acronym: BEVANEC

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital Haut Lévêque, CHU Bordeaux

location_facility: Service de Gastroentérologie, CHU de Rouen

location_facility: Pôle Régional de Cancérologie, CHU de Poitiers

location_facility: Service d'Oncologie Endocrinienne, Institut Gustave Roussy

location_facility: Service d'Hépatogastroentérologie, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Timone, APHM

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Salpêtrière, APHP

location_facility: Service d'Hépatogastroentérologie, CHU d'Angers

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens

location_facility: Service d'Hépato-Gastroentérologie et Cancérologie, Hôpital Robert Debré, CHU de Reims

location_facility: Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble

location_facility: Département d'Oncologie Médicale, Institut Paoli Calmettes

location_facility: Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne

location_facility: Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon

location_facility: Service de Gastroentérologie, CHU Henri Mondor

location_facility: Service d'Oncologie et Radiothérapie, Institut Sainte Catherine

location_facility: Service de Gastroentérologie, Hôpital Cochin, APHP

location_facility: Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard

location_facility: Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP

location_facility: Service d'Oncologie Médicale, Hôpital Saint Eloi, CHU de Montpellier

location_facility: Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret

location_facility: Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service d'Hépatogastroentérologie, CHR d'Orléans

location_facility: Service de Gastro-Entérologie, Hôpital Nord, CHU de ST-Etienne

location_facility: Département d'Oncologie Médicale, Hôpital Saint-Antoine

location_facility: Service d'Oncologie Médicale, Hôpital Civil, CHU de Strasbourg

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Européen Georges Pompidou, APHP

title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment After the Failure of the Cisplatin (or Carboplatin)-Etoposide Combination in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer. A Phase 2 Non-comparative Randomized Study

summary:
Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.

Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date.

The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.


title: Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.

acronym: PARODOL

summary:
Health care professionals lack tools to deal with acute pain in patients with moderate to severe dementia during daily nursing situations. Care-induced pain in institutionalized persons with cognitive impairments can cause anxiety and behavioral problems.The aim of this study is to demonstrate that a systematic identification of pain associated with the use of social robots such as the PARO robot may contribute to a better anticipation and management of care-induced pain. The investigators hypothesize that an individual use of the PARO robot would bring relaxation to the patient, a distraction regarding the aversive situation of care and, thus, it would prevent manifestations of acute pain in patients with dementia.

Secondary objectives of the study :

determine the effect of the use of PARO during painful cares on quality of life, medication of patients, and perceived workload of the health-care team.
examine socio-demographic and clinical responders' participants to the intervention, and,
identify essential elements regarding cost-effectiveness of a systematic evaluation of pain and a mediation with the PARO robot in care-induced pain

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Résidence Mutualiste " La Cerisaie "
Résidence Mutualiste " Marie Lagrevol "
Résidence Mutualiste " L'adret "
Hôpital Broca
Résidence Mutualiste " Les Tilleuls "

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


title: Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years

acronym: PhASAge

summary: Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Bordeaux

location_facility:
Hospices Civils de Lyon
CHU de Bordeaux
University Hospital, Poitiers
CHU de Grenoble Alpes
Hospital Métropole Savoie

intervention_type: Drug

status_simplified: Ongoing


title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

acronym: EVALYMPH

summary: Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hôpital Saint Louis-Lariboisière CHU PARIS 5

location_facility: Hôpital La pitié-Salpetrière CHU PARIS 3

location_facility: Centre de Lutte contre le Cancer, TOULOUSE

intervention_type: Other


title: Candidate Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors in Chronic Phase-chronic Myelogenous Leukemia Patients in CCR Without Achieving a Deep Molecular Response: an Adaptative Trial Based on a Drop Loser Design

acronym: ACTIW

summary:
Patients will be randomized in phase II trials to continue on the same TKI versus one of the alternative treatment approaches. If a patient is not eligible for one of the treatments, he (she) will be randomized between the options for which he (she) is eligible.

The trial will start with current available treatment options (experimental arms). New available treatment options may be open at any times later on. Authorized TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib.

For all options the treatment duration is for a minimum of 12 months and will be continued in the absence of adverse events following investigator decision. Each therapeutic option will be detailed in term of combination modalities, dose, dose adaptation, specific warnings, specific exclusion and inclusion criteria. The decision to introduce a new option will depend on the general pace of recruitment and on the assessment of the potential efficacy and safety of the new treatment, and will be implemented after scientific review by a protocol amendment.

Primary objective:

A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib, bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence of MR4.5 as compare to control.

Secondary objectives:

A. To determine the safety of selected therapies

B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms

C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms

D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms

E. To estimate treatment free remission (TFR) in patients eligible for discontinuation studies

F. To investigate the relationship between biological activity and the clinical efficacy of the selected therapies

G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells and other biological markers of interest

H. To estimate duration of response, progression-free survival, event free survival and overall survival.

primary_purpose: Treatment

lead_sponsor: Versailles Hospital

location_facility:
Simona LAPUSAN_St Antoine
Thorsten BRAUN
Hopital l'Archet
Institut Universitaire contre le Cancer
Hôpital La Source
Hôpital René Huguenin
Delphine REA _St louis
Franck NICOLINI
Etienne
CH Henri Mondor
Martine GARDEMBAS
Rousselot
CHU Estaing
Viviane DUBRUILLE
CHU de LIMOGES
CHU Côte de Nacre
Pascale CONY.MAKHOUL
Cayssials
CHU de Rennes - Pontchaillou
Eric JOURDAN
CHU Tours
CHU Lille
Institut P Calmette


title: Prediction of Adalimumab Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive Spondyloarthritis: Pilot Study

acronym: PRESHUM

summary:
The main objective of this trial is to search for biomarkers associated with the success of adalimumab treatment in order to generate an algorithm to predict the response to this treatment at 6 months in spondyloarthritis and to define its metrological properties on this cohort.

The algorithm will allow to better target patients who will have an important benefit/risk ratio for adalimumab treatment.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17. Review.

ReferenceCitation: Baeten D, Kruithof E, Van den Bosch F, Van den Bossche N, Herssens A, Mielants H, De Keyser F, Veys EM. Systematic safety follow up in a cohort of 107 patients with spondyloarthropathy treated with infliximab: a new perspective on the role of host defence in the pathogenesis of the disease? Ann Rheum Dis. 2003 Sep;62(9):829-34.

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ReferenceCitation: Brandt J, Khariouzov A, Listing J, Haibel H, Sörensen H, Grassnickel L, Rudwaleit M, Sieper J, Braun J. Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylosing spondylitis. Arthritis Rheum. 2003 Jun;48(6):1667-75.

ReferenceCitation: Braun J, de Keyser F, Brandt J, Mielants H, Sieper J, Veys E. New treatment options in spondyloarthropathies: increasing evidence for significant efficacy of anti-tumor necrosis factor therapy. Curr Opin Rheumatol. 2001 Jul;13(4):245-9. Review.

ReferenceCitation: Braun J, Brandt J, Listing J, Zink A, Alten R, Golder W, Gromnica-Ihle E, Kellner H, Krause A, Schneider M, Sörensen H, Zeidler H, Thriene W, Sieper J. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet. 2002 Apr 6;359(9313):1187-93.

ReferenceCitation: Braun J, Pham T, Sieper J, Davis J, van der Linden S, Dougados M, van der Heijde D; ASAS Working Group. International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Sep;62(9):817-24. Review.

ReferenceCitation: Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. Epub 2004 Jun 8. Review.

ReferenceCitation: Claudepierre P, Wendling D, Breban M, Goupillle P, Dougados M. Ankylosing spondylitis, spondyloarthropathy, spondyloarthritis, or spondylarthritis: what's in a name? Joint Bone Spine. 2012 Dec;79(6):534-5. doi: 10.1016/j.jbspin.2012.06.003. Epub 2012 Jul 28.

ReferenceCitation: Haibel H, Rudwaleit M, Brandt HC, Grozdanovic Z, Listing J, Kupper H, Braun J, Sieper J. Adalimumab reduces spinal symptoms in active ankylosing spondylitis: clinical and magnetic resonance imaging results of a fifty-two-week open-label trial. Arthritis Rheum. 2006 Feb;54(2):678-81.

ReferenceCitation: Hennigan S, Ackermann C, Kavanaugh A. Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy. Core Evid. 2008 Jul 31;2(4):295-305.

ReferenceCitation: Kavanaugh A, Klareskog L, van der Heijde D, Li J, Freundlich B, Hooper M. Improvements in clinical response between 12 and 24 weeks in patients with rheumatoid arthritis on etanercept therapy with or without methotrexate. Ann Rheum Dis. 2008 Oct;67(10):1444-7. doi: 10.1136/ard.2008.094524. Epub 2008 Jun 5.

ReferenceCitation: Lyngberg KK, Harreby M, Bentzen H, Frost B, Danneskiold-Samsøe B. Elderly rheumatoid arthritis patients on steroid treatment tolerate physical training without an increase in disease activity. Arch Phys Med Rehabil. 1994 Nov;75(11):1189-95.

ReferenceCitation: Machado P, Landewé R, Lie E, Kvien TK, Braun J, Baker D, van der Heijde D; Assessment of SpondyloArthritis international Society. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011 Jan;70(1):47-53. doi: 10.1136/ard.2010.138594. Epub 2010 Nov 10.

ReferenceCitation: Madland TM, Larsen A, Brun JG. S100 proteins calprotectin and S100A12 are related to radiographic changes rather than disease activity in psoriatic arthritis with low disease activity. J Rheumatol. 2007 Oct;34(10):2089-92. Epub 2007 Sep 1.

ReferenceCitation: McIntosh E. The cost of rheumatoid arthritis. Br J Rheumatol. 1996 Aug;35(8):781-90.

ReferenceCitation: Maksymowych WP. Biomarkers in axial spondyloarthritis. Curr Opin Rheumatol. 2015 Jul;27(4):343-8. doi: 10.1097/BOR.0000000000000180. Review.

ReferenceCitation: Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

family: Maksymowych

full_name: Walter P Maksymowych

given: Walter P

sequence: first

family: Dougados

full_name: Maxime Dougados

given: Maxime

sequence: additional

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Sieper

full_name: Joachim Sieper

given: Joachim

family: Braun

full_name: Jürgen Braun

given: Jürgen

family: Citera

full_name: Gustavo Citera

given: Gustavo

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Logeart

full_name: Isabelle Logeart

given: Isabelle

family: Wajdula

full_name: Joseph Wajdula

given: Joseph

family: Jones

full_name: Heather Jones

given: Heather

family: Marshall

full_name: Lisa Marshall

given: Lisa

family: Bonin

full_name: Randi Bonin

given: Randi

family: Pedersen

full_name: Ron Pedersen

given: Ron

family: Vlahos

full_name: Bonnie Vlahos

given: Bonnie

family: Kotak

full_name: Sameer Kotak

given: Sameer

family: Bukowski

full_name: Jack F Bukowski

given: Jack F

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Mounach A, El Maghraoui A. Efficacy and safety of adalimumab in ankylosing spondylitis. Open Access Rheumatol. 2014 Aug 13;6:83-90. eCollection 2014. Review.

ReferenceCitation: Pham T, van der Heijde D, Calin A, Khan MA, van der Linden S, Bellamy N, Dougados M; ASAS Working Group. Initiation of biological agents in patients with ankylosing spondylitis: results of a Delphi study by the ASAS Group. Ann Rheum Dis. 2003 Sep;62(9):812-6.

ReferenceCitation: Trocmé C, Gaudin P, Berthier S, Barro C, Zaoui P, Morel F. Human B lymphocytes synthesize the 92-kDa gelatinase, matrix metalloproteinase-9. J Biol Chem. 1998 Aug 7;273(32):20677-84.

ReferenceCitation: Trocmé C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.

ReferenceCitation: Van Den Bosch F, Kruithof E, Baeten D, Herssens A, de Keyser F, Mielants H, Veys EM. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum. 2002 Mar;46(3):755-65.

ReferenceCitation: Wendling D, Claudepierre P, Lohse A, Toussirot E, Breban M. [Therapeutic use of anti-TNF-alpha agents in spondyloarthropathies]. Presse Med. 2003 Oct 4;32(32):1517-24. Review. French.

ReferenceCitation: Yelin E, Wanke LA. An assessment of the annual and long-term direct costs of rheumatoid arthritis: the impact of poor function and functional decline. Arthritis Rheum. 1999 Jun;42(6):1209-18.

location_facility:
CHU de Saint-Etienne
CH de Belfort
CHU de Grenoble
CHRU de Clermont-Ferrand
CHU de Besançon


title: Frequency of Pompe's Disease and Neuromuscular Etiologies in Patients With Restrictive Respiratory Failure Associated With Signs of Muscle Weakness

summary:
A breach of respiratory function may be one of the elements more or less early or predominant clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency, approximately 7% due to a neuromuscular disease. The frequency and type of impairment are dependent on the underlying pathology.

The neuromuscular restrictive respiratory failure (IRR) remains partially unknown pulmonologists, especially because the signs of muscle weakness are sometimes difficult to detect. However, respiratory diseases are a major concern in neuromuscular diseases because they can have an impact both on sleep (not sleep, ...) on the daily activities (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients. Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in some cases reveal the disease and thus constitute the chief complaint of a patient with a neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical symptoms in about 30% of patients.

An algorithm was developed to guide practitioners and help them in their diagnostic approach to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does not allow precise identification of the neuromuscular causes.

At the patient level, this can have an impact by extending the time before placing a diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of practitioners with regard to the particular Pompe disease and neuromuscular diseases in general may be beneficial to patients.

This study aims to:

i) awareness pulmonologists to the possibility of neuromuscular an IRR.

ii) characterize the frequency of neuromuscular origin of IRR in a broad population of patients with concomitant signs muscle weakness.

iii) reduce the time to diagnosis by directing patients to neuromuscular reference center early.

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Clinique Saint Joseph
Hôpital Tenon
CHU d'Angers
CHRU de Tours
GH Pitié Salpêtrière
CHI de Créteil
CHU de Toulouse
CHU de St Etienne
CHU de Nice
Polyclinique les Bleuets
CH de Cannes
CHU le Bocage
CHU de Rouen
CHU de Brest
Hôpital Raymond Poincaré
CHRU de Lille
CHU de Limoges
Cabinet Dr Pereira-Cortese
Hôpital Saint Louis
CH d'Escartons
Centre hospitalier d'Argenteuil

status_simplified: Unknown


type: Other Identifier

title: Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis

acronym: FTR

summary: This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

ReferenceType: derived

ReferenceCitation: Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.

family: Catho

full_name: Heloise Catho

given: Heloise

family: Guigard

full_name: Sebastien Guigard

given: Sebastien

family: Toffart

full_name: Anne-Claire Toffart

given: Anne-Claire

family: Frey

full_name: Gil Frey

given: Gil

family: Chollier

full_name: Thibaut Chollier

given: Thibaut

family: Brichon

full_name: Pierre-Yves Brichon

given: Pierre-Yves

family: Roux

full_name: Jean-François Roux

given: Jean-François

family: Sakhri

full_name: Linda Sakhri

given: Linda

family: Bertrand

full_name: Dominique Bertrand

given: Dominique

family: Aguirre

full_name: Charles Aguirre

given: Charles

family: Gorain

full_name: Sandy Gorain

given: Sandy

family: Wuyam

full_name: Bernard Wuyam

given: Bernard

family: Arbib

full_name: François Arbib

given: François

family: Borel

full_name: Jean Christian Borel

given: Jean Christian

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

evidence: oa journal (via doaj)

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: University Hospital, Grenoble

location_facility: GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD


title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.

summary: The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.

time_perspective: Cross-Sectional

lead_sponsor: Hoffmann-La Roche

intervention_type: Biological

lead_sponsor_type: industriel


title: Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P

acronym: AFFIHLA-P

summary: The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

time_perspective: Retrospective

location_facility:
Hôpital Européen Georges Pompidou
Hôpital Foch
CHU Bordeaux
Hôpital Marie Lannelongue
AP-HP Hôpital Bichat


title: A European, Multicenter, Randomized, Open-label, Phase II Trial Aiming to Assess the Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

acronym: RT-Immune

summary:
This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients.

Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive:

Arm A: Radiotherapy followed by atezolizumab then surgery.
Arm B: Atezolizumab followed by surgery then radiotherapy.
Arm C: Radiotherapy then surgery followed by atezolizumab.

The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same:

Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W).
Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy.
Surgery will be performed as per institutional practice.

Randomisation will be stratified according to histological subtypes as follows:

Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Centre Oscar Lambret
Institut Claudius Regaud
Institut Gustave Roussy
Institut Bergonie

intervention_type: Combination Product


title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer

acronym: EndoQOL

summary: Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Eugène Marquis
Centre François Baclesse
Centre Oscar Lambret
Centre Henri Becquerel
Institut Gustave Roussy


title: Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet

acronym: MFM-tablet

summary:
Motor Function Measure (MFM) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure (MFM) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist.

Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. The reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. The second interest is to implement directly the MFM data in the MFM base.

The hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease.

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie

location_facility: Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon

location_facility: Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P

location_facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU

location_facility: Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE


title: Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

summary:
EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility.

The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient.

The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect.

The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.

lead_sponsor: Cerecare

location_facility:
Dr Enjalbert
Dr Pontier
Dr Michot
Dr Benistan
SLB Pharma

intervention_type: Device


title: Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis

acronym: PrEP

summary:
HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals (tenofovir & emtricitabine) is a prevention strategy for HIV-negative people at high risk of acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk of HIV infection, especially among men who have sex with men (MSM). Since its introduction, an increase in sexually transmitted infections (STIs) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (Chemsex).

In this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

lead_sponsor: University Hospital, Montpellier

location_facility:
Hospital of Alès
CEGIDD
UH NIMES
Uh Montpellier
Hospital of Perpignan


title: Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study

acronym: IDIS

summary:
DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017.

A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.

As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.

The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.

This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.

lead_sponsor: Gelscom SAS

location_facility:
Hospital St-Etienne
Hospital St-Dié-des-Vosges
Hospital Valence
Hospital SUD La Reunion
Hospital Pellegrin


title: Internet Gaming Disorder Prevalence of Teenager Psychiatric Inpatient of 4 Psychiatric Units of French Region Auvergne-Rhône-Alpes

acronym: IGDPD

summary:
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.

The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.

Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.

IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.

location_facility: Psychopathologie du Développement Hôpital Femme Mère Enfant

location_facility: Service de pédopsychiatrie Centre hospitalier Pierre Oudot

location_facility: Service de pédopsychiatrie - Unité H.Flavigny Centre hospitaliser Le Vinatier

location_facility: Service de psychiatrie adulte Hôpital Pierre Wertheimer-GHE

location_facility: Service de pédopsychiatrie - Unité Adolescents ULYSSE - Centre hospitalier St Jean-de-Dieu


title: A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

summary: The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.

ReferenceCitation: Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Dô P, Bylicki O, Monnet I, Corre R, Audigier-Valette C, Locatelli-Sanchez M, Molinier O, Guisier F, Urban T, Ligeza-Poisson C, Planchard D, Amour E, Morin F, Moro-Sibilot D, Zalcman G; French Cooperative Thoracic Intergroup. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16. Erratum in: Lancet Oncol. 2019 Mar;20(3):e132.

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Greillier

full_name: Laurent Greillier

given: Laurent

family: Lantuejoul

full_name: Sylvie Lantuejoul

given: Sylvie

family: Dô

full_name: Pascal Dô

given: Pascal

family: Bylicki

full_name: Olivier Bylicki

given: Olivier

family: Monnet

full_name: Isabelle Monnet

given: Isabelle

family: Corre

full_name: Romain Corre

given: Romain

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

family: Locatelli-Sanchez

full_name: Myriam Locatelli-Sanchez

given: Myriam

family: Molinier

full_name: Olivier Molinier

family: Guisier

full_name: Florian Guisier

given: Florian

family: Urban

full_name: Thierry Urban

given: Thierry

family: Ligeza-Poisson

full_name: Catherine Ligeza-Poisson

given: Catherine

family: Planchard

full_name: David Planchard

given: David

family: Amour

full_name: Elodie Amour

given: Elodie

family: Morin

full_name: Franck Morin

given: Franck

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: DEBIEUVRE

full_name: Didier DEBIEUVRE

given: Didier

family: HIRET

full_name: Sandrine HIRET

given: Sandrine

family: CADRANEL

full_name: Jacques CADRANEL

given: Jacques

family: FRABOULET-MOREAU

full_name: Séverine FRABOULET-MOREAU

given: Séverine

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

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
CHU Strasbourg
HCL Lyon Sud
Dijon - CHU
AP-HM Hôpital Nord
CHU
AP-HP Hôpital Bichat
CHU Tours - Pneumologie
Avignon - Institut Sainte-Catherine
Pontoise - CH
AP-HP Hopital Tenon - Pneumologie
Gustave Roussy
Angers - CHU
Grenoble - CHU
Rouen - CHU
CHRU Lille - Hopital Calmette
Rennes - CHU
Centre Hospitalier - Pneumologie
Toulouse - CHU Larrey
Centre Etienne Dolet
Toulon - CHI
Mulhouse - CH


title: A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

summary:
A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering ASNase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. But indeed the use of ASNase varies between protocols considering the different brands, the dose and the administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.

This is a French prospective multicentric cohort study of children and adolescents with ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).

It aims to answer to two different issues:

Randomized question: what is the best way to administer pegaspargase? A cohort of children and adolescents with standard or medium risk ALL will be randomized to receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization.
Non randomized question: In the High/Very High Risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All patients will receive 2500 IU/m2 per dose during consolidation and delayed intensifications.

ipd_sharing: Undecided

location_facility:
CHU Armand Trousseau
CHU Saint Louis
CHU Robert Debré
CHu
CHRU
CHU
Chu-Ihope


title: Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases

summary: The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

lead_sponsor: University Hospital, Brest

location_facility:
Ch Le Mans
CH d'AIX
CHU de DIJON
CHD Vendée
CH de MACON


title: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

acronym: SAVE

summary:
SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis.

The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.

SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits.

10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group.

The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated.

The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: a Multi Center Randomized Open Study in Young Adults Admitted to Emergency Room for Acute Alcohol Intoxication (AAI).

acronym: IFACAP

summary: BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.

status: Terminated

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou

location_facility: Centre Hospitalier Universitaire Amiens Picardie


type: Registry Identifier

title: Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

acronym: BIOMAN

summary:
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.

Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.

For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.

The potentially identified biomarkers will not change routine management of the pregnancies in the study.

lead_sponsor: University Hospital, Toulouse

location_facility: Maison de Sante Protestante de Bagatelle/Bordeaux


title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)

summary:
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:

NIV (Non Invasive Ventilation)
HFNC (High-flow nasal canula oxygen therapy)

ReferenceCitation: Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.

family: Rodriguez

full_name: Maeva Rodriguez

given: Maeva

family: Ragot

full_name: Stéphanie Ragot

given: Stéphanie

family: Coudroy

full_name: Rémi Coudroy

given: Rémi

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Vignon

full_name: Philippe Vignon

given: Philippe

family: Forel

full_name: Jean-Marie Forel

given: Jean-Marie

family: Demoule

full_name: Alexandre Demoule

given: Alexandre

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Nseir

full_name: Saad Nseir

given: Saad

family: Colin

full_name: Gwenhael Colin

given: Gwenhael

family: Pons

full_name: Bertrand Pons

given: Bertrand

family: Danin

full_name: Pierre-Eric Danin

given: Pierre-Eric

family: Devaquet

full_name: Jérome Devaquet

given: Jérome

family: Prat

full_name: Gwenael Prat

given: Gwenael

family: Merdji

full_name: Hamid Merdji

given: Hamid

family: Petitpas

full_name: Franck Petitpas

family: Vivier

full_name: Emmanuel Vivier

given: Emmanuel

family: Mekontso-Dessap

full_name: Armand Mekontso-Dessap

given: Armand

family: Nay

full_name: Mai-Anh Nay

given: Mai-Anh

family: Asfar

full_name: Pierre Asfar

given: Pierre

family: Dellamonica

full_name: Jean Dellamonica

given: Jean

family: Argaud

full_name: Laurent Argaud

given: Laurent

family: Ehrmann

ReferenceCitation: Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.

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

ReferenceCitation: Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.

location_facility:
Hôpital C. NICOLLE
CHU Strasbourg
Chu E. Herriot
Chu Cochin
CHU Poitiers
Limoges University Hospital
CHU marseille
CHU La cavale Blanche
Hopital de l'Archet
University Hospital of Poitiers
CHU Dijon
CHU louis MOURIER
Hôpital FOCH
CHU Guadeloupe
Chu Mondor
CH Vendée
CHU Lapeyronie
CHU La Pitié Salpétrière
Chu Tenon
Chu Tours
CH St Joseph St Luc
CH La Rochelle
CHU Angers
CH
LYON Sud
CHU Lille
CHU La Source


type: EudraCT Number

title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

acronym: IPI+RTS

summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.

lead_sponsor: University Hospital, Lille

location_facility: Centre Régional de Lutte Contre le Cancer Eugène Marquis

intervention_type: Radiation


title: Analyse du caractère prédictif de l'échographie Ganglionnaire Pour le Diagnostic de bégninité ou malignité d'Une adénopathie Superficielle

acronym: EGAS

summary:
Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram).

Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.

location_facility:
Cabinet Plouegat Guerrand
Cabinet Penmarch
Cabinet Brest Centre
Cabinet Brest
Cabinet Le Guilvinec
Cabinet Quimper
CHIC Quimper
CHRU de Brest
Cabinet Ergue Gaberic
Caninet Brest Centre
Cabinet Ergue Gaberit
Cabinet Lanmeur
Cabinet Lesconil
Cabinet Lamneur
Cabine Le Guivinec


title: Validation de la Version française du Score de Fatigue " Brief Fatigue Inventory (BFI)

acronym: EAMG

summary:
Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in routine as well as research oriented clinical practice.

Various questionnaires measuring fatigue have been developed, but few have been validated in french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one study. BFI (Brief Fatigue Inventory) has been translated but never validated in french language.

The main purpose of this study is to validate psychometrically the french version of BFI.

location_facility:
Cabinet Plouegat Guerrand
Cabinet Penmarch
Cabinet Brest Centre
Cabinet Camaret/mer
Cabinet Le Guilvinec
Cabinet Quimper
Cabinet Rosporden
Cabinet Lanmeur
Cabinet Ergue Gaberic
Cabinet Lesconil
Cabinet Lamneur


title: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

acronym: LABMI

summary: B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.

lead_sponsor: University Hospital, Angers

location_facility: University Hospital of Trousseau (Paris)

location_facility: University Hospital of Robert Debre (Paris)


title: Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation

acronym: QUEPAL

summary: Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).

ReferenceCitation: Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Brédart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.

family: Bouleuc

full_name: Carole Bouleuc

given: Carole

family: Savignoni

full_name: Alexia Savignoni

given: Alexia

family: Chevrier

full_name: Marion Chevrier

given: Marion

family: Renault-Tessier

full_name: Evelyne Renault-Tessier

given: Evelyne

family: Burnod

full_name: Alexis Burnod

given: Alexis

family: Chvetzoff

full_name: Gisele Chvetzoff

given: Gisele

family: Poulain

full_name: Phillipe Poulain

given: Phillipe

family: Copel

full_name: Laure Copel

given: Laure

family: Cottu

full_name: Paul Cottu

given: Paul

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Brédart

full_name: Anne Brédart

given: Anne

family: Dolbeault

full_name: Sylvie Dolbeault

given: Sylvie

journal_name: Journal of Pain and Symptom Management

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

license: cc-by-nd

license_normalized: cc-by-nd

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

repository_normalized: HAL

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Institut Curie

location_facility:
Hopital René Huguenin
Centre Alexis Vautrin
Polyclinique de l'Ormeau
Institut Curie
Léon Berard


title: Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial

acronym: OXYDOPA

summary: This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

location_facility:
University Hospital of Marseille
University Hospital of Bordeaux
University Hospital of Lille
University Hospital of Nancy
Hospital of Aix-en-Provence
Henri Mondor Hospital
University Hospital of Strasbourg
University Hospital of Nîmes - Caremeau
University Hospital of Rouen
Hospital Pierre Wertheimer
Chu Toulouse
University Hospital of Clermont-Ferrand
Pitié-Salpêtrière Hospital
University Hospital of Poitiers
University Hospital of Rennes
University Hospital of Nantes
CHU Amiens
University Hospital of Limoges


title: A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice

acronym: GRAPHE

summary: Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

ReferenceCitation: Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry). Endoscopy. 2016 Dec;48(12):1084-1095. Epub 2016 Oct 19.

lead_sponsor: Nantes University Hospital

location_country: Monaco France

location_facility: Henri Mondor University Hospital (AP-HP)

location_facility: Georges Pompidou University Hospital (AP-HP)

location_facility: Lariboisière University Hospital (AP-HP)


title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

acronym: PRECISE

summary: Observational study on long PR interval using the SafeR mode in bradycardia patients.

lead_sponsor: LivaNova

location_facility:
CH Le Havre
CH Dinan
Hôpital Nord
Cabinet Valognes
CMCM Le Mans
Clinique des 2 Caps
CH St Malo
Clinique A. Paré
CHU Poitiers
Hopital Henri Mondor
CHU La Timone
Cabinet Cherbourg
hôpital privé Antony
Clinique Keraudren
CCN St Denis
CH Lorient
CH Chartres
Cabinet Alès
CH Villefrance
CH Sens
Ch Chaumont
CH Thionville
CH Valenciennes
Hôpital L. Pasteur
CH Lomme
hôpital Sud
CH Helfaut
CHU Brest
CH du Pays d'Aix
CH Basse Terre
CH Annecy
CH Montfermeil
Cabinet Paris
Cabinet Forbach
CH Douarnenez
CH Poissy St Germain
CMC Port Marly
CH Bourges
CH Alençon
CH Orléans
CH Evreux
Cabinet Creutzwald
CH Privé Metz
Clinique Melun
CH Corbeil Essonnes
Clinique St Hilaire
CH Haguenau
HIA Percy
Clinique Montpellier
CH Lannion
CH St Nazaire
CHU Caen
hôpital d'Argenteuil
hôpital St André
CH Forbach
CMCO Evry
NCN Nantes
CH St Joseph


title: Multicenter Study on the Contribution of Surgical Treatment by ST2R Technique (Simultaneous Translation on Two Rods) in Scoliosis of the Children and Adolescents

summary:
Although practiced for many years, surgical correction of scoliosis is relatively subject published for idiopathic scoliosis and a few published for other types of scoliosis.

This study involves a creation of an observatory of patients undergoing scoliosis by ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.

The main objective is to analyze the three-dimensional correction of the deformity after intervention and its maintenance over time depending on the etiology of scoliosis.

This research is conducted in pediatric surgery services specialized in this technique.

Correcting radiographic parameters is directly related to the surgical procedure. The quality of life of patients is indirectly affected by the surgery. Secondary objectives are to analyze the surgical technique and to evaluate its impact on the quality of life of patients.

This study will firstly to have a better understanding in:

Scoliosis of the children and adolescents and their surgical treatment;
The impact of the surgical procedure by the ST2R technique on the three-dimensional correction, and the patient's quality of life; and secondly, better management of patients requiring surgery for scoliosis as well as a public health impact.

status: Active, not recruiting

lead_sponsor: Fondation Lenval

location_facility: Hôpital mère-enfant pédiatrie, CHU Nantes


ReferenceCitation: Galaine J, Borg C, Godet Y, Adotévi O. Interest of Tumor-Specific CD4 T Helper 1 Cells for Therapeutic Anticancer Vaccine. Vaccines (Basel). 2015 Jun 30;3(3):490-502. doi: 10.3390/vaccines3030490. Review.

ReferenceCitation: Dosset M, Godet Y, Vauchy C, Beziaud L, Lone YC, Sedlik C, Liard C, Levionnois E, Clerc B, Sandoval F, Daguindau E, Wain-Hobson S, Tartour E, Langlade-Demoyen P, Borg C, Adotévi O. Universal cancer peptide-based therapeutic vaccine breaks tolerance against telomerase and eradicates established tumor. Clin Cancer Res. 2012 Nov 15;18(22):6284-95. doi: 10.1158/1078-0432.CCR-12-0896. Epub 2012 Oct 2.

ReferenceCitation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillère B, Tartour E, Borg C, Adotévi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.

ReferenceCitation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619.

ReferenceCitation: Adotévi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28. Review.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

acronym: UCPVax

location_facility: Centre Hospitalier Régional Universitaire de Besançon

source: euctr

title: Anticancer Therapeutic Vaccination Using Telomerase-derives Universal Cancer Peptides in Metastatic Non Small Cell Lung Cancer : A Phase I/II Study

summary:
UCPVAx is a therapeutic vaccine based on the telomerase-derived UCP designed to induce strong TH1 CD4 T cell responses in cancer patients.

Three doses of UCPVax (0,25 mg, 0,5 mg and 1 mg) will be tested in this phase I/II study by using Continuous Reassessment Method (CRML) dose escalation design model.

The phase I is a dose escalation study designed to evaluate safety of use of UCPVax and to estimate its Maximum Tolerated Dose (MTD).

The phase II is a dose deescalation designed to evaluate the immunogenicity of UCPVax according to the dose level.


title: Multicentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: STOPECU

summary: Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults. It is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The discovery of complement alternative pathway as a major risk factor for aHUS has led to the design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab. Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS patients with a dramatic decrease in the risk of end-stage renal disease. However, the optimal duration of eculizumab therapy is still debated. The present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with aHUS.

ReferenceCitation: Fakhouri F, Fila M, Hummel A, Ribes D, Sellier-Leclerc AL, Ville S, Pouteil-Noble C, Coindre JP, Le Quintrec M, Rondeau E, Boyer O, Provôt F, Djeddi D, Hanf W, Delmas Y, Louillet F, Lahoche A, Favre G, Châtelet V, Launay EA, Presne C, Zaloszyc A, Caillard S, Bally S, Raimbourg Q, Tricot L, Mousson C, Le Thuaut A, Loirat C, Frémeaux-Bacchi V. Eculizumab discontinuation in children and adults with atypical hemolytic-uremic syndrome: a prospective multicenter study. Blood. 2021 May 6;137(18):2438-2449. doi: 10.1182/blood.2020009280.

name: Department of Nephrology, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France;

name: Service of Nephrology and Hypertension, Department of Medicine, Lausanne University Hospital, Lausanne, Switzerland;

family: Fakhouri

full_name: Fadi Fakhouri

given: Fadi

name: Department of Pediatric Nephrology, CHU de Montpellier, Montpellier, France;

family: Fila

full_name: Marc Fila

given: Marc

name: Department of Adult Nephrology and Renal Transplantation, Hôpital Universitaire Necker, Paris, France;

family: Hummel

full_name: Aurélie Hummel

given: Aurélie

name: Department of Adult Nephrology, CHU de Toulouse, Toulouse, France;

family: Ribes

full_name: David Ribes

given: David

name: Department of Pediatric Nephrology, CHU de Lyon, Lyon, France;

family: Sellier-Leclerc

full_name: Anne-Laure Sellier-Leclerc

given: Anne-Laure

name: Department of Adult Nephrology and Immunology, CHU de Nantes, Nantes, France;

family: Ville

full_name: Simon Ville

given: Simon

name: Department of Adult Nephrology, CHU de Lyon, Lyon, France;

family: Pouteil-Noble

full_name: Claire Pouteil-Noble

given: Claire

name: Department of Internal Medicine, Centre Hospitalier (CH) Le Mans, Le Mans, France;

family: Coindre

full_name: Jean-Philippe Coindre

given: Jean-Philippe

name: Department of Nephrology and Renal Transplantation, CHU de Montpellier, Montpellier, France;

family: Le Quintrec

full_name: Moglie Le Quintrec

given: Moglie

name: Intensive Care Nephrology and Transplantation Department, Hôpital Tenon, Assistance Publique–Hôpitaux de Paris (AP-HP) and Sorbonne Université, Paris, France;

family: Rondeau

full_name: Eric Rondeau

given: Eric

name: Centre de Référence des Microangiopathies Thrombotiques and

name: Centre de Référence des Maladies Rénales Héréditaires de l’Enfant et de l’Adulte, Department of Pediatric Nephrology, Institut Imagine, Hôpital Necker Enfants Malades, AP-HP and Université de Paris, Paris, France;

family: Boyer

full_name: Olivia Boyer

given: Olivia

name: Department of Adult Nephrology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, Lille, France;

family: Provôt

full_name: François Provôt

given: François

name: Department of Pediatric Nephrology, CHU d’Amiens, Amiens, France;

family: Djeddi

full_name: Djamal Djeddi

given: Djamal

name: Department of Nephrology, CH Alpes-Léman, Condamine-sur-Arve, France;

family: Hanf

full_name: William Hanf

given: William

name: Department of Nephrology, CHU de Bordeaux, Bordeaux, France;

family: Delmas

full_name: Yahsou Delmas

given: Yahsou

name: Department of Pediatric Nephrology, CHU de Rouen, Roeun, France;

family: Louillet

full_name: Ferielle Louillet

given: Ferielle

name: Department of Pediatric Nephrology, CHRU de Lille, Lille, France;

family: Lahoche

full_name: Annie Lahoche

given: Annie

name: Department of Adult Nephrology, CHU de Nice, Nice, France;

family: Favre

full_name: Guillaume Favre

given: Guillaume

name: Department of Adult Nephrology, CHU de Caen, Caen, France;

family: Châtelet

full_name: Valérie Châtelet

given: Valérie

name: Department of Pediatric Nephrology, CHU de Nantes, Nantes, France;

family: Launay

full_name: Emma Allain Launay

given: Emma Allain

name: Department of Adult Nephrology, CHU d’Amiens, Amiens, France;

family: Presne

full_name: Claire Presne

family: Zaloszyc

full_name: Ariane Zaloszyc

given: Ariane

name: Department of Adult Nephrology, CHU de Strasbourg, Strasbourg, France;

family: Caillard

full_name: Sophie Caillard

given: Sophie

name: Department of Adult Nephrology, CH Métropole Savoie, Chambéry, France;

name: Department of Adult Nephrology, CHU de Bichat, Paris, France;

name: Department of Nephrology, Hôpital Foch, Suresnes, France;

name: Department of Nephrology, CHU de Dijon, Dijon, France;

name: Direction de la Recherche, Plateforme de Méthodologie et Biostatistique, CHU de Nantes, Nantes, France;

name: Department of Pediatric Nephrology, CHU Robert Debré, Paris, France; and

name: Service d’Immunologie, Hôpital Européen Georges Pompidou, AP-HP and Paris University, Paris, France

location_facility:
Hopital Necker
CHU Strasbourg
CHU Montpellier
CHU Nantes
CH métropole Savoie
CHU lyon
CHU Amiens
Ch Le Mans
CHRU Lille
CH Dijon
CH Metz Thionville
Hopital FOCH
CHU Bordeaux
CH Alpes Léman
AP-HM
CHU Caen
BICHAT
CHU toulouse
CHU Nice
Hôpital Européen Georges Pompidou
CHU Rouen
Hopital Tenon


title: Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

acronym: NVCI

summary:
The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting.

Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV

Very low: <10% occurrence of CINV;
Low: 10 to 30% occurrence of CINV;
Average: 30 to 90% occurrence of CINV;
High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite.

Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure.

Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV.

These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved.

The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy.

Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.

lead_sponsor: Hopital Foch

location_facility: Centre spécilaisé en cancérologie Paris Nord


title: A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease

acronym: ECIPE

summary: This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
CHRU Lille
Institut Mutualiste Montsouris
Hopital Tourcoing
Hopital Saint Louis
Hopital Saint-Antoine
Chu Rouen
Chu Tours
Chu Amiens
Chu Nantes
Hopital Beaujon
CHU NICE
Chu Toulouse
Chu Montpellier
Chu Saint-Etienne
Hopital Bicetre
Hopital Nord
Hopital Louis Mourier
Chi Le Raincy Montfermeil

intervention_type: Procedure


lead_sponsor: Novartis Pharmaceuticals

acronym: SUNRISE

title: A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

summary: Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.


ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

acronym: NEOPAN

location_facility: Institut de cancérologie de l'Ouest - Site Paul Papin

location_facility: Groupe Hospitalier du Havre Jacques Monod

location_facility: Institut de cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Intercommunal Aix-Pertuis

location_facility: Centre de Cancérologie du Grand Montpellier

ipd_sharing: Yes

title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

summary: French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.


title: Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

acronym: TRANSFECMV

summary: Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented

primary_purpose: Basic Science

lead_sponsor: University Hospital, Limoges

location_facility: Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus

location_facility: Centre de biologie pathologie / Laboratoire de virologie


title: Longterm Clinical Outcome Study of the Femoral Cementless Ti/HA Polarstem - A Multicenter Retrospective 10-years Follow-up Study

acronym: PR

summary:
The primary purpose of this study is to demonstrate the POLARSTEM™ Ti/HA cumulative femoral stem revision rate at 10 years.

The secondary purpose of this study is to provide 10 years of safety and effectiveness data of POLARSTEM™ Ti/HA in terms of radiographic and clinical performance

lead_sponsor: Smith & Nephew Orthopaedics AG

location_facility:
Clinique du Renaison
Clinique la Parisière
Centre Hospitalier du Forez- Montbrison
Infirmerie Protestante de Lyon
Centre Hospitalier de Montélimar


title: Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)

summary:
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).

Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.

Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Assistance Publique-Hopitaux de Paris
Hôpital Édouard Herriot
Chu Saint Etienne
Ch Regional D'Orleans
CHU de Toulouse


title: Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy in the Complex Regional Pain Syndrome of the Upper Limb : a Multicentric Randomized Open Study.

acronym: AlgoMIR

summary:
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps.

Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.

location_facility: Consultation Douleur de la Mutualité de la Loire


title: Evaluation of the Information Letter to Relatives in the Context of Genetic Assessments

acronym: LIPEG

summary: The decree of June 20th 2013 (n° 2013-527) suggests a protocol regarding the transmission of information to the relatives after genetic diagnosis of a serious condition. This decree includes a specific model of letter that can be sent to relatives by genetic professionals. We evaluated the understanding and feelings after the reading of the decree's letter (letter A) on patients and the public. A focus group drafted a new version of the letter (letter B) through these observations. The two letter models (A vs B) are compared in terms of impact through precise items (understanding and feelings) on three populations: patients, public and genetic professionals. Assumption is made that the letter B will be preferred to the letter A. Overall, we aim at giving a letter formulation accommodating as many people as possible to standardize practices.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve


title: Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)

summary: This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

ReferenceCitation: Schmidt M, Jaber S, Zogheib E, Godet T, Capellier G, Combes A. Feasibility and safety of low-flow extracorporeal CO(2) removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS. Crit Care. 2018 May 10;22(1):122. doi: 10.1186/s13054-018-2038-5.

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Jaber

full_name: Samir Jaber

given: Samir

family: Zogheib

full_name: Elie Zogheib

given: Elie

family: Godet

full_name: Thomas Godet

given: Thomas

family: Capellier

full_name: Gilles Capellier

given: Gilles

family: Combes

full_name: Alain Combes

given: Alain

journal_name: Critical Care

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

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

version: submittedVersion

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Feasibility and safety of low-flow extracorporeal CO2 removal managed with a renal replacement platform to enhance lung-protective ventilation of patients with mild-to-moderate ARDS

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: CHU CLERMONT FERRAND, Département Anesthésie Réanimation

location_facility: CHU AMIENS, Département Anesthésie Réanimation

location_facility: CHU MONTPELLIER, Département Anesthésie Réanimation

location_facility: Hopital Pitié Salpetriere, Reanimation Medicale


title: Study of cccDNA in Liver Transplant Patients With B Virus Markers

acronym: ECOGREFFE-B

summary: The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hépatologie, Hôpital de la Croix-Rousse


title: A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period

acronym: TERICIS

summary:
National, multicenter study:

The study consists of 3 periods:

A baseline visit to confirm that patient is still in CIS status. All patients will be clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to exclude MS patients according to 2010 Mc Donald's criteria.
Treatment period with timed evaluations
Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and accelerated elimination procedure. All patients who discontinue the study drug and according to investgator's decision, will perform the accelerated elimination procedure and the post- accelerated elimination visits (at 2 and 4 weeks after the end of treatment (EOT).

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Strasbourg
CHU de Lille
CHU de Nice
CHU de Montpellier
CHU de Besançon


title: Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy

acronym: TelOG

summary:
There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.

The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).

External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.

However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.

The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Hospitalier
Centre Hospitalier du Havre
CHU
Centre François Baclesse


title: Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

acronym: M'RHICO

summary: This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.

ReferenceCitation: Constantin JM, Jaber S, Futier E, Cayot-Constantin S, Verny-Pic M, Jung B, Bailly A, Guerin R, Bazin JE. Respiratory effects of different recruitment maneuvers in acute respiratory distress syndrome. Crit Care. 2008;12(2):R50. doi: 10.1186/cc6869. Epub 2008 Apr 16.

ReferenceCitation: Rangel-Castilla L, Gopinath S, Robertson CS. Management of intracranial hypertension. Neurol Clin. 2008 May;26(2):521-41, x. doi: 10.1016/j.ncl.2008.02.003. Review. Erratum in: Neurol Clin. 2008 Aug;26(3):xvii. Rangel-Castillo, Leonardo [corrected to Rangel-Castilla, Leonardo].

ReferenceCitation: Chesnut RM. Care of central nervous system injuries. Surg Clin North Am. 2007 Feb;87(1):119-56, vii. Review.

ReferenceCitation: Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218. Review.

lead_sponsor: University Hospital, Toulouse

location_facility:
UH Nantes
UH Montpellier
UH Clermont-Ferrand
UH Caen
UH Toulouse


title: Pulmonary Artery Denervation for Treatment of Pulmonary Arterial Hypertension

acronym: DENERV'AP

summary:
Pulmonary hypertension is a rare condition that leads to right ventricular dysfunction and premature death. Only modest improvements of outcomes have been observed with the current available advanced specific drug therapy. Pulmonary hypertension advanced therapy is also expensive and leads to frequent adverse effects, sometimes serious. Results from a pilot study, the first-in-man experience of pulmonary artery denervation, demonstrated a clinical improvement in 13 patients with severe pulmonary hypertension despite optimal medical management. However this single non-randomized study requires confirmation.

The investigators propose a prospective multi-center, randomized, single-blinded trial. Its main objective will be to assess, in patients with uncontrolled pulmonary hypertension despite optimal medical management, the efficacy of pulmonary artery denervation in reducing mean pulmonary artery pressure (mPAP) at six months, compared to continued medical treatment following a simulated (sham) procedure.

The principal evaluation criteria will be the mPAP change (in mm Hg) as measured by right heart catheterization.

The study will run for 18 months and it will be necessary to recruit 50 patients.

All adult patients (with the exception of pregnant women and individuals unable to receive an appropriate information and to give their free and informed consent) with uncontrolled pulmonary arterial hypertension despite optimal medical management will be invited to participate, in the absence of any exclusion criteria.

The investigators will also measure changes in clinical, biological, echocardiographic and hemodynamic prognostic markers in both groups.

location_facility:
AP-HM
CHU de Nice
CHU de Grenoble
AP-HP
CHU de Toulouse


acronym: CARPEMAN

summary: This is a Multicenter prospective diagnostic study.

location_facility:
Centre Françis Baclesse
Centre Henri Becquerel
CHU
Institut de Cancérologie de l'Ouest


title: Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck

acronym: TEmPoRAL

summary: Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years

lead_sponsor: Center Eugene Marquis

location_facility: Centre d'Oncologie St Vincent - Boulevard de la Boutière


title: A Randomized Phase III of Adjuvant Targeted Radionuclide Therapy With In111-Pentetreotide in Patients With Digestive Neuroendocrine Tumors After Complete Surgical Resection of Liver Metastases.

acronym: TERAVECT

summary:
TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy.

In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Haut Lévêque - CHU Bordeaux
Hôpital R. Salengro
Hôptal Cochin
Hôpital Hôtel Dieu
Hôpital Beaujon


title: Dynamic of the Acquisition of Antibiotic Resistance in Integrons in Neonatology Newborns

summary: Antibiotic resistance is a major public health issue as multiresistant bacteria (MRB) are increasing. Among the actions to control resistance, one is an interesting lead: to prevent the emergence of resistant bacteria by limiting possibilities for bacteria to acquire resistance. Mechanisms of resistance genes acquisition are deeply studied but there are few data on the dynamic of acquisition over time. Among the genetic components that disseminate resistance genes, resistance integrons (RI) play a major role in the acquisition and dissemination of antibiotic resistance in gram-negative bacteria. The digestive tract of the newborn (NB), which is initially sterile, is colonized by a bacterial microbiota during the first days of life. It thus appears to be an appropriate model to study the dynamic of resistance acquisition. This project intends to follow the NB of neonatology over time in order to study the dynamic of the digestive acquisition of RI and MRB

location_facility:
University Hospital
Hospital center
University hospital


title: Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units

summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

lead_sponsor: Nantes University Hospital

location_facility:
Rennes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Nantes University Hospital


title: A Randomized Controlled Non-inferiority Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

acronym: LIA

summary: The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.

lead_sponsor: Hospital Ambroise Paré Paris

location_facility:
Clinique Claude Bernard
Clinique Jules Verne
Hospital Ambroise Paré Paris
Polyclinique du Plateau
Institut Mutualiste Montsouris


title: An Open Label First-in-Human Adjuvant Phase I Study of a Synthetic Multiple Antigenic Glycopeptide Displaying a Tri Tn Glycotop (MAG-Tn3) Plus AS15, as a Therapeutic Vaccine Candidate in Patients With Non Metastatic, HER2 Negative Localized Breast Cancer at High-Risk of Relapse

acronym: MAGTRIVACSEIN

summary: The purpose of this study is to evaluate if a maximum tolerated dose (MTD) can be obtained following 2 administrations of the MAG-Tn3 + AS15 cancer vaccine when administered at doses of 30 µg, 100 µg or 300 µg IM every three weeks.

lead_sponsor: Institut Pasteur

location_facility: Institut de Cancérologie de l'OUEST - Centre René Gauducheau


title: Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients

summary:
Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.

Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.

The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.

ReferenceCitation: Darmon M, Bourmaud A, Reynaud M, Rouleau S, Meziani F, Boivin A, Benyamina M, Vincent F, Lautrette A, Leroy C, Cohen Y, Legrand M, Morel J, Terreaux J, Schnell D. Performance of Doppler-based resistive index and semi-quantitative renal perfusion in predicting persistent AKI: results of a prospective multicenter study. Intensive Care Med. 2018 Nov;44(11):1904-1913. doi: 10.1007/s00134-018-5386-3. Epub 2018 Oct 5.

family: Darmon

full_name: Michael Darmon

given: Michael

family: Bourmaud

full_name: Aurelie Bourmaud

given: Aurelie

family: Reynaud

full_name: Marie Reynaud

given: Marie

family: Rouleau

full_name: Stéphane Rouleau

given: Stéphane

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

family: Boivin

full_name: Alexandra Boivin

given: Alexandra

family: Benyamina

full_name: Mourad Benyamina

given: Mourad

family: Vincent

full_name: François Vincent

given: François

family: Lautrette

full_name: Alexandre Lautrette

given: Alexandre

family: Leroy

full_name: Christophe Leroy

given: Christophe

family: Cohen

full_name: Yves Cohen

given: Yves

family: Legrand

full_name: Matthieu Legrand

family: Morel

full_name: Jérôme Morel

given: Jérôme

family: Terreaux

full_name: Jeremy Terreaux

given: Jeremy

family: Schnell

full_name: David Schnell

given: David

journal_name: Intensive Care Medicine

location_facility:
Chu de Saint Etienne
CHU Gabriel Montpied
CHU Avicenne
CHRU de Strasbourg
CHU Saint-Louis


title: The Effectiveness of Low Energy Shockwave Therapy for Improving Erectile Dysfunction in Men: a Double Blind Randomized Controlled Trial

acronym: Shock-ED

summary: The primary objective of this study is to evaluate the change from baseline in the erectile function domain of the International Index of Erectile Function (IIEF-EF) scores in patients receiving 4 weekly treatments of shockwave therapy versus those receiving a sham treatment. The change will be evaluated at 3 months after the end of a sequence of 4 weekly treatments.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Lyon - Centre Hospitalier Lyon Sud