title: A Phase I Dose Escalation Trial Evaluating the Impact of an in Situ Immunization Strategy With Intra-Tumoral Injections of Pexa-Vec in Combination With Ipilimumab in Metastatic / Advanced Solid Tumors With Injectable Lesions.

acronym: ISI-JX

summary: The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs target the immune system rather than cancer cells in order to stimulate the anti-tumor immune response. In situ immunization is a strategy where immunomodulatory products such as pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune response. Of importance, pre-clinical rationale has demonstrated that combination of anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore, provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor responses on local (injected) and distant (not injected) tumor sites. In solid injectable refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming. Our proposal is to conduct a 2-part Phase I clinical trial in order to define the feasibility, the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab in combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD and RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor effect of the combination.

location_facility:
Centre Léon Bérard
Hopital Saint Louis
Centre Hospitalier Lyon Sud
Institut Gustave Roussy
Institut Bergonie


title: Phase II Study of First Line Treatment of Chronic Graft Versus Host Disease With Arsenic Trioxide

acronym: GvHD-ATO

summary: This study aims to evaluate the early chronic GvHD events (first line therapy), if the addition of arsenic trioxide to standard therapy with corticosteroids, with or without cyclosporine, will be effective in controlling chronic GvHD and to reduce the duration of corticosteroid therapy

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Medsenic

location_facility: CHU de Caen - Institut d'Hématologie de Basse Normandie

location_facility: Institut Paoli Calmettes - Département d'hématologie - Centre de Recherche en Cancérologie de Marseille

location_facility: CHU Hôtel Dieu - Service Hématologie Clinique

location_facility: Institut Universitaire du Cancer - Oncopole - Service d'Hématologie

location_facility: Hôpital Saint Antoine - Hématologie et thérapie cellulaire - AP-HP

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure

acronym: IOXSOR

summary: IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Angers

location_facility:
University Hospital
Hospital center
Hospital

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy

acronym: FOLOUT

summary: 15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population

status: Terminated

design_allocation: Randomized

lead_sponsor: University Hospital, Lille

location_facility:
Hôpital Jeanne de Flandre - CHRU
CHU de Caen
CH Roubaix
Ch Valenciennes
CHU Rouen

intervention_type: Other


title: Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study - T-TREAt

acronym: T-TREAt

summary:
Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. Traumatic events that may trigger PTSD include violent personal assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies.

The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. But the therapeutic response stays partial, even combining these treatments.

To improve the PTSD treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation (tDCS) to enhance the trauma-focused therapy results.

status: Recruiting

lead_sponsor: University Hospital, Tours

location_facility:
CHU Angers
CHU Poitiers
CHU Tours
CHU Nantes
CHU Rennes

intervention_type: Device

status_simplified: Ongoing


title: Phase I/II Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO®) in Renal Cell Carcinoma Patients With Bone Metastases.

acronym: EIFFEL

summary: This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.

design_allocation: Non-Randomized

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility:
Centre François Baclesse
CHU Bordeaux (St. André)
Hopital Europeen Georges Pompidou
Hôpital Cochin
Institut Gustave Roussy


title: Analysis of Circulating Tumor Markers in the Blood

acronym: ALCINA

summary: Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

ReferenceType: derived

ReferenceCitation: Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabières C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.

name: Department of Medical Oncology, Institut du Cancer Montpellier, Montpellier University, Montpellier, France

family: Sinoquet

full_name: Léa Sinoquet

given: Léa

sequence: first

name: Institut de Recherche en Cancérologie de Montpellier, INSERM U1194, Montpellier University, Montpellier, France

family: Jacot

full_name: William Jacot

given: William

sequence: additional

name: Biometrics Unit, Institut du Cancer Montpellier, Montpellier University, Montpellier, France

family: Gauthier

full_name: Ludovic Gauthier

given: Ludovic

family: Pouderoux

full_name: Stéphane Pouderoux

given: Stéphane

family: Viala

full_name: Marie Viala

given: Marie

name: Laboratory of Rare Human Circulating Cells (LCCRH), University Medical Centre of Montpellier, Montpellier, France

name: CREEC/CANECEV, MIVEGEC (CREES), University of Montpellier, CNRS, IRD, Montpellier, France

family: Cayrefourcq

full_name: Laure Cayrefourcq

given: Laure

family: Quantin

full_name: Xavier Quantin

given: Xavier

family: Alix-Panabières

full_name: Catherine Alix-Panabières

given: Catherine

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Chemistry

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Darrigues L, Pierga JY, Bernard-Tessier A, Bièche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0.

family: Darrigues

full_name: Lauren Darrigues

given: Lauren

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Bernard-Tessier

full_name: Alice Bernard-Tessier

given: Alice

family: Bièche

full_name: Ivan Bièche

given: Ivan

family: Silveira

full_name: Amanda Bartolini Silveira

given: Amanda Bartolini

family: Michel

full_name: Marc Michel

given: Marc

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Cottu

full_name: Paul Cottu

given: Paul

family: Cabel

full_name: Luc Cabel

given: Luc

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Geiss

full_name: Romain Geiss

given: Romain

ReferenceCitation: Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2.

title: Plasma thymidine kinase 1 activity and outcome of ER+ HER2− metastatic breast cancer patients treated with palbociclib and endocrine therapy

ReferenceCitation: Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabières C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.

name: Department of Medical Oncology, Institut du Cancer Montpellier (ICM), Montpellier University, Montpellier, France

name: Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier University, Montpellier, France

name: Laboratory of Rare Human Circulating Cells (LCCRH), University Medical Centre of Montpellier, Montpellier University EA2415, Montpellier, France

name: Biometrics Unit, Institut du Cancer Montpellier (ICM), Montpellier University, Montpellier, France

name: Department of Radiation Oncology, Institut du Cancer Montpellier (ICM), Montpellier University, Montpellier, France

name: Translational Research Unit, Institut du Cancer Montpellier (ICM), Montpellier University, Montpellier, France

name: Clinical Research Center, Institut du Cancer Montpellier (ICM), Montpellier University, Montpellier, France

name: Department of Medical Oncology, Institut Curie, PSL Research University, Paris, France

name: Versailles Saint Quentin en Yvelines University, Paris, Saclay University, Saint Cloud, Paris, France

name: Circulating Tumor Biomarkers Laboratory, Institut Curie, PSL Research University, Paris, France

location_facility:
Institut Curie (Paris hospital)
Institut du Cancer de Montpellier
Centre Georges François Leclerc
Institut Mutualiste Montsouris
Institut Curie (St Cloud hospital)


title: Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET ( Positron Emission Tomography) F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin

acronym: CMTpostopFDOPA

summary:
The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.

This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.

The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.

Obtained data will be compared to the "gold standard" based on :

nodes cytology when they could be punctured
histology when a new surgery will be recommended
surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)

ipd_sharing: Undecided

lead_sponsor: Institut Claudius Regaud

location_facility:
ICM Montpellier
CHU Limoges
Institut Claudius Regaud
CHU Haut-Lévêque
CHU Timone


title: Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year

summary: This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20.

family: Hilliquin

full_name: Pascal Hilliquin

given: Pascal

family: Barnetche

full_name: Thomas Barnetche

given: Thomas

family: Baillet

full_name: Athan Baillet

given: Athan

family: Flipo

full_name: René-Marc Flipo

given: René-Marc

family: Lespessailles

full_name: Eric Lespessailles

given: Eric

family: Roux

full_name: Christian Roux

given: Christian

family: Fardellone

full_name: Patrice Fardellone

given: Patrice

family: Gilbert-Marceau

full_name: Anika Gilbert-Marceau

given: Anika

family: Idier

full_name: Isabelle Idier

given: Isabelle

family: Constantin

full_name: Arnaud Constantin

given: Arnaud

family: Shipley

full_name: Emilie Shipley

given: Emilie

family: Baudens

full_name: Guy Baudens

given: Guy

family: Saraux

full_name: Alain Saraux

given: Alain

journal_name: Rheumatology and Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hoffmann-La Roche

location_facility: Centre medical des coteaux; Rhumatologie

location_facility: Hopitaux du Leman site Thonon; Rhumatologie

location_facility: Centre Hopsitalier Saint Nazaire; Medecine Polyvalente

location_facility: Infirmerie Protestante; Medecine interne Cancerologie

location_facility: Cabinet de Rhumatologie MSP de Beaublanc

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: Hopital Pierre Nouveau;Medecine C Unite Rhumatologie

location_facility: Hopital Sud Anne de Bretagne; Rhumatologie

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Ch Louis Pasteur; Rhumato Med Interne Neurologie

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Hopital Edouard Herriot; Pavillon F Rhumatologie

location_facility: Ch Lyon Sud; Rhumato Secteur Jules Courmont

location_facility: Hopital Gabriel Montpied; Service de Rhumatologie

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie

location_facility: Institut Calot Helio Marin; Rhumatologie

location_facility: Hopital Victor Jousselin; Rhumatologie 4EME Sud

location_facility: Hopital Instruction Armees Begin; Rhumatologie

location_facility: CH de Juvisy sur Orge; Consult. externes


title: Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?

acronym: FT-KBP

summary: The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.

primary_purpose: Prevention

lead_sponsor: Hopital Foch

location_facility: Centre hospitalier intercommunal de Créteil


title: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

summary:
Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).

primary_purpose: Other

ReferenceType: background

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

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

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.

acronym: WHATELSE

summary: The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

location_facility: Centre de Luttre Contre le Cancer Alexis Vautrin

location_facility: Centre Hospitalier Universitaire St Antoine

location_facility: Centre Hospitalier Universitaire de Besançon


title: Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma

acronym: ACTES

summary: The aim of this pilot study is to correlate the sorafenib plasma concentration to observed toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning a larger interventional study to adjust sorafenib daily dose to plasma concentration.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU de Limoges
CHU de Bordeaux
CHU de Montpellier
Institut Bergonié
CHU de Toulouse

intervention_type: Biological


title: A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer

acronym: CHEOPS

summary: The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier de l'Agglomération Montargoise


title: A Randomized, Open-label, Comparative, Multicenter, Phase II Study of the Efficacy and Safety of REGorafenib Versus Tamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

acronym: REGOVAR

summary: The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

status: Active, not recruiting

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Centre Hospitalier Universitaire Bretonneau


acronym: TICTAVI

summary: Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in the aim to minimize cerebral embolization. But for now, the best antiplatelet regimen has to be determined. In this context, investigators want to evaluate the safety of use of ticagrelor alone versus standardized therapy which involves lysine acetylsalicylate and clopidogrel. In this study, we will randomly compare 154 patients in each group in terms of early safety (30 days) after the procedure.

location_facility:
CHRU de Lille
CHU de Bordeaux
APHP
CHRU de Nîmes
APHM


title: Frailty and Body Composition in the Elderly Cancer Patients Treated With Chemotherapy

acronym: FRACTION

summary: The investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

ReferenceCitation: Steinmeyer Z, Gérard S, Filleron T, Lozano S, Brechemier D, Abellan Van Kan G, Mourey L, Cristol-Dalstein L, De Decker L, Rolland Y, Balardy L. Low lean mass and chemotherapy toxicity risk in the elderly: the Fraction study protocol. BMC Cancer. 2019 Nov 27;19(1):1153. doi: 10.1186/s12885-019-6377-7.

lead_sponsor: University Hospital, Toulouse

location_facility: Institut du Cancer de Montpellier Val d'Aurelle


lead_sponsor: Center Eugene Marquis

acronym: VesiCaP

location_facility:
Centre Eugene Marquis
Clinique Pasteur Lanroze
Hôpital Saint Louis
CH Bretagne Sud
CH Lyon Sud

type: EudraCT Number

source: euctr

title: Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer

summary: The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.


title: APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

acronym: APCext

summary:
The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and endstage liver disease has led to an increase in the gap between patients on waiting-lists and available liver grafts. In order to compensate for this scarcity, use of liver grafts harvested from extended criteria donors (ECD) has become more and more frequent.

However, these ECD grafts are known to be associated with a higher rate of primary non function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to ischemia-reperfusion injury (IRI).

During OLT, the clamping of the portal vein induces blood congestion in the splanchnic territory leading to increased gut permeability, bacterial translocation and release of endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI.

Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic congestion and could therefore decrease IRI and improve liver graft function. However, TPCS remains poorly used as no randomised trial succeeds to show its benefit on liver function due to lack of power.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Toulouse
CHU Tours
CHU Bordeaux
CHU Rennes
Hospices Civils Lyon

intervention_type: Procedure


title: VEDO-PREDIRESP Project: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Crohn's Disease

acronym: VEDO-PREDIRESP

summary:
Vedolizumab (VDZ) is a monoclonal antibody which has shown its efficacy in Crohn's disease by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Crohn's disease in patients in failure with anti-TNF (Tumor Necrosis Factor) agents.

For Crohn's disease patients treated with vedolizumab, a strong association between vedolizumab serum levels and clinical response to induction and maintenance was demonstrated by anterior studies.

It could be of paramount interest to early identify Crohn's Disease patients under vedolizumab who will be responders to vedolizumab induction and to identify those who will achieve clinical remission under maintenance therapy with vedolizumab.

Researchers decided to assess the clinical response to vedolizumab induction at week 10. For clinically non-responders at week 10, an additional dose of 300 mg of vedolizumab will be infused at week 10 and then every four weeks.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Lyon-Sud, Hospices Civils de Lyon, PIERRE-BENITE


title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

acronym: Esostrate

summary:
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.

The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.

Evaluation of the response 5 to 6 weeks after the RCT.

Step 2: Randomisation in patients with a complete clinical response:

Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence

Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre d'oncologie et de radiothérapie du Pays Basque


title: A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma

acronym: NACRE

summary: The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

lead_sponsor: UNICANCER

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Gustave Roussy Cancer Campus Grand Paris

location_facility: Centre Médical Oncogard Institut de cancérologie du Gard

intervention_type: Radiation


title: Evaluation of the Effectiveness of Personalized Short and Intensive Educational SPA Therapy Prevention of Upper Limb Musculoskeletal Disorders (MSDs).

acronym: MUSKA

summary: The main objective of this work is to demonstrate superiority to three months of a standardized short course of SPA Therapy of 6 days associated with personalized health education program compared to conventional therapy in the management of MSDs on the functional capabilities of the employees in their daily lives (personal or professional)

ReferenceCitation: McBeth J, Jones K. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):403-25. Review.

ReferenceCitation: Kamaleri Y, Natvig B, Ihlebaek CM, Bruusgaard D. Localized or widespread musculoskeletal pain: does it matter? Pain. 2008 Aug 15;138(1):41-46. doi: 10.1016/j.pain.2007.11.002. Epub 2008 Feb 20.

ReferenceCitation: Solidaki E, Chatzi L, Bitsios P, Markatzi I, Plana E, Castro F, Palmer K, Coggon D, Kogevinas M. Work-related and psychological determinants of multisite musculoskeletal pain. Scand J Work Environ Health. 2010 Jan;36(1):54-61. Epub 2009 Dec 11.

ReferenceCitation: Fan ZJ, Smith CK, Silverstein BA. Assessing validity of the QuickDASH and SF-12 as surveillance tools among workers with neck or upper extremity musculoskeletal disorders. J Hand Ther. 2008 Oct-Dec;21(4):354-65. doi: 10.1197/j.jht.2008.02.001.

ReferenceCitation: Polson K, Reid D, McNair PJ, Larmer P. Responsiveness, minimal importance difference and minimal detectable change scores of the shortened disability arm shoulder hand (QuickDASH) questionnaire. Man Ther. 2010 Aug;15(4):404-7. doi: 10.1016/j.math.2010.03.008.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Gautheron V, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Revel M, Poiraudeau S. Reliability, validity and responsiveness of the French version of the questionnaire Quick Disability of the Arm, Shoulder and Hand in shoulder disorders. Man Ther. 2009 Apr;14(2):206-12. doi: 10.1016/j.math.2008.01.013. Epub 2008 Apr 23.

ReferenceCitation: Fayad F, Lefevre-Colau MM, Macé Y, Fermanian J, Mayoux-Benhamou A, Roren A, Rannou F, Roby-Brami A, Gautheron V, Revel M, Poiraudeau S. Validation of the French version of the Disability of the Arm, Shoulder and Hand questionnaire (F-DASH). Joint Bone Spine. 2008 Mar;75(2):195-200. Epub 2007 Aug 30.

ReferenceType: result

ReferenceCitation: Meroni R, Scelsi M, Boria P, Sansone V. Shoulder disorders in female working-age population: a cross sectional study. BMC Musculoskelet Disord. 2014 Apr 4;15:118. doi: 10.1186/1471-2474-15-118.

family: Meroni

full_name: Roberto Meroni

given: Roberto

family: Scelsi

full_name: Michele Scelsi

given: Michele

family: Boria

full_name: Paola Boria

given: Paola

family: Sansone

full_name: Valerio Sansone

given: Valerio

currency_apc_doaj: GBP

journal_name: BMC Musculoskeletal Disorders

license: cc-by

license_normalized: cc-by

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: Università degli Studi di Milano - Institutional Research Information System

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Parot-Schinkel E, Descatha A, Ha C, Petit A, Leclerc A, Roquelaure Y. Prevalence of multisite musculoskeletal symptoms: a French cross-sectional working population-based study. BMC Musculoskelet Disord. 2012 Jul 20;13:122. doi: 10.1186/1471-2474-13-122.

family: Parot-Schinkel

full_name: Elsa Parot-Schinkel

given: Elsa

family: Descatha

full_name: Alexis Descatha

given: Alexis

family: Ha

full_name: Catherine Ha

given: Catherine

family: Petit

full_name: Audrey Petit

given: Audrey

family: Leclerc

full_name: Annette Leclerc

given: Annette

family: Roquelaure

full_name: Yves Roquelaure

given: Yves

ReferenceCitation: Lanhers C, Pereira B, Gay C, Hérisson C, Levyckyj C, Dupeyron A, Coudeyre E. Evaluation of the efficacy of a short-course, personalized self-management and intensive spa therapy intervention as active prevention of musculoskeletal disorders of the upper extremities (Muska): a research protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2016 Dec 9;17(1):497.

lead_sponsor: Association Francaise pour la Recherche Thermale


title: Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

summary:
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.

A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia.

Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.

ReferenceCitation: Dequin PF, Heming N, Meziani F, Plantefève G, Voiriot G, Badié J, François B, Aubron C, Ricard JD, Ehrmann S, Jouan Y, Guillon A, Leclerc M, Coffre C, Bourgoin H, Lengellé C, Caille-Fénérol C, Tavernier E, Zohar S, Giraudeau B, Annane D, Le Gouge A; CAPE COVID Trial Group and the CRICS-TriGGERSep Network. Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1298-1306. doi: 10.1001/jama.2020.16761.

name: Médecine Intensive-Réanimation, CHU de Tours, Tours, France

name: INSERM U1100, Centre d'Etude des Pathologies Respiratoires, Université de Tours, Tours, France

name: INSERM CIC1415, CHU de Tours, Tours, France

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

name: Médecine Intensive Réanimation, Hôpital Raymond Poincaré (GHU APHP Université Paris Saclay), Garches, France, and RHU RECORDS and FHU SEPSIS

name: INSERM U1173, Université de Versailles SQY-Université Paris Saclay, Garches, France

family: Heming

full_name: Nicholas Heming

given: Nicholas

name: Médecine Intensive Réanimation, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

name: INSERM UMR 1260, Université de Strasbourg, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: Réanimation polyvalente, CH Victor Dupouy, Argenteuil, France

family: Plantefève

full_name: Gaëtan Plantefève

given: Gaëtan

name: Médecine Intensive Réanimation, Hôpital Tenon (Assistance Publique–Hôpitaux de Paris), Paris, France

family: Voiriot

full_name: Guillaume Voiriot

given: Guillaume

name: Réanimation Polyvalente, Hôpital Nord Franche-Comté, Trevenans, France

family: Badié

full_name: Julio Badié

given: Julio

name: Réanimation Polyvalente, CHU de Limoges, Limoges, France

name: INSERM UMR 1092, Université de Limoges, Limoges, France

name: INSERM CIC 1435, CHU de Limoges, Limoges, France

family: François

full_name: Bruno François

given: Bruno

name: Médecine Intensive Réanimation, CHRU de Brest, Brest, France

name: Université de Bretagne Occidentale, Brest, France

family: Aubron

full_name: Cécile Aubron

given: Cécile

name: Université de Paris, IAME U1137, Médecine Intensive Réanimation, DMU ESPRIT, Hôpital Louis Mourier, Assistance Publique–Hôpitaux de Paris, Colombe, France

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

family: Ehrmann

full_name: Stephan Ehrmann

given: Stephan

family: Jouan

full_name: Youenn Jouan

given: Youenn

family: Guillon

full_name: Antoine Guillon

given: Antoine

name: Délégation à la Recherche Clinique et à l’Innovation, CHU de Tours, Tours, France

full_name: Marie Leclerc

given: Marie

family: Coffre

full_name: Carine Coffre

given: Carine

name: Pharmacie à Usage Interne, CHU de Tours, Tours, France

family: Bourgoin

full_name: Hélène Bourgoin

given: Hélène

name: Centre régional de pharmacovigilance et d'information sur le médicament, service de pharmacosurveillance, CHU de Tours, Tours, France

family: Lengellé

full_name: Céline Lengellé

given: Céline

family: Caille-Fénérol

full_name: Caroline Caille-Fénérol

given: Caroline

family: Tavernier

full_name: Elsa Tavernier

name: INSERM, Centre de Recherche des Cordeliers, Sorbonne Université, Université de Paris, Paris, France

family: Zohar

full_name: Sarah Zohar

given: Sarah

name: Université de Tours, Université de Nantes, INSERM, SPHERE U1246, Tours, France

family: Giraudeau

full_name: Bruno Giraudeau

family: Annane

full_name: Djillali Annane

given: Djillali

family: Le Gouge

full_name: Amélie Le Gouge

given: Amélie

location_facility: Service de Réanimation Médicale, CHR d'Orléans

location_facility: Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes

location_facility: Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres

location_facility: Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP

location_facility: Service de Réanimation Polyvalente, CH de Saint Malo

location_facility: Service de Réanimation Médicale, CHU de Brest

location_facility: Service de Réanimation, Hôpital Louis Mourier

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg

location_facility: Service de Réanimation, CHU Côte de Nacre

location_facility: Service de Réanimation Médicale, CHU de Grenoble

location_facility: Service de Réanimation Polyvalente, CHD La Roche sur Yon

location_facility: Service de Réanimation Médicale Polyvalente, Hôpital G Montpied

location_facility: Service de Réanimation, CHR Metz-Thionville

location_facility: Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers

location_facility: Service de Réanimation HIA Clermont-Tonnerre

location_facility: Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP

location_facility: Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban

location_facility: Service de Réanimation Polyvalente, CHU de Limoges

location_facility: Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille

location_facility: Service de Réanimation Médicale, CHU de Dijon

location_facility: Service de Réanimation Médicale, CHU de Nancy

location_facility: Service de Réanimation Polyvalente, CH d'Argenteuil

location_facility: Service de Réanimation Médicale, Hôpital Nord

location_facility: Service de Réanimation - Unité de Soins Continus, CH d'Angoulême

location_facility: Service de Réanimation Médicale, Hôpital Cochin, APHP

location_facility: Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes


title: Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease

acronym: AIR

summary:
This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination with unenhanced (without injection of contrast media) low dose (to limit the effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung cancer (LC).

LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55 years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of false positive that require repeat follow-up and also invasive investigations, but also false negatives with metastatic LC being discovered between screening rounds.

Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on LDCT.

The study will focus on patients at very high risk for lung cancer i.e. smokers and ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).

The study will enroll 600 participants who will undergo three rounds of screening at one year intervals, each round combining search for CTC on a blood sample and LDCT. Each participant will be followed for at least one year after the last screening round

ReferenceCitation: Ilie M, Hofman V, Long-Mira E, Selva E, Vignaud JM, Padovani B, Mouroux J, Marquette CH, Hofman P. "Sentinel" circulating tumor cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. PLoS One. 2014 Oct 31;9(10):e111597. doi: 10.1371/journal.pone.0111597. eCollection 2014.

ReferenceCitation: Marquette CH, Boutros J, Benzaquen J, Ferreira M, Pastre J, Pison C, Padovani B, Bettayeb F, Fallet V, Guibert N, Basille D, Ilie M, Hofman V, Hofman P; AIR project Study Group. Circulating tumour cells as a potential biomarker for lung cancer screening: a prospective cohort study. Lancet Respir Med. 2020 Jul;8(7):709-716. doi: 10.1016/S2213-2600(20)30081-3. Erratum in: Lancet Respir Med. 2020 Dec;8(12):e94.

family: Marquette

full_name: Charles-Hugo Marquette

given: Charles-Hugo

family: Boutros

full_name: Jacques Boutros

given: Jacques

family: Benzaquen

full_name: Jonathan Benzaquen

given: Jonathan

family: Ferreira

full_name: Marion Ferreira

given: Marion

family: Pastre

full_name: Jean Pastre

given: Jean

family: Pison

full_name: Christophe Pison

given: Christophe

family: Padovani

full_name: Bernard Padovani

given: Bernard

family: Bettayeb

full_name: Faiza Bettayeb

given: Faiza

family: Fallet

full_name: Vincent Fallet

given: Vincent

family: Guibert

full_name: Nicolas Guibert

given: Nicolas

family: Basille

full_name: Damien Basille

given: Damien

family: Ilie

full_name: Marius Ilie

given: Marius

family: Hofman

full_name: Véronique Hofman

given: Véronique

full_name: Paul Hofman

given: Paul

family: MARQUETTE

full_name: Charles-Hugo MARQUETTE

family: BOUTROS

full_name: Jacques BOUTROS

family: FERREIRA

full_name: Marion FERREIRA

family: PASTRE

full_name: Jean PASTRE

family: PADOVANI

full_name: Bernard PADOVANI

family: BETTAYEB

full_name: Faiza BETTAYEB

family: FALLET

full_name: Vincent FALLET

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

ReferenceCitation: Leroy S, Benzaquen J, Mazzetta A, Marchand-Adam S, Padovani B, Israel-Biet D, Pison C, Chanez P, Cadranel J, Mazières J, Jounieaux V, Cohen C, Hofman V, Ilie M, Hofman P, Marquette CH; AIR Project Study Group. Circulating tumour cells as a potential screening tool for lung cancer (the AIR study): protocol of a prospective multicentre cohort study in France. BMJ Open. 2017 Dec 26;7(12):e018884. doi: 10.1136/bmjopen-2017-018884.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Hôpital Nord
Hôpital TENON
Hospices Civils de Lyon
CHU de Dijon
CHU de Reims
CHRU de Lille
CHU de Nancy
Hôpital Bichat
CHU d'Amiens
CHU de Strasbourg
CHU de Toulouse
CHU de Tours
CHU de Montpellier
CH de Roubaix
CHU de Grenoble
Hôpital Cochin
Hôpital Européen Georges Pompidou
CHU de Rouen
CHU de Saint Etienne
CHU de Rennes


title: Early Postnatal Discharge in a French Perinatal Network

acronym: SORPRISE

summary: The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.

primary_purpose: Health Services Research

ReferenceCitation: Liu S. Rate of neonatal hospital readmission after discharge following birth. Canadian Perinatal Health Report 2003; 104-106. http://www.hc-sc.gc.ca/pphb-dgspsp/rhs-ssg/index.html

ReferenceCitation: Ellberg L, Högberg U, Lundman B, Källén K, Håkansson S, Lindh V. Maternity care options influence readmission of newborns. Acta Paediatr. 2008 May;97(5):579-83. doi: 10.1111/j.1651-2227.2008.00714.x.

ReferenceCitation: Radmacher P, Massey C, Adamkin D. Hidden morbidity with "successful"early discharge.J Perinatol.2002;22:15-20 VIBoulvain M, Perneger TV, Othenin-Girard V, PetrouS, Berner M, Irion O. Home-based versus hospital-based postnatal care:arandomisedtrial.BJOG: an International Journal of Obstetrics and Gynaecology 2004; 111: 807-813.

ReferenceCitation: Oddie SJ, Hammal D, Richmond S, Parker L. Early discharge and readmission to hospital in the first month of life in the Northern Region of the UK during 1998: a case cohort study. Arch Dis Child. 2005 Feb;90(2):119-24.

ReferenceCitation: Sainz Bueno JA, Romano MR, Teruel RG, Benjumea AG, Palacín AF, González CA, Manzano MC. Early discharge from obstetrics-pediatrics at the Hospital de Valme, with domiciliary follow-up. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):714-26.

ReferenceCitation: Johansson K, Aarts C, Darj E. First-time parents' experiences of home-based postnatal care in Sweden. Ups J Med Sci. 2010 May;115(2):131-7. doi: 10.3109/03009730903431809.

ReferenceCitation: Shaw E, Levitt C, Wong S, Kaczorowski J; McMaster University Postpartum Research Group. Systematic review of the literature on postpartum care: effectiveness of postpartum support to improve maternal parenting, mental health, quality of life, and physical health. Birth. 2006 Sep;33(3):210-20. Review.

ReferenceCitation: Bravo P, Uribe C, Contreras A. Early postnatal hospital discharge: the consequences of reducing length of stay for women and newborns. Rev Esc Enferm USP. 2011 Jun;45(3):758-63. Review.

ReferenceCitation: OCDE (2009), Panorama de la santé 2009 : Les indicateurs de l'OCDE, Éditions OCDE.doi : 10.1787/health_glance-2009-fr

ReferenceCitation: Smith LF. Postnatal care: development of a psychometric multidimensional satisfaction questionnaire (the WOMBPNSQ) to assess women's views. Br J Gen Pract. 2011 Oct;61(591):e628-37. doi: 10.3399/bjgp11X601334.

ReferenceCitation: Antoniotti S, Baumstarck-Barrau K, Siméoni MC, Sapin C, Labarère J, Gerbaud L, Boyer L, Colin C, François P, Auquier P. Validation of a French hospitalized patients' satisfaction questionnaire: the QSH-45. Int J Qual Health Care. 2009 Aug;21(4):243-52. doi: 10.1093/intqhc/mzp021. Epub 2009 Jun 23.

ReferenceCitation: Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol. 1998 Nov;51(11):1171-8.

ReferenceCitation: Edinburgh Depression Scale Translated Government of Western Australia Department of Health www.folkhalsoguiden.se/upload/Psykisk Hälsa/Edinburgh Depression Scale Translated Government of Western Australia Department of Health.pdf

ReferenceCitation: DOMECQ, S. AUSTRUY, J.VIOT, F. CADIOT, C POURIN. Evaluation de la satisfaction des correspondants externes : Rapport régional, mars 2009. CCECQA -Hôpital Xavier Arnozan -33604 Pessac www.ccecqa.asso.fr

lead_sponsor: University Hospital, Grenoble

location_facility:
Hopital Couple Enfant
CH Voiron
Clinique Mutualiste
Clinique Belledonne
Clinique des Cèdres

intervention_type: Behavioral


title: Evaluation of the Impact of a Nurse-led Telephone Follow-up on Treatment Compliance of Patients Treated From a Locally Advanced or Metastatic Non-small-cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation(s).The PARTAGE Study.

summary:
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.

At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.

Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:

Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).

Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).

All the patients will be seen according to normal practice by the study medical team.

Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.

lead_sponsor: Boehringer Ingelheim

location_facility: HOP Centre Hospitalier de Béziers, Pneumo, Béziers

location_facility: HOP Nord Ouest de Villefranche, oncologie, Gleize

location_facility: HOP Saint Joseph et Saint Luc, Pneumo, Lyon

location_facility: HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence

location_facility: HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse

location_facility: Centre médical N de Pontoux, Oncologie, Chalon sur Saône

location_facility: CTR d'Oncologie de Gentilly, Onco, Nancy

location_facility: CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence

location_facility: HOP Hôpital Robert Boulin, Pneumo, Libourne

location_facility: HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin

location_facility: HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo

location_facility: Centre Hospitalier Intercommunal, Oncolgie, Crétail

location_facility: HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay


title: Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable

summary:
Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.

Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.

lead_sponsor: Versailles Hospital

location_facility:
Hopital Necker
Hôpital V. Dupouy
Hopital Henri Mondor
Hôpital de la Conception
CH Versailles
Centre Antoine Lacassagne
Hôpital Saint Antoine
Hôpital Huriez, CHU de Lille
CHU Dijon
Hopital St Louis
CHU d'Orléans
IGR
CHU Limoges
CH Avicenne
Institut de Cancérologie de la Loire
HIA Percy
CH Dunkerque
C.H.U d'Amiens - Hôpital Sud
CHU Caen
CHU Lyon Sud
Centre H Becquerel


ReferenceCitation: Jørgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Støier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12.

ReferenceCitation: Jørgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Støier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):399-405.

ReferenceCitation: Kwakkel G, Kollen B, Twisk J. Impact of time on improvement of outcome after stroke. Stroke. 2006 Sep;37(9):2348-53. Epub 2006 Aug 24.

ReferenceCitation: Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. Epub 2004 Oct 7. Review.

ReferenceCitation: Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7.

ReferenceCitation: Goldstein LB, Davis JN. Physician prescribing patterns following hospital admission for ischemic cerebrovascular disease. Neurology. 1988 Nov;38(11):1806-9.

ReferenceCitation: Goldstein LB, Davis JN. Clonidine impairs recovery of beam-walking after a sensorimotor cortex lesion in the rat. Brain Res. 1990 Feb 5;508(2):305-9.

ReferenceCitation: Goldstein LB. Influence of common drugs and related factors on stroke outcome. Curr Opin Neurol. 1997 Feb;10(1):52-7. Review.

ReferenceCitation: Goldstein LB. Potential effects of common drugs on stroke recovery. Arch Neurol. 1998 Apr;55(4):454-6.

ReferenceCitation: Goldstein LB. Effects of amphetamines and small related molecules on recovery after stroke in animals and man. Neuropharmacology. 2000 Mar 3;39(5):852-9. Review.

ReferenceCitation: Goldstein LB. Neurotransmitters and motor activity: effects on functional recovery after brain injury. NeuroRx. 2006 Oct;3(4):451-7. Review.

ReferenceCitation: Tardy J, Pariente J, Leger A, Dechaumont-Palacin S, Gerdelat A, Guiraud V, Conchou F, Albucher JF, Marque P, Franceries X, Cognard C, Rascol O, Chollet F, Loubinoux I. Methylphenidate modulates cerebral post-stroke reorganization. Neuroimage. 2006 Nov 15;33(3):913-22. Epub 2006 Sep 14.

ReferenceCitation: Crisostomo EA, Duncan PW, Propst M, Dawson DV, Davis JN. Evidence that amphetamine with physical therapy promotes recovery of motor function in stroke patients. Ann Neurol. 1988 Jan;23(1):94-7.

ReferenceCitation: Walker-Batson D, Smith P, Curtis S, Unwin H, Greenlee R. Amphetamine paired with physical therapy accelerates motor recovery after stroke. Further evidence. Stroke. 1995 Dec;26(12):2254-9.

primary_purpose: Supportive Care

acronym: BacloTox

location_facility: l'Institut Hélio Marin de la côte d'azur

location_facility: Groupe Pellegrin, University Hospital Bordeaux

title: Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.

summary: Stroke is the first cause of motor impairment and disability in adults. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an increase of disability. Then antispastic drugs are frequently prescribed to the patients even during the post-stroke recovery phase. Until recently most of french patients were treated by oral tablets of baclofen. Now the number of patients receiving intramuscular injections of botulinum A toxin is increasing. However in the literature, these drugs have been tested in post-stroke spasticity during the chronicle phase, after the sixth month and their action on motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the effects of its drugs on motor recovery. The main criterion of its study is the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two months, will be included in the try. They receive at the same time oral tablets for five months and intramuscular injections. Patients are randomized in three arms planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed before treatment start, one month and three months later. Spasticity, functional abilities, capacity in the activities of daily life, pain and quality of life will be also assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive difference of 12 points in the time course of FMA in the botulinum toxin group in comparison with the baclofen group will be considered as the minimum relevant effect. 300 patients have been planned to be included in 20 centers during the 2 years of trial.


title: Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death

acronym: FIBROSCAME

summary:
According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012).

According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in the obese population. Steatosis results mostly from alcohol consumption and from metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain medications. NAFLD involves up to 30% of the population in Western countries and its prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly, the improvement of liver grafts selection based on objective quantitative criteria which takes into account the degree of liver steatosis appears crucial to increase the number of hepatic transplants.

lead_sponsor: University Hospital, Limoges

location_facility:
Croix Rousse Hospital
AP-HP Kremlin Bicêtre
University Hospital
Nice University Hospital
Univesity Hospital
AP-HP Henri MONDOR
Estaing University Hospital


title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.

acronym: VISTA

summary: The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

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

lead_sponsor: Pfizer

location_facility: Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie

location_facility: Clinique Alleray Labrouste Service d'Oncologie Médicale

location_facility: CHU Dupuytren Limoges Service d'Oncologie

location_facility: CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie

location_facility: Hôpital Européen Georges Pompidou Service d'Oncologie Médicale

location_facility: Clinique Hartman Service de Radiothérapie

location_facility: Hôpital Privé Jean Mermoz Service d'Oncologie Médicale

location_facility: CHP du Cotentin - Site de Cherbourg Service d'Oncologie

location_facility: CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale

location_facility: Centre Hospitalier de la region d'Annecy Pole Medecine

location_facility: CH de Cornouaille Service d'Oncologie Médicale

location_facility: Centre Hospitalier de Carcassonne Service d'Oncologie

location_facility: Institut Franco Britannique Service Oncologie Médicale

location_facility: CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie

location_facility: Centre Hospitalier Layne Service d'Oncologie

location_facility: Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive

location_facility: Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques

location_facility: Polyclinique de Gentilly Service Oncologie Médicale

location_facility: Centre Clinical Service d'Oncologie-Radiothérapie

location_facility: Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie

location_facility: Centre Hospitalier Annecy Genevois Service Pneumologie

location_facility: CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale

location_facility: Hôpital Louis Pasteur Service de Pneumologie - Médecine F

location_facility: CH William Morey Service d'Oncologie Médicale

location_facility: Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie

location_facility: CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie

location_facility: Centre Hospitalier de la Dracénie Service d'Oncologie

location_facility: Institut Mutualiste Montsouris Service Oncologie Médicale

location_facility: Centre Hospitalier Emile Durkheim Service Oncologie

location_facility: Clinique Claude Bernard Service Chimiothérapie

location_facility: Centre hospitalier Louis Pasteur Service de Pneumologie

location_facility: Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique

location_facility: Hôpital Bretonneau Service d'Oncologie Médicale

location_facility: Centre Léon Bérard Service d'Oncologie Médicale

location_facility: Centre Hospitalier Service Onco-Hématologie

location_facility: Clinique Pasteur Lanroze Service Oncologie

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie

location_facility: Clinique du Dr Maymard Service d'Oncologie

location_facility: Hôpital Avicenne Service Gastro-Entérologie

location_facility: Clinique Rambot La Provençale Tour d'Aygosi

location_facility: Hôpital de Falconaja Furiani Service d'Oncologie

location_facility: Hôpital de Thionville Service Oncologie Médicale

location_facility: Centre de Radiothérapie SCP Strasbourg Oncologie Libérale

location_facility: Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage

location_facility: CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie

location_facility: Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie

location_facility: CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie

location_facility: Centre Hospitalier Service de Pneumologie

location_facility: Hôpital Tenon Service d'oncologie médicale

location_facility: CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie

location_facility: Centre Hospitalier Service de Médecine 2 - Hôpital de jour

location_facility: CHU - Hôpital Jean Minjoz Service Oncologie Médicale

location_facility: Clinique Chirurgicale Pasteur Service Oncologie Médicale

location_facility: Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique

location_facility: Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie

location_facility: Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie

location_facility: Centre Hospitalier de Narbonne Oncologie / Hématologie

location_facility: Hôpital de Saint-Avold Service Oncologie II

location_facility: ICO Centre Paul Papin Service d'Oncologie Médicale

location_facility: Centre Hospitalier Privé Clairval Service de Cancérologie

location_facility: Clinique Claude Bernard Service de Chimiothérapie

location_facility: Centre Hospitalier de Cholet Service d' Oncologie Médicale

location_facility: Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines

location_facility: Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)

location_facility: Centre Marie Curie A l'attention de Laëtitia

location_facility: Clinique Clementville Service d'Oncologie

location_facility: Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie

location_facility: CHI Fréjus Saint Raphaël Service d'Oncologie Médicale


title: A 6-month, Open Label, Randomised, Efficacy Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via the Dry Powder Inhaler ELLIPTA™ Compared With Usual ICS/LABA Maintenance Therapy Delivered by Dry Powder Inhaler in Subjects With Persistent Asthma

summary: The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S] or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

ReferenceCitation: Devillier P, Humbert M, Boye A, Zachgo W, Jacques L, Nunn C, West S, Nicholls A, Antoun Z, Spinu L, Grouin JM. Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β(2)-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial. Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.

family: Devillier

full_name: Philippe Devillier

given: Philippe

family: Humbert

full_name: Marc Humbert

given: Marc

family: Boye

full_name: Alain Boye

given: Alain

family: Zachgo

full_name: Wolfgang Zachgo

given: Wolfgang

family: Jacques

full_name: Loretta Jacques

given: Loretta

family: Nunn

full_name: Carol Nunn

given: Carol

family: West

full_name: Sarah West

given: Sarah

family: Nicholls

full_name: Andy Nicholls

given: Andy

family: Antoun

full_name: Zeina Antoun

given: Zeina

family: Spinu

full_name: Luminita Spinu

given: Luminita

family: Grouin

full_name: Jean-Marie Grouin

given: Jean-Marie

journal_name: Respiratory Medicine

evidence: open (via crossref license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial

lead_sponsor: GlaxoSmithKline

location_country: Germany France


title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial

summary: Since critically ill patients are exposed to stressful conditions, the investigators evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in the Intensive Care Unit (ICU) .

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.

family: Kalfon

full_name: Pierre Kalfon

given: Pierre

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Loundou

full_name: Anderson Loundou

given: Anderson

family: Gauzit

full_name: Rémy Gauzit

given: Rémy

family: Lepape

full_name: Alain Lepape

family: Laurens

full_name: Jean Laurens

given: Jean

family: Garrigues

full_name: Bernard Garrigues

given: Bernard

family: Pottecher

full_name: Thierry Pottecher

given: Thierry

family: Mallédant

full_name: Yannick Mallédant

given: Yannick

journal_name: Intensive Care Medicine

ReferenceCitation: Kalfon P, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Audibert J, Ben Salah A, Mauchien B, Sossou A, Venot M, Robert R, Follin A, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Baumstarck K; IPREA Study Group. Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay. Crit Care. 2020 Dec 7;24(1):685. doi: 10.1186/s13054-020-03396-2.

family: Boucekine

full_name: Mohamed Boucekine

given: Mohamed

family: Estagnasie

full_name: Philippe Estagnasie

family: Geantot

full_name: Marie-Agnès Geantot

given: Marie-Agnès

family: Berric

full_name: Audrey Berric

given: Audrey

family: Simon

full_name: Georges Simon

given: Georges

family: Floccard

full_name: Bernard Floccard

family: Signouret

full_name: Thomas Signouret

given: Thomas

family: Fromentin

full_name: Mélanie Fromentin

given: Mélanie

family: Nyunga

full_name: Martine Nyunga

given: Martine

family: Audibert

full_name: Juliette Audibert

given: Juliette

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

ReferenceCitation: Baumstarck K, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Kalfon P; IPREA Study group. Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA. Health Qual Life Outcomes. 2019 Feb 7;17(1):29. doi: 10.1186/s12955-019-1101-5.

title: Assessment of patients’ self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA

ReferenceCitation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

ReferenceCitation: Kalfon P, Mimoz O, Loundou A, Geantot MA, Revel N, Villard I, Amour J, Azoulay E, Garrouste-Orgeas M, Martin C, Sharshar T, Baumstarck K, Auquier P. Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial. Trials. 2016 Feb 16;17:87. doi: 10.1186/s13063-016-1211-x.

location_facility: CHU Hôpital Européen Georges Pompidou APHP


title: Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

summary: This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

lead_sponsor: University Hospital, Angers

location_facility: Institut de Cancérologie Lucien Neuwirth


title: An Open Label Non Randomized Access Study of Trametinib for Patients With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

summary: This is a single arm open label, multicenter, non randomized, access study of trametinib for subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV). Trametinib may be given as monotherapy or in combination since first line metastatic melanoma as per inclusion criteria. Subjects who received prior BRAF inhibitor may be included if they have not progressed under such treatment or if they have presented limited progression as per eligibility criteria. It is estimated that between 250 and 400 subjects with histologically confirmed cutaneous melanoma with a BRAF V600E/K positive mutation that is either advanced unresectable (stage IIIc) or distant metastatic (stage IV) will be enrolled.

status: No longer available

study_type: Expanded Access


title: A Multicentre, Randomised, Double-blind, Controlled, Phase IIIb Study to Assess the Efficacy and Safety of Rivaroxaban 10mg od Versus Enoxaparin 4000 UI for VTE PROphylaxis in NOn Major Orthopaedic Surgery

acronym: PRONOMOS

summary:
PRONOMOS is an international multicentre, interventional, parallel, randomised, double-blind non-inferiority study comparing rivaroxaban 10mg od to an active comparator, enoxaparin 4000 UI od in 4040 valid subjects requiring orthopaedic surgery (except low risk such material removal foot surgery or hallux valgus without patient risk factor [6], and major orthopaedic surgeries for femoral neck and trochanteric fractures, THR, TKR)

Pre-randomization treatment with LMWH anticoagulant is allowed for a maximum duration of 24 hours. However, only a single pre-randomization dose of LMWH is allowed. After randomization, patients allocated to the rivaroxaban arm will receive rivaroxaban 10 mg once-daily started 6-10 hours provided haemostasis has been established after surgery or 24h hours after LMWH injection if needed for the intended treatment duration of 2 to 12 weeks based on medical judgment (according to immobilization). Patients allocated to the comparator arm will receive enoxaparin once daily for the same intended treatment duration. All patients will have a 30-day observational period after cessation of treatment.

ReferenceCitation: Samama CM, Laporte S, Rosencher N, Girard P, Llau J, Mouret P, Fisher W, Martínez-Martín J, Duverger D, Deygas B, Presles E, Cucherat M, Mismetti P; PRONOMOS Investigators. Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery. N Engl J Med. 2020 May 14;382(20):1916-1925. doi: 10.1056/NEJMoa1913808. Epub 2020 Mar 29.

name: From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique–Hôpitaux de Paris Centre−Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) ...

family: Samama

full_name: C. Marc Samama

given: C. Marc

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Rosencher

full_name: Nadia Rosencher

given: Nadia

family: Girard

full_name: Philippe Girard

given: Philippe

family: Llau

full_name: Juan Llau

given: Juan

family: Mouret

full_name: Patrick Mouret

given: Patrick

family: Fisher

full_name: William Fisher

given: William

family: Martínez-Martín

full_name: Javier Martínez-Martín

given: Javier

family: Duverger

full_name: Daniel Duverger

given: Daniel

family: Deygas

full_name: Béatrice Deygas

given: Béatrice

family: Presles

full_name: Emilie Presles

given: Emilie

family: Cucherat

full_name: Michel Cucherat

given: Michel

family: Mismetti

full_name: Patrick Mismetti

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

location_facility: CHU Toulouse - Hôpital Pierre-Paul Riquet

location_facility: Hôpitaux Universitaires de Strasbourg C.C.O.M


ReferenceCitation: Duffaud F, Italiano A, Bompas E, Rios M, Penel N, Mir O, Piperno-Neumann S, Chevreau C, Delcambre C, Bertucci F, Boudou-Rouquette P, Cancel M, Perrin C, Saada-Bouzid E, Monard L, Schiffler C, Chaigneau L, Hervieu A, Collard O, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in patients with metastatic or locally advanced chondrosarcoma: Results of a non-comparative, randomised, double-blind, placebo controlled, multicentre phase II study. Eur J Cancer. 2021 Jun;150:108-118. doi: 10.1016/j.ejca.2021.03.039. Epub 2021 Apr 22.

family: Duffaud

full_name: Florence Duffaud

given: Florence

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Bompas

full_name: Emannuelle Bompas

given: Emannuelle

family: Rios

full_name: Maria Rios

given: Maria

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Mir

full_name: Olivier Mir

given: Olivier

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Delcambre

full_name: Corinne Delcambre

given: Corinne

family: Bertucci

full_name: François Bertucci

given: François

family: Boudou-Rouquette

full_name: Pascaline Boudou-Rouquette

given: Pascaline

family: Cancel

full_name: Mathilde Cancel

given: Mathilde

family: Perrin

full_name: Christophe Perrin

given: Christophe

family: Saada-Bouzid

full_name: Esma Saada-Bouzid

given: Esma

family: Monard

full_name: Laure Monard

given: Laure

family: Schiffler

full_name: Camille Schiffler

given: Camille

family: Chaigneau

full_name: Loic Chaigneau

given: Loic

family: Hervieu

full_name: Alice Hervieu

given: Alice

family: Collard

full_name: Olivier Collard

family: Bouvier

full_name: Corinne Bouvier

family: Vidal

full_name: Vincent Vidal

given: Vincent

family: Chabaud

full_name: Sylvie Chabaud

given: Sylvie

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

journal_name: European Journal of Cancer

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

ReferenceCitation: Duffaud F, Mir O, Boudou-Rouquette P, Piperno-Neumann S, Penel N, Bompas E, Delcambre C, Kalbacher E, Italiano A, Collard O, Chevreau C, Saada E, Isambert N, Delaye J, Schiffler C, Bouvier C, Vidal V, Chabaud S, Blay JY; French Sarcoma Group. Efficacy and safety of regorafenib in adult patients with metastatic osteosarcoma: a non-comparative, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Oncol. 2019 Jan;20(1):120-133. doi: 10.1016/S1470-2045(18)30742-3. Epub 2018 Nov 23.

ipd_sharing_description: no individual participant data is shared

location_facility: Institut de cancerologie de l'ouest site Rene Gauducheau

location_facility: Institut de cancerologie de lorraine alexis Vautrin

location_facility: Institut de Cancérologie Lucien Neuwirth (ICLN)

title: A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

summary:
INDICATION:

Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas


title: Phase II Randomized Trial Evaluting Aflibercept Associated With LV5FU2 Regimen as First Line Treatment of Non-resectalbe Metastatic Colorectal Cancers

acronym: FOLFA

summary: This is what the FFCD 11-01 - PRODIGE 25 trial proposes to study, as a preliminary for strategic studies evaluating the usefulness of including targeted therapeutics from the first line with aflibercept +/- LV5FU2.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Institut de cancérologie de Bourgogne - GRRECC


title: A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance

acronym: TAPAZ

summary: Study of Pazopanib and weekly Paclitaxel in patients with platinum resistant/refractory ovarian cancer who relapse during bevacizumab maintenance.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Cochin

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: ICL Institut de Cancérologie de Lorraine

location_facility: "Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie"

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire Bretonneau


lead_sponsor: University Hospital, Brest

location_country: France Switzerland

acronym: SYMPTOMS

location_facility: CHU Strasbourg - Service de Médecine Interne

location_facility: CH Intercommunal Toulon La Seyne sur Mer

location_facility: CHRU Strasbourg- Service HTA et Maladies Vasculaires

location_facility: Clinique Mutualiste Médico-chirurgical "Beau Soleil"

title: Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients Aged 70 Years and Older : a Randomized Placebo-Controlled Study The SYMPTOMS (SYstematic Elderly Medical Patients Thromboprophylaxis : Efficacy on Symptomatic OutcoMeS) Study

summary:
Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden.

The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.

Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.

However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.


title: Consultations Reason for Genital, Urinary or Psychological Humans in General Practice

acronym: GETUP

summary: Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Economically, the impact of the disease are significant. In the year preceding the detection of premature ejaculation patients visit twice their physician. The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting room, considered it important to talk with their GP about their sexual concerns. Almost half of them preferred that their GP initiate any discussions about sexuality. More than two thirds of the respondents would have liked their GP to signal his or her open-mindedness by directly addressing sexual topics during the consultation. In 2008 a qualitative study brought to the fore the strategies used by GPs to initiate the discussion on premature ejaculation . GPs who mentioned premature ejaculation with their patient described three attitude-related strategies and three investigative strategies.

ReferenceCitation: Barais M, Costa M, Montalvo C, Rannou V, Vaillant-Roussel H, Costa D, Cadier S, Pereira B. Talking about premature ejaculation in primary care: the GET UP cluster randomised controlled trial. BJGP Open. 2021 Dec 3. pii: BJGPO.2021.0168. doi: 10.3399/BJGPO.2021.0168. [Epub ahead of print]

ReferenceCitation: Barais M, Vaillant Roussel H, Costa D, Derriennic J, Pereira B, Cadier S. Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason - GET UP: study protocol for a cluster randomised controlled trial. Trials. 2018 Nov 12;19(1):622. doi: 10.1186/s13063-018-2947-2.

family: Barais

full_name: Marie Barais

given: Marie

family: Vaillant Roussel

full_name: Hélène Vaillant Roussel

given: Hélène

family: Costa

full_name: David Costa

given: David

family: Derriennic

full_name: Jérémy Derriennic

given: Jérémy

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Cadier

full_name: Sébastien Cadier

given: Sébastien

journal_name: Trials

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

title: Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason – GET UP: study protocol for a cluster randomised controlled trial

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility: Cabinet médical - 89 Bis Rue de la Calade

location_facility: Cabinet médical - Esplanade Mitterrand 5

location_facility: Cabinet médical - 39 rue Saint Philibert

location_facility: Cabinet médical du 5 Descente des Oliviers


acronym: BEVABEL

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

location_facility: Institut de cancérologie de l'Ouest - Site René Gauducheau

location_facility: Gustave Roussy, Cancer Campus, Grand Paris

title: Prospective Phase II Study of Gemcitabine Plus Platinum Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma

summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.


title: A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression

acronym: GRID

summary:
The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009.

The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites.

Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.

lead_sponsor: Hospices Civils de Lyon

location_facility: CHU Estaing 1 place Lucie et Raymond Aubrac