title: Multicenter Study, Randomized, Parallel Group Controlled, Testing the Effectiveness of a Behavioral Cognitive Therapy (BCT) vs Usual Local Practice on the Fatigue of Patients With Relapsing Remittent Multiple Sclerosis (RRMS)

summary:
Multiple sclerosis (MS) is a chronic inflammatory disease that leads to demyelination of the central nervous system. Fatigue is one of the most frequent and most disabling symptoms of MS. Up to 86% of individuals with MS experience fatigue at any one time; 65% consider it to be one of their three most troubling symptoms. Fatigue may limit or prevent participation in dayly activities and reduce psychological well-being (1, 2). Pharmacological and non-pharmacological treatments are available for MS-related fatigue, but evidence on effectiveness is mostly inconclusive or non-existent. The psychological approaches of fatigue management are interesting. To date, three RCTs using cognitive-behavioral group-based approaches in MS fatigue management programs have demonstrated their effectiveness (3-6). The results demonstrated a reduction in fatigue scores and better self-management of the disease in general. However, if these programs are effective at the time of their application and in the medium term, the issue of maintaining long-term therapeutic benefits is problematic.

The aim of this research is to assess the effectiveness of the FACETS program (6), on a population of French patients with RRMS over a 18 month period. This program focuses on the management of fatigue and is based on a conceptual framework that incorporates elements of cognitive-behavioral, self-efficacy, self-management and energy effectiveness theories. It consists of six once-weekly sessions of 90 minutes, with homework activities between the sessions. It is designed for groups of 6 to 10 people. The investigators propose to add 4 booster sessions to the FACETS program, at week 6, 12, 18 et 36 after the end of the program, in order to activate and reinforce the cognitive and behavioral processes and enhance the benefits of FACETS in the longer term.

This trial is randomized controlled comparative comparing a group receiving a FACETS program with a group receiving only a current local practice. Socio-demographic and medical data are measured as well as fatigue impact, fatigue severity, anxiety and depression, sleep disorder and quality of life.

The expected results are a significantly greater decrease in fatigue severity and impact in the FACETS group than the control group post intervention and this difference will be maintained at 1 year.

ReferenceCitation: Edgley KJ. Sullivan M, Dehoux E. A survey of multiple sclerosis: II. Determinants of employment status. Can J Rehabil 4:127-132, 1991

ReferenceCitation: Multiple Sclerosis Council. Fatigue and Multiple Sclerosis - Clinical Practice Guidelines, 1998.

ReferenceCitation: Bowcher H, May M. Occupational Therapy for the Management of Fatigue in Multiple Sclerosis, Br J Occup Ther, 61(11):488-492, 1998.

ReferenceCitation: Castell BD, Kazantzis N, Moss-Morris RE. Cognitive Behavioral Therapy and Graded Exercise for Chronic Fatigue Syndrome: A Meta-Analysis. Clin Psychol Sci Pract. 18(4):311-324, 2012.

ReferenceCitation: Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6.

ReferenceCitation: van Kessel K, Moss-Morris R, Willoughby E, Chalder T, Johnson MH, Robinson E. A randomized controlled trial of cognitive behavior therapy for multiple sclerosis fatigue. Psychosom Med. 2008 Feb;70(2):205-13. doi: 10.1097/PSY.0b013e3181643065. Epub 2008 Feb 6.

family: van Kessel

full_name: Kirsten van Kessel

given: Kirsten

family: Moss-Morris

full_name: Rona Moss-Morris

given: Rona

family: Willoughby

full_name: Ernest Willoughby

given: Ernest

family: Chalder

full_name: Trudie Chalder

given: Trudie

family: Johnson

full_name: Malcolm H. Johnson

given: Malcolm H.

family: Robinson

full_name: Elizabeth Robinson

given: Elizabeth

journal_name: Psychosomatic Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: A Randomized Controlled Trial of Cognitive Behavior Therapy for Multiple Sclerosis Fatigue

ReferenceCitation: Thomas S, Thomas PW, Kersten P, Jones R, Green C, Nock A, Slingsby V, Smith AD, Baker R, Galvin KT, Hillier C. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1092-9. doi: 10.1136/jnnp-2012-303816. Epub 2013 May 21.

family: Thomas

full_name: Sarah Thomas

given: Sarah

full_name: Peter W Thomas

given: Peter W

family: Kersten

full_name: Paula Kersten

given: Paula

family: Jones

full_name: Rosemary Jones

given: Rosemary

family: Green

full_name: Colin Green

given: Colin

family: Nock

full_name: Alison Nock

given: Alison

family: Slingsby

full_name: Vicky Slingsby

given: Vicky

full_name: Angela Davies Smith

given: Angela Davies

family: Baker

full_name: Roger Baker

given: Roger

family: Galvin

full_name: Kathleen T Galvin

given: Kathleen T

family: Hillier

full_name: Charles Hillier

given: Charles

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Brighton - University of Brighton Repository

repository_institution: University of Exeter - Open Research Exeter

repository_institution: Bournemouth University - Bournemouth University Research Online

ReferenceCitation: Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. Review. Erratum in: Lancet 2002 Aug 24;360(9333):648.

ReferenceCitation: Brañas P, Jordan R, Fry-Smith A, Burls A, Hyde C. Treatments for fatigue in multiple sclerosis: a rapid and systematic review. Health Technol Assess. 2000;4(27):1-61. Review.

ReferenceCitation: Johansson S, Ytterberg C, Hillert J, Widén Holmqvist L, von Koch L. A longitudinal study of variations in and predictors of fatigue in multiple sclerosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):454-7. doi: 10.1136/jnnp.2007.121129.

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Guillemin F. [Reconsidering fatigue at the onset of multiple sclerosis]. Rev Neurol (Paris). 2009 Mar;165 Suppl 4:S135-44. doi: 10.1016/S0035-3787(09)72125-3. Review. French.

title: Reconsidérer l’apparition du handicap dès le début de la SEP : la fatigue

ReferenceCitation: Monks J. Experiencing symptoms in chronic illness: fatigue in multiple sclerosis. Int Disabil Stud. 1989 Apr-Jun;11(2):78-83.

ReferenceCitation: Grima DT, Torrance GW, Francis G, Rice G, Rosner AJ, Lafortune L. Cost and health related quality of life consequences of multiple sclerosis. Mult Scler. 2000 Apr;6(2):91-8.

ReferenceCitation: Flensner G, Landtblom AM, Söderhamn O, Ek AC. Work capacity and health-related quality of life among individuals with multiple sclerosis reduced by fatigue: a cross-sectional study. BMC Public Health. 2013 Mar 15;13:224. doi: 10.1186/1471-2458-13-224.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: White LJ, Castellano V. Exercise and brain health--implications for multiple sclerosis: Part 1--neuronal growth factors. Sports Med. 2008;38(2):91-100. Review.

ReferenceCitation: Ritvo PG, Fisk JD, Archibald CJ, Murray TJ, Field C. Psychosocial and neurological predictors of mental health in multiple sclerosis patients. J Clin Epidemiol. 1996 Apr;49(4):467-72.

ReferenceCitation: Schwid SR, Covington M, Segal BM, Goodman AD. Fatigue in multiple sclerosis: current understanding and future directions. J Rehabil Res Dev. 2002 Mar-Apr;39(2):211-24. Review.

ReferenceCitation: Racke MK, Hawker K, Frohman EM. Fatigue in multiple sclerosis: is the picture getting simpler or more complex? Arch Neurol. 2004 Feb;61(2):176-7.

ReferenceCitation: Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. Review.

ReferenceCitation: Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. Epub 2007 Apr 4. Review.

ReferenceCitation: Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD007280.

ReferenceCitation: Vanage SM, Gilbertson KK, Mathiowetz V. Effects of an energy conservation course on fatigue impact for persons with progressive multiple sclerosis. Am J Occup Ther. 2003 May-Jun;57(3):315-23.

ReferenceCitation: Mathiowetz VG, Finlayson ML, Matuska KM, Chen HY, Luo P. Randomized controlled trial of an energy conservation course for persons with multiple sclerosis. Mult Scler. 2005 Oct;11(5):592-601.

ReferenceCitation: Lee MA, Smith S, Palace J, Matthews PM. Defining multiple sclerosis disease activity using MRI T2-weighted difference imaging. Brain. 1998 Nov;121 ( Pt 11):2095-102.

ReferenceCitation: Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.

ReferenceCitation: Feinstein A, Magalhaes S, Richard JF, Audet B, Moore C. The link between multiple sclerosis and depression. Nat Rev Neurol. 2014 Sep;10(9):507-17. doi: 10.1038/nrneurol.2014.139. Epub 2014 Aug 12. Review.

ReferenceCitation: Knoop H, van Kessel K, Moss-Morris R. Which cognitions and behaviours mediate the positive effect of cognitive behavioural therapy on fatigue in patients with multiple sclerosis? Psychol Med. 2012 Jan;42(1):205-13. doi: 10.1017/S0033291711000924. Epub 2011 Jun 15.

ReferenceCitation: Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73.

ReferenceCitation: Ruet A, Deloire MS, Charré-Morin J, Hamel D, Brochet B. A new computerised cognitive test for the detection of information processing speed impairment in multiple sclerosis. Mult Scler. 2013 Oct;19(12):1665-72. doi: 10.1177/1352458513480251. Epub 2013 Mar 4.

name: Centre Hospitalo-Universitaire (CHU) France

ReferenceCitation: Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43.


title: PREOPTI-DAM: High-flow Nasal Cannula Oxygen Versus Standard Oxygenation During Intubation for Patient at Risk of Difficult Intubation: A Randomized Controlled Clinical Trial

acronym: PREOPTI-DAM

summary: Tracheal intubation in operating room for patients at risk of difficult intubation remains a critical event. The aim of this study is to determine whether Nasal High Flow Therapy by nasal cannula Optiflow® administered before and during intubation is more efficient than the standard care for pre-oxygenation and oxygenation during anticipated difficult intubation

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Vourc'h M, Huard D, Feuillet F, Baud G, Guichoux A, Surbled M, Tissot M, Chiffoleau A, Guitton C, Jaber S, Asehnoune K. Preoxygenation in difficult airway management: high-flow oxygenation by nasal cannula versus face mask (the PREOPTIDAM study). Protocol for a single-centre randomised study. BMJ Open. 2019 Apr 25;9(4):e025909. doi: 10.1136/bmjopen-2018-025909.

family: Vourc’h

full_name: Mickael Vourc’h

given: Mickael

sequence: first

family: Huard

full_name: Donatien Huard

given: Donatien

sequence: additional

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Baud

full_name: Gabrielle Baud

given: Gabrielle

family: Guichoux

full_name: Arthur Guichoux

given: Arthur

family: Surbled

full_name: Marielle Surbled

given: Marielle

family: Tissot

full_name: Melanie Tissot

given: Melanie

family: Chiffoleau

full_name: Anne Chiffoleau

given: Anne

family: Guitton

full_name: Christophe Guitton

given: Christophe

family: Jaber

full_name: Samir Jaber

given: Samir

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

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

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Nantes University Hospital

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Comparison of Two Regimens of Individualized, Adjustable Human Milk Fortification in Pretem Infants Using a New Modular Protein-only Fortifier

summary: The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.

primary_purpose: Other

lead_sponsor: Nestlé

intervention_type: Combination Product

lead_sponsor_type: industriel


title: Preoperative Anxiety Level, Premeds and General Anaesthetic Proceedings

summary:
Although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. Furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use.

We want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. We also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

study_type: Observational

time_perspective: Prospective

lead_sponsor: CHU de Reims


type: Other Identifier

title: Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old. Mono-centric Prospective Study

acronym: BACCHUS

summary:
The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major.

The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

status: Terminated

ReferenceType: background

ReferenceCitation: Zouboulis CC, Makrantonaki E. Clinical aspects and molecular diagnostics of skin aging. Clin Dermatol. 2011 Jan-Feb;29(1):3-14. doi: 10.1016/j.clindermatol.2010.07.001. Review.

ReferenceCitation: Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5.

ReferenceCitation: Shin MH, Rhie GE, Park CH, Kim KH, Cho KH, Eun HC, Chung JH. Modulation of collagen metabolism by the topical application of dehydroepiandrosterone to human skin. J Invest Dermatol. 2005 Feb;124(2):315-23.

ReferenceCitation: Röck K, Grandoch M, Majora M, Krutmann J, Fischer JW. Collagen fragments inhibit hyaluronan synthesis in skin fibroblasts in response to ultraviolet B (UVB): new insights into mechanisms of matrix remodeling. J Biol Chem. 2011 May 20;286(20):18268-76. doi: 10.1074/jbc.M110.201665. Epub 2011 Mar 17.

ReferenceCitation: Varani J, Spearman D, Perone P, Fligiel SE, Datta SC, Wang ZQ, Shao Y, Kang S, Fisher GJ, Voorhees JJ. Inhibition of type I procollagen synthesis by damaged collagen in photoaged skin and by collagenase-degraded collagen in vitro. Am J Pathol. 2001 Mar;158(3):931-42.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Procedure

status_simplified: Unknown


title: Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients : Determination of Indicators of the Premature Degradation of the Orthostatic Posture, Gait Initiation and Walking

acronym: WALKING-SEP

summary:
Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system. Patients are suffering from balance and gait impairments at the early stage of the disease.

85 % of the MS patients report gait disorders, which impact their autonomy and their quality of life and increase the risk of fall.

The three-dimensional analysis of the walking by a motion capture system associated with force platforms allows the quantification of the complex walking disorders, to look for the cause, as well as side effects such as compensation strategies.

According to the 2006 report of the French National Authority for Health, the 3D analysis of walking is essential in chronic pathologies to evaluate and quantify gait disorders. This analysis allows the functional follow-up of the patients throughout their rehabilitation. Some studies, on a small and heterogeneous population of MS patients, showed changes during the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation of lower limbs at early stages of the disease. Only two studies evaluate the joint power during walking in MS patients. However, these studies have some limits.

The 3D analysis of the walking proposed in this study would allow the biomechanical characterization of the gait impairments of MS patients through tasks such as walking, gait initiation and orthostatic posture. This methodology would contribute to adapt treatments and the rehabilitation care, at an early stage of the disease.

From a functional point of view, the gait initiation is an interesting dynamic task to be evaluated. Indeed, it represents the transition between the upright posture and the stabilized walking. Throughout this complex task, a stereotypical motor program is set up during a first phase of anticipatory postural adjustments, which allows the creation of dynamic conditions essential for the execution of the first step. The gait initiation is little documented for MS patients despite the risk of fall clinically highlighted. The articular power during the gait initiation was never estimated in MS patients. On the other hand, there is no study establishing correlations between the Expanded Disability Status Scale functional features and the impairments of the gait initiation.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Lille Catholic University

intervention_type: Diagnostic Test


title: Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress : Pathophysiology of Suicidal Behaviors Study Model

acronym: ROI

summary:
Use lay language.

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

BPD (Borderline Personality Disorder) 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.

Borderline Personality Disorder 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 Borderline Personality Disorder

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

People with a Borderline Personality Disorder are highly sensitive to it.

Moreover, neuropeptides such as oxytocin (OXT), vasopressin and opioid are known to be involved in the regulation of the emotions, especially those linked to relationship.

The purpose of this study is to improve knowledge in suicidal behaviors.

After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD will be compared to healthy controls (HC).

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

status: Recruiting

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Montpellier

intervention_type: Other

status_simplified: Ongoing


title: Immediate Efficacy Assessment of SCENAR's Session on a Common Spinal Pain Syndrome

summary: Randomized, singled blinded, controlled trial of the efficacy of a SCENAR session in patients with vertebral pain. SCENAR is an electrotherapy device.

lead_sponsor: Hopital Foch


title: Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery

acronym: PELOPS

summary:
In 2015, more than 50% of surgical procedures were performed in outpatient settings. Successful pain management after outpatient surgery is crucial, and requires a perfect cooperation between caregivers and patients, with clear information on the analgesics use at home. Different strategies to control postoperative pain were adopted by hospitals performing outpatient surgery. However, up to half of patients receive little or no information about the treatment of postoperative pain, and at least one third of them are not able to follow postoperative analgesia instructions. There is a clear unmet need in pain treatment during first 48-72 hours after discharge, with important number of emergency calls and readmissions. The most common causes of rescue calls after outpatient surgery are uncontrolled pain and questions about medications or post-operative care.

Structured education interventions using psychological techniques to enhance engagement and behavior were found to be beneficial for better acute pain management in outpatient settings after orthopedic surgery.

We hypothesize that an educational intervention based on the rational perception of postoperative pain and discomfort, and the proper use of analgesics would improve the quality of pain management at home and reduce analgesics-related side effects.

Principal objective of this study is to evaluate the impact of a preoperative educational intervention on effectiveness of postoperative pain self-management in outpatient settings compared to the current practice.

Secondary objectives are to evaluate the prevalence of analgesics use and the incidence of severe pain episodes, as well as side effects. The occurrence of neurological pain, quality of sleep, and patient's comfort will be evaluated at 30th day after surgery.

primary_purpose: Prevention

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit

intervention_type: Behavioral


title: Microscopic Peritoneal Metastases After Complete Macroscopic Cytoreductive Surgery for Epithelial Ovarian Cancer

acronym: MicroPCI

summary: The objective of the cytoreductive surgery carried out for the management of ovarian cancers is to obtain a complete macroscopic cytoreduction. This means that all visible peritoneal metastases must be resected. The peritoneum is the most frequent site of recurrence after initial management. There is no data on the existence, prevalence of microscopic peritoneal metastases. It nevertheless represents a therapeutic target (intraperitoneal chemotherapy). The main objective is the demonstration of microscopic peritoneal metastases in macroscopically healthy peritoneum after complete macroscopic cytoreductive surgery.

primary_purpose: Basic Science

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix


title: Evaluation of the Prevalence, the Diagnosis Tests, and the Associated Morbimortality of Sarcopenia in Hepatobiliary Surgery

acronym: SARFO

summary: The sarcopenia is defined as a loss of muscle mass and a loss of muscle function ( strength or performance). Some studies showed that the sarcopenia increase the postoperative complications and the overall survival in abdominal surgery. But the sarcopenia is not evaluated in the Hepatobiliary surgery. This prospective, monconcentrique study aim to evaluate the prevalence of sarcopenia, and its associated morbimortality in hepatobiliary surgery for malignant or benign tumors.

lead_sponsor: University Hospital, Angers


title: Microglial Activation in Narcolepsy Type 1 and Kleine-Levin Syndrome: Positron Emission Tomography (PET) Study in [18F] DPA-714

acronym: NARCOGLIE

summary: Type 1 narcolepsy (NT1) is a chronic sleep disorder caused by the selective and irreversible loss of neurons from the hypothalamus, which synthesizes a neurotransmitter: hypocretin (Hcrt) / orexin. The exact cause of this destruction is still unknown, but the autoimmune hypothesis is strongly favored, involving the interaction of genetic and environmental factors. The treatment of NT1 is currently only symptomatic, targeting hypersomnolence and cataplexy. To prevent the destruction of Hcrt neurons, immunomodulatory agents have been tested, with varying efficacy, probably due to varying degrees of hypothalamic impairment and stages of disease progression. During microglial activation, a condition associated with neuroinflammation in the brain, there is an increase in the mitochondrial translocation protein (TSPO), which can be quantified in vivo by specific tracers, such as the [18F] DPA- 714, in positron emission tomography (PET), a very sensitive nuclear imaging technique. The aim here is to study microglial activation in PET [18F] DPA-714 in NT1 patients with recent evolution in comparison with controls; then analyze the effect of age, and the severity of symptoms on this PET imaging biomarker. The hypothesis is that microglial activation, especially of the hypothalamic region, is greater in NT1 than controls.

intervention_type: Radiation


title: SubArachnoid Hemorrhage HEadache Treated by Lumbar Puncture

acronym: SAH-HELP

summary: Headache control is one of the major challenges in patients who suffered an acute aneurysmal subarachnoid hemorrhage (aSAH). Headache affects 90% of the patient and is resistant to the major pain medication. It results from the increased intracranial pressure and the inflammation caused by the accumulation of arterial blood in the subarachnoid space. Hemorrhagic cerebrospinal fluid (CSF) removal by a lumbar puncture (LP), is well tolerated, reduces intracranial pressure and accelerates the clearance of the blood products from CSF. Nonetheless it has never been tested in a randomized trial. The investigators aim to compare in patients who experienced a low grade aSAH, the variation of headache intensity after CSF removal by LP vs. Sham LP in addition to predefined analgesic protocol management.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse


title: Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma

acronym: PERCAHEC

summary: The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.

primary_purpose: Diagnostic


title: Feasibility of Modified Constraint-induced Movement Therapy Combined With Visual-spatial Cueing Strategy in Patients With Acute Stroke

acronym: ITHEMICAL

summary: The aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.


title: Initiation of an in Vitro Model of the Cystic Fibrosis Bronchial Epithelium Via Induced Pluripotent Stem Cell Technology

acronym: PaCyFIC

summary: In order to further enable physiopathology studies, the aim of this project is to validate an in vitro model of cystic fibrosis created using induced pluripotent stemcell (iPS) differentiated bronchial epithelium from cystic fibrosis (CF) patients homozygous for the p.Phe508del mutation of the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

location_facility: Hôpital Arnaud de Villeneuve - CHU de Montpellier


title: Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.

summary: The main objective of the project "MucoFong" (19021906 national french program n which Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the respiratory tract of CF patients responsible for either colonization or authentic infectious diseases. The Mucofong data allowed the team to provide for the 1st time national French guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. The main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux


intervention_type: Drug

lead_sponsor: Institut de Cancérologie de la Loire

acronym: HOMEORAD

location_facility: Institut de Cancérologie Lucien Neuwirth

type: EudraCT Number

source: euctr

title: Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

summary:
Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.

Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.

Homeopathy is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.


title: A Study of the Relationship Between Personality Disorders and Substance Use Disorders in a Sexual Context in the Man Having Sex With Other Men Population - An Observational Study Based on a Cross-sectional Survey.

acronym: PSYCHEMS

summary:
Chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones, GHB/GBL, methamphetamine, cocaine and ketamine. This can cause infectious or psychiatric complications, addictions, and often goes with high risk sexual behaviours. Recent studies have highlighted the relationship between personality disorders, substance use disorders and risky sexual behaviours. It is important to understand the factors associated with chemsex in order to offer adapted prevention and care plans.

The study hypothesis is that personality disorders, evaluated with the PDQ-4+ questionnaire, are more frequent among man having sex with other men with a substance use disorder linked to chemsex than among man having sex with other men who have never practised chemsex.

time_perspective: Cross-Sectional

location_facility: CSAPA - Service Hépato-gastroentérologie


title: Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness

summary:
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.

Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).

Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.

ReferenceCitation: Hamzaoui O, Gouëzel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414. Erratum in: Crit Care Med. 2021 Jun 1;49(6):e662.

family: Hamzaoui

full_name: Olfa Hamzaoui

given: Olfa

family: Gouëzel

full_name: Corentin Gouëzel

given: Corentin

family: Jozwiak

full_name: Mathieu Jozwiak

given: Mathieu

family: Millereux

full_name: Maude Millereux

given: Maude

family: Sztrymf

full_name: Benjamin Sztrymf

given: Benjamin

family: Prat

full_name: Dominique Prat

given: Dominique

family: Jacobs

full_name: Frederic Jacobs

given: Frederic

family: Monnet

full_name: Xavier Monnet

given: Xavier

family: Trouiller

full_name: Pierre Trouiller

given: Pierre

family: Teboul

full_name: Jean-Louis Teboul

given: Jean-Louis

journal_name: Critical Care Medicine

lead_sponsor: Hopital Antoine Beclere


title: Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases

acronym: CLEAN

summary: National multicentric observatory of low bowel preparations in patients with IBD

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Identification of Respiratory Profiles From Nasal Pressure Signals

acronym: IPR-SAINS

summary:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries.

Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used.

As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.

ReferenceCitation: Pegoraro JA, Lavault S, Wattiez N, Similowski T, Gonzalez-Bermejo J, Birmelé E. Machine-learning based feature selection for a non-invasive breathing change detection. BioData Min. 2021 Jul 18;14(1):33. doi: 10.1186/s13040-021-00265-8.

family: Pegoraro

full_name: Juliana Alves Pegoraro

given: Juliana Alves

family: Lavault

full_name: Sophie Lavault

given: Sophie

family: Wattiez

full_name: Nicolas Wattiez

given: Nicolas

family: Similowski

full_name: Thomas Similowski

given: Thomas

family: Gonzalez-Bermejo

full_name: Jésus Gonzalez-Bermejo

given: Jésus

family: Birmelé

full_name: Etienne Birmelé

given: Etienne

bso_classification: Biology (fond.)

journal_name: BioData Mining

license: cc-by

license_normalized: cc-by

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

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

location_facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière


title: Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.

acronym: Bis-qCON-IV

summary: Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.


title: Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. A Single-blind, Randomised, Comparative, Multicentre Clinical Trial vs. Discectomy Alone.

acronym: INTREUR

summary:
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.

The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.

ReferenceCitation: Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.

ReferenceCitation: Galarza M, Gazzeri R, De la Rosa P, Martínez-Lage JF. Microdiscectomy with and without insertion of interspinous device for herniated disc at the L5-S1 level. J Clin Neurosci. 2014 Nov;21(11):1934-9. doi: 10.1016/j.jocn.2014.02.029. Epub 2014 Oct 3.

ReferenceType: result

ReferenceCitation: Bae J, Lee SM, Lee SH, Shin SH, Kim HJ, Kim KH. The Likelihood of Reaching Substantial Clinical Benefit After an Interlaminar Dynamic Spacer for Chronic Low Back Pain: A Clinical and Radiologic Analysis of a Prospective Cohort. World Neurosurg. 2017 May;101:589-598. doi: 10.1016/j.wneu.2017.02.083. Epub 2017 Feb 27.

family: Bae

full_name: Junseok Bae

given: Junseok

family: Lee

full_name: Shih Min Lee

given: Shih Min

full_name: Sang-Ho Lee

given: Sang-Ho

family: Shin

full_name: Sang-Ha Shin

given: Sang-Ha

family: Kim

full_name: Ho-Jin Kim

given: Ho-Jin

full_name: Kyeong Hwan Kim

given: Kyeong Hwan

journal_name: World Neurosurgery

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Quanta Medical


title: Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn

summary: To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities

lead_sponsor: University Hospital, Lille


title: Genetic an Functional Studies of Patient With Inflammatory Bowel Disease

acronym: MINOTOR

summary: The objective of this study is to study the response of macrophages, isolated from patients with ulcerative colitis (Crohn's disease) or Crohn's disease (CD), to 6 candidate enterogenous and their derivatives, depending on the genotype for associated polymorphisms. to the development of IBD


title: Prospective Study, Monocentric, Randomized, Double Blind Evaluating the Non Inferiority of Non Capsular Suture in Arthroscopic Treatment of Cam or Mixed-type Femoroacetabular Impingement Without Hip Dysplasia

acronym: SUTURCAP

summary:
Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular impingement treatment. However, no consensus exist concerning capsular suture or not. According to capsular incision size, articular instability can persist if no suture is performed. In contrast, tightly suture can cause post-operative joint stiffness.

This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

lead_sponsor: Clinique de la Sauvegarde


type: Registry Identifier

title: Assessment of the Impact of the Use of the ARA 2 Connected Toothbrush on Short-term Oral Hygiene During the Pre-operative Period of Alveolar Bone Grafts for Patients With Unilateral or Bilateral Cleft Lip and Palate. Oral Hygiene and Connected Toothbrush Before Alveolar Bone Graft for Cleft Lip and Palate.

acronym: HBD-GPP

summary:
Alveolar bone graft is an essential step in the primary surgical treatment of unilateral or bilateral cleft lip and palate. The procedure involves repairing the alveolar cleft by an autologous iliac bone graft.

Clinical experience suggests that a large number of the post-operative complications in this procedure are related to pre-and post-operative oral hygiene issues.

The main objective of this research is the evaluation of pre-operative oral hygiene in children benefiting from alveolar bone graft and having a type Quad Helix orthodontic device.

The secondary objectives are to describe the use of the Ara ® Toothbrush by a population of children with a cleft lip and palate and to know whether the use of the Ara ® toothbrush has an influence on the occurrence of post-operative complications evaluated at 6 months of intervention (delays in scarring, suture dehiscence, fistulas, surgical site infections, total or partial graft loss).


title: Comparison of the Stiffness of the Lumbar Back Muscles Between Low Back Pain and Healthy Controls Using Magnetic Resonance Elastography and Shear Wave Elastography

acronym: PARA-ELASTO

summary: Chronic low back pain remains a major public health issue. Low back pain is frequently associated with stiffness changes of the lumbar back muscles. The techniques which assess the stiffness of the back muscles are poorly reliable and do not allow the quantification of stiffness changes. Elastography (magnetic resonance imaging and ultrasound) can be used to objectively and non-invasively quantify in vivo tissue elasticity. The aim of the investigator's study is to compare the stiffness in the main lumbar back muscles (i.e. the erector spinae and the multifidus) by using magnetic resonance elastography and shear wave elastography.

study_start_date_type: Anticipated


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.

ipd_sharing_description: NC


title: Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel

acronym: ANI-MICI

summary: The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).


title: Prevalence of Obstructive Sleep Apnea Syndrome in Patients With a History of Sudden Sensorineural Hearing Loss

acronym: SAS-SB

summary: This study studies the prevalence between obstructive sleep apnea syndrome and sensorineural hearing loss. We recruit patients who have been treated for sudden sensorineural hearing loss in Poitiers' University Hospital between 2010 et 2017, and we detect if they have OSA with a ventilatory polygraphy.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital


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: Evaluation of a New Long-term Total Articular Prosthesis Follow-up Strategy by Simple Questionnaire and Radiography

acronym: Follow-up

summary:
Ever-evolving prosthetic activity as described in a Swedish study that predicts 469 TKA per 10,000 inhabitants in 2130. Increased consultation of controls and post-arthroplasty follow-up is expected. There is a legal obligation to ensure long-term follow-up without official recommendation on follow-up procedures. The objective is to compare a consultation + Xray by the surgeon versus an Xray and a questionnaire completed by the patient who had a knee or hip replacement. This is to demonstrate the equivalence of both.

All patients who come back for an annual check of a prosthesis should complete this questionnaire and perform an X-ray of their prosthesis. The study lasts one year and includes all the patients with a previous knee or hip arthroplasty.

The result of the questionnaire and Xray will be compared to that of the consultation and Xray.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability

acronym: HRV REEDUC

summary:
Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.

The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.

This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.


title: A Randomized Controlled Study Comparing the Influence of a Mindfulness-based Stress Reduction Program vs. Routine Management on Psychological Variables and Biological Markers Related to Immuno-inflammation Associated With Psychological Stress in Caregivers of Patients With Severe Psychiatric Disorders.

acronym: MindInfCare

summary:
The objective of this project is to study the influence of mindfulness meditation on psychological health (stress level, affects, emotions) and physical health parameters (rate of inflammatory markers in the blood, activity of white blood cells involved in immuno-inflammation) in caregivers of people with psychiatric disorders. This study will provide the objective scientific data required for the development of mindfulness meditation programs for psychiatric caregivers.

80 participants will be randomly assigned to one of the following two groups:

40 participants in the "Mindfulness" group who will attend mindfulness meditation sessions in addition to their standard follow-up
40 participants in the "Control" group who will have a standard follow-up The duration of participation is 12 months and includes 3 visits and 8 mindfulness-based meditation sessions for the "Mindfulness" group.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Becoming Children With Perinatal Anoxo-Ischemic Encephalopathy Without Indication of Therapeutic Hypothermia

acronym: SARNATUN

summary:
There are 3 levels of severity of anoxo-ischemic encephalopathy (EAI): mild, moderate and severe. Therapeutic hypothermia is beneficial in children with moderate EAI. It is ineffective in severe EAI and may be deleterious if there is no EAI. He continues to question his interest in light EAIs.

There are few studies on the becoming of children with a mild anoxic-ischemic encephalopathy and not set hypothermia.

The main hypothesis of the study is that term newborns with anoxo-ischemic encephalopathy who did not require therapeutic hypothermia have normal psychomotor development at 2 years.

location_facility: Service de Réanimation néonatale - Hôpital de la Croix Rousse


title: Analysis of B Cell Differentiation in Multiple Sclerosis

acronym: ABCD-SEP

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

lead_sponsor: Rennes University Hospital


title: Citrulline Efficacy to Improve Carbohydrate Metabolism Abnormalities in the Patient Treated With High Doses of Statin

acronym: STATIMPROVE

summary:
Hypercholesterolemia is a major cardiovascular risk factor. Statins are the first-line drug treatment for hypercholesterolemia and have been shown to be effective in both primary and secondary prevention of cardiovascular disease. However, long-term statin therapy is associated with impaired carbohydrate metabolism and increased risk of developing type 2 diabetes (T2D), particularly in patients with metabolic syndrome. The risk of developing T2D is higher with high doses of statins.

Currently the benefits of statins on the reduction of major cardiovascular events and mortality are considered superior to the risk of statin-induced diabetes T2D, and no change in clinical practice has been recommended to date. However, it now appears necessary to develop strategies to reduce the adverse effects of statins on carbohydrate metabolism and maintain the carbohydrate tolerance of patients on statins, especially in those at risk of developing T2D under statins.

Statins are able to induce the expression and activity of an enzyme synthesizing nitric oxide (NO), the endothelial NO synthase (eNOS), which helps improving insulin sensitivity and insulin secretion. However, availability and metabolism of its substrate arginine is impaired in obesity and T2D. The investigators thus hypothesized that providing citrulline to statin treated patients, the arginine precursor with better gastrointestinal tolerance and bioavailability than arginine, would beneficially impact their glucose homeostasis.

Tested in vivo by Béatrice Morio, a member of the CarMeN laboratory, combining citrulline to atorvastatin improved glucose tolerance and insulin sensitivity in mice fed a high fat-high sucrose diet. These data therefore suggest that combining citrulline to atorvastatin may improve glucose tolerance in statin-treated patients at high risk of developing T2D.

The objective of the study is therefore to investigate the impact of citrulline supplementation (5g/d) vs. placebo for 4 weeks on glucose tolerance assessed during an oral glucose tolerance test in patients at risk for developing T2D and treated with atorvastatin (40 or 80 mg / day).

location_facility: Endocrinology and diabetology service, Louis Pradel Hospital

intervention_type: Dietary Supplement


title: Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery

acronym: STEMI-MR

summary:
Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias. For this specific population, ESC guidelines currently recommend a waiting period of up to 40 days after a STEMI with severe left ventricular dysfunction before considering ICD implantation for primary prevention of sudden death.This delay is allocated to judge left ventricular recovery.

This study aims to see whether early cardiac MRI with specific sequences can help predict which patients will most probably not recover their left ventricular function and benefit from earlier ICD implantation.

ReferenceCitation: Daly C, Kwong RY. Cardiac MRI for myocardial ischemia. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):123-31. Review.

ReferenceCitation: Perazzolo Marra M, Lima JA, Iliceto S. MRI in acute myocardial infarction. Eur Heart J. 2011 Feb;32(3):284-93. doi: 10.1093/eurheartj/ehq409. Epub 2010 Nov 25. Review.

ReferenceCitation: Schelbert EB, Wong TC. Imaging the area at risk in myocardial infarction with cardiovascular magnetic resonance. J Am Heart Assoc. 2014 Aug 21;3(4). pii: e001253. doi: 10.1161/JAHA.114.001253.

ReferenceCitation: Haaf P, Garg P, Messroghli DR, Broadbent DA, Greenwood JP, Plein S. Cardiac T1 Mapping and Extracellular Volume (ECV) in clinical practice: a comprehensive review. J Cardiovasc Magn Reson. 2016 Nov 30;18(1):89. Review.

ReferenceCitation: Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimský P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393.

lead_sponsor: University Hospital, Montpellier


title: Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.

acronym: HEMODAIRTRAQ

summary:
News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.

Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.


title: Screening of Obstructive Sleep Apnea by Smartphone Homemade Video in Childood Snoring Population

acronym: SMARTSAS

summary: The aim of the study is to evaluate the value of a video recording of the child sleep on smartphone made by the parents and comparing it to ventilatory polygraphy (PV) on the one hand and to the clinical evaluation method (clinical examination + Spruyt and Gozal score) on the other hand.

ReferenceCitation: Pateron B, Marianowski R, Monteyrol PJ, Couloigner V, Akkari M, Chalumeau F, Fayoux P, Leboulanger N, Franco P, Mondain M. French Society of ENT (SFORL) guidelines (short version) on the roles of the various treatment options in childhood obstructive sleep apnea-hypopnea syndrome. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Aug;135(4):265-268. doi: 10.1016/j.anorl.2018.04.005. Epub 2018 May 3.

ReferenceCitation: Spruyt K, Gozal D. Screening of pediatric sleep-disordered breathing: a proposed unbiased discriminative set of questions using clinical severity scales. Chest. 2012 Dec;142(6):1508-1515. doi: 10.1378/chest.11-3164.

ReferenceCitation: Nguyên XL, Lévy P, Beydon N, Gozal D, Fleury B. Performance characteristics of the French version of the severity hierarchy score for paediatric sleep apnoea screening in clinical settings. Sleep Med. 2017 Feb;30:24-28. doi: 10.1016/j.sleep.2016.01.021. Epub 2016 Mar 14.

ReferenceCitation: Sivan Y, Kornecki A, Schonfeld T. Screening obstructive sleep apnoea syndrome by home videotape recording in children. Eur Respir J. 1996 Oct;9(10):2127-31.

ReferenceCitation: Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172.


title: Construction and Validation of a Simplified Provocation Tests for the Diagnosis of Non Steroidal Anti-inflammatory Drugs (NSAID) Hypersensitivity

acronym: NSAID

summary:
Background : Non steroidal anti-inflammatory drugs are responsible for 25% of reported adverse drug events which include immunological and non-immunological hypersensitivity reactions. NSAIDs have been reported to be the second most common cause of drug-induced hypersensitivity reaction (DHR). They are almost mandatory in a human life and therefore, the drug allergy work-up goes up until a DPT in order to confirm or rule out the diagnosis.

Objective: Detect eliciting dose thresholds during NSAIDs DPT in order to suggest optimal step doses and to describe subgroups at higher risk during the DPT

Methods:This retrospective study, using the survival analysis, comprised all patients who attended the allergy service of the UH of Montpellier from 1997 till 2017 with a clinical history related to NSAIDs DHR, who underwent NDAIDs DPT that turned positive and who gave their consent to be included in the study . The Patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).


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.

lead_sponsor: Nantes University Hospital


title: Intraoperative Ventilatory Leak Flow to Predict Prolonged Alveolar Air Leak After Lung Resection Surgery: a Prospective Study

acronym: AIR-LEAK

summary:
After lung resection surgery, patients usually receive a postoperative pleural drain. Prolongated alveolar air leak (PAAL) is a frequent complication after lung surgery (6 to 26% of patients), defined by the European Society of Thoracic Surgeons (ESTS) as a duration of drainage greater than or equal to five days. PAAL is most often due to prolongated bubbling of the drain. Prolonged drainage is a leading cause of prolongated hospital stay, increasing care costs.

The risk of prolongated drainage can not be predicted with sufficient accuracy. Existing risk scores for PAAL do not take into account the intraoperative ventilatory leakage (IVL). IVL is a parameter displayed on the ventilator (anaesthetic machine that make the patient breathing during surgical procedure). There is new evidences suggesting that IVL could predict the risk of PAAL after lung resection surgery, but these data have to be supplemented by a well conducted prospective study.


title: Does Energy Replacement Modify Post-exercise Energy Intake in Adolescents With Obesity?

summary: The aim of the present study is to compare the effect of an exercise alone versus. An exercise followed by the ingestion of an energy replacement snack on the following energy intake, food reward and appetite feelings in adolescents with obesity.


title: Development of a Real-time Signal Processing Algorithm, for Beat-beat Measurement of Fetal Heart Rate and Uterine Contractions by Coupling Non-invasive ABDOminal Sensors

acronym: RCF-ABDO

summary:
The CIC-IT 1403 laboratory of the University Hospital of Lille has developed a technological solution for acquiring and synchronizing abdominal ECG, acoustic and Doppler signals.

The purpose of this clinical trial is to build a database of signals issued from this device to develop signal processing algorithms to allow optimization of the fetal heart rate calculation.

This study will be carried out in the maternity ward of the Jeanne de Flandre Hospital in the maternal-fetal pathology department Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.

For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes.

This procedure will not affect the usual care of the patient


title: Chronic Non-inflammatory Pains in Rheumatopediatrics

acronym: RHUMEDOL

summary:
The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

status: Withdrawn

ReferenceCitation: Ravelli A, Martini A. Juvenile idiopathic arthritis. Lancet. 2007 Mar 3;369(9563):767-778. doi: 10.1016/S0140-6736(07)60363-8. Review.

ReferenceCitation: Consolaro A, Ravelli A. Paediatric rheumatology: Juvenile idiopathic arthritis--are biologic agents effective for pain? Nat Rev Rheumatol. 2013 Aug;9(8):447-8. doi: 10.1038/nrrheum.2013.108. Epub 2013 Jul 2.

ReferenceCitation: Tupper SM, Rosenberg AM, Pahwa P, Stinson JN. Pain intensity variability and its relationship with quality of life in youths with juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 Apr;65(4):563-70. doi: 10.1002/acr.21850.

ReferenceCitation: Lalloo C, Stinson JN. Assessment and treatment of pain in children and adolescents. Best Pract Res Clin Rheumatol. 2014 Apr;28(2):315-30. doi: 10.1016/j.berh.2014.05.003. Review.

ReferenceCitation: Duffield SJ, Miller N, Zhao S, Goodson NJ. Concomitant fibromyalgia complicating chronic inflammatory arthritis: a systematic review and meta-analysis. Rheumatology (Oxford). 2018 Aug 1;57(8):1453-1460. doi: 10.1093/rheumatology/key112. Review.

ReferenceCitation: McErlane F, Beresford MW, Baildam EM, Chieng SE, Davidson JE, Foster HE, Gardner-Medwin J, Lunt M, Wedderburn LR, Thomson W, Hyrich KL; Childhood Arthritis Prospective Study (CAPS). Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis. Ann Rheum Dis. 2013 Dec;72(12):1983-8. doi: 10.1136/annrheumdis-2012-202031. Epub 2012 Dec 20.

ReferenceCitation: Reynolds CR. Concurrent validity of "What I think and feel:" the Revised Children's Manifest Anxiety Scale. J Consult Clin Psychol. 1980 Dec;48(6):774-5.

ReferenceCitation: Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8.

ReferenceCitation: Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39.

ReferenceCitation: Drake C, Nickel C, Burduvali E, Roth T, Jefferson C, Pietro B. The pediatric daytime sleepiness scale (PDSS): sleep habits and school outcomes in middle-school children. Sleep. 2003 Jun 15;26(4):455-8.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Functional Unit of "Pain and Palliative Medicine"- Necker-Enfants malades Hospital


title: Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets and Evaluation of the Potential Impact of Concomitant Food Intake on the Relative Bioavailability of GKT137831 in Healthy Male Subjects

summary:
The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.

This will be a randomized three-way open cross-over study.

lead_sponsor: Genkyotex SA


title: Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures

summary: The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.

ReferenceCitation: Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.

name: Centre Orthopédique Santy, Hôpital Privé Jean Mermoz, FIFA Medical Centre of Excellence, Groupe Ramsay GDS, Lyon, France.

family: Sonnery-Cottet

full_name: Bertrand Sonnery-Cottet

given: Bertrand

family: Pioger

full_name: Charles Pioger

given: Charles

family: Vieira

full_name: Thais Dutra Vieira

given: Thais Dutra

family: Franck

full_name: Florent Franck

given: Florent

family: Kajetanek

full_name: Charles Kajetanek

family: Fayard

full_name: Jean-Marie Fayard

given: Jean-Marie

family: Thaunat

full_name: Mathieu Thaunat

given: Mathieu

name: Sano Orthopedics, Advanced Orthopedics and Sports Medicine, Kansas City, Missouri, USA.

family: Saithna

full_name: Adnan Saithna

given: Adnan

currency_apc_doaj: USD

journal_name: Orthopaedic Journal of Sports Medicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Ascopharm Groupe Novasco

location_facility: Hôpital Privé Jean Mermoz - Centre Paul Santy


lead_sponsor: Hospices Civils de Lyon

acronym: TIGRE

title: Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.

summary:
Pseudoprogression is a phenomenon related to post-treatment rearrangements (including radiation necrosis). It appears early in the first year after treatment and accounts for 30 to 50% of patients followed with glioblastoma. On MRI (current gold standard with international therapeutic response evaluation criteria RANO 2010), pseudoprogression is manifested by a progression of morphological abnormalities (contrast enhancement, FLAIR hypersignal) and can simulate tumor recurrence, even though the corticosteroid improved or kept clinical symptoms stabilized. In view of prognosis, the current diagnostic tools have not enough diagnosis accuracy for differentiation between pseudo-progression and early tumor recurrence, and are based on MRI retrospective analysis (2-3 months after). Recurrence of glioblastoma, is characterized by a higher amino acid metabolism than pseudoprogression, also 11C-Methionine (11C-MET), positron emitting radiotracer, showed promising results to differentiate these two entities. To date, hybrid 11C-MET PET-MRI studies remains limited to small sample size (a few dozen patients), and none focuses exclusively on glioblastoma.

Hypothesis of our study is that 11C-MET PET-MRI may be performed as a first-line MRI for suspected pseudoprogression and may changes therapeutic decision making and also patient prognosis.

The main objective is to evaluate the performance of hybrid PET-MRI imaging with 11C-MET to differentiate pseudoprogression from glioblastoma recurrence in patients treated with surgery and radiochemotherapy, compared to multimodality MRI).


title: Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks

acronym: FREELIFE-KID

summary: The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).

status: Active, not recruiting


title: Can we Predict COronary Resistance By EYE Examination ?

acronym: COREYE

summary:
Prospective interventional study, open, non-comparative and non-randomized. The research concerns physiological parameters of the coronary and ocular blood circulation.

At the coronary level, the curves of pressure and Doppler flow will be extracted from ComboMap® (Philips). The coronary microvascular resistances, basal and hyperemic, will be determined by the average ratio of the distal pressure and flow.

At the ocular level, a fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed. The measures of the FFR and the coronary microvascular resistance will be determined by a specific guidewire allowing simultaneous measures of pressure and Doppler flow (ComboWire®, Philips), in 200 patients with intermediate stenosis of the left anterior descending artery (LDA). Topological parameters characterizing the retinal area and choriocapillaries will be determined by statistical approaches and mathematical morphology.

To establish a predictor of the coronary microvascular resistance from the eye vascular parameters, we shall use a non-linear regression by supervised machine learning. The main cardiovascular risk factors (hypertension, diabetes, dyslipidemia, age, sex) will be part of predetermined input features for the machine learning.

location_facility: Hospices Civils de Lyon - Hopital de la Croix Rousse


title: Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report

summary:
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks.

This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.


title: Slow Expiratory Technique Efficacy on 24 Hours Food Ingestion in Children Under Than 12 Months, Hospitalized for Bronchiolitis : a Randomized Controlled Study

acronym: BRONCHIOL-EAT

summary: The purpose of this study is to determine wether a single chest physiotherapy session with slow expiratory technique (SET) improves infants with viral bronchiolitis quality of life (food intake and sleep) on the next 24 hours.

ReferenceCitation: Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum in: Pediatrics. 2015 Oct;136(4):782.

ReferenceCitation: Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.

family: Gajdos

full_name: Vincent Gajdos

given: Vincent

family: Katsahian

full_name: Sandrine Katsahian

given: Sandrine

family: Beydon

full_name: Nicole Beydon

given: Nicole

family: Abadie

full_name: Véronique Abadie

given: Véronique

family: de Pontual

full_name: Loïc de Pontual

given: Loïc

family: Larrar

full_name: Sophie Larrar

given: Sophie

family: Epaud

full_name: Ralph Epaud

given: Ralph

family: Chevallier

full_name: Bertrand Chevallier

family: Bailleux

full_name: Sylvain Bailleux

given: Sylvain

family: Mollet-Boudjemline

full_name: Alix Mollet-Boudjemline

given: Alix

family: Bouyer

full_name: Jean Bouyer

given: Jean

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Labrune

full_name: Philippe Labrune

given: Philippe

journal_name: PLoS Medicine

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

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

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

title: Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial

ReferenceCitation: Gajdos V, Beydon N, Bommenel L, Pellegrino B, de Pontual L, Bailleux S, Labrune P, Bouyer J. Inter-observer agreement between physicians, nurses, and respiratory therapists for respiratory clinical evaluation in bronchiolitis. Pediatr Pulmonol. 2009 Aug;44(8):754-62. doi: 10.1002/ppul.21016.


title: Optimization of Performances During Thrombectomy Through In Situ Simulation

acronym: OPTISS

summary:
The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals.

The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).

location_facility: Hôpital neurologique, Centre Hospitalier Universitaire


title: A Study of the Effect of Intracerebral Electrical Stimulation on the Optimisation of Presurgical Planning in Drug-refractory Partial Epilepsy (StiMiC)

acronym: StiMiC

summary: Patients with drug-refractory epilepsy sometimes need to be implanted with intracerebral electrodes in order to identify their seizure onset zone. During this procedure, direct electrical brain stimulations represent a standard clinical practice to assess seizure sensitivity and for functional mapping. This study aims at assessing if extending the range of stimulation frequencies of the usual clinical frequencies is of benefit for the definition of the seizure onset zone and hence for the presurgical planning.

lead_sponsor: University Hospital, Toulouse


title: The Performance of the Synek Score to Predict Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

summary:
Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use.

We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Relevance of an Adapted and Supervised Physical Activity Program in Fibromyalgia Patients. The FIMOUV 1 Study. Interventional, Controlled, Randomized, Open Study of an Original Outpatient Management.

acronym: FIMOUV 1

summary:
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Calculation of Normal MUNIX Variation in an Healthy Population

acronym: MUNIX

summary:
Motor unit number index (MUNIX) is an electrophysiological technique that estimates the number of motor units in a muscle. This data can be changed by natural evolution or by treatment in peripheral neuropathy. Alfortunately, normal value for MUNIX variation does not exist. Thus, it is difficult to assume improvement or worsening of the MUNIX for an individual subject.

Our objective is to calculate normal variation of MUNIX in 4 muscles : tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus. Measurement will be performed at inclusion and 3 monthes later in 100 healthy subjects. This trial will be prospective in several French centres sepecialized in neuromuscular evaluation

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Des Hopitaux de Marseille


title: Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

acronym: SAFARI

summary: The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

lead_sponsor: Ciliatech


title: Serious Games and Non Technical Skills Training: Are Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenario

summary: The aim of the study is to assess if a training on post-partum hemorrhage management with serious game scenarios specifically designed to teach non technical skills improve non technical skills scoring in a high-fidelity simulation session.

lead_sponsor: Ilumens


title: Ultrasound Study of the Diaphragm Evolution Under ECMO

acronym: DIAG-ECMO

summary: Evaluate the evolution of diaphragmatic muscle effort in cardiogenic shock in ECMO patient with ultrasounds during the first weaning attempt in intensive care patients.

ipd_sharing_description: futur participation in respiratory protocols may include our datas.

lead_sponsor: Association Pro-arte


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.

family: Roncin

full_name: César Roncin

given: César

family: Scemama

full_name: Ugo Scemama

given: Ugo

family: Zieleskiewicz

full_name: Laurent Zieleskiewicz

given: Laurent

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Lesavre

full_name: Nathalie Lesavre

given: Nathalie

family: Vialet

full_name: Renaud Vialet

given: Renaud

journal_name: Anaesthesia Critical Care & Pain Medicine


title: Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea for the Early Detection of Significant Cardiac Events.

summary:
Obstructive sleep apnea (OSA) syndrome affects 40-60% of patients presenting with cardiovascular diseases. Cheyne-Stokes respiration is a type of central apnea characterised by the presence of at least three consecutive episodes of apnea and/or hypopnea separated by a crescendo-decrescendo variation of the breathing amplitude with a cycle length ≥ 40 seconds and a central apnea/hypopnea index ≥ 5/h, for at least two hours of recording.

The association between heart failure and Cheynes-Stokes respiration is known and a recent study showed that Cheynes-Stokes respiration was associated with more severe heart failure. Moreover, a medical and medical/financial benefit of the early detection of cardiac decompensation has been reported.

The purpose of this feasibility study is to investigate the benefit of Cheyne-Stokes respiration remote monitoring in CPAP-treated patients with OSA for the early detection of significant cardiac events (heart failure, rhythm disorder, diastolic dysfunction).

To achieve this aim, a modified approach of CPAP remote monitoring is proposed based on the performance of the latest generation of positive pressure devices from ResMed, AirSense™ 10 Autoset™, which can detect and record the presence of Cheynes-Stokes respiration. For a period of 12 months, in addition to the usual daily remote monitoring (CPAP adherence, pressure settings, level of air leakages), the healthcare provider will systematically monitor the CSR data whenever the AHI increases significantly. Physicians will be alerted when a CSR occurs and they will see the patients within a short time for pulmology and cardiology consultations in order to screen the onset of significant cardiac event.

After the 12-month period of modified remote monitoring, the telemedicine returns to the usual procedure. Patients who had at least one CSR occurrence during the first 12-month period will be followed up to 24 months to assess their medical condition.

lead_sponsor: Groupe Medical de Pneumologie, Polyclinique Saint-Laurent


title: Diagnostic and Prognostic Value of Miss-1 Study in Children and Adult With Nephrotic Syndrome MISSNEPHROTIQUE

acronym: MISS-N

summary:
The nephrotic syndrome is a rare disease defined by a proteinuria >3g/24h and a hypoalbuminemia < 30g/L. Genetic and immune are the main causes. The acquired idiopathic nephrotic syndrome presents histologically minimal glomerular lesions, sometimes associated with segmental and focal hyalinosis. The idiopathic nephrotic syndrome (INS) represents 85% of children's glomerular nephropathy and 25-30% of adult's.

Relapses are frequents, and can be pejorative up to 10% and lead to end-stage kidney failure.

Another immune cause is the extramembranous glomerulonephritis mediated by molecular targets specific autoantibodies expressed at the podocytes surface.

Other immune causes include lupus nephropathy, ANCA vascularitis, Goodpasture disease, Berger disease.

Easy diagnosis between these causes can be made with the renal biopsy.

Miss-1, a new protein activated during a inflammatory event, could be an actor in nephrotic syndromes by modifying the podocyte's adhesion on the glomerular basal membrane. This would modulate the structure and function of the slit diaphragm, as well as junctions between the podocyte and the glomerular basal membrane, regulating podocytes' apoptosis.

ReferenceCitation: Shalhoub RJ. Pathogenesis of lipoid nephrosis: a disorder of T-cell function. Lancet. 1974 Sep 7;2(7880):556-60.

ReferenceCitation: Eddy AA, Symons JM. Nephrotic syndrome in childhood. Lancet. 2003 Aug 23;362(9384):629-39. Review.

ReferenceCitation: van den Berg JG, Weening JJ. Role of the immune system in the pathogenesis of idiopathic nephrotic syndrome. Clin Sci (Lond). 2004 Aug;107(2):125-36. Review.

location_facility: Service de Néphrologie et Dialyses Paris, Hôpital Tenon


title: Cryogenic Preservation of Spermatozoa : Comparative Study Between Both Dry and Liquid Phase Nitrogen Storages

summary: The reference technique for the conservation of gametes is storage in liquid nitrogen but new vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of liquid nitrogen compared with liquid-phase storage, depending on the duration of cryopreservation.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of an Online Decision Support Tool for Young Women With Breast Cancer During the Proposal for Preservation of Fertility

acronym: DECISIF

summary: Comparative study of two information modalities during the care course, aiming to propose the preservation of fertility to young women with breast cancer (but not yet under treatment): standard oral information during the PF consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.

ReferenceCitation: Benoit A, Grynberg M, Morello R, Sermondade N, Grandazzi G, Moutel G. Does a web-based decision aid improve informed choice for fertility preservation in women with breast cancer (DECISIF)? Study protocol for a randomised controlled trial. BMJ Open. 2020 Feb 10;10(2):e031739. doi: 10.1136/bmjopen-2019-031739.

apc_source: openAPC

family: Benoit

full_name: Alexandra Benoit

given: Alexandra

family: Grynberg

full_name: Michael Grynberg

given: Michael

family: Morello

full_name: Rémy Morello

given: Rémy

family: Sermondade

full_name: Nathalie Sermondade

family: Grandazzi

full_name: Guillaume Grandazzi

given: Guillaume

family: Moutel

full_name: Grégoire Moutel

given: Grégoire

location_facility: Reproduction medicine and fertility preservation ANTOINE BECLERE Hospital


title: EYE-Mobile TRACKer IN the Diagnosis of Minimal Hepatic Encephalopathy

acronym: EyeMTRACKIN-HE

summary:
Hepatic encephalopathy (HE) corresponds to the neurological or the neuropsychological symptoms caused by an acute or chronic liver disease and/or porto-systemic shunt. Many patients present neurological symptoms even if their liver disease is stabilized. Furthermore, HE is associated with an altered quality of life and an increased mortality. Its incidence is high with 30 to 80% of cirrhotic patients that will display according to retained diagnostic criteria. HE symptoms are going from subtle neuropsychological abnormalities detected only on neuropsychological testing, minimal HE, to altered consciousness, overt HE. Recently, the therapeutic armamentarium has increased with now several drugs (rifaximin, ammonia lowering agents) that are able to prevent new bouts of HE. Unfortunately, the diagnosis of minimal HE is difficult and no gold-standard is available. None of the proposed test is rapid and easily performed at bedside.

Recently, different studies suggest the potential interest of the study of the ocular movements in HE. Abnormalities in ocular saccades could be an early predictor of cortical impairment. In a pilot feasibility study using an eye-tracker, we could show that cirrhotic patients with minimal HE had, compared to healthy controls, increased latencies, decreased speed of voluntary and reflex saccades, more errors in anti-saccades, more anticipations saccades and more difficulties to fix the target.

Our hypothesis was that the use of the eye-tracker will enable the diagnosis of minimal HE by studying the characteristics of saccades and anti-saccades.

Since no gold-standard is available for the diagnosis of minimal HE, we will use the conclusion of an adjudication committee formed by 2 experts. Their clinical judgment will take into account the results of medical history, clinical examination, neuropsychological testing, PHES, Critical Flicker Frequency test (CFF), ammonemia levels, EEG and brain MRI with spectroscopy.


title: Biological Diagnosis of Granulomatous Pneumocystis Pneumonia

acronym: NC

summary:
The intra-alveolar form of Pneumocystis jiroveci pneumonia (PjP) is a common pathology in immunocompromised patients, particularly those infected with HIV. The diagnosis is based on the detection of Pj in a LBA. Intra-tissue granulomatous form (PGP) is a rare entity observed in non-HIV immunocompromised patients. In this case, the LBA is mostly non-contributory and the diagnosis is based solely on the detection of cysts on histological examination on biopsy of a pulmonary nodule. For many years, it has been clearly demonstrated that the use of a specific PCR clearly improves the biological diagnosis of PcP. However, in case of granulomatous form this method is not implemented because the diagnostic hypothesis is not mentioned.

In 2018, two cases of PGP were diagnosed at 3-month intervals at Montpellier University Hospital Center. The diagnostic confirmation was obtained with PCR Pj. In this context the investigators will investigate the interest of implementing PCR Pj on biopsies on pulmonary nodules from hospitalized patients between 2015 and 2018. In all selected patients, histopathological aspect of the nodule was compatible with a PGP and, no other diagnosis has been confirmed (infectious, tumoral, inflammatory ...). Finally, 17 patients were selected to check retrospectively, if the presence of Pj could be at the origin of the pathology.