title: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

acronym: ACTIDEP

summary: Old age (> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.

location_facility: Centre Mémoire de Ressources et de Recherche (CMRR),

location_facility: Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte

location_facility: Service de Radiologie- Neuroradiologie,CHU bretonneau

location_facility: CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale

location_facility: CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie


title: TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up

acronym: TIPIC-UNV

summary: TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study

acronym: CALVI

summary:
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.

Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Centre Léon Bérard
Centre Hospitalier Métropole Savoie
Chu Limoges
CH Jacques Lacarin
Institut de Cancérologie de la Loire
Chu Clermont-Ferrand

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography

acronym: DOCTA

summary: This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.

status: Unknown status

time_perspective: Other

lead_sponsor: Aquitania Opthalmologica

location_facility:
CHU Strasbourg
Hôpital de la Croix-Rousse
CHU Bordeaux
CHU Nice
CHU Nantes
CHU Dijon

intervention_type: Other

status_simplified: Unknown


title: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years

acronym: Steinert

summary: The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.

ipd_sharing: No

lead_sponsor: University Hospital, Lille

location_facility: Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1


title: Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

acronym: OCRIS

summary: This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

status: Active, not recruiting

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Pitié Salpêtrière University Hospital (APHP)


title: Multi-Omics and IPSCs to Improve the Diagnosis of Rare Intellectual Disabilities

acronym: MIDRID

summary:
Background Genetic factors play a major role in intellectual disability (ID) but the underlying cause is not determined in many cases.

This proposal is the continuation of the previous interregional project HUGODIMS, the aim of which was to perform whole exome sequencing (WES) in 69 thoroughly selected simplex ID parent-child trios. Thanks to HUGODIMS consortium, the underlying genetic cause of ID was determined or highly suspected in 48 cases (69.5%) and 7 novel ID genes were identified.

Hypothesis Investigators hypothesize that an approach combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (iPSC)-derived neural cells would improve diagnosis of ID. The current proposal is therefore a proof-of concept project aiming at assessing the relevance and effectiveness of this multi-omics approach.

Aims and Methods Ten individuals with ID recruited through HUGODIMS, in whom WES have failed to identify pathogenic variants will be included.

The workflow is the following:

Whole genome sequencing (WGS) (Nantes) of these 10 negative trios.
Bio-informatics analyses

In 3 WGS negative cases, 3 positive controls bearing distinct mutations in CAMK2a (a novel ID gene identified thanks to HUGODIMS), and 3 healthy negative controls:

Derivation of induced pluripotent stem cell (iPSC)-derived neural progenitors (iPSC core facility at Nantes)
Targeted and non-targeted metabolomics analyses performed on iPSC-derived neuronal cells (Angers)
RNA sequencing performed on the 9 cell lines (Rennes)
Morphological analyses of differentiated neuronal cell lines derived from 3 affected individuals and 3 positive controls bearing CMK2a mutations (Tours)
Integration and validation of data from multi-omics and morphological approaches

Expected results and impact Investigatrors expect that this approach combining multi-omics and iPSC will help to improve diagnosis and understanding of genetic ID of unknown cause

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Angers

location_facility:
CHU Angers
CHU Poitiers
CHU de Bourgogne
CHU Nantes
HCL Lyon
CHU Rennes


title: Universal Haplotype-Based Non Invasive Prenatal Diagnosis by Linked-Read Sequencing (10XGenomics™ Technology)

acronym: NID

summary:
Description of the presence of cell-free fetal DNA in maternal plasma allowed the possibility of non-invasive prenatal diagnosis. Whereas detection of paternally-inherited alleles is straightforward and being quickly implemented in routine, detection of maternally-inherited alleles remains challenging.

To date, the main approach that is being developped, called Relative Haplotype Dosage Analysis, relies on the identification of an allelic imbalance between the mother's wild-type and mutant alleles, relative to the fetal's contribution. This approach therefore requires the study of a propositus to identify the morbid haplotype, which is not always possible in the context of an ongoing pregnancy.

In this study, we aim to evaluate the contribution of new technologies, such as linked-read Sequencing, to allow direct identification of parental haplotype in the context of non-invasive prenatal diagnosis.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Nantes
CHRU de Dijon
CH Saint Brieuc
CHRU de Brest
CHU de Rennes
CHU de Rouen


title: The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

acronym: REVER

summary:
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.

lead_sponsor: Institut Claudius Regaud

location_facility:
Clinique Claude Bernard
Centre Hospitalier de Rodez
Clinique Pasteur
IUCT-O
Clinique Capio La Croix Du Sud
Centre Hospitalier Auch


title: Teaching the Basics of Electroencephalography to Critical Care Teams

summary:
Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.

The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.

ReferenceType: derived

ReferenceCitation: Legriel S, Jacq G, Lalloz A, Geri G, Mahaux P, Bruel C, Brochon S, Zuber B, André C, Dervin K, Holleville M, Cariou A. Teaching Important Basic EEG Patterns of Bedside Electroencephalography to Critical Care Staffs: A Prospective Multicenter Study. Neurocrit Care. 2021 Feb;34(1):144-153. doi: 10.1007/s12028-020-01010-5.

family: Legriel

full_name: Stephane Legriel

given: Stephane

sequence: first

family: Jacq

full_name: Gwenaëlle Jacq

given: Gwenaëlle

sequence: additional

family: Lalloz

full_name: Amandine Lalloz

given: Amandine

family: Geri

full_name: Guillaume Geri

given: Guillaume

family: Mahaux

full_name: Pedro Mahaux

given: Pedro

family: Bruel

full_name: Cedric Bruel

given: Cedric

family: Brochon

full_name: Sandie Brochon

given: Sandie

family: Zuber

full_name: Benjamin Zuber

given: Benjamin

family: André

full_name: Cécile André

given: Cécile

family: Dervin

full_name: Krystel Dervin

given: Krystel

family: Holleville

full_name: Mathilde Holleville

given: Mathilde

family: Cariou

full_name: Alain Cariou

given: Alain

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurocritical Care

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Ictal Group

location_facility: Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital

location_facility: Department of Anesthesia and Critical Care, Beaujon Hospital

location_facility: Medical Intensive Care Unit - Cochin Teaching Hospital

location_facility: Intensive Care Unit - Versailles Hospital

location_facility: Medico-Surgical Intensive Care Unit - Saint Joseph Hospital


type: EudraCT Number

title: Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study

summary: ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

ipd_sharing: Undecided

location_facility:
Hôpital Roger Salengro, CHU
CH ARRAS
CH DOUAI
Chu Rouen
Hopital Victor Provo - Roubaix
CH LENS


title: Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

acronym: AES ODEFSEY

summary:
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.

At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon Hospital
Le Mans Hospital
Angers University Hospital
Nantes University Hospital
Laval Hospital
Saint-Nazaire Hospital


title: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

acronym: MOTIVATE

summary:
This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.

The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

The study data (immune-related adverse events) will be collected during each administration of the treatment.

A questionnaire will be completed by the patient before the treatment administrations.

Patients will be followed until disease progression or up to 12 months of treatment.

ReferenceCitation: Cabarrou B, Gomez-Roca C, Viala M, Rabeau A, Paulon R, Loirat D, Munsch N, Delord JP, Filleron T. Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial. Invest New Drugs. 2020 Dec;38(6):1879-1887. doi: 10.1007/s10637-020-00938-x. Epub 2020 May 7. Review.

family: Cabarrou

full_name: Bastien Cabarrou

given: Bastien

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Viala

full_name: Marie Viala

given: Marie

family: Rabeau

full_name: Audrey Rabeau

given: Audrey

family: Paulon

full_name: Rodolphe Paulon

given: Rodolphe

family: Loirat

full_name: Delphine Loirat

given: Delphine

family: Munsch

full_name: Nadia Munsch

given: Nadia

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Filleron

full_name: Thomas Filleron

given: Thomas

journal_name: Investigational New Drugs

location_facility: Institut Regional Du Cancer de Montpellier (Icm)

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Third Generation Cognitive Behavioural Therapy Versus Treatment-as-usual for Attention Deficit and Hyperactivity Disorder: a Randomized, 2-parallel-group, Evaluator Blinded, Superiority Trial

acronym: Hyper-mCBT

summary: The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and depression, and improve self-confidence, emotional control, social integration and school results.

location_facility:
Hôpital Pierre Wertheimer
CH Charles Perrens
APHP - Hôpital Robert Debré
CHU Montpellier
APHM - Hôpital Salvator
CHU Nimes

intervention_type: Behavioral


title: Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections

acronym: VECAR

summary: The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

primary_purpose: Prevention

lead_sponsor: Rennes University Hospital

location_facility:
CHU Angers
CHU Toulouse
Hôpital Pitié Salpêtrière
CHU Bordeaux
CHU Lille
CHU Rennes

intervention_type: Device


title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

summary: Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.

lead_sponsor: Octapharma

location_facility: CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque


title: Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)

summary:
This study is a phase I/II, multicenter, open-label study starting with a phase I part followed by a Phase II part.

The phase I part of the study aims at evaluating the safety and efficacy (in terms of abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be enrolled in each cohort.

Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients will be enrolled in the phase II part of the study in order to evaluate the activity (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints inhibitors in patients with metastatic melanoma.

66 patients will be included in the phase II.

status: Terminated

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Combination Product


type: Registry Identifier

title: Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients

acronym: MYCOGENIE

summary: The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.

ReferenceType: background

ReferenceCitation: Suarez F, Lortholary O, Buland S, Rubio MT, Ghez D, Mahé V, Quesne G, Poirée S, Buzyn A, Varet B, Berche P, Bougnoux ME. Detection of circulating Aspergillus fumigatus DNA by real-time PCR assay of large serum volumes improves early diagnosis of invasive aspergillosis in high-risk adult patients under hematologic surveillance. J Clin Microbiol. 2008 Nov;46(11):3772-7. doi: 10.1128/JCM.01086-08. Epub 2008 Sep 24.

ReferenceCitation: Dannaoui E, Gabriel F, Gaboyard M, Lagardere G, Audebert L, Quesne G, Godichaud S, Verweij PE, Accoceberry I, Bougnoux ME. Molecular Diagnosis of Invasive Aspergillosis and Detection of Azole Resistance by a Newly Commercialized PCR Kit. J Clin Microbiol. 2017 Nov;55(11):3210-3218. doi: 10.1128/JCM.01032-17. Epub 2017 Aug 16.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Necker - Enfants maladies (AP-HP)

intervention_type: Diagnostic Test


title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

summary:
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

ReferenceCitation: Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25° head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.

family: Falempin

full_name: Anne-Sophie Falempin

given: Anne-Sophie

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Binakdane

full_name: Fatima Binakdane

given: Fatima

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Smirdec

full_name: Margot Smirdec

given: Margot

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
Hôpital Nord-Ouest
Pôle Santé République
CHU Clermont-Ferrand
Hôpital Saint-Louis / AP-HP
Polyclinique Saint Odilon
Centre Hospitalier Alpes-Léman

intervention_type: Procedure


title: Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment

acronym: IPIO-PA

summary: The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.

primary_purpose: Supportive Care

location_facility:
Hôpital privé du Confluent
CHU de Nantes
ICO Nantes
ICO Angers
CHD Vendée
CH Saint Nazaire


title: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

summary:
This study concerns elderly patients with cancer with onco-geriatric assessment.

This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.

lead_sponsor: Centre Francois Baclesse

location_facility:
CH
Centre François Baclesse
Ch Compiegne
Centre Hospitalier
Centre Henri Becquerel
CHU


title: Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study

summary: Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.

design_allocation: Non-Randomized

lead_sponsor: Nestlé

location_facility: CHU Bordeaux - Hôpital Pellegrin Enfants


title: Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis

acronym: COMPO-CLOT

summary:
The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.

The main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.

time_perspective: Cross-Sectional

ReferenceCitation: Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study group†. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.

name: Univ de Paris, Laboratory of Vascular Translational Science, U1148 Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France (L.D.M., J.-P.D., M.S., V.O., S.D., C.D., B.H.-T.-N., M.M.).

name: Department of Interventional Neuroradiology Rothschild Foundation Hospital, Paris, France (L.D.M., J.-P.D., M.P., R.B., M.M.).

family: Di Meglio

full_name: Lucas Di Meglio

given: Lucas

family: Desilles

full_name: Jean-Philippe Desilles

given: Jean-Philippe

family: Solonomenjanahary

full_name: Mialitiana Solonomenjanahary

given: Mialitiana

name: Univ. Lille, CHU Lille, EA 2694, Santé publique: épidémiologie et qualité des soins, France (J.L.).

family: Labreuche

full_name: Julien Labreuche

given: Julien

family: Ollivier

full_name: Véronique Ollivier

given: Véronique

family: Dupont

full_name: Sebastien Dupont

given: Sebastien

family: Deschildre

full_name: Catherine Deschildre

given: Catherine

name: Department of Clinical Research, Rothschild Foundation Hospital, Paris, France (M.B.M.).

family: Maacha

full_name: Malek Ben Maacha

given: Malek Ben

name: Department of Stroke Centre and Diagnostic and Interventional Neuroradiology, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France (A.C., B.L.).

family: Consoli

full_name: Arturo Consoli

given: Arturo

family: Lapergue

full_name: Bertrand Lapergue

given: Bertrand

family: Piotin

full_name: Michel Piotin

given: Michel

family: Blanc

full_name: Raphael Blanc

given: Raphael

family: Ho-Tin-Noe

full_name: Benoit Ho-Tin-Noe

given: Benoit

family: Mazighi

full_name: Mikael Mazighi

given: Mikael

family: Désilles

full_name: Jean-Philippe Désilles

family: Redjem

full_name: Hocine Redjem

given: Hocine

family: Smajda

full_name: Stanislas Smajda

given: Stanislas

family: Ciccio

full_name: Gabriele Ciccio

given: Gabriele

family: Escalard

full_name: Simon Escalard

given: Simon

family: Delvoye

full_name: Francois Delvoye

given: Francois

family: Maier

full_name: Benjamin Maier

given: Benjamin

family: Hebert

full_name: Solene Hebert

given: Solene

family: Hamdani

full_name: Mylene Hamdani

given: Mylene

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

publisher: Ovid Technologies (Wolters Kluwer Health)

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

acronym: PARACT

summary: The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

ReferenceCitation: Verot E, Bouleftour W, Macron C, Rivoirard R, Chauvin F. Effect of PARACT (PARAmedical Interventions on Patient ACTivation) on the Cancer Care Pathway: Protocol for Implementation of the Patient Activation Measure-13 Item (PAM-13) Version. JMIR Res Protoc. 2020 Dec 8;9(12):e17485. doi: 10.2196/17485.

family: Verot

full_name: Elise Verot

given: Elise

family: Bouleftour

full_name: Wafa Bouleftour

given: Wafa

family: Macron

full_name: Corinne Macron

given: Corinne

family: Rivoirard

full_name: Romain Rivoirard

given: Romain

family: Chauvin

full_name: Franck Chauvin

given: Franck

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

license: cc-by

license_normalized: cc-by

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Clinique de l'infirmerie protestante de Lyon

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy

acronym: POCADIMS

summary:
Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS.

Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy.

Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations.

This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision.

CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b<>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context.

Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.

location_facility: Centre d'imagerie médicale de la découverte

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Régional et Universitaire de Brest


title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

acronym: RECO-Sepsis

summary:
Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.

ReferenceCitation: Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.

apc_source: openAPC

family: Cour

full_name: Martin Cour

given: Martin

family: Buisson

full_name: Marielle Buisson

given: Marielle

family: Klouche

full_name: Kada Klouche

given: Kada

family: Bouzgarrou

full_name: Radhia Bouzgarrou

given: Radhia

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Quenot

full_name: Jean-Pierre Quenot

given: Jean-Pierre

family: Zeni

full_name: Fabrice Zeni

given: Fabrice

family: Beuret

full_name: Pascal Beuret

given: Pascal

family: Ovize

full_name: Michel Ovize

given: Michel

family: Argaud

full_name: Laurent Argaud

given: Laurent

journal_name: Trials

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Edouard Herriot
CHU de Saint-Etienne
CHU de Clermont-Ferrand
CHU de Montpellier
CHU de Grenoble
CH de Roanne


title: Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

acronym: SAPPRO

summary: The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

location_facility:
Clinique Beau-Soleil
HFME - Hospices Civils de Lyon
CHU de clermont-Ferrand
CHU de Lille
CHU de Montpellier
CHU Nimes


title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

acronym: STEP

summary:
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.

The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.

ReferenceCitation: Gouëffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Aug 13. doi: 10.1007/s00270-021-02940-z. [Epub ahead of print]

family: Gouëffic

full_name: Yann Gouëffic

given: Yann

family: Picquet

full_name: Jean Picquet

given: Jean

family: Schneider

full_name: Fabrice Schneider

family: Kaladji

full_name: Adrien Kaladji

given: Adrien

family: Marret

full_name: Olivier Marret

given: Olivier

family: Muller

full_name: Laurent Muller

family: Guyomarc’h

full_name: Béatrice Guyomarc’h

given: Béatrice

family: Riche

full_name: Valéry-Pierre Riche

given: Valéry-Pierre

family: Chaillou

full_name: Philippe Chaillou

given: Philippe

family: Guillou

full_name: Marie Guillou

given: Marie

family: Nasr

full_name: Bahaa Nasr

given: Bahaa

journal_name: CardioVascular and Interventional Radiology

location_facility:
CHU Angers
CHU de Poitiers
CHD La Roche-sur-Yon
CH de Cholet
CHU de Rennes
CHU Brest


title: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial

acronym: ChimioPal

summary: The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.

study_start_date_type: Anticipated

status: Withdrawn

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre


title: A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.

acronym: PREGRALL

summary: Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.

ReferenceCitation: Cabridain C, Aubert H, Kaeffer B, Badon V, Boivin M, Dochez V, Winer N, Faurel-Paul E, Planche L, Riochet D, Maruani A, Perrotin F, Droitcourt C, Lassel L, Tching-Sin M, Rogers NK, Bodinier M, Barbarot S. Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e024974. doi: 10.1136/bmjopen-2018-024974.

family: Cabridain

full_name: Clémentine Cabridain

given: Clémentine

family: Aubert

full_name: Hélène Aubert

given: Hélène

family: Kaeffer

full_name: Bertrand Kaeffer

given: Bertrand

family: Badon

full_name: Virginie Badon

given: Virginie

family: Boivin

full_name: Marion Boivin

given: Marion

family: Dochez

full_name: Vincent Dochez

given: Vincent

family: Winer

full_name: Norbert Winer

given: Norbert

family: Faurel-Paul

full_name: Elodie Faurel-Paul

given: Elodie

family: Planche

full_name: Lucie Planche

given: Lucie

family: Riochet

full_name: David Riochet

given: David

family: Maruani

full_name: Annabel Maruani

given: Annabel

family: Perrotin

full_name: Franck Perrotin

given: Franck

family: Droitcourt

full_name: Catherine Droitcourt

given: Catherine

family: Lassel

full_name: Linda Lassel

given: Linda

family: Tching-Sin

full_name: Martine Tching-Sin

given: Martine

family: Rogers

full_name: Natasha K Rogers

given: Natasha K

family: Bodinier

full_name: Marie Bodinier

family: Barbarot

full_name: Sebastien Barbarot

given: Sebastien

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

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

location_facility:
CHU Angers
University Hospital
CHU Nantes
CHD Vendée
Centre Hospitalo Universitaire


title: Multicenter Phase II Study Evaluating the Efficacy of Radiotherapy With Modulation Intensity and Integrated Boost (SIB-IMRT) at the Dose of 80Gy, Associated With Chemotherapy by Temozolomide in the Treatment of Adult Glioblastomas

acronym: Glio-SIB-Up

summary:
Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four people per 100,000 inhabitants are diagnosed with this disease every year. The standard treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is 14.6 months [13.2-16.8].

In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions, associated with TMZ is feasible and well tolerated by patients with glioblastoma.

The aim of this present phase II clinical trial is to evaluate the overall survival at 18 months for patients with glioblastoma receiving TMZ, according to standard protocol, associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions.

Secondary objectives are tolerance, survival free progression and quality of live evaluations.

Sixty seven patients will be enrolled in this present trial.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
Centre de Cancérologie Des Dentellières
Institut de cancérologie de Lorraine
Centre d'oncologie et de radiothérapie
Centre Georges François Leclerc
Paul Strauss
CHU Besançon


title: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

acronym: ERHEA

summary:
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre

ReferenceCitation: Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Béné MC, Horvais V, Lienhart A, Trossaërt M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18.

name: Haemophilia Centre University Hospital NantesFrance

family: Desjonqueres

full_name: Alexandre Desjonqueres

given: Alexandre

name: Haemophilia Centre University Hospital RennesFrance

family: Guillet

full_name: Benoit Guillet

given: Benoit

name: Haemophilia Centre University Hospital AngersFrance

family: Beurrier

full_name: Philippe Beurrier

given: Philippe

name: Haemophilia Centre University Hospital BrestFrance

family: Pan‐Petesch

full_name: Brigitte Pan‐Petesch

given: Brigitte

name: Haemophilia Centre University Hospital ToursFrance

family: Ardillon

full_name: Laurent Ardillon

given: Laurent

name: Haemophilia Centre Hospital Le MansLe MansFrance

family: Pineau‐Vincent

full_name: Fabienne Pineau‐Vincent

given: Fabienne

family: Sigaud

full_name: Marianne Sigaud

given: Marianne

family: Fouassier

full_name: Marc Fouassier

given: Marc

family: Ternisien

full_name: Catherine Ternisien

family: Gillet

full_name: Benjamin Gillet

given: Benjamin

family: Béné

full_name: Marie‐Christine Béné

given: Marie‐Christine

family: Horvais

full_name: Valerie Horvais

given: Valerie

name: Haemophilia Centre University Hospital Lyon France

family: Lienhart

full_name: Anne Lienhart

given: Anne

family: Trossaërt

full_name: Marc Trossaërt

journal_name: British Journal of Haematology

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility:
Lyon University Hospital
Brest University Hospital
Rennes University Hospital
Le Mans Hospital
Tours University Hospital
Angers University Hospital


title: A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)

acronym: TROPHIMMUN

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles.

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

ReferenceCitation: You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Joly F, Hajri T, Maucort-Boulch D, Bin S, Rousset P, Devouassoux-Shisheboran M, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Langlois-Jacques C, Mercier C, Villeneuve L, Freyer G, Golfier F. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.

name: Centre de Référence des Maladies Trophoblastiques, Lyon, France

name: Université de Lyon, Université Claude Bernard Lyon 1, Faculté de Médecine Lyon-Sud, CICLY, Lyon, France

name: Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon, Centre d'Investigation de Thérapeutiques en Oncologie et Hématologie de Lyon, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Lyon, France

family: You

full_name: Benoit You

name: Service de Chirurgie Gynécologique et Oncologique, Obstétrique, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France

family: Bolze

full_name: Pierre-Adrien Bolze

given: Pierre-Adrien

name: Hôpital Tenon, Pôle Onco-Hématologie Hôpitaux Universitaires de l'Est Parisien, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris, France

family: Lotz

full_name: Jean-Pierre Lotz

given: Jean-Pierre

name: Service de Gynécologie Obstétrique, Unité de Diagnostic Anténatal, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France

family: Massardier

full_name: Jérome Massardier

given: Jérome

name: Département d’Oncologie Médicale, Institut Claudius Regaud, IUCT-ONCOPOLE, Toulouse, France

family: Gladieff

full_name: Laurence Gladieff

given: Laurence

name: Clinical Research Department, Centre François Baclesse, Caen Cedex, France

family: Joly

full_name: Florence Joly

given: Florence

family: Hajri

full_name: Touria Hajri

given: Touria

name: Service de Biostatistique, Hospices Civils de Lyon, Lyon; and CNRS UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

name: Unité Recherche et Epidémiologie Cliniques - Pôle de Santé Publique, Centre Hospitalier Lyon Sud, Pierre-Bénite, France

family: Bin

full_name: Sylvie Bin

given: Sylvie

name: Radiologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France

family: Rousset

full_name: Pascal Rousset

given: Pascal

name: Anatomopathologie, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Bénite, France

family: Devouassoux-Shisheboran

full_name: Mojgan Devouassoux-Shisheboran

given: Mojgan

family: Roux

full_name: Adeline Roux

given: Adeline

family: Alves-Ferreira

full_name: Marine Alves-Ferreira

given: Marine

family: Grazziotin-Soares

full_name: Daniele Grazziotin-Soares

given: Daniele

family: Langlois-Jacques

full_name: Carole Langlois-Jacques

given: Carole

family: Mercier

full_name: Catherine Mercier

given: Catherine

family: Villeneuve

full_name: Laurent Villeneuve

family: Freyer

full_name: Gilles Freyer

given: Gilles

family: Golfier

full_name: Francois Golfier

given: Francois

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: American Society of Clinical Oncology (ASCO)

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Validation of an Allergic Rhinitis Control Test in Children

acronym: ARCTEnfants

summary: Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

lead_sponsor: University Hospital, Montpellier

location_facility:
Maison de santé de Lasalle
CH Louis Pasteur
University hospital of Montpellier
CH de MILLAU
Hôpital Trousseau,
Centre (Ctre) Medical Ravas - Malbosc


title: Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)

summary:
The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

lead_sponsor: Poitiers University Hospital

location_facility:
Hospital center
University Hospital Center
Hospital Center


title: Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

acronym: Rexochir

summary: This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy

ReferenceCitation: Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.

family: Laurent

full_name: Hélène Laurent

given: Hélène

family: Galvaing

full_name: Géraud Galvaing

given: Géraud

family: Thivat

full_name: Emilie Thivat

given: Emilie

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

family: Aubreton

full_name: Sylvie Aubreton

family: Richard

full_name: Ruddy Richard

given: Ruddy

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Costes

full_name: Frederic Costes

given: Frederic

family: Filaire

full_name: Marc Filaire

given: Marc

lead_sponsor: Centre Jean Perrin

location_facility: CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,

location_facility: Centre de Recherche en Nutrition Humaine

location_facility: Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel


summary: The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals

time_perspective: Retrospective

location_facility:
IME Le Reverdi
Association UNI-TEDS
Hôpital Sainte Anne
Association Agir et Vivre l'Autisme
IME Eclair
IME notre Ecole


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

lead_sponsor: UNICANCER

acronym: PANIRINOX

location_facility: CHU Carémeau - Institut de Cancérologie du Gard

ipd_sharing: Yes

source: euctr

title: Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

summary:
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.

Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.


title: Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

acronym: CACAOD

summary:
This is a prospective, multicentric, randomized, open labeled superiority trial

This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.

The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.

lead_sponsor: University Hospital, Angers

location_facility:
CHU Clermont-ferrand
CHU de St Etienne
Chu Angers
CHU de Poitiers
CH Le MANS


title: Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

summary: Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

lead_sponsor: Oticon Medical

location_facility:
CHU Lyon Hôpital Edouard Herriot
CHU Rennes Pontchaillou
Hôpital Rothschild
CHRU Lille Hôpital Roger Salengro
CHU Tours Bretonneau
Hôpital la Pitié Salpêtrièr


title: Evaluation in Real Life Conditions of Sacubitril-valsartan Combination in Patients With Chronic Heart Failure and Sleep Apnea Syndrome

summary:
Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS.

SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.

The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.

ReferenceCitation: Jaffuel D, Molinari N, Berdague P, Pathak A, Galinier M, Dupuis M, Ricci JE, Mallet JP, Bourdin A, Roubille F. Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design. ESC Heart Fail. 2018 Jun;5(3):222-230. doi: 10.1002/ehf2.12270. Epub 2018 Feb 22.

ReferenceType: result

ReferenceCitation: Jaffuel D, Nogue E, Berdague P, Galinier M, Fournier P, Dupuis M, Georger F, Cadars MP, Ricci JE, Plouvier N, Picard F, Puel V, Mallet JP, Suehs CM, Molinari N, Bourdin A, Roubille F. Sacubitril-valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO-SAS study. ESC Heart Fail. 2021 Aug;8(4):2513-2526. doi: 10.1002/ehf2.13455. Epub 2021 Jun 8.

name: Department of Pneumology Arnaud de Villeneuve, Regional University Hospital of Montpellier  Montpellier France

name: PhyMedExp, University of Montpellier, INSERM U1046, CNRS UMR 9214  Montpellier France

family: Jaffuel

full_name: Dany Jaffuel

given: Dany

name: Department of Medical Information Montpellier University Hospital, IMAG UMR 5149, Montpellier University  Montpellier France

family: Nogue

full_name: Erika Nogue

given: Erika

name: Department of Cardiology Béziers Hospital  Béziers France

name: MSP de Béziers, Pôle médical spécialisé  Béziers France

family: Berdague

full_name: Philippe Berdague

given: Philippe

name: Department of Cardiology University Hospital of Rangueil  Toulouse France

family: Galinier

full_name: Michel Galinier

given: Michel

family: Fournier

full_name: Pauline Fournier

given: Pauline

name: Department of Pneumology, Respiratory Tracts Center Hôpital Larrey  Toulouse France

family: Dupuis

full_name: Marion Dupuis

given: Marion

family: Georger

full_name: Frédéric Georger

given: Frédéric

name: Centre Médecine du Sommeil et Assistance respiratoire Béziers Hospital  Béziers France

family: Cadars

full_name: Marie‐Pierre Cadars

given: Marie‐Pierre

name: Department of Cardiology University Hospital Caremeau  Nîmes France

family: Ricci

full_name: Jean‐Etienne Ricci

given: Jean‐Etienne

name: Department of Pneumology University Hospital Caremeau  Nîmes France

family: Plouvier

full_name: Nathalie Plouvier

given: Nathalie

name: Heart Failure Unit Haut‐Lévêque Hospital  Pessac France

family: Picard

full_name: François Picard

given: François

name: PEAS, Nouvelle Clinique Bel‐Air  Bordeaux France

family: Puel

full_name: Vincent Puel

given: Vincent

family: Mallet

full_name: Jean‐Pierre Mallet

given: Jean‐Pierre

family: Suehs

full_name: Carey M. Suehs

given: Carey M.

family: Molinari

full_name: Nicolas Molinari

given: Nicolas

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

name: Department of Cardiology Regional University Hospital of Montpellier  Montpellier France

family: Roubille

full_name: François Roubille

journal_name: ESC Heart Failure

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

repository_normalized: HAL

title: Sacubitril‐valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO‐SAS study

location_facility: Centre Hospitalier Universitaire de Montpellier


type: Other Grant/Funding Number

title: Assessment of the Prevalence and Severity of Urinary and Ano-rectal Functional Disorders and Their Impact on Quality of Life and Sexuality on CF Adults of the North-West CF Network

acronym: PerineoMuco

summary: This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

lead_sponsor: Fondation Ildys

location_facility: CF Center - Groupe Hospitalier Sud Réunion

location_facility: CF Center - Fondation Ildys Site de Perharidy


title: Benefits Evaluation of Selfia® Adapted Underwear for Multiple Sclerosis Patients With Severe to Moderate Handicap Performing Self-catheterization : a Multicenter, Prospective, Uncontrolled and Before/After Study.

acronym: KML

summary:
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability.

Secondly, the study aims to :

Estimate the effect of underwear on quality of life, tiredness linked to the act, comfort in the realization of SC, complications with SC, third party intervention ;
Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd week of evaluation ;
Measure if the patient reused underwear and if he bought it at 6 months and at 1 year

lead_sponsor: Lille Catholic University

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


title: Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial

acronym: AVASMUC

summary: Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial colonization is facilitated by a reduced mucociliary function and some previous studies suggest that the microbiology of the upper airways might influence the microbiology of the lower airway. The aim of this randomized control study is to demonstrate efficacy of antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores, quality of life and lung function

ReferenceCitation: Aanaes K, von Buchwald C, Hjuler T, Skov M, Alanin M, Johansen HK. The effect of sinus surgery with intensive follow-up on pathogenic sinus bacteria in patients with cystic fibrosis. Am J Rhinol Allergy. 2013 Jan;27(1):e1-4. doi: 10.2500/ajra.2013.27.3829.

ReferenceCitation: Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.

ReferenceCitation: Boucher RC. Human airway ion transport. Part one. Am J Respir Crit Care Med. 1994 Jul;150(1):271-81. Review.

ReferenceCitation: Boucher RC. Human airway ion transport. Part two. Am J Respir Crit Care Med. 1994 Aug;150(2):581-93. Review.

ReferenceCitation: Coste A, Gilain L, Roger G, Sebbagh G, Lenoir G, Manach Y, Peynegre R. Endoscopic and CT-scan evaluation of rhinosinusitis in cystic fibrosis. Rhinology. 1995 Sep;33(3):152-6.

ReferenceCitation: Digoy GP, Dunn JD, Stoner JA, Christie A, Jones DT. Bacteriology of the paranasal sinuses in pediatric cystic fibrosis patients. Int J Pediatr Otorhinolaryngol. 2012 Jul;76(7):934-8. doi: 10.1016/j.ijporl.2012.02.043. Epub 2012 Apr 17.

ReferenceCitation: Durand M, Pourchez J, Aubert G, Le Guellec S, Navarro L, Forest V, Rusch P, Cottier M. Impact of acoustic airflow nebulization on intrasinus drug deposition of a human plastinated nasal cast: new insights into the mechanisms involved. Int J Pharm. 2011 Dec 12;421(1):63-71. doi: 10.1016/j.ijpharm.2011.09.023. Epub 2011 Sep 21.

ReferenceCitation: Durand M, Le Guellec S, Pourchez J, Dubois F, Aubert G, Chantrel G, Vecellio L, Hupin C, De Gersem R, Reychler G, Pitance L, Diot P, Jamar F. Sonic aerosol therapy to target maxillary sinuses. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):244-50. doi: 10.1016/j.anorl.2011.09.002. Epub 2012 Aug 24.

ReferenceCitation: Gysin C, Alothman GA, Papsin BC. Sinonasal disease in cystic fibrosis: clinical characteristics, diagnosis, and management. Pediatr Pulmonol. 2000 Dec;30(6):481-9. Review.

ReferenceCitation: Hansen SK, Rau MH, Johansen HK, Ciofu O, Jelsbak L, Yang L, Folkesson A, Jarmer HØ, Aanæs K, von Buchwald C, Høiby N, Molin S. Evolution and diversification of Pseudomonas aeruginosa in the paranasal sinuses of cystic fibrosis children have implications for chronic lung infection. ISME J. 2012 Jan;6(1):31-45. doi: 10.1038/ismej.2011.83. Epub 2011 Jun 30.

ReferenceCitation: Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7.

ReferenceCitation: Knowles MR, Robinson JM, Wood RE, Pue CA, Mentz WM, Wager GC, Gatzy JT, Boucher RC. Ion composition of airway surface liquid of patients with cystic fibrosis as compared with normal and disease-control subjects. J Clin Invest. 1997 Nov 15;100(10):2588-95. Erratum in: J Clin Invest 1998 Jan 1;101(1):285.

ReferenceCitation: Konstan MW, Morgan WJ, Butler SM, Pasta DJ, Craib ML, Silva SJ, Stokes DC, Wohl ME, Wagener JS, Regelmann WE, Johnson CA; Scientific Advisory Group and the Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis. Risk factors for rate of decline in forced expiratory volume in one second in children and adolescents with cystic fibrosis. J Pediatr. 2007 Aug;151(2):134-9, 139.e1. Epub 2007 Jun 22.

ReferenceCitation: Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

ReferenceCitation: Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6.

ReferenceCitation: Regnis JA, Robinson M, Bailey DL, Cook P, Hooper P, Chan HK, Gonda I, Bautovich G, Bye PT. Mucociliary clearance in patients with cystic fibrosis and in normal subjects. Am J Respir Crit Care Med. 1994 Jul;150(1):66-71.

ReferenceCitation: Robertson JM, Friedman EM, Rubin BK. Nasal and sinus disease in cystic fibrosis. Paediatr Respir Rev. 2008 Sep;9(3):213-9. doi: 10.1016/j.prrv.2008.04.003. Epub 2008 Jul 31. Review.

ReferenceCitation: Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolaryngol Head Neck Surg. 2002 Dec;127(6):558-68.

ReferenceCitation: Walter S, Gudowius P, Bosshammer J, Römling U, Weissbrodt H, Schürmann W, von der Hardt H, Tümmler B. Epidemiology of chronic Pseudomonas aeruginosa infections in the airways of lung transplant recipients with cystic fibrosis. Thorax. 1997 Apr;52(4):318-21.

lead_sponsor: Virginie ESCABASSE

location_facility: Centre Hospitalier Universitaire de Clermont ferrand

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Universitaire de la Timone

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Regional Central Database Recording of Chronic Myeloid Leukemia

acronym: LMC

summary: It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: IPOXA, Phase I/II Dose Escalation Trial Aiming to Evaluate the Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis of Colorectal Origin and Uncertain Resectability.

acronym: IPOXA

summary:
Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of rare primary peritoneal cancers, or more frequently distant extension of digestive cancers (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be considered as a distinct oncological entity as its genesis, natural history, and response to systematic treatments differ to those of other metastases. The development of PC, observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of the disease. The prognosis is defined by the possibility of complete resection, possibly after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based on overall survival in several randomized trials, among which one evaluated oxaliplatin. The evaluation of the clinical benefit-risk related to the repeated administration of non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of colorectal origin is already being investigated by several international teams.

The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin, in this combination, could increase the response of peritoneal lesions known to be relatively insensitive to IV chemotherapy.

location_facility: Département de Chirurgie Cancérologique, Centre Léon Bérard

location_facility: Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon

location_facility: Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL)

location_facility: Service de Chirurgie Digestive et Cancérologique, CHU NORD

location_facility: Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud


title: Interest of Self-compression Technique on Tolerance of Mammography

acronym: ITACTs

summary:
Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

ReferenceCitation: Henrot P, Boisserie-Lacroix M, Boute V, Troufléau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

name: Department of Radiology, Institut de Cancérologie de Lorraine Alexis Vautrin, Vandœuvre-lès-Nancy, France

family: Henrot

full_name: Philippe Henrot

name: Department of Radiology, Institut Bergonié, Bordeaux, France

family: Boisserie-Lacroix

full_name: Martine Boisserie-Lacroix

given: Martine

name: Department of Radiology, Centre François Baclesse, Caen, France

family: Boute

full_name: Véronique Boute

given: Véronique

family: Troufléau

full_name: Philippe Troufléau

family: Boyer

full_name: Bruno Boyer

given: Bruno

family: Lesanne

full_name: Grégory Lesanne

given: Grégory

family: Gillon

full_name: Véronique Gillon

family: Desandes

full_name: Emmanuel Desandes

given: Emmanuel

family: Netter

full_name: Edith Netter

given: Edith

family: Saadate

full_name: Maryam Saadate

given: Maryam

name: Department of Radiology, Institut Curie, Paris, France

family: Tardivon

full_name: Anne Tardivon

given: Anne

name: Centre d’Imagerie Majorelle, Nancy, France

family: Grentzinger

full_name: Christine Grentzinger

given: Christine

family: Salleron

full_name: Julia Salleron

given: Julia

family: Oldrini

full_name: Guillaume Oldrini

given: Guillaume

journal_name: JAMA Internal Medicine

oa_colors: green other

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Cabinet de radiologie
Centre François Baclesse
Institut de Cancérologie de Lorraine
Polyclinique Majorelle
Institut Curie
Institut Bergonié


title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial

acronym: PROVECS

summary:
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.

The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.

ReferenceCitation: Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.

family: Lagier

full_name: David Lagier

given: David

family: Fischer

full_name: François Fischer

given: François

family: Fornier

full_name: William Fornier

given: William

family: Huynh

full_name: Thi Mum Huynh

given: Thi Mum

family: Cholley

full_name: Bernard Cholley

given: Bernard

family: Guinard

full_name: Benoit Guinard

given: Benoit

family: Heger

full_name: Bob Heger

given: Bob

family: Quintana

full_name: Gabrielle Quintana

given: Gabrielle

family: Villacorta

full_name: Judith Villacorta

given: Judith

family: Gaillat

full_name: Francoise Gaillat

given: Francoise

family: Gomert

full_name: Romain Gomert

given: Romain

family: Degirmenci

full_name: Su Degirmenci

given: Su

family: Colson

full_name: Pascal Colson

given: Pascal

family: Lalande

full_name: Marion Lalande

given: Marion

family: Benkouiten

full_name: Samir Benkouiten

given: Samir

family: Minh

full_name: Tam Hoang Minh

given: Tam Hoang

family: Pozzi

full_name: Matteo Pozzi

given: Matteo

family: Collart

full_name: Frederic Collart

given: Frederic

family: Latremouille

full_name: Christian Latremouille

given: Christian

family: Vidal Melo

full_name: Marcos F. Vidal Melo

given: Marcos F.

family: Velly

full_name: Lionel J. Velly

given: Lionel J.

family: Jaber

full_name: Samir Jaber

family: Fellahi

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

ReferenceCitation: Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.

name: for the PROVECS investigators and the ARCOTHOVA group

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: CHU MontpellierHôpital Arnaud de VILLENEUVE


title: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

acronym: Digi-NewB

summary: Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

lead_sponsor: Rennes University Hospital

location_facility:
Brest University Hospital
Rennes University Hospital
Tours University Hospital
Angers University Hospital
Poitiers University Hospital
Nantes University Hospital


title: Evaluation of Changes in Consumption of Drugs and Substances After Incarceration

acronym: COSMOS

summary: To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.

lead_sponsor: Nantes University Hospital

location_facility:
La Roche sur Yon Hospital
Le Mans Hospital
Fontenay Le Comte Hospital
Angers University Hospital
Nantes University Hospital
Laval Hospital


title: Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset

summary: In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI

lead_sponsor: University Hospital, Grenoble

location_facility: H. Hartmann Institute of Radiotherapy and Radiosurgery

intervention_type: Radiation


title: Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients

summary: Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

ReferenceCitation: Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. Epub 2004 Feb 27.

ReferenceCitation: Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.

ReferenceCitation: Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790. Review.

ReferenceCitation: Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.

ReferenceCitation: Lundell S, Holmner Å, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27. Review.

ReferenceCitation: Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28. Review.

ReferenceCitation: Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656. Review.

ReferenceCitation: Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25. Review.

ReferenceCitation: Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18. Review.

ReferenceCitation: Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43. Review.

ReferenceCitation: Kitsiou S, Paré G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174. Review.

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lead_sponsor: Air Liquide Santé International

location_facility: Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

location_facility: Cabinet Privé de Cardiologie - 2, rue jean jaurès

location_facility: Cabinet privé de pneumologie - 28 avenue de Genève

location_facility: Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet

location_facility: cabinet privé de médecine générale - 18, rue Louis Haase

location_facility: Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy


title: Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial

acronym: WeightPump

summary: The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.

lead_sponsor: Icadom

location_facility:
Marseille European Hospital
Alpes Léman Hospital
Métropole Savoie Hospital
Pierre Oudot Hospital
Grenoble University Hospital
Annecy-Genevois Hospital


title: Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?

acronym: RESOPSYBB

summary:
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.

This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.

The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.

location_facility:
Medical-social center Pilotière
Medical-Social center Port Boyer
Medical-social Center Dalby Millet
Medical-social Saint-Servan
Medical-social St-Etienne de Montluc
Medical-Social center Bellevue


title: Comparison of Medical Results of Testicular Sperm Extraction by Conventional Surgery and Microsurgical Track

acronym: Microsperm

summary: To compare motile sperm extraction rate between microTESE and conventional TESE in 18-50 years-old men with non obstructive azoospermia.

ReferenceCitation: Tsujimura A, Matsumiya K, Miyagawa Y, Tohda A, Miura H, Nishimura K, Koga M, Takeyama M, Fujioka H, Okuyama A. Conventional multiple or microdissection testicular sperm extraction: a comparative study. Hum Reprod. 2002 Nov;17(11):2924-9.

lead_sponsor: University Hospital, Toulouse


title: A Phase I/II Trial to Assess the Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Recurrent Advanced/Metastatic Endometrial Cancer Patients

acronym: ENDOLA

summary:
Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/ year). The 5-year overall survivals of patients at diagnosis with locally advanced and metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with platinum-based chemotherapy, there is lack of effective drug in this disease, which explains the poor prognosis of patients.

The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been shown to be effective beyond first chemotherapy line.

Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.

Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable toxicity profile.

Metformin may increase the anti-proliferative effects of olaparib because it downregulates IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.

lead_sponsor: Hospices Civils de Lyon

location_facility: Département de Cancérologie Cervico-Faciale et Thoracique, Centre Oscar Lambret

location_facility: Service d'Oncologie Médicale, Institut Curie

location_facility: Service d'Oncologie Médicale, Centre François Baclesse

location_facility: Comité Gynécologique, Institut Gustave Roussy

location_facility: Département d'Oncologie Médicale, Centre Antoine Lacassagne


title: Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

acronym: AVATAR

summary: The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other complications; Kappetein et al 2012)..

ReferenceCitation: Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve