title: Clearance of Acetate During Fluid Resuscitation of Critically Ill Burn Patients: The CARE Trial.

acronym: CARE

summary:
Balanced solutions with low chloride concentration could represent an alternative to high chloride concentration solutions. Such balanced solutions contain other acid as buffers (i.e. acetate and/or gluconate). However, acetate has been associated with alteration of cardiac function when used as buffer in dialysate when high acetate concentrations are used and could promote the development of metabolic acidosis if it accumulates. Therefore, the safety of such solutions remains poorly explored. Because critically ill patients receive large amount of fluid during the early phase of resuscitation, large amount of acetate are to be administrated if such solutions are used. While acetate-containing solutions have been suggested to be safe in this setting, studies are still lacking regarding clearance and accumulation in critically ill patients.

It is expected to include 28 patients, the objective to analyze the data of 20 patients.

ReferenceCitation: Hahn RG. Should anaesthetists stop infusing isotonic saline? Br J Anaesth. 2014 Jan;112(1):4-6. doi: 10.1093/bja/aet292.

ReferenceCitation: Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.

ReferenceCitation: Zhou F, Peng ZY, Bishop JV, Cove ME, Singbartl K, Kellum JA. Effects of fluid resuscitation with 0.9% saline versus a balanced electrolyte solution on acute kidney injury in a rat model of sepsis*. Crit Care Med. 2014 Apr;42(4):e270-8. doi: 10.1097/CCM.0000000000000145.

ReferenceCitation: Davies PG, Venkatesh B, Morgan TJ, Presneill JJ, Kruger PS, Thomas BJ, Roberts MS, Mundy J. Plasma acetate, gluconate and interleukin-6 profiles during and after cardiopulmonary bypass: a comparison of Plasma-Lyte 148 with a bicarbonate-balanced solution. Crit Care. 2011;15(1):R21. doi: 10.1186/cc9966. Epub 2011 Jan 14.

ReferenceCitation: Morgan TJ, Power G, Venkatesh B, Jones MA. Acid-base effects of a bicarbonate-balanced priming fluid during cardiopulmonary bypass: comparison with Plasma-Lyte 148. A randomised single-blinded study. Anaesth Intensive Care. 2008 Nov;36(6):822-9. Erratum in: Anaesth Intensive Care. 2012 Jul;40(4):719.

location_facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital


type: EudraCT Number

title: Impact of Empaglifozine on Cardiac Ectopic Fat

acronym: EMPACEF

summary: There is substantial evidence supporting the fact that ectopic fat accumulation is an important contributor to type 2 diabetes complications and cardiovascular risk [1]. Epicardial adipose tissue (EAT), located between the myocardium and the visceral layer of the pericardium has been associated with atrial fibrillation and with coronary artery disease [2, 3] and its abundance predicts the number of cardiac events within 8 years [4]. In addition, myocardial steatosis has been shown to be an independent predictor of diastolic dysfunction [5] [6]. Furthermore, in type 2 diabetic patients, bariatric surgery can reduce cardiac ectopic fat accumulation and improve cardiac function [7] [8]. When added to standard care, 10 or 25 mg/d of empagliflozin, an inhibitor of sodium-glucose cotransporter 2 (iSGLT2), significantly reduces the risk of death, cardiovascular death, and hospitalisation for heart failure among individuals with type 2 diabetes and established cardiovascular disease when compared to placebo [9]. The mechanisms of empagliflozin-improved cardiovascular outcomes in type 2 diabetic patients at high risk of cardiovascular events are not known. We hypotheses that empaglifozin could modulate cardiac ectopic fat and cardiac metabolism in obese type 2 diabetic patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gaborit B, Ancel P, Abdullah AE, Maurice F, Abdesselam I, Calen A, Soghomonian A, Houssays M, Varlet I, Eisinger M, Lasbleiz A, Peiretti F, Bornet CE, Lefur Y, Pini L, Rapacchi S, Bernard M, Resseguier N, Darmon P, Kober F, Dutour A. Effect of empagliflozin on ectopic fat stores and myocardial energetics in type 2 diabetes: the EMPACEF study. Cardiovasc Diabetol. 2021 Mar 1;20(1):57. doi: 10.1186/s12933-021-01237-2.

family: Gaborit

full_name: B. Gaborit

given: B.

sequence: first

family: Ancel

full_name: P. Ancel

given: P.

sequence: additional

family: Abdullah

full_name: A. E. Abdullah

given: A. E.

family: Maurice

full_name: F. Maurice

given: F.

family: Abdesselam

full_name: I. Abdesselam

given: I.

family: Calen

full_name: A. Calen

given: A.

family: Soghomonian

full_name: A. Soghomonian

family: Houssays

full_name: M. Houssays

given: M.

family: Varlet

full_name: I. Varlet

family: Eisinger

full_name: M. Eisinger

family: Lasbleiz

full_name: A. Lasbleiz

family: Peiretti

full_name: F. Peiretti

family: Bornet

full_name: C. E. Bornet

given: C. E.

family: Lefur

full_name: Y. Lefur

given: Y.

family: Pini

full_name: L. Pini

given: L.

family: Rapacchi

full_name: S. Rapacchi

given: S.

family: Bernard

full_name: M. Bernard

family: Resseguier

full_name: N. Resseguier

given: N.

family: Darmon

full_name: P. Darmon

family: Kober

full_name: F. Kober

family: Dutour

full_name: A. Dutour

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cardiovascular Diabetology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Biomarkers of Antidepressant Resistance - BIORESA

acronym: BIORESA

summary:
According to the WHO, major depressive disorders have become the second worldwide cause of disability. Treatment, long-term medication, leads to frequent resistance (up to 40%).

Establishing a cerebral molecular signature of depression is not feasible in humans (need for cerebral samples). The alternative is to use peripheral biological samples (blood, urine, saliva).

Metabolomic is the integrated and quantitative study of all the metabolites of a biological system. This aims to define the metabolic status of an organism for a particular condition.

Metabolites are derived from biological extracts (cells, tissues, serum, plasma, urine, etc.) and are detected by:

liquid or gas chromatography coupled to mass spectrometry (LC-MS, GC-MS),
proton nuclear magnetic resonance (1 H-NMR). The biomarkers resulting from these studies have become important diagnostic criteria, measured objectively and evaluated as indicators of a normal or pathological state, or even predictors of treatment efficacy.

This approach allows the discovery of biomarkers that best describe the status of a disease for better understanding and are usable in a context of individualized medicine, with effects on clinical practice and management.

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: University Hospital, Tours

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Bioimpedance Variation of Free Flap for After Clamping - MONITRANS

acronym: MONITRANS

summary:
MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home.

Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology.

During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations.

Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Device


title: Tracking and Exploring the Source of Viral REbound

acronym: TESOVIR

summary: Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Descours B, Petitjean G, López-Zaragoza JL, Bruel T, Raffel R, Psomas C, Reynes J, Lacabaratz C, Levy Y, Schwartz O, Lelievre JD, Benkirane M. CD32a is a marker of a CD4 T-cell HIV reservoir harbouring replication-competent proviruses. Nature. 2017 Mar 23;543(7646):564-567. doi: 10.1038/nature21710. Epub 2017 Mar 15. Erratum in: Nature. 2017 Jun 28;546(7660):686.

family: Descours

full_name: Benjamin Descours

given: Benjamin

family: Petitjean

full_name: Gaël Petitjean

given: Gaël

family: López-Zaragoza

full_name: José-Luis López-Zaragoza

given: José-Luis

family: Bruel

full_name: Timothée Bruel

given: Timothée

family: Raffel

full_name: Raoul Raffel

given: Raoul

family: Psomas

full_name: Christina Psomas

given: Christina

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Lacabaratz

full_name: Christine Lacabaratz

given: Christine

family: Levy

full_name: Yves Levy

given: Yves

family: Schwartz

full_name: Olivier Schwartz

given: Olivier

family: Lelievre

full_name: Jean Daniel Lelievre

given: Jean Daniel

family: Benkirane

full_name: Monsef Benkirane

given: Monsef

bso_classification:
Earth, Ecology,
Energy and applied biology

journal_name: Nature

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier Régional d'Orléans

status_simplified: Ongoing


title: Comparison of Peripheral Perfusion Level Between Two Groups of Newborns According to Their Infectious Status Defined by the Criteria of the Center for Disease Control and Prevention (CDC)

summary:
Despite advances in medicine, secondary neonatal infection remains a continuing concern because of the associated high morbidity and mortality. The usual mechanism of infection responds to the transmission of germs by the equipment used for care (eg, catheters) and by the hands of caregivers. In preterm infants in particular, some infections can also have an endogenous source, by translocation of colonization germs present in the digestive tract.

The first line of prevention of secondary infection corresponds to compliance with the rules of hand hygiene, work surfaces and equipment carried out, the effect of which on the control of the incidence of secondary infection is regularly demonstrated. When declared, bacterial infection should be treated as quickly as possible with appropriate and effective antibiotics to preserve the healing prognosis. Compared to the infant and the larger child, clinical signs of calling are atypical and discrete. In the absence of staff trained to monitor newborns specifically, there is a real risk of discovering the existence of the infection only at an advanced stage corresponding, among other things, to circulatory collapse. This risk is not completely excluded, even with experienced practitioners, because the positive signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems has reduced mortality by 30% in the units where it has been applied. This is probably due to the fact that early warning made it possible to start the antibiotic treatment earlier and to complete the bacteriological diagnosis in order to better orient the therapeutic attitude. The best criteria for early diagnosis by automated systems were provided by the statistical analysis of cardiac variability, the results of the research and correspond to the standard deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial aggression has an impact on many vegetative variables outside of the electrocardiogram, our current research aims to determine whether the analysis of the perfusion index (PI) Which are of interest for detecting disturbances in the early stages of infection in newborns. IP corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the constant part of the opto-plethysmography wave; It is obtained from signals recorded in a non-invasive manner by the same infrared sensor for pulse oximetry.

status: Unknown status

study_type: Observational

time_perspective: Prospective

status_simplified: Unknown


title: Mortality of Patients Undergoing Fracture of the Upper Extremity u Femur at the University Hospital of Amiens

acronym: FESF-Amiens

summary:
Fractures of the upper femur (EFSF) represent a major public health problem in the elderly. Approximately 1.6 million patients are victims each year of an EFSF and this number is increasing as a result of the aging of the population.

In a recent Amiens retrospective study the mortality was estimated to be 22.5% at 1 year of the fracture. In surviving patients, the impact on loss of autonomy and degradation of quality of life is considerable.

The reduction of the incidence of post-operative complications includes the identification of risk factors.

No prospective study in Amiens has investigated the mortality and the study of the variables involved in the prognosis and long-term mortality of these patients.


title: The Impact of Meditation Practice on Attention and Emotion Regulation :Studies on Neural Correlation in Brain Imagery and Biomarkers of Stress and Inflammation

acronym: MEDITATION

summary: The main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. By investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG), ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI; including Diffusion tensor - DTI). These brain measures will then be linked to behavioral measurements. Experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.

design_allocation: Non-Randomized

lead_sponsor: Hospices Civils de Lyon


title: Patient Follow-up After Consultation in Emergency Department

summary: Each year more than 15 million French people visit the emergency services and almost 80% of them come out without hospitalization after having undergone a clinical examination and possibly additional examinations.

primary_purpose: Device Feasibility


title: Study on the Parameters That Influence Perceptual Decisions

summary: The study aimed to understand how payoffs for others influence perceptual decision making. The research consists in testing how varying monetary payoffs for another modify the perceptual decision making processes. The use of drift diffusion models on a random dots task enable the characterization of the decision parameter(s) that are modulated when a decision is made to win payoffs for others as compared to decisions for self-benefits. Once the parameter revealed through behavioral experiment, neuroimaging is applied to find the neural correlates of the effects of taking others into account in the decision making process.

status: Terminated


title: Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence

summary: The purpose of the study is to describe the number of diagnosis of bipolar depression and comorbid suicidal behavior according to the diagnostic criteria of the DSM-5.

primary_purpose: Screening

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval

lead_sponsor_type: industriel


title: Reduced Time on Floor After Falls at Night of People Living in Long Term Care Facilities - NoDelayFall Study

acronym: NoDelayFall

summary:
In the context of reduce staff for supervision of dependent elderly, automated risk alert systems could have a positive impact on the organization of night care by better targeting monitoring. Residents' sleep could be less affected with use of automatic alert system than by systematic monitoring visits. One study shows an improvement in the humor of residents after the use of such a system.

The hypothesis of the study is that the use of a bed-raising detection system linked with the activation of a lighting environment and a caregivers alert system (Etolya-F® gerontechnology device, Anaxi Technology Company) would reduce intervention time in this population, thus limiting the time spent on floor and its physical and psychological consequences.

status: Withdrawn

ReferenceType: background

ReferenceCitation: Rapp K, Becker C, Cameron ID, König HH, Büchele G. Epidemiology of falls in residential aged care: analysis of more than 70,000 falls from residents of bavarian nursing homes. J Am Med Dir Assoc. 2012 Feb;13(2):187.e1-6. doi: 10.1016/j.jamda.2011.06.011. Epub 2011 Aug 4.

ReferenceCitation: Pellfolk T, Gustafsson T, Gustafson Y, Karlsson S. Risk factors for falls among residents with dementia living in group dwellings. Int Psychogeriatr. 2009 Feb;21(1):187-94. doi: 10.1017/S1041610208007837. Epub 2008 Oct 6.

ReferenceCitation: Jensen J, Lundin-Olsson L, Nyberg L, Gustafson Y. Falls among frail older people in residential care. Scand J Public Health. 2002;30(1):54-61.

ReferenceCitation: Vu MQ, Weintraub N, Rubenstein LZ. Falls in the nursing home: are they preventable? J Am Med Dir Assoc. 2006 Mar;7(3 Suppl):S53-8, 52.

ReferenceCitation: Lach HW, Parsons JL. Impact of fear of falling in long term care: an integrative review. J Am Med Dir Assoc. 2013 Aug;14(8):573-7. doi: 10.1016/j.jamda.2013.02.019. Epub 2013 Apr 16. Review.

ReferenceCitation: Fleming J, Brayne C; Cambridge City over-75s Cohort (CC75C) study collaboration. Inability to get up after falling, subsequent time on floor, and summoning help: prospective cohort study in people over 90. BMJ. 2008 Nov 17;337:a2227. doi: 10.1136/bmj.a2227.

ReferenceCitation: Bergland A, Laake K. Concurrent and predictive validity of "getting up from lying on the floor". Aging Clin Exp Res. 2005 Jun;17(3):181-5.

ReferenceCitation: Lester P, Haq M, Vadnerkar A, Feuerman M. Falls in the nursing home setting: does time matter? J Am Med Dir Assoc. 2008 Nov;9(9):684-6. doi: 10.1016/j.jamda.2008.06.007. Epub 2008 Sep 25.

ReferenceCitation: Pélissier C, Vohito M, Fort E, Sellier B, Agard JP, Fontana L, Charbotel B. Risk factors for work-related stress and subjective hardship in health-care staff in nursing homes for the elderly: A cross-sectional study. J Occup Health. 2015;57(3):285-96. doi: 10.1539/joh.14-0090-OA. Epub 2015 Apr 10.

ReferenceCitation: Capezuti E, Brush BL, Lane S, Rabinowitz HU, Secic M. Bed-exit alarm effectiveness. Arch Gerontol Geriatr. 2009 Jul-Aug;49(1):27-31. doi: 10.1016/j.archger.2008.04.007. Epub 2008 Jun 3.

ReferenceCitation: Banerjee S, Steenkeste F, Couturier P, Debray M, Franco A. Telesurveillance of elderly patients by use of passive infra-red sensors in a 'smart' room. J Telemed Telecare. 2003;9(1):23-9.

ReferenceCitation: Lipsitz LA, Tchalla AE, Iloputaife I, Gagnon M, Dole K, Su ZZ, Klickstein L. Evaluation of an Automated Falls Detection Device in Nursing Home Residents. J Am Geriatr Soc. 2016 Feb;64(2):365-8. doi: 10.1111/jgs.13708. Epub 2016 Jan 19.

ReferenceCitation: Tinetti ME, Williams CS. Falls, injuries due to falls, and the risk of admission to a nursing home. N Engl J Med. 1997 Oct 30;337(18):1279-84.

ReferenceCitation: Parker MJ, Gillespie WJ, Gillespie LD. Effectiveness of hip protectors for preventing hip fractures in elderly people: systematic review. BMJ. 2006 Mar 11;332(7541):571-4. Epub 2006 Mar 2. Review.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility: Résidence St François CH ANNECY-GENEVOIS


title: Impact of Tracheal Tube Fixing Site on Its Mobility During Head Mobilization

acronym: Fix-IOT

summary:
This study evaluate the secondary shifting of the tracheal tube when the head is moved under general anaesthesia. Two sites of fixation (the maxilla and the mandible) are tested in a prospective, double blind, randomized and crossover designed study.

The study test the hypothesis that taping the tracheal tube on the mandible better prevents a secondary tube move.

primary_purpose: Supportive Care

ReferenceCitation: Conrardy PA, Goodman LR, Lainge F, Singer MM. Alteration of endotracheal tube position. Flexion and extension of the neck. Crit Care Med. 1976 Jan-Feb;4(1):8-12.

ReferenceCitation: Yap SJ, Morris RW, Pybus DA. Alterations in endotracheal tube position during general anaesthesia. Anaesth Intensive Care. 1994 Oct;22(5):586-8.

ReferenceCitation: Hartrey R, Kestin IG. Movement of oral and nasal tracheal tubes as a result of changes in head and neck position. Anaesthesia. 1995 Aug;50(8):682-7.

ReferenceCitation: Sugiyama K, Yokoyama K. Displacement of the endotracheal tube caused by change of head position in pediatric anesthesia: evaluation by fiberoptic bronchoscopy. Anesth Analg. 1996 Feb;82(2):251-3.

ReferenceCitation: Rost JR, Frush DP, Auten RL. Effect of neck position on endotracheal tube location in low birth weight infants. Pediatr Pulmonol. 1999 Mar;27(3):199-202.

ReferenceCitation: Olufolabi AJ, Charlton GA, Spargo PM. Effect of head posture on tracheal tube position in children. Anaesthesia. 2004 Nov;59(11):1069-72.

ReferenceCitation: Weiss M, Knirsch W, Kretschmar O, Dullenkopf A, Tomaske M, Balmer C, Stutz K, Gerber AC, Berger F. Tracheal tube-tip displacement in children during head-neck movement--a radiological assessment. Br J Anaesth. 2006 Apr;96(4):486-91. Epub 2006 Feb 7. Review.

ReferenceCitation: Jordi Ritz EM, Von Ungern-Sternberg BS, Keller K, Frei FJ, Erb TO. The impact of head position on the cuff and tube tip position of preformed oral tracheal tubes in young children. Anaesthesia. 2008 Jun;63(6):604-9. doi: 10.1111/j.1365-2044.2008.05440.x.

family: Jordi Ritz

full_name: E.-M. Jordi Ritz

family: Von Ungern-Sternberg

full_name: B. S. Von Ungern-Sternberg

given: B. S.

family: Keller

full_name: K. Keller

given: K.

family: Frei

full_name: F. J. Frei

given: F. J.

family: Erb

full_name: T. O. Erb

given: T. O.

journal_name: Anaesthesia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Kim JT, Kim HJ, Ahn W, Kim HS, Bahk JH, Lee SC, Kim CS, Kim SD. Head rotation, flexion, and extension alter endotracheal tube position in adults and children. Can J Anaesth. 2009 Oct;56(10):751-6. doi: 10.1007/s12630-009-9158-y. Epub 2009 Jul 29.

family: Kim

full_name: Jin-Tae Kim

given: Jin-Tae

full_name: Hyun-Jung Kim

given: Hyun-Jung

family: Ahn

full_name: Wonsik Ahn

given: Wonsik

full_name: Hee-Soo Kim

given: Hee-Soo

family: Bahk

full_name: Jae-Hyon Bahk

given: Jae-Hyon

family: Lee

full_name: Sang-Chul Lee

given: Sang-Chul

full_name: Chong-Sung Kim

given: Chong-Sung

full_name: Seong-Deok Kim

given: Seong-Deok

journal_name: Canadian Journal of Anesthesia/Journal canadien d'anesthésie

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: University Hospital, Brest


title: Clinical Situations Leading to the Prescription of Neuroleptics by General Practitioner in the Elderly. Practice Survey

acronym: NEUGERPRAT

summary:
Behavioral disorders of psychiatric or neurological origin in the elderly are an emerging public health problem. Its management can include a prescription of psychotropic drugs (anxiolytics, hypnotics, neuroleptics, antidepressants for the most part). Many studies highlight the misuse of psychotropic drugs in this specific and vulnerable population, as well as the need for targeted actions.

As for neuroleptics, there is a deleterious over-prescription in the so-called productive behavioral disorders (cries, agitation, aggressiveness, ambulation), in particular in the patient with Alzheimer's disease (80% of patients) or related. The same applies to behavioral disorders in an acute episode of confusion, which also constitute a situation for the prescribing of psychotropic drugs in the elderly. The frailty of the elderly associated with neuroleptics is the cause of a significant iatrogenic (falls, confusions, excessive sedation, etc.), iatrogeny is largely avoidable.

There is little data on the representation of behavioral disorders in the elderly, whereas the recognition and management of behavioral disorders are functions of the tolerance of the entourage and the training of the caregivers. Significant data exist in the literature about diagnosis, risk factors, factors favoring or triggering behavioral disorders and somatic pathologies to be sought urgently.

The available recommendations on the drug treatment of behavioral disorders are complex and inappropriate in light of new data, including the dangerousness of psychotropic drugs. The deleterious effect of long-term drug treatments is proved. There is no validated drug strategy, especially in acute confusions of the elderly.

One study showed that there was a change in the type of neuroleptic prescribed between 2003 and 2010. Half of the general practitioners studied during this period switched from a first-generation neuroleptic to a second-generation neuroleptic. Nevertheless, the type of molecule chosen remains at the discretion of the treating physician or even required a psychiatric opinion or a passage in the emergencies. In the case where the practitioner initiates a prescription in office, in the home or in EHPAD, certain situations require the choice of a neuroleptic with or without pre-therapeutic assessment.


type: Registry Identifier

title: Contrast Enhanced Ultrasound of Carotid Plaque in Acute Ischemic Stroke

acronym: CUSCAS

summary: This is a biomedical, single-center, and prospective study of a consecutive patients cohort in acute ischemic stroke with carotid plaque.

primary_purpose: Prevention

ipd_sharing: Undecided

lead_sponsor: Versailles Hospital


title: Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.

acronym: SIMOVI IRM 2

summary:
The problem posed is the possibility of objectively assessing facial muscle mobility.

Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.

Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation.

Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections.

Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example.

The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.

primary_purpose: Other


title: Astrocytoma / Desmoplastic Gamliogliomes (DIA / DIG) - Study of the French Cohort of the Last 20 Years : Clinical, Anatomopathological, Molecular and Radiological Charactersics

acronym: DIA/DIG

summary:
Astrocytomas / infantile desmoplastic gangliogliomas (DIA / DIG) are rare brain tumors usually affecting infants. They represent about 0.5% of all pediatric brain tumors. DIA / DIG occurs mainly in the first 2 years of life, with a sex ratio M / F of 1.7 to 1. From a histological point of view, DIA / DIG are neuroepithelial tumors. These tumors may have a purely astrocytic differentiation (DIA) or be composed of tumor cells with astrocytic and neuronal differentiation (DIG). The desmoplastic component is usually adjacent to the meninges and is defined by the increase or modification of connective tissues related to the presence of neoplastic cells with the formation of a collagen-rich extracellular matrix.

Due to their benign biological behavior and favorable clinical course, they are classified in benign tumors, ie grade I according to the WHO classification. However, all tumors called DIA / DIG do not behave in a benign manner. Cases of metastatic cerebrospinal and malignant disorders have been described. It appears that about 40% of DIG cases require additional medical treatment such as chemotherapy, radiotherapy and / or new surgery, and 15% of infants and children with GIDD die from the disease. It is possible that what is grouped within the DIA / DIG is a heterogeneous group of tumors, evolution and prognosis very variable.

The cytogenetic knowledge of DIA / DIG is very limited and is only available on small numbers of cases. Cytogenetic analyzes of several cases of DIG showed normal karyotypes. More recently, a CGH-Array study of 3 cases of DIA / DIG did not find any significant chromosomal gains or losses.

It has been shown, however, that a mutation involving BRAF (BRAF rearrangement or BRAF V600E mutations) was a recurrent element in low grade gliomas, particularly in pediatric patients.

It is also suggested that deregulation of BRAF activity in some DIA / DIG may indicate the importance of the MAPK (mitogen-activated protein kinase) pathway in signaling pathways for DIA / DIG development. However, data on the link between the BRAF gene and DIA / DIG remains very limited. Thus, further studies are needed to study the other members of the MAPK pathway in DIA / DIG (eg PI3K / AKT / mTOR). This could provide new therapeutic possibilities involving targeted therapies specific to the MAPK signaling pathway.

It appears that DIA / DIG does not all behave in a benign manner and some would undergo a malignant transformation that could be due to chromosomal alterations such as, for example, TP53, PI3K. In addition, because of the limited number of cases, it would be interesting to study the characteristics of patients with DIA / DIG in order to study their characteristics and whether there are clinical, pathological, cytogenetic and / Molecular forms between benign and malignant forms.

time_perspective: Retrospective


title: Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.

acronym: Bi-GLAM

summary:
Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.

It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.


title: Descriptive Study of the Evolution in Proportion of Regulatory B Lymphocytes in Patients Hospitalized in Intensive Care for Severe Sepsis

acronym: DELyBREG

summary:
Severe sepsis and septic shock are the most severe forms of sepsis (which associates a systemic inflammatory response with infection). These are serious pathologies with a lethality estimated at almost 40% at 28 days (after the onset of sepsis).

After a first pro-inflammatory phase, a second compensatory phase called Compensatory Anti-Inflammatory Response Syndrome (CARS) takes place quickly. Patients then show signs of immunosuppression and profound alterations in immune functions. It is during this phase that the vast majority of deaths occur, far from the onset of the shock, which is related to the inability of the immune system to eliminate the initial infectious agent and / or a greater susceptibility Important to develop secondary infections (nosocomial infection, latent virus reactivation ...).

The CARS phase has been the subject of studies focusing on measuring the plasma concentration of anti-inflammatory cytokines (such as Interleukin (IL) -10), the percentage of regulatory T lymphocytes (Treg), Or the percentage of monocytic expression of HLA-DR in septic patients.

The investigator proposes to carry out the first study on a newly described regulatory lymphocytic subpopulation: regulatory B lymphocytes (Breg) from a quantitative and functional point of view in severe septic states.


title: Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First Month After Returning Home, Since the Introduction of Standard Outpatients (According to HAS 2014 Recommendations) at the Amiens-Picardie University Hospital

acronym: COMPLISTAN

summary:
Prior to the HAS recommendations of March 2014, the "mother - newborn" couple was discharged from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section.

The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings.

In March 2014, the HAS published new recommendations on maternity leave arrangements for the "mother - newborn" couple, the organization of postpartum follow - up for the mother and pediatric follow - up for the newborn. The HAS then defines so-called "optimal" conditions for so-called "standard" outputs, with 9 criteria to respect respectively for the mother and the newborn.

If the mother-to-newborn couple respects these so-called optimal conditions and is eligible according to the respective criteria, the latter leaves at home after 72 hours and before 96 hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery.

As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an arbitrary choice was made to allow a "standard" release to the "mother-newborn" couple only if the child was born between 00H00 and 11H59 so that his clinical examination of exit is carried out at 72 hours of the birth as recommended by the recommendations of the HAS.

These recommendations being recent (2014), no study has studied the impact and consequences on the triad "father / mother-newborn" of these exits including the occurrence of possible complications or events: re-hospitalizations again The early termination of breastfeeding, and whether the follow-up procedures advocated by the HAS are being followed.


title: Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.

acronym: NEUROSEV

summary:
The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%.

Cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation.

Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).


title: Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients

acronym: VE-CART

summary:
Renal transplant patients have on average 3-5 times more risk of developing cancer than the general population. This rate can be increased up to 10 to 15 times in some type of cancer like kidney cancer. Among the identified risk factors, immunosuppressants and, in particular, calcineurin inhibitors (ciclosporin and tacrolimus) play a major role in increasing cancers apart from their depressant effects on the immune system.

Calcineurin inhibitors (CCN) are the basis of immunosuppressive therapy in renal transplantation. Several mechanisms have been implicated to explain their pro-oncogenic properties. One related to an increase in VEGF expression seems particularly interesting in the study of renal cell carcinoma in the transplanted patient. Indeed, the physiopathology of kidney cancer has clearly been associated with an increase in the production of VEGF. Furthermore, some polymorphisms of the gene encoding VEGF have already been associated with the survival of patients with renal carcinoma and the circulating level of VEGF in the general population. The search for an association between the polymorphisms of the VEGF gene and renal carcinoma in renal transplant patients could thus identify patients whose risk of renal cell carcinoma (cRCC) post-transplantation is increased. If the involvement of certain polymorphisms in the development of cRCC was confirmed in this population, their research before the introduction of the immunosuppressive treatment would make it possible to direct the choice of treatment towards molecules without pro-oncogenic property in the Patients such as mTOR protein inhibitors (sirolimus, everolimus). This research project is therefore in line with the desire to move towards a more "personalized" medicine that could be beneficial for the patient.

intervention_type: Genetic


title: Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service? Randomized Controlled Trial

acronym: KISEVEN

summary: Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation


title: Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?

acronym: SynchroPrema

summary: Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive development of the baby.


title: Evaluation of the Measurement of Cardiac Output by the NEXFIN HD Monitor in Peroperative

acronym: NEXFIN

summary:
Continuous perioperative cardiac output (DC) and blood pressure (PA) monitoring contributes to hemodynamic stability and ensures adequate perfusion pressure, resulting in a reduction in morbidity and mortality and length of hospital stay.

The monitors usually used in perioperative are either semi-invasive and difficult for calibration (oesophageal Doppler) or invasive (arterial catheter).

The Nexfin HD allows these two measurements and it is completely non-invasive, remains to validate its use in peroperative.


title: Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

acronym: ADULT

summary:
Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.

These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.

study_start_date_type: Anticipated

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon


ReferenceCitation: Bittel DC, Kibiryeva N, Sell SM, Strong TV, Butler MG. Whole genome microarray analysis of gene expression in Prader-Willi syndrome. Am J Med Genet A. 2007 Mar 1;143A(5):430-42.

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ReferenceCitation: Guastella AJ, Einfeld SL, Gray KM, Rinehart NJ, Tonge BJ, Lambert TJ, Hickie IB. Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders. Biol Psychiatry. 2010 Apr 1;67(7):692-4. doi: 10.1016/j.biopsych.2009.09.020. Epub 2009 Nov 7.

ReferenceCitation: Guastella AJ, Gray KM, Rinehart NJ, Alvares GA, Tonge BJ, Hickie IB, Keating CM, Cacciotti-Saija C, Einfeld SL. The effects of a course of intranasal oxytocin on social behaviors in youth diagnosed with autism spectrum disorders: a randomized controlled trial. J Child Psychol Psychiatry. 2015 Apr;56(4):444-52. doi: 10.1111/jcpp.12305. Epub 2014 Aug 2.

ReferenceCitation: Hall SS, Lightbody AA, McCarthy BE, Parker KJ, Reiss AL. Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome. Psychoneuroendocrinology. 2012 Apr;37(4):509-18. doi: 10.1016/j.psyneuen.2011.07.020. Epub 2011 Aug 20.

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ReferenceCitation: Tauber M, Mantoulan C, Copet P, Jauregui J, Demeer G, Diene G, Rogé B, Laurier V, Ehlinger V, Arnaud C, Molinas C, Thuilleaux D. Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients. Orphanet J Rare Dis. 2011 Jun 24;6:47. doi: 10.1186/1750-1172-6-47.

family: Tauber

full_name: Maïthe Tauber

given: Maïthe

family: Mantoulan

full_name: Carine Mantoulan

given: Carine

family: Copet

full_name: Pierre Copet

given: Pierre

family: Jauregui

full_name: Joseba Jauregui

given: Joseba

family: Demeer

full_name: Genevieve Demeer

given: Genevieve

family: Diene

full_name: Gwenaëlle Diene

given: Gwenaëlle

family: Rogé

full_name: Bernadette Rogé

given: Bernadette

family: Laurier

full_name: Virginie Laurier

given: Virginie

family: Ehlinger

full_name: Virginie Ehlinger

family: Arnaud

full_name: Catherine Arnaud

given: Catherine

family: Molinas

full_name: Catherine Molinas

family: Thuilleaux

full_name: Denise Thuilleaux

given: Denise

journal_name: Orphanet Journal of Rare Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

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

ReferenceCitation: van Lieshout CF, de Meyer RE, Curfs LM, Koot HM, Fryns JP. Problem behaviors and personality of children and adolescents with Prader-Willi syndrome. J Pediatr Psychol. 1998 Apr;23(2):111-20.

ReferenceCitation: Yatawara CJ, Einfeld SL, Hickie IB, Davenport TA, Guastella AJ. The effect of oxytocin nasal spray on social interaction deficits observed in young children with autism: a randomized clinical crossover trial. Mol Psychiatry. 2016 Sep;21(9):1225-31. doi: 10.1038/mp.2015.162. Epub 2015 Oct 27.

location_facility: Centre de référence du syndrome de Prader-Willi Hôpital des Enfants

title: Effects of Intranasal Administrations of Oxytocin on Behavioural Troubles, Hyperphagia and Social Skills in Children With Prader-Willi Syndrome Aged From 3 to 12 Years.

summary: Positive results in preclinical and clinical studies in adults and infants with Prader-Willi syndrome lead investigators to set up a new study in children with Prader-Willi syndrome. The objective of this study is to document effects of oxytocin intranasal administrations on behavioural troubles in children with Prader-Willi syndrome aged from 3 to 12 years.


title: Induction Therapy With Docetaxel, Cisplatin, 5-Fluoro Uracil and Pembrolizumab in Untreated Locally-advanced Unresectable Squamous Cell Head and Neck Carcinoma (Pembrolizumab and Induction Chemotherapy in Head and Neck Squamous Cell Carcinoma. PICH Study)

acronym: PICH

summary:
Non-randomized phase I/II, open-labeled clinical study, 1-arm, multicenter, of docetaxel (T), cisplatin (P), 5-fluorouracil (F) and pembrolizumab every 21 days for 3 cycles followed by radiotherapy (RT) combined with carboplatin in untreated unresectable locally-advanced Head and Neck Squamous Cell Carcinoma (HNSCC).

The TPF and pembrolizumab combination will be called TP²F.

lead_sponsor: Centre Antoine Lacassagne


title: Involvement of Viral Infections in the Pathogenesis of Chronic Lymphocytic Thyroiditis

acronym: Etude thyrovir

summary:
Autoimmune diseases represent a heterogeneous group of pathologies whose etiopathogenic mechanisms are most often unknown. Autoimmune diseases are the leading cause of morbidity and mortality in young women and autoimmune thyroid diseases are the most common.

Viral infections are the main environmental factors suspected of triggering autoimmune diseases. Several viruses are certainly involved, all of which are possibly capable of triggering an autoimmune response. However, the precise identification of the viruses involved remains to be established.

It has been shown for the first time by the 2005 PHRC that enteroviral RNA is present in perioperative specimens of thyroid tissue. However, this case-control study did not show any difference between the thyroid group and the group other thyroid pathologies It has been recently published that Parvovirus is possibly involved in thyroiditis: the parvoviral genome is present in the thyroid tissue of Hashimoto thyroiditis operated and more precisely is present within the thyrocytes itself.


ReferenceCitation: Juntas-Morales R, Pageot N, Bendarraz A, Alphandéry S, Sedel F, Seigle S, Camu W. High-dose pharmaceutical grade biotin (MD1003) in amyotrophic lateral sclerosis: A pilot study. EClinicalMedicine. 2020 Jan 27;19:100254. doi: 10.1016/j.eclinm.2019.100254. eCollection 2020 Feb.

family: Juntas-Morales

full_name: Raul Juntas-Morales

given: Raul

family: Pageot

full_name: Nicolas Pageot

given: Nicolas

family: Bendarraz

full_name: Abdelkarim Bendarraz

given: Abdelkarim

family: Alphandéry

full_name: Sébastien Alphandéry

given: Sébastien

family: Sedel

full_name: Frédéric Sedel

given: Frédéric

family: Seigle

full_name: Stéphanie Seigle

given: Stéphanie

family: Camu

full_name: William Camu

given: William

currency_apc_doaj: USD

journal_name: EClinicalMedicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug

lead_sponsor: MedDay Pharmaceuticals SA

source: euctr

title: Effect of MD1003 in Amyotrophic Lateral Sclerosis: a Randomized Double Blind Placebo Controlled Pilot Study

summary: This is a 6-month double blind randomized 2:1 placebo-controlled study with two arms (placebo, biotin 300 mg/day). The study will be followed by a 6-month extension phase during which all patients will receive biotin 300 mg/day.


title: Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

summary:
The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.

The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.

Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.

A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility, bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.

No previous clinical trial

lead_sponsor: Laboratoire Ceraver-Osteal


title: Construction and Validation of a Functional Score for the Detection of Ruptures of the Anterior Cruciate Ligament in the Immediate Post-traumatic Period

acronym: ACL-TS

summary:
This study develops the construction and validation of a reliable functional screening score in LCA ruptures in the immediate post-traumatic period.

This score, realizable in an emergency, would be an early warning signal requiring an emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA ruptures at a time when ligament testing maneuvers are too painful to be contributory to the diagnosis. It would avoid a premature return to dangerous activity for the knee with a rupture of the LCA.

The other impact would be economical since it would avoid the realization of unnecessary MRI.

On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The hypothesis of the study is that a validated functional score would make it possible to sort the patients in the emergencies and to prescribe the MRI only in the cases of effective rupture of the LCA.

status: Active, not recruiting

ReferenceCitation: Ahldén M, Hoshino Y, Samuelsson K, Araujo P, Musahl V, Karlsson J. Dynamic knee laxity measurement devices. Knee Surg Sports Traumatol Arthrosc. 2012 Apr;20(4):621-32. doi: 10.1007/s00167-011-1848-7. Epub 2011 Dec 31. Review.

ReferenceCitation: Bollen SR, Scott BW. Rupture of the anterior cruciate ligament--a quiet epidemic? Injury. 1996 Jul;27(6):407-9.

ipd_sharing_description: In this study, the individual participant data (IPD) is not available to other researchers

lead_sponsor: French Arthroscopic Society


title: Analysis of the Role of Hepatocyte SLAMF3 Receptor and Drug Resistance Proteins (MDR) in Resistance to Treatment With Sorafenib in CHC Patients

summary:
Primary liver cancer or hepatocellular carcinoma (HCC) is the 7th most common cancer in humans; 9th in women (figures from the Association for Research against Cancer ARC). This cancer is a major public health problem on a global scale. Patients, whose diagnosis is often late, are at advanced stages of the pathology, even those who benefit from locoregional treatments have a poor prognosis and suffer from a lack of curative therapeutic strategies. CHC is highly refractory to cytotoxic chemotherapy and so far the response rates to conventional systemic chemotherapy has provided a clinical benefit where survival was prolonged by more than 25% in patients with advanced CHC. Further efforts are needed to effectively manage HCC. Knowledge of the mechanisms regulating proliferation and inhibiting the sensitivity of transformed cells to apoptosis is the key to the development of more effective therapeutic strategies.

Several new therapies, called targeted therapies, are tested in clinical trials. Currently, the most effective molecular agent for targeting the Raf pathway is sorafenib capable of also inhibiting tyrosine kinases of VEGFR and PDGFR. Sorafenib, a multikinase inhibitor, decreases the proliferation of tumor cells in vitro that inhibit the activity of targets present in tumor cells (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and tumor vascularization VEGFR-2, VEGFR-3, and PDGFR-beta). Despite the real benefit of this treatment, its efficacy (three months of overall survival) and its indication remain limited to Child-Pugh A, WHO 0-2 patients in whom curative treatment is contraindicated. In addition, several patients have resistance to Sorafenib and thus find themselves in therapeutic failure, thus limiting the therapeutic choice for these patients.

Resistance to treatment with Sorafenib limits the therapeutic choice. The mechanisms responsible for this resistance remain to be elucidated. Drug resistance proteins, MDR Multi-Drug Resistance, is a family of molecules whose expression increases in the cancer cell and ensures the repression of chemotherapy molecules outside the target cancer cell. This family includes the proteins ABCG2, MDR and MRP1. Our in vitro studies show that treatment of CHC Huh-7 cells with Sorafenib (10 mM) induces the specific expression of the transcripts of the MRP-1 protein without any effect on the expression of the ABCG2 and MDR protein. In addition, sorafenib has an effect on the expression of hepatocyte SLAMF3 receptor transcripts, a receptor recently identified in hepatocyte tissue. Indeed, it has been shown that the expression of SLAMF3 is lowered in the cancerous tissue compared to the healthy tissue and that the reintroduction of a strong expression in the cancer cell inhibits its proliferation by inhibiting the MAPK Erk pathway, Cancer cells to apoptosis and inhibits the uptake of tumor masses in the Nude mouse (I. Marcq, et al., 2013).


title: Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty

acronym: IPPVM

summary: Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.


title: The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position and on Spatial Frame Reference in Chronic Stroke Patients

acronym: VIBR-HEMI

summary: One of the causes of disability in patients suffering from a stroke is postural imbalance. Sensory stimulation improves the postural symmetry of the subject transitorily and they are thought to have an effect on the spatial frame of reference through a sensory recalibration. Studies have shown that sensory stimulation by vibration of neck muscles have an immediate effect on static balance and when walking. The objective of this preliminary study is to test the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in standing position and on spatial frame reference in chronic patients.

lead_sponsor: Rennes University Hospital


type: Other Identifier

title: Coupling Between Adaptation of Saccadic Eye Movements and Visuo-spatial Perception and Attention Processes: a Behavioural Study in Humans.

summary: This research aims to highlight the key roles of the cerebellar and cortical fronto-parietal networks in the coupling of eye movements with visual perception and visuo-spatial attention.

intervention_type: Behavioral


title: The Value of 99mTc-Leukoscan® Scintigraphy in the Diagnosis of Infectious Endocarditis on Surgical Materials

acronym: PLEIM

summary:
Infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. Despite a well validated indication for the detection of septic emboli, the value of FDG-PET for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes.

To improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. An alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( Sulesomab , Leukoscan®). This scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. To knowledge of investigators, the value of Leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.


title: Prevalence of Sarcopenia in Chronic Obstructive Patients Hospitalized in Pneumology at the CHU of Clermont-Ferrand

acronym: SARCOBS

summary: The prevalence of sarcopenia is high in many organ pathologies such as COPD, but remains little studied in acute respiratory failure. Sarcopenia is a health problem representative of frailty, loss of autonomy and decreased muscle strength. The frequency and evolution of sarcopenia is unknown in patients having chronic bronchic obstruction with exacerbation.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


title: Robot-assisted Lobectomy Versus Video-assisted Lobectomy : a Prospective Observational Study

summary:
This prospective and observational cohort studies the morphine consumption difference during the first 48 hours after a lung lobectomy between patients operated with a robot assisted or a video-assisted technique for a lung cancer lobectomy.

Second outcome was to search eventual cardiac output difference during the surgery in 100 patients (50 in each group) using a non invasive monitoring device of cardiac output

All patients operated between january 2016 and March 2017 for a lung cancer lobectomy were included.

lead_sponsor: Hospital Nord

location_facility: Departement anesthesie reanimation hopital nord


title: Mitochondrial Activity and Myosteatosis in the Cachexia of Cancers of the Upper Aerodigestive Tract

acronym: MYOMEC

summary:
Loss of muscle mass (scientific term: cachexia) affects about 80% of patients with advanced cancer and impacts their prognosis by decreasing tolerance and response to treatment, decreasing quality of life and survival. The prognosis in these patients depends directly on the importance of the loss of muscle mass. Preserving it is therefore an essential therapeutic objective. It is therefore important to understand perfectly the mechanism of this muscular loss. The accumulation of fat in the muscle (scientific term: myosteatosis) could be a mechanism responsible for this loss of muscle mass. It is indeed a hypothesis proved on animal models. Moreover, it has recently been shown that more the cancer patient loses weight, more his muscle contains fat. This lets think that this deposit of fat in the muscle would be directly related to the loss of muscle mass. All of these observations could not be clearly established in humans and investigators are seeking by this study to illuminate these mechanisms at the human level. A better understanding of these mechanisms would allow investigator to set up targeted treatments against the accumulation of fat in the muscle, which would significantly improve the quality of life of patients with cancer of the aerodigestive pathways and their chances of recovery.

The MYOMEC study includes the inclusion of healthy patients (to form a control group) but also patients with cancer of the upper aero-digestive tract. The study will be divided into two parts: clinical examination and nutritional evaluation the day before surgery at the time of the participants' admission to hospital and then the biological samples during surgery. The nutritional examination consists in collecting the morphological data of the patient, namely:

Its weight, size, calculation of the body mass index Tests of muscular strength (wearing weight of 1, 2 and 3 kilos) Measurement of the percentage of fat mass and lean mass (Impedancemetry)

In this study, participants benefit from the following investigations:

Clinical examination complete with elaboration of the clinical nutritional status, realized the day before the surgical intervention in hospitalization.
Elaboration of the radiological nutritional status by a complementary analysis of the scanner envisaged in the balance of extension of the disease
Performing surgical site sampling during surgery without additional invasive procedure and under general anesthesia. It will be realized:

A muscle biopsy of the sterno-cleido-mastoid muscle (neck muscle) (maximum volume 5 mm3), A tumor biopsy (maximum volume 5mm3). A blood sample (maximum volume 5ml)

No invasive procedure, supplemental examination or additional consultation is required for the whole off-set study for the extensive muscular percutaneous biopsy regarding which additional patient agreement will be required. No additional follow-up is required when participating in this study. Participation in this study does not entail any particular constraint or additional treatment. The duration of the patient's participation is defined as follows: from the date of the preoperative consultation or from the consultation of announcement until his / her discharge from hospital. The exclusion period defined in this study extends from the date of inclusion of the patient to the date of the surgical procedure, during which time the patient can not participate in another clinical research protocol.

intervention_type: Procedure


title: CT Evaluation of Cardiovascular Risk Markers in Obese Patients

acronym: RisqOScan

summary:
Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.

Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.

The aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.


title: A Pilot Study on the Prevention of the Vascular RISK Related to Atrial Fibrillation After Intracranial Hemorrhage by Closing the Left Auricle

acronym: RIVAFAG

summary: Atrial fibrillation (AF) is a frequent heart rhythm disorder, responsible for the formation of cardiac thrombi, which can embolize in the systemic circulation, responsible for strokes (Cerebrovascular accidents). AF increases the risk of stroke and stroke-related disability. Preventing the thromboembolic risk associated with FMD is therefore a public health issue. The reference treatment is oral anticoagulation but this treatment is contraindicated in patients with a history of intracranial hemorrhage. The percutaneous closure of the auricle is a recent technique which makes it possible to exclude this appendix from the left atrium where the majority of thrombi are formed in the framework of the AF. Comparative studies have shown the effectiveness of this technique, appearing to be similar to that of anticoagulation. However, in view of the per-procedural risk, the indication of closure was retained by the health authorities only in the event of a contraindication to oral anticoagulants in patients with non-valvular AF with a high thromboembolic risk. Patients with a history of intracranial hemorrhage are therefore candidates for this technique, but there are few studies where these patients were included. The risk-benefit must be demonstrated over the long term, in terms of ischemic, hemorrhagic recurrence and becoming functional and cognitive.

intervention_type: Diagnostic Test


title: Investigation of Immunological and Pharmacological Factors for Response to Adalimumab in Rheumatoid Arthritis, With Analysis of CD4 + Follicular Helper T Subpopulations

acronym: PROMETHEE

summary: Interventional study with minimal risks and constraints, prospective, mono-centric.


title: Connectome Characterization With Aging Using Functional and Structural MRI

acronym: AGE-CONNECT

summary: The main aim of this project is to develop a new model to characterize brain connectivity and its changes with aging. This characterization will be based on new sensitive and specific markers, allowing a better understanding of structural and functional brain networks. To this end, two complementary MRI methods will be developed: 1) Resting-state functional MRI (rs-fMRI) which allows the measurement of cerebral activity in different cortical gray matter regions, and 2) high angular resolution diffusion imaging (HARDI) MRI, which allows to characterize brain tissue microarchitecture. HARDI sequences will be developed to acquire and reconstruct fiber tractography of patient's brains. In combination with conventional MRI, both HARDI and rs-fMRI will be used to estimate the connection degree between each pair of cortical regions, so- called "Connectome". Once generated, brain networks will be quantified through numerous graph metrics, such as graph density, global efficiency and assortativity (etc.), reflecting the organization and topology of subjects' connectivity with aging.


title: A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease

acronym: RadioPARP

summary: A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.

ReferenceCitation: Loap P, Loirat D, Berger F, Ricci F, Vincent-Salomon A, Ezzili C, Mosseri V, Fourquet A, Ezzalfani M, Kirova Y. Combination of Olaparib and Radiation Therapy for Triple Negative Breast Cancer: Preliminary Results of the RADIOPARP Phase 1 Trial. Int J Radiat Oncol Biol Phys. 2021 Feb 1;109(2):436-440. doi: 10.1016/j.ijrobp.2020.09.032. Epub 2020 Sep 21.

family: Loap

full_name: Pierre Loap

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Berger

full_name: Frederique Berger

given: Frederique

family: Ricci

full_name: Francesco Ricci

given: Francesco

family: Vincent-Salomon

full_name: Anne Vincent-Salomon

given: Anne

family: Ezzili

full_name: Cyrine Ezzili

given: Cyrine

family: Mosseri

full_name: Veronique Mosseri

given: Veronique

family: Fourquet

full_name: Alain Fourquet

given: Alain

family: Ezzalfani

full_name: Monia Ezzalfani

given: Monia

family: Kirova

full_name: Youlia Kirova

given: Youlia

journal_name: International Journal of Radiation Oncology*Biology*Physics

lead_sponsor: Institut Curie

intervention_type: Radiation


title: Build-up of Action Representation During Neurodevelopment: Dysfunctions in Autism Spectrum Disorders?

acronym: ASD-BARN

summary:
Autistic spectrum disorders (ASD) are highly debilitating developmental syndromes which core feature is social and communications disorders. Motor skill impairments are frequently described in autism, but few studies have addressed the question of their origin and their specificity. Furthermore, it is not clear whether motor problems encountered in autism are related to dyspraxia, or if they present with specific features. This project aims at deciphering the origin of motor problems encountered by children who grow-up with autism in order to propose early interventions that could influence the other developmental trajectories, such as the social one.

Brain dynamics during sensori-motor learning is explored by applying magnetoencephalography (MEG) during the Bimanual Load-Lifting paradigm. Different motor processes namely: proprioceptive monitoring, use and update of a sensori-motor representation, anticipatory executive control will be correlated to brain oscillation modulation, both topographically and temporally. Two groups of children (aged between 7 and 12) are compared: a group of children with ASD and a control group of typically developing children.


title: Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

acronym: PrevAsPI-Obs

summary: Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.


title: Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation

acronym: PPROM

summary:
Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.


title: Evaluation of the Interest and Tolerance of a Photoprotection Strategy in Prevention of Phototoxicities in Patients Undergoing Vemurafenib Treatment Associated or Not With Cobimetinib

summary:
Vemurafenib is an anti-cancer treatment indicated as monotherapy in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.

Cobimetinib is indicated in combination with Vemurafenib in the treatment of adult patients with non-resectable or metastatic melanoma carrying a BRAF V600 mutation.

These treatments are associated with a lot of adverse reactions, which may lead to dose reduction, temporary interruption or discontinuation of treatment, which often leads to treatment failure or a decrease in treatment compliance.

The most commonly reported adverse reactions (> 30%) with Vemurafenib are arthralgia, rash, photosensitivity reaction, nausea, alopecia and pruritus. The most commonly reported adverse events (> 20%) associated with Cobimetinib / Vemurafenib are diarrhea, rash, nausea, pyrexia, photosensitivity reaction, increase of alanine aminotransferase, elevation of aspartate aminotransferase, blood creatine phosphokinase elevation and vomiting.

The risk of presenting a phototoxicity adverse event with Vemurafenib in monotherapy or in combination with Cobimetinib is very common (≥ 1/10) according to MedDRA.

The use of optimal photoprotection including the repeated daily use of external photoprotection products is currently recommended for all patients receiving treatment with vemurafenib or with the combination of vemurafenib and cobimetinib.

lead_sponsor: Michele Sayag


title: Multicenter Pilot Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy

summary: The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.

lead_sponsor: BBraun Medical SAS


title: Therapeutic Implications of Early Transesophageal Echocardiography in Embolic Stroke of Undetermined Source (ESUS)

acronym: ETO

summary:
The ESUS concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. The following etiological workup is required in this setting: head CT or MRI, 12-lead ECG, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, CT angiography, catheter angiography). Transesophageal echocardiography (TEE) is considered not to be required.

However, aortic arch atheroma as diagnosed by TEE in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. The European Association of Echocardiography considers that TEE is the gold standard for the diagnosis and the characterization of aortic atheroma. It is also the method of choice for the diagnosis of infectious endocarditis.

The aim of this work was to evaluate the rate of patients with a therapeutic modification induced by TEE (mainly anticoagulation and surgery), in consecutive patients admitted with ESUS at our institution stroke unit.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A de Rothschild


title: Comparison of the Predictive and Prognostic Value of Cellular Dysoxia Markers in the Postoperative Period of Cardiac Surgery With Extracorporeal Circulation

summary: The study consist of evaluation in cardiac surgery with cardiopulmonary bypass (CPB) setting the ability of PCO2 derived variables (ΔPCO2, ΔPCO2/C(a-v)O2 ratio), compared to lactate and ScVO2 to predict major postoperative adverse events.

ReferenceCitation: Shahbazi S, Khademi S, Shafa M, Joybar R, Hadibarhaghtalab M, Sahmeddini MA. Serum Lactate Is not Correlated with Mixed or Central Venous Oxygen Saturation for Detecting Tissue Hypo Perfusion During Coronary Artery Bypass Graft Surgery: A Prospective Observational Study. Int Cardiovasc Res J. 2013 Dec;7(4):130-4. Epub 2013 Dec 1.

ReferenceCitation: Laine GA, Hu BY, Wang S, Thomas Solis R, Reul GJ Jr. Isolated high lactate or low central venous oxygen saturation after cardiac surgery and association with outcome. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1271-6. doi: 10.1053/j.jvca.2013.02.031. Epub 2013 Sep 5.

family: Laine

full_name: Greg A. Laine

given: Greg A.

family: Hu

full_name: BeeBee Y. Hu

given: BeeBee Y.

family: Wang

full_name: Suwei Wang

given: Suwei

family: Thomas Solis

full_name: R. Thomas Solis

given: R.

family: Reul

full_name: George J. Reul

given: George J.

suffix: Jr.

journal_name: Journal of Cardiothoracic and Vascular Anesthesia

title: Isolated High Lactate or Low Central Venous Oxygen Saturation After Cardiac Surgery and Association With Outcome

ReferenceCitation: Balzer F, Sander M, Simon M, Spies C, Habicher M, Treskatsch S, Mezger V, Schirmer U, Heringlake M, Wernecke KD, Grubitzsch H, von Heymann C. High central venous saturation after cardiac surgery is associated with increased organ failure and long-term mortality: an observational cross-sectional study. Crit Care. 2015 Apr 16;19:168. doi: 10.1186/s13054-015-0889-6.

family: Balzer

full_name: Felix Balzer

given: Felix

family: Sander

full_name: Michael Sander

given: Michael

family: Simon

full_name: Mark Simon

given: Mark

family: Spies

full_name: Claudia Spies

given: Claudia

family: Habicher

full_name: Marit Habicher

given: Marit

family: Treskatsch

full_name: Sascha Treskatsch

given: Sascha

family: Mezger

full_name: Viktor Mezger

given: Viktor

family: Schirmer

full_name: Uwe Schirmer

given: Uwe

family: Heringlake

full_name: Matthias Heringlake

given: Matthias

family: Wernecke

full_name: Klaus-Dieter Wernecke

given: Klaus-Dieter

family: Grubitzsch

full_name: Herko Grubitzsch

given: Herko

family: von Heymann

full_name: Christian von Heymann

given: Christian

journal_name: Critical Care

ReferenceCitation: Futier E, Robin E, Jabaudon M, Guerin R, Petit A, Bazin JE, Constantin JM, Vallet B. Central venous O₂ saturation and venous-to-arterial CO₂ difference as complementary tools for goal-directed therapy during high-risk surgery. Crit Care. 2010;14(5):R193. doi: 10.1186/cc9310. Epub 2010 Oct 29.

evidence: oa repository (via OAI-PMH title and first author match)

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

title: Central venous O2 saturation and venous-to-arterial CO2 difference as complementary tools for goal-directed therapy during high-risk surgery

ReferenceCitation: Gasparovic H, Gabelica R, Ostojic Z, Kopjar T, Petricevic M, Ivancan V, Biocina B. Diagnostic accuracy of central venous saturation in estimating mixed venous saturation is proportional to cardiac performance among cardiac surgical patients. J Crit Care. 2014 Oct;29(5):828-34. doi: 10.1016/j.jcrc.2014.04.012. Epub 2014 Apr 26.

ReferenceCitation: Robin E, Futier E, Pires O, Fleyfel M, Tavernier B, Lebuffe G, Vallet B. Central venous-to-arterial carbon dioxide difference as a prognostic tool in high-risk surgical patients. Crit Care. 2015 May 13;19:227. doi: 10.1186/s13054-015-0917-6.

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

ReferenceCitation: Ospina-Tascón GA, Umaña M, Bermúdez W, Bautista-Rincón DF, Hernandez G, Bruhn A, Granados M, Salazar B, Arango-Dávila C, De Backer D. Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O 2 content difference ratio as markers of resuscitation in patients with septic shock. Intensive Care Med. 2015 May;41(5):796-805. doi: 10.1007/s00134-015-3720-6. Epub 2015 Mar 20.

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

title: Combination of arterial lactate levels and venous-arterial CO2 to arterial-venous O2 content difference ratio as markers of resuscitation in patients with septic shock

ReferenceCitation: Mallat J, Lemyze M, Meddour M, Pepy F, Gasan G, Barrailler S, Durville E, Temime J, Vangrunderbeeck N, Tronchon L, Vallet B, Thevenin D. Ratios of central venous-to-arterial carbon dioxide content or tension to arteriovenous oxygen content are better markers of global anaerobic metabolism than lactate in septic shock patients. Ann Intensive Care. 2016 Dec;6(1):10. doi: 10.1186/s13613-016-0110-3. Epub 2016 Feb 3.

ReferenceCitation: Moussa MD, Durand A, Leroy G, Vincent L, Lamer A, Gantois G, Joulin O, Ait-Ouarab S, Deblauwe D, Caroline B, Decoene C, Vincentelli A, Vallet B, Labreuche J, Kipnis E, Robin E. Central venous-to-arterial PCO2 difference, arteriovenous oxygen content and outcome after adult cardiac surgery with cardiopulmonary bypass: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):279-289. doi: 10.1097/EJA.0000000000000949.

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille


title: Investigation of the Links Between Waking-life and Dream Content in the Case of the Death of a Close Relative

acronym: DreamDeath

summary: The aim of the study is to investigate a possible role of dreaming in emotion regulation testing whether dreaming of a close relative recently deceased is correlated with a positive evolution of the bereavement process

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Hôpital le Vinatier/Inserm


title: Evaluation of NT-proBNP in Chronic Inflammatory Bowel Disease

acronym: NT-pro-MICI

summary:
NT-proBNP is a major diagnostic and prognostic marker in cardiology, but it is also a new marker for biological inflammation, especially in rheumatology.

Its evaluation in chronic inflammatory bowel disease was carried out in a preliminary study, the OPERA study where in a population of 12 patients showed an increase in NT-proBNP correlated with the biological and endoscopic activity of the disease. This larger study is therefore a pilot study that could see NTproBNP as a new biomarker of inflammation in MICI.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Association Between Trend in Length of Stay and Risk of Readmission at Hospital After Surgery

acronym: ELIPSE

summary: Medical and surgical innovations have allowed to shorter length of hospital stay (LOS). We assume that hospitals with uncontrolled reduction in LOS may expose patients to unsafe care. At the institutional level, a dynamic analysis of LOS evolution over time could clarify the existence of a link with the risk of readmission.

location_facility: Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon


title: Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

acronym: METHO-PR

summary:
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.

The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.

For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.

ReferenceCitation: Mary A, Boursier A, Desailly Henry I, Grados F, Séjourné A, Salomon S, Fardellone P, Brazier M, Goëb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.

name: Amiens Picardie University HospitalInserm 1088, and Picardie Jules Verne University Amiens France

family: Mary

full_name: Aurélien Mary

given: Aurélien

family: Boursier

full_name: Amélie Boursier

given: Amélie

family: Desailly Henry

full_name: Isabelle Desailly Henry

given: Isabelle

family: Grados

full_name: Franck Grados

given: Franck

family: Séjourné

full_name: Alice Séjourné

given: Alice

family: Salomon

full_name: Sarah Salomon

given: Sarah

name: Inserm 1088, Picardie Jules Verne University, and Amiens Picardie University Hospital Amiens France

family: Fardellone

full_name: Patrice Fardellone

given: Patrice

family: Brazier

full_name: Michel Brazier

given: Michel

name: Picardie Jules Verne University, and EA 4666 Amiens France

family: Goëb

full_name: Vincent Goëb

given: Vincent

journal_name: Arthritis Care & Research


title: Development of an in Vitro Hematopoietic Culture System and Application to Myelodysplastic Syndromes.

acronym: HEMASTEM

summary: Myelodysplastic syndromes (MDS) are myeloid hemopathies characterized by ineffective clonal haematopoiesis, peripheral cytopenias and a predisposition to the occurrence of acute myeloid leukemias. Their diagnosis involves a cytological evaluation of the medulla, while their prognosis, in addition to extrinsic factors depending on the patient himself (age, comorbidities), intrinsic factors. The cytological evaluation is subject to a certain subjectivity since qualitative and the diagnosis is sometimes difficult in the absence of marker of clonality. More and more studies emphasize the interest of flow cytometry (CMF) in the diagnosis of SMD: by looking for qualitative and / or quantitative aberrations of the expression of membrane markers, CMF allows to establish scores Diagnosis that we have put in place within the laboratory. However, these studies are based on a static model that studies the phenotypic characteristics of patients at a given time but does not really reflect ineffective hematopoiesis. A dynamic model for in vitro reproduction of hematopoiesis would be an innovative tool for the study of SMD. This project aims to develop and standardize a system of differentiation in liquid medium of hematopoietic stem cells (CSH) in mature cells by studying each stage of the differentiation in terms of proliferation, apoptosis and phenotypic expression. HSCs will be obtained by CD34 + sorting from the medullary sample at diagnosis: the investigator will study cell proliferation, apoptosis and the acquisition of surface markers, in order to identify the quantitative and qualitative abnormalities associated with the differentiation of haematopoietic progenitors Smart. This should make it possible to identify diagnostic and prognostic factors in terms of response to treatment, acutism and survival.


title: The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.

summary:
There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.


title: PREOPTI-POOP: Preoxygenation Optimisation in Obese Patients: High-flow Nasal Cannula Oxygen Versus Non-invasive Ventilation : A Single-centre Randomized Controlled Study. "

acronym: PREOPTI-POOP

summary: Oro-tracheal intubation in operating room in obese patients with BMI > 35kg/m2 remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® is more efficient than the BIPAP preoxygenation before orotracheal intubation after crash induction in obese patients

ReferenceCitation: Vourc'h M, Baud G, Feuillet F, Blanchard C, Mirallie E, Guitton C, Jaber S, Asehnoune K. High-flow Nasal Cannulae Versus Non-invasive Ventilation for Preoxygenation of Obese Patients: The PREOPTIPOP Randomized Trial. EClinicalMedicine. 2019 Jun 5;13:112-119. doi: 10.1016/j.eclinm.2019.05.014. eCollection 2019 Aug.

family: Vourc'h

full_name: Mickael Vourc'h

given: Mickael

family: Baud

full_name: Gabrielle Baud

given: Gabrielle

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Blanchard

full_name: Claire Blanchard

given: Claire

family: Mirallie

full_name: Eric Mirallie

given: Eric

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Jaber

full_name: Samir Jaber

given: Samir

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

version: submittedVersion

repositories:
HAL
PubMed Central

lead_sponsor: Nantes University Hospital

location_facility: Nantes University Hospital, Hôtel Dieu, Medical intensive care unit


title: Intérêt de l'électroporation irréversible Dans le Traitement de l'adénocarcinome du pancréas

summary: The aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.

lead_sponsor: Poitiers University Hospital


title: Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant

acronym: INCIPAVE

summary:
Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.

lead_sponsor: Sylvie Chevret


title: Phenomenological and Psychopathological Factors Associated to Hallucinations in Parkinson's Disease

acronym: HALLUPARK

summary:
This study aims to describe hallucinations prevalence in a sample of patients affected by Parkinson's disease and consulting in an outpatient facility.

An unique one hour interview will be offered to volunteers patients. Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.

The study hypothesis is that hallucinations prevalence in Parkinson's disease is underestimated and is higher than usually described in the scientific literature when all hallucinations modalities and minor hallucinatory phenomenons are searched for.

location_facility: Hôpital des Charpennes. Centre de Recherche Clinique - vieillissement, cerveau, fragilité


title: Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.

acronym: IPoTAIG

summary: Autoimmune thyroiditis and goitres are frequent pathologies.


title: The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.

acronym: ANI

summary: The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.


title: Relationship Between the Pupillary Pain Index Measured One Minute Before Incision and the Motor, Hemodynamic and Electroencephalographic Reaction to Skin Incision in Patients Under General Anesthesia

summary: During routine general anesthesia (not standardized, left to the discretion of the attending anesthesiologist), pupillary pain index was measured one minute before skin incision. Then, variations in heart rate, blood pressure and bispectral index during the three minutes following skin incision were recorded, as well as the occurrence of movements.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression

acronym: NEUROPHONE

summary: The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.

lead_sponsor: University Hospital, Grenoble


title: Prevalence of Replication of Human Herpes Virus 6 (HHV6) in Blood and Skin During Exanthemia, in Patients With Hemopathy. Is There a Correlation With the Etiology of the Exanthema?

acronym: REPLIPO

summary: To look for the replication of HHV6 by PCR in the skin, in these patients with haemopathies presenting an exanthema. This will make it possible to evaluate the prevalence of the positivity of this PCR in the skin. Then the investigator can investigate whether there is an association between the positivity of HHV6 PCR in the blood and / or skin and the viral etiology of the exanthema. If this association exists, it will make it possible to improve the diagnosis in the context of the exanthema and thus to improve the therapeutic management of these patients.


title: Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma

acronym: SCANN'AIR

summary: New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.

lead_sponsor: University Hospital, Montpellier