title: E-lombactifs: Evaluation of the Impact a Smartphone Application on Adherence an Exercise Program in Chronic Low Back Pain

acronym: E-lombactifs

summary:
The main objective is to assess the impact of smartphone application on adherence to a physical exercise program in chronic low back pain patients.

Adherence to a physical exercise program will be assessed at the start of the protocol, at three weeks and six months.

A control group will benefit from conventional care in a rehabilitation center and an intervention group will benefit from a conventional care in a rehabilitation center accompanied by education in the use of a smartphone application including physical exercises and information about low back pain.

The hypothesis of the search is that adherence is better in intervention group than control group at 6 months due to education in the use of smartphone application.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Albumin and Prognosis of Severely Burned Patients Prospective, Observational Study for the BurnICU Group of ESICM

acronym: ALBUBURN

summary:
Hemodynamic management has long been identified as a key factor affecting burn prognosis. However, large amounts of crystalloid infusion have been associated with the development or aggravation of organ failure (acute respiratory distress syndrome, vascular injury, acute renal failure, and intra-abdominal hypertension) which worsens the final prognosis.

The use of albumin during the first 24 hours of burn resuscitation is controversial since capillary leakage may cause transcapillary passage of large molecules into the interstitial space. In fact, human albumin has multiple physiological effects, including regulation of colloidal osmotic pressure, antioxidant properties, nitric oxide modulation and buffering capacities, plasma binding and transport of various substances, which may be particularly important in severe burns.

Currently available data suggest that administration of exogenous albumin during the first 24 hours of resuscitation of severe burn patients may be associated with improved outcomes. Multi-centre randomized controlled trials with adequate power should be undertaken in burned patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Arlati S, Storti E, Pradella V, Bucci L, Vitolo A, Pulici M. Decreased fluid volume to reduce organ damage: a new approach to burn shock resuscitation? A preliminary study. Resuscitation. 2007 Mar;72(3):371-8. doi: 10.1016/j.resuscitation.2006.07.010. Epub 2006 Nov 29.

ReferenceCitation: Mason SA, Nathens AB, Finnerty CC, Gamelli RL, Gibran NS, Arnoldo BD, Tompkins RG, Herndon DN, Jeschke MG; Inflammation and the Host Response to Injury Collaborative Research Program.. Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Ann Surg. 2016 Dec;264(6):1142-1147. doi: 10.1097/SLA.0000000000001615.

ReferenceCitation: Soussi S, Taccori M, De Tymowski C, Depret F, Chaussard M, Fratani A, Jully M, Cupaciu A, Ferry A, Benyamina M, Serror K, Boccara D, Chaouat M, Mimoun M, Cattan P, Zagdanski AM, Anstey J, Mebazaa A, Legrand M; PRONOBURN group. Risk Factors for Acute Mesenteric Ischemia in Critically Ill Burns Patients-A Matched Case-Control Study. Shock. 2019 Feb;51(2):153-160. doi: 10.1097/SHK.0000000000001140.

ReferenceCitation: Klein MB, Hayden D, Elson C, Nathens AB, Gamelli RL, Gibran NS, Herndon DN, Arnoldo B, Silver G, Schoenfeld D, Tompkins RG. The association between fluid administration and outcome following major burn: a multicenter study. Ann Surg. 2007 Apr;245(4):622-8. doi: 10.1097/01.sla.0000252572.50684.49.

ReferenceCitation: Markell KW, Renz EM, White CE, Albrecht ME, Blackbourne LH, Park MS, Barillo DA, Chung KK, Kozar RA, Minei JP, Cohn SM, Herndon DN, Cancio LC, Holcomb JB, Wolf SE. Abdominal complications after severe burns. J Am Coll Surg. 2009 May;208(5):940-7; discussion 947-9. doi: 10.1016/j.jamcollsurg.2008.12.023. Epub 2009 Mar 26.

ReferenceCitation: Cooper AB, Cohn SM, Zhang HS, Hanna K, Stewart TE, Slutsky AS; ALBUR Investigators. Five percent albumin for adult burn shock resuscitation: lack of effect on daily multiple organ dysfunction score. Transfusion. 2006 Jan;46(1):80-9. doi: 10.1111/j.1537-2995.2005.00667.x.

ReferenceCitation: Cochran A, Morris SE, Edelman LS, Saffle JR. Burn patient characteristics and outcomes following resuscitation with albumin. Burns. 2007 Feb;33(1):25-30. doi: 10.1016/j.burns.2006.10.005.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique

status_simplified: Ongoing


title: Étude du Mouvement de l'opérateur et de l'Endoscope au Cours de la Coloscopie

acronym: ScopeGuide

summary: The aim of the study is to record and analyze endoscopist and endoscope motions to identify key movements during colonoscopy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ReferenceCitation: Kaltenbach T, Leung C, Wu K, Yan K, Friedland S, Soetikno R. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011 May;56(5):1496-502. doi: 10.1007/s10620-011-1614-1. Epub 2011 Mar 16.

ipd_sharing: No

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC

intervention_type: Procedure

status_simplified: Completed


title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations

summary: This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)

study_start_date_type: Anticipated

status: Unknown status

design_allocation: Randomized

location_facility: Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris

intervention_type: Other

status_simplified: Unknown


title: Tracheobronchial Bioengineering Using Aortic Matrices

acronym: TRITON

summary: A technic of tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic has been implemented by Pr E. Martinod in his thoracic surgery dept. The purpose of this study is to analyze the records of all the patients who have benefited from this treatment.

ReferenceType: derived

ReferenceCitation: Martinod E, Radu DM, Onorati I, Portela AMS, Peretti M, Guiraudet P, Destable MD, Uzunhan Y, Freynet O, Chouahnia K, Duchemann B, Kabbani J, Maurer C, Brillet PY, Fath L, Brenet E, Debry C, Buffet C, Leenhardt L, Clero D, Julien N, Venissac N, Tronc F, Dutau H, Marquette CH, Juvin C, Lebreton G, Cohen Y, Zogheib E, Beloucif S, Planes C, Tresallet C, Bensidhoum M, Petite H, Rouard H, Miyara M, Vicaut E. Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients. Am J Transplant. 2022 Dec;22(12):2961-2970. doi: 10.1111/ajt.17137. Epub 2022 Jul 14.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

location_facility: Hopital AVICENNES Service de Chirurgie Thoracique


title: Multicenter Randomized Study : Does Correction of 25 OH-VITAmin D With Cholecalciferol Supplementation Increase Muscle Strength in hemoDIALysis Patients?

acronym: VITADIAL

summary: Muscle strength decreases as renal failure progresses. Low muscle strength affects more than 50% of hemodialysis patients and leads to daily life activities impairment. In the general population, numerous studies have linked low 25OH-vitamin D (25OHD) concentrations to the loss of the muscle strength and low physical performances. Data on native vitamin D and muscle function are scarce in the chronic renal failure (CKD) population, but low 25OHD levels have been associated with poor muscle strength. In this protocol of an ongoing study named VITADIAL testing if cholecalciferol supplementation in hemodialysis patients with low 25OHD improve their muscle strength.

primary_purpose: Treatment

ReferenceCitation: Bataille S, Pedinielli N, Carreno E, Prezelin-Reydit M, Chauveau P, Jean G, Robert T, Bobot M, Seret G, Jouve E, Lavainne F, Serveaux M, Vrigneaud L, Gentile S. VITADIAL "Does correction of 25 OH-VITAmin D with cholecalciferol supplementation increase muscle strength in hemoDIALysis patients?": study protocol for a randomized controlled trial. Trials. 2021 May 25;22(1):364. doi: 10.1186/s13063-021-05302-9.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Institut Phoceen de Nephrologie

intervention_type: Drug

lead_sponsor_type: industriel


type: Registry Identifier

title: Diagnostic Accuracy of Electrochemical Skin Conductance Measurement in Paediatric Small Fibre Neuropathy Following Neurotoxic Chemotherapy

acronym: SUDOPED

summary: The purpose of this study is to determine the diagnostic accuracy of a newly developed tool (Electrochemical Skin Conductances (ESC) measurement) easy-to-perform, non-invasive, highly reproductible and not requiring specific training, to identify pediatric chemotherapy-induced-peripheral-neuropathies (CIPN). CIPN are a frequent (20 to 75% depending on the drug), early and potentially severe long-lasting and dose limiting adverse effect of treatments in immuno-hematology and cancerology. The pathophysiology, the chronology of injury (ie small then large sensory nerve fiber or vice-versa) and the age-related short/long-term impact on peripheral nerves remain largely not understood. Clinical signs of CIPN are highly heterogenous, often under-recognized and include diverse sensory symptoms and pain. Persistent loss of sensation and strength as well as neuropathic pain may have a short/long-term impact in term of functional limitations and quality of life. There is a lack of specific and sensitive measurement tools for CIPN in the pediatric population. Neurophysiological tools (except electro-neuro-myography allowing only the assessment of large myelinated nerves) are not implemented in the pediatric oncology-hematology everyday practice: they are often invasive and/or poorly reproducible, not accessible for "bedside" follow-up, and lacking normative values, thus often dedicated only to research. ESC may provide an early and quantitative assessment of small fiber dysfunction in children, a prerequisite for the identification of additional preventive or curative approaches in CIPN.

ReferenceCitation: Kandula T, Farrar MA, Kiernan MC, Krishnan AV, Goldstein D, Horvath L, Grimison P, Boyle F, Baron-Hay S, Park SB. Neurophysiological and clinical outcomes in chemotherapy-induced neuropathy in cancer. Clin Neurophysiol. 2017 Jul;128(7):1166-1175. doi: 10.1016/j.clinph.2017.04.009. Epub 2017 Apr 25.

ReferenceCitation: Kandula T, Farrar MA, Cohn RJ, Mizrahi D, Carey K, Johnston K, Kiernan MC, Krishnan AV, Park SB. Chemotherapy-Induced Peripheral Neuropathy in Long-term Survivors of Childhood Cancer: Clinical, Neurophysiological, Functional, and Patient-Reported Outcomes. JAMA Neurol. 2018 Aug 1;75(8):980-988. doi: 10.1001/jamaneurol.2018.0963. Erratum In: JAMA Neurol. 2018 Aug 1;75(8):1028.

ReferenceCitation: Gilchrist LS, Tanner L. The pediatric-modified total neuropathy score: a reliable and valid measure of chemotherapy-induced peripheral neuropathy in children with non-CNS cancers. Support Care Cancer. 2013 Mar;21(3):847-56. doi: 10.1007/s00520-012-1591-8. Epub 2012 Sep 20.

ReferenceCitation: Gibbons CH, Wang N, Freeman R. Capsaicin induces degeneration of cutaneous autonomic nerve fibers. Ann Neurol. 2010 Dec;68(6):888-98. doi: 10.1002/ana.22126.

ReferenceCitation: Castro J, Miranda B, Castro I, de Carvalho M, Conceicao I. The diagnostic accuracy of Sudoscan in transthyretin familial amyloid polyneuropathy. Clin Neurophysiol. 2016 May;127(5):2222-7. doi: 10.1016/j.clinph.2016.02.013. Epub 2016 Feb 27.

ReferenceCitation: Lefaucheur JP, Wahab A, Plante-Bordeneuve V, Sene D, Menard-Lefaucheur I, Rouie D, Tebbal D, Salhi H, Creange A, Zouari H, Ng Wing Tin S. Diagnosis of small fiber neuropathy: A comparative study of five neurophysiological tests. Neurophysiol Clin. 2015 Dec;45(6):445-55. doi: 10.1016/j.neucli.2015.09.012. Epub 2015 Nov 17.

ReferenceCitation: Leclair-Visonneau L, Bosquet T, Magot A, Fayet G, Gras-Le Guen C, Hamel A, Pereon Y. Electrochemical skin conductance for quantitative assessment of sweat function: Normative values in children. Clin Neurophysiol Pract. 2016 Jul 27;1:43-45. doi: 10.1016/j.cnp.2016.07.001. eCollection 2016.

collaborators: Société Française de lutte contre les cancers et leucémies de l'enfant et de l'adolescent (SFCE)

intervention_type: Diagnostic Test


title: Evaluation of the Correlation Between the Respiratory Index Events Generated by Sunrise® Versus Polysomnography for Sleep Apnea Syndrome Diagnosis

acronym: SENSAPNEA

summary:
Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and depression. The prevalence of SAS is still growing with social and economic repercussion. Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis. However, it is a constraining and expensive technology. In order to improve patients' life quality, many new technologies have been developed for the SAS diagnosis.

The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS diagnosis, in comparison with PSG. This solution consists in a chin sensor recording mandibular movements and measuring the respiratory event index (ERI) through an artificial intelligence algorithm analysis.

primary_purpose: Diagnostic

ReferenceCitation: Kelly JL, Ben Messaoud R, Joyeux-Faure M, Terrail R, Tamisier R, Martinot JB, Le-Dong NN, Morrell MJ, Pepin JL. Diagnosis of Sleep Apnoea Using a Mandibular Monitor and Machine Learning Analysis: One-Night Agreement Compared to in-Home Polysomnography. Front Neurosci. 2022 Mar 15;16:726880. doi: 10.3389/fnins.2022.726880. eCollection 2022.

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

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

publisher_dissemination: Frontiers

lead_sponsor: University Hospital, Grenoble

collaborators: Sunrise Icadom DOCAPOST

sponsor_collaborators:
University Hospital, Grenoble
Sunrise
Icadom
DOCAPOST


title: Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract : The SAOS-K Study

acronym: SAOS-K

summary:
Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)

ReferenceType: result

ReferenceCitation: Huyett P, Kim S, Johnson JT, Soose RJ. Obstructive sleep apnea in the irradiated head and neck cancer patient. Laryngoscope. 2017 Nov;127(11):2673-2677. doi: 10.1002/lary.26674. Epub 2017 May 23.

oa_host_type: closed

publisher_dissemination: Wiley

ReferenceCitation: Gilat H, Shpitzer T, Guttman D, Soudry E, Feinmesser R, Bachar G. Obstructive sleep apnea after radial forearm free flap reconstruction of the oral tongue. Laryngoscope. 2013 Dec;123(12):3223-6. doi: 10.1002/lary.24125. Epub 2013 Apr 10.

ReferenceCitation: Loth A, Michel J, Giorgi R, Santini L, Rey M, Elbaum JM, Roux N, Giovanni A, Dessi P, Fakhry N. Prevalence of obstructive sleep apnoea syndrome following oropharyngeal cancer treatment: A prospective cohort study. Clin Otolaryngol. 2017 Dec;42(6):1281-1288. doi: 10.1111/coa.12869. Epub 2017 Apr 18.

ReferenceCitation: Faiz SA, Balachandran D, Hessel AC, Lei X, Beadle BM, William WN Jr, Bashoura L. Sleep-related breathing disorders in patients with tumors in the head and neck region. Oncologist. 2014 Nov;19(11):1200-6. doi: 10.1634/theoncologist.2014-0176. Epub 2014 Oct 1.

oa_colors: green other

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Oxford University Press

lead_sponsor: Centre Hospitalier Sud Francilien


title: Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment

summary:
Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work.

Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study.

The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Institut Universitaire de la Face et du Cou


type: Other Identifier

title: Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test

acronym: DEPEDIACOL

summary:
Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon gastro-enterological hepatology and nutrition

intervention_type: Biological


title: Clinical Trial for Near Infrared Endoventricular Illumination for Neuroprotection in Very Early Cases of Parkinson's Disease (Ev-NIRT)

acronym: Ev-NIRT

summary:
Parkinson's disease has only pharmacological (essentially dopaminergic) and surgical treatment (essentially high-frequency deep brain stimulation), that are symptomatically effective. none of them is curative, and has the ability to slow down the disease and to protect dopaminergic neurons from death by neurodegeneration. Experimental results, based on preclinical studies, suggest that brain illumination in the Near-InfraRed (NIR) range is likely to slow down this neurodegenerative process.

Thus, a medical device system (called Ev-NIRT) has been developed for 670 nm intracerebral illumination of the substantia nigra pars compacta (SNpc), and is planned to be tested for the treatment of Parkinson's disease.

In this pilot study the investigators will evaluate the feasibility and tolerance of surgery and brain illumination thanks to the Ev-NIRT medical device, in a group of 7 de novo Parkinson's patients implanted with the innovative medical device. Patients will be monitored for 4 years.

ReferenceCitation: Chabardes S, Carron R, Seigneuret E, Torres N, Goetz L, Krainik A, Piallat B, Pham P, David O, Giraud P, Benabid AL. Endoventricular Deep Brain Stimulation of the Third Ventricle: Proof of Concept and Application to Cluster Headache. Neurosurgery. 2016 Dec;79(6):806-815. doi: 10.1227/NEU.0000000000001260.

ReferenceCitation: Darlot F, Moro C, El Massri N, Chabrol C, Johnstone DM, Reinhart F, Agay D, Torres N, Bekha D, Auboiroux V, Costecalde T, Peoples CL, Anastascio HD, Shaw VE, Stone J, Mitrofanis J, Benabid AL. Near-infrared light is neuroprotective in a monkey model of Parkinson disease. Ann Neurol. 2016 Jan;79(1):59-75. doi: 10.1002/ana.24542. Epub 2015 Dec 12.

ReferenceCitation: Moro C, El Massri N, Darlot F, Torres N, Chabrol C, Agay D, Auboiroux V, Johnstone DM, Stone J, Mitrofanis J, Benabid AL. Effects of a higher dose of near-infrared light on clinical signs and neuroprotection in a monkey model of Parkinson's disease. Brain Res. 2016 Oct 1;1648(Pt A):19-26. doi: 10.1016/j.brainres.2016.07.005. Epub 2016 Jul 7.

ReferenceCitation: Reinhart F, Massri NE, Chabrol C, Cretallaz C, Johnstone DM, Torres N, Darlot F, Costecalde T, Stone J, Mitrofanis J, Benabid AL, Moro C. Intracranial application of near-infrared light in a hemi-parkinsonian rat model: the impact on behavior and cell survival. J Neurosurg. 2016 Jun;124(6):1829-41. doi: 10.3171/2015.5.JNS15735. Epub 2015 Nov 27.

ReferenceCitation: Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015.

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique

intervention_type: Device


title: Cardiac Thrombus in Early Cardiac CT Scan in Etiological Workup of Ischemic Stroke: Prospective Study

acronym: CCT STROKE

summary:
Stroke can be linked to atherosclerosis of the large vessels, occlusion of the small intracerebral vessels (gaps), cardioembolic pathology or other rarer etiologies.

The cardioembolic etiology of stroke in elderly patients may be difficult to prove. Paroxysmal atrial fibrillation (AF) is a common cause of cerebral infarction (25%). Detecting AF is not easy. A 24-hour long-term holter and an implantable cardiac monitor (Reveal®) may be required. This etiology is all the more important as it requires anticoagulation treatment reducing the risk of recurrence in the short and long term. The left atrium thrombus is an indisputable marker of atrial fibrillation but it is rarely seen. Other cardiac etiologies such as a thrombus in the left ventricle, a large plaque or a thrombus of the aortic arch are possible. Finally, the permeable oval foramen and the aneurysm of the intra-auricular septum constitute a cause apart in young subjects (<60 years).

Typically, the search for thrombus of the left atrium goes through a trans-thoracic cardiac ultrasound and a transesophageal cardiac ultrasound. These examinations, often negative, are performed several days after the onset of the cerebral infarction. The transesophageal cardiac ultrasound, considered as the "gold standard" examination to look for an intracardiac thrombus and an embologenic plaque in the aortic arch, is poorly tolerated. It is rarely performed in patients over 75 years of age. In addition, the length of stay for these patients may increase due to the wait for these exams.

Several studies have validated the non-inferiority of the cardiac scanner compared to the transesophageal cardiac ultrasound for the detection of intracardiac thrombus (left atrium or left ventricle).

In the study by Hur et al. performed in 55 consecutive patients with a probable cardioembolic infarction, 14 thrombi of the left atrium were detected and confirmed by the cardiac scanner, but the patients were young, with a median age of 61 years. In the Berlin prospective HEBRAS study, 475 patients underwent cardiovascular MRI. The results are being analyzed but the cardiac scanner is more sensitive for the detection of thrombus in the left atrium.

A prospective study confirmed that the cardiac scanner is more precise in differentiating the left atrial thrombus from circulatory stasis in patients with stroke In this study, there is no information on the time between the stroke and the completion of the cardiac scanner.

Almost all patients with stroke benefit from an angio-scan of the CT scan of supra-aortic trunks as part of the urgent assessment on Day 1 or Day 2. The investigators propose to perform at the same time a cardiac scanner in order to allow a rapid morphological cardiological assessment, at the level of the left atrium, the left ventricle and the arch of the aorta.

status: Active, not recruiting

ReferenceCitation: Cresti A, Garcia-Fernandez MA, Sievert H, Mazzone P, Baratta P, Solari M, Geyer A, De Sensi F, Limbruno U. Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study. EuroIntervention. 2019 Jun 12;15(3):e225-e230. doi: 10.4244/EIJ-D-19-00128.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Left atrial appendage thrombi in stroke patients: detection with two-phase cardiac CT angiography versus transesophageal echocardiography. Radiology. 2009 Jun;251(3):683-90. doi: 10.1148/radiol.2513090794. Epub 2009 Apr 14.

ReferenceCitation: Haeusler KG, Grittner U, Fiebach JB, Endres M, Krause T, Nolte CH. HEart and BRain interfaces in Acute ischemic Stroke (HEBRAS)--rationale and design of a prospective oberservational cohort study. BMC Neurol. 2015 Oct 22;15:213. doi: 10.1186/s12883-015-0458-2.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: PubMed Central;refubium.fu-berlin.de

ReferenceCitation: Hur J, Kim YJ, Lee HJ, Ha JW, Heo JH, Choi EY, Shim CY, Kim TH, Nam JE, Choe KO, Choi BW. Cardiac computed tomographic angiography for detection of cardiac sources of embolism in stroke patients. Stroke. 2009 Jun;40(6):2073-8. doi: 10.1161/STROKEAHA.108.537928. Epub 2009 Apr 16.

ReferenceCitation: Romero J, Husain SA, Kelesidis I, Sanz J, Medina HM, Garcia MJ. Detection of left atrial appendage thrombus by cardiac computed tomography in patients with atrial fibrillation: a meta-analysis. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):185-94. doi: 10.1161/CIRCIMAGING.112.000153. Epub 2013 Feb 13.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Ajlan AM, Bagdadi RR, Alama MN, Ayoub O. Impact of Implementing Cardiac CT in Evaluating Patients Suspected of Cardioembolic Stroke. J Comput Assist Tomogr. 2016 May-Jun;40(3):380-6. doi: 10.1097/RCT.0000000000000369.

ReferenceCitation: Taina M, Vanninen R, Sipola P, Muuronen A, Jakala P, Hedman M. Cardiac CT Differentiates Left Atrial Appendage Thrombi from Circulatory Stasis in Acute Stroke Patients. In Vivo. 2016 09-10;30(5):671-6.

ReferenceCitation: Shankar V, Bangdiwala SI. Observer agreement paradoxes in 2x2 tables: comparison of agreement measures. BMC Med Res Methodol. 2014 Aug 28;14:100. doi: 10.1186/1471-2288-14-100.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_concat: PubMed Central;g158bk50m

publisher_dissemination: Springer

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Evaluation of the Efficacy and Tolerance of Plasmapheresis by Double Cascade Filtration in a University Centre

acronym: DFPPSURV

summary: A study is being carried out to evaluate the biological, technical and clinical/biological efficacy of this technique, the practice of which is standardized in the department, in order to evaluate our practices and to improve them if necessary. As part of this study, the investigators will ask all patients scheduled for this procedure to participate in this observational prospective study without changing usual practices.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes, Hôpital Universitaire Caremeau


title: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, in Difficulty Driving of Electric Wheelchairs

summary: The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.

lead_sponsor: Pôle Saint Hélier

sponsor_collaborators:
Pôle Saint Hélier
INSA Rennes


title: Diabetes Screening in Patients on Long-Term Glucocorticoid Therapy

acronym: DIACORT

summary:
Glucocorticoids are widely prescribed in the treatment of many inflammatory, autoimmune or allergic diseases, but also in transplant patients or patients with malignant hematological diseases (leukaemia, lymphoma, myeloma, etc.). They have many side effects, including effects on carbohydrate metabolism.

Corticosteroids are diabetogenic because they disrupt pancreatic insulin secretion and decrease the insulin sensitivity of target tissues (liver, muscle, adipose tissue).

The use of glucocorticoids may lead to the development of corticosteroid-induced diabetes in non-diabetic patients.

Corticosteroid-induced diabetes is frequently found in clinical practice. Incidence figures for corticosteroid-induced diabetes vary widely.

Case-control studies show odds ratios of corticosteroid-induced diabetes onset ranging from 1.36 and 2.23. In two of these studies, the diagnostic criterion was the prescription of a hypoglycemic treatment. Smaller studies, retrospective or prospective, show incidence rates of corticosteroid-induced diabetes ranging from 8.8 to 52%. This difference in incidence rates is explained by the different glucocorticoid doses, glucocorticoid durations, conditions requiring glucocorticoid therapy, and diagnostic criteria for corticosteroid-induced diabetes that vary from study to study. In kidney transplantation, diabetes concerns 16% of patients before the age of 40, and up to 52% after the age of 50. The diagnostic criteria used in the literature are often fasting and post prandial glycemia. The differences in incidence rates found with these two diagnostic methods can be explained by the pharmacokinetics of glucocorticoids. The main glucocorticoids prescribed have a duration of action of 12 to 16 hours. As they are generally prescribed in the morning as a single daily dose, fasting morning blood glucose levels are often normal while postprandial blood glucose levels are increased. This observation has been presented in 2 studies. However, the 2 diagnostic criteria were not statistically compared in these studies.

While according to the American Diabetes Association, the 3 criteria used to diagnose diabetes are fasting glycemia, glycemia 2 hours after an oral glucose load of 75 g and glycated hemoglobin, these last 2 diagnostic criteria are, to the investigator's knowledge, not used in the scientific literature to screen for corticosteroid-induced diabetes.

In current practice, the diagnostic criteria used are disparate. To date, there are no studies that have determined which diagnostic criterion is the most effective in screening for corticosteroid-induced diabetes. The current recommendations recommend early diagnosis and treatment in order to achieve satisfactory glycemic control as quickly as possible. These recommendations have been shown to be effective in reducing the risk of degenerative complications of diabetes, but it is important to screen for corticosteroid-induced diabetes with the most relevant diagnostic criterion in order to optimise its management.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI

acronym: FLOWHAND

summary:
Allotransplants of vascularized composite tissues are subject to chronic vascular rejection, which can lead to graft loss. Currently, no imaging technique allows a reproducible quantitative exploration of the arterial trees of the hand, and therefore a satisfactory monitoring of transplants. Since 2014, flow MRI has been applied to the analysis of small-calibre arteries by the Image Processing Team at the Amiens-Picardie University Hospital. Between 2015 and 2017, several acquisitions were made in 3 patients who received facial allotransplantation, and the team recently developed a flow MRI protocol dedicated to the study of arterial trees in the hand.

The main objective is to measure vascular flows of radial, ulnar and interdigital arterial trees in normal (healthy volunteers) and pathological situations (patients with radial forearm flap reconstruction and patients with hand allotransplantation) using the specifically developed flow MRI protocol.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Development and Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program

acronym: LIFE-SCREEN

summary: The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on biological pathways linked to colorectal cancer development including physical fitness, anthropometrics, biomarkers for nutrition, and metabolic health.

primary_purpose: Prevention

lead_sponsor: International Agency for Research on Cancer

collaborators:
Centre Leon Berard
Hôpital Edouard Herriot
University of Bordeaux

intervention_type: Behavioral


title: An Open Label, Randomized Controlled Study to Compare Healing of Severe Diabetic Foot Ulcers and Forefoot Amputations in Diabetics With and Without Moderate Peripheral Arterial Disease Treated With Kerecis Omega3 Wound and SOC vs. SOC Alone

acronym: Odinn

summary: This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

ReferenceCitation: Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31. doi: 10.1016/j.amjmed.2003.06.006.

ReferenceCitation: Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847.

lead_sponsor: Kerecis Ltd.

collaborators: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study

acronym: FAC

summary: Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

lead_sponsor: University Hospital, Rouen


title: Self-identification Based Intervention Targeting Sexual Orientation and Gender Identity

acronym: LGBT

summary:
Despite increased visibility and acceptance of the LGBT community (Lesbian, Gay, Bisexual and Transgender), in some parts of society, many LGBT people struggle with self-acceptance. Minority Stress Theory, described in the scientific literature, explains that health disparities among populations such as the LGBT population can be explained by stressors induced by a hostile, homophobic culture, which results in harm suffered, expectations of rejection, and internalized homophobia. The harm suffered may include acts of discrimination, harassment, violence (physical or linguistic). But more deeply, two important points of this theory: 1) the expectations of the LGBT person to experience rejection based on their identity and the anti-LGBT social stigma, 2) internalized homophobia, which is a social internalization from negativity against homosexuality and transgender to the initial stages of the identity development of an individual who can continue throughout his life. Perceived harm, stigma and lived rejection are associated with an increased propensity to experience significant psychological pain. LGBT people are more likely to develop self-identification based on sexual orientation or gender, making them more vulnerable to any rejection signal.

There is a growing scientific interest around Cognitive and Behavioral Therapies (CBT) of 3rd wave, also called therapies derived from Buddhism, or therapies based on meditation. These programs aim to observe and test, through an experiential meta-cognitive practice, the dogmas or preconceptions (about ourselves, others, and the world) and mental attitudes that guide our choices without our knowledge and are at the origin of suffering, in order to gain inner freedom. These practices constitute an experiential scientific methodology of self-knowledge and reality. These secular programs have become a standard treatment in the management of stress, chronic pain, and the prevention of relapsing depression. In addition, the interest of these practices has been demonstrated in many areas of somatic and psychiatric medicine (including depression and suicidal behavior), but also for the promotion of mental health in the general population. This topic is the subject of more than 15,000 international scientific publications with reading committee (Medline indexed), and of strong interest and shared by both the scientific community and the general public.

Scientists are currently deepening these therapies with a focus on wisdom-based self-identification. Beyond the name "therapies", this educational information is key to life for everyone. Who am I ? Am I defined by my social roles, my physical characteristics, my preferences? How to face external challenges? How to develop real self-confidence?

Dr Déborah Ducasse offers a conference on the theme: "Sexual orientation, gender: where is the problem?" Nowhere. Self-identification. ". This conference will take place on 05/15/2020, on the occasion of World Day Against Homophobia.

In line with the OECD press release in 2019 "The LGBT challenge: how to improve the integration of sexual and gender minorities? "(Panorama de la société 2019: Social Indicators of the OECD), the investigators want to assess whether an intervention targeting valid self-identification can 1) have a positive impact on the acceptance and discrimination indicators of the OECD ; 2) have an impact on valid self-identification.

Direct benefits are expected, psychologically and socially, in the fight against discrimination, inclusion and self-acceptance.

In the medium and long term: major public health interest via the adaptation of psychoeducational interventions based on self-identification in order to prevent psychosocial risks and suicidal behavior in connection with an altered self-identification based on sexual orientation and gender.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort

acronym: MAB-CF

summary:
Our project is to describe retrospectively and prospectively CF patients treated with biotherapy in French CF centers.

Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.

Secondary objective: To describe adverse events potentially related to the biotherapies.


title: Water Load Test Value for Hyponatremia Due to a Syndrome of Inappropriate Antidiuresis (SIAD)

acronym: WATERLINE

summary: Acute water load test has been using to diagnose renal ability to excrete water for decades. Latest recommendations for the diagnosis of hyponatremia do not recommend performing such a test. The investigators aim at, retrospectively, study the value of acute water load test in patients suffering from a syndrome of inappropriate antidiuresis.

lead_sponsor: European Georges Pompidou Hospital

location_facility: European Georges Pompidou Hospital, APHP


title: Measurements of Sexual Steroids' Concentrations in Prostatic Tissue From Samples Taken by Biopsy Needle on Fresh Operating Parts : Measurements' Reliability

acronym: Pré-HORM

summary:
In the investigators's previous work, measurements of intra-prostatic concentrations of sex steroids were determined on samples taken from the operating room using a punch.

In order to study the in-vivo intra-prostatic concentrations of sex steroid, it is necessary to validate a measurement technique performed on samples obtained by a biopsy needle used in standard care for prostate biopsy punctures allowing the diagnosis and follow-up of prostate cancer.

The aim of this project is to validate this measurement technique carried out on samples obtained by the biopsy needle and to define the optimal number of carrots obtained by biopsy offering dosage results comparable to the punch.

lead_sponsor: Hopital Foch


title: Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.

acronym: DeprescrIPP

summary:
Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.

primary_purpose: Health Services Research

ReferenceCitation: Nguyen-Soenen J, Rat C, Gaultier A, Schirr-Bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022 Feb 17;22(1):219. doi: 10.1186/s12913-022-07496-3.

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

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

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

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

lead_sponsor: Nantes University Hospital


title: Comparative Study of Two Cognitive Stimulation Approaches Using the Non-verbal Communication on People With Alzheimer's Disease and/or Related Diseases at a Moderate to Advanced Stage of Evolution

acronym: GEMAN

summary:
Cognitive impairements in Alzheimer's and apparented disorders may lead to the decreased engagement in activities, spetially in moderate and advanced stages of evolution. The lack of stimulation for people with dementia is associated with the risk of challenging behaviors, depressives symptoms, sleeping disorders or faster cognitive deterioration. Those challenges may lead to the increased administration of pharmacological treatments, though the risks of neurleptics use in this population are currently known. In this context, non-pharacological interventions hold a significant place in dementia care.

This research focuses on cognitve stimulation activities. More precisly, our study compares two aproaches using the reading groups. The first type (" usual " reading group) is based on the principle of stimulating those cognitive functions which dicreases with the evolution of dementia. The second (Montessori reading group) approach relies on the idea to use preserved capacities in order to compensate the cognitive impariments.

The aim of our study is to compare the impact of these two non-pharmalogical interventions on non-verbal communication. The collected datas will help analyzing and understanding the internal and behavioral states of people living with dementia. Our study will also extend relfexions about cognitive stimulation groups in care institutions.

status: Withdrawn

primary_purpose: Supportive Care

sponsor_collaborators:
University Hospital, Montpellier
University of Geneva, Switzerland


type: EudraCT Number

title: A Single-center, Double-blind for Cenerimod, Open-label for Moxifloxacin, Placebo-controlled, Parallel-group, Randomized Study in Healthy Male and Female Subjects to Investigate I: the Effect of Cenerimod on the QTc Interval II: the Effect of Cenerimod on the Pharmacokinetics of Combined Oral Contraceptives III: the Effect of Charcoal on the Pharmacokinetics of Cenerimod.

summary:
This is a single-center, randomized, double-blind for cenerimod, open-label for moxifloxacin, placebo- and moxifloxacin-controlled, parallel-group study to investigate the effect of cenerimod on the duration of the QT interval in healthy male and female participants.

Participants will be randomly assigned to one of the 4 treatments: placebo, cenerimod 0.5 mg, cenerimod 4 mg or moxifloxacin.

lead_sponsor: Idorsia Pharmaceuticals Ltd.


title: Study of Behavioural and Psychological Symptoms as Functional Prognostic Factors in Neurodegenerative Early Onset Major Neurocognitive Disorders

acronym: NEODEM

summary: NEODEM is a multicenter cohort study of patients with early-onset degenerative dementia (before age 65), the main objective of which is to study behavioral disorders and in particular depression as functional prognostic factors at 3 years.

lead_sponsor: University Hospital, Bordeaux

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: NEODEM

titre: Pronostic fonctionnel des démences neurodégénératives de début précoce : NEODEM une cohorte prospective sur trois ans

discipline_principale: démence / malades jeunes / pronostic /  imagerie /  biomarqueurs

nom_porteur: AURIACOMBE

prenom_porteur: Sophie


title: A Prospective Study to Evaluate the Risk of Recurrence of Cervical Artery Dissection During Subsequent Pregnancies

summary: Cervical artery dissection (CAD) accounts for about 2% of all strokes, and is a major cause of stroke in young people (about 15%). Many cases of CAD during pregnancy and puerperium have been described, suggesting that pregnancy and puerperium may be potential risk factors for CAD. The purpose of this study is to determine whether pregnancy and puerperium are also recurrence risk factors for CAD.


title: Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

acronym: MODEX

summary: This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)

status: Terminated

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
ISAE-SUPAERO

location_facility: Universty hospital of Toulouse (Rangueil)


title: Mathematic Modeling at Micro and Macroscopic Level of Primary Central Nervous System Lymphomas (PCNSL)

acronym: LOC-MODEL

summary: We plan to analyze 100 PCNSL homogenously treated with high-dose methotrexate based chemotherapy using NGS of PCNSL samples. We will perform DNA-seq and RNA-seq from tumor samples. This data will be combined with their magnetic resonance imaging (MRI) at different time points: at diagnosis, at the end of the treatment and at disease progression. Among the 100 PCNSL that will be included, 70 will be from a retrospective (training set) from patients included in the French National PCNSL dataset (LOC cohort) and 30 PCNSL from a prospective cohort from patients included in a phase III clinical trial (BLOCAGE, PHRC 2014). On the one hand, we will perform a radiomics analysis (quantitative imaging) using 3D tumor and edema segmentation. This analysis will help us to elucidate the potential correlation of MRI phenotypes and genotype (using high-throughput data). In addition, we will use the radiomics data combined with in vitro and in vivo data (using a mouse model of PCNSL) as well as immunohistochemistry data to obtain a multidimensional mathematical modeling of PCNSL clinical evolution that will allow us to better predict the clinical course of this rare subtype of brain tumor.

time_perspective: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Impact of Executive Functions and Language on Social Cognition in Pediatric Epilepsy

acronym: TOMEPI

summary: The purpose of this study is to investigate the development of social cognition skills in pediatric epilepsy compared to healthy children. There are evidences indicating that children with epilepsy have executive dysfunctions and language problems. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. Moreover, the literature regarding development of non epileptic children, with ordinary development indicates that executive functions and language are linked to the emergence of social cognition. Then, the investigators asked if children with epilepsy, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Children with epilepsy and a control group of healthy volunteers will be compared to identify relationships between executive functions, language and social cognition.

primary_purpose: Basic Science

lead_sponsor: CHU de Reims


title: Identification of Biomarkers in Ischemic Stroke - Clinical Trial

acronym: IBIS-CT

summary: The objective of the study is to determine RNA blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Liquid Biopsies (Blood, Gastric Fluid) for the Personalized Management of Patients With Hereditary Diffuse Gastric Cancer: a Pilot Project

acronym: LISA-HDGC

summary: Activating somatic mutations and methylation profiles identified by liquid biopsies could identify CDH1 and CTNNA1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper G-I endoscopy.

ipd_sharing_description: Data entry and management under the responsibility of Dr Patrick Benusiglio investigator coordinating the study

intervention_type: Genetic


title: Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP

summary:
Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Physiological Study to Assess Mechanism of Action of MOBIDERM® in Lower-limb Lymphedema Patients

acronym: ACTIODERM

summary:
MOBIDERM® demonstrated his interest through clinical studies on the treatment of lower or upper limb lymphedema (Mestre et al 2017; Quéré et al. 2014). This CE (Conformity European)-marking device is well established both in ambulatory and hospitalisation. Nevertheless, the mechanism of action of this device had never been confirmed and no experimental clinical studies had been performed. The hypothesis is that the MOBIDERM system creates a pressure differential between the contact zone underneath the foam cubes composing the system and their surrounding area, leading to a shear effect on the subcutaneous tissues treated.

The aim of this study is thus to assess the mechanism of action of MOBIDERM on the lymphatic system by evaluating quantitative and qualitative effects of this medical device on lymphatic system, oedema volume and cutaneous parameters in 10 lymphoedema patients during their hospitalisation for reduction phase.

ReferenceCitation: Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.

ReferenceCitation: Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

lead_sponsor: Thuasne

sponsor_collaborators:
Thuasne
University Hospital, Tours
Delta Consultants


title: Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room

acronym: VERAPOP

summary:
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.

A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.

location_facility: Plateau technique Centre François-Xavier Michelet


title: Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy

acronym: MuciLight

summary: This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.

lead_sponsor: Centre Oscar Lambret

collaborators:
Fondation Apicil
Santelys Association

sponsor_collaborators:
Centre Oscar Lambret
Fondation Apicil
Santelys Association


title: Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018

acronym: PAROMIP

summary: A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.


title: Non Invasive Cardiac Output Evaluation With Starling SV for Lung Elective Surgery

acronym: NICOLE

summary: Intraoperative hemodynamic optimization decreases postoperative complications and length of stay in high risk patient. Therefore, continuous monitoring of cardiac output (Qc) is recommended to guide fluid management. Thoracic bio-reactance is a recent technique that allows cardiac output non-invasive monitoring. However, additional clinical validation studies in humans are required to better define the typologies of patients for whom this monitoring could be proposed routinely. Lung surgery is defined as an intermediate or high risk surgery regarding postoperative cardiac complications. However, surgical patients rarely benefit from continuous monitoring of cardiac output, the available methods being considered too invasive or insufficiently reliable in daily practice. Thoracic bio-reactance (Non Invasive Cardiac Output Monitor (NICOM) Starling SV) has not been studied in this subgroup of clinically relevant patients.

lead_sponsor: Hospices Civils de Lyon


title: Acetazolamide and Statins for the Treatment of Chronic Mountain Sickness in Highlanders: A Randomized Controlled Trial

summary: This study aims to assess the effect of two drugs for the treatment of chronic mountain sickness in highlanders.

lead_sponsor: Centre d'Expertise sur l'Altitude EXALT

location_facility: Association EXALT, UM Sport Pathologies, Hôpital Sud, Avenue Kimberley


title: Multicenter RCT Comparing Two Brushes of Different Diameters for Biliary Stenosis: RX Cytology Brush, BOSTON vs. Infinity® Brush, US Endoscopy. BIB Study (BIliary Brushing)

acronym: BIB

summary: The aim of this prospective national multicenter randomized study is to compare, during an ERCP for VBP stenosis, the sensitivity of two biliary brushes: the INFINITY® vs the RX Cytology Brush® The main objective is the comparison of the rates of positive diagnosis of biliary brushing in cases of adenocarcinoma stenosis The total number of subjects required: 50 (25 patients per group) Duration of the inclusion period: 2 years Duration of participation for each subject: from 7 days to 12 months (in case of negative initial withdrawal) Total duration of the study: 3 years

lead_sponsor: Société Française d'Endoscopie Digestive


title: Diagnostic Performances of Preoperative Echo-guided Uterine Biopsy in the Management of Suspect Uterine Sarcoma Tumors

acronym: BIOPSAR

summary: This is a prospective multi-center interventional study that will be performed in an effort to assess the diagnostic accuracy performance of preoperative vaginal ultrasound-guided biopsy (VUGB) to detect the exact histology of uterine tumors and thereafter triage cases being eligible for morcellation during laparoscopic resection. Ten tertiary French centers will participate in the present study.

status: Not yet recruiting

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
GIRCI SOHO

nom_etablissement: INSTITUT BERGONIE

type_etablissement: CLCC

acronyme: BIOPSAR

titre: Performances diagnostiques de la biopsie utérine échoguidée  pré- chirurgicale dans la prise en charge des tumeurs utérines suspectes de sarcomes

discipline_principale: gynécologie chirurgicale

nom_porteur: GUYON

prenom_porteur: Frédéric


title: A Prospective Randomized, Open-label, Blind Evaluator, Evaluating the Efficacy of Proximal Venous Angioplasty-stenting vs Optimal Medical Treatment on Post-thrombotic Syndrome Reduction

acronym: EndoPTS

summary: The project will highlight the potential benefit of endovascular therapy on post thrombotic syndrome reduction after proximal iliac DVT. There is actually not real standard of care for the treatment of this pathology. A clear evidence of efficacy of endovascular therapy will be of great benefit for both the patients and the healthcare system, and will provide new data for further international guidelines

lead_sponsor: University Hospital, Grenoble

location_facility: Grenoble-Alps University Hospital (CHUGA)

appel_a_projets: PHRCN

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: EndoPTS

titre: Etude prospective, randomisée en ouvert, d'évaluation en aveugle, evaluant l'efficacité de la recanalisation veineuse proximale en phase chronique vs traitement médical optimal sur la réduction du syndrome post thrombotique

discipline_principale: médecine vasculaire

nom_porteur: Pernod

prenom_porteur: Gilles


title: Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.

acronym: MONA

summary:
Background :

Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity).

Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied.

Objectives of the study :

- Main objective :

To describe adult patients with cystic fibrosis in terms of :

Nutritional profile
Food behaviour
Physical activity
Rest energy expenditure
Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.

time_perspective: Cross-Sectional

location_facility: Service de médecine interne - CRCM Lyon Adultes, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon


title: Assessment of the Lived Experience of the Disease of the Patients Followed at the CHU of Gui de Chauliac for a Keratoconus and Their Habit of Eye Rubbing

acronym: Rub'Cornea

summary: Evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. To do this, the investigators used a questionnaire made by a Bordeaux team with questions on the experience of the patients' illness, their management and their friction habits

lead_sponsor: University Hospital, Montpellier


title: Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study

acronym: DELTA

summary:
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit.

Two of those strategies are based on electrical impedance tomography (EIT) monitoring.

lead_sponsor: University Hospital, Angers


title: A Kinetic Study of Lipoprotein in Humans for a Better Understanding of Lipoprotein(a) Metabolism Under PCSK9 Variations (Hu-La-u-P Study)

acronym: HuLaUP

summary: The aim is to study the relationship between lipoprotein(a) [Lp(a)] and PCSK9 (Proprotein Convertase Subtilisin/Kexin type 9) in humans with a kinetic study of lipoproteins in patients with dramatic increase of Lp(a) and controls.

lead_sponsor: Nantes University Hospital

collaborators: Centre de Recherche en Nutrition Humaine Ouest (CRNH)


title: Induced Membrane Properties in Children and Adults

acronym: EMIH

summary: Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Study Through Imaging of Mediastinal and Abdominopelvic Secondary Lymphoid Organs (Lymph Nodes) in Patients With Severe Combined Immunodeficiencies (SCID) Who Have Recieved Bone Narrow Allograft

acronym: LymphImaging

summary:
To investigate the presence of seconday of lymphoid organs in patients who underwent allogenic hematopoietic stem cell transplantation 15 to 45 years ago.

The goal aims to assess the development of seconday lymphoid organs given the fact that the absence of myeloablation these patients present a split chimerism between T lymphocytes and the other leucocytes. Thus, they may not be able to generate seconday lymphoid organs. Practically, whole body MRI is being used to visualise and quantify both mediastinal and intraabdominal lymph nodes. Delta will be compared with those obtained in healthy age-matched individuals. It is scheduled to include 15 patients and 15 controls.

ReferenceCitation: Berteloot L, Molina TJ, Bruneau J, Picard C, Barlogis V, Secq V, Abdo C, Boddaert N, Griscelli C, Neven B, Fischer A. Alternative pathways for the development of lymphoid structures in humans. Proc Natl Acad Sci U S A. 2021 Jul 20;118(29):e2108082118. doi: 10.1073/pnas.2108082118.

publisher_dissemination: Proceedings of the National Academy of Sciences

lead_sponsor: Association Pour l'Aide a la Recherche en Immunologie Pediatrique


title: Intensive Robotic Rehabilitation in Children With Hemiparesia Using GEOSYSTEM

acronym: RIPHIGEO

summary: Cerebral palsy is the most frequent motor deficiency in children. Among other, it can leads to spastic diplegia or hemiplegia. Walking abilities is an important skill to the families' point of view in term of independence in curent life. Improving the walking parameters has been the main objective in several studies of rehabilitation. The G-EO system is a last generation robot assisting gait training that can adjust cadence, walk lengh, ankle and hip angles and other walking parameters to movement captation. Its superiority in terms of walking abilities has been demonstrated in adults with stroke sequelae. Only one study was realized in pediatric patients with spastic diplegia with promising results. The investigators hypothesize that intensive robot-assited gait training using the G-EO system in hemiplegic children can improve their walking abilities.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Université d'Auvergne


title: Retrospective Study Assessing the Concordance of the IHC4 Score Performed in Local Pathology Laboratory or in a Central Laboratory to a Molecular Gold Standard Test Endopredict in Breast Cancer Infiltrating ER+ HER2-

acronym: GEFPICS IHC4

summary: Retrospective observational, multicentric study assessing the immunohistochemistry (IHC) based test IHC4 score in infiltrating early breast cancer: comparison of the score performed in local laboratory vs in a central laboratory and concordance with a molecular gold standard classifier (EndoPredict).

lead_sponsor: UNICANCER

sponsor_collaborators:
UNICANCER
Roche Diagnostics


title: Interest of a Period of Fasting Before Extubation in Resuscitation Patients: a Prospective Observational Study

acronym: NUTRIGUS

summary:
Orotracheal extubation in resuscitation is a situation in which there is an elevated risk of inhalation. In resuscitation, enteral nutrition that is administered in a continuous flow is likely to accumulate in the stomach. Gastric motility in resuscitation patients may be impaired for many reasons:

Iatrogenic: Catecholamines, sedatives and opioids slow down the digestive system and decrease the tone of the lower esophageal sphincter
Shock, polytrauma, sepsis, pain or discomfort, or mechanical ventilation again create an alteration in gastric emptying.

Enteral nutrition is commonly discontinued to manage extubation, but it is not systematic. Discontinuation leads to a decrease in caloric intake.

Gastric ultrasound is a minimally invasive, reliable and promising means of monitoring that allows the stomach to be visualized directly. Studies on healthy subjects and in anaesthesia have made it possible to validate ultrasound in the context of the study of gastric content using both quantitative (including measurement of the antral area) and qualitative criteria. Measurement of the antral area was also studied in resuscitation. Antral area and gastric volume are closely related, with a correlation coefficient ranging from 0.6 to 0.91.

Identifying patients at risk of inhalation by ultrasound could allow individualized enteral nutrition management prior to extubation in the resuscitation unit, and thus optimize nutritional management.

The objective of the study is to identify factors associated with greated antral area in patients hospitalized in the intensive care unit. The hypothesis is that continued enteral nutrition before extubation is associated with increased gastric volume as measured by ultrasound.

ReferenceCitation: Nguyen M, Drihem A, Berthoud V, Dransart-Raye O, Bartamian L, Gounot I, Guinot PG, Bouhemad B. Fasting does not guarantee empty stomach in the intensive care unit: A prospective ultrasonographic evaluation (The NUTRIGUS study). Anaesth Crit Care Pain Med. 2021 Dec;40(6):100975. doi: 10.1016/j.accpm.2021.100975. Epub 2021 Nov 4.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children With Autism Spectrum Disorder Aged 8-12 Years Old

acronym: TIPI

summary: This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders or another neurodevelopmental condition.

lead_sponsor: Hôpital le Vinatier


title: Observational Study Evaluating the Psychic Impact of the Diagnostic Announcement and Care for Children Treated for Cancer

acronym: IPSYLON

summary: The cancer diagnostic announcement and cancer care are both physical and psychological highlights. The main objective is to analyze significant psychological difficulties in children aged 6 to 16 treated for cancer.

lead_sponsor: Centre Leon Berard


title: Prospective Study to Investigate the Relevance of Monitoring Area Under the Curve of Mycophenolic Acid in Patients Receiving Mycophenolate Mofetil to Treat a Diffuse Cutaneous or a Pulmonary Involvement of Systemic Sclerosis

acronym: SCLERAMAC

summary: To define a target value of AUC MPA to improve the modified Rodnan score and / or respiratory impairment (DLCO or FVC) at one year in patients receiving MMF for the treatment of diffuse cutaneous or interstitial lung damage of systemic sclerosis.

ReferenceCitation: van Gelder T, Le Meur Y, Shaw LM, Oellerich M, DeNofrio D, Holt C, Holt DW, Kaplan B, Kuypers D, Meiser B, Toenshoff B, Mamelok RD. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit. 2006 Apr;28(2):145-54. doi: 10.1097/01.ftd.0000199358.80013.bd.

ReferenceCitation: Zahr N, Arnaud L, Marquet P, Haroche J, Costedoat-Chalumeau N, Hulot JS, Funck-Brentano C, Piette JC, Amoura Z. Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil. Arthritis Rheum. 2010 Jul;62(7):2047-54. doi: 10.1002/art.27495.

ReferenceCitation: Chaigne B, Gatault P, Darrouzain F, Barbet C, Degenne D, Francois M, Szymanski P, Rabot N, Golea G, Diot E, Maillot F, Lebranchu Y, Nivet H, Paintaud G, Halimi JM, Guillevin L, Buchler M. Mycophenolate mofetil in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis: a prospective pharmacokinetics and clinical study. Clin Exp Immunol. 2014 May;176(2):172-9. doi: 10.1111/cei.12246.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Nutritional State and Care Pathway of Hospitalized Malnourished Patients, Within 3 Months of Admission

acronym: Nutriker

summary:
Malnourished patients are at risk of many complications, including infections, pressure ulcers and readmissions. Little is known about their care pathway after hospital discharge.

This study aims to determine care pathways of malnourished patients after hospital discharge and to determine what they need to better take care of their malnutrition.

lead_sponsor: Rennes University Hospital


title: Effectiveness of PACT Intervention, Delivered by Parents, Guided by Videoconference, on the Autism of Their Children With ASD

acronym: iPACT

summary: Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.

ReferenceCitation: Jurek L, Occelli P, Denis A, Amestoy A, Maffre T, Dauchez T, Oreve MJ, Baghdadli A, Schroder C, Jay A, Zelmar A, Revah-Levy A, Gallifet N, Aldred C, Garg S, Green J, Touzet S, Geoffray MM; IFPAD study group. Efficacy of parent-mediated communication-focused treatment in toddlers with autism (PACT) delivered via videoconferencing: a randomised controlled trial study protocol. BMJ Open. 2021 Apr 7;11(4):e044669. doi: 10.1136/bmjopen-2020-044669.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: British Medical Journal

nom_etablissement: CH LE VINATIER

type_etablissement: EPSM

acronyme: IFPAD

titre: Impact de l'intervention avec le modèle d'intervention précoce de Denver (ESDM  Early Start Denver Model) conduite par les parents, formés et accompagnés par visioconférence, sur le développement des interactions sociales chez l'enfant avec un trouble du spectre autistique

discipline_principale: autre

nom_porteur: GEOFFRAY

prenom_porteur: Marie-Maude


title: Observational Study of the Pharmacological Reversal of the Residual Neuromuscular Blockade in Bariatric Surgery

acronym: NEOCURE

summary:
Obesity in the world represents a growing share of the general population. At hospital, the management of these patients could be problematic especially when calculating the drug dosage.

According to the French guidelines, neostigmine, a cholinesterase inhibitor, should be used to reverse a residual neuromuscular blockade at a dose of 0.4 mg/kg of total body weight in non-obese patients. In morbidly-obese patients, with the modification of the fat/lean mass ratio, the optimal dose of neostigmine is non-consensual. To calculate the dose of neostigmine, some anesthesiologists use the total body weight, others use the ideal body weight and others use the adjusted body weight.

Due to this practice variability, It may be useful to observe the mean time to recovery of neuromuscular blockade and side effects after pharmacological reversal according to the dosage of neostigmine.

lead_sponsor: Poitiers University Hospital


title: Cognitive Functions in Adults With Sickle Cell Disease and Cognitive Complaints: Neuropsychological Assessment and Links to Demographic, Clinical, Biological, Neuroradiological Outcomes and Validation of a Cognitive Assessment Tool.

acronym: Drépa-COG

summary:
Sickle cell disease (SCD) is an inherited blood disorder. Symptoms include acute and chronic complications. Due to progress in SCD care, patients with SCD are living longer than before and we focus more attention in chronic complications.

Children with SCD experience worse cognitive functions than healthy children, and fewer is known about cognitive functions in adults. Studies suggest lower cognitive performance in SCD, mostly in executive functions and processing speed, but the biological and anatomical substrates of cognitive decline are not yet well established in SCD. Often times, cognitive impairments and cerebral disorders are not diagnosed and treated in adults with SCD.

The main objective of this study is to propose a deep neuropsychological assessment in adults with SCD and cognitive complaints and to highlight links between cognitive functions and clinical, biological and neuroradiological markers. The hypothesis of this study is that cognitive functions are associated with severity of the SCD, with bood abnormalities, with MRI markers and Transcranial Doppler (TCD) markers of cerebrovascular disease. The secondary objective of this study is to validate a brief cognitive assessment tool (BEARNI tool) in adults with SCD.

This study is an observational cross-sectional study that will enroll adults with SCD and cognitive complaint.

lead_sponsor: Hospices Civils de Lyon


title: Virtual Reality for Preoperative Anxiety in Interventional Cardiology

acronym: No PANIC

summary: Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.


title: Phase II of Adaptative Magnetic Resonance-Guided Stereotactic Body Radiotherapy (SBRT) for Treatment of Primary or Secondary Progressive Liver Tumors

acronym: RASTAF

summary:
Hepatic metastases are common in solid cancers (up to 30% of patients with colorectal cancer and up to 50% of patients during their follow-up). The incidence of primary liver cancer increases due to the increase in chronic liver diseases induced by excessive alcohol consumption, hepatitis B and C viruses, and excess fat in the liver. Surgical excision of these liver lesions is the reference treatment but it cannot always be realised.

Stereotactic radiotherapy is a recent technique proposed to hepatic metastases treatment from solid cancers and primary hepatic lesions (HCC or cholangiocarcinomas); it is possible to deliver high doses of radiation in the most conformational way possible in order to limit the irradiation of the non-tumor liver. The results of this stereotactic radiotherapy are currently very good with control rates of 75 to 80% at 1 and 2 years with acceptable rates of severe toxicities of 10%. However, the fear of hepatic, digestive (colon, esophagus, stomach) or even cardiac toxicities limits its using to the majority of patients because coupled with a conventional scanner it do not allow direct visualization of the lesion.

Due to its non-irradiating nature, MRI guided stereotactic radiotherapy can generate continuous imaging, during the irradiation session, offering " in live " a visualization of the tumor target and organs at risk of proximity. In increasing the precision and safety in the delivery of irradiation, it allows to hope for several areas for improvement of treatment:

reduced uncertainty margins
an increase in the dose delivered
the accessibility of tumor lesions near sensitive organs (esophagus, stomach, heart chambers, intestines, duodenum, right kidney).

More, this accelerator allows a re-optimization of the initial dosimetric plan to the anatomical changes of the day to allow an MRI guided adaptive radiotherapy.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


title: Electrocardiogram in General Practice : the EGG Study

acronym: EGG

summary:
Existing resources to assist interpretation of ElectroCardioGram (ECG) in general practice provide specialized and comprehensive reading based on pathologies and ElectroCardioGram (ECG) signs rather than ElectroCardioGram (ECG) indications.

Describing practices in general medicine could help prioritize the relevance of clinical and ECG signs for the general practitioner, enabling to adjust the reading given the context.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Metacognition Assessment in Patient With Multiple Sclerosis

acronym: METACOGSEP

summary: This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

ReferenceCitation: Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. doi: 10.1007/s00415-006-1103-1.

ReferenceCitation: Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.

ReferenceCitation: Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. doi: 10.1080/01688639108401046.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Grenoble Alps


title: Multimarker Approach for Acute Dyspnea in Elderly Patients Admitted in the Emergency Department

acronym: READ-MA

summary:
Elderly people constitute the largest proportion of emergency department (ED) patients, representing 12% of all ED admissions. The need for diagnostic tests or therapeutic interventions is much greater in this patient population. Cardiovascular diseases and symptoms represent 12% of the causes for ED admission, and patients suffering from cardiovascular disease are those whose ED visit lasts longest.

The diagnostic approach in the ED in elderly patients admitted for acute dypsnoea is complex, and early identification of acute left-sided heart failure (ALSHF) is vital as it has an impact on prognosis. The clinical signs are difficult to interpret, and are non-specific, particularly at the acute phase and in elderly or obese patients. Indeed, some authors have reported up to 50% of diagnostic errors in elderly patients.

Measure of the blood concentration of a natriuretic peptide allows a quick diagnosis. However, peptides alone suffer from several limitations, particularly in situations that are often encountered in elderly patients, such as sepsis, renal failure, acute coronary syndrome, pulmonary embolism, chronic respiratory failure, atrial fibrillation and high body mass index. Diagnostic performance deteriorates with increasing age, and there is a significant increase in this grey-zone in patients aged ≥75 years. In critical situations in elderly patients, assessment of natriuretic peptides serve mainly to rule out a diagnosis of left heart failure.

Some authors have studied other biomarkers showing their performance in the diagnosis of ALSHF. These are biomarkers involved in remodeling and myocardial fibrosis (ST2, Galectin-3) or involved in myocardial injury (High-sensitivity Troponin-I).

Therefore, a combined "multimarker" approach could improve the diagnostic performance of ALSHF.

READ (NCT02531542) is a diagnostic study including patients over the age of 75 admitted to acute dyspnea in the ED, to demonstrate the superiority of an ultrasound protocol (the READ protocol) on NT-proBNP in the ALSHF diagnosis.

The hypothesis is that the diagnostic accuracy of a multimarker diagnostic approach, namely the READ-MA method, combining NT-proBNP, High-sensitivity Troponin-I, ST2 and Galectin-3 would be superior to that of NT-proBNP assessment for the diagnosis of ALSHF in elderly patients (≥75 years) admitted to the ED.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Evaluation of an Immersive Audiovisual Distraction Device Impact on Peroperative Opioid Consumption. A Prospective Randomized Controlled Study

acronym: AmbuCineView

summary:
This study evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption for outpatient procedures with Remifentanil added to local anesthesia.

Half of patients will receive an audiovisual distraction device while the other half not.

ReferenceCitation: Marsdin E, Noble JG, Reynard JM, Turney BW. Audiovisual distraction reduces pain perception during shockwave lithotripsy. J Endourol. 2012 May;26(5):531-4. doi: 10.1089/end.2011.0430. Epub 2012 Feb 8.

ReferenceCitation: Lee DW, Chan AC, Wong SK, Fung TM, Li AC, Chan SK, Mui LM, Ng EK, Chung SC. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial. Endoscopy. 2004 Mar;36(3):197-201. doi: 10.1055/s-2004-814247.

ReferenceCitation: Eccleston C, Crombez G. Pain demands attention: a cognitive-affective model of the interruptive function of pain. Psychol Bull. 1999 May;125(3):356-66. doi: 10.1037/0033-2909.125.3.356.

ReferenceCitation: Boselli E. Interest of Analgesia/Nociception Index (ANI) for monitoring the relative parasympathetic tone in anesthetized and awake patients. Douleurs (Paris) (2018)

ReferenceCitation: Boselli et al. Analgesia monitoring using Analgesia/Nociception Index: Results of clinical studies in awake and anesthetized patients. Le Praticien en anesthésie réanimation. 2015;19:78-86

ReferenceCitation: Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia / nociception balance evaluation using heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:1194-7. doi: 10.1109/IEMBS.2010.5625971.

ReferenceCitation: Papaioannou V, Chouvarda I, Gaertner E, Benyamina M, Ferry A, Maurel V, Soussi S, Blet A, Chaouat M, Plaud B, Mebazaa A, Legrand M; PRONOBURN Group. Heart rate variability and cardiac baroreflex inhibition-derived index predicts pain perception in burn patients. Burns. 2016 Nov;42(7):1445-1454. doi: 10.1016/j.burns.2016.04.017. Epub 2016 May 8.

ReferenceCitation: Issa R, Julien M, Decary E, Verdonck O, Fortier LP, Drolet P, Richebe P. Evaluation of the analgesia nociception index (ANI) in healthy awake volunteers. Can J Anaesth. 2017 Aug;64(8):828-835. doi: 10.1007/s12630-017-0887-z. Epub 2017 Apr 21.

ReferenceCitation: Boselli E, Musellec H, Martin L, Bernard F, Fusco N, Guillou N, Hugot P, Paqueron X, Yven T, Virot C. Effects of hypnosis on the relative parasympathetic tone assessed by ANI (Analgesia/Nociception Index) in healthy volunteers: a prospective observational study. J Clin Monit Comput. 2018 Jun;32(3):487-492. doi: 10.1007/s10877-017-0056-5. Epub 2017 Aug 20.

ReferenceCitation: Le Guen M, Jeanne M, Sievert K, Al Moubarik M, Chazot T, Laloe PA, Dreyfus JF, Fischler M. The Analgesia Nociception Index: a pilot study to evaluation of a new pain parameter during labor. Int J Obstet Anesth. 2012 Apr;21(2):146-51. doi: 10.1016/j.ijoa.2012.01.001. Epub 2012 Feb 21.

ReferenceCitation: Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

ReferenceCitation: Yi P, Pryzbylkowski P. Opioid Induced Hyperalgesia. Pain Med. 2015 Oct;16 Suppl 1:S32-6. doi: 10.1111/pme.12914.

ReferenceCitation: Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.

ReferenceCitation: Facco E, Stellini E, Bacci C, Manani G, Pavan C, Cavallin F, Zanette G. Validation of visual analogue scale for anxiety (VAS-A) in preanesthesia evaluation. Minerva Anestesiol. 2013 Dec;79(12):1389-95. Epub 2013 Jul 9.

ReferenceCitation: Abend R, Dan O, Maoz K, Raz S, Bar-Haim Y. Reliability, validity and sensitivity of a computerized visual analog scale measuring state anxiety. J Behav Ther Exp Psychiatry. 2014 Dec;45(4):447-53. doi: 10.1016/j.jbtep.2014.06.004. Epub 2014 Jun 18.

ReferenceCitation: Hornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available.

ReferenceCitation: Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.

ReferenceCitation: Wismeijer AA, Vingerhoets AJ. The use of virtual reality and audiovisual eyeglass systems as adjunct analgesic techniques: a review of the literature. Ann Behav Med. 2005 Dec;30(3):268-78. doi: 10.1207/s15324796abm3003_11.

lead_sponsor: University Hospital, Caen


title: Reward and Punishment Sensitivity in Bipolar Disorders

acronym: Recodec-BP

summary:
Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors.

While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers.
This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls


title: Demonstration of the Presence of a Carbonyl Stress in the Hair Follicles of Postpartum Women

summary: In this study, the investigator will try to highlight the presence of carbonyl compounds in the hair follicles of postpartum women by comparing these compounds before and after delivery.

ipd_sharing_description: Proof of concept study, with confidential data

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Results of FilmArray® Gastro-intestinal Panel (GI Panel) and Serum Procalcitonin (PCT) in Acute Colitis and Infectious Diarrhea in the Emergency Department.

acronym: PRODIARRAY

summary:
Acute diarrhea and acute colitis of infectious origin are common reasons for consultation at the emergency department. The current etiological diagnostic approach is limited to the determination of markers of inflammation, such as CRP and blood leukocytes, which lack specificity and sensitivity for bacterial infection. The stool culture can detect bacterial pathogens in the stool with a result at least 48 hours later and a positivity rate <50%.

This study will describe the procalcitonin (PCT) concentrations (a biomarker of bacterial infection) in this population to evaluate its usefulness depending on the viral or bacterial etiology identified by stool multiplex gastro-intestinal PCR panel (GI panel) and stool culture.

The investigators hypothesize that PCT levels will be higher if the GI panel or the stool culture identifies a bacteria or a parasite, as it is the case in respiratory tract infections. If there is a detection of a virus by the GI panel or both the stool culture and the GI panel are negative, the investigators expect that PCT values will be lower or negative.

the investigators will include the patients admitted to the ED with a suspicion of infectious diarrhea or acute colitis in order to have a large representative panel of infectious diarrhea etiologies.

Only the patients having a blood sample prescribed as the routine care will be included. The blood sample is useful for dosing CRP and whole blood cell count (WBC), which are part of current biologic analyses performed in this context. After getting the patient's consent, the investigator will add the PCT dosage in blood sampling and will ask the patient to provide a stool sample, in order to have a stool culture and to perform an extended investigation for the pathogens through multiplex PCR technology (Filmarray ®GI panel).

The physician will be asked if all these results (the ones ordered currently together with the dosage of PCT and the GI panel) will change his/her decision to start an antibiotic.

Patients will receive a phone call at day 15 after their initial admission in the emergency department and will be asked if he/she has consulted a new physician or if a new treatment by antibiotics was started.

Data collection procedures: Data from the medical file will be collected by the investigators and the emergency department clinical research assistant. All the data will be pseudonymized. The collection will be done at the day of admission in the emergency department and after the phone interview at Day15.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Biofire


title: Development of a Source-monitoring Task in French Adapted to Neuroimaging Protocols

acronym: SOUMO

summary:
Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Source-monitoring processes are usually studied using experimental behavioral tasks. These tasks, which are very heterogeneous, are not all available in French and, for the most part, cannot be used in neuroimaging protocols.

The aim of this project is to develop an experimental task which allows the measurement of source-monitoring performances, and which is adapted to neuroimaging protocols in a French-speaking population.


title: Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity.

acronym: RECHOBIOL

summary: Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Biosynex Company


title: Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home

acronym: Frailcoach

summary:
Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.

Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".

lead_sponsor: CHU de Reims