title: Facilitation of Weaning From Ventilator by Loxapine

summary: Patients may be very agitated during the weaning period from mechanical ventilation. Administration of loxapine, a neuroleptic that does not notably affect ventilatory drive, may help in obtaining an adequate level of cooperation and, therefore, in reducing the duration of mechanical ventilation.

ReferenceCitation: Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91.

ReferenceCitation: Truman B, Ely EW. Monitoring delirium in critically ill patients. Using the confusion assessment method for the intensive care unit. Crit Care Nurse. 2003 Apr;23(2):25-36; quiz 37-8. Review. Erratum in: Crit Care Nurse. 2003 Jun;23(3):14.

location_facility: Service de Réanimation, Hopital Louis Mourier


title: Randomized Controlled Trial of Mechanical and Infectious Complications of Central Versus Peripheral Venous Catheters in ICU Patients

summary: The purpose of this study is to compare the mechanical and infectious complications of peripheral versus central venous catheters in critically ill patients. Group allocation will be performed by randomization.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Timsit JF. [Updating of the 12th consensus conference of the Société de Réanimation de langue française (SRLF): catheter related infections in the intensive care unit]. Ann Fr Anesth Reanim. 2005 Mar;24(3):315-22. Review. French.

ReferenceCitation: Polderman KH, Girbes AJ. Central venous catheter use. Part 1: mechanical complications. Intensive Care Med. 2002 Jan;28(1):1-17. Epub 2001 Dec 4. Review.

ReferenceCitation: Polderman KH, Girbes AR. Central venous catheter use. Part 2: infectious complications. Intensive Care Med. 2002 Jan;28(1):18-28. Epub 2001 Nov 29. Review.

ReferenceType: derived

ReferenceCitation: Ricard JD, Salomon L, Boyer A, Thiery G, Meybeck A, Roy C, Pasquet B, Le Mière E, Dreyfuss D. Central or peripheral catheters for initial venous access of ICU patients: a randomized controlled trial. Crit Care Med. 2013 Sep;41(9):2108-15. doi: 10.1097/CCM.0b013e31828a42c5.

family: Ricard

full_name: Jean-Damien Ricard

given: Jean-Damien

sequence: first

family: Salomon

full_name: Laurence Salomon

given: Laurence

sequence: additional

family: Boyer

full_name: Alexandre Boyer

given: Alexandre

family: Thiery

full_name: Guillaume Thiery

given: Guillaume

family: Meybeck

full_name: Agnes Meybeck

given: Agnes

family: Roy

full_name: Carine Roy

given: Carine

family: Pasquet

full_name: Blandine Pasquet

given: Blandine

family: Le Mière

full_name: Eric Le Mière

given: Eric

family: Dreyfuss

full_name: Didier Dreyfuss

given: Didier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Central or Peripheral Catheters for Initial Venous Access of ICU Patients

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Study of Program Interest "Bouge" to Improve the Daily Physical Activity and Tolerance in Processings Treatment of Pregnant Women

acronym: BOUGE GROSSESS

summary: Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest

location_facility:
CH de Morlaix
Clinique KERAUDREN
Chic Quimper
CHRU de Brest

status_simplified: Unknown


title: Multicentre, Open-label Phase 2 Trial Evaluating the Efficacy of CARBOPLATIN in Metastatic Prostate Cancer With Gene Alterations in the Homologous Recombination Pathway

acronym: PRO-CARBO

summary:
The investigators propose a phase II study to evaluate the efficacy of carboplatin monotherapy in the tumor subgroup of metastatic castration-resistant prostatic carcinomas with somatic abnormality in the Homologous Recombination (HR) pathway.

This study may also better characterize the molecular abnormalities of tumors required for the carboplatin response

status: Terminated

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Francois Baclesse

location_facility:
Chu Rouen
Centre François Baclesse
Institut Gustave ROUSSy IGR
Centre Oscar Lambret

intervention_type: Drug

lead_sponsor_type: industriel


title: Impact of Aspergillus on Chronic Obstructive Pulmonary Disease Evolution

acronym: AspergBPCO

summary: This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.

primary_purpose: Health Services Research

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU Amiens-Picardie
CHU St Quentin
Clinique de l'Europe
CH Abbeville

intervention_type: Diagnostic Test


title: A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study

summary:
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression.

Maintenance of virological suppression and immunological factors are also assessed.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere


title: Study of the Cognition of Patients Treated With

acronym: COG-IMMUNO

summary:
The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.

Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.

The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy

status: Recruiting

location_facility:
CHU CAEN
Centre François Baclesse
Chu Amiens
Chru Lille

intervention_type: Other

status_simplified: Ongoing


title: Efficiency of Antibacterial Prophylaxis (Levofloxacin) in Azacitidine Treated Patients

acronym: AZABAC

summary: Infections are a major life-threatening complication in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML). Currently there is no guidelines about antibacterial prophylaxis to prevent infections in patients with myelodysplastic syndrome or acute myeloid leukaemia. The investigators will conduct a randomized prospective study to evaluate the benefit of prophylactic antibacterial by levofloxacin on febrile episode in Azacytidine treated patients (MDS and AML).

lead_sponsor: Centre Henri Becquerel

location_facility:
CHU Caen
CHRU Lille
CHU Amiens
Centre Henri Becquerel


title: Exploration of Dyspnea at Non-high BNP

acronym: NEON HFpEF

summary:
Patients with unexplained stress dyspnea ( ≥ stage 2 NYHA), no significant underlying lung disease, with an ejection fraction > 50%, normal resting filling pressures, NTproBNP < 220 pg/ml in < 75 years, and < 450 pg/ml in ≥ 75 years will be studied with stress echocardiography and cardiometabolic stress test (VO2). These patients may have abnormal adaptation during exercise, suggesting that chronic symptoms may be related to a heart failure with preserved ejection fraction (HFPEF). More accurate and earlier diagnosis of HFPEF using stress echocardiography and VO2 may better manage stress dyspnea in patients and prevent progression of HFPEF.

A clinical assessment will be offered to people with unexplained stress dyspnea. The procedures and products used in this study are usually used as part of HFpEF's diagnostic strategy. During this assessment, carried out on an outpatient basis, an anamnesis collection, a cardiovascular clinical examination, an evaluation of dyspnea by the NYHA functional class and by 2 questionnaires, an electrocardiogram will be carried out, a 6-minute walk test, a biological blood test, a trans thoracic rest and stress cardiac ultrasound, respiratory functional tests (with diffusion capacity of lung for carbon monoxide (DLCO) and blood gas), and a metabolic stress test. A follow-up at 1 and 2 years is planned (visit, sampling and resting echocardiography).

study_type: Observational

time_perspective: Prospective

location_facility:
Hopital Bicêtre
Polyclinique de Poitiers
CHU Pontchaillou
CCM RANGUEIL - LARREY CHU toulouse


title: Coronary Artery Bifurcation Revascularization Without kIssing ballOon infLation by rEpoT: The CABRIOLET Study

acronym: CABRIOLET

summary:
The presence of a coronary bifurcation complicates percutaneous revascularization. Bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. Provisional stenting techniques with balloon juxtaposition as Kissing Balloon Inflation (KBI) fail to demonstrate a clinical benefits. This is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. A new sequential technique, named rePOT, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included KBI. RePOT associates an initial proximal optimizing technique (POT), a side branch inflation and a final POT.

A first clinical study (n=106 patients) confirmed these excellent mechanical results with serial OCT analysis and demonstrated an excellent short term safety. Since 2017, rePOT is recommended in Europe in clinical practice.

This large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with rePOT technique before a large randomise trial.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Département de cardiologie Hôpital Gabriel Montpied CHU de Clermont Ferrand

location_facility: Département de cardiologie Clinique Axium

location_facility: Fédération de cardiologie médicale - Hôpital Cardiologique Louis Pradel - Hospices civils de Lyon


title: Randomised Double Blinded Phase II AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptide (LIPO-5) Versus Placebo in Non Infected HIV Volunteers (ANRS VAC 18)

summary: This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 epitopes. LIPO-5 has been shown to be immunogenic and well tolerated in a first phase I trial in non-HIV infected volunteers. Lower doses of each peptide could have a similar immunogenicity.

ReferenceCitation: Richert L, Hue S, Hocini H, Raimbault M, Lacabaratz C, Surenaud M, Wiedemann A, Tisserand P, Durier C, Salmon D, Lelièvre JD, Chêne G, Thiébaut R, Lévy Y; ANRS Vaccine Network/Vaccine Research Institute. Cytokine and gene transcription profiles of immune responses elicited by HIV lipopeptide vaccine in HIV-negative volunteers. AIDS. 2013 Jun 1;27(9):1421-31. doi: 10.1097/QAD.0b013e32835f5b60.

family: Richert

full_name: Laura Richert

given: Laura

family: Hue

full_name: Sophie Hue

given: Sophie

family: Hocini

full_name: Hakim Hocini

given: Hakim

family: Raimbault

full_name: Mathieu Raimbault

given: Mathieu

family: Lacabaratz

full_name: Christine Lacabaratz

given: Christine

family: Surenaud

full_name: Mathieu Surenaud

family: Wiedemann

full_name: Aurélie Wiedemann

given: Aurélie

family: Tisserand

full_name: Pascaline Tisserand

given: Pascaline

family: Durier

full_name: Christine Durier

family: Salmon

full_name: Dominique Salmon

given: Dominique

family: Lelièvre

full_name: Jean-Daniel Lelièvre

given: Jean-Daniel

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

family: Thiébaut

full_name: Rodolphe Thiébaut

given: Rodolphe

family: Lévy

full_name: Yves Lévy

given: Yves

journal_name: AIDS

ReferenceCitation: Salmon-Céron D, Durier C, Desaint C, Cuzin L, Surenaud M, Hamouda NB, Lelièvre JD, Bonnet B, Pialoux G, Poizot-Martin I, Aboulker JP, Lévy Y, Launay O; ANRS VAC18 trial group. Immunogenicity and safety of an HIV-1 lipopeptide vaccine in healthy adults: a phase 2 placebo-controlled ANRS trial. AIDS. 2010 Sep 10;24(14):2211-23. doi: 10.1097/QAD.0b013e32833ce566.

family: Salmon-Céron

full_name: Dominique Salmon-Céron

family: Desaint

full_name: Corinne Desaint

given: Corinne

family: Cuzin

full_name: Lise Cuzin

given: Lise

family: Hamouda

full_name: Nadine Ben Hamouda

given: Nadine Ben


title: A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes (Intramuscular And Intradermal) in Healthy Adult Volunteers. ANRS VAC16 Trial

summary: Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.

ReferenceCitation: Launay O, Durier C, Desaint C, Silbermann B, Jackson A, Pialoux G, Bonnet B, Poizot-Martin I, Gonzalez-Canali G, Cuzin L, Figuereido S, Surenaud M, Ben Hamouda N, Gahery H, Choppin J, Salmon D, Guérin C, Bourgault Villada I, Guillet JG; ANRS VAC16 Study Group. Cellular immune responses induced with dose-sparing intradermal administration of HIV vaccine to HIV-uninfected volunteers in the ANRS VAC16 trial. PLoS One. 2007 Aug 22;2(8):e725.

location_facility: Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux

intervention_type: Biological


title: Efficacy and Tolerability of an Antiretroviral bi-Therapy in HIV-1 Infected Patients With Multidrug Resistant HIV ANRS 109 Vista Trial.

summary: This study investigated whether a calibrated reduction in antiretroviral drug pressures could stabilize the evolution and the pathogenic potential of resistant HIV viruses.

design_allocation: Non-Randomized

location_facility: Service de Medecine Interne hopital Avicenne


title: Arterial Calcifications: Role of Tissue-nonspecific Alkaline Phosphatase in Phosphate and Pyrophosphate Homeostasis. PIPAL Study.

acronym: PIPAL

summary: Vascular calcification is a common finding in chronic kidney disease and increases arterial stiffness leading to augmented cardiovascular morbidity. The calcification process is thoroughly regulated by pro and anticalcifying agents. The investigators hypothesize that imbalance in these compounds could depend on alkaline phosphatase activity. Therefore, the investigators will measure ALP activity, calcifications score, arterial stiffness and perform a bio-collection in monogenic rare diseases characterized by various levels of anticalcifying agents and in diverse CKD stages characterized by various levels of procalcifying compounds.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service de Médecine Vacsulaire - CHU d'ANGERS

location_facility: Service de Rhumatologie - Hôpital Cochin


type: Other Identifier

title: Determinants of the Long-Term Success of Bariatric Surgery "- Multicenter Regional Observational Study: Regional Multicentre Prospective Study

acronym: PRECOS

summary: The management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

lead_sponsor: University Hospital, Lille

location_facility:
Ch Boulogne-Sur-Mer
Hôpital Claude Huriez, CHU
CH ARRAS
Ch de Valenciennes


title: COrtical Superficial Siderosis and REcurrent Lobar Intracerebral Hemorrhage in Cerebral Amyloid Angiopathy.

acronym: CORELIA

summary:
Cerebral amyloid angiopathy (CAA) is a major cause of lobar intracerebral hemorrhage (ICH) in the elderly with high risk of recurrence.

The investigators aim to determine the relationship between cortical superficial siderosis (cSS), a MRI hemorrhagic marker of CAA and the risk of symptomatic ICH recurrence in a multicentric prospective cohort of patients with acute lobar ICH related to CAA. The investigators hypothesize that patients with cSS have an increased risk of recurrent symptomatic ICH relative to those without cSS.

lead_sponsor: University Hospital, Toulouse

location_facility:
Gui de Chauliac Hospital
CHU Purpan. Hôpital Pierre-Paul Riquet
Pellegrin Hospital
Lariboisière Hospital


title: Efficacy and Safety of the Association With Pentoxyphilline and Tocopherol on the Fibrosis in Patients With Chronic Hepatitis C

summary: The fibrosis of liver is a complication of chronic hepatitis C. There is actually no established treatment for fibrosis of the liver. Pentoxyphilline and tocopherol may have an activity on fibrosis. The aim of the study is to analyse the efficacy and the safety of the combination with pentoxyphilline and tocopherol (12 months) on liver fibrosis, in patients with chronic hepatitis C, who are non-long-term responders, or with intolerance or contra-indication to interferon-alfa and ribavirin.


title: Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126

summary: In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.

ReferenceCitation: Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Federspiel MC, Cherfils C, Costagliola D, Bonnefont-Rousselot D; French National Agency for AIDS and Viral Hepatitis Research (ANRS) 126 study group. Effects of rosuvastatin versus pravastatin on low-density lipoprotein diameter in HIV-1-infected patients receiving ritonavir-boosted protease inhibitor. AIDS. 2012 Sep 10;26(14):1801-5.

ReferenceCitation: Bittar R, Giral P, Aslangul E, Assoumou L, Valantin MA, Kalmykova O, Fesel-Fouquier V, Costagliola D, Bonnefont-Rousselot D; ANRS 126 study group. Determinants of low-density lipoprotein particle diameter during antiretroviral therapy including protease inhibitors in HIV-1-infected patients. Antivir Ther. 2012;17(5):855-60. doi: 10.3851/IMP2065. Epub 2012 Feb 9.

family: Bittar

full_name: Randa Bittar

given: Randa

family: Giral

full_name: Philippe Giral

given: Philippe

family: Aslangul

full_name: Elisabeth Aslangul

given: Elisabeth

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: Valantin

full_name: Marc-Antoine Valantin

given: Marc-Antoine

family: Kalmykova

full_name: Olga Kalmykova

given: Olga

family: Fesel-Fouquier

full_name: Valérie Fesel-Fouquier

given: Valérie

family: Costagliola

full_name: Dominique Costagliola

family: Bonnefont-Rousselot

full_name: Dominique Bonnefont-Rousselot

journal_name: Antiviral Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

location_facility: service de Médecine Interne Hopital Hotel Dieu


title: Comparative Value of a Serious Game and a Traditional Teaching Method to Improve Clinical Reasoning Skills Necessary to Detect Patient Deterioration: A Randomized Study in Nursing Students

summary: Detection of patient deterioration is a major healthcare problem. Indeed, acute clinical deterioration of the patient is often preceded by changes of several physiological parameters within 6 to 24h before the event occurs. The combination of i) early detection ii) rapid response and iii) efficient clinical management influences the patient's prognosis. Education of nurses, who are frontline healthcare providers, is therefore essential. Serious games might represent an interesting immersive educational tool to train a large number of healthcare professionals with high flexibility but assessment of their learning efficacy should be demonstrated. A serious game named LabforGames Warning has been developed for nursing students with the aims of improving their ability to detect clinical deterioration and to promote adequate interprofessional communication. The objective of this study will be to compare the respective value of digital simulation (using the above mentioned serious game) and a traditional teaching method to improve the clinical reasoning skills necessary to detect patient deterioration.

ReferenceCitation: Dory V, Gagnon R, Vanpee D, Charlin B. How to construct and implement script concordance tests: insights from a systematic review. Med Educ. 2012 Jun;46(6):552-63. doi: 10.1111/j.1365-2923.2011.04211.x. Review.

ReferenceCitation: Blanié A, Amorim MA, Benhamou D. Comparative value of a simulation by gaming and a traditional teaching method to improve clinical reasoning skills necessary to detect patient deterioration: a randomized study in nursing students. BMC Med Educ. 2020 Feb 19;20(1):53. doi: 10.1186/s12909-020-1939-6.

family: Blanié

full_name: Antonia Blanié

given: Antonia

family: Amorim

full_name: Michel-Ange Amorim

given: Michel-Ange

family: Benhamou

full_name: Dan Benhamou

given: Dan

currency_apc_doaj: GBP

journal_name: BMC Medical Education

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Université Paris-Sud

location_facility:
IFSI Paul Guiraud
IFSI Sud Francilien
IFSI etampes
IFSI Perray Vaucluse


title: A Phase II Of An Optimized LV-5FU-Oxaliplatin Strategy With Celebrex In Metastatic Colorectal Cancer, Optimox2-Celecoxib Study

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of colorectal cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining celecoxib with leucovorin, fluorouracil, and oxaliplatin in treating patients who have metastatic colorectal cancer.

ReferenceType: result

ReferenceCitation: André T, Tournigand C, Mineur L, Fellague-Chebra R, Flesch M, Mabro M, Hebbar M, Postel Vinay S, Bidard FC, Louvet C, de Gramont A. Phase II study of an optimized 5-fluorouracil-oxaliplatin strategy (OPTIMOX2) with celecoxib in metastatic colorectal cancer: a GERCOR study. Ann Oncol. 2007 Jan;18(1):77-81. doi: 10.1093/annonc/mdl336. Epub 2006 Oct 9.

family: André

full_name: T. André

given: T.

family: Tournigand

full_name: C. Tournigand

given: C.

family: Mineur

full_name: L. Mineur

given: L.

family: Fellague-Chebra

full_name: R. Fellague-Chebra

given: R.

family: Flesch

full_name: M. Flesch

given: M.

family: Mabro

full_name: M. Mabro

family: Hebbar

full_name: M. Hebbar

family: Postel Vinay

full_name: S. Postel Vinay

given: S.

family: Bidard

full_name: F.C. Bidard

family: Louvet

full_name: C. Louvet

family: de Gramont

full_name: A. de Gramont

given: A.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

intervention_type: Procedure


title: Duloxetine Versus Venlafaxine Extended Release in the Treatment of Major Depressive Disorder

summary: How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression

ReferenceCitation: Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4.

family: Dodd

full_name: Seetal Dodd

given: Seetal

family: Berk

full_name: Michael Berk

given: Michael

family: Kelin

full_name: Katarina Kelin

given: Katarina

family: Zhang

full_name: Qianyi Zhang

given: Qianyi

family: Eriksson

full_name: Elias Eriksson

given: Elias

family: Deberdt

full_name: Walter Deberdt

given: Walter

family: Craig Nelson

full_name: J. Craig Nelson

given: J.

journal_name: Journal of Affective Disorders

oa_host_type: repository

repository_institution: University of Melbourne - Minerva Access

version: acceptedVersion

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


type: Registry Identifier

title: A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma.

lead_sponsor: Children's Cancer and Leukaemia Group


title: Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.


title: Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC


title: Development of an Epileptic Seizure Detection Algorithm by Continuous Analysis of the Electrocardiogram

acronym: EPICARD

summary: The aim of our project is to develop an epileptic seizure detection algorithm based on the the continuous analysis of the Electrocardiogram

location_facility:
Hôpital Roger Salengro, CHU
Ch de Valencienne
Ch Bethune
Chu Amiens Salouël


title: Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer

summary:
RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors.

PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

primary_purpose: Diagnostic

lead_sponsor: UNICANCER

intervention_type: Radiation


title: Phase III Study of Combination Chemotherapy in Children With T Cell and Pre-B Cell Non-Hodgkin's Lymphoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase III trial to study the effectiveness of combination chemotherapy in treating children who have non-Hodgkin's lymphoma.

ReferenceCitation: Ducassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7.


title: Phase III Randomized Study of Cisplatin and Etoposide With or Without Epirubicin and Cyclophosphamide for Extensive Stage Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is more effective in treating patients with extensive stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without epirubicin and cyclophosphamide in treating patients who have extensive stage small cell lung cancer.

ReferenceCitation: Pujol JL, Daurès JP, Rivière A, Quoix E, Westeel V, Quantin X, Breton JL, Lemarié E, Poudenx M, Milleron B, Moro D, Debieuvre D, Le Chevalier T. Etoposide plus cisplatin with or without the combination of 4'-epidoxorubicin plus cyclophosphamide in treatment of extensive small-cell lung cancer: a French Federation of Cancer Institutes multicenter phase III randomized study. J Natl Cancer Inst. 2001 Feb 21;93(4):300-8.

ReferenceCitation: Pujol JL, Duares JP, Riviere A, et al.: Doublet etoposide - cisplatin (EP) versus quadruplet cisplatin - cyclophosphamide - epirubicin - etoposide (PCDE) in extensive disease small cell lung cancer (Ed-SCLC): a FNCLCC phase III multicenter study. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A-1892, 2000.


title: Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer

PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal cancer.


title: A PROSPECTIVE RANDOMISED NON SURGICAL TREATMENT OF OESOPHAGEAL CANCER WITH COMBINED CHEMOTHERAPY AND EXTERNAL BEAM IRRADIATION WITH VS WITHOUT HIGH-DOSE BRACHYTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether external-beam radiation therapy plus chemotherapy is more effective with or without internal radiation therapy.

PURPOSE: Randomized phase III trial to compare chemotherapy and external-beam radiation therapy with or without internal radiation therapy in treating patients with stage I, stage II, or stage III esophageal cancer.

lead_sponsor: Centre Hospitalier Lyon Sud

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud


title: A PROSPECTIVE RANDOMISED TRIAL OF INDUCTION CHEMOTHERAPY WITH 5-FU CONTINUOUS IV INFUSION AND CISPLATIN VERSUS SURGERY IN RESECTABLE ADENOCARCINOMA OF THE LOW THIRD OF THE ESOPHAGUS AND CARDIOESOPHAGEAL JUNCTION

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

ReferenceCitation: Boige V, Pignon J, Saint-Aubert B, et al.: Final results of a randomized trial comparing preoperative 5-fluorouracil (F)/cisplatin (P) to surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC ACCORD07-FFCD 9703 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-4510, 200s, 2007.

ReferenceCitation: Ychou M, Pignon JP, Lasser P, et al.: Phase III preliminary results of preoperative fluorouracil (F) and cisplatin (P) versus surgery alone in adenocarcinoma of stomach and lower esophagus (ASLE): FNLCC 94012-FFCD 9703 trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-4026, 2006.

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: INTERNATIONAL RANDOMIZED STUDY FOR THE SALVAGE TREATMENT OF GERM CELL TUMOURS

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow transplantation is a more effective treatment for men with germ cell tumors.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with bone marrow transplantation in treating men with relapsed germ cell tumors.


title: Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown PPC Z-M

acronym: PPC Z-M

summary:
Preformed metal pediatric crowns (PPCm) are currently considered the best method of restoring Primary molars affected by severe carious lesions compared to restorations made with various restorative materials (amalgams, composites, CVI-based materials). Due to their unsightly appearance, denounced by many parents, more aesthetic zirconia (PPCz) preformed pediatric crowns have been recently marketed. In the absence of an evaluation of the latter, this multi-center split-mouth two-year randomized clinical trial (RCT) proposes to to investigate the effectiveness of PPCz for the management of dental caries or structural anomalies. More specifically, the primary objective of this RCT is to assess in primary molars the success of PPCz in comparison with PPCm. The control treatment will be PPCm since this is the standard crown option.

One hundred children and one aged at least 4 years must be recruited in ninedepartments of Pediatric Dentistry in the university hospitals of Bordeaux, Lille, Nancy, Nantes, Nice, Paris 1&2, Strasbourg and Toulouse. They will be included if they have two similar primarymolars of the same arch (for example first right and left maxillary primary molars ) and equally affected, to be crowned. The two types of crowns to be used in the same child, PPCm(3M Espe) and PPCz(Ezpédo), will be affected by randomization using a computerized and centralized system: primary molars will first be allocated to PPCm and, one to two weeks later, the contralateral primary molar will be restored by PPCz. The children will be checked every 6 months for a period of 2 years after the placement of the two types of crowns . During these four control visits, primary and secondary outcomes will be assessed clinically and radiographically. The primary outcome is the success of the treatment defined by the absence of major failure. A composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis will be used to define major failure (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph). The secondary outcomes are parental and child satisfaction (size, form and color), retention and fracture of the PPC, the wear of the antagonist tooth, the gingival state near PPC using the indices Löe and Silness to record plaque index (PI), gingival index (GI) and depth of the pocket (DI) on the crowned tooth and the two adjacent ones. Each center has a trained and / or calibrated operator and evaluator.

ReferenceCitation: Lopez-Cazaux S, Aiem E, Velly AM, Muller-Bolla M. Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial. Trials. 2019 Aug 24;20(1):530. doi: 10.1186/s13063-019-3559-1.

family: Lopez-Cazaux

full_name: Serena Lopez-Cazaux

given: Serena

family: Aiem

full_name: Elody Aiem

given: Elody

family: Velly

full_name: Ana Miriam Velly

given: Ana Miriam

family: Muller-Bolla

full_name: Michèle Muller-Bolla

given: Michèle

journal_name: Trials

location_facility:
CHU Stransbourg
CHRU Lille
CHU de Nice
CHU de Nantes


title: Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.

acronym: ADHESIPH

summary:
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation.

Patients will be randomized into one of two study arms:

Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist.

Arm B: Standard follow-up during the treatment period.

Patients will be followed during 6 months.

status: Active, not recruiting

lead_sponsor: Institut Claudius Regaud

location_facility: Centre Hospitalier Intercommunal Castres Mazamet


title: Improvement of Nutritional Status in Elderly Residents of Long-term Facilities: Impact of Two Strategies (Oral Care and Dietary Control)

acronym: Nutrident

summary:
Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven.

The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
AP-HP, Louis Mourier Hospital
AP-HP, Hôpital René Muret-Bigottini
Institut ROGUET
Hôpital de Puteaux
Centre gérontologie Les Abondances
Hôpital Bretonneau


type: EudraCT Number

title: Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?

acronym: GLIAPARK

summary: Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa (TSPO) by Positron Emission Tomography (PET).

lead_sponsor: Nantes University Hospital

location_facility:
Centre Eugène Marquis
CHU de Rennes
CHU de Tours
CHU de Nantes


acronym: BABH

location_facility:
CHU d'Angers
Hôpital Ambroise Paré
CHU de Montpellier Hôpital St Eloi
Hôpital Femme Mère Enfant

source: euctr

title: BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT). A National, Multicenter Phase III Study

summary:
The recognized manifestations of HHT are all due to abnormalities of vascular structure. Epistaxis and digestive arteriovenous malformations may be responsible for severe hemorrhages in 5% of HHT patients, requiring repeated blood transfusions and are associated with high morbidity. There is currently no standard and efficient management of this severe symptom. It is also well known that HHT-associated hemorrhages have the greatest negative impact on quality of life among HHT patients, and is responsible for anemia, blood transfusions, hospitalizations, depressive syndrome and a high psycho-social impact.

Since 2006, it has been suggested by animal models and then by clinical reports that anti-VEGF therapy may be useful to treat HHT. 4 case reports have been published on efficacy of intravenous bevacizumab, a humanized monoclonal antibody in HHT on severe hemorrhages.

Intravenous bevacizumab has been used in a previous clinical trial to measure efficacy and tolerance of this drug in HHT patients with severe liver involvement. Furthermore, a reduction was observed in the duration of the nosebleeds after treatment and was encouraging to treat bleeding. We completed this study by a pharmacokinetic-pharmacodynamic (PK-PD) model in order to assess the individual concentration-effect relationship of bevacizumab.

However, no randomized prospective study has been performed and published to evaluate the efficacy in this indication. A total of 24 patients will be randomized versus placebo in a multicenter phase III trial. The Avastin or placebo will be infused at 5mg/kg every 14 days with a total of 6 cures with a 3 months following period.


title: Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial

acronym: NIVOLD

summary: Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.

lead_sponsor: University Hospital, Rouen

location_facility:
CH Elbeuf
CHU de Rouen
CH Dieppe
Le Havre, Jacques Monod Hospital


title: Usefulness of a Visual Analogue Scale to Evaluate Anxiety in the Painful Hospitalized Patient

acronym: EVANX

summary: Today, there is no simple tool for measuring patient anxiety. The primary purpose of this study is to evaluate the ability of the Visual Analogue Scale (VAS) to measure anxiety in painful hospitalized patients, and to correlate it to STAI-Ya and HAD-7A auto questionnaires.

lead_sponsor: Lille Catholic University

location_facility:
Lille Catholic Hospitals
Roubaix Hospital
Tourcoing hospital
Wattrelos hospital


title: Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation

acronym: MUMOFRAT

summary: Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control

lead_sponsor: University Hospital, Brest

location_facility:
Centre Eugène Marquis
Clinique d'Oncologie et Radiothérapie
Institut de Cancérologie de l'Ouest
CHRU de Brest


ReferenceCitation: Boilève A, Maillard A, Wagner M, Dromain C, Laurent C, Dupont Bierre E, Le Sourd S, Audemar F, Ulusakarya A, Guerin-Meyer V, Smisth D, Pezzella V, De Baere T, Goere D, Gelli M, Taieb J, Boige V. Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol. BMC Cancer. 2020 Jan 30;20(1):74. doi: 10.1186/s12885-020-6571-7.

family: Boilève

full_name: Alice Boilève

given: Alice

family: Maillard

full_name: Aline Maillard

given: Aline

family: Wagner

full_name: Mathilde Wagner

given: Mathilde

family: Dromain

full_name: Clarisse Dromain

given: Clarisse

family: Laurent

full_name: Christophe Laurent

given: Christophe

family: Dupont Bierre

full_name: Eric Dupont Bierre

given: Eric

family: Le Sourd

full_name: Samuel Le Sourd

given: Samuel

family: Audemar

full_name: Franck Audemar

given: Franck

family: Ulusakarya

full_name: Ayhan Ulusakarya

given: Ayhan

family: Guerin-Meyer

full_name: Veronique Guerin-Meyer

given: Veronique

family: Smisth

full_name: Denis Smisth

given: Denis

family: Pezzella

full_name: Veronica Pezzella

given: Veronica

family: De Baere

full_name: Thierry De Baere

given: Thierry

family: Goere

full_name: Diane Goere

given: Diane

family: Gelli

full_name: Maximiliano Gelli

given: Maximiliano

family: Taieb

full_name: Julien Taieb

given: Julien

family: Boige

full_name: Valérie Boige

given: Valérie

journal_name: BMC Cancer

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

repository_normalized: HAL

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

title: Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy – a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol

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

location_facility:
Ico Paul Papin
Gustave Roussy
Centre Eugene Marquis
Chp Saint Gregoire

title: A Randomized Phase II Study Comparing Treatment Intensification With CIAH Plus Systemic Chemotherapy to Systemic Chemotherapy Alone in Patients With Liver-only Colorectal Metastases Considered Still Non Resectable After at Least Two Months of Systemic Induction Chemotherapy

summary: National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy.


title: Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease

acronym: IMPACT

summary: The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

time_perspective: Other

lead_sponsor: University Hospital, Grenoble

location_facility: Centre Expert Régional pour la maladie de Parkinson


title: Welcoming Patients in Emergency Departments: Impact of the Mediator

acronym: MEDIA

summary:
Violence in the workplace is becoming a serious phenomenon in the contemporary world of work. Hospital staff, like any employee working in contact with the public, is particularly exposed to this violence. In emergency departments, the number of patients treated and their heterogeneity, the problems of communicating with healthcare professionals, and waiting times, favor conflict situations. In the already tense context of the emergencies, the incivilities or violent acts have an impact on the well-being of professionals. In order to prevent these situations of violence, a solution could be to integrate a professional with specific skills into the teams to perform mediation functions between caregivers and patients.

The aim of the study is to evaluate the impact of the presence of a mediator in emergency services on personal (verbal or physical) attacks on professionals (caregivers, doctors, administrative staff).

ReferenceCitation: Charrier P, Occelli P, Buchet-Poyau K, Douplat M, Delaroche-Gaudin M, Fayard-Gonon F, Jacquin L, Potinet V, Sigal A, Tazarourte K, Touzet S. Strategies used by emergency care professionals to handle interpersonal difficulties with patients: a qualitative study. BMJ Open. 2021 Feb 8;11(2):e042362. doi: 10.1136/bmjopen-2020-042362.

family: Charrier

full_name: Philippe Charrier

given: Philippe

family: Occelli

full_name: Pauline Occelli

given: Pauline

family: Buchet-Poyau

full_name: Karine Buchet-Poyau

given: Karine

family: Douplat

full_name: Marion Douplat

given: Marion

family: Delaroche-Gaudin

full_name: Marine Delaroche-Gaudin

given: Marine

family: Fayard-Gonon

full_name: Florence Fayard-Gonon

given: Florence

family: Jacquin

full_name: Laurent Jacquin

given: Laurent

family: Potinet

full_name: Véronique Potinet

given: Véronique

family: Sigal

full_name: Alain Sigal

given: Alain

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Touzet

full_name: Sandrine Touzet

given: Sandrine

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'accueil des urgences - Centre hospitalier Lyon Sud - HCL

location_facility: Service médical d'accueil des urgences - Hôpital de la Croix Rousse - HCL

location_facility: Service d'urgences médicales et chirurgicales - Hôpital Edouard Herriot - HCL

location_facility: Pôle Information Médicale, Evaluation, Recherche - Hospices Civils de Lyon

intervention_type: Behavioral


title: FDG PET Evaluation for Marginal Zone Lymphoma and Its Prognostic Role: an International Multicenter Retrospective Analysis

acronym: PIMENTO

summary:
The general aim of the present study is to assess the role of PET for the staging and for the assessment of response and outcome prediction in Marginal Zone Lymphoma (MZL). This study will be conducted as a multicenter retrospective analysis of MZL for whom PET scan are available as DICOM file for central review.

The study is designed as a retrospective collection of patients with MZL enrolled in the prospective IELSG36 and IELSG38 trials sponsored by IELSG and in the observational NF10 study sponsored by Federazione Italiana Linfomi (FIL), with the possibility to add additional cases from participating institutions.

The study will be conducted on performed scans. No additional scan or procedure will be required for study purposes.

The study will be divided into two sections with different aims:

Part A will be conducted to understand the role of PET for the staging of MZL. PET scans will be analyzed and compared with data retrieved from CT scan and from other staging procedures, also including bone marrow biopsy, ultrasound, and laboratory exams. This part of the study will describe ability of PET to identify pathologic lesions and to contribute to staging definition or to stage migration.

Part B will be conducted to validate standardized criteria for response assessment in MZL including FDG-PET among procedures and to define the prognostic role of metabolic response in MZL. For this purpose the primary endpoint for this part of the study is defined as the progression free survival. Secondary endpoint will be Overall survival, and response rate defined with conventional procedures and rate of histological transformation.

time_perspective: Retrospective

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Italy France Switzerland

location_facility: Fondazione IRCCS - Cà Granda Ospedale Maggiore Policlinico

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: IRCCS Centro di Riferimento Oncologico di Aviano

location_facility: "G. Rodolico", AOU Policlinico Vittorio Emanuele

location_facility: Istituto Oncologico della Svizzera Italiana

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Fondazione IRCCS Policlinico S. Matteo di Pavia

location_facility: Azienda Ospedaliera - Ospedale di Circolo e Fondazione Macchi di Varese


title: Totum-63 Effect on Glucose and Lipid Homeostasis in People With Abdominal Obesity Associated With Impaired Glucose Tolerance or Untreated Type 2 Diabetes and Hypertriglyceridemia

acronym: TOTUM-63 TWO

summary: Given the data on the active ingredients of Totum-63, this research aims to evaluate the effect of its chronic consumption (24 weeks) on glucose and lipid homeostasis and especially on fasting plasma glucose in volunteers with abdominal obesity associated with impaired glucose tolerance or untreated type 2 diabetes and hypertriglyceridemia. This clinical study is designed to estimate the effect of Totum-63, active ingredient of Valedia, on several glucose and lipid homeostasis related parameters since these data are still unknown for this specific dietary supplement formula. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.

lead_sponsor: Valbiotis

location_country: Slovenia Ireland Serbia France

location_facility: University Medical Centre Ljubljana / Poseidon CRO

location_facility: Clinical Center of Vojvodina / Poseidon CRO

location_facility: Biofortis Mérieux NutriSciences Clinical Investigation Center

location_facility: Clinical center of Kragujevac, / Poseidon CRO

intervention_type: Dietary Supplement


title: Assessment of Continuous Measurement of Transcutaneous CO2 for Evaluation of Alveolar Dead Space During Exercise.

acronym: TEASE

summary:
The study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of Pt CO2, which would be used as a surrogate for arterial PaCO2. Validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the CO2 diffusion from the arterial compartment (PaCO2) to the cutaneous one (PtCO2), in particular when rapid changes of CO2 might be induced by exercise.

The evaluation will be done in 2 different settings:

intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between PaCO2 and PtCO2 readouts;
routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling.

Following assessment of validity of the measurement (and the lag time PaCO2-PtCO2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: Healthy subjects, patients with Chronic Obstructive Pulmonary Disease (COPD), chronic heart failure (CHF), hyperventilation, Pulmonary artery hypertension (PAH), or interstitial lung disease (ILD)

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
Service de Pneumologie CHU Grenoble
Service de réanimation médicale - CHMS
Service de pneumologie CHMS
Service de pneumologie


title: Evaluation of the Beckman Coulter Access Hepatitis B Virus (HBV) Serological Marker Assays as an Aid in the Diagnosis of HBV Infection: EU Clinical Trial Protocol

summary:
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.

The study will involve a multicenter, prospective and retrospective collection of samples, and testing of samples with the investigational Hepatitis B Virus assays as required per the European Union Common Technical Specification. All samples collected will be anonymized or pseudo-anonymised, leftover, remnant samples. Pseudo-anonymised collection of samples will require documented patient consent (oral or written).

lead_sponsor: Beckman Coulter, Inc.

location_facility: Centre de Ressources Biologiques Biobanque de Picardie CHU Amiens-Picardie

location_facility: Laboratoire de Virologie, Laboratoire associé au CNR du VIH Institut de Biologie Clinique ; hôpital C : Nicolle, CHU Rouen

location_facility: Etablissement Français du Sang (EFS) Hauts-de-France - Normandie


title: SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

acronym: SMART

summary: The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

ReferenceCitation: Herrmann HC, Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Verdoliva S, Chang Y, Gada H, Gillam L, Guerrero M, Mahoney PD, Petronio AS, Rogers T, Rovin J, Szerlip M, Whisenant B, Mehran R, Tchetche D. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J. 2021 Sep 26;243:92-102. doi: 10.1016/j.ahj.2021.09.011. [Epub ahead of print]

family: Herrmann

full_name: Howard C. Herrmann

given: Howard C.

family: Abdel-Wahab

full_name: Mohamed Abdel-Wahab

given: Mohamed

family: Attizzani

full_name: Guilherme F. Attizzani

given: Guilherme F.

family: Batchelor

full_name: Wayne Batchelor

given: Wayne

family: Bleiziffer

full_name: Sabine Bleiziffer

given: Sabine

family: Verdoliva

full_name: Sarah Verdoliva

given: Sarah

family: Chang

full_name: Yanping Chang

given: Yanping

family: Gada

full_name: Hemal Gada

given: Hemal

family: Gillam

full_name: Linda Gillam

given: Linda

family: Guerrero

full_name: Mayra Guerrero

given: Mayra

family: Mahoney

full_name: Paul D. Mahoney

given: Paul D.

family: Petronio

full_name: Anna Sonia Petronio

given: Anna Sonia

family: Rogers

full_name: Toby Rogers

given: Toby

family: Rovin

full_name: Joshua Rovin

given: Joshua

family: Szerlip

full_name: Molly Szerlip

given: Molly

family: Whisenant

full_name: Brian Whisenant

given: Brian

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Tchetche

full_name: Didier Tchetche

given: Didier

journal_name: American Heart Journal

title: Rationale and Design of the Small Annuli Randomized to EvolutTM or SAPIENTM Trial (SMART Trial)

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
Netherlands
Germany
Finland
France
Israel
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Hospital of the University of Pennsylvania

location_facility: Victoria Heart Institute Foundation/Royal Jubilee Hospital

location_facility: Texas Health Presbyterian Hospital/Dallas

location_facility: University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

location_facility: Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum

location_facility: Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund

location_facility: The Icahn School of Medicine at Mount Sinai

location_facility: University Hospitals Cleveland Medical Center

location_facility: St. Michaels Hospital/Unity Health Toronto

location_facility: AscensionVia Christi St. Francis Hospital


title: Identification of Dysglycemia With Continuous Glucose Monitoring: A Prospective Study to Assess the Relationship With Clinical Evolution in Cystic Fibrosis

acronym: ProspeC-F

summary:
Cystic fibrosis (CF)-related diabetes (CFRD) is the most important emerging complication after pulmonary complications. This specific form of diabetes is associated with an increased morbidity and mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while a similar percentage is afflicted with milder dysglycemia also called pre-diabetes abnormalities.

In order to identify patients at risk and to implement early therapeutic measures, an annual CFRD screening test is recommended for CF patients after 10 years of age. The standard 2-hour oral glucose tolerance test (OGTT) is the recommended screening test. However, this test is perceived by both patients and CF care teams as unpleasant while adding a significant burden and workload, resulting in screening rates lower than 50% in most centers. An ideal alternative test should be simpler, less invasive, more sensitive than an OGTT to establish risks for lung function and/or nutritional deterioration, and predict future CFRD risk. To date, compared to the OGTT, no alternative screening method has demonstrated its effectiveness. However, continuous glucose monitoring (CGM) is emerging as a possible alternative method.

In patients living with CF, CGM is easy to use and can identify early dysglycemia, which in turn, can predict increased risk of accelerated decline of pulmonary function and/or weight, higher risk of pseudomonas colonization, and future risk of CFRD. However, these observations are based on studies of small sample size with very limited prospective data. Furthermore, many of the multiple CGM metrics that have been standardized are based on the risk of complications associated with Type 1 and Type 2 Diabetes.

Thus, there is a need for prospective studies to identify the CGM metrics and the cut-off level that is relevant as a predictor of clinical deterioration and/or CFRD risk in CF. The identification of such CF-specific criteria would provide important information to target at-risk patients.

lead_sponsor: Institut de Recherches Cliniques de Montreal

location_country: Canada France

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Institut de recherches cliniques de Montréal


title: Evaluation of the Implementation and Results of the Health Digital Territories Program in the Five Pilot Territories (EvaTSN Project )

acronym: EvaTSN

summary: The aim is to evaluate a national health information technology-based program to improve healthcare coordination and access to information.

ReferenceCitation: Saillour-Glénisson F, Duhamel S, Fourneyron E, Huiart L, Joseph JP, Langlois E, Pincemail S, Ramel V, Renaud T, Roberts T, Sibé M, Thiessard F, Wittwer J, Salmi LR; EvaTSN Research group. Protocole of a controlled before-after evaluation of a national health information technology-based program to improve healthcare coordination and access to information. BMC Health Serv Res. 2017 Apr 21;17(1):297. doi: 10.1186/s12913-017-2199-y.

apc_source: openAPC

family: Saillour-Glénisson

full_name: Florence Saillour-Glénisson

given: Florence

family: Duhamel

full_name: Sylvie Duhamel

given: Sylvie

family: Fourneyron

full_name: Emmanuelle Fourneyron

given: Emmanuelle

family: Huiart

full_name: Laetitia Huiart

given: Laetitia

family: Joseph

full_name: Jean Philippe Joseph

given: Jean Philippe

family: Langlois

full_name: Emmanuel Langlois

given: Emmanuel

family: Pincemail

full_name: Stephane Pincemail

given: Stephane

family: Ramel

full_name: Viviane Ramel

given: Viviane

family: Renaud

full_name: Thomas Renaud

given: Thomas

family: Roberts

full_name: Tamara Roberts

given: Tamara

family: Sibé

full_name: Matthieu Sibé

given: Matthieu

family: Thiessard

full_name: Frantz Thiessard

given: Frantz

family: Wittwer

full_name: Jerome Wittwer

given: Jerome

family: Salmi

full_name: Louis Rachid Salmi

given: Louis Rachid

journal_name: BMC Health Services Research

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

location_facility: Agence régionale de santé de Rhône Alpes

location_facility: Agence Régionale de Santé (ARS) Ile-de-France


title: A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, Compared With Placebo in Combination With Docetaxel, in Patients Receiving Second Line Treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)

summary: The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients.

ReferenceCitation: Soria JC, Fülöp A, Maciel C, Fischer JR, Girotto G, Lago S, Smit E, Ostoros G, Eberhardt WEE, Lishkovska P, Lovick S, Mariani G, McKeown A, Kilgour E, Smith P, Bowen K, Kohlmann A, Carlile DJ, Jänne PA. SELECT-2: a phase II, double-blind, randomized, placebo-controlled study to assess the efficacy of selumetinib plus docetaxel as a second-line treatment of patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2017 Dec 1;28(12):3028-3036. doi: 10.1093/annonc/mdx628.

family: Soria

full_name: J.-C. Soria

family: Fülöp

full_name: A. Fülöp

given: A.

family: Maciel

full_name: C. Maciel

given: C.

family: Fischer

full_name: J.R. Fischer

family: Girotto

full_name: G. Girotto

given: G.

family: Lago

full_name: S. Lago

given: S.

family: Smit

full_name: E. Smit

given: E.

family: Ostoros

full_name: G. Ostoros

family: Eberhardt

full_name: W.E.E. Eberhardt

family: Lishkovska

full_name: P. Lishkovska

given: P.

family: Lovick

full_name: S. Lovick

family: Mariani

full_name: G. Mariani

family: McKeown

full_name: A. McKeown

family: Kilgour

full_name: E. Kilgour

family: Smith

full_name: P. Smith

family: Bowen

full_name: K. Bowen

given: K.

family: Kohlmann

full_name: A. Kohlmann

family: Carlile

full_name: D.J. Carlile

family: Jänne

full_name: P.A. Jänne

oa_colors: green hybrid

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
Brazil
Netherlands
Germany
France
Bulgaria
Poland
Hungary
United States


title: Prevalence of Fabry's Disease in a Population of Patients With Chronic Pain

acronym: DOUFABIS

summary: Fabry disease is a rare inherited metabolic disorder that predominantly affects heart, kidneys and nervous system. Fabry disease has been searched in series of patients presenting different isolated signs caused by the affection of one of these organs. Acroparesthesias and chronic crises of pain of different origins are reported in the large majority of patients during the progression of the disease. Moreover, this signs are frequently inaugurating the disease. The investigators have previously performed a preliminary single-center study which permitted to identify one female patient with Fabry disease in a series of 147 consecutive patients with chronic pain tested. The investigators now propose to confirm the results of our preliminary study. The investigators plan to evaluate the prevalence of Fabry disease in a series of 1000 patients suffering from chronic pains of undetermined aetiology and consecutively recruited.

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Douleurs Chroniques, CH de la Côte Basque

location_facility: Centre d'évaluation et de traitement de la Douleur, Hôpital Pierre-Paul Ricquet

location_facility: Centre Douleurs Chroniques, CHU de Bordeaux

location_facility: Pôle Anesthésie Consultation douleur, CHRU de Lille

location_facility: Service de Médecine de la Douleur et de Médecine Palliative, Hôpital Lariboisière-APHP

location_facility: Centre de la Douleur, CHRU de Strasbourg

location_facility: CeRCa, Unité de Neuromyologie, CHU de Fort de France

location_facility: Service de lutte contre la douleur et d'Anesthésie, CH Périgueux

location_facility: Centre de la douleur de l'Adulte et de l'Enfant, CHU de Grenoble

location_facility: Médecine - Consultations Douleur, CH de La Réole

location_facility: Unité Douleur et Soins Palliatifs, CH La Rochelle-Réaunis

location_facility: Service d'Explorations Fonctionnelles et Consultations Neurologiques, CH Lyon-Sud

location_facility: Centre d'Evaluation et de Traitement de la Douleur, CHU de Nîmes

location_facility: Service de médecine Polyvalent, CH de La Dracénie

location_facility: Centre d'Analgésie Pédiatrique, Equipe Régionale Ressource en Soins Palliatifs-Equipe " Enfant-Do ", CHU de Toulouse

location_facility: Cs douleur chronique GHSR, CHU Sud Réunion

location_facility: Pole enfant - CETD Salengro, CHRU de Lille

intervention_type: Genetic


title: Long Term Prognostic of Neonatal Hypoxic Ischemic Encephalopathy in the Era of Neuroprotective Treatment With Hypothermia

acronym: LyTONEPAL

summary:
The primary objective is to evaluate neonatal characteristics, and biological and clinical investigations as predictive factors of death, or of severe and moderate neurodevelopmental disability at 3 years, in a large population-based cohort of full-term and late preterm neonates with moderate or severe HIE.

Contrary to most previous studies which have often analyzed the accuracy of one factor among all other clinical investigations, the investigators objective's is to seek a relevant combination of several factors among the following list:

Neonatal characteristics: gestational age and birthweight, maternal disease, acute intrapartum event, delivery mode, acidosis, neurological examination, place of birth and neonatal transfer
Laboratory investigations: pH, lactates and new biological markers as detailed below
Clinical investigations: aEEG, EEG, MRI, diffusion-weighted MRI

ReferenceCitation: Volpe JJ. Neonatal encephalopathy: an inadequate term for hypoxic-ischemic encephalopathy. Ann Neurol. 2012 Aug;72(2):156-66. doi: 10.1002/ana.23647.

ReferenceCitation: Use and abuse of the Apgar score. Committee on Fetus and Newborn, American Academy of Pediatrics, and Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Pediatrics. 1996 Jul;98(1):141-2.

ReferenceCitation: Fenichel GM. Hypoxic-ischemic encephalopathy in the newborn. Arch Neurol. 1983 May;40(5):261-6. Review.

ReferenceCitation: Levene ML, Kornberg J, Williams TH. The incidence and severity of post-asphyxial encephalopathy in full-term infants. Early Hum Dev. 1985 May;11(1):21-6.

ReferenceCitation: Beck J, Bednarek N, Pierrat V, Vilotitch A, Loron G, Alison M, Guellec I, Hertz-Pannier L, de Launay C, Ego A, Vo-Van P, Ancel PY, Debillon T. Cerebral injuries in neonatal encephalopathy treated with hypothermia: French LyTONEPAL cohort. Pediatr Res. 2021 Nov 20. doi: 10.1038/s41390-021-01846-3. [Epub ahead of print]

family: Beck

full_name: Jonathan Beck

given: Jonathan

family: Bednarek

full_name: Nathalie Bednarek

given: Nathalie

family: Pierrat

full_name: Véronique Pierrat

given: Véronique

family: Vilotitch

full_name: Antoine Vilotitch

given: Antoine

family: Loron

full_name: Gauthier Loron

given: Gauthier

family: Alison

full_name: Marianne Alison

given: Marianne

family: Guellec

full_name: Isabelle Guellec

given: Isabelle

family: Hertz-Pannier

full_name: Lucie Hertz-Pannier

given: Lucie

family: de Launay

full_name: Catherine de Launay

given: Catherine

family: Ego

full_name: Anne Ego

given: Anne

family: Vo-Van

full_name: Philippe Vo-Van

given: Philippe

family: Ancel

full_name: Pierre-Yves Ancel

given: Pierre-Yves

family: Debillon

full_name: Thierry Debillon

given: Thierry

journal_name: Pediatric Research

ReferenceCitation: Debillon T, Bednarek N, Ego A; LyTONEPAL Writing Group. LyTONEPAL: long term outcome of neonatal hypoxic encephalopathy in the era of neuroprotective treatment with hypothermia: a French population-based cohort. BMC Pediatr. 2018 Aug 1;18(1):255. doi: 10.1186/s12887-018-1232-6.

journal_name: BMC Pediatrics

repository_institution: University of Geneva - Archive ouverte UNIGE

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

location_facility:
CHU St Pierre
Chu Strasbourg
CHU Montpellier
Chru Lille
Chu La Miletrie
Chu Bordeaux
CHU St Denis
CHU Clermond-Ferrand
Chu Grenoble
Chu Besancon
Chu Limoges
Chu Marseille
Chu Reims
Chu Rouen
Chu Tours
CHU FORT de France
Chi Creteil
Chu Brest
CHU CAEN
Chu Dijon
Chu Amiens
Chu Toulouse


title: Comparison of Subclavian, Femoral and Internal Jugular Venous Catheterization in Term of Complications in the Intensive Care Unit: a Randomized Controlled Trial

summary:
Central venous catheters are needed in the critical care setting to administer drugs. Three sites are available to gain vascular access: subclavian, internal jugular and femoral. Each site has complications, but there is no randomized controlled study which compared the 3 sites.

The investigators hypothesis is that subclavian catheterization reduces the risk of major complications compared to internal jugular or femoral.

ReferenceCitation: Parienti JJ, Mongardon N, Mégarbane B, Mira JP, Kalfon P, Gros A, Marqué S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.

family: Parienti

full_name: Jean-Jacques Parienti

given: Jean-Jacques

family: Mongardon

full_name: Nicolas Mongardon

given: Nicolas

family: Mégarbane

full_name: Bruno Mégarbane

given: Bruno

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Kalfon

full_name: Pierre Kalfon

given: Pierre

family: Gros

full_name: Antoine Gros

family: Marqué

full_name: Sophie Marqué

given: Sophie

family: Thuong

full_name: Marie Thuong

given: Marie

family: Pottier

full_name: Véronique Pottier

family: Ramakers

full_name: Michel Ramakers

given: Michel

family: Savary

full_name: Benoît Savary

given: Benoît

family: Seguin

full_name: Amélie Seguin

given: Amélie

family: Valette

full_name: Xavier Valette

given: Xavier

family: Terzi

full_name: Nicolas Terzi

family: Sauneuf

full_name: Bertrand Sauneuf

given: Bertrand

family: Cattoir

full_name: Vincent Cattoir

given: Vincent

family: Mermel

full_name: Leonard A. Mermel

given: Leonard A.

family: du Cheyron

full_name: Damien du Cheyron

given: Damien

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Pages J, Hazera P, Mégarbane B, du Cheyron D, Thuong M, Dutheil JJ, Valette X, Fournel F, Mermel LA, Mira JP, Daubin C, Parienti JJ; 3SITES Study Group. Comparison of alcoholic chlorhexidine and povidone-iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study. Intensive Care Med. 2016 Sep;42(9):1418-26. doi: 10.1007/s00134-016-4406-4. Epub 2016 Jun 16.

family: Pages

full_name: Justine Pages

given: Justine

family: Hazera

full_name: Pascal Hazera

given: Pascal

title: Comparison of alcoholic chlorhexidine and povidone–iodine cutaneous antiseptics for the prevention of central venous catheter-related infection: a cohort and quasi-experimental multicenter study

location_facility: Polyvalent Intensive Care Unit, Mémorial France Etats-Unis

location_facility: Médical Intensive Care Unit, Lariboisière, AP-HP

location_facility: Medical Intensive Care Unit, Cochin, AP-HP


title: Histoplasmosis in the Guiana Shield and the French West Indies: Evaluating Prevalence in HIV + Patients With a Rapid Diagnostic Test Using an ELISA Capture Method for the Detection of Histoplasma Antigens in Blood and Urine.

acronym: EDIRAPHIS

summary: Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

time_perspective: Cross-Sectional

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Suriname France

location_facility: Academisch Ziekenhuis Paramaribo Hospital


acronym: AVC-MODE

summary:
The oropharyngeal junction participates in 3 interpenetrating functions: Swallowing, Breathing and Speech. In the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients.

Understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke.

The main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.

location_facility:
Hospital
University hospital


title: Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE

acronym: EuroSCOREbio

summary:
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge for both patient, and surgical team. It is also important for health care decisionmakers to have predictive tools to compare alternative technics such as conventional cardiac surgery and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in this purpose. Its success is the result of a good balance between predictive capability and simplicity. It consists almost exclusively of clinical variables.

However, the objectivity and the predictive ability of some of those clinical items remain controversial, particularly those addressing severity of illness for high-risk patients. For instance, the degree of priority is submitted to the subjective assessment by the surgical team at the time of surgery. Objective data describing the severity of patients arriving in the operating room are still missing.

Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH), heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I), respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen, CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and nutritional status (albumin).

In ICU, many scores use biological data to measure, on daily basis, the severity of the patient status. Their routine use is simplified by applications available on smartphones. They are drawn into hospital information systems.

In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is of particular interest because it detects underlying diabetes if unknown (emergent situation) or reflects its poor control before surgery. This criterion could be more reliable than the simple information of patient treated by insulin (EuroSCORE II criterion).

Finally, the reinforcement of existing scores with biological variables is recommended by the group of recommendations in prognostic research strategy (PROGRESS 2014), rather than creating new scores ex nihilo.

The hypothesis is that adding biological data collected at the time of arrival of the patient in the operating room would better qualify the patients' severity condition and therefore increase the risk prediction of early mortality and severe morbidity after cardiac surgery. The purpose of this study is to test this hypothesis and especially test whether the biological data would increase the EuroSCORE II performance, by improving the prediction for high-risk patients.

lead_sponsor: University Hospital Center of Martinique

location_facility:
CHU de Dijon
CHU d'Angers
CHU de Bordeaux
CHU de Limoges
CHU de Clermont-Ferrand
Hôpital Bichat (AP-HP)
CHU de La Réunion
CHU de Martinique
Hôpital Pitié-Salpêtrière (AP-HP)
CHU de Toulouse


title: Immediate vs. Delayed Stenting After Primary Percutaneous Reperfusion in ST Elevation Myocardial Infarction

acronym: PRIMACY

summary: The purpose of this research project is to improve how we treat heart attacks. The study will assess whether it might not be better to wait a few hours before implanting the coronary stent into the coronary artery rather than implanting it immediately, in order to allow the drugs to completely dissolve the clot. This might help to reduce the risks of the clot migrating and damaging the heart. By delaying coronary stent implantation, we hope to be able to reduce the size of the infarction and reduce the risk of suffering from heart failure following a heart attack.

lead_sponsor: Montreal Heart Institute

location_facility: Centre Hospitalier Régional de Lanaudière

location_facility: Ch de Montpellier-Hôpital A. de Villneuve


title: A Phase II Study Evaluating FOLFOX + Panitumumab According to a "Stop and go" Strategy With a Reintroduction Loop After Progression on Fluoropyrimidine as Maintenance Treatment, as the First Line in Patients With Metastatic Colorectal Adenocarcinoma Without a RAS Mutation

acronym: OPTIPRIME

summary: Single-arm, multi-centre phase II study The primary objective is to evaluate the time to failure of the strategy.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Martinique France

location_facility:
Hopital Sud
Centre Hospitalier Schaffner
Groupe Hospitalier Pitie-Salpetriere
Hopital Duchenne
Clinique Claude Bernard
Chu Cochin
Chu D'Angers
Centre Marie Curie
Ch Cote Basque
Chru Hopital Claude Huriez 4Eme Est
Hopital Morvan - Chu
Clinique Pasteur
Chu de Fort de France
Ch de Niort - Sce D'Oncologie
Cmco Cote D'Opale
Ch St Joseph-St Luc
Centre Francois Baclesse
Clinique Ste Anne
Centre Hospitalier General
Ch de Cholet
Hopitaux Civils de Colmar
Ch de Meaux
Hopital Prive Du Confluent Sas
Chd Vendee
Ch de Beauvais
Hopital Layne
Polyclinique de Courlancy
Centre Paul Strauss
Chi de Frejus Saint-Raphael
Polyclinique Saint Privat
Hopital Les Bonnettes
CH
Polyclinique de Gentilly
Clinique de L'Europe
Centre Hospitalier
Polyclinique de Blois - 3Eme Etage
Hopital Prive D'Antony
Ch Cahors
Service de Medecine
Clinique Trenel
Polyclinique de L'Ormeau
Ch de Beziers Cedex
Ch Du Mans
Hopital Europeen Marseille
Hopital Jacques Monod

intervention_type: Combination Product


title: Open-label, Non-randomized, Phase 2 Study Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma

summary: An open-label, non-randomized, two-stage, multicenter study evaluating clinical efficacy, safety and pharmacokinetics of PQR309 in patients with relapsed or refractory Primary Central Nervous System Lymphoma (PCNSL).

status: Withdrawn

lead_sponsor: PIQUR Therapeutics AG

location_facility: Hématologie, Départment d'ongolgie médicale


title: Modulation of Anti-tumor T Cell Responses in Cancer Patients Treated by Concomitant Radiochemotherapy

acronym: i-RTCT

summary: The aim of this study is to evaluate modulation of anti-tumor T cell responses in cancer patients treated by concomitant radiochemotherapy (i-RTCT)

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Centre Georges François LECLERC
Hôpital Nord Franche-Comté
Institut Jean Godinot
CHU de Besançon


title: The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial

acronym: TRANBURN

summary:
Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.

Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).

Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

ReferenceCitation: Farny B, Fontaine M, Payre J, Ravat F, Poupelin J-C, Latarjet J. Évaluation des pertes sanguines lors des chirurgies d'excision-autogreffe de peau chez les patients brûlés. Anesthésie & Réanimation. 2015;1:A307-8.

ReferenceCitation: Jennes S, Degrave E, Despiegeleer X, Grenez O. Effect of Tranexamic Acid on Blood Loss in Burn Surgery: A Preliminary Study. Journal of Burn Care & Rehabilitation. 2003;24:S59.

ReferenceCitation: Mercuriali F, Inghilleri G. Proposal of an algorithm to help the choice of the best transfusion strategy. Curr Med Res Opin. 1996;13(8):465-78.

ReferenceCitation: Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054. Review.

ReferenceCitation: Zufferey P, Merquiol F, Laporte S, Decousus H, Mismetti P, Auboyer C, Samama CM, Molliex S. Do antifibrinolytics reduce allogeneic blood transfusion in orthopedic surgery? Anesthesiology. 2006 Nov;105(5):1034-46. Review.

ReferenceCitation: CRASH-2 trial collaborators, Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejía-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.

ReferenceCitation: Desai MH, Herndon DN, Broemeling L, Barrow RE, Nichols RJ Jr, Rutan RL. Early burn wound excision significantly reduces blood loss. Ann Surg. 1990 Jun;211(6):753-9; discussion 759-62.

ReferenceCitation: Curinga G, Jain A, Feldman M, Prosciak M, Phillips B, Milner S. Red blood cell transfusion following burn. Burns. 2011 Aug;37(5):742-52. doi: 10.1016/j.burns.2011.01.016. Epub 2011 Mar 1. Review.

lead_sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon

location_facility: Centre Commun de Traitement des Brûlés - Hôpital Edouard Herriot

location_facility: Centre des brûlés inter-régional Méditerranée - Hôpital de la Conception

location_facility: Service de réanimation des brûlés de Mercy (CHR Metz-Thionville)


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

summary: As safety information pertaining to the long-term use of HU remains incomplete in spite of the first safety study (ESCORT-HU), an extension of the latter is proposed. ESCORT-HU Extension study aims at evaluating the long-term safety of Siklos® focusing on some questions regarding its safety when used in current practice in adults and paediatric patients treated with Siklos® and followed for up to 5 years. The study will focus on the following concerns : occurrence and incidence of malignancies, leg ulcers, male fertility impairment and serious unexpected AEs causally related to Siklos®.

lead_sponsor: ADDMEDICA SASA

location_country:
Italy
Guadeloupe
French Guiana
France
Greece
Martinique
Germany

location_facility: Tours Regional University Hospital Center Adults

location_facility: Intercommunal Hospital Center of Créteil Adults and Children

location_facility: Marne-La-Vallée Hospital Center Children

location_facility: Centre Hospitalier de l'Ouest Guyanais Franck Joly Children

location_facility: Clocheville Regional University Hospital Center Children

location_facility: Georges Pompidou European Hospital Adults

location_facility: Hôpital RICOU - CHU Pointe-à-Pitre Abymes Children

location_facility: Centre Hospitalier de l'Ouest Guyanais Franck Joly Adults

location_facility: Hematology and oncology institute Children

location_facility: Toulouse University Institute of cancer Adults


title: Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study

acronym: PROTOACCEPT

summary: The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).

ReferenceCitation: Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.

family: Pahus

full_name: Laurie Pahus

given: Laurie

family: Suehs

full_name: Carey Meredith Suehs

given: Carey Meredith

family: Halimi

full_name: Laurence Halimi

given: Laurence

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Chanez

full_name: Pascal Chanez

family: Jaffuel

full_name: Dany Jaffuel

given: Dany

family: Marciano

full_name: Julie Marciano

given: Julie

family: Gamez

full_name: Anne-Sophie Gamez

given: Anne-Sophie

family: Vachier

full_name: Isabelle Vachier

given: Isabelle

family: Molinari

full_name: Nicolas Molinari

journal_name: BMC Medical Ethics

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

version: submittedVersion

repositories:
HAL
PubMed Central

ReferenceCitation: Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29.

name: Institut Montpelliérain Alexander Grothendieck, CNRS, Université de Montpellier, Montpellier, France

name: Department of Medical Information, Montpellier University Hospital, Hôpital La Colombière, Montpellier, France

name: Department of Respiratory Diseases, University of Montpellier, CHU Montpellier, Montpellier, France

full_name: Carey Suehs

given: Carey

name: Clinique des bronches, allergies et sommeil, Hôpital Nord, Assistance Publique –Hôpitaux de Marseille, Marseille, France

name: Laboratoire Adhésion et Inflammation (LAI), INSERM U1067 / CNRS UMR7333, Aix-Marseille University, Marseille, France

name: PhyMedExp, INSERM U1046, CNRS UMR9214, Université de Montpellier, Montpellier, France

location_facility: Centre Hospitalier Universitaire de Montpellier