title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

summary: This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.

ReferenceCitation: Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.

ReferenceCitation: Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7.


title: Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)

acronym: FARO

summary: Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: Data available under reasonable request

lead_sponsor: University Hospital, Angers

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Completed


title: Granulomatous-Lymphocytic Interstitial Lung Disease (GLILD) Diagnosed in Children and Young Adults With Common Variable Immunodeficiency

acronym: pGLILD

summary: 8 to 22% of patients with common variable immunodeficiency (CVID) will develop Granulomatous Lymphocytic Interstitial Lung Disease (GLILD), which has emerged as a major cause of mortality. Little is known about GLILD in children and young adults. The aim of this study was to describe the clinical, functional, radiological and pathological features of children and young adults diagnosed with GLILD.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Bates CA, Ellison MC, Lynch DA, Cool CD, Brown KK, Routes JM. Granulomatous-lymphocytic lung disease shortens survival in common variable immunodeficiency. J Allergy Clin Immunol. 2004 Aug;114(2):415-21.

ReferenceCitation: Park JH, Levinson AI. Granulomatous-lymphocytic interstitial lung disease (GLILD) in common variable immunodeficiency (CVID). Clin Immunol. 2010 Feb;134(2):97-103. doi: 10.1016/j.clim.2009.10.002. Epub 2009 Nov 8. Review.

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility:
Chu Besancon
CHRU Nancy
CHRU Bordeaux
Hôpital Necker Enfants Malades
Chru Dijon Bourgogne
CHU Montpellier

status_simplified: Unknown


title: Anti-tumor Specific Immune Response in Head and Neck Cancers

acronym: CORISAT

summary:
The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head & Neck Squamous Cell Carcinoma

Secondary purposes are:

Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);
Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS
Study of relationship between anti-tumor immune response and clinical stage as well as DFS.

time_perspective: Prospective

location_facility: Service ORL - Institut Louis Mathieu - CHRU NANCY

intervention_type: Other


type: Other Identifier

title: Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy

acronym: ECOST-CRT

summary: The primary objective is to determine whether comprehensive remote follow-up in HF patients with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure hospitalizations, whichever comes first, when compared to basic remote monitoring, over a 27-month follow-up.

status: Recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

lead_sponsor: University Hospital, Lille

status_simplified: Ongoing


intervention_type: Drug

status: Active, not recruiting

lead_sponsor: Federation Francophone de Cancerologie Digestive

primary_purpose: Treatment

acronym:
DURIGAST

 DURIGAST

location_facility:
Chu - Aphp - Hôpital Saint Louis
Privé - Clinique Capio Belharra
Ch - Centre Hospitalier de Bézier
Privé - Pôle Santé Léonard de Vinci
Chu - Hôpital Morvan
Ch - Hôpital Henri Duffaut
Chu - Hôpital La Miletrie
Chu - Hôpital Sud
Prive - Institut Montsouris
Chu - Hôpital Robert Debré
Privé - Clinique de L'Europe
Ch - Hôpital Germon Et Gauthier
Privé - Polyclinique Bordeaux Nord
Privé - Clinique Tivoli
Chu - Hôpital Côte de Nacre
Ch - Hôpital Claude Bernard
Privé - Clinique Sainte Catherine
Ch - Hôpital Côte Basque
Privé - Hôpital Privé D'Antony
Prive - Clinique Jean Mermoz
Ch - Hôpital Victor Dupouy
Ch - Centre Hospitalier de Carcassonne
Privé - Clinique Saint Côme
Privé - Clinique Des Cèdres
Ch - Hopitaux Civils de Colmar
Ch - Centre Hospitalier
Chu - Hôpital Estaing
Privé - Hôpital Privé Paul D'Egine
Privé - Clinique Maurice Tubiana
Privé - Infirmerie Protestante
Ch - Centre Hospitalier de Cholet
Chu - Hôpital Hôtel Dieu
Ch - Hôpital Duchenne
Ch - Chp Du Cotentin
Chu - Hôpital Jean Minjoz

type: EudraCT Number

source: euctr

title: A Randomized Phase II Study Evaluating FOLFIRI + Durvalumab vs FOLFIRI + Durvalumab and Tremelimumab in Second-line Treatment of Patients With Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

summary:
Gastric adenocarcinoma is the 4th most frequent cancer and the 2nd leading cause of cancer mortality. Most of the patients have metastatic, locally advanced or recurrent unresectable disease. So, systemic treatment remains an important issue especially since chemotherapy improves survival and quality of life (compared to best supportive care alone).

Second-line chemotherapy-based treatment improves overall survival (OS) as compared to best supportive care alone in patients with an acceptable general condition (performance status 0-2). Indeed, with docetaxel monotherapy there was a significant difference in overall survival for the chemotherapy arm with a median of 5.2 versus 3.6 months in best supportive care alone arm (HR=0.67, p=0.01). Irinotecan monotherapy also significantly improves overall survival compared to supportive care alone in a phase III study (4.0 versus 2.4 months; HR=0.48, 95%CI 0.25-0.92; p=0.012).

Based on a phase III trial FOLFIRI (5-FU plus irinotecan) is one most used regimen in second-line in European countries, especially in France. FFCD 0307 trial, a phase III comparing FOLFIRI-ECX (epirubicin-cisplatin-capecitabine) to the reverse sequence (ECX-FOLFIRI), showed that both sequences are possible.

Preliminary results in metastatic gastric cancer with anti-PD1 mAbs are highly promising. In a trial with pembrolizumab, only PD-L1 positive tumors were eligible to the treatment with a cut off at 1%. Thirty-nine patients were enrolled and 67% had received at least two prior chemotherapy regimens. The overall response rate was 22%. The median PFS and OS were 1.9 months and 11.4 months, respectively. KEYNOTE-059 Phase 2 multicohort study with pembrolizumab monotherapy in advanced gastric cancer treatment has been presented at ASCO 2017 meeting. Among 259 patients included in the trial response rate was 11.6%. OS was 5.6 months. Response rates were 15.5% in PDL1+ tumors versus 6.4% in PDL1- tumors and 57.1% in MSI tumors versus 9% in MSS tumors. Up until now, overlap between microsatellite instability and PD-L1 expression is unknown in gastric cancer. An anti-PD-L1 mAb (avelumab) was evaluated in a phase Ib expansion study (n=20, Japanese patients), with 15% of objective response rate and 11.9 weeks for progression-free survival. A second cohort with avelumab included 55 patients for maintenance therapy after first-line chemotherapy, with 7.3% of objective response rate and 14 weeks of PFS. Phase I/II CheckMate-032 evaluated nivolumab (anti-PD-1) ± ipilimumab (anti-CTLA4) at different doses in advanced gastric cancer (17). The overall response rate was between 8% to 24% and the median OS between 4.8 to 6.9 months according to treatment arm.

Others anti-PD1/anti-PD-L1/anti-CTLA4 mAbs are also currently under investigation in gastric cancer alone or in combination with chemotherapy. Nevertheless, up until now there is no published data concerning ICI plus chemotherapy in gastric cancer. The present randomized multicentric non-comparative phase II study aimed to assess the rate of patients alive and without progression at 4 months with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, pre-treated with fluoropyrimidine + platinum +/- taxane, with two arms Folfiri plus durvalumab versus Folfiri plus durvalumab plus tremelimumab. Indeed, most patients in the French multicentric first-line GASTFOX trial (506 patients planned between 2017 and 2020) can be included in the second-line setting in the DURIGAST trial. Due to the lack of data concerning Folfiri plus durvalumab plus tremelimumab combination, a safety run-in phase will be performed at the beginning of the DURIGAST trial.

lead_sponsor_type: industriel


title: Echocardiography and PEA Measurements in CRT Therapy

summary: This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.

lead_sponsor: LivaNova

location_facility:
Nouvelles Cliniques Nantaises
CHU Rennes
CHU Pontchaillou
Clinique Bizet


title: Evaluation of Diaphragmatic Function in Mechanically Ventilated Patients With Transient Shear Wave Elastography

acronym: Elasto-ICU

summary:
Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound.

Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Fossé Q, Poulard T, Niérat MC, Virolle S, Morawiec E, Hogrel JY, Similowski T, Demoule A, Gennisson JL, Bachasson D, Dres M. Ultrasound shear wave elastography for assessing diaphragm function in mechanically ventilated patients: a breath-by-breath analysis. Crit Care. 2020 Nov 27;24(1):669. doi: 10.1186/s13054-020-03338-y.

family: Fossé

full_name: Quentin Fossé

given: Quentin

sequence: first

family: Poulard

full_name: Thomas Poulard

given: Thomas

sequence: additional

family: Niérat

full_name: Marie-Cécile Niérat

given: Marie-Cécile

family: Virolle

full_name: Sara Virolle

given: Sara

family: Morawiec

full_name: Elise Morawiec

given: Elise

family: Hogrel

full_name: Jean-Yves Hogrel

given: Jean-Yves

family: Similowski

full_name: Thomas Similowski

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Gennisson

full_name: Jean-Luc Gennisson

given: Jean-Luc

family: Bachasson

full_name: Damien Bachasson

given: Damien

family: Dres

full_name: Martin Dres

given: Martin

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care

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: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device


title: Development of a New Non-radioactive Test for Measuring Glomerular Filtration Rate Using the Tetrapeptide N-acetyl-Ser-Asp-Lys-Pro-amide (AcSDKP-NH2)

summary: The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Mesmin C, Cholet S, Blanchard A, Chambon Y, Azizi M, Ezan E. Mass spectrometric quantification of AcSDKP-NH2 in human plasma and urine and comparison with an immunoassay. Rapid Commun Mass Spectrom. 2012 Jan 30;26(2):163-72. doi: 10.1002/rcm.5326.

name: CEA, iBiTec-S, Service de Pharmacologie et d'Immunoanalyse, laboratoire d'étude du métabolisme des médicaments; 91191; Gif-sur-Yvette Cedex; France

family: Mesmin

full_name: Cédric Mesmin

given: Cédric

family: Cholet

full_name: Sophie Cholet

given: Sophie

family: Blanchard

full_name: Anne Blanchard

given: Anne

family: Chambon

full_name: Yann Chambon

given: Yann

family: Azizi

full_name: Michel Azizi

given: Michel

family: Ezan

full_name: Eric Ezan

given: Eric

bso_classification: Chemistry

journal_name: Rapid Communications in Mass Spectrometry

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Clinical Investigation Center, European George Pompidou Hospital


title: Evaluation of the Impact of Personalized Pharmaceutical Collaborative Care Integrated to a Multidisciplinary Psychosocial Program on the Burden Felt by Caregivers of Elderly Patients With Alzheimer's Disease and Related Disorders and Evaluated at 18-month Follow-up

acronym: PHARMAID

summary:
Caring for patients with Alzheimer Disease or Related Disorders (ADRD) is accompanied with a caregiver burden that increases with the progression of the disease. This burden can have physical, psychological, emotional, social and financial issue on the informal caregivers who are often represented as hidden secondary patients. They frequently have a higher risk of developing mood disorders as depression, anxiety, stress, sleep disorders and a lower quality of life associated with a greater use of psychotropic drugs. They also incur higher risk of heart disease and mortality. The embrittlement of the caregiver is a major factor of early institutionalization of patient. In the PIXEL study, the mean age of the men caregivers was 73.9 years and 64.8 for the women caregivers. Elderly themselves, especially spouses, the informal caregivers are also exposed to common chronic diseases and associated polypharmacy with a higher risk of developing drug-related problems due to aging and negligence of their own health care. These risks are increased mainly in the elderly because of changes in pharmacokinetic and pharmacodynamic parameters related to aging, acute or chronic diseases and the potentially inappropriate prescription (PIP). Previous studies have shown the effectiveness and positive impact of optimization of the therapeutics by a clinical pharmacist on the reduction of drug-related problems, length of hospital stay, readmission rates, quality of life and mortality. The patient's medication management is usually delegated to the informal caregiver, who must also manage his own treatment. The caregiver may face difficulties with therapeutics (e.g., inappropriate dosage form, adverse effects and patient refusal) that could impact on its compliance with treatment or that of his relative. No previous study has evaluated the impact of pharmaceutical collaborative care including personalized interview with a clinical pharmacist and optimization of drug prescribing among patients with ADRD and their caregivers.

However, many studies have assessed the effectiveness of non-pharmacological interventions on caregiver burden, mood disorders and the patient institutionalization. Meta-analysis showed a moderate improvement of the caregiver burden.

The main objective of the PHARMAID study is to measure the impact of personalized pharmaceutical collaborative care integrated to a multidisciplinary psychosocial program on the burden of ADRD caregivers and assessed at 18-month follow-up.

primary_purpose: Health Services Research

ReferenceCitation: Novais T, Moutet C, Delphin-Combe F, Dauphinot V, Colin C, Krolak-Salmon P, Mouchoux C; PHARMAID study group. PHARMAID study protocol: Randomized controlled trial to assess the impact of integrated pharmaceutical care at a psychosocial intervention on caregiver's burden in Alzheimer's disease or related diseases. Contemp Clin Trials. 2017 Feb;53:137-142. doi: 10.1016/j.cct.2016.12.020. Epub 2016 Dec 19.

family: Novais

full_name: T. Novais

given: T.

family: Moutet

full_name: C. Moutet

given: C.

family: Delphin-Combe

full_name: F. Delphin-Combe

given: F.

family: Dauphinot

full_name: V. Dauphinot

given: V.

family: Colin

full_name: C. Colin

family: Krolak-Salmon

full_name: P. Krolak-Salmon

given: P.

family: Mouchoux

full_name: C. Mouchoux

journal_name: Contemporary Clinical Trials

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Pharmacy unit and Clinical Research Center VCF (" Aging Brain Frailty ") University hospital of Lyon, Charpennes Hospital / University Lyon / INSERM, U1028; CNRS, UMR5292; Lyon Neuroscience Research Center


type: Registry Identifier

title: Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease (AETIONOMY)

acronym: AETIONOMY

summary: The AETIONOMY project will generate a refined taxonomy and testable mechanisms underlying the derived stratification of patients.

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

location_country: Germany Sweden France Spain

location_facility: Karolinska Institutet (KI), Karolinska University Hospital S3:01

location_facility: Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Rossello 149- 153

location_facility: Universitaetsklinikum Bonn (UKB), Sigmund-Freud 25 Strasse

location_facility: CIC Neurosciences - ICM - Hôpital Pitié-Salpêtrière, 47-83 Bd de l'Hôpital


title: A Multicenter Randomized Superiority Study To Compare The Effects Of An 8-Weeks Mindfulness-based Intervention Versus Health Education Programme On Mental Health And Wellbeing In Individuals With Subjective Cognitive Decline

acronym: SCD-WELL

summary:
The European Commission Horizon 2020 programme has funded the SCD-WELL trial to investigate the efficacy of mindfulness-based training to reduce anxiety in individuals with Subjective Cognitive Decline (SCD), in comparison to an active comparison condition.

It is increasingly recognized that most neuropathological processes start years before the onset of clinical Alzheimer's disease (AD). Hence, there is a growing urgency to target individuals in the earliest stages for intervention when neurodegeneration is still limited. Individuals clinically judged to have SCD, defined by subjectively experienced cognitive decline but normal performance on cognitive tests, are at increased risk for future cognitive decline and AD. These individuals with SCD currently have no established treatment options. Symptoms of anxiety have high prevalence in this population, and evidence from recent longitudinal research links anxiety with significantly accelerated cognitive decline in at risk individuals. Effectively reducing anxiety in this population may therefore not only relieve participants from burdensome symptoms, but may also slow cognitive decline and delay or prevent the onset of AD.

The investigators chose to study the efficacy of a mindfulness-based intervention to reduce anxiety in this population because this type of intervention has been shown to reduce anxiety in a number of populations, including in older adults. Further, accumulating evidence indicates that intensive mindfulness training effectively down-regulates a number of other adverse psychological and biological risk factors for AD, such as stress, depression, insomnia, feelings of loneliness and social exclusion, and cardiovascular risk factors. These findings are relevant to AD because approximately a third of AD cases worldwide might be attributable to potentially modifiable risk factors. In spite of the increased use of mindfulness-based interventions to treat clinical symptoms, these trials often suffer from the lack of an adequate comparison condition and lack of follow up to know whether initial benefits are maintained.

primary_purpose: Other

ReferenceCitation: Marchant NL, Barnhofer T, Coueron R, Wirth M, Lutz A, Arenaza-Urquijo EM, Collette F, Poisnel G, Demnitz-King H, Schild AK, Coll-Padros N, Delphin-Combe F, Whitfield T, Schlosser M, Gonneaud J, Asselineau J, Walker Z, Krolak-Salmon P, Molinuevo JL, Frison E, Chételat G, Jessen F, Klimecki OM; The Medit-Ageing Research Group. Effects of a Mindfulness-Based Intervention versus Health Self-Management on Subclinical Anxiety in Older Adults with Subjective Cognitive Decline: The SCD-Well Randomized Superiority Trial. Psychother Psychosom. 2021;90(5):341-350. doi: 10.1159/000515669. Epub 2021 Apr 19.

family: Marchant

full_name: Natalie L. Marchant

given: Natalie L.

family: Barnhofer

full_name: Thorsten Barnhofer

given: Thorsten

family: Coueron

full_name: Roxane Coueron

given: Roxane

family: Wirth

full_name: Miranka Wirth

given: Miranka

family: Lutz

full_name: Antoine Lutz

given: Antoine

family: Arenaza-Urquijo

full_name: Eider M. Arenaza-Urquijo

given: Eider M.

family: Collette

full_name: Fabienne Collette

given: Fabienne

family: Poisnel

full_name: Géraldine Poisnel

given: Géraldine

family: Demnitz-King

full_name: Harriet Demnitz-King

given: Harriet

family: Schild

full_name: Ann-Katrin Schild

given: Ann-Katrin

family: Coll-Padros

full_name: Nina Coll-Padros

given: Nina

full_name: Floriane Delphin-Combe

given: Floriane

family: Whitfield

full_name: Tim Whitfield

given: Tim

family: Schlosser

full_name: Marco Schlosser

given: Marco

family: Gonneaud

full_name: Julie Gonneaud

given: Julie

family: Asselineau

full_name: Julien Asselineau

given: Julien

family: Walker

full_name: Zuzana Walker

given: Zuzana

full_name: Pierre Krolak-Salmon

given: Pierre

family: Molinuevo

full_name: José Luis Molinuevo

given: José Luis

family: Frison

full_name: Eric Frison

family: Chételat

full_name: Gael Chételat

given: Gael

family: Jessen

full_name: Frank Jessen

given: Frank

family: Klimecki

full_name: Olga M. Klimecki

given: Olga M.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

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

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

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

repository_institution: University College London - UCL Discovery

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

location_facility: The Department of Psychiatry at University of Cologne (UKK)

location_facility: The Clinical Research Memory Centre of Lyon (CMRR), department of the University Hospitals of Lyon - Hospices Civils de Lyon (HCL)

location_facility: The Division of Psychiatry at University College London (UCL).

location_facility: The Consorci Institut D'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)


title: Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer (EARLY HEART Study) in the Frame of the Implications of MEDIcal Low Dose RADiation Exposure (MEDIRAD) European Project

acronym: EARLY-HEART

summary:
Breast cancer (BC) radiotherapy leads to coincidental radiation of the heart, resulting in increased risk of a variety of heart diseases. Identifying BC patients with the highest risk of radiation-induced cardiac complications is crucial for developing strategies for primary and secondary prevention. Little has been done on the relationship between dose distribution to different anatomical cardiac structures during radiotherapy and early cardiovascular changes that may lead to cardiac complications.

In the framework of the European project MEDIRAD, the EARLY-HEART multicenter prospective cohort was launched in August 2017, involving 5 investigating centers from France, Netherlands, Germany, Spain and Portugal. With 250 BC patients prospectively followed for 2 years, the main objective is to identify and validate the most important cardiac imaging (echocardiography, computed tomography coronary angiography, cardiac magnetic resonance imaging) and circulating biomarkers of radiation-induced cardiovascular changes arising in the first 2 years after BC radiotherapy.

ReferenceCitation: Walker V, Crijns A, Langendijk J, Spoor D, Vliegenthart R, Combs SE, Mayinger M, Eraso A, Guedea F, Fiuza M, Constantino S, Tamarat R, Laurier D, Ferrières J, Mousseaux E, Cardis E, Jacob S. Early Detection of Cardiovascular Changes After Radiotherapy for Breast Cancer: Protocol for a European Multicenter Prospective Cohort Study (MEDIRAD EARLY HEART Study). JMIR Res Protoc. 2018 Oct 1;7(10):e178. doi: 10.2196/resprot.9906.

full_name: Valentin Walker

given: Valentin

family: Crijns

full_name: Anne Crijns

given: Anne

family: Langendijk

full_name: Johannes Langendijk

given: Johannes

family: Spoor

full_name: Daan Spoor

given: Daan

family: Vliegenthart

full_name: Rozemarijn Vliegenthart

given: Rozemarijn

family: Combs

full_name: Stephanie E Combs

given: Stephanie E

family: Mayinger

full_name: Michael Mayinger

given: Michael

family: Eraso

full_name: Arantxa Eraso

given: Arantxa

family: Guedea

full_name: Ferran Guedea

given: Ferran

family: Fiuza

full_name: Manuela Fiuza

given: Manuela

family: Constantino

full_name: Susana Constantino

given: Susana

family: Tamarat

full_name: Radia Tamarat

given: Radia

family: Laurier

full_name: Dominique Laurier

given: Dominique

family: Ferrières

full_name: Jean Ferrières

given: Jean

family: Mousseaux

full_name: Elie Mousseaux

given: Elie

family: Cardis

full_name: Elisabeth Cardis

given: Elisabeth

family: Jacob

full_name: Sophie Jacob

given: Sophie

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: PubMed Central - Europe PMC

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

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

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

lead_sponsor: Institut de Radioprotection et de Surete Nucleaire

location_country: Netherlands France Spain Germany Portugal

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Associação para Investigação e Desenvolvimento da Faculdade de Medicina


title: A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

summary: The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.

ReferenceCitation: Itzykson R, Kosmider O, Renneville A, Gelsi-Boyer V, Meggendorfer M, Morabito M, Berthon C, Adès L, Fenaux P, Beyne-Rauzy O, Vey N, Braun T, Haferlach T, Dreyfus F, Cross NC, Preudhomme C, Bernard OA, Fontenay M, Vainchenker W, Schnittger S, Birnbaum D, Droin N, Solary E. Prognostic score including gene mutations in chronic myelomonocytic leukemia. J Clin Oncol. 2013 Jul 1;31(19):2428-36. doi: 10.1200/JCO.2012.47.3314. Epub 2013 May 20.

name: Raphaël Itzykson, Margot Morabito, Olivier A. Bernard, William Vainchenker, Nathalie Droin, Eric Solary, Institut Gustave Roussy, Villejuif; Raphaël Itzykson, Margot Morabito, William Vainchenker, Nathalie Droin, Eric Solary, Université Paris-Sud, Le Kremlin-Bicêtre, Orsay; Olivier Kosmider, François Dreyfus, Michaela Fontenay, Assistance Publique–Hôpitaux de Paris, Hôpital Cochin; Olivier Kosmider, François Dreyfus, Michaela Fontenay, Université Paris Descartes; Olivier Kosmider, Michaela Fontenay,...

family: Itzykson

full_name: Raphaël Itzykson

given: Raphaël

family: Kosmider

full_name: Olivier Kosmider

given: Olivier

family: Renneville

full_name: Aline Renneville

given: Aline

family: Gelsi-Boyer

full_name: Véronique Gelsi-Boyer

given: Véronique

family: Meggendorfer

full_name: Manja Meggendorfer

given: Manja

family: Morabito

full_name: Margot Morabito

given: Margot

family: Berthon

full_name: Céline Berthon

given: Céline

family: Adès

full_name: Lionel Adès

given: Lionel

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

family: Vey

full_name: Norbert Vey

given: Norbert

family: Braun

full_name: Thorsten Braun

given: Thorsten

family: Haferlach

full_name: Torsten Haferlach

given: Torsten

family: Dreyfus

full_name: François Dreyfus

given: François

family: Cross

full_name: Nicholas C.P. Cross

given: Nicholas C.P.

family: Preudhomme

full_name: Claude Preudhomme

given: Claude

family: Bernard

full_name: Olivier A. Bernard

given: Olivier A.

family: Fontenay

full_name: Michaela Fontenay

given: Michaela

family: Vainchenker

full_name: William Vainchenker

given: William

family: Schnittger

full_name: Susanne Schnittger

given: Susanne

family: Birnbaum

full_name: Daniel Birnbaum

given: Daniel

family: Droin

full_name: Nathalie Droin

given: Nathalie

family: Solary

full_name: Eric Solary

given: Eric

publisher: American Society of Clinical Oncology (ASCO)

title: Prognostic Score Including Gene Mutations in Chronic Myelomonocytic Leukemia

ReferenceCitation: Braun T, Itzykson R, Renneville A, de Renzis B, Dreyfus F, Laribi K, Bouabdallah K, Vey N, Toma A, Recher C, Royer B, Joly B, Vekhoff A, Lafon I, Sanhes L, Meurice G, Oréar C, Preudhomme C, Gardin C, Ades L, Fontenay M, Fenaux P, Droin N, Solary E; Groupe Francophone des Myélodysplasies. Molecular predictors of response to decitabine in advanced chronic myelomonocytic leukemia: a phase 2 trial. Blood. 2011 Oct 6;118(14):3824-31. doi: 10.1182/blood-2011-05-352039. Epub 2011 Aug 9.

name: Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP), Hématologie Clinique, University Paris XIII, Bobigny, France;

name: Inserm Unité Mixte de Recherche (UMR) 1009, Institut Gustave Roussy; University Paris-Sud XI, Villejuif, France;

name: Centre Hospitalier Universitaire (CHU) de Lille, Hématologie biologique, University of Lille, Lille, France;

name: CHU Estaing, Hématologie clinique adulte et thérapie cellulaire, Clermont Ferrand, France;

name: Hôpital Cochin, AP-HP, Hématologie Clinique, University Paris V, Paris, France;

name: Centre Hospitalier (CH) du Mans, Hématologie et Oncologie, Le Mans, France;

name: Hôpital Haut-Lévêque, Maladies du Sang, University of Bordeaux, Bordeaux, France;

name: Institut Paoli-Calmette, Département d'Hématologie, Marseille, France;

name: Hôpital Henri Mondor, AP-HP, Hématologie Clinique, University Paris XII, Créteil, France;

name: CHU de Toulouse, Hématologie Clinique, Hôpital Purpan, Inserm UMR 1037, Cancer Research Center of Toulouse, Centre National de la Recherche Scientifique (CNRS) ERL 5294, Université Toulouse III Paul Sabatier, Toulouse, France;

name: CHU Amiens, Service d'Hématologie Clinique, University of Amiens, Amiens, France;

name: CH Sud Francilien, Hématologie Clinique, Corbeil Essonnes, France;

name: Hôpital Saint-Antoine, AP-HP, Hématologie Clinique, University Paris IV, Paris, France;

name: CHU Le Bocage, Hématologie Clinique, University of Burgundy, Dijon, France;

name: CH de Perpignan, Hématologie Clinique, Perpignan, France; and

name: Groupe Hospitalier (GH) Broca-Cochin-Hôtel-Dieu, AP-HP, Hématologie biologique, Institut Cochin, Inserm U1016, CNRS UMR 8104, Université Paris Descartes, Paris, France

name: on behalf of the Groupe Francophone des Myélodysplasies

location_facility:
Hopital Necker
Hopital de la Cote Basque
CHR La Source orléans
CHU d'Amiens
CHU Haut-Lévèque
Hopital Henri Mondor
Centre Hospitalier du Mans
Centre Henri Becquerel
CH Angers
CHU de
Hopital d'Instruction des Armées Percy
Hôpital Archet1
Hôpital Boulogne Sur Mer
Centre Hospitalier Joffre
Hôpital Saint-Antoine.
Institut gustave Roussy
Centre Hospitalier Sud-Francilien
Hematology Dpt, Hopital Purpan
CHU de Dijon
CHU de Bicêtre
Hopital Hotel Dieu
Hôpital Avignon
Institut Paoli Calmettes
Hôpital Avicenne
CHU Bretoneau
Hôpital Versailles
Hoiptal St Louis
CHU de Reims
Hopital Cochin
CHU de nantes
CHU Caremeau


title: Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor

acronym: MOZOBIL

summary:
This is a retrospective observational cohort database analysis. The study will review retrospectively the records of patients undergoing a first peripheral blood stem cell mobilization for multiple myeloma in the databases from approximately 15 hospitals which are part of the IFM collaborative group. Patient records will be divided into two groups of 50 patients minimum, maximum 100 patients or up to the number of patient records that could be extracted. The first group of patients will have received plerixafor plus G-CSF without the administration of chemotherapy as a mobilization strategy and a second group of patients will have received cyclophosphamide plus G-CSF as a mobilization strategy.

All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide will be included.

All data that will be analyzed will be extracted from the selected IFM institutions which are located in France.

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: Institut Curie Centre de Lutte Contre le Cancer (CLCC)

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges


title: Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.

acronym: SCLEROGLIVEC

summary: In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule, as recently also proposed after the discovery of autoantibodies activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in scleroderma is currently available. This study will test the safety and efficacy of imatinib in the treatment of patients with scleroderma and severe cutaneous involvement.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de dermatologie - CHU de Limoges

location_facility: Néphrologie et Médecine interne - CH de Valenciennes

location_facility: Service de Médecine interne - CHU de Tours

location_facility: Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan

location_facility: Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux

location_facility: Service de Rhumatologie - CHU de Strasbourg

location_facility: Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux

location_facility: Service de Médecin interne - Hôpital central

location_facility: Service de Dermatologie - CHU de Toulouse - Hopital Purpan

location_facility: Service de Médecine interne - Hôpital Saint Louis


title: Aging,Sleep and Cognitive Process

acronym: SOMVIE

summary: The aim of the study is to determine the impact of aging, circadian rhythms and sleep deprivation on executive performances. Volunteers will complete a 40-hour extended wakefulness period in constant condition (semi-recumbent posture in bed, constant dim light levels < 10 lux, food and liquid intake at regular intervals) in order to control the circadian system. The volunteers will not be allowed to sleep in the sleep deprivation protocol ("high sleep pressure protocol") and will adopt a short wakefulness/sleep cycle (150/75 minutes) in the multiple nap protocol ("low sleep pressure protocol"). Tests and scales will be repeated every 3H45

primary_purpose: Basic Science

location_facility:
Genpphass
Uh Purpan
Medes-Imps


title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO

acronym: EuroECMO-COVID

summary:
In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

ReferenceCitation: Bolotin S, Pebody R, White PJ, McMenamin J, Perera L, Nguyen-Van-Tam JS, Barlow T, Watson JM; UK Severe Influenza Surveillance System (USISS) Steering Group. A new sentinel surveillance system for severe influenza in England shows a shift in age distribution of hospitalised cases in the post-pandemic period. PLoS One. 2012;7(1):e30279. doi: 10.1371/journal.pone.0030279. Epub 2012 Jan 23.

ReferenceCitation: Dawood FS, Iuliano AD, Reed C, Meltzer MI, Shay DK, Cheng PY, Bandaranayake D, Breiman RF, Brooks WA, Buchy P, Feikin DR, Fowler KB, Gordon A, Hien NT, Horby P, Huang QS, Katz MA, Krishnan A, Lal R, Montgomery JM, Mølbak K, Pebody R, Presanis AM, Razuri H, Steens A, Tinoco YO, Wallinga J, Yu H, Vong S, Bresee J, Widdowson MA. Estimated global mortality associated with the first 12 months of 2009 pandemic influenza A H1N1 virus circulation: a modelling study. Lancet Infect Dis. 2012 Sep;12(9):687-95. doi: 10.1016/S1473-3099(12)70121-4. Epub 2012 Jun 26. Erratum in: Lancet Infect Dis. 2012 Sep;12(9):655.

ReferenceCitation: Simonsen L, Spreeuwenberg P, Lustig R, Taylor RJ, Fleming DM, Kroneman M, Van Kerkhove MD, Mounts AW, Paget WJ; GLaMOR Collaborating Teams. Global mortality estimates for the 2009 Influenza Pandemic from the GLaMOR project: a modeling study. PLoS Med. 2013 Nov;10(11):e1001558. doi: 10.1371/journal.pmed.1001558. Epub 2013 Nov 26.

ReferenceCitation: Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, Xing F, Liu J, Yip CC, Poon RW, Tsoi HW, Lo SK, Chan KH, Poon VK, Chan WM, Ip JD, Cai JP, Cheng VC, Chen H, Hui CK, Yuen KY. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet. 2020 Feb 15;395(10223):514-523. doi: 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.

ReferenceCitation: Drosten C, Günther S, Preiser W, van der Werf S, Brodt HR, Becker S, Rabenau H, Panning M, Kolesnikova L, Fouchier RA, Berger A, Burguière AM, Cinatl J, Eickmann M, Escriou N, Grywna K, Kramme S, Manuguerra JC, Müller S, Rickerts V, Stürmer M, Vieth S, Klenk HD, Osterhaus AD, Schmitz H, Doerr HW. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1967-76. Epub 2003 Apr 10.

ReferenceCitation: Ksiazek TG, Erdman D, Goldsmith CS, Zaki SR, Peret T, Emery S, Tong S, Urbani C, Comer JA, Lim W, Rollin PE, Dowell SF, Ling AE, Humphrey CD, Shieh WJ, Guarner J, Paddock CD, Rota P, Fields B, DeRisi J, Yang JY, Cox N, Hughes JM, LeDuc JW, Bellini WJ, Anderson LJ; SARS Working Group. A novel coronavirus associated with severe acute respiratory syndrome. N Engl J Med. 2003 May 15;348(20):1953-66. Epub 2003 Apr 10.

ReferenceCitation: Zaki AM, van Boheemen S, Bestebroer TM, Osterhaus AD, Fouchier RA. Isolation of a novel coronavirus from a man with pneumonia in Saudi Arabia. N Engl J Med. 2012 Nov 8;367(19):1814-20. doi: 10.1056/NEJMoa1211721. Epub 2012 Oct 17. Erratum in: N Engl J Med. 2013 Jul 25;369(4):394.

ReferenceCitation: de Groot RJ, Baker SC, Baric RS, Brown CS, Drosten C, Enjuanes L, Fouchier RA, Galiano M, Gorbalenya AE, Memish ZA, Perlman S, Poon LL, Snijder EJ, Stephens GM, Woo PC, Zaki AM, Zambon M, Ziebuhr J. Middle East respiratory syndrome coronavirus (MERS-CoV): announcement of the Coronavirus Study Group. J Virol. 2013 Jul;87(14):7790-2. doi: 10.1128/JVI.01244-13. Epub 2013 May 15.

ReferenceCitation: Spina S, Marrazzo F, Migliari M, Stucchi R, Sforza A, Fumagalli R. The response of Milan's Emergency Medical System to the COVID-19 outbreak in Italy. Lancet. 2020 Mar 14;395(10227):e49-e50. doi: 10.1016/S0140-6736(20)30493-1. Epub 2020 Feb 28.

ReferenceCitation: Ebrahim SH, Memish ZA. COVID-19: preparing for superspreader potential among Umrah pilgrims to Saudi Arabia. Lancet. 2020 Mar 14;395(10227):e48. doi: 10.1016/S0140-6736(20)30466-9. Epub 2020 Feb 27.

ReferenceCitation: Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

ReferenceCitation: Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum in: Lancet. 2020 Jan 30;:.

family: Huang

full_name: Chaolin Huang

given: Chaolin

family: Wang

full_name: Yeming Wang

given: Yeming

family: Li

full_name: Xingwang Li

given: Xingwang

family: Ren

full_name: Lili Ren

given: Lili

family: Zhao

full_name: Jianping Zhao

given: Jianping

family: Hu

full_name: Yi Hu

given: Yi

family: Zhang

full_name: Li Zhang

given: Li

family: Fan

full_name: Guohui Fan

given: Guohui

family: Xu

full_name: Jiuyang Xu

given: Jiuyang

family: Gu

full_name: Xiaoying Gu

given: Xiaoying

family: Cheng

full_name: Zhenshun Cheng

given: Zhenshun

family: Yu

full_name: Ting Yu

given: Ting

family: Xia

full_name: Jiaan Xia

given: Jiaan

family: Wei

full_name: Yuan Wei

given: Yuan

family: Wu

full_name: Wenjuan Wu

given: Wenjuan

family: Xie

full_name: Xuelei Xie

given: Xuelei

family: Yin

full_name: Wen Yin

given: Wen

full_name: Hui Li

given: Hui

family: Liu

full_name: Min Liu

given: Min

family: Xiao

full_name: Yan Xiao

given: Yan

family: Gao

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

name: Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Pulmonary Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Emergency Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Laboratory Medicine, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

name: Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

title: Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
France
Czechia
Greece
Israel
Lithuania
Poland
Hungary
Belgium
Russian Federation
Portugal
Denmark
Germany
United Kingdom

location_facility: A.O.U. Città della Salute e della Scienza - Molinette Hospital

location_facility: Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash

location_facility: Bambino Gesù Hospital and Research Institute

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Children's Medical Hospital, University of Essen, Essen, Germany

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: City Hospital No 40, Saint Petersburg, Russia

location_facility: University Heart Center Freiburg - Bad Krozingen

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: City Hospital No 41, Ekaterinburg, Russia

location_facility: Copenhagen University Hospital at Herlev

location_facility: Heart Center Leipzig - University Hospital

location_facility: Royal Brompton & Harefield NHS Foundation Trust

location_facility: City Clinical Hospital No. 67, Moscow, Russia


title: Psychophysiological Study of Pain Perception in Depressed Patients With Suicidal Risk

summary:
Joiner's interpersonal theory of suicide postulates that the wish of death comes from feelings of perceived burdensomeness and thwarted belongingness. But, only people who have acquired the capability to kill themselves will attempt suicide. The acquired capability refers to a reduction of fear to death, and a higher pain tolerance. Indeed, to commit suicide involves to endure pain during the act. Thus, higher pain tolerance seems to be a necessary feature for suicidal act.

Past studies have shown higher pain threshold and tolerance in suicidal patients, whatever the stimulus was (electric, thermic or mechanical), compared to patients without suicide history. Moreover, Caceda and colleagues demonstrated higher pain threshold in recent suicide attempters (suicidal act within 72h) compared with depressed patients. Five days after the initial evaluation, pain threshold of recent suicide attempters decreased to be similar to depressed patients with suicidal ideation. Therefore, it may exist a specific state during which the pain tolerance is increased. During this "hypoalgesic state" patients with suicidal ideation could attempt suicide to get relief from suffering.

However, little is known about the specific mechanisms that are responsible for the higher pain threshold and tolerance in suicide attempters. Pain is a dynamic system that results from excitatory and inhibitory messages. The modification of one of these mechanisms could explain the higher tolerance in recent suicide attempters. Three of them are of particular interest:

The conditioned pain modulation (CPM) is a modulatory pain mechanism. CPM works through descending pathway that reaches the spinal cord and modulates pain processing from the first nociceptive synapse.In recent suicidal patients, an increase of the CPM could explain higher pain tolerance.
The "wind-up" mechanism is defined as the highest excitability of the second order nerve. Even if the stimulus remains stable, pain continuously raises. In recent suicide attempters, a reduction of this mechanism could explain higher pain tolerance.
The threshold of Aδ and C nociceptors. If a nociceptive fiber is less excitable than the other, it would explain higher pain threshold.

lead_sponsor: University Hospital, Montpellier

location_facility:
Clinic La Lironde
University Hospital of Montpellier


title: Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

acronym: SEPSISEO

summary:
Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Les Hôpitaux Universitaires de Strasbourg


title: Evaluation of the Biocompatibility of Cartridge Blood Set Versus Standard Blood Line: A Pilot Monocentric Open Randomized and Cross-over Study.

summary: The primary objective is to collect data to evaluate the biocompatibility of two types of blood circuit, already on the market.

ReferenceCitation: Lucchi L, Ligabue G, Marietta M, Delnevo A, Malagoli M, Perrone S, Stipo L, Grandi F, Albertazzi A. Activation of coagulation during hemodialysis: effect of blood lines alone and whole extracorporeal circuit. Artif Organs. 2006 Feb;30(2):106-10.

lead_sponsor: Baxter Healthcare Corporation


title: Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

acronym: ILEHOS

summary:
Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

status: Terminated

location_facility: Hôpital de Hautepierre-Service de Chirurgie Digestive

location_facility: CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne

location_facility: Hôpital Jean Minjoz - Service de Chirurgie Digestive

location_facility: Hôpital Emile MULLER - Service de Chirurgie Digestive

location_facility: Hôpitaux Civils de Colmar - Service de Chirurgie Digestive

location_facility: Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive


title: Detect, Monitor and Prevent Vascular Abnormalities Associated With Turner Syndrome

acronym: AVAST

summary:
Turner syndrome is a genetic condition, rare, due to the total or partial absence of one X chromosome, affecting 1/2500 newborn female. It combines almost constantly short stature and ovarian failure with infertility.

Other anomalies are inconstant: morphological characteristics of varying intensity, associated malformations, and increased risk of acquired diseases ...

The prognosis of patients reaching the Turner Syndrome is linked to cardiovascular complications (congenital heart disease, dilatation of the ascending aorta with risk of dissection or rupture of aneurysm), causing early mortality with reduction of life expectancy of at least 10 years.

For these reasons, screening for heart disease and dilatation of the ascending aorta is established and is intended to prevent the complications associated with medical treatment and / or surgery to increase life expectancy and reduce the co-morbidities.

On the vascular level, the recommendations other than those relating to the monitoring of the diameter of the ascending aorta include research of renal artery stenosis by doppler ultrasound if the patient is hypertensive and looking for lymphedema.

However, other arterial lesions were described in the literature, outside of the aneurysm of the ascending aorta. These peripheral arterial lesions can also be life and / or functional prognosis of the patient. Ascending aorta dilation seems not to be exclusive in Turner syndrome.

In addition, specific vascular lesions outside the affected artery are described: hepatic cirrhosis by vascular depletion, lymphedema and varicose veins. The prevalence of venous or lymphatic disease is unknown.

A single-center review of 9 cases of patients followed at the University Hospital of Strasbourg showed the presence of vascular lesions discovered incidentally during assessments performed for reasons other than cardiovascular screening: cystic lymphangioma, internal carotid aneurysm, agenesis of the inferior vena cava, early varicose veins, embryonic cerebral artery, etc ... None of these patients showed any dilatation of the ascending aorta or heart disease. Peripheral vascular abnormalities in this patient group are exclusive.

In this study, we seek to demonstrate that arterial disease in Turner syndrome involve the entire arterial territory and is not confined to the ascending aorta. Screening for arterial lesions should be performed on the entire arterial vascular tree and regularly in the course of time, especially as the presence of cardiovascular risk factors increases with the age of these patients.

The venous and lymphatic vascular damage in the literature and in our series of cases in University Hospital of Strasbourg description should also lead to the detection of these lesions.

These vascular complications can be alone responsible for the reduction in life expectancy or responsible for serious morbidity. Improved screening of associated vascular lesions is necessary to enable the best prevention of cardiovascular complications.

It is also to establish the prevalence of vascular anomalies, whether arterial, venous or lymphatic, to better understand the disease and its management. By collecting systematically karyotype leading to diagnosis, it may be possible to make a link between the genetic defect and heart or vascular disease.

location_facility: Service d'endocrinologie, Hôpital Civil, Hôpitaux Universitaires

location_facility: Service HTA, maladies vasculaires et pharmacologie clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service d'explorations fonctionnelles non invasives cardio-vasculaires, Nouvel Hôpital Civil, Hôpitaux Universitaires

location_facility: Service de gynécologie, Centre Médico Chirurgical Obstétrical, Hôpitaux Universitaires

location_facility: Service de Chirurgie et Médecine Vasculaire, CHU Jean Minjoz

intervention_type: Procedure


title: A Phase 1, First-in-Human, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours

summary:
The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.

The study comprises two stages, each with distinct purposes, patient populations, and procedures:

Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours.
Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.

lead_sponsor: Kazia Therapeutics Limited

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


summary: The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).

ReferenceCitation: Grollemund B, Dissaux C, Gavelle P, Martínez CP, Mullaert J, Alfaiate T, Guedeney A; CLIP team (Cleft Lip & palate Infant Parent). The impact of having a baby with cleft lip and palate on parents and on parent-baby relationship: the first French prospective multicentre study. BMC Pediatr. 2020 May 18;20(1):230. doi: 10.1186/s12887-020-02118-5.

family: Grollemund

full_name: Bruno Grollemund

given: Bruno

family: Dissaux

full_name: Caroline Dissaux

given: Caroline

family: Gavelle

full_name: Pascale Gavelle

given: Pascale

family: Martínez

full_name: Carla Pérez Martínez

given: Carla Pérez

family: Mullaert

full_name: Jimmy Mullaert

given: Jimmy

family: Alfaiate

full_name: Toni Alfaiate

given: Toni

family: Guedeney

full_name: Antoine Guedeney

given: Antoine

journal_name: BMC Pediatrics

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
PubMed Central
Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

ReferenceCitation: Grollemund B, Guedeney A, Vazquez MP, Picard A, Soupre V, Pellerin P, Simon E, Velten M, Dissaux C, Kauffmann I, Bruant-Rodier C, Danion-Grilliat A. Relational development in children with cleft lip and palate: influence of the waiting period prior to the first surgical intervention and parental psychological perceptions of the abnormality. BMC Pediatr. 2012 Jun 8;12:65. doi: 10.1186/1471-2431-12-65.

family: Vazquez

full_name: Marie-Paule Vazquez

given: Marie-Paule

family: Picard

full_name: Arnaud Picard

given: Arnaud

family: Soupre

full_name: Véronique Soupre

given: Véronique

family: Pellerin

full_name: Philippe Pellerin

given: Philippe

family: Simon

full_name: Etienne Simon

given: Etienne

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

location_facility: CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro

location_facility: CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central

location_facility: CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1

location_facility: APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale


title: Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

acronym: INFRASAS

summary:
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:

Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?

ReferenceCitation: Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. Review.

ReferenceCitation: Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. Review.

ReferenceCitation: Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. Review.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. Epub 2005 May 18.

ReferenceCitation: Stanke-Labesque F, Pépin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Lévy P, Bäck M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.

family: Stanke-Labesque

full_name: Françoise Stanke-Labesque

given: Françoise

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: de Jouvencel

full_name: Tiphaine de Jouvencel

given: Tiphaine

family: Arnaud

full_name: Claire Arnaud

given: Claire

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

family: Petri

full_name: Marcelo H. Petri

given: Marcelo H.

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Jourdil

full_name: Jean François Jourdil

given: Jean François

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Bäck

full_name: Magnus Bäck

given: Magnus

journal_name: Journal of Lipid Research

oa_colors: green hybrid

evidence: open (via crossref license)

lead_sponsor: University Hospital, Grenoble

location_facility: France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory

location_facility: France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system


title: Performance of the Pulmonary Embolism Rule-out Criteria (the PERC Rule) Combined With Implicit Low Clinical Probability (Gestalt) to Rule-out PE Without Further Exams

acronym: PERCEPIC

summary:
PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule.

PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.

ReferenceCitation: Penaloza A, Soulié C, Moumneh T, Delmez Q, Ghuysen A, El Kouri D, Brice C, Marjanovic NS, Bouget J, Moustafa F, Trinh-Duc A, Le Gall C, Imsaad L, Chrétien JM, Gable B, Girard P, Sanchez O, Schmidt J, Le Gal G, Meyer G, Delvau N, Roy PM. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study. Lancet Haematol. 2017 Dec;4(12):e615-e621. doi: 10.1016/S2352-3026(17)30210-7. Epub 2017 Nov 14.

family: Penaloza

full_name: Andrea Penaloza

given: Andrea

family: Soulié

full_name: Caroline Soulié

given: Caroline

family: Moumneh

full_name: Thomas Moumneh

given: Thomas

family: Delmez

full_name: Quentin Delmez

given: Quentin

family: Ghuysen

full_name: Alexandre Ghuysen

given: Alexandre

family: El Kouri

full_name: Dominique El Kouri

given: Dominique

family: Brice

full_name: Christian Brice

given: Christian

family: Marjanovic

full_name: Nicolas S Marjanovic

given: Nicolas S

family: Bouget

full_name: Jacques Bouget

given: Jacques

family: Moustafa

full_name: Fares Moustafa

given: Fares

family: Trinh-Duc

full_name: Albert Trinh-Duc

given: Albert

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

family: Imsaad

full_name: Lionel Imsaad

given: Lionel

family: Chrétien

full_name: Jean-Marie Chrétien

given: Jean-Marie

family: Gable

full_name: Béatrice Gable

given: Béatrice

family: Girard

full_name: Philippe Girard

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

family: Meyer

full_name: Guy Meyer

given: Guy

family: Delvau

full_name: Nicolas Delvau

given: Nicolas

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

journal_name: The Lancet Haematology

location_facility:
UH Erasme
UH Nantes
Hospital of Saint-Brieuc
UH Poitiers
UH Clermont-Ferrand
UH Angers
Hospital of Argenteuil
Hospital of Le Mans
Hospital of Agen
Clinique Universitaire Saint-Luc
UH Rennes
UH Liège


title: Enregistrement Des Bruits Vasculaires de l'artère Iliaque Externe Par STETHOscope électronique en Post - Effort Chez le SPORTif

acronym: Stethosport

summary: Define responses to exercise on both arterial bruits and oxymetry in patients referred for suspected endofibrosis.


title: Evaluation of the Efficacy on Urinary Continence and Quality of Life of the Sub-urethral Tape I-STOP® Using the Transobturator and Perineal Route on Male Incontinent After Radical Prostatectomy.

summary: The main objective is to evaluate the clinical efficacy on continence, quality of life and tolerance of the sub-urethral tape I-STOP on male patient suffering of incontinence significant and embarrassing after a radical prostatectomy.

lead_sponsor: CL Medical


title: Retinal Neurodegenerative Signs in Alzheimer's Diseases

acronym: SIGNAL

summary:
A few studies suggest that patients suffering from neurodegenerative diseases (such a multiple sclerosis or Alzheimer's disease (AD)) show decreased thickness of the retinal nerve fiber layer (RNFL), indicating axonal degeneration. High-definition spectral domain optical coherence tomography (SD-OCT), performed without radiation in a few seconds per eye, offers a precise and standardized estimation of this parameter, which could constitute a biomarker for cerebral axonal degeneration. These RNFL deficits might even be the earliest sign of AD, prior to damage of the hippocampal region that impacts memory.

Besides, some associations of AD with some degenerative diseases of the eye (glaucoma, microvascular abnormalities, age-related macular degeneration (AMD)) have also been reported.

It therefore seems interesting to determine whether RNFL thickness, and other ocular parameters, may give some indications for a better detection of AD and cognitive decline in the elderly.


title: A Dose-Escalation Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-9722 (a PARP 1 and PARP 2 Inhibitor) in Combination With Gemcitabine and Cisplatin in Patients With Advanced Solid Tumors or Mantle Cell Lymphoma

summary: The primary objective of the study is to determine the maximum tolerated dose (MTD) of CEP-9722 in combination with gemcitabine and cisplatin in patients with advanced solid tumors or mantle cell lymphoma.

lead_sponsor: Cephalon

location_country: Belgium France

location_facility:
Teva Investigational Site 2
Teva Investigational Site 1
Teva Investigational Site 3


title: Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy (HARMONIC-RT)

acronym: HARMONIC-RT

summary: The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of modern external beam radiotherapy techniques in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

study_start_date_type: Anticipated

time_perspective: Other

location_country: Denmark Germany Belgium France

location_facility: University Hospital Essen, The West German Proton Therapy Centre Essen


title: Open-label, Randomized, and Multicenter Phase III Clinical Trial Comparing Immunogenicity of Double-dose (40 µg at S0, S4 and S24), Versus Standard Dose Vaccination (20 µg at S0, S4 and S24), Against Hepatitis B Virus in HIV-1-infected Patients Without Any Previous Immune Response After Primary Immunization Plus One Single Boost

acronym: B-BOOST

summary:
HIV infected patients exposed to Hepatitis B virus are more susceptible to develop a chronic and severe liver disease, with a major risk of cirrhosis and liver cancer.

However, immune response to standard Hepatitis B vaccination is decreased in HIV-infected patients, compared to non HIV-infected individuals, and, in case of response, its durability has to be carefully followed up. This study compares the efficacy of two strategies of revaccination in HIV-infected patients who didn't respond to previous hepatitis B vaccination. Failure is defined by two conditions: non response to the primary immunization (2 to 4 single-dose injections received before the screening visit) and failure to a single 20 µg boost before being included in the study.

ReferenceCitation: Rey D, Piroth L, Wendling MJ, Miailhes P, Michel ML, Dufour C, Haour G, Sogni P, Rohel A, Ajana F, Billaud E, Molina JM, Launay O, Carrat F; ANRS HB04 B-BOOST study group. Safety and immunogenicity of double-dose versus standard-dose hepatitis B revaccination in non-responding adults with HIV-1 (ANRS HB04 B-BOOST): a multicentre, open-label, randomised controlled trial. Lancet Infect Dis. 2015 Nov;15(11):1283-91. doi: 10.1016/S1473-3099(15)00220-0. Epub 2015 Aug 6.

family: Rey

full_name: David Rey

given: David

family: Piroth

full_name: Lionel Piroth

family: Wendling

full_name: Marie-Josée Wendling

given: Marie-Josée

family: Miailhes

full_name: Patrick Miailhes

given: Patrick

family: Michel

full_name: Marie-Louise Michel

given: Marie-Louise

family: Dufour

full_name: Cécilie Dufour

given: Cécilie

family: Haour

full_name: Georges Haour

given: Georges

family: Sogni

full_name: Philippe Sogni

given: Philippe

family: Rohel

full_name: Alexandra Rohel

given: Alexandra

family: Ajana

full_name: Faiza Ajana

given: Faiza

family: Billaud

full_name: Eric Billaud

given: Eric

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Launay

full_name: Odile Launay

given: Odile

family: Carrat

full_name: Fabrice Carrat

given: Fabrice

journal_name: The Lancet Infectious Diseases

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre de Soins de l'Infection par le VIH NHC, Hôpitaux Universitaires Strasbourg, 1 place de l'hôpital

intervention_type: Biological


title: Real-World Observational Study of Zavicefta (Registered) (Ceftazidime-avibactam) to Characterize Use Patterns, Effectiveness and Safety - EZTEAM Study

acronym: EZTEAM

summary: This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
Austria
France
Russian Federation
Spain
Germany

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF

location_facility: FSBI "Hematological Research Center" MoH of RF

location_facility: SBIH Republican Clinical Hospital n.a. G. G. Kuvatov

location_facility: SBIH of Moscow City Clinical Hospital # 7

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov


title: Comparison of Sedation Using Pentobarbital or Chlorpromazine in Pediatric Non-invasive Imaging Procedure: A Before and After Study

acronym: PREIMAPED

summary: Sedation is often required for pediatric medical imaging procedures to ensure compliance and quality images. Recommendations exist regarding pediatric sedation, but there are currently no guidelines regarding the choice of the sedative drug. We aim to compare the efficacy and adverse events of per os pentobarbital with intravenous chlorpromazine in children undergoing diagnostic imaging procedures.

status: Not yet recruiting

lead_sponsor: University Hospital, Brest


title: Determinants of Repeated Spontaneous Miscarriages and Unexplained Fetal Deaths (DEFI-2)

summary:
The DEFI-1 study recruited 625 women witnesses and 299 of their spouses. With regard to case couples, 271 cases were recruited from the spontaneous repeated miscarriages (SRM) subgroup (≥3 spontaneous miscarriage (SM) from trimester 1 of pregnancy) and 93 from the unexplained fetal death in utero (FDIU) subgroup from trimesters 2 and 3 of pregnancy.

The main objective of the DEFI 2 study is to increase the number of case-pairs in these 2 particular subgroups to replicate the results of the genetic determinants highlighted from cases and controls with extreme phenotypes and obtain a sufficient number of women with FDIUs to identify specific determinants.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication


title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

summary: The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.


title: Multicentric, Prospective Study of Efficacy and Safety of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Marrow

acronym: MatriBone

summary: The main objective of this clinical study is the estimation of the rate of intersomatic fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous substitute with a biomaterial (MatriBONE associated with the autologous bone marrow), associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow. Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar canal and\or spondylolisthesis.

ReferenceCitation: Anand N, Hamilton JF, Perri B, Miraliakbar H, Goldstein T. Cantilever TLIF with structural allograft and RhBMP2 for correction and maintenance of segmental sagittal lordosis: long-term clinical, radiographic, and functional outcome. Spine (Phila Pa 1976). 2006 Sep 15;31(20):E748-53.

ReferenceCitation: Battié MC, Videman T, Levälahti E, Gill K, Kaprio J. Genetic and environmental effects on disc degeneration by phenotype and spinal level: a multivariate twin study. Spine (Phila Pa 1976). 2008 Dec 1;33(25):2801-8. doi: 10.1097/BRS.0b013e31818043b7.

ReferenceCitation: Battié MC, Videman T, Kaprio J, Gibbons LE, Gill K, Manninen H, Saarela J, Peltonen L. The Twin Spine Study: contributions to a changing view of disc degeneration. Spine J. 2009 Jan-Feb;9(1):47-59. doi: 10.1016/j.spinee.2008.11.011.

ReferenceCitation: Carter JD, Swearingen AB, Chaput CD, Rahm MD. Clinical and radiographic assessment of transforaminal lumbar interbody fusion using HEALOS collagen-hydroxyapatite sponge with autologous bone marrow aspirate. Spine J. 2009 Jun;9(6):434-8. doi: 10.1016/j.spinee.2008.11.004. Epub 2008 Dec 25.

ReferenceCitation: Chen Z, Zhao J, Liu A, Yuan J, Li Z. Surgical treatment of recurrent lumbar disc herniation by transforaminal lumbar interbody fusion. Int Orthop. 2009 Feb;33(1):197-201. doi: 10.1007/s00264-008-0531-1. Epub 2008 Mar 21.

ReferenceCitation: el-Masry MA, Khayal H, Salah H. Unilateral transforaminal lumbar interbody fusion (TLIF) using a single cage for treatment of low grade lytic spondylolisthesis. Acta Orthop Belg. 2008 Oct;74(5):667-71.

ReferenceCitation: Goyal N, Wimberley DW, Hyatt A, Zeiller S, Vaccaro AR, Hilibrand AS, Albert TJ. Radiographic and clinical outcomes after instrumented reduction and transforaminal lumbar interbody fusion of mid and high-grade isthmic spondylolisthesis. J Spinal Disord Tech. 2009 Jul;22(5):321-7. doi: 10.1097/BSD.0b013e318182cdab.

ReferenceCitation: Houten JK, Post NH, Dryer JW, Errico TJ. Clinical and radiographically/neuroimaging documented outcome in transforaminal lumbar interbody fusion. Neurosurg Focus. 2006 Mar 15;20(3):E8.

ReferenceCitation: Jagannathan J, Sansur CA, Oskouian RJ Jr, Fu KM, Shaffrey CI. Radiographic restoration of lumbar alignment after transforaminal lumbar interbody fusion. Neurosurgery. 2009 May;64(5):955-63; discussion 963-4. doi: 10.1227/01.NEU.0000343544.77456.46.

ReferenceCitation: Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L. Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1693-8.

ReferenceCitation: Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, Hilibrand AS, Albert TJ. Complications associated with single-level transforaminal lumbar interbody fusion. Spine J. 2009 Aug;9(8):623-9. doi: 10.1016/j.spinee.2009.04.004. Epub 2009 May 30.

ReferenceCitation: Rihn JA, Makda J, Hong J, Patel R, Hilibrand AS, Anderson DG, Vaccaro AR, Albert TJ. The use of RhBMP-2 in single-level transforaminal lumbar interbody fusion: a clinical and radiographic analysis. Eur Spine J. 2009 Nov;18(11):1629-36. doi: 10.1007/s00586-009-1046-1. Epub 2009 May 28.

ReferenceCitation: Sasso RC, LeHuec JC, Shaffrey C; Spine Interbody Research Group. Iliac crest bone graft donor site pain after anterior lumbar interbody fusion: a prospective patient satisfaction outcome assessment. J Spinal Disord Tech. 2005 Feb;18 Suppl:S77-81.

ReferenceCitation: Schleicher P, Beth P, Ottenbacher A, Pflugmacher R, Scholz M, Schnake KJ, Haas NP, Kandziora F. Biomechanical evaluation of different asymmetrical posterior stabilization methods for minimally invasive transforaminal lumbar interbody fusion. J Neurosurg Spine. 2008 Oct;9(4):363-71. doi: 10.3171/SPI.2008.9.10.363.

ReferenceCitation: Xiao Y, Li F, Chen Q. Transforaminal lumbar interbody fusion with one cage and excised local bone. Arch Orthop Trauma Surg. 2010 May;130(5):591-7. doi: 10.1007/s00402-009-0917-6. Epub 2009 Jun 30.

ReferenceCitation: Xiao YX, Chen QX, Li FC. Unilateral transforaminal lumbar interbody fusion: a review of the technique, indications and graft materials. J Int Med Res. 2009 May-Jun;37(3):908-17. Review.

ReferenceCitation: Yan DL, Pei FX, Li J, Soo CL. Comparative study of PILF and TLIF treatment in adult degenerative spondylolisthesis. Eur Spine J. 2008 Oct;17(10):1311-6. doi: 10.1007/s00586-008-0739-1. Epub 2008 Aug 7.

location_facility: Unité d'Orthopédie-Traumatologie rachis II, Pellegrin


lead_sponsor: University Hospital, Lille

acronym:
HyQvia

 HyQvia

location_facility:
Hôpital Necker
Hôpital St Louis
CHU de Strasbourg
Hôpital de la Conception
CHRU, Hôpital Claude Huriez
CHU de Nantes - Hôtel Dieu
Hôpital Haut Lévèque

title: Assessment of the IgG Trough Level in Subjects With Primary Immunodeficiency Switching From Standard Subcutaneous Immunoglobulin (SCIG) to Every Other Week HyQvia

summary: Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy and Other CentroNuclear Myopathies

acronym: NatHis-CNM

summary: This is the 2 years extension of the prospective and longitudinal study of the natural history and functional status of patients with myotubular myopathy and other centronuclear (CNM) sponsored by Dynacure including ten additional pediatric patients with mutation in MTM1 or DNM2 genes). the patients are planned to be enrolled in one year leading to an expected total number of 70 patients followed at least over 1 year period. Data from the study will be used to characterize the disease course of CNM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

lead_sponsor: Institut de Myologie, France

location_country: Italy France Belgium Spain Germany

location_facility: Hôpital Femme Mère Enfant, CHU Lyon L'Escale

location_facility: Centre de référence neuromusculaire, CHR La Citadelle


title: Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients?

acronym: ETPARK-REMED

summary: Dopaminergic drug can have adverse effects leading to potential serious consequences. Therapeutic patient education must promote the understanding of drugs to improve its management. This study tries to evaluate the effect of therapeutic education workshop on Parkinson disease's drug (drug workshop) on the evolution of drug's representations in patients with Parkinson's disease compared to a control group.

ReferenceCitation: Canivet C, Costa N, Ory-Magne F, Arcari C, Mohara C, Pourcel L, Derumeaux H, Bérard E, Bourrel R, Molinier L, Brefel-Courbon C. Clinical Impact and Cost-Effectiveness of an Education Program for PD Patients: A Randomized Controlled Trial. PLoS One. 2016 Sep 29;11(9):e0162646. doi: 10.1371/journal.pone.0162646. eCollection 2016.

ReferenceCitation: Ory Magne F, Arcari C, Canivet C, Sarrail M, Fabre MH, Mohara C, Brefel Courbon C. [A therapeutic educational program in Parkinson's disease: ETPARK]. Rev Neurol (Paris). 2014 Feb;170(2):128-33. doi: 10.1016/j.neurol.2013.08.007. Epub 2013 Nov 20. French.

family: Ory Magne

full_name: F. Ory Magne

given: F.

family: Arcari

full_name: C. Arcari

given: C.

family: Canivet

full_name: C. Canivet

family: Sarrail

full_name: M. Sarrail

given: M.

family: Fabre

full_name: M.H. Fabre

family: Mohara

full_name: C. Mohara

family: Brefel Courbon

full_name: C. Brefel Courbon

journal_name: Revue Neurologique

title: Éducation thérapeutique chez le patient parkinsonien : le programme ETPARK

lead_sponsor: University Hospital, Toulouse


title: Prospective Study of Dysarthria, and the Appearance of Non-dopaminergic Signs in Idiopathic PARKinson's Disease

acronym: Prodygi-II

summary:
Pilot study:

Longitudinal follow up of the PRODY-GI cohort for parkinson's disease (PD)
Observational study of upper and lower axial symptoms' occurence in 30 PD patients in on and off drug conditions, 30 aged matched control subjects and 10 control subjects with supra nuclear palsy
Multi modal approach: functional MRI, clinical , ENT assessment, respiratory assessment, neuropsychological and gait evaluations


title: An Exploratory Study of the Feasibility of the Installation by a Paramedical Staff of a Standardized Meditation Technique "Body-scan", in the Management of Anxiety in Hospitalized Parkinsonian Patients

summary: The aim of the study is to constitute a proof of concept study for a larger study investigating the effect of mindfulness on anxiety and agitation in Parkinson's disease (PD) based on the results of a preliminary feasibility.

location_facility: Service de neurologie motricité,Hôpital Pellegrin


title: Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease

acronym: NEPHRODENT

summary:
A large panel of oral and dental diseases exist in patients suffering from chronic kidney disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and saliva and it has been already described in the literature. The consequences of oral diseases in systemic health are substantial, including increase of inflammatory parameters, alteration of nutrition and increase of cardiovascular risk factors. It has been shown before that several oral diseases can be considered as cardiovascular risk factor in the general population and in diabetic patients through the chronic inflammatory pathway. In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in this population of patients, at different stages of the disease (stages 2 to 5).

The main objective will be to describe the oral diseases at each stage of CKD. Secondary objectives will be: (1) To evaluate the link between the oral health and the chronic kidney disease stage, the nutritional and inflammatory status; (2) Among patients needing dental treatments, to evaluate after 6 months and 12 months whether dental cares have an influence on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of dental treatments after the dental consultation including advises on dental health.

location_facility: Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin


title: Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study

acronym: AFP

summary: Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.

ReferenceCitation: Bénet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glélé LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.

name: Service d’Hygiène, Epidémiologie, Infectiovigilance et Prévention, Hospices Civils de Lyon, Lyon, France

name: Équipe Épidémiologie et Santé Internationale, Laboratoire des Pathogènes Émergents, Fondation Mérieux, Centre International de Recherche en Infectiologie, Institut National de la Santé et de la Recherche Médicale U1111, Centre National de la Recherche Scientifique Unité Mixte de Recherche 5308, École Nationale Supérieure de Lyon, Université Claude Bernard Lyon 1, Lyon, France

family: Bénet

full_name: Thomas Bénet

given: Thomas

family: Amour

full_name: Sélilah Amour

given: Sélilah

name: Centre National de Référence des Infections Respiratoires, Région Sud

name: Laboratoire de Virologie, Hôpital de la Croix-Rousse, Groupement Hospitalier Nord, Hospices Civils de Lyon, Lyon, France

family: Valette

full_name: Martine Valette

given: Martine

family: Saadatian-Elahi

full_name: Mitra Saadatian-Elahi

given: Mitra

name: Service d’Epidémiologie et d’Hygiène Hospitalière, CHU de Dijon, Dijon, France

family: Aho-Glélé

full_name: Ludwig Serge Aho-Glélé

given: Ludwig Serge

name: Unité de Gestion du Risque Infectieux, Service d’Infectiologie, CHU de Saint-Etienne, Saint-Etienne, France

name: Laboratoire des Agents Infectieux et Hygiène, CHU de Saint-Etienne, Saint-Etienne, France

family: Berthelot

full_name: Philippe Berthelot

name: Service de médecine et santé au travail, Groupement Hospitalier Est, Hospices Civils de Lyon, Bron, France

name: Ifsttar, UMRESTTE, UMR T_9405 Univ Lyon, Université Claude Bernard Lyon1, Lyon, France

family: Denis

full_name: Marie-Agnès Denis

given: Marie-Agnès

family: Grando

full_name: Jacqueline Grando

given: Jacqueline

name: Service d’hygiène hospitalière, CHU Grenoble Alpes, Grenoble, France

name: Université Grenoble Alpes, CNRS, Grenoble INP, TIMC-IMAG, Grenoble, France

family: Landelle

full_name: Caroline Landelle

given: Caroline

family: Astruc

full_name: Karine Astruc

given: Karine

name: Centre d’Investigation Clinique, Inserm CIC1406, CHU de Grenoble Alpes, Grenoble, France

family: Paris

full_name: Adeline Paris

given: Adeline

family: Pillet

full_name: Sylvie Pillet

given: Sylvie

name: Inserm, F-CRIN, Réseau Innovative Clinical Research in Vaccinology (I-REIVAC), Lyon center, France

family: Lina

full_name: Bruno Lina

given: Bruno

family: Vanhems

full_name: Philippe Vanhems

family: Bardou

full_name: Marc Bardou

given: Marc

family: Bour

full_name: Jean-Baptiste Bour

given: Jean-Baptiste

family: Fontana

full_name: Luc Fontana

given: Luc

family: Mallaret

full_name: Marie-Reine Mallaret

given: Marie-Reine

family: Lupo

full_name: Julien Lupo

given: Julien

family: Morand

full_name: Patrice Morand

given: Patrice

family: Pothier

full_name: Pierre Pothier

given: Pierre

family: Pozzetto

full_name: Bruno Pozzetto

family: Robert

full_name: Olivier Robert

given: Olivier

location_facility: Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health