title: Impact of an Early and Collegial Consideration of Patients' Vulnerability Comparing to Usual Care. Cluster Randomized Control Study "Mort-A-l'Hôpital 2"

summary: In 2003, MAHO study (Ferrand E, Jabre P, Vincent-Genod C, et al. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 168: 867-875.) evaluated the way 3793 patients died in 200 French hospitals and showed that their conditions of death were not optimal. The 22th April 2005 French Law precised patient's end of life rights with necessity to refrain from any unreasonable obstinacy, the right to refuse treatments and the obligation of a collegial process decision when the patient is not conscious. Since then, studies haven't demonstrate any improvement and found that palliative strategy in France is much less used than in other developed countries.

ReferenceCitation: Truog RD, Cist AF, Brackett SE, Burns JP, Curley MA, Danis M, DeVita MA, Rosenbaum SH, Rothenberg DM, Sprung CL, Webb SA, Wlody GS, Hurford WE. Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med. 2001 Dec;29(12):2332-48.

ReferenceCitation: Ferrand E, Jabre P, Vincent-Genod C, Aubry R, Badet M, Badia P, Cariou A, Ellien F, Gounant V, Gil R, Jaber S, Jay S, Paillaud E, Poulain P, Regnier B, Reignier J, Socie G, Tardy B, Lemaire F, Brun-Buisson C, Marty J; French Mort-a-l'Hôpital Group. Circumstances of death in hospitalized patients and nurses' perceptions: French multicenter Mort-a-l'Hôpital survey. Arch Intern Med. 2008 Apr 28;168(8):867-75. doi: 10.1001/archinte.168.8.867.

family: Ferrand

full_name: Edouard Ferrand

given: Edouard

journal_name: Archives of Internal Medicine

oa_host_type: publisher

evidence: open (via free pdf)

title: Circumstances of Death in Hospitalized Patients and Nurses' Perceptions<subtitle>French Multicenter Mort-a-l’Hôpital Survey</subtitle>

ReferenceCitation: Ferrand E, Robert R, Ingrand P, Lemaire F; French LATAREA Group. Withholding and withdrawal of life support in intensive-care units in France: a prospective survey. French LATAREA Group. Lancet. 2001 Jan 6;357(9249):9-14.

ReferenceCitation: Ferrand E, Lemaire F, Regnier B, Kuteifan K, Badet M, Asfar P, Jaber S, Chagnon JL, Renault A, Robert R, Pochard F, Herve C, Brun-Buisson C, Duvaldestin P; French RESSENTI Group. Discrepancies between perceptions by physicians and nursing staff of intensive care unit end-of-life decisions. Am J Respir Crit Care Med. 2003 May 15;167(10):1310-5. Epub 2003 Jan 24.

ReferenceCitation: Ferrand E, Marty J; French LATASAMU Group. Prehospital withholding and withdrawal of life-sustaining treatments. The French LATASAMU survey. Intensive Care Med. 2006 Oct;32(10):1498-505. Epub 2006 Aug 2.

ReferenceCitation: Prendergast TJ, Claessens MT, Luce JM. A national survey of end-of-life care for critically ill patients. Am J Respir Crit Care Med. 1998 Oct;158(4):1163-7.

ReferenceCitation: Sprung CL, Cohen SL, Sjokvist P, Baras M, Bulow HH, Hovilehto S, Ledoux D, Lippert A, Maia P, Phelan D, Schobersberger W, Wennberg E, Woodcock T; Ethicus Study Group. End-of-life practices in European intensive care units: the Ethicus Study. JAMA. 2003 Aug 13;290(6):790-7.

ReferenceCitation: Ferrand E, Jabre P, Fernandez-Curiel S, Morin F, Vincent-Genod C, Duvaldestin P, Lemaire F, Hervé C, Marty J. Participation of French general practitioners in end-of-life decisions for their hospitalised patients. J Med Ethics. 2006 Dec;32(12):683-7.

ReferenceCitation: Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.

family: Temel

full_name: Jennifer S. Temel

given: Jennifer S.

family: Greer

full_name: Joseph A. Greer

given: Joseph A.

family: Muzikansky

full_name: Alona Muzikansky

given: Alona

family: Gallagher

full_name: Emily R. Gallagher

given: Emily R.

family: Admane

full_name: Sonal Admane

given: Sonal

family: Jackson

full_name: Vicki A. Jackson

given: Vicki A.

family: Dahlin

full_name: Constance M. Dahlin

given: Constance M.

family: Blinderman

full_name: Craig D. Blinderman

given: Craig D.

family: Jacobsen

full_name: Juliet Jacobsen

given: Juliet

family: Pirl

full_name: William F. Pirl

given: William F.

family: Billings

full_name: J. Andrew Billings

given: J. Andrew

family: Lynch

full_name: Thomas J. Lynch

given: Thomas J.

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

title: Early Palliative Care for Patients with Metastatic Non–Small-Cell Lung Cancer

ReferenceCitation: Kelley AS, Meier DE. Palliative care--a shifting paradigm. N Engl J Med. 2010 Aug 19;363(8):781-2. doi: 10.1056/NEJMe1004139.

family: Kelley

full_name: Amy S. Kelley

given: Amy S.

family: Meier

full_name: Diane E. Meier

given: Diane E.

title: Palliative Care — A Shifting Paradigm

ReferenceCitation: Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.

name: All authors: Massachusetts General Hospital Cancer Center, Boston, MA.

publisher: American Society of Clinical Oncology (ASCO)

title: Effect of Early Palliative Care on Chemotherapy Use and End-of-Life Care in Patients With Metastatic Non–Small-Cell Lung Cancer

ReferenceCitation: Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.

title: Early Palliative Care in Advanced Lung Cancer

location_facility:
Hiopital Foch Néphrologie
Hôpital Georges Clemenceau
Hopital Foch Neurochirurgie
Centre Hospitalier de Soissons
Groupe Hospitalier Paris - Saint-Joseph
CHU
Hopital Foch Chirurgie Urologique
Hopital privé Oncologie Médicale
Hopital Lariboisiere Medecine interne
CHRU
Centre Hospitalier Universitaire
Hôpital Bicêtre
Hopital Foch Cardiologie
Hôpital Avicenne
Hôpital Privé Medecine interne
Hopital Foch Médecine Interne
CH
Centre Hospitalier
Hopîtal Foch Urgences
Hopital Cochin Gastro-Enterologie
Hôpital Ambroise Paré


title: Economic Evaluation of Prostatic Urethral Lift (Urolift)

acronym: ECOLIFT

summary:
Prostatic urethral lift (Urolift) has been developed as a minimally invasive alternative to transurethral resection of the prostate with no need of general anaesthesia, less need of urinary catheter and less exposure to post-operative complication. Its efficacy and safety have been assessed by 2 clinical randomized trials with evidence of urinary symptom improvement remaining inferior to TURP but durable for 5 years. Urolift preserved overall quality of life better than TURP. Urolift has been recommended by the European Association of Urology guidelines and recognized by French authorities but cannot be financed by the hospital itself. Reimbursement of the implants by healthcare system is therefore needed for the distribution of Urolift in France.

The additional cost of the implants could be compensated by a reduced length of hospital stay and a lower rate of post-operative complications inducing healthcare expenditures. This study aims to assess if Urolift could be a cost-effective therapeutic strategy compared to transurethral surgery with 2 phases design: a field study comparing patients treated with Urolift to those treated with TURP/laser during 1 year follow-up, and an additional study comparing healthcare consumptions during 3 years follow-up between each group using data of the French National Claims Database (SNDS database).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire de Bordeaux

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: French National Prospective Cohort of Children With Port Wine Stain on a Limb = "Cohorte Nationale d'Enfants Avec Angiome Plan de Membre inférieur"

acronym: CONAPE

summary:
Port Wine Stain on a limb can be either isolated or associated with complications (venous or orthopedic impairment, arteriovenous malformations), leading sometimes to complex syndromes (Klippel-Trenaunay syndrome,Parkes-Weber syndrome).

Little is known about epidemiology of port wine stains: their evolution during the growth of the child, the frequency of complications, genetic data, and prognostic factors.

This prospective french national cohort will help for : description of the evolution of port wine stain and possible complications; prognostic factors for complications ; association with mutations of RASA1 gene; quality of life of these children. It will also help for global appreciation of the management of this disease in France.

status: Unknown status

study_type: Interventional

primary_purpose: Prevention

lead_sponsor: University Hospital, Tours

location_facility: Service de Dermatologie, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service de Dermatologie, Hôpital St Eloi

location_facility: Service de Dermatologie, Bâtiment tardieu

intervention_type: Genetic

status_simplified: Unknown


ReferenceType: background

ReferenceCitation: Lingor P, Weber M, Camu W, Friede T, Hilgers R, Leha A, Neuwirth C, Günther R, Benatar M, Kuzma-Kozakiewicz M, Bidner H, Blankenstein C, Frontini R, Ludolph A, Koch JC; ROCK-ALS Investigators. ROCK-ALS: Protocol for a Randomized, Placebo-Controlled, Double-Blind Phase IIa Trial of Safety, Tolerability and Efficacy of the Rho Kinase (ROCK) Inhibitor Fasudil in Amyotrophic Lateral Sclerosis. Front Neurol. 2019 Mar 27;10:293. doi: 10.3389/fneur.2019.00293. eCollection 2019.

ReferenceType: derived

ReferenceCitation: Lingor P, Koch JC, Statland JM, Hussain S, Hennecke C, Wuu J, Langbein T, Ahmed R, Günther R, Ilse B, Kassubek J, Kollewe K, Kuttler J, Leha A, Lengenfeld T, Meyer T, Neuwirth C, Tostmann R, Benatar M. Challenges and opportunities for Multi-National Investigator-Initiated clinical trials for ALS: European and United States collaborations. Amyotroph Lateral Scler Frontotemporal Degener. 2021 Aug;22(5-6):419-425. doi: 10.1080/21678421.2021.1879866. Epub 2021 Feb 3.

name: Department of Neurology, School of Medicine, Technical University of Munich, Klinikum rechts der Isar, München, Germany

family: Lingor

full_name: Paul Lingor

given: Paul

sequence: first

name: Department of Neurology, University Medical Center Göttingen, Göttingen, Germany

family: Koch

full_name: Jan C. Koch

given: Jan C.

sequence: additional

name: Department of Neurology, University of Kansas Medical Center, Kansas City, Kansas, USA

family: Statland

full_name: Jeffrey M. Statland

given: Jeffrey M.

name: Department of Neurology, University of Miami, Miami, Florida, USA

family: Hussain

full_name: Sumaira Hussain

given: Sumaira

name: Department for International Cooperations, University Medical Center Göttingen, Göttingen, Germany

family: Hennecke

full_name: Christiane Hennecke

given: Christiane

family: Wuu

full_name: Joanne Wuu

given: Joanne

name: Clinical Trials Unit, University Medical Center Göttingen, Göttingen, Germany

family: Langbein

full_name: Thomas Langbein

given: Thomas

family: Ahmed

full_name: Raees Ahmed

given: Raees

name: Department of Neurology, Technische Universität Dresden and German Center for Neurodegenerative Diseases, Dresden, Germany

family: Günther

full_name: René Günther

given: René

name: Department of Neurology, Jena University Hospital, Jena, Germany

family: Ilse

full_name: Benjamin Ilse

given: Benjamin

name: Department of Neurology, RKU, University of Ulm, Ulm, Germany

family: Kassubek

full_name: Jan Kassubek

given: Jan

name: Department of Neurology, Hannover Medical School, Hannover, Germany

family: Kollewe

full_name: Katja Kollewe

given: Katja

family: Kuttler

full_name: Josua Kuttler

given: Josua

name: Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany

family: Leha

full_name: Andreas Leha

given: Andreas

family: Lengenfeld

full_name: Teresa Lengenfeld

given: Teresa

name: Center for ALS and other Motor Neuron Disorders, Charité – Universitätsmedizin Berlin, Berlin, Germany

family: Meyer

full_name: Thomas Meyer

name: Neuromuscular Disease Unit/ALS Clinic, Kantonsspital St. Gallen, St. Gallen, Switzerland

family: Neuwirth

full_name: Christoph Neuwirth

given: Christoph

family: Tostmann

full_name: Ralf Tostmann

given: Ralf

family: Benatar

full_name: Michael Benatar

given: Michael

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

design_allocation: Randomized

intervention_type: Drug

lead_sponsor: University Medical Center Goettingen

primary_purpose: Treatment

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire Montpellier

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Centre Hospitalier Universitaire Marseille

title: Inhibition of Rho Kinase (ROCK) With Fasudil as Disease-modifying Treatment for ALS

summary: Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder and therapeutic options are limited. The rho kinase (ROCK) inhibitor Fasudil was shown to be neuroprotective, induced axonal regeneration and improved survival and behavioral outcome in models of ALS and other neurodegenerative diseases. The aim of this phase IIa, multi-center and double-blind study is to analyze the safety, tolerability and efficacy of fasudil in two different doses compared to placebo in approximately 16 trial sites in Germany, France and Switzerland. Intravenous application of fasudil will be performed in 80 patients and placebo in 40 patients two times daily for 20 treatment days. The hypothesis is that fasudil is safe and well-tolerated and its application will significantly improve the clinical outcome in patients with ALS.


title: Benefits and Tolerance of Exercise in Patients With Generalized and Stabilized Myasthenia Gravis

acronym: MGEX

summary: The purpose of this study is to demonstrate that a 3 months physical exercise programme improves the Quality of Life of patients with generalized Myasthenia Gravis (MG) stabilized since at least 6 months under prednisone and/or azathioprine.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Birnbaum S, Porcher R, Portero P, Clair B, Demeret S, Eymard B, Gargiulo M, Louët E, Berrih-Aknin S, Le Panse R, Aegerter P, Hogrel JY, Sharshar T; MGEX Study Group. Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Neuromuscul Disord. 2021 Aug;31(8):726-735. doi: 10.1016/j.nmd.2021.05.002. Epub 2021 May 27.

family: Birnbaum

full_name: S Birnbaum

given: S

family: Porcher

full_name: R Porcher

given: R

family: Portero

full_name: P Portero

given: P

family: Clair

full_name: B Clair

given: B

family: Demeret

full_name: S Demeret

family: Eymard

full_name: B Eymard

family: Gargiulo

full_name: M Gargiulo

given: M

family: Louët

full_name: E Louët

given: E

family: Berrih-Aknin

full_name: S Berrih-Aknin

family: Le Panse

full_name: R Le Panse

family: Aegerter

full_name: P Aegerter

family: Hogrel

full_name: JY Hogrel

given: JY

family: Sharshar

full_name: T Sharshar

given: T

family: Azerad

full_name: Sylvie Azerad

given: Sylvie

family: Bassez

full_name: Guillaume Bassez

given: Guillaume

family: Behin

full_name: Anthony Behin

given: Anthony

full_name: Sonia Berrih-Aknin

given: Sonia

family: Bolgert

full_name: Francis Bolgert

given: Francis

family: Ait-Younes

full_name: Nawal Derridj Ait-Younes

given: Nawal Derridj

family: Domingo

full_name: Yasmine Domingo

given: Yasmine

family: Frenkian

full_name: Mélinée Frenkian

given: Mélinée

family: Friedman

full_name: Diane Friedman

given: Diane

family: Jobic

full_name: Asmaa Jobic

given: Asmaa

ReferenceCitation: Birnbaum S, Hogrel JY, Porcher R, Portero P, Clair B, Eymard B, Demeret S, Bassez G, Gargiulo M, Louët E, Berrih-Aknin S, Jobic A, Aegerter P, Thoumie P, Sharshar T; MGEX Study Group. The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Trials. 2018 Jan 18;19(1):49. doi: 10.1186/s13063-017-2433-2.

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

location_facility: ICU and medical surgery department, Raymond Poincaré Hospital


type: Other Identifier

title: Multi-center, National, Randomized, Exploratory Study Evaluating Telemonitoring and Experimentation in Telemedicine for the Improvement of Healthcare Pathways (ETAPES Program) Compared to Standard of Care in Patients With Chronic Respiratory Failure Receiving Non-invasive Home Ventilation (e-VENT)

acronym: e-VENT

summary:
The ETAPES Program, a French national Experimentation in Telemedicine for the Improvement of Healthcare Pathways, was launched in 2018 for 4 years. Its objectives were to provide a temporary public reimbursement for medical telemonitoring in order to determine the benefits for the patient and the impact on medical organization and healthcare costs. In particular, this program applies to patients suffering from hypercapnic chronic respiratory failure and requiring home non invasive ventilation (NIV). For these patients, the ETAPES program combines NIV telemonitoring and therapeutic education.

e-VENT study aims at evaluating the ETAPES program, implemented using the Chronic Care Connect™ telemonitoring solution, versus Standard of Care, on the effectiveness of home NIV, measured by average PtCO2, reflecting the level of nocturnal alveolar hypoventilation.

primary_purpose: Health Services Research

lead_sponsor: Air Liquide Santé International

intervention_type: Device

lead_sponsor_type: industriel


type: EudraCT Number

title: Double Blind Randomized Study to Assess the Efficacy of BF2.649 Compared to Placebo in add-on to Sodium Oxybate in the Treatment of Narcoleptic Patients With Residual Excessive Daytime Sleepiness (EDS) During 8 Weeks

acronym: HARMONY IV

summary: This is a multicentric international phase III, double blind randomized study assessing efficacy and safety in parallel group of BF2.649 (pitolisant) compared to placebo in add-on to sodium oxybate of narcoleptic patients with residual Excessive Daytime Sleepiness (EDS) during 8 weeks

lead_sponsor: Bioprojet

status_simplified: Completed


title: A Randomized, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With High Risk Essential Thrombocythemia, Who Are Resistant or Intolerant to Hydroxyurea: A FIM Study

summary: Prospective national multicenter randomized open label phase IIb RUXBETA trial.

status: Terminated

ipd_sharing: Yes

ipd_sharing_description: e crf

lead_sponsor: French Innovative Leukemia Organisation


title: Medico-economical Evaluation on Buccodental Teleexpertise in Nursing Home

acronym: e-DENT-EHPAD

summary:
Oral care in medical and social institutions is a real public health problem. The impact of poor oral health on the general state of residents but also on their overall quality of life is significant.

The development of a precise regulatory framework for telemedicine in France aims to transform experiments into sustainable medical activities. Odontology often set aside in this reflection, must be reintegrated. The use of tele-expertise for the oral care of nursing home residents should make it possible to replace oral health in medico-social institutions. The investigators will assess in a cluster randomized controlled study whether the buccodental telemedicine has a viable economic model and a significant impact on the overall health of facility for dependent elderly persons residents.

The medico-economic impact of the buccodental telexpertise is fundamental for the development of this innovative activity.

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Montpellier

location_facility:
EHPAD Saint Jean
EHPAD Saint Jean Pla de Corts
EHPAD Korian La Colombe
EHPAD Montpellieret
EHPAD Le Sherpa
EHPAD Korian La Pompignane
EHPAD Korian Perier
EHPAD Pierre Laroque
Résidence mutualiste de Pezilla
EHPAD Françoise Gauffier
EHPAD La Carriera
EHPAD Via Domitia
EHPAD La Roselière

intervention_type: Other


title: Effect of Sacral Nerve Stimulation on Enteric Nervous System

summary: Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. The investigators hypothtized that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces changes in ENS.

lead_sponsor: University Hospital, Rouen

location_facility:
Nantes University Hospital
Rouen University Hospital


title: Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase With Age More Than 70, Diagnosis of CML is Being Performed Within 1 Year

summary: The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase with age more than 70, diagnosis of cml is being performed within 1 year. Quality of life will be carefully assessed.

design_allocation: Non-Randomized

lead_sponsor: Poitiers University Hospital


title: Bacterial and Human Biomarkers of Prognostic Value for Severe Legionnaire's Disease

acronym: Proglegio

summary:
Legionnaires' disease (LD) is a relatively common pneumonia in France (1200 cases/year), 98% of cases are hospitalized and 40% require intensive care unit (ICU) admission. Risk factors that may predispose to acquisition of LD are well known. Some studies suggest that genetic factor may also enhance susceptibility to LD.

The mortality rate remains high (10% to 33% in ICUs) despite improved diagnostic and therapeutic management of patients. Few prospective studies have assessed the factors associated with LD outcomes, particularly death, and most of them involved a limited number of patients.

In a multicentre cohort study, the investigators recently identified risk factors associated with higher mortality such as female sex, age, ICU stay, renal failure, corticosteroid treatment and enhanced pro-inflammatory status, as assessed by higher C-reactive protein level (PMID: 22005914). Other factors are suspected but their involvement has not been formally demonstrated including a high infectious bacterial load, particular virulence of Legionella strain, and an in vivo selection of mutants resistant to prescribed antibiotics. Disease progression is highly variable from one patient to another, and usually remains unpredictable. There are no objective criteria to predict the prognosis of these patients.

The clinical course of patients with LD remains difficult to predict because no predictive biomarkers have yet been characterized and the demonstration of the presence of mutants to antibiotics in vivo has never been done.

The main objective of the study is to correlate the L. pneumophila load (detected by PCR) to the clinical outcome of the LD infection. Clinical severity will measured by the SOFA score (Sepsis -Related Organ Failure Assessment) or the PELOD score (Pediatric Logistic Organ Dysfunction).

Secondary objectives are to identify new host and bacterial biomarkers associated with poor outcome of LD.

lead_sponsor: Hospices Civils de Lyon

location_facility:
CHU d'Angouleme
APHP Hôpital Bichat
CHU Rennes
Hôpital Saint Louis - APHP
CHU de Nantes
Hôpital Tenon
CHRU Besancon
Centre Hospitalier Lyon Sud
CHU Saint Etienne
CHU Lille
Hopital Edouard Heriot
CHU Dijon
CHU Grenoble
CH Gustave Dron
CHU Brest
Hôpital de la Croix Rousse
CHU Amiens
CHU Strasbourg Nouvel Hôpital Civil


title: Comparison of Radical Prostatectomy for the Treatment of Prostate Cancer, Performed by Robot-assisted or Standard Laparoscopy or by Laparotomy : a Multicentric Prospective Study.

acronym: EMUPRO

summary: Minimally invasive surgery has developed widely since the 1980s and has revolutionized the practices of surgeons. In urology, the development of laparoscopy and then robot-assisted surgery has considerably improved the management of pathologies. In France, as in all the countries concerned, the spread of robotic surgery has taken place without prior studies validating this new technology, nor organizational rules in terms of quality and access to care. The report of the Haute Autorité de Santé dated November 2016 underlines the weakness of the methodological quality of studies and meta-analyzes evaluating robot-assisted total prostatectomy compared to other surgical techniques by laparotomy or conventional laparoscopy. It therefore appears important to evaluate in a large study the interest of this technique in order to help the authorities to decide on the real benefit of this technology and to provide reliable answers to the patients.

ipd_sharing: Undecided

lead_sponsor: Elsan

location_facility:
Clinique Guillaume De Varye
Clinique Saint-Augustin
Polyclinique de Gentilly
Polyclinique Médipôle Saint-Roch
Clinique de Saint AUGUSTIN
Hôpital Privé La Châtaigneraie
Centre clinical
Pôle Santé Sud
Clinique de l'Estrée
Hôpital privé Océane


title: Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)

acronym: SARA-OBS

summary:
The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US.

300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.

Participants aged ≥ 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test and the 400-metre walking test will be administered at the main visits. Patient Reported Outcomes (PROs) will be completed by the patients at the same visits.

lead_sponsor: Biophytis

location_country:
Italy
United States
Belgium
France

location_facility: Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet

location_facility: Jean Mayer USDA Human Nutrition research Center on Aging Tufts University


title: Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

summary: Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

lead_sponsor: Goupe d'Etudes et de Recherche Clinique En Rhumatologie


title: Lutein Influence on Macula of Persons Issued From Amd Parents

acronym: LIMPIA

summary: Age-related macular degeneration (AMD) is a degenerative disease of the centre of the retina (named macula) and is the leading cause of blindness in industrialized countries. There is growing interest in the potential preventive role of two carotenoids (lutein and zeaxanthin) of dietary origin, which specifically accumulate in the macula, where they form the macular pigment. A first step towards the demonstration of a preventive effect of macular pigment for AMD consists in the evaluation of the effect of lutein and zeaxanthin supplementation on their plasma and retinal concentrations.

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ReferenceCitation: Tan JS, Wang JJ, Flood V, Rochtchina E, Smith W, Mitchell P. Dietary antioxidants and the long-term incidence of age-related macular degeneration: the Blue Mountains Eye Study. Ophthalmology. 2008 Feb;115(2):334-41. Epub 2007 Jul 30.

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ReferenceCitation: VandenLangenberg GM, Mares-Perlman JA, Klein R, Klein BE, Brady WE, Palta M. Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study. Am J Epidemiol. 1998 Jul 15;148(2):204-14.

ReferenceCitation: Cho E, Seddon JM, Rosner B, Willett WC, Hankinson SE. Prospective study of intake of fruits, vegetables, vitamins, and carotenoids and risk of age-related maculopathy. Arch Ophthalmol. 2004 Jun;122(6):883-92.

ReferenceCitation: van Leeuwen R, Boekhoorn S, Vingerling JR, Witteman JC, Klaver CC, Hofman A, de Jong PT. Dietary intake of antioxidants and risk of age-related macular degeneration. JAMA. 2005 Dec 28;294(24):3101-7.

ReferenceCitation: Beatty S, Murray IJ, Henson DB, Carden D, Koh H, Boulton ME. Macular pigment and risk for age-related macular degeneration in subjects from a Northern European population. Invest Ophthalmol Vis Sci. 2001 Feb;42(2):439-46.

ReferenceCitation: Bone RA, Landrum JT, Mayne ST, Gomez CM, Tibor SE, Twaroska EE. Macular pigment in donor eyes with and without AMD: a case-control study. Invest Ophthalmol Vis Sci. 2001 Jan;42(1):235-40. Erratum in: Invest Ophthalmol Vis Sci 2001 Mar;42(3):548.

ReferenceCitation: Bernstein PS, Zhao DY, Wintch SW, Ermakov IV, McClane RW, Gellermann W. Resonance Raman measurement of macular carotenoids in normal subjects and in age-related macular degeneration patients. Ophthalmology. 2002 Oct;109(10):1780-7.

ReferenceCitation: Obana A, Hiramitsu T, Gohto Y, Ohira A, Mizuno S, Hirano T, Bernstein PS, Fujii H, Iseki K, Tanito M, Hotta Y. Macular carotenoid levels of normal subjects and age-related maculopathy patients in a Japanese population. Ophthalmology. 2008 Jan;115(1):147-57. doi: 10.1016/j.ophtha.2007.02.028.

ReferenceCitation: Hammond BR Jr, Johnson EJ, Russell RM, Krinsky NI, Yeum KJ, Edwards RB, Snodderly DM. Dietary modification of human macular pigment density. Invest Ophthalmol Vis Sci. 1997 Aug;38(9):1795-801.

ReferenceCitation: Berendschot TT, Goldbohm RA, Klöpping WA, van de Kraats J, van Norel J, van Norren D. Influence of lutein supplementation on macular pigment, assessed with two objective techniques. Invest Ophthalmol Vis Sci. 2000 Oct;41(11):3322-6.

ReferenceCitation: Bone RA, Landrum JT, Guerra LH, Ruiz CA. Lutein and zeaxanthin dietary supplements raise macular pigment density and serum concentrations of these carotenoids in humans. J Nutr. 2003 Apr;133(4):992-8. Erratum in: J Nutr. 2003 Jun;133(6):1953.

ReferenceCitation: Koh HH, Murray IJ, Nolan D, Carden D, Feather J, Beatty S. Plasma and macular responses to lutein supplement in subjects with and without age-related maculopathy: a pilot study. Exp Eye Res. 2004 Jul;79(1):21-7.

ReferenceCitation: Wenzel AJ, Gerweck C, Barbato D, Nicolosi RJ, Handelman GJ, Curran-Celentano J. A 12-wk egg intervention increases serum zeaxanthin and macular pigment optical density in women. J Nutr. 2006 Oct;136(10):2568-73.

ReferenceCitation: Bone RA, Landrum JT, Cao Y, Howard AN, Alvarez-Calderon F. Macular pigment response to a supplement containing meso-zeaxanthin, lutein and zeaxanthin. Nutr Metab (Lond). 2007 May 11;4:12.

ReferenceCitation: Thurnham DI, Trémel A, Howard AN. A supplementation study in human subjects with a combination of meso-zeaxanthin, (3R,3'R)-zeaxanthin and (3R,3'R,6'R)-lutein. Br J Nutr. 2008 Dec;100(6):1307-14. doi: 10.1017/S0007114508971336. Epub 2008 Apr 11.

ReferenceCitation: Huang LL, Coleman HR, Kim J, de Monasterio F, Wong WT, Schleicher RL, Ferris FL 3rd, Chew EY. Oral supplementation of lutein/zeaxanthin and omega-3 long chain polyunsaturated fatty acids in persons aged 60 years or older, with or without AMD. Invest Ophthalmol Vis Sci. 2008 Sep;49(9):3864-9. doi: 10.1167/iovs.07-1420. Epub 2008 Apr 30.

ReferenceCitation: Schalch W, Cohn W, Barker FM, Köpcke W, Mellerio J, Bird AC, Robson AG, Fitzke FF, van Kuijk FJ. Xanthophyll accumulation in the human retina during supplementation with lutein or zeaxanthin - the LUXEA (LUtein Xanthophyll Eye Accumulation) study. Arch Biochem Biophys. 2007 Feb 15;458(2):128-35. Epub 2006 Nov 7.

ReferenceCitation: Trieschmann M, Beatty S, Nolan JM, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. Changes in macular pigment optical density and serum concentrations of its constituent carotenoids following supplemental lutein and zeaxanthin: the LUNA study. Exp Eye Res. 2007 Apr;84(4):718-28. Epub 2006 Dec 19.

ReferenceCitation: Johnson EJ, Chung HY, Caldarella SM, Snodderly DM. The influence of supplemental lutein and docosahexaenoic acid on serum, lipoproteins, and macular pigmentation. Am J Clin Nutr. 2008 May;87(5):1521-9.

ReferenceCitation: De Jong PT, Klaver CC, Wolfs RC, Assink JJ, Hofman A. Familial aggregation of age-related maculopathy. Am J Ophthalmol. 1997 Dec;124(6):862-3.

ReferenceCitation: Klaver CC, Wolfs RC, Assink JJ, van Duijn CM, Hofman A, de Jong PT. Genetic risk of age-related maculopathy. Population-based familial aggregation study. Arch Ophthalmol. 1998 Dec;116(12):1646-51.

ReferenceCitation: Young TL. Molecular genetics of human myopia: an update. Optom Vis Sci. 2009 Jan;86(1):E8-E22. doi: 10.1097/OPX.0b013e3181940655.

ReferenceCitation: Nolan JM, Stack J, O' Donovan O, Loane E, Beatty S. Risk factors for age-related maculopathy are associated with a relative lack of macular pigment. Exp Eye Res. 2007 Jan;84(1):61-74. Epub 2006 Nov 1. Review.

ReferenceCitation: Nolan JM, Stack J, O'connell E, Beatty S. The relationships between macular pigment optical density and its constituent carotenoids in diet and serum. Invest Ophthalmol Vis Sci. 2007 Feb;48(2):571-82.

ReferenceCitation: Zeimer M, Hense HW, Heimes B, Austermann U, Fobker M, Pauleikhoff D. [The macular pigment: short- and intermediate-term changes of macular pigment optical density following supplementation with lutein and zeaxanthin and co-antioxidants. The LUNA Study]. Ophthalmologe. 2009 Jan;106(1):29-36. doi: 10.1007/s00347-008-1773-4. German.

ReferenceCitation: Akbaraly NT, Faure H, Gourlet V, Favier A, Berr C. Plasma carotenoid levels and cognitive performance in an elderly population: results of the EVA Study. J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):308-16.

ReferenceCitation: Cunnane SC, Plourde M, Pifferi F, Bégin M, Féart C, Barberger-Gateau P. Fish, docosahexaenoic acid and Alzheimer's disease. Prog Lipid Res. 2009 Sep;48(5):239-56. doi: 10.1016/j.plipres.2009.04.001. Epub 2009 Apr 10. Review.

ReferenceCitation: Rinaldi P, Polidori MC, Metastasio A, Mariani E, Mattioli P, Cherubini A, Catani M, Cecchetti R, Senin U, Mecocci P. Plasma antioxidants are similarly depleted in mild cognitive impairment and in Alzheimer's disease. Neurobiol Aging. 2003 Nov;24(7):915-9.

ReferenceCitation: Johnson EJ, McDonald K, Caldarella SM, Chung HY, Troen AM, Snodderly DM. Cognitive findings of an exploratory trial of docosahexaenoic acid and lutein supplementation in older women. Nutr Neurosci. 2008 Apr;11(2):75-83. doi: 10.1179/147683008X301450.

ReferenceCitation: Wolf-Schnurrbusch UE, Röösli N, Weyermann E, Heldner MR, Höhne K, Wolf S. Ethnic differences in macular pigment density and distribution. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3783-7.

ReferenceCitation: Isaacs B, Akhtar AJ. The set test: a rapid test of mental function in old people. Age Ageing. 1972 Nov;1(4):222-6.

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ReferenceCitation: Samieri C, Féart C, Proust-Lima C, Peuchant E, Dartigues JF, Amieva H, Barberger-Gateau P. ω-3 fatty acids and cognitive decline: modulation by ApoEε4 allele and depression. Neurobiol Aging. 2011 Dec;32(12):2317.e13-22. doi: 10.1016/j.neurobiolaging.2010.03.020. Epub 2010 Jun 8.

ReferenceCitation: Korobelnik JF, Rougier MB, Delyfer MN, Bron A, Merle BMJ, Savel H, Chêne G, Delcourt C, Creuzot-Garcher C. Effect of Dietary Supplementation With Lutein, Zeaxanthin, and ω-3 on Macular Pigment: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Nov 1;135(11):1259-1266. doi: 10.1001/jamaophthalmol.2017.3398.

name: Service d’Ophtalmologie, Centre Hospitalier Universitaire Bordeaux, Bordeaux, France2Universitaire Bordeaux, Institut National de la Santé et de la Récherche Médicale, Bordeaux Population Health Research Center, Team Lifelong Exposures Health and Aging (LEHA), Unité Mixte de Recherche (UMR) 1219, Bordeaux, France

family: Korobelnik

full_name: Jean-François Korobelnik

given: Jean-François

family: Rougier

full_name: Marie-Bénédicte Rougier

given: Marie-Bénédicte

family: Delyfer

full_name: Marie-Noëlle Delyfer

given: Marie-Noëlle

name: Service d’Ophtalmologie, Centre Hospitalier Universitaire de Dijon, Dijon, France

family: Bron

full_name: Alain Bron

given: Alain

family: Merle

full_name: Bénédicte M. J. Merle

given: Bénédicte M. J.

family: Savel

full_name: Hélène Savel

given: Hélène

name: Universitaire Bordeaux, Institut National de la Santé et de la Récherche Médicale, Bordeaux Population Health Research Center, Team Lifelong Exposures Health and Aging (LEHA), Unité Mixte de Recherche (UMR) 1219, Bordeaux, France4Centre Hospitalier Universitaire de Bordeaux, Pôle de Santé Publique, Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique and Centre d’Investigation Clinique (CIC) 1401–Epidémiologie Clinique (EC), Bordeaux, France

family: Chêne

full_name: Geneviève Chêne

given: Geneviève

family: Delcourt

full_name: Cécile Delcourt

given: Cécile

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

journal_name: JAMA Ophthalmology

oa_colors: green other

oa_host_type: publisher;repository

license_normalized: no license

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

location_facility: Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin

location_facility: Service Ophtalmologie - Hôpital général CHU de Dijon


title: Chronic Sleep Restriction and Driving in Healthy Subjects or Snorers : Interindividual Vulnerability and Recovery Factors

acronym: PRIVASOM

summary: Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.

location_facility: Laboratoire d'Imagerie et de Neurosciences Cognitives (LINC)

location_facility: University Hospital Bordeaux, Groupe Hospitalier Pellegrin


ReferenceType: result

ReferenceCitation: Schmid P, Abraham J, Chan S, Wheatley D, Brunt AM, Nemsadze G, Baird RD, Park YH, Hall PS, Perren T, Stein RC, Mangel L, Ferrero JM, Phillips M, Conibear J, Cortes J, Foxley A, de Bruin EC, McEwen R, Stetson D, Dougherty B, Sarker SJ, Prendergast A, McLaughlin-Callan M, Burgess M, Lawrence C, Cartwright H, Mousa K, Turner NC. Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial. J Clin Oncol. 2020 Feb 10;38(5):423-433. doi: 10.1200/JCO.19.00368. Epub 2019 Dec 16.

name: Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom

name: Barts Hospital NHS Trust, London, United Kingdom

family: Schmid

full_name: Peter Schmid

given: Peter

name: Velindre National Health Service (NHS) Trust, Cardiff, United Kingdom

family: Abraham

full_name: Jacinta Abraham

given: Jacinta

name: Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

family: Chan

full_name: Stephen Chan

given: Stephen

name: Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom

family: Wheatley

full_name: Duncan Wheatley

given: Duncan

name: University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom

family: Brunt

full_name: Adrian Murray Brunt

given: Adrian Murray

name: Institute of Clinical Oncology, Tbilisi, Georgia

family: Nemsadze

full_name: Gia Nemsadze

given: Gia

name: Cancer Research UK Cambridge Centre, Cambridge, United Kingdom

family: Baird

full_name: Richard D. Baird

given: Richard D.

name: Samsung Medical Centre, Seoul, Republic of Korea

family: Park

full_name: Yeon Hee Park

given: Yeon Hee

name: Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, United Kingdom

family: Hall

full_name: Peter S. Hall

given: Peter S.

name: Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom

family: Perren

full_name: Timothy Perren

given: Timothy

name: National Institute for Health Research Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, University College London, London, United Kingdom

family: Stein

full_name: Robert C. Stein

given: Robert C.

name: Institute of Oncology, Medical University of Pécs, Pecs, Hungary

family: Mangel

full_name: László Mangel

given: László

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Phillips

full_name: Melissa Phillips

given: Melissa

family: Conibear

full_name: John Conibear

given: John

name: Ramon y Cajal University Hospital, Madrid, Spain

family: Cortes

full_name: Javier Cortes

given: Javier

family: Foxley

full_name: Andrew Foxley

given: Andrew

family: de Bruin

full_name: Elza C. de Bruin

given: Elza C.

family: McEwen

full_name: Robert McEwen

given: Robert

family: Stetson

full_name: Daniel Stetson

given: Daniel

family: Dougherty

full_name: Brian Dougherty

given: Brian

family: Sarker

full_name: Shah-Jalal Sarker

given: Shah-Jalal

family: Prendergast

full_name: Aaron Prendergast

given: Aaron

family: McLaughlin-Callan

full_name: Max McLaughlin-Callan

given: Max

family: Burgess

full_name: Matthew Burgess

given: Matthew

name: Institute of Cancer Research, London, United Kingdom

name: Royal Marsden Hospital, London, United Kingdom

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

repository_institution: University College London - UCL Discovery

repository_institution: Keele University - Keele Research Repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
France
Georgia
Romania
Hungary
United Kingdom
Korea, Republic of

location_facility: University of Pécs - Clinical Center Institute of Oncotherapy

location_facility: Sf. Nectarie SRL Oncologie Medical Center

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Yeovil District Hospital NHS Foundation Trust

location_facility: Royal Marsden NHS Foundation Trust-Fulham

location_facility: University Hospitals Coventry and Warwickshire NHs Trust

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Prof. Dr. I. Chiricuta Oncology Institute

location_facility: University Hospital of North Staffordshire NHS Trust

location_facility: Glan Clwyd Hospital BCU Health Board NHS Wales

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Guys and St Thomas' NHS Foundation Trust

location_facility: Southampton University Hospitals NHS Trust

location_facility: Abertawe Bro Margannwg University Health Board

location_facility: Southend University Hospital NHS Foundation Trust

title: A Phase II, Double-blind, Randomised, Placebo-controlled Study of the AKT Inhibitor AZD5363 in Combination With Paclitaxel in Triple-Negative Advanced or Metastatic Breast Cancer (PAKT).

summary:
PAKT was an investigator-led, placebo-controlled, randomized phase II trial performed in 42 academic medical centers in the United Kindom, South Korea, France, Hungary, Romania, and Georgia. Patients were randomly assigned (1:1) to receive paclitaxel plus capivasertib or paclitaxel plus placebo. Stratification was by number of metastatic sites (< 3 v ≥ 3) and interval from the end of prior adjuvant or neoadjuvant chemotherapy (≤ 12 v > 12 months v no prior chemotherapy).

Paclitaxel was administered as a once-per-week intravenous infusion of 90 mg/m2 over approximately 1 hour on days 1, 8, and 15 of each 28-day treatment cycle. Capivasertib 400 mg or placebo was administered orally twice per day on an intermittent weekly dosing schedule, with treatment on days 2 to 5 of weeks 1, 2, and 3 within each 28-day cycle. All treatments were continued until disease progression, development of unacceptable toxicity, or withdrawal of consent. If paclitaxel treatment was discontinued before disease progression, patients could continue to receive capivasertib or placebo alone. In case of adverse events (AEs), capivasertib or placebo could be reduced to 320 mg twice per day and subsequently to 240 mg twice per day. Capivasertib or placebo could be interrupted for up to 4 weeks for toxicity.

Tumor assessments included computed tomography scanning or magnetic resonance imaging of the chest, abdomen, and pelvis at baseline, every 8 weeks during treatment, and at progression. Patients who discontinued treatment for any reason other than progression were required to follow the same schedule of assessments until progression, initiation of another treatment, death, or withdrawal of consent.


title: Transplantation of Human Embryonic Stem Cell-derived CD15+ Isl-1+ Progenitors in Severe Heart Failure

acronym: ESCORT

summary: The purpose of the study is to assess the feasibility and safety of a transplantation of cardiac-committed progenitor cells derived from human embryonic stem cells in patients with severe heart failure.

ReferenceCitation: Puymirat E, Geha R, Tomescot A, Bellamy V, Larghero J, Trinquart L, Bruneval P, Desnos M, Hagège A, Pucéat M, Menasché P. Can mesenchymal stem cells induce tolerance to cotransplanted human embryonic stem cells? Mol Ther. 2009 Jan;17(1):176-82. doi: 10.1038/mt.2008.208. Epub 2008 Oct 7.

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

family: Geha

full_name: Raghed Geha

given: Raghed

family: Tomescot

full_name: André Tomescot

given: André

family: Bellamy

full_name: Valérie Bellamy

given: Valérie

family: Larghero

full_name: Jérôme Larghero

given: Jérôme

family: Trinquart

full_name: Ludovic Trinquart

given: Ludovic

family: Bruneval

full_name: Patrick Bruneval

given: Patrick

family: Desnos

full_name: Michel Desnos

given: Michel

family: Hagège

full_name: Albert Hagège

given: Albert

family: Pucéat

full_name: Michel Pucéat

family: Menasché

full_name: Philippe Menasché

given: Philippe

journal_name: Molecular Therapy

oa_colors: green hybrid

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Can Mesenchymal Stem Cells Induce Tolerance to Cotransplanted Human Embryonic Stem Cells?

ReferenceCitation: Menasché P, Vanneaux V, Hagège A, Bel A, Cholley B, Parouchev A, Cacciapuoti I, Al-Daccak R, Benhamouda N, Blons H, Agbulut O, Tosca L, Trouvin JH, Fabreguettes JR, Bellamy V, Charron D, Tartour E, Tachdjian G, Desnos M, Larghero J. Transplantation of Human Embryonic Stem Cell-Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction. J Am Coll Cardiol. 2018 Jan 30;71(4):429-438. doi: 10.1016/j.jacc.2017.11.047.

family: Vanneaux

full_name: Valérie Vanneaux

family: Bel

full_name: Alain Bel

given: Alain

family: Cholley

full_name: Bernard Cholley

given: Bernard

journal_name: Journal of the American College of Cardiology

title: Transplantation of Human Embryonic Stem Cell–Derived Cardiovascular Progenitors for Severe Ischemic Left Ventricular Dysfunction


title: Pharmacological Treatment of a Rare Genetic Disease: Pilot Trial Phase II-III With N-acetylcysteine in Myopathy Associated SEPN1-RM (Selenoprotein N-related Myopathy)

acronym: SelNac

summary: The objective of this study is to determine whether the administration of N-acetylcysteine (NAC) improves oxidative stress. To determine this, the study will assess the impact of oral treatment on the balance between reduced and oxidized form of glutathione in erythrocytes of peripheral blood.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Triple Resynchronization in Paced Heart Failure Patients

summary: The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).

lead_sponsor: Abbott Medical Devices

location_facility: Department of Cardiology - CHU Pontchaillou


title: "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"

acronym: PAH-DBoQ

summary: To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.

time_perspective: Cross-Sectional

lead_sponsor: Association de Recherche en Physiopathologie Respiratoire

location_facility: Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,


type: Registry Identifier

title: Consequences of Respiratory Devices on Caregivers: CAP2 Study

summary:
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.

The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.

To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.

study_start_date_type: Anticipated

ipd_sharing_description: All specific individual participant data that underlie results in a publication will be made available upon reasonable request to the principal investigator

lead_sponsor: Asten Sante


title: Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

acronym: AMBU-ENDO

summary:
To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

location_facility: Hôpital Bichat-Claude Bernard Gynécologie obstétrique

location_facility: Service de Chirurgie Gynécologique Obstétrique Reproduction Humaine

location_facility: HEGP - Chirurgie Cancérologique Gynécologique et du Sein

location_facility: Service de chirurgie gynécologique, Centre de lutte contre le cancer

location_facility: Service de chirurgie gynécologique, hôpital Pitié-salpêtrière

location_facility: Service de chirurgie gynécologique, Centre Hospitalier Simone Veil

location_facility: Service de chirurgie gynécologique, hôpital Tenon


title: Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

acronym: DOAL

summary: Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital Femme Mère Enfant, 32 Avenue Doyen Jean Lépine


title: Study of Hypothalamic Metabolism in Spontaneous Cluster Headache Attacks

summary: Cluster headache is characterized by unilateral excruciating head pain and autonomic dysfunction. Hypothalamic overactivity was observed in nitrate-induced cluster-headache and in only one case of spontaneous cluster headache 'Sprenger et al, 2004). This prompted the application of hypothalamic deep brain stimulation. The aim of this data is to precise the localisation of the hypothalamic activation.

primary_purpose: Basic Science

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Pôle de Neurosciences Cliniques CHU Timone


title: Prospective Trial to Evaluate How Therapeutic Drug Monitoring of Protease Inhibitors Increases Virologic Success and Tolerance of HAART (ANRS 111 COPHAR2)

summary: This Cophar2 study is a trial which evaluates repeated early therapeutic drug monitoring, from weeks 2 to 24, after the initiation of HAART including either indinavir/r, lopinavir/r or the new 625 mg formulation of nelfinavir twice-a-day (bid). If trough concentrations were out of the range given for each protease inhibitor (PI), the PI dose was adjusted.

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

location_facility: Service de Medecine Interne Hopital Cochin


title: Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor

acronym: Lum-Iva-Biota

summary:
n2015, VERTEX company - producing already KALYDECO (IVACAFTOR, VX-770) potentiator molecule that is recommended for the treatment of CF patients aged ≥ 6 y, with CFTR mutation altering the channel regulation (class III mutations) as G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549Nou S549R) -was allowed by the Federal Drug Administration (FDA) and European Medicines Agency (EMEA) for producing and using ivacaftor combination (such as lumacaftor/ ivacaftor initially, and more recently tezacaftor/ivacaftor, tezacaftor/ivacaftor/VX-659, tezacaftor/ivacaftor/VX-445 and tezacaftor/ivacaftor/VX-152) in clinical trials for patient with cystic fibrosis, according to age and mutation eligibility criteria.

Since 2016, the French patients homozygous for the p.Phe508del mutation and older than 12 years are able to be treated with the association LUMACAFTOR-IVACAFTOR and this French authorization is being extended for 6-11 years old children (while the European Commission has already granted an extension of the Marketing Authorization for lumacaftor/ivacaftor to include 6-11 years old children with cystic fibrosis since January 2018). Patients treated by lumacaftor/ivacaftor (or other ivacaftor new combinations) are closely monitored according to criteria established by the working group "New Therapeutic Approaches" of the French Society Cystic fibrosis.

This study is a phase IV observational trial for a period of 1 year. In this context, the team aims at initiating a comprehensive monitoring of the lung and gut mycobiota and microbiota evolution under LUMACAFTOR-IVACAFTOR (or other ivacaftor combinations) treatment. This project is directly linked to the monitoring of cystic fibrosis patients who begin treatment with LUMACAFTOR-IVACAFTOR (or other ivacaftor combinations) in France. The pro- and eukaryotic microbiota analysis is based on the secondary use of sputum and stool samples associated with several clinical data of CF patients under ivacaftor combinations and follow-up during the 1st year of therapy. According to the French law, Lum-Iva-Biota project is a non-interventional study. It aims at demonstrating that changes in the hydration of secretions at the pulmonary and intestinal levels related to LUMACAFTOR-IVACAFTOR therapy (or other new generation of ivacaftor combinations) promote a change in the lung and gut mycobiota and microbiota profiles which may achieve the characteristics of the "healthy type" (in terms of composition, richness and diversity).

time_perspective: Retrospective

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

intervention_type: Biological


title: Clinical Evaluation of Instrumented Wheel of Wheelchair as Biomedical Device Quantifying the Displacement Efficiency

acronym: FRM

summary:
The purpose of this study is to validate an instrumented wheel such as a new biomedical device. The physicians will compare this instrumented wheel with another instrumentation "Ergometer roller", each patient will try the both instrumentations, physical and physiological parameters will be measured.

The increase rate of radial power during the cardiac stress test may be more important when the physicians use the instrumented wheel.


title: A Multi-centre Randomised Controlled Trial to Compare the Effectiveness of Two Rehabilitation Programs in Patients With Multiple Sclerosis.

acronym: REHABMUSCLE

summary: The purpose of this study was to compare the effectiveness of two rehabilitation programs (one month) in patients with multiple sclerosis. The first program is combined with physiotherapy, endurance training and resistance training. The second one is physiotherapy in private practice. Another purpose is to assess the length of the benefits of the combined program.

location_facility: Physical medicine and rehabilation Department, Hôpital RAYMOND POINCARE

intervention_type: Behavioral


title: Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures for Lung Applications (Biopsies and Ablation) and Liver Procedures in Interventional Radiology: a Feasibility Study

summary:
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.

This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.

lead_sponsor: Mauna Kea Technologies


title: A Randomized Phase III Clinical Trial to Evaluate the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer

acronym: LIBELULE

summary:
Lung cancer is diagnosed at metastatic stage in 60% of the cases. For these patients, first-line treatment is based on histology and molecular characterization of non-squamous non-small cell lung cancer (NSCLC). Thus, quality and quantity of tumor tissue are crucial to determine the appropriate treatment (targeted therapies, chemotherapy and immunotherapy).

However, in routine practice, tissue quality and quantity can be limited (25%), resulting in the need for tumor rebiopsy for molecular analysis. Therefore, lung cancer patients often experience substantial delays before treatment initiation that may be associated with worse patient experience of subsequent cancer care and poorer clinical outcomes.

"Liquid biopsies" (LB) are used to detect genomic alterations in cell-free circulating DNA (cfDNA). Since very recently, they are routinely used in reference centers for the detection of EGFR-mutations when tissue is not sufficient for molecular characterization. Importantly, the feasibility and clinical relevance of systematic liquid biopsies in routine practice has never been evaluated in patients with suspicious advanced lung cancer.

Investigators hypothesize that using systematic LB in patients with clinical suspicion of metastatic lung cancer may reduce time-to-treatment initiation and avoid tissue rebiopsy.

Investigators performed a retrospective study including 250 NSCLC patients treated in a tertiary Cancer Center and in the University Hospital of Lyon, France. The mean time-to-appropriate frontline treatment initiation (TTI) was 42+/-22.5 days. With the use of LB at the time of first consultation, the investigators believe it is possible to reduce the mean TTI down to 33 days (21% reduction in TTI) in the overall population with suspicious metastatic lung cancer, including a 50% and 40% reduction in TTI for EGFR/ALK/ROS1/BRAF V600E subgroups and KRAS/LKB1/ERBB2/c-MET/BRAF non V600E subgroups, respectively.

Investigators therefore designed a "real-life" randomized study to evaluate the feasibility and clinical relevance of LB to decrease the TTI, which may in turn improve patients' outcome. Genomic analyses of circulating cfDNA will be performed using a robust and highly sensitive technology (InVision®), that profiles the presence of genomic aberrations in a panel of 35 genes including mutations, insertion/deletions and rearrangements, including all actionable alterations required to initiate the appropriate first-line therapy (EGFR-, ALK-, ROS1 and BRAF V600E).

lead_sponsor: Centre Leon Berard

location_facility: Groupe Hospitalier de la région de Mulhouse et Sud-Alsace

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Diagnostic Test


title: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project

acronym: IMPROVED

summary:
Background :

Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism.

In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED.

Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS.

These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders.

Purpose : The investigators hypothesized that

a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS,
improves anti-pneumococcal vaccination at 6 months,
in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).

lead_sponsor: Centre Hospitalier Princesse Grace

location_country: Monaco France

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand


title: Target-Controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison in Pediatric Patients Between Manual Perfusion and Automated Perfusion

acronym: LoopPed

summary: To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during pediatric anesthesia

lead_sponsor: Hopital Foch

location_facility:
Hôpital Foch
Hôpital Necker Enfants


title: An Investigation of Susceptibility Genes for Rare Cancers in Children by Exome Sequencing

acronym: EXOCARE

summary:
Other than high-dose radiation and previous chemotherapy, few strong risk factors have been identified as causes of childhood cancer. Geneticists estimate that 5 to 10% of all cancers diagnosed during the paediatric period occur in children born with a genetic mutation, increasing their lifetime risk of neoplasia. Such genetic risk is higher in children with congenital anomalies and specific genetic syndromes. Some germline genetic alterations are well known (e.g. P53 protein (P53), Neurofibromatosis type 1(NF1)), however many children with none of these mutations have clinical presentations that strongly suggest the involvement of a genetic predisposition. Comprehensive genetic testing for all such patients is an important factor for improving disease surveillance. Such opportunities are now available thanks to whole exome sequencing (WES). In oncology, an important clinical application of WES will be to routinely identify mutations associated with inherited cancer predispositions and to guide cancer risk-management decisions.

Our project is a national translational multicenter genetics study aimed at identifying genes involved in paediatric cancer predisposition by WES in a very select population of children with both developmental delay and cancer. Our project relies on the TED register (Tumeur Et Développement), an initiative by the French organisation SFCE (Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'Adolescent) involving 30 child cancer units in France. This database includes the information of more than 500 paediatric cancer patients with congenital abnormalities. The investigators plan to sequence the germline and tumour exome of 100 patients with developmental delay in a trio-design consisting of 300 people and 100 tumours.

The investigators believe that the ExoCaRe project will provide answers to the genetic origins of certain particular childhood cancers. The ExoCaRe project relies on a genetic study to identify genetic risk factors for rare forms of childhood cancer and aims to establish more personalised treatment. It is aimed at improving genetic counselling for families and will be fully integrated in the genetic counselling process. The information provided by our study will be used to improve the management approach to an initial cancer by clarifying the risks of other cancers in related families. The investigators hope to identify new germline genes predisposing to cancer that will be of interest in understanding tumour biology.

lead_sponsor: University Hospital, Angers

location_country: France Réunion

location_facility: University Hospital of Saint Denis de La Reunion

location_facility: Institut of Haematology and Paediatric Oncology of Lyon


title: Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Patients With Metastatic Melanoma

summary: This is a Phase 2 study being conducted at multiple centers in the United States and France. Patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). The purpose of the study is to test whether the angiogenesis inhibitor AG-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.

lead_sponsor: Pfizer

location_country:
United States
France


title: Sleepiness and Performances Degradation in Adults Presenting an Attention-Deficit/ Hyperactivity Disorder (ADHD)

acronym: SOMTDA/H

summary: The Attention Deficit/ Hyperactivity Disorder (ADHD) is a developmental disorder which affects 3 to 5 % of school age children. This disorder persists in the adulthood for 60 % of subjects. Children with ADHD are sleepier during the day than normal children. However, there is no information concerning the diurnal sleepiness of adults with ADHD and the impact of this sleepiness on their driving capacity. The investigators postulate that the negative impact of ADHD is due to an awakening disorder which adds to the attentional disorder. The aim of this study is to estimate both the sleepiness by a Maintenance Wakefulness Test (MWT) and the capacity to drive in adults with ADHD.

ReferenceCitation: Bioulac S, Chaufton C, Taillard J, Claret A, Sagaspe P, Fabrigoule C, Bouvard MP, Philip P. Excessive daytime sleepiness in adult patients with ADHD as measured by the Maintenance of Wakefulness Test, an electrophysiologic measure. J Clin Psychiatry. 2015 Jul;76(7):943-8. doi: 10.4088/JCP.14m09087.

family: Bioulac

full_name: Stéphanie Bioulac

given: Stéphanie

family: Chaufton

full_name: Cyril Chaufton

given: Cyril

family: Taillard

full_name: Jacques Taillard

given: Jacques

family: Claret

full_name: Astrid Claret

given: Astrid

family: Sagaspe

full_name: Patricia Sagaspe

given: Patricia

family: Fabrigoule

full_name: Colette Fabrigoule

given: Colette

family: Bouvard

full_name: Manuel P. Bouvard

given: Manuel P.

family: Philip

full_name: Pierre Philip

given: Pierre

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

title: Excessive Daytime Sleepiness in Adult Patients With ADHD as Measured by the Maintenance of Wakefulness Test, an Electrophysiologic Measure

location_facility:
Hôpital Charles Perrens
CHU de Bordeaux


title: Impact of an Information and Education Program on Sexuality and Social Integration in Women With a Spinal Cord Injury

acronym: SexSIFem

summary: The purpose of this study is to assess the impact on sexuality in women with a spinal cord injury, twelve months after their first return to home, of a program including structured information and education on sexuality, delivered 6 months after their first return to home.

primary_purpose: Supportive Care

location_facility: Physical and Rehabilitation Medicine Department, Raymond Poincaré Hospital


title: Prospective, Monocentric Study Comparing Cystectomy to PlasmaJet Ablation in the Surgical Management of Ovarian Endometriomas

summary:
Objective: To compare loss of ovarian parenchyma following ovarian endometrioma ablation using the PlasmaJet system versus cystectomy, using postoperative examination by 3D ultrasound.

Design: Prospective comparative study. Setting: Two experienced surgeons practicing in two University tertiary referral centers.

Patients: Fifty women with no previous history of ovarian surgery managed for unilateral ovarian endometrioma > 30 mm in diameter.

Interventions: Endometrioma ablation by plasma energy using the PlasmaJet system and ovarian tissue sparing cystectomy.

Main Outcome Measures: 3D ultrasound assessment of postoperative reduction in ovarian volume and antral follicle count (AFC) .

ReferenceCitation: Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3). pii: e2014.00002. doi: 10.4293/JSLS.2014.00002.

family: Roman

full_name: Horace Roman

given: Horace

family: Bubenheim

full_name: Michael Bubenheim

given: Michael

family: Auber

full_name: Mathieu Auber

given: Mathieu

family: Marpeau

full_name: Loïc Marpeau

given: Loïc

family: Puscasiu

full_name: Lucian Puscasiu

given: Lucian

journal_name: JSLS : Journal of the Society of Laparoendoscopic Surgeons

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: The Society of Laparoendoscopic Surgeons

title: Antimullerian Hormone Level and Endometrioma Ablation Using Plasma Energy

lead_sponsor: Plasma Surgical Inc


title: Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study

summary: The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.


title: A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer

summary: Patients (pts) with stage IIIA/IIIB NSCLC received NVBiv 25 mg/m² + CDDP 80 mg/m² on D1 and NVBo 60 mg/m² on D8 every 3 weeks (q3w) for 2 cycles as induction. Pts with response or non change received NVBo 20 mg fixed dose on D1 D3 D5 + CDDP 80 mg/m² on D1 q3w for 2 more cycles during RT(66 Gy/6.5 w).

ReferenceCitation: Lerouge D, Rivière A, Dansin E, Chouaid C, Dujon C, Schott R, Lavole A, Le Pennec V, Fabre E, Crequit J, Martin F, Dehette S, Fournel P, Precheur-Agulhon B, Lartigau E, Zalcman G. A phase II study of cisplatin with intravenous and oral vinorelbine as induction chemotherapy followed by concomitant chemoradiotherapy with oral vinorelbine and cisplatin for locally advanced non-small cell lung cancer. BMC Cancer. 2014 Mar 30;14:231. doi: 10.1186/1471-2407-14-231.

family: Lerouge

full_name: Delphine Lerouge

given: Delphine

family: Rivière

full_name: Alain Rivière

family: Dansin

full_name: Eric Dansin

given: Eric

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Dujon

full_name: Cécile Dujon

given: Cécile

family: Schott

full_name: Roland Schott

given: Roland

family: Lavole

full_name: Armelle Lavole

given: Armelle

family: Le Pennec

full_name: Vincent Le Pennec

given: Vincent

family: Fabre

full_name: Elizabeth Fabre

given: Elizabeth

family: Crequit

full_name: Jacky Crequit

given: Jacky

family: Martin

full_name: Francis Martin

given: Francis

family: Dehette

full_name: Stéphanie Dehette

family: Fournel

full_name: Pierre Fournel

family: Precheur-Agulhon

full_name: Bénédicte Precheur-Agulhon

given: Bénédicte

family: Lartigau

full_name: Eric Lartigau

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Pierre Fabre Medicament


title: Does Patient Look to Internet for Anesthesia Information Before Surgery : a Prospective International Questionaire Study

acronym: e-anesth

summary: Patients need information for perioperative period and internet may be an interesting alternative.This study analysed by questionaire what does patient look on internet: information of perioperative period and specifically for anesthesia. Questionaire (8 questions) are distributed to the patient before surgery and after they were prepared by surgeon. Population : adult (> 18 y), no emergency procedure.The mean question is the use of internet for anesthesia information.

ReferenceCitation: Nucci B, Claret PG, Leclerc G, Chaumeron A, Grillo P, Buleon C, Leprince V, Raux M, Minville V, Futier E, Lefrant JY, Cuvillon P; Anaesthesia Internet Study Group. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey. Eur J Anaesthesiol. 2017 Dec;34(12):831-835. doi: 10.1097/EJA.0000000000000686.

family: Nucci

full_name: Bastian Nucci

given: Bastian

family: Claret

full_name: Pierre-Geraud Claret

given: Pierre-Geraud

family: Leclerc

full_name: Gilles Leclerc

given: Gilles

family: Chaumeron

full_name: Arnaud Chaumeron

given: Arnaud

family: Grillo

full_name: Philippe Grillo

given: Philippe

family: Buleon

full_name: Clément Buleon

given: Clément

family: Leprince

full_name: Vincent Leprince

family: Raux

full_name: Mathieu Raux

family: Minville

full_name: Vincent Minville

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Lefrant

full_name: Jean-Yves Lefrant

given: Jean-Yves

family: Cuvillon

full_name: Philippe Cuvillon

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Pierre and Marie Curie University

location_facility:
CHU Toulouse
CHU Caremeau


title: A Simple Blind Controlled Randomized Trial: Cephalic Version by Acupuncture-moxibustion vs Placebo for Breech Presentation

acronym: ACUVERSE

summary: For breech presentation, the cesarean section rate is decreased by external cephalic version. This is a painful operation, with some rare but serious complications. The aim of this trial is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to correct breech presentation before 37 weeks of gestation.

ReferenceCitation: Coulon C, Poleszczuk M, Paty-Montaigne MH, Gascard C, Gay C, Houfflin-Debarge V, Subtil D. Version of breech fetuses by moxibustion with acupuncture: a randomized controlled trial. Obstet Gynecol. 2014 Jul;124(1):32-39. doi: 10.1097/AOG.0000000000000303.

family: Coulon

full_name: Capucine Coulon

given: Capucine

family: Poleszczuk

full_name: Marion Poleszczuk

given: Marion

family: Paty-Montaigne

full_name: Marie-Hélène Paty-Montaigne

given: Marie-Hélène

family: Gascard

full_name: Cécile Gascard

given: Cécile

family: Gay

full_name: Charlotte Gay

given: Charlotte

family: Houfflin-Debarge

full_name: Véronique Houfflin-Debarge

given: Véronique

family: Subtil

full_name: Damien Subtil

given: Damien

journal_name: Obstetrics & Gynecology

title: Version of Breech Fetuses by Moxibustion With Acupuncture

lead_sponsor: University Hospital, Lille

location_facility: Hopital Jeanne de Flandre, CHRU de Lille


type: Other Grant/Funding Number

title: Impact of the Use of C-reactive Protein in a Micro-method on the Prescription of Antibiotics in General Practitioners Consulting in the Office

acronym: VIP

summary:
Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success.

C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high.

The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.

ReferenceCitation: Gulliford MC, Moore MV, Little P, Hay AD, Fox R, Prevost AT, Juszczyk D, Charlton J, Ashworth M. Safety of reduced antibiotic prescribing for self limiting respiratory tract infections in primary care: cohort study using electronic health records. BMJ. 2016 Jul 4;354:i3410. doi: 10.1136/bmj.i3410.

ReferenceCitation: Llor C, Moragas A, Cots JM, López-Valcárcel BG; Happy Audit Study Group. Estimated saving of antibiotics in pharyngitis and lower respiratory tract infections if general practitioners used rapid tests and followed guidelines. Aten Primaria. 2017 Jun - Jul;49(6):319-325. doi: 10.1016/j.aprim.2016.07.002. Epub 2016 Nov 22.

ReferenceCitation: van Vugt SF, Verheij TJ, de Jong PA, Butler CC, Hood K, Coenen S, Goossens H, Little P, Broekhuizen BD; GRACE Project Group. Diagnosing pneumonia in patients with acute cough: clinical judgment compared to chest radiography. Eur Respir J. 2013 Oct;42(4):1076-82. doi: 10.1183/09031936.00111012. Epub 2013 Jan 24.

ReferenceCitation: Huang Y, Chen R, Wu T, Wei X, Guo A. Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies. Br J Gen Pract. 2013 Nov;63(616):e787-94. doi: 10.3399/bjgp13X674477. Review.

ReferenceCitation: Kapasi AJ, Dittrich S, González IJ, Rodwell TC. Host Biomarkers for Distinguishing Bacterial from Non-Bacterial Causes of Acute Febrile Illness: A Comprehensive Review. PLoS One. 2016 Aug 3;11(8):e0160278. doi: 10.1371/journal.pone.0160278. eCollection 2016. Review.

ReferenceCitation: Ivaska L, Niemelä J, Leino P, Mertsola J, Peltola V. Accuracy and feasibility of point-of-care white blood cell count and C-reactive protein measurements at the pediatric emergency department. PLoS One. 2015 Jun 2;10(6):e0129920. doi: 10.1371/journal.pone.0129920. eCollection 2015.

ReferenceCitation: Esposito S, Tremolati E, Begliatti E, Bosis S, Gualtieri L, Principi N. Evaluation of a rapid bedside test for the quantitative determination of C-reactive protein. Clin Chem Lab Med. 2005;43(4):438-40.

ReferenceCitation: Cohen R, Lécuyer A, Wollner C, Deberdt P, Thollot F, Henriquet V, de La Rocque F. [Evaluation of impact of CRP rapid test in management of febrile children in ambulatory pediatric practice]. Arch Pediatr. 2008 Jun;15(6):1126-32. doi: 10.1016/j.arcped.2008.03.007. Epub 2008 May 16. French.

ReferenceCitation: Cohen R, Romain O, Levy C, Perreaux F, Decobert M, Hau I, Lécuyer A, Lesprit E, Maman L, Roullaud S, Chéron G, Bekri A, d'Athis P, Henriquet V, de La Rocque F. [Impact of CRP rapid test in management of febrile children in paediatric emergency units of Ile-de-France]. Arch Pediatr. 2006 Dec;13(12):1566-71. Epub 2006 Oct 27. French.

ReferenceCitation: Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum in: Lancet Glob Health. 2017 Jan;5(1):e39.

ReferenceCitation: Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ. C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 Aug;33(4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26.

ReferenceCitation: Verlee L, Verheij TJ, Hopstaken RM, Prins JM, Salomé PL, Bindels PJ. [Summary of NHG practice guideline 'Acute cough']. Ned Tijdschr Geneeskd. 2012;156(0):A4188. Review. Dutch.

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lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
61bis Boulevard de Charonne
1 Rue Colette Magny
391 Rue des Pyrénées
50 Rue de la Justice
22 rue de Silly
237 Rue de la Croix Nivert,
20 avenue Gorges Sand
25 Rue de Fécamp
25 avenue des frères Lumière
19 Rue du Midi
72 Boulevard Davout
258 Bis Rue de Paris
8 Rue Saint-Exupéry


title: Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology

acronym: GLIO-TEP

summary: 18F-Fluorothymidine is a recently developed PET tracer to image tumor cell proliferation. Very few data report an interest of using such a tracer for cerebral malignant tumor management. In our project, we want to compare the tumoral volumes obtained with PET and MRI, with the gold standard histopathological diagnosis according to the WHO grading malignancy scale and the Ki-67 proliferation index, for preoperative evaluation as much as for tumoral postoperative residue evaluation. Furthermore, we want to explore the interest of 18F-FLT-PET volume to better delineate tumoral volume in radiotherapeutic management of gliomas.

ReferenceCitation: Choi SJ, Kim JS, Kim JH, Oh SJ, Lee JG, Kim CJ, Ra YS, Yeo JS, Ryu JS, Moon DH. [18F]3'-deoxy-3'-fluorothymidine PET for the diagnosis and grading of brain tumors. Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):653-9. Epub 2005 Feb 15.

ReferenceCitation: Chen W, Cloughesy T, Kamdar N, Satyamurthy N, Bergsneider M, Liau L, Mischel P, Czernin J, Phelps ME, Silverman DH. Imaging proliferation in brain tumors with 18F-FLT PET: comparison with 18F-FDG. J Nucl Med. 2005 Jun;46(6):945-52.

location_facility: Hôpital Pellegrin-tripode , CHU de Bordeaux

intervention_type: Radiation


title: Digital Preop-planning of Total Hip Arthroplasties in Orthopedic

acronym: PLANORTHO

summary: Residual leg length discrepancy is a common issue after total hip arthroplasty(THA). Digital preoperative planning may improve the accuracy of the surgical procedure and may help the surgeon to precisely predict implants sizes

lead_sponsor: University Hospital, Toulouse


title: Evaluating Efficacy and Safety of Medium-chain Triglycerides Used as a Temporary Intraocular Tamponading Agent for Retinal Detachment Treated by Endocular Surgery

acronym: MCT

summary:
Background : Surgery is needed in order to flatten and position a detached retina onto the choroid, to allow sealing of the tears and to prevent or reverse vision loss. In case of complex retinal detachment vitrectomies followed by ocular endotamponade - non-solid implants used in ophthalmology - is the most common treatment. Despite several options used by surgeons were not entirely satisfactory, no innovation were marketed in the ocular endotamponade field since decades.

Purpose : Regarding comparative physico-chemical properties of medium-chain triglycerides (MCT) with current tamponading agents (silicone oil or gases), it will be proposed to evaluate the MCT as an ocular endotamponade product.

location_facility: University Hospital Toulouse (Hospital Pierre Paul Riquet)


title: Needle-based Confocal Laser Endomicroscopy in CT-guided Procedures in Interventional Radiology With Applications in Liver and Kidneys: a Feasibility Study

summary:
This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: Kidneys and liver.

This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.


title: Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen

summary:
In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs.

The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk.

Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age.

We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster.

A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules.

The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Centre Hospitalier Regional Lille
Hopital Bichat
Centre Hospitalier Universitaire Nantes
Centre Hospitalier Universitaire Rennes
Hopital Cochin
Chu de Rouen
Chu de Dijon
Centre Hospitalier Tours
APHM
Centre Hospitalier de Saint-Etienne


title: Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study

acronym: SOMILEO

summary:
During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return.

Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed.

As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.

status: Active, not recruiting

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut Regional Du Cancer Val D'Aurelle