title: Efficacy of Phosphatidylserine Enriched With Polyunsaturated n-3 Fatty Acid Supplementation on Attention Deficit Disorders in Children With Epilepsy. A Randomized Double-blind Placebo-controlled Trial

summary:
Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include:

To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.
To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles.
To assess the tolerance of a supplementation of PS-Omega 3.
To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.

To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,

on attention disorders in children with epilepsy,
on quality of life,
and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.

location_facility:
CHRU Lille
Hospices Civils de Lyon
Hôpital de Hautepierre
CHU d'Angers
CHU de Amiens
Hôpital Necker-Enfants malades
Hôpital de la Timone
CHU de Tours
Hôpital Robert-Debré
Hôpital Brabois - Rue du Morvan
Hôpital des Enfants - Pellegrin
CHU de Rennes
CHU de Toulouse


intervention_type: Biological

status: Unknown status

study_type: Interventional

lead_sponsor: University Hospital, Angers

enrollment_type: Anticipated

primary_purpose: Diagnostic

acronym: LEUCOPRO

location_facility: CHU CH CHRU

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.

summary:
Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.

The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.

lead_sponsor_type: academique

status_simplified: Unknown


title: Value of Prostate Health Index for Prostate Cancer Diagnosis

summary:
Prostate biopsies are the gold standard for prostate cancer (PCa) diagnosis. They are performed according to the results of the measurement of prostate-specific antigen (PSA) in the serum of patients with PCa suspicion. More than half of the prostate biopsies reveal eventually negative because of the poor specificity of prostate-specific antigen assay. The Prostate Health Index (PHI) is a new diagnostic tool that has been described as a good predictor of prostate biopsy outcome. No large study has been performed so far in France. This study aim to evaluate Prostate Health Index diagnostic performances in a large multicentric French cohort of patients undergoing prostate biopsies because of clinical and/or biological suspicion of prostate cancer.

Prostate Health Index will be measured in patients directed to prostate biopsies according to usual practices. Inclusion of 400 patients within 6 months in 12 French centers is expected. The ability of Prostate Health Index to predict prostate cancer at biopsy will be evaluated in terms of intrinsic and extrinsic diagnostic performances including sensitivity, specificity, predictive values, diagnostic accuracy, area under receiver operating curves and decision curve analyses.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Unité Médicale d'Oncologie et de Transfert - Service de Biochimie et Biologie Moléculaire - Centre Hospitalier Lyon-Sud

intervention_type: Device

status_simplified: Completed


title: Multicenter RCT to Assess the Impact of Improvements in Lexico-syntactic Readability and Good Practice in Writing on the Comprehension of Written Information Given to Patients Participating in Clinical Trials.

acronym: LISYCOM

summary: The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B, Guillot K, Bosson JL, Hommel M. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med. 2005 Jan 15;34(1):13-8. French.

ReferenceCitation: Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comités de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol. 2005 Jun;19(3):395-9.

ReferenceCitation: Okaïs C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. Epub 2007 Mar 21. French.

ReferenceCitation: Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104.

ReferenceCitation: Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Mélis M, Ribuot C, Brandt C, Bosson JL, Hommel M, Cracowski JL. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol. 2007 Apr;21(2):207-14.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Research Center, University Hospital Grenoble

intervention_type: Other


title: Medical Economics of Urinary PCA3 Test for Prostate Cancer Diagnosis

summary:
The ultrasound-guided biopsies of the prostate is the validated technique for the diagnosis of prostate cancer, the first human cancer and second leading cause of cancer death. Overall, in more than half of cases, prostate biopsies performed in search of a prostate cancer are negative. In this population, there is no consensus recommendation on how to care, leading to repeated invasive biopsies, potential sources of complications.

The PCA3 urine test (ProgensaTM, GenProbe) is an innovative diagnostic tool to predict the positivity of prostate biopsies, especially in patients who had at least one negative biopsy. Proposed in clinical practice in France as a commercial kit, it is expensive and is not covered by health insurance. It is therefore essential to assess the medical and economic impact of its introduction into medical practice.

The investigators propose to set up a study of high standard of proof, multicenter, based on recruitment of patients treated in hospitals. This working hypothesis is that the availability of the PCA3 test results would reduce the number of invasive biopsies performed incorrectly in patients already had at least one negative biopsy, thus improving the diagnostic strategy of prostate cancer.

location_facility:
CHU Angers
Hôpital Edouard Herriot
Centre Hospitalier Alpes Leman
Hôpital de la Milétrie
Hôpital privé des Pays de Savoie
Hôpital Tenon
Centre Hospitalier de Valence
Centre Hospitalier Lyon Sud
Hôpital Pitié-Salpêtrière,
Hôpital du Bocage
Centre hospitalier de Thonon les bains
Hôpital de la Cavale blanche


title: Medical Economic Evaluation and of Quality of Life of the Kidney Living Donors. Comparison of the Taking of Kidney by cœliosurgery (Pure or " Hand-assisted "), by cœliosurgery Assisted by Robot and by the Classic Technique of Open Donor Nephrectomy.

acronym: DOVIREIN

summary:
The main objective of this multicentre study is to conduct the evaluation of cost-efficiency of various techniques of kidney taking with regard the quality of life of the kidney living donors.

It will allow to compare three techniques of taking (open donor nephrectomy, cœliosurgery pure or " hand-assisted " and cœliosurgery assisted by robot) and to determine their respective advantages in quality of life, then their medico-economic consequences in a cost-efficiency approach from the point of view of the society.

The evaluation will concern the donor and the receiver followed three months after the taking.

The open donor nephrectomy will be the technique of reference with which will be compared the two others.

ReferenceType: derived

ReferenceCitation: Achit H, Guillemin F, Karam G, Ladrière M, Baumann C, Frimat L, Hosseini K, Hubert J. Cost-effectiveness of four living-donor nephrectomy techniques from a hospital perspective. Nephrol Dial Transplant. 2020 Nov 1;35(11):2004-2012. doi: 10.1093/ndt/gfz143.

name: Clinical Epidemiology Centre CIC 1433 Inserm, University Hospital of Nancy, Nancy, France

family: Achit

full_name: Hamza Achit

given: Hamza

sequence: first

family: Guillemin

full_name: Francis Guillemin

given: Francis

sequence: additional

name: Department of Urology, University Hospital of Nantes, Site Hôtel-Dieu, Nantes, France

family: Karam

full_name: Georges Karam

given: Georges

name: Department of Nephrology, University Hospital of Nancy, Site Brabois, Nancy, France

family: Ladrière

full_name: Marc Ladrière

given: Marc

name: Department of Methodology, Promotion and Investigation, University Hospital of Nancy, Nancy, France

family: Baumann

full_name: Cedric Baumann

given: Cedric

family: Frimat

full_name: Luc Frimat

given: Luc

family: Hosseini

full_name: Kossar Hosseini

given: Kossar

name: Department of Urology, University Hospital of Nancy, Site Brabois, Nancy, France

name: IADI-UL-INSERM (U1254), University Hospital of Nancy, Nancy, France

family: Hubert

full_name: Jacques Hubert

given: Jacques

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Nephrology Dialysis Transplantation

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU Côte de Nacre de CAEN
Hôpital Necker
Hôpital de Rangueil
Hôpital Tenon
CHU Bicêtre
CHU Pasteur
Hôpital Pitié Salpêtrière
CHU Hautepierre
CHU Saint Jacques de Besançon
CMC Foch
CHU Hôtel Dieu
Hôpital Claude Huriez
CHU Montpied de Clermont-Ferrand
CHU Hôpital de la Conception
CHU Brabois
CHU Hôpital Michallon de Grenoble
Hôpital Saint-Louis
CHU Henri Mondor
CHU Lapeyronie
Hôpital Edouard Herriot de Lyon
Hôpital Charles Nicolle
CHU Bretonneau
CHU Saint Etienne
CHU Lyon Sud

intervention_type: Procedure


title: Interest in Programming Caesarean Section at 38 Weeks of Pregnancy With Antenatal Betamethasone to Prevent Neonatal Respiratory Distress and to Avoid Emergency Caesarean Section Before Planned Date.

summary:
Comparison of two randomized group :

caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before.
caesarean section planned at 39 weeks without corticosteroid.

The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.

primary_purpose: Prevention

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Le Parc Centre pour la Mère et l'Enfant
Centre Hospitalier de Haguenau
Hôpital de Hautepierre
Hôpital de Hasenrain
Cmco-Sihcus


title: Effects of Induced Moderate HYPOthermia on Mortality in Cardiogenic Shock Patients Rescued by Veno-arterial ExtraCorporeal Membrane Oxygenation (ECMO)

acronym: HYPO-ECMO

summary:
A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.

The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).

primary_purpose: Treatment

ReferenceCitation: Jacquot A, Lepage X, Merckle L, Girerd N, Levy B. Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study). BMJ Open. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697.

apc_source: openAPC

family: Jacquot

full_name: Audrey Jacquot

given: Audrey

family: Lepage

full_name: Xavier Lepage

given: Xavier

family: Merckle

full_name: Ludovic Merckle

given: Ludovic

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

family: Levy

full_name: Bruno Levy

given: Bruno

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility: CHU Bordeaux - Groupe Hospitalier SaintAndré

location_facility: CHU Clermont-Ferrand -Hopital G. Montpied

location_facility: CHU Toulouse Hôpital - Pierre Paul Riquet


type: Other Identifier

title: A Pilot Study of Pharmacokinetics, Tolerance and Efficacy of Raltegravir Combined to Two Fully Active Molecules Among Nucleosi(ti)de Analogs and Enfuvirtide Before and After Liver Transplant in HIV Infected Patients With End Stage Liver Disease (ANRS 148 LIVERAL)

acronym: LIVERAL

summary: This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service de Médecine Interne, Hôpital de Bicêtre

intervention_type: Drug


title: Anaphylaxis to Neuromuscular Blocking Agents and Pholcodine Exposure. Case-control Study

acronym: ALPHO

summary:
The main objective of this study is to compare pholcodine exposure in patients having presented with a perianaesthetic anaphylactic reaction to a NMBA (cases) to pholcodine exposure in matched anaesthetised patients with injection of NMBA, who did not present with an anaphylactic reaction (controls).

The secondary objectives of the study are:

To compare anti-pholcodine IgE, anti-ammonium IV IgE and total IgE levels between the case and control groups.
To study the concordance between exposure to pholcodine in cases and controls, by means of a patient self-questionnaire on the one hand and, on the other hand, by a computerized drug history, supplemented where relevant by the drug master file.
To study the impact of taking 1, 2 or 3 sources in account for pholcodine exposition.
To study the association between exposure to pholcodine and the presence/levels of pholcodine-specific IgE, reflecting sensitisation to pholcodine.
To study NMBA and pholcodine cross-sensitisation by testing skin reactions to pholcodine in case patients allergic to (at least) one NMBA.

design_allocation: Non-Randomized

location_facility:
CHU de Strasbourg
CHU de Clermont-Ferrand
CHU de TOURS
CHU de MONTPELLIER
CHU de Saint Etienne
CHRU de Nancy
CHU de Toulouse
CHU de Besançon
AP-HP- Hôpital Bichat
CHU de Bordeaux
CHU de Poitiers
CHU de Caen
CHU de NANTES
Hospices Civils de Lyon
CHU de Dijon
CHU d' ANGERS
CHU de Nice
CHU de Rouen
AP-HM
CHU de Reims
CHRU de Lille
CHU de Limoges
AP-HP Paris TENON
Fondation Hôpital St Joseph


title: The Clinical Evaluation of the Laser Interstitial Thermal Therapy (LITT ), Under "Real Time" MRI Guidance, for the "Minimal Invasive" Treatment of Liver Metastasis - a Phase IIa Mono-centric Study, Without Direct Benefice to the Patient

summary: The purpose of this study is to determine if the, MR guided, laser interstitial thermal therapy (LITT) treatment technique can be safety and efficiently used for the human liver metastasis

lead_sponsor: BioTex, Inc.

lead_sponsor_type: industriel


title: MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II

acronym: MAINRITSAN 2

summary: The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.

ReferenceCitation: Charles P, Terrier B, Perrodeau É, Cohen P, Faguer S, Huart A, Hamidou M, Agard C, Bonnotte B, Samson M, Karras A, Jourde-Chiche N, Lifermann F, Gobert P, Hanrotel-Saliou C, Godmer P, Martin-Silva N, Pugnet G, Matignon M, Aumaitre O, Viallard JF, Maurier F, Meaux-Ruault N, Rivière S, Sibilia J, Puéchal X, Ravaud P, Mouthon L, Guillevin L; French Vasculitis Study Group. Comparison of individually tailored versus fixed-schedule rituximab regimen to maintain ANCA-associated vasculitis remission: results of a multicentre, randomised controlled, phase III trial (MAINRITSAN2). Ann Rheum Dis. 2018 Aug;77(8):1143-1149. doi: 10.1136/annrheumdis-2017-212878. Epub 2018 Apr 25. Erratum in: Ann Rheum Dis. 2019 Sep;78(9):e101.

family: Charles

full_name: Pierre Charles

given: Pierre

family: Terrier

full_name: Benjamin Terrier

given: Benjamin

family: Perrodeau

full_name: Élodie Perrodeau

given: Élodie

family: Cohen

full_name: Pascal Cohen

given: Pascal

family: Faguer

full_name: Stanislas Faguer

given: Stanislas

family: Huart

full_name: Antoine Huart

given: Antoine

family: Hamidou

full_name: Mohamed Hamidou

given: Mohamed

family: Agard

full_name: Christian Agard

given: Christian

family: Bonnotte

full_name: Bernard Bonnotte

given: Bernard

family: Samson

full_name: Maxime Samson

given: Maxime

family: Karras

full_name: Alexandre Karras

given: Alexandre

family: Jourde-Chiche

full_name: Noémie Jourde-Chiche

given: Noémie

family: Lifermann

full_name: François Lifermann

given: François

family: Gobert

full_name: Pierre Gobert

family: Hanrotel-Saliou

full_name: Catherine Hanrotel-Saliou

given: Catherine

family: Godmer

full_name: Pascal Godmer

family: Martin-Silva

full_name: Nicolas Martin-Silva

family: Pugnet

full_name: Grégory Pugnet

given: Grégory

family: Matignon

full_name: Marie Matignon

given: Marie

family: Aumaitre

full_name: Olivier Aumaitre

given: Olivier

family: Viallard

full_name: Jean-François Viallard

given: Jean-François

family: Maurier

full_name: François Maurier

family: Meaux-Ruault

full_name: Nadine Meaux-Ruault


acronym: AUTOHYPNOSE-TP

summary:
Patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.

The study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.

status: Terminated

primary_purpose: Supportive Care

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Pathophysiological Mechanisms of Fibromuscular Dysplasia

acronym: MeDyA

summary: Fibromuscular dysplasia is an non inflammatory non atherosclerotic obstructive arterial disease affecting mid-size arteries. It is considered as a rare vascular disease of unknown origin. Fibromuscular dysplasia may become symptomatic depending on location and severity of narrowing of the arterial lumen. for example,when a stenosis develops within a renal artery, arterial hypertension may develop. The cause of fibromuscular dysplasia is unknown. Several factors have been suggested to be associated with it: tobacco abuse or oestrogens. In order to progress into identifying possible causative mechanisms of the disease, we design a pathophysiology study destined to assess endothelial function in patients with fibromuscular dysplasia and to identify possible plasmatic biomarkers of the disease.

ReferenceCitation: Bruno RM, Marais L, Khettab H, Lorthioir A, Frank M, Jeunemaitre X, Laurent S, Boutouyrie P, Azizi M. Deep Vascular Phenotyping in Patients With Renal Multifocal Fibromuscular Dysplasia. Hypertension. 2019 Feb;73(2):371-378. doi: 10.1161/HYPERTENSIONAHA.118.12189.

name: From the Department of Clinical and Experimental Medicine, University of Pisa, Italy (R.M.B.)

name: INSERM U970, Paris Cardiovascular Research Center (PARCC), France (R.M.B., L.M., X.J., S.L., P.B.)

family: Bruno

full_name: Rosa Maria Bruno

given: Rosa Maria

family: Marais

full_name: Louise Marais

given: Louise

name: APHP, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France (H.K., A.L., M.F., X.J., S.L., P.B., M.A.)

family: Khettab

full_name: Hakim Khettab

given: Hakim

family: Lorthioir

full_name: Aurélien Lorthioir

given: Aurélien

family: Frank

full_name: Michael Frank

given: Michael

family: Jeunemaitre

full_name: Xavier Jeunemaitre

given: Xavier

name: Department of Pharmacology, Paris Descartes University, France (S.L., P.B., M.A.)

family: Laurent

full_name: Stéphane Laurent

given: Stéphane

family: Boutouyrie

full_name: Pierre Boutouyrie

given: Pierre

family: Azizi

full_name: Michel Azizi

given: Michel

journal_name: Hypertension

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Phase II, Multicenter, Open Label, Prospective to Evaluate Efficacy and Tolerance of a Chemoimmunotherapy With HyperCVAD or Vincristine/Dexamethasone Plus the Anti-CD22 Monovlonal Antobody Epratuzumab for the Treatment of Adult Relapsed/Refractory CD22+ B-Acute Lymphoblastic Leukaemia Patients : CHEPRALL Study, a GRAALL Study.

acronym: CHEPRALL

summary:
Patients with relapsed/refractory adult acute lymphoblastic leukemia (ALL)have a very dismal prognosis. In this case, allogeneic transplantation is the only curative treatment when patient have obtained a second complete remission (CR. In France, in patients younger than 60 years old,the HyperCVAD regimen used by the MDAnderson in Houston is generally applied. In older patients (>=60 years)or young patients <= 60 years no eligible for intense chemotherapy, a combination of vincristine + Dexamethasone is generally chosen in order to avoid too much toxicity but the result is worse in term of CR.

More than 90% of ALL with a B phenotype (2/3 of cases in adults)express the surface antigen CD22 on leukemic blasts which thus represents an interesting target for therapy. Epratuzumab is a humanized anti-CD22 antibody produced by Immunomedics, Inc, Morris Plain (New Jersey, USA). Epratuzumab has already shown efficacy in lymphoma patients. Only one study, including 15 children, has been published so far reporting the efficacy and the toxicity of Epratuzumab in the setting of ALL in monotherapy, one can observe 8 stable disease, 3 progressions and 4 partial responses. When combining chemotherapy and Epratuzumab, 9CR were observed with acceptable toxicity. Tolerance was acceptable.

The French GRAALL group proposes to test an age-adapted combination of chemotherapy + Epratuzumab, in refractory/relapses CD22+ B ALL patients in order to improve their prognosis, in term of CR, survival and of number of patients eligible for allograft.

lead_sponsor: Nantes University Hospital

location_facility:
Purpan Hospital
Edouard Herriot Hospital
HEnri Mondor Hospital
Haut-Leveque Hospital
University Hospital
CHU de Poitiers
Institut Paoli Calmette
Saint Louis Hospital
Angers University Hospital
Nantes University Hospital
St Antoine


title: A Randomized, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)

summary: This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end of treatment, patients with a confirmed complete response, partial response or stable disease will be followed for up to 2 years to assess time to disease progression. Approximately 80 patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the following European countries: France, Germany, Poland, Sweden and the United Kingdom.

lead_sponsor: Cephalon

location_country:
Sweden
France
Poland
Germany
United Kingdom

location_facility: Hematologisektionen Medicincentrum Akademiska sjukhuset

location_facility: Hematologkliniken Karolinska Universitetssjukhuset, Huddinge

location_facility: Samodzielny Publiczny Szpital Kliniczny AM Klinika Hematologii

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Akademickie Centrum Kliniczne Akdemii Medycznej w Gdansku Klinika Hematologii

location_facility: Uniwersytet Jagiellonski Collegium Medicum Katedra i Klinika Hematologii

location_facility: Leeds General Infirmary Department of Haematology

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Hematologii Instytutu Medycyny Wewnetrznej Uniwersytetu Medycznego w Lodzi

location_facility: Centrum för Hematologi Karolinska Universitetssjukhuset, Solna

location_facility: Service maladies du sang CHRU- rue Michel Polonovski

location_facility: Prywatna Praktyka Lekarska z Osrodkiem Badan Klinicznych Prof. L. Szczepanskiego

location_facility: Royal Bournemouth Hospital Dept. of Haematology

location_facility: Chef du Service d'Hematologie Clinique CHU Clemenceau

location_facility: Stobhill Hospital Department of Haematology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Cardiff and Vale NHS Trust University Hospital of Wales

location_facility: Medizinische Poliklinik der Universität Hämatologie/Onkologie

location_facility: Charité - Benjamin Franklin Medizinische Klinik III Hämatologie, Onkologie und Transfusionsmedizin

location_facility: Leicester Royal Infirmary Department of Oncology & Haematology

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Katedra i Klinika Hematologii Onkologii i Chorob Wewnetrznych AM


title: Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma

acronym: MYOCET

summary:
The purpose of this study is to determine the toxicity and tolerance of Myocet® in children and adolescents with refractory or relapsed malignant glioma, with a dose diminished of 20% of the dose recommended for adults and a dose recommended for adults, administered in single dose in 1-hour perfusion each 21 days.

Other purposes are to determine the recommended dose of Myocet and to assess the response to drug. Pharmacokinetics of doxorubicin (free and encapsulated forms) and its metabolite doxorubicinol during 72 hours after Myocet administration will also be studied.

location_facility: Unité d'Hémato-Oncologie, CHU, Hôpital des enfants


title: Distal Phalangeal Bone Involvement Observed by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) in Patients With Nail Psoriasis

acronym: PSUPSO

summary:
Nearly 30% of patients with cutaneous psoriasis (PsO) developed psoriatic arthritis (PsA). Among these patients 20 % will have severe destructive arthritis. The risk of developing PsA is significantly higher in patients with nail involvement (OR = 2.24; 95% CI [1.26-3.98]). The risk is particularly high for the peripheral form of PsA and onycholysis (OR=2.80; 95% CI [1.34-5.85]).

Thus the investigators wanted to test the hypothesis that onycholysis, in patients without PsA, is a potential clinical marker of subclinical distal enthesopathy and, by extension, of bone micro-structural alterations.

Patients and Methods

The investigators will recruit 4 groups of subjects:

Patients with peripheral PsA,
Patients with psoriatic nail onycholysis,
Patients with PsO only
Healthy match control subjects. The investigators will assess the presence of enthesopathy by ultrasonography and bone structural damages (by HR-pQCT) in all subjects at baseline and 4 years.

ReferenceCitation: Villani AP, Boutroy S, Coutisson C, Carlier MC, Barets L, Marotte H, Richert B, Chapurlat RD, Jullien D, Confavreux CB. Distal phalangeal bone erosions observed by HR-pQCT in patients with psoriatic onycholysis. Rheumatology (Oxford). 2021 Mar 2;60(3):1176-1184. doi: 10.1093/rheumatology/keaa415.

name: Hospices Civils de Lyon, Service de Dermatologie – Hôpital Edouard Herriot, Lyon, France

name: Université Claude Bernard Lyon I, Lyon, France

name: Groupe Ongle de la Société Française de Dermatologie, Paris, France

family: Villani

full_name: Axel P Villani

given: Axel P

family: Boutroy

full_name: Stéphanie Boutroy

given: Stéphanie

family: Coutisson

full_name: Céline Coutisson

given: Céline

name: Département de Biochimie, Hospices Civils de Lyon, Lyon, France

family: Carlier

full_name: Marie-Christine Carlier

given: Marie-Christine

name: Hospices Civils de Lyon, Service de Rhumatologie – Hôpital Edouard Herriot, Lyon, France

family: Barets

full_name: Loïs Barets

given: Loïs

name: SAINBIOSE INSERM 1059, Université de Lyon, Saint Etienne, France

name: Service de Rhumatologie, Centre Hospitalo-Universitaire de Saint-Etienne, Saint-Etienne, France

family: Marotte

full_name: Hubert Marotte

given: Hubert

name: Département de Dermatologie – CHU Brugmann – St Pierre et Reine Fabiola, Université Libre de Bruxelles, Bruxelles, Belgique

family: Richert

full_name: Bertrand Richert

given: Bertrand

family: Chapurlat

full_name: Roland D Chapurlat

given: Roland D

family: Jullien

full_name: Denis Jullien

given: Denis

name: Hospices Civils de Lyon, Service de Rhumatologie – Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

family: Confavreux

full_name: Cyrille B Confavreux

given: Cyrille B

journal_name: Rheumatology

oa_host_type: repository

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

location_facility: Centre des Métastases Osseuses (CEMOS) Pavillon F - Rhumatology Hôpital Edouard Herriot, 5 place d'Arsonval

intervention_type: Radiation


title: HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis

summary: Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

ReferenceCitation: Seror R, Baron G, Hachulla E, Debandt M, Larroche C, Puéchal X, Maurier F, de Wazieres B, Quéméneur T, Ravaud P, Mariette X. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis. 2014 Dec;73(12):2074-81. doi: 10.1136/annrheumdis-2013-203586. Epub 2013 Jul 29.

family: Seror

full_name: Raphaèle Seror

given: Raphaèle

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Hachulla

full_name: Eric Hachulla

given: Eric

family: Debandt

full_name: Michel Debandt

family: Larroche

full_name: Claire Larroche

given: Claire

family: Puéchal

full_name: Xavier Puéchal

family: Maurier

full_name: François Maurier

given: François

family: de Wazieres

full_name: Benoît de Wazieres

given: Benoît

family: Quéméneur

full_name: Thomas Quéméneur

given: Thomas

family: Ravaud

full_name: Philippe Ravaud

given: Philippe

family: Mariette

full_name: Xavier Mariette

journal_name: Annals of the Rheumatic Diseases


title: Vaccine Attitudes and Practices of Hospital Specialists

acronym: SPECIVAC

summary: This study aims to evaluate the perceptions and knowledge of hospital specialists regarding vaccine recommendations targeting their patients, to study their behavior with respect to these recommendations and to quantify their vaccine hesitancy.

time_perspective: Cross-Sectional

location_facility: Service d'Hygiène, Epidémiologie et Prévention, Groupement Hospitalier Edouard Herriot et Unité de recherche clinique ne Immunologie du centre hospitalier Lyon Sud

intervention_type: Behavioral


title: Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

acronym: PNEUMO-VITA-C

summary: Pneumonia is the second common infection and its risk increases for elderly. In this population, it is the first cause of mortality by infections, and source of many complications. Geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. It is well known that vitamin C is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin C, and for one of those studies it was noted a significant reduction of mortality. The main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.

lead_sponsor: University Hospital, Bordeaux


title: Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance

acronym: RACINE

summary: Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.

location_facility: Departement of Radiology, Hopital Europeen Georges Pompidou,


title: Pharmacological Postconditioning During the Aortic Valvular Surgery

acronym: PC Pharma CVA

summary: Primary objective: To evaluate the efficacy of the cyclosporin A administration to induce a cardioprotection during the valvular surgery.

ReferenceType: result

ReferenceCitation: Chiari P, Angoulvant D, Mewton N, Desebbe O, Obadia JF, Robin J, Farhat F, Jegaden O, Bastien O, Lehot JJ, Ovize M. Cyclosporine protects the heart during aortic valve surgery. Anesthesiology. 2014 Aug;121(2):232-8. doi: 10.1097/ALN.0000000000000331.

name: From the Department of Anesthesiology and Critical Care (P.C., O.D., O.B., J.-J.L.), Clinical Investigation Center (N.M., M.O.), Department of Cardiology (N.M., M.O.), and Department of Cardiothoracic Surgery (J.-F.O., J.R., F.F., O.J.), Centre Hospitalier Universitaire Louis Pradel, Lyon, France; Lyon University, Inserm U1060, CarMeN Laboratory, Univ Lyon-1, Lyon, France (P.C., N.M., J.-F.O., O.

family: Chiari

full_name: Pascal Chiari

given: Pascal

family: Angoulvant

full_name: Denis Angoulvant

family: Mewton

full_name: Nathan Mewton

given: Nathan

family: Desebbe

full_name: Olivier Desebbe

given: Olivier

family: Obadia

full_name: Jean-François Obadia

given: Jean-François

family: Robin

full_name: Jacques Robin

given: Jacques

family: Farhat

full_name: Fadi Farhat

given: Fadi

family: Jegaden

full_name: Olivier Jegaden

family: Bastien

full_name: Olivier Bastien

family: Lehot

full_name: Jean-Jacques Lehot

given: Jean-Jacques

family: Ovize

full_name: Michel Ovize

given: Michel

journal_name: Anesthesiology

title: Cyclosporine Protects the Heart during Aortic Valve Surgery


title: Liver Transplantation in Patients With Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Coinfection ANRS HC08 Thevic

summary: To show the feasibility of liver transplantation in HCV-HIV coinfected patients. To study the two-year survival after transplantation, the interaction between HCV and HIV after transplantation, the influence of HIV on HCV recurrence after transplantation, the interaction between immunosuppressive and antiretroviral drugs in particular anti-proteases, immunological follow-up and quality of life of these patients

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Centre hepato biliaire hopital paul Brousse


title: Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients: a Multicenter Randomized, Double-blind Study. The ALDOCURE Trial

acronym: ALDOCURE

summary:
Study hypothesis : Pre-operative aldosterone receptor blockade may reduce post-operative atrial fibrillation (POAF) occurrence within 5 days after coronary artery bypass graft surgery (CABG) ± aortic valve replacement (AVR) without any heart failure or any mitral surgery.

Primary efficacy criterion : occurrence of POAF occurring from randomization and within 5 days after surgery, assess, in a standardized manner, by continuous ECG monitoring (during the ICU stay) or Holter-ECG monitoring (during the stepdown unit stay).

Primary objective: To establish whether pre-operative administration of spironolactone leads to a reduction in POAF incidence occurring from randomization and within 5 days after surgery, compared with placebo, in patients referred for on-pump elective CABG surgery ± AVR without heart failure.

Study design : Phase III drug trial - Randomized, double blind, multicentre, prospective study.

ReferenceCitation: Alexandre J, Ollitrault P, Fischer MO, Fellahi JL, Rozec B, Cholley B, Dolladille C, Chequel M, Allouche S, Legallois D, Saplacan V, Buklas D, Beygui F, Parienti JJ, Milliez P. Spironolactone and perioperative atrial fibrillation occurrence in cardiac surgery patients: Rationale and design of the ALDOCURE trial. Am Heart J. 2019 Aug;214:88-96. doi: 10.1016/j.ahj.2019.04.023. Epub 2019 May 9.

family: Alexandre

full_name: Joachim Alexandre

given: Joachim

family: Ollitrault

full_name: Pierre Ollitrault

given: Pierre

family: Fischer

full_name: Marc-Olivier Fischer

given: Marc-Olivier

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

family: Rozec

full_name: Bertrand Rozec

given: Bertrand

family: Cholley

full_name: Bernard Cholley

given: Bernard

family: Dolladille

full_name: Charles Dolladille

given: Charles

family: Chequel

full_name: Mathieu Chequel

given: Mathieu

family: Allouche

full_name: Stéphane Allouche

given: Stéphane

family: Legallois

full_name: Damien Legallois

given: Damien

family: Saplacan

full_name: Vladimir Saplacan

given: Vladimir

family: Buklas

full_name: Dimitrios Buklas

given: Dimitrios

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Parienti

full_name: Jean-Jacques Parienti

family: Milliez

full_name: Paul Milliez

given: Paul

journal_name: American Heart Journal

evidence: open (author manuscript)

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: Undecided

lead_sponsor: University Hospital, Caen

location_facility:
CHU Caen
Gaillard


title: Evaluation of the Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations of Poor Prognosis

acronym: RAPAMALYMPH

summary:
To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.

The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.

status: Recruiting

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Jeanne de Flandres, CHU
Hu Robert Debre Aphp - Paris

status_simplified: Ongoing


title: Effect Of The System In The Enriched Fat Metabolism Of The Child Reached Mitochondrial Cytopathy

acronym: MITOX

summary:
The aim of the present study is to compare Resting Energy Expenditure (REE) between normal fat diet (NFD) as a control vs high fat diet (HFD) as a treatment in Mitochondrial cytopathies disorders ( MID's ) patients. Secondary objectives is to compare diet induced thermogenesis (DIT) and body composition between NFD vs HFD.

This study is a randomized cross-over study. Normal fat diet (ie 10 % proteins, 45 % lipids, 45 % carbohydrates) is the imposed diet at baseline, high fat diet (ie 10 % proteins, 30 % lipids, 60 % carbohydrates is used according to the cross-over design trial. Main evaluation criteria is REE and second evaluation criteria is DIT both measured by indirect calorimetry ). 36 included MID subjects will be included in this study. Main evaluation criteria and second evaluation criteria will be measured at baseline, 1 month, 2 month and 3 month.


title: Post-prandial Hypotension and Sleepiness in Parkinson's Disease and Other Synucleinopathies: the Model of an Oral Glucose Load

acronym: HYPOSOMNPARK

summary: Excessive daytime sleepiness (EDS) is observed in 30 to 50 % of patients with Parkinson's disease (PD) patients, Dementia with Lewy Bodies (DLB) and Multiple System Atrophy (MSA). It is a major complain and represents a socially relevant problem as unintended episodes of sleep can also occur while driving for example. Arterial hypotension is frequently observed in patients with PD, DLB and MSA and considered as a marker of autonomic failure. Sleepiness is known to occur preferentially when patients are having arterial hypotension whatever the cause (i.e. postprandial period, administration of hypotensive medication such as dopamine agonists). We hypothesize that arterial hypotension is associated with abnormal sleepiness. We have observed this association in an on-going epidemiological survey Hyperglycaemia induced by oral glucose load - a standardized model simulating food intake during a meal - provokes arterial hypotension in the majority of Parkinson's disease patients with dysautonomia. It can be hypothesised that sleep attacks in these patients could be mediated by this fall in blood pressure.

lead_sponsor: University Hospital, Toulouse

location_facility: UHToulouse UHBordeaux


title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

acronym: MEC ORL

summary: The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Effects of Inspiratory Muscle Training Combined With a Pulmonary Rehabilitation Program Versus a Program of Pulmonary Rehabilitation Alone on Dyspnea: a Randomized Trial

acronym: IMT

summary: The purpose of this study is to determinate whether inspiratory muscle training (IMT) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on Dyspnea in chronic obstructive pulmonary disease (COPD) subjects with a normal maximum inspiratory pressure (IP > 60 cmH2O).

lead_sponsor: University Hospital, Brest

location_facility:
Hospital of Morlaix
Brest University Hospital


title: What Should be the Best Physiotherapy Early After Stroke ?

acronym: AMOBES

summary: This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.

ReferenceCitation: Yelnik AP, Quintaine V, Andriantsifanetra C, Wannepain M, Reiner P, Marnef H, Evrard M, Meseguer E, Devailly JP, Lozano M, Lamy C, Colle F, Vicaut E; AMOBES Group. AMOBES (Active Mobility Very Early After Stroke): A Randomized Controlled Trial. Stroke. 2017 Feb;48(2):400-405. doi: 10.1161/STROKEAHA.116.014803. Epub 2016 Dec 22.

name: From the PRM Department, GH Lariboisière F. Widal, AP-HP, Paris Diderot University, UMR8257, Paris, France (A.P.Y., V.Q., C.A., M.W., H.M., M.E.); Neurological Department GH Lariboisière F. Widal, AP-HP, Paris Diderot University, Paris, France (P.R.); Department of Neurology and Stroke Centre (E.M.) and PRM Department (J.P.D., M.L.), GH Paris Nord Val de Seine, AP-HP, Paris Diderot University, Paris, France; Neurological Department (C.L.) and PRM Department (F.C.), Sainte Anne Hospital, Paris...

family: Yelnik

full_name: Alain P. Yelnik

given: Alain P.

family: Quintaine

full_name: Victorine Quintaine

given: Victorine

family: Andriantsifanetra

full_name: Cedric Andriantsifanetra

given: Cedric

family: Wannepain

full_name: Marie Wannepain

given: Marie

family: Reiner

full_name: Peggy Reiner

given: Peggy

family: Marnef

full_name: Hélène Marnef

given: Hélène

family: Evrard

full_name: Mathilde Evrard

given: Mathilde

family: Meseguer

full_name: Elena Meseguer

given: Elena

family: Devailly

full_name: Jean Pascal Devailly

given: Jean Pascal

family: Lozano

full_name: Monica Lozano

given: Monica

family: Lamy

full_name: Catherine Lamy

given: Catherine

family: Colle

full_name: Florence Colle

given: Florence

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Andriantsifanétra

full_name: Cédric Andriantsifanétra

given: Cédric

family: Barbi

full_name: Margaux Barbi

given: Margaux

family: Brans

full_name: Julien Brans

given: Julien

family: Chabriat

full_name: Hugues Chabriat

given: Hugues

family: Mawet

full_name: Jerome Mawet

given: Jerome

family: Wanepain

full_name: Marie Wanepain

family: Amarenco

full_name: Pierre Amarenco

family: Dien

full_name: Agnes Dien

given: Agnes

family: Ortega

full_name: Balma Ortega

given: Balma

family: Perez

full_name: Sylvia Perez

name: Paris Pitié-Salpétrière University Hospital

name: Créteil Henri Mondor University Hospital

name: Clinical Research Unit GHU Saint Louis-Lariboisière-Fernand Widal, AP-HP, Paris Diderot University

location_facility: Service de Neurologie - Hôpital Lariboisière


title: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study

acronym: POLLAIR

summary: Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hospices Civiles de Lyon
CHU Saint-Etienne


title: Prospective Follow-up of a Multicentric Cohort of Children With Prenatal Discovery of Mild Isolated Cerebral Ventriculomegaly. Evaluation at 2 and 5 Years.

summary:
Isolated uni or bilateral mild cerebral ventriculomegaly represents the most frequent "minor" cerebral anomalies discovered by antenatal echography. There are not French data making it possible to specify the incidence and the prevalence of this pathology and international data of the prevalence are very heterogeneous, going, according to the published series, of 1.48 to 22 per 1000 births.

The prognostic of ventriculomegaly remains dubious : the studies have small populations, are for the majority retrospectives with a short and often vague follow-up. The announced rate of after-effects varies between 0 and 48 %.

The objective of this study is to evaluate the neuropsychological development until the 5 years age of the children for whom a prenatally diagnosis of mild isolated ventriculomegaly was carried (absence of another cerebral or extra-cerebral anomaly in imagery and a negative aetiology). This prospective cohort will be compared with children for whom no neurological anomaly was prenatally detected.

The children diagnosed for an mild isolated cerebral ventriculomegaly will be identified by the investigators among medical files of the Centers of Prenatal Diagnosis (CPDPN) of the UH of Angers and the UH of Nantes. The patient inclusion will be done at the 2 years age after parental agreement, with a follow-up at 5 years. The control children will be included under the same conditions after having ensured of the normality of the echographies of 22 and 30 gestational weeks. The follow-up of these 2 cohorts will be based on the 2 years obligatory paediatric examination, and on the network "Naitre ensemble" set up in the Pays de la Loire Loire. In addition to the clinical routine examinations, standardized neuropsychological examinations will be done (Brunet Lezine Revised score at 2 years, NEPSY at 5 years and ASQ at 2 and 5 years).

This study will allow to compare the neuropsychological development at school age of the children diagnosed for a foetal mild, apparently isolated, cerebral ventriculomegaly from children not presenting any foetal anomaly, to evaluate the incidence of the mild isolated ventriculomegaly, to identify the predictive factors of the neuropsychological anomalies in the children diagnosed for ventriculomegaly and to compare (in the children diagnosed for ventriculomegaly), the neuropsychological development at the school age of the children having a ventricular atrium between 10 and 12 mm with those having a ventricular atrium between 12,1 and 15 mm.

This study will allow to define the neuropsychological morbidity of the foetal mild isolated cerebral ventriculomegaly and will allow to define the best clinical and educational follow up of these children and their family.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Nantes
UH of Angers


title: Evaluation of Two Protocols to Prevent the Acquisition of Methicillin-Resistant Staphylococcus Aureus in Intensive Care Units.

summary: Nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. According to the Center for Disease Control (USA), Staphylococcus aureus is responsible for approximately 10% of cases. In Europe, 79% of the S.aureus strains are resistant to methicillin, a routinely used antibiotic. Recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. Therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant S. Aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

ReferenceCitation: Chaix C, Durand-Zaleski I, Alberti C, Brun-Buisson C. Control of endemic methicillin-resistant Staphylococcus aureus: a cost-benefit analysis in an intensive care unit. JAMA. 1999 Nov 10;282(18):1745-51.

ReferenceCitation: Girou E, Pujade G, Legrand P, Cizeau F, Brun-Buisson C. Selective screening of carriers for control of methicillin-resistant Staphylococcus aureus (MRSA) in high-risk hospital areas with a high level of endemic MRSA. Clin Infect Dis. 1998 Sep;27(3):543-50.

ReferenceCitation: Camus C, Bellissant E, Sebille V, Perrotin D, Garo B, Legras A, Renault A, Le Corre P, Donnio PY, Gacouin A, Le Tulzo Y, Thomas R. Prevention of acquired infections in intubated patients with the combination of two decontamination regimens. Crit Care Med. 2005 Feb;33(2):307-14.

ReferenceCitation: Camus C, Bellissant E, Legras A, Renault A, Gacouin A, Lavoué S, Branger B, Donnio PY, le Corre P, Le Tulzo Y, Perrotin D, Thomas R. Randomized comparison of 2 protocols to prevent acquisition of methicillin-resistant Staphylococcus aureus: results of a 2-center study involving 500 patients. Infect Control Hosp Epidemiol. 2011 Nov;32(11):1064-72. doi: 10.1086/662180. Epub 2011 Sep 29.

family: Camus

full_name: Christophe Camus

given: Christophe

family: Bellissant

full_name: Eric Bellissant

family: Legras

full_name: Annick Legras

given: Annick

family: Renault

full_name: Alain Renault

given: Alain

family: Gacouin

full_name: Arnaud Gacouin

given: Arnaud

family: Lavoué

full_name: Sylvain Lavoué

given: Sylvain

family: Branger

full_name: Bernard Branger

given: Bernard

family: Donnio

full_name: Pierre-Yves Donnio

given: Pierre-Yves

family: Corre

full_name: Pascal le Corre

given: Pascal le

family: Tulzo

full_name: Yves Le Tulzo

given: Yves Le

family: Perrotin

full_name: Dominique Perrotin

given: Dominique

family: Thomas

full_name: Rémi Thomas

given: Rémi

journal_name: Infection Control & Hospital Epidemiology

publisher: Cambridge University Press (CUP)

publisher_dissemination: Cambridge University Press

publisher_group: Cambridge University Press

publisher_normalized: Cambridge University Press

title: Randomized Comparison of 2 Protocols to Prevent Acquisition of Methicillin-ResistantStaphylococcus aureus: Results of a 2-Center Study Involving 500 Patients

lead_sponsor: Rennes University Hospital

location_facility: Service de Réanimation Médicale - Hôpital Bretonneau

location_facility: Service de Maladies Infectieuses et Réanimation Médicale - Hôpital Pontchaillou


title: Cytochrome P450 2E1 and Iron Overload

summary: The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

location_facility: Unité d'Investigation Clinique - Hôpital Pontchaillou


title: Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients

acronym: ASAP

summary: Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.

lead_sponsor: MicroPort CRM


type: Registry Identifier

title: Pathogenic Study of Adult Immune Enteropathies

acronym: ENTEROPAH

summary: The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.

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

location_facility:
Hôpital Henri Mondor
Hôpital Saint Antoine
Hôpital Saint Louis
Hôpital Cochin
Hôpital Bicêtre
Hôpital Beaujon

intervention_type: Genetic


title: Study of the Agreement Between Two Methods of Measuring Brachial Systolic Pressure (SFATI or Auscultatory) in Pregnant Women With or Without Blood Pressure Disorders and Search for Markers of Arterial Stiffness in Pre-eclampsia.

acronym: SFATI GROPE

summary: The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method is an accurate means of measuring systolic blood pressure in pregnant women at a risk of pre-eclampsia. As the presence of arterial calcifications only changes the concordance between the SFATI method and the auscultatory reference method if calcifications are very severe, it should make it possible to identify, at an early stage, those women with a higher risk of developing pre-eclampsia. This is a transversal study with monocentric prospective recruitment to evaluate a non-CE (Conformité Européenne) -marked medical device in a diagnostic situation.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation de la COagulopathie et de la Dysfonction enDOthéliale Comme Facteur prédictif de la gravité de l'Infection Par SARS-CoV-2 / COVID-19

acronym: SARCODO

summary:
On 30 January 2020, WHO declared the SARS-CoV-2 outbreak as a public health emergency of international concern. Compared to SARS-CoV, which caused an outbreak of SARS in 2003, SARS-CoV-2 has a higher transmission capacity. Although the clinical manifestations of SARS-CoV-2 are dominated by respiratory symptoms, some patients have severe cardiovascular damage. In addition, patients with underlying cardiovascular disease may be at increased risk of death. Therefore, understanding the impairments caused by SARS-CoV-2 to the cardiovascular system and the underlying mechanisms is of the utmost importance.

Circulating endothelial cells (CECs) are generally considered markers of lesions and may be non-invasive markers of pulmonary vascular dysfunction during SARS-CoV-2 infection. Another marker of endothelial activation could be circulating extracellular vesicles. They could also be involved in the spread of the virus. Thus this project proposes to study different aspects of the diagnosis and pathophysiology of SARS-CoV-2. We propose to fully study activation state of coagulation and endothelium on a plasma and cellular side in patients diagnosed with SARS-CoV-2/COVID19. The different forms of the disease will be included: without lung disease, with a more or less severe lung disease, i.e. having evolved or not towards acute respiratory distress syndrome (ARDS). Extensive research of biomarkers will be compared to the detection of the virus in the respiratory tract as well as in the blood. This work will contribute to a better description of disease pathophysiology and should allow us to identify a patient profile in whom preventive or curative anticoagulant therapy could be considered.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Cochin


title: Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases

acronym: TRANSIMMUNOM

summary: The family of inflammatory/autoimmune systemic diseases (IAD) form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.

ReferenceCitation: Lorenzon R, Mariotti-Ferrandiz E, Aheng C, Ribet C, Toumi F, Pitoiset F, Chaara W, Derian N, Johanet C, Drakos I, Harris S, Amselem S, Berenbaum F, Benveniste O, Bodaghi B, Cacoub P, Grateau G, Amouyal C, Hartemann A, Saadoun D, Sellam J, Seksik P, Sokol H, Salem JE, Vicaut E, Six A, Rosenzwajg M, Bernard C, Klatzmann D. Clinical and multi-omics cross-phenotyping of patients with autoimmune and autoinflammatory diseases: the observational TRANSIMMUNOM protocol. BMJ Open. 2018 Aug 30;8(8):e021037. doi: 10.1136/bmjopen-2017-021037.

family: Lorenzon

full_name: Roberta Lorenzon

given: Roberta

family: Mariotti-Ferrandiz

full_name: Encarnita Mariotti-Ferrandiz

given: Encarnita

family: Aheng

full_name: Caroline Aheng

given: Caroline

family: Ribet

full_name: Claire Ribet

given: Claire

family: Toumi

full_name: Ferial Toumi

given: Ferial

family: Pitoiset

full_name: Fabien Pitoiset

given: Fabien

family: Chaara

full_name: Wahiba Chaara

given: Wahiba

family: Derian

full_name: Nicolas Derian

given: Nicolas

family: Johanet

full_name: Catherine Johanet

given: Catherine

family: Drakos

full_name: Iannis Drakos

given: Iannis

family: Harris

full_name: Sophie Harris

given: Sophie

family: Amselem

full_name: Serge Amselem

given: Serge

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

family: Benveniste

full_name: Olivier Benveniste

given: Olivier

family: Bodaghi

full_name: Bahram Bodaghi

given: Bahram

family: Cacoub

full_name: Patrice Cacoub

given: Patrice

family: Grateau

full_name: Gilles Grateau

given: Gilles

family: Amouyal

full_name: Chloe Amouyal

given: Chloe

family: Hartemann

full_name: Agnes Hartemann

family: Saadoun

full_name: David Saadoun

given: David

family: Sellam

full_name: Jeremie Sellam

given: Jeremie

family: Seksik

full_name: Philippe Seksik

given: Philippe

family: Sokol

full_name: Harry Sokol

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

location_facility: CIC Paris-Est, Hôpital PITIE SALPETRIERE


summary: The project aims to precisely quantify the postprandial amino acid utilization of egg proteins in vivo in humans, and also to assess their satiating power, in relation with nutrient postprandial waves and incretin secretions. For that purpose, 2 independent studies are conducted. The first one is realized using stable isotopes on 8 volunteers ingesting an egg test meal. The second one is a cross over design performed on 30 volunteers to compare the satiating effect of 2 equivalent snacks: whole eggs or cottage cheese.

primary_purpose: Basic Science

ReferenceCitation: Fromentin C, Tomé D, Nau F, Flet L, Luengo C, Azzout-Marniche D, Sanders P, Fromentin G, Gaudichon C. Dietary proteins contribute little to glucose production, even under optimal gluconeogenic conditions in healthy humans. Diabetes. 2013 May;62(5):1435-42. doi: 10.2337/db12-1208. Epub 2012 Dec 28.

family: Fromentin

full_name: C. Fromentin

given: C.

family: Tome

full_name: D. Tome

given: D.

family: Nau

full_name: F. Nau

given: F.

family: Flet

full_name: L. Flet

given: L.

family: Luengo

full_name: C. Luengo

family: Azzout-Marniche

full_name: D. Azzout-Marniche

family: Sanders

full_name: P. Sanders

given: P.

full_name: G. Fromentin

given: G.

family: Gaudichon

full_name: C. Gaudichon

journal_name: Diabetes

oa_colors: green other

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Dietary Proteins Contribute Little to Glucose Production, Even Under Optimal Gluconeogenic Conditions in Healthy Humans

lead_sponsor: Institut National de la Recherche Agronomique

location_facility:
Centre de recherche sur volontaires
Centre de recherche sur Volontaires

intervention_type: Dietary Supplement


title: Recherche de Marqueurs Pronostiques électro-physiologiques précoces Chez l'Aphasique après un Accident Vasculaire cérébral.APHA-TMS

acronym: APHA-TMS

summary: The purpose of this study is to study, among the aphasic person, if motor function ( studied by Motor Evoked Potentials) performed within the first 14 days after a stroke can predict a good recovery from aphasia 6 months of the initial episode.

primary_purpose: Other

ReferenceCitation: Dickey L, Kagan A, Lindsay MP, Fang J, Rowland A, Black S. Incidence and profile of inpatient stroke-induced aphasia in Ontario, Canada. Arch Phys Med Rehabil. 2010 Feb;91(2):196-202. doi: 10.1016/j.apmr.2009.09.020.

family: Dickey

full_name: Laura Dickey

given: Laura

family: Kagan

full_name: Aura Kagan

given: Aura

family: Lindsay

full_name: M. Patrice Lindsay

given: M. Patrice

family: Fang

full_name: Jiming Fang

given: Jiming

family: Rowland

full_name: Alexandra Rowland

given: Alexandra

family: Black

full_name: Sandra Black

given: Sandra

journal_name: Archives of Physical Medicine and Rehabilitation

title: Incidence and Profile of Inpatient Stroke-Induced Aphasia in Ontario, Canada

ReferenceCitation: El Hachioui, H., H. F. Lingsma, et al. (2013).

ReferenceCitation: Fadiga L, Craighero L, Buccino G, Rizzolatti G. Speech listening specifically modulates the excitability of tongue muscles: a TMS study. Eur J Neurosci. 2002 Jan;15(2):399-402.

ReferenceCitation: Meister IG, Wilson SM, Deblieck C, Wu AD, Iacoboni M. The essential role of premotor cortex in speech perception. Curr Biol. 2007 Oct 9;17(19):1692-6. Epub 2007 Sep 27.

ReferenceCitation: Meister IG, Sparing R, Foltys H, Gebert D, Huber W, Töpper R, Boroojerdi B. Functional connectivity between cortical hand motor and language areas during recovery from aphasia. J Neurol Sci. 2006 Sep 25;247(2):165-8. Epub 2006 Jun 5.

ReferenceCitation: Meister IG, Buelte D, Staedtgen M, Boroojerdi B, Sparing R. The dorsal premotor cortex orchestrates concurrent speech and fingertapping movements. Eur J Neurosci. 2009 May;29(10):2074-82. doi: 10.1111/j.1460-9568.2009.06729.x. Epub 2009 May 9.

family: Meister

full_name: Ingo G. Meister

given: Ingo G.

family: Buelte

full_name: Dorothee Buelte

given: Dorothee

family: Staedtgen

full_name: Mario Staedtgen

given: Mario

family: Boroojerdi

full_name: Babak Boroojerdi

given: Babak

family: Sparing

full_name: Roland Sparing

given: Roland

bso_classification: Biology (fond.)

journal_name: European Journal of Neuroscience

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Tokimura H, Tokimura Y, Oliviero A, Asakura T, Rothwell JC. Speech-induced changes in corticospinal excitability. Ann Neurol. 1996 Oct;40(4):628-34.


title: Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer

acronym: NANOCOL

summary:
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.

Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).

location_facility:
Gustave Roussy
Centre Hospitalier Lyon Sud


title: PReoperative Chemoradiation With Paclitaxel-carboplatin or With Fluorouracil-oxaliplatine-acide Folinique (FOLFOX) for Resectable Esophageal and Junctional Cancer - A Randomized Phase II Trial

acronym: PROTECT

summary:
Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy treatment is the FOLFOX. It is a combination of three drugs administered intravenously: fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.

Another protocol of chemotherapy is widely used by certain European and American teams, due to promising results : a combination of two drugs administered intravenously: Paclitaxel and Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one treatment over the other.

The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments.

status: Active, not recruiting

ReferenceCitation: Messager M, Mirabel X, Tresch E, Paumier A, Vendrely V, Dahan L, Glehen O, Vasseur F, Lacornerie T, Piessen G, El Hajbi F, Robb WB, Clisant S, Kramar A, Mariette C, Adenis A. Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial. BMC Cancer. 2016 May 18;16:318. doi: 10.1186/s12885-016-2335-9.

family: Messager

full_name: Mathieu Messager

given: Mathieu

family: Mirabel

full_name: Xavier Mirabel

given: Xavier

family: Tresch

full_name: Emmanuelle Tresch

given: Emmanuelle

family: Paumier

full_name: Amaury Paumier

given: Amaury

family: Vendrely

full_name: Véronique Vendrely

given: Véronique

family: Dahan

full_name: Laetitia Dahan

given: Laetitia

family: Glehen

full_name: Olivier Glehen

given: Olivier

family: Vasseur

full_name: Frederique Vasseur

given: Frederique

family: Lacornerie

full_name: Thomas Lacornerie

given: Thomas

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

family: El Hajbi

full_name: Farid El Hajbi

given: Farid

family: Robb

full_name: William B. Robb

given: William B.

family: Clisant

full_name: Stéphanie Clisant

given: Stéphanie

family: Kramar

full_name: Andrew Kramar

given: Andrew

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Adenis

full_name: Antoine Adenis

given: Antoine

journal_name: BMC Cancer

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

title: Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin—folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial

location_facility:
University Hospital of Lille
Centre Oscar Lambret


title: EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)

acronym: ICA-MEESSI

summary:
Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.

European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Comparison of Thoracolumbar Back Pain After Brace Treatment Versus Percutaneous Instrumentation in Adult Pyogenic Spondylodiscitis Combined With Antibiotic Treatment

acronym: COROSIVE

summary: Pyogenic spondylitis in adults is usually treated by antibiotics according to bacteria evidenced in a diagnostic intervertebral disc puncture. Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine. Percutaneous minimally invasive posterior spinal instrumentation has evolved over the last decade and indications in infections arouse over the last years. This procedure is interesting as it is performed through small skin incisions only. It avoids paravertebral muscle dissection and thus limits intraoperative bleeding and access morbidity. Recent retrospective data suggests that this internal fixation represents a theoretical advantage over brace treatment by lowering back pain and increasing patient's quality of life in the short run, up to 3 months, but no randomized study was published. The patient's autonomy, including walking ability and daily activities, might improve more rapidly after a percutaneous procedure. Additionally, the sagittal alignment of the thoracolumbar spine could be better maintained by internal fixation, which might prevent progression into kyphosis and improve long-term outcome. The hypothesis is the superiority of percutaneous minimally invasive instrumentation on brace treatment in term of quality of life, back pain and quality of osseous healing.

location_facility: CHU de Bordeaux - Hôpital Pellegrin - Unité d'orthopédie-traumatologie rachis I

location_facility: Hôpitaux Universitaires de Strasbourg - Service de chirurgie du rachis

location_facility: CHU Nice - Hôpital Pasteur 2 - Unité de Chirurgie Rachidienne

location_facility: Hôpital Beaujon - Service de Chirurgie Orthopédique et Traumatologie

location_facility: CHRU de Lille - Hôpital Roger-Salengro - Service de Neurochirurgie

location_facility: CHU Lyon - Hôpital Pierre Wertheimer - Service de Neurochirurgie C et chirurgie du rachis

location_facility: Hôpital Gui de Chauliac - Service de Neurochirurgie

location_facility: Hôpital Central - Service de Neurochirurgie

location_facility: CHU François Mitterand - Bocage central - Service de Neurochirurgie

location_facility: CHU Marseille - Hôpital Timone - Service de chirurgie orthopédique et traumatologique

location_facility: CHU Hôtel Dieu - Service de Neurotraumatologie

location_facility: Hôpital Pitié - Salpêtrière - Service de Chirurgie orthopédique

location_facility: CHU Reims - Hôpital Maison Blanche - Service de Neurochirurgie

location_facility: Hôpital européen Georges-Pompidou - Service d'Orthopédie/Traumotologie

location_facility: CHU Caremeau - Service d'orthopédie-traumatologie


title: Multicenter Randomized Two-arms Study Evaluating the BK Viral Clearance in Kidney Transplant Recipients With BK Viremia After Reduction of Immunosuppression Alone vs. Reduction of Immunosuppression and Replacement of Mycophenolate Mofetil by Everolimus

acronym: BK EVER

summary: BK virus nephropathy (BKVN), a consequence of the strong immunosuppressive therapy given after kidney transplantation, represents a growing problem in the kidney transplant (KT) setting. In recent cohorts, BKVN concerns up to 10% of kidney transplant recipients and early signs of BK virus (BKV) infection as development of asymptomatic viruria and viremia are even much more frequent (40% and 20% of patients, respectively). In this context, finding strategies to prevent BKV infection or treat patients before the occurrence of BKV nephropathy is challenging. For several years, detection of BKV replication by real-time PCR in urine and/or blood of kidney transplant recipients at early stages of infection allowed adaptation of their therapy. As BKV reactivates essentially in patients with over-immunosuppression, the first step of the treatment is the reduction of immunosuppression. However, reducing immunosuppression (IS) can lead to acute rejection and allograft loss. Other treatments have been proposed (cidofovir, quinolones) but their toxicity profile or their lack of clinical efficacy are now demonstrated. Hence, an efficient and safe strategy against uncontrolled BKV replication is urgently needed. MTor-inhibitors are well known immunosuppressive drugs used in organ transplantation to prevent graft-rejection. They have furthermore anti-viral effects that can be beneficial for prevention of viral infections after transplantation. Recent evidence that inhibition of mTor pathway had an impact on BK infected cells provides additional insight into the observed benefits associated with these drugs. The aim of our study is to evaluate the effect of the mTor inhibitor everolimus on the prevention of severe BKV infection (BKV nephropathy or loss of the allograft) after kidney transplantation compared to the reduction of immunosuppression alone in kidney recipients with BK viremia.

location_facility:
AP-HP - Hôpital Georges Pompidou
CHU - Hôpital de la Cavale Blanche
AP-HP Hôpital Necker
Les Hôpitaux Universitaires
CHU - Hôpital Sud
CHU Poitiers - Hôpital Jean Bernard
CHU - Hôpital Maison Blanche
CHU - Hôpital Dupuytren
CHU Rennes - Hôpital Pontchaillou
CHRU d'Angers
CHU Hôpital Gabriel Montpied
CHRU - Hôpital Bretonneau
CHU Côte de Nacre


title: Trenza Embolization Device for Intrasaccular Aneurysm Treatment

summary: The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.

lead_sponsor: Stryker Neurovascular


title: An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.

acronym: ALTO

summary: The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.

lead_sponsor: Stallergenes Greer


title: Effect of a Plant-based Ingredient on Generalized Hormonal Responses

summary: The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.

lead_sponsor: Unilever R&D


title: Evaluation of Standardized Management of Knee Arthritis Patients

acronym: ARTIST

summary: International recommendations (ACR,EULAR) emphasize physical exercise and weight loss for patients suffering from knee osteoarthritis. Nevertheless, number of patients receiving advices for these 2 points still low. This study evaluates the impact of a standardized medical intervention (patient education, weight reduction and physical exercise) in knee osteoarthritis patients.

primary_purpose: Educational/Counseling/Training

ReferenceCitation: Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000 Sep;43(9):1905-15.

ReferenceCitation: Messier SP, Gutekunst DJ, Davis C, DeVita P. Weight loss reduces knee-joint loads in overweight and obese older adults with knee osteoarthritis. Arthritis Rheum. 2005 Jul;52(7):2026-32.

ReferenceCitation: Ravaud P, Flipo RM, Boutron I, Roy C, Mahmoudi A, Giraudeau B, Pham T. ARTIST (osteoarthritis intervention standardized) study of standardised consultation versus usual care for patients with osteoarthritis of the knee in primary care in France: pragmatic randomised controlled trial. BMJ. 2009 Feb 23;338:b421. doi: 10.1136/bmj.b421.

family: Ravaud

full_name: P Ravaud

given: P

family: Flipo

full_name: R-M Flipo

given: R-M

family: Boutron

full_name: I Boutron

given: I

family: Roy

full_name: C Roy

given: C

family: Mahmoudi

full_name: A Mahmoudi

given: A

family: Giraudeau

full_name: B Giraudeau

given: B

family: Pham

full_name: T Pham

given: T

journal_name: BMJ

oa_colors: green hybrid

lead_sponsor: Almirall, SAS


title: Multicenter Randomized Study Comparing Morbidity and Quality of Life Associated in the Treatment by Surgical Resection and the Conservative Treatment, After Favorable Evolution of Purulent Peritonitis That Originates From Diverticulitis Treated by Mini-invasive Surgery.

acronym: SIGMOIDITE

summary:
Sigmoid diverticular diseases is a pathologie frequent in patients above 60 years old. A person with diverticulosis may have few or no symptoms. When a diverticulum ruptures and infection sets in around the diverticulum the condition is called diverticulitis. An individual suffering from diverticulitis may have abdominal pain, abdominal tenderness, and fever. Bleeding originates from a diverticulum, it is called diverticular bleeding. Frequent hospitalisations as a result of the evolution of purulent peritonitis that originates from diverticulitis treated by mini-invasive surgery results.

Radiological percutaneous drainage and washing of the abdominal cavity during laparoscopic generalized purulent peritonitis of diverticular origin have been identified as therapeutic options by HAS (French health authorities), followed by second stage resection-anastomosis under elective surgery. It has been observed in patients that if only drainage and washing are performed (without resection), then the morbidity (10%) and mortality (1.5%) rates are much lower than usual rates (after resection) respectively 20-40% and 10-30%. Furthermore this reduces the risks of postoperatory complications.

Some studies have shown that the attitude of non-distance resection of the acute episode was associated with a recurrence rate of diverticulitis less than 5% recurrence without gravity. In addition, the morbidity associated with intervention sigmoid resection is around 30%.

The question arises in our daily practice, or not to propose systematic resection of sigmoid diverticulitis after an acute episode of severe purulent peritonitis or abscess types supported initially by minimally invasive.

The primary objective of the study is to determine, after clinical improvement linked to conservative treatment of perforated diverticulitis Hinchey peritonitis stage II and III, if a conservative approach reduces morbidity compared with a cold sigmoid resection attitude as currently recommended.

The secondary objective of the study is to determine if conservative treatment reduces mortality, length of hospital stay compared with cumulative sigmoid diverticular disease and improves quality of life.

location_facility: Chirurgie générale et digestive,Hôpital de Hautepierre,

location_facility: Chirurgie digestive et hépato-bibliaire,Hôpital Pitié Salpêtrière

location_facility: Service de chirurgie digestiveCentre Hospitalier Bretagne Sud

location_facility: Centre Hospitalier Bretagne Atlantique, 20 bd du général Guillaudot,

location_facility: Clinique Universitaire de Chirurgie Digestive et de l'Urgence

location_facility: Chirurgie Digestive, Centre Hospitalier Emile Muller, 20, avenue de Dr R Laennec

location_facility: Chirurgie Générale et Digestive, CHU RANGUEIL Avenue Jean Poulhes 31054

location_facility: Unité clinique de chirurgie digestive, Hopital Lariboisière, 2 rue Ambroise Paré

location_facility: Chirurgie digestive, Hôpital Louis Mourier APHP, 178 rue des renouillers

location_facility: Service de chirurgie digestive Hotel Dieu

location_facility: Chirurgie Générale et Digestive du Pr Fourtanier,Centre Hospitalier Universitaire

location_facility: chirurgie digestive et générale, Hôpital C Huriez Place de Verdun


title: Ultrasound-guided Median Nerve Block With Dextrose 5% Hydrodissection: Determination of the Minimal Effective Volume of Local Anesthetic

acronym: VMAL

summary:
Ultrasound guidance can reduce the required local anesthetic volume for successful peripheral nerve block.

The aim of the study is to determine the minimum volume of local anesthetic to achieve an ultrasound-guided median nerve block with a dextrose 5% hydrodissection approach.

lead_sponsor: Hopital Foch

location_facility:
Hopital privé de l'Ouest Parisien
Centre Hospitalier de la Côte Basque


title: Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments

summary:
The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.

In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Pilot Study Evaluating Maraviroc (Celsentri®)Intensification Benefit in HIV Infected Patients Presenting Insufficient Immune Restoration Despite Controlled Viral Load With Antiretroviral Treatment. ANRS 145 MARIMUNO

acronym: 145 MARIMUNO

summary:
This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4<350 cells/mL and CD4 earning <100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: French National Agency for Research on AIDS and Viral Hepatits


title: Impact of Beverage Consumption With Varying Sweetening Systems During Meal on Post-prandial Glucose and Insulin Concentrations, and Lipid Metabolism in Overweight and Obese Subjects

summary: The purpose of this clinical study is to investigate the effect of drinking a sugar-sweetened beverage along with a meal on insulin concentrations and, glucose and lipid metabolism, in overweight and obese subjects, during a 10-hour visit.

lead_sponsor: Danone Research


title: Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis

acronym: ROC

summary: Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice.

ReferenceCitation: Nguyen MVC, Courtier A, Adrait A, Defendi F, Couté Y, Baillet A, Guigue L, Gottenberg JE, Dumestre-Pérard C, Brun V, Gaudin P. Fetuin-A and thyroxin binding globulin predict rituximab response in rheumatoid arthritis patients with insufficient response to anti-TNFα. Clin Rheumatol. 2020 Sep;39(9):2553-2562. doi: 10.1007/s10067-020-05030-6. Epub 2020 Mar 24.

family: Nguyen

full_name: Minh Vu Chuong Nguyen

given: Minh Vu Chuong

family: Courtier

full_name: Anaïs Courtier

given: Anaïs

family: Adrait

full_name: Annie Adrait

given: Annie

family: Defendi

full_name: Federica Defendi

given: Federica

family: Couté

full_name: Yohann Couté

given: Yohann

family: Baillet

full_name: Athan Baillet

given: Athan

family: Guigue

full_name: Lisa Guigue

given: Lisa

family: Gottenberg

full_name: Jacques-Eric Gottenberg

given: Jacques-Eric

family: Dumestre-Pérard

full_name: Chantal Dumestre-Pérard

given: Chantal

family: Brun

full_name: Virginie Brun

given: Virginie

family: Gaudin

full_name: Philippe Gaudin

given: Philippe

journal_name: Clinical Rheumatology

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Virone A, Bastard JP, Fellahi S, Capeau J, Rouanet S, Sibilia J, Ravaud P, Berenbaum F, Gottenberg JE, Sellam J. Comparative effect of tumour necrosis factor inhibitors versus other biological agents on cardiovascular risk-associated biomarkers in patients with rheumatoid arthritis. RMD Open. 2019 Jul 21;5(2):e000897. doi: 10.1136/rmdopen-2019-000897. eCollection 2019.

family: Virone

full_name: Alexandre Virone

given: Alexandre

family: Bastard

full_name: Jean-Philippe Bastard

given: Jean-Philippe

family: Fellahi

full_name: Soraya Fellahi

given: Soraya

family: Capeau

full_name: Jacqueline Capeau

given: Jacqueline

family: Rouanet

full_name: Stéphanie Rouanet

family: Sibilia

full_name: Jean Sibilia

given: Jean

full_name: Philippe Ravaud

family: Berenbaum

full_name: Francis Berenbaum

given: Francis

family: Sellam

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

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

ReferenceCitation: Rivière E, Sellam J, Pascaud J, Ravaud P, Gottenberg JE, Mariette X. Serum IL-33 level is associated with auto-antibodies but not with clinical response to biologic agents in rheumatoid arthritis. Arthritis Res Ther. 2018 Jun 8;20(1):122. doi: 10.1186/s13075-018-1628-6.

ReferenceCitation: Gottenberg JE, Brocq O, Perdriger A, Lassoued S, Berthelot JM, Wendling D, Euller-Ziegler L, Soubrier M, Richez C, Fautrel B, Constantin AL, Mariette X, Morel J, Gilson M, Cormier G, Salmon JH, Rist S, Lioté F, Marotte H, Bonnet C, Marcelli C, Sellam J, Meyer O, Solau-Gervais E, Guis S, Ziza JM, Zarnitsky C, Chary-Valckenaere I, Vittecoq O, Saraux A, Pers YM, Gayraud M, Bolla G, Claudepierre P, Ardizzone M, Dernis E, Breban MA, Fain O, Balblanc JC, Aberkane O, Vazel M, Back C, Candon S, Chatenoud L, Perrodeau E, Sibilia J, Ravaud P. Non-TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug: A Randomized Clinical Trial. JAMA. 2016 Sep 20;316(11):1172-1180. doi: 10.1001/jama.2016.13512.

name: Department of Rheumatology, National Reference Center for Systemic Autoimmune Diseases, Strasbourg University Hospital, Université de Strasbourg, Strasbourg, France

name: Department of Rheumatology, Centre Hospitalier Princesse Grâce, Monaco

name: Department of Rheumatology, Rennes University Hospital, Rennes, France

name: Department of Rheumatology, Centre Hospitalier de Cahors, Cahors, France

name: Department of Rheumatology, Nantes University Hospital, Nantes, France

name: Department of Rheumatology, Besançon University Hospital, Besançon, France

name: Department of Rheumatology, Nice University Hospital, Nice, France

name: Department of Rheumatology, Clermont-Ferrand University Hospital, Clermont-Ferrand, France

name: Department of Rheumatology, Bordeaux University Hospital, Bordeaux, France

name: Department of Rheumatology, Hôpital La Pitié Salpétrière, Paris, France

name: Department of Rheumatology, Toulouse University Hospital, Toulouse, France

name: Department of Rheumatology, Hôpital Kremlin Bicêtre, Kremlin Bicêtre, France

name: Department of Rheumatology, Montpellier University Hospital, Montpellier, France

name: Department of Rheumatology, Grenoble University Hospital, Grenoble, France

name: Department of Rheumatology, Centre Hospitalier de La Roche Sur Yon, La Roche Sur Yon, France

name: Department of Rheumatology, Reims University Hospital, Reims, France

name: Department of Rheumatology, Centre Hospitalier d’Orléans, Orléans, France

name: Department of Rheumatology, Hôpital Lariboisière, Paris, France

name: Department of Rheumatology, Saint-Etienne University Hospital, Saint-Etienne, France

name: Department of Rheumatology, Limoges University Hospital, Limoges, France

name: Department of Rheumatology, Caen University Hospital, Caen France

name: Department of Rheumatology, Hôpital Saint-Antoine, Paris, France

name: Department of Rheumatology, Hôpital Bichat, Paris, France

name: Department of Rheumatology, Poitiers University Hospital, Poitiers, France

name: Department of Rheumatology, Marseille University Hospital, Marseille, France

name: Department of Rheumatology, Hôpital La Croix Saint Simon, Paris, France

name: Department of Rheumatology, Centre Hospitalier du Havre, Le Havre, France

name: Department of Rheumatology, Nancy University Hospital, Nancy, France

name: Department of Rheumatology, Rouen University Hospital, Rouen, France

name: Department of Rheumatology, Brest University Hospital, Brest, France

name: Department of Internal Medicine, Institut Montsouris, Paris, France

name: Department of Rheumatology, Centre Hospitalier de Cannes, Cannes, France

name: Department of Rheumatology, Hôpital Mondor, Créteil, France

name: Department of Rheumatology, Centre Hospitalier de Mulhouse, Mulhouse, France

name: Department of Rheumatology, Centre Hospitalier du Mans, Le Mans, France

name: Department of Rheumatology, Hôpital Ambroise Paré, Paris, France

name: Department of Internal Medicine, Hôpital Saint-Antoine, Paris, France

name: Department of Rheumatology, Centre Hospitalier de Belfort, Belfort, France

name: Department of Direction de la recherche clinique et de l’innovation, Strasbourg University Hospital, Strasbourg, France

name: Department of Immunology, Hôpital Necker, Paris, France

name: Department of Epidemiology and Biostatistics, Hotel Dieu, Paris, France

title: Non–TNF-Targeted Biologic vs a Second Anti-TNF Drug to Treat Rheumatoid Arthritis in Patients With Insufficient Response to a First Anti-TNF Drug

location_facility: Centre Hospitalier - Princesse Grâce de Monaco

location_facility: Groupe Hospitalier du Havre - Hôpital J.Monod

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier de Belfort-Montbéliard

location_facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source

location_facility: Groupe Hospitalier Diaconesses - Hôpital de la Croix Saint-Simon

location_facility: Centre Hospitalier de Mulhouse - Hôpital Emile Muller


title: Schnitzler Syndrome: Clinical Study, Physiopathological and Search for Genetic

summary: The Schnitzler syndrome is a rare entity characterized by an urticarial rash and recurrent fever in a patient with a monoclonal IgM component. Other frequent signs include joint, bone and muscle pain, enlarged spleen, liver and lymph nodes, increased blood sedimentation rate (BSR), elevated neutrophil count and abnormalities on bone morphologic investigations. In 2001, the investigators proposed criteria to diagnose this syndrome, which are currently admitted in the literature. The main complications of the Schnitzler syndrome are a difficult-to-control inflammatory anemia, AA-amyloidosis and malignant B lymphoproliferative disorders. About 15% of patients with a Schnitzler will eventually develop a lymphoproliferative disorder; thus this syndrome allows studying the relationship between lymphomagenesis and inflammation. By many aspects, the Schnitzler syndrome is reminiscent of auto-inflammatory syndromes. Though the term auto-inflammatory disease is as to yet restricted to diseases with Mendelian inheritance, some polygenic inflammatory diseases like for example Crohn's disease clearly involve pathogenetic pathways shared with the monogenic auto-inflammatory syndromes. The investigators stipulate that this could also be the case in the Schnitzler syndrome for the following reasons: (1) this is a recurrent fever of unknown cause; (2) the peculiar eruption, characterized pathologically by a neutrophilic infiltrate very similar to the one observed in the auto-inflammatory cryopyrinopathies (CINCA/NOMID syndrome, Muckle-Wells syndrome and familial cold-urticaria); the investigators recently individualized this particular eruption, significantly associated with systemic inflammatory disease, within the group of neutrophilic urticarias (Kieffer et al. Medicine, in press); (3) the occurrence of aseptic neutrophilic osteitis, very similar to the one reported in patients with Majeed syndrome, another auto-inflammatory syndrome; (4) a significant increase of neutrophil count, not otherwise explained; (5) a spectacular response to the IL-1 inhibitor, within hours after the first injection, similar to what is reported in the PAPA (pyogenic arthritis, pyoderma gangrenosum and acne) syndrome or the cryopyrinopathies, suggesting a direct pathogenic effect of IL-1.

location_country: Italy France

location_facility: Service de Rhumatologie Centre Hospitalier du Mans

location_facility: Service de Dermatologie Hôpital Saint Eloi 80 avenue A Fliche

location_facility: Service de médecine interne Hôpital Tenon4, rue de la Chine

location_facility: Unité de médecine interne Centre Hospitalier G. Renon

location_facility: Azienda Ospedaliero Universitaria Policlinico

location_facility: Centre Hospitalier Général Bd Yves du Manoir

location_facility: Clinica DermatologicaUnivesité de GênesVialle Benedetto

location_facility: Service de médecine interne-néphrologie Centre Hospitalier Valenciennes

location_facility: Service de dermatologieCHU GUERIN2 rue de la Milétrie

location_facility: Service médecine interne et thérapeutique Hôpital sainte marguerite

location_facility: Service d'immuno-hématologie Hôpital St-Louis 1 av Claude Vellefaux

location_facility: Service de DermatologieCHU Morvan5 avenue Foch

location_facility: Service de dermatologie CHU Hôtel Dieu1 place Alexis Ricordeau

location_facility: Service de Médecine Interne Hôpital Claude-Huriez


title: Claudication Evaluation During Rowing ExerciseS. Rehabilitation Arteritis of Lower Limbs by Rowing

acronym: CERES

summary: Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in arteriopathy when performing rowing on effort.

time_perspective: Retrospective


title: Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor

acronym: GLUCORRECTOR

summary:
Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years.

At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion.

Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group.

These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.

time_perspective: Other

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Hôpital NORD - Assistance Publique Hôpitaux de Marseille

location_facility: Clinique "Mucoviscidose" Presqu'île de Perharidy