title: A Single-arm, Phase II Study of Sunitinib in Patients With Von Hippel-Lindau (VHL) Disease

acronym: VHLSUT

summary:
VHL patients may benefit from sunitinib. This study will investigate the following objectives :

PRIMARY OBJECTIVE

To determine the objective response rate according to RECIST criteria, in VHL patients with advanced tumors or tumors untreatable by other means, and treated with sunitinib.

SECONDARY OBJECTIVES

To evaluate the safety and tolerability of sunitinib in VHL patients according to the NCI-CTC criteria Version 3.0.
To determine the following time-to-event endpoints: overall survival, time to disease progression, progression free survival, time to response and duration of response.
To evaluate quality of life in VHL patients receiving sunitinib.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Hospital Saint André - Service de cancérologie

location_facility: Hôpital Européen Georges Pompidou - Service d'Oncologie Médicale


title: Impact of COVID-19 Pandemic in Perinatal Mental Health

summary: Introduction: Coronavirus disease 2019 (COVID-19) is a new pathology, declared a public health emergency by the World Health Organization, which can have negative consequences for pregnant women and their newborns. It is estimated that 1 in 5 women will develop a mental illness in the perinatal period. COVID-19 pandemic has been associated with anxiety and depression in the population. The current pandemic is a unique stressor with potentially wide-ranging consequences in the perinatal period, but little is known about the impact of COVID-19 on perinatal mental health. Thus, the objective of this study is to explore the experiences of pregnant and new mothers during the current pandemic, particularly its impact on perinatal mental health (including depression, anxiety, PTSD and psychological distress). Methods: The study design is a prospective observational study, with a baseline assessment and three follow-ups: one month; three months; and six months post baseline. This international study will be carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, United Kingdom) Chile and Brazil. The study population will comprise pregnant women and new mothers with an infant under six months of age, covering a broad range of women across the perinatal period. Ethics and dissemination: The study and handling of the data will follow all national required data protection standards. Each researcher (or team of researchers) involved will submit the project to their local ethical committee before starting the project. Results from the project will be disseminated in peer reviewed journals and international conferences.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Yu N, Li W, Kang Q, Xiong Z, Wang S, Lin X, Liu Y, Xiao J, Liu H, Deng D, Chen S, Zeng W, Feng L, Wu J. Clinical features and obstetric and neonatal outcomes of pregnant patients with COVID-19 in Wuhan, China: a retrospective, single-centre, descriptive study. Lancet Infect Dis. 2020 May;20(5):559-564. doi: 10.1016/S1473-3099(20)30176-6. Epub 2020 Mar 24.

ReferenceCitation: World Health Organization (2020). WHO guidelines on Intrapartum care for a positive childbirth experience and Interim guidance on Clinical management of severe acute respiratory infection (SARI) when COVID-19 disease is suspected. https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf

ReferenceCitation: Royal College of Obstetricians & Gynaecologists: Coronavirus (COVID-19) infection and pregnancy https://www.rcog.org.uk/globalassets/documents/guidelines/2020-04-03-coronavirus-covid-19-infection-in-pregnancy.pdf

ReferenceCitation: Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.

ReferenceCitation: Shorey S, Chee CYI, Ng ED, Chan YH, Tam WWS, Chong YS. Prevalence and incidence of postpartum depression among healthy mothers: A systematic review and meta-analysis. J Psychiatr Res. 2018 Sep;104:235-248. doi: 10.1016/j.jpsychires.2018.08.001. Epub 2018 Aug 3. Review.

ReferenceCitation: Caparros-Gonzalez RA. [Maternal and neonatal consequences of coronavirus COVID-19 infection during pregnancy: a scoping review]. Rev Esp Salud Publica. 2020 Apr 17;94. pii: e202004033. Review. Spanish.

ReferenceCitation: Moraes EV, Toledo OR, David FL, Godoi BN, Monteiro KA, Deluqui TC, Teixeira TW, Carvalho AL, Avelino MM. Implications of the clinical gestational diagnosis of ZIKV infection in the manifestation of symptoms of postpartum depression: a case-control study. BMC Psychiatry. 2019 Jun 26;19(1):199. doi: 10.1186/s12888-019-2157-9.

ReferenceCitation: Dos Santos Oliveira SJG, Dos Reis CL, Cipolotti R, Gurgel RQ, Santos VS, Martins-Filho PRS. Anxiety, depression, and quality of life in mothers of newborns with microcephaly and presumed congenital Zika virus infection: a follow-up study during the first year after birth. Arch Womens Ment Health. 2017 Jun;20(3):473-475. doi: 10.1007/s00737-017-0724-y. Epub 2017 Apr 21.

ReferenceCitation: Lebel C, MacKinnon A, Bagshawe M, Tomfohr-Madsen L, Giesbrecht G. Elevated depression and anxiety symptoms among pregnant individuals during the COVID-19 pandemic. J Affect Disord. 2020 Dec 1;277:5-13. doi: 10.1016/j.jad.2020.07.126. Epub 2020 Aug 1. Erratum in: J Affect Disord. 2021 Jan 15;279:377-379.

ReferenceCitation: Wu, Y. T., Zhang, C., Liu, H., Duan, C. C., Li, C., Fan, J. X., ... & Guo, Y. (2020). Perinatal Depression of Women Along with 2019 Novel Coronavirus Breakout in China. Available at SSRN: https://ssrn.com/abstract=3539359 or http://dx.doi.org/10.2139/ssrn.3539359

ReferenceCitation: Thomason, M.E., Graham, A., VanTieghem, M.R. (2020). The COPE-IS: Coronavirus Perinatal Experiences - Impact Survey. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/.

ReferenceCitation: Thomason, M.E., Graham, A., Smyser, C.D., Rogers, C.E. (2020). The COPE-IU: Coronavirus Perinatal Experiences - Impact Update. Available on the Open Science Framework (OSF) at https://osf.io/uqhcv/

ReferenceCitation: Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems

ReferenceCitation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7.

ReferenceCitation: Weathers, F. W., Litz, B. T., Keane, T. M., Palmieri, P. A., Marx, B. P., & Schnurr, P. P. (2013). The PTSD Checklist for DSM-5 (PCL-5) - Extended Criterion A [Measurement instrument]. Available from https://www.ptsd.va.gov/

ReferenceCitation: Bracken-Roche D, Bell E, Macdonald ME, Racine E. The concept of 'vulnerability' in research ethics: an in-depth analysis of policies and guidelines. Health Res Policy Syst. 2017 Feb 7;15(1):8. doi: 10.1186/s12961-016-0164-6. Erratum in: Health Res Policy Syst. 2017 Apr 3;15(1):29.

ReferenceType: derived

ReferenceCitation: Motrico E, Bina R, Domínguez-Salas S, Mateus V, Contreras-García Y, Carrasco-Portiño M, Ajaz E, Apter G, Christoforou A, Dikmen-Yildiz P, Felice E, Hancheva C, Vousoura E, Wilson CA, Buhagiar R, Cadarso-Suárez C, Costa R, Devouche E, Ganho-Ávila A, Gómez-Baya D, Gude F, Hadjigeorgiou E, Levy D, Osorio A, Rodriguez MF, Saldivia S, González MF, Mattioli M, Mesquita A; Riseup-PPD-COVID-19 Group. Impact of the Covid-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19): protocol for an international prospective cohort study. BMC Public Health. 2021 Feb 17;21(1):368. doi: 10.1186/s12889-021-10330-w.

family: Motrico

full_name: Emma Motrico

given: Emma

sequence: first

family: Bina

full_name: Rena Bina

given: Rena

sequence: additional

family: Domínguez-Salas

full_name: Sara Domínguez-Salas

given: Sara

family: Mateus

full_name: Vera Mateus

given: Vera

family: Contreras-García

full_name: Yolanda Contreras-García

given: Yolanda

family: Carrasco-Portiño

full_name: Mercedes Carrasco-Portiño

given: Mercedes

family: Ajaz

full_name: Erilda Ajaz

given: Erilda

family: Apter

full_name: Gisele Apter

given: Gisele

family: Christoforou

full_name: Andri Christoforou

given: Andri

family: Dikmen-Yildiz

full_name: Pelin Dikmen-Yildiz

given: Pelin

family: Felice

full_name: Ethel Felice

given: Ethel

family: Hancheva

full_name: Camellia Hancheva

given: Camellia

family: Vousoura

full_name: Eleni Vousoura

given: Eleni

family: Wilson

full_name: Claire A Wilson

given: Claire A

family: Buhagiar

full_name: Rachel Buhagiar

given: Rachel

family: Cadarso-Suárez

full_name: Carmen Cadarso-Suárez

given: Carmen

family: Costa

full_name: Raquel Costa

given: Raquel

family: Devouche

full_name: Emmanuel Devouche

given: Emmanuel

family: Ganho-Ávila

full_name: Ana Ganho-Ávila

given: Ana

repository_institution: Cyprus University of Technology - Ktisis at Cyprus University of Technology

location_country:
Brazil
Chile
Spain
Cyprus
France
Bulgaria
Albania
Greece
Israel
Malta
Portugal
Turkey
United Kingdom

location_facility:
Bar-Ilan University
Beder College University
Universidade do Minho
King'S College London
University of Athens
Kırklareli Üniversitesi
Universidad Loyola Andalucia
Sofia University
Universidad de Concepción
University of Malta
Groupe Hospitalier du Havre
European University Cyprus
Universidade Presbiteriana Mackenzie


title: A Multicenter Randomized Control Trial in Children With Moderate to Severe Atopic Dermatitis to Assess the Benefit of a Nurse-led One-to-one Education Program in Addition to Standard Care Compared to Standard Care Alone on the Long Term Control of Disease Severity at 6 Months

acronym: EDUDA

summary:
Atopic dermatitis is a chronic relapsing disease, which is highly prevalent in children (15%). Therapeutic patient education (TPE) has been recognized as a key priority topic for future AD research. The strongest evidence in favour of TPE efficacy in AD comes from a large study assessing repeated multi-disciplinary group education sessions in a hospital setting. However, this type of intervention is both resource and time consuming and is not adapted to typical French practice. However, in some french dermatology centers, simple "first level" nurse-led TPE interventions are offered in addition to physicians consultations. Unfortunately, the content of these interventions seems to vary greatly depending on the caregiver and the center and the benefits of these practices have not yet been assessed. Therefore, nurse-led TPE is not considered as current care in France for AD patients.
Thus, there is a need to rigorously assess the benefits of additional, well-structured, simple nurse-led individual TPE interventions for children with AD and their families compared to standard care alone. This study will be the first large, adequately powered, multicenter RCT trial assessing this type of intervention in children with AD.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

ipd_sharing: No

lead_sponsor: Nantes University Hospital

location_facility: Groupe Hospitalier de L Institut Catholique de Lille

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Canaux de COmmuniCAtion et Fonctionnement du CErveau: Étude Pilote en IRMf

acronym: COCACE

summary:
Communication is a social process involving individuals exchanging messages. It is usual to observe different reactions according to the manner of communication, the manner in which such information is exchanged.

In this work, it will be examined how different communication modalities cause different reactions in a person. We make the assumption that each communication modality is based on a different brain network.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Cross-Sectional

enrollment_type: Anticipated

lead_sponsor: University Hospital, Tours

status_simplified: Ongoing


title: Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus

acronym: WICD-MI

summary: Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia [VT] or ventricular fibrillation [VF]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

lead_sponsor: Central Hospital, Nancy, France

location_facility: Clinique Cardiologique Du Nord Saint-Denis


title: Effect of Early Use of Levosimendan Versus Placebo on Top of a Conventional Strategy of Inotrope Use on a Combined Morbidity-mortality Endpoint in Patients With Cardiogenic Shock

acronym: LevoHeartShock

summary: Cardiogenic shock (CS) mortality remains high (40%). Despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with CS. Based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. Inotropic agents increase myocardial contractility, thereby increasing cardiac output. Dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. It may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing cAMP or calcium concentration. At present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. Our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.

primary_purpose: Treatment

ipd_sharing: Undecided

location_facility: CHU Montpellier, Arnaud de Villeneuve Hospital

location_facility: Hospices Civils de Lyon - Louis Pradel Hospital

location_facility: APHP, La Pitié Salpêtrière (medical intensive care unit)

location_facility: APHP, Lariboisière Hospital (intensive care unit and toxicology)

location_facility: APHP -Lariboisière Hospital (Cardiology department)

intervention_type: Drug


title: Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire

summary:
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.

Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg

intervention_type: Procedure


title: Do Sleep and Circadian Rhythm Disturbances Impact the Cognitive and Behavioural Development of Children With Autism?

summary:
The primary objective of this study is to undertake a longitudinal investigation of the impact of sleep and circadian rhythm disturbances on cognitive and behavioural trajectories in children with autism spectrum disorder (ASD) age 3-10 years old.

This innovative study will use objective quantifiable measures of sleep and circadian rhythms in addition to subjective measures.

The investigators aim to assess the hypotheses that, in pre-pubertal children with ASD,

sleep disturbances are correlated with circadian rhythm disturbances;
both sleep and circadian rhythm disturbances are negatively correlated with cognitive performance and positively correlated with behavioural disturbances;
sleep and circadian rhythm disturbances, most notably abnormal melatonin secretion, impact the cognitive and behavioural development of children with ASD, depending on age (prospective longitudinal analyses).

primary_purpose: Other

location_facility:
CHU de Lyon - CHS Le Vinatier
CHU Gui de Chaulhiac
Hôpitaux Universitaires de Strasbourg
CHU de TOURS - Hôpital Bretonneau
CHRU de Lille - Hôpital Roger Salengro


title: Clinical Trial of Pentoxifylline Administration Versus Placebo on Survival in Patients With Cirrhosis and Severe Liver Failure

acronym: PENTOCIR

summary:
In patients with cirrhosis and liver failure, pro-inflammatory cytokines (TNF alpha) might be responsible of severe complications and death. Thus, the prevention of cytokine production should prevent complications and mortality.

The aim of this study is to study the 2 months survival rate in patients with severe cirrhosis (Child-Pugh C) with pentoxifylline - an inhibitor of cytokine production. The 6 month mortality, the proportion of transplanted patients, the occurrence of complications (bacterial infection, renal failure, hepatic encephalopathy and gastrointestinal bleeding), plasma cytokine levels and fibrotest - a marker of fibrosis - will be also studied. This is a multicenter double blind randomized trial with a placebo.

All adult patients with severe cirrhosis might be randomized after written consent. Patients with severe carcinoma, intolerance or contraindication to pentoxifylline will not be included. Patients receive either pentoxifylline or placebo 3 times a day for 6 months. Three hundred and forty two patients are necessary to decrease mortality rate by 50% at 2 months in a beta risk of 10% and an alpha risk of 5%. Patients will be seen every month.

ReferenceCitation: Lebrec D, Thabut D, Oberti F, Perarnau JM, Condat B, Barraud H, Saliba F, Carbonell N, Renard P, Ramond MJ, Moreau R, Poynard T; Pentocir Group. Pentoxifylline does not decrease short-term mortality but does reduce complications in patients with advanced cirrhosis. Gastroenterology. 2010 May;138(5):1755-62. doi: 10.1053/j.gastro.2010.01.040. Epub 2010 Jan 25.

family: Lebrec

full_name: Didier Lebrec

given: Didier

family: Thabut

full_name: Dominique Thabut

given: Dominique

family: Oberti

full_name: Frederic Oberti

given: Frederic

family: Perarnau

full_name: Jean–Marc Perarnau

given: Jean–Marc

family: Condat

full_name: Bertrand Condat

given: Bertrand

family: Barraud

full_name: Helene Barraud

given: Helene

family: Saliba

full_name: Faouzi Saliba

given: Faouzi

family: Carbonell

full_name: Nicolas Carbonell

given: Nicolas

family: Renard

full_name: Philippe Renard

given: Philippe

family: Ramond

full_name: Marie–Jose Ramond

given: Marie–Jose

family: Moreau

full_name: Richard Moreau

given: Richard

family: Poynard

full_name: Thierry Poynard

given: Thierry

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gastroenterology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Pentoxifylline Does Not Decrease Short-term Mortality but Does Reduce Complications in Patients With Advanced Cirrhosis

lead_sponsor: Assistance Publique - Hôpitaux de Paris

status_simplified: Completed


title: Evaluation médico-économique de la Stimulation unilatérale du Sinus Carotidien Dans le Traitement de l'Hypertension artérielle résistante: Essai Multicentrique contrôlé, randomisé, Ouvert Avec évaluation d'efficacité Tensionnelle et de sécurité

acronym: ESTIM-rHTN

summary: Medico-economics assessment (cost-effectiveness) of the unilateral carotid barostimulation with Barostim NeoTM compared to usual care in patients with resistant hypertension (multicenter randomized, PROBE trial), followed-up for 12 months, with a lifetime-long modeling.

status: Active, not recruiting

location_facility:
CHU de RENNES
Hospices civils de Lyon
CHRU de Lille
CHU de Bordeaux
CHU de Poitiers
CHU de Grenoble
Clinique Pasteur
GH la Pitié Salpêtrière
HEGP
CHRU de Tours
APHP -Hotel Dieu hospital
APHM
Hôpital Arthur Gardiner
CHRU de Nancy
CHU de Toulouse

intervention_type: Device


title: A New Modified-release Tablet Formulation of Prednisone (Lodotra®) in Patients With Nocturnal Asthma

acronym: MONA

summary: The purpose of the study is to evaluate in subjects suffering from nocturnal asthma, the efficacy and safety of modified release Prednisone on signs and symptoms.

design_allocation: Non-Randomized

lead_sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland

lead_sponsor_type: industriel


title: Interest of MR Urography in the Evaluation of Functional Consequences of Urinary Tract in Children and Adults

summary: The objective of functional Uro MR is to add to an initial morphological phase, based on T2 and T1 weighted MR sequences, a sequential contrast-enhanced acquisition allowing to obtain functional semi-quantitative parameters from time-intensity curves from ROIs placed on the aorta, renal parenchyma and cavities. If the equivalence with the renal scintigraphy is demonstrated, it would be possible to have both the morphological and functional approach of an obstructed kidney in one MR examination, without exposure to diagnostic irradiation.

location_facility:
Chu Poitiers
Chu Rennes
Fondation LENVAL
Ap-Hm Marseille
Chu Angers
AP-HP Robert Debré
Chu Reims
AP-HP Trousseau
Chu Rouen
Chu Strasbourg
Chu Tours
CHU NANCY Hôpital Brabois enfant
Chru Lille
AP-HP Bicêtre
Chu Bordeaux
AP-HP Saint Vincent de Paul


title: Occupational Respiratory Allergies and Gene-environment Interactions

acronym: ARPEIGE

summary:
The purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma.

Secondary purposes are:

to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration;
to estimate medical-social becoming of diagnosed work-related asthma after one year;
to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

status: Unknown status

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Michallon - CHU de Grenoble

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Intercommunal de Créteil

location_facility: Centre de consultation de pathologies professionnelles, AP-HP groupe hospitalier Cochin

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Lyautey - CHU de Strasbourg

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Civil - CHU de Strasbourg

location_facility: Centre de consultation de pathologies professionnelles, Centre Hospitalier Lyon-Sud

location_facility: Centre de consultation de pathologies professionnelles, immeuble Tourville - CHU de Nantes

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Fernand-Widal

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Purpan - CHU de Toulouse

location_facility: Centre de consultation de pathologies professionnelles, CHRU Nancy

location_facility: Centre de consultation de pathologies professionnelles, Hôpital Pellegrin - CHU de Bordeaux

location_facility: Centre de consultation de pathologies professionnelles, Hôpital côte de Nacre - CHU de Caen


title: Optimizing the Use of Vasopressor After Coronary Reperfusion in Cardiogenic Shock Secondary to Myocardial Infarction. Pathophysiological Study Comparing the Efficacy and Cardio-circulatory Tolerability of Epinephrine and Norepinephrine

acronym: OptimaCC

summary: The efficacy and tolerability of norepinephrine and epinephrine in cardiogenic shock after reperfused myocardial infarction will be compared, by following cardiac index evolution as main criteria. The study is a pilot pathophysiological study, randomized, double blind and multicenter.

ReferenceCitation: Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286. doi: 10.1002/ejhf.1600. Epub 2019 Aug 31.

name: Inserm UMR‐S 942, Cardiovascular Markers in Stress Conditions (MASCOT)University of Paris Paris France

family: Takagi

full_name: Koji Takagi

given: Koji

name: Department of Anaesthesiology, Burn and Critical CareUniversity Hospitals Saint‐Louis–Lariboisière, AP‐HP Paris France

family: Blet

full_name: Alice Blet

given: Alice

name: Intensive Care Medicine Brabois, CHRU de Nancy, INSERM U1116, 54511, Vandoeuvre‐les‐NancyUniversité de Lorraine Nancy France

family: Levy

full_name: Bruno Levy

given: Bruno

family: Deniau

full_name: Benjamin Deniau

given: Benjamin

family: Azibani

full_name: Feriel Azibani

given: Feriel

family: Feliot

full_name: Elodie Feliot

given: Elodie

name: 4TEEN4 Pharmaceuticals GmbH Hennigsdorf Germany

family: Bergmann

full_name: Andreas Bergmann

given: Andreas

family: Santos

full_name: Karine Santos

given: Karine

family: Hartmann

full_name: Oliver Hartmann

given: Oliver

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Kimmoun

full_name: Antoine Kimmoun

given: Antoine

journal_name: European Journal of Heart Failure

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Levy B, Clere-Jehl R, Legras A, Morichau-Beauchant T, Leone M, Frederique G, Quenot JP, Kimmoun A, Cariou A, Lassus J, Harjola VP, Meziani F, Louis G, Rossignol P, Duarte K, Girerd N, Mebazaa A, Vignon P; Collaborators. Epinephrine Versus Norepinephrine for Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2018 Jul 10;72(2):173-182. doi: 10.1016/j.jacc.2018.04.051.

family: Clere-Jehl

full_name: Raphael Clere-Jehl

given: Raphael

family: Legras

full_name: Annick Legras

given: Annick

family: Morichau-Beauchant

full_name: Tristan Morichau-Beauchant

given: Tristan

family: Leone

full_name: Marc Leone

given: Marc

family: Frederique

full_name: Ganster Frederique

given: Ganster

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Cariou

full_name: Alain Cariou

journal_name: Journal of the American College of Cardiology

repository_normalized: HELDA - Digital Repository of the University of Helsinki

location_facility:
CHU de STRASBOURG / NHC
CHU Toulouse
AP-HP-Hôpital Cochin
CHU de BESANCON / Hôpital Jean Minjoz
CHU de LIMOGES Hôpital Dupuytren
CH de MULHOUSE
Chru Tours
CHU de DIJON
APHM Hôpital NORD
Nancy Brabois university hospital
Chr Metz Thionville


type: Other Identifier

title: A Multicentre Controlled and Randomized Study Assessing the Effect of Dulaglutide add-on to Dietary Reinforcement Versus Dietary Reinforcement Alone in Patients With Type 2 Diabetes and Carriers of a Non-alcoholic Steatohepatitis

acronym: REALIST

summary:
GLP-1 analogues represent new treatments in diabetes that cause weight loss. Their effect on NASH in humans is unknown. A decrease in Alanine Aminotransferase (ALT) has been reported in pooled Exenatide/Placebo and Liraglutide/Placebo studies. More recently, LEAN study has shown that Liraglutide will result in improvements in liver histology in patients with NASH. It should be of high interest to investigate the effect of another GLP-1 Agonist as effective as Liraglutide, i.e. Dulaglutide in NASH.

Dulaglutide is one of the five GLP-1 receptor agonists approved for type 2 diabetes mellitus (T2DM). It is an effective treatment because it is dosed once-weekly, provides HbA1c reduction similar to Liraglutide, weight reduction similar to Exenatide, and has an adverse effect profile similar to other GLP-1 receptor agonists. Reduction in body weight was observed in patients treated with Dulaglutide, irrespective of nausea and/or vomiting.The search for a direct effect of Dulaglutide on liver fat overload in patients with type2 diabetes is required before considering the effectiveness of this treatment in NASH in diabetic populations. No current GLP-1 study has been designed with a control group with the same weight loss than as in the treatment group.

Primary objective: The investigators aim to study the effect of Dulaglutide 1.5 mg (TRULICITY®) add-on to dietary reinforcement after 52 weeks of treatment, on the improvement of liver histology compared to dietary reinforcement alone in patients with type 2 diabetes and carriers of non-alcoholic steatohepatitis.

Secondary objectives:

After 52 weeks of treatment, to assess the effect of dulaglutide (TRULICITY®) add-on to dietary reinforcement on Fibrosis score, Transaminase levels, body composition as measured by dual energy X-ray absorptiometry, lipid profile, glycemic control and weight. The effect of the treatment will also be assessed on quality of life.
At 24 weeks after completion of the treatment, to assess the sustainability of dulaglutide (TRULICITY®) treatment add-on to dietary reinforcement on ALT and AST rates as well as on weight.

location_facility:
CHRU de NANCY
CHU de ROUEN
CHRU de MONTPELLIER
CHU de TOULOUSE
Chu Marseille
CHU de REIMS
CHU de DIJON
G.H.M les Portes du Sud
CHU de CAEN


title: Search for New Genes Involved in Molecular Etiology of Rett Syndrome Through Comparative Genomic Hybridization on DNA Microarrays

acronym: RETT

summary:
Rett syndrome (RTT) is a genetic encephalopathy and the typical form is caused by mutations in the gene MECP2. It is a genetically heterogeneous pathology. CDKL5 and FOXG1 have been recently discovered being involved in other forms of RTT. However, at least 5% of typical forms and more other atypical forms are not linked to any of 3 genes known to be involved in the disease.

The purpose of this study is to identify new genes involved in molecular etiology of typical and atypical forms of RTT.

primary_purpose: Basic Science

location_facility: Laboratoire de Génétique chromosomique, CHU Hôpital l'Archet 2

location_facility: Unité de génétique, Groupe hospitalier Hôpital Flaubert

location_facility: Laboratoire de Génétique, Hôpitaux de Brabois, CHU de Nancy

location_facility: Service de neuropédiatrie, CHU Hôpital Gui de Chauliac

location_facility: Handicaps de l'Enfant - Pavillon Ste Marie, CHU St Jacques

location_facility: Service de génétique médicale, CHU Hôpital Purpan, CHU de Toulouse

location_facility: Centre de Génétique Hôpital d'Enfants, CHU de Dijon

location_facility: Service de Neuropédiatrie, Hôpital St Jacques, CHU de Besançon


title: Endothelial Function Study Before Cardiovascular Surgery in COPD and/or SAS Patients

acronym: COPD-OSAS

summary:
The aim of this clinical trial is to evaluate the effect of chronic obstructive pulmonary disease (COPD) and/or obstructive sleep apnea syndrome (OSAS) on the endothelial function, before cardiovascular surgery, compared to non COPD non OSAS patients undergoing also a cardiovascular surgery, by an observational physiological study.

An interim analysis will be performed when 100 patients will be included.

ReferenceCitation: Fabbri LM, Rabe KF. From COPD to chronic systemic inflammatory syndrome? Lancet. 2007 Sep 1;370(9589):797-9.

lead_sponsor: University Hospital, Grenoble

location_facility:
Mutualist Hospital group
University Hospital of Angers
University Hospital of Grenoble


title: Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.

acronym: EPURE

summary: Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.

ReferenceCitation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2:CD013109. doi: 10.1002/14651858.CD013109.pub2.

name: Showa University Research Administration Center (SURAC); Showa University; Tokyo Japan

name: Division of Nephrology, Department of Medicine, School of Medicine; Showa University; Tokyo Japan

family: Hasegawa

full_name: Takeshi Hasegawa

given: Takeshi

name: Division of Nephrology, Department of Medicine; Showa University Fujigaoka Hospital; Yokohama Japan

family: Nishiwaki

full_name: Hiroki Nishiwaki

given: Hiroki

name: Global Health Nursing, Graduate School of Nursing Science; St. Luke's International University; Tokyo Japan

family: Ota

full_name: Erika Ota

given: Erika

name: Rehabilitation Teaching and Research Unit, Department of Medicine; University of Otago; Wellington New Zealand

family: Levack

full_name: William MM Levack

given: William MM

name: Department of Data Science; The Institute of Statistical Mathematics; Tokyo Japan

family: Noma

full_name: Hisashi Noma

given: Hisashi

journal_name: Cochrane Database of Systematic Reviews

ReferenceCitation: Girerd S, Frimat L, Ducloux D, Le Meur Y, Mariat C, Moulin B, Mousson C, Rieu P, Dali-Youcef N, Merckle L, Lepage X, Rossignol P, Girerd N, Jaisser F. EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial. Trials. 2018 Oct 30;19(1):595. doi: 10.1186/s13063-018-2956-1.

family: Girerd

full_name: Sophie Girerd

given: Sophie

family: Frimat

full_name: Luc Frimat

given: Luc

family: Ducloux

full_name: Didier Ducloux

given: Didier

family: Le Meur

full_name: Yannick Le Meur

given: Yannick

family: Mariat

full_name: Christophe Mariat

given: Christophe

family: Moulin

full_name: Bruno Moulin

family: Mousson

full_name: Christiane Mousson

given: Christiane

family: Rieu

full_name: Philippe Rieu

given: Philippe

family: Dali-Youcef

full_name: Nassim Dali-Youcef

given: Nassim

family: Merckle

full_name: Ludovic Merckle

given: Ludovic

family: Lepage

full_name: Xavier Lepage

given: Xavier

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

full_name: Nicolas Girerd

given: Nicolas

family: Jaisser

full_name: Frédéric Jaisser

given: Frédéric

currency_apc_doaj: GBP

location_facility:
CHRU Besançon
CHU Saint Etienne
CHU Reims-Hôpital Maison Blanche
CHU Dijon- Hôpital Bocage Central
CHU Brest
NHC -CHRU Strasbourg
CHRU de Nancy


title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

acronym: IEI-CEM

summary: The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

location_facility: Service de Pathologie Professionnelle, Hôpital Cochin, Hôpitaux Universitaires Paris Centre


title: The Effect of the Probiotic Bifidobacterium Animalis Ssp. Lactis 420 (B420) on Body Fat Mass in Overweight and Obese Individuals Following Healthy Lifestyle Intervention: A Randomized, Double-blind, Placebo-controlled, Multi-center Study

acronym: QLSlimCapHL

summary: A randomized, double-blind, placebo-controlled, multi-center, parallel group study on overweight and obese individuals following healthy lifestyle consisting of calorie-reduced diet (20% calorie restriction) and increase in daily activity (1000 steps more per day once compared to the baseline steps)

lead_sponsor: Danisco France SAS

location_country: France Spain

location_facility:
CAP Hostalets
CAP Perelada
CAP Centelles
CAP Muralles
CEN nutriment
Eurofins Optimed
Biofortis SAS
Cap Vallcarca

intervention_type: Dietary Supplement


title: A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine

summary: A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.

status: Withdrawn

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital Edouard Heriot, dpt Hématologie Clinique

location_facility: Centre Hospitalier Universitaire de STRASBOURG

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: Optimizing Prophylaxis in Patients With Severe Haemophilia A by Tailoring the Infusions to Individual Patients' Needs Using the Calibrated Automated Thrombin Generation Test

acronym: OPTIPHASE

summary: Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint destruction. In 1960s, prophylactic therapy was developed involving the infusion of clotting factor on a regular schedule in order to keep clotting levels sufficiently high to prevent spontaneous bleeding episodes. Prophylaxis is started at an early age before the age of 2 years or after the first joint bleed. The Malmö experience indicates that treatment is most effective when administered in large doses at least 3 times weekly. However, such an intensive treatment in young boys may be very difficult to carry out for home treatment. Currently, there is no international recommendation on prophylactic therapy regimens. Because of the high cost and limited availability of factor concentrates, dosing is an important issue in prophylaxis therapy. It was recently shown that 24 hours after FVIII concentrate administration, in patients presenting similar FVIIII levels, thrombin generation capacity may be significantly different. In addition, independently of the FVIII level, a correlation was found between severe clinical bleeding phenotype and thrombin generating capacity. The aim of the present clinical study is to assess the thrombin generation test as the main surrogate marker to evaluate the coagulating capacity of haemophiliacs on prophylaxis regimen. Optimizing prophylactic therapy to patient's phenotype with no loss of clinical effectiveness can significantly improve patients' quality of life, protect haemophilic children against arthropathy and possibly limit the cost of the prophylaxis therapy.

lead_sponsor: Hospices Civils de Lyon


title: Impact of the Restrictive Visiting Policy During the Covid-19 Pandemic on Anxiety, Depression and Post-traumatic Stress Disorder for Relatives of ICU Patients

acronym: HAD-Covid

summary: To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CH Vichy
CH Grenoble
Centre Jean Perrin
University hospital, Clermont-Ferrand
University hopistal, Lyon
CH Rodez
CH Cannes
CH Aurillac
CH Moulins
CH Le Puy-en-Velay
CH Périgueux


title: Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

acronym: MIVAR

summary:
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.

Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.

This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

ReferenceCitation: Lasocki S, Bruckert V, Campfort M, Leger M, Rineau E. Restrictive transfusion targets the heart now! Insight from the REALITY study. Anaesth Crit Care Pain Med. 2021 Apr;40(2):100854. doi: 10.1016/j.accpm.2021.100854. Epub 2021 Mar 27.

family: Lasocki

full_name: Sigismond Lasocki

given: Sigismond

family: Bruckert

full_name: Vincent Bruckert

given: Vincent

family: Campfort

full_name: Maeva Campfort

given: Maeva

family: Leger

full_name: Maxime Leger

given: Maxime

family: Rineau

full_name: Emmanuel Rineau

given: Emmanuel

journal_name: Anaesthesia Critical Care & Pain Medicine

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
Hôpital de Hautepierre
Hôpital Gui de Chauliac
Hôpital Gabriel Montpied
CHU Nantes
CHU Rennes


title: Phase II Evaluating the Efficacy of the Dual Inhibition of Phosphoinositide 3 Kinase (PI3K)/Akt /Mammalian Target Of Rapamycine (mTOR) Signaling Pathway by PF-05212384 (PKI-587) for Patients With Myeloid Neoplasm Secondary to Chemo-radiotherapy (t-AML/MDS) or de Novo Relapsed or Refractory AML.

acronym: LAM-PIK

summary: Phase II open-label single-arm prospective multicentric clinical trial of PF-05212384 (PKI-587) delivered by intravenous route. A 2-stage Fleming design will be employed.

lead_sponsor: Institut Curie

location_facility:
Institut Paoli Calmette
Hôpital Cochin
Institut Curie - Hôpital René Huguenin
Hôpital Saint-Louis
CHU de Toulouse


title: Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

acronym: APT'x

summary: Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Clermont-Ferrand, CHU Site Gabriel-Montpied


title: Multicentric Phase II Trial of Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS / GETUG P07)

acronym: OLIGOPELVIS

summary: There is an increasing number of reports describing the existence of a proportion of prostate cancer patients who present with a reduced number of metastases (<5 lesions) at relapse. This oligometastatic status has also been recognized in other tumor types such as melanoma, soft tissue sarcoma, liver, lung, and breast cancer, and has influenced the management of these malignancies in that a more radical treatment such as surgical resection has been employed. Positron Emission Tomography-Computed Tomography (PET-CT) studies with tracers such as choline or acetate are reliable tools to help with the diagnosis of oligometastatic disease after biochemical treatment failure in prostate cancer. An aggressive treatment combining androgen depriving therapy (ADT) and and high-dose irradiation to the oligometastatic lesions, as detected by PET-CT, may be proposed for these oligometastatic patients. Such a treatment strategy may hypothetically succeed to prolong the failure-free interval between two consecutive ADT courses, or even cure selected patients with limited metastatic burden. In this study the investigators plan to assess biochemical or clinical relapse-free survival at 2 years of prostate cancer with 1-5 oligometastases treated concomitantly with high-dose conformal Radiation Therapy and LH-RH agonists.

ReferenceCitation: Supiot S, Rio E, Pacteau V, Mauboussin MH, Campion L, Pein F. OLIGOPELVIS - GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer. BMC Cancer. 2015 Sep 25;15:646. doi: 10.1186/s12885-015-1579-0.

family: Supiot

full_name: Stephane Supiot

given: Stephane

family: Rio

full_name: Emmanuel Rio

family: Pacteau

full_name: Valérie Pacteau

given: Valérie

family: Mauboussin

full_name: Marie-Hélène Mauboussin

given: Marie-Hélène

family: Campion

full_name: Loïc Campion

given: Loïc

family: Pein

full_name: François Pein

given: François

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: OLIGOPELVIS – GETUG P07: a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer

ReferenceCitation: Ploussard G, Almeras C, Briganti A, Giannarini G, Hennequin C, Ost P, Renard-Penna R, Salin A, Lebret T, Villers A, Soulié M, de la Taille A, Flamand V. Management of Node Only Recurrence after Primary Local Treatment for Prostate Cancer: A Systematic Review of the Literature. J Urol. 2015 Oct;194(4):983-8. doi: 10.1016/j.juro.2015.04.103. Epub 2015 May 9. Review.

name: Department of Urology, Saint Jean Languedoc Hospital, Toulouse, France

name: INSERM U955, Team 7, Paris Est University, Créteil, France

family: Ploussard

full_name: Guillaume Ploussard

given: Guillaume

family: Almeras

full_name: Christophe Almeras

name: Unit of Urology, Division of Oncology, Urological Research Institute, Istituti di Ricovero e Cura a Carattere Scientifico, Ospedale San Raffaele, Milan, Italy

family: Briganti

full_name: Alberto Briganti

given: Alberto

name: Department of Urology, University of Udine, Udine, Italy

family: Giannarini

full_name: Gianluca Giannarini

given: Gianluca

name: Department of Radiation Oncology, Saint Louis Hospital, Paris 7 University, Paris, France

family: Hennequin

full_name: Christophe Hennequin

name: Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium

family: Ost

full_name: Piet Ost

given: Piet

name: Department of Radiology, Pitié Salpétrière Hospital, Paris 6 University, Paris, France

family: Renard-Penna

full_name: Raphaële Renard-Penna

given: Raphaële

family: Salin

full_name: Ambroise Salin

given: Ambroise

name: Department of Urology, Foch Hospital, Université Versailles St. Quentin en Yvelines, Suresnes, France

family: Lebret

full_name: Thierry Lebret

given: Thierry

name: Department of Urology, Lille University Medical Center, Lille University France, Lille, France

family: Villers

full_name: Arnauld Villers

name: Department of Urology, Rangueil Hospital, University of Toulouse, Toulouse, France

name: Department of Urology, Mondor Hospital, Paris Est University, Créteil, France

publisher: Ovid Technologies (Wolters Kluwer Health)


title: Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences

acronym: EMPHYREM

summary: Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.

ReferenceCitation: Benlala I, Berger P, Girodet PO, Dromer C, Macey J, Laurent F, Dournes G. Automated Volumetric Quantification of Emphysema Severity by Using Ultrashort Echo Time MRI: Validation in Participants with Chronic Obstructive Pulmonary Disease. Radiology. 2019 Jul;292(1):216-225. doi: 10.1148/radiol.2019190052. Epub 2019 Jun 4.

family: Benlala

full_name: Ilyes Benlala

given: Ilyes

family: Berger

full_name: Patrick Berger

given: Patrick

family: Girodet

full_name: Pierre-Olivier Girodet

given: Pierre-Olivier

family: Dromer

full_name: Claire Dromer

given: Claire

family: Macey

full_name: Julie Macey

given: Julie

family: Laurent

full_name: François Laurent

family: Dournes

full_name: Gaël Dournes

given: Gaël

journal_name: Radiology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Radiological Society of North America (RSNA)

lead_sponsor: University Hospital, Bordeaux


title: Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease

acronym: PIMPARK

summary:
There is no consensus on the treatment of Impulse Control Disorder (ICD) in Parkinson Disease (PD) though it is recommended to reduce the dosage of dopamine agonists (DA).

Reduction of DA frequently leads to a worsening of motor signs (parkinsonism or dyskinesias due to the concomitant increase of levodopa doses) and non-motor signs with the appearance of a DA withdrawal syndrome (DAWS).

Chronic stimulation of the sub-thalamic nuclei may reduce ICD but is restricted to a minority of patients and cases of new-onset ICD symptoms post stimulation have been reported. The benefit of amantadine in pathological gambling is controversial and the efficacy of clozapine has been reported in a few cases but with serious safety limitations. Very recently, naltrexone did not significantly improve ICD.

Thus, an efficacious and safe treatment of ICD in PD remains an unmet need for clinical practice.

Recently, it has been reported that pimavanserin, a selective serotonin 5-HT2A inverse agonist with a satisfactory safety profile without motor side effects, was efficient in improving psychosis, insomnia and day-time sleep in PD.

Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

The link between serotonin and ICD has been well established, since the enhancement of 5HT2A receptors stimulation is associated to ICD, since serotonin modulates mesolimbic dopaminergic reward system transmission and given that serotonin neurotransmission is increased during chronic intake of dopamine agonist such as pramipexole which is well-known to induce ICD in PD patients. Thus, there is a large body of evidence suggesting that the decrease of the 5HT2A activity could be efficient in reducing ICD in PD. This further supports the concept of testing the efficacy of pimavanserin (a selective 5HT2A inverse agonist) for treating ICD in PD. Our aim is to conduct a study evaluating the efficacy and safety of pimavanserin on ICD in PD.

This clinical trial is conducted with the support of the French NS-Park/FCRIN (French Clinical Research Infrastructure Network) network.

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, Hopital Henri Mondor

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Grenoble Alpes

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Limoges

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rouen, Hopital Charles Nicolle

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson CHU Clermont-Ferrand, Hopital Gabriel Montpied

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Nantes, Hopital Laennec

location_facility: SERVICE DE NEUROLOGIE Centre Expert Parkinson Hopital de la Pitié-Salpêtrière

location_facility: SERVICE DE NEUROLOGIE Unité de Mouvements Anormaux/Centre expert Parkinson, CHU de Strasbourg, Hopital de Hautepierre

location_facility: Centre d'Inverstigation Clinique, CHU de Poitiers

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, Hopital de la Timone

location_facility: SERVICE DE NEUROLOGIE C, Unité mouvement anormaux/Centre expert Parkinson, CHU de Lyon, Hopital neurologique Pierre Wertheimer

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CHU de Rennes, Hopital Pontchaillou

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvement Anormaux/Centre expert Parkinson, CHU de Lille, Hopital Roger Salengro

location_facility: SERVICE DE NEUROLOGIE, Unité Mouvements Anormaux/Centre expert Parkinson, CIC, CHU de Toulouse, Hopital Pierre-Paul Riquet

intervention_type: Behavioral


title: Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease

acronym: FIREBROB

summary:
Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.

Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.

Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of COPD and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.

ReferenceCitation: Dupin I, Allard B, Ozier A, Maurat E, Ousova O, Delbrel E, Trian T, Bui HN, Dromer C, Guisset O, Blanchard E, Hilbert G, Vargas F, Thumerel M, Marthan R, Girodet PO, Berger P. Blood fibrocytes are recruited during acute exacerbations of chronic obstructive pulmonary disease through a CXCR4-dependent pathway. J Allergy Clin Immunol. 2016 Apr;137(4):1036-1042.e7. doi: 10.1016/j.jaci.2015.08.043. Epub 2015 Oct 23.

family: Dupin

full_name: Isabelle Dupin

given: Isabelle

family: Allard

full_name: Benoit Allard

given: Benoit

family: Ozier

full_name: Annaig Ozier

given: Annaig

family: Maurat

full_name: Elise Maurat

given: Elise

family: Ousova

full_name: Olga Ousova

given: Olga

family: Delbrel

full_name: Eva Delbrel

given: Eva

family: Trian

full_name: Thomas Trian

given: Thomas

family: Bui

full_name: Hoang-Nam Bui

given: Hoang-Nam

family: Guisset

full_name: Olivier Guisset

given: Olivier

family: Blanchard

full_name: Elodie Blanchard

given: Elodie

family: Hilbert

full_name: Gilles Hilbert

given: Gilles

family: Vargas

full_name: Frédéric Vargas

given: Frédéric

family: Thumerel

full_name: Matthieu Thumerel

given: Matthieu

family: Marthan

full_name: Roger Marthan

given: Roger

journal_name: Journal of Allergy and Clinical Immunology


title: Clinical Study of a Single Ciliopathy: Alström Syndrome

summary:
The aim of the study is to characterize the clinical manifestations of ALMS within the ciliopathies to prevent complications and determine preventive and therapeutic targets.

The investigators believe that the clinical consequences of mutations in the gene result ALMS1 unprecedented protests and the ALMS study should help to be informed, not only about the understanding and decision support other ciliopathies, but also about some common diseases, as some physiopathogenic roads could be common; the rare disease being exacerbated a model of the channel concerned. Secondarily, the clinical data generated by this project will also be used as part of basic research (eg comparison with results in animal models, use of human cells for in vitro studies or transcriptomic ....) (which will be a secondary upgrading to this work).

location_facility: Service de physiologie et des Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service d'Imagerie 1, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Cardiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de néphrologie et hémodialyse, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de Médecine Interne, Endocrinologie et Nutrition, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Clinique Psychiatrique, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service d'ORL et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Psychothérapie pour Enfants et Adolescents, Hôpital Civil, Hôpitaux Universitaires

location_facility: Centre d'Investigation Clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires

location_facility: Service de Pédiatrie 1, Hôpital de Hautepierre, Hôpitaux Universitaires

location_facility: Service de Génétique Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires


title: Study of the Benefit / Risk Ratio of Oral Anticoagulation in Hemodialysis Patients With Atrial Fibrillation

acronym: AVKDIAL

summary:
Guidelines recommend oral anticoagulation with vitamin K antagonists for atrial fibrillation whenever the CHADS2VASC score is superior or equal to 2. As there are no specific guidelines for the hemodialysis patients with atrial fibrillation, the general guidelines apply. However, several retrospective studies suggest that these patients do not benefit from the oral anticoagulation regarding the risk of stroke and may even experience more bleedings and deaths.

The aim of this prospective study is to prospectively compare the hemorrhagic and thrombotic risks of oral anticoagulation in comparison with no anticoagulation in hemodialysis patients with atrial fibrillation.

location_facility: Centre Hospitalier de Haguenau - service de Néphrologie

location_facility: Service Néphrologie, Dialyse, Transplantation

location_facility: Service de Néphrologie et médecine interne


title: An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products

summary:
The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.

The secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.

The primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.

Each test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.

The subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.

100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.

lead_sponsor: Coloplast A/S

location_country: Denmark Germany France Iceland

location_facility:
Hôpital Nord
Sygehus Sønderjylland i Aabenraa
Hôpital de Pontchaillou, CHRU de Rennes
Sanitätshaus Fürst GmbH
Bispebjerg Hospital
Hôpital Hôtel Dieu de Nantes
Odense Universitetshospital
Landspitali University Hospital
CHRU La Milétrie
Hvidovre Hospital
Hôpital Lariboisière


title: Metabolic Efficiency of Combined Pancreatic Islet and Lung Transplant for the Treatment of End-Stage Cystic Fibrosis : a Pilot Study

acronym: PIM

summary: Patients with end-stage cystic fibrosis (CF) and severe CF-related diabetes (CFRD) may benefit from combined lung-pancreatic islet transplantation. A recent case series showed that combined bilateral lung and pancreatic islet transplantation is a viable therapeutic option for patients with end-stage CF and CFRD. The use of different organs from a single donor may lead to reduced immunogenicity. As the prevalence of CFRD has increased dramatically with the improved life expectancy of patients with CF, islet transplantation should be considered at the end-stage CF. By restoring metabolic control, the investigators hypothesize that islet transplantation may improve the management of CF patients undergoing lung transplant and decrease the complication rate in the early postoperative period.

location_facility: Service de la Clinique d'Endocrinologie, maladies métaboliques et Nutrition

location_facility: Service de pneumologie, Nouvel Hôpital Civil

location_facility: Service de chirurgie, Nouvel Hôpital Civil

location_facility: Service d'Anesthésie-Réanimations chirurgicales, Nouvel Hôpital Civil

location_facility: Unité d'Endocrinologie, Diabétologie et Médecine Métabolique - Hôpital Foch

location_facility: Service d'imagerie radiologique et de médecine nucléaire, Centre Hospitalier Lyon-Sud

location_facility: Service d'Endocrinologie, Pavillon médical

location_facility: CRCM adulte, Centre Hospitalier Lyon-Sud

location_facility: Service de Radiologie Interventionnelle, CHU de Grenoble

location_facility: Service de Radiologie, Hôpital de Hautepierre

location_facility: Service d'Endocrinologie, CHU de Grenoble

location_facility: Service d'endocrinologie, diabète et maladies métaboliques

location_facility: Service de Chirurgie Thoracique, HOPITAL LOUIS PRADEL

location_facility: Service de Chirurgie Thoracique et Transplantation Pulmonaire - Hôpital Foch

location_facility: Réanimation Cardiovasculaire et Thoracique, Hôpital Michallon

location_facility: Service de pneumologie, Hôpital Louis Pradel

location_facility: Service de Chirurgie Cardiaque, CHU Grenoble

location_facility: CRCM AdulteCHU de Grenoble, Hôpital A. Michallon

location_facility: Service de Pneumologie, Hôpital A. MICHALLON , CHU de Grenoble

location_facility: Service d'Urologie et chirurgie de la Transplantation, Groupement Hospitalier Edouard Herriot

location_facility: Service de médecine de la transplantation et immunologie clinique, Hôpital Edouard Herriot

location_facility: Service de Néphrologie et Immuno-transplantation


title: A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis

summary: The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.

lead_sponsor: Pierre Fabre Dermo Cosmetique


title: Study of the Effects of Mindfulness on Impulsive Eating, Motivation Toward Exercise, and Weight Loss in Obese Patients: Randomized Controlled Trial

acronym: MindOb

summary: The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.

ReferenceCitation: Ruffault A, Carette C, Lurbe I Puerto K, Juge N, Beauchet A, Benoliel JJ, Lacorte JM, Fournier JF, Czernichow S, Flahault C. Randomized controlled trial of a 12-month computerized mindfulness-based intervention for obese patients with binge eating disorder: The MindOb study protocol. Contemp Clin Trials. 2016 Jul;49:126-33. doi: 10.1016/j.cct.2016.06.012. Epub 2016 Jun 29.

family: Ruffault

full_name: Alexis Ruffault

given: Alexis

family: Carette

full_name: Claire Carette

given: Claire

family: Lurbe i Puerto

full_name: Kàtia Lurbe i Puerto

given: Kàtia

family: Juge

full_name: Nicolas Juge

given: Nicolas

family: Beauchet

full_name: Alain Beauchet

given: Alain

family: Benoliel

full_name: Jean-Jacques Benoliel

given: Jean-Jacques

family: Lacorte

full_name: Jean-Marc Lacorte

given: Jean-Marc

family: Fournier

full_name: Jean F. Fournier

given: Jean F.

family: Czernichow

full_name: Sébastien Czernichow

given: Sébastien

family: Flahault

full_name: Cécile Flahault

given: Cécile

journal_name: Contemporary Clinical Trials

oa_host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

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

lead_sponsor: University of Paris 5 - Rene Descartes

location_facility: Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris


title: Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Laparoscopic Abdominal, Gynecological and Urological Surgery

acronym: NOBLE-Laparo

summary: A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.

lead_sponsor: Biom'Up France SAS

location_country: Austria Germany France

location_facility: Kliniken der Stadt Koln, Krankenhaus Merheim


title: Randomized Clinical Trial Evaluating Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy: the PENTOCLO Trial

acronym: PENTOCLO

summary:
Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve complication of radiotherapy, that is spontaneously irreversible with no medical treatment to limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to assess a possible symptomatic regression by a sensory-motor neurological quantifiable and reproducible score (modified Subjective Objective Medical management Analytic, SOMA).

The investigators previously developed a successful PE treatment in symptomatic RI injuries via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a major significant radiation-induced fibrosis regression, then the PE clodronate combination (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50 partial RIP.

The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its tolerance in long survival patients irradiated before for cancer and presenting with partial RIP of upper or lower legs.

The investigators calculated to include 60 patients to show a significant clinical difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with prednisone 20 (2d/7) for all patients.

RIP is assessed before treatment and every 6 months by a standardized sensory-motor neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and various neurological scales of assessment (Visual Analog Scale for pain / VAS for paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS], muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and electrophysiology.

ReferenceCitation: Pradat PF, Maisonobe T, Psimaras D, Lenglet T, Porcher R, Lefaix JL, Delanian S. [Radiation-induced neuropathies: collateral damage of improved cancer prognosis]. Rev Neurol (Paris). 2012 Dec;168(12):939-50. doi: 10.1016/j.neurol.2011.11.013. Epub 2012 Jun 27. Review. French.

family: Pradat

full_name: P.-F. Pradat

family: Maisonobe

full_name: T. Maisonobe

given: T.

family: Psimaras

full_name: D. Psimaras

given: D.

family: Lenglet

full_name: T. Lenglet

family: Porcher

full_name: R. Porcher

given: R.

family: Lefaix

full_name: J.-L. Lefaix

family: Delanian

full_name: S. Delanian

given: S.

journal_name: Revue Neurologique

title: Neuropathies post-radiques : un dommage collatéral chez les patients cancéreux long-survivants

location_facility:
Hôpital Saint-Louis
Groupe Hospitalier Pitié-Salpêtrière


lead_sponsor: ANRS, Emerging Infectious Diseases

acronym: ANRS STIMAGO

type: EudraCT Number

source: euctr

title: Pilot Study to Evaluate the Benefits and the Risks of Methylphenidate for the Treatment of Cocaine Dependence

summary: This phase II pilot study aims at evaluating the benefits and the risks of methylphenidate (Concerta®) for the treatment of cocaine/crack dependence in terms of cocaine/crack use reduction and adverse events.


title: Place de l'Iode RadioActif Dans l'HyperThyroïdiE Sub-clinique (PIRHATES)/ Evaluation of the Interest of Subclinical Hyperthyroidism Treatment

summary: Objective: To determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Marie-Pierre Teissier
Jean-Louis Wemeau
Jacques Bringer
Pierre Lecomte
Jean-Marcel Brun
Jacques Orgiazzi
Brigitte Delemer
Philippe Caron
Laurence Leenhardt
Philippe Thiéblot
Richard Marechaud
Jean-Marc Kuhn
Bernard Conte-Delvox
Centre Paul Strauss
Hopitaux Universitaires de Strasbourg
Marc Klein
CH de Montbrison
Patrick Roger
Michel Rodier
Bruno Estour
Claire Schvartz


title: Micro and Macro Vascular Dysfunction Induced by Antiangiogenic Therapy: Identification of New Vascular Biomarkers (DYVA-AAGG)

acronym: DYVA-AAGG

summary: project is a pilot prospective, longitudinal, before-after, open label multicentric study.


title: The VICTORIA Study (Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation) Comparison Anti-vitamin K Versus Anti-Xa.

acronym: VICTORIA

summary: The VICTORIA Study (Vascular CalcIfiCation and sTiffness induced by ORal antIcoAgulation) is a comparative, parallel, prospective, controlled and randomized study of the structural and functional impact of rivaroxaban versus anti-vitamin K drugs on the arterial vasculature.

ipd_sharing: Yes

ipd_sharing_description: Data and biological samples could be shared upon acceptance between both organizations


title: Prevention of Hepatitis B Virus Mother-to-Child Transmission (MTCT) From HIV-HBV Co-infected Pregnant Women by Use of Nucleosides/Nucleotides Analogues With Dual Activity During Pregnancy.

summary: Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

ReferenceCitation: Sellier PO, Schnepf N, Amarsy R, Maylin S, Lopes A, Mazeron MC, Flateau C, Morgand M, Ciraru-Vigneron N, Berthe A, Simoneau G, Evans J, Souak S, Matheron S, Benifla JL, Simon F, Bergmann JF. Short article: Hepatitis B virus status in children born to HIV/HBV coinfected women in a French hospital: a cross-sectional study. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):328-32. doi: 10.1097/MEG.0000000000000559.

family: Sellier

full_name: Pierre O. Sellier

given: Pierre O.

family: Schnepf

full_name: Nathalie Schnepf

given: Nathalie

family: Amarsy

full_name: Rishma Amarsy

given: Rishma

family: Maylin

full_name: Sarah Maylin

given: Sarah

family: Lopes

full_name: Amanda Lopes

given: Amanda

family: Mazeron

full_name: Marie-Christine Mazeron

given: Marie-Christine

family: Flateau

full_name: Clara Flateau

given: Clara

family: Morgand

full_name: Marjolaine Morgand

given: Marjolaine

family: Ciraru-Vigneron

full_name: Nicole Ciraru-Vigneron

given: Nicole

family: Berthe

full_name: Aurore Berthe

given: Aurore

family: Simoneau

full_name: Guy Simoneau

given: Guy

family: Evans

full_name: John Evans

given: John

family: Souak

full_name: Safia Souak

given: Safia

family: Matheron

full_name: Sophie Matheron

given: Sophie

family: Benifla

full_name: Jean-Louis Benifla

given: Jean-Louis

family: Simon

full_name: François Simon

given: François

family: Bergmann

full_name: Jean-François Bergmann

given: Jean-François

journal_name: European Journal of Gastroenterology & Hepatology

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Short article

lead_sponsor: Hopital Lariboisière


title: Prevention of Hepatitis B Virus (HBV) Mother-to-Child (MTC) Transmission by Serovaccination of Newborns and Use of Tenofovir DF During the Last Trimester of Pregnancy in Mothers With HBV DNA Above 100, 000 I.U/mL

summary: The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

primary_purpose: Prevention

ReferenceCitation: Sellier PO, Maylin S, Berçot B, Chopin D, Lopes A, Simoneau G, Evans J, Delcey V, Bénifla JL, Simon F, Bergmann JF. Prospective interventional study of tenofovir in pregnancy to prevent vertical transmission of hepatitis B in highly viremic women. Eur J Gastroenterol Hepatol. 2017 Mar;29(3):259-263. doi: 10.1097/MEG.0000000000000793.

family: Sellier

full_name: Pierre O. Sellier

given: Pierre O.

family: Berçot

full_name: Béatrice Berçot

given: Béatrice

family: Chopin

full_name: Dorothée Chopin

given: Dorothée

family: Delcey

full_name: Véronique Delcey

given: Véronique

family: Bénifla

full_name: Jean-Louis Bénifla


title: Comparative Study of Fluoride Metabolism, Bone Remodelling and Mineral Density in HIV + Men Being Given Tenofovir With FTC, Emtricitabine (TRUVADA®), or Without (VIREAD®), as Part of Their Antiretroviral Therapy.

summary:
HIV+ patients are considered at risk for excessive bone fragility. Several factors could contribute: age, male sex, low body mass index (BMI), HIV infection per se, vitamin D deficiency, using tenofovir/a protease inhibitor (time on and/or current use). Tenofovir is used in a backbone of nucleosides/nucleotides analogues with emtricitabine (FTC), licensed as TRUVADA®, or without this analogue, licensed as VIREAD®. FTC closely resembles lamivudine (3TC) but is 5-fluorinated, the daily intake of fluoride is ~15 mg. Fluoride induces bone formation by stimulating osteoblasts, of often impaired bone quality.

The aim of the study is to compare in a cross-sectional design fluoride levels, bone renewal, bone mineral density (BMD) in HIV+ male patients treated by TRUVADA® or VIREAD® for more than 60 months. The patients will be randomly selected, then matched according to age, ethnic origin, BMI.


title: Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration

summary: The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.

ReferenceCitation: Medioni J, Brizard M, Elaidi R, Reid PF, Benlhassan K, Bray D. Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study. Contemp Clin Trials Commun. 2017 Jul 23;7:186-188. doi: 10.1016/j.conctc.2017.07.008. eCollection 2017 Sep.

lead_sponsor: Celtic Biotech Ltd


summary:
Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a promising preventive effect of glyceryl nitrate. This study should provide a final answer to the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a prospective, randomized, double blind, placebo-controlled multicenter trial. The investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France.

The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours). Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis; post procedure pancreatitis-related mortality; and adverse events.

ReferenceType: result

ReferenceCitation: Freeman ML. Post-ERCP pancreatitis: patient and technique-related risk factors. JOP. 2002 Nov;3(6):169-76. Review.

ReferenceCitation: Demols A, Deviere J. New frontiers in the pharmacological prevention of post-ERCP pancreatitis: the cytokines. JOP. 2003 Jan;4(1):49-57. Review.

ReferenceCitation: Testoni PA. Preventing post-ERCP pancreatitis: where are we? JOP. 2003 Jan;4(1):22-32. Review.

ReferenceCitation: Mariani A. Pharmacological prevention of post-ERCP pancreatitis: which therapy is best? JOP. 2003 Jan;4(1):68-74. Review.

ReferenceCitation: Murray B, Carter R, Imrie C, Evans S, O'Suilleabhain C. Diclofenac reduces the incidence of acute pancreatitis after endoscopic retrograde cholangiopancreatography. Gastroenterology. 2003 Jun;124(7):1786-91.

ReferenceCitation: Sand J, Nordback I. Prospective randomized trial of the effect of nifedipine on pancreatic irritation after endoscopic retrograde cholangiopancreatography. Digestion. 1993;54(2):105-11.

ReferenceCitation: Sudhindran S, Bromwich E, Edwards PR. Prospective randomized double-blind placebo-controlled trial of glyceryl trinitrate in endoscopic retrograde cholangiopancreatography-induced pancreatitis. Br J Surg. 2001 Sep;88(9):1178-82.

ReferenceCitation: Moretó M, Zaballa M, Casado I, Merino O, Rueda M, Ramírez K, Urcelay R, Baranda A. Transdermal glyceryl trinitrate for prevention of post-ERCP pancreatitis: A randomized double-blind trial. Gastrointest Endosc. 2003 Jan;57(1):1-7.

ReferenceCitation: Harrison LI, Riedel DJ, Machacek JH, Crowley JK, Kanniainen CM, Hoglin JA, Robison TS, Zumhofe JM. Bioequivalence Comparison of Two Drug-in-Adhesive Transdermal Nitroglycerin Patches. Am J Ther. 1996 Aug;3(8):580-585.

ReferenceCitation: Pande H, Thuluvath P. Pharmacological prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis. Drugs. 2003;63(17):1799-812. Review.

ReferenceCitation: Freeman ML. Prevention of post-ERCP pancreatitis: pharmacologic solution or patient selection and pancreatic stents? Gastroenterology. 2003 Jun;124(7):1977-80.

ReferenceCitation: Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. Review.

ReferenceCitation: Nøjgaard C, Hornum M, Elkjaer M, Hjalmarsson C, Heyries L, Hauge T, Bakkevold K, Andersen PK, Matzen P; European Post-ERCP Pancreatitis Preventing Study Group. Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial. Gastrointest Endosc. 2009 May;69(6):e31-7. doi: 10.1016/j.gie.2008.11.042.

family: Nøjgaard

full_name: Camilla Nøjgaard

given: Camilla

family: Hornum

full_name: Mads Hornum

given: Mads

family: Elkjaer

full_name: Margarita Elkjaer

given: Margarita

family: Hjalmarsson

full_name: Claes Hjalmarsson

given: Claes

family: Heyries

full_name: Laurent Heyries

given: Laurent

family: Hauge

full_name: Truls Hauge

given: Truls

family: Bakkevold

full_name: Kåre Bakkevold

given: Kåre

family: Andersen

full_name: Per Kragh Andersen

given: Per Kragh

family: Matzen

full_name: Peter Matzen

given: Peter

journal_name: Gastrointestinal Endoscopy

lead_sponsor: Hvidovre University Hospital

location_country: Denmark Norway Sweden France

location_facility: Div of Gastroenterology, dept. of Int Medicine Affiliated Hospital University of Oslo, Østfold Fredrikstad

location_facility: Serv Gastroenterologie Hopital Sainte Marguerite

location_facility: Helse Fonna HF Haugesund Sjukehus Kirurgisk - vest blokk gastro

location_facility: Dept of Medical Gastroenterology S, Odense Universitetshospital

location_facility: Dept of Surgery, University Hospital Malmö

location_facility: Dept. of Medical Gastroenterology F, KAS Gentofte

location_facility: Department of Medical and Surgical Gastroenterology, KAS Glostrup


title: A Multi-Centre, Open Label, Phase II Study of the Safety, Efficacy and Pharmacokinetic (PK) Profile of CAP-232 Administered Through Continuous Intravenous Infusion in Patients With Metastatic Kidney Cancer

summary: The purpose of this study was to evaluate the safety and efficacy of CAP-232 in the treatment of patients with previously treated (refractory) renal cell carcinoma

ReferenceCitation: Tejeda M, Gaál D, Hullán L, Hegymegi-Barakonyi B, Kéri G. Evaluation of the antitumor efficacy of the somatostatin structural derivative TT-232 on different tumor models. Anticancer Res. 2006 Sep-Oct;26(5A):3477-83.

ReferenceCitation: Tejeda M, Gaál D, Hullán L, Csuka O, Schwab R, Szokoloczi O, Kéri G. A comparison of the tumor growth inhibitory effect of intermittent and continuous administration of the somatostatin structural derivative TT-232 in various human tumor models. Anticancer Res. 2006 Jul-Aug;26(4B):3011-5.

ReferenceCitation: Gyergyay F, Gödény M, Sármay G, Kralovanszky J, Papp E, Gergye M, Vincze B, Kéri G, Bodrogi I : Antitumor activity and pharmacology of TT-232 (a novel somatostatin structural derivative) in malignant melanoma patients JCO, 2004 ASCO Annual Meeting Proceedings Vol 22, No 14S (July 15 Supplement), 2004: 3151

lead_sponsor: Thallion Pharmaceuticals

location_facility:
CRLC Val d'Aurelle Paul-Lamarque
Institut de Cancérologie de la Loire


title: Advantage of Using Intraoperative Visual Evoked Potentials to Preserve Visual Function During Surgical Procedures Near the Optical Pathways

acronym: VISUOPEV

summary:
Visual morbidity (visual acuity and/or visual field deficit) must be taken into account during neurosurgical procedures for lesions near the optical pathways. Part of this morbidity is due to surgical manipulation. There is no validated tool for intraoperative visual monitoring and few publications have studied this issue.

In a preliminary work based on analysis of these publications, we defined technical, anaesthetic and analytical parameters in order to optimise intraoperative visual evoked potentials monitoring. These parameters are special devices used for transpalpebral stimulation, complete intravenous anaesthesia without halogen or nitrous oxide, and pertinent analysis criteria of visual evoked potential (VEP). We suppose that these improvements will increase reliability of intraoperative VEP.


title: Continuous Popliteal Sciatic Nerve Block Interest in Postoperative Pain Management for Patients With Leg Amputation

acronym: CAPDAF

summary:
Analgesia following leg amputation is based on morphine administration. For elderly patients of ASA physical status 2 or 3, morphine sparing is possible when perinervous block techniques are used. Phantom limb pain complicates leg amputation in 50 to 80% of cases. Prevention of these pains has been studied in various clinical trials but the interest of perinervous block technique remains to be evaluated.

The purpose of the study is to evaluate the benefit of perioperative locoregional analgesia by ropivacaine via a popliteal sciatic catheter on intravenous morphine consumption during the 72 first postoperative hours following leg (below knee) amputation The study will be randomized, double blinded, controlled clinical trial and 84 patients undergoing leg amputation (below knee) will be included Patients will be divided into 2 groups: one group of patients who will benefit perioperative locoregional analgesia by ropivacaine via a popliteal sciatic catheter and morphine for analgesia and the other one who will benefit placebo through the catheter and morphine.

The investigators will evaluate the efficacy of the continuous popliteal sciatic nerve block in postoperative analgesia after leg amputation and prove the efficacy of a perioperative analgesia by continuous popliteal sciatic nerve block to prevent phantom limb pain after leg amputation in patients of ASA physical status 2 or 3.

location_facility: Département d'anesthésie réanimation I, Hopital Pellegrin, CHU de Bordeaux


title: Assessment of the Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin. Multicentric, Double-Blinded, Randomized Study. ANRS HC18 Paropeg

summary: Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

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

location_facility: Service d'Hépato-gastroentérologie CHU de Nancy


title: Observational Cohort Study to Characterise the Current Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients Hospitalised in Intensive Care Units in Europe

summary:
The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients.

Study patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit.

Data of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).

ReferenceCitation: Hiesmayr M, Csomos A, Dams K, Elke G, Hartl W, Huet O, Krzych LJ, Kuechenhoff H, Matejovic M, Puthucheary ZA, Rooyackers O, Tetamo R, Tjäder I, Vaquerizo C. Protocol for a prospective cohort study on the use of clinical nutrition and assessment of long-term clinical and functional outcomes in critically ill adult patients. Clin Nutr ESPEN. 2021 Jun;43:104-110. doi: 10.1016/j.clnesp.2021.01.048. Epub 2021 Feb 12.

family: Hiesmayr

full_name: M. Hiesmayr

given: M.

family: Csomos

full_name: A. Csomos

given: A.

family: Dams

full_name: K. Dams

given: K.

family: Elke

full_name: G. Elke

given: G.

family: Hartl

full_name: W. Hartl

given: W.

family: Huet

full_name: O. Huet

given: O.

family: Krzych

full_name: L.J. Krzych

family: Kuechenhoff

full_name: H. Kuechenhoff

given: H.

family: Matejovic

full_name: M. Matejovic

family: Puthucheary

full_name: Z.A. Puthucheary

family: Rooyackers

full_name: O. Rooyackers

family: Tetamo

full_name: R. Tetamo

given: R.

family: Tjäder

full_name: I. Tjäder

given: I.

family: Vaquerizo

full_name: C. Vaquerizo

given: C.

journal_name: Clinical Nutrition ESPEN

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

lead_sponsor: Fresenius Kabi

location_country:
Italy
Austria
Sweden
France
Czechia
Poland
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: The Royal London Hospital, Barts Health NHS Trust & Queen Mary University of London

location_facility: Hospices Civils de Lyon - Hópital Edouard Herriot

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Clinic of Internal Medicine and Gastroenterology, University Hospital Brno

location_facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Hradec Králové

location_facility: Dél-Pesti Centrumkórház - National Institute of Hematology and Infectiology

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: University Hospital Olomouc Palacky University in Olomouc Faculty of Medicine and Dentistry

location_facility: Centre Hospitalier Régional Universitaire de Besançon

location_facility: Hospital Universitario de Fuenlabrada - Intensive Care Unit

location_facility: KRH Klinikum Siloah - Klinik für Gastroenterologie, Interventionelle Endoskopie und Diabetologie

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. Z o.o.

location_facility: Clinique Universitaire Saint-Luc - Université Catholique de Louvain (UCL)

location_facility: University of Debrecen - Department of Anaesthesiology and Intensive Therapy

location_facility: Klinikum Wetzlar-Braunfels - Klinik für Geriatrie

location_facility: UKSH Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Centre Hospitalier Universitaire de Saint-Étienne - Hopital Nord

location_facility: University Hospital Pilsen University Hospital in Pilsen (Fakultní nemocnice Plzeň: Úvodní strana)

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: 3rd Department of Internal Medicine - Metabolic Care and Gerontology, University Hospital Hradec Králové

location_facility: III Internal Gerontometabolic Clinic, University Hospital Hradec Králové

location_facility: Charité Universitatsmedizin - Medizinische Klinik mit Schwerpunkt Nephrologie und Internistische Intensivmedizin

location_facility: Karolinska University Hospital, PMI Huddinge, B31

location_facility: Hôpital Trousseau - Surgical Intensive Care Unit

location_facility: Hospital Center University of Caen Normandie

location_facility: Centre Hospitalier Universitaire de Grenoble - Hôpital Michallon

location_facility: Clinic of Anesthesiology, Resuscitation and Intensive Care, University Hospital Brno

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: 10 Wojskowy Szpital Kliniczny z Polikliniką w Bydgoszczy

location_facility: Hospital Universitario Dr Josep Trueta de Girona - Intensive Care Unit

location_facility: Charité Universitätsmedizin - Campus Benjamin Franklin

location_facility: Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois


title: Phase I Clinical Trial of Rapamycin and Irinotecan in Pediatric Patients With Refractory Solid Tumors

acronym: RAPIRI

summary: Therapeutic solutions to treat solid tumors that are resistant to conventional treatments are now limited. Laboratory data in animals (on pediatric tumors such as brain tumors, sarcomas and neuroblastomas) have shown that the combination of irinotecan (HIF1alpha inhibitor) and rapamycin (mTOR inhibitor) allowed to block development of blood vessels in the tumor and could, in some cases, stop its progression. This drug combination has already been tested in adult patients with refractory tumors and seems to give encouraging results with stabilization of the tumor. The dose and toxicity of irinotecan and rapamycin are known when these drugs are administered separately and in a context different from that of refractory tumors. RAPIRI is a phase I clinical trial whose principal objectives are to determine the maximum dose at which these two molecules may be administered and to assess the safety of this new combination of drugs.

location_facility: Hôpital des Enfants - Groupe Hospitalier Pellegrin

location_facility: Institut Hémato-Oncologie Pédiatrique (IHOP)


title: First Single-blind Sequential Placebo-controlled Prospective Phase IIA Pilot Study Assessing the Effects of PXT00864 in Mild AD Patients

acronym: PLEODIAL-I

summary: The purpose of this study is to assess the safety and efficacy on cognitive impairment and functioning of several doses of PXT00864 (new fixed combination of acamprosate and baclofen at low dose) in patients with mild Alzheimer Disease.

lead_sponsor: Pharnext SA


title: 24-week Open-label Extension Study Evaluating the Effect of PXT00864 in Mild Alzheimer's Disease Patients Further to PLEODIAL-I Completion

acronym: PLEODIAL-II

summary: PLEODIAL-II study is an extension of the previous pilot PLEODIAL-I study (CLN-PXT00864-03 protocol) and is designed for the descriptive analysis of patients with mild AD who are exposed to PXT00864 over an additional 24-week period.


summary: The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.

lead_sponsor: Pierre Fabre Medicament


title: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF

summary: Prevention trial of nosocomial infections in neutropenic prematures with G-CSF

ReferenceCitation: Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.

family: Kuhn

full_name: Pierre Kuhn

given: Pierre

family: Messer

full_name: Jean Messer

given: Jean

family: Paupe

full_name: Alain Paupe

given: Alain

family: Espagne

full_name: Sandrine Espagne

given: Sandrine

family: Kacet

full_name: Nadine Kacet

given: Nadine

family: Mouchnino

full_name: Genevieve Mouchnino

given: Genevieve

family: Klosowski

full_name: Serge Klosowski

given: Serge

family: Krim

full_name: Gérard Krim

given: Gérard

family: Lescure

full_name: Sandra Lescure

given: Sandra

family: Le Bouedec

full_name: Stephane Le Bouedec

given: Stephane

family: Meyer

full_name: Pierre Meyer

family: Astruc

full_name: Dominique Astruc

given: Dominique

journal_name: The Journal of Pediatrics

title: A Multicenter, Randomized, Placebo-Controlled Trial of Prophylactic Recombinant Granulocyte-Colony Stimulating Factor in Preterm Neonates with Neutropenia

location_facility:
Jean-Louis Demarquez
Pierre Andrini
Bernard Guillois
Alain Menget
Jean Messer
Marie Thieuleux
Jean-Bernard Gouyon
André Labbe
Xavier Hernandorena