title: Phase II Study of Iberdomide (Cc220) Maintenance After Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma Patients

summary: This is a phase II study to evaluate the efficacy and safety of different doses of iberdomide continuous therapy as maintenancetreatment after transplant.

lead_sponsor: European Myeloma Network

sponsor_collaborators:
European Myeloma Network
Celgene Corporation
Healt Data Specialists - HeaDS (CRO)
EMN Research Italy Impresa Sociale Srl

location_country: Italy Greece Netherlands France

location_facility: Alexandra General Hospital -Department of Clinical Therapeutics N.K. Univ. of Athens

location_facility: CHU Hôtel-Dieu, 1, place Alexis Ricordeau, 44093 NANTES Cedex 1, FRANCE

location_facility: Ospedale Generale Regionale-Divisione di Ematologia e Centro Trapianto Midollo Osseo

location_facility: Vrije Universiteit Medical Center (VUMC)


title: Randomized Double Blind Placebo-controlled Clinical Study : Effect of IBSIUM on the Improvement of Gastro-intestinal Disorders Associated to the Irritable Bowel Syndrome (IBS) With C Phenotype (Predominant-constipation)

acronym: IBS-GO

summary: The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Mourey F, Decherf A, Jeanne JF, Clement-Ziza M, Grisoni ML, Machuron F, Legrain-Raspaud S, Bourreille A, Desreumaux P. Saccharomyces cerevisiae I-3856 in irritable bowel syndrome with predominant constipation. World J Gastroenterol. 2022 Jun 14;28(22):2509-2522. doi: 10.3748/wjg.v28.i22.2509.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Baishideng Publishing Group Inc.

ipd_sharing: No

lead_sponsor: Lesaffre International

location_facility:
Institut Pasteur de Lille
Eurofins Optimed
Biofortis Mérieux NutriSciences
General pratices
Créabio Rhône Alpes

intervention_type: Dietary Supplement

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective, Randomized, Open, Multicentric Study Intended to Evaluate the Efficacy and Tolerability of Sequential Treatment Based on Rabbit Anti-T-lymphocyte Serum, of Mycophenolate Mofetil and of Cyclosporin, Without Concomitant Corticosteroids, After a First Cadaveric Renal Transplant

summary: The trial is planned as a multicentric, randomized, prospective, open study in accordance with a 1/1 plan, on parallel groups and 2 arms of treatment. A total of 200 patients with chronic renal insufficiency, included in the French national waiting list of the Establishment Français des Greffes [French Transplants Institution] and receiving a first renal transplant will be included, after signed agreement, in this study. All the patients will receive organs taken from brain-dead subjects. The patients will be given immunosuppressant treatment based on rabbit anti-T lymphocyte serum, CellCeptÒ and NeoralÒ cyclosporin. One group of 100 randomised patients will be given standard corticosteroid therapy as well during the first six months following the transplant. This group will be compared with a second group of 100 randomised patients who will be given a single dose of corticosteroids. The main aim of this study is to evaluate the number of acute rejection episodes in patients given a first renal transplant and subjected to an immunosuppressant protocol not containing corticosteroids. The hypothesis which is proposed is that, in the absence of corticosteroids and/or calcineurin inhibitors (i.e. cyclosporin and tacrolimus), antilymphocyte serum results in a certain state of "tolerance" in respect of the allograft. The second objective concerns the beneficial effect which the absence of corticosteroids may have on short- and long-term postoperative morbidity and mortality. One may in fact assume that the absence of corticosteroids will result in an extension of the transplant patient's life expectancy as a result of the reduction in cardiovascular complications. Cardiovascular complications are the most frequent cause of death after a renal transplant.

ReferenceCitation: Cantarovich D, Rostaing L, Kamar N, Saint-Hillier Y, Ducloux D, Mourad G, Garrigue V, Wolf P, Ellero B, Cassuto E, Albano L, Soulillou JP; FRANCIA Study Trial Investigators Group. Corticosteroid avoidance in adult kidney transplant recipients under rabbit anti-T-lymphocyte globulin, mycophenolate mofetil and delayed cyclosporine microemulsion introduction. Transpl Int. 2010 Mar 1;23(3):313-24. doi: 10.1111/j.1432-2277.2009.00971.x. Epub 2009 Oct 19.

lead_sponsor: Nantes University Hospital

location_facility:
Nice Universitary Hospital
Nantes University Hospital
Montpellier Universitary Hospital
Besançon Universitary Hospital
Strasbourg Universitary Hospital

intervention_type: Drug

lead_sponsor_type: academique


type: Other Identifier

type: Other Grant/Funding Number

title: CO2 Removal in Severe Acute exacerbatIons of Chronic Obstructive Lung Diseases

acronym: CORAIL

summary: The aim of the study is to determine which standard of care strategy will best benefit very severe Acute Exacerbation (AE) of Chronic Obstructive Pulmonary Disease (COPD), single versus reinforced with ECCO2R and assess the respective efficacy and the safety. Very severe AE of COPD will be defined by high risk of Non-Invasive Ventilation (NIV) failure defined by need of intubation and/or in-Intensive Care Unit (ICU) mortality (Stratum 1) or by Invasive Mechanical Ventilation (IMV) after NIV failure and/or with severe hyperinflation and hypercapnia (Stratum 2).

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators:
Ministry of Health, France
Xenios AG

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Xenios AG

location_facility: Hôpital d'Instruction des Armées Robert Picqué

location_facility: Hôpital européen Georges Pompidou - APHP

intervention_type: Device

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: CORAIL

titre: Epuration extra-corporelle du CO2 au cours des exacerbations aigues sévères des insuffisances respiratoires chroniques

discipline_principale: anesthésiologie / réanimation

nom_porteur: DIEHL

prenom_porteur: Jean Luc


type: EudraCT Number

title: Faecal Microbiota Transplantation for Prevention of Graft-versus-host Sisease After Allogeneic Stem Cell Transplantation for Haematological Malignancies

acronym: TMF-Allo

summary:
The aim of this study is to assess the Fecal Microbiota Transplantation (FMT) efficacy in the prevention of allogeneic hematopoietic stem cell transplantation (allo-HSCT) complications and particularly Graft versus Host Disease (GvHD).

The hypothesis of this study is that allogeneic FMT may improve outcomes of these patients.

ipd_sharing_description: Full protocol, participant-level data, statistical codes, trial datasets and analyses will be made available on request from the corresponding author after examining the request.

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Ministry of Health, France
French Society of Hematology

location_facility: Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens Picardie - Site Sud

location_facility: Plateforme d'Investigation Clinique / Centre d'Investigation Clinique - Inserm 1405, CHU Gabriel Montpied Clermont-Ferrand

location_facility: Service d'Hématologie Clinique CHU Nantes

location_facility: Service de thérapie Cellulaire et d'Hématologie Clinique Adulte CHU Estaing - Clermont-Ferrand

location_facility: Service d'Hématologie clinique Hôpital Pitié-Salpêtrière

location_facility: Service d'Hématologie Adultes Hôpital Necker

location_facility: Service d'hématologie greffe Hôpital St Louis

location_facility: Service d'hématologie clinique, département de greffe de moelle CHU Nice

location_facility: Service des Maladies du sang Hôpital HURIEZ, CHRU de Lille

location_facility: Hématologie clinique et thérapie cellulaire Hôpital Haut-Lévèque

location_facility: Service d'Hématologie et de Médecine interne Hôpital Brabois CHRU Nancy

location_facility: Hématologie clinique Institut de Cancérologie de la Loire

location_facility: Service d'Hématologie Centre Hospitalier Lyon Sud

location_facility: Service de thérapie cellulaire et l'hématologie clinique adulte CHU Limoges

appel_a_projets: PHRCK

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

acronyme: TMF-allo

titre: TMF-allo- Transplantation de microbiote fécal dans la prévention de la réaction du greffon contre l'hôte après allogreffe de cellules souches hématopoïétiques pour une hémopathie maligne

discipline_principale: cancer

nom_porteur: BAY

prenom_porteur: Jacques-Olivier


title: Impact of Early Low-Calorie Low-Protein Versus Standard-Calorie Standard-Protein Feeding on Outcomes of Ventilated Adults With Shock: a Randomised, Controlled, Multicentre, Open-label, Parallel-group Study (NUTRIREA-3)

summary: Among critically ill patients requiring mechanical ventilation and catecholamines for shock, nearly 40% to 50% die, and functional recovery is often delayed in survivors. International guidelines include early nutritional support (≤48 h after admission), 20-25 kcal/kg/d at the acute phase, and 1.2-2 g/kg/d protein. These targets are rarely achieved in patients with severe critically illnesses. Recent data challenge the wisdom of providing standard amounts of calories and protein during the acute phase of critical illness. Studies designed to improve enteral nutrition delivery showed no outcome benefits with higher intakes. Instead, adding parenteral nutrition to increase intakes was associated with longer ICU stays and more infectious complications. Studies suggest that higher protein intakes during the acute phase may be associated with greater muscle wasting and ICU-acquired weakness. The optimal calorie and protein supply at the acute phase of severe critical illness remains unknown. NUTRIREA-3 will be the first trial to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding potentially associated with improved muscle preservation, translating into shorter mechanical ventilation and ICU-stay durations, lower ICU-acquired infection rates, lower mortality, and better long-term clinical outcomes. This multicentre, randomized, controlled, open trial will compare, in patients receiving mechanical ventilation and treated with vasoactive agent for shock two strategies for initiating nutritional support at the acute phase of ICU management (D0-D7): early calorie/protein restriction (6 kcal/kg/d/0.2-0.4 g/kg/d, Low group) or standard calorie/protein targets (25 kcal/kg/d/1.0-1.3 g/kg/d, Standard group). Patients in both groups will receive enteral or parenteral nutrition appropriate for their critical illness. Two alternative primary end-points will be evaluated: all-cause mortality by day 90 and time to discharge alive from the ICU. Second end-points will be calories and proteins delivered, nosocomial infections, gastro-intestinal complications, glucose control, liver dysfunctions, muscle function at the time of readiness for ICU discharge and quality of life at 3 months and 1 year after study inclusion.

primary_purpose: Supportive Care

ReferenceCitation: Reignier J, Le Gouge A, Lascarrou JB, Annane D, Argaud L, Hourmant Y, Asfar P, Badie J, Nay MA, Botoc NV, Brisard L, Bui HN, Chatellier D, Chauvelot L, Combes A, Cracco C, Darmon M, Das V, Debarre M, Delbove A, Devaquet J, Voicu S, Aissaoui-Balanant N, Dumont LM, Oziel J, Gontier O, Groyer S, Guidet B, Jaber S, Lambiotte F, Leroy C, Letocart P, Madeux B, Maizel J, Martinet O, Martino F, Mercier E, Mira JP, Nseir S, Picard W, Piton G, Plantefeve G, Quenot JP, Renault A, Guerin L, Richecoeur J, Rigaud JP, Schneider F, Silva D, Sirodot M, Souweine B, Reizine F, Tamion F, Terzi N, Thevenin D, Thiery G, Thieulot-Rolin N, Timsit JF, Tinturier F, Tirot P, Vanderlinden T, Vinatier I, Vinsonneau C, Maugars D, Giraudeau B. Impact of early low-calorie low-protein versus standard-calorie standard-protein feeding on outcomes of ventilated adults with shock: design and conduct of a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). BMJ Open. 2021 May 11;11(5):e045041. doi: 10.1136/bmjopen-2020-045041.

oa_colors: green gold

evidence: oa journal (via doaj)

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

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

repository_normalized: HAL

license: cc-by

license_normalized: cc-by

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

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

sponsor_collaborators:
Nantes University Hospital
Ministry of Health, France
University Hospital, Tours

location_country: Guadeloupe France

location_facility: Hôpital de Hautepierre CHU de Strasbourg

location_facility: Centre Hospitalier Bretagne Atlantique - Vannes Auray

intervention_type: Procedure

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

titre: Impact des apports caloriques et protidiques sur le devenir des patients de réanimation traités par ventilation mécanique invasive et amines vasoactives : Essai clinique contrôlé randomisé multicentrique Nutrirea-3.

nom_porteur: Reignier

prenom_porteur: Jean


title: Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation

acronym: CHLOVIS

summary: Heart Failure (HF) with systolic dysfunction is associated with a poor prognosis in the long term despite the use of many effective drug treatment in reducing morbidity and mortality. In this context, cardiac resynchronization (CR), either alone or combined with a defibrillator function, has improved by about 30 to 40% of morbidity and mortality in this population of patients with heart failure. The information on the CR are now well established for patients with stage III-IV NYHA (New York Heart Association), with systolic dysfunction (EF ≤ 35%), presence of left bundle branch block wide (≥ 120 ms) and when medical treatment is optimal. As a result, the number of implanted devices continue to grow even if the implant procedures of cardiac resynchronization devices (CRD) are long, difficult and associated with significant complications with a risk of reoperation estimated between 10 and 15% . One of the most feared during implantation devices stimulation or defibrillation risk is represented by the risk of infection that will lead inevitably to explantation of the device. Despite the use of several preventive measures, including the use of an antiseptic shower, a local preparation for alcoholic povidone iodine (API) (PVPI 5% ethanol + 70%) and antibiotic prophylaxis clinical studies the most recent have clearly demonstrated that the risk of infection was associated with the duration of the intervention and was higher for procedures CR, it is noted in 2.4% in the short term and would be close to 3 to 4% in the medium term. Infections of implantable devices are associated with a poor prognosis, even in an excess mortality. It has been shown that the majority of infections may be linked to local contamination during surgery reinforcing the idea that prevention is mainly based on local measures and the reduction of operating time.

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators:
Ministry of Health, France
CareFusion

location_facility:
CH la Rochelle
CH d'Aix en Provence
CH d'Annecy
CHU de Rouen
CHU d'Amiens
Ch St Joseph St Luc
CHU de Lille
CHU de Dijon
CHU de Toulouse
CHU de Strasbourg
CHU de Nimes
CHU d'Angers
CH de Périgueux
CHU de Saint-Etienne
CH d'Avignon
CHU de Reims
CHU de Brest
CHU de Grenoble
CHU de Montpellier
AP-HM
CHU de Bordeaux
CHU de Caen
CHU de Clermont-Ferrand
CH de Chartres


title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

summary: The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.

ReferenceCitation: Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Club rTMS et Psychiatrie

collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

location_country: Monaco France

location_facility: C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A

location_facility: EPS de Ville Evrard - Unité de Saint-Denis

location_facility: C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO

location_facility: C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie

location_facility: Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique

location_facility: C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie

location_facility: C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie

location_facility: C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte

intervention_type: Other


title: An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)

acronym: ESPHALL

summary: The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Arico M, Rottgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.

ReferenceCitation: Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cave H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial. Lancet Haematol. 2018 Dec;5(12):e641-e652. doi: 10.1016/S2352-3026(18)30173-X.

oa_host_type: repository

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

unpaywall_oa_status: green

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

version: acceptedVersion

lead_sponsor: Rennes University Hospital

collaborators:
Ministry of Health, France
Novartis

sponsor_collaborators:
Rennes University Hospital
Ministry of Health, France
Novartis

location_facility: Service d'hématologie pédiatrique - Hôpital Sud

location_facility: Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle

location_facility: Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique

location_facility: Hématologie, Oncologie pédiatrique-CHU Saint Etienne

location_facility: Service hématologie pédiatrique Hôpital Saint-Jacques

location_facility: Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu

location_facility: Hématologie oncologie pédiatrique-CHU Caen

location_facility: Hémato-Oncologie Pédiatrique - Hôpital d'Enfants

location_facility: Service d'hémato-oncologie - Hôpital des Enfants Pellegrin

location_facility: Hématologie Pédiatrique - Hôpital Trousseau


title: Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome.

acronym: POEMS

summary:
POEMS syndrome is a rare form of B cell dyscrasia combining a proliferation usually of plasma cells, a polyneuropathy, osteocondensing bone lesions and multiple other clinical signs. Lenalidomide appears to be particularly efficient in this pathology.

The investigators propose a phase II multicentre protocol, based on the use of lenalidomide combined with dexamethasone in patients presenting a POEMS syndrome, either de novo or resistant or in relapse.

Patients who can be treated by local radiation or intensive treatment with stem cell support will undergo 2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment (Group 1), the other patients will undergo 9 cycles of the Len-Dex combination (Group 2).

A biological study is coupled with this clinical protocol in order to define the best biological markers predicting clinical responses, to better understand the POEMS pathophysiological mechanisms and to set up a bank of samples which can be used to study this rare pathology.

lead_sponsor: University Hospital, Limoges

sponsor_collaborators:
University Hospital, Limoges
Ministry of Health, France
Celgene Corporation

location_facility:
Hôpital Saint-Louis
Centre Léon Bérard
CHU de Caen
Hospices Civil de Lyon
CHU de Lille
CHU de Toulouse
Pitié Salpétrière
CHU de Limoges
CHU d'Angers
CHU de Nantes
Hôpital Necker


title: Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia (VAP): an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Many studies provide evidence for the benefit of lower respiratory tract surveillance, mostly by culture of endotracheal secretions, to predict bacterial pathogens (especially multi-drugs resistant pathogens) involved in VAP. The DEMETER study (NCT02515617) assessing the medico-economical impact of the subglottic secretions drainage (SSD) provides the opportunity to evaluate the accuracy of the subglottic secretions culture surveillance to predict pathogens involved in VAP (in comparison with the concomitant endotracheal secretions surveillance). These subglottic and tracheal secretions culture surveillance will be masked to the investigators of the DEMETER Study.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceType: background

ReferenceCitation: Brusselaers N, Labeau S, Vogelaers D, Blot S. Value of lower respiratory tract surveillance cultures to predict bacterial pathogens in ventilator-associated pneumonia: systematic review and diagnostic test accuracy meta-analysis. Intensive Care Med. 2013 Mar;39(3):365-75. doi: 10.1007/s00134-012-2759-x. Epub 2012 Nov 28.

lead_sponsor: Centre Hospitalier Departemental Vendee

sponsor_collaborators:
Centre Hospitalier Departemental Vendee
Ministry of Health, France
University Hospital, Tours

location_country: Belgium France

location_facility: Centre Hospitalier Intercommunal des Portes de l'Oise

location_facility: CHU La Réunion, site de Saint Denis de la Réunion


title: Impact of the Subglottic Secretions Drainage on the Tracheal Secretions Colonisation: an Ancillary Study of the DEMETER Trial (NCT02515617)

summary:
Meta-analysis provide evidence for the benefit of the subglottic secretions drainage (SSD) to reduce the occurrence of Ventilator-Associated Pneumonia (VAP). Nevertheless, the diagnosis of VAP is widely considered as subjective and prone to both false-positive and false negative assignments. In ths way, the impact of SSD remains controversial and its use limited in Intensive Care Units. The DEMETER study assessing the medico-economical impact of the the subglottic secretions drainage (NCT02515617) provides the opportunity to evaluate the dynamics of tracheal colonisation with and without the realisation of SSD. This evaluation would reinforce the results observed during the DEMETER study in considering the adjudicated VAP incidence.

This ancillary study will be performed in 14 centers participating to the DEMETER study

ReferenceCitation: Girou E, Buu-Hoi A, Stephan F, Novara A, Gutmann L, Safar M, Fagon JY. Airway colonisation in long-term mechanically ventilated patients. Effect of semi-recumbent position and continuous subglottic suctioning. Intensive Care Med. 2004 Feb;30(2):225-233. doi: 10.1007/s00134-003-2077-4. Epub 2003 Nov 29.

collaborators:
Ministry of Health, France
University Hospital, Tours


title: Observational, Longitudinal, Prospective, French, Multicentre Study Conducted on Adult and Paediatric Patients Treated With Micafungin in Prophylaxis and Followed Over a 3 Months' Period in Routine Medical Practice

acronym: OLYMPE

summary: The purpose of this observational study is to describe the actual conditions of prescription of micafungin in antifungal prophylaxis in French haematological and onco-haematological units. The efficacy and the safety outcomes will be described.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma S.A.S.


title: A Randomized Open-label Phase II Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

summary:
Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor.

Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway.

LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).

status: Terminated

lead_sponsor: Centre Francois Baclesse

sponsor_collaborators:
Centre Francois Baclesse
National Cancer Institute, France
ARC Foundation for Cancer Research

location_facility:
Institut Bergonié
Centre Léon Bérard
Institut Gustave Roussy
Hôpital St Louis, AP-HP
Institut Claudius Regaud
Centre Henri Becquerel
Institut de Cancérologie de l'Ouest
Centre Georges-François Leclerc
Hegp, Ap-Hp
Centre Eugène Marquis
Centre François Baclesse
Institut Paoli Calmettes
Centre Jean Perrin
Institut Curie

status_simplified: Unknown


title: Prospective, Randomized, Double-blind, Placebo-controlled Study on Parallel Groups Evaluating the Efficacy and Safety of Cranberry (Vaccinium Macrocarpon) in Prevention of Urinary Tract Infections in Multiple Sclerosis Patients.

acronym: CANNEBERGE

summary: Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.

ReferenceCitation: Gallien P, Amarenco G, Benoit N, Bonniaud V, Donze C, Kerdraon J, de Seze M, Denys P, Renault A, Naudet F, Reymann JM. Cranberry versus placebo in the prevention of urinary infections in multiple sclerosis: a multicenter, randomized, placebo-controlled, double-blind trial. Mult Scler. 2014 Aug;20(9):1252-9. doi: 10.1177/1352458513517592. Epub 2014 Jan 8.

publisher_dissemination: SAGE Publications

sponsor_collaborators:
Rennes University Hospital
Pierre Fabre Laboratories
Ministry of Health, France

location_facility: Centre Mutualiste de Rééducation et de Réadaptation Fonctionnelles de KERPAPE

location_facility: Rééducation Neurologique et Explorations Périnéales - Hôpital Rothschild

location_facility: Service de médecine physique et réadapation Hopital de Rangueil

location_facility: Médecine Physique et Réadaptation - Groupe Hospitalier de l'institut Catholique de Lille - Hôpital Saint Philibert

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pellegrin

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Raymond Poincaré

location_facility: Unité de Médecine Physique et Réadaptation - CHU Jean Minjoz

location_facility: Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

location_facility: Consultations maladies infectieuses et tropicales, Hôpital Raymond Poincaré

location_facility: Centre de Médecine Physique et Réadaptation Notre Dame de Lourdes


title: IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma

summary: Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.

ReferenceCitation: Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chretien ML, Rigaudeau S, Dib M, Nicolas-Virelizier E, Escoffre-Barbe M, Belhadj K, Mariette C, Stoppa AM, Araujo C, Doyen C, Fontan J, Kolb B, Garderet L, Brechignac S, Malfuson JV, Jaccard A, Lenain P, Borel C, Hebraud B, Benbrahim O, Dorvaux V, Manier S, Augeul-Meunier K, Vekemans MC, Randriamalala E, Chaoui D, Caers J, Chaleteix C, Benboubker L, Vincent L, Glaisner S, Zunic P, Slama B, Eveillard JR, Humbrecht-Kraut C, Morel V, Mineur P, Eisenmann JC, Demarquette H, Richez V, Vignon M, Caillot D, Facon T, Moreau P, Colin AL, Olivier P, Wuilleme S, Avet-Loiseau H, Corre J, Attal M. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study. Blood. 2022 May 5;139(18):2747-2757. doi: 10.1182/blood.2021014635. Erratum In: Blood. 2023 Mar 9;141(10):1234.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

publisher_dissemination: American Society of Hematology

lead_sponsor: University Hospital, Toulouse

collaborators:
Ministry of Health, France
Janssen, LP

sponsor_collaborators:
University Hospital, Toulouse
Ministry of Health, France
Janssen, LP

location_facility: Centre Hospitalier de Versailles-Hôpital André Mignot

location_facility: Institut de Cancérologie de la Loire Lucien Neuwirth

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame


title: Prospective, Longitudinal Study of the Natural History and Functional Status of Patients With Myotubular Myopathy (MTM)

acronym: MTM

summary: This is a prospective, non-interventional, longitudinal study of the natural history and function of approximately 60 patients with MTM from the United States, Canada and Europe. The duration of the study, including the enrollment period, will be 36 months. Data from the study will be used to characterize the disease course of MTM and determine which outcome measures will be the best to assess the efficacy of potential therapies.

ReferenceCitation: Herman GE, Finegold M, Zhao W, de Gouyon B, Metzenberg A. Medical complications in long-term survivors with X-linked myotubular myopathy. J Pediatr. 1999 Feb;134(2):206-14. doi: 10.1016/s0022-3476(99)70417-8.

ReferenceCitation: Jungbluth H, Sewry CA, Buj-Bello A, Kristiansen M, Orstavik KH, Kelsey A, Manzur AY, Mercuri E, Wallgren-Pettersson C, Muntoni F. Early and severe presentation of X-linked myotubular myopathy in a girl with skewed X-inactivation. Neuromuscul Disord. 2003 Jan;13(1):55-9. doi: 10.1016/s0960-8966(02)00194-3.

ReferenceCitation: McEntagart M, Parsons G, Buj-Bello A, Biancalana V, Fenton I, Little M, Krawczak M, Thomas N, Herman G, Clarke A, Wallgren-Pettersson C. Genotype-phenotype correlations in X-linked myotubular myopathy. Neuromuscul Disord. 2002 Dec;12(10):939-46. doi: 10.1016/s0960-8966(02)00153-0.

ReferenceCitation: Jungbluth H, Wallgren-Pettersson C, Laporte J. Centronuclear (myotubular) myopathy. Orphanet J Rare Dis. 2008 Sep 25;3:26. doi: 10.1186/1750-1172-3-26.

ReferenceCitation: Annoussamy M, Lilien C, Gidaro T, Gargaun E, Che V, Schara U, Gangfuss A, D'Amico A, Dowling JJ, Darras BT, Daron A, Hernandez A, de Lattre C, Arnal JM, Mayer M, Cuisset JM, Vuillerot C, Fontaine S, Bellance R, Biancalana V, Buj-Bello A, Hogrel JY, Landy H, Servais L. X-linked myotubular myopathy: A prospective international natural history study. Neurology. 2019 Apr 16;92(16):e1852-e1867. doi: 10.1212/WNL.0000000000007319. Epub 2019 Mar 22.

repositories_concat: PubMed Central;www.repositoriosalud.es

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Valerion Therapeutics, LLC

collaborators:
Institut de Myologie, France
Genethon

sponsor_collaborators:
Valerion Therapeutics, LLC
Institut de Myologie, France
Genethon

location_country:
Germany
Italy
Belgium
United States
Spain
Canada
France

location_facility: Hospital for Sick Children, 555 University Avenue

location_facility: Boston Children's Hospital, 300 Longwood Avenue

location_facility: Institut de Myologie, GH Pitié Salpêtrière, Bâtiment Babinski

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hôpital Femme Mère Enfant, CHU Lyon Escale


title: Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.

acronym: DEQOLAGE

summary:
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.

The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.

status: Unknown status

collaborators: Research Team CEpiA (Clinical Epidemiology and Ageing) EA7376, University Paris Est Créteil (UPEC)

collaborators: Research Team APEMAC EA4360, University of Lorraine

collaborators: Unité de Recherche Clinique Mondor, Hôpital Henri Mondor

collaborators: Unité de Coordination en Onco-Gériatrie (UCOG) Sud Val-de-Marne

collaborators: Quality of life and cancer clinical research platform

location_facility:
Hôpital Saint Louis
CHRU Nancy
Hôpital Henri Mondor


title: TREg Activation in the Treatment of the PELADE (Alopecia Areata). Double Blind Randomized Placebo Controlled Comparative Study Using Low Doses of IL2

acronym: TreatPelade

summary:
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.

The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nimes - Dermatologie
AP-HP St Louis - Dermatologie
CHU de Nice - dermatologie
CHI St Raphael Fréjus - Dermatologie
AP-HM - La timone - Dermatologie
CHU Montpellier - Dermatologie


title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study

acronym: COG-ANGIO

summary: Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

sponsor_collaborators:
Centre Francois Baclesse
Hoffmann-La Roche

location_facility:
Centre François BACLESSE
CHU
Hôpital Georges Pompidou
Institut Gustave Roussy
Centre Henri Becquerel


title: New Participatory Research Strategy and Multidimensional Phenotyping Towards Personalized Preventive Nutritional Support for Elderly People

acronym: MetabotypAGE

summary: There is high inter-individual variability in the response to feeding, which is determined by multiple interacting factors such as age, sex, genotype, gut microbiota, eating behaviors, physical activity or even socio-demographic factors. Original studies have recently demonstrated the possibility of predicting the postprandial response to the diet of healthy individuals on the basis of in-depth phenotyping, and of offering them foods adapted to their own metabolic capacities according to their belonging to different groups of individuals defined on the basis of the similarity of their metabolic capacities. Due to different life trajectories, inter-individual variability could be amplified upon entry into the aging period, which could explain at least in part why traditional strategies for managing chronic age-related pathologies are insufficient. The investigators aim is to propose a new strategy to better understand inter-individual variability in the response to food in the elderly based on deep phenotyping.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Other

ReferenceCitation: Ordovas JM, Ferguson LR, Tai ES, Mathers JC. Personalised nutrition and health. BMJ. 2018 Jun 13;361:bmj.k2173. doi: 10.1136/bmj.k2173.

ReferenceCitation: Delude CM. Deep phenotyping: The details of disease. Nature. 2015 Nov 5;527(7576):S14-5. doi: 10.1038/527S14a. No abstract available.

ReferenceCitation: de Toro-Martin J, Arsenault BJ, Despres JP, Vohl MC. Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. Nutrients. 2017 Aug 22;9(8):913. doi: 10.3390/nu9080913.

ReferenceCitation: Berry SE, Valdes AM, Drew DA, Asnicar F, Mazidi M, Wolf J, Capdevila J, Hadjigeorgiou G, Davies R, Al Khatib H, Bonnett C, Ganesh S, Bakker E, Hart D, Mangino M, Merino J, Linenberg I, Wyatt P, Ordovas JM, Gardner CD, Delahanty LM, Chan AT, Segata N, Franks PW, Spector TD. Human postprandial responses to food and potential for precision nutrition. Nat Med. 2020 Jun;26(6):964-973. doi: 10.1038/s41591-020-0934-0. Epub 2020 Jun 11. Erratum In: Nat Med. 2020 Nov;26(11):1802.

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: King's College London - Research Portal

publisher_dissemination: Springer-Nature

ReferenceCitation: Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001.

oa_host_type: publisher

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Hillesheim E, Ryan MF, Gibney E, Roche HM, Brennan L. Optimisation of a metabotype approach to deliver targeted dietary advice. Nutr Metab (Lond). 2020 Sep 29;17:82. doi: 10.1186/s12986-020-00499-z. eCollection 2020.

repository_institution: University College Dublin - Research Repository at University College Dublin

ipd_sharing_description: Sharing of all IPD that underlie results in a publication

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

location_facility: Centre de Recherche en Odontologie Clinique, Faculté de Chirurgie Dentaire

location_facility: Plateforme d'Exploration de la Mobilité (CHU Clermont-Ferrand)


title: Brain-computer Interface in the Diagnosis of Disorders of Consciousness

acronym: AWAKE

summary:
The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury.

Assumptions :

Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)
Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

collaborators: Clinique Fontfroide, Montpellier, France

location_facility:
Hôpital d'Uzès
CHU de Montpellier
CHU de Nîmes
Clinique Fontfroide


title: Randomized Trial of Loco-regional Radiotherapy Added to Pembrolizumab Alone or With Chemotherapy Versus Systemic Treatment Alone for Patients With Newly Diagnosed Head and Neck Squamous Cell Carcinoma With Synchronous Metastases

acronym: PembroMetaRT

summary: Study to evaluate the efficacy of treatment by radiotherapy and pembrolizumab in newly diagnosed metastatic head & neck cancers

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

sponsor_collaborators:
UNICANCER
GORTEC
National Cancer Institute, France

location_facility: Hopital Nord Franche Comté - Site de Mittan

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Institut de Cancérologie Strasbourg-Europe


title: National Oesophageal and Gastric Carcinomas Data Base Construction: the FREGAT (French EsoGastric Tumours) Data Base

acronym: FREGAT

summary: This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.

ReferenceCitation: Mariette C, Renaud F, Piessen G, Gele P, Copin MC, Leteurtre E, Delaeter C, Dib M, Clisant S, Harter V, Bonnetain F, Duhamel A, Christophe V, Adenis A; Fregat Working Group. The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers. BMC Cancer. 2018 Feb 6;18(1):139. doi: 10.1186/s12885-018-3991-8.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
French Eso-Gastric Tumors Working Group
National Cancer Institute, France

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand

location_facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)


title: Assessment of Biomarkers Initially Identified in Whole Blood by DNA Microarrays in Patients With Aggressive Lymphoma BMS_LyTrans

acronym: BMS-LyTrans

summary: Diffuse Large B-cell Lymphoma (DLBCL) is the most frequent high grade lymphoma in adults. Although immunotherapy has improved its prognosis, DLBCL is a heterogeneous disease with patients exhibiting a wide range of outcomes with a 5-year overall survival ranging between 55 to 94% depending of the International Prognostic Index factor. Diagnostic and prognostic biomarkers are mandatory to optimize treatment. Transcriptomics has been used to detect such new biomarkers using microarrays analyses applied to RNA collected from total tumor tissues or cell extracts. Molecular prognostic factors have been thoroughly studied in DLBCL tumor tissues. However, it is a big challenge to obtain transcriptomic-qualified tumor samples in a multicentric and prospective clinical trial. Coordinating nvestigator hypothesized that blood may be a deep source of native and secreted analytes and therefore carries transcriptomic signatures related to DLBCL and its prognosis. This project is organized in the extension of the GOELAMS-075 clinical trial which concerns aggressive DLBCL.

sponsor_collaborators:
Rennes University Hospital
French Innovative Leukemia Organisation
National Cancer Institute, France

location_facility: Bordeaux University Hospital ( Haut-Lévêque Hospital)


title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

acronym: ROBO-GYN

summary: The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

ReferenceCitation: Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25.

lead_sponsor: Centre Oscar Lambret

collaborators: CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie

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


title: A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma

acronym: O-Mel-Inib

summary: The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

sponsor_collaborators:
Centre Oscar Lambret
Novartis
National Cancer Institute, France

location_facility: Centre Hospitalier Regional Universitaire


title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

acronym: SBRT-NSCLC

summary:
The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy.

Eligible patients will be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years.

The number of patients required in this multicentric prospective study is 120:

20 patients in the SBRT-1 arm (cyberknife),
80 patients in the SBRT-2 arm (linear accelerator-based)
20 patients in the conformational radiotherapy arm.

This is a prospective, multicentric, non comparative and non randomized study.

ReferenceCitation: Noel G, Bollet MA, Noel S, Feuvret L, Boisserie G, Tep B, Delattre JY, Baillet F, Ambroise Valery C, Cornu P, Mazeron JJ. Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1555-61. doi: 10.1016/j.ijrobp.2005.04.037. Epub 2005 Jul 18.

ReferenceCitation: Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481

ReferenceCitation: Pommier P. Modélisation spatiale et médico-économique des thérapeutiques innovantes : à propos du projet français ETOILE d'hadronthérapie par ions carbone. Thèse de Science en économie de la santé ; juin 2005

ReferenceCitation: Pommier P, Ndiaga Gueye N, Buron C, Meyroneinc S. Modélisation du coût de l'innovation thérapeutique pour l'aide à la décision. Application à la radiothérapie par ions carbone (projet ETOILE). Santé et systémique 2007 ; 10 : 217-31

ReferenceCitation: Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005

ReferenceCitation: Tschung Sibley G. Radiotherapy for patient with medically inoperable stage I non-small cell lung cancer smaller doses and higher doses - a review. Cancer 2003;41:1-11

ReferenceCitation: Timmerman R, Papiez L, McGarry R, Likes L, DesRosiers C, Frost S, Williams M. Extracranial stereotactic radioablation: results of a phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003 Nov;124(5):1946-55. doi: 10.1378/chest.124.5.1946.

ReferenceCitation: McGarry RC, Papiez L, Williams M, Whitford T, Timmerman RD. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: phase I study. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1010-5. doi: 10.1016/j.ijrobp.2005.03.073. Epub 2005 Aug 22.

ReferenceCitation: Whyte RI, Crownover R, Murphy MJ, Martin DP, Rice TW, DeCamp MM Jr, Rodebaugh R, Weinhous MS, Le QT. Stereotactic radiosurgery for lung tumors: preliminary report of a phase I trial. Ann Thorac Surg. 2003 Apr;75(4):1097-101. doi: 10.1016/s0003-4975(02)04681-7.

ReferenceCitation: Xia T, Li H, Sun Q, Wang Y, Fan N, Yu Y, Li P, Chang JY. Promising clinical outcome of stereotactic body radiation therapy for patients with inoperable Stage I/II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):117-25. doi: 10.1016/j.ijrobp.2006.04.013. Epub 2006 Jun 9.

ReferenceCitation: Nagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19.

ReferenceCitation: Onishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31. doi: 10.1002/cncr.20539.

ReferenceCitation: Hof H, Herfarth KK, Munter M, Hoess A, Motsch J, Wannenmacher M, Debus J J. Stereotactic single-dose radiotherapy of stage I non-small-cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):335-41. doi: 10.1016/s0360-3016(02)04504-2.

ReferenceCitation: Uematsu M, Shioda A, Suda A, Fukui T, Ozeki Y, Hama Y, Wong JR, Kusano S. Computed tomography-guided frameless stereotactic radiotherapy for stage I non-small cell lung cancer: a 5-year experience. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):666-70. doi: 10.1016/s0360-3016(01)01703-5.

ReferenceCitation: Fukumoto S, Shirato H, Shimzu S, Ogura S, Onimaru R, Kitamura K, Yamazaki K, Miyasaka K, Nishimura M, Dosaka-Akita H. Small-volume image-guided radiotherapy using hypofractionated, coplanar, and noncoplanar multiple fields for patients with inoperable Stage I nonsmall cell lung carcinomas. Cancer. 2002 Oct 1;95(7):1546-53. doi: 10.1002/cncr.10853.

ReferenceCitation: Lax I, Blomgren H, Naslund I, Svanstrom R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83. doi: 10.3109/02841869409121782.

ReferenceCitation: Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70. doi: 10.3109/02841869509127197.

ReferenceCitation: Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996 Aug;17(4):343-6. doi: 10.1016/0197-2456(96)00075-x. No abstract available.

ReferenceCitation: Krol AD, Aussems P, Noordijk EM, Hermans J, Leer JW. Local irradiation alone for peripheral stage I lung cancer: could we omit the elective regional nodal irradiation? Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):297-302. doi: 10.1016/0360-3016(95)00227-8.

ReferenceCitation: Gauden SJ, Tripcony L. The curative treatment by radiation therapy alone of Stage I non-small cell lung cancer in a geriatric population. Lung Cancer. 2001 Apr;32(1):71-9. doi: 10.1016/s0169-5002(00)00199-9.

ReferenceCitation: Morita K, Fuwa N, Suzuki Y, Nishio M, Sakai K, Tamaki Y, Niibe H, Chujo M, Wada S, Sugawara T, Kita M. Radical radiotherapy for medically inoperable non-small cell lung cancer in clinical stage I: a retrospective analysis of 149 patients. Radiother Oncol. 1997 Jan;42(1):31-6. doi: 10.1016/s0167-8140(96)01828-2.

ReferenceCitation: Sirzen F, Kjellen E, Sorenson S, Cavallin-Stahl E. A systematic overview of radiation therapy effects in non-small cell lung cancer. Acta Oncol. 2003;42(5-6):493-515. doi: 10.1080/02841860310014453.

ReferenceCitation: Bradley JD, Wahab S, Lockett MA, Perez CA, Purdy JA. Elective nodal failures are uncommon in medically inoperable patients with Stage I non-small-cell lung carcinoma treated with limited radiotherapy fields. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):342-7. doi: 10.1016/s0360-3016(02)04614-x.

lead_sponsor: Centre Leon Berard

collaborators: The Biostatistics and Therapy Evaluation Unit

location_facility:
Hôpital Tenon
Centre Antoine Lacassagne
Centre Leon Berard
Centre Alexis Vautrin
CHLS
Centre Oscar Lambret
Centre Georges François Leclerc
Centre René Gauducheau
Centre Val d'Aurelle Paul Lamarque

intervention_type: Radiation


title: French Multicenter Study Assessing Angioplasty With Taxus Drug Eluting Stent in Unprotected Left Main Coronary Artery Associated to Other Coronary Lesions or Not

summary: The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
Boston Scientific Corporation

location_facility: Institut Hospitalier Jacques Cartier-ICPS


title: Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS

summary: This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion

time_perspective: Retrospective

lead_sponsor: University Hospital, Gasthuisberg

location_country: Germany Italy Poland Denmark Netherlands Austria Switzerland Spain France

location_facility: Thoracic Department, Institut Mutualiste Montsouris

location_facility: Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery

location_facility: Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital

location_facility: Department of Cardiothoracic Surgery, Rigshospitalet

location_facility: Division of Thoracic Surgery, Ospedali Riuniti Ancona


title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

acronym: ESCORT-HU

summary: In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

ReferenceCitation: de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galacteros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: ADDMEDICA SASA

location_country:
Germany
Italy
Guadeloupe
French Guiana
Martinique
Greece
France

location_facility: Centre Hospitalier Intercommunal André Grégoire

location_facility: Hôpital Henri Mondor, centre de la Drépanocytose

location_facility: Hôpital Robert Debré, immunologie-hématologie pédiatrique

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Azienda Ospedaliera Universitaria Integrata (AOUI Verona)

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: Azienda Ospedaliera-University of Padova

location_facility: Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie

location_facility: Hôpital de la Conception, médecine interne

location_facility: Centre Hospitalier Delafontaine, médecine interne

location_facility: Institut Universitaire du cancer; médecine interne

location_facility: Centre Hospitalier de Gonesse, médecine interne

location_facility: Hôpital Louis Mourier; service de pédiatrie

location_facility: Centre Hospitalier de Gonesse, pédiatrie

location_facility: Centre Hospitalier Delafontaine, pédiatrie

location_facility: Hôpital Necker enfants, maladies infectieuses et tropicales

location_facility: Hôpital Necker; maladies infectieuses et tropicales


title: adaptatiVe Endovascular Strategy to the CloT MRI in Large Intracranial Vessel Occlusion

acronym: VECTOR

summary:
In the VECTOR trial, the aim is to analyze, in case of SVS+ occlusions, a first line Embotrap II added to CA combined strategy compare to CA alone strategy.

Many practitioners are convinced that a first line strategy with CA alone is easy, safe, rapid and efficient. Maybe, after two, three, four ... passes and with the secondary help of a combined strategy, a high rate of eTICI 2b/3 could be reached with a CA first line strategy. But this could go with a higher number of passes, a waste of time and a suboptimal angiographic results (eTICI 2b) due to distal emboli, especially in case of friable, non-well organized, red blood cell rich (RBC) i.e. SVS + thrombi (25-28). This could, be related to worst clinical outcome at 3 months. VECTOR asks a relevant question: Do the invetigators have to add the use of an Embotrap II or III to the CA, from the first passes, in case of SVS+ clots?

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
University Hospital, Lille
Central Hospital, Nancy, France

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: A Randomized, Multicenter, Phase III Trial Comparing Induction CT With Docetaxel, Cisplatin and 5-FU (TPF) Followed by Concurrent CT-RT to Concurrent CT Alone, in Nasopharyngeal Cancers Staged as T2b, T3, T4 and/or With Lymph Node Involvement (>N1)

summary: This is a randomized, multicenter, phase III trial comparing induction chemotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) followed by concurrent chemoradiotherapy to concurrent chemoradiotherapy alone, in nasopharyngeal cancers staged as T2b, T3, T4 and/or with lymph node involvement (≥ N1. The main end point is the event free survival.

ReferenceCitation: Tao Y, Auperin A, Graff P, Lapeyre M, Gregoire V, Maingon P, Geoffrois L, Verrelle P, Calais G, Gery B, Martin L, Alfonsi M, Deprez P, Bardet E, Pignon T, Rives M, Sire C, Bourhis J. Very accelerated radiotherapy or concurrent chemoradiotherapy for N3 head and neck squamous cell carcinoma: Pooled analysis of two GORTEC randomized trials. Oral Oncol. 2017 Aug;71:61-66. doi: 10.1016/j.oraloncology.2017.06.002. Epub 2017 Jun 9.

ReferenceCitation: Bourhis J, Sire C, Graff P, Gregoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Auperin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. doi: 10.1016/S1470-2045(11)70346-1. Epub 2012 Jan 18.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_country: Romania Tunisia Morocco France

location_facility:
University of Casablanca
Hôpital Habib Bourguiba
Hôpital de la Pitié-Salpétrière
Institut Gustave Roussy
University of Cluj


title: Predictive Signature of Benralizumab Response

acronym: BENRAPRED

summary:
The objective of the study is to establish the predictive value of early blood gene expression signature of Benralizumab response associated with a significant reduction of the number of exacerbations in treated severe asthmatic patients.

This trial is a French, multicenter and no-randomized trial. Patients enrolled will be clinically followed for 16 months (the treatment period: 12 months and 1 month follow-up; 6 clinical visit on site and in phone call at 13 months)

ipd_sharing: Undecided

sponsor_collaborators:
Nantes University Hospital
AstraZeneca
Ministère de la Santé - France

location_facility: Centre hospitalier Intercommunal Aix-en-Provence

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Médipôle Hôpital Mutualiste de Villeurbanne

acronyme: BENRAPRED

titre: Signature Prédictive de la Réponse au Benralizumab

discipline_principale: pneumologie

nom_porteur: BLANC

prenom_porteur: François-Xavier


title: Modelling of Pharyngeal Laryngeal Effectiveness to Assess Swallowing Disorders

acronym: Eph-L

summary:
The purpose of this study is to collect the signals of pharyngeal laryngeal activity through five non-invasive sensors (microphone, accelerometer, surface electromyography (EMG), nasal cannula and oximeter) in order to identify indicators of functional efficiency of swallowing, protection of the lower airways and phonation.

440 patients (subjects with swallowing disorders), spread over 4 centers and 80 healthy subjects spread over 2 centers will be recruited for the study in an interventional research study involving the prospective, multicentric and longitudinal.

Pharyngolaryngeal effectiveness will be measured from 6 indicators identified by examinations or reference tests grouped into 3 functions:

swallowing: pharyngeal transport capacity (Yale Residue) and Penetration Aspiration Scale (PAS) rated by videofluoroscopy of swallowing (VFS) or flexible endoscopic evaluation of swallowing (FEES);
airway protection: cough trigger (citric acid test) and cough power (peak expiratory flow);
phonation: vocal efficiency (maximum phonation time) and velar efficiency (nasal scores).

The signals obtained from the 5 sensors will be annotated. Stochastic modelling based on hidden Markov models will be used initially and followed by the implementation of deep neural networks to model indicators. For the complication's prediction algorithm, deep neural networks will also be used to evaluate signal-based methods.

The expected benefits are to obtain automated recognition of pharyngeal-laryngeal effectiveness to diagnose swallowing disorders using objective and quantifiable indicators, non-invasive devices, to assess the severity of these disorders and to identify the risk of complications.

collaborators: Institut de Recherche en Informatique de Toulouse (IRIT)

location_facility:
University hospital of Rouen
University Hospital of Toulouse
University hospital of Bordeaux
University hospital of Tours


title: Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"

acronym: LLIFT

summary:
The NAFLD is the first cause of liver disease worldwide. The severe form of NAFLD, the NASH progresses to cirrhosis and is responsible of liver mortality. The diagnosis of NASH requires liver biopsy that cannot be used for the screening of the disease.

The broad prevalence of the disease limits also the generalization of liver biopsy even for diagnosis. There is an urgent need for the use and the validation of liver diagnosis biomarkers for the diagnosis of NASH.

sponsor_collaborators:
University Hospital, Lille
RHU PreciNASH Task 1.4
Région Nord-Pas de Calais, France

location_facility:
CH LENS
GHIRCL saint Philibert
Hop Claude Huriez Chu Lille
Ch Valenciennes
CH de Douai
CH ARRAS
Chu Amiens Picardie


title: Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?

summary:
Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler's regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.

The French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.

Thus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery [1]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

time_perspective: Cross-Sectional

ReferenceCitation: Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012 May 29;10:51. doi: 10.1186/1741-7015-10-51.

ReferenceCitation: Legras A, Mordant P, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Long-term survival of patients with pN2 lung cancer according to the pattern of lymphatic spread. Ann Thorac Surg. 2014 Apr;97(4):1156-62. doi: 10.1016/j.athoracsur.2013.12.047. Epub 2014 Feb 26.

ReferenceCitation: Lin IF, Chang WP, Liao YN. Shrinkage methods enhanced the accuracy of parameter estimation using Cox models with small number of events. J Clin Epidemiol. 2013 Jul;66(7):743-51. doi: 10.1016/j.jclinepi.2013.02.002. Epub 2013 Apr 6.

ReferenceCitation: Pecuchet N, Rozenholc Y, Zonta E, Pietrasz D, Didelot A, Combe P, Gibault L, Bachet JB, Taly V, Fabre E, Blons H, Laurent-Puig P. Analysis of Base-Position Error Rate of Next-Generation Sequencing to Detect Tumor Mutations in Circulating DNA. Clin Chem. 2016 Nov;62(11):1492-1503. doi: 10.1373/clinchem.2016.258236. Epub 2016 Sep 13.

ReferenceCitation: Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10. doi: 10.1016/0895-4356(95)00048-8.

ReferenceCitation: Tapak L, Saidijam M, Sadeghifar M, Poorolajal J, Mahjub H. Competing risks data analysis with high-dimensional covariates: an application in bladder cancer. Genomics Proteomics Bioinformatics. 2015 Jun;13(3):169-76. doi: 10.1016/j.gpb.2015.04.001. Epub 2015 Apr 20.

ReferenceCitation: Um SW, Joung JG, Lee H, Kim H, Kim KT, Park J, Hayes DN, Park WY. Molecular Evolution Patterns in Metastatic Lymph Nodes Reflect the Differential Treatment Response of Advanced Primary Lung Cancer. Cancer Res. 2016 Nov 15;76(22):6568-6576. doi: 10.1158/0008-5472.CAN-16-0873. Epub 2016 Sep 13.

ReferenceCitation: Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Ministry of Health, France
Université de Paris

location_facility: Hôpital du Haut-Lévêque, CHU de Bordeaux

appel_a_projets: PRTK

titre: De la tumeur aux ganglions, hétérogénéité moléculaire et signature métastatique comme marqueur de rechute précoce dans les cancers bronchiques non à petites cellules IIIA-N2 opérés.

nom_porteur: LE PIMPEC-BARTHES

prenom_porteur: Françoise


title: Medical and Economical Evaluation of Contrast-enhanced Ultrasound Imaging for the Early Estimate of Bevacizumab Effect on Colorectal Cancer Liver Metastases

summary: Bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. Contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. The aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. The primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic RECIST criteria. The secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.

primary_purpose: Diagnostic

ReferenceCitation: Bleuzen A, Huang C, Olar M, Tchuenbou J, Tranquart F. Diagnostic accuracy of contrast-enhanced ultrasound in focal lesions of the liver using cadence contrast pulse sequencing. Ultraschall Med. 2006 Feb;27(1):40-8. doi: 10.1055/s-2005-858944.

ReferenceCitation: Forsberg F, Ro RJ, Potoczek M, Liu JB, Merritt CR, James KM, Dicker AP, Nazarian LN. Assessment of angiogenesis: implications for ultrasound imaging. Ultrasonics. 2004 Apr;42(1-9):325-30. doi: 10.1016/j.ultras.2003.12.026.

ReferenceCitation: Broillet A, Hantson J, Ruegg C, Messager T, Schneider M. Assessment of microvascular perfusion changes in a rat breast tumor model using SonoVue to monitor the effects of different anti-angiogenic therapies. Acad Radiol. 2005 May;12 Suppl 1:S28-33. doi: 10.1016/j.acra.2005.02.021. No abstract available.

ReferenceCitation: Niermann KJ, Fleischer AC, Donnelly EF, Schueneman AJ, Geng L, Hallahan DE. Sonographic depiction of changes of tumor vascularity in response to various therapies. Ultrasound Q. 2005 Jun;21(2):61-7; quiz 149, 153-4.

ReferenceCitation: Preda A, Novikov V, Moglich M, Turetschek K, Shames DM, Brasch RC, Cavagna FM, Roberts TP. MRI monitoring of Avastin antiangiogenesis therapy using B22956/1, a new blood pool contrast agent, in an experimental model of human cancer. J Magn Reson Imaging. 2004 Nov;20(5):865-73. doi: 10.1002/jmri.20184.

ReferenceCitation: Gerber HP, Ferrara N. Pharmacology and pharmacodynamics of bevacizumab as monotherapy or in combination with cytotoxic therapy in preclinical studies. Cancer Res. 2005 Feb 1;65(3):671-80.

ReferenceCitation: Zondor SD, Medina PJ. Bevacizumab: an angiogenesis inhibitor with efficacy in colorectal and other malignancies. Ann Pharmacother. 2004 Jul-Aug;38(7-8):1258-64. doi: 10.1345/aph.1D470. Epub 2004 Jun 8.

ReferenceCitation: Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

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

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris


title: Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Children With Sickle Cell Anemia ( DREPAGREFFE-2)

summary: The purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial Doppler-detected cerebral vasculopathy included in the national "Sickle Cell Transplant" protocol and whose 1- and 3-year results were published in JAMA (Journal of the American Medical Association) in 2019 and in BHJ in 2020.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

collaborators: Centre National de la Recherche Scientifique, France

location_facility: Centre Hospitalier Intercommunal de Créteil


acronym: TACTIK

summary:
This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCRPC defined as ≥5 circulating tumor cells (CTCs) / 7.5 mL after 2 cycles of docetaxel.

Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients with ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.

A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥5 CTCs / 7.5 mL before docetaxel chemotherapy and <5 CTCs / 7.5 mL after 2 cycles of docetaxel) will receive 6 additional cycles of docetaxel.

sponsor_collaborators: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility:
Centre Léon Berard
ICO-Site Paul Papin
CHD Vendée
ICO-Site René Gauducheau
Stéphane CULINE

title: Personalized Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic During Chemotherapy: A GETUG-AFU 28 Study

source: euctr


title: Impact of Early Enteral vs. Parenteral Nutrition on Mortality in Patients Requiring Mechanical Ventilation and Catecholamines: Multicenter, Randomized Controlled Trial (NUTRIREA-2)

summary: The purpose of this study is to assess the hypothesis that, as compared to early intravenous feeding, early nutrition via the enteral route is associated with reduced Day 28-mortality in critically ill patients treated with mechanical ventilation and vasoactive drug.

ReferenceCitation: Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

ReferenceCitation: Brisard L, Le Gouge A, Lascarrou JB, Dupont H, Asfar P, Sirodot M, Piton G, Bui HN, Gontier O, Hssain AA, Gaudry S, Rigaud JP, Quenot JP, Maxime V, Schwebel C, Thevenin D, Nseir S, Parmentier E, El Kalioubie A, Jourdain M, Leray V, Rolin N, Bellec F, Das V, Ganster F, Guitton C, Asehnoune K, Bretagnol A, Anguel N, Mira JP, Canet E, Guidet B, Djibre M, Misset B, Robert R, Martino F, Letocart P, Silva D, Darmon M, Botoc V, Herbrecht JE, Meziani F, Devaquet J, Mercier E, Richecoeur J, Martin S, Greau E, Giraudeau B, Reignier J. Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2). Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507.

publisher_dissemination: Springer

lead_sponsor: Centre Hospitalier Departemental Vendee

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

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: CHU de Strasbourg - Hôpital de Hautepierre


title: Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial

acronym: EOMEC/CP

summary:
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.

In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.

This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.

lead_sponsor: Lille Catholic University

collaborators: Initiatives de parents de Jeunes Epileptiques du Nord

collaborators: Unité de Traitement des Signaux Biomédicaux - HEI

location_facility:
IEM Ellen Poidatz
IEM Sévigné
IEM Christian Dabbadie
IEM Vent de Bise


title: Randomized Study Comparing Sentinel Node (SN) Policy to Current French Initial Staging Protocols in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence

acronym: SENTIRAD

summary: The aim of this study is to evaluate the sentinel node policy in early stage endometrial carcinomas at intermediate and high risk of recurrence (by comparing the sentinel node policy to current initial staging protocols).

status: Active, not recruiting

ReferenceCitation: Aboulouard S, Wisztorski M, Duhamel M, Saudemont P, Cardon T, Narducci F, Lemaire AS, Kobeissy F, Leblanc E, Fournier I, Salzet M. In-depth proteomics analysis of sentinel lymph nodes from individuals with endometrial cancer. Cell Rep Med. 2021 Jun 15;2(6):100318. doi: 10.1016/j.xcrm.2021.100318. eCollection 2021 Jun 15.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories:
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: LillOA (Lille Open Archive);PubMed Central

repositories_institution: Université de Lille (University Of Lille) - LillOA

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

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

location_facility: Centre Hospitalier Régional Universitaire


title: Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

acronym: OPTION

summary: The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Poland
Denmark
Australia
Netherlands
Belgium
United States
Spain
France

location_facility: Kaiser Permanente Santa Clara Medical Center

location_facility: DHZC - Deutsches Herzzentrum der Charité

location_facility: Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow

location_facility: Presbyterian University of Pennsylvania Medical Center

location_facility: Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

location_facility: Medical Center of the Rockies (Loveland)

location_facility: Christus Trinity Mother Frances Health System

location_facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Lindner Center for Research and Education at Christ Hospital

location_facility: St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

location_facility: University Clinical Hospital in Poznań/ UNIWERSYTECKI SZPITAL KLINICZNY W POZNANIU

location_facility: University of Southern California Hospital

location_facility: Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee

location_facility: Cardiovascular Associates of the Delaware Valley


title: Open Label Assessment of VistaCare® Treatment in Current Medical Practice in Patients With Acute and Chronic Leg Wounds.

summary: Assessment of the safety and performance of the VistaCare® medical device in current medical practice in the treatment of acute and chronic lower limb wounds.

lead_sponsor: DTAMedical SAS

location_facility:
Hôpital La Timone
Hôpital de la Conception
CHU Henri Mondor
CHU de Nantes Centre des Brûlés


title: Prospective, Randomized, Single-blind, Multinational, Long-term Study for the Evaluation of the Clinical Outcome, Oxidation Profile and Wear Analysis of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

acronym: VIKEP

summary: Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty

lead_sponsor: Aesculap AG

collaborators:
Raylytic GmbH
B. Braun Medical France

sponsor_collaborators:
Aesculap AG
Raylytic GmbH
B. Braun Medical France

location_country: Germany France

location_facility: Universitätsklinikum Rostock, Klinik für Orthopädie


title: Evaluation of a Closed-loop Insulin Delivery System at Home With Tailored Home Care Services in Poorly Controlled Type 2 Diabetes: a Randomized Controlled Trial vs Usual Care

acronym: CLOSEAP+

summary:
Closed-loop insulin delivery system has the potential to improve the condition of many poorly controlled insulin-treated Type 2 Diabetes (T2D) patients.

A wide acceptance of the Artificial Pancreas (AP) usage in T2D care will strongly depend on the identification of subpopulations and care settings where the AP could significantly improve the risk- and cost-benefit balances of T2D management as compared to established practice.

The aim of this interventional study, therefore, is to investigate whether a therapeutic solution combining an automated insulin delivery AP system with a tailored Home Healthcare Provider (HHP) service can improve blood glucose control, reduce the rate of acute metabolic complications (hypoglycaemia and hyperglycaemia), improve both the patients quality of life and experience, and reduce the healthcare related costs in patients with uncontrolled T2D needing home nursing care for their daily insulin treatment versus usual care.

lead_sponsor: Air Liquide Santé International

collaborators: International Clinical Trials Association

location_facility:
CHRU Brest
CHU Nantes
Hopital Européen de Marseille
CHU Strasbourg
CHU Toulouse
CHRU Nancy-Hôpitaux de Brabois
CHU Caen
CHU Rouen
APHP Lariboisière
CHU Amiens


title: Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women

acronym: Ossébo

summary:
Primary objective: to evaluate the effectiveness of a fall prevention exercise program in preventing falls resulting in fractures and other physical traumas.

Secondary objectives:

to better understand the mechanisms by which physical exercise prevents falls and ensuing injuries (improvement in physical functional abilities, global physical activity level, general physical and psychological wellbeing and self-confidence).
to determine the individual factors associated with long-term adherence to the exercise program.

ReferenceCitation: Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. doi: 10.1136/bmj.328.7441.680.

ReferenceCitation: Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, Wagner EH. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M218-24. doi: 10.1093/gerona/52a.4.m218.

ReferenceCitation: Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. doi: 10.1136/bmj.315.7115.1065.

ReferenceCitation: Campbell AJ, Robertson MC, Gardner MM, Norton RN, Buchner DM. Falls prevention over 2 years: a randomized controlled trial in women 80 years and older. Age Ageing. 1999 Oct;28(6):513-8. doi: 10.1093/ageing/28.6.513.

ReferenceCitation: Robertson MC, Devlin N, Gardner MM, Campbell AJ. Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial. BMJ. 2001 Mar 24;322(7288):697-701. doi: 10.1136/bmj.322.7288.697.

ReferenceCitation: Lord SR, Castell S, Corcoran J, Dayhew J, Matters B, Shan A, Williams P. The effect of group exercise on physical functioning and falls in frail older people living in retirement villages: a randomized, controlled trial. J Am Geriatr Soc. 2003 Dec;51(12):1685-92. doi: 10.1046/j.1532-5415.2003.51551.x.

ReferenceCitation: Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14. doi: 10.1093/ageing/32.4.407.

ReferenceCitation: Day L, Fildes B, Gordon I, Fitzharris M, Flamer H, Lord S. Randomised factorial trial of falls prevention among older people living in their own homes. BMJ. 2002 Jul 20;325(7356):128. doi: 10.1136/bmj.325.7356.128.

ReferenceCitation: Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. doi: 10.1093/gerona/60.2.187.

ReferenceCitation: Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. doi: 10.1002/14651858.CD000340.

ReferenceCitation: Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.

ReferenceCitation: Lord SR, Tiedemann A, Chapman K, Munro B, Murray SM, Gerontology M, Ther GR, Sherrington C. The effect of an individualized fall prevention program on fall risk and falls in older people: a randomized, controlled trial. J Am Geriatr Soc. 2005 Aug;53(8):1296-304. doi: 10.1111/j.1532-5415.2005.53425.x.

ReferenceCitation: Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. doi: 10.1056/NEJM199409293311301.

ReferenceCitation: Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc. 2002 May;50(5):905-11. doi: 10.1046/j.1532-5415.2002.50218.x.

ReferenceCitation: Kannus P, Sievanen H, Palvanen M, Jarvinen T, Parkkari J. Prevention of falls and consequent injuries in elderly people. Lancet. 2005 Nov 26;366(9500):1885-93. doi: 10.1016/S0140-6736(05)67604-0.

ReferenceCitation: Wolf SL, Barnhart HX, Kutner NG, McNeely E, Coogler C, Xu T. Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J Am Geriatr Soc. 1996 May;44(5):489-97. doi: 10.1111/j.1532-5415.1996.tb01432.x.

ReferenceCitation: Buchner DM, Hornbrook MC, Kutner NG, Tinetti ME, Ory MG, Mulrow CD, Schechtman KB, Gerety MB, Fiatarone MA, Wolf SL, et al. Development of the common data base for the FICSIT trials. J Am Geriatr Soc. 1993 Mar;41(3):297-308. doi: 10.1111/j.1532-5415.1993.tb06708.x.

ReferenceCitation: El-Khoury F, Cassou B, Latouche A, Aegerter P, Charles MA, Dargent-Molina P. Effectiveness of two year balance training programme on prevention of fall induced injuries in at risk women aged 75-85 living in community: Ossebo randomised controlled trial. BMJ. 2015 Jul 22;351:h3830. doi: 10.1136/bmj.h3830.

ReferenceCitation: Castro-Lionard K, Dargent-Molina P, Fermanian C, Gonthier R, Cassou B. Use of calcium supplements, vitamin D supplements and specific osteoporosis drugs among French women aged 75-85 years: patterns of use and associated factors. Drugs Aging. 2013 Dec;30(12):1029-38. doi: 10.1007/s40266-013-0121-9.

collaborators: Institut national de prevention et d'education pour la sante

collaborators: Partenariats institutions-citoyens pour la recherche et l'innovation, Région Ile de France

location_facility: Centre de Recherche Clinique, CHU Amiens Sud

location_facility: Centre Hospitalier Universitaire Charles Nicolle

location_facility: Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier


title: Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer: A Phase II Trial

acronym: SKYLINE

summary: This is a phase II study, preceded by a safety run-in, with two independent cohorts (cohort A in early Triple Negative Breast Cancer (TNBC) patients and cohort B in late in metastatic TNBC patients) designed to evaluate the efficacy of atezolizumab, tiragolumab and chemotherapy.

ipd_sharing_description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Hoffmann-La Roche

intervention_type: Biological


title: Metabolic Reprogramming in Renal Tubular Cells in Acute Kidney Injury Following Severe Trauma

acronym: METAKIT

summary:
Severe trauma remains the leading cause of death in people under 50, and is associated with high morbidity, including severe disability, with a substantial socio-economic impact. Secondary to trauma, multiple mechanisms (inflammatory, ischemic, oxidative, etc.) setting in rapidly, leads to organ failure, one of the three first cause of death. Vascular damage, with vasoplegia, renal damage, with acute kidney injury (AKI), and pulmonary damage, with acute respiratory distress syndrome (ARDS), are the most frequently observed but all organs can be affected whatever the type of trauma. For these reasons, identifying the pathophysiological pathways involved in organ failure induced by severe trauma is a major step towards limiting the morbidity and mortality induced by trauma, and proposing therapies to prevent them.

Because of the variability of lesions in these patients, and the multiplicity of pathways activated, the mechanisms involved and their causality with organ failure following severe trauma, are still poorly understood. Given their frequency and importance in terms of morbidity and mortality, the investigators decided to take a particular interest in the mechanisms leading to renal and pulmonary injury. The investigators' hypothesis is that the study of urinary and blood markers not performed as part of clinical routine would provide a better understanding of the pathophysiological mechanisms leading to organ failure secondary to severe trauma, and more specifically to renal and pulmonary injuries. With TRAUMATEC study, the investigators will explore mechanisms leading to AKI and ARDS through blood and urine samples of 60 severe trauma patients sampled over the first 48 hours after ICU admission and a reference of 20 healthy volunteers.