title: Evaluation by Oncologists of Strategies for the Prevention and Treatment of Chemotherapy-induced Peripheral Neuropathies: Observational and Cross-sectional Study

acronym: EVANEURO

summary:
Chemotherapy induced peripheral neuropathy (CIPN) is one of the most deleterious adverse effect of neurotoxic anticancer drugs affecting up to 40% of patients. These neurotoxic anticancer agents include mainly: cisplatin (bronchopulmonary cancers), oxaliplatin (colorectal cancers), paclitaxel (breast cancers and bronchopulmonary cancers), docetaxel (breast cancers and bronchopulmonary cancers) and bortezomib (multiple myeloma).

CIPN affects not only the quality of life of patients, it also has a major impact on oncology strategy, forcing oncologists to reduce dose-intensity, to stop an ongoing chemotherapy regimen and to change therapeutic strategies, with a risk of compromising patients' survival.

There is no real preventive or curative treatment (except duloxetine) for CIPN and it is not known what is the practice of oncologists in France? However, it is essential to know the degree of sensitivity of oncologists to this problem and their practice.

With this study, the investigators propose to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.

ReferenceCitation: Selvy M, Pereira B, Kerckhove N, Busserolles J, Farsi F, Guastella V, Merle P, Pezet D, Balayssac D. Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists' professional practices. Support Care Cancer. 2021 Jul;29(7):4033-4043. doi: 10.1007/s00520-020-05928-6. Epub 2021 Jan 5.

family: Selvy

full_name: Marie Selvy

given: Marie

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Kerckhove

full_name: Nicolas Kerckhove

given: Nicolas

family: Busserolles

full_name: Jérôme Busserolles

given: Jérôme

family: Farsi

full_name: Fadila Farsi

given: Fadila

family: Guastella

full_name: Virginie Guastella

given: Virginie

family: Merle

full_name: Patrick Merle

given: Patrick

family: Pezet

full_name: Denis Pezet

given: Denis

family: Balayssac

full_name: David Balayssac

given: David

journal_name: Supportive Care in Cancer

title: Prevention, diagnosis and management of chemotherapy-induced peripheral neuropathy: a cross-sectional study of French oncologists’ professional practices

lead_sponsor: University Hospital, Clermont-Ferrand


title: COMET Study Effectiveness of a Cognitive Remediation Program of Memory in Patients With Temporal Lobe Epilepsy

acronym: COMETE

summary:
Studies on the cognitive function have highlighted promising results concerning attention. In contrast, in the field of memory, the single cohort study that has been carried out, has not been randomised, with non comparable groups, the significant outcomes are therefore to be balanced.

In this study, patients with focal and structural temporal lobe epilepsy will be randomised in 2 groups : the COMETE group where patients will attend a specific rehabilitation programme of memory and the control group where patients will benefit from a standard treatment.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Brissart H, Daniel F, Morele E, Leroy M, Debouverie M, Defer GL. [Cognitive rehabilitation in multiple sclerosis: a review of the literature]. Rev Neurol (Paris). 2011 Apr;167(4):280-90. doi: 10.1016/j.neurol.2010.07.039. Epub 2010 Dec 21. Review. French.

ReferenceType: result

ReferenceCitation: Brissart H, Leroy M, Morele E, Baumann C, Spitz E, Debouverie M. Cognitive rehabilitation in multiple sclerosis. Neurocase. 2013;19(6):553-65. doi: 10.1080/13554794.2012.701644. Epub 2012 Aug 1.

family: Brissart

full_name: H. Brissart

given: H.

sequence: first

family: Leroy

full_name: M. Leroy

given: M.

sequence: additional

family: Morele

full_name: E. Morele

given: E.

family: Baumann

full_name: C. Baumann

given: C.

family: Spitz

full_name: E. Spitz

family: Debouverie

full_name: M. Debouverie

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurocase

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Cognitive rehabilitation in Multiple sclerosis

lead_sponsor: Central Hospital, Nancy, France

location_facility: Service de Neurologie, Hôpital Central, CHRU de Nancy

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline

summary:
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.

Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.

Setting: 27 Intensive Care Units (ICU) in France

Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

Patients: 800 patients could be included during the first 6 hours of their septic shock.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Laboratoire français de Fractionnement et de Biotechnologies

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: The Contribution of Intra-arterial Thrombectomy in Acute Ischemic Stroke in Patients Treated With Intravenous Thrombolysis

acronym: THRACE

summary:
THRACE is a controled, multicenter and randomized trial.

The primary objective of this study is to determine whether a combined approach intravenous thrombolysis (IV) + Mechanical thrombectomy is superior to the reference treatment with IV thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (National Institutes of Health Stroke Scale [NIHSS] ≥ 10).

The second objective is to determine the cost-effectiveness of this procedure compared to the standard (IV thrombolysis). The assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the IV thrombolysis in 3 months and less than or at worst neutral to 1 year.

status: Terminated

ReferenceType: derived

ReferenceCitation: Riou-Comte N, Gory B, Soudant M, Zhu F, Xie Y, Humbertjean L, Mione G, Oppenheim C, Guillemin F, Bracard S, Richard S; THRACE investigators. Clinical imaging factors of excellent outcome after thrombolysis in large-vessel stroke: a THRACE subgroup analysis. Stroke Vasc Neurol. 2021 Jun 8. pii: svn-2020-000852. doi: 10.1136/svn-2020-000852. [Epub ahead of print]

apc_source: doaj

family: Riou-Comte

full_name: Nolwenn Riou-Comte

given: Nolwenn

family: Gory

full_name: Benjamin Gory

given: Benjamin

family: Soudant

full_name: Marc Soudant

given: Marc

family: Zhu

full_name: François Zhu

given: François

family: Xie

full_name: Yu Xie

given: Yu

family: Humbertjean

full_name: Lisa Humbertjean

given: Lisa

family: Mione

full_name: Gioia Mione

given: Gioia

family: Oppenheim

full_name: Catherine Oppenheim

given: Catherine

family: Guillemin

full_name: Francis Guillemin

given: Francis

family: Bracard

full_name: Serge Bracard

given: Serge

family: Richard

full_name: Sébastien Richard

given: Sébastien

currency_apc_doaj: GBP

journal_name: Stroke and Vascular Neurology

oa_host_type: publisher

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Derraz I, Pou M, Labreuche J, Legrand L, Soize S, Tisserand M, Rosso C, Piotin M, Boulouis G, Oppenheim C, Naggara O, Bracard S, Clarençon F, Lapergue B, Bourcier R; ASTER and the THRACE Trials Investigators. Clot Burden Score and Collateral Status and Their Impact on Functional Outcome in Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2021 Jan;42(1):42-48. doi: 10.3174/ajnr.A6865. Epub 2020 Nov 12.

family: Derraz

full_name: I. Derraz

given: I.

family: Pou

full_name: M. Pou

family: Labreuche

full_name: J. Labreuche

given: J.

family: Legrand

full_name: L Legrand

given: L

family: Soize

full_name: S. Soize

given: S.

family: Tisserand

full_name: M. Tisserand

family: Rosso

full_name: C. Rosso

family: Piotin

full_name: M. Piotin

name: on behalf of the ASTER and the THRACE Trials Investigators

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

publisher: American Society of Neuroradiology (ASNR)

ReferenceCitation: Boulouis G, Bricout N, Benhassen W, Ferrigno M, Turc G, Bretzner M, Benzakoun J, Seners P, Personnic T, Legrand L, Trystram D, Rodriguez-Regent C, Charidimou A, Rost NS, Bracard S, Cordonnier C, Oppenheim C, Naggara O, Henon H. White matter hyperintensity burden in patients with ischemic stroke treated with thrombectomy. Neurology. 2019 Oct 15;93(16):e1498-e1506. doi: 10.1212/WNL.0000000000008317. Epub 2019 Sep 13.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Provost C, Soudant M, Legrand L, Ben Hassen W, Xie Y, Soize S, Bourcier R, Benzakoun J, Edjlali M, Boulouis G, Raoult H, Guillemin F, Naggara O, Bracard S, Oppenheim C. Magnetic Resonance Imaging or Computed Tomography Before Treatment in Acute Ischemic Stroke. Stroke. 2019 Mar;50(3):659-664. doi: 10.1161/STROKEAHA.118.023882.

name: From the Imaging Department, INSERM UMR S1266, Sainte-Anne Hospital, Paris Descartes University, France (C.P., L.L., W.B.H., J.B., M.E., G.B., O.N., C.O.)

name: INSERM CIC-1433 Clinical Epidemiology, Nancy Hospital, France (M.S., F.G.)

name: Department of Neuroradiology, INSERM U1254, Lorraine University, Nancy, France (Y.X., S.B.)

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Reims, France (S.S.)

name: Department of Diagnostic and Interventional Neuroradiology, University Hospital of Nantes, France (R.B.)

name: Department of Neuroradiology, University Hospital of Rennes, France (H.R.).

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

ReferenceCitation: Achit H, Soudant M, Hosseini K, Bannay A, Epstein J, Bracard S, Guillemin F; THRACE Investigators. Cost-Effectiveness of Thrombectomy in Patients With Acute Ischemic Stroke: The THRACE Randomized Controlled Trial. Stroke. 2017 Oct;48(10):2843-2847. doi: 10.1161/STROKEAHA.117.017856. Epub 2017 Sep 15.

name: From the Department of Clinical Epidemiology, INSERM CIC-EC 1433 (H.A., M.S., K.H., J.E.), Department of Medical Information (A.B.), and Department of Diagnostic and Interventional Neuroradiology, INSERM U 947 (S.B.), University Hospital of Nancy, France; and Department of Clinical Epidemiology, INSERM CIC-EC 1433, EA 4360 APEMAC, University of Lorraine and University Hospital of Nancy, France (F.G.).

ReferenceCitation: Bracard S, Ducrocq X, Mas JL, Soudant M, Oppenheim C, Moulin T, Guillemin F; THRACE investigators. Mechanical thrombectomy after intravenous alteplase versus alteplase alone after stroke (THRACE): a randomised controlled trial. Lancet Neurol. 2016 Oct;15(11):1138-47. doi: 10.1016/S1474-4422(16)30177-6. Epub 2016 Aug 23. Erratum in: Lancet Neurol. 2016 Nov;15(12):1203.


title: Efficacy of Infusions of Mesenchymal Stem Cells From Wharton Jelly in the Moderate to Severe SARS-Cov-2 Related Acute Respiratory Distress Syndrome (COVID-19): A Phase IIa Double-blind Randomized Controlled Trial

summary:
Mesenchymal stem cells (MSCs) are of potential help in acute respiratory distress syndrome (ARDS), due to their anti-inflammatory properties.

The investigators will analyze the effect of 3 iterative infusions of ex vivo expanded Wharton's Jelly MSCs (total dose 2.10^6/kg) in patients with ARDS due to COVID19, who require mechanical ventilation.

ipd_sharing: No

intervention_type: Biological


title: Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.

acronym: FLADESIL

summary:
To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

Group 1 : 48 eyes primarily treated with gas tamponade
Group 2 : 11 eyes primarily treated with silicone oil tamponade
Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse

study_type: Observational

time_perspective: Retrospective


title: Evaluation of the Contribution of Comparative Genomic Hybridization Compared to Karyotype for the Detection of Genetic Abnormalities According to Ultrasound Call Signs in Prenatal Screening: the Cohort of the Nancy Multidisciplinary Center for Prenatal Diagnosis From 2012 to 2018

summary:
Pre-natal diagnosis is developing nowadays thanks to the improvement of ultrasound performances but also of genetic analysis techniques.

The karyotype was previously the reference technique for genetic analysis. The development of comparative genomic hybridization, consisting of comparative genomic hybridization on DNA sequences and allowing the diagnosis of unbalanced chromosomal rearrangements, has made it possible to increase the resolution threshold for the detection of genetic anomalies. This technique can be performed both pre and post natal. In pre-natal, the indications for this genetic study are based on ultrasound signs and are regularly updated in the international literature. Due to the complete analysis of the genome and the increase of the resolution threshold, genetic anomalies not related to the detected ultrasound pathology may be discovered and may pose ethical problems from a genetic counseling point of view.

To date, the diagnostic performance of comparative genomic hybridization as a complement to karyotype is being confirmed and needs to be clarified in order to limit the risk of incidental discovery of genetic anomalies whose significance remains unknown.

Through the study that the investigator would like to carry out, the investigator seek to evaluate the diagnostic contribution of this comparative genomic hybridization technique compared to the data provided by the karyotype according to the various ultrasound call signs on the Nancy cohort of files presented to the multidisciplinary pre-natal diagnosis committee, since the launch of the comparative genomic hybridization in Nancy in 2012 until 2018.

status: Enrolling by invitation

ReferenceCitation: Rudolf G, Lovrečić L, Tul N, Teran N, Peterlin B. The frequency of CNVs in a cohort population of consecutive fetuses with congenital anomalies after the termination of pregnancy. Mol Genet Genomic Med. 2019 Jun;7(6):e658. doi: 10.1002/mgg3.658. Epub 2019 Apr 19.

ReferenceCitation: Stosic M, Levy B, Wapner R. The Use of Chromosomal Microarray Analysis in Prenatal Diagnosis. Obstet Gynecol Clin North Am. 2018 Mar;45(1):55-68. doi: 10.1016/j.ogc.2017.10.002. Epub 2017 Dec 9. Review.

ReferenceCitation: Lo JO, Shaffer BL, Feist CD, Caughey AB. Chromosomal microarray analysis and prenatal diagnosis. Obstet Gynecol Surv. 2014 Oct;69(10):613-21. doi: 10.1097/OGX.0000000000000119. Review.

ReferenceCitation: Lee CN, Lin SY, Lin CH, Shih JC, Lin TH, Su YN. Clinical utility of array comparative genomic hybridisation for prenatal diagnosis: a cohort study of 3171 pregnancies. BJOG. 2012 Apr;119(5):614-25. doi: 10.1111/j.1471-0528.2012.03279.x. Epub 2012 Feb 7.

ReferenceCitation: Wou K, Levy B, Wapner RJ. Chromosomal Microarrays for the Prenatal Detection of Microdeletions and Microduplications. Clin Lab Med. 2016 Jun;36(2):261-76. doi: 10.1016/j.cll.2016.01.017. Epub 2016 Mar 28. Review.

ReferenceCitation: Levy B, Wapner R. Prenatal diagnosis by chromosomal microarray analysis. Fertil Steril. 2018 Feb;109(2):201-212. doi: 10.1016/j.fertnstert.2018.01.005. Review.

ReferenceCitation: Wapner RJ, Martin CL, Levy B, Ballif BC, Eng CM, Zachary JM, Savage M, Platt LD, Saltzman D, Grobman WA, Klugman S, Scholl T, Simpson JL, McCall K, Aggarwal VS, Bunke B, Nahum O, Patel A, Lamb AN, Thom EA, Beaudet AL, Ledbetter DH, Shaffer LG, Jackson L. Chromosomal microarray versus karyotyping for prenatal diagnosis. N Engl J Med. 2012 Dec 6;367(23):2175-84. doi: 10.1056/NEJMoa1203382.


title: Impact of Physiotherapy Session With or Without Non Invasive Ventilation in the Patient Benefiting From High Nasal Flow Oxygenation After Cardiac Surgery: a Pilot Study

summary:
This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.

Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.

The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?

Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.

Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.

status: Recruiting

status_simplified: Ongoing


title: Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.

summary: Our aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.

intervention_type: Diagnostic Test


title: Impact of Alarm Reduction on Delirium in ICU

acronym: ALADIN

summary: Delirium is an acute and fluctuating disturbance of consciousness and can occur in 80% of critically ill patients. Delirium is more frequent in mecanically ventilated patients and is associated with longer hospital stay, increased cognitive impairment and mortality. On the occasion of the change of the monitors in the ICU ward, allowing a total withdrawal of alarms in patients room, this study evaluates the prevalence of delirium before and after the alarm withdrawal. During the first period the patients will be monitored as usual, and during the second period patients will be monitored without alarms ringing in patients room. Delirium will be screened with a validated, clinical tool.

time_perspective: Prospective


title: French Renal Epidemiology and Information Network (REIN) Registry in Lorraine

acronym: REIN-LOR

summary: The Renal Epidemiology and Information Network (REIN) Registry was created in 2002 (after study pilot in 2001) to contribute to the development and evaluation of health strategies aiming at improving prevention and management of end-stage renal disease, and promoting clinical and epidemiological research in this field. It relies on a network of nephrologists, epidemiologists, patients and public health representatives, coordinated regionally and nationally.

ReferenceCitation: Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

family: Lassalle

full_name: Mathilde Lassalle

given: Mathilde

family: Ayav

full_name: Carole Ayav

given: Carole

family: Frimat

full_name: Luc Frimat

given: Luc

family: Jacquelinet

full_name: Christian Jacquelinet

given: Christian

family: Couchoud

full_name: Cécile Couchoud

given: Cécile

journal_name: Néphrologie & Thérapeutique

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Couchoud C, Stengel B, Landais P, Aldigier JC, de Cornelissen F, Dabot C, Maheut H, Joyeux V, Kessler M, Labeeuw M, Isnard H, Jacquelinet C. The renal epidemiology and information network (REIN): a new registry for end-stage renal disease in France. Nephrol Dial Transplant. 2006 Feb;21(2):411-8. Epub 2005 Oct 18.

ipd_sharing: Undecided

ipd_sharing_description: Open to partnership


title: Pilot Study of an Online Therapeutic Education Program for Patients With Inflammatory Bowel Disease

acronym: EDUMICILOR

summary:
EDUMICILOR is a monocentric prospective pilot study for patients with inflammatory bowel disease (IBD).

During the study, patients will participate in an online therapeutic education program.

They will first have an appointment with a nurse to establish a personalized educational diagnosis. Then they will participate in the online therapeutic education program for about 6 months (depends on the educational needs, expectations and patient's availabilities).

The main objective of this study is to assess the feasibility of an online therapeutic education program for IBD patients.


title: Short Telomere in Patients at High Cardiovascular Risk: a Simple Marker or a Major Determinant of Accelerated Arterial Aging

acronym: TELARTA

summary:
The prevailing view in telomere epidemiology is that leukocyte telomere length (LTL) is associated with atherosclerosis and accelerated aging since it serves as a biomarker of the cumulative burden of inflammation and oxidative stress during adult life. Our recent results however, indicate that telomere length (TL) is mainly determined at birth and childhood. Since short telomeres ante cede atherosclerosis, the investigators hypothesize that TL is not just a simple marker, but a real determinant of arterial aging. That is because TL reflects cellular repair capacity and a short LTL denotes diminished repair reserves. This hypothesis cannot be tested by measurements of LTL alone, since this parameter reflects TL at birth and its age-dependent attrition thereafter. The investigators propose, therefore, a model that makes it possible to examine different elements of TL dynamics in different tissues: leukocytes, skeletal muscle, endothelial progenitor cells (EPCs), skin or subcutaneous fat in patients with or without atherosclerosis.

Our model is based on the following premises, which are derived from observations that TL is synchronized (equivalent) across somatic tissues/cells of the newborn:

TL in skeletal muscle mainly reflects TL at birth
The difference in TL between muscle and leukocytes in adults (approximately 1.5 Kbp) mainly reflects LTL attrition during the growth period, i.e., childhood/adolescence
TL in EPCs determines the cell proliferative ability and therefore capacity for vessels repair during aging.

The general aim of the present project is to examine the links of arterial aging with TL, as expressed in different tissues, and LTL dynamics, as expressed in the difference between TLs of muscle and leukocytes.

time_perspective: Cross-Sectional

ReferenceCitation: Toupance S, Simonici S, Labat C, Dumoulin C, Lai TP, Lakomy C, Regnault V, Lacolley P, Dignat George F, Sabatier F, Aviv A, Benetos A; TELARTA consortium †. Number and Replating Capacity of Endothelial Colony-Forming Cells are Telomere Length Dependent: Implication for Human Atherogenesis. J Am Heart Assoc. 2021 May 18;10(10):e020606. doi: 10.1161/JAHA.120.020606. Epub 2021 May 6.

name: Inserm DCAC Université de Lorraine Nancy France

name: CHRU‐Nancy Pôle Maladies du vieillissement, Gérontologie et Soins Palliatifs and Fédération Hospitalo‐Universitaire CARTAGE‐PROFILES Université de Lorraine Nancy France

family: Toupance

full_name: Simon Toupance

given: Simon

name: Inserm INRA C2VN Aix Marseille University Marseille France

family: Simonici

full_name: Stéphanie Simonici

given: Stéphanie

family: Labat

full_name: Carlos Labat

given: Carlos

family: Dumoulin

full_name: Chloé Dumoulin

given: Chloé

name: Center of Human Development and Aging Rutgers The State University of New Jersey New Jersey Medical School Newark NJ

family: Lai

full_name: Tsung‐Po Lai

given: Tsung‐Po

family: Lakomy

full_name: Cécile Lakomy

family: Regnault

full_name: Véronique Regnault

given: Véronique

family: Lacolley

full_name: Patrick Lacolley

given: Patrick

family: Dignat George

full_name: Françoise Dignat George

given: Françoise

family: Sabatier

full_name: Florence Sabatier

given: Florence

family: Aviv

full_name: Abraham Aviv

given: Abraham

family: Benetos

full_name: Athanase Benetos

given: Athanase

family: Gautier

full_name: Sylvie Gautier

given: Sylvie

family: Watfa

full_name: Ghassan Watfa

given: Ghassan

family: Louis

full_name: Huguette Louis

given: Huguette

family: Folio

full_name: Mélanie Folio

given: Mélanie

family: Schmitt

full_name: Margaux Schmitt

given: Margaux

family: Ayad

full_name: Oualid Ayad

given: Oualid

family: Didier

full_name: Agnes Didier

given: Agnes

family: Vauthier

full_name: Sandrine Vauthier

given: Sandrine

family: François

full_name: Nelly François

given: Nelly

family: Visvikis‐Siest

full_name: Sophie Visvikis‐Siest

given: Sophie

family: Stathopolou

full_name: Maria G. Stathopolou

given: Maria G.

family: Kimura

journal_name: Journal of the American Heart Association

title: Number and Replating Capacity of Endothelial Colony‐Forming Cells are Telomere Length Dependent: Implication for Human Atherogenesis

ReferenceCitation: Benetos A, Toupance S, Gautier S, Labat C, Kimura M, Rossi PM, Settembre N, Hubert J, Frimat L, Bertrand B, Boufi M, Flecher X, Sadoul N, Eschwege P, Kessler M, Tzanetakou IP, Doulamis IP, Konstantopoulos P, Tzani A, Korou M, Gkogkos A, Perreas K, Menenakos E, Samanidis G, Vasiloglou-Gkanis M, Kark JD, Malikov S, Verhulst S, Aviv A. Short Leukocyte Telomere Length Precedes Clinical Expression of Atherosclerosis: The Blood-and-Muscle Model. Circ Res. 2018 Feb 16;122(4):616-623. doi: 10.1161/CIRCRESAHA.117.311751. Epub 2017 Dec 14.

name: From the INSERM UMRS 1116 (A.B., S.T., C.L.), Department of Geriatric Medicine, CHRU de Nancy (A.B., S.G.), Department of Vascular Surgery, CHRU de Nancy (N.S., S.M.), Department of Urology, CHRU de Nancy (J.H., P.E.), Department of Nephrology, CHRU de Nancy (L.F., M.K.), and Department of Cardiology, CHRU de Nancy (N.S.), Université de Lorraine, Nancy, France; Center of Human Development and Aging, Rutgers, The State University of New Jersey, New Jersey Medical School, Newark (M.K., A.A.);...

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database


type: Other Identifier

title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery

acronym: ReveSTAN

summary:
Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation.

Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.


title: Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility

acronym: FabLife

summary:
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.

The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.

primary_purpose: Health Services Research

lead_sponsor: FabLife

location_facility:
Drouot Laboratory
Tenon Hospital (AP-HP)

intervention_type: Device


title: A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

summary: This multicenter, open-label, single arm, interventional, long-term extension (LTE) study will evaluate the safety and efficacy of tocilizumab (TCZ, RoActemra/Actemra) in French participants with moderate to severe RA who have completed the Week 97 visit of WA22762 LTE study (NCT01194414) (EudraCT Number 2010-018375-22). Participants from France, who completed the Week 97 visit of the WA22762 LTE study and considered as responders (defined as having improvement in disease activity score based on 28-joint count [DAS28] of greater than [>] 1.2 points) will continue TCZ treatment within this local LTE study for a maximum of 156 weeks of subcutaneous (SC) TCZ treatment, or until SC TCZ becomes commercially available, whichever occurs first.

lead_sponsor: Hoffmann-La Roche


title: Effects of Combined Ventricular Unloading and Pharmacological Therapy on Left Ventricular Metabolic Dysfunction in Heart Failure

summary:
Cardiac function may improve in patients with end-stage heart failure who receive long-term support with ventricular assist devices (VAD). Reverse left ventricular remodeling may be sufficient in some cases to allow explantation of the VAD. However, some questions continue to await definitive answers. This study is designed to assess the myocardial recovery under VAD support with optimal pharmacological therapy (high doses [group I] of statins, beta-blockers, angiotensin-converting enzyme inhibitors versus standard doses [group II]).

The study is a randomized, single-blind trial performed at the Department of Cardiac Surgery, University of Strasbourg, France. Twenty patients with end-stage heart failure who will be supported by VAD (Thoratec paracorporeal device) as a bridge to heart transplantation will be included. Reverse left ventricular remodeling and myocardial function will be studied by: echocardiography, respiratory mitochondrial function, exercise testing, cardiac hormonal function, and inflammatory response. Myocardial biopsies will be obtained at the time of VAD implantation and heart transplantation. The follow-up will be performed every 4 weeks during the VAD support period. The hypothesis of this trial is that reverse left ventricular remodeling and myocardial function will improve under optimal medical therapy especially by a high dose statin.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Chirurgie Cardiovasculaire - Hôpital Civil

location_facility: Service de Physiologie Clinique - Hôpital Civil


title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne

summary:
Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.

The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.

design_allocation: Non-Randomized

primary_purpose: Other


title: Comparison of Mortality in Severe SARS-Cov-2 Infection Caused by the 501Y.V2 Variant and B.1.1.7 Variant

acronym: VARICOVID

summary: In January 2021, the incidence of COVID-19-and its mortality started rising for the third time in France. This rise may associate with three emerging variants, namely, V1, V2, and V3, which are the 20I/501Y.V1 ("English"), 20H/501Y.V2 ("South African"), and 20J/501Y.V3 ("Brazilian") variants, respectively. V1 was recently suggested to increase mortality in people in the United Kingdom who tested positive for COVID-19 on community screening. Very little is known about V2 infection, including its outcomes relative to other strains. In early 2021, V2 spread to the Grand-Est region (northeastern France). Here, the investigators aimed to report mortality data of patients admitted in ICU between February and April 2021 in 3 hospitals in Grand-Est: Metz, Thionville and Nancy.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

location_facility:
CHR Metz Thionville
CHRU Nancy


title: Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area

acronym: COVAL-NANCY

summary:
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area.

A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted.

The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study

primary_purpose: Screening

ipd_sharing: Yes


title: EASYX-1 : A Multicenter Study on Safety and Efficacy of Easyx Liquid Embolization Agent Used in Five Separate Indications

summary: The EASYX™ Liquid Embolic is a new injectable, precipitating polymeric agent for the obliteration of vascular spaces through direct puncture or catheter access performed under X-ray guidance. The embolic liquid is an iodinized Polyvinyl Alcohol (PVA) Polymer ether. Iodine groups are covalently grafted to the PVA polymer backbone, whereby a stable nondegradable polymer with the desired features is created. The resulting polymer is dissolved in Dimethyl Sulfoxide (DMSO). EASYX™ is CE-marked since December 2016 and has been used in humans a few time for type II endoleaks, portal vein and varicocele (<10 cases at the date of submission). The purpose of this study is to evaluate the safety and efficacy of EASYX™ embolization liquid for the percutaneous treatment of vascular lesions, i.e. embolization of varicocele, type II endoleaks, portal vein before surgery, active peripheral bleeding or angiomyolipoma (AML).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP - Hopital Europeen Georges-Pompidou Paris, France


title: French Hypertrophic Cardiomyopathy Observatory

acronym: REMY

summary:
Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.

The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)

time_perspective: Other

ReferenceCitation: Mirabel M, Damy T, Donal E, Huttin O, Labombarda F, Eicher JC, Cervino C, Laurito M, Offredo L, Tafflet M, Jouven X, Giura G, Desnos M, Jeunemaître X, Empana JP, Charron P, Habib G, Réant P, Hagège A; REMY working group of the French Society of Cardiology. Influence of centre expertise on the diagnosis and management of hypertrophic cardiomyopathy: A study from the French register of hypertrophic cardiomyopathy (REMY). Int J Cardiol. 2019 Jan 15;275:107-113. doi: 10.1016/j.ijcard.2018.09.083. Epub 2018 Sep 28.

family: Mirabel

full_name: Mariana Mirabel

given: Mariana

family: Damy

full_name: Thibaud Damy

given: Thibaud

family: Donal

full_name: Erwan Donal

given: Erwan

family: Huttin

full_name: Olivier Huttin

given: Olivier

family: Labombarda

full_name: Fabien Labombarda

given: Fabien

family: Eicher

full_name: Jean-Christophe Eicher

given: Jean-Christophe

family: Cervino

full_name: Claudio Cervino

given: Claudio

family: Laurito

full_name: Marianna Laurito

given: Marianna

family: Offredo

full_name: Lucile Offredo

given: Lucile

family: Tafflet

full_name: Muriel Tafflet

given: Muriel

family: Jouven

full_name: Xavier Jouven

given: Xavier

family: Giura

full_name: Geltrude Giura

given: Geltrude

family: Desnos

full_name: Michel Desnos

given: Michel

family: Jeunemaître

full_name: Xavier Jeunemaître

family: Empana

full_name: Jean-Philippe Empana

given: Jean-Philippe

family: Charron

full_name: Philippe Charron

given: Philippe

family: Habib

full_name: Gilbert Habib

given: Gilbert

family: Réant

full_name: Patricia Réant

given: Patricia

family: Hagège

full_name: Albert Hagège

given: Albert

journal_name: International Journal of Cardiology

lead_sponsor: French Cardiology Society


type: Registry Identifier

title: How a Patient's Words Change the Rewarding Value of Food: Mapping the Neurocognitive Shift Generated by Motivational Interviewing During the Therapy of Food Addiction Onto the Brain - MOTIVFOOD

acronym: MOTIVFOOD

summary: Why in some situations can words soothe our cravings? This research proposal will test the power of self-generated reasons for behavioural change in food addiction, which concerns about three out of ten persons and causes major life hazards such as obesity, diabetes and cancer. While food addiction is becoming more and more frequent in western societies, not much is known about its underlying neurocognitive mechanisms and how to tackle it. This study aims to investigate if and why certain types of affirmation-based therapies such as motivational interviewing (MI) are beneficial for the treatment of food addiction. The working hypothesis proposes that cognitive regulation-based self-control underpins the neurocognitive shift of a patient's willingness to change addictive behaviour, generated by the patient during MI therapy of food addiction. To test this hypothesis this study combines functional magnetic resonance imaging with behavioural testing of dietary decision-making following a participant's change or sustain talk statements. It will compare three groups of participants with and without food addiction and obesity and lean controls. This study will contribute to the improvement of therapies based upon talking oneself in and out of addiction promoting goals. Findings will provide a better understanding of how our everyday life dietary decision-environments prompt good intentions such as improving long-term nutritional quality to actual behaviours such as forgoing immediate desire.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

intervention_type: Behavioral


title: Neuronal Correlates of Agency in Dystonia

summary:
In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:

(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.

status: Active, not recruiting

primary_purpose: Basic Science


title: Determinants of Health Status and Quality of Life of Patients and Their Parents With Inherited Metabolic Diseases Diagnosed During Childhood and Requiring Restrictive and Specific Diet

acronym: MHMRSQol

summary: The general objective is study medical, socioeconomic, behavioral, health environmental, school and professional integration, and short- and medium- term quality of life determinants for all patients under 18 years old, residing in France for which the diagnosis of inherited metabolic diseases with specific regime (MHMRS) has been achieved during their childhood.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille


title: Effect of Enzyme Replacement Therapy in Patients With Juvenile-Onset Pompe Disease: a Long-term Observational Study

summary:
Pompe disease is known as glycogen storage disease type II, an autosomal recessive disease that results from acid alpha-glucosidase (GAA) deficiency leading to lysosomal glycogen accumulation. Patients with classic infantile form have less than 1% of enzyme activity, which explains severe impairment before one year with rapid death without treatment, while later-onset form shows progressive symptoms later in childhood (juvenile form) or adulthood (adult form).

Enzyme replacement therapy (ERT) consists of periodic intravenous infusion of missing GAA produced by the recombinant method. ERT improves significantly the cardiac function and the children's survival in classic infantile form. This therapy has been approved for all patients with Pompe's disease in the United States and the European Union since 2006, but its efficacy was not clear for patients with later-onset form. Recent studies show motor improvement in adult patients, but there is little published data for the juvenile form disease. A separate analysis of juvenile form is justified as patients are still in a developmental stage and show clinical symptoms early in life, may have more severe disease and a different response to ERT. The recommendation is no treatment in the absence of clinical symptoms, but the consensus does not stratify patients into juvenile- or adult-onset form. ERT is an expensive long-term therapy, and its administration every 2 weeks in the hospital is a great limitation for patients. Therefore, an evaluation of the treatment effect in patients with the juvenile form is necessary.


title: Development of New Multi-contrasts Approaches by Magnetic Resonance Imaging at 3 Tesla Dedicated to Targeting Subthalamic Nucleus on Parkinsonian Patients.

summary:
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) is a validated procedure, used in many French and international centers for the treatment of severe forms of Parkinson's disease (PD). The improvement of parkinsonian motor symptoms by stimulation of the STN is 50 to 80% on average. The main advantage of DBS is that the surgery has low morbidity and mortality, it is adaptable to the patient's symptoms and its effect is reversible. This treatment is now a routine and more than 85,000 patients worldwide have benefited from the installation of this system. Since 1997, this treatment is available to patients followed in the Pitié Salpêtrière (GHPS).

The accuracy of preoperative anatomic targeting in stereotactic neurosurgery will improve with the use of high-field MRI. However, several new issues and inherent in that high-field MRI should be evaluated before the images can be used directly.

The chosen sequences must be short to be feasible, minimizing patient discomfort, and evaluated on several patients to ensure the low interindividual variability. In addition, the quality of the display on all of the sections should provide a reliable three-dimensional information. Finally, the quality of targeting and its possible improvement should be checked.

ReferenceCitation: Benabid AL, Koudsie A, Benazzouz A, Piallat B, Krack P, Limousin-Dowsey P, Lebas JF, Pollak P. Deep brain stimulation for Parkinson's disease. Adv Neurol. 2001;86:405-12. Review.

ReferenceCitation: Bejjani BP, Dormont D, Pidoux B, Yelnik J, Damier P, Arnulf I, Bonnet AM, Marsault C, Agid Y, Philippon J, Cornu P. Bilateral subthalamic stimulation for Parkinson's disease by using three-dimensional stereotactic magnetic resonance imaging and electrophysiological guidance. J Neurosurg. 2000 Apr;92(4):615-25.

ReferenceCitation: Egidi M, Rampini P, Locatelli M, Farabola M, Priori A, Pesenti A, Tamma F, Caputo E, Chiesa V, Villani RM. Visualisation of the subthalamic nucleus: a multiple sequential image fusion (MuSIF) technique for direct stereotaxic localisation and postoperative control. Neurol Sci. 2002 Sep;23 Suppl 2:S71-2.

ReferenceCitation: Longhi M, Ricciardi G, Tommasi G, Nicolato A, Foroni R, Bertolasi L, Beltramello A, Moretto G, Tinazzi M, Gerosa M. The Role of 3T Magnetic Resonance Imaging for Targeting the Human Subthalamic Nucleus in Deep Brain Stimulation for Parkinson Disease. J Neurol Surg A Cent Eur Neurosurg. 2015 May;76(3):181-9. doi: 10.1055/s-0033-1354749. Epub 2015 Mar 12.

ReferenceCitation: Lefranc M, Derrey S, Merle P, Tir M, Constans JM, Montpellier D, Macron JM, Le Gars D, Peltier J, Baledentt O, Krystkowiak P. High-resolution 3-dimensional T2*-weighted angiography (HR 3-D SWAN): an optimized 3-T magnetic resonance imaging sequence for targeting the subthalamic nucleus. Neurosurgery. 2014 Jun;74(6):615-26; discussion 627. doi: 10.1227/NEU.0000000000000319.

ReferenceCitation: Yelnik J, Bardinet E, Dormont D, Malandain G, Ourselin S, Tandé D, Karachi C, Ayache N, Cornu P, Agid Y. A three-dimensional, histological and deformable atlas of the human basal ganglia. I. Atlas construction based on immunohistochemical and MRI data. Neuroimage. 2007 Jan 15;34(2):618-38. Epub 2006 Nov 15.

ReferenceCitation: Breit S, LeBas JF, Koudsie A, Schulz J, Benazzouz A, Pollak P, Benabid AL. Pretargeting for the implantation of stimulation electrodes into the subthalamic nucleus: a comparative study of magnetic resonance imaging and ventriculography. Neurosurgery. 2006 Feb;58(1 Suppl):ONS83-95.

ReferenceCitation: Cheng CH, Huang HM, Lin HL, Chiou SM. 1.5T versus 3T MRI for targeting subthalamic nucleus for deep brain stimulation. Br J Neurosurg. 2014 Aug;28(4):467-70. doi: 10.3109/02688697.2013.854312. Epub 2013 Nov 5.

ReferenceCitation: Patil PG, Conrad EC, Aldridge JW, Chenevert TL, Chou KL. The anatomical and electrophysiological subthalamic nucleus visualized by 3-T magnetic resonance imaging. Neurosurgery. 2012 Dec;71(6):1089-95; discussion 1095. doi: 10.1227/NEU.0b013e318270611f.

ReferenceCitation: Marques JP, Kober T, Krueger G, van der Zwaag W, Van de Moortele PF, Gruetter R. MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field. Neuroimage. 2010 Jan 15;49(2):1271-81. doi: 10.1016/j.neuroimage.2009.10.002. Epub 2009 Oct 9.

ReferenceCitation: Liu T, Eskreis-Winkler S, Schweitzer AD, Chen W, Kaplitt MG, Tsiouris AJ, Wang Y. Improved subthalamic nucleus depiction with quantitative susceptibility mapping. Radiology. 2013 Oct;269(1):216-23. doi: 10.1148/radiol.13121991. Epub 2013 May 14.

ReferenceCitation: Xiao Y, Fonov VS, Beriault S, Gerard I, Sadikot AF, Pike GB, Collins DL. Patch-based label fusion segmentation of brainstem structures with dual-contrast MRI for Parkinson's disease. Int J Comput Assist Radiol Surg. 2015 Jul;10(7):1029-41. doi: 10.1007/s11548-014-1119-4. Epub 2014 Sep 24.

ReferenceCitation: Starr PA, Martin AJ, Ostrem JL, Talke P, Levesque N, Larson PS. Subthalamic nucleus deep brain stimulator placement using high-field interventional magnetic resonance imaging and a skull-mounted aiming device: technique and application accuracy. J Neurosurg. 2010 Mar;112(3):479-90. doi: 10.3171/2009.6.JNS081161.

ReferenceCitation: Bardinet E, Belaid H, Grabli D, Welter ML, Vidal SF, Galanaud D, Derrey S, Dormont D, Cornu P, Yelnik J, Karachi C. Thalamic stimulation for tremor: can target determination be improved? Mov Disord. 2011 Feb 1;26(2):307-12. doi: 10.1002/mds.23448. Epub 2010 Dec 13.

intervention_type: Procedure


title: Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle

acronym: FUSIMAGINE

summary:
A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.

ReferenceCitation: Demené C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30.


title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

acronym: REMAIN

summary: The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

lead_sponsor: AstraZeneca


title: Pain Associated With ICU Procedures: An International Study

acronym: Europain®

summary:
Pain associated with procedures performed on adult ICU patients is ubiquitous and the subject of research attention.While there is growing evidence about the prevalence, characteristics and measurement of procedural pain in ICUs, most of this evidence has been derived from English-speaking patients in the United States who were able to verbally report the intensity and distress of this pain. Frequently performed procedures include turning,chest tube removal,wound care/wound dressing change,endotracheal suctioning,central catheter insertion(arterial/venous, have been a focus for research. Other potentially painful procedures, including lumbar puncture and physiotherapy,are numerous and have not been systematically studied in adults.

Patients unable to verbally report their pain have not been able to participate in procedural pain studies, which has limited the generalizability of study results to a narrow population of ICU patients.

The Specific Aims of this proposed European-based, international study of ICU patients undergoing selected procedures are to:

Describe patient self-reports of pain intensity and distress
Describe the behaviors exhibited by patients during a procedure, comparing the behaviors exhibited by those able versus unable to self-report pain intensity and pain distress
Examine predictors of amount of pain intensity, behavioral responses, and analgesic use related to procedures such as gender, age, language spoken, country, and type of hospital.

Validated pain intensity, pain distress, and behavioral observation instruments will be methodically translated into the predominant languages spoken in our international study sites; research and training packets similar to those developed in a large, multisite study in the United States will be developed and provided to data collection sites; and data collection will occur over a 6-month period of time. Study data will be analyzed and disseminated at international meetings and in publications.

ReferenceCitation: Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, Roche-Campo F, Mancebo J, Divatia JV, Soares M, Ionescu DC, Grintescu IM, Vasiliu IL, Maggiore SM, Rusinova K, Owczuk R, Egerod I, Papathanassoglou ED, Kyranou M, Joynt GM, Burghi G, Freebairn RC, Ho KM, Kaarlola A, Gerritsen RT, Kesecioglu J, Sulaj MM, Norrenberg M, Benoit DD, Seha MS, Hennein A, Periera FJ, Benbenishty JS, Abroug F, Aquilina A, Monte JR, An Y, Azoulay E. Determinants of procedural pain intensity in the intensive care unit. The Europain® study. Am J Respir Crit Care Med. 2014 Jan 1;189(1):39-47. doi: 10.1164/rccm.201306-1174OC.

family: Puntillo

full_name: Kathleen A Puntillo

given: Kathleen A

family: Max

full_name: Adeline Max

given: Adeline

family: Timsit

full_name: Jean-Francois Timsit

given: Jean-Francois

family: Vignoud

full_name: Lucile Vignoud

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Robleda

full_name: Gemma Robleda

given: Gemma

family: Roche-Campo

full_name: Ferran Roche-Campo

given: Ferran

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Divatia

full_name: Jigeeshu V Divatia

given: Jigeeshu V

family: Soares

full_name: Marcio Soares

given: Marcio

family: Ionescu

full_name: Daniela C Ionescu

given: Daniela C

family: Grintescu

full_name: Ioana M Grintescu

given: Ioana M

family: Vasiliu

full_name: Irena L Vasiliu

given: Irena L

family: Maggiore

full_name: Salvatore Maurizio Maggiore

given: Salvatore Maurizio

family: Rusinova

full_name: Katerina Rusinova

given: Katerina

family: Owczuk

full_name: Radoslaw Owczuk

given: Radoslaw

family: Egerod

full_name: Ingrid Egerod

given: Ingrid

family: Papathanassoglou

full_name: Elizabeth D.E. Papathanassoglou

given: Elizabeth D.E.

family: Kyranou

full_name: Maria Kyranou

given: Maria

family: Joynt

full_name: Gavin M Joynt

given: Gavin M

family: Burghi

full_name: Gastón Burghi

given: Gastón

family: Freebairn

full_name: Ross C Freebairn

given: Ross C

family: Ho

full_name: Kwok M Ho

given: Kwok M

family: Kaarlola

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Determinants of Procedural Pain Intensity in the Intensive Care Unit: The Europain Study


title: Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest

acronym: CO LUPUS

summary: Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

primary_purpose: Diagnostic

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM

summary:
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.

Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.

Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.

The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.

location_facility:
Clinique Sainte Anne
AURAL Strasbourg
CH de Valenciennes
Hôpitaux Universitaires de Strasbourg
CH de Nancy
Hospices civils de Colmar
CH de Besançon
CH de Dijon
CH de Mulhouse
AURAL Clinique Sainte Anne
AURAL Colmar
CH d'Amiens
AURAL Mulhouse


title: Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4.

acronym: COAT IFN

summary:
Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments

The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Comparative Evaluation on Blood Pressure Effect of an Equivalent Sodium Intake, in the Form of Bicarbonate or Chloride, for Hypertensive Subjects.

acronym: SODIVASC-II

summary:
Numerous large-scale epidemiological studies have made it possible to establish a link between the average consumption of table salt (sodium chloride) and blood pressure figures. In France, according to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), salt intakes could be estimated from 2 national food consumption surveys INCA 1 and INCA 2. This made it possible to take a photograph of food consumption habits and to show that the average consumption of salt contained in food in France is 8.7g/day for men and 6.7g/day for women. To these contributions must also be added 1 to 2g of salt for the resalting and the cooking water. According to the food consumption survey INCA 3, french plate still contains a large part of processed foods and still a little too much salt (on average 9g/day for men and 7g/day for women at compare with the objectives of the National Health Nutrition Program of 8g/day and 6.5g/day respectively). In addition, the World Health Organization (WHO) recommends consuming less than 5g of salt per day.

In this context, sodium intake through mineral water was also questioned. Both in terms of basic and clinical research, the biological effects of dietary sodium chloride intake have been the subject of a great deal of work for several decades. The mechanisms of transmission in the induced or hemodynamic effects related to the absorption of Na multiple debates and their impact on cardiovascular risks remain very uncertain. Work has shown that all subjects do not react homogeneously to sodium chloride intakes, thus determining what are called "NaCl-sensitive" people who in a situation of major sodium intake will show an increase of peripheral vascular resistance and an increase in blood pressure, much more marked than in subjects called " NaCl resistant ".

"NaCl-sensitive" people represent 10 to 30% of the population, with notable differences according to ethnic origins, regions and continents. A marked overrepresentation of this phenotype is observed in patients with hypertension or with a family history of hypertension.

Furthermore, studies conducted on animals and humans show that sodium intake does not have the same impact on the parameters mentioned above, depending on whether it is in the form of chloride or bicarbonate salt.

On the basis of these elements, the investigators developed a clinical study protocol intended to demonstrate a possible differential effect in the biological effects of the same sodium orally intake (2.56g per day), depending on the salt origin.

location_facility: Platform of Clinical Investigation / Clinical Investigation Center French Institute of Health and Medical Research-1405 University Hospital

intervention_type: Dietary Supplement


title: Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy

acronym: ENZYMELA

summary:
To characterize and quantify immune cells expressing the Interleukine 4 induced gene 1 (IL4I1) immunosuppressive enzyme in the blood and in tissue of melanoma patients (primary tumor, sentinel lymph nodes and cutaneous metastases).

Then, to compare the results obtained in different clinical settings:

in cases of progression of the disease slower or faster compared to the prognosis established by clinical and pathological data
before and after treatments with immunotherapy (anti Programmed Death ligand 1 (anti-PD1) or anti-PD1 and anti Cytotoxic T Lymphocyte associated protein 4 (anti-CTLA-4)) and / or targeted therapies (BRAF inhibitors and /or methyl ethyl ketone (MEK)).

ReferenceCitation: Ramspott JP, Bekkat F, Bod L, Favier M, Terris B, Salomon A, Djerroudi L, Zaenker KS, Richard Y, Molinier-Frenkel V, Castellano F, Avril MF, Prévost-Blondel A. Emerging Role of IL-4-Induced Gene 1 as a Prognostic Biomarker Affecting the Local T-Cell Response in Human Cutaneous Melanoma. J Invest Dermatol. 2018 Dec;138(12):2625-2634. doi: 10.1016/j.jid.2018.06.178. Epub 2018 Jul 23.

ReferenceCitation: Bod L, Lengagne R, Wrobel L, Ramspott JP, Kato M, Avril MF, Castellano F, Molinier-Frenkel V, Prévost-Blondel A. IL4-induced gene 1 promotes tumor growth by shaping the immune microenvironment in melanoma. Oncoimmunology. 2017 Jan 13;6(3):e1278331. doi: 10.1080/2162402X.2016.1278331. eCollection 2017.

ipd_sharing_description:
The clinical data at the diagnosis and the relapse/no relapse information have to be shared from the groups 1 and 2.

The clinical response to treatments will be shared.


title: Mucle Resilience: Muscular Markers Predictive of Functional Recovery After Femoral Neck Fracture in Orthogeriatrics

acronym: HIPRESM

summary:
The aging of the population is a major public health problem, particularly with regard to the quality of life and the maintenance of autonomy.

The fracture of the upper end of the femur (EFSF) is a pathology:

Frequent, affecting the elderly: in France, 80,000 patients / year, 83% aged ≥ 75 years (DREES, 2011),
severe, on mortality and autonomy: 40% will not recover their walking capacity earlier than 6 months, 13% of patients > 85 years old walk unaided at 4 months and 11% of patients will be newly admitted to an institution in 6 months after the fracture (UPOG / PSL data).
and costly: costs related to acute care (excluding prostheses and osteosynthesis equipment), are estimated at € 475 million for health insurance in France.

Currently, despite optimized orthogeriatric management, it is difficult to predict how the individual will respond / recover from acute stress related to the EFSF. Physical resilience is an emerging concept in medicine that defines the dynamic ability of a subject to resist or recover from functional decline as a result of stress or disruption. In this context, developing new approaches to assessing resilience is important, to take into account this resilience specific to each patient in order to develop a personalized functional rehabilitation strategy. The objective of the HIPRESM study is to be able to identify, in elderly patients after an EFSF intervention, the muscular signature associated with good functional recovery (= physical resilience). The goal of the investigators is to develop software that will provide this muscle signature by measuring and analyzing parameters from high-definition surface electromyography (HD-sEMG). This technology is innovative, non-invasive and portable, CE marked but not yet used in clinical routine.

location_facility: APHP - Pitie Salpetriere Hospital - UPOG


title: French National Observatory on Infective Endocarditis

acronym: ObservatoireEI

summary:
The objective of this observatory is to provide a national database of infective endocarditis, informed by all volunteer centers, using a standardized case report forms.

Such an observatory will describe the clinical profile, microbiological, therapeutic and evolving of infective endocarditis (IE); analyze the risk factors for the disease and its prognosis factors of evolution; describe management practices; evaluate and compare in the real drug treatment strategies (including antibiotics) and surgical.

ReferenceCitation: Selton-Suty C, Goehringer F, Venner C, Thivilier C, Huttin O, Hoen B; membres de l'Endocarditis Team du CHU de Nancy. [Complications and prognosis of infective endocarditis]. Presse Med. 2019 May;48(5):532-538. doi: 10.1016/j.lpm.2019.04.002. Epub 2019 May 2. Review. French.

family: Selton-Suty

full_name: Christine Selton-Suty

given: Christine

family: Goehringer

full_name: François Goehringer

given: François

family: Venner

full_name: Clément Venner

given: Clément

family: Thivilier

full_name: Carine Thivilier

given: Carine

family: Huttin

full_name: Olivier Huttin

given: Olivier

family: Hoen

full_name: Bruno Hoen

given: Bruno

journal_name: La Presse Médicale

title: Complications et pronostic de l’endocardite infectieuse

ReferenceCitation: Hoen B, Elfarra M, Huttin O, Goehringer F, Venner C, Selton-Suty C; l'Endocarditis Team du CHU de Nancy. [Treatment of infectious endocarditis]. Presse Med. 2019 May;48(5):539-548. doi: 10.1016/j.lpm.2019.04.015. Epub 2019 May 18. Review. French.

family: Elfarra

full_name: Mazen Elfarra

given: Mazen

evidence: open (author manuscript)

license_normalized: no license

version: acceptedVersion

title: Traitement de l’endocardite infectieuse

ReferenceCitation: N'Guyen Y, Duval X, Revest M, Saada M, Erpelding ML, Selton-Suty C, Bouchiat C, Delahaye F, Chirouze C, Alla F, Strady C, Hoen B; AEPEI study group. Time interval between infective endocarditis first symptoms and diagnosis: relationship to infective endocarditis characteristics, microorganisms and prognosis. Ann Med. 2017 Mar;49(2):117-125. doi: 10.1080/07853890.2016.1235282. Epub 2016 Nov 3.

name: Service de Médecine Interne, Maladies infectieuses et Immunologie Clinique, Hôpital Robert Debré, CHU Reims, Reims, France;

family: N’Guyen

full_name: Yohan N’Guyen

given: Yohan

name: Inserm CIC-1425; AP-HP, Hôpital Universitaire Bichat; Inserm UMR-1137 IAME; Université Paris Diderot, Paris 7, France;

family: Duval

full_name: Xavier Duval

given: Xavier

name: Maladies Infectieuses et Réanimation Médicale, Centre Hospitalier Universitaire, Rennes, France;

family: Revest

full_name: Matthieu Revest

given: Matthieu

name: Service de Maladies Infectieuses et Tropicales, Centre Hospitalier de Perpignan 20, Perpignan, France;

family: Saada

full_name: Matthieu Saada

name: Inserm, CIC-1433 Epidemiologie Clinique & CHU Nancy, Pôle S2R, Epidémiologie et Evaluation Cliniques, Nancy, France;

family: Erpelding

full_name: Marie-Line Erpelding

given: Marie-Line

name: Service de Cardiologie, Centre Hospitalier Régional Universitaire, Vandoeuvre-les-Nancy, France;

name: Centre National de Référence des Staphylocoques, Bron, France;

name: Lyon Hôpital Cardiologique Louis Pradel, Université Claude Bernard, Bron, France;

name: UMR 6249 Laboratoire Chrono-Environnement Université de Bourgogne Franche-Comté, Besançon, France;

name: Apemac, EA4360; Inserm, CIC-1433, Université de Lorraine, Université Paris Descartes, Vandoeuvre les Nancy, France;

name: Clinique Saint André-Groupe Courlancy, Cabinet d'infectiologie, Reims, France;

name: Faculté de Médecine Hyacinthe Bastaraud, Université des Antilles et de la Guyane, Pointe-à-Pitre, France;

name: Inserm CIC1424, Service de Maladies Infectieuses et Tropicales, Dermatologie, Médecine Interne, Centre Hospitalier Universitaire de Pointe-à-Pitre/Abymes -BP 465, Pointe-à-Pitre, France

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

ReferenceCitation: Lefèvre B, Hoen B, Goehringer F, Sime WN, Aissa N, Alauzet C, Jeanmaire E, Hénard S, Filippetti L, Selton-Suty C, Agrinier N; for AEPEI study group (Association pour l'Etude et la Prévention de l'Endocardite Infectieuse). Antistaphylococcal penicillins vs. cefazolin in the treatment of methicillin-susceptible Staphylococcus aureus infective endocarditis: a quasi-experimental monocentre study. Eur J Clin Microbiol Infect Dis. 2021 Dec;40(12):2605-2616. doi: 10.1007/s10096-021-04313-3. Epub 2021 Aug 12.

name: for AEPEI study group (Association pour l’Etude et la Prévention de l’Endocardite Infectieuse)

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

ReferenceCitation: Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI Study Group. Impact of referral bias on prognostic studies outcomes: insights from a population-based cohort study on infective endocarditis. Ann Epidemiol. 2021 Feb;54:29-37. doi: 10.1016/j.annepidem.2020.09.008. Epub 2020 Sep 18.

ReferenceCitation: Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI study group. Data on prognostic factors associated with 3-month and 1-year mortality from infective endocarditis. Data Brief. 2020 Nov 1;33:106478. doi: 10.1016/j.dib.2020.106478. eCollection 2020 Dec.

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


title: Evaluation of the Methods and Effectiveness of Care for Eligible Medical and Surgical Patients on Admission in Continuous Monitoring Units

acronym: UNISURC

summary:
In France, Intensive Medicine is carried out in three types of structures: intensive care units, intensive care unit and units Continuous Monitoring (USC). Created in the 90s as intermediate structures between conventional care units and intensive care units, these units are assigned to the care of patients whose conditions and treatment are fear the occurrence of one or more critical failures requiring to be monitored, or whose condition, at the end of one or more critical failure is too severe or unstable to allow a return to a classical inpatient unit.

Thus, USC represent a milestone in the journey of patients whose condition is critical: patients from the emergency services, patients in the immediate postoperative period, coming out of intensive care patients, or finally in conventional hospitalization patients whose condition s 'worse. The creation of the USC is not subject to authorization but must be contractualized between the hospital and the Regional Health Agency (ARS) because it is resource intensive. Organizations and their operating modes are guided by the recommendations of the French Society of Anesthesia and Intensive Care (SFAR), and the Society of French Language Resuscitation (SRLF) published in 2005.The US establishment has a beneficial effect on the quality of care and the care pathway of patients at risk shown by the reduction in morbidity and mortality, the rate of admission and / or USC readmission of length of stay and hospital stay costs.

It is possible to objectify provided first establish an inventory on the activity of these units and the patient base supported. To judge the benefit of the assumption by the USC, it is necessary to assess the adequacy of patients managed with an updated specification and defined by a group of experts.


title: Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire : Concordance Study.

summary: The treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. However, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. To date, only a physical activity questionnaire adapted to CHF could provide information regarding both the type and dose of daily physical activity. Such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities < 3 MET, activities between 3 and 5 MET, and activities > 5 MET). During its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor largely recognized in CHF. A second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the DLW method (R2 = 0.81; individual relative error < 7%). However, the high cost of the DLW method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general CHF population in France.

primary_purpose: Prevention

ReferenceCitation: Garet M, Barthélémy JC, Degache F, Costes F, Da-Costa A, Isaaz K, Lacour JR, Roche F. A questionnaire-based assessment of daily physical activity in heart failure. Eur J Heart Fail. 2004 Aug;6(5):577-84.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service de Physiologie Clinique et de l'Exercice, CHU de Saint-Etienne


title: Pilot Suty of the Assessment of Food Preferences After Bariatric Surgery (BariaTaste Pilot)

summary:
More than 50,000 patients in France benefit from bariatric surgery every year. However, nutritional complications (protein malnutrition, hypoglycaemia) are common and primary or secondary weight failures (weight recovery) account for almost 20% of operated. Weight loss and the metabolic effects of surgery are not related only to a reduction in dietary intakes, but also to mechanisms independent of caloric reduction, such as eating behaviour after bariatric surgery (Gastric Bypass or sleeve gastrectomy). These choices are guided by perceived changes in the properties of the food, resulting in changes in tastes, palatability and more generally food preferences. Among available tools to evaluate dietary preferences we selected the Food Leeds Preference Questionnaire (FLPQ) to assess those modifications. During this test, photographs of food products classified according to predetermined characteristics are presented with different instructions and response design to estimate liking, wanted for food, implicitly or explicitly. Our main hypothesis is that the use of the Food Leeds Preference Questionnaire will highlight differences in dietary preferences according to the type of bariatric surgery performed.

We will be conducted a study observational study on three parallel groups: a control group composed of patients suffering from unoperated obesity, a group of patients operated for a sleeve gastrectomy and a group of patients operated for a gastric bypass. We will include 45 patients per group. The patients will have to pass the Leeds Food Preference Questionnaire (LFPQ). Our judgment criterion will be the degree of food preference assessed using the LFPQ. Participants will also be assessed on behavioural parameters with the Binge Eating Scale, the Yale Food Addiction Scale Version 2.0 and the Urgency, lack of Premeditation, lack of Perseverance and Sensation seeking Impulsive behavior scale (UPPS-P) short version.

lead_sponsor: Hospices Civils de Lyon


title: Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)

acronym: PAIRS-AJA

summary:
Adolescents and young adults (AYA) with cancer have to deal with a relatively segmented organization of care between pediatric and adult medicine structures in France. However, the third french Plan Cancer 2014-2019 helped in the recognition of the specificities of the AYA affected by cancer and allowed the creation of specific structures in some care units in France, whose primary goal is the preservation of the social link.

Indeed, peer relations contribute to access to quality social support, which is an important variable in patient adjustment with cancer. The adolescents that perceive higher social support report less psychological distress and exhibit higher adaptation scores.

It nevertheless happens that AYA experience negative social support, often from friends because of contact reduction during the disease. Patients can then elect to turn towards non-intimate relations such as support groups. The main risk when a AYA with cancer defines a sick peer as one bringing him quality social support is the installation of a sense of guilt, for example, when a young person is confronted with disease negative progress or with peer death. The more an adolescent identifies with the deceased, the more he is able to consider his own mortality.

AYA units are developing in France, creating a community of sick adolescents. These communities are precious for AYA and allow information and experience sharing, a feeling of reduced isolation and a greater emotional closeness with peers suffering from the same disease.

How is social support from peers and close friends perceived by these young people in AYA units and through the social networks? What can the consequences of the evolution of peer disease be on AYA? What is the impact of the mourning of sick peers on these young people? What are the predictors?

lead_sponsor: Institut Curie

location_facility:
Centre Leon Berard
INSTITUT CURIE - site Paris


title: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre

summary: The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

ReferenceCitation: Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Philippon

full_name: Bénédicte Philippon

given: Bénédicte

family: Fabre

full_name: Xavier Fabre

family: Kaaki

full_name: Mahmoud Kaaki

given: Mahmoud

journal_name: Annals of Intensive Care

oa_colors: green gold

oa_host_type: publisher;repository

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Centre Hospitalier de Roanne


title: Evaluation of the Relevance Indicators of Quality of Care for Dying Patients Based on Analysis of Care and Follow-up Course of the Leonetti Law. EFIQUAVIE Study

acronym: EFIQUAVIE

summary:
The study uses a mixed method study to evaluate wether the use of the indicators of the Quality of end-of-life cancer care, developed by Earle et al [Earle JCO 2003; DOI: 10.1200/JCO.2003.03.059] would be relevant and measurable in France. The qualitative part of study was designed to investigate the representations of quality by face-to face interviews with family carer of recently deceased cancer patients, and with their oncologists, and nurses. The quantitative part of the study, consisted in a decedents case series analysis, diagnosed with advanced cancer and followed up in 5 centers. Data on trajectory of care were collected from different complementary sources associating national mortality data, hospital activity data, and health records.

The study was approved by the French data protection authority (CNIL) number 611273.

location_facility:
APHP Hôpital Européen Georges Pompidou
APHP Hôpital Cochin
APHP Hôpital Henri Mondor
Institut Curie
Institut Gustave Roussy


title: Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

acronym: TMSCCS

summary: The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool for improving schizophrenic symptoms, in particular resistant hallucinations, has been increasingly studied over the past decades. Several studies have demonstrated that low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal Junction (TPJ), which are known to decrease local activity, significantly reduced auditory verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high level of inter-individual variability in the responses to non-invasive brain stimulation treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring controversy about the efficacy of these approaches (as currently performed), as well as about how to increase its efficacy and consistency. Accordingly, the objectives of this project are to better understand the impact of rTMS on the brains of patients with resistant auditory hallucinations, and to use this information not only to better understand this condition but to develop more efficient and consistent therapies. Thus, in this study, the investigators focus more specifically on resistant auditory hallucinations in schizophrenia, which is a common symptom in schizophrenic patients, and can be treated by rTMS. The investigators hypothesize that there is a baseline difference in anatomical and/or functional connectivity between responder and non-responder patients who are treated with rTMS. Therefore, our project will aim to determine some anatomical and functional connectivity markers of response to rTMS treatment in patients with schizophrenia

ReferenceCitation: Thomas F, Bouaziz N, Gallea C, Schenin-King Andrianisaina P, Durand F, Bolloré O, Benadhira R, Isaac C, Braha-Zeitoun S, Moulier V, Valero-Cabré A, Januel D. Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial. Trials. 2019 Apr 23;20(1):229. doi: 10.1186/s13063-019-3311-x.

family: Thomas

full_name: Fanny Thomas

given: Fanny

family: Bouaziz

full_name: Noomane Bouaziz

given: Noomane

family: Gallea

full_name: Cécile Gallea

given: Cécile

family: Schenin-King Andrianisaina

full_name: Palmyre Schenin-King Andrianisaina

given: Palmyre

family: Durand

full_name: Florence Durand

given: Florence

family: Bolloré

full_name: Ombline Bolloré

given: Ombline

family: Benadhira

full_name: René Benadhira

given: René

family: Isaac

full_name: Clémence Isaac

given: Clémence

family: Braha-Zeitoun

full_name: Sonia Braha-Zeitoun

given: Sonia

family: Moulier

full_name: Virginie Moulier

given: Virginie

family: Valero-Cabré

full_name: Antoni Valero-Cabré

given: Antoni

family: Januel

full_name: Dominique Januel

given: Dominique

journal_name: Trials

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility: Unité de Recherche Clinique, EPS Ville Evrard


title: Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2

summary:
The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study. Each participant will complete a detailed questionnaire detailing their training history. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.

In part 2 of the study cardiac MRI will be performed at rest before the EDT cycling ride completion. An ECG registration using a RootiRx will be realized during and up to 6 hours after the cycling ride. An echocardiography and cardiac MRI will be repeated in each cyclist between 3 and 6 hours after EDT cycling ride completion. A blood sample will be obtained at that time after the ride. This time point is chosen based on the highest troponin release that 3 to 6 hours post-exercise would allow a sufficient amount of time for inflammation to develop and be detectable, corresponding with the time when cardiac Troponin T is typically detectable and representing the liberation of enzymes from damaged myocytes.

Finally, a third cardiac MRI will be repeated 24 hours after start of the cycling ride to verify the evolution of possible inflammation over this time period.

lead_sponsor: Jessa Hospital

location_country: Belgium France

location_facility: Centre Hospitalier Universitaire de Nice


title: CHRONIC OPTIC NEUROPATHY IN MULTIPLE SCLEROSIS: DEMYELINATING AND/OR PRIMARY DEGENERATIVE PATHOPHYSIOLOGY?

summary:
Patients with multiple sclerosis (MS) may show chronic signs of optic neuropathy (CON) that may follow acute optic neuritis (secondary form of CON, S-CON) or occur independently of any acute demyelinating lesion of the optic nerve (primary form of CON, P-CON). In both S-CON and P-CON, a long term progressive ganglion cell axonal loss occurs. This axonal damage could be secondary to retrograde atrophy of axons within plaques of demyelination or a primary progressive degeneration of ganglion cells, but the underlying physiopathology has not been fully questioned in the different profile types of CON.

In this project, investigators aim at understanding the pathophysiology of S-CON and P-CON, i.e. secondary to demyelination or primary degeneration, in patients complaining of persistent visual complaints. In a first cross sectional study, 30 MS patients with mild to moderate P-CPON or S-CON and 30 age-matched control subjects will perform an extensive neuro-ophthalmological assessment including clinical examination, visual evoked potentials (pattern and low contrast), electroretinogram (pattern and multifocal ERG), OCT (peripapillary and macular volume scan segmentation protocols) and MRI of the optic nerve. In these patients with mild to moderate CON, investigators aim at differentiating patients showing predominant demyelination from those showing pure or predominant axonal degeneration. Visual function assessment and degree of axonal degeneration will be compared and correlated in the two types of underlying pathophysiology and in the group of control subject. In a following longitudinal study, the patients will be re-assessed a year later in order to evaluate the progression of CON in both profile types. Our hypothesis would be that visual function and progression is worse in the degeneration group as compared to the demyelination group. This study should help to find reliable measures of the pathophysiology of CON and correlate it with the long-term visual prognostic of the disease.

location_facility: Unité de Neuro-Ophtalmologie - Hôpital Neurologique - HOSPICES CIVILS DE LYON


title: Research for Angiostrongylus Cantonensis and Costaricensis in French West Indies and French Guiana: a Clinical and Environmental Study

acronym: ACCRAG

summary:
Hospitals in the French West Indies (Fort-de-France (Martinique); Basse-Terre and Pointe-à-Pitre (Guadeloupe); and French Guiana (Cayenne, Saint-Laurent du Maroni)) have noted the emergence of eosinophilic meningitis cases in recent years. This finding is part os eosinophilic meningitis cases emergence and meningoencephalitis caused by the parasite Angiostrongylus cantonensis on the American continent and in the Greater Antilles.

In 2013, the investigation of an eosinophilic meningitis case by the Basse-Terre hospital team with a positive specific PCR in the CSF (CDC, Atlanta, USA) showed the first case of neuromeningeal angiostrongylosis in Guadeloupe. A similar case was diagnosed by serology at Pointe-à-Pitre University Hospital a few years earlier without having been published, and another serious case diagnosed also at Pointe-à-Pitre University Hospital Center in January 2017. The team at the Martinique University Hospital Center also reported several cases of eosinophilic meningitis with positive serologies for A. cantonensis carried out in laboratories outside Martinique (Laboratory of Parasitology, Gonesse, France; Thailand; and Tropical Institute and Public Health, Switzerland) in recent years.

The emergence of this parasitosis is related to the introduction of the intermediate host Achatina fulica on the American continent and the geographical evolution of the angiostrongylosis cases is intrinsically linked to that of the Achatins. To date, only two studies report the environmental presence of Angiostrongylus cantonensis in the Lesser Antilles. One proved the presence in rats (23.4%) on the island of Grenada, and the other in Guadeloupe, showing that 32.4% of Achatina fulica collected carried the parasite by specific PCR. In Martinique, where the number of cases is increasing, and in French Guiana, where there is an increase in the number of cases in neighboring countries, especially Brazil, no study has been conducted on this parasite.

In parallel with this finding, several serious digestive tables associated with strong hypereosinophilia were reported in Martinique and Guadeloupe in the 90s but also in recent years, the last case in December 2016. Etiological diagnoses were established by the discovery of Angiostrongylus costaricensis parasite in ileal pathological specimens. However, these cases could never be investigated by serology or specific PCR due to lack of diagnostic tools available in the French West Indies and Guiana region, and more broadly in metropolitan France.

lead_sponsor: University Hospital Center of Martinique


title: Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

acronym: TOOLBAR

summary:
The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels.

Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support.

In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor.

A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

summary: This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.

lead_sponsor: Fresenius Medical Care France


title: Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old

acronym: HUMERUS

summary:
Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates.

The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.

location_facility: Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard