title: Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

acronym: PROCOAG

summary:
Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP.

To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion.

ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion.

Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.

ReferenceCitation: Bouzat P, Bosson JL, David JS, Riou B, Duranteau J, Payen JF; PROCOAG study group. Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study. Trials. 2021 Sep 16;22(1):634. doi: 10.1186/s13063-021-05524-x.

family: Bouzat

full_name: Pierre Bouzat

given: Pierre

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: David

full_name: Jean-Stéphane David

given: Jean-Stéphane

family: Riou

full_name: Bruno Riou

given: Bruno

family: Duranteau

full_name: Jacques Duranteau

given: Jacques

family: Payen

full_name: Jean-François Payen

given: Jean-François

family: Levrat

full_name: Albrice Levrat

given: Albrice

family: Abback

full_name: Paër-Selim Abback

given: Paër-Selim

family: Garrigue

full_name: Delphine Garrigue

given: Delphine

family: Marcotte

full_name: Guillaume Marcotte

given: Guillaume

family: Charbit

full_name: Jonathan Charbit

given: Jonathan

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Leone

full_name: Marc Leone

given: Marc

family: Pottecher

full_name: Julien Pottecher

given: Julien

location_facility:
Montpellier University Hospital
Strasbourg University Hospital
AP-HP Beaujon
HCL - Lyon Sud
Lille University Hospital
AP-HP Pitié Salpetrière
Grenoble University Hospital
AP-HP Kremlin Bicêtre
Annecy University Hospital
HCL - Hôpital Edouard Herriot
Nantes University Hospital
AP-HM - Marseille Nord


title: Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology

acronym: PRE-TRANS

summary: Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal dominant inherited disease resulting in the abnormal multi-system deposition of amyloid proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years after onset of symptoms if untreated. The prevalence of the disease remains still poorly understood and usually the search for this pathology is done in a third line of investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as possible. With this study, investigator decided to test for TTR mutation all patients presented with neuropathy of unknown etiology at the first line of investigation. The goal of this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best strategy to test this population for TTR mutations.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Nantes University Hospital

location_facility: CHP Saint-Grégoire - Cabinet de Neurologie ENMG

intervention_type: Genetic

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Identifier

title: Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR Monoclonal Antibody

acronym: OPTIMAG

summary:
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.

Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.

There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.

These food supplements rich in magnesium are sold without proof of effectiveness. Moreover, the prescription of oral magnesium supplementation adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance.

The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.

Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

lead_sponsor: Weprom

location_facility:
Centre d'Oncolgie Saint Yves
GHBS Lorient
Centre Hospitalier Centre Bretagne
Centre Hospitalier
Polyclinique de Gentilly
Centre Hospitalier Départemental
CORT 37
Centre Maurice TUBIANA
CHRU Tours
CARIO-HPCA Plérin
Centre Jean Bernard

intervention_type: Other

lead_sponsor_type: industriel


title: Chemotherapy Intensification in Patients With High Lactate Dehydrogenase Values and Soluble Syndecan-1 Levels

acronym: CLavSyn

summary:
In first-line metastatic colorectal cancer (mCRC), baseline prognostic factors allowing death risk and strategy stratification are lacking. In this setting, a simple biological scoring system have recently been proposed, including LDH and CD138 binary status seric values, identifying one third of patients with worst prognostic.

Intensified-chemotherapy strategies, combining 5-fluorouracile, Oxaliplatin, Irinotecan and Bevacizumab, are beneficial for patients having a bad prognostic, defined by the BRAFV600E mutation, concerning 5-8% of first line mCRC.

For the 30% of patients with LDH-CD138 elevated score, the purpose of CLavSyn phase II study is to compare the PFS of one intensified arm (FOLFOXIRI Bevacizumab) to one standard chemotherapy arm, in order to better discriminate treatment strategies, at metastatic diagnosis.

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Jary M, Lecomte T, Bouché O, Kim S, Dobi E, Queiroz L, Ghiringhelli F, Etienne H, Léger J, Godet Y, Balland J, Lakkis Z, Adotevi O, Bonnetain F, Borg C, Vernerey D. Prognostic value of baseline seric Syndecan-1 in initially unresectable metastatic colorectal cancer patients: a simple biological score. Int J Cancer. 2016 Nov 15;139(10):2325-35. doi: 10.1002/ijc.30367. Epub 2016 Aug 13.

name: Department of Medical Oncology; University Hospital; Besançon France

name: INSERM, Unit 1098, University of Bourgogne- Franche Comté; Besançon France

name: Clinical Investigation Center 1431, EFS Bourgogne-Franche Comté; Besançon France

family: Jary

full_name: Marine Jary

given: Marine

sequence: first

name: CNRS, Unit 7292, University François-Rabelais; Tours France

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital; Tours France

family: Lecomte

full_name: Thierry Lecomte

given: Thierry

sequence: additional

name: Department of HepatoGastroenterology and Digestive Oncology; University Hospital Robert Debré; Reims France

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Kim

full_name: Stefano Kim

given: Stefano

family: Dobi

full_name: Erion Dobi

given: Erion

family: Queiroz

full_name: Lise Queiroz

given: Lise

name: Department of Medical Oncology; Leclerc Anticancer Center; Dijon France

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

name: Department of Gastroenterology; University Hospital; Besançon France

family: Etienne

full_name: Hélène Etienne

given: Hélène

name: INSERM, Clinical Investigational Center CIC 1415; Tours France

family: Léger

full_name: Julie Léger

given: Julie

family: Godet

full_name: Yann Godet

given: Yann

family: Balland

full_name: Jérémy Balland

given: Jérémy

name: Department of Digestive Surgery and Liver Transplantation; University Hospital; Besançon France

family: Lakkis

full_name: Zaher Lakkis

given: Zaher

family: Adotevi

full_name: Olivier Adotevi

name: Methodological and Quality of Life in Oncology Unit; EA 3181, University Hospital; Besançon France

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Borg

full_name: Christophe Borg

given: Christophe

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: International Journal of Cancer

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Institut de Cancérolgie de Montpellier- ICM

location_facility: Centre Hospitalier Universitaire de Besançon

intervention_type: Drug


title: Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

summary:
The study will be conducted in crossover trial, with two 12-weeks periods separated by a Wash-out period of at least one month. According to randomization ,patients will be provided with either Diabeloop system or the usual system.

Patients will be trained for the use of blood glucose meter, of external Insulin Pump and Diabeloop system.

In both treatment periods, the same blood glucose meter will be used throughout the duration of the study.

In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be performed during four weeks to improve the efficacy of Diabeloop system with data collection, to test the manual settings by health care providers and patients and to check the good-working of the follow-up platform.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Benhamou PY, Madrolle S, Lablanche S, Gallegos A, Tourki Y, Franc S, Doron M, Charpentier G. Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38-e39. Diabetes Care. 2020 Oct;43(10):e167. doi: 10.2337/dc20-1291.

family: Benhamou

full_name: Pierre Yves Benhamou

given: Pierre Yves

family: Madrolle

full_name: Stéphanie Madrolle

given: Stéphanie

family: Lablanche

full_name: Sandrine Lablanche

given: Sandrine

family: Gallegos

full_name: Alexandre Gallegos

given: Alexandre

family: Tourki

full_name: Yousra Tourki

given: Yousra

family: Franc

full_name: Sylvia Franc

given: Sylvia

family: Doron

full_name: Maeva Doron

given: Maeva

family: Charpentier

full_name: Guillaume Charpentier

given: Guillaume

journal_name: Diabetes Care

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Comment on Leelarathna et al. Duration of Hybrid Closed-Loop Insulin Therapy to Achieve Representative Glycemic Outcomes in Adults With Type 1 Diabetes. Diabetes Care 2020;43:e38–e39

ReferenceCitation: Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, Guerci B, Chaillous L, Lukas-Croisier C, Jeandidier N, Hanaire H, Borot S, Doron M, Jallon P, Xhaard I, Melki V, Meyer L, Delemer B, Guillouche M, Schoumacker-Ley L, Farret A, Raccah D, Lablanche S, Joubert M, Penfornis A, Charpentier G; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health. 2019 May;1(1):e17-e25. doi: 10.1016/S2589-7500(19)30003-2. Epub 2019 May 2.

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

family: Reznik

full_name: Yves Reznik

given: Yves

family: Thivolet

full_name: Charles Thivolet

given: Charles

family: Schaepelynck

full_name: Pauline Schaepelynck

given: Pauline

family: Renard

full_name: Eric Renard

given: Eric

family: Guerci

full_name: Bruno Guerci

given: Bruno

family: Chaillous

full_name: Lucy Chaillous

given: Lucy

family: Lukas-Croisier

full_name: Celine Lukas-Croisier

given: Celine

family: Jeandidier

full_name: Nathalie Jeandidier

given: Nathalie

ReferenceCitation: Benhamou PY, Huneker E, Franc S, Doron M, Charpentier G; Diabeloop Consortium. Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study. Acta Diabetol. 2018 Jun;55(6):549-556. doi: 10.1007/s00592-018-1123-1. Epub 2018 Mar 9.

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

location_facility: Centre Hospitalier Universitaire Jean Minjoz


title: Management of Symptomatic Advanced Pancreatic Adenocarcinoma: "Urgence Pancreas" - A Prospective A.R.CA.D Cohort Study

summary: This study assessed the feasibility and effects of an early integrative supportive care program in patient with Advanced pancreatic adenocarcinoma (aPDAC).

status: Unknown status

primary_purpose: Health Services Research

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital Henri Mondor
Centre Léon Bérard
Grope Hospitalier Paris Saint Joseph
CH Layne
Institut Hospitalier Franco-Britannique
Hopitaux du Léman
Hôpital Pitié Salpêtrière
Hôpital Cochin
CHU Tours - Hôpital Trousseau
Institut Sainte Catherine
Institut Mutualiste Montsouris
Hôpital Beaujon

intervention_type: Procedure

status_simplified: Unknown


title: Phase II Study of Adaptative Radiotherapy for Locally Advanced Cervical Cancer

acronym: ARCOL

summary: This study evaluates the effect of adaptative Intensity-Modulated Radiation Therapy (IMRT) in the treatment of locally advanced cervical cancer on acute genito-urinary (GU), and gastrointestinal (GI) toxicities. Every patients will be treated according to the adaptative IMRT strategy.

primary_purpose: Other

ipd_sharing_description: Not authorized in France

lead_sponsor: Center Eugene Marquis

location_facility:
Centre rené Gauducheau
Centre Eugène Marquis
Centre Léon Bérard
Centre François Baclesse
Institut de Cancérologie de l'Ouest
Centre Alexis Vautrin
Centre Oscar Lambret
CHU Poitiers
CHU de Tours
Centre Henri Becquerel
Gustave Roussy
CLCC Georges François Leclerc


title: Multicentric Randomized Prospective Study Assessing the Impact of the Bougie Calibration Size During Laparoscopic Sleeve Gastrectomy on the Rate of Postoperative Staple-line Leak Rate

acronym: BOUST

summary: Staple-line leak is the most frequent and incapacitating complication after laparoscopic sleeve gastrectomy (LSG). The aim of this prospective randomized trial is to compare the staple-line leak rate after LSG according to the use of a standard bougie calibre (34, 36 or 38 Fr) or 48-Fr, assuming that a higher diameter is correlated with a lower risk of leak, without lowering long-term weight loss.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Gaillard M, Lainas P, Agostini H, Dagher I, Tranchart H. Impact of the calibration bougie diametre during laparoscopic sleeve gastrectomy on the rate of postoperative staple-line leak (BOUST): study protocol for a multicentre randomized prospective trial. Trials. 2021 Nov 15;22(1):806. doi: 10.1186/s13063-021-05734-3.

family: Gaillard

full_name: Martin Gaillard

given: Martin

family: Lainas

full_name: Panagiotis Lainas

given: Panagiotis

family: Agostini

full_name: Hélène Agostini

given: Hélène

family: Dagher

full_name: Ibrahim Dagher

given: Ibrahim

family: Tranchart

full_name: Hadrien Tranchart

given: Hadrien

currency_apc_doaj: GBP

journal_name: Trials

oa_host_type: publisher

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: CHI - Centre Hospitalier Poissy/Saint-Germain-en-Laye

location_facility: Service de chirurgie générale et digestive, œsogastrique et bariatrique - Hôpital Bichat

location_facility: Centre hospitalier Intercommunal de Créteil


title: Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses

acronym: PEG-MF

summary:
Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news.

A non-opposition consent form need to be signed before entering this study.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-α2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.

family: Ianotto

full_name: Jean-Christophe Ianotto

given: Jean-Christophe

family: Chauveau

full_name: Aurélie Chauveau

given: Aurélie

family: Boyer-Perrard

full_name: Françoise Boyer-Perrard

given: Françoise

family: Gyan

full_name: Emmanuel Gyan

given: Emmanuel

family: Laribi

full_name: Kamel Laribi

given: Kamel

family: Cony-Makhoul

full_name: Pascale Cony-Makhoul

given: Pascale

family: Demory

full_name: Jean-Loup Demory

given: Jean-Loup

family: de Renzis

full_name: Benoit de Renzis

given: Benoit

family: Dosquet

full_name: Christine Dosquet

given: Christine

family: Rey

full_name: Jerome Rey

given: Jerome

family: Roy

full_name: Lydia Roy

given: Lydia

family: Dupriez

full_name: Brigitte Dupriez

given: Brigitte

family: Knoops

full_name: Laurent Knoops

given: Laurent

family: Legros

full_name: Laurence Legros

given: Laurence

family: Malou

full_name: Mohamed Malou

given: Mohamed

family: Hutin

full_name: Pascal Hutin

given: Pascal

family: Ranta

full_name: Dana Ranta

given: Dana

family: Benbrahim

full_name: Omar Benbrahim

given: Omar

family: Ugo

full_name: Valérie Ugo

given: Valérie

family: Lippert

full_name: Eric Lippert

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

publisher: Ferrata Storti Foundation (Haematologica)

location_facility:
CH des pays de Morlaix
AP-HP Hôpital Saint Louis
CHU d'Angers
CHU de Nancy
CHIC de Cornouaille
Centre Hospitalier du Mans
Centre Hospitalier de Lens
Centre Hospitalier de Tours
Institut Paoli Calmette
CHRU de Brest
Hopital du genevois
Centre Hospitalier de Nice


title: Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study

acronym: SACHA

summary: Prospective, multicenter, observational study with a three-year inclusion period (from January 1, 2012 to December 31, 2015) and a 6-month follow-up

ReferenceCitation: Bouget J, Balusson F, Viglino D, Roy PM, Lacut K, Pavageau L, Oger E. Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study. PLoS One. 2020 Aug 7;15(8):e0237022. doi: 10.1371/journal.pone.0237022. eCollection 2020.

family: Bouget

full_name: Jacques Bouget

given: Jacques

family: Balusson

full_name: Frédéric Balusson

given: Frédéric

family: Viglino

full_name: Damien Viglino

given: Damien

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Lacut

full_name: Karine Lacut

given: Karine

family: Pavageau

full_name: Laure Pavageau

given: Laure

family: Oger

full_name: Emmanuel Oger

given: Emmanuel

currency_apc_doaj: USD

journal_name: PLOS ONE

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

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Bouget J, Balusson F, Maignan M, Pavageau L, Roy PM, Lacut K, Scailteux LM, Nowak E, Oger E. Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3-year period population-based prospective cohort study. Br J Clin Pharmacol. 2020 Dec;86(12):2519-2529. doi: 10.1111/bcp.14362. Epub 2020 Jun 1.

name: Univ Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES  Rennes France

name: Emergency Department University Hospital  Grenoble France

family: Maignan

full_name: Maxime Maignan

given: Maxime

name: Emergency Department University hospital  Nantes France

name: Emergency Department University hospital  Angers France

full_name: Pierre‐Marie Roy

given: Pierre‐Marie

name: CIC 1412, Université de Bretagne Loire, Université de Brest, INSERM, CHRU de Brest  Brest France

family: Scailteux

full_name: Lucie‐Marie Scailteux

given: Lucie‐Marie

family: Nowak

journal_name: British Journal of Clinical Pharmacology

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

title: Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3‐year period population‐based prospective cohort study

location_facility:
Nouvelles Cliniques Nantaises
Hôpital Privé Sévigné
Centre Hospitalier Privé
CHU de Nantes
CHU d'Angers
Clinique de l'Anjou
CHU de Grenoble
CHU de Rennes
CHU de Brest
Clinique des Cèdres
Groupe Hospitalier Mutualiste
Hôpital Inter-Armées


title: Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma. The International Extranodal Lymphoma Study Group (IELSG) 36 Phase II Prospective Study

summary:
Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the disease pursues an aggressive course and most patients die of lymphoma progression within 3-4 years.

Retrospective studies have indicated that purine analogous achieved very high response rates in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in combination with chemotherapy has been reported to be very effective in producing a rapid clearance of neoplastic cells.

location_country: Italy France

location_facility: Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Sede Di Meldola (Fc)

location_facility: Irccs Istituto Dermatologico S. Gallicano (Ifo)

location_facility: A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

location_facility: Ospedale S. Maria Delle Croci Di Di Ravenna

location_facility: Irccs Centro Di Riferimento Oncologico Di Basilicata (Crob)

location_facility: Lille cedex (CHRU Lille - Hôpital Claude Huriez)

location_facility: Dijon (CHU de Dijon - Hôpital d'Enfants)

location_facility: Nantes cedex 01 (CHU de Nantes - Hôtel Dieu)

location_facility: A.O. Universitaria Policlinico Di Modena

location_facility: Vandoeuvre-les-Nancy cedex (CHU Brabois)

location_facility: Irccs Fondazione Centro S. Raffaele Del Monte Tabor

status_simplified: Completed


title: Impact of the PRISM-care Multidisciplinary Oncology Program Versus Usual Care on Secured Drug Intake of Patients With Kidney Cancer, Through Self-management of Adverse Events Related to Oral Targeted Therapies, Control of Drug Interactions, and Sharing of the Information Between Ambulatory and Hospital Settings.

acronym: PRISM care

summary:
The rise of oral targeted therapies favors outpatient care of cancer patients but exposes them to new risks compared to the injectable chemotherapy in the hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. The clinical consequences (reduced efficacy and potentialized toxicity) are all the more important that ambulatory monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings.

Adverse drug reactions are a major concern, as such, and because they involve prescription changes (dose reduction, treatment interruption). This results in a decrease in the dose taken and a risk of loss of efficacy.

In the context of metastatic renal cell carcinoma, the risk of iatrogenicity is even higher because the oral targeted therapies available in this indication have a safety profile marked by potentially serious toxicities (hematologic and cardiac toxicity) or are known to reduce the treatment adherence (digestive and skin toxicities). In addition, these molecules are metabolized by the CYP3A4 hepatic cytochrome, which leads to avoid associating them with drugs inducing and / or inhibiting the CYP3A4, because of the risk of toxicity and / or loss of efficacy.

The investigators propose to assess a program set up to secure drug taking by enhancing self-management of side effects and control of drug interactions by the patient. This program includes pharmaceutical visits and involves inpatient and outpatient (doctor, referent pharmacist and liberal nurse) professionals.

The hypothesis of the study is that the PRISM care program will improve self-management of side effects by the patient, resulting in a relative dose intensity of oral chemotherapy improved compared to usual care.

primary_purpose: Supportive Care

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon Groupement Hospitalier Sud Service pharmaceutique Unité de Pharmacie Clinique Oncologique Pavillon Marcel Bérard 1G 165 chemin du Grand Revoyet

location_facility: Centre de Lutte Contre le Cancer Jean Perrin

location_facility: ICL Institut de Cancérologie de la Loire Lucien Neuwirth

intervention_type: Behavioral


title: Improve the Quality of Life After a Hospitalization in Critical Care Thanks to a Program of Prevention of Discomforts Perceived by the Patients of Critical Care Base on Targeted Measures

acronym: AQVAR

summary: Demonstrate that the IPREA3 program (Study: Impact of Multicomponent Intervention to Reduce Perceived Discomforts of the patients in intensive care) reducing discomforts perceived by the patients of intensive care, implemented at the level of the whole intensive care unit, reduce the incidence of the depressive symptoms one year after intensive care exit.

ReferenceCitation: Griffiths J, Fortune G, Barber V, Young JD. The prevalence of post traumatic stress disorder in survivors of ICU treatment: a systematic review. Intensive Care Med. 2007 Sep;33(9):1506-18. Epub 2007 Jun 9. Review.

ReferenceCitation: Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Long-Term Cognitive Impairment after Critical Illness

ReferenceCitation: Davydow DS, Hough CL, Zatzick D, Katon WJ. Psychiatric symptoms and acute care service utilization over the course of the year following medical-surgical ICU admission: a longitudinal investigation*. Crit Care Med. 2014 Dec;42(12):2473-81. doi: 10.1097/CCM.0000000000000527.

family: Davydow

full_name: Dimitry S. Davydow

given: Dimitry S.

family: Hough

full_name: Catherine L. Hough

given: Catherine L.

family: Zatzick

full_name: Douglas Zatzick

given: Douglas

family: Katon

full_name: Wayne J. Katon

given: Wayne J.

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Psychiatric Symptoms and Acute Care Service Utilization Over the Course of the Year Following Medical-Surgical ICU Admission

ReferenceCitation: Davydow DS, Zatzick D, Hough CL, Katon WJ. A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical-surgical intensive care unit admission. Gen Hosp Psychiatry. 2013 May-Jun;35(3):226-32. doi: 10.1016/j.genhosppsych.2012.12.005. Epub 2013 Jan 28.

family: Zatzick,

full_name: Douglas Zatzick,

journal_name: General Hospital Psychiatry

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: A longitudinal investigation of posttraumatic stress and depressive symptoms over the course of the year following medical–surgical intensive care unit admission

ReferenceCitation: Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Mallédant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-8. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.

ReferenceCitation: Kalfon P, Alessandrini M, Boucekine M, Renoult S, Geantot MA, Deparis-Dusautois S, Berric A, Collange O, Floccard B, Mimoz O, Julien A, Robert R, Audibert J, Renault A, Follin A, Thevenin D, Revel N, Venot M, Patrigeon RG, Signouret T, Fromentin M, Sharshar T, Vigne C, Pottecher J, Levrat Q, Sossou A, Garrouste-Orgeas M, Quenot JP, Boulle C, Azoulay E, Baumstarck K, Auquier P; IPREA-AQVAR Study Group. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year. Intensive Care Med. 2019 Feb;45(2):223-235. doi: 10.1007/s00134-018-05511-y. Epub 2019 Jan 30.

location_facility:
CHU Hautepierre
CH Douai
CH Lens
CH Le Puy en Velay
CH Troyes
CHU Cochin APHP
CHU NHC
C.H. de Chartres
CHU Saint Louis APHP
CHU Beaujon APHP
CHU Edouard Herriot
CH La Rochelle


title: A Multicentric, Randomized, Non Comparative, Open-label Phase I/II Evaluating AZD2014 (Dual Mammalian Target of Rapamycin Complex 1/2 (mTORC1/mTORC2) Inhibitor) in Combination With Anastrozole Versus Anastrozole Alone in the Treatment of Metastatic Hormone Receptor-positive Endometrial Adenocarcinoma

acronym: VICTORIA

summary:
The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile.

The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients.

The study is divided in 2 steps :

A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity.
A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).

ReferenceCitation: Bokhman JV. Two pathogenetic types of endometrial carcinoma. Gynecol Oncol. 1983 Feb;15(1):10-7.

ReferenceCitation: Levine DA, Hoskins WJ. Update in the management of endometrial cancer. Cancer J. 2002 May-Jun;8 Suppl 1:S31-40. Review.

ReferenceCitation: Murali R, Soslow RA, Weigelt B. Classification of endometrial carcinoma: more than two types. Lancet Oncol. 2014 Jun;15(7):e268-78. doi: 10.1016/S1470-2045(13)70591-6. Review.

ReferenceCitation: Creasman WT, Odicino F, Maisonneuve P, Quinn MA, Beller U, Benedet JL, Heintz AP, Ngan HY, Pecorelli S. Carcinoma of the corpus uteri. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S105-43.

ReferenceCitation: Sonoda Y. Optimal therapy and management of endometrial cancer. Expert Rev Anticancer Ther. 2003 Feb;3(1):37-47. Review.

ReferenceCitation: Decruze SB, Green JA. Hormone therapy in advanced and recurrent endometrial cancer: a systematic review. Int J Gynecol Cancer. 2007 Sep-Oct;17(5):964-78. Epub 2007 Apr 18. Review.

ReferenceCitation: Kokka F, Brockbank E, Oram D, Gallagher C, Bryant A. Hormonal therapy in advanced or recurrent endometrial cancer. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007926. doi: 10.1002/14651858.CD007926.pub2. Review.

ReferenceCitation: Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB. A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2000 Aug;78(2):212-6.

ReferenceCitation: Diaz-Padilla I, Duran I, Clarke BA, Oza AM. Biologic rationale and clinical activity of mTOR inhibitors in gynecological cancer. Cancer Treat Rev. 2012 Oct;38(6):767-75. doi: 10.1016/j.ctrv.2012.02.001. Epub 2012 Feb 29. Review.

ReferenceCitation: Slomovitz BM, Coleman RL. The PI3K/AKT/mTOR pathway as a therapeutic target in endometrial cancer. Clin Cancer Res. 2012 Nov 1;18(21):5856-64. doi: 10.1158/1078-0432.CCR-12-0662. Epub 2012 Oct 18. Review.

ReferenceCitation: Oza AM, Elit L, Tsao MS, Kamel-Reid S, Biagi J, Provencher DM, Gotlieb WH, Hoskins PJ, Ghatage P, Tonkin KS, Mackay HJ, Mazurka J, Sederias J, Ivy P, Dancey JE, Eisenhauer EA. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011 Aug 20;29(24):3278-85. doi: 10.1200/JCO.2010.34.1578. Epub 2011 Jul 25.

ReferenceCitation: Slomovitz BM, Jiang Y, Yates MS, Soliman PT, Johnston T, Nowakowski M, Levenback C, Zhang Q, Ring K, Munsell MF, Gershenson DM, Lu KH, Coleman RL. Phase II study of everolimus and letrozole in patients with recurrent endometrial carcinoma. J Clin Oncol. 2015 Mar 10;33(8):930-6. doi: 10.1200/JCO.2014.58.3401. Epub 2015 Jan 26.

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ReferenceCitation: Trimble EL, Harlan LC, Clegg LX, Stevens JL. Pre-operative imaging, surgery and adjuvant therapy for women diagnosed with cancer of the corpus uteri in community practice in the United States. Gynecol Oncol. 2005 Mar;96(3):741-8.

ReferenceCitation: Setiawan VW, Yang HP, Pike MC, McCann SE, Yu H, Xiang YB, Wolk A, Wentzensen N, Weiss NS, Webb PM, van den Brandt PA, van de Vijver K, Thompson PJ; Australian National Endometrial Cancer Study Group, Strom BL, Spurdle AB, Soslow RA, Shu XO, Schairer C, Sacerdote C, Rohan TE, Robien K, Risch HA, Ricceri F, Rebbeck TR, Rastogi R, Prescott J, Polidoro S, Park Y, Olson SH, Moysich KB, Miller AB, McCullough ML, Matsuno RK, Magliocco AM, Lurie G, Lu L, Lissowska J, Liang X, Lacey JV Jr, Kolonel LN, Henderson BE, Hankinson SE, Håkansson N, Goodman MT, Gaudet MM, Garcia-Closas M, Friedenreich CM, Freudenheim JL, Doherty J, De Vivo I, Courneya KS, Cook LS, Chen C, Cerhan JR, Cai H, Brinton LA, Bernstein L, Anderson KE, Anton-Culver H, Schouten LJ, Horn-Ross PL. Type I and II endometrial cancers: have they different risk factors? J Clin Oncol. 2013 Jul 10;31(20):2607-18. doi: 10.1200/JCO.2012.48.2596. Epub 2013 Jun 3. Review.

ReferenceCitation: Singh M, Zaino RJ, Filiaci VJ, Leslie KK. Relationship of estrogen and progesterone receptors to clinical outcome in metastatic endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2007 Aug;106(2):325-33. Epub 2007 May 25.

ReferenceCitation: Kauppila A. Progestin therapy of endometrial, breast and ovarian carcinoma. A review of clinical observations. Acta Obstet Gynecol Scand. 1984;63(5):441-50. Review.

ReferenceCitation: Lentz SS, Brady MF, Major FJ, Reid GC, Soper JT. High-dose megestrol acetate in advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 1996 Feb;14(2):357-61.

ReferenceCitation: Thigpen JT, Brady MF, Alvarez RD, Adelson MD, Homesley HD, Manetta A, Soper JT, Given FT. Oral medroxyprogesterone acetate in the treatment of advanced or recurrent endometrial carcinoma: a dose-response study by the Gynecologic Oncology Group. J Clin Oncol. 1999 Jun;17(6):1736-44.

ReferenceCitation: Whitney CW, Brunetto VL, Zaino RJ, Lentz SS, Sorosky J, Armstrong DK, Lee RB; Gynecologic Oncology Group study. Phase II study of medroxyprogesterone acetate plus tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):4-9.

ReferenceCitation: Thigpen T, Brady MF, Homesley HD, Soper JT, Bell J. Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2001 Jan 15;19(2):364-7.

ReferenceCitation: Ma BB, Oza A, Eisenhauer E, Stanimir G, Carey M, Chapman W, Latta E, Sidhu K, Powers J, Walsh W, Fyles A. The activity of letrozole in patients with advanced or recurrent endometrial cancer and correlation with biological markers--a study of the National Cancer Institute of Canada Clinical Trials Group. Int J Gynecol Cancer. 2004 Jul-Aug;14(4):650-8.

ReferenceCitation: Laplante M, Sabatini DM. mTOR signaling in growth control and disease. Cell. 2012 Apr 13;149(2):274-93. doi: 10.1016/j.cell.2012.03.017. Review.

ReferenceCitation: Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

family: Baselga

full_name: José Baselga

given: José

family: Campone

full_name: Mario Campone

given: Mario

family: Piccart

full_name: Martine Piccart

given: Martine

family: Burris

full_name: Howard A. Burris

given: Howard A.

suffix: III

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

family: Sahmoud

full_name: Tarek Sahmoud

given: Tarek

family: Noguchi

full_name: Shinzaburo Noguchi

given: Shinzaburo

family: Gnant

full_name: Michael Gnant

given: Michael

family: Pritchard

full_name: Kathleen I. Pritchard

given: Kathleen I.

family: Lebrun

full_name: Fabienne Lebrun

given: Fabienne

family: Beck

full_name: J. Thaddeus Beck

given: J. Thaddeus

family: Ito

full_name: Yoshinori Ito

given: Yoshinori

family: Yardley

full_name: Denise Yardley

given: Denise

family: Deleu

full_name: Ines Deleu

given: Ines

family: Perez

full_name: Alejandra Perez

given: Alejandra

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Vittori

full_name: Luc Vittori

given: Luc

title: Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer

ReferenceCitation: Turina M, Christ-Crain M, Polk HC Jr. Diabetes and hyperglycemia: strict glycemic control. Crit Care Med. 2006 Sep;34(9 Suppl):S291-300. Review.

ReferenceCitation: White DA, Camus P, Endo M, Escudier B, Calvo E, Akaza H, Uemura H, Kpamegan E, Kay A, Robson M, Ravaud A, Motzer RJ. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinoma. Am J Respir Crit Care Med. 2010 Aug 1;182(3):396-403. doi: 10.1164/rccm.200911-1720OC. Epub 2010 Mar 1.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Noninfectious Pneumonitis after Everolimus Therapy for Advanced Renal Cell Carcinoma

ReferenceCitation: Albiges L, Chamming's F, Duclos B, Stern M, Motzer RJ, Ravaud A, Camus P. Incidence and management of mTOR inhibitor-associated pneumonitis in patients with metastatic renal cell carcinoma. Ann Oncol. 2012 Aug;23(8):1943-1953. doi: 10.1093/annonc/mds115. Epub 2012 Jun 11. Review.

ReferenceCitation: Ruggero D. Translational control in cancer etiology. Cold Spring Harb Perspect Biol. 2013 Feb 1;5(2). pii: a012336. doi: 10.1101/cshperspect.a012336. Review. Erratum in: Cold Spring Harb Perspect Biol. 2012 Nov;4(11). doi:10.1101/cshperspect.a015891.

ReferenceCitation: Elagöz S, Aricí DS, Aker H. Relationship between FIGO grade and AgNOR, S100-positive langerhans cells in endometrial adenocarcinoma. Pathol Int. 2000 Aug;50(8):616-9.

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ReferenceCitation: Belin S, Beghin A, Solano-Gonzàlez E, Bezin L, Brunet-Manquat S, Textoris J, Prats AC, Mertani HC, Dumontet C, Diaz JJ. Dysregulation of ribosome biogenesis and translational capacity is associated with tumor progression of human breast cancer cells. PLoS One. 2009 Sep 25;4(9):e7147. doi: 10.1371/journal.pone.0007147.

ReferenceCitation: Marcel V, Ghayad SE, Belin S, Therizols G, Morel AP, Solano-Gonzàlez E, Vendrell JA, Hacot S, Mertani HC, Albaret MA, Bourdon JC, Jordan L, Thompson A, Tafer Y, Cong R, Bouvet P, Saurin JC, Catez F, Prats AC, Puisieux A, Diaz JJ. p53 acts as a safeguard of translational control by regulating fibrillarin and rRNA methylation in cancer. Cancer Cell. 2013 Sep 9;24(3):318-30. doi: 10.1016/j.ccr.2013.08.013.

ReferenceCitation: Choi YW, Kim YW, Bae SM, Kwak SY, Chun HJ, Tong SY, Lee HN, Shin JC, Kim KT, Kim YJ, Ahn WS. Identification of differentially expressed genes using annealing control primer-based GeneFishing in human squamous cell cervical carcinoma. Clin Oncol (R Coll Radiol). 2007 Jun;19(5):308-18. Epub 2007 Apr 2.

ReferenceCitation: Su H, Xu T, Ganapathy S, Shadfan M, Long M, Huang TH, Thompson I, Yuan ZM. Elevated snoRNA biogenesis is essential in breast cancer. Oncogene. 2014 Mar 13;33(11):1348-58. doi: 10.1038/onc.2013.89. Epub 2013 Apr 1.

ReferenceCitation: Hein N, Hannan KM, George AJ, Sanij E, Hannan RD. The nucleolus: an emerging target for cancer therapy. Trends Mol Med. 2013 Nov;19(11):643-54. doi: 10.1016/j.molmed.2013.07.005. Epub 2013 Aug 15. Review.

ReferenceCitation: Burger K, Mühl B, Harasim T, Rohrmoser M, Malamoussi A, Orban M, Kellner M, Gruber-Eber A, Kremmer E, Hölzel M, Eick D. Chemotherapeutic drugs inhibit ribosome biogenesis at various levels. J Biol Chem. 2010 Apr 16;285(16):12416-25. doi: 10.1074/jbc.M109.074211. Epub 2010 Feb 16.

ReferenceCitation: Bywater MJ, Poortinga G, Sanij E, Hein N, Peck A, Cullinane C, Wall M, Cluse L, Drygin D, Anderes K, Huser N, Proffitt C, Bliesath J, Haddach M, Schwaebe MK, Ryckman DM, Rice WG, Schmitt C, Lowe SW, Johnstone RW, Pearson RB, McArthur GA, Hannan RD. Inhibition of RNA polymerase I as a therapeutic strategy to promote cancer-specific activation of p53. Cancer Cell. 2012 Jul 10;22(1):51-65. doi: 10.1016/j.ccr.2012.05.019.

ReferenceCitation: Silvera D, Formenti SC, Schneider RJ. Translational control in cancer. Nat Rev Cancer. 2010 Apr;10(4):254-66. doi: 10.1038/nrc2824. Review.

ReferenceCitation: Hannan KM, Brandenburger Y, Jenkins A, Sharkey K, Cavanaugh A, Rothblum L, Moss T, Poortinga G, McArthur GA, Pearson RB, Hannan RD. mTOR-dependent regulation of ribosomal gene transcription requires S6K1 and is mediated by phosphorylation of the carboxy-terminal activation domain of the nucleolar transcription factor UBF. Mol Cell Biol. 2003 Dec;23(23):8862-77.

ReferenceCitation: Iadevaia V, Liu R, Proud CG. mTORC1 signaling controls multiple steps in ribosome biogenesis. Semin Cell Dev Biol. 2014 Dec;36:113-20. doi: 10.1016/j.semcdb.2014.08.004. Epub 2014 Aug 19. Review.

ReferenceCitation: Peltonen K, Colis L, Liu H, Trivedi R, Moubarek MS, Moore HM, Bai B, Rudek MA, Bieberich CJ, Laiho M. A targeting modality for destruction of RNA polymerase I that possesses anticancer activity. Cancer Cell. 2014 Jan 13;25(1):77-90. doi: 10.1016/j.ccr.2013.12.009.

ReferenceCitation: Woiwode A, Johnson SA, Zhong S, Zhang C, Roeder RG, Teichmann M, Johnson DL. PTEN represses RNA polymerase III-dependent transcription by targeting the TFIIIB complex. Mol Cell Biol. 2008 Jun;28(12):4204-14. doi: 10.1128/MCB.01912-07. Epub 2008 Apr 7.

ReferenceCitation: Whittaker S, Martin M, Marais R. All roads lead to the ribosome. Cancer Cell. 2010 Jul 13;18(1):5-6. doi: 10.1016/j.ccr.2010.06.008.

ReferenceCitation: Crowley E, Di Nicolantonio F, Loupakis F, Bardelli A. Liquid biopsy: monitoring cancer-genetics in the blood. Nat Rev Clin Oncol. 2013 Aug;10(8):472-84. doi: 10.1038/nrclinonc.2013.110. Epub 2013 Jul 9. Review.

ReferenceCitation: Dawson SJ, Rosenfeld N, Caldas C. Circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Jul 4;369(1):93-4. doi: 10.1056/NEJMc1306040.

ReferenceCitation: Murtaza M, Dawson SJ, Tsui DW, Gale D, Forshew T, Piskorz AM, Parkinson C, Chin SF, Kingsbury Z, Wong AS, Marass F, Humphray S, Hadfield J, Bentley D, Chin TM, Brenton JD, Caldas C, Rosenfeld N. Non-invasive analysis of acquired resistance to cancer therapy by sequencing of plasma DNA. Nature. 2013 May 2;497(7447):108-12. doi: 10.1038/nature12065. Epub 2013 Apr 7.

ReferenceCitation: Frenel JS, Carreira S, Goodall J, Roda D, Perez-Lopez R, Tunariu N, Riisnaes R, Miranda S, Figueiredo I, Nava-Rodrigues D, Smith A, Leux C, Garcia-Murillas I, Ferraldeschi R, Lorente D, Mateo J, Ong M, Yap TA, Banerji U, Gasi Tandefelt D, Turner N, Attard G, de Bono JS. Serial Next-Generation Sequencing of Circulating Cell-Free DNA Evaluating Tumor Clone Response To Molecularly Targeted Drug Administration. Clin Cancer Res. 2015 Oct 15;21(20):4586-96. doi: 10.1158/1078-0432.CCR-15-0584. Epub 2015 Jun 17.

location_facility: Institut régional du Cancer Montpellier (ICM)


title: Treatment With HMG-COA Reductase Inhibitor (Simvastatin) of Growth and Bone Abnormalities in Children With Noonan Syndrome: A Phase III Randomised, Double Blind, Placebo-controlled Therapeutic Trial

acronym: RASTAT

summary: This study evaluate the efficacy of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-COA) reductase inhibitors, also known as "statins" in the treatment of growth and skeletal abnormalities in children with Noonan syndrome. Half of patients will receive simvastatin while the other half will receive a placebo.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Bordeaux Unité de Génétique pédiatrique

location_facility: CHU Marseille La Timone Unité d'Endocrinologie pédiatrique

location_facility: Hôpital Trousseau Unité d'endocrinologie pédiatrique

location_facility: CHU Rennes Unité de Génétique pédiatrique

location_facility: CHU Lyon Unité d'endocrinologie pédiatrique

location_facility: CHRU Lille Unité d'endocrinologie pédiatrique

location_facility: Hôpital Robert Debré Unité de Génétique pédiatrique

location_facility: CHU Angers Unité d'endocrinologie pédiatrique

location_facility: CHU Nancy Unité de Génétique pédiatrique


title: Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies

acronym: IMMUNOBIOTA

summary:
This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.

In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.

lead_sponsor: Imagine Institute

location_facility: Hôpital Jeanne de Flandre, CHRU de Lille


title: Clinical, Electrophysiological and Biological Diagnostic Criteria of Sensory Neuronopathies

summary: The diagnosis of sensory neuronopathy is difficult to establish because the only certainty criterion is based on the detection of specific lesions in the posterior spinal ganglion which is usually not possible. There is to date no clinical and electrophysiological criteria or validated biomarker for the diagnosis of this type of neuropathy. In a retrospective study, we analyzed the files of patients with peripheral sensory neuronopathy certain and established clinical and electrophysiological diagnostic criteria for sensitive neuronopathy. We therefore wish now validate these criteria and investigate possible associated antibodies on a prospective cohort of patients.

status: Terminated

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CHU Angers
AP-HM
Hospices Civils de Lyon
Chu de Tours
CHU Poitiers
Hopital Pitie Salpetriere
Chu Strasbourg
CHU Clermont-Ferrand
CHU de Montpellier
CHU de Grenoble
CHU de Nimes
Chu Saint-Etienne


title: Efficacy of a Dental Health Promotion Program in Patients With Schizophrenia

acronym: EBENE

summary:
There are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. The aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention.

This is an interventional trial, randomized in clusters. The participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance).

For each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. The follow-up will evaluate dental health and quality of life.

ReferenceCitation: Denis F, Millot I, Abello N, Carpentier M, Peteuil A, Soudry-Faure A. Study protocol: a cluster randomized controlled trial to assess the effectiveness of a therapeutic educational program in oral health for persons with schizophrenia. Int J Ment Health Syst. 2016 Oct 5;10:65. eCollection 2016.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CH de Saint-Rémy et Nord Franche Comté
CH La Chartreuse
Chs Epsan
CH Esquirol
CHS du Jura
CH de Jury
CH de Novillars
CHU de DIJON
CHS de la Savoie
CH de Semur en Auxois
CH Le Vinatier
CHU de Besançon


title: Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair

summary:
In accordance with national guidelines surgical repair of rotator cuff tear is the first-line strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff muscles and articular status. In appropriate situations, a satisfactory result is expected in more than 80% of cases with a very good long-term outcome. On the other hand, the first-line strategy in older patients is conservative as the main objective is the treatment of pain and stiffness of the shoulder which can be achieved at least in the short-term with general and local medications and physiotherapy. In addition, poor prognostic factors such as massive tears and muscle fatty infiltration or atrophy, are more frequently present in those patients, leading to poor results of surgical treatment and a high risk of iterative tear after repair.

Because of a lack of evaluation, there is currently no identified prognostic factor of medical treatment and on the other hand no clinical situation in which a surgical repair is mandatory. Therefore, investigator designed this study as an observatory with the follow up of patients with a symptomatic rotator cuff tear treated conservatively.

location_facility:
Chu de Saint Etienne
Chu de Tours
Clinique Du Parc
Centre de Rhumatologie
Hopital Cochin
Hopital Lariboisiere
Clinique Orthocèdres
Hopital Ambroise Pare
Hopital Corentin-Celton
Chu de Strasbourg
Centre Orthopedique Santy
Cabinet de Rhumatologie


ReferenceCitation: Maruani A, Tavernier E, Boccara O, Mazereeuw-Hautier J, Leducq S, Bessis D, Guibaud L, Vabres P, Carmignac V, Mallet S, Barbarot S, Chiaverini C, Droitcourt C, Bursztejn AC, Lengellé C, Woillard JB, Herbreteau D, Le Touze A, Joly A, Léauté-Labrèze C, Powell J, Bourgoin H, Gissot V, Giraudeau B, Morel B. Sirolimus (Rapamycin) for Slow-Flow Malformations in Children: The Observational-Phase Randomized Clinical PERFORMUS Trial. JAMA Dermatol. 2021 Nov 1;157(11):1289-1298. doi: 10.1001/jamadermatol.2021.3459.

name: University of Tours, University of Nantes, Institut National de la Santé et de la Recherche Médicale, SPHERE U1246, Tours, France

name: Centre Hospitalier Régional Universitaire Tours, Department of Dermatology, Reference Center for Genodermatoses and Rare Skin Diseases (Maladies Génétiques rares à Expression Cutanée–Tours), Tours, France

name: Centre Hospitalier Régional Universitaire Tours, Institut National de la Santé et de la Recherche Médicale Clinical Investigation Center 1415, Tours, France

family: Maruani

full_name: Annabel Maruani

given: Annabel

family: Tavernier

full_name: Elsa Tavernier

given: Elsa

name: Department of Dermatology and Reference Center for Genodermatoses and Rare Skin Diseases (Maladies Génétiques rares à Expression Cutanée–Necker), University Hospital Necker-Enfants Malades, Paris, France

family: Boccara

full_name: Olivia Boccara

given: Olivia

name: Department of Dermatology, University Hospital Center of Toulouse, Toulouse, France

family: Mazereeuw-Hautier

full_name: Juliette Mazereeuw-Hautier

given: Juliette

family: Leducq

full_name: Sophie Leducq

given: Sophie

name: Department of Dermatology, University Hospital Center of Montpellier, Montpellier, France

family: Bessis

full_name: Didier Bessis

given: Didier

name: University Hospital Center of Lyon, Consultation Multidisciplinaire Lyonnaise des Angiomes, Lyon, France

family: Guibaud

full_name: Laurent Guibaud

given: Laurent

name: Department of Dermatology, University Hospital Center of Dijon, Dijon, France

family: Vabres

full_name: Pierre Vabres

given: Pierre

family: Carmignac

full_name: Virginie Carmignac

given: Virginie

name: Department of Dermatology, University Hospital Center of Marseille, Marseille, France

family: Mallet

full_name: Stéphanie Mallet

given: Stéphanie

name: Department of Dermatology, University Hospital Center of Nantes, Nantes, France

family: Barbarot

full_name: Sébastien Barbarot

given: Sébastien

name: Department of Dermatology, University Hospital Center of Nice, Nice, France

family: Chiaverini

full_name: Christine Chiaverini

given: Christine

name: Department of Dermatology, University Hospital Center of Rennes, Rennes, France

family: Droitcourt

full_name: Catherine Droitcourt

given: Catherine

name: Department of Dermatology, University Hospital Center of Nancy, Nancy, France

family: Bursztejn

full_name: Anne-Claire Bursztejn

given: Anne-Claire

name: Centre Hospitalier Régional Universitaire Tours, Department of Clinical Pharmacology, Regional Pharmacovigilance Center, Tours, France

family: Lengellé

full_name: Céline Lengellé

given: Céline

name: Centre Hospitalier Universitaire Limoges, Department of Pharmacology and Toxicology, University of Limoges, Institut National de la Santé et de la Recherche Médicale Unité Mixte de Recherche 850, Limoges, France

family: Woillard

full_name: Jean-Baptiste Woillard

given: Jean-Baptiste

name: University of Tours, Centre Hospitalier Régional Universitaire Tours, Department of Neuroradiology, Reference Center for Genodermatoses and Rare Skin Diseases (Maladies Génétiques rares à Expression Cutanée–Tours), Tours, France

family: Herbreteau

full_name: Denis Herbreteau

given: Denis

name: Centre Hospitalier Régional Universitaire Tours, Department of Pediatric Surgery, Reference Center for Genodermatoses and Rare Skin Diseases (Maladies Génétiques rares à Expression Cutanée–Tours), Tours, France

family: Le Touze

full_name: Anne Le Touze

given: Anne

name: Centre Hospitalier Régional Universitaire Tours, Department of Pediatric Maxillofacial Surgery, Reference Center for Genodermatoses and Rare Skin Diseases (Maladies Génétiques rares à Expression Cutanée–Tours), Tours, France

family: Joly

full_name: Aline Joly

given: Aline

name: Department of Dermatology, University Hospital Center of Bordeaux, Bordeaux, France

family: Léauté-Labrèze

full_name: Christine Léauté-Labrèze

name: Department of Pediatric Dermatology, Hospital Sainte-Justine, Montréal, Québec, Canada

family: Powell

full_name: Julie Powell

given: Julie

name: Centre Hospitalier Régional Universitaire Tours, Department of Pharmacy, Tours, France

family: Bourgoin

full_name: Hélène Bourgoin

given: Hélène

family: Gissot

full_name: Valérie Gissot

given: Valérie

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

name: University of Tours, Centre Hospitalier Régional Universitaire Tours, Department of Pediatric Radiology, Tours, France

family: Morel

full_name: Baptiste Morel

given: Baptiste

ReferenceCitation: Maruani A, Boccara O, Bessis D, Guibaud L, Vabres P, Mazereeuw-Hautier J, Barbarot S, Chiaverini C, Blaise S, Droitcourt C, Mallet S, Martin L, Lorette G, Woillard JB, Jonville-Bera AP, Rollin J, Gruel Y, Herbreteau D, Goga D, le Touze A, Leducq S, Gissot V, Morel B, Tavernier E, Giraudeau B; Groupe de Recherche de la Societé Française de Dermatologie Pédiatrique. Treatment of voluminous and complicated superficial slow-flow vascular malformations with sirolimus (PERFORMUS): protocol for a multicenter phase 2 trial with a randomized observational-phase design. Trials. 2018 Jun 27;19(1):340. doi: 10.1186/s13063-018-2725-1.

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

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

location_facility: Service de dermatologie, Hôpital Larrey, CHU Toulouse

location_facility: Service de radiologie Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon

location_facility: Consultations externes de Dermatologie, Hôpital Clocheville, CHU Tours

location_facility: Service de Dermatologie, Hôpital St Eloi, CHU Montpellier

location_facility: Service de Dermatologie, Hôpital Pontchaillou, CHU RENNES

location_facility: Service de Dermatologie, Hôpital Hôtel-Dieu, CHU Nantes

location_facility: Service de Dermatologie, vénéréologie et cancérologie cutanée, Hôpital La Timone APHM

location_facility: Explorations Médecine Vasculaire Hôpital A. Michallon, CHU de Grenoble

location_facility: Service de dermatologie, Hôpital du Bocage, CHU Dijon

title: Treatment of Superficial Voluminous Complicated Slow-flow Vascular Malformations With Sirolimus: a Phase 2 Trial in Children Observational-phase Designed

summary:
The most recent classification, adopted by International Society for the Study of Vascular Anomalies (ISSVA) in 1996, and updated in Melbourne in 2014, divides these lesions into two broad categories: vascular tumors and vascular malformations. Vascular malformations (VMs) are subdivided into high-flow VM and slow-flow VM.

Slow-flow VMs consist of congenital anomalies which may involve abnormal capillaries vessels, venous vessels, lymphatic vessels or combination of several of them. They can be superficial (involving cutaneous and subcutaneous tissues) and/or may have visceral involvement. They can be limited or diffuse, and are sometimes components of genetic hypertrophic syndromes.

The diagnosis of slow-flow VMs is performed on physical examination (biopsy may be required for confirmation), and is completed with imaging (ultrasonography and magnetic resonance imaging (MRI)). Slow-flow VMs may be particularly voluminous; associated with underlying hypertrophy responsible for functional impairment; painful; associated with seepage or continuous cutaneous bleeding; complicated with visceral signs or hematologic disturbances (anemia, thrombopenia). Management requires dedicated multispecialty care. There are no guidelines for treatment, and management may include no intervention - but natural history of these VMs is progressive worsening -, compression by physical bandage, sclerotherapy, resection (when feasible),anti-inflammatory or anti-coagulation drugs.

Case reports and series have provided evidence for supporting the need for a clinical trial of sirolimus by reporting successful treatment on several children with complicated vascular anomalies. The choice of sirolimus is rational. Mammalian target of rapamycin (mTOR) is a serine/threonine kinase regulated by phosphoinositide-3-kinase involved in cell mobility, cell growth and angiogenesis. Sirolimus inhibits mTOR, which induces inhibition of angiogenesis, in particular lymphangiogenesis, which has been demonstrated in several models.


type: EudraCT Number

title: Impact of a Melatonin Supplementation on the Quality of Life in Elderly Metastatic Cancer Patients (> = 70 Years) - PHRC-K13-170

acronym: MEQAPAG

summary:
Melatonin may represent an effective complementary treatment to standard anticancer treatments in order to reduce asthenia, depression, sleep disturbances, cognitive impairment and performance status as part of quality of life. Moreover, melatonin has been evaluated in several clinical trials in cancer patients with no side effects. It could be particularly of interest in elderly cancer patients as they exhibit a significant deficiency of melatonin production .

The investigators propose to perform a prospective and randomized study to study the effect of a melatonin supplementation on the quality of life of elderly advanced/metastatic cancer patients (age ≥ 70) treated for a locally advanced or metastatic cancer.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie de l'ouest - Site René Gauducheau

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Institut de Cancérologie de l'ouest - Site Paul Papin


title: Neoadjuvant Phase II Trial Combining [3 FEC 100 Followed by 3 Docetaxel Associated With Trastuzumab Plus Pertuzumab] or [6 Docetaxel, Carboplatin Associated With Trastuzumab Plus Pertuzumab] According to TOP2A Status in Patients With T1c Operable, HER2-positive Breast Cancer

acronym: NeoTOP

summary:
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression.

A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.

design_allocation: Non-Randomized

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Regional Universitaire de Brest - Hôpital Morvan

location_facility: Institut de Cancerologie de L'Ouest - Site Paul Papin

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

location_facility: Institut Regional Du Cancer Montpellier Val D'Aurelle

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin


title: Randomized Controlled Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair: Functional and Anatomical Results at Four Years Follow-up

summary:
The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.

The secondary objectives of this study are the following:

to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
to overall quality of life assessment and expectations of patients.
to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).

ReferenceCitation: Lucot JP, Fritel X, Debodinance P, Bader G, Cosson M, Giraudet G, Collinet P, Rubod C, Fernandez H, Fournet S, Lesavre M, Deffieux X, Faivre E, Trichot C, Demoulin G, Jacquetin B, Savary D, Botchorichvili R, Campagne Loiseau S, Salet-Lizee D, Villet R, Gadonneix P, Delporte P, Ferry P, Aucouturier JS, Thirouard Y, de Tayrac R, Fatton B, Wagner L, Nadeau C, Wattiez A, Garbin O, Youssef Azer Akladios C, Thoma V, Baulon Thaveau E, Saussine C, Hermieu JF, Delmas V, Blanc S, Tardif D, Fauconnier A; GROG (groupe de recherche en gynécologie et obstétrique). [PROSPERE randomized controlled trial: laparoscopic sacropexy versus vaginal mesh for cystocele POP repair]. J Gynecol Obstet Biol Reprod (Paris). 2013 Jun;42(4):334-41. doi: 10.1016/j.jgyn.2013.03.012. Epub 2013 Apr 22. French.

lead_sponsor: University Hospital, Lille

location_facility: Groupe Hospitalier Diaconesses Croix St-Simon

location_facility: CH La Rochelle Service de Gynécologie Obstétrique

location_facility: CHRU de Lille - Service de Gynécologie médico chirurgicale

location_facility: Hôpital BICETRE / Service de Gynécologie Obstétrique

location_facility: CHI Poissy-St-Germain / Service de gynécologie


title: Comparison of Long-term Results of UGYTEX® Sub-bladder Mesh Placed Via a Transvaginal Transobturator Approach Versus Subvesical Plication Without Reinforcement in the Surgical Treatment of Bladder Prolapse

acronym: PRO-CURE II

summary: The main purpose of this study is to evaluate the long-term (5-8 years) functional prolapse recurrence rate of the 147 patients enrolled, randomized and analyzed in the study PRO-CURE I.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: APHP - Centre Hospitalier Universitaire de Bicêtre

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: CH d'Issoire - Centre Hospitalier Paul Ardier

intervention_type: Device


title: Individualized Blood Glucose Control in ICU.

acronym: CONTROLING

summary: During the last 2 decades, the management of hyperglycemia in critically ill patients has become one of the most discussed topics in the intensive-care field. The initial data suggesting significant benefit from the normalization of blood glucose levels in critically ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some studies suggested that strict blood glucose control might benefit in non-diabetic patient and worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target based on glycated hemoglobin measured at ICU admission would improve outcome when compared to a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a randomized double blinded study in which Blood glucose control is piloted in both groups by a web-guided protocol that directly gives instruction to nurses (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers. Primary end point is 90 d outcome after randomization.

ReferenceCitation: Bohé J, Abidi H, Brunot V, Klich A, Klouche K, Sedillot N, Tchenio X, Quenot JP, Roudaut JB, Mottard N, Thiollière F, Dellamonica J, Wallet F, Souweine B, Lautrette A, Preiser JC, Timsit JF, Vacheron CH, Ait Hssain A, Maucort-Boulch D; CONTROLe INdividualisé de la Glycémie (CONTROLING) Study Group. Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial. Intensive Care Med. 2021 Nov;47(11):1271-1283. doi: 10.1007/s00134-021-06526-8. Epub 2021 Sep 29.

location_facility: CHU de Dijon - Complexe Hospitalier du Bocage

location_facility: CHU de Clermont Ferrand - Gabriel Montpied

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud


title: Construction and Validation of a Tool for Automatic Identification of Care Pathways at Risk of Sub-optimality in the Management of Severe Infections in Children (DIABACT IV)

acronym: DIABACT IV

summary: Community bacterial infection remains to this day a common cause of morbidity and mortality in children, which preventability is a challenge for clinicians. In a previous work, the investigators found that 76% supported children admitted to the ICU for severe bacterial infection were appraised as suboptimal and significantly associated with an increased risk of death. In this context, the investigators seek to identify indicators of extractable data PMSI and SNIIR -AM associated with a higher risk of suboptimal early taking care of children with severe bacterial infection in order to combine them and use them as a score or decision tree that the investigators will validate data from a national prospective multicenter study including 512 children admitted to the ICU for severe infection. The investigators then propose a score associated with a risk of suboptimality care to evaluate the performance of the healthcare system .

location_facility:
Stéphane Leteurtre
Thierry Debillon
Jacques Sizun
Stéphane Dauger
Sylvain Renolleau
Hugues Patural
Olivier Brissaud
Etienne Javouhey
Elise Launay
Gilles Cambonie
Angers University Hospital
AP-HP


title: Assessing the Risk of CMV Infection of the Renal Transplant About R + by Cellular Immunity Analyzed by the QuantiFERON ®-CMV Test.

acronym: QUANTIC-R+

summary:
Cytomegalovirus (CMV) infection was observed in over 30% of organ recipients with high morbidity. Moreover, no prophylaxis, 75% R + D-transplanted, 55%, R + D + and D-25% R + develop CMV. The number of available antiviral drugs is reduced and noticeable side effects (neutropenia, renal toxicity) lead to premature discontinuation of therapy or the use of reduced doses that promote non-response to treatment and the emergence of resistance. In case of neutropenia, there are more an increased risk of secondary rejection due to the reduction of immunosuppressive treatment rendered necessary by the haematological reached.

Rational use of these molecules is necessary with essential today as the optimal duration of prophylaxis primary issues and the prophylaxis of recurrences in case of CMV infection reported in.

lead_sponsor: University Hospital, Limoges

location_facility:
Virologie
Foch Hospital
Bactériologie Virologie

intervention_type: Biological


title: Evaluation of the Nutritional Status of Patients With Multiple Sclerosis and Relationship With Fatigue

acronym: NUTRISEP

summary: Multiple sclerosis (MS) is a chronic progressive neurological disease, the leading cause of disability after injury accidents in young adults. Among the many symptoms, fatigue is very common with a significant impact on quality of life. Also, the disability caused by multiple sclerosis can alter food intake and can cause nutritional deficiencies. Nutrients such as proteins, minerals (iron, calcium, magnesium), some vitamins (B12, 25 OHD) are often deficient in this population with consequences in physical performance such as endurance and muscle strength. We propose to study the link between fatigue and shortcomings encountered in a defined population of MS patients.

lead_sponsor: Lille Catholic University

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier de Boulogne, Hôpital Duchenne

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: A Randomized Prospective, Multicentric, Open Label, Phase II Study Aiming to Evaluate the Efficacity and Safety of EVEROLIMUS as Neo-adjuvant Therapy in Patients With Primary or Relapsed Chondrosarcomas

acronym: CHONRAD

summary:
The mainstay of chondrosarcoma treatment is a wide surgical resection. Unfortunately, this is a rare occurrence, and patients with incomplete resection have very poor therapeutic options. In this context, it becomes important to find new therapeutic strategies to slow down tumor progression and to reduce tumor size before resection.

Pre-clinical and clinical data suggest that EVEROLIMUS should be efficient as adjuvant and neo-adjuvant therapy in chondrosarcoma.

Then, investigators propose a phase II, randomized, open label study compounded by 3 arms (1:1:1) to assess efficiency of EVEROLIMUS as neo-adjuvant therapy in patients with primary or relapsed chondrosarcomas :

ARM 1 = No treatment; ARM 2 = 2,5 mg Everolimus/day; ARM 3 = 10 mg Everolimus/day.

The treatments will be taken for 4 weeks before surgery, apart from any premature withdrawn

status: Suspended

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ReferenceCitation: Lee FY, Mankin HJ, Fondren G, Gebhardt MC, Springfield DS, Rosenberg AE, Jennings LC. Chondrosarcoma of bone: an assessment of outcome. J Bone Joint Surg Am. 1999 Mar;81(3):326-38.

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ReferenceCitation: Marina N, Gebhardt M, Teot L, Gorlick R. Biology and therapeutic advances for pediatric osteosarcoma. Oncologist. 2004;9(4):422-41. Review.

ReferenceCitation: Fingar DC, Blenis J. Target of rapamycin (TOR): an integrator of nutrient and growth factor signals and coordinator of cell growth and cell cycle progression. Oncogene. 2004 Apr 19;23(18):3151-71. Review.

ReferenceCitation: Hay N, Sonenberg N. Upstream and downstream of mTOR. Genes Dev. 2004 Aug 15;18(16):1926-45. Review.

ReferenceCitation: Faivre S, Kroemer G, Raymond E. Current development of mTOR inhibitors as anticancer agents. Nat Rev Drug Discov. 2006 Aug;5(8):671-88. doi: 10.1038/nrd2062.

ReferenceCitation: Wan X, Mendoza A, Khanna C, Helman LJ. Rapamycin inhibits ezrin-mediated metastatic behavior in a murine model of osteosarcoma. Cancer Res. 2005 Mar 15;65(6):2406-11.

ReferenceCitation: Raymond E, Alexandre J, Faivre S, Vera K, Materman E, Boni J, Leister C, Korth-Bradley J, Hanauske A, Armand JP. Safety and pharmacokinetics of escalated doses of weekly intravenous infusion of CCI-779, a novel mTOR inhibitor, in patients with cancer. J Clin Oncol. 2004 Jun 15;22(12):2336-47. Epub 2004 May 10.

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ReferenceCitation: Dudkin L, Dilling MB, Cheshire PJ, Harwood FC, Hollingshead M, Arbuck SG, Travis R, Sausville EA, Houghton PJ. Biochemical correlates of mTOR inhibition by the rapamycin ester CCI-779 and tumor growth inhibition. Clin Cancer Res. 2001 Jun;7(6):1758-64.

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lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Régional Universitaire de Tours, Hôpital Trousseau

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Centre Hospitalier Universitaire de Nantes, Hôtel Dieu

location_facility: Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau


type: Other Grant/Funding Number

title: Comparison of the Efficiency of Intra-uterine Insemination and in Vitro Fertilization in Women Over 37 Years

acronym: AMPAGE

summary: As age increases the chances for a woman to become pregnant decrease as well spontaneously as through assisted reproductive technologies (ART). For the treatment of unexplained infertilities two techniques can be used: intra-uterine insemination (IUI) and in vitro fertilization (IVF). The aim of the present study is to compare the efficiency in term of delivery rate of IUI and IVF in couples in whom the female age is over 37 years.

location_facility: Centre Hospitalier des Quatre Villes, Saint-Cloud Service de Médecine de la Reproduction

location_facility: Centre Hospitalier Intercommunal de Créteil, Service d'AMP

location_facility: CHU Dijon Laboratoire de biologie de la reproduction

location_facility: CHI Poissy St-Germain en Laye, centre d'AMP

location_facility: CHU Montpellier, Médecine de la Reproduction

location_facility: CHRU Brest Hôpital Morvan, service d'AMP


title: Secondary Bilateral or Controlateral Sacral Nerve Stimulation in Overactive Bladder Patients With Unilateral Stimulation Failure - Multicenter Study

acronym: NEUROBIL

summary: Unilateral sacral neuromodulation (SNM) has emerged as a valuable treatment for patient with low urinary tract dysfunction when failure or bad tolerance to anticholinergic treatment for overactive bladder. However, in the medium or long term, some patients failed to benefit from unilateral stimulation (unilateral neuromodulation). A contralateral stimulation could be tested then implanted to restore the efficacy. An other option is to perform a bilateral stimulation of the sacral nerves that could lead to a summation effects better than unilateral stimulation. Therefore, if a unilateral sacral nerve stimulation fails, a contralateral or a bilateral test should be considered.

ReferenceCitation: van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, Lycklama á Nijholt AA, Siegel S, Jonas U, Fowler CJ, Fall M, Gajewski JB, Hassouna MM, Cappellano F, Elhilali MM, Milam DF, Das AK, Dijkema HE, van den Hombergh U. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007 Nov;178(5):2029-34. Epub 2007 Sep 17.

ReferenceCitation: Pham K, Guralnick ML, O'Connor RC. Unilateral versus bilateral stage I neuromodulator lead placement for the treatment of refractory voiding dysfunction. Neurourol Urodyn. 2008;27(8):779-81. doi: 10.1002/nau.20577.

family: Pham

full_name: Khanh Pham

given: Khanh

family: Guralnick

full_name: Michael L. Guralnick

given: Michael L.

family: O'Connor

full_name: R. Corey O'Connor

given: R. Corey

journal_name: Neurourology and Urodynamics

ReferenceCitation: Marcelissen TA, Leong RK, Serroyen J, van Kerrebroeck PE, De Wachter SG. The use of bilateral sacral nerve stimulation in patients with loss of unilateral treatment efficacy. J Urol. 2011 Mar;185(3):976-80. doi: 10.1016/j.juro.2010.10.065. Epub 2011 Jan 19.

name: Department of Urology, Maastricht University Medical Centre and Department of Methodology and Statistics, Maastricht University (JS), Maastricht, The Netherlands

family: Marcelissen

full_name: Tom A.T. Marcelissen

given: Tom A.T.

family: Leong

full_name: Randall K. Leong

given: Randall K.

family: Serroyen

full_name: Jan Serroyen

given: Jan

family: van Kerrebroeck

full_name: Philip E.V. van Kerrebroeck

given: Philip E.V.

family: De Wachter

full_name: Stefan G.G. De Wachter

given: Stefan G.G.

journal_name: Journal of Urology

title: The Use of Bilateral Sacral Nerve Stimulation in Patients With Loss of Unilateral Treatment Efficacy

lead_sponsor: University Hospital, Rouen

location_facility:
AP-HM
AP-HP Tenon
UH Nantes
UH Rouen
UH Grenoble
Lille University Hospital
Hospices civiles de Lyon
AP-HP Pitié Salpetrière
GHICL Lille Saint Philibert
UH Nîmes
UH Caen
UH Toulouse


title: Randomized Double-blind Study on the Benefit of Spironolactone for Treating Acne of Adult Woman.

acronym: FASCE

summary:
Acne vulgaris of adult woman has increased over the past 10 years; it affects currently 20% to 30% of adult women.

The physiopathology of adult woman acne is distinguished from the teenager one by essentially 2 factors:

hormonal factor with a peripheral hyperandrogenism coupled with an hypersensibility of cutaneous androgens receptors of these women. But this point is still at the stage of hypothesis.
inflammatory factor linked with Propionibacterium Aces ; indeed these women received most of the time many cures of local and systematic antibiotics at the origin of resistant Propionibacterium Aces strains which lead to a chronical activation of cutaneous innate immunity.

On a therapeutic plan, four types of systemic treatment, approved in this indication are:

Tetracyclines which are problematic for the bacterial resistance and consequently constant relapse when they are stopped.
Zinc salts which target only the inflammatory lesions and were shown less effective than cycline
Antiandrogens, with acetate of cyproterone associated with risks of phlebitis and pulmonary embolism, and increase risk of triglycerides, cholesterol and hepatic balance.
The last alternative is represented by isotretinoin but the use in women of childbearing potential is binding because of the teratogen risks and the hyperandrogenism represents an identified risk of relapse.

In this context, the spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at sebaceous gland and inhibits Luteinizing hormone (LH) production at the pituitary level. It is not submitted to isotretinoin constraints, does not lead to bacterial resistance and targets the peripheral hyperandrogenism.

Currently, very few studies have been performed and on a weak number of patients but they showed that at low doses (lower than 200mg/day), spironolactone can be effective against acne.

In that context, it seemed clearly interesting to perform the first double-blind randomized study spironolactone vs cyclines which remains the moderate acne reference treatment and to demonstrate the superiority of spironolactone's efficacy in order to establish it as alternative way to cycline.

ReferenceCitation: Poinas A, Lemoigne M, Le Naour S, Nguyen JM, Schirr-Bonnans S, Riche VP, Vrignaud F, Machet L, Claudel JP, Leccia MT, Hainaut E, Beneton N, Dert C, Boisrobert A, Flet L, Chiffoleau A, Corvec S, Khammari A, Dréno B. FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial. Trials. 2020 Jun 25;21(1):571. doi: 10.1186/s13063-020-04432-w.

family: Poinas

full_name: Alexandra Poinas

given: Alexandra

family: Lemoigne

full_name: Marie Lemoigne

given: Marie

family: Le Naour

full_name: Sarah Le Naour

given: Sarah

family: Nguyen

full_name: Jean-Michel Nguyen

given: Jean-Michel

family: Schirr-Bonnans

full_name: Solène Schirr-Bonnans

given: Solène

family: Riche

full_name: Valery-Pierre Riche

given: Valery-Pierre

family: Vrignaud

full_name: Florence Vrignaud

given: Florence

family: Machet

full_name: Laurent Machet

given: Laurent

family: Claudel

full_name: Jean-Paul Claudel

given: Jean-Paul

family: Leccia

full_name: Marie-Thérèse Leccia

given: Marie-Thérèse

family: Hainaut

full_name: Ewa Hainaut

given: Ewa

family: Beneton

full_name: Nathalie Beneton

given: Nathalie

family: Dert

full_name: Cécile Dert

given: Cécile

family: Boisrobert

full_name: Aurélie Boisrobert

given: Aurélie

family: Flet

full_name: Laurent Flet

family: Chiffoleau

full_name: Anne Chiffoleau

family: Corvec

full_name: Stéphane Corvec

given: Stéphane

family: Khammari

full_name: Amir Khammari

given: Amir

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

location_facility:
Chru Brest
Cabinet du Dr Jean-Paul Claudel
CH Le Mans
CHU Poitiers
CHU Caen
CHU Grenoble
CHU de Nantes - Dermatologie
CHRU Tours
CH La Rochelle


title: ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE

acronym: ADOPT-PRESTAGE

summary:
As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized.

PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being.

ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life, evaluation of changes in patients' behaviors and economic evaluation.

location_facility: Service d'oncologie médicale, Cnetre Léon Bérard

location_facility: Service de Gériatrie, Centre Hospitalier de Givors

location_facility: Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL

location_facility: Service d'oncologie, Centre Hospitalier Annecy Genevois

location_facility: Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL

location_facility: service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne

location_facility: Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole

location_facility: Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL

location_facility: Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)


title: Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors

summary: The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.

lead_sponsor: Oticon Medical

location_facility: CHU Nice - Institut Universitaire de la Face et du Cou

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)

acronym: FibroMR

summary: The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.

lead_sponsor: Rennes University Hospital

location_facility:
CHU de Nantes
CHU d'Angers
CHU de Bordeaux
Centre Hospitalier Bretagne Atlantique
CH de Saint Brieuc
CHD Vendée
CHU de Rennes
Groupe Hospitalier Bretagne Sud
CHU de Toulouse


title: Study of cardiovAscular Contrasted Phenotypes in Patients With FamIliaI hypercholesteRolemia

acronym: SAFIR

summary: The main objective of SAFIR is to identify the atherosclerotic genetic factors in these patients, which will identify new therapeutic targets for the treatment of CV and Familial Hypercholesterolemia diseases. In addition, SAFIR will allow the identification of new CV protection biomarkers, which will be useful tools for the development of a personalized medicine for the management of dyslipidemias.

ipd_sharing: Undecided

lead_sponsor: Nantes University Hospital

location_facility:
Toulouse Hospital
Rennes University Hospital
CHRU de Lille
Saint-Antoine Hospital
Louis Pradel Cardiovascular Hospital
La Conception Hospital
Le Bocage Hospital
Pitié-Salpêtrière Hospital
Nantes University Hospital


title: Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association

summary:
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.

The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.

lead_sponsor: Poitiers University Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers

intervention_type: Combination Product


title: Validation of a Score Assessing Physical and Cognitive Activities of Patients in Follow-up Care and Rehabilitation Departments: the SOFMER Activity Score

acronym: SAS

summary:
A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...

The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).

We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.

lead_sponsor: Hospices Civils de Lyon

location_facility: Département de Rééducation Neurologique - Hôpital Sud - CHU de Grenoble

location_facility: Service de Médecine Physique et de Réadaptation - F.Widal - APHP

location_facility: Service SSRS Enfants et Adolescents, Fondation Ildys

location_facility: Service de Médecine Physique et Réadaptation - Pôle Couple Mère-Enfant - HOPITAL DE BELLEVUE

location_facility: Médecine physique et réadaptation - Hôpital Raymond Poincaré - APHP

location_facility: Service de Médecine physique et Réadaptation - Hôpital Henry Gabrielle


title: Double Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's Disease

acronym: APOMORPHEE

summary: The purpose of the study is to demonstrate that continuous apomorphine treatment during the night compared with placebo improves sleep quality in insomniac patient with Parkinson's disease.

lead_sponsor: Clinique Beau Soleil

location_facility:
Hôpital CIVIL
Clinique Beau Soleil
CHU de NIMES
Chu Gabriel Montpied
Chu Ponchaillou
Centre hospitalier JACQUES LACARIN
CHU de NANTES - HOPITAL NORD
Hôpital de la TIMONE
Hôpital de HAUTEPIERRE