title: Reduction of Spontaneous Prematurity: Impact of Antibiotic Treatment (Josamycin) in Case of Positive PCR for Ureaplasma Spp and/or Mycoplasma Hominis in Amniotic Fluid

acronym: PREMYC

summary: The purpose of this study is to test the effectiveness of an antibiotic treatment (Josamycin) in the case of positive PCR for Ureaplasma spp. and/or Mycoplasma hominis in the second quarter on the risk of premature birth.

ReferenceCitation: Kayem G, Doloy A, Schmitz T, Chitrit Y, Bouhanna P, Carbonne B, Jouannic JM, Mandelbrot L, Benachi A, Azria E, Maillard F, Fenollar F, Poyart C, Bebear C, Goffinet F. Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial. PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.

family: Kayem

full_name: Gilles Kayem

given: Gilles

family: Doloy

full_name: Alexandra Doloy

given: Alexandra

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

family: Chitrit

full_name: Yvon Chitrit

given: Yvon

family: Bouhanna

full_name: Philippe Bouhanna

given: Philippe

family: Carbonne

full_name: Bruno Carbonne

given: Bruno

family: Jouannic

full_name: Jean Marie Jouannic

given: Jean Marie

family: Mandelbrot

full_name: Laurent Mandelbrot

given: Laurent

family: Benachi

full_name: Alexandra Benachi

family: Azria

full_name: Elie Azria

given: Elie

family: Maillard

full_name: Francoise Maillard

given: Francoise

family: Fenollar

full_name: Florence Fenollar

given: Florence

family: Poyart

full_name: Claire Poyart

given: Claire

family: Bebear

full_name: Cécile Bebear

given: Cécile

family: Goffinet

full_name: François Goffinet

given: François

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

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

location_facility: Groupe Hospitalier Chenevier-Mondor, CHI


title: Acute STEMI Treated With Primary Angioplasty and Intravenous 0.5 mg/kg Lovenox or UFH to Lower Ischemic and Bleeding Events

acronym: ATOLL

summary: Randomized evaluation of enoxaparin (0.5mg/kg IV) versus UFH (50-70IU/kg with GPIIb/IIIa inhibitors; 70-100IU without GPIIb/IIIa inhibitors). Anticoagulation can be continued after the procedure using the same agents as those allocated per randomization (enoxaparin SC, UHF IV or SC)

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Montalescot G, Zeymer U, Silvain J, Boulanger B, Cohen M, Goldstein P, Ecollan P, Combes X, Huber K, Pollack C Jr, Bénezet JF, Stibbe O, Filippi E, Teiger E, Cayla G, Elhadad S, Adnet F, Chouihed T, Gallula S, Greffet A, Aout M, Collet JP, Vicaut E; ATOLL Investigators. Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial. Lancet. 2011 Aug 20;378(9792):693-703. doi: 10.1016/S0140-6736(11)60876-3.

family: Montalescot

full_name: Gilles Montalescot

sequence: first

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

sequence: additional

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Boulanger

full_name: Bertrand Boulanger

given: Bertrand

family: Cohen

full_name: Marc Cohen

given: Marc

family: Goldstein

full_name: Patrick Goldstein

given: Patrick

family: Ecollan

full_name: Patrick Ecollan

family: Combes

full_name: Xavier Combes

given: Xavier

family: Huber

full_name: Kurt Huber

given: Kurt

family: Pollack

full_name: Charles Pollack

given: Charles

suffix: Jr

family: Bénezet

full_name: Jean-François Bénezet

given: Jean-François

family: Stibbe

full_name: Olivier Stibbe

given: Olivier

family: Filippi

full_name: Emmanuelle Filippi

given: Emmanuelle

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Elhadad

full_name: Simon Elhadad

given: Simon

family: Adnet

full_name: Frédéric Adnet

given: Frédéric

family: Chouihed

full_name: Tahar Chouihed

given: Tahar

family: Gallula

full_name: Sébastien Gallula

given: Sébastien

family: Greffet

full_name: Agnès Greffet

given: Agnès

family: Aout

full_name: Mounir Aout

given: Mounir

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Vicaut

full_name: Eric Vicaut

given: Eric

ReferenceCitation: Silvain J, O'Connor SA, Yan Y, Kerneis M, Hauguel-Moreau M, Zeitouni M, Overtchouk P, Ankri A, Brugier D, Vicaut E, Ecollan P, Galier S, Collet JP, Montalescot G; ATOLL Investigators. Biomarkers of Thrombosis in ST-Segment Elevation Myocardial Infarction: A Substudy of the ATOLL Trial Comparing Enoxaparin Versus Unfractionated Heparin. Am J Cardiovasc Drugs. 2018 Dec;18(6):503-511. doi: 10.1007/s40256-018-0294-z.

journal_name: American Journal of Cardiovascular Drugs

location_facility: La Pitié-Salpétrière Hospital - Cardiology department


title: Determination of the Glycemic Index and the Insulinemic Index of a Sweetener

summary: The purpose of the study is to determine the glycemic index and the insulinemic index of a sweetener syrup

primary_purpose: Basic Science

lead_sponsor: Routin SA

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: LBP003: Characteristics of the Changes in the Cutaneous Immune System After Intradermal Antigen Injections

summary: The goal of the vaccination is to induce humoral (antibody) and intracellular (T lymphocyte) responses. Various data show that intradermal vaccination is more efficient than intramuscular vaccination: the humoral response is statistically better after intradermic vaccination, compared to intramuscular vaccination, even in target populations such as older subjects or immunosuppressed patients

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Hospices Civils de Lyon

intervention_type: Biological

lead_sponsor_type: academique

status_simplified: Unknown


title: COREV : A Multi-center, Randomized, Open-label Study Evaluating the Efficacy on Renal Function of Everolimus in Heart Transplant Recipients With Established Chronic Renal Failure

acronym: COREV

summary:
After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.

This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :

Renal function improvement
Vasculopathy and major cardiac event reduction
Maintenance of immunosuppressive efficacy

study_start_date_type: Actual

intervention_type: Drug


title: Prevention of Dehydration in Premature Babies Between 32 and 34+6 Gestational Age, Weighing Between 1700 and 2200 g, During the First Days of Life, Using Oral Rehydration Solution in Alternative to Intravenous Infusion

acronym: SROPREMA

summary: This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère

intervention_type: Procedure


title: Citrulline Supplementation in Elderly Malnourished and Hospitalised Subjects: Effects on Protein Metabolism

acronym: CIPROAGE

summary: The aim of this study is to evaluate the effects of a supplementation of citrulline for three weeks in elderly malnourished and hospitalised subjects on muscle protein synthesis.

ReferenceType: background

ReferenceCitation: Moinard C, Nicolis I, Neveux N, Darquy S, Bénazeth S, Cynober L. Dose-ranging effects of citrulline administration on plasma amino acids and hormonal patterns in healthy subjects: the Citrudose pharmacokinetic study. Br J Nutr. 2008 Apr;99(4):855-62. Epub 2007 Oct 22.

ReferenceCitation: Osowska S, Duchemann T, Walrand S, Paillard A, Boirie Y, Cynober L, Moinard C. Citrulline modulates muscle protein metabolism in old malnourished rats. Am J Physiol Endocrinol Metab. 2006 Sep;291(3):E582-6. Epub 2006 Apr 11.

intervention_type: Dietary Supplement


title: Analyse en médecine d'Urgence d'Une stratégie d'Utilisation combinée de Deux Marqueurs Biologiques Dans le Diagnostic de Syndrome Coronaire Aigu Non ST+: étude Des Performances de la Heart-Fatty Acid Binding Protein et de l' Ischemia Modified Albumin dès la première Heure de Prise en Charge

summary: Early diagnostic of non ST elevation coronary syndrome in patients admitted to the emergency room is difficult. Two news biochemical markers have been assessed and studies have suggested that heart fatty binding protein and ischemia modified albumin are early markers of myocardial necrosis and myocardial ischemia. The aim of the study is to analyse the predictive value of association of heart fatty binding protein and ischemia modified albumin for non ST segment elevation acute coronary syndrome diagnosis in the first hour of management in the emergency room.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Charpentier S, Maupas-Schwalm F, Cournot M, Elbaz M, Botella JM, Lauque D. Combination of copeptin and troponin assays to rapidly rule out non-ST elevation myocardial infarction in the emergency department. Acad Emerg Med. 2012 May;19(5):517-24. doi: 10.1111/j.1553-2712.2012.01350.x.

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Maupas-Schwalm

full_name: Françoise Maupas-Schwalm

given: Françoise

family: Cournot

full_name: Maxime Cournot

given: Maxime

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

family: Botella

full_name: Jean Marie Botella

given: Jean Marie

family: Lauque

full_name: Dominique Lauque

given: Dominique

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Academic Emergency Medicine

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Combination of Copeptin and Troponin Assays to Rapidly Rule Out Non-ST Elevation Myocardial Infarction in the Emergency Department

ReferenceCitation: Charpentier S, Cournot M, Lauque D, Girardi C, Bounes V, Elbaz M, Ducassé JL. Usefulness of initial glucose level to improve acute coronary syndrome diagnosis in the emergency department. Emerg Med J. 2011 Jul;28(7):564-8. doi: 10.1136/emj.2010.094284. Epub 2010 Jul 20.

full_name: S. Charpentier

given: S.

full_name: M. Cournot

given: M.

full_name: D. Lauque

given: D.

family: Girardi

full_name: C. Girardi

given: C.

family: Bounes

full_name: V. Bounes

given: V.

full_name: M. Elbaz

family: Ducasse

full_name: J. L. Ducasse

given: J. L.

journal_name: Emergency Medicine Journal

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Charpentier S, Ducassé JL, Cournot M, Maupas-Schwalm F, Elbaz M, Baixas C, Juchet H, Lang T, Lauque D. Clinical assessment of ischemia-modified albumin and heart fatty acid-binding protein in the early diagnosis of non-ST-elevation acute coronary syndrome in the emergency department. Acad Emerg Med. 2010 Jan;17(1):27-35. doi: 10.1111/j.1553-2712.2009.00614.x.

family: DucassÃ©

full_name: Jean Louis DucassÃ©

given: Jean Louis

full_name: FranÃ§oise Maupas-Schwalm

given: FranÃ§oise

title: Clinical Assessment of Ischemia-modified Albumin and Heart Fatty Acidâbinding Protein in the Early Diagnosis of Non-ST-elevation Acute Coronary Syndrome in the Emergency Department


title: Comparative Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control on the Gastric Lesions Induced by the Aspirin With the Low Dose Among Patients Treated With the Long Course

acronym: Aspylori

summary: Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not definite particularly in patients without history of ulcer and infected by H. pylori.The aim of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori infection but who have any history of ulcer.

status: Withdrawn


type: Other Identifier

type: Other Grant/Funding Number

type: EudraCT Number

title: Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases

acronym: MEDOR

summary:
RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

primary_purpose: Supportive Care

lead_sponsor: Institut Bergonié


title: Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes

summary: This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Novo Nordisk A/S


title: Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.

acronym: IROCHIM

summary: The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.


title: Descriptive, Cross-sectional and Prospective Epidemiology Study, on the Identification of Insulin-like Growth Factor-1 Status in Idiopathic Short Stature Children (EPIGROW Study)

acronym: EPIGROW

summary: The purpose of the protocol is to describe the distribution of IGF-1 deficiency in the studied population of Idiopathic Short Children without Growth Hormone Deficiency or any other identified cause of short stature and not treated with recombinant Growth Hormone or IGF-1

time_perspective: Cross-Sectional

lead_sponsor: Ipsen


title: Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography

acronym: EVASCAN

summary:
Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.


title: ComParative Diagnostic Study Between MSCT and Stress Echography in Patients Presenting With Suspected Acute Coronary Syndrome Without ST Segment Elevation.

acronym: PEPSI

summary: The aim of this study is to define the best prognostic strategy for patients presenting suspected acute CORONARY syndrome, between MSCT and stress echocardiography.


title: Physiopathological Study and Pharmacological Modulation of Cutaneous Atrophy's Markers Induced by Glucocorticoids

summary:
Methodology :Phase III study, single centre, double blind, versus excipient, randomised, controlateral design.

Selection of the patients :Number of subjects required 60 :

30 patients needing an oral corticotherapy
30 patients needing a topical corticotherapy

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_facility: Centre Hopitalier Universitaire de Toulouse


title: Health Economic Evaluation of Rapid Detection of Bacteraemia and Fungemia by Real Time PCR for Cases of Febrile Neutropenia, Suspicion of Endocarditis and Severe Sepsis in Intensive Care Units

acronym: EVAMICA

summary:
The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.

Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.

ReferenceCitation: Cambau E, Durand-Zaleski I, Bretagne S, Brun-Buisson C, Cordonnier C, Duval X, Herwegh S, Pottecher J, Courcol R, Bastuji-Garin S; EVAMICA study team. Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial. Intensive Care Med. 2017 Nov;43(11):1613-1625. doi: 10.1007/s00134-017-4766-4. Epub 2017 Apr 3.

family: Cambau

full_name: Emmanuelle Cambau

given: Emmanuelle

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Bretagne

full_name: Stéphane Bretagne

given: Stéphane

family: Brun-Buisson

full_name: Christian Brun-Buisson

given: Christian

family: Cordonnier

full_name: Catherine Cordonnier

given: Catherine

family: Duval

full_name: Xavier Duval

given: Xavier

family: Herwegh

full_name: Stéphanie Herwegh

given: Stéphanie

family: Pottecher

full_name: Julien Pottecher

given: Julien

family: Courcol

full_name: René Courcol

given: René

family: Bastuji-Garin

full_name: Sylvie Bastuji-Garin

given: Sylvie

journal_name: Intensive Care Medicine

oa_host_type: repository

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer


title: Prognostic Value of Negative Affectivity in Patients With Heart Failure

acronym: PANIC

summary: This prospective observational study is designed to confirm the prognostic and economic impact of depression in ambulatory patients with systolic or diastolic heart failure, to explore the impact of other psychosocial patterns such as type D personality, anxiety disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate potential pathophysiological and behavioral pathways.


title: Evaluation of Multidetector Raw Computerized Tomography in the Etiological Analysis of Acute Ischemic Stroke: the "COCASE" Protocol.

acronym: COCASE

summary: This is a prospective study including acute ischemic stroke patients aged 18 to 90. Multidetector raw CT is performed in acute ischemic stroke patients. Heart, neck vessels and brain arteries are studied during the same acquisition. Results are compared with the standard methods including transesophageal echocardiography (TEE), Doppler ultrasound (DUS) and MR angiography (MRA) of neck vessels. The main criteria is the ability of CT to classify the stroke etiology correctly according to the TOAST classification in comparison with the standard methods.

ReferenceCitation: Boussel L, Cakmak S, Wintermark M, Nighoghossian N, Loffroy R, Coulon P, Derex L, Cho TH, Douek PC. Ischemic stroke: etiologic work-up with multidetector CT of heart and extra- and intracranial arteries. Radiology. 2011 Jan;258(1):206-12. doi: 10.1148/radiol.10100804. Epub 2010 Nov 9.

family: Boussel

full_name: Loic Boussel

given: Loic

family: Cakmak

full_name: Serkan Cakmak

given: Serkan

family: Wintermark

full_name: Max Wintermark

given: Max

family: Nighoghossian

full_name: Norbert Nighoghossian

given: Norbert

family: Loffroy

full_name: Romaric Loffroy

given: Romaric

family: Coulon

full_name: Philippe Coulon

given: Philippe

family: Derex

full_name: Laurent Derex

given: Laurent

family: Cho

full_name: Tae Hee Cho

given: Tae Hee

family: Douek

full_name: Philippe C. Douek

given: Philippe C.

journal_name: Radiology

publisher: Radiological Society of North America (RSNA)

title: Ischemic Stroke: Etiologic Work-up with Multidetector CT of Heart and Extra- and Intracranial Arteries

intervention_type: Device


title: A Phase II Trial Evaluating the Safety and the Efficacy of High-Dose Imatinib in Relapsed/Refractory c-Kit Positive and BCR-Abl Negative AML Patients

summary: This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failure. Response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.

lead_sponsor: Nantes University Hospital


summary: We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.

primary_purpose: Prevention

lead_sponsor: Elvir SAS


title: Pharmacokinetics of Piperacillin and Tazobactam in Anuric Septic Patients Treated by Continuous Veno Venous Hemodiafiltration

acronym: PTCRRT

summary: The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

lead_sponsor: University Hospital, Toulouse


title: Immunoregulation of Periodontal Disease

summary: Our design is to test in hospital practice a selection of immune parameters that could assess the pathophysiology and progression of periodontal lesions.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hopital de la Conception- Laboratoire d'Immunologie


title: Ontogenesis of the P-glycoprotein in Human Lymphocytes: Influence of the Human Immunodeficiency Virus (HIV) and Antiretroviral Therapeutics

acronym: Onto-Pgp

summary: The P-glycoprotein (P-gp) is a membranous transporter that modulates the intracellular concentrations of many drugs and plays thus a major role in the efficacy of the therapeutics that act within the lymphocytes, such as antiretroviral drugs. We aim at studying the evolution of this transporter's expression and activity on lymphocytes in relation with the human development from newborns to adults. We also aim at studying the influence of HIV and antiretroviral treatments on this transporter, especially anti-protease drugs, within the children population.


title: Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route: Pilot Study

summary: The aim of this pilot study conducted in post-menopausal women is to evaluate the effect of 17ß-estradiol administration on inflammatory-immune cells, namely antigen-presenting cells (monocytes/dendritic cells), and more precisely on their activation by inflammatory stimuli. This study will allow us to determine our ability to recruit menopausal women and to characterize the optimal primary end-point among the numerous criteria tested

ReferenceCitation: Seillet C, Laffont S, Trémollières F, Rouquié N, Ribot C, Arnal JF, Douin-Echinard V, Gourdy P, Guéry JC. The TLR-mediated response of plasmacytoid dendritic cells is positively regulated by estradiol in vivo through cell-intrinsic estrogen receptor α signaling. Blood. 2012 Jan 12;119(2):454-64. doi: 10.1182/blood-2011-08-371831. Epub 2011 Nov 16.

name: Centre National de la Recherche Scientifique, U5282, Toulouse, France;

name: Université de Toulouse, Université Paul Sabatier, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France;

family: Seillet

full_name: Cyril Seillet

given: Cyril

family: Laffont

full_name: Sophie Laffont

given: Sophie

name: Inserm, U1048, Institut des Maladies Métaboliques et Cardiovasculaires, Toulouse, France;

name: Centre Hospitalier Universitaire, Toulouse, France; and

name: Centre de Ménopause, Hôpital Paule de Viguier, Toulouse, France

family: Trémollières

full_name: Florence Trémollières

given: Florence

family: Rouquié

full_name: Nelly Rouquié

given: Nelly

family: Ribot

full_name: Claude Ribot

given: Claude

family: Arnal

full_name: Jean-François Arnal

given: Jean-François

family: Douin-Echinard

full_name: Victorine Douin-Echinard

given: Victorine

family: Gourdy

full_name: Pierre Gourdy

given: Pierre

family: Guéry

full_name: Jean-Charles Guéry

given: Jean-Charles

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology


title: DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome

acronym: DAPREB

summary: The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is implanted to prevent sudden cardiac death. ICD are however associated with potential complications and are not available in all countries.Pharmacological blockade of specific ion channels (Ito) represents a promising therapeutic approach in this syndrome.The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.The aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility in Brugada patients requiring an electrophysiological study for arrhythmic risk stratification.

location_facility: Lariboisière University Hospital - Cardiology department


title: Observational Study on Efficacy on Glycaemic Control of Slow-acting Insulin Analogue in Type 2 Diabetes

acronym: LIGHT

summary: This study is conducted in Europe. The aim of this observational study is to describe the conditions for the concomitant administration of a slow-acting insulin analogue with oral antidiabetics (OADs) in order to improve blood glucose control in type 2 diabetes.

ReferenceCitation: Vergès B, Brun JM, Tawil C, Alexandre B, Kerlan V. Strategies for insulin initiation: insights from the French LIGHT observational study. Diabetes Metab Res Rev. 2012 Jan;28(1):97-105. doi: 10.1002/dmrr.1288.

family: Vergès

full_name: Bruno Vergès

given: Bruno

family: Brun

full_name: Jean Marcel Brun

given: Jean Marcel

family: Tawil

full_name: Camille Tawil

given: Camille

family: Alexandre

full_name: Bertrand Alexandre

given: Bertrand

family: Kerlan

full_name: Véronique Kerlan

given: Véronique

journal_name: Diabetes/Metabolism Research and Reviews


title: Management of Patients With Alpha-1 Antitrypsin Deficiency Associated Emphysema. A National Registry.

summary: The aim of this study is to describe the natural history of patients with alpha-1 antitrypsin associated emphysema and to figure out associated prognostic factors.

ReferenceCitation: Gauvain C, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Thabut G. Health-related quality of life in patients with alpha-1 antitrypsin deficiency: the French experience. COPD. 2015 May;12 Suppl 1:46-51. doi: 10.3109/15412555.2015.1022645.

family: Gauvain

full_name: Clément Gauvain

given: Clément

family: Mornex

full_name: Jean-François Mornex

family: Pison

full_name: Christophe Pison

given: Christophe

family: Cuvelier

full_name: Antoine Cuvelier

given: Antoine

family: Balduyck

full_name: Malika Balduyck

given: Malika

family: Pujazon

full_name: Marie-Christine Pujazon

given: Marie-Christine

family: Fournier

full_name: Michel Fournier

given: Michel

family: AitIlalne

full_name: Brahim AitIlalne

given: Brahim

family: Thabut

full_name: Gabriel Thabut

given: Gabriel

journal_name: COPD: Journal of Chronic Obstructive Pulmonary Disease

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Health-Related Quality of Life in Patients with Alpha-1 Antitrypsin Deficiency: The French Experience

ReferenceCitation: Thabut G, Mornex JF, Pison C, Cuvelier A, Balduyck M, Pujazon MC, Fournier M, AitIlalne B, Porcher R. Performance of the BODE index in patients with α1-antitrypsin deficiency-related COPD. Eur Respir J. 2014 Jul;44(1):78-86. doi: 10.1183/09031936.00168113. Epub 2014 Feb 13.

full_name: G. Thabut

given: G.

full_name: J.-F. Mornex

full_name: C. Pison

given: C.

full_name: A. Cuvelier

given: A.

full_name: M. Balduyck

given: M.

full_name: M.-C. Pujazon

full_name: M. Fournier

full_name: B. AitIlalne

given: B.

family: Porcher

full_name: R. Porcher

given: R.

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

title: Performance of the BODE index in patients with 1-antitrypsin deficiency-related COPD

location_facility: Departement d'épidémiologie, Hôpital Bichat


title: Phase 2 Study of a New Mechanical Ventilation Weaning Strategy Governs by a Respiratory Behaviour Status Assessment for Patients With Altered Level of Consciousness

acronym: ORGAR

summary: The purpose of this study is to determine if a weaning strategy from artificial ventilation governs by respiratory behaviour status assessed by our method is safe enough.

location_facility: Anesthesia and CCM; Lariboisière Hospital


title: Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.

summary: A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years

ReferenceCitation: Pigneux A, Béné MC, Guardiola P, Recher C, Hamel JF, Sauvezie M, Harousseau JL, Tournilhac O, Witz F, Berthou C, Escoffre-Barbe M, Guyotat D, Fegueux N, Himberlin C, Hunault M, Delain M, Lioure B, Jourdan E, Bauduer F, Dreyfus F, Cahn JY, Sotto JJ, Ifrah N. Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study. J Clin Oncol. 2017 Feb;35(4):387-393. doi: 10.1200/JCO.2016.67.6213. Epub 2016 Oct 24.

name: Arnaud Pigneux and Mathieu Sauvezie, Centre Hospitalier Universitaire (CHU) Bordeaux, Université Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM) 1035, Bordeaux; Marie C. Béné and Jean-Luc Harousseau, Hôpital Hôtel Dieu, Nantes; Philippe Guardiola, Mathilde Hunault, and Norbert Ifrah, CHU Angers, UMR INSERM U892/CNRS 6299; Jean-Francois Hamel, Université Nantes Angers Le Mans, CHU Angers, Angers; Christian Recher, CHU de Toulouse, Université de Toulouse III, Toulouse; Olivier...

family: Pigneux

full_name: Arnaud Pigneux

given: Arnaud

family: Béné

full_name: Marie C. Béné

given: Marie C.

family: Guardiola

full_name: Philippe Guardiola

given: Philippe

family: Recher

full_name: Christian Recher

given: Christian

family: Hamel

full_name: Jean-Francois Hamel

given: Jean-Francois

family: Sauvezie

full_name: Mathieu Sauvezie

given: Mathieu

family: Harousseau

full_name: Jean-Luc Harousseau

given: Jean-Luc

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Witz

full_name: Francis Witz

given: Francis

family: Berthou

full_name: Christian Berthou

family: Escoffre-Barbe

full_name: Martine Escoffre-Barbe

given: Martine

family: Guyotat

full_name: Denis Guyotat

given: Denis

family: Fegueux

full_name: Nathalie Fegueux

given: Nathalie

family: Himberlin

full_name: Chantal Himberlin

given: Chantal

family: Hunault

full_name: Mathilde Hunault

given: Mathilde

family: Delain

full_name: Martine Delain

family: Lioure

full_name: Bruno Lioure

given: Bruno

family: Jourdan

full_name: Eric Jourdan

given: Eric

family: Bauduer

full_name: Frederic Bauduer

given: Frederic

family: Dreyfus

full_name: Francois Dreyfus

given: Francois

family: Cahn

full_name: Jean-Yves Cahn

given: Jean-Yves

family: Sotto

full_name: Jean-Jacques Sotto

given: Jean-Jacques

family: Ifrah

full_name: Norbert Ifrah

given: Norbert

publisher: American Society of Clinical Oncology (ASCO)


title: Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.

summary:
Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established.

The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

lead_sponsor: University Hospital, Tours

location_facility: Service de Gynécologie Obstétrique CHRU Tours


title: Cellular Immunity, Cytomegalovirus Infection and Septic Shock in ICU Patients

summary: This prospective study evaluate the immune status of patients admitted in ICU.CMV remains dormant in the body, but in people with immune deficiency, CMV could reactivate and cause life-threatening pneumonia.

ReferenceCitation: Matta J, Baratin M, Chiche L, Forel JM, Cognet C, Thomas G, Farnarier C, Piperoglou C, Papazian L, Chaussabel D, Ugolini S, Vély F, Vivier E. Induction of B7-H6, a ligand for the natural killer cell-activating receptor NKp30, in inflammatory conditions. Blood. 2013 Jul 18;122(3):394-404. doi: 10.1182/blood-2013-01-481705. Epub 2013 May 17.

name: Centre d’Immunologie de Marseille-Luminy, Institut National de la Santé et de la Recherche Médicale, U1104, Marseille, France;

name: Centre National de la Recherche Scientifique, Unité Mixte de Recherche 7280, Marseille, France;

name: Aix Marseille Université, UM2, Marseille, France;

family: Matta

full_name: Jessica Matta

given: Jessica

family: Baratin

full_name: Myriam Baratin

given: Myriam

name: Service de Médecine Interne, Assistance Publique–Hôpitaux de Marseille, Hôpital de la Conception, Marseille, France;

name: Réanimation-Détresses Respiratoires et Infections Sévères, Assistance Publique–Hôpitaux de Marseille, Unité de Recherche sur les Maladies Infectieuses et Tropicales Émergentes CNRS-UMR 6236, Aix-Marseille Université, Marseille, France;

family: Chiche

full_name: Laurent Chiche

given: Laurent

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

name: Service d’Immunologie, Assistance Publique–Hôpitaux de Marseille, Hôpital de la Conception, Marseille, France; and

family: Cognet

full_name: Céline Cognet

given: Céline

family: Thomas

full_name: Guillemette Thomas

given: Guillemette

family: Farnarier

full_name: Catherine Farnarier

given: Catherine

family: Piperoglou

full_name: Christelle Piperoglou

given: Christelle

family: Papazian

full_name: Laurent Papazian

name: Benaroya Research Institute, Seattle, WA

family: Chaussabel

full_name: Damien Chaussabel

given: Damien

family: Ugolini

full_name: Sophie Ugolini

given: Sophie

family: Vély

full_name: Frédéric Vély

given: Frédéric

family: Vivier

full_name: Eric Vivier

title: Induction of B7-H6, a ligand for the natural killer cell–activating receptor NKp30, in inflammatory conditions

ReferenceCitation: Forel JM, Chiche L, Thomas G, Mancini J, Farnarier C, Cognet C, Guervilly C, Daumas A, Vély F, Xéridat F, Vivier E, Papazian L. Phenotype and functions of natural killer cells in critically-ill septic patients. PLoS One. 2012;7(12):e50446. doi: 10.1371/journal.pone.0050446. Epub 2012 Dec 6.

family: Mancini

full_name: Julien Mancini

given: Julien

family: Guervilly

full_name: Christophe Guervilly

given: Christophe

family: Daumas

full_name: Aurélie Daumas

given: Aurélie

title: Phenotype and Functions of Natural Killer Cells in Critically-Ill Septic Patients

location_facility: Hôpital de Sainte Marguerite- Service de Réanimation Médicale


title: Comparative Medico-Economic Evaluation of Micrographic Mohs Surgery (MMS) and Traditional Surgical Excision With Immediate or Differed Reconstruction to Treat High Recurrence Risk Basal-Cell Carcinomas (BCC)

acronym: BACHIMO

summary:
Mohs' micrographic surgery (MMS) is a treatment of choice for high recurrence risk basal-cell carcinomas (BCC). Realized under local anaesthesia, it induces very low recurrence rates and spares unnecessary excision of intact surrounding tissues, thus decreasing the needs for flaps, skin grafts, and allows immediate reconstruction…. Its disadvantages are mainly: need for a significant training of the operator, the pathologist and the non-medical personnel; longer duration of the procedure, with higher a priori costs, and constraints for the patient related to the duration of the intervention. Traditional surgical excision with immediate or differed reconstruction is the technique of reference. Provided that re-excisions are performed as long as previous ones do not guarantee free margins, it gives good results. Its real costs are poorly known and can be enhanced by several considerations: multiplicity of the operational acts if the initial excision is insufficient, more complex reconstruction procedures, duration of post-operative dressings, ….

The investigators' objective is to know the costs of the surgical treatment of the high risk CBC, comparing the CMM with the surgical excision with immediate or differed reconstruction, along with its effectiveness defined by the absence of recurrence. by its impact on the quality of life of the patient. It is a prospective, multicentric, comparative, not randomized, open, cohort study, of the type "here and elsewhere". Patients with high-risk CBC, as defined by the French ANAES Guidelines (2004), will be included:

clinically morpheaform aspect or ill-limited margins, aggressive histological forms;
already recurred BCC (except for superficial BCCs));
nodular BCC located in the high-risk zone (nose, peri-orificial areas of the head) and with diameter larger than 1 cm.

The effectiveness will be measured by the rate of recurrence at 5 years (as measured by the prolongation of the follow-up after the surgical procedure). The utility from the patient point of view will be evaluated by a specific dermatologic quality of life questionnaire (Skindex) and by a generic questionnaire (Euroqol 5D), supplemented by a questionnaire of satisfaction of the care (Attkisson). The economic perspectives studied will be those of the hospital, of the payer and of the society. Direct medical costs will be evaluated by micro-costing. The main production factors implied in the realization of one CMM or one traditional surgery in dermatology/surgery and anatomopathology wards will be identified, counted, and developed. The measuring units will be the estimate of the time devoted to each individual procedure, reported to the total activity of each ward and the wages of the various categories of personnel implied, and the unit costs in consumable and redeemable material, reported to their utilisation factor. The hospital indirect costs will be estimated by the financial services of the hospitals. Accrual of 150 CMM and 300 traditional excisions will be performed within a two year period of time.

lead_sponsor: Hospital Ambroise Paré Paris


title: Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode.

acronym: HTAP-SCLERO

summary:
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT).

In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques.

So, the analysis of the right ventricular function appears capital, because:

it is recognized like an essential determinant of the symptoms and effort capacity,
its prevalence, physiopathology and prognostic values remain unknown in this pathology,
its interest in the starting of the treatment remains to be specified.

The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT:

the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode,
the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise.
the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period.

This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.

ReferenceCitation: Thuny F, Lovric D, Schnell F, Bergerot C, Ernande L, Cottin V, Derumeaux G, Croisille P. Quantification of myocardial extracellular volume fraction with cardiac MR imaging for early detection of left ventricle involvement in systemic sclerosis. Radiology. 2014 May;271(2):373-80. doi: 10.1148/radiol.13131280. Epub 2014 Jan 15.

family: Thuny

full_name: Franck Thuny

given: Franck

family: Lovric

full_name: Daniel Lovric

given: Daniel

family: Schnell

full_name: Frédéric Schnell

family: Bergerot

full_name: Cyrille Bergerot

given: Cyrille

family: Ernande

full_name: Laura Ernande

given: Laura

family: Cottin

full_name: Vincent Cottin

given: Vincent

family: Derumeaux

full_name: Geneviève Derumeaux

given: Geneviève

family: Croisille

full_name: Pierre Croisille

given: Pierre

publisher_dissemination: Radiological Society of North America (RSNA)

title: Quantification of Myocardial Extracellular Volume Fraction with Cardiac MR Imaging for Early Detection of Left Ventricle Involvement in Systemic Sclerosis


title: Repetitive Trans-cranial Magnetic Stimulation of the Motor Cortex in Fibromyalgia: A Prospective Randomized Blinded Placebo-controlled Study Evaluating the Clinical Efficiency and the Metabolic Correlate in 18FDG-PET

summary: Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

ReferenceCitation: Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.

family: Boyer

full_name: L. Boyer

given: L.

family: Dousset

full_name: A. Dousset

given: A.

family: Roussel

full_name: P. Roussel

given: P.

family: Dossetto

full_name: N. Dossetto

given: N.

family: Cammilleri

full_name: S. Cammilleri

given: S.

family: Piano

full_name: V. Piano

given: V.

family: Khalfa

full_name: S. Khalfa

family: Mundler

full_name: O. Mundler

given: O.

family: Donnet

full_name: A. Donnet

family: Guedj

full_name: E. Guedj

given: E.

journal_name: Neurology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: rTMS in fibromyalgia: A randomized trial evaluating QoL and its brain metabolic substrate

location_facility: Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire


title: Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo

summary:
308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.

The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Department of Dermatology, University Hospital of Nice

intervention_type: Radiation


title: A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum

summary: In this trial the efficacy and safety of Mirena was investigated during the first year of use

lead_sponsor: Bayer


title: Biologic Evaluation of Renal Toxicity of Cisplatin and Ifosfamide (TOXIPLAT)

summary:
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is evaluating kidney damage in patients receiving cisplatin and ifosfamide for solid tumors.

status: Suspended

lead_sponsor: Institut Claudius Regaud


title: An Open-Label, Comparative, Randomized, Prospective Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids

summary:
Experience with tacrolimus in pancreas transplantation has become a standard for immunosuppression in almost all pancreas centers over the world. Several centers have shown very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin inhibitor and mycophenolate mofetil with or without corticosteroids.

The use of sirolimus in SPK transplant patients has for the moment only been studied, with good results, in association with tacrolimus or cyclospsorine (CsA). In renal transplantation, there is also evidence that sirolimus (Rapamune) is a potent immunosuppressant that significantly reduces the incidence of acute rejection when given with CsA, effective as base therapy in the post-induction period. Because of Rapamune's effectiveness and different safety profile, it might be advantageous in terms of reduced nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of acute rejection.

To explore this further, the following study is designed to assess the use of SRL versus TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de novo simultaneous pancreas-kidney transplant recipients.

ReferenceCitation: Cantarovich D, Kervella D, Karam G, Dantal J, Blancho G, Giral M, Garandeau C, Houzet A, Ville S, Branchereau J, Delbos F, Guillot-Gueguen C, Volteau C, Leroy M, Renaudin K, Soulillou JP, Hourmant M. Tacrolimus- versus sirolimus-based immunosuppression after simultaneous pancreas and kidney transplantation: 5-year results of a randomized trial. Am J Transplant. 2020 Jun;20(6):1679-1690. doi: 10.1111/ajt.15809. Epub 2020 Feb 28.

name: CHU Nantes Université de Nantes Inserm Centre de Recherche en Transplantation et Immunologie UMR 1064 ITUN Nantes France

name: CHU Nantes Université de Nantes Institut de Transplantation, Urologie, Néphrologie Nantes France

family: Cantarovich

full_name: Diego Cantarovich

given: Diego

family: Kervella

full_name: Delphine Kervella

given: Delphine

family: Karam

full_name: Georges Karam

given: Georges

family: Dantal

full_name: Jacques Dantal

given: Jacques

family: Blancho

full_name: Gilles Blancho

given: Gilles

family: Giral

full_name: Magali Giral

given: Magali

family: Garandeau

full_name: Claire Garandeau

given: Claire

family: Houzet

full_name: Aurélie Houzet

family: Ville

full_name: Simon Ville

given: Simon

family: Branchereau

full_name: Julien Branchereau

given: Julien

name: Laboratoire d'Histocompatibilité Etablissement Français du Sang EFS, Pays de la Loire Nantes France

family: Delbos

full_name: Florent Delbos

given: Florent

family: Guillot‐Gueguen

full_name: Cécile Guillot‐Gueguen

given: Cécile

name: Plateforme de Méthodologie et de Biostatistique Centre Hospitalier Universitaire de Nantes Nantes France

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Leroy

full_name: Maxime Leroy

given: Maxime

name: Service d'Anatomie et de Cytologie Pathologique Centre Hospitalier Universitaire Nantes Nantes France

family: Renaudin

full_name: Karine Renaudin

given: Karine

family: Soulillou

full_name: Jean‐Paul Soulillou

given: Jean‐Paul

family: Hourmant

full_name: Maryvonne Hourmant

given: Maryvonne

journal_name: American Journal of Transplantation

title: Tacrolimus‐ versus sirolimus‐based immunosuppression after simultaneous pancreas and kidney transplantation: 5‐year results of a randomized trial


title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741

summary: The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.

lead_sponsor: Orion Corporation, Orion Pharma


title: Primary vs. Secondary Anastomosis After Sigmoid Colon Resection for Perforated Diverticulitis (Hinchey Stage III and IV): a Prospective Multicentric Randomized Trial

acronym: DIVERTI

summary: This study compares primary resection with anastomosis and Hartmann's procedure in an adult population with acute perforated colonic diverticulitis (Hinchey Stage III and IV) METHODS: The primary end point was postoperative mortality. Secondary end points included surgical and medical morbidity, operative time, and length of postoperative hospitalization.

lead_sponsor: University Hospital, Rouen


title: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

summary: Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

lead_sponsor: Humanigen, Inc.


title: Effect of Milk Proteins and Protein Feeding Pattern on Body Composition and Protein Metabolism in Energy Restricted Obese Subjects

acronym: SURPROL-CF-H

summary: The purpose of this study is to minimize the loss of lean body mass that occurs during a weight-loss program in obese people by changing the nature of ingested protein and the pattern of protein feeding

ReferenceCitation: Arnal MA, Mosoni L, Boirie Y, Houlier ML, Morin L, Verdier E, Ritz P, Antoine JM, Prugnaud J, Beaufrère B, Mirand PP. Protein pulse feeding improves protein retention in elderly women. Am J Clin Nutr. 1999 Jun;69(6):1202-8.

ReferenceCitation: Arnal MA, Mosoni L, Boirie Y, Houlier ML, Morin L, Verdier E, Ritz P, Antoine JM, Prugnaud J, Beaufrère B, Mirand PP. Protein feeding pattern does not affect protein retention in young women. J Nutr. 2000 Jul;130(7):1700-4.

ReferenceCitation: Boirie Y, Dangin M, Gachon P, Vasson MP, Maubois JL, Beaufrère B. Slow and fast dietary proteins differently modulate postprandial protein accretion. Proc Natl Acad Sci U S A. 1997 Dec 23;94(26):14930-5.

ReferenceCitation: Dangin M, Guillet C, Garcia-Rodenas C, Gachon P, Bouteloup-Demange C, Reiffers-Magnani K, Fauquant J, Ballèvre O, Beaufrère B. The rate of protein digestion affects protein gain differently during aging in humans. J Physiol. 2003 Jun 1;549(Pt 2):635-44. Epub 2003 Mar 28.

ReferenceCitation: Dardevet D, Sornet C, Bayle G, Prugnaud J, Pouyet C, Grizard J. Postprandial stimulation of muscle protein synthesis in old rats can be restored by a leucine-supplemented meal. J Nutr. 2002 Jan;132(1):95-100.

ReferenceCitation: Lacroix M, Bos C, Léonil J, Airinei G, Luengo C, Daré S, Benamouzig R, Fouillet H, Fauquant J, Tomé D, Gaudichon C. Compared with casein or total milk protein, digestion of milk soluble proteins is too rapid to sustain the anabolic postprandial amino acid requirement. Am J Clin Nutr. 2006 Nov;84(5):1070-9.

lead_sponsor: Institut National de la Recherche Agronomique

location_facility: Unité d'Exploration Nutritionnelle (Nutritional Exploration Unit)


title: International Phase II Study Evaluating the Association of CHOP-rituximab With Consolidation by Early Ibritumomab Tiuxetan-Y90 in Patients Aged 65 to 80 Years With CD20+ Large Cell Malignant Lymphoma and no Prior Therapy

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.

lead_sponsor: Centre Antoine Lacassagne


title: Efficacy of Surgical Coronary Revascularization Associated With Stem Cells Injection in Patients With Severe Chronic Ischemic Heart Disease With Residual Viability. A Prospective, Controlled Pilot Trial.

summary:
Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of > 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization.

Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: Departements of CardiacSurgery, Cardiology and Radiology


title: Comparative, Multicentre, Randomized, Double-blind Study to Assess the Efficacy of Tacrolimus 0.1% Ointment Versus Fluticasone 0.005% Ointment in Adult Patients Suffering From Moderate to Severe Atopic Dermatitis and Presenting With So-called 'Red Face' Lesions of the Head and Neck.

summary: Patients with facial atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed or change for the other ointment.

lead_sponsor: Astellas Pharma Inc


title: Comparative, Multicentre, Randomised, Double-blind Study to Assess the Efficacy of Tacrolimus 0.03% Ointment Versus Fluticasone 0.005% Ointment in Children Aged 2 Years or Over Suffering From Moderate to Severe Atopic Dermatitis.

summary: Children with atopic eczema and a poor response to topical corticosteroid applied either Protopic or Fluticasone ointment twice a day for 3 weeks. They could continue during 3 more weeks once a day if needed.


title: Targeted Intensification by a Preparative Regimen for Patients With High-grade B-Cell Lymphoma Utilizing Standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy (RIT) Combined With High-dose BEAM Followed by Autologous Stem Cell Transplantation (ASCT)

summary: The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma

ReferenceCitation: Fruchart C, Tilly H, Morschhauser F, Ghesquières H, Bouteloup M, Fermé C, Van Den Neste E, Bordessoule D, Bouabdallah R, Delmer A, Casasnovas RO, Ysebaert L, Ciappuccini R, Briere J, Gisselbrecht C. Upfront consolidation combining yttrium-90 ibritumomab tiuxetan and high-dose therapy with stem cell transplantation in poor-risk patients with diffuse large B cell lymphoma. Biol Blood Marrow Transplant. 2014 Dec;20(12):1905-11. doi: 10.1016/j.bbmt.2014.07.024. Epub 2014 Jul 26.

family: Fruchart

full_name: Christophe Fruchart

given: Christophe

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Ghesquières

full_name: Hervé Ghesquières

family: Bouteloup

full_name: Marie Bouteloup

given: Marie

family: Fermé

full_name: Christophe Fermé

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Bordessoule

full_name: Dominique Bordessoule

given: Dominique

family: Bouabdallah

full_name: Reda Bouabdallah

given: Reda

family: Delmer

full_name: Alain Delmer

given: Alain

family: Casasnovas

full_name: René Olivier Casasnovas

given: René Olivier

family: Ysebaert

full_name: Loïc Ysebaert

given: Loïc

family: Ciappuccini

full_name: Renaud Ciappuccini

given: Renaud

family: Briere

full_name: Josette Briere

given: Josette

family: Gisselbrecht

full_name: Christian Gisselbrecht

given: Christian

journal_name: Biology of Blood and Marrow Transplantation

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Upfront Consolidation Combining Yttrium-90 Ibritumomab Tiuxetan and High-Dose Therapy with Stem Cell Transplantation in Poor-Risk Patients with Diffuse Large B Cell Lymphoma

ipd_sharing: No

lead_sponsor: Lymphoma Study Association

location_facility: service d'onco hématologie adultes, hôpital Saint Louis


title: Longitudinal Cohort Study Comparing 2 Surgical Techniques (Roux-en-Y Gastric Bypass and Adjustable Gastric Banding) in Patients With Class 3 Obesity and Type 2 Diabetes

acronym: OBEDIAB

summary:
Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of "Roux-en-Y gastric bypass" is more effective than the "Adjustable Gastric Band" on weight loss.

This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the responsible mechanisms.

The evaluation will be made preoperatively and 1 year later as assessed by the decline in HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.

lead_sponsor: University Hospital, Lille


title: Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

acronym: EXPLOR

summary: Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.

lead_sponsor: Novartis Pharmaceuticals


title: Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers

acronym: HEPEPO

summary: The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.

ReferenceCitation: Lainé F, Laviolle B, Ropert M, Bouguen G, Morcet J, Hamon C, Massart C, Westermann M, Deugnier Y, Loréal O. Early effects of erythropoietin on serum hepcidin and serum iron bioavailability in healthy volunteers. Eur J Appl Physiol. 2012 Apr;112(4):1391-7. doi: 10.1007/s00421-011-2097-7. Epub 2011 Aug 5.

family: Lainé

full_name: Fabrice Lainé

given: Fabrice

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Ropert

full_name: Martine Ropert

given: Martine

family: Bouguen

full_name: Guillaume Bouguen

given: Guillaume

family: Morcet

full_name: Jeff Morcet

given: Jeff

family: Hamon

full_name: Catherine Hamon

given: Catherine

family: Massart

full_name: Catherine Massart

family: Westermann

full_name: Mark Westermann

given: Mark

family: Deugnier

full_name: Yves Deugnier

given: Yves

family: Loréal

full_name: Olivier Loréal

given: Olivier

bso_classification: Biology (fond.)

journal_name: European Journal of Applied Physiology

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Rennes University Hospital

location_facility: Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou


title: Peripheral Endothelial Function and Coronary Status in Asymptomatic Type 2 Diabetic Patients: Relations With Coronary Microcirculation Assessed With Trans-thoracic Echo-doppler

acronym: PEFDIA

summary: Silent myocardial ischemia is usual in type 2 diabetic patients and associated with coronary stenoses and endothelial dysfunction or both. We therefore hypothesized that peripheral endothelial dysfunction is a marker of silent myocardial ischemia. The aim of the study is, in 120 asymptomatic type 2 diabetic patients, to evaluate the relations between coronary status, assessed with myocardial scintigraphy and subsequent coronary angiography in case of abnormality, and peripheral endothelial function, according to post-occlusive hyperaemia endothelium-dependent brachial artery dilation.

ReferenceCitation: Cosson E, Pham I, Valensi P, Pariès J, Attali JR, Nitenberg A. Impaired coronary endothelium-dependent vasodilation is associated with microalbuminuria in patients with type 2 diabetes and angiographically normal coronary arteries. Diabetes Care. 2006 Jan;29(1):107-12.

ReferenceCitation: Pham I, Nguyen MT, Valensi P, Rousseau H, Nitenberg A, Vicaut E, Cosson E. Noninvasive study of coronary microcirculation response to a cold pressor test. Eur J Clin Invest. 2015 Feb;45(2):135-43. doi: 10.1111/eci.12389. Epub 2015 Jan 7.

name: Clinical Physiology Department; Jean Verdier Hospital; APHP; HUPSSD; Bondy France

name: UFR Santé, Médecine, Biologie Humaine; EA 2363 ‘Réponses cellulaires et fonctionnelles à l'hypoxie’; Sorbonne Paris-Cité; Paris 13 University; Bobigny France

family: Pham

full_name: Isabelle Pham

given: Isabelle

name: Department of Endocrinology-Diabetology-Nutrition; Jean Verdier Hospital; AP-HP; HUPSSD; Paris 13 University; CRNH-IdF; CINFO; Bondy France

name: Unité de Recherche Epidémiologique Nutritionnelle; Paris 13 University; Sorbonne Paris-Cité; U557 INSERM/U11125 INRA/CNAM/Université Paris13; Bobigny France

family: Nguyen

full_name: Minh-Tuan Nguyen

given: Minh-Tuan

family: Valensi

full_name: Paul Valensi

given: Paul

name: Lariboisière Hospital; Unit of Clinical Research; Paris 7 University; AP-HP; Paris France

family: Rousseau

full_name: Hélène Rousseau

given: Hélène

family: Nitenberg

full_name: Alain Nitenberg

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Cosson

full_name: Emmanuel Cosson

given: Emmanuel

journal_name: European Journal of Clinical Investigation

ReferenceCitation: Nguyen MT, Pham I, Valensi P, Rousseau H, Vicaut E, Laguillier-Morizot C, Nitenberg A, Cosson E. Flow-mediated-paradoxical vasoconstriction is independently associated with asymptomatic myocardial ischemia and coronary artery disease in type 2 diabetic patients. Cardiovasc Diabetol. 2014 Jan 15;13:20. doi: 10.1186/1475-2840-13-20.

full_name: Minh Tuan Nguyen

given: Minh Tuan

family: Laguillier-Morizot

full_name: Christelle Laguillier-Morizot

given: Christelle

currency_apc_doaj: GBP

journal_name: Cardiovascular Diabetology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

location_facility: Hôpital Jean Verdier Service of Endocrinologie-Diabétologie-Nutrition


title: Rationale, Study Design and Baseline Data of the TRANSQUAL Clinical Trial: A Study to Evaluate the Impact of Different Milk Fatty Acid Profiles on Cardiovascular Risk Factors in Healthy Volunteers; Focus on Trans Fatty Acids

acronym: TRANSQUAL WPC

summary: The investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.

location_facility: Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine


title: Tryptophan, Serotonin and Kynurenine in Septic Shock

acronym: TSK

summary: Septic shock is a major cause of mortality and morbidity worldwide. Serotonin (5-HT) is released by activated platelets into the circulation, and is mediator of endothelial dysfunction. 5-HT metabolism is known in immune system via specific 5-HT receptor, also in effects on the peripheral nervous system. Kinetic of 5-HT, tryptophan, kynurenine, MAO activity and IDO activity in human septic shock was never investigated.

ReferenceCitation: Troché G, Henry-Lagarrigue M, Soppelsa F, Legriel S, Yehia A, Bruneel F, Bédos JP, Spreux-Varoquaux O. Tryptophan pathway catabolites (serotonin, 5-hydroxyindolacetic acid, kynurenine) and enzymes (monoamine oxidase and indole amine 2,3 dioxygenase) in patients with septic shock: A prospective observational study versus healthy controls. Medicine (Baltimore). 2020 May;99(19):e19906. doi: 10.1097/MD.0000000000019906.

family: Troché

full_name: Gilles Troché

given: Gilles

family: Henry-Lagarrigue

full_name: Matthieu Henry-Lagarrigue

given: Matthieu

family: Soppelsa

full_name: Frédérique Soppelsa

given: Frédérique

family: Legriel

full_name: Stephane Legriel

given: Stephane

family: Yehia

full_name: Aihem Yehia

given: Aihem

family: Bruneel

full_name: Fabrice Bruneel

given: Fabrice

family: Bédos

full_name: Jean-Pierre Bédos

given: Jean-Pierre

family: Spreux-Varoquaux

full_name: Odile Spreux-Varoquaux

given: Odile

currency_apc_doaj: USD

journal_name: Medicine

evidence: open (via page says license)

lead_sponsor: Versailles Hospital


title: Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment

summary: The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hopital de la Timone- Service de neurologie et de neuropsychologie


title: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality

summary: The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.

location_facility: Hopital de la Conception- Service de Néphrologie et de transplantation rénale


title: State Dependent Resonance in the BG-cortical Loops

summary: Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.


title: Use of a Bearable Continuous Interstitial Glucose Monitoring Device (GuardianR) During Teaching Sessions to Functional Insulin Therapy Concept in Patients Suffering From Type 1 Diabetes: Evaluation at 6 and 12 Months

summary: The objective of the project is to evaluate advantages from the use of a bearable continuous interstitial glucose monitoring device (GuardianR) during educative sessions of diabetic patients dedicated to functional insulin therapy teaching. This concept of intensified treatment is based on testing and explanation of simplified decision making algorithms to adapt insulin dose to every true life conditions. As self monitoring of capillary glucose level is needed to validate those algorithms, we postulate that using a device able to permanently control interstitial glucose readable by both medical team and patient himself (during the session and the 5 following days after discharge) could significantly improve safety and efficiency of such educative session.


title: Significance of the High-risk Hpv Viral Load

summary: The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.

location_facility: Hopital Nord, service de gynécologie-obstétrique


title: Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

summary: Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

location_facility: Hopital Nord- Service de gynécologie-obstétrique


summary: Classical imaging techniques are inaccurate to detect residual cholesteatoma. The aim of our study is to evaluate the value of diffusion-weighted MR imaging and delayed contrast enhanced T1 weighted spin-echo sequences in the detection of residual cholesteatoma in children, in a large serie of surgically verified cases.

location_facility: Hôpital de la Timone- Service de radiologie pédiatrique et d'ORL pédiatrique


title: Follow up of Ventilatory Function in Infant After One (or More) Bronchiolitis During the First Year of Life. Course Towards Asthma

summary:
A significant proportion of asthma is diagnosed during childhood. Bronchiolitis is the most common lower respiratory tract illness (LRI) in early life and the present work is a prospective study undertaken to highlight the possible relationship between LRI in early life and trigger of atopy and asthma in 3 year-old childhood, using paediatric lung function testing.

Twenty nine infants (8 females and 21 males) were included in our study. The beginning of the study started at least three weeks after the first bronchiolitis episode. Pulmonary function test was realized using an infant specific body plethysmography (Babybody, Erich Jaeger, Germany). Same tests were performed at 18 and 24 months. At 30 and 36 months, pulmonary function was evaluated by measuring respiratory resistances using oscillometry and occlusion systems (Masterlab-IOS, Erich Jaeger, Germany). If measured data showed an obstruction, a bronchodilatator was inhaled to assess reversibility. When results were normal, a bronchial provocation test, using inhaled metacholine, was performed.

Skin prick tests (SPTs) were performed during the first exam, and at 24 and 36 months (Stallergenes-DHS).

Collection of data was largely incomplete due to a number of patients lost of follow up. Based on the available data, it can be conclude that most of lung tests results were in the normal range but a non negligible bronchial hyper reactivity was documented (41% of patients).

This study must be continued to increase the number of included patients and to continue their follow up during a longer time.

ReferenceCitation: Wright AL, Taussig LM, Ray CG, Harrison HR, Holberg CJ. The Tucson Children's Respiratory Study. II. Lower respiratory tract illness in the first year of life. Am J Epidemiol. 1989 Jun;129(6):1232-46.

ReferenceCitation: Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. Epub 2004 Oct 29.

ReferenceCitation: Van Bever HP, Wieringa MH, Weyler JJ, Nelen VJ, Fortuin M, Vermeire PA. Croup and recurrent croup: their association with asthma and allergy. An epidemiological study on 5-8-year-old children. Eur J Pediatr. 1999 Mar;158(3):253-7.

ReferenceCitation: Schauer U, Hoffjan S, Bittscheidt J, Köchling A, Hemmis S, Bongartz S, Stephan V. RSV bronchiolitis and risk of wheeze and allergic sensitisation in the first year of life. Eur Respir J. 2002 Nov;20(5):1277-83.

ReferenceCitation: Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5.

ReferenceCitation: Sampson HA, Albergo R. Comparison of results of skin tests, RAST, and double-blind, placebo-controlled food challenges in children with atopic dermatitis. J Allergy Clin Immunol. 1984 Jul;74(1):26-33.


title: Effectiveness of Pit and Fissure Sealants in the Prevention of Dental Caries

summary: This randomized clinical trial is aimed at testing the efficacy of pit and fissure sealants, in a current environmental context different from that of the seventies and eighties. It has a split mouth design. 4OO subjects are included and the duration of follow up is 2 years.

location_facility: Centre Hospitalier Universitaire de Nice


title: Efficacy of Monetary Incentives for Primary Care Physicians on Patients' Recruitment

acronym: COFRASAanc

summary:
Patients' recruitment is difficult in clinical trial. Financial incentives are frequently proposed to clinicians in private funded trials. However, the effect of these financial incentives has never been evaluated.

The purpose of this study is to evaluate the effect of financial incentive on the rate of recruitment of patients in a cohort study.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Groupe hospitalier Bichat-Claude Bernard


title: Hemodynamic and Biological Effects of Fludrocortisone and Hydrocortisone, in Healthy Volunteers With Aldosterone Induced Suppression

summary: Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular responsiveness, the role of fludrocortisone remains to be elucidated. The purpose of our study is to investigate the effect of a physiological dose of fludrocortisone and/or hydrocortisone on phenylephrine-mean arterial pressure dose-response relationship in healthy volunteers with aldosterone suppression induced by intravenous sodium loading.

location_facility: Unité d'Investigation Clinique - Hôpital de Pontchaillou