title: RAndomized Controlled Trial of a Multiple INtervention proGram to Decrease Heart Failure Rehospitalization

acronym: RACING-HF

summary: The prevalence of heart failure (HF) is constantly increasing in France due to the aging of the population, better management of etiological factors and improved treatments (drug / interventional). On the other hand, re-hospitalizations for heart failure continue to increase, exceeding reception capacities and constitute a real challenge for current public health systems. The PRADO system provides administrative support (through a health insurance advisor) in the management of patient appointments with their doctors as well as home visits by a nurse trained in heart failure. Other interventional medical and educational interventions performed during an out-of-hospital consultation guided by a computer platform would help to optimize the care and continuity of care.

lead_sponsor: French Cardiology Society

location_facility: Centre Hopsitalier Lucie et Raymond Aubrac


title: Comparison of the Effectiveness of Two Psycho-physical Interventions: Mindfulness Based Relapse Prevention (MBRP) and Unguided Meditative Relaxation in Patients With Alcohol Use Disorder

acronym: MBRP

summary: Alcohol use disorder (AUD) is the second highest preventable cause of death in France. Only 3% of patients are prescribed approved drugs for reducing alcohol consumption or maintenance of abstinence. Increasing evidence supports the efficacy of psychotherapies such as cognitive and behavioral therapies (CBT) in AUD. However, some patients are resistant to CBT and the positive effects of CBT could wane over time, resulting in mid- and long-term relapses. Mindfulness practice is increasingly widespread in the United States and its efficacy in various fields appears very promising. The study investigators hypothesize that the Mindfulness Based Relapse Prevention (MBRP) program will be more efficient than a relaxation/meditation without guidance control program in AUD.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Le CSAPA - Association Charonne
Hopital Paul Brousse
Hôpital Corentin-Celton
Clinique Des Epinettes
CHU de Nantes
Hopital Pitié-Salpétriere
CHU de Nimes

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Ongoing


title: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial

summary:
This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.

This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.

The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

study_start_date_type: Actual

status: Active, not recruiting

primary_purpose: Prevention

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Nestlé

location_facility: Maternité Régionale Universitaire A. Pinard - CHRU Nancy

intervention_type: Dietary Supplement

lead_sponsor_type: industriel


title: Probe-based Confocal Laser Endomicroscopy for Assessment of Mucosal Healing in Ulcerative Colitis: Development and Validation of the ENHANCE Score

acronym: ENHANCE

summary:
The aim of the study is to construct and validate an endomicroscopic score correlated with microscopic inflammation activity in patients with UC.

Probe-based confocal laser endomicroscopy (pCLE) is a new endoscopic imaging modality, which offers the possibility to perform in vivo mucosal microscopic analysis in real time during endoscopy.

Primary Objectives : Development and validation of a UC endomicroscopic score, after correlation between pCLE data and histological data using the Geboes' score as a gold standard during ulcerative colitis.

Secondary Objectives:

Identify predictive factors for the response to adalimumab.
Identify predictive factors for recurrence in patients with UC in remission (Mayo score 0 or 1).
Safety of the pCLE procedure

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: European Georges Pompidou Hospital

status_simplified: Unknown


title: Spa Therapy for Upper Limb Lymphoedema : a Randomized and Comparative Study

acronym: THERMOEDEME

summary:
The lymphoedema is a chronic disease caused by an insufficiency of lymphatic system. In France, 100 000 persons are disabled by this disease.

The most classic form is the "swollen arm" which affects the women after surgery and radiotherapy treatments in breast cancer.

The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of arm lymphoedema post breast cancer treatments.

status: Recruiting

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. Review.

ReferenceCitation: International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003 Jun;36(2):84-91. Review.

ReferenceCitation: Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15.

family: Carpentier

full_name: Patrick H. Carpentier

given: Patrick H.

sequence: first

family: Blaise

full_name: Sophie Blaise

given: Sophie

sequence: additional

family: Satger

full_name: Bernadette Satger

given: Bernadette

family: Genty

full_name: Céline Genty

given: Céline

family: Rolland

full_name: Carole Rolland

given: Carole

family: Roques

full_name: Christian Roques

given: Christian

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Vascular Surgery

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5. Review.

ReferenceCitation: Norman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res. 2004 Oct;4(5):581-5. doi: 10.1586/14737167.4.5.581.

ReferenceCitation: Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. Review.

ReferenceCitation: Devoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7.

ReferenceCitation: Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.

ReferenceCitation: Vignes S. [Management of limb lymphedema]. Rev Med Interne. 2012 May;33(5):268-72. doi: 10.1016/j.revmed.2011.12.012. Epub 2012 Jan 31. French.

ReferenceCitation: Carpentier PH, Fabry R. Crénothérapie des maladies vasculaires. In: Queneau P, editor. Médecine Thermale, faits et preuves. Paris: Masson Ed; 2000. p. 102-15.

ReferenceCitation: Carpentier PH, Colomb M, Poensin D, Satger B. [Incidence of erysipelas of the lower limbs in a spa resort. Efficacy of a strategy of sanitation education (La Lechere: 1992-1997)]. J Mal Vasc. 2001 Apr;26(2):97-9. French.

ReferenceCitation: Blaise S, Villemur B, Richaud C, Rastel D, Bucci B, Evra V, Bouchet JY, Satger B; Réseau GRANTED. [Designing a therapeutic education program for patients with lymphedema: live with lymphedema]. J Mal Vasc. 2012 Feb;37(1):1-8. doi: 10.1016/j.jmv.2011.10.006. Epub 2011 Dec 21. French.

ReferenceCitation: Carpentier PH, Satger B, Poensin D, Trens C, Arnold M, Trolliet C, Noilhetas J, Chauvin E, Laurès J Therapeutic education combined with balneotherapy in lymphedema patients. Communication acceptée à l'American Venous Forum (Orlando 25/02/2016, publication en préparation)

ReferenceCitation: Launois R, Alliot F. Quality of Life Scale in Upper Limb Lymphoedema - A validation Study. Lymphology 33, 2000 (Suppl) : 266-74.

lead_sponsor: Association Francaise pour la Recherche Thermale

location_facility:
CH Lourdes
Centre Léon Berard
CHU Toulouse
Clinique du Tonkin
Cabinet de médecine vasculaire
Thermes Barbotan Les Bains
CHU Amiens Picardie
CH Tarbes
Thermes Argelès-Gazost
Thermes Luz Saint Sauveur
Clinique générale HPDA
Thermes La Léchère
Groupe Hospitalier Mutualiste

intervention_type: Other


title: Partnerships Between Schools and Public Mental Health Departments: Investigation of Multi-professional Interventions for Children Aged 3 to 8 With Mental Health Issues (Parpsych-Ed).

acronym: Parpsych-Ed

summary: Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France. They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need. Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs. Theses also facilitate community support. One of them, early-interventions involve caregivers. Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.

ipd_sharing: Undecided

lead_sponsor: GCS pour la recherche et la formation en sante mentale

location_facility:
EPSM de Guadeloupe
EPSM Barthélémy Durand
Centre Hospitalier de Saint Denis
EPSM Val de Lys
Fondation Bon Sauveur de la Manche
Centre Hospitalier Sainte Anne


title: Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.

acronym: CONCEPTION

summary: Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.

lead_sponsor: University Hospital, Toulouse

location_facility: APHP Hôpital Necker, Lactarium Régional d'Ile de France

intervention_type: Biological


title: Phase II Randomized Trial Evaluating the Administration of Sorafenib or Pravastatin or Association Sorafenib-pravastatin or Best Supportive Care for the Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

acronym: PRODIGE 21

summary: The incidence of Hepatocellular Carcinoma (HCC) is currently increasing in Europe and in France and about 2 / 3 of patients, are not eligible for curative treatment at the time of diagnosis. The palliative management of patients with advanced and symptomatic disease is complex and requires treatment combining anti-tumor activity and safety in patients with impaired liver functions. Sorafenib is the standard of care in a palliative setting, but the benefit of sorafenib in patient with altered liver function is uncertain. The aim of this trial is to study the interest of sorafenib in patients with HCC and impaired liver function compared to pravastatin (a drug with anti-tumoral activity in HCC) or to the combination sorafenib/pravastatin or to best supportive care (usually used in these patients).

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

family: Llovet

full_name: Josep M. Llovet

given: Josep M.

family: Ricci

full_name: Sergio Ricci

given: Sergio

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Hilgard

full_name: Philip Hilgard

given: Philip

family: Gane

full_name: Edward Gane

given: Edward

family: Blanc

full_name: Jean-Frédéric Blanc

given: Jean-Frédéric

family: de Oliveira

full_name: Andre Cosme de Oliveira

given: Andre Cosme

family: Santoro

full_name: Armando Santoro

given: Armando

family: Raoul

full_name: Jean-Luc Raoul

family: Forner

full_name: Alejandro Forner

given: Alejandro

family: Schwartz

full_name: Myron Schwartz

given: Myron

family: Porta

full_name: Camillo Porta

given: Camillo

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

family: Greten

full_name: Tim F. Greten

given: Tim F.

family: Galle

full_name: Peter R. Galle

given: Peter R.

family: Seitz

full_name: Jean-François Seitz

given: Jean-François

family: Borbath

full_name: Ivan Borbath

given: Ivan

family: Häussinger

full_name: Dieter Häussinger

given: Dieter

family: Giannaris

full_name: Tom Giannaris

given: Tom

family: Shan

full_name: Minghua Shan

given: Minghua

family: Moscovici

full_name: Marius Moscovici

given: Marius

family: Voliotis

full_name: Dimitris Voliotis

given: Dimitris

title: Sorafenib in Advanced Hepatocellular Carcinoma

ReferenceCitation: Taras D, Blanc JF, Rullier A, Dugot-Senant N, Laurendeau I, Vidaud M, Rosenbaum J. Pravastatin reduces lung metastasis of rat hepatocellular carcinoma via a coordinated decrease of MMP expression and activity. J Hepatol. 2007 Jan;46(1):69-76. Epub 2006 Jul 28.

ReferenceCitation: Kawata S, Yamasaki E, Nagase T, Inui Y, Ito N, Matsuda Y, Inada M, Tamura S, Noda S, Imai Y, Matsuzawa Y. Effect of pravastatin on survival in patients with advanced hepatocellular carcinoma. A randomized controlled trial. Br J Cancer. 2001 Apr 6;84(7):886-91.

ReferenceCitation: Lersch C, Schmelz R, Erdmann J, Hollweck R, Schulte-Frohlinde E, Eckel F, Nader M, Schusdziarra V. Treatment of HCC with pravastatin, octreotide, or gemcitabine--a critical evaluation. Hepatogastroenterology. 2004 Jul-Aug;51(58):1099-103.

ReferenceCitation: Cohen DE, Anania FA, Chalasani N; National Lipid Association Statin Safety Task Force Liver Expert Panel. An assessment of statin safety by hepatologists. Am J Cardiol. 2006 Apr 17;97(8A):77C-81C. Epub 2006 Feb 3.

ReferenceCitation: Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13. Review.

ReferenceCitation: Blanc JF, Khemissa F, Bronowicki JP, Monterymard C, Perarnau JM, Bourgeois V, Obled S, Abdelghani MB, Mabile-Archambeaud I, Faroux R, Seitz JF, Locher C, Senellart H, Villing AL, Audemar F, Costentin C, Deplanque G, Manfredi S, Edeline J; PRODIGE 21 collaborators. Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child-Pugh B cirrhosis. Hepatol Int. 2021 Feb;15(1):93-104. doi: 10.1007/s12072-020-10120-3. Epub 2021 Jan 9.

title: Phase 2 trial comparing sorafenib, pravastatin, their combination or supportive care in HCC with Child–Pugh B cirrhosis

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital Hautepierre

location_facility: Centre Régional de Lutte contre le Cancer Centre Paul Strauss

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital civil

location_facility: CHU de Bordeaux, Hôpital du Haut Lévèque

location_facility: Centre René Gauducheau CLCC Nantes Atlantique


type: Other Identifier

title: An International Field-Testing Study Of The Reliability And Validity Of A Patient Satisfaction Module (QLQ-SAT32) Assessing Cancer Patients' Perception Of The Quality Of Care Received Within The Hospital

summary:
RATIONALE: Questionnaires may help determine cancer patients' satisfaction with the quality of care they received in the hospital.

PURPOSE: Clinical trial to determine the effectiveness of questionnaires in assessing cancer patients' satisfaction with the quality of care they received in the hospital.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Sweden
France
Belgium
Spain
United Kingdom

location_facility:
Uppsala University Hospital
Centre Alexis Vautrin
Hospital De Navarra
Centre Regional Francois Baclesse
Institut Curie - Section Medicale
Sahlgrenska University Hospital
Centre Paul Strauss
Bristol Royal Infirmary
Institut Jules Bordet
Institut Gustave Roussy
Institut Bergonie

status_simplified: Completed


title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Prospective, Randomized Controlled Study

acronym: HomeCareSIMEOX

summary:
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.

By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves.

The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.

lead_sponsor: Physio-Assist

location_facility: Nice University-Affiliated Hospital : Pneumo-pediatric department

location_facility: Grenoble University Hospital : pneumo-pediatric department

location_facility: Marseille University Hospital - Pneumology department

location_facility: Nice University-Affiliated Hospital : Pneumology department

location_facility: Grenoble University-Affiliated Hospital : Pneumology department

intervention_type: Device


title: Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry

summary:
Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.

Because of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).

This registry is opened in France and in Belgium

time_perspective: Other

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme


title: Impact of the Suicide Attempt on the Close Entourage: Traumatic Stress and Medico-economic Concerns, in Medium and Long Term

acronym: IMTAP

summary:
With 11.000 deaths and 150.000 attempts each year in France, the suicide represents an important public health problem. For each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (Terra 2001). In term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide and 3.750.000 people (annually) touched by the "suicide attempt" of a close relative. It seems indeed important to have Public Health data on this cascade repercussion of the suicide attempt.

A suicide attempt propagates a suffering cascade on the various circles of the family and close entourage, which can be measured in term of traumatic stress and medico-economic impact.

Objective = To measure the medico-economic impact on the entourage, in the 3 months following the suicide attempt and at 1 year.

lead_sponsor: University Hospital, Lille

location_facility:
Le Vinatier Hospital
University Hospital, Clermont-Ferrand
University Hospital, Lille
University Hospital, Brest
University Hospital, Nancy
General Hospital, Quimper
University Hospital, Nice
EPSM Lille Metropole
University Hospital, Caen
Tenon Hospital, Paris
University Hospital, Limoges
University Hospital, Angers


title: Study of Family COsegregation of Nucleotide VARiants in the Panel of Genes to Validate Their Use in Genetic Counseling

acronym: COVAR

summary: The aim of the COVAR project is to classify reliably a maximum of VUS of the French database in order to use them for the genetic counseling. The results obtained through this study will have a major impact on clinical management of the patients and their families conducting in some cases to propose a prophylactic surgery.

primary_purpose: Diagnostic

lead_sponsor: Institut Curie

location_country: Martinique Réunion France Guadeloupe

location_facility: Institut Claudius Regaud - IUCT - Oncopole

location_facility: Institut de Cancérologie Strasbourg Europe ICANS

location_facility: Hopital de Hautepierre - Hôpital Universitaire

intervention_type: Genetic


title: Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2011).

acronym: Inspired

summary: Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHRU Lille
CHU Rouen


title: Responsiveness and Validation Study of MFM-20 in SMA Patients Treated With Nusinersen: Retro NusiMFM

acronym: RetroNusiMFM

summary:
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (MFM-20).

In order to show the possible use of MFM-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-20 and the validity of the scale in this population.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de neuropédiatrie et neurochirurgie de l'enfant Centre de Référence maladies neuromusculaires AOC CHU d'Angers

location_facility: Service de génétique médicale Pôle de Pédiatrie CHU Estaing

location_facility: Service de Neurologie et réanimation pédiatriques CHU Paris IdF Ouest - Hôpital Raymond Poincaré

location_facility: Hospices Civils de Lyon, Hôpital Femme Mère Enfant

location_facility: Service de pédiatrie CHU de Saint-Etienne

location_facility: Unité de Neurologie Pédiatrique Centre de Référence Maladies NeuroMusculaires Hôpital des Enfants CHU Toulouse

location_facility: Institut I-Motion - Centre de recherche pédiatrique en pathologies neuromusculaires CHU Paris Est - Hôpital d'Enfants Armand-Trousseau


title: Responsiveness and Validation Study of MFM-32 in SMA Patients Treated With Nusinersen: NusiMFM

acronym: NusiMFM

summary:
The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items originally validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (MFM-20).

In order to prove the possible use of MFM-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-32 and the validity of the scale in this population.

location_facility: Service de neuropédiatrie et neurochirurgie de l'enfant Centre de Référence des Maladies Neuromusculaires AOC CHU d'Angers

location_facility: Service de Neurologie et réanimation pédiatriques

location_facility: Institut I-Motion - Centre de recherche pédiatrique en pathologies neuromusculaires

location_facility: L'Escale, Service central de rééducation pédiatrique Hospices Civils de Lyon Hôpital Mere Enfant


title: Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants

summary: Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.

ReferenceCitation: Barbé F, Hansen C, Badonnel Y, Legagneur H, Vert P, Boutroy MJ. Severe side effects and drug plasma concentrations in preterm infants treated with doxapram. Ther Drug Monit. 1999 Oct;21(5):547-52.

ReferenceType: derived

ReferenceCitation: Greze E, Benard M, Hamon I, Casper C, Haddad FE, Boutroy MJ, Hascoët JM. Doxapram Dosing for Apnea of Prematurity Based on Postmenstrual Age and Gender: A Randomized Controlled Trial. Paediatr Drugs. 2016 Dec;18(6):443-449.

lead_sponsor: Jean Michel Hascoet

location_facility:
Hopital des Enfants
Maternite Regionale Universitaire

intervention_type: Drug


title: Prevalence, With Medical Imaging, of the Parenchymatous and/or Ductal Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

acronym: PAPAFA

summary: Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility: Groupe Hospitalier Mutualiste des Eaux Claires

location_facility: Centre des maladies du foie et de l'appareil digestif

intervention_type: Procedure


title: OP2C : Prialt® Observatory in Clinical Practice

summary:
Ziconotide is a powerful analgesic marketed since 2009 in France and reserved for the intrathecal route.

It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of spinal toxicity and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug or tachyphylaxis.

However, during these studies many undesirable effects were highlighted, especially neuropsychic which limited its use. This toxicity was mainly related to the administration of too high doses.

In recent years, the use of ziconotide intrathecally has again become a relevant option. Indeed, it is recommended as a first line in the intrathecal treatment options.

However, there is a lack of data on the current use of ziconotide in current practice.

The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut de Cancerologie de L'Ouest
CHU NICE
Clinique Breteche
Institut Curie
Hopital - Foch
Centre Leon Berard
Institut de Cancerologie de Montpellier


title: Cohort of Hospitalized Patients Suspected of Leptospirosis

acronym: COLEPT

summary: COLEPT is a prospective interventional study that intends to better inform about leptospirosis, a neglected zoonotic infectious disease. During prospective follow-up of hospitalized acute leptospirosis cases, the participants will be assessed during 1 year for epidemiological, clinical, bacteriological and immunological data. Main intervention consists in blood sampling and biological bank constitution.

primary_purpose: Supportive Care

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

location_facility:
Groupe Hospitalier Est Réunion (GHER)
CHU de La Réunion site Sud (GHSR)
CHU de La Réunion site Nord
Centre Hospitalier Ouest Réunion (CHOR)


title: National Prospective and Retrospective Follow-up of Patients With COVID-19 Infected Chronic Lymphocytic Leukemia / Lymphocytic Lymphoma or Waldenström Disease

summary:
The COVID-19 epidemic (Coronavirus Disease 2019) which is currently raging in France is an emerging infectious disease linked to a virus of the genus coronavirus (SARS-CoV-2). The first cases were reported in Wuhan, China, in late December 2019 [1]. Globally, it has been placed in the "pandemic" stage by the WHO since March 11, 2020. Coronavirus viruses have been responsible for epidemics in the past such as the SARS epidemic in 2002 (Syndrome Severe Acute Respiratory) linked to the SARS-CoV virus, or the epidemic of MERS (Middle East Respiratory Syndrome) that affected the Middle East in 2012.

Patients with chronic lymphocytic leukemia (CLL) / lymphocytic lymphoma or Waldenstrom Disease (WD) therefore represent a population at high risk of developing a severe form in the event of COVID-19 infection.

To date, no data is available in the literature to assess the impact of the COVID-19 epidemic in this population of patients with CLL / lymphocytic lymphoma or WD.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Avicenne - Centre de Recherche Clinique


title: Effectiveness of Coordinated Care to Reduce the Risk of Prolonged Disability Among Patients Suffer From Subacute or Recurrent Acute Low Back Pain in Primary Care

acronym: COLOMB

summary:
Common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. Its management in France mainly depends on general practioners, and sometime on physiotherapists.

A coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals.

The main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Angers

location_facility: Cluster Châteauneuf sur Sarthe / Morannes


title: National Prospective and Comparative Study on the Mode of Delivery of Twins

acronym: JUMODA

summary: The purpose of this study is to determine the best obstetrical practices for twin delivery.

ReferenceCitation: Barrett JF, Hannah ME, Hutton EK, Willan AR, Allen AC, Armson BA, Gafni A, Joseph KS, Mason D, Ohlsson A, Ross S, Sanchez JJ, Asztalos EV; Twin Birth Study Collaborative Group. A randomized trial of planned cesarean or vaginal delivery for twin pregnancy. N Engl J Med. 2013 Oct 3;369(14):1295-305. doi: 10.1056/NEJMoa1214939. Erratum in: N Engl J Med. 2013 Dec 12;369(24):2364.

ReferenceCitation: Smith GC. Perinatal death in twins. Author's reply on absolute risk. BMJ. 2007 Apr 14;334(7597):762.

ReferenceCitation: Smith GC, Shah I, White IR, Pell JP, Dobbie R. Mode of delivery and the risk of delivery-related perinatal death among twins at term: a retrospective cohort study of 8073 births. BJOG. 2005 Aug;112(8):1139-44.

ReferenceCitation: Smith GC, Pell JP, Dobbie R. Birth order, gestational age, and risk of delivery related perinatal death in twins: retrospective cohort study. BMJ. 2002 Nov 2;325(7371):1004.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Cost-effectiveness Evaluation of the Use of a Patient Specific Instrument for Surgical Resection of Malignant Bone Tumor Within the Pelvis Versus the Conventional Surgical Treatment

acronym: MARGIC

summary:
Primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases in France per year).

The reference treatment is a surgical "en bloc" resection associated or not to a medical treatment. This surgery remains highly challenging because of the complex three-dimensional geometry of the pelvic bone and the proximity of important organs and neurovascular structures. The local recurrence rate is significantly increased when the resection does not respect a safe tissues margin (R0 margin).

A new technology has been developed and used in different reference sites the Patient Specific Instrument (PSI), manufactured by 3D-Side. The PSI allows for a more secure and reliable surgical gesture, leading to more frequent R0 margins.

The main objective of this study is to compare the efficiency of the PSI for bone tumor resections within the pelvis with respect to the reference method.

design_allocation: Non-Randomized

lead_sponsor: Nantes University Hospital

location_facility:
Paris Hospital Kremlin-Bicêtre
Lyon CRCM Les Massues
Lyon Centre Léon Bérard
Lille University Hospital
Marseille University Hospital
Nancy Centre Chirurgical Emile Gallé
Nantes University Hospital
Paris Hospital Cochin


title: Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference

summary:
Chronic liver diseases (CLDs) represent a major worldwide public health burden. Worldwide estimations show that 844 million people have CLDs, a lot more than other chronic diseases such as diabetes or cardiovascular diseases. CLD is most of the time an asymptomatic, progressive, and potentially fatal disease. With its complications it becomes one of the major causes of mortality worldwide. Globally, hepatitis B virus and hepatitis C virus, alcoholic liver disease and non-alcoholic steatohepatitis, are the most important causes of liver disease.

The diagnosis of liver lesions remains an important issue for these patients. The prognosis and management of liver disease greatly depends on the amount of liver fibrosis. In early stages, it is the main factor predicting long-term outcome of these patients. The liver biopsy still represents the gold standard diagnostic tool for liver fibrosis assessment, although a wide spectrum of noninvasive tools are now commonly used as a surrogate to the liver biopsy. It includes direct and indirect serum markers of liver fibrosis, but also several imaging-based methods, including transient elastography (FibroScan®, Echosens, Paris, France).

Even if the liver fibrosis is the key pathological feature of progressive liver disease, the accumulation of excessive hepatic triglyceride, hepatic steatosis, is today recognized as an important factor in the pathogenesis of a number of CLD. The magnetic resonance imaging (MRI) techniques are sensitive to steatosis and show interesting diagnostic performances, especially the MRI using the proton density fat fraction (MRI-PDFF) which has shown at least equivalence in accuracy for quantifying hepatic steatosis with both 1H Magnetic Resonance Spectroscopy and with histological grade, across several studies. Therefore, this technique is now part of the gold standard diagnostic tool to establish the grade of hepatic steatosis. Echosens has developed an ultrasonic controlled attenuation parameter (CAP) designed to quantify hepatic steatosis using a process based on vibration controlled transient elastography (VCTE™).

Echosens is working on improving the diagnostic accuracy of the CAP measurement performed with the FibroScan. This protocol is set-up to compare the diagnostic performances of the first generation of the CAP and the second generation of the CAP to the reference, the MRI-PDFF, in patients with CLD, all etiologies combined.

lead_sponsor: Echosens

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut Lévêque

location_facility: Hôpitaux Universitaires Paris Seine Saint-Denis - Service Hépatologie

location_facility: CHU Rennes Hôpital Pontchaillou - Service des Maladies du Foie

location_facility: Hôpital Saint-Antoine - Service Hépatologie


title: Post-registration Observational Study on the Custom-made Abdominal Aortic Endograft Fenestrated Anaconda™

acronym: EPI-EFA

summary:
The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for carrying out the act recommended by the CNEDiMTS (Committee in charge of medical device review), namely the carrying out of a post-registration study for the renewal of the authorization. This renewal of registration is conditioned by the set-up of a long-term follow-up study of all patients treated with the Fenestrated Anaconda ™ in France.

To do this, this study will be carried out in partnership with the Federation of Medical Specialties (FSM) and the National Professional Council (CNP) of Vascular Surgery in order to have the data necessary for the renewal of the registration of the Fenestrated Anaconda ™ from the registry called Datavasc developed by the CNP and available online on the FSM's electronic platform.

lead_sponsor: Vascutek Ltd.

location_facility: Groupe Hospitalier Mutualiste de GRENOBLE

location_facility: CHU de de DIJON BOURGOGNE - Hôpital François Mitterrand

location_facility: CHU de CLERMONT-FERRAND - site Gabriel-Montpied

location_facility: CHR de METZ-THIONVILLE - Hôpital de Mercy


ReferenceCitation: Cariou B, Hanf R, Lambert-Porcheron S, Zaïr Y, Sauvinet V, Noël B, Flet L, Vidal H, Staels B, Laville M. Dual peroxisome proliferator-activated receptor α/δ agonist GFT505 improves hepatic and peripheral insulin sensitivity in abdominally obese subjects. Diabetes Care. 2013 Oct;36(10):2923-30. doi: 10.2337/dc12-2012. Epub 2013 May 28.

family: Cariou

full_name: B. Cariou

given: B.

family: Hanf

full_name: R. Hanf

given: R.

family: Lambert-Porcheron

full_name: S. Lambert-Porcheron

given: S.

family: Zair

full_name: Y. Zair

given: Y.

family: Sauvinet

full_name: V. Sauvinet

given: V.

family: Noel

full_name: B. Noel

family: Flet

full_name: L. Flet

given: L.

family: Vidal

full_name: H. Vidal

given: H.

family: Staels

full_name: B. Staels

family: Laville

full_name: M. Laville

given: M.

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Dual Peroxisome Proliferator-Activated Receptor / Agonist GFT505 Improves Hepatic and Peripheral Insulin Sensitivity in Abdominally Obese Subjects

ReferenceCitation: Staels B, Rubenstrunk A, Noel B, Rigou G, Delataille P, Millatt LJ, Baron M, Lucas A, Tailleux A, Hum DW, Ratziu V, Cariou B, Hanf R. Hepatoprotective effects of the dual peroxisome proliferator-activated receptor alpha/delta agonist, GFT505, in rodent models of nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Hepatology. 2013 Dec;58(6):1941-52. doi: 10.1002/hep.26461. Epub 2013 Oct 29.

name: Université Lille Nord de France; Lille France

name: Université Droit et Santé de Lille; Lille France

full_name: Bart Staels

given: Bart

family: Rubenstrunk

full_name: Anne Rubenstrunk

given: Anne

full_name: Benoit Noel

given: Benoit

family: Rigou

full_name: Géraldine Rigou

given: Géraldine

family: Delataille

full_name: Philippe Delataille

given: Philippe

family: Millatt

full_name: Lesley J. Millatt

given: Lesley J.

family: Baron

full_name: Morgane Baron

given: Morgane

family: Lucas

full_name: Anthony Lucas

name: Department of Hepatogastroenterology; Pitie-Salpetriere University Hospital, University Pierre et Marie Curie Paris VI; Paris France

name: Department of Endocrinology; l'Institut du Thorax, Nantes University Hospital; Nantes France

title: A Pilot Study to Evaluate the Efficacy of GFT505 (80mg) Orally Administered Once Daily for 8 Weeks on Insulin Sensitivity Using a Glucose Clamp Technique and Safety in Male Patients With Insulin Resistance and Abdominal Obesity. A Multicentre, Randomised, Single Blind, Placebo-Controlled, Cross Over Study.

summary: The purpose of this study is to demonstrate the efficacy on insulin sensitivity of GFT505 at 80mg/d in male patients with insulin resistance and abdominal obesity. Evaluation will be made using a glucose clamp technique.


title: IntraCranial ANeurysms: From Familial Forms to Pathophysiological Mechanisms

acronym: I-CAN

summary: Intracranial aneurysm (IA) is an asymptomatic cerebrovascular abnormality affecting 3.2% of the general population. The devastating complication of IA is its rupture, resulting in subarachnoid haemorrhage that can lead to severe disability and death. Unfortunately, there are neither reliable clues nor diagnostic tools to predict the formation and/or the fate of an IA in a given individual. Also, there is no pharmacological drug available to prevent the rupture of aneurysm and subsequent subarachnoid haemorrhage. Current treatments are invasive with a significant risk of procedural morbidity. Thus, still now, the management of patients with IA remains extremely challenging and still controversial. Although the pathogenesis of IA has been the subject of many studies for the last decade, the mechanisms underlying IA formation, growth and rupture are still mostly unknown and relevant animal models of IA are not available. Familial history of IA predisposes to IA formation and rupture and increasing evidence suggest a genetic component of IA formation, with heterogeneous modes of inheritance and penetrance. This project, gathering neuroradiologists, geneticists and vascular biologists, addresses the urgent need to understand the pathogenic mechanisms of IA to develop diagnostic and predictive tools of risk of IA. The investigators propose to identify IA-causing variants by whole-exome sequencing in familial forms of the disease. The investigators hypothesises that the functional analysis of the causal/susceptibility variants thus identified will provide clues to understanding the pathological mechanisms of IA formation, and the bases for developing diagnostic tools. This project aims at meeting this challenge. Based on preliminary data that already allowed to identify such a variant, and the combination of genetic and functional investigations, the specific objectives of this project are: - To identify IA-causing variants in familial forms of the disease by whole-exome sequencing; - To understand the function of these genes/variants in the formation and rupture of IA by molecular and cellular approaches and generation of relevant animal models; - To discover potential biomarkers of risk of IA formation and/or rupture.

ReferenceCitation: L'Allinec V, Chatel S, Karakachoff M, Bourcereau E, Lamoureux Z, Gaignard A, Autrusseau F, Jouan S, Vion AC, Loirand G, Desal H, Naggara O, Redon R, Edjlali M, Bourcier R. Prediction of Unruptured Intracranial Aneurysm Evolution: The UCAN Project. Neurosurgery. 2020 Jul 1;87(1):150-156. doi: 10.1093/neuros/nyaa093.

name: CHU Nantes, Neuroradiology Department, Nantes, France

name: Angers University Hospital, Radiology Department, Angers, France

name: Université de Nantes, CHU Nantes, CNRS, Inserm, l’institut du thorax, Nantes, France

family: L’Allinec

full_name: Vincent L’Allinec

given: Vincent

family: Chatel

full_name: Stéphanie Chatel

given: Stéphanie

name: CHU Nantes, CIC Inserm 1413, Clinique des Données, Nantes, France

family: Karakachoff

full_name: Matilde Karakachoff

given: Matilde

name: CHU Nantes, CIC Inserm 1413, l’institut du thorax, Nantes, France

family: Bourcereau

full_name: Emmanuelle Bourcereau

given: Emmanuelle

name: CHU Nantes, Direction de la recherche, Nantes, France

family: Lamoureux

full_name: Zeineb Lamoureux

given: Zeineb

family: Gaignard

full_name: Alban Gaignard

given: Alban

name: Université de Nantes, ONIRIS, Inserm UMR 1229, RMeS, Regenerative Medicine and Skeleton, Nantes, France

name: Ecole Polytechnique de l’Université de Nantes, Nantes, France

family: Autrusseau

full_name: Florent Autrusseau

given: Florent

family: Jouan

full_name: Solène Jouan

given: Solène

family: Vion

full_name: Anne-Clemence Vion

given: Anne-Clemence

family: Loirand

full_name: Gervaise Loirand

given: Gervaise

family: Desal

full_name: Hubert Desal

given: Hubert

name: Department of Neuroradiology, Université Paris-Descartes-Sorbonne-Paris-Cité, IMABRAIN-INSERM-UMR1266, DHU-Neurovasc, Centre Hospitalier Sainte-Anne, Paris, France

family: Naggara

full_name: Olivier Naggara

given: Olivier

family: Redon

full_name: Richard Redon

given: Richard

family: Edjlali

full_name: Myriam Edjlali

given: Myriam

family: Bourcier

full_name: Romain Bourcier

given: Romain

journal_name: Neurosurgery

oa_host_type: repository

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

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_facility: Lariboisière University Hospital (AP-HP)

location_facility: La Pitié-Salpétrière University Hospital (AP-HP)

location_facility: Kremlin-Bicêtre University Hospital (AP-HP)


title: A Phase II Trial Assessing Immunogenicity and Safety of COVID-19 mRNA Vaccine BNT162b2 in Adult Volunteers With no History of SARS-CoV-2 Infection Administered With Two Doses of Vaccine (D1-D29) and in Adult Volunteers With Documented History of SARS-CoV-2 Infection (of More Than 5 Months) Administered With Only One Dose of Vaccine

acronym: CoviCompareP

summary:
As previously shown, individuals who experienced COVID-19 have developed some protective immunity to reinfection. The magnitude and duration of protection from reinfection conferred by the infection may be weaker after an asymptomatic infection as it is after a symptomatic COVID-19 episode. Moreover, it is known that immunity decreases among older adults compared to younger individuals often referred to as ''immune senescence,'' and leading to a decreased efficacy of vaccination.

This study raises the question of whether a single administration of BNT162b2 in participants with prior SARS-CoV-2 infection leads to sufficient and durable immune response.

We propose to evaluate the level of the single BNT162b2 vaccine dose response according to the severity of the previous SARS-CoV-2 infection in young and elderly participants with the same immunogenicity analyses to assess this response in participants receiving the two-dose vaccination regimen.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre de Recherche Clinique, CHU Côte de Nacre

location_facility: Service des maladies infectieuses, CHU de Caremeau

location_facility: CIC1434, Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg


title: Study Multicenter, Controlled, Prospective, Non-randomized Test to Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis

acronym: TRAP-Myéline

summary: The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,

status: Terminated

location_facility:
University Hospital of Marseille
University Hospital of Bordeaux
University Hospital of Lille
Hopital neurologigue Pierre Wertheimer
University Hospital of clermont Ferrand
University Hospital of Montpellier
University Hospital of Toulouse
University Hospital of Nice
University Hospital of Rennes
University Hospital of Nantes
University Hospital of Strasbourg


type: Registry Identifier

title: Clinical Application of New Pheochromocytoma Markers: INSERM Pilot Study of the Specificity of Elevated Plasma EM66 Concentrations in Patients With Pheochromocytoma or Paraganglioma Compared to Patients With Essential Hypertension

acronym: PHEO

summary: Pheochromocytoma or paraganglioma are tumors generating hypertension as a symptom. Different biological tests are currently available to diagnose these tumors. However, they all lack specificity since they do not distinguish cases of hypertension without pheochromocytoma or paraganglioma. To improve the diagnostic specificity of these tumors, the investigators are testing a new marker called EM66.

lead_sponsor: University Hospital, Rouen

location_facility: Inserm U982/EA 4310; Rouen University (DC2N)

location_facility: Endocrinology Department, Gustave-Roussy Institute


title: Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

acronym: IMAP+

summary: Alzheimer's disease (AD) is a major public health problem due to its socio-economic weight. An early diagnosis of AD is urgently needed as it would constitute a determinant breakthrough from a social, financial and research standpoints. Therefore, the investigators need predictive markers of AD, and neuroimaging is a particularly promising tool, especially when using complementary neuroimaging techniques and a longitudinal design, allowing to assess the relationships between the different biomarkers of the disease, their dynamic and their chronology.

ReferenceCitation: Kuhn E, Moulinet I, Perrotin A, La Joie R, Landeau B, Tomadesso C, Bejanin A, Sherif S, De La Sayette V, Desgranges B, Vivien D, Poisnel G, Chételat G. Cross-sectional and longitudinal characterization of SCD patients recruited from the community versus from a memory clinic: subjective cognitive decline, psychoaffective factors, cognitive performances, and atrophy progression over time. Alzheimers Res Ther. 2019 Jul 8;11(1):61. doi: 10.1186/s13195-019-0514-z.

family: Kuhn

full_name: Elizabeth Kuhn

given: Elizabeth

family: Moulinet

full_name: Inès Moulinet

given: Inès

family: Perrotin

full_name: Audrey Perrotin

given: Audrey

family: La Joie

full_name: Renaud La Joie

given: Renaud

family: Landeau

full_name: Brigitte Landeau

given: Brigitte

family: Tomadesso

full_name: Clémence Tomadesso

given: Clémence

family: Bejanin

full_name: Alexandre Bejanin

given: Alexandre

family: Sherif

full_name: Siya Sherif

given: Siya

family: De La Sayette

full_name: Vincent De La Sayette

family: Desgranges

full_name: Béatrice Desgranges

given: Béatrice

family: Vivien

full_name: Denis Vivien

given: Denis

family: Poisnel

full_name: Géraldine Poisnel

given: Géraldine

family: Chételat

full_name: Gaëlle Chételat

given: Gaëlle

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Gonneaud J, Arenaza-Urquijo EM, Fouquet M, Perrotin A, Fradin S, de La Sayette V, Eustache F, Chételat G. Relative effect of APOE ε4 on neuroimaging biomarker changes across the lifespan. Neurology. 2016 Oct 18;87(16):1696-1703. Epub 2016 Sep 28.

location_facility: Inserm - EPHE - University of Caen U1077


title: Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

acronym: PASAPAS

summary:
Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

ReferenceType: result

ReferenceCitation: Majed B, Moreau T, Senouci K, Salmon RJ, Fourquet A, Asselain B. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008 Sep;111(2):329-42. Epub 2007 Oct 16.

ReferenceCitation: Trédan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Pérol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.

family: Trédan

full_name: Olivier Trédan

family: Bajard

full_name: Agathe Bajard

given: Agathe

family: Meunier

full_name: Anne Meunier

given: Anne

family: Roux

full_name: Pascale Roux

given: Pascale

family: Fiorletta

full_name: Ingrid Fiorletta

given: Ingrid

family: Gargi

full_name: Thérèse Gargi

given: Thérèse

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Guastalla

full_name: Jean-Paul Guastalla

given: Jean-Paul

family: Lallemand

full_name: Yolande Lallemand

given: Yolande

family: Faure

full_name: Christelle Faure

given: Christelle

family: Pérol

full_name: David Pérol

given: David

family: Bachmann

full_name: Patrick Bachmann

given: Patrick

journal_name: Clinical Nutrition

title: Body weight change in women receiving adjuvant chemotherapy for breast cancer: A French prospective study

ReferenceCitation: Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86.

ReferenceCitation: Newton RU, Galvão DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008 Jun;9(2-3):135-46. doi: 10.1007/s11864-008-0065-1. Epub 2008 Aug 13. Review.

family: Newton

full_name: Robert U. Newton

given: Robert U.

family: Galvão

full_name: Daniel A. Galvão

given: Daniel A.

journal_name: Current Treatment Options in Oncology

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Exercise in Prevention and Management of Cancer

ReferenceCitation: Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51.

ReferenceCitation: Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chézet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Trédan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666.

apc_source: doaj

family: Febvey-Combes

full_name: Olivia Febvey-Combes

given: Olivia

name: University of Lyon, Villeurbanne, France

family: Jobard

full_name: Elodie Jobard

given: Elodie

name: University of Clermont Auvergne, Clermont-Ferrand, France

family: Rossary

full_name: Adrien Rossary

given: Adrien

name: Institut Universitaire de France, Paris, France

name: Grenoble Alpes University, Grenoble, France

name: Clermont-Ferrand University Hospital, Jean Perrin Cancer Center, Clermont-Ferrand, France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

ReferenceCitation: Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lépine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Pérol D, Trédan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.

ReferenceCitation: Foucaut AM, Morelle M, Kempf-Lépine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Pérol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Trédan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.


title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

acronym: Antenatal

summary: Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

ReferenceCitation: Hogan J, Dourthe ME, Blondiaux E, Jouannic JM, Garel C, Ulinski T. Renal outcome in children with antenatal diagnosis of severe CAKUT. Pediatr Nephrol. 2012 Mar;27(3):497-502. doi: 10.1007/s00467-011-2068-6. Epub 2011 Dec 14.

ReferenceCitation: Seeds JW. Diagnostic mid trimester amniocentesis: how safe? Am J Obstet Gynecol. 2004 Aug;191(2):607-15. Review.

ReferenceCitation: Clark TJ, Martin WL, Divakaran TG, Whittle MJ, Kilby MD, Khan KS. Prenatal bladder drainage in the management of fetal lower urinary tract obstruction: a systematic review and meta-analysis. Obstet Gynecol. 2003 Aug;102(2):367-82. Review.

ReferenceCitation: Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD; Percutaneous vesicoamniotic shunting in Lower Urinary Tract Obstruction (PLUTO) Collaborative Group. Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial. Lancet. 2013 Nov 2;382(9903):1496-506. doi: 10.1016/S0140-6736(13)60992-7. Epub 2013 Aug 14.

ReferenceCitation: Schmoor C, Sauerbrei W, Schumacher M. Sample size considerations for the evaluation of prognostic factors in survival analysis. Stat Med. 2000 Feb 29;19(4):441-52.

ReferenceCitation: Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999 Sep 15;282(11):1061-6. Erratum in: JAMA 2000 Apr 19;283(15):1963.

ReferenceCitation: Rutjes AW, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ. 2006 Feb 14;174(4):469-76.

ReferenceCitation: Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006 Oct;59(10):1087-91. Epub 2006 Jul 11. Review.

ReferenceCitation: Klein J, Lacroix C, Caubet C, Siwy J, Zürbig P, Dakna M, Muller F, Breuil B, Stalmach A, Mullen W, Mischak H, Bandin F, Monsarrat B, Bascands JL, Decramer S, Schanstra JP. Fetal urinary peptides to predict postnatal outcome of renal disease in fetuses with posterior urethral valves (PUV). Sci Transl Med. 2013 Aug 14;5(198):198ra106. doi: 10.1126/scitranslmed.3005807.

lead_sponsor: University Hospital, Toulouse

location_country:
Italy
Switzerland
Netherlands
France
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: Hôpital des Enfants Hôpitaux universitaire Genève (HUG)

location_facility: Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)

location_facility: FetalMedicine Centre Birmingham Women's Hospital

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Polish Mothers Memorial Hospital Research Institute

location_facility: Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud

location_facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

location_facility: Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan

location_facility: CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique

location_facility: Leiden University Medical Center Dept of prenatal diagnosis and therapy

location_facility: Centre Olympe de Gouges du CHRU de Tours


title: Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting

acronym: ARCTIC

summary: Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel / Prasugrel is maintained during the subsequent 6 months of follow-up.

ReferenceCitation: Collet JP, Cuisset T, Rangé G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrié D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monségu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthélémy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

family: Cuisset

full_name: Thomas Cuisset

family: Rangé

full_name: Grégoire Rangé

given: Grégoire

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Elhadad

full_name: Simon Elhadad

given: Simon

family: Pouillot

full_name: Christophe Pouillot

given: Christophe

family: Henry

full_name: Patrick Henry

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Carrié

full_name: Didier Carrié

given: Didier

family: Boueri

full_name: Ziad Boueri

given: Ziad

family: Belle

full_name: Loic Belle

given: Loic

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Rousseau

full_name: Hélène Rousseau

given: Hélène

family: Aubry

full_name: Pierre Aubry

given: Pierre

family: Monségu

full_name: Jacques Monségu

given: Jacques

family: Sabouret

full_name: Pierre Sabouret

family: O'Connor

full_name: Stephen A. O'Connor

given: Stephen A.

family: Abtan

full_name: Jérémie Abtan

given: Jérémie

family: Kerneis

full_name: Mathieu Kerneis

given: Mathieu

family: Saint-Etienne

full_name: Christophe Saint-Etienne

family: Barthélémy

full_name: Olivier Barthélémy

given: Olivier

family: Beygui

full_name: Farzin Beygui

given: Farzin

family: Silvain

full_name: Johanne Silvain

given: Johanne

title: Bedside Monitoring to Adjust Antiplatelet Therapy for Coronary Stenting

ReferenceCitation: Collet JP, Cayla G, Cuisset T, Elhadad S, Rangé G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.

title: Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: Rationale and design of the Assessment with a double Randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and Clopidogrel after DES implantation, and (2) Treatment Interruption versus Continuation, 1 year after stenting (ARCTIC) study

ReferenceCitation: Lattuca B, Silvain J, Yan Y, Pouillot C, Cuisset T, Cayla G, Henry P, Diallo A, Elhadad S, Rangé G, Lhermusier T, Boueri Z, Motreff P, Carrié D, Vicaut E, Montalescot G, Collet JP. Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007749. doi: 10.1161/CIRCINTERVENTIONS.118.007749. Epub 2019 Nov 7.

name: Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).

name: Cardiology Department, Caremeau University Hospital, ACTION Study Group, Montpellier University, Nîmes, France (B.L., G.C.).

name: Emergency and Critical Care Center, Beijing Anzhen Hospital, Capital Medical University, China (Y.Y.).

name: Cardiology Department, Sainte Clotilde Clinic, St. Denis de la Réunion, France (C.P.).

name: ACTION Study Group, Cardiology Department, La Timone Hospital, Marseille, France (T.C.).

name: Cardiology Department (P.H.), Lariboisière University Hospital, Paris, France.

name: ACTION Study Group, Epidemiology and Clinic Research Unit (A.D., E.V.), Lariboisière University Hospital, Paris, France.

name: Cardiology department, Lagny-Marne la Vallée Hospital, France (S.E.).

name: Cardiology department, Chartres Hospital, Le Coudray, France (G.R.).

name: Cardiology Department, Rangueil University Hospital, Toulouse, France (T.L., D.C.).

name: Cardiology Department, Bastia Hospital, France (Z.B.).

name: Cardiology Department, Gabriel Montpied University Hospital, Clermont-Ferrand, France (P.M.)

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Collet JP, Hulot JS, Cuisset T, Rangé G, Cayla G, Van Belle E, Elhadad S, Rousseau H, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthélémy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC investigators. Genetic and platelet function testing of antiplatelet therapy for percutaneous coronary intervention: the ARCTIC-GENE study. Eur J Clin Pharmacol. 2015 Nov;71(11):1315-24. doi: 10.1007/s00228-015-1917-9. Epub 2015 Aug 13.

journal_name: European Journal of Clinical Pharmacology

ReferenceCitation: Collet JP, Silvain J, Barthélémy O, Rangé G, Cayla G, Van Belle E, Cuisset T, Elhadad S, Schiele F, Lhoest N, Ohlmann P, Carrié D, Rousseau H, Aubry P, Monségu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Montalescot G; ARCTIC investigators. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial. Lancet. 2014 Nov 1;384(9954):1577-85. doi: 10.1016/S0140-6736(14)60612-7. Epub 2014 Jul 15.

ReferenceCitation: Montalescot G, Rangé G, Silvain J, Bonnet JL, Boueri Z, Barthélémy O, Cayla G, Belle L, Van Belle E, Cuisset T, Elhadad S, Pouillot C, Henry P, Motreff P, Carrié D, Rousseau H, Aubry P, Monségu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Collet JP; ARCTIC Investigators. High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: A landmark analysis of the ARCTIC study. Circulation. 2014 May 27;129(21):2136-43. doi: 10.1161/CIRCULATIONAHA.113.007524. Epub 2014 Apr 9.

name: From the ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Université Paris 6, Paris, France (G.M., J.S., O.B., P.S., S.A.O., M.K., J.-P.C.); Hôpital Louis Pasteur, Le Coudray, France (G.R.); Hôpital de la Timone, Marseille, France (J.-L.B., T.C.); CH de Bastia, Bastia, France (Z.B.); CHU Carémeau, Nîmes, France (G.C.); CH de la Région Annecienne, Annecy, France (L.B.); Hôpital Cardiologique, Lille, France (E.V.B.); CH de Lagny, Marne-la-Vallée, France (S.E.); Clinique Sainte...

title: High On-Treatment Platelet Reactivity as a Risk Factor for Secondary Prevention After Coronary Stent Revascularization

location_facility: Institut de Cardiologie- Hopital la Pitié Salpétrière


title: Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study

summary: This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy >90%, assuming a success rate >95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.

location_country: France Spain

location_facility:
Hôpital Saint André
Hôpital de l'Archet
Hôpital Necker
Hôpital Croix Rousse
CHU Hôtel Dieu
Hôpital Pitié-Salpétrière
Hôpital Gui de Chauliac
Hôpital Saint Louis
Hôpital Européen Georges Pompidou
Hospital de la santa Creu i San Pau
Hospital Clinic
Hôpital Bichat Claude Bernard
Hospital de Bellvitge
Hôpital Cochin
Hôpital Avicenne
Hôpital Jean Verdier
Hôpital Bicêtre
Hôpital Sainte marguerite
Hôpital Bretonneau


title: Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke (AVCnn7 Years Study)

summary:
While perinatal ischemic stroke is the most frequent form of childhood stroke, early determinants of outcome remain poorly understood. Two main structural biases limit the accuracy of most studies: heterogeneity of the population and short follow-up.

Perinatal ischemic stroke includes several conditions that differ in pathophysiology and timing of occurrence. Yet, it is not surprising that risk factors and outcome depend primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal insult. Even though the original lesion is static and focal in perinatal stroke, its consequences grow over time within the maturing brain and affect all fields of neurodevelopment.

The objective of the AVCnn study was to delineate the determinants, clinical and imaging presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the opportunity to regularly monitor a large cohort of children having suffered an NAIS.

ReferenceCitation: Thébault G, Martin S, Brouillet D, Brunel L, Dinomais M, Presles É, Fluss J, Chabrier S; AVCnn Study Group. Manual dexterity, but not cerebral palsy, predicts cognitive functioning after neonatal stroke. Dev Med Child Neurol. 2018 Oct;60(10):1045-1051. doi: 10.1111/dmcn.13752. Epub 2018 Apr 6.

name: INSERM, UMR1059 Sainbiose University of Saint‐Étienne University of Lyon Saint‐Étienne

name: University Paul Valéry Montpellier 3 University Montpellier Montpellier

family: Thébault

full_name: Guillaume Thébault

given: Guillaume

family: Martin

full_name: Sophie Martin

given: Sophie

family: Brouillet

full_name: Denis Brouillet

given: Denis

family: Brunel

full_name: Lionel Brunel

given: Lionel

name: Laboratoire d'Ingénierie des Systèmes Automatisés (LISA) University of Angers Angers

name: Physical and Rehabilitation Medicine Department LUNAM CHU Angers Angers France

family: Dinomais

full_name: Mickaël Dinomais

given: Mickaël

family: Presles

full_name: Émilie Presles

given: Émilie

name: Paediatric Neurology Unit Geneva University Hospitals Geneva Switzerland

family: Fluss

full_name: Joel Fluss

given: Joel

name: Paediatric Physical and Rehabilitation Medicine Department French Centre for Paediatric Stroke INSERM CIC1408 CHU Saint‐Étienne Saint‐Étienne France

family: Chabrier

full_name: Stéphane Chabrier

given: Stéphane

family: Darteyre

full_name: Stéphane Darteyre

family: Dégano

full_name: Céline Dégano

given: Céline

family: Delion

full_name: Matthieu Delion

given: Matthieu

family: Deron

full_name: Johanna Deron

given: Johanna

family: Dray

full_name: Gérard Dray

given: Gérard

family: Drutel

full_name: Laure Drutel

given: Laure

family: Groeschel

full_name: Samuel Groeschel

given: Samuel

family: Hertz‐Pannier

full_name: Lucie Hertz‐Pannier

given: Lucie

family: Husson

full_name: Béatrice Husson

given: Béatrice

family: Kossorotoff

full_name: Manoëlle Kossorotoff

given: Manoëlle

family: Lazaro

full_name: Leila Lazaro

given: Leila

family: Lefranc

full_name: Jérémie Lefranc

family: The Tich

full_name: Sylvie Nguyen The Tich

given: Sylvie Nguyen

family: Peyric

full_name: Émeline Peyric

given: Émeline

family: Ravel

full_name: Magaly Ravel

given: Magaly

family: Renaud

journal_name: Developmental Medicine & Child Neurology

ReferenceCitation: Dinomais M, Thébault G, Hertz-Pannier L, Gautheron V, Nguyen The Tich S, Fluss J, Chabrier S; AVCnn Study Group. Is there an excess of left-handedness after neonatal stroke? Cortex. 2017 Nov;96:161-164. doi: 10.1016/j.cortex.2017.08.007. Epub 2017 Aug 16.

ReferenceCitation: Groeschel S, Hertz-Pannier L, Delion M, Loustau S, Husson B, Kossorotoff M, Renaud C, Nguyen The Tich S, Chabrier S, Dinomais M; AVCnn study group. Association of transcallosal motor fibres with function of both hands after unilateral neonatal arterial ischemic stroke. Dev Med Child Neurol. 2017 Oct;59(10):1042-1048. doi: 10.1111/dmcn.13517. Epub 2017 Aug 17.

name: Experimental Pediatric Neuroimaging Department of Child Neurology University Hospital Tübingen Tuebingen Germany

name: UNIACT Neurospin Institut Frédéric Joliot Paris France

name: Département de neurochirurgie and Laboratoire d'anatomie Faculté de médecine Angers LUNAM Université d'Angers Angers France

name: Laboratoire Angevin de Recherche en Maths (LAREMA) LUNAM Université d'Angers Angers France

name: Pediatric Radiology Department University Hospital Bicêtre Assistance‐Publique‐Hopitaux de Paris Paris‐Sud University Paris France

name: Paediatric Neurology Department French Center for Paediatric Stroke University Hospital Necker‐Enfants‐Malades AP‐HP Paris France

name: CHU Saint‐Étienne Inserm Univ Lyon Centre national de référence de l'AVC de L'Enfant Service de médecine physique et de réadaption pédiatrique Saint‐Étienne France

name: Pediatric Neurology Department and Environment Périnatale et Santé University Hospital Lille France

name: CHU Angers Département de Médecine Physique et de Réadaption and LUNAM Université d'Angers Laboratoire Angevin de Rechereche en Ingénierie des Systèmes (LARIS) Angers France

ReferenceCitation: Dinomais M, Hertz-Pannier L, Groeschel S, Delion M, Husson B, Kossorotoff M, Renaud C, Chabrier S, The Tich SN; AVCnn Study Group. Does Contralesional Hand Function After Neonatal Stroke Only Depend on Lesion Characteristics? Stroke. 2016 Jun;47(6):1647-50. doi: 10.1161/STROKEAHA.116.013545. Epub 2016 May 10.

name: From the Physical and Rehabilitation Medicine Department (M. Dinomais) and Neurosurgery Department (M. Delion), University Hospital Angers, LUNAM-Angers University, Angers, France; UNIACT-Neurospin, CEA-Saclay, InsermU1129 and Paris-Descartes University, Sorbonne Paris-Cité, Paris, France (L.H.-P); Department of Child Neurology, University Hospital Tübingen, Tübingen, Germany (S.G.); Pediatric Radiology Department, University Hospital Bicêtre (B.H.) and Pediatric Neurology Department, University...

ReferenceCitation: Chabrier S, Peyric E, Drutel L, Deron J, Kossorotoff M, Dinomais M, Lazaro L, Lefranc J, Thébault G, Dray G, Fluss J, Renaud C, Nguyen The Tich S; Accident Vasculaire Cérébral du nouveau-né (AVCnn; [Neonatal Stroke]) Study Group. Multimodal Outcome at 7 Years of Age after Neonatal Arterial Ischemic Stroke. J Pediatr. 2016 May;172:156-161.e3. doi: 10.1016/j.jpeds.2016.01.069. Epub 2016 Mar 9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Hopital Necker
Chu de Saint Etienne
Centre Hospitalier de La Cote Basque
Chu D'Angers
Chu de Brest


title: Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema

acronym: OMHADIA

summary: Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.

ReferenceCitation: Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Lévy BI, Vicaut E. Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4707-11.

location_facility: Service d'ophtalmologie, Hôpital de la Vision, La Timone

location_facility: Service d'Ophtalmologie IV, Hôpital des XV-XX

location_facility: Service d'Ophtalmologie, Hôpital Avicenne

location_facility: Hôpital Lariboisière, service d'Ophtalmologie


title: Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

summary: HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.

lead_sponsor: Association Pour L'utilisation Rein Artificiel Région Lyonnaise

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot


type: EudraCT Number

title: Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

acronym: NIVOTHYM

summary: The aim of the phase II Nivothym study is to collect data on activity and toxicity of nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously received a first platinum-based chemotherapy.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Switzerland
Netherlands
France
Belgium
Spain
United Kingdom

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord (APHM)


title: SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE

summary: The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU de Caen
CHU Toulouse
CHU de Nancy
University Hospital Grenoble
CHU Jean Minjoz
Chu Montpellier
Centre Hospitalier Sud Francilien


lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Italy Switzerland France Belgium Portugal

acronym: MALIBU

location_facility: Fondazione IRCCS - Cà Granda - Ospedale Maggiore Policlinico

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: IRCCS Centro di Riferimento Oncologico di Aviano

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova IRCCS

location_facility: CHU de Grenoble - Hôpital Albert MICHALLON

location_facility: Fondazione IRCCS - Policlinico San Matteo

location_facility: Università degli Studi di Roma La Sapienza

location_facility: Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: AAST Grande Ospedale Metropolitano Niguarda

location_facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori

location_facility: A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterand

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti - Università Politecnica delle Marche

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

source: euctr

title: MALIBU Trial - Phase II Study of Combination Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

summary:
Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients.

Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed.

The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately


title: An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

summary: This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

ReferenceCitation: Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. Review.

ReferenceCitation: Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9.

ReferenceCitation: Sillanpää M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76.

ReferenceCitation: Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. Review.

ReferenceCitation: Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6.

ReferenceCitation: Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. Erratum in: Neurology 2000 Apr 25;54(8):1712.

ReferenceCitation: Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84.

ReferenceCitation: Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99.

ReferenceCitation: Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10.

ReferenceCitation: Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8.

ReferenceCitation: McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9.

ReferenceCitation: Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. Review.

ReferenceCitation: Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7.

ReferenceCitation: Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E. The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22. Erratum in: Epilepsia. 2014 Sep;55(9):1476. Epilepsia. 2015 Jun;56(6):983.

name: TIGER CRNL INSERM U1028 CNRS 5292 and Hospices Civils de Lyon and Claude Bernard Lyon‐1 University Lyon France

family: Ryvlin

full_name: Philippe Ryvlin

given: Philippe

name: The Pennsylvania State University Hershey Pennsylvania U.S.A

family: Gilliam

full_name: Frank G. Gilliam

given: Frank G.

name: Department of Neurology University Hospital Center of Montréal (Notre‐Dame Hospital) Montréal Quebec Canada

family: Nguyen

full_name: Dang K. Nguyen

given: Dang K.

name: Institute of Neurosurgery Catholic University of the Sacred Heart Roma Italy

family: Colicchio

full_name: Gabriella Colicchio

given: Gabriella

name: Neurological Clinic University of Pisa Pisa Italy

family: Iudice

full_name: Alfonso Iudice

given: Alfonso

name: Department of Biomedical and Neuromotor Sciences RCCS Institute of Neurological Sciences University of Bologna Bologna Italy

family: Tinuper

full_name: Paolo Tinuper

given: Paolo

name: Pediatric Neuropsychiatry University Hospital Center Ancona Italy

family: Zamponi

full_name: Nelia Zamponi

given: Nelia

name: Regional Epilepsy Center Italy Magna Graecia University of Catanzaro United Hospitals of Reggio Calabria Italy

family: Aguglia

full_name: Umberto Aguglia

given: Umberto

name: Kempenhaeghe Neurology Department Oosterhout The Netherlands

family: Wagner

full_name: Louis Wagner

given: Louis

name: Neurology Department CHU Grenoble Grenoble France

family: Minotti

full_name: Lorella Minotti

given: Lorella

name: ZEE Center for Epilepsy University Clinic of Erlangen Erlangen Germany

family: Stefan

full_name: Hermann Stefan

given: Hermann

name: Department of Neurology UZ Gent Gent Belgium

family: Boon

full_name: Paul Boon

given: Paul

name: QEII Health Sciences Centre Dalhousie University Halifax Nova Scotia Canada

family: Sadler

full_name: Mark Sadler

given: Mark

name: Department of Neurosciences Epilepsy Center University of Torino Torino Italy

family: Benna

full_name: Paolo Benna

family: Raman

full_name: Pradheep Raman

given: Pradheep

name: Department of Internal Medicine and Therapeutics C. Mondino National Neurological Institute University of Pavia Pavia Italy

family: Perucca

full_name: Emilio Perucca

given: Emilio

journal_name: Epilepsia

oa_colors: green hybrid

title: The long‐term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: The PuLsE (Open Prospective Randomized Long‐term Effectiveness) trial

location_country:
Italy
Sweden
Netherlands
France
Norway
Belgium
Spain
Germany
United Kingdom
Canada

location_facility: Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE

location_facility: Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica

location_facility: Universita di Bologna, Clinica Neurologica

location_facility: Kings College Hospital, Dept of Neurosurgery

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Hospital Clínico Universitario, Servicio de neurología

location_facility: Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau

location_facility: Stichting Epilepsie Instituut Nederland, Dienst Neurologie

location_facility: Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie

location_facility: Centro Epilessia, Dipartimento di Neuroscienze

location_facility: ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie

location_facility: Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience

location_facility: Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum

location_facility: Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics

location_facility: Foothills Hospital, Neurology Department

location_facility: Hôpital Sainte-Anne, Service de Neurochirurgie

location_facility: Montreal Neurological Institute, Clinical Research

location_facility: Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie

location_facility: Addenbrookes Hospital, Dept of Neurosurgery

location_facility: Hôpital Neurologique, Untité d'épileptologie

location_facility: Hospital General de Valencia, Neurology/Neurophisiology

location_facility: Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation

location_facility: Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie

location_facility: Hospital General Basico De La Defensa de Valencia, Servicio de neurología

location_facility: UZ Gent, Department of Neurology, 1K12/A

location_facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile

location_facility: Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia

location_facility: Medisch Spectrum Twente, Dienst Neurologie

location_facility: Universitätskliniken Bonn, Klinik für Epileptologie

location_facility: Hospital Ruber Internacional, Servicio de neurología

location_facility: Hopital Roger Salengro, Service de Neurologie

location_facility: Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik

location_facility: Universitetssjukhuset i Lund, Neurologiska kliniken

location_facility: Walton Centre, Dept of Neurosciences, Clinical Sciences Centre