title: Impact of Cefotaxime and Ceftriaxone on the Emergence and Carrying of Multidrug-Resistant Bacteria and Relationship to Residual Antibiotic Levels in Stool

acronym: CROCTX

summary:
Among enterobacteria, the production of ESBL is the first cause of multidrug resistance. The first cases of ESBL-producing enterobacteriaceae (EBLSE) infections were described during the 1980s and subsequently experienced global spread. Since the beginning of the century, the prevalence of EBLSE infections, especially among E. coli and K. pneumoniae, has increased dramatically. The emergence of multidrug-resistant enterobacteria is currently posing a real public health problem. The European antimicrobial resistance surveillance network evaluated, among clinical strains, the resistance rate for 3rd generation cephalosporins (C3G) at 9.5% for Escherichia coli and 28% for Klebsiella pneumoniae. The consequences of multidrug-resistant enterobacterial infections, which are mainly represented by ESBLs, are currently well known, both from the individual point of view (increase in mortality and length of hospital stay) and collective (increase of costs of care).

Data from the literature reveal an increased risk of ESBL bacteremia in patients with rectal carriage of ESBL-producing enterobacteria. The study by Goulenok et al. found as a risk factor for EBLSE bacteremia in patients known to be carriers at the rectal level the existence of antibiotic selection pressure and the presence of a urinary catheter. Woerther et al. have explained in their work that the digestive microbiota confers resistance to colonization by BMR. The impact of antibiotics on the latter leads to a probable rupture of this barrier and a loss of this resistance to colonization. In addition, each antibiotherapy does not impact the digestive microbiota equally and it seems that antibiotics with high anti-anaerobic activity or high biliary elimination are the most impacting. It is therefore essential, at a time of multidrug resistance, to focus on the influence of antibiotics on the digestive microbiota and the emergence and carriage of BMR.

Ceftriaxone and cefotaxime are two injectable injectable third-generation cephalosporins (C3G) commonly used in clinical practice. Despite their similar spectrum of action, it should be noted that they have substantially different pharmacokinetic properties, especially with regard to their half-life and their elimination routes (mainly urinary for cefotaxime, mixed: biliary and urinary for ceftriaxone). Some works have already been interested in this topic. Grohs et al. carried out a comparative study between ceftriaxone and cefotaxime on the emergence of AmpC hyperproducing enterobacteria (HL-CASE). This single-site study demonstrated that, at a hospital level, the preferential use of cefotaxime rather than ceftriaxone had collective and ecological benefits at the service level. Indeed, their results conclude that resistance development is weaker, as well as more limited carriage of HL-CASE Enterobacterial strains by replacing ceftriaxone with cefotaxime. It should be noted, however, that the modification of prescribing practices of C3G has been coupled with various measures to limit the emergence of AmpC hyperproductive enterobacteria (reinforcement of hygiene rules, awareness of the health care team at EBLSE, control of antibiotic ...).

In a context where the emergence of multidrug-resistant bacteria continues to increase, it seems appropriate to conduct a study to compare the impact of the use of ceftriaxone or cefotaxime on the emergence of BMR at the individual level. In the absence of a study clearly establishing the link between C3G types (ceftriaxone, cefotaxime) and the emergence of BMR and in line with the above research, this study aims to compare the microbiological impact of the use of either of these two C3Gs (in terms of emergence of bacterial resistance and impact on the diversity and quantity of digestive digestive bacteria). The study will have two periods: Period 1 during which patients hospitalized in the emergency department or in internal medicine and receiving C3G antibiotics will receive ceftriaxone, and the period 2 during which cefotaxime is cephalosporin used in first intention in these same patients.

Thus, this research project, by focusing on these 5 parameters in patients treated with ceftriaxone or cefotaxime, should make it possible to prove the influence of these antibiotherapies on the carriage of BMR (deleterious action on the diversity and the quantity of the intestinal bacterial flora, resulting in an increase in the relative fecal abundance of these BMRs promoting their carriage). In addition, the hypothesis is that, contrary to current data, cefotaxime is found at sufficiently high concentrations in the feces to have an impact on the microbiota equivalent to that of ceftriaxone, despite less significant biliary elimination.

This study therefore aims to compare their impacts on the microbiota and in particular on the emergence of multidrug-resistant bacteria (BMR) and enteropathogens such as Clostridium difficile.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis

acronym: ihMTMS

summary: The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hotipaux de Marseille

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: The Role of the Upper Colliculus in the Idiopathic Blepharospasm : a Pilot Study in Functional MRI

acronym: COLL-BSP

summary: This pilot study aims at investigating the role of superior colliculus in patients with idiopathic blepharospasm (BSP) de novo, compared to healthy subjects.

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

enrollment_type: Actual

lead_sponsor: University Hospital, Grenoble

intervention_type: Other

status_simplified: Completed


title: Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

acronym: APS Follow Up

summary: The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time

ReferenceType: background

ReferenceCitation: Pereira FR, Macri F, Jackowski MP, Kostis WJ, Gris JC, Beregi JP, Mekkaoui C. Diffusion tensor imaging in patients with obstetric antiphospholipid syndrome without neuropsychiatric symptoms. Eur Radiol. 2016 Apr;26(4):959-68. doi: 10.1007/s00330-015-3922-x. Epub 2015 Jul 23.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

intervention_type: Procedure


title: Evaluation of CARdiac Morphological and Functional Abnormalities by Echocardiography and Magnetic Resonance Imaging in Malnourished Patients Suffering From Anorexia Nervosa

acronym: CARERA

summary:
Anorexia nervosa is an eating disorder occurring in adolescent females, characterized by voluntary dietary restriction, intense fear of gaining weight, and disturbed body image perception. Anorexia nervosa is characterized by the potential severity of its prognosis. While complete remission occurs in about 50% of cases, up to 20% of patients will develop a chronic relapsing form that leads to social disintegration. Moreover, anorexia nervosa has the highest mortality rate among psychiatric diseases with a risk of death of up to 10%. 30% of deaths in anorexia nervosa are attributed to cardiac complications remaining insufficiently described, and their screening at a preclinical stage is still poorly codified. Echocardiography findings show reduced left ventricular mass, pericardial effusion or mitral valve prolapse ; in addition, systolic function appears to be preserved whereas a global diastolic dysfunction, estimated with trans-mitral flow and global longitudinal strain. While the interest of cardiac echography has been well established, only one study used MRI as a means of cardiac evaluation in anorexia nervosa: interestingly, local myocardial fibrosis is pointed and could potentially contribute to cardiac rhythm disorders. No study has yet used T1-Mapping MRI to evaluate if diffuse myocardial fibrosis is prevalent in this population group.

The investigators conduct a transversal, observational, monocentric study whereby malnourished patients with anorexia nervosa and age- and sex- matched, normal weight, healthy volunteers will undergo a gadolinium-enhanced cardiac MRI. The primary objective of this study is to evaluate and compare the frequency of cardiac fibrosis in those populations. Other cardiac MRI parameters will be described and compared as secondary objectives. Moreover, non-cardiac parameters evaluated by MRI such as adipose tissue distribution in anorexia nervosa patients compared with controls.

In addition, patients with anorexia nervosa, a clinical, morphological and biological evaluation, including anthropometric parameters, biphotonic absorptiometry, resting electrocardiogram, cardiac echography and classical biological markers of malnutrition, will be done.

study_start_date_type: Anticipated

status: Unknown status

location_facility: Assistance Pubique Des Hopitaux de Marseille

status_simplified: Unknown


title: Non-invasive Technology for Early Signal Detection of Hypoxemia With ORI During Intubation

acronym: NESOI

summary:
Intubation of patients in the intensive care unit (ICU) carries a risk of potentially severe complications, including cardiac arrest. Hypoxemia is common in ICU patients requiring intubation, which must be performed rapidly to avoid aspiration, since the patient is usually not in the fasted state. Studies have assessed interventions designed to improve intubation success rates, such as routine neuromuscular blockade. Care bundles combined with training on simulators have improved the safety of intubation. Nevertheless, intubation in the ICU still carries higher morbidity and mortality rates compared to intubation in the operating room.

Preoxygenation is a cornerstone of safety for intubation in the ICU. Several recent trials have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow nasal cannula, bag valve mask) with conflicting results. A main reason for those results is that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to the operating room: gas monitoring are not available in ICU and even if it was the case, high flow demand from the patient, and agitation will make it inefficient. Additionally, desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity and mortality; so anticipation of desaturation is a major concern for ICU's physician because it's impacting care (face mask ventilation, early insertion of subglottic device). The oxygen reserve index (ORI) is a new parameter for monitoring oxygen reserve non-invasively.

In this context, the investigators purpose to analyze efficiency of preoxygenation and time allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a pilot observational study in our medical ICU in a university hospital.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Hille H, Le Thuaut A, Canet E, Lemarie J, Crosby L, Ottavy G, Garret C, Martin M, Seguin A, Lamouche-Wilquin P, Morin J, Zambon O, Miaihle AF, Reignier J, Lascarrou JB. Oxygen reserve index for non-invasive early hypoxemia detection during endotracheal intubation in intensive care: the prospective observational NESOI study. Ann Intensive Care. 2021 Jul 17;11(1):112. doi: 10.1186/s13613-021-00903-8.

lead_sponsor: Nantes University Hospital


title: Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin

acronym: Témocilline

summary: The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Drug


type: Registry Identifier

title: Prevalence of Platelet Dysfunction Inblood With a Bleeding History

acronym: DysPlaq

summary:
Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates.

In recent decades, considerable progress has been made in understanding qualitative platelet disorders.

In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.

primary_purpose: Diagnostic

ipd_sharing: Undecided

lead_sponsor: Etablissement Français du Sang

intervention_type: Biological

lead_sponsor_type: industriel


title: Impact of Deep Endometriosis Surgery on Sexual Health

acronym: SSACE

summary:
Endometriosis is a disease affecting between 5 and 15% of women and more than 40% of infertile women.

The main stakes of this disease are that it is benign but difficult to diagnose, often very painful, difficult to predict, potentially recurrent, while being resolvable at menopause. It affects women of childbearing age and can cause infertility and pain during intercourse. Also, by its characteristics, it can significantly deteriorate the quality of life.

The management of endometriosis, from diagnosis to treatment, is not consensual. There are medical or surgical treatments depending on the severity of the lesions, their location and the severity of the symptoms. Deep endometriosis, that is to say when there is digestive, urinary, utero sacral or peritoneal ligament more than 5mm deep, poses, in particular, a therapeutic problem because surgery is often the only option but it can be decadent.

Due to genital involvement, this disease has a real impact on the sexuality of patients. Surgery allows in a number of cases to reduce pain, including those occurring during intercourse. But the impact on sexuality in a more global way remains to be studied. The latter can be improved by the reduction of pain, but impacted by the surgery which is not insignificant on the representation of the woman of her own body.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of the Impact of a Screening Strategy Based on a Home Urinary Test in Non-respondent Women on a First Invitation to Papillomavirus Screening, on the Participation Rate Compared to a Uterine Cervix Smear Screening, With Taking Into Account the Socio-economic Level, During the Organized Screening for Cervical Cancer in Brittany

acronym: PapU-Access

summary:
This is a population-based, prospective, multicenter and open-label study. 12,500 female non-respondents to the uterine cervix smear from 30 to 65 years of age in the context of the organized cervical cancer screening of the uterus, in the 4 Breton departments, will be proposed after stratification by age and socio-economic level at the revival of the cervical cancer of the uterus screening by the structure of management of Rennes, an invitation to the Human Papilloma Virus urine test thanks to the sampling kit sent to the home. It is planned a revival by simple mail after 4 months in one woman out of two who did not respond to this invitation to assess the impact of a recovery. This group represents about 5% of the eligible population in Brittany. The specimen will be sent by post with the signed consent and a questionnaire to the Hospital of Brest in virology laboratory for the detection of Human Papilloma Virus DNA (QPCR) in the urine (HPU test) and typing (LipA). In the case of a positive Human Papilloma Virus test, the woman being tested has a strong incentive to do the cervical cancer of the uterus with her doctor or midwife. In the case of abnormal smear, follow-up continues according to national recommendations to a gynecologist. All the data is collected on a software from the LINKS company, with the networking of the 4 Breton centers, the virology laboratory, and the Anatomy-Cytology-Pathology laboratories in Brittany; this collection will allow after extraction, a statistical analysis of the data. The analysis of the participation rate in this new screening, for each level of the socio-economic level, will allow a comparison with the participation in smear's revival of organized screening, between women's groups according to the socio-economic level of their residential place.

The project will take place over 24 months in 3 phases:

D0-M6: Pre-inclusion phase with implementation of the protocol (regulatory procedures, production of newsletters, consent, questionnaire, preparation of urine collection kits, postal validation).
M6-M18: Inclusion phase with start of the study, sending invitations and inclusion, Human Papillomavirus Urinary testing and uterine cervix smear monitoring.
M18-M24: Post-inclusion phase with assessment of the inclusions on the 4 Breton departments, verification and analysis of the data according to the socio-economic level, recovery of the uterine cervix smear stimulus data, realization of the statistical analyzes and budget impact analysis, communications and publications.

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: University Hospital, Brest


title: Feasibility of Protective Ventilation Based on the Alveolar Ventilation in Paediatric Anaesthesiology and Intensive Care.

acronym: PROVENTIPED

summary: Protective ventilation decreased morbidity and mortality in adults' patients and is now a standard of care in intensive care unit and in anesthesiology. In children, there is no evidence in the literature to recommend protective ventilation during anaesthesia. Moreover the ratio of instrumental dead space to tidal volume is higher in children than in adults. Therefore, it is difficult to propose an "optimal" tidal volume for all children. The objective of this study is to evaluate the use of alveolar ventilation (estimated by the volumetric capnography) in children under anesthesia. The hypothesis is that in children, alveolar ventilation reported to ideal body weight is a constant to maintain normocarbia, unlike the tidal volume.

location_facility: Pediatric anesthesia division, Hôpital Femme Mère Enfant, Hospices Civils de Lyon


title: ProLyPhy-GEP : Pesticide Associated Lymphomas: Expression of Treatment Resistance Genes

acronym: ProLyPhy-GEP

summary:
Lymphomagenesis is partially known, and some risk factor are identified like those inducing immune deficiencies: chronic exposure to HIV, immune suppressor therapies or commun variable immunodeficiency. Parts of the mechanisms leading to NHL development after pesticide exposure are the disruption of immune surveillance against cancer cell. Pro-oncogenic action of metabolites is the most important mechanisms of action for pesticides. Thus, pesticides are metabolized in pro-oxidant compounds disturbing the redox homeostasis in the haematopoietic and immune cells precursors, promoting proliferation and survival, and inducing DNA breaks. Some of them induce direct DNA breaks and non-conform reparation, leading to activation of oncogenes; and other induces transcription factors for oncogenic signalling pathways. DNA reparation and adaptation to a higher ROS level are associated with resistance against cytotoxic chemotherapy treatment with induction of detoxification mechanism by tumour cells.

That DNA repair pathways, which are targeted by chemotherapy could also explain a part of chemo-resistance. It was therefore suggested that DLBCL dependence to specific DNA repair pathways could be targeted to hamper repair of intrinsic DNA damage occurring during B-lymphoma cells proliferation or to increase DNA damage induced by chemotherapy.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Cohort Study of Adult Patients With Down Syndrome at Risk of Developing Alzheimer's Disease

summary:
TriAL21 study is an interventional, open, one arm, prospective, national and single center study.

A total of 200 patients with Down syndrome, aged 35 years and over, without diagnosis of Alzheimer's disease will be enrolled into the study.

Participating centre is Institut Jérôme Lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with Down syndrome.

ReferenceCitation: Sinai A, Mokrysz C, Bernal J, Bohnen I, Bonell S, Courtenay K, Dodd K, Gazizova D, Hassiotis A, Hillier R, McBrien J, McCarthy J, Mukherji K, Naeem A, Perez-Achiaga N, Rantell K, Sharma V, Thomas D, Walker Z, Whitham S, Strydom A. Predictors of Age of Diagnosis and Survival of Alzheimer's Disease in Down Syndrome. J Alzheimers Dis. 2018;61(2):717-728. doi: 10.3233/JAD-170624.

ReferenceCitation: McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.

ReferenceCitation: Mann DM. Alzheimer's disease and Down's syndrome. Histopathology. 1988 Aug;13(2):125-37. Review.

ReferenceCitation: Coppus A, Evenhuis H, Verberne GJ, Visser F, van Gool P, Eikelenboom P, van Duijin C. Dementia and mortality in persons with Down's syndrome. J Intellect Disabil Res. 2006 Oct;50(Pt 10):768-77. Review.

ReferenceCitation: Lautarescu BA, Holland AJ, Zaman SH. The Early Presentation of Dementia in People with Down Syndrome: a Systematic Review of Longitudinal Studies. Neuropsychol Rev. 2017 Mar;27(1):31-45. doi: 10.1007/s11065-017-9341-9. Epub 2017 Mar 13. Review.

ReferenceCitation: Neale N, Padilla C, Fonseca LM, Holland T, Zaman S. Neuroimaging and other modalities to assess Alzheimer's disease in Down syndrome. Neuroimage Clin. 2017 Nov 6;17:263-271. doi: 10.1016/j.nicl.2017.10.022. eCollection 2018. Review.

ReferenceCitation: Vemuri P, Jack CR Jr. Role of structural MRI in Alzheimer's disease. Alzheimers Res Ther. 2010 Aug 31;2(4):23. doi: 10.1186/alzrt47.

ReferenceCitation: Lleó A, Cavedo E, Parnetti L, Vanderstichele H, Herukka SK, Andreasen N, Ghidoni R, Lewczuk P, Jeromin A, Winblad B, Tsolaki M, Mroczko B, Visser PJ, Santana I, Svenningsson P, Blennow K, Aarsland D, Molinuevo JL, Zetterberg H, Mollenhauer B. Cerebrospinal fluid biomarkers in trials for Alzheimer and Parkinson diseases. Nat Rev Neurol. 2015 Jan;11(1):41-55. doi: 10.1038/nrneurol.2014.232. Epub 2014 Dec 16. Review.

ReferenceCitation: Hulstaert F, Blennow K, Ivanoiu A, Schoonderwaldt HC, Riemenschneider M, De Deyn PP, Bancher C, Cras P, Wiltfang J, Mehta PD, Iqbal K, Pottel H, Vanmechelen E, Vanderstichele H. Improved discrimination of AD patients using beta-amyloid(1-42) and tau levels in CSF. Neurology. 1999 May 12;52(8):1555-62.

ReferenceCitation: KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9.

ReferenceCitation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86.

ReferenceCitation: Deb S, Hare M, Prior L, Bhaumik S. Dementia screening questionnaire for individuals with intellectual disabilities. Br J Psychiatry. 2007 May;190:440-4.

ReferenceCitation: Ball SL, Holland AJ, Huppert FA, Treppner P, Watson P, Hon J. The modified CAMDEX informant interview is a valid and reliable tool for use in the diagnosis of dementia in adults with Down's syndrome. J Intellect Disabil Res. 2004 Sep;48(Pt 6):611-20.

ReferenceCitation: Kim J, Basak JM, Holtzman DM. The role of apolipoprotein E in Alzheimer's disease. Neuron. 2009 Aug 13;63(3):287-303. doi: 10.1016/j.neuron.2009.06.026. Review.

ReferenceCitation: Carmona-Iragui M, Santos T, Videla S, Fernández S, Benejam B, Videla L, Alcolea D, Blennow K, Blesa R, Lleó A, Fortea J. Feasibility of Lumbar Puncture in the Study of Cerebrospinal Fluid Biomarkers for Alzheimer's Disease in Subjects with Down Syndrome. J Alzheimers Dis. 2017;55(4):1489-1496. doi: 10.3233/JAD-160827.

lead_sponsor: Institut Jerome Lejeune


title: Evaluation of Manual Dexterity in a Monocentric Cohort of Peritoneal Dialysis Patients

acronym: DEXTER

summary: The objective of the study is to measure the manual dexterity of patients treated by peritoneal dialysis - transversal study

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Caen


type: Other Identifier

title: Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity

summary: The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice

primary_purpose: Treatment

location_facility: Assistance Publique Hopitaux de Marseille


title: Monitoring Drug-induced Uveitis

acronym: UVETOX

summary: Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: OCS-Tapering-Delphi: Expert Statements Concerning the Tapering of Oral Corticosteroids (OCS) for the Treatment of Asthma: A Delphi Consensus Study

summary: The objectives of this study are to use the Delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning OCS tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

ipd_sharing: Yes

ipd_sharing_description: Anonymized data will be shared on an appropriate public platform at the time of publication.

lead_sponsor: Association Jean Baptiste Desbrest


title: A Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's Disease

acronym: CUREPARK

summary:
This is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 Parkinson's Disease (PD) patients. Patients will be randomized in 2 groups receiving Bumetanide or placebo for 4 months:

Group 1 (20 PD patients): bumetanide
Group 2 (20 PD patients): placebo intake identically to group 1.

design_allocation: Randomized

ReferenceCitation: Damier P, Hammond C, Ben-Ari Y. Bumetanide to Treat Parkinson Disease: A Report of 4 Cases. Clin Neuropharmacol. 2016 Jan-Feb;39(1):57-9. doi: 10.1097/WNF.0000000000000114.

ReferenceCitation: Lozovaya N, Eftekhari S, Cloarec R, Gouty-Colomer LA, Dufour A, Riffault B, Billon-Grand M, Pons-Bennaceur A, Oumar N, Burnashev N, Ben-Ari Y, Hammond C. GABAergic inhibition in dual-transmission cholinergic and GABAergic striatal interneurons is abolished in Parkinson disease. Nat Commun. 2018 Apr 12;9(1):1422. doi: 10.1038/s41467-018-03802-y.

lead_sponsor: B&A Therapeutics


title: A Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Tolerance of Sodium Oxybate in Patients Affected With Idiopathic Hypersomnia

acronym: SODHI

summary: this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using Epworth sleepiness scale over 8 weeks compared to placebo


title: Pathology of Helicases and Premature Aging: Study by Derivation of hiPS

acronym: HeliPS

summary:
Topic of this work is the involvement of replicative helicases in human premature ageing syndrome. Replicative helicases are ubiquitous and essential during numerous reactions of the DNA metabolism.

The family of replicative helicases (RecQL) is involved in the replication/repair of the DNA and in the telomere maintenance. There are 5 enzymes in human and 3 of them are involved in clinically recognizable syndromes: WRN for the Werner syndrome, BLM for the Bloom syndrome and RECQL4 for the Rothmund Thomson syndrome. All are responsive of a high cancer risk due to genomic instability. Molecular and cellular mechanisms involved in these diseases of ageing are unknown. Moreover, for all of them, there is not therapeutic or preventive solution.

status: Terminated


title: Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.

acronym: Stryker-KneeKG

summary:
The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.


title: Per-operative Exploration of the Peri-pancreatic Lymphatic Pathways During Pancreatic Surgical Resection

summary:
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) Pancreatic cancer has a poor prognosis. Surgical resection is the only curative treatment. Major pancreatectomies lead to high postoperative morbidity rate, up to 30%. For some tumors, limited resection are increasedly performed, but the rate of pancreatic fistula is even higher, up to 40%.

No precise "anatomic" pancreatic segmentation currently exists. If such segmentation is described, pancreatic resections, major of minor, may have better outcomes.

The aim of this study is to demonstrate the existence of independent pancreatic segments, following the lymphatic drainage of the gland.

ReferenceCitation: Renard Y, Perrenot C, Labrousse M, Avisse C, Rhaiem R, Piardi T, Braun M, Perez M. Exploration of peripancreatic lymphatic pathways in a live porcine model. Ann Anat. 2019 Sep;225:57-64. doi: 10.1016/j.aanat.2019.06.003. Epub 2019 Jul 5.

lead_sponsor: CHU de Reims


title: Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects

acronym: I-TSPT-R

summary:
In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested.

This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment.

The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.

lead_sponsor: Centre Hospitalier de Niort


title: Refleeve : A Retrospective Study to Evaluate the Prevalence of the Barett's Esophagus by Gastro-osephagal Endoscopy in Morbid Obese Patients Treated by Sleeve Gastrectomy and the Advantage of the Systematic Detection in the Prevention of Esophageal Carcinoma

acronym: Refleeve

summary: Severe Gastroesophageal reflux disease (GERD) leading to a chronic aggression of esophagus mucosa, called Barrett's esophagus is a main complication of Sleeve gastrectomy for morbid obesity. Barrett's esophagus is considered as a early stage of neoplastic transformation to adenocarcinoma. Since this last years, six european bariatric centers have adopted the policy to realize endoscopy before and five years or more after sleeve gastrectomy. Investigators worked out a database comprizing the Endoscopic features and patient characteristics. Refleeve projet aim to analyse the long term follow-up datas of 100 patients, evaluate the prevalence of Barret's esophagus and investigate the advantage of the systemetic detection to prevent esophagus adenocarcinomas.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases

acronym: PAKITO

summary: The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.


title: Reliability and Reproducibility of Automated Angular Measurement in Strabismus

acronym: FREGMA

summary:
Angular measurement of deviation is an essential element in the clinical evaluation of strabic patients. It is performed by orthoptic methods. However, studies show that the same patient presents a great variability of his angular measurement between 2 consultations, and between 2 observers.

Automated angle measurement is a recent concept that aims to overcome the defects of subjective angle measurement by alternate occlusion test and prismatic bar.

Improvements made by these devices would provide reliable, objective and reproducible measurements of the angle of deviation by increasing the accuracy of strabal angle assessment, improving decision making and surgical follow-up, decreasing inter-examiner variability and variability over time, and facilitating data comparison to improve scientific publication possibilities.

The Gazelab® device is a video-oculograph combined with a laser projection system and an infrared camera. It allows an objective angular evaluation, in non-dissociating physiological conditions, possible even in the absence of binocular vision and allows an analysis of the deviation in all positions.

There is extremely little data in the literature on automated measuring devices. The Gazelab tool is still little known in the strabology discipline and seems to have a number of advantages over other devices. The interest of this examination towards this pathology led the ophthalmology department to use it in the current practice, and since recently it is an act nomenclaturé.


title: MEG Versus EEG HR for the Localization of the Epileptogenic Zone as Part of the Pre-surgical Assessment of Epilepsy

acronym: EPIMEEG

summary:
Drug-resistant partial epilepsies are disabling diseases for which surgical treatment may be indicated. The determination of the area to be operated (or 'epileptogenic zone') is based on a bundle of clinical arguments and neuroimaging, having a direct impact on surgical success.

Epileptic patients have electrical abnormalities that can be detected with surface electrophysiological examinations such as surface EEG or MagnetoEncephalography (MEG). The intracerebral source of these abnormalities can be localized in the brain using source modeling techniques from MEG signals or EEG signals if a sufficient number of electrodes is used (> 100, so-called high EEG technique Resolution = EEG HR). EEG HR and MEG are two infrequent state-of-the-art techniques.

The independent contribution of EEG HR and MEG for the localization of the epileptogenic zone has been shown in several studies. However, several modeling studies have shown that MEG and EEG HR have a different detection capacity and spatial resolution depending on the cortical generators studied. Modeling studies suggest that MEG has better localization accuracy than EEG for most cortical sources.

No direct comparison of the locating value of MEG and EEG HR for the localization of the epileptogenic zone has been performed to date in a large-scale clinical study.

In this prospective study, 100 patients with partial epilepsy who are candidates for epilepsy surgery, and for some of them with intracranial EEG recording, will benefit from two advanced electrophysiological examinations including magnetoencephalographic recording (MEG). ) interictal electrophysiological abnormalities and high-resolution EEG recording (128 electrodes) in addition to the usual examinations performed as part of the pre-surgical assessment, prior to cortectomy and / or intracranial EEG recording.

Based on recent work conducted in humans, we postulate:

that the MEG and the EEG HR make it possible to precisely determine the epileptogenic zone, by using two approaches of definition of the epileptogenic zone (zone operated in the cured patients, zone at the origin of the crises during the intracranial recordings), but that the MEG is a little more precise than the EEG HR for the determination of the epileptogenic zone (we will try to highlight a difference of about 10%)
that the quantitative study of the complementarity between EEG HR and MEG for modeling sources of epileptic spikes will show an added value in the use of both methods compared to the use of only one of the two methods
that it is possible to determine the epileptogenic zone by determining the MEG model zone having the highest centrality value (hub) within the intercritical network by studying networks using graph theory.


title: Identifying Immune-related Biomarkers to Predict the Efficacy of Cancer Immunotherapy-IMMUNO-SUP-IPC 2017-002

acronym: IMMUNO-SUP

summary:
The development of Immune Checkpoint Blockade (ICB) is a revolution in medical oncology as ICB have changed the standard treatments of several metastatic tumor types. However, the response rate to ICB is low, and the biological bases for this response heterogeneity are poorly understood.

In the frame of Immunosup study, we will collect blood (at baseline, post infusion of ICB n°2/4/8 and at progression) and tumor samples (optional: at baseline and progression) from patients with locally advanced or metastatic cancer, treated with ICB, in order to determine if the dynamics of immunosuppressive actors (MDSC, TReg, Immunosuppressive cytokines) predicts response to these immunotherapies.

status: Active, not recruiting

lead_sponsor: Institut Paoli-Calmettes


title: Safety Assessment of Angioplasty Procedures

acronym: SCRAP

summary: Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.

ReferenceType: result

ReferenceCitation: Meunier L, Godin M, Souteyrand G, Mottin B, Valy Y, Lordet V, Benoit C, Bakdi R, Laurençon V, Genereux P, Waliszewski M, Allix-Béguec C. Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study). Clin Res Cardiol. 2022 Jul 1. doi: 10.1007/s00392-022-02054-7. [Epub ahead of print] Erratum in: Clin Res Cardiol. 2022 Aug 4;:.

ipd_sharing_description:
Data will be made available with publication. A Digital Object Identifier will be used.

Keywords are Coronary Artery Disease, Percutaneous Coronary Intervention, Angioplasty, Drug-eluting stent, Drug-coated balloon, Patient Outcome Assessment.

The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients. The database will be made available through Zenodo.

Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. The data will be made available to the community of scientists and clinicians interested in percutaneous coronary intervention.

lead_sponsor: Groupe Hospitalier de la Rochelle Ré Aunis


title: Retrospective Study About 17 Cases of Child With Bacterial Meningitis Coupled With Cerebral Vasculitis

summary:
Purulent meningitis are life-threatening diseases in childhood. Cerebral vasculitis have been described in bacterial meningitis, but poor is known about their physiology and their impact on outcome.

The investigators decide to realize a retrospective mono-centric study carried out at Montpellier university hospital which looks back at a 7-year study(2009-2016).

The Investigators selected purulent meningitis cases based on the bacteriological data provided by the HDB (hospital data base). The Investigators divides in two groups : Group A if patients present a cerebral vasculitis ( radiologic diagnostic by RMI or tomodensitometry), in all, cases the diagnosis of vasculitis was confirmed by a radiologist specialised in neuropaediatrics by a second reading;Group B purulent meningitis with a cerebral vasculitis imaging.

Tuberculous meningitis, meningitis in CSF shunt, and in patients having chemotherapy were excluded.

The investigators report clinical and biological finding, inflammatory marker at the onset. The Investigators register also the clinical evolution and sequelae


title: Exploratory Study of the Needs of Type 1 Diabetic Patients in Therapeutic Education in Order to Reconcile Diabetes and Work.

acronym: ET-DIT

summary: Diabetes mellitus is an important disease around the world and the number of diabetic people increase every day. The type 1 diabetes often occurred in the youth and people have to learn to work with it and its complication. Conversely, diabetic people sometimes have trouble to manage their diabetes with working obligation. Actually, French therapeutic education don't teach how to reconcile diabetes and work. The study hypothesis is that type 1 diabetic people can be helped by therapeutic education in order to reconcile the management of their diabetes and their work. This study is a qualitative study. Interviews will help to find the needs of the type 1 diabetic patients to reconcile diabetes and work.

location_facility: Médecine et santé au travail - Hôpital Cardiologique Louis Pradel - Groupement hospitalier Est


title: MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial

acronym: METOGiA

summary:
Giant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. It is characterized by a granulomatous inflammation of the wall of large vessels, involving especially the aorta and extra-cranial branches of the external carotid, with vascular remodelling leading to ischemic manifestations such as temporal headaches, jaw claudication, scalp tenderness and visual loss. Most patients with GCA also present signs of systemic inflammation, including weight loss, fatigue and fever, together with an increased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level.

Glucocorticoids (GC) are the cornerstone of the treatment of GCA. They are very effective and are usually given for 18-24 months to avoid relapses. Therefore, most patients develop GC-related complications that cause morbidity and disability. GC sparing strategies are thus required to improve the treatment of GCA.

A 12-month treatment with tocilizumab (TCZ) has recently been shown to be effective in inducing and maintaining remission of GCA, with a dramatic GC-sparing effect. However, TCZ is an expensive drug; TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients; and importantly around 40% of patients relapse within 6 months after TCZ discontinuation, whether prescribed for 12 months or 4 months.
In association with 6 months of prednisone, 10 mg/week of methotrexate (MTX) for 24 months lowers the risk of relapse at 24 months from 84% to 45%.

Therefore, the hypothesis is that 12 months of MTX treatment (0.3 mg/Kg/week, without exceeding 20 mg/week) is not inferior to 12 months of TCZ (162 mg SC/week) in term of prevention of relapse at 18 months. The MTX strategy might be more cost effective than TCZ.

In the present study, it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial. Moreover, the economic consequences associated with the use of MTX rather than TCZ will be also assess.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Representation and Medication Use in Juvenile Idiopathic Arthritis - RUMAJI

acronym: RUMAJI

summary: According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.


title: Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma

acronym: MYELOCHOL

summary: Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.

ReferenceCitation: Mesguich C, Hulin C, Latrabe V, Asselineau J, Bordenave L, Perez P, Hindie E, Marit G. Prospective Comparison of 18F-Choline Positron Emission Tomography/Computed Tomography (PET/CT) and 18F-Fluorodeoxyglucose (FDG) PET/CT in the Initial Workup of Multiple Myeloma: Study Protocol of a Prospective Imaging Trial. JMIR Res Protoc. 2020 Sep 10;9(9):e17850. doi: 10.2196/17850.

lead_sponsor: University Hospital, Bordeaux

location_facility: Bordeaux University Hospital - Haut-Lévêque


title: Macro and Microcirculatory Effects of the Combination of Norepinephrine and Octreotide for the Treatment of Cirrhotic Patients With Hemorrhagic Shock

acronym: HemodyNoOc

summary: Octreotide is used to decrease portal pressure of cirrhotic patients admitted for variceal bleeding. When patients are in haemorrhagic shock, the recommended drug to increase arterial pressure is norepinephrine. Microcirculatory effects of octreotide when it is added to noradrenaline has not been investigated yet. The aim of the study is to evaluate the effect of octreotide plus norepinephrine for patient with haemorrhagic shock after variceal bleeding.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction

acronym: RECaVoLL

summary:
The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation.

The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important.

Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity.

It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction.

There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.

location_facility: Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon


title: Versailles Hospital Cardiac Arrest Registry

summary:
Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.

Data collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).

On-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and/or hospital/neurologist charts and/or general practitionner phone interview.

lead_sponsor: Versailles Hospital


title: Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 ml) in Healthy Volunteers

acronym: AUTOT-SPORT

summary: The purpose of this study is to evaluate if differences between samples of subjects obtained before autologous blood transfusion or samples of non-transfused subjects and samples of subjects after autologous blood transfusion can be identified. Analyses performed will focus on the morphological and biochemical parameters of red blood cells and associated microparticles. The final goal would be to find markers of autologous blood transfusion, that could be used to identify such doping practice.

status: Not yet recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Etablissement Français du Sang IDF, Hôpital de la Pitié Salpêtrière


type: EudraCT Number

title: A Phase I/II Study of the Safety of CD34+ Haematopoietic Stem/Progenitor Cells and CD4+ T Lymphocytes Transduced With LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct, in HIV-1 Infected Patients With High-risk Lymphoma

acronym: GENHIV

summary: The purpose of this study is to evaluate the safety and the feasibility, and the success of engraftment of the introduction of Cal-1 gene-transduced haematopoietic cell populations (Ttn and HSPCtn) in patients with HIV-1-related high-risk lymphoma.


title: Is Mental Motor Imagery Training Using "GHOST", a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion

acronym: GHOST

summary: Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.

lead_sponsor: Nantes University Hospital


title: Prevention of Atelectasis, Via High Flow Nasal Cannula to Obtain a PEP, During General Anesthesia for MRI by Sevoflurane in Children, Evaluated by Lung MRI and Echography

acronym: PREVAT-PED

summary:
Anesthesia causes respiratory changes and complications, which are the main causes of complications and anesthesia-related deaths.

Among the complications, the rapid appearance of lung atelectasis is well known, deteriorating the hematosis during anesthesia, and inducing secondary pulmonary complications.

Prevention or limitation of the atelectasis would be a way to improve the safety of patients who have a limited respiratory function.

The application of a positive expiratory pressure (PEP) is an effective prevention method for atelectasis, that have been only demonstrate in patients under mechanical ventilation.

The high flow nasal cannula is a non-invasive technique easy to perform and allowing a PEP. High flow nasal cannula is safe to use, and the interface is free from local skin complications.

Chest X-ray (bad sensibility) or CT are usually used for the diagnosis of atelectasis, but these two exams involve irradiation for patient. MRI and pulmonary ultrasonography has now been validated in adults. MRI are relatively long, and allow to investigate the atelectasis with only a short additional acquisition time.

Thus, it would be the first study on the effect of the PEP on the impact and the volume of the atelectasis during general anesthesia in spontaneous ventilation in children. By the way this is the first study on lung's anatomical effects of high flow nasal cannula.

It is a monocentric, intervention, randomized, superiority study whose main purpose is to show the reduction of the atelectasis through the use of high flow nasal cannula versus a high concentration mask for pediatric anesthesia during MRI.

The studied population is all the children between 6 months and 5 years with a pediatric indication of general anesthesia for MRI.

The primary goal is to show a reduction of volume (cm3) of the atelectasis via the application of a PEP by high flow nasal cannula.

The main assessment criteria is the ratio of atelectasis volume/total lung volume.

The prevalence of the atelectasis will be evaluated by MRI lung and measured using 3D reconstruction software. The duration of the examination and the anesthesia is slighty lengthened, 3 to 5 minutes for a 40 minutes' exam.

The secondary objective is to show a match between the atelectasis on MRI and ultrasound.

ReferenceCitation: Roncin C, Scemama U, Zieleskiewicz L, Loundou A, Lesavre N, Vialet R. Atelectasis prevention during anaesthesia using high-flow nasal cannula therapy: A paediatric randomised trial using MRI images. Anaesth Crit Care Pain Med. 2020 Dec;39(6):819-824. doi: 10.1016/j.accpm.2020.08.009. Epub 2020 Oct 17.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Risk Factors of Bleeding in Patients Undergoing Peripheral Veno Arterial Extra Corporeal Membrane Oxygenation

acronym: ECMO bleeding

summary: Veno arterial extracorporeal membrane oxygenation (VA ECMO) is used, for cardiogenic shock, refractory cardiac arrest and post cardiotomy cardiac failure. Bleeding is frequent complications during VA ECMO and is associated with increased mortality. The aim of our study was to identify early factors associated with major bleeding in patients supported by VA ECMO


title: Validation of a Bimanual and Scenarized 3D Motion Analysis Protocol of Upper Limbs in Children With Unilateral Spastic Cerebral Palsy

acronym: BE-API

summary:
Cerebral Palsy, in particular in its unilateral spastic form (uCP), is the main cause of motor disability in children, with a prevalence of 2/1000 births. These children have upper limb motor impairments that hinder the realization of activities of daily life in bimanual situations. 3D motion analysis (3DMA) is an objective and precise tool, considered as the gold standard for gait analysis. The existing 3DMA protocols consist of movements too standardized, in unimanual situations away from gestures of everyday life, or have not been validated in bimanual situations.

In a preliminary study, a 3DMA bimanual protocol was study. it was composed of 4 tasks integrated into a game scenario to have more spontaneity of movements, similar to those experienced by children in daily life. It allows the exploration of all degrees of freedom of the upper limb. Results showed an excellent acceptability and within day reliability on 20 uCP children and 20 typically developing children (TDC) for funct

ReferenceCitation: Cacioppo M, Lempereur M, Marin A, Rauscent H, Crétual A, Brochard S, Bonan I. Motor patterns of the impaired upper limb in children with unilateral cerebral palsy performing bimanual tasks. Clin Biomech (Bristol, Avon). 2022 Jul;97:105710. doi: 10.1016/j.clinbiomech.2022.105710. Epub 2022 Jun 22.

ReferenceCitation: Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.

lead_sponsor: Rennes University Hospital


title: Choice and Optimal Settings of Non Invasive Respiratory Support in Preterm Newborns < 30 Gestational Weeks

summary: Noninvasive respiratory supports (NRS), such as continuous positive airway pressure (CPAP), noninvasive ventilation, high flow nasal cannula (HFNC) or nasal oxygen (O2), are commonly used in preterm newborns hospitalized in neonatal intensive care unit. However, given the lack of validated criteria, clinicians usually choose the NRS according to clinical parameters and patients' comfort. Several studies have demonstrated the interest of the measurement of the work of breathing (WOB) to optimize the settings of NRS in children, but no study has already demonstrated the utility of WOB to optimize the settings of NRS in preterm infants. Therefore, the aim of this study is to measure the WOB during the utilisation of three different NRS (CPAP, HFNC, O2), in order to optimize the choice of the type and settings of NRS in a randomized group of 30 newborns born prematurely before 30 gestational weeks and still requiring NRS at 29 post conceptual weeks. Moreover, the investigators will compare in the newborns with the optimized NRS by WOB vs. a standard care control group (NRS type and settings determined as clinical routine): 1) the respiratory morbidity and mortality one month after the initial assessment, and at the time of hospital discharge (or transfer) or at 36 weeks of age corrected (whatever comes first), 2) the weaning time of the NRS, 3) the incidence and severity of broncho-pulmonary dysplasia (BPD) at 36 weeks of age corrected. Indeed, incidence of BPD is still around 40% in premature infants born before 28 gestational weeks. The hypothesis of the investigators' study is that the optimization of the type and settings of the NRS could reduce the weaning delay and contribute to reduce the incidence and severity of BPD in premature newborns.

ReferenceCitation: Liptsen E, Aghai ZH, Pyon KH, Saslow JG, Nakhla T, Long J, Steele AM, Habib RH, Courtney SE. Work of breathing during nasal continuous positive airway pressure in preterm infants: a comparison of bubble vs variable-flow devices. J Perinatol. 2005 Jul;25(7):453-8.

ReferenceCitation: Shetty S, Hickey A, Rafferty GF, Peacock JL, Greenough A. Work of breathing during CPAP and heated humidified high-flow nasal cannula. Arch Dis Child Fetal Neonatal Ed. 2016 Sep;101(5):F404-7. doi: 10.1136/archdischild-2015-309310. Epub 2016 Jan 14.

ReferenceCitation: de Jongh BE, Locke R, Mackley A, Emberger J, Bostick D, Stefano J, Rodriguez E, Shaffer TH. Work of breathing indices in infants with respiratory insufficiency receiving high-flow nasal cannula and nasal continuous positive airway pressure. J Perinatol. 2014 Jan;34(1):27-32. doi: 10.1038/jp.2013.120. Epub 2013 Sep 26.

ReferenceCitation: Saslow JG, Aghai ZH, Nakhla TA, Hart JJ, Lawrysh R, Stahl GE, Pyon KH. Work of breathing using high-flow nasal cannula in preterm infants. J Perinatol. 2006 Aug;26(8):476-80. Epub 2006 May 11.

lead_sponsor: Hôpital Necker-Enfants Malades


title: Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia

acronym: SPOC

summary: Main purpose of this study is to compare comfort level of patients, after otosclerosis surgery, under local or general anesthesia.

location_facility: Centre Hospitalier Universitaire de Rennes


title: Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality

summary:
Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery.

The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies

lead_sponsor: University Hospital, Montpellier


title: Contribution of Functional MRI in Assessment of Auditory Processing Disorders

acronym: IRMf-TTA

summary:
Auditory Processing Disorder (APD) affects 0.5-7% of the pediatric population. This disorder is responsible for a child's low hearing ability. The diagnosis of APD is difficult because of polymorphic symptoms possibly entangled with other difficulties (learning, communication, attention ...). There is currently no gold standard in the literature for diagnosing APD. Investigators opened multidisciplinary consultation for the children suspected of APD. The purpose of this study is to analyze the results of the multidisciplinary assessment performed on these children (audiometry, cortical auditory brainstem response (ABR), behavioral assessment, psychometric evaluation, genetic analysis) to the results of functional MRI (fMRI) at rest and in activation. The goal is to find radiological MRI-fMRI markers in these patients that improve the diagnosis of APD.

Investigators will compare the f-MRI results between three groups of children in order to find specific radiological markers of APD :

group 1 : children diagnosed with an Auditory Processing Disorder (APD)
group 2 : children suspect of APD
group 3 : children without APD (controls)

ReferenceCitation: Chermak GD, Bamiou DE, Vivian Iliadou V, Musiek FE. Practical guidelines to minimise language and cognitive confounds in the diagnosis of CAPD: a brief tutorial. Int J Audiol. 2017 Jul;56(7):499-506. doi: 10.1080/14992027.2017.1284351. Epub 2017 Feb 28. Review.

ReferenceCitation: Moore DR, Ferguson MA, Edmondson-Jones AM, Ratib S, Riley A. Nature of auditory processing disorder in children. Pediatrics. 2010 Aug;126(2):e382-90. doi: 10.1542/peds.2009-2826. Epub 2010 Jul 26.

ReferenceCitation: Barker MD, Kuruvilla-Mathew A, Purdy SC. Cortical Auditory-Evoked Potential and Behavioral Evidence for Differences in Auditory Processing between Good and Poor Readers. J Am Acad Audiol. 2017 Jun;28(6):534-545. doi: 10.3766/jaaa.16054.

ReferenceCitation: Tomlin D, Rance G. Maturation of the Central Auditory Nervous System in Children with Auditory Processing Disorder. Semin Hear. 2016 Feb;37(1):74-83. doi: 10.1055/s-0035-1570328.

ReferenceCitation: Sharma M, Purdy SC, Kelly AS. Comorbidity of auditory processing, language, and reading disorders. J Speech Lang Hear Res. 2009 Jun;52(3):706-22. doi: 10.1044/1092-4388(2008/07-0226). Epub 2008 Dec 8.

ReferenceCitation: de Wit E, Visser-Bochane MI, Steenbergen B, van Dijk P, van der Schans CP, Luinge MR. Characteristics of Auditory Processing Disorders: A Systematic Review. J Speech Lang Hear Res. 2016 Apr 1;59(2):384-413. doi: 10.1044/2015_JSLHR-H-15-0118. Review.

ReferenceCitation: Demanez L, Dony-Closon B, Lhonneux-Ledoux E, Demanez JP. Central auditory processing assessment: a French-speaking battery. Acta Otorhinolaryngol Belg. 2003;57(4):275-90.

ReferenceCitation: Sharma A, Kraus N, McGee TJ, Nicol TG. Developmental changes in P1 and N1 central auditory responses elicited by consonant-vowel syllables. Electroencephalogr Clin Neurophysiol. 1997 Nov;104(6):540-5.

ReferenceCitation: Sharma A, Dorman MF, Spahr AJ. Rapid development of cortical auditory evoked potentials after early cochlear implantation. Neuroreport. 2002 Jul 19;13(10):1365-8.

ReferenceCitation: Sharma A, Martin K, Roland P, Bauer P, Sweeney MH, Gilley P, Dorman M. P1 latency as a biomarker for central auditory development in children with hearing impairment. J Am Acad Audiol. 2005 Sep;16(8):564-73.

ReferenceCitation: Sharma A, Glick H, Campbell J, Biever A. CENTRAL AUDTIORY DEVELOPMENT IN CHILDREN WITH HEARING LOSS: CLINICAL RELEVANCE OF THE P1 CAEP BIOMARKER IN HEARING-IMPAIRED CHILDREN WITH MULTIPLE DISABILITIES. Hearing Balance Commun. 2013 Sep;11(3). doi: 10.3109/21695717.2013.812378.

ReferenceCitation: Sharma M, Purdy S C, Kelly A S. The contribution of speech-evoked cortical auditory evoked potentials to the diagnosis and measurement of intervention outcomes in children with auditory processing disorder. Semin Hear. 2014;35(1):51-64

ReferenceCitation: Purdy SC, Kelly AS, Davies MG. Auditory brainstem response, middle latency response, and late cortical evoked potentials in children with learning disabilities. J Am Acad Audiol. 2002 Jul-Aug;13(7):367-82.

ReferenceCitation: Anderson S, Chandrasekaran B, Yi HG, Kraus N. Cortical-evoked potentials reflect speech-in-noise perception in children. Eur J Neurosci. 2010 Oct;32(8):1407-13. doi: 10.1111/j.1460-9568.2010.07409.x.

ReferenceCitation: Cunningham J, Nicol T, Zecker S, Kraus N. Speech-evoked neurophysiologic responses in children with learning problems: development and behavioral correlates of perception. Ear Hear. 2000 Dec;21(6):554-68.

ReferenceCitation: Punch S, Van Dun B, King A, Carter L, Pearce W. Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia. Semin Hear. 2016 Feb;37(1):36-52. doi: 10.1055/s-0035-1570331.

ReferenceCitation: Martin BA, Tremblay KL, Korczak P. Speech evoked potentials: from the laboratory to the clinic. Ear Hear. 2008 Jun;29(3):285-313. doi: 10.1097/AUD.0b013e3181662c0e. Review. Erratum in: Ear Hear. 2008 Dec;29(6):979.

ReferenceCitation: Micallef LA. Auditory Processing Disorder (APD): Progress in Diagnostics So Far. A Mini-Review on Imaging Techniques. J Int Adv Otol. 2015 Dec;11(3):257-61. doi: 10.5152/iao.2015.1009. Review.

ReferenceCitation: Owen JP, Marco EJ, Desai S, Fourie E, Harris J, Hill SS, Arnett AB, Mukherjee P. Abnormal white matter microstructure in children with sensory processing disorders. Neuroimage Clin. 2013 Jun 23;2:844-53. doi: 10.1016/j.nicl.2013.06.009. eCollection 2013.

ReferenceCitation: Kim MJ, Jeon HA, Lee KM, Son YD, Kim YB, Cho ZH. Neuroimaging features in a case of developmental central auditory processing disorder. J Neurol Sci. 2009 Feb 15;277(1-2):176-80. doi: 10.1016/j.jns.2008.10.020. Epub 2008 Dec 6.

ReferenceCitation: Belin P, Zatorre RJ, Lafaille P, Ahad P, Pike B. Voice-selective areas in human auditory cortex. Nature. 2000 Jan 20;403(6767):309-12.

ReferenceCitation: Thomsen T, Rimol LM, Ersland L, Hugdahl K. Dichotic listening reveals functional specificity in prefrontal cortex: an fMRI study. Neuroimage. 2004 Jan;21(1):211-8.

ReferenceCitation: Pluta A, Wolak T, Czajka N, Lewandowska M, Cieśla K, Rusiniak M, Grudzień D, Skarżyński H. Reduced resting-state brain activity in the default mode network in children with (central) auditory processing disorders. Behav Brain Funct. 2014 Sep 26;10(1):33. doi: 10.1186/1744-9081-10-33.

ReferenceCitation: Bartel-Friedrich S, Broecker Y, Knoergen M, Koesling S. Development of fMRI tests for children with central auditory processing disorders. In Vivo. 2010 Mar-Apr;24(2):201-9.

intervention_type: Diagnostic Test


title: Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study

summary:
Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.

The aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.

intervention_type: Dietary Supplement


title: Study of Binaural Squelch Effect Among Patients Undergoing Unilateral Otosclerosis Surgery: Comparison of Understanding in Noise Before-after Surgery

acronym: CBOU

summary:
Patients with unilateral transmission hypoacusis due to otosclerosis undergoing stapedectomy surgery will be prospectively included.

They will be undergoing a free field vocal audiometry using the Oldenburg MATRIX software to evaluated the squelch effect gain between audiometry before and after 9months after surgery.

Our hypothesis is to show a squelch effect with the rehabilitation of the binaural audition.

ReferenceCitation: Rudic M, Keogh I, Wagner R, Wilkinson E, Kiros N, Ferrary E, Sterkers O, Bozorg Grayeli A, Zarkovic K, Zarkovic N. The pathophysiology of otosclerosis: Review of current research. Hear Res. 2015 Dec;330(Pt A):51-6. doi: 10.1016/j.heares.2015.07.014. Epub 2015 Aug 12. Review.

ReferenceCitation: Vasama JP, Linthicum FH Jr. Temporal bone histopathology case of the month: otosclerosis. Am J Otol. 1998 May;19(3):398-9.

ReferenceCitation: Veillon F, Riehm S, Emachescu B, Haba D, Roedlich MN, Greget M, Tongio J. Imaging of the windows of the temporal bone. Semin Ultrasound CT MR. 2001 Jun;22(3):271-80. Review.

ReferenceCitation: Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001 Mar;22(2):249-57. Review.

ReferenceCitation: Wegner I, van Waes AM, Bittermann AJ, Buitinck SH, Dekker CF, Kurk SA, Rados M, Grolman W. A Systematic Review of the Diagnostic Value of CT Imaging in Diagnosing Otosclerosis. Otol Neurotol. 2016 Jan;37(1):9-15. doi: 10.1097/MAO.0000000000000924. Review.

ReferenceCitation: Gros A, Vatovec J, Sereg-Bahar M. Histologic changes on stapedial footplate in otosclerosis. Correlations between histologic activity and clinical findings. Otol Neurotol. 2003 Jan;24(1):43-7.

ReferenceCitation: Husain Q, Lin KF, Selesnick SH. Stapes prosthesis length and hearing outcomes. Laryngoscope. 2018 Mar;128(3):722-726. doi: 10.1002/lary.26700. Epub 2017 May 31.

ReferenceCitation: Fayad JN, Semaan MT, Meier JC, House JW. Hearing results using the SMart piston prosthesis. Otol Neurotol. 2009 Dec;30(8):1122-7. doi: 10.1097/MAO.0b013e3181be645d.

ReferenceCitation: Avan P, Giraudet F, Büki B. Importance of binaural hearing. Audiol Neurootol. 2015;20 Suppl 1:3-6. doi: 10.1159/000380741. Epub 2015 May 19. Review.

ReferenceCitation: Weiss R, Leinung M, Baumann U, Weißgerber T, Rader T, Stöver T. Improvement of speech perception in quiet and in noise without decreasing localization abilities with the bone conduction device Bonebridge. Eur Arch Otorhinolaryngol. 2017 May;274(5):2107-2115. doi: 10.1007/s00405-016-4434-2. Epub 2016 Dec 28.

ReferenceCitation: Gartrell BC, Jones HG, Kan A, Buhr-Lawler M, Gubbels SP, Litovsky RY. Investigating long-term effects of cochlear implantation in single-sided deafness: a best practice model for longitudinal assessment of spatial hearing abilities and tinnitus handicap. Otol Neurotol. 2014 Oct;35(9):1525-32. doi: 10.1097/MAO.0000000000000437.

ReferenceCitation: Schleich P, Nopp P, D'Haese P. Head shadow, squelch, and summation effects in bilateral users of the MED-EL COMBI 40/40+ cochlear implant. Ear Hear. 2004 Jun;25(3):197-204.

ReferenceCitation: Jansen S, Luts H, Wagener KC, Kollmeier B, Del Rio M, Dauman R, James C, Fraysse B, Vormès E, Frachet B, Wouters J, van Wieringen A. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol. 2012 Mar;51(3):164-73. doi: 10.3109/14992027.2011.633568. Epub 2011 Nov 28.

ReferenceCitation: De Seta E, Rispoli G, Balsamo G, Covelli E, De Seta D, Filipo R. Indication for surgery in otosclerotic patients with unilateral hearing loss. Otol Neurotol. 2009 Dec;30(8):1116-21. doi: 10.1097/MAO.0b013e3181bc3c22.

ReferenceCitation: Baguant A, Schmerber S, Baguant K, Quatre R. Binaural squelch effect in unilateral otosclerosis surgery: comparison of speech intelligibility in noise before-after surgery. Eur Arch Otorhinolaryngol. 2022 Mar;279(3):1301-1310. doi: 10.1007/s00405-021-06797-3. Epub 2021 Apr 12.

lead_sponsor: University Hospital, Grenoble


title: Activated Cytotoxic T-lymphocytes CD8+/HLA-DR+ and Acute Cellular Rejection After Lung Transplantation

summary:
The objectives of the study is to identify associations between acute rejection and the increase of T (CD4/CD8) and B circulating lymphocytes expressing specific markers of activation and differentiation (HLA-DR, CD25, CD38, CD45RO, CCR7).

110 adults over 18 years, on national waiting list for a first lung transplantation in the centers of Marseille and Strasbourg, whatever the lung disease, and who will be transplanted and benefit immunosuppressive induction therapy that specifically targets T lymphocytes will be included. Peripheral venous blood sampling just prior to pulmonary transplantation, at day 15 and one month post-transplant will be realized for lymphocyte phenotyping by flow cytometry (CD45, CD3, CD4, CD8, CD19, HLA-DR, CD25, CD38, CD45RO, CCR7). Acute rejection will be evaluated at 1 month and 1 year post-transplant by trans-bronchial biopsies.

The two main perspectives are to 1) find a specific, non-invasive, blood-based diagnostic marker of acute post-lung transplant rejection with diagnostic performance equivalent to trans-bronchial biopsy 2) demonstrate a specific blood marker, non-invasive, predictive of acute rejection in order to adapt immunosuppressive therapy early and reduce the occurrence of this risk.


title: Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block

summary:
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.

The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation


title: Assess Prevalence of Urinary Functional Disorders in Women of 40 and More, Visiting a General Practitioner, Occupational Medicine or Health Examination Center in Puy-de-Dôme

summary: Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients

acronym: Easy EDSS

summary:
The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.

Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.

The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.


title: Prospective Study of Volumetric Gluteal Region by Parasacral Perforator Flaps in Circumferential Body Lift

summary: The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


title: Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

summary:
Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance.

However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems.

In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia.

The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia "medtronic Minimed with SmartGuard technology" in type 1 diabetic children, especially on the time spent in hypoglycemia .

lead_sponsor: CHU de Reims


title: Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulins for Severe Acute Exacerbation of Idiopathic Pulmonary Fibrosis Admitted in ICU: an Open, Randomized, Controlled Trial

acronym: EXCHANGE-IPF

summary: Idiopathic pulmonary fibrosis (IPF) is a fibroproliferative, irreversible disease of unknown cause, occurring mainly in patients older than 50. IPF is a rare but fatal lung disease, with an estimated prevalence of 14 to 28/100000 and a median survival time of 3 years. Acute exacerbation of IPF (AE-IPF) is a major event of IPF, as it is responsible for the death of 30-50 % of IPF patients; its annual incidence varies between 5 and 10%. The current literature indicates that IPF is associated with the development of an auto-immunity process targeting epithelial and endothelial lung cells. Autoantibodies have been associated with a poorer prognosis. A study by DONAHOE et al. (Plos One, 2015) indicates that the combination of corticosteroids, plasma exchanges, rituximab and immunoglobulins may improve the prognosis of the most severe forms of AE-IPF. In that study, the observed survival rate in patients receiving this combination of treatment was 70% as compared with 20% in historical controls. This therapeutic combination approach is designed both to eliminate and inhibit the production of circulating antibodies targeting the lungs. Considering the high mortality rate of an AE-IPF episode and the potential benefit of such an original approach, a well-conducted randomized controlled trial is critical.


title: Impact of Regulatory Framework Change for Zolpidem Prescriptions (Secure Prescription) on Consumption and Misuse of Sedatives Drugs.

acronym: ZORRO

summary: For several years, the French Addictovigilance Network (FAN) highlights potential problematic consumptions with zolpidem. To prevent abuse and misuse of zolpidem, the French Health Products Agency has changed the regulatory framework of zolpidem prescription. Thus, since the 10th of April 2017 zolpidem prescriptions have to be secured (particular support, dosage written out). The investigators hypothesized that this change will affect zolpidem consumption but also the consumption of all sedative drugs. In order to assess the incidence of the regulatory change for zolpidem prescription the investigators conduct a two part study: an epidemiological study with French National Health Insurance Fund for Employees database and an observational study with general practitioners and zolpidem consumers.

ReferenceCitation: Istvan M, Rousselet M, Laforgue EJ, Guerlais M, Gérardin M, Jolliet P, Feuillet F, Victorri-Vigneau C. Did the pattern of use of zolpidem change since the enforcement of a new prescription rule? A latent class analysis using the French health insurance database. Expert Opin Drug Saf. 2022 Sep;21(9):1225-1234. doi: 10.1080/14740338.2022.2047930. Epub 2022 Mar 8.

ReferenceCitation: Gérardin M, Rousselet M, Caillet P, Grall-Bronnec M, Loué P, Jolliet P, Victorri-Vigneau C. French national health insurance database analysis and field study focusing on the impact of secure prescription pads on zolpidem consumption and sedative drug misuse: ZORRO study protocol. BMJ Open. 2019 Jun 28;9(6):e027443. doi: 10.1136/bmjopen-2018-027443.


title: Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

acronym: BOVARY Pilot

summary: BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared

lead_sponsor: Institut de Cancérologie de Lorraine


title: Validation of an Early Detection Questionnaire of Burnout in Healthcare Workers at Clermont-Ferrand University Hospital

summary: Burnout is a public health issue. Healthcare workers are particularly at risk of burnout with occupational stress identified as the major risk factor. The "Health Work Environment" service is composed of physicians, nurses and psychologist with the aim of providing efficient and adapted care for healthcare workers at CHU of Clermont-Ferrand. In addition, they must ensure a role of primary, secondary and tertiary prevention. With regard to burnout, the majority of the work carried out concerns tertiary prevention, that is to say the care of a person in a situation of burnout. It would be necessary to carry out secondary prevention in order that people at risk of burnout can be detected earlier. However, there is currently no individual questionnaire to detect early burnout


title: Cohort Study Evaluating 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma

acronym: FDG-IMMUN

summary: The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Radiation


title: Efficacy of a Dialectical Behavior Therapy and Acceptance Commitment Therapy Short Program for Prevention of Suicidal Behavior in Patients With Borderline Personality Disorder

acronym: DIABOLO

summary:
According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority.

Borderline personality disorder (BPD) is a common condition affecting 6% of the population.

This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment.

BPD is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a BPD.

Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt.

People with a BPD are highly sensitive to it. Unfortunately, patient care for this disorder is limited. Pharmacological strategies didn't show any efficacy and psychotherapies, although proven effective, are difficult to set up.

As BPD is strongly related to suicidal attempts it appears to be a good model to study suicidal behavior. Thus, this study could improve knowledge in this field.

Suicidal behavior in patients receiving the standard therapy (dialectic behavioural therapy: DBT) will be compared to patients receiving dialectical behavior therapy and acceptance commitment therapy (ACT).

Clinical data reflecting how the participant is feeling will be collected as well.

status: Withdrawn

intervention_type: Behavioral


title: Dental Implants in Patients With X-linked Hypophosphatemia

acronym: IMPLANTS-XLH

summary: X-linked hypophosphatemia (XLH) is a rare genetic skeletal disease where increased phosphate wasting in the kidney leads to hypophosphatemia and prevents normal mineralization of bone and dentin, with osteomalacia as a principal manifestation. In previous works, the investigators have shown that adults with XLH present with more frequent and severe periodontitis than in the general population, and that vitamin D and phosphate supplementation improves their periodontal health, as it does for the osteomalacia. Their medical records also reveal that early implant failure is dramatically increased in these patients, when no supplementation is implemented, and standard surgical protocols followed. In contrast, the investigator's preliminary data showed that successful osseointegration was achieved with supplementation prior and after implant placement and extended healing time. Here, the investigators propose to assess the current recommendations for implant therapy in XLH patients, with 24 implants placed. The current recommendations consist of: 1) supplementation with vitamin D and phosphate for 3 months prior to implant placement and 6 months after; 2) implant healing time extended to 6 months. If osseointegration is achieved, prosthesis will be fabricated. Radiographic and clinical examination at 6, 12, 18 and 24 months after placement of the definitive restoration will evaluate the implant osseointegration, crestal bone level and peri-implant tissues health.

location_facility: Service d'Odontologie - Hôpital Bretonneau - 23 rue Joseph de Maistre


title: Management of Anal Fistula of Crohn Disease

acronym: FISTUCROHN

summary: The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

time_perspective: Other


title: Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability

acronym: EVALDI

summary: Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.


title: Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study

acronym: AROMA

summary: AROMA study is a randomised controlled parallel-group single-site study. Patients randomized in the experimental group benefit from the aromatherapy at their arrival in the operating theatre in the recovery room. 2 drops of essential oils are applied on a compress placed next to the head of the patient. This compress is kept until the patient is leaving the operating theatre. Patients randomized in the control group don't benefit from the aromatherapy. The anxiety evolution is measured in both groups with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The hypothesis is that aromatherapy alleviate peri operative anxiety during an ambulatory elective upper limb surgery under loco-regional anesthesia.

lead_sponsor: University Hospital, Lille


title: A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

acronym: VIRTOPSY+

summary: The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

ReferenceCitation: Addison S, Arthurs OJ, Thayyil S. Post-mortem MRI as an alternative to non-forensic autopsy in foetuses and children: from research into clinical practice. Br J Radiol. 2014 Apr;87(1036):20130621. doi: 10.1259/bjr.20130621. Review.

ReferenceCitation: Brookes JA, Hall-Craggs MA, Sams VR, Lees WR. Non-invasive perinatal necropsy by magnetic resonance imaging. Lancet. 1996 Oct 26;348(9035):1139-41.

ReferenceCitation: Breeze AC, Jessop FA, Set PA, Whitehead AL, Cross JJ, Lomas DJ, Hackett GA, Joubert I, Lees CC. Minimally-invasive fetal autopsy using magnetic resonance imaging and percutaneous organ biopsies: clinical value and comparison to conventional autopsy. Ultrasound Obstet Gynecol. 2011 Mar;37(3):317-23. doi: 10.1002/uog.8844.

ReferenceCitation: Kang X, Cannie MM, Arthurs OJ, Segers V, Fourneau C, Bevilacqua E, Cos Sanchez T, Sebire NJ, Jani JC. Post-mortem whole-body magnetic resonance imaging of human fetuses: a comparison of 3-T vs. 1.5-T MR imaging with classical autopsy. Eur Radiol. 2017 Aug;27(8):3542-3553. doi: 10.1007/s00330-016-4725-4. Epub 2017 Jan 23.

ReferenceCitation: Cannie M, Votino C, Moerman P, Vanheste R, Segers V, Van Berkel K, Hanssens M, Kang X, Cos T, Kir M, Balepa L, Divano L, Foulon W, De Mey J, Jani J. Acceptance, reliability and confidence of diagnosis of fetal and neonatal virtuopsy compared with conventional autopsy: a prospective study. Ultrasound Obstet Gynecol. 2012 Jun;39(6):659-65. doi: 10.1002/uog.10079. Epub 2012 May 22.

ReferenceCitation: Griffiths PD, Paley MN, Whitby EH. Post-mortem MRI as an adjunct to fetal or neonatal autopsy. Lancet. 2005 Apr 2-8;365(9466):1271-3.

ReferenceCitation: Sebire NJ, Weber MA, Thayyil S, Mushtaq I, Taylor A, Chitty LS. Minimally invasive perinatal autopsies using magnetic resonance imaging and endoscopic postmortem examination ("keyhole autopsy"): feasibility and initial experience. J Matern Fetal Neonatal Med. 2012 May;25(5):513-8. doi: 10.3109/14767058.2011.601368. Epub 2011 Aug 10.

ReferenceCitation: Woodward PJ, Sohaey R, Harris DP, Jackson GM, Klatt EC, Alexander AL, Kennedy A. Postmortem fetal MR imaging: comparison with findings at autopsy. AJR Am J Roentgenol. 1997 Jan;168(1):41-6.

ReferenceCitation: Thayyil S, Sebire NJ, Chitty LS, Wade A, Olsen O, Gunny RS, Offiah A, Saunders DE, Owens CM, Chong WK, Robertson NJ, Taylor AM. Post mortem magnetic resonance imaging in the fetus, infant and child: a comparative study with conventional autopsy (MaRIAS Protocol). BMC Pediatr. 2011 Dec 22;11:120. doi: 10.1186/1471-2431-11-120.

ReferenceCitation: D'Hondt A, Cassart M, De Maubeuge R, Soto Ares G, Rommens J, Avni EF. Postmortem fetal magnetic resonance imaging: where do we stand? Insights Imaging. 2018 Aug;9(4):591-598. doi: 10.1007/s13244-018-0627-0. Epub 2018 Jun 4. Review.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Study of the Influence of Blue Light Emitted by Computer / Television Screens on Melasma Single-center, Interventional, Randomized, Single-blind Study (Masked Investigator) MELABLUE Study

acronym: MELABLUE

summary:
Melasma is a fairly common condition resulting in hyperpigmented macules on the face. Melasma is difficult to treat and has a significant negative impact on the patient's quality of life.

Melasma is worsen when exposed to high energy visible light (blue and violet light) of the solar spectrum. Blue light emitted by LED screens from computers, tablets, televisions and even mobile phones is currently suspected (via media channels) to induce harmful effects on the skin, including pigmentation and photoaging. These screens, however, emit much lower irradiances than those of the solar spectrum, and the probability that these irradiances impact the skin is very low.

The objective of the study is to assess the effect of blue light emitted by computer/television screens on the intensity of melasma pigmentation. To do this, it is proposed to use maximized conditions that could be encountered in normal daily life, namely a simulation of blue light exposure (420-490nm) at 20 cm from a laptop LED screen, 8 hours a day for 5 days. Since it is not proposed to expose a person for 8 hours a day, a solar simulator with appropriate filters will be used to emit a spectrum of between 420 and 490 nm with a compatible intensity for an acceptable duration of exposure (around 30 minutes a day).

Twelve patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified MASI on standardized photographs. A final evaluation visit will be performed at Day 15.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie


title: Identification of Difficulties During a First Request for a Personal Autonomy Allowance by Beneficiaries and Identification of the Role of the Attending Physician During This Request.

acronym: IDAPA

summary: The objective of this study is to identify the difficulties when first applying for a first Resource Allocation (Personal autonomy allowance - APA) by beneficiaries and their relatives through a qualitative study and secondarily identification of the role of the attending physician during this request.

location_facility: Conseil Départemental -Pôle Solidarité Humaine


title: Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice

summary: A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.

lead_sponsor: Biotech Dental