometriosis lesions are heterogeneous and three phenotypes of the disease are well recognized and are fundamentally different from each other: superficial peritoneal endometriosis (peritoneal implants), ovarian endometrioma (cyst ovarian endometriosis), and deeply infiltrating endometriosis (invasive nodules greater than 5 mm).

The investigators performed a prospective multicenter comparative study to assess the maternal and fetal risks related to endometriosis during pregnancy, regarding disease phenotype, This study will evaluate with sufficient power the risk of prematurity and obstetrical complications associated with endometriosis according to disease phenotype.

This study aims to provide new informations to pregnant women with endometriosis, guide the monitoring of pregnancy, optimize management strategies based on the nature of complications and ultimately to improve the health of women and their unborn child

intervention_type: Biological


title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

acronym: Cross Iron

summary: Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

location_facility: Hôpital Lapeyronie - Département Anesthésie Réanimation A


title: Ultrasound-guided Pudendal Nerve Block in Children: A Descriptive Study of Feasibility

summary:
Objective: Description of a new transperineal technique of pudendal nerve block (PNB), under ultrasound-guidance.

Methods : Successive inclusions after parental consent of 60 children undergoing perineal surgery under general anesthesia and pudendal nerve block. Data were collected from induction of anesthesia to second post-operative day (24 hrs. after admission in recovery room). Ease of PNB achievement was the primary objective evaluated. Efficiency in preoperative and postoperative period was also reported.


title: Hypospadias and Exome: Identification of New Genes for Familial Hypospadias

summary:
Hypospadias is the second most common malformation of the male genitalia and consists in a congenital hypoplasia of its ventral face. Hypospadias results from abnormal development of the penis that leaves the urethral meatus proximal to its normal glanular position. Meatus position may be located anywhere along the penile shaft, but more severe forms of hypospadias may have a urethral meatus located at the scrotum or perineum. Glandular and penile anterior represents approximately 70% of all the diagnosed cases.

The frequency of family reached depend on the severity of hypospadias. The number of children which have hypospadias mutation discovered by classical technique is low. Families are often the cause of the discovery of new genes involved in sexual differentiation because they allow comparison of genomes of related persons, and detect more easily mutations.

intervention_type: Genetic


title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)

acronym: RICAOS

summary:
Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.


title: Illiteracy and Vulnerability to Alzheimer's Disease: Evaluation of Amyloid Pathology by PET Imaging

acronym: AVILL

summary: The goal of this study is to improve the diagnosis of Alzheimer's disease (AD) at two different stages (MCI and dementia) in illiterate subjects, using FDG- fluorodeoxyglucose - and florbetapir F 18 -PET imaging. This study will compare amyloid load and cerebral metabolism dysfunction in literate versus illiterate MCI and AD patients.

intervention_type: Radiation


title: Does the Mycophenolate Improve the Ability of Weaning Patients Off the Treatment in Chronic Inflammatory Demyelinating Polyradiculopathy (CIDP)

acronym: MYCOPID

summary: The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.


title: Treatment of the Bilateral Severe Uveitis by IVT of Regulator T-cells: Study of Tolerance of Dose

acronym: UVEREG

summary: Uveitis is a leading cause of blindness in the children and young adult's populations. One third of etiology are idiopathic. The reference treatments are corticosteroids and immunosuppressive agents. They have significant side effects, and patient's compliance is often poor. In addition, some uveitis are more resistant. Also, in these situations of deadlock therapeutic, investigators propose a cell therapy by administering regulatory T cells (Tregs) in the vitreous of patients.

status: Suspended

location_facility: Department of ophthalmology Groupe Hospitalier Pitié-Salpêtrière - Charles FOIX


title: Medico-economic Comparative Assessment of Conventional and CAD/CAM Dental Restorations; Impact on Hospital Dentistry Departments

acronym: EVACFAOD

summary:
Dental restorations (crowns, inlays or onlays) can be made conventionally or by CAD/CAM. The current literature is weak and does not separate the medical results of these two techniques. However, the efficiencies enabled by CAD/CAM could, for the price of an initial investment, improve service to the patient by reducing the time required for these restorations, and possibly lower care costs.

The aim of the study is to compare immediate medical results and short-term prosthetic restorations made conventionally or by CAD/CAM in randomized patients, and evaluate economic impacts and organizational aspects.

location_facility: Service d'Odontologie Hôpital Pitié salpêtrière


title: Evaluation of Efficacy and Safety of a Cashew Apple Extract on Weight Management and Associated Metabolic Risk Factors in Overweight/Obese Volunteers: a Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial

summary: The purpose of this study is to assess the efficacy and safety of a cashew apple extract on weight management and associated metabolic risk factors in overweight/obese volunteers, versus placebo, after 12 weeks of treatment.

ReferenceCitation: Janssen I, Katzmarzyk PT, Ross R. Waist circumference and not body mass index explains obesity-related health risk. Am J Clin Nutr. 2004 Mar;79(3):379-84.

ReferenceCitation: Ribeiro da Silva LM, Teixeira de Figueiredo EA, Silva Ricardo NM, Pinto Vieira IG, Wilane de Figueiredo R, Brasil IM, Gomes CL. Quantification of bioactive compounds in pulps and by-products of tropical fruits from Brazil. Food Chem. 2014 Jan 15;143:398-404. doi: 10.1016/j.foodchem.2013.08.001. Epub 2013 Aug 9.

ReferenceCitation: Kuczmarski RJ, Flegal KM. Criteria for definition of overweight in transition: background and recommendations for the United States. Am J Clin Nutr. 2000 Nov;72(5):1074-81.

ReferenceCitation: P. Suganya and R. Dharshini. Value added products from cashew apple - an alternate nutritional source. International Journal of current research, Vol. 3, Issue 7, pp. 177-180, July 2011

ReferenceCitation: Prasertsri P, Roengrit T, Kanpetta Y, Tong-Un T, Muchimapura S, Wattanathorn J, Leelayuwat N. Cashew apple juice supplementation enhanced fat utilization during high-intensity exercise in trained and untrained men. J Int Soc Sports Nutr. 2013 Mar 7;10(1):13. doi: 10.1186/1550-2783-10-13.

ReferenceCitation: Vergara CMAC, Honorato TL, Maia GA, Rodrigues S. Prebiotic effect of fermented cashew apple (Anacardium occidentale L) juice. LWT-Food Sci Technol. 2010; 43:141-145.

lead_sponsor: Dialpha

location_facility: Clinical Nutrition Center Naturalpha (CNCN)

intervention_type: Dietary Supplement


title: Passage à l'Acte en Maison d'arrêt : Recherche d'éléments Contextuels récurrents Prospectifs et rétrospectifs

acronym: CoDiRCE

summary: The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.

ReferenceCitation: Haute Autorité de Santé. Dangerosité psychiatrique : étude et évaluation des facteurs de risque de violence hétéro-agressive chez les personnes ayant des troubles schizophréniques ou des troubles de l'humeur. In: Service des bonnes pratiques professionnelles. Saint-Denis La Plaine: Service documentation - information des publics; 2011.

ReferenceCitation: Quinsey VL, Harris GT, Rice ME, Cormier CA. Violent Offenders: Appraising and Managing Risk, Second Edition. American Psychological Association. Washington, DC, US 2006. 462 p.

ReferenceCitation: Moulin V, Favard A-N.

ReferenceCitation: Moulin V, Senon J-L. Évaluation de la dynamique criminelle et des processus qui sous-tendent l'agir infractionnel dans un cadre expertal, 2010.

ReferenceCitation: Litinetskaia M. Dangerosité, délinquance et passage à l'acte : psychopathologie et prédictivité. Annales médico-psychologiques 170. 99-102; 2012.

ReferenceCitation: Côté G. Vers une définition de la psychopathie. Pham TH & Côté. Villeneuve d'Ascq, France: Presse Universitaire du Septentrion; 2000. 240 p.

ReferenceCitation: Balier C. Psychanalyse des comportements violents. Puf. Rouge LF. Paris1988

ReferenceCitation: Gravier B. Violence et psychopathie. Psychiatrie légale et criminologie clinique. Issy-les-Moulineaux : Elsevier Masson, 2013. Les âges de la vie. ISBN : 978-2-294-73163-1; 2013.

ReferenceCitation: Hare RD, Craigen D. Psychopathy and physiological activity in a mixed-motive game situation. Psychophysiology. 1974 Mar;11(2):197-206.

ReferenceCitation: Vanderstukken O. Troubles de l'attention et des fonctions executives chez les psychopathes. Université catholique de Louvain;1998.

ReferenceCitation: Pham TH. [Psychometric evaluation of the Hare Psychopathy Questionnaire in a Belgian prison population]. Encephale. 1998 Sep-Oct;24(5):435-41. French.

ReferenceCitation: Etude de Cote G, Sheilagh H, Toupin J. citée par Pham TH, Cote G. Psychopathie : Théorie et Recherche. Septentrion Presse Universitaire; 2000.

ReferenceCitation: Sreenivasan S, Kirkish P, Eth S, Mintz J, Hwang S, Van Gorp W, Van Vort W. Predictors of recidivistic violence in criminally insane and civilly committed psychiatric inpatients. Int J Law Psychiatry. 1997 Spring;20(2):279-91.

ReferenceCitation: Méry B. Diplôme Inter-Universitaire de psychiatrie criminelle et médicolégale. "Organisation du système pénitentiaire " ; Mars 2014.

ReferenceCitation: Hare RD, Neumann CN. The PCL-R Assessment of Psychopathy: Development, Structural Properties, and New Directions. C. Patrick ed. New York: Guilford; 2006.

ReferenceCitation: Cote G, Hodgins S, Toupin J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8; 2000.

ReferenceCitation: COTE G., HODGINS S., TOUPIN J. Psychopathie : Prévalence et spécificité clinique. Psychopathie : théorie et recherche. Paris : Septentrion Presse Universitaire, 2000, p 47-75. ISBN 2-85939-612-8. 2000.

ReferenceCitation: Salekin RT, Rogers R, Sewell KW. Construct validity of psychopathy in a female offender sample: a multitrait-multimethod evaluation. J Abnorm Psychol. 1997 Nov;106(4):576-85.

ReferenceCitation: Ministère de la Justice, Statistiques trimestrielles de la population prise en charge en milieu fermé [Consulté le 30/01/2015]. Disponible à partir de l'URL : http://www.justice.gouv.fr/art_pix/trimestrielle_MF_janvier_2014.pdf - Tableau 1. 2014.)

ReferenceCitation: Pham TH. L'évaluation de la psychopathie. Psychiatrie légale et criminologie clinique. Les âges de la vie. Issy-les-Moulineaux : Elsevier Masson; 2000

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

acronym: EPMR-MA

summary: Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

lead_sponsor: Rennes University Hospital


title: Development and Implementation of a Computerized Adaptative Testing (CAT) of Self-perceived Quality of Care in Psychiatry

acronym: QDSPsyCAT

summary:
Objectives

to develop and validate a Computerized Adaptative Testing (CAT) of self-perceived quality of care in Psychiatry.
to analyze the implementation of this new measure in clinical practice : qualitative analysis of the relationship patient/professional.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Lançon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Misdrahi D, Llorca PM, Coldefy M, Auquier P, Baumstarck K, Boyer L. A conceptual framework to develop a patient-reported experience measure of the quality of mental health care: a qualitative study of the PREMIUM project in France. J Mark Access Health Policy. 2021 Feb 23;9(1):1885789. doi: 10.1080/20016689.2021.1885789.

name: Aix-Marseille Univ, School of Medicine - La Timone Medical Campus, EA 3279: CEReSS - Health Service Research and Quality of Life Center, Marseille, France

family: Fernandes

full_name: S Fernandes

given: S

family: Fond

full_name: G Fond

given: G

family: Zendjidjian

full_name: X Zendjidjian

given: X

family: Michel

full_name: P Michel

given: P

family: Lançon

full_name: C Lançon

given: C

family: Berna

full_name: F Berna

given: F

family: Schurhoff

full_name: F Schurhoff

family: Aouizerate

full_name: B Aouizerate

given: B

family: Henry

full_name: C Henry

family: Etain

full_name: B Etain

family: Samalin

full_name: L Samalin

given: L

family: Leboyer

full_name: M Leboyer

given: M

family: Misdrahi

full_name: D Misdrahi

given: D

family: Llorca

full_name: PM Llorca

given: PM

name: Institute for Research and Information in Health Economics (IRDES), Paris, France

family: Coldefy

full_name: M Coldefy

family: Auquier

full_name: P Auquier

family: Baumstarck

full_name: K Baumstarck

given: K

family: Boyer

full_name: L Boyer

journal_name: Journal of Market Access & Health Policy

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

ReferenceCitation: Fernandes S, Fond G, Zendjidjian XY, Baumstarck K, Lançon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L; French PREMIUM Group. Measuring the Patient Experience of Mental Health Care: A Systematic and Critical Review of Patient-Reported Experience Measures. Patient Prefer Adherence. 2020 Nov 3;14:2147-2161. doi: 10.2147/PPA.S255264. eCollection 2020. Review.

ReferenceCitation: Fernandes S, Fond G, Zendjidjian X, Michel P, Baumstarck K, Lancon C, Berna F, Schurhoff F, Aouizerate B, Henry C, Etain B, Samalin L, Leboyer M, Llorca PM, Coldefy M, Auquier P, Boyer L. The Patient-Reported Experience Measure for Improving qUality of care in Mental health (PREMIUM) project in France: study protocol for the development and implementation strategy. Patient Prefer Adherence. 2019 Jan 21;13:165-177. doi: 10.2147/PPA.S172100. eCollection 2019.

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

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hopital de la conception Assistance Publique Hôpitaux de Marseille