title: Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial

acronym: EMPIRICUS

summary: Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.

ReferenceCitation: Timsit JF, Azoulay E, Schwebel C, Charles PE, Cornet M, Souweine B, Klouche K, Jaber S, Trouillet JL, Bruneel F, Argaud L, Cousson J, Meziani F, Gruson D, Paris A, Darmon M, Garrouste-Orgeas M, Navellou JC, Foucrier A, Allaouchiche B, Das V, Gangneux JP, Ruckly S, Maubon D, Jullien V, Wolff M; EMPIRICUS Trial Group. Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1555-1564. doi: 10.1001/jama.2016.14655.

name: UMR1137-IAME Inserm, Paris Diderot University, Paris, France2Medical and Infectious Diseases ICU, Bichat-Claude Bernard University Hospital, Paris, France

family: Timsit

full_name: Jean-Francois Timsit

given: Jean-Francois

name: Saint-Louis University Hospital, Medical ICU, Paris, France

family: Azoulay

full_name: Elie Azoulay

given: Elie

name: Medical ICU, Albert Michallon University Hospital, Grenoble, France

family: Schwebel

full_name: Carole Schwebel

given: Carole

name: Medical ICU, François Mitterrand University Hospital, Dijon, France

family: Charles

full_name: Pierre Emmanuel Charles

given: Pierre Emmanuel

name: UMR5525 CNRS-Grenoble Alpes University, Parasitology-Mycology, Grenoble Alpes University Hospital, Grenoble, France

family: Cornet

full_name: Muriel Cornet

given: Muriel

name: Medical ICU, Gabriel Montpied University Hospital, Clermont-Ferrand, France

family: Souweine

full_name: Bertrand Souweine

given: Bertrand

name: Medical ICU, Lapeyronie University Hospital, Montpellier, France

family: Klouche

full_name: Kada Klouche

given: Kada

name: Intensive Care Unit, Department of Anesthesia and Critical Care Medicine, University of Montpellier, Saint Eloi Teaching Hospital, Montpellier, France

family: Jaber

full_name: Samir Jaber

given: Samir

name: Medical ICU, Institut de Cardiologie, Hôpital de la Pitié–Salpêtrière, Assistance Publique–Hôpitaux de Paris, Paris, France

family: Trouillet

full_name: Jean-Louis Trouillet

given: Jean-Louis

name: Medical ICU, André Mignot Hospital, Versailles, France

family: Bruneel

full_name: Fabrice Bruneel

given: Fabrice

name: Medical ICU, Edouard Herriot University Hospital, Lyon, France

family: Argaud

full_name: Laurent Argaud

given: Laurent

name: Medical Surgical ICU, CHU de Reims, Reims France

family: Cousson

full_name: Joel Cousson

given: Joel

name: Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: Medical ICU, Bordeaux University Hospital, France

family: Gruson

full_name: Didier Gruson

given: Didier

name: Pharmacy Department, Grenoble Alpes University Hospital, Grenoble, France

family: Paris

full_name: Adeline Paris

given: Adeline

name: Medical ICU, Saint-Etienne University Hospital, Saint-Priest en Jarez, France

family: Darmon

full_name: Michael Darmon

given: Michael

name: Medical-Surgical ICU, Saint-Joseph Hospital Network, Paris, France

family: Garrouste-Orgeas

full_name: Maité Garrouste-Orgeas

given: Maité

name: Reanimation Médicale, CHU Jean Minjoz, Besancon, France

family: Navellou

full_name: Jean-Christophe Navellou

given: Jean-Christophe

name: Surgical ICU, APHP, Beaujon Hospital, Clichy, France

family: Foucrier

full_name: Arnaud Foucrier

given: Arnaud

name: Surgical ICU, Edouard Heriot Hospital, Hospices Civils de Lyon, France

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

name: Polyvalent ICU, CHI André Grégoire, Montreuil, France

family: Das

full_name: Vincent Das

given: Vincent

name: Mycology Lab, Rennes University Hospital, Rennes, France

family: Gangneux

full_name: Jean-Pierre Gangneux

given: Jean-Pierre

name: ICUREsearch, Department of Biostatistics, Paris, France

family: Ruckly

full_name: Stéphane Ruckly

given: Stéphane

name: Pharmacology Department, Georges Pompidou Hospital, Paris Descartes University, Paris, France

ReferenceCitation: Timsit JF, Azoulay E, Cornet M, Gangneux JP, Jullien V, Vésin A, Schir E, Wolff M. EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial. Trials. 2013 Nov 21;14:399. doi: 10.1186/1745-6215-14-399.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

location_facility: University Hospital of La Pitié Salpetrière


ReferenceType: derived

ReferenceCitation: Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.

family: Cortot

full_name: Alexis B. Cortot

given: Alexis B.

sequence: first

family: Audigier-Valette

full_name: Clarisse Audigier-Valette

given: Clarisse

sequence: additional

family: Molinier

full_name: Olivier Molinier

given: Olivier

family: Le Moulec

full_name: Sylvestre Le Moulec

given: Sylvestre

family: Barlesi

full_name: Fabrice Barlesi

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Dumont

full_name: Patrick Dumont

given: Patrick

family: Pouessel

full_name: Damien Pouessel

given: Damien

family: Poulet

full_name: Claire Poulet

given: Claire

family: Fontaine-Delaruelle

full_name: Clara Fontaine-Delaruelle

given: Clara

family: Hiret

full_name: Sandrine Hiret

given: Sandrine

family: Dixmier

full_name: Adrien Dixmier

given: Adrien

family: Renault

full_name: Patrick-Aldo Renault

given: Patrick-Aldo

family: Becht

full_name: Catherine Becht

given: Catherine

family: Raffy

full_name: Olivier Raffy

family: Dayen

full_name: Charles Dayen

given: Charles

family: Mazieres

full_name: Julien Mazieres

given: Julien

family: Pichon

full_name: Eric Pichon

given: Eric

family: Langlais

full_name: Alexandra Langlais

given: Alexandra

family: Morin

full_name: Franck Morin

given: Franck

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Besse

full_name: Benjamin Besse

given: Benjamin

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non–small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study

design_allocation: Randomized

intervention_type: Drug

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)

title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer

summary:
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.

Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.

Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.


title: Addition of Suberoylanilide Hydroxamic Acid (Vorinostat) to Azacitidine in Patients With Higher Risk Myelodysplastic Syndromes (MDS): a Phase II add-on Study in Patients With Azacitidine Failure.

acronym: GFM-AZA-VOR

summary:
Azacytidine (AZA) is the current standard of care for frontline patient treated with high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this agents have shown more responses based on phase I/II data. In the present study, we will use the combination of these two drugs to try to create a synergetic effect and generate a response for patients who experienced treatment failure after AZA.

All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days. Study Design

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Hopital Saint Louis - AP-HP, Hematology Dpt

lead_sponsor_type: industriel

status_simplified: Unknown


type: Registry Identifier

type: Other Identifier

title: Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer

acronym: COMET

summary:
Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.

The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.

The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Vasseur A, Cabel L, Tredan O, Chevrier M, Dubot C, Lorgis V, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Luporsi E, Mouret-Reynier MA, Dalenc F, Lemonnier J, Savignoni A, Tanguy ML, Bidard FC, Pierga JY. Prognostic value of CEC count in HER2-negative metastatic breast cancer patients treated with bevacizumab and chemotherapy: a prospective validation study (UCBG COMET). Angiogenesis. 2020 May;23(2):193-202. doi: 10.1007/s10456-019-09697-7. Epub 2019 Nov 26.

family: Vasseur

full_name: Antoine Vasseur

given: Antoine

family: Cabel

full_name: Luc Cabel

given: Luc

family: Tredan

full_name: Olivier Tredan

given: Olivier

family: Chevrier

full_name: Marion Chevrier

given: Marion

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Lorgis

full_name: Véronique Lorgis

given: Véronique

family: Jacot

full_name: William Jacot

given: William

family: Goncalves

full_name: Anthony Goncalves

given: Anthony

family: Debled

full_name: Marc Debled

given: Marc

family: Levy

full_name: Christelle Levy

given: Christelle

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Jouannaud

full_name: Christelle Jouannaud

family: Luporsi

full_name: Elisabeth Luporsi

given: Elisabeth

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Lemonnier

full_name: Jerome Lemonnier

given: Jerome

family: Savignoni

full_name: Alexia Savignoni

given: Alexia

family: Tanguy

full_name: Marie-Laure Tanguy

given: Marie-Laure

family: Bidard

full_name: Francois-Clement Bidard

given: Francois-Clement

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

journal_name: Angiogenesis

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Yes

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

location_facility:
Centre Antoine Lacassagne
Centre Alexis Vautrin
Institut Gustave Roussy
Centre Catherine de Sienne
Centre Val d'Aurelle
Centre Hospitalier
Hôpital Européen
Centre Jean Perrin
Institut Jean Godinot
Centre Paul Strauss
Institut Claudius Regaud
Institut Paoli Calmettes
Institut Curie
CHU Grenoble
Centre Georges Francois Leclerc
Centre Leon Berard
Centre Francois Baclesse
Institut Bergonie


ReferenceCitation: Leleu X, Karlin L, Macro M, Hulin C, Garderet L, Roussel M, Arnulf B, Pegourie B, Kolb B, Stoppa AM, Brechiniac S, Marit G, Thielemans B, Onraed B, Mathiot C, Banos A, Lacotte L, Tiab M, Dib M, Fuzibet JG, Petillon MO, Rodon P, Wetterwald M, Royer B, Legros L, Benboubker L, Decaux O, Escoffre-Barbe M, Caillot D, Fermand JP, Moreau P, Attal M, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myélome (IFM). Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. Blood. 2015 Feb 26;125(9):1411-7. doi: 10.1182/blood-2014-11-612069. Epub 2015 Jan 9.

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: Hôpital Lyon Sud, Lyon Pierre Benite, France;

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Macro

full_name: Margaret Macro

given: Margaret

name: Hôpital de Brabois, Nancy Vandoeuvre, France;

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

name: Hôpital Saint Antoine, Assistance Publiques des Hôpitaux de Paris, Paris, France;

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Roussel

full_name: Murielle Roussel

given: Murielle

name: Hôpital Saint Louis, Assistance Publique–Hôpitaux de Paris, Paris, France;

family: Arnulf

full_name: Bertrand Arnulf

given: Bertrand

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

family: Kolb

full_name: Brigitte Kolb

name: Institut Paoli Calmettes, Marseille, France;

family: Stoppa

full_name: Anne Marie Stoppa

given: Anne Marie

name: Hôpital Bobigny-Avicennes, Assistance Publiques–Hôpitaux de Paris, Paris, France;

family: Brechiniac

full_name: Sabine Brechiniac

given: Sabine

name: Hôpital du Haut-Lévèque, Bordeaux Pessac, France;

family: Marit

full_name: Gerald Marit

given: Gerald

family: Thielemans

full_name: Beatrice Thielemans

given: Beatrice

family: Onraed

full_name: Brigitte Onraed

family: Mathiot

full_name: Claire Mathiot

given: Claire

name: Hôpital de la côte basque, Bayonne, France;

family: Banos

full_name: Anne Banos

given: Anne

family: Lacotte

full_name: Laurence Lacotte

given: Laurence

name: Hôpital Départemental, La Roche sur Yon, France;

family: Tiab

full_name: Mourad Tiab

given: Mourad

family: Dib

full_name: Mamoun Dib

given: Mamoun

family: Fuzibet

full_name: Jean-Gabriel Fuzibet

given: Jean-Gabriel

family: Petillon

full_name: Marie Odile Petillon

given: Marie Odile

name: Hopital de Perigueux, Perigueux, France;

family: Rodon

full_name: Philippe Rodon

given: Philippe

family: Wetterwald

full_name: Marc Wetterwald

family: Royer

full_name: Bruno Royer

given: Bruno

family: Legros

full_name: Laurence Legros

location_facility: Centre hospitalier départemental La Roche sur Yon

title: A Multicenter Open Label Phase II Study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma Patients With Deletion 17p or Translocation (4;14) Adverse Karyotypic Abnormalities-IFM2010-02

summary: The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)


title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

acronym: ImiReduc

summary:
Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.

study_start_date_type: Actual

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

lead_sponsor_type: academique

status_simplified: Ongoing


type: EudraCT Number

title: Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum

acronym: MYCA

summary: The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.

status: Completed

ReferenceCitation: Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, You B. Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Gynecol Oncol. 2019 Jan;152(1):68-75. doi: 10.1016/j.ygyno.2018.10.043. Epub 2018 Nov 14.

family: Romeo

full_name: Clémence Romeo

given: Clémence

family: Joly

full_name: Florence Joly

given: Florence

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: El Kouri

full_name: Claude El Kouri

given: Claude

family: Mercier-Blas

full_name: Anne Mercier-Blas

family: Berton-Rigaud

full_name: Dominique Berton-Rigaud

given: Dominique

family: Kalbacher

full_name: Elsa Kalbacher

given: Elsa

family: Cojocarasu

full_name: Oana Cojocarasu

given: Oana

family: Fabbro

full_name: Michel Fabbro

given: Michel

family: Cretin

full_name: Jacques Cretin

given: Jacques

family: Zannetti

full_name: Alain Zannetti

given: Alain

family: Abadie-Lacourtoisie

full_name: Sophie Abadie-Lacourtoisie

given: Sophie

family: Mollon

full_name: Delphine Mollon

given: Delphine

family: Hardy-Bessard

full_name: Anne-Claire Hardy-Bessard

given: Anne-Claire

family: Provansal

full_name: Magali Provansal

given: Magali

family: Blot

full_name: Emmanuel Blot

given: Emmanuel

family: Delbaldo

full_name: Catherine Delbaldo

given: Catherine

family: Lesoin

full_name: Anne Lesoin

family: Freyer

full_name: Gilles Freyer

given: Gilles

family: You

full_name: Benoît You

given: Benoît

journal_name: Gynecologic Oncology

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre hospitalier privé de Saint Grégoire

location_facility: Centre Hospitalier General de Valenciennes

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire


title: SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

acronym: SHOview

summary: Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

ReferenceType: result

ReferenceCitation: Barrière P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.

family: Barrière

full_name: P. Barrière

given: P.

family: Dewailly

full_name: D. Dewailly

given: D.

family: Duhamel

full_name: A. Duhamel

given: A.

family: Gayet

full_name: V. Gayet

given: V.

journal_name: Gynécologie Obstétrique Fertilité & Sénologie

title: Le syndrome d’hyperstimulation ovarienne après stimulation par hMG hautement purifiée dans le cadre de la fécondation in vitro : étude observationnelle SHOview

lead_sponsor: Ferring Pharmaceuticals

location_facility: Cabinet Mirabeau Roy René (there may be other sites in this country)

location_facility: Cabinet Médical Lille avenue de Dunkerque

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

intervention_type: Other

status_simplified: Completed


title: Impact of Either Audit and Feedback Only or Audit and Feedback Associated to Cooperative Work Meetings Between Hospital Geriatricians and Nursing Home Staff on Quality Indicators and Health Care Practices in Nursing Homes.

acronym: IQUARE

summary:
Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality indicators is not well-established.

The main objective: The main purpose of the IQUARE study was to examine the impact of two types of audit and feedback interventions on NH quality indicators and on residents dependence levels in a 18-month follow-up.

Study hypothesis: We hypothesised that audit and feedback associated to educational and professional supportive interventions are more efficacy in improving NH quality indicators than audit and feedback only.

Secondary objectives: Investigate the impact of the interventions on

Residents:

Functional decline rate
Drug prescriptions (quantity and quality)
Prevalence of adverse health outcomes (e.g., falls)

NHs:

Planning and implementation of therapeutic measures

design_allocation: Non-Randomized

primary_purpose: Health Services Research

ReferenceCitation: Dubucs X, de Souto Barreto P, Rolland Y. Organizational and environmental factors associated with transfers of nursing home residents to emergency departments. Eur Geriatr Med. 2018 Jun;9(3):339-346. doi: 10.1007/s41999-018-0059-x. Epub 2018 May 8.

family: Dubucs

full_name: Xavier Dubucs

given: Xavier

family: de Souto Barreto

full_name: Philipe de Souto Barreto

given: Philipe

family: Rolland

full_name: Yves Rolland

given: Yves

journal_name: European Geriatric Medicine

ReferenceCitation: Cool C, Cestac P, McCambridge C, Rouch L, de Souto Barreto P, Rolland Y, Lapeyre-Mestre M. Reducing potentially inappropriate drug prescribing in nursing home residents: effectiveness of a geriatric intervention. Br J Clin Pharmacol. 2018 Jul;84(7):1598-1610. doi: 10.1111/bcp.13598. Epub 2018 May 14.

name: UMR INSERM 1027; University of Toulouse III; Toulouse France

name: Pôle Pharmacie, Centre Hospitalo-Universitaire (CHU) de Toulouse; 1 avenue Jean Poulhès F 31059 Toulouse France

family: Cool

full_name: Charlène Cool

given: Charlène

family: Cestac

full_name: Philippe Cestac

given: Philippe

family: McCambridge

full_name: Cécile McCambridge

given: Cécile

family: Rouch

full_name: Laure Rouch

given: Laure

name: Gérontopôle de Toulouse, Institut du Vieillissement; Centre Hospitalo-Universitaire de Toulouse; Toulouse France

name: UMR 7268 Aix-Marseille, Laboratoire d'Anthropologie bioculturelle, droit, éthique et santé; France

name: Service de Pharmacologie Médicale et Clinique, CIC Inserm 1436; CHU de Toulouse; 37 Allées Jules Guesde F 31000 Toulouse France

family: Lapeyre-Mestre

full_name: Maryse Lapeyre-Mestre

given: Maryse

journal_name: British Journal of Clinical Pharmacology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Laffon de Mazières C, Lapeyre-Mestre M, Vellas B, de Souto Barreto P, Rolland Y. Organizational Factors Associated With Inappropriate Neuroleptic Drug Prescribing in Nursing Homes: A Multilevel Approach. J Am Med Dir Assoc. 2015 Jul 1;16(7):590-7. doi: 10.1016/j.jamda.2015.01.092. Epub 2015 Mar 10.

family: Laffon de Mazières

full_name: Clarisse Laffon de Mazières

given: Clarisse

family: Vellas

full_name: Bruno Vellas

given: Bruno

journal_name: Journal of the American Medical Directors Association

lead_sponsor: Agence Régionale de la Santé - Midi Pyrénées

location_facility: EHPAD Hermitage et Terrasses de Rabastens

location_facility: EHPAD Villégiale Saint Jacques CHIC - CASTRES/MAZAMET

location_facility: Centre hospitalier du Pays d´Olmes - Laroques d´Olmes

location_facility: EHPAD Résidence Mutualiste La Pyrénéenne

location_facility: EHPAD du Centre Hospitalier Des Deux Rives

location_facility: Centre hospitalier du Pays d´Olmes - Résidence du Touyre


title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial

acronym: IDEAL-ICU

summary: The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Barbar SD, Binquet C, Monchi M, Bruyère R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.

ReferenceCitation: Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyère R, Lebert C, Bohé J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.

name: From Réanimation Médicale, Centre Hospitalier Universitaire (CHU) de Nîmes (S.D.B., B. Louart, R.T.), and Saint Eloi, CHU de Montpellier, Université de Montpellier, and INSERM Unité 1046 (S.J.), Service de Réanimation Médicale, CHU Lapeyronie (K.K.), Montpellier, Université de Strasbourg, Faculté de Médecine, Hôpitaux Universitaires de Strasbourg, Service de Réanimation, Nouvel Hôpital Civil, Strasbourg (R.C.-J., F. Meziani, J.H.), Service de Médecine Intensive Réanimation, Hôpital Universitaire François...

family: Barbar

full_name: Saber D. Barbar

given: Saber D.

family: Clere-Jehl

full_name: Raphaël Clere-Jehl

given: Raphaël

family: Bourredjem

full_name: Abderrahmane Bourredjem

given: Abderrahmane

family: Hernu

full_name: Romain Hernu

given: Romain

family: Montini

full_name: Florent Montini

given: Florent

family: Bruyère

full_name: Rémi Bruyère

given: Rémi

family: Lebert

full_name: Christine Lebert

given: Christine

family: Bohé

full_name: Julien Bohé

given: Julien

family: Badie

full_name: Julio Badie

given: Julio

family: Eraldi

full_name: Jean-Pierre Eraldi

given: Jean-Pierre

family: Rigaud

full_name: Jean-Philippe Rigaud

given: Jean-Philippe

family: Levy

full_name: Bruno Levy

family: Siami

full_name: Shidasp Siami

given: Shidasp

family: Louis

full_name: Guillaume Louis

given: Guillaume

family: Bouadma

full_name: Lila Bouadma

given: Lila

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

family: Klouche

full_name: Kada Klouche

given: Kada

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

family: Piton

full_name: Gaël Piton

given: Gaël

family: Annane

full_name: Djillali Annane

given: Djillali

family: Jaber

full_name: Samir Jaber

given: Samir

family: van der Linden

full_name: Thierry van der Linden

given: Thierry

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

location_facility: CHU de Strasbourg - Nouvel hôpital civil

location_facility: Groupe Hospitalier de l'institut Catholique de LILLE

location_facility: Hôpital Raymond-Poincaré GARCHES (AP-HP)


title: Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

acronym: EVACEL

summary:
Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.

H0 a 24 months progression free survival rate less than 35% is unacceptable
H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%

ReferenceCitation: Walter T, Lepage C, Coriat R, Barbier E, Cadiot G, Caroli-Bosc FX, Aparicio T, Bouhier-Leporrier K, Hentic-Dhome O, Gay F, Dupont-Gossart AC, Duluc M, Lepere C, Lecomte T, Smith D, Petorin C, Di-Fiore F, Ghiringhelli F, Legoux JL, Guimbaud R, Baudin E, Lombard-Bohas C, de Baère T; FFCD 1104 investigators/investigators. Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study. Eur J Cancer. 2019 Dec;123:92-100. doi: 10.1016/j.ejca.2019.09.021. Epub 2019 Oct 31.

family: Walter

full_name: Thomas Walter

given: Thomas

family: Lepage

full_name: Come Lepage

given: Come

family: Coriat

full_name: Romain Coriat

given: Romain

family: Barbier

full_name: Emilie Barbier

given: Emilie

family: Cadiot

full_name: Guillaume Cadiot

family: Caroli-Bosc

full_name: Francois-Xavier Caroli-Bosc

given: Francois-Xavier

family: Aparicio

full_name: Thomas Aparicio

family: Bouhier-Leporrier

full_name: Karine Bouhier-Leporrier

given: Karine

family: Hentic-Dhome

full_name: Olivia Hentic-Dhome

given: Olivia

family: Gay

full_name: Frédérique Gay

given: Frédérique

family: Dupont-Gossart

full_name: Anne-Claire Dupont-Gossart

given: Anne-Claire

family: Duluc

full_name: Muriel Duluc

given: Muriel

family: Lepere

full_name: Céline Lepere

given: Céline

family: Lecomte

full_name: Thierry Lecomte

family: Smith

full_name: Denis Smith

given: Denis

family: Petorin

full_name: Caroline Petorin

given: Caroline

family: Di-Fiore

full_name: Frédéric Di-Fiore

given: Frédéric

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

family: Legoux

full_name: Jean-Louis Legoux

given: Jean-Louis

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

family: Baudin

full_name: Eric Baudin

given: Eric

family: Lombard-Bohas

full_name: Catherine Lombard-Bohas

given: Catherine

family: de Baère

full_name: Thierry de Baère

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hôpital Edouard Herriot
Centre GF Leclerc
Hôpital Saint André
CHU Cochin
Hôpital Côte de Nacre
Hôpital Rangueil
Hôpital Trousseau
CHU La Timone
Hôpital Robert Debré
CHR
Hôpital Avicenne
CHU - Hôtel Dieu
CHU - Hôpital François Mitterand
Hôpital Européen Georges Pompidou
CHU - Estaing
CHU
Institut Gustave Roussy
Hôpital Beaujon


title: Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

summary:
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.

The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).

The secondary objectives are:

safety of the treament,
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
rectal tumor response rate (CT scan, MRI and endocopy),
metastasis response rate,
disease free survival after complete resection (of primitive tumor and metastases),
progression free survival (local or distal),
overall survival, quality of life (QLQ-C30 + CR 29).

ReferenceCitation: Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.

family: Bachet

full_name: J.B. Bachet

family: Lucidarme

full_name: O. Lucidarme

given: O.

family: Levache

full_name: C.B. Levache

family: Barbier

full_name: E. Barbier

given: E.

family: Raoul

full_name: J.L. Raoul

full_name: T. Lecomte

given: T.

family: Desauw

full_name: C. Desauw

given: C.

family: Brocard

full_name: F. Brocard

given: F.

family: Pernot

full_name: S. Pernot

given: S.

family: Breysacher

full_name: G. Breysacher

given: G.

family: Lagasse

full_name: J.P. Lagasse

family: Di Fiore

full_name: F. Di Fiore

family: Etienne

full_name: P.L. Etienne

family: Dupuis

full_name: O.J.M. Dupuis

family: Aleba

full_name: A. Aleba

given: A.

family: Lepage

full_name: C. Lepage

family: Taieb

full_name: J. Taieb

given: J.

family: Dahan

full_name: L. Dahan

given: L.

family: Auby

full_name: D. Auby

given: D.

family: Khemissa

full_name: F. Khemissa

full_name: F. Ghiringhelli

family: Nguyen

full_name: S. Nguyen

family: Bedjaoui

full_name: A. Bedjaoui

family: Terrebonne

full_name: E. Terrebonne

family: Thaury

full_name: J. Thaury

location_facility:
Ipc - Cac
CHU La Timone
CHR - Gasto
Clinique Armoricaine
CHU
Polyclinique le Languedoc
CH Robert Morlevat
Polyclinique de l'Ormeau
Clinique Saint Jean du Languedoc
Hôpitaux du Leman
Polyclinique Côte Basque Sud
CHRU - Hôpital Huriez
CHU d'Estaing
Avicennes
Centre G.F. Leclerc
Polyclinique
Centre Cahterine de Sienne
CAC
AP - HP - Pitié Salpêtrière
CHD Vendée
Colmar Ch
Clinique Victor Hugo
CH
CH Layne
CH Georges Menon
CHRU Trousseau
CHU - Ht Lévêque
CH Le Foll
Institut Bergonie


title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

summary: This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Hôpital Sainte Marguerite - Dermatologie

location_facility: Hôpital Saint Louis - Service de Dermatologie

location_facility: Centre Hospitalier de Valence - Dermatologie

location_facility: Centre Hospitalier - Service de Médecine Interne

location_facility: Hôpital Rothschild - Consultation de Dermatologie

location_facility: Hôpital Broussais - Rééducation Vasculaire

location_facility: Cabinet de Dermatologie 1,rue dembarrère

location_facility: Hôpitaux Civils de Colmar - Service de Dermatologie

location_facility: Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I

location_facility: Hôpital C. Foix - Service de Gérontologie

location_facility: Hôpital Charles NICOLLE - Service de Dermatologie

location_facility: Centre Hospitalier Intercommunal Poissy Saint Germain

location_facility: Hôpital Claude Huriez - Clinique Dermatologique

location_facility: Cabinet de Dermatologie 43, rue Jean Lecanuet

location_facility: Hôpital d'Instruction des Armées Desgenettes

location_facility: Centre Hospitalier Laennec - Dermatologie

location_facility: Centre Hospitalo-Universitaire d'Amiens - Dermatologie


title: A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

summary: This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

lead_sponsor: Hoffmann-La Roche


title: Prevention of Oversedation in Intensive Care Patients Under Mechanical Ventilation : the AWARE Multicentric Randomized Trial

acronym: AWARE

summary: The purpose of the present study is to determine whether administration of sedation according to a strategy including a bundle of measures to prevent oversedation is associated with a reduction in mortality of intensive care unit patients requiring mechanical ventilation, compared to administration of sedation according to usual practices.

primary_purpose: Prevention

ReferenceCitation: Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2.

ReferenceCitation: Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8.

ReferenceCitation: Constantin JM, Chanques G, De Jonghe B, Sanchez P, Mantz J, Payen JF, Sztark F, Richebé P, Lagneau F, Capdevila X, Bazin JE, Lefrant JY. [Current use of sedation and analgesia: 218 resuscitations in France services practices survey]. Ann Fr Anesth Reanim. 2010 May;29(5):339-46. doi: 10.1016/j.annfar.2010.01.014. Epub 2010 Apr 13. French.

ReferenceCitation: Brook AD, Ahrens TS, Schaiff R, Prentice D, Sherman G, Shannon W, Kollef MH. Effect of a nursing-implemented sedation protocol on the duration of mechanical ventilation. Crit Care Med. 1999 Dec;27(12):2609-15.

ReferenceCitation: De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appéré-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med. 2005 Jan;33(1):120-7.

ReferenceCitation: Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aubé H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6.

ReferenceCitation: Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7.

ReferenceCitation: Strøm T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

ReferenceCitation: Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS. Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

ReferenceCitation: SRLF Trial Group. Impact of oversedation prevention in ventilated critically ill patients: a randomized trial-the AWARE study. Ann Intensive Care. 2018 Sep 21;8(1):93. doi: 10.1186/s13613-018-0425-3.

family: de Jonghe

full_name: Bernard de Jonghe

given: Bernard

family: Aboab

full_name: Jérôme Aboab

given: Jérôme

family: Aissaoui

full_name: Nadia Aissaoui

given: Nadia

family: Annane

full_name: Djillali Annane

given: Djillali

family: Audoin

full_name: Corinne Audoin

given: Corinne

family: Baudel

full_name: Jean-Luc Baudel

given: Jean-Luc

family: Brouard

full_name: Florence Brouard

given: Florence

family: Cambonie

full_name: Alexandre Cambonie

given: Alexandre

family: Camilatto

full_name: Isabelle Camilatto

given: Isabelle

family: Chergui

full_name: Karim Chergui

given: Karim

family: Das

full_name: Vincent Das

given: Vincent

family: da Silva

full_name: Daniel da Silva

given: Daniel

family: Devos

full_name: Nicolas Devos

given: Nicolas

family: Deye

full_name: Nicolas Deye

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Ganster

full_name: Frédérique Ganster

given: Frédérique

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

family: Grimaldi

full_name: David Grimaldi

given: David

family: Gourdin

full_name: Emmanuelle Gourdin

given: Emmanuelle

family: Gros

full_name: Antoine Gros

given: Antoine

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

title: Impact of oversedation prevention in ventilated critically ill patients: a randomized trial—the AWARE study

location_facility:
CH Francois Miterrand
Hopital l'Archet
CHU d'Angers
Hopital Antoine Beclere
CH de St-Malo
CH de Pontoise
CHU Kremlin-Bicetre
CHD Les Oudairies
Hopital Avicenne
CH Leon Binet
CHU Marseille Hopital Nord
Hopital Notre-Dame de Bon Secours
CH Germon et Gauthier
Hopital Ambroise Pare
CHRU de la Cavale Blanche
Hopital St Louis
CH St-Joseph St-Luc
Hôpital Saint-Esprit
CH Poissy
CHU Henri Mondor
Groupe Hospitalier Edouard Herriot
Hopital Raymond Poincare
HIA Béjin
Hopital Tenon
CH de Meaux
Institut Gustave Roussy
Institut Mutualiste Montsouris
CH Sud Francilien
CHRU Bretonneau
Hopital Delafontaine
Hopital Privé d'Antony
CH d'Argenteuil
CH de la Région d'Annecy
Hopital Jean Bernard
CHR d'Orléans Hopital la Source
Hopital Roger Salengro
Hopital de la Timone
Hopital Laennec
CH de Versailles
CH de St-Brieuc
Hopital St-Andre
GHIRM
CH Princesse Grace


title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

acronym: TSARINE

summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Paul Papin
Hôpital Tenon
Clinique des Ormeaux- Vauban
Centre G-François Baclesse
Centre Hospitalier de Mulhouse
Centre Etienne DOLET
Centre Léonard de Vinci
Centre Antoine Lacassagne
Centre Médical de Forcilles
Centre Azuréen de Cancérologie
Centre de Cancérologie Paris Nord
CHU Dupuytren
Centre René Huguenin
Centre Maurice Tubiana
Centre Oscar LAMBRET
Clinique Clinique Clementville
Institut Gustave Roussy
Centre Bourgogne
Centre Alexis Vautrin
Centre Catherine de Sienne
Oncorad Garonne
Centre Hospitalier
Centre Hospitalier LYON SUD
Centre médical Oncogard
Clinique Hartmann
Centre Catalan d'Oncologie

intervention_type: Radiation


title: Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)

acronym: THORN

summary:
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single, dual, or triple chamber).

The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate therapies (IT), and to take preventive actions in order to reduce the burden of these inappropriate therapies.

THORN is an observational epidemiologic, prospective and multicenter registry. The primary objective is to measure the relative proportion of patients experiencing at least one inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD patients.

ReferenceCitation: Perrin T, Boveda S, Defaye P, Rosier A, Sadoul N, Bordachar P, Klug D, Ritter P, Belhameche M, Babuty D, Mansourati J, Lazarus A, Deharo JC. Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry. Europace. 2019 Apr 1;21(4):607-615. doi: 10.1093/europace/euy284.

name: Department of Cardiology, Centre Hospitalier Universitaire La Timone, Marseille, France

family: Perrin

full_name: Tilman Perrin

given: Tilman

name: Department of Cardiology, Clinique Pasteur, Toulouse, France

family: Boveda

full_name: Serge Boveda

given: Serge

name: Department of Cardiology, Centre Hospitalier Universitaire Albert Michalon, Grenoble, France

family: Defaye

full_name: Pascal Defaye

given: Pascal

name: Department of Cardiology, Hôpital Privé Jacques Cartier, Massy, France

family: Rosier

full_name: Arnaud Rosier

given: Arnaud

name: Department of Cardiology, Centre Hospitalier Universitaire Brabois, Nancy, France

family: Sadoul

full_name: Nicolas Sadoul

name: Department of Cardiology, Centre Hospitalier Universitaire de Haut-Lévêque, Pessac, France

family: Bordachar

full_name: Pierre Bordachar

given: Pierre

name: Department of Cardiology, Centre Hospitalier Régional Universitaire de Lille, Lille, France

family: Klug

full_name: Didier Klug

given: Didier

family: Ritter

full_name: Philippe Ritter

given: Philippe

name: Department of Cardiology, Centre Hospitalier de Marne-la-Vallée, Jossigny, France

family: Belhameche

full_name: Mohamed Belhameche

given: Mohamed

name: Department of Cardiology, Centre Hospitalier Régional Universitaire Trousseau, Chambray-lès-Tours, France

family: Babuty

full_name: Dominique Babuty

given: Dominique

name: Department of Cardiology, Centre Régional Hospitalier Universitaire Brest, Hôpital de La Cavale Blanche, Brest, France

family: Mansourati

full_name: Jacques Mansourati

given: Jacques

name: Department of Cardiology, Clinique Ambroise Paré, Neuilly-sur-Seine, France

family: Lazarus

full_name: Arnaud Lazarus

family: Deharo

full_name: Jean-Claude Deharo

given: Jean-Claude

journal_name: EP Europace

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Hôpital Nord
CH de Lagny sur Marne
CHG de Chateauroux
CH de la Cote Basque
CH de Valenciennes
Clinique Saint Joseph
CH de Pau
CH d'Aix en Provence
CHU Clermont-Ferrand
CH Bretagne Atlantique
CHU de Montpellier
CHU la Cavale Blanche
CH de Périgueux
Hôpital Georges Pompidou
CH Robert Boulin
CHU G. & R. Laënnec
CHU (Hôpital Pontchaillou)
Clinique Saint Pierre
Clinique Lafourcade
CH d'Angoulême
CH de Troyes
CHU de Nancy
CH William-Morey
Hôpital Font Pré
Hôpital Albert Schweitzer
CH de Valence
Clinique Pasteur
CH de Rodez
CHU de St-Etienne
CH d'Avignon
CHU de Dijon
CH de Moulins
CHU Nîmes
CH de Haguenau
Clinique de la Sauvegarde
CHU Bordeaux
CH de Saint Brieuc
Hôpital Cardiologique
Chu Hôpital Charles Nicolle
CH de DAX
CH de Villefranche
CHI de Montfermeil
Clinique Ambroise Paré
CHRU de Lille
Hôpital La Timone
Institut Jacques Cartier
Clinique du Milénaire
Hôpital Militaire
CH St Luc St Joseph
CHU la Mileterie
CH d'Angers
CHU Albert Michalon
Clinique Saint Augustin
Centre Hospitalier Sud Francilien
CHRU Tours (Hôpital Trousseau)


title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum

acronym: CHIVA

summary:
Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.

In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.

Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).

This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

ReferenceCitation: Aide N, Fauchille P, Coquan E, Ferron G, Combe P, Meunier J, Alexandre J, Berton D, Leary A, De Rauglaudre G, Bonichon N, Pujade Lauraine E, Joly F. Predicting tumor response and outcome of second-look surgery with (18)F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1998-2008. doi: 10.1007/s00259-020-05092-3. Epub 2020 Nov 21.

family: Aide

full_name: Nicolas Aide

given: Nicolas

family: Fauchille

full_name: Pauline Fauchille

given: Pauline

family: Coquan

full_name: Elodie Coquan

given: Elodie

family: Ferron

full_name: Gwenael Ferron

given: Gwenael

family: Combe

full_name: Pierre Combe

family: Meunier

full_name: Jérome Meunier

given: Jérome

family: Alexandre

full_name: Jerôme Alexandre

given: Jerôme

family: Berton

full_name: Dominique Berton

family: Leary

full_name: Alexandra Leary

given: Alexandra

family: De Rauglaudre

full_name: Gaétan De Rauglaudre

given: Gaétan

family: Bonichon

full_name: Nathalie Bonichon

given: Nathalie

family: Pujade Lauraine

full_name: Eric Pujade Lauraine

given: Eric

family: Joly

full_name: Florence Joly

given: Florence

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

license: cc-by

license_normalized: cc-by

title: Predicting tumor response and outcome of second-look surgery with 18F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer

ReferenceCitation: Robelin P, Tod M, Colomban O, Lachuer J, Ray-Coquard I, Rauglaudre G, Joly F, Chevalier-Place A, Combe P, Lortholary A, Hamizi S, Raban N, Ferron G, Meunier J, Berton-Rigaud D, Alexandre J, Kaminsky MC, Dubot C, Leary A, Malaurie E, You B. Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study). Gynecol Oncol. 2020 Oct;159(1):256-263. doi: 10.1016/j.ygyno.2020.07.021. Epub 2020 Jul 22.

family: Robelin

full_name: Patrick Robelin

given: Patrick

family: Tod

full_name: Michel Tod

given: Michel

family: Colomban

full_name: Olivier Colomban

given: Olivier

family: Lachuer

full_name: Joel Lachuer

given: Joel

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Milétrie - Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg

acronym: CELEST

summary:
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear.

ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.

CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle

ReferenceCitation: Fowkes FJ, Price JF, Fowkes FG. Incidence of diagnosed deep vein thrombosis in the general population: systematic review. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):1-5. Review.

ReferenceCitation: Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000 May;83(5):657-60.

ReferenceCitation: Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13. Review.

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7.

ReferenceCitation: Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997 Jul-Aug;82(4):423-8.

ReferenceCitation: Gabriel F, Labiós M, Portolés O, Guillén M, Corella D, Francés F, Martínez M, Gil J, Saiz C. Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis. Thromb Haemost. 2004 Aug;92(2):328-36.

ReferenceCitation: Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. Review.

ReferenceCitation: Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002 May 27;162(10):1144-8.

ReferenceCitation: Bergqvist D, Jendteg S, Johansen L, Persson U, Odegaard K. Cost of long-term complications of deep venous thrombosis of the lower extremities: an analysis of a defined patient population in Sweden. Ann Intern Med. 1997 Mar 15;126(6):454-7.

ReferenceCitation: Brandjes DP, Büller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, ten Cate JW. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997 Mar 15;349(9054):759-62.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56.

ReferenceCitation: Milne AA, Ruckley CV. The clinical course of patients following extensive deep venous thrombosis. Eur J Vasc Surg. 1994 Jan;8(1):56-9.

ReferenceCitation: Partsch H, Blättler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg. 2000 Nov;32(5):861-9.

ReferenceCitation: Kahn SR, Elman E, Rodger MA, Wells PS. Use of elastic compression stockings after deep venous thrombosis: a comparison of practices and perceptions of thrombosis physicians and patients. J Thromb Haemost. 2003 Mar;1(3):500-6.

ReferenceCitation: Benkö T, Cooke EA, McNally MA, Mollan RA. Graduated compression stockings: knee length or thigh length. Clin Orthop Relat Res. 2001 Feb;(383):197-203.

ReferenceCitation: Sajid MS, Tai NR, Goli G, Morris RW, Baker DM, Hamilton G. Knee versus thigh length graduated compression stockings for prevention of deep venous thrombosis: a systematic review. Eur J Vasc Endovasc Surg. 2006 Dec;32(6):730-6. Epub 2006 Aug 23. Review.

ReferenceCitation: Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8.

ReferenceCitation: Arpaia G, Cimminiello C, Mastrogiacomo O, de Gaudenzi E. Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial. Blood Coagul Fibrinolysis. 2007 Mar;18(2):131-7.

ReferenceCitation: Roumen-Klappe EM, den Heijer M, van Rossum J, Wollersheim H, van der Vleuten C, Thien T, Janssen MC. Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome. J Thromb Thrombolysis. 2009 May;27(4):400-5. doi: 10.1007/s11239-008-0229-7. Epub 2008 May 15.

ReferenceCitation: Delluc A, Gouedard C, De Saint Martin L, Garcia C, Roguedas AM, Bressollette L, Misery L, Mottier D, Le Gal G. [Incidence, risk factors and skin manifestations of post-thrombotic syndrome: a four-year follow-up of patients included in the EDITH study]. Rev Med Interne. 2010 Nov;31(11):729-34. doi: 10.1016/j.revmed.2010.07.018. Epub 2010 Sep 29. French.

lead_sponsor: Laboratoires Innothera

location_facility:
Ch La Rochelle
CH Armentières
Hia Brest
Chru Lille
Hôpital du bocage
CHU
Cabinet
Chu Clermont-Ferrand
Chu Angers
Chra Annecy
CHU Gabriel Montpied
CH Pierre-Bénite
CHRU Amiens
Centre Hospitalier d'Armentieres
Chu St Etienne
Clinique Victor PAUCHET
Ch Chalon Sur Saone
Chu Grenoble
Hopital Saint Philibert
Chu Montpellier
Hôpital St Joseph
Chu Brest
Chu Hotel Dieu
CH de Chambéry
CHR Orléans
Chu Toulouse
HEGP
CH Mâcon
Ch Bourgoin-Jallieu

intervention_type: Device


title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

summary: The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

ReferenceCitation: Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim™ (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.

family: Kamioner

full_name: Didier Kamioner

given: Didier

family: Fruehauf

full_name: Stefan Fruehauf

given: Stefan

family: Maloisel

full_name: Fréderic Maloisel

given: Fréderic

family: Cals

full_name: Laurent Cals

given: Laurent

family: Lepretre

full_name: Stéphane Lepretre

given: Stéphane

family: Berthou

full_name: Christian Berthou

given: Christian

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer

location_facility:
Chu Rennes
H.I.A Saint Anne
Ch Duffaut
STE ANNE
Clinique Ste Marguerite
CHG Dieppe
Chu St Eloi
Clinique des Bonnettes
Ico Angers
Clinique St Faron
Chu Gabriel Montpied
Pole Sante Republique
CHG Cahors
Saint Antoine
Centre Rene Huguenin
Ch Chambery
Chp Clairval
Hopital Troyes
TENON
Ch Le Mans
Ch St Malo
CH Boulogne-sur-Mer
CH Sainte Musse
Hopital Foch
MEDIPOLE
Clinique Porte St Cloud
Clinique Belvédère
Clinique du Cap d'Or
Victor Hugo
HARTMANN
Centre frederic joliot curie
Clinique Pasteur
CHU SUD
CHR
CHU Purpan
Inst. Claudius Regaud
Clinique des Dentellieres
CH de Draguignan
Clinique Ste Marie
Hopital Des Courses
Chu Timone
Clinique St Laurent
Chp St Greg
Cac Jean Godinot
CHICAS
Clinique Beausoleil
CHU du BOCAGE
Chr Brive
CAC Paul Strauss
Polyclinique Cesson
CHG
Saint Louis
Chu Grenoble
CHI de Fréjus
Hopital Louis Pasteur
Hopital A.Pare
BEAUJON
Hopital Mignot
CHG William MOREY
Chi Frejus - St Raphael
Chu Estaing
Chg St Jean
Ch Du Pays D'Aix
IPC
Fondation Saint Joseph
Hopital St Quentin
CHRA
Ch Cholet
CH Jacques Monod
Hopital Franco Britannique
Centre Oscar Lambret
Ch Valence
Victor Dubos
Hpt Rene Dubos
Hopital Jean Monnet
CH Emile Muller
Clinique Rambot
Clinique de l'Ormeau
Chu Hopital Civil
Clinique CONVERT
CHU Caremeau
Clinique Vitalia Desertines
Icl St Etienne
CHG St Gaudens

intervention_type: Biological


title: Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients

summary: This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.

lead_sponsor: Novo Nordisk A/S


title: A Multicentre Prospective Phase II Single Arm Trial Evaluating the Benefit of Therapy With Lenalidomide (Revlimid®) in Relapsed or Refractory Primary-cutaneous Large B-cell Lymphoma (Leg-type) After First Line Treatment by Chemotherapy Plus Rituximab for the French Study Group of Cutaneous Lymphoma (GFELC)

acronym: REV-LEG

summary:
In spite of high initial response rate after a first line treatment by R-polychemotherapy, cutaneous but also extra-cutaneous recurrences occur after 2 years in about half of the patients with PCBCL-LT. Thereafter there is no consensus concerning patients care: radiotherapy has only a palliative effect, advanced age often limits using more aggressive chemotherapies and no treatment has demonstrated a prolonged efficacy in these relapsing cases. Therefore new alternatives therapeutic options are needed. Lenalidomide has an antineoplastic pro-apoptotic effect but also immunomodulatory, and antiangiogenic properties. Preliminary results suggest its efficacy in relapsing or refractory diffuse large B-cells lymphomas, especially of nongerminal cells phenotype. By analogy with these results, lenalidomide appears as an attractive candidate in PCLBCL-LT, more specially as it has a manageable toxicity even in advanced age patients.

If the lenalidomide efficacy is confirmed in relapsing PCLBCL-LT, this will plead its evaluation as maintenance therapy after R-chemotherapy in order to avoid recurrences.

lead_sponsor: University Hospital, Bordeaux

location_facility: AP-HP Groupe hospitalier Bichat - Claude Bernard


title: End-of-life in French Intensive Care Units: Perception of the Quality of Dying and Experience of Physicians, Nurses and Relatives. Validation of the CAESAR Scale

acronym: CAESAR

summary:
The purpose of the study is to evaluate the quality of the dying process in french ICUs (assessed by the CAESAR scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives.

Our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (PTSD)).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Réanimation polyvalente Centre hospitalier d'Angoulême

location_facility: Réanimation Centre Hospitalier Intercommunal André Grégoire

location_facility: Service d'anesthésie et de réanimation Hôpital Nord

location_facility: Réanimation polyvalente CH Sud Francilien

location_facility: Neuro-réanimation chirurgicale Groupe hospitalier Pitié-Salpêtrière

location_facility: Réanimation Médico-Chirugicale CH Chambéry

location_facility: Service de réanimation, détresses respiratoires et infections sévères Hôpital Nord

location_facility: Réanimation Polyvalente Centre Hospitalier de Gonesse

location_facility: Réanimation Médicale Groupement Hospitalier Edouard Herriot

location_facility: Réanimation polyvalente Hôpital Roger Salengro

location_facility: Service de réanimation polyvalente CH de Saint Lô

location_facility: Service de réanimation médico-chirurgicale Institut Gustave Roussy

location_facility: Anesthésie-Réanimation CHU de Nantes- Hôtel Dieu

location_facility: Réanimation médicale Centre hospitalier Pays d'Aix

location_facility: Réanimation polyvalente Hôpital Les Oudairies

location_facility: Réanimation chirurgicale Hôpital Saint-Louis

location_facility: Service d'anesthésie et de réanimation Chu Timone

location_facility: Service de réanimation médicale Hôpital Victor Provo

location_facility: Reanimation medicale, Hôpital Saint Louis

location_facility: Réanimation polyvalente GH Edouard Herriot

location_facility: Réanimation médicale CHU de la Cavale Blanche

location_facility: Réanimation médicale CHU de Nancy- Hôpital central

location_facility: Service de réanimation polyvalente CH de Valenciennes

location_facility: Service de réanimation Hôpital Saint Joseph

location_facility: Réanimation Polyvalente CH Bretagne Atlantique

location_facility: Réanimation médicale Hôpital de La Croix Rousse

location_facility: Réanimation polyvalente Centre hospitalier de Versailles

location_facility: Service de réanimation médicale CHU CH Nicolle

location_facility: Réanimation Centre hospitalier Marc Jacquet

location_facility: Service de réanimation Institut Paoli Calmettes

location_facility: Réanimation médicale Hôpital Saint André

location_facility: Service de réanimation polyvalente CHR - Hôpital de la Source

location_facility: Réanimation médico-chirurgicale CH de Roanne

location_facility: réanimation chirurgicale Groupe Hospitalier Universitaire Carémeau

location_facility: Réanimation Polyvalente Centre Hospitalier Victor Dupouy

location_facility: Service de réanimation médicale et toxicologique CHU Lariboisière


title: The Medical-financial Evaluation of Pre-therapeutic Screening by a Joint Phenotypic-pharmacogenetic Approach for Metabolic Fluoropyrimidine Enzyme Deficiency in Terms of Serious Toxicity Risk Prevention : a Multicentric Case Study

acronym: DPD côlon

summary: The aim of this study is to demonstrate the medical and financial benefit of pre-therapeutic screening of DPD deficiency for predicting toxicity to fluoropyrimidines.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Hôpital Henri Mondor
Hôpital Purpan
Centre d'oncologie de Gentilly
Institut Claudius Regaud
ICO Paul Papin
CH Sarthe et Loir
Centre Hospitalier du Haut Anjou
Centre Antoine Lacassagne
Centre Hospitalier Lyon Sud
CHU Trousseau
CHU Côte de Nacre
Centre Hospitalier Les oudairies
Centre François Baclesse
Centre Oscar Lambret
Centre Hospitalier
Pôle Santé Léonard de Vinci
CHU Hotel Dieu
CHU Jean Minjoz
CHU Morvan
HEGP
Clinique des Cèdres
ICO René Gauducheau

intervention_type: Genetic


lead_sponsor: Sanofi Pasteur, a Sanofi Company

acronym: Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE

location_facility:
SPMSD Investigational Site 164
SPMSD Investigational Site 114
SPMSD Investigational Site 145
SPMSD Investigational Site 117
SPMSD Investigational Site 148
SPMSD Investigational Site 120
SPMSD Investigational Site 116
SPMSD Investigational Site 140
SPMSD Investigational Site 106
SPMSD Investigational Site 107
SPMSD Investigational Site 124
SPMSD Investigational Site 147
SPMSD Investigational Site 151
SPMSD Investigational Site 102
SPMSD Investigational Site 139
SPMSD Investigational Site 123
SPMSD Investigational Site 130
SPMSD Investigational Site 157
SPMSD Investigational Site 162
SPMSD Investigational Site 115
SPMSD Investigational Site 194
SPMSD Investigational Site 150
SPMSD Investigational Site 133
SPMSD Investigational Site 155
SPMSD Investigational Site 134
SPMSD Investigational Site 128
SPMSD Investigational Site 197
SPMSD Investigational Site 199
SPMSD Investigational Site 129
SPMSD Investigational Site 103
SPMSD Investigational Site 135
SPMSD Investigational Site 161
SPMSD Investigational Site 193
SPMSD Investigational Site 113
SPMSD Investigational Site 121
SPMSD Investigational Site 160
SPMSD Investigational Site 153
SPMSD Investigational Site 101
SPMSD Investigational Site 136
SPMSD Investigational Site 110
SPMSD Investigational Site 163
SPMSD Investigational Site 152
SPMSD Investigational Site 198
SPMSD Investigational Site 125
SPMSD Investigational Site 141

source: euctr

title: Antibody Persistence in 11 to 13-year-old Children Previously Vaccinated at 6 Years Old With Either REVAXIS or DT Polio, and Immune Response to a Booster Dose of TETRAVAC-ACELLULAIRE

summary:
PRIMARY OBJECTIVES

To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE


title: Confirmation of the Antiviral Effects of Midodrine Identified With a Gene Expression Signature-based Screening of Inluenza A Virus Infected Cells

acronym: FLUMED

summary:
Rationale:

Classical antiviral therapies target viral proteins and are consequently subject to resistance. To counteract this limitation, alternative strategies have been developed that target cellular factors. We hypothesized that such an approach could also be useful to identify broad-spectrum antivirals. The influenza A virus was used as a model for its viral diversity and because of the need to develop therapies against unpredictable viruses as recently underlined by the H1N1 pandemic. Gene-expression signature-based screening identified broadly effective influenza A antivirals. Midodrine showed great results in inhibiting viral growth and was the most suited to confirm its efficacy in vivo.

The main objective of the study is to assess the efficacy of midodrine taken at usual recommended dose (7.5mg/day) versus no treatment on viral replication kinetics of virus Influenza A.

Secondary objectives: evaluation of the number of patients with a normalized viral load 2, 3 5 and 7 days post-treatment; description of the anti-viral efficacy of midodrine defined as the delay to obtain a prolonged negativity of viral RNA; description of the tolerance of midodrine, evaluation of the clinical response to study treatment; evaluation of the dynamic of viral replication; analysis of the frequency of emergence of mutants and associated resistance.

Methods:

This is a multicenter, randomized, open-label study comparing patients aged 18 to 65 years infected by influenza A virus. Nasopharyngeal washing will be performed at day 0 (randomization), 2, 3, 5 to show the viral replication evolution.

161 patients will be randomized as follows :

Arm 1 : Midodrine, 2.5 mg, 3 times a day
Arm 2 : No treatment The recruitment is performed by general practitioners in the Lyon area.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital D'Instruction des Armées Desgenettes


title: Medico-economic Evaluation of Subcutaneous Automatic Resorbable Staples Device

summary: A surgery made by an external incision requires to stitch the subcutaneous plans, usually performed using absorbable synthetic sutures hold on wire needle. This national, prospective, multicentric, and randomized study is devoted to estimate a technique of suture of the subcutaneous plans based on an implantable medical device delivering automatically absorbable staples. This particularly innovative technique lets to expect a tolerance and an efficiency at least equivalent to the reference technique (main objective). Moreover, this technique allows to anticipate a reduction of the duration of surgical procedure and anesthetic time while limiting the risks of blood wounds of the medical staff.The medical economic part of this study will check, from the point of view of the health care hospital, wether the technique is likely to reduce the costs and time consuming theater room procedures.

lead_sponsor: Nantes University Hospital

location_facility: Rennes University Hospital "CHU Pontchaillou"

location_facility: Montpellier University Hospital "Hôpital Gui de Chauliac"

location_facility: Bordeaux University Hospital "Centre FX. Michelet"

location_facility: Brest University Hospital "Hôpital du Morvan"

location_facility: Lille University Hospital "Hôpital Roger Salengro"

location_facility: Caen University Hospital "Hôpital de la Côte de Nacre"

location_facility: Strasbourg University Hospital "Hôpital Hautepierre"

location_facility: "Assistance Publique des Hôpitaux de Marseille - La Conception"

location_facility: "Assistance Publique des Hôpitaux de Paris - Hôpital Bichat"


title: Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)

acronym: PREMANDYSK

summary: Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This treatment is usually maintained for no more than the first few months of management, before resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more modern use of the drug is at a more advanced stage of PD when dyskinesia are already established and become disabling for the patients. There is no data between these two extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia suggest that the early and prolonged use of amantadine in the early years of management, before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism of brain plasticity-of the "disease modification" type.

lead_sponsor: University Hospital, Toulouse

location_facility:
CH Charles Nicolle
Hopital pitié Salpétriére
CHU de Strasbourg
Hopital Lyon
CHU de Bordeaux
CH Jean Rougier
CHU Dupuytren
CH de Narbonne
CHU Clermont-Ferrand
Hopital de la Timone
CHG Aix en Provence
Hopital Jean Bernard
CHU Dijon
CHU Lille
CH Montauban
CHu de Nantes
hopital Saint Eloi
CHU de Toulouse


title: An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

summary: The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.

lead_sponsor: Goethe University

location_country: Germany France Spain

location_facility: Hospital Universitario Germans Trias i Pujol (ICO - Badalona)

location_facility: University Hospital of Frankfurt, Medical Dept. II

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hospital Universitario 12 de Octubre (Madrid)

location_facility: Hospital Universitario Virgen del Rocío (Sevilla)

location_facility: CHRU de Strasbourg - Hôpital Hautepierre

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille, hôpital Saint-Vincent

location_facility: Hospital Universitario y Politécnico La Fe (Valencia)

location_facility: "Institut Universitaire du Cancer (CHU de Toulouse - Hôpital Purpan)"

location_facility: Hospital Clínico Universitario de Salamanca


title: Study of Tumor Characteristics, Patient Care and Prognosis of Women With Breast Cancer During a Pregnancy Diagnosed Between 2000 and 2014

summary: This is a non-interventional, retrospective, multicentre study involving women having had a breast cancer during their pregnancy, diagnosed between 2000 and 2014 (cases) and non-pregnant women having had a breast cancer between 2000 and 2009 (controls).

time_perspective: Retrospective

location_facility: Hôpital Bretonneau - Centre régional de cancérologie Henry Kaplan

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: CHRU La Peyronie et Centre Val d'Aurelle


title: Assessment and Monitoring of Renal Proximal Tubular Tolerance of Nucleoside and Nucleotide Analogues Using Early Screening Tools in Patients Chronically Mono-infected With Hepatitis B Virus.

acronym: HBVSECURE

summary: Nucleotide analogues are associated in the long term with a risk of proximal tubular nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed, with osteopenia or osteoporosis. This toxicity has been particularly documented for tenofovir (TDF) in HIV disease, but its prevalence varies widely in the literature and is mainly associated with comorbidities: on average this prevalence is 0.39% after 48 weeks with exceptional cases of Fanconi syndrome described. In HBV monoinfection after 60 months of treatment with TDF, an 11% decrease of creatinine clearance (CreatCl) is observed. A single study showed a significant increase in creatinine level with entecavir (ETV) therapy, a second-generation nucleoside, hitherto not described as nephrotoxic. Furthermore, if the direct renal toxic effect characteristic of HIV in the kidney is well known, the role of HBV is less clear. Thus, HBV treatment appears to have a renal protective effect. The monitoring tools recommended by the SPC, CreatCl and plasma phosphorus level are late markers of tubular damage. The threshold of phosphate tubular reabsorption (TmPi/GFR) and the fractional excretion of uric acid (FEUA) are unexpensive early screening tools. However, the long-term evolution of this subclinical tubular involvement in HBV monoinfection is not known.

lead_sponsor: University Hospital, Limoges

location_facility: Hospices Civils de Lyon - Hôpital Croix Rousse


title: A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

summary: This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.


title: Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

summary: This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.


title: A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive

summary: This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

time_perspective: Other

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Hopital Emile Muller; Oncologie Radiotherapie

location_facility: Chevelle Christian; Centre De Radiotherapie

location_facility: Polyclinique Sainte Marguerite; Chimiotherapie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: Polyclinique De Courlancy; Chimiotherapie Ambulatoire

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: Hopital Des Diaconesses; Hopital De Jour

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Hopital Augustin Morvan; Hopital De Jour

location_facility: Polyclinique Du Val De Saone; Chimiotherapie

location_facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hopital Edouard Herriot; Pavillon F Rhumatologie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hopital Europeen La Roseraie;Radiotherapie

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Polyclinique Du Beaujolais; Chimiotherapie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Ch Pitie Salpetriere; Oncologie Medicale


title: Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

acronym: ACT SOLO

summary: This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

ReferenceCitation: Flipo RM, Maillefert JF, Chazerain P, Idier I, Coudert M, Tebib J. Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study. RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Maillefert

full_name: Jean-Francis Maillefert

given: Jean-Francis

family: Chazerain

full_name: Pascal Chazerain

given: Pascal

family: Idier

full_name: Isabelle Idier

family: Coudert

full_name: Mathieu Coudert

given: Mathieu

family: Tebib

full_name: Jacques Tebib

given: Jacques

journal_name: RMD Open

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: An Ambispective, Non Interventional Study of 2 Cohorts (Triple Negative or HR+) of Patients With HER2- Metastatic or Locally Advanced Breast Cancer Treated With Avastin® (Bevacizumab) 1st Line for at Least 12 Months and Without Progression for at Least 12 Months.

summary: This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12 months and without disease progression for at least 12 months. Data will be collected retrospectively (from the diagnosis to the inclusion in the study) and for 18 months from study start.


title: Interest of a High Dose of Erythropoietin Administered During Graft Processing for Early Graft Outcome in Kidney Transplant Recipients.

acronym: FRETEP

summary:
Background : Numerous studies have outlined the cellular pleiotropic effects of erythropoietin (EPO) and their role in the prevention of ischemic-reperfusion lesion such as after acute ischemic injury of the brain or the heart. However, most of these studies were carried out in animal models and no definitive proof exists today to demonstrate that EPO has similar beneficial effects in human pathology.

Purpose : The aim of the study is to demonstrate that in humans, EPO can protect against ischemic-reperfusion lesions in a model of ischemia i.e. kidney transplantation.

location_facility: CHU de BORDEAUX - Service de Néphrologie

location_facility: CHU de TOULOUSE - Service de Néphrologie


title: Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

acronym: (R-HAD)

summary: The purpose of this study is to evaluate the efficacy and safety of rituximab, high-dose ara-c and dexamethasone (r-had) alone or in combination with bortezomib in patients with relapsed or refractory mantle cell lymphoma.

status: Unknown status

lead_sponsor: Prof. Dr. M. Dreyling (co-chairman)

location_country: Germany France

location_facility: Harz-Klinikum Wernigerode-Blankenburg GmbH, Innere Medizin, Hämato-Onkologie und Palliativmedizin

location_facility: Klinikum Magdeburg gemeinnützige GmbH, Klinik f. Hämatologie/Onkologie

location_facility: Ammerland-Klinik GmbH, Klinik für innere Medizin

location_facility: Diakonie Klinikum Jung Stilling Krankenhaus

location_facility: Klinikum der J.W. Goethe-Universtität Frankfurt, Medizinische Klinik II, Hämatologie/Onkologie

location_facility: Krankenhaus der Barmherzigen Brüder, 1. Medizinische Abteilung

location_facility: Klinikum der Universität zu Köln, Klinik I f. Innere Medizin

location_facility: Kreisklinik Altötting-Burghausen, Sektion Hämatologie/Onkologie und Palliativmedizin

location_facility: Hôpital Albert Michallon, Service hématologie

location_facility: Westpfalz-Klinikum GmbH, I. Medizinische Klinik

location_facility: Klinikum Nord Nürnberg, 5. Med. Klinik, Onkologie/Hämatologie

location_facility: CH de Bretagne Atlantique, Service Hématologie

location_facility: Clinique Victor Hugo, Service hématologie

location_facility: Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus)

location_facility: Hôpital Haut Lévêque, Service hématologie

location_facility: Universitätsklinik Essen, Klinik für Hämatologie

location_facility: CH Sud Francilien de Corbeil, Service hématologie

location_facility: Klinikum d. Phillips-Universität, Klinik für Innere Medizin Hämatol./Onkologie/Immunologie

location_facility: Schlossberg Klinik, Oberstaufen Internistische Onkologie

location_facility: Diakonieklinikum Stuttgart, Medizinische Klinik II

location_facility: Hôpital Jean Bernard, Service hématologie

location_facility: Asklepios Klinik St. Georg, Abteilung Hämatologie

location_facility: Klinikum Schwäbisch Gmünd, Zentrum Innere Medizin

location_facility: Universitätsklinikum Ulm, Innere Medizin III

location_facility: Heinrich-Braun-Krankenhaus, Klinik für Innere Medizin III

location_facility: Kath. Krankenhaus Hagen gem. GmbH St.-Marien-Hospital

location_facility: Mutterhaus der Borromäerinnen, Medizinische Abteilung

location_facility: Hôpital Bretonneau, Service hématologie, Bâtiment H. Kaplan

location_facility: LMU München - Klinikum Großhadern Medizinische Klinik III

location_facility: Hôpital Henri Mondor, Service hématologie

location_facility: Vivantes Klinikum Neukölln, Medizinische Klinik I - Hämatologie und Onkologie

location_facility: UKSH im Städt. Krankenhaus Kiel, II. Med. Klinik und Poliklinik im SSK

location_facility: CHU Necker, Service d'hématologie - adulte

location_facility: Centre Hospitalier de la côte Basque, Service hématologie


ReferenceCitation: Oldenburg B, Koningsberger JC, Van Berge Henegouwen GP, Van Asbeck BS, Marx JJ. Iron and inflammatory bowel disease. Aliment Pharmacol Ther. 2001 Apr;15(4):429-38. Review.

ReferenceCitation: Vijverman A, Piront P, Belaiche J, Louis E. Evolution of the prevalence and characteristics of anemia in inflammatory bowel diseases between 1993 and 2003. Acta Gastroenterol Belg. 2006 Jan-Mar;69(1):1-4.

ReferenceCitation: Ormerod TP. Observations on the incidence and cause of anaemia in ulcerative colitis. Gut. 1967 Apr;8(2):107-14.

ReferenceCitation: Wilson A, Reyes E, Ofman J. Prevalence and outcomes of anemia in inflammatory bowel disease: a systematic review of the literature. Am J Med. 2004 Apr 5;116 Suppl 7A:44S-49S. Review.

ReferenceCitation: Gasche C, Berstad A, Befrits R, Beglinger C, Dignass A, Erichsen K, Gomollon F, Hjortswang H, Koutroubakis I, Kulnigg S, Oldenburg B, Rampton D, Schroeder O, Stein J, Travis S, Van Assche G. Guidelines on the diagnosis and management of iron deficiency and anemia in inflammatory bowel diseases. Inflamm Bowel Dis. 2007 Dec;13(12):1545-53.

ReferenceCitation: Gisbert JP, Gomollón F. Common misconceptions in the diagnosis and management of anemia in inflammatory bowel disease. Am J Gastroenterol. 2008 May;103(5):1299-307. doi: 10.1111/j.1572-0241.2008.01846.x. Review.

family: Gisbert

full_name: Javier P Gisbert

given: Javier P

family: Gomollón

full_name: Fernando Gomollón

given: Fernando

journal_name: The American Journal of Gastroenterology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Common Misconceptions in the Diagnosis and Management of Anemia in Inflammatory Bowel Disease

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

acronym: FER

location_facility:
CHU Bordeaux - Pessac
Chu Rennes
CHRU Lille
Hopital Saint Louis
CHU LYON
CHU CAEN
Hopital Cochin
Chu Rouen
Hopital St Antoine
Chu Amiens
Chu Nantes
Hopital Beaujon
Chu Tours
Chu Saint Etienne
Chu Toulouse
Chu Marseille - Hopital Nord
Hopital Bicetre
Chu Clermont-Ferrand

title: A Controlled, Randomised, Double-blind, Multicenter Study, Comparing Ferrisat Versus Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

summary:
Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.

Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.

The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.