ReferenceCitation: Quenel-Tueux N, Debled M, Rudewicz J, MacGrogan G, Pulido M, Mauriac L, Dalenc F, Bachelot T, Lortal B, Breton-Callu C, Madranges N, de Lara CT, Fournier M, Bonnefoi H, Soueidan H, Nikolski M, Gros A, Daly C, Wood H, Rabbitts P, Iggo R. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer. Br J Cancer. 2015 Aug 11;113(4):585-94. doi: 10.1038/bjc.2015.247. Epub 2015 Jul 14.

family: Quenel-Tueux

full_name: Nathalie Quenel-Tueux

given: Nathalie

family: Debled

full_name: Marc Debled

given: Marc

family: Rudewicz

full_name: Justine Rudewicz

given: Justine

family: MacGrogan

full_name: Gaetan MacGrogan

given: Gaetan

family: Pulido

full_name: Marina Pulido

given: Marina

family: Mauriac

full_name: Louis Mauriac

given: Louis

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Lortal

full_name: Barbara Lortal

given: Barbara

family: Breton-Callu

full_name: Christelle Breton-Callu

given: Christelle

family: Madranges

full_name: Nicolas Madranges

given: Nicolas

family: de Lara

full_name: Christine Tunon de Lara

given: Christine Tunon

family: Fournier

full_name: Marion Fournier

given: Marion

family: Bonnefoi

full_name: Hervé Bonnefoi

family: Soueidan

full_name: Hayssam Soueidan

given: Hayssam

family: Nikolski

full_name: Macha Nikolski

given: Macha

family: Gros

full_name: Audrey Gros

given: Audrey

family: Daly

full_name: Catherine Daly

family: Wood

full_name: Henry Wood

given: Henry

family: Rabbitts

full_name: Pamela Rabbitts

given: Pamela

family: Iggo

full_name: Richard Iggo

given: Richard

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pélissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

title: Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.

PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.


title: Assessment of [18F]FLT-PET Imaging for Diagnosis and Prognosis of Brain Tumors

acronym: FLT

summary: The primary objective of this study is to assess the efficacy of the radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a tracor of cell proliferation, using Positron Emission Tomography (PET) imaging for the tumor diagnosis and prognosis in a group of 50 patients with different type of brain tumors.[F-18]FLT PET imaging will be compared to the current used imaging techniques of MRI, spectroscopy imaging, PET imaging using [11C]MET tracer, immunohistochemical analysis and clinical parameters.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: University Hospital, Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Impact for Care for Patients With Alcohol Addiction and Treated for ORL Cancer

summary: The aim of the study is to compare the hospitalisation period in ORL surgery for two groups of patients. One of them will be treated for alcohol addiction to weaning them before the surgery ORL. The other group will be treated with usual methods.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: Department of Clinical Research and Innovation

location_facility: Fédération des maladies de l'appareil digestif - Hôpital ARCHET

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


title: Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

summary: During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


type: EudraCT Number

title: Double Blind Randomized Controlled Study of the Effect of Botulinum Toxin Injection in Rectus Femoris and Triceps on the Length and the Strength of These Muscles During Locomotion in Chronic Hemiparetic Patients

acronym: FOLOTOX

summary:
The aim of this randomized controlled study is to quantify the modification during locomotion of chronic hemiparetic patients of the strength and the length of Rectus Femoris and Triceps Surae induced by botulinum toxin injection type A.

The main hypotheses of this study based on previous studies are that botulinum toxin injection increases on one hand the length of the muscle injected during gait and on the other hand decreased the strength of the muscles injected.

The investigators also hypothesized that botulinum toxin injection improved the strength of the antagonist muscles and normalized the pattern of strength of the muscles injected during gait.

study_start_date_type: Actual

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Supiot A, Geiger M, Bensmail D, Aegerter P, Pradon D, Roche N. Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX). BMC Neurol. 2018 Aug 2;18(1):104. doi: 10.1186/s12883-018-1110-8.

family: Supiot

full_name: Anthony Supiot

given: Anthony

sequence: first

family: Geiger

full_name: Maxime Geiger

given: Maxime

sequence: additional

family: Bensmail

full_name: Djamel Bensmail

given: Djamel

family: Aegerter

full_name: Phillippe Aegerter

given: Phillippe

family: Pradon

full_name: Didier Pradon

given: Didier

family: Roche

full_name: Nicolas Roche

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMC Neurology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre de rééducation de l'ADAPT Montargis

location_facility: Service de médecine physique et réadaptation CHU de Brest

intervention_type: Drug


title: A Comparison Between Individual and Wastewater SARS-CoV2 RNA Sequencing

acronym: Cagablea

summary: The aim is to compare the percentage of the different SARS-CoV2 lineages that are detected in wastewater samples with matched clinical samples. About 1,400 swab samples from patients living in Nice were tested by Biogroup between Oct 19th and Oct 23rd (Week 43 of 2020). The sequence of 81 PCR positive samples, corresponding to all samples that were unambiguously assigned to one of the wastewater catchment areas and their lineage was determined. These values were compared to values measured in wastewater.

study_type: Observational

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Nice Hospital
Ipmc . Cnrs


type: Other Identifier

title: Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence

acronym: APEX-ADO

summary: The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.

primary_purpose: Basic Science

ReferenceType: background

ReferenceCitation: Ahr E, Houdé O, Borst G. Inhibition of the mirror generalization process in reading in school-aged children. J Exp Child Psychol. 2016 May;145:157-65. doi: 10.1016/j.jecp.2015.12.009. Epub 2016 Jan 27.

ReferenceCitation: Cachia A, Borst G, Vidal J, Fischer C, Pineau A, Mangin JF, Houdé O. The shape of the ACC contributes to cognitive control efficiency in preschoolers. J Cogn Neurosci. 2014 Jan;26(1):96-106. doi: 10.1162/jocn_a_00459. Epub 2013 Aug 5.

ReferenceCitation: Borst G, Cachia A, Vidal J, Simon G, Fischer C, Pineau A, Poirel N, Mangin JF, Houdé O. Folding of the anterior cingulate cortex partially explains inhibitory control during childhood: a longitudinal study. Dev Cogn Neurosci. 2014 Jul;9:126-35. doi: 10.1016/j.dcn.2014.02.006. Epub 2014 Feb 27.

ipd_sharing: No

lead_sponsor: Centre Hospitalier St Anne

location_facility: Centre de Recherche Clinique (CRC) - CHSA


title: EPIBRAINRAD : Study of Neurological Complication After Radiotherapy for Glioblastoma High Grade

acronym: EPIBRAINRAD

summary:
The survival time and the number of long time survivors after radiotherapy in brain cancer patients have increased for the last decades. Therefore the topic of late-delayed neurotoxic effects of this therapy gains more and more importance. Among these side effects, the main and most frequent one is the leukoencephalopathy, a diffused and progressive damage of the white matter characterized by myelin loss, loss of axons and vascular lesions. The incidence rate assessment, as well as the occurrence time, is based on retrospective studies with low numbers of patients, but seems to reach 30 to 50 % of the patients according to the follow-up. The risk seems to be increased during the first two years after the radiotherapy, but persists for decades.

To gain further insight in the radiation-induced leukoencephalopathy, the objective of this project is to study the onset and evolution of leukoencephalopathy in a 3-year prospective cohort of patients having undergone cerebral radiotherapy for glioma (stage 3-4), using specific cognitive tests, Magnetic Resonance Imagery (MRI) scans of the brain and predictive bio-markers of cognitive impairments.

time_perspective: Prospective

ReferenceCitation: Durand T, Jacob S, Lebouil L, Douzane H, Lestaevel P, Rahimian A, Psimaras D, Feuvret L, Leclercq D, Brochet B, Tamarat R, Milliat F, Benderitter M, Vayatis N, Noël G, Hoang-Xuan K, Delattre JY, Ricard D, Bernier MO. EpiBrainRad: an epidemiologic study of the neurotoxicity induced by radiotherapy in high grade glioma patients. BMC Neurol. 2015 Dec 18;15:261. doi: 10.1186/s12883-015-0519-6.

family: Durand

full_name: Thomas Durand

given: Thomas

family: Jacob

full_name: Sophie Jacob

given: Sophie

family: Lebouil

full_name: Laura Lebouil

given: Laura

family: Douzane

full_name: Hassen Douzane

given: Hassen

family: Lestaevel

full_name: Philippe Lestaevel

given: Philippe

family: Rahimian

full_name: Amithys Rahimian

given: Amithys

family: Psimaras

full_name: Dimitri Psimaras

given: Dimitri

family: Feuvret

full_name: Loïc Feuvret

given: Loïc

family: Leclercq

full_name: Delphine Leclercq

given: Delphine

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Tamarat

full_name: Radia Tamarat

given: Radia

family: Milliat

full_name: Fabien Milliat

given: Fabien

family: Benderitter

full_name: Marc Benderitter

given: Marc

family: Vayatis

full_name: Nicolas Vayatis

family: Noël

full_name: Georges Noël

given: Georges

family: Hoang-Xuan

full_name: Khê Hoang-Xuan

given: Khê

family: Delattre

full_name: Jean-Yves Delattre

given: Jean-Yves

family: Ricard

full_name: Damien Ricard

given: Damien

family: Bernier

full_name: Marie-Odile Bernier

given: Marie-Odile

location_facility:
Hopital Pitié Salpétriere
Centre paul Strauss


title: Management of Cognitive Difficulties After Cancer Treatments in Women Treated for Breast Cancer: Feasibility Study (Step 1 of the Cog-Stim Protocol)

acronym: COG STIM

summary: Investigator general objective is therefore to study and compare the benefit of several methods of management of cognitive difficulties reported by patients during treatment for breast cancer, among several treatments, offered independently in patients' homes and supervised from a distance: adapted physical activity only, cognitive stimulation only, and adapted physical activity coupled with cognitive stimulation (during separate sessions). The study will therefore be the first to include a group benefiting from these two management methods, which will make it possible to assess the individual benefit of cognitive stimulation sessions and adapted physical activity but also the benefit of combined sessions.As this type of combined management has never been the subject of a study, and previous studies relating to a single type of management having raised patient adhesion difficulties, it does not seem certain that this type of care is feasible in practice. Before studying its effectiveness, it is therefore essential to check the feasibility and acceptability of such a program combining sessions of adapted physical activity and cognitive stimulation sessions.Investigator will therefore first carry out a feasibility study, longitudinal and monocentric, which will assess the adherence of patients treated for breast cancer to the performance of cognitive stimulation sessions coupled with sessions of adapted physical activity.This feasibility study is a key stage of the Cog-Stim protocol because its results will probably highlight the obstacles to the intervention program, which will allow the investigator to propose adjustments to improve the study design for the following stages of the protocol. (design optimization).

status: Recruiting

primary_purpose: Other

lead_sponsor: Centre Francois Baclesse

status_simplified: Ongoing


title: The COVISTRESS Study: Influence of the COvid-19 Epidemic on STRESS

acronym: COVISTRESS

summary: The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Single-Dose, Double-Blind, Crossover, Placebo- and Moxifloxacin (Open-Label)-Controlled Study of the Effects of Lecozotan SR on Cardiac Repolarization in Healthy Adult Subjects

summary: This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer


title: Study of the Performance of Ambulatory Nocturnal Polygraphy in the Diagnosis of Sleep Apnea in Multiple System Atrophy

summary: The purpose of this study is to determine whether ambulatory polygraphy during a short hospitalization in a neurology unit has the same performance than inpatient polysomnography, the actual gold standard, in the diagnosis of sleep apnea in patients suffering from multiple system atrophy (MSA).

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital du Haut-Lévêque - Département de Neurologie - Centre de référence nationale maladie rare AMS

intervention_type: Device


title: Pilot Study on Efficacy and Tolerance of Peg-interferon Alpha-2a (Pegasys) Added to Tenofovir DF and Emtricitabine (Truvada) in AGHBe Positive HBV-HIV Co-infected Patients. ANRS HB 01 EMVIPEG.

summary: HBe seroconversion is an important goal for anti-HBV treatment, since it is associated with a non progressive liver infection and a better clinical outcome. However, the rate of HBe seroconversion is low in HIV-HBV co-infected patients, mostly treated by tenofovir and emtricitabine. This study will evaluate the efficacy and the safety of a one-year Peg-interferon alpha 2a additional treatment in patients already treated by tenofovir and emtricitabine without reaching HBe seroconversion.

design_allocation: Non-Randomized

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

location_facility: Service d'Hépato-Gastroentérologie Hopital Hôtel-Dieu


title: A Phase II Study Evaluating the Non-inferiority of the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy (PDT)

acronym: Flexithera

summary: This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.

status: Terminated

ReferenceCitation: Lecomte F, Vignion-Dewalle AS, Vicentini C, Thecua E, Deleporte P, Duhamel A, Mordon S, Mortier L. Evaluating the Noninferiority of a New Photodynamic Therapy (Flexitheralight) Compared With Conventional Treatment for Actinic Keratosis: Protocol for a Phase 2 Study. JMIR Res Protoc. 2019 Apr 26;8(4):e11530. doi: 10.2196/11530.

apc_source: openAPC

family: Lecomte

full_name: Fabienne Lecomte

given: Fabienne

family: Vignion-Dewalle

full_name: Anne Sophie Vignion-Dewalle

given: Anne Sophie

family: Vicentini

full_name: Claire Vicentini

given: Claire

family: Thecua

full_name: Elise Thecua

given: Elise

family: Deleporte

full_name: Pascal Deleporte

given: Pascal

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Mordon

full_name: Serge Mordon

given: Serge

family: Mortier

full_name: Laurent Mortier

given: Laurent

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

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

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

version: submittedVersion

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

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications

lead_sponsor: University Hospital, Lille


title: 3 T Multimodal MRI in Idiopathic RBD

acronym: ALICE

summary: Idiopathic rapid eye movement sleep behavior disorder (iRBD) is characterized by nocturnal violence, increased muscle tone during REM sleep and the lack of any other neurological disease. However, iRBD can precede parkinsonism and dementia by several years. The causes of the loss of muscle atonia during REM sleep in these patients are unclear. Using 3 T MRI and neuromelanin- sensitive sequences, the signal intensity was previously found to be reduce in the locus coeruleus/subcoeruleus area of patients with Parkinson's disease and RBD. Here, the investigators aimed at studying the integrity of the locus coeruleus/ subcoeruleus complex with neuromelanin-sensitive imaging in 21 patients with iRBD and compared the results with those from 21 age- and gender-matched healthy volunteers. All subjects will undergo a clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging.

ReferenceType: result

ReferenceCitation: Ehrminger M, Latimier A, Pyatigorskaya N, Garcia-Lorenzo D, Leu-Semenescu S, Vidailhet M, Lehericy S, Arnulf I. The coeruleus/subcoeruleus complex in idiopathic rapid eye movement sleep behaviour disorder. Brain. 2016 Apr;139(Pt 4):1180-8. doi: 10.1093/brain/aww006. Epub 2016 Feb 26.

family: Ehrminger

full_name: Mickael Ehrminger

given: Mickael

family: Latimier

full_name: Alice Latimier

given: Alice

family: Pyatigorskaya

full_name: Nadya Pyatigorskaya

given: Nadya

family: Garcia-Lorenzo

full_name: Daniel Garcia-Lorenzo

given: Daniel

family: Leu-Semenescu

full_name: Smaranda Leu-Semenescu

given: Smaranda

family: Vidailhet

full_name: Marie Vidailhet

given: Marie

family: Lehericy

full_name: Stéphane Lehericy

given: Stéphane

family: Arnulf

full_name: Isabelle Arnulf

given: Isabelle

journal_name: Brain

oa_colors: green hybrid

evidence: open (via free pdf)

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

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil


title: Feasibility of at Home Remote Monitoring Following a Stay in Intensive Rehabilitation in Patients With Chronic Swallowing Disorders Caused by Treatment for Cancer of the Aero-digestive Tract: Pilot Study

summary: The study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "MAX Educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Toulouse


title: Tobacco and Alcohol Risk Reduction for Women Treated for Breast Cancer and Partner Involvement : Benefits of a Brief Motivational Couple-based Intervention.

acronym: IBMC

summary: This study will examine the benefits of involving partner in a Screening, Brief Intervention and Referral to Treatment (SBIRT) program for tobacco and alcohol for women treated for breast cancer. Using a two-arm randomized trial (couple brief motivational intervention (CBMI) versus individual brief motivational intervention (IBMI) with repeated measures at 6 weeks, 3 and 6 months.

lead_sponsor: Institut Bergonié

intervention_type: Behavioral


title: Nutrition and Chemotherapy, Representation and Practice in a Cancer Care Centre (JEUNETCHIMIO)

acronym: JEUNETCHIMIO

summary:
Patients treated for cancer nowadays have many means of information and tend to become more and more involved in their health. The interest of a therapeutic fast with detoxifying or even curative properties, with a specific indication for cancer patients treated by chemotherapy, is nowadays relayed by the media. To date, there are no studies conducted on the scope of this information in cancer patients or on the attitudes of oncologists towards this practice and possible positioning requests from patients.

We hypothesize that the choice of this practice and its modalities are rarely discussed with oncologists, although it may have deleterious repercussions on the patient's health.

We propose a research based on the principles of sociological intervention. Its objectives are a first review of the issue and the establishment of a joint working group, including patients, carers and researchers, which will propose solutions to improve the patient/carer dialogue on this issue.

lead_sponsor: Institut de Cancérologie de la Loire

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Effectiveness of Screening and Brief Interventions for Alcohol and/or Tobacco During Breast Cancer Treatment: A Phase III, Pilot Prospective Randomized Trial (ONKODETOX)

acronym: ONKODETOX

summary:
Despite scientific, clinical and political incentives, alcohol and/or tobacco screening and brief intervention (SBI) services are poorly implemented in oncology settings. Motivational brief interventions are recognized as particularly effective in changing health behaviors, especially consumption behaviors. The motivational approach is more and more used in primary care setting but still few studies explore its effectiveness with breast cancer patients.

This study aims to compare two intervention arms : educational advices intervention (EAI) versus brief motivational intervention (BMI) for alcohol and/or tobacco consumption in breast cancer women, during their treatment.

In this pilot prospective randomized trial, various psychological and behavioral, variables are measured (alcohol and tobacco consumption, distress, anxiety and depressive disorders, quality of life, motivation for change, empowerment) before the brief intervention, and after 3 and 6 month.


title: High Intensity Focused Ultrasound Treatment of Breast Tumors. BRIFU Study (Breast Resection By HIFU)

acronym: BRIFU

summary: Monocentric prospective study evaluating the efficacy of High intensity focused ultrasound (HIFU) in breast tumors.


type: Registry Identifier

title: Potential Role of CD9 and Implication of Motility Process in Pathogenesis of TEL/ALM1-positive ALL Relapses (LAL TEL/ALM1 and CD9).

acronym: LAL TEL/ALM1

summary: Down regulation of CD9 in TEL/AML1-positive ALL is addressed in motility assays to explore its role in B-ALL pathogenesis and its potential implication in relapses (and prognosis).

lead_sponsor: Rennes University Hospital


title: Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma

acronym: SIB-IMRT

summary: The main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.

lead_sponsor: Centre Georges Francois Leclerc

intervention_type: Radiation


title: Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.

acronym: Radioscapho

summary:
The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

time_perspective: Retrospective

lead_sponsor: University Hospital, Montpellier


title: Influence of Vitamins Status on Severe Obesity Related Complications

acronym: OBESEPI

summary: The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.

ReferenceCitation: Antoine D, Li Z, Quilliot D, Sirveaux MA, Meyre D, Mangeon A, Brunaud L, Guéant JL, Guéant-Rodriguez RM. Medium term post-bariatric surgery deficit of vitamin B12 is predicted by deficit at time of surgery. Clin Nutr. 2021 Jan;40(1):87-93. doi: 10.1016/j.clnu.2020.04.029. Epub 2020 Apr 25.

family: Antoine

full_name: Darlène Antoine

given: Darlène

family: Li

full_name: Zhen Li

given: Zhen

family: Quilliot

full_name: Didier Quilliot

given: Didier

family: Sirveaux

full_name: Marie-Aude Sirveaux

given: Marie-Aude

family: Meyre

full_name: David Meyre

given: David

family: Mangeon

full_name: Alice Mangeon

family: Brunaud

full_name: Laurent Brunaud

family: Guéant

full_name: Jean-Louis Guéant

given: Jean-Louis

family: Guéant-Rodriguez

full_name: Rosa-Maria Guéant-Rodriguez

given: Rosa-Maria

journal_name: Clinical Nutrition

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Li Z, Gueant-Rodriguez RM, Quilliot D, Sirveaux MA, Meyre D, Gueant JL, Brunaud L. Folate and vitamin B12 status is associated with insulin resistance and metabolic syndrome in morbid obesity. Clin Nutr. 2018 Oct;37(5):1700-1706. doi: 10.1016/j.clnu.2017.07.008. Epub 2017 Jul 24.

family: Gueant-Rodriguez

full_name: Rosa-Maria Gueant-Rodriguez

family: Gueant

full_name: Jean-Louis Gueant

lead_sponsor: University of Lorraine


title: Lung Function Impairment and Postural Spirometry Changes in Ambulatory Myotonic Dystrophy Patients

summary:
Myotonic dystrophy Type 1 (MD1, Steinert's disease), an autosomal dominant multisystem disease, is of the most common muscular dystrophies in adults, with a European prevalence of 3-15/100 000. The disease course is progressive, associating muscular weakness, wasting and myotonia. Respiratory dysfunction is common, involving a restrictive ventilatory abnormality and alveolar hypoventilation, originating from respiratory muscle weakness. Depending on the degree of impairment of their lung function, the quality of life and the prognosis of MD1 patients may be very variable. However, time course and prevalence of such respiratory function impairment have not been clearly identified. More importantly, factors able to predict poor respiratory outcome have not been defined and therefore early prognosis can not be assessed during the follow-up of these patients. In other neuromuscular disorders, especially Amyotrophic Lateral Sclerosis (ALS), postural spirometry has been recommended to improve the detection of diaphragmatic involvement and some authors have suggested that the supine fall in the forced vital capacity could be used to initiate noninvasive positive pressure ventilation and predicts some respiratory symptoms.

In a sample of ambulatory patients with MD1, our study was designed to prospectively achieve two aims: 1) to assess the respective prevalence of a ventilatory restrictive pattern, respiratory muscle weakness, hypoxemia and hypercapnia and 2) to evaluate whether postural changes in lung volumes contribute to sensitize the diagnosis of respiratory weakness and could be used as a predictor of poor respiratory function, including hypoxemia, hypercapnia and restrictive ventilatory disease.

lead_sponsor: University of Nancy


title: Pilot Study on the Identification of Cortical Excitability Changes Measured by Transcranial Magnetic Stimulation (TMS) as Markers of Antidepressant Response

acronym: EXCIPSY

summary: Depression is a common issue but there is no marker of response to an antidepressant treatment.The measurement of variation of the cortical excitability in responders to a selective serotonin reuptake inhibitor (SSRI) (compared to no-responders) had never been done before. In the study of Robol et al. (2004) concerning the acute effects of citalopram on markers of cortical excitability, the authors have pointed out an increase on the cortical silent period (CSP) after administration of citalopram (2.5 hours). The investigators hypothesize that this effect remains later and that the diminution of cortical excitability could be a biomarker of antidepressant response. In this case, they expect that the variation of CSP between day 1 and day 28 is higher in responders to a SSRI (citalopram) compared to non-responders. the investigators lead a pilot, prospective, multicentric study in drug-naive patients to compare the variation of the markers of cortical excitability (the CSP but to the resting motor threshold RMT, the motor evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF) between day 1 and day 28 in responders to citalopram, compared to non-responders.

lead_sponsor: Centre Hospitalier du Rouvray


acronym: BRAINSTORM

location_facility:
CHRU Tours
University Hospital of Toulouse

source: euctr

title: SARS-CoV-2 Neurotropism, micRoglial ActivatioN and Cytokine dySregulaTiOn in COVID-19 Patients With Delirium

summary: Emerging evidence indicates that SARS-CoV-2, the etiologic agent of COVID-19, can cause neurological, neuropsychological and psychiatric complications. Given the global dimensions of the current pandemic, there is to consider the possible large-scale neurocognitive impact of COVID-19. Therefore, there is an urgent need for longitudinal studies to determine the acute and chronic effects that COVID-19 may have on the Central Nervous System. These putative effects include the possibility that the CNS serves as a reservoir for the virus, and that COVID-19 triggers CNS deleterious inflammatory cascades and neurodegenerative process. The public implications of these effects are very important in the long term.


title: Symptoms of Depression, Stress and Burnout, and Long-term Psychological Impact in Health Care Professionals Exposed to the Novel Coronavirus Disease 2019 Outbreak (HARD-COVID-19 - Health cAre woRkers exposeD to covID-19)

summary:
Health care workers working in hospital or nursing home for elderly people involved in the coronavirus epidemic are facing several challenges such as direct exposure and involvement in the resolution of major public health emergencies, exposure to potentially fatal contamination, physical exhaustion, unadjusted work organizations, the unusual number of deaths among patients, colleagues and close relatives, and significant ethical challenges in decision-making.

Preliminary data suggests that frontline and lay professionals suffer from different types of psychological distress. These data highlight the importance of screening for psychological distress in response to the scale of the pandemic and the provision of targeted psychological interventions, such as Eye Movement Desensitization and Reprocessing (EMDR, desensitization and neuro-emotional integration by eye movements), to improve the psychological well-being of healthcare workers exposed to COVID-19.

This project is both a cohort study with the proposal of a randomized trial to evaluate an intervention adapted to the exceptional circumstances of the crisis. As such, it is designed as Trial(s) Within Cohort design (TWIC).

lead_sponsor: University Hospital, Tours

location_facility: Bretonneau Regional Universitary Hospital


title: Measurement and Relationships of Proprioceptive Isokinetic Repositioning With Muscle Strength, Functional Testing, and Self-reported Questionaires Before and After Anterior Cruciate Ligament Reconstruction: A Prospective Study With 12-months Post Operative Follow-up.

acronym: PRO-ACL

summary: This prospectively study aims to evaluate the evolution of knee joint proprioception on isokinetic dynamometer before and after Anterior Cruciate Ligament (ACL) reconstruction and its relationships with muscle strength, self reported questionnaire and return to sport. This study will include 30 athletes with isolated ACL rupture, and treated with ACL reconstruction surgery and 15 healthy volunteers.

lead_sponsor: University Hospital, Caen


title: Monitoring the HeMAtological TOXicity of Drugs

acronym: HeMATOX

summary: Several drugs and chemotherapies seem to have an impact on the hematological system. This study investigates reports of hematological toxicities, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

location_facility: Rhumatology department, CHU Strasbourg, Hautepierre hospital


title: Monitoring the IMmUological TOXicity of Drugs

acronym: MIMUTOX

summary: Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

ReferenceCitation: Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3.

family: Arnaud

full_name: Laurent Arnaud

family: Lebrun-Vignes

full_name: Bénédicte Lebrun-Vignes

given: Bénédicte

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

journal_name: Annals of the Rheumatic Diseases

oa_host_type: publisher

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20.

family: Mertz

full_name: Philippe Mertz

given: Philippe

journal_name: Journal of Allergy and Clinical Immunology

ReferenceCitation: Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.

family: Gavand

full_name: Pierre-Edouard Gavand

given: Pierre-Edouard

family: Martin

full_name: Thierry Martin

given: Thierry

family: Chasset

full_name: François Chasset

given: François

family: Tebacher-Alt

full_name: Martine Tebacher-Alt

given: Martine

family: Lambert

full_name: Aude Lambert

given: Aude

family: Muller

full_name: Charlotte Muller

given: Charlotte

family: Sibilia

full_name: Jean Sibilia

given: Jean

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.


title: Study of the Functioning of Prospective Memory in Breast Cancer and the Influence of Sleep

acronym: PROSOM-K

summary: The results of this study will contribute to a better understanding of prospective memory deficit processes in breast cancer in relation to sleep disorders frequently reported in this pathology. In the long term, a better understanding will make it possible to envisage appropriate treatments to compensate for these memory difficulties and to improve the autonomy of the patients.

ReferenceCitation: Duivon M, Perrier J, Joly F, Licaj I, Grellard JM, Clarisse B, Lévy C, Fleury P, Madeleine S, Lefèvre N, Rauchs G, Lecouvey G, Fraisse F, Viader F, Eustache F, Desgranges B, Giffard B. Impact of breast cancer on prospective memory functioning assessed by virtual reality and influence of sleep quality and hormonal therapy: PROSOM-K study. BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.

family: Duivon

full_name: Mylène Duivon

given: Mylène

family: Perrier

full_name: Joy Perrier

given: Joy

family: Joly

full_name: Florence Joly

given: Florence

family: Licaj

full_name: Idlir Licaj

given: Idlir

family: Grellard

full_name: Jean-Michel Grellard

given: Jean-Michel

family: Clarisse

full_name: Bénédicte Clarisse

family: Lévy

full_name: Christelle Lévy

given: Christelle

family: Fleury

full_name: Philippe Fleury

family: Madeleine

full_name: Sophie Madeleine

given: Sophie

family: Lefèvre

full_name: Nicolas Lefèvre

given: Nicolas

family: Rauchs

full_name: Géraldine Rauchs

given: Géraldine

family: Lecouvey

full_name: Grégory Lecouvey

given: Grégory

family: Fraisse

full_name: Florence Fraisse

family: Viader

full_name: Fausto Viader

given: Fausto

family: Eustache

full_name: Francis Eustache

given: Francis

family: Desgranges

full_name: Béatrice Desgranges

given: Béatrice

family: Giffard

full_name: Bénédicte Giffard

journal_name: BMC Cancer

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

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

location_facility:
Centre François Baclesse
Inserm-Ephe-Unicaen U1077 (


title: Ex Vivo and in Vitro Assessment of the Pharmacological Properties of Molecule Prima in the Restoration of Physiological Differentiation of Gene p63 Dependant Epithelium

acronym: PRIMAculture

summary:
Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients.

P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.

status: Suspended

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Opthalmologique A de Rothschild


title: Evaluation of the Cardioprotective Effect of Intracoronary Injection of Morphine During Reperfusion in Acute Myocardial Infarction

acronym: MIAMI

summary: The purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (AMI).

ReferenceCitation: Le Corvoisier P, Gallet R, Lesault PF, Audureau E, Paul M, Ternacle J, Ghostine S, Champagne S, Arrouasse R, Bitari D, Mouillet G, Dubois-Randé JL, Berdeaux A, Ghaleh B, Deux JF, Teiger E. Intra-coronary morphine versus placebo in the treatment of acute ST-segment elevation myocardial infarction: the MIAMI randomized controlled trial. BMC Cardiovasc Disord. 2018 Oct 19;18(1):193. doi: 10.1186/s12872-018-0936-8.

family: Le Corvoisier

full_name: Philippe Le Corvoisier

given: Philippe

family: Gallet

full_name: Romain Gallet

given: Romain

family: Lesault

full_name: Pierre-François Lesault

given: Pierre-François

family: Audureau

full_name: Etienne Audureau

given: Etienne

family: Paul

full_name: Muriel Paul

given: Muriel

family: Ternacle

full_name: Julien Ternacle

given: Julien

family: Ghostine

full_name: Saïd Ghostine

given: Saïd

family: Champagne

full_name: Stéphane Champagne

given: Stéphane

family: Arrouasse

full_name: Raphaele Arrouasse

given: Raphaele

family: Bitari

full_name: Dalila Bitari

given: Dalila

family: Mouillet

full_name: Gauthier Mouillet

given: Gauthier

family: Dubois-Randé

full_name: Jean-Luc Dubois-Randé

given: Jean-Luc

family: Berdeaux

full_name: Alain Berdeaux

given: Alain

family: Ghaleh

full_name: Bijan Ghaleh

given: Bijan

family: Deux

full_name: Jean-François Deux

given: Jean-François

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

journal_name: BMC Cardiovascular Disorders

location_facility:
Henri Mondor Hospital
Hopital Marie Lannelongue


title: Upper Airways in Pregnancy: Evaluation by the Acoustic Reflection Method

acronym: MAVAG

summary:
It is well known that airway management can be difficult during pregnancy. Increased risks for difficult intubation in pregnant women have been often reported. Thus, pregnancy is regarded as a period of high anesthesiologic risk.

Generalized weight gain is a well known factor influencing the upper airway in pregnant women. However, the modifications of the airway itself are less well documented.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave allowing the analysis of the longitudinal cross-sectional area profile of the examined cavity. It is a noninvasive and harmless method.

The aim of the study is to evaluate by acoustic reflection method the physiological modifications of the upper airways during pregnancy.

Women enrolled in the study will undergo an acoustic recording during the first, second, and third trimester of pregnancy, as well as two days and one month after delivery. Forty pregnant women will be included in this monocentric, prospective, open labelled study.

Moreover, a single acoustic recording will be performed in 10 other pregnant women undergoing an MRI for obstetrical purpose. The estimated caliber of the upper airways by MRI and acoustic method will be compared.

ReferenceCitation: Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.

ReferenceCitation: Louis B, Fodil R, Jaber S, Pigeot J, Jarreau PH, Lofaso F, Isabey D. Dual assessment of airway area profile and respiratory input impedance from a single transient wave. J Appl Physiol (1985). 2001 Feb;90(2):630-7.

lead_sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

location_facility:
Armand Trousseau University Hospital
Hôpital d'Enfants Armand Trousseau


title: Validation of the French Version of the Geriatric Mental State: a Structured and Standardized Interview for Diagnosis of Psychiatric Disorders in the Elderly

acronym: GMS-Package

summary:
A major public health issues of today's aging population is the development of knowledge and expertise in geriatric medicine and psychiatry of the elderly. The depressive disorders and dementia, are among the psychiatric conditions most common in older age. They are the subject of much clinical research, in which brain imaging techniques used to establish correlations anatomo-clinical and radiological-clinical. The prerequisite for the realization of such work locally, is the validation in their French version of clinical assessment tools most commonly used internationally, ensuring reliability, acceptability and comparability of results. Among these tools, "Geriatric Mental Schedule (GMS) Package", is the reference tool for research in psychiatry of the elderly. It is a standardized and structured questionnaire that allows to establish with reliability and reproducibility on the basis of answers to questions, major psychiatric diagnoses in the elderly. It has been validated in several languages (German, Spanish, Italian, Dutch, but also Chinese, Korean ...), but is still not available in French.

Hypothesis: Validate the the French version of "Geriatric Mental Schedule (GMS) Package", to establish diagnoses of dementia and depressive disorders.

location_facility:
University Hospital
CHU-Limoges- CMRR


title: Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C

acronym: Fibrosar

summary:
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.

The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: CHU Angers, Service d'hépato-gastroentérologie


lead_sponsor: Merck KGaA, Darmstadt, Germany

acronym: EXPRESS

title: Open Label Pilot Study on Gene Expression Profiling of the Endometrial Tissue in Patients Undergoing Assisted Reproductive Technology [ART: In Vitro Fertilization (IVF)/ Intracytoplasmic Sperm Injection (ICSI)] With GONAL-f®

summary:
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.

The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.


acronym: ATTAC-PCO

title: A Phase IIIb Randomized Open-label Study to Compare the Estradiol Level on the Releasing Day in Two Regimen of Cetrotide® 0.25 mg Used From Day 1 or From Day 7 of the Menstrual Cycle (Day 0 or Day 6 of Stimulation) in Polycystic Ovarian (PCO) Women in ART (IVF/ICSI).

summary: This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from Day 1 or Day 7 of the menstrual cycle (Day 0 or Day 6 of stimulation) in polycystic ovarian (PCO) women in assisted reproductive technology (ART).


title: Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated Over a Period of 3 Years or 5 Years if Applicable, in Comparison With a Historic Cohort of Non-treated Children With Hypochondroplasia

summary: This study is conducted to describe the efficacy and safety of recombinant human growth hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.

ReferenceCitation: Pinto G, Cormier-Daire V, Le Merrer M, Samara-Boustani D, Baujat G, Fresneau L, Viaud M, Souberbielle JC, Pineau JC, Polak M. Efficacy and safety of growth hormone treatment in children with hypochondroplasia: comparison with an historical cohort. Horm Res Paediatr. 2014;82(6):355-63. doi: 10.1159/000364807. Epub 2014 Oct 15.

family: Pinto

full_name: Graziella Pinto

given: Graziella

family: Cormier-Daire

full_name: Valérie Cormier-Daire

given: Valérie

family: Le Merrer

full_name: Martine Le Merrer

given: Martine

family: Samara-Boustani

full_name: Dinane Samara-Boustani

given: Dinane

family: Baujat

full_name: Geneviève Baujat

given: Geneviève

family: Fresneau

full_name: Laurence Fresneau

given: Laurence

family: Viaud

full_name: Magali Viaud

given: Magali

family: Souberbielle

full_name: Jean Claude Souberbielle

given: Jean Claude

family: Pineau

full_name: Jean Claude Pineau

family: Polak

full_name: Michel Polak

given: Michel

journal_name: Hormone Research in Paediatrics

publisher: S. Karger AG

publisher_dissemination: S. Karger AG

publisher_group: S. Karger AG

publisher_normalized: S. Karger AG

title: Efficacy and Safety of Growth Hormone Treatment in Children with Hypochondroplasia: Comparison with an Historical Cohort

location_facility: Endocrinologie Pédiatrique - centre des maladies rares de la croissance -Hôpital Necker Enfants Malades


title: Evaluation of New Biomarkers Predictive of Efficacy Betablockers in PEComa and Vascular Pediatric Tumors

acronym: PEC-Hem

summary:
PEComa is rare tumor affecting particularly patients with Tuberous Sclerosis. Biological similarities were seen between PEComa and infantile hemangioma. Propranolol is highly efficient to treat infantile hemangioma and we believe that this drug can also be useful for the treatment of PEComa.

Purpose : to understand the mechanism of action of propranolol in PEComas and related pediatric vascular lesions and to select possible novel targets of betablockers in vascular tumors related to PEComas by using YAP oncogene activation as a molecular marker

lead_sponsor: University Hospital, Bordeaux


title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

summary:
To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
each treatment beeing allocated by randomization

lead_sponsor: University Hospital, Angers


title: The Clinical Evaluation of the Stereotactic, MR Guided, Laser Interstitial Thermal Therapy (LITT ) for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice

summary: The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

ReferenceCitation: Carpentier A, McNichols RJ, Stafford RJ, Guichard JP, Reizine D, Delaloge S, Vicaut E, Payen D, Gowda A, George B. Laser thermal therapy: real-time MRI-guided and computer-controlled procedures for metastatic brain tumors. Lasers Surg Med. 2011 Dec;43(10):943-50. doi: 10.1002/lsm.21138. Epub 2011 Nov 22.

family: Carpentier

full_name: Alexandre Carpentier

given: Alexandre

family: McNichols

full_name: Roger J. McNichols

given: Roger J.

family: Stafford

full_name: R. Jason Stafford

given: R. Jason

family: Guichard

full_name: Jean-Pierre Guichard

given: Jean-Pierre

family: Reizine

full_name: Daniel Reizine

given: Daniel

family: Delaloge

full_name: Suzette Delaloge

given: Suzette

family: Vicaut

full_name: Eric Vicaut

given: Eric

family: Payen

full_name: Didier Payen

given: Didier

family: Gowda

full_name: Ashok Gowda

given: Ashok

family: George

full_name: Bernard George

given: Bernard

journal_name: Lasers in Surgery and Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Laser thermal therapy: Real-time MRI-guided and computer-controlled procedures for metastatic brain tumors

lead_sponsor: BioTex, Inc.


title: Obesity and Pregnancy : Study of Factors Influencing Participation in a Program Combining Physical Activity and Nutritional Counseling

acronym: OGAN

summary:
Background:

Obesity increasingly affects young women and contributes to increased maternal, fetal and neonatal complications. Maternal obesity contributes to the subsequent development of childhood obesity not only through social and environmental mechanisms but also through biological processes referring to the original concept of the developmental health and disease. Data suggest that management during pregnancy through nutrition counseling and adequate physical activity will help to break the familial vicious circle of obesity. To help program to be effective it is important to understand the factors that modulate participation. However, few studies have been conducted to assess the determinants that influence participation.

Goal:

The main objective is to analyze 15 factors that influence participation in a program combining physical activity and nutritional counseling among pregnant women with BMI ≥ 25 kg/m2. Secondary objectives are :

to identify the data that influence adherence and to show that assiduous women will have a better control of weight gain and a reduction of maternal and fetal complications.
to understand the biological mechanisms involved

Strategy and method:

A prospective research evaluating the participation in an educational program, including nutritional support and adequate physical activity, will be offered to overweight and obese pregnant women. The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week. Fifteen independent variables likely to influence participation will be analyzed. The association between participation and the risk of maternal and fetal pregnancy complications related to obesity will be analysed. Meanwhile, more fundamental research will be considered to determine of the biological factors involved.

ReferenceCitation: Deruelle P. [Obesity and pregnancy]. Gynecol Obstet Fertil. 2011 Feb;39(2):100-5. doi: 10.1016/j.gyobfe.2010.12.001. Epub 2011 Feb 12. French.

ReferenceCitation: Thangaratinam S, Rogozinska E, Jolly K, Glinkowski S, Roseboom T, Tomlinson JW, Kunz R, Mol BW, Coomarasamy A, Khan KS. Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence. BMJ. 2012 May 16;344:e2088. doi: 10.1136/bmj.e2088.

lead_sponsor: University Hospital, Lille


title: Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2

summary: The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device

ReferenceCitation: Boveda S, Marijon E, Jacob S, Defaye P, Winter JB, Bulava A, Gras D, Albenque JP, Combes N, Pavin D, Delarche N, Teubl A, Lambiez M, Chevalier P; Mona Lisa Study Group. Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study. Eur Heart J. 2009 May;30(10):1237-44. doi: 10.1093/eurheartj/ehp071. Epub 2009 Mar 4.

family: Boveda

full_name: S. Boveda

given: S.

family: Marijon

full_name: E. Marijon

given: E.

family: Jacob

full_name: S. Jacob

family: Defaye

full_name: P. Defaye

given: P.

family: Winter

full_name: J. B. Winter

given: J. B.

family: Bulava

full_name: A. Bulava

given: A.

family: Gras

full_name: D. Gras

given: D.

family: Albenque

full_name: J. P. Albenque

given: J. P.

family: Combes

full_name: N. Combes

given: N.

family: Pavin

full_name: D. Pavin

family: Delarche

full_name: N. Delarche

family: Teubl

full_name: A. Teubl

family: Lambiez

full_name: M. Lambiez

given: M.

family: Chevalier

full_name: P. Chevalier

journal_name: European Heart Journal

lead_sponsor: Guidant Corporation

location_facility:
CHG Perigueux
Hôpital Louis Pradel
Hôpital Pontchaillou
CHU Nîmes
CHG Albi
Clinique Pasteur
CH La Croix Rousse
Nouvelle Clinique Nantaise
CHU Michalon
Centre Cardiologique du Nord


title: A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly

summary:
Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly.

The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.

ReferenceCitation: Dechamps A, Diolez P, Thiaudière E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.

family: Dechamps

full_name: Arnaud Dechamps

given: Arnaud

journal_name: Archives of Internal Medicine

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effects of Exercise Programs to Prevent Decline in Health-Related Quality of Life in Highly Deconditioned Institutionalized Elderly Persons

lead_sponsor: Association de Recherche Gerontologique


title: Qualitative Study of the Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation on the Parental Adjustment of the First Year

acronym: INEMAT

summary: Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.


title: Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.

acronym: GABATHOMIE

summary: To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.

location_facility: Department of Thoracic Surgery, Lille University Hospital


title: Hemodynamic Efficiency of an Hemodialysis Treatment With High Permeability (HDHP) During the Early Period of Post-resuscitation Shock

acronym: Hyperdia

summary:
Rationale: Despite spontaneous cardiac activity recovery, a shock occurs in more than half of patients after resuscitation for cardiac arrest. This acute circulatory insufficiency presents similar characteristics with septic shock and is responsible of most early deaths. Most frequently, usual treatments are unable to control this shock and to avoid the appearance of multiple organ failure.

Aim of the study: In addition to conventional therapeutics, an early plasma epuration of inflammatory mediators (HDHP) could be able to improve hemodynamic parameters and to reduce the shock duration. This improvement could have an impact on multiple organ dysfunctions and also on early mortality.

ReferenceCitation: Geri G, Grimaldi D, Seguin T, Lamhaut L, Marin N, Chiche JD, Pène F, Bouglé A, Daviaud F, Morichau-Beauchant T, Arnaout M, Champigneulle B, Zafrani L, Bourcier S, Nguyen YL, Charpentier J, Mira JP, Coste J, Vinsonneau C, Cariou A. Hemodynamic efficiency of hemodialysis treatment with high cut-off membrane during the early period of post-resuscitation shock: The HYPERDIA trial. Resuscitation. 2019 Jul;140:170-177. doi: 10.1016/j.resuscitation.2019.03.045. Epub 2019 Apr 8.

family: Geri

full_name: Guillaume Geri

given: Guillaume

family: Grimaldi

full_name: David Grimaldi

given: David

family: Seguin

full_name: Thierry Seguin

given: Thierry

family: Lamhaut

full_name: Lionel Lamhaut

given: Lionel

family: Marin

full_name: Nathalie Marin

given: Nathalie

family: Chiche

full_name: Jean-Daniel Chiche

given: Jean-Daniel

family: Pène

full_name: Frédéric Pène

given: Frédéric

family: Bouglé

full_name: Adrien Bouglé

given: Adrien

family: Daviaud

full_name: Fabrice Daviaud

given: Fabrice

family: Morichau-Beauchant

full_name: Tristan Morichau-Beauchant

given: Tristan

family: Arnaout

full_name: Michel Arnaout

given: Michel

family: Champigneulle

full_name: Benoit Champigneulle

given: Benoit

family: Zafrani

full_name: Lara Zafrani

given: Lara

family: Bourcier

full_name: Simon Bourcier

given: Simon

family: Nguyen

full_name: Yen-Lan Nguyen

given: Yen-Lan

family: Charpentier

full_name: Julien Charpentier

given: Julien

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Coste

full_name: Joël Coste

given: Joël

family: Vinsonneau

full_name: Christophe Vinsonneau

given: Christophe

family: Cariou

full_name: Alain Cariou

given: Alain

journal_name: Resuscitation

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Medical intensive care unit of Cochin-St Vincent de Paul university Hospital


title: Functionnal Magnetic Resonnance Imaging (fMRI)Study of Cerebral Substrates of New Musical and Pictorial Learning in Alzheimer Patients

acronym: INCAS

summary:
This research attempts to better understand the altered and preserved memory mechanisms in Alzheimer disease, particularly to better apprehend learning implicit memory processes, and give a scientific support to non-pharmalogical interventions. At the present time, it is possible to delay the emergence of the symptoms related to this disease, eventually to decrease it, but not to cure it. Yet, care these patients became a crucial question and the solutions proposed to healthy aging people are not appropriate for Alzheimer patients who present specific disorders. The improvement of the quality of life of the institutionalized patients lies on a better comprehension of their disorders but also of their preserved abilities. The literature testifies of a great heterogeneity in the clinical expression of this disease, however we noticed two constants with regard to the capabilities generally announced as being preserved, on one hand, the implicit memory, and on the other hand the artistic aptitudes, and more particularly musical capabilities.

Patients with Alzheimer disease present a particularly severe and early deterioration of episodic memory. Thus, at the beginning of the disease the explicit acquisition of new knowledge becomes increasingly difficult. However, some clinical observations, such as new learning of unknown songs, even with patients at a severe stage of the illness, seem to support the assumption of a preservation of some implicit learning abilities. Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly at the beginning stage of the illness: preserved effects of perceptual priming, procedural learning. Thus, we are mainly interested by the effects of exposure and the rising of a feeling of familiarity, both showing preserved implicit learning abilities, for moderate to severe Alzheimer patients. However, no study was carried out to date using the neuroimaging techniques, among Alzheimer patients at a moderated to severe stage of illness, with the main objective to identify the cerebral substrates implied in the learning of new knowledge.

Indeed, several studies already showed preserved implicit memory capabilities among patients with Alzheimer disease, mostly were performed at the beginning stage of the illness and none of them have studied theses learning abilities for moderate to severe Alzheimer patients.

The objective of this work is to specify, in severe form of Alzheimer disease, the cognitive mechanisms allowing the memorizing (feeling of familiarity) of new information and thus to highlight neural networks underlying this learning process (recently learned stimuli vs old stimuli). The goal is to propose a positive image of the Alzheimer patients, in understanding which cognitive mechanisms and cerebral areas allow these learning capabilities.

20 patients Alzheimer at a moderate to severe stage, 20 patients at a mild to moderate stage of the illness, and 20 healthy aging participants, are selected after a neurological interview and a neuropsychological evaluation. The whole of the included participants take part of the experimental protocol organized in two phases: - the phase of familiarization and the phase of test. The phase of familiarization consists of the repeated exposure (daily session before the MRI acquisition) of new songs and new painting until obtaining a high feeling of familiarity for each item. The phase of test is carried out in the 3T MRI camera, it comprises an anatomical (T1, T2 MRI) and a functional acquisitions. The functional acquisition corresponds to a passive listening and seeing tasks of musical and pictorial stimuli. Finally, all participants realize a debriefing phase that allows obtaining a feedback on the familiarity of stimuli presented during the functional acquisition.


title: From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations

acronym: ALCOBRAIN

summary: This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.

intervention_type: Genetic


title: Molecular Profiling of Advanced Soft-tissue Sarcomas. A Phase III Study

acronym: MULTISARC

summary:
MULTISARC is a randomized multicenter study assessing whether high throughput molecular analysis (next generation sequencing exome - NGS) is feasible in advanced/metastatic soft-tissue sarcoma patients, that is, whether NGS can be conducted for a large proportion of patients, with results available within reasonnable delays.

In parallel, MULTISARC aims to assess efficacy of an innovative treatment strategy guided by high throughput molecular analysis (next generation sequencing exome, RNASeq [NGS]) in patients with Advanced/metastatic soft-tissue sarcomas. At the end of first-line treatment, participant's tumor profile of experimental Arm NGS (treatment strategy based on NGS results) will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each participant. Participants for whom a targetable genomic alteration has been identified will be proposed to enter in one of the subsequent phase II single-arm sub-trial.

primary_purpose: Health Services Research

ReferenceCitation: Italiano A, Dinart D, Soubeyran I, Bellera C, Espérou H, Delmas C, Mercier N, Albert S, Poignie L, Boland A, Bourdon A, Geneste D, Cavaille Q, Laizet Y, Khalifa E, Auzanneau C, Squiban B, Truffaux N, Olaso R, Gerber Z, Wallet C, Bénard A, Blay JY, Laurent-Puig P, Deleuze JF, Lucchesi C, Mathoulin-Pelissier S; MULTISARC study group. Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial. BMC Cancer. 2021 Nov 5;21(1):1180. doi: 10.1186/s12885-021-08878-2.

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Dinart

full_name: Derek Dinart

given: Derek

family: Soubeyran

full_name: Isabelle Soubeyran

given: Isabelle

family: Bellera

full_name: Carine Bellera

given: Carine

family: Espérou

full_name: Hélène Espérou

given: Hélène

family: Delmas

full_name: Christelle Delmas

given: Christelle

family: Mercier

full_name: Noémie Mercier

given: Noémie

family: Albert

full_name: Sabrina Albert

given: Sabrina

family: Poignie

full_name: Ludivine Poignie

given: Ludivine

family: Boland

full_name: Anne Boland

given: Anne

family: Bourdon

full_name: Aurélien Bourdon

given: Aurélien

family: Geneste

full_name: Damien Geneste

given: Damien

family: Cavaille

full_name: Quentin Cavaille

given: Quentin

family: Laizet

full_name: Yec’han Laizet

given: Yec’han

family: Khalifa

full_name: Emmanuel Khalifa

given: Emmanuel

family: Auzanneau

full_name: Céline Auzanneau

given: Céline

family: Squiban

full_name: Barbara Squiban

given: Barbara

family: Truffaux

full_name: Nathalène Truffaux

given: Nathalène

family: Olaso

full_name: Robert Olaso

given: Robert

family: Gerber

full_name: Zuzana Gerber

given: Zuzana

family: Wallet

full_name: Cédrick Wallet

given: Cédrick

family: Bénard

full_name: Antoine Bénard

family: Blay

full_name: Jean-Yves Blay

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

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


title: Clinical, Molecular and Metabolic Comparison Between Early Onset Parkinsonian, With or Without Parkin Mutation: Physiopathological Perspectives

summary:
Parkinson's disease is one of the most frequent neurodegenerative diseases, and for which the mechanisms remains unknown. Since the implication of susceptibility factors is highly suspect, we have recently shown that one monogenic form due to alterations in the Parkin gene was responsible for an important proportion of early onset familial and isolated cases. Nevertheless, it not has been determined yet the relationship between idiopathic Parkinson's disease and secondary Parkinson's disease with a Parkin gene mutation at the clinical, neuropsychological, metabolic and physiopathological levels. For establishing phenotype-genotype correlations, we propose to compare the phenotype of patients carrying a Parkin mutation (parkin " + ", n=25) to those of early onset parkinsonians without a Parkin mutation (Parkin " - ", n = 25), and for some aspects (neuropsychological, behavioural and psychiatric evaluations) to the healthy brothers and sisters of Parkin cases "+"(n = 25). The evaluation will carry on the clinical aspects (quantification of the parkinsonian syndrome and reactivity to levodopa, neuropsychological, behavioural and psychiatric evaluations), molecular (types of abnormalities in the Parkin gene) and metabolic (PET - tomography by positron emission) of the disease.

Parkinson's disease caused by Parkin gene mutations is associated with an important and homogeneous loss of dopaminergic neurons of the substantia nigra pars compacta, which is different from those observed during the idiopathic Parkinson's disease. The corresponding dopaminergic deficit should be associated with an excellent reactivity to levodopa, to a cognitive deficit and to behavioural and/or psychiatric attitudes, in relation with the massive alteration of dopaminergic efferences.

This multidisciplinary approach on Parkin cases will be performed in the centers for of clinical investigations of Grenoble and Paris, with the help of the French Parkinson's Disease Study Group, and two centers for TEP (Lyon and Orsay). This project will allow to a better definition of diagnostic criteria of Parkin " + " cases, which will help for the molecular diagnosis in early onset cases, and will study precisely the clinical, psychiatric and metabolic consequences of a massive and homogeneous dopaminergic denervation, which seems to be different of idiopathic Parkinson's disease.

location_facility: Pitié-Salpêtrière Hospital - Service of Psychiatry

location_facility: Pitié-Salpêtrière Hospital - Centre of Clinical Investigations

location_facility: Pitié-Salpêtrière Hospital - Federation of Neurology


title: Natural History, Genetic Bases and Phenotype-genotype Correlations in Autosomal Dominant Spinocerebellar Degenerations

summary:
The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically and genetically, group of rare diseases and of severe evolution. So far, the responsible genes for less than 50% of the cases are known and because of their rarity, there are no phenotype-genotype correlations and well-defined disease history.

The aims of the project are to develop and validate quantitative tools of the cerebellar syndrome and of the spasticity, to establish links between the phenotype and the result of the molecular analysis, to identify new loci/genes responsible for these disorders, and to establish the natural history of the disease according to the genotype.

To this end, a prospective and multicentric study is proposed for recruiting and evaluating, clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers involved. A DNA collection will be set up in order to search for the implication of new loci and genes. A clinico-genetic database will be set up combining data from successive clinical evaluations and those of genotyping.

This strategy will allow access to genetic counselling and molecular diagnosis (positive, presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype correlations and the information concerning the relative frequency of the genes. The detailed description, with the help of new evaluation tools and of the follow-up of the natural history of the disease according to the genotype, constitutes a crucial step in the design of therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by specialized centers will allow better care of the patients.

ReferenceCitation: Klebe S, Durr A, Rentschler A, Hahn-Barma V, Abele M, Bouslam N, Schöls L, Jedynak P, Forlani S, Denis E, Dussert C, Agid Y, Bauer P, Globas C, Wüllner U, Brice A, Riess O, Stevanin G. New mutations in protein kinase Cgamma associated with spinocerebellar ataxia type 14. Ann Neurol. 2005 Nov;58(5):720-9.

ReferenceCitation: Stevanin G, Hahn V, Lohmann E, Bouslam N, Gouttard M, Soumphonphakdy C, Welter ML, Ollagnon-Roman E, Lemainque A, Ruberg M, Brice A, Durr A. Mutation in the catalytic domain of protein kinase C gamma and extension of the phenotype associated with spinocerebellar ataxia type 14. Arch Neurol. 2004 Aug;61(8):1242-8.

ReferenceCitation: Stevanin G, Durr A, Dussert C, Penet C, Brice A. Mutations in the FGF14 gene are not a major cause of spinocerebellar ataxia in Caucasians. Neurology. 2004 Sep 14;63(5):936.

ReferenceCitation: Waters MF, Minassian NA, Stevanin G, Figueroa KP, Bannister JP, Nolte D, Mock AF, Evidente VG, Fee DB, Müller U, Dürr A, Brice A, Papazian DM, Pulst SM. Mutations in voltage-gated potassium channel KCNC3 cause degenerative and developmental central nervous system phenotypes. Nat Genet. 2006 Apr;38(4):447-51. Epub 2006 Feb 26.

ReferenceCitation: Depienne C, Tallaksen C, Lephay JY, Bricka B, Poea-Guyon S, Fontaine B, Labauge P, Brice A, Durr A. Spastin mutations are frequent in sporadic spastic paraparesis and their spectrum is different from that observed in familial cases. J Med Genet. 2006 Mar;43(3):259-65. Epub 2005 Jul 31.

ReferenceCitation: Depienne C, Fedirko E, Forlani S, Cazeneuve C, Ribaï P, Feki I, Tallaksen C, Nguyen K, Stankoff B, Ruberg M, Stevanin G, Durr A, Brice A. Exon deletions of SPG4 are a frequent cause of hereditary spastic paraplegia. J Med Genet. 2007 Apr;44(4):281-4. Epub 2006 Nov 10.

ReferenceCitation: Depienne C, Fedirko E, Faucheux JM, Forlani S, Bricka B, Goizet C, Lesourd S, Stevanin G, Ruberg M, Durr A, Brice A. A de novo SPAST mutation leading to somatic mosaicism is associated with a later age at onset in HSP. Neurogenetics. 2007 Aug;8(3):231-3. Epub 2007 Jun 28.

ReferenceCitation: Hanein S, Dürr A, Ribai P, Forlani S, Leutenegger AL, Nelson I, Babron MC, Elleuch N, Depienne C, Charon C, Brice A, Stevanin G. A novel locus for autosomal dominant "uncomplicated" hereditary spastic paraplegia maps to chromosome 8p21.1-q13.3. Hum Genet. 2007 Nov;122(3-4):261-73. Epub 2007 Jun 28.

ReferenceCitation: Ribaï P, Depienne C, Fedirko E, Jothy AC, Viveweger C, Hahn-Barma V, Brice A, Durr A. Mental deficiency in three families with SPG4 spastic paraplegia. Eur J Hum Genet. 2008 Jan;16(1):97-104. Epub 2007 Oct 24.

ReferenceCitation: du Montcel ST, Charles P, Ribai P, Goizet C, Le Bayon A, Labauge P, Guyant-Maréchal L, Forlani S, Jauffret C, Vandenberghe N, N'guyen K, Le Ber I, Devos D, Vincitorio CM, Manto MU, Tison F, Hannequin D, Ruberg M, Brice A, Durr A. Composite cerebellar functional severity score: validation of a quantitative score of cerebellar impairment. Brain. 2008 May;131(Pt 5):1352-61. doi: 10.1093/brain/awn059. Epub 2008 Mar 31.

family: du Montcel

full_name: Sophie Tezenas du Montcel

given: Sophie Tezenas

family: Charles

full_name: Perrine Charles

given: Perrine

family: Ribai

full_name: Pascale Ribai

given: Pascale

family: Goizet

full_name: Cyril Goizet

given: Cyril

family: Le Bayon

full_name: Alice Le Bayon

given: Alice

family: Labauge

full_name: Pierre Labauge

given: Pierre

family: Guyant-Maréchal

full_name: Lucie Guyant-Maréchal

given: Lucie

family: Forlani

full_name: Sylvie Forlani

given: Sylvie

family: Jauffret

full_name: Celine Jauffret

given: Celine

family: Vandenberghe

full_name: Nadia Vandenberghe

given: Nadia

family: N’Guyen

full_name: Karine N’Guyen

given: Karine

family: Le Ber

full_name: Isabelle Le Ber

given: Isabelle

family: Devos

full_name: David Devos

given: David

family: Vincitorio

full_name: Carlo-Maria Vincitorio

given: Carlo-Maria

family: Manto

full_name: Mario-Ubaldo Manto

given: Mario-Ubaldo

family: Tison

full_name: François Tison

given: François

family: Hannequin

full_name: Didier Hannequin

given: Didier

family: Ruberg

full_name: Merle Ruberg

given: Merle

family: Brice

full_name: Alexis Brice

given: Alexis

family: Durr

full_name: Alexandra Durr

given: Alexandra

ReferenceCitation: Goizet C, Boukhris A, Mundwiller E, Tallaksen C, Forlani S, Toutain A, Carriere N, Paquis V, Depienne C, Durr A, Stevanin G, Brice A. Complicated forms of autosomal dominant hereditary spastic paraplegia are frequent in SPG10. Hum Mutat. 2009 Feb;30(2):E376-85. doi: 10.1002/humu.20920.

ReferenceCitation: Tezenas du Montcel S, Durr A, Rakowicz M, Nanetti L, Charles P, Sulek A, Mariotti C, Rola R, Schols L, Bauer P, Dufaure-Garé I, Jacobi H, Forlani S, Schmitz-Hübsch T, Filla A, Timmann D, van de Warrenburg BP, Marelli C, Kang JS, Giunti P, Cook A, Baliko L, Melegh B, Boesch S, Szymanski S, Berciano J, Infante J, Buerk K, Masciullo M, Di Fabio R, Depondt C, Ratka S, Stevanin G, Klockgether T, Brice A, Golmard JL. Prediction of the age at onset in spinocerebellar ataxia type 1, 2, 3 and 6. J Med Genet. 2014 Jul;51(7):479-86. doi: 10.1136/jmedgenet-2013-102200. Epub 2014 Apr 29. Erratum in: J Med Genet. 2014 Sep;51(9):613. Bela, Melegh [corrected to Melegh, Béla].

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

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

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: University College London - UCL Discovery

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

ReferenceCitation: Tezenas du Montcel S, Charles P, Goizet C, Marelli C, Ribai P, Vincitorio C, Anheim M, Guyant-Maréchal L, Le Bayon A, Vandenberghe N, Tchikviladzé M, Devos D, Le Ber I, N'Guyen K, Cazeneuve C, Tallaksen C, Brice A, Durr A. Factors influencing disease progression in autosomal dominant cerebellar ataxia and spastic paraplegia. Arch Neurol. 2012 Apr;69(4):500-8. doi: 10.1001/archneurol.2011.2713.

title: Factors Influencing Disease Progression in Autosomal Dominant Cerebellar Ataxia and Spastic Paraplegia

location_facility:
Hôpital Purpan
Hôpital Pitié-Salpêtrière
Hôpital La Timone
Hôpital Charles Nicolle
Hôpital Neurologique Pierre Wertheimer
CHU de Grenoble
Hôpital Carémeau
Hôpital Pellegrin


title: Estimation of Cardiac Output in the Operating Room by Pulse Wave Analysis and Esophageal Doppler Blood Velocity: Comparison of the Two Methods

acronym: TRIPLEFLOW

summary: During major surgery, it is recommended to monitor invasive arterial blood pressure and cardiac output (CO) during hemodynamic interventions (fluid challenge or vasopressors). Esophageal Doppler is currently considered as the reference method for monitoring cardiac output in the operating room. The PRAM method (pressure recording analytical method) with the MostCareUp monitor (Vytech, Padova, Italy) and the LTIA method (long time interval analysis) allow cardiac output estimation derived from non-calibrated arterial pressure waveform analysis. Few studies have looked at relative changes in cardiac output during hemodynamic intervention with these two methods. The aim of this study is to compare the relative changes in cardiac output during hemodynamic interventions as measured using PRAM and LTIA methods, compared to esophageal Doppler.

location_facility: AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care


title: Use of Home-based Connected Devices to Early Detect and Treat Pulmonary Exacerbations: Feasibility and Clinical Validity in CF Patients

acronym: MucoExocet

summary:
Early detection of pulmonary exacerbations (PEx) in Cystic Fibrosis (CF) patients is important to quickly trigger treatment and reduce respiratory damage. The investigators hypothesize that using home-based connected devices (CDs) in educated patients applying Cumulative sum charts (CUSUM) to monitor physiological parameters (PP) and patients' perception reported (PRP), will allow early detection of PEx.

Objective: to study clinical validity of using CDs and evaluate adherence and satisfaction in CF patients and teams

Design: 3 phase multicenter study in 36 CF patients aged >=12 years. Phase 1, patients are equipped during 3 months with CDs. PP and PRP to estimate CUSUM parameters are collected. In phase 2, patient's personalized educational plan to manage alerts is built. In phase 3, PP and PRP are collected during 12 months. Clinical validity, change in patients clinical data, quality of Life/Anxiety-Depression/Satisfaction, patients and teams' acceptance and adherence are assessed.

ReferenceCitation: Morsa M, Perrin A, David V, Rault G, Le Roux E, Alberti C, Gagnayre R, Pougheon Bertrand D. Use of Home-Based Connected Devices in Patients With Cystic Fibrosis for the Early Detection and Treatment of Pulmonary Exacerbations: Protocol for a Qualitative Study. JMIR Res Protoc. 2021 Aug 18;10(8):e14552. doi: 10.2196/14552.

family: Morsa

full_name: Maxime Morsa

given: Maxime

family: Perrin

full_name: Amélie Perrin

given: Amélie

family: David

full_name: Valérie David

given: Valérie

family: Rault

full_name: Gilles Rault

given: Gilles

family: Le Roux

full_name: Enora Le Roux

given: Enora

family: Alberti

full_name: Corinne Alberti

given: Corinne

family: Gagnayre

full_name: Rémi Gagnayre

given: Rémi

family: Pougheon Bertrand

full_name: Dominique Pougheon Bertrand

given: Dominique

location_facility: CF pediatrics center - Hopital André Mignot

location_facility: CF adults and pediatrics center - American Memorial Hospital

location_facility: CF pediatrics center - Hopital Mère-Enfant

location_facility: CF adults center - Hopital Albert Calmette

location_facility: CF pediatrics center - Hopital Robert Debré

location_facility: CF adults and pediatrics center- Perharidy


title: Understanding and Overcoming the Early Adaptive Resistance to EGFR Tyrosine-kinase Inhibitors in Lung Cancer Patients

acronym: LUNG-RESIST

summary: Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKI) are effective therapies for advanced lung cancer patients bearing EGFR-activating mutations, but are not curative due to the invariable apparition of resistances. The investigator team have identified a new phenotype related to drug tolerance after EGFR-TKI treatment that shares several characteristics of a known process of Therapy-Induced Senescence (TIS), which could be a major event of drug tolerance in patients. Using cutting-edge technologies, patient-derived xenografts (PDX) and circulating tumor cells (CTC), the investigator team will perform an exhaustive characterization of the phenotypic and molecular changes associated with this drug-tolerant state in patients. Their results should lead to new therapeutic approaches to eliminate the reservoir of drug-tolerant cells and to prevent emergence of resistance mutations responsible for the relapse of patients.

lead_sponsor: University Hospital, Toulouse


title: Study of the Efficacy of Propranolol for the Management of Epistaxis in Hereditary Hemorrhagic Telangiectasia Patients

acronym: EPERO

summary: Hereditary Hemorrhagic Telangiectasia (HHT) is a genetic disorder of angiogenesis associated with disabling epistaxis. Management of these nose bleedings requires more effective treatment. Propranolol, a beta-blocker, is a potentially useful therapeutic considering its anti-angiogenic properties. Our objective is to explore the efficacy of propranolol, three months after its introduction, on the cumulative duration of epistaxis in HHT patients.

location_facility: CHU de Bordeaux - service de médecine interne


title: CARdiomyopathy in Type 2 DIAbetes Mellitus

acronym: CARDIATEAM

summary: The objective of the CARDIATEAM clinical study is to assess the uniqueness of diabetic cardiomyopathy (DCM) relative to other forms of cardiomyopathy using unsupervised clustering approaches based on deep phenotyping (clinical, imaging and biological) information.

location_country:
Netherlands
France
Spain
Germany
United Kingdom

location_facility: department of diabetology and nutrition, APHM

location_facility: Diabetology departement, Lariboisière Hospital

location_facility: Academisch ziekenhuis Maastricht, Cardiology

location_facility: University Medical Center Groningen (UMCG), Cardiology/Cardio Research

location_facility: Diabetology department, Cochin Institute

location_facility: University of Dundee, Div of Molecular&Clinical Medicine

location_facility: Cardiology Outpatient Department at Hôpital Henri Mondor.


title: Fluconazole Versus Micafungin in Neonates With Suspected or Culture-proven Candidiasis: a Randomized Pharmacokinetic and Safety Study (TINN Project - Treat Infections iN Neonates)

acronym: TINN

summary:
This study is designed to determine whether micafungin is as efficacious as the current standard of fluconazole, to compare the safety of the two drugs in the treatment of proven neonatal candidiasis.

It is also designed to further elucidate the pharmacokinetics of the two products in the growing and developing neonate and premature infant.

location_country: Italy Netherlands France Belgium Spain


title: GENomic Biomarkers for PARKinson's Disease

acronym: Genepark

summary:
The main goal of the GENEPARK consortium is to employ innovative haemogenomic approaches to determine gene expression profiles specific for genetic and idiopathic Parkinson's disease (PD) patients. These gene expression signatures will be utilised clinically as non-invasive diagnostic tests for PD. The sensitivity of the newly developed diagnostic test will be determined by extensive validations on an independent cohort of PD patients, whereas the specificity will be assessed by testing patients with atypical parkinsonisms, including multiple system atrophy, progressive supranuclear palsy and diffuse Lewy body disease. In order to test the specificity of the diagnostic set in other disorders that affect basal ganglia, Huntington's disease and dopa responsive dystonia patients will be analysed. The second objective of the proposal is to determine correlations between gene expression signatures and different stages of PD and thus provide the basis for early diagnosis and monitoring of disease progression. These changes in blood gene expression will be correlated with alterations detected by neuroimaging in the brain of PD patients. Such combinations of molecular and morphological markers of disease may ultimately facilitate the selection and monitoring of neuroprotective therapies for PD. Finally, GENEPARK aims to develop new bioinformatic software tools for selection of genomic biomarkers using microarray data. A set of established computational tools will be applied and novel methods, some of them based on mechanistic modelling of the neurodegenerative diseases, will be developed in order to study the advantages and limitations of the different methodologies.

With special emphasis on the careful clinical selection of patients and sufficient power regarding patient numbers, as well as extensive quality control and validation of the data, GENEPARK aims to develop a standardised approach to development and validation of haemogenomic biomarkers of disease.

location_country: Germany Slovenia Croatia France

location_facility: Meditterranean Institute for Life Sciences

location_facility: University of Lübeck and Neuroimage Nord


title: Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy

acronym: Epi-FaR

summary: The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.

ReferenceCitation: Bragin A, Wilson CL, Staba RJ, Reddick M, Fried I, Engel J Jr. Interictal high-frequency oscillations (80-500 Hz) in the human epileptic brain: entorhinal cortex. Ann Neurol. 2002 Oct;52(4):407-15.

ReferenceCitation: Crépon B, Navarro V, Hasboun D, Clemenceau S, Martinerie J, Baulac M, Adam C, Le Van Quyen M. Mapping interictal oscillations greater than 200 Hz recorded with intracranial macroelectrodes in human epilepsy. Brain. 2010 Jan;133(Pt 1):33-45. doi: 10.1093/brain/awp277. Epub 2009 Nov 17.

ReferenceCitation: Demont-Guignard S, Benquet P, Gerber U, Biraben A, Martin B, Wendling F. Distinct hyperexcitability mechanisms underlie fast ripples and epileptic spikes. Ann Neurol. 2012 Mar;71(3):342-52. doi: 10.1002/ana.22610.

ReferenceCitation: Jacobs J, Levan P, Châtillon CE, Olivier A, Dubeau F, Gotman J. High frequency oscillations in intracranial EEGs mark epileptogenicity rather than lesion type. Brain. 2009 Apr;132(Pt 4):1022-37. doi: 10.1093/brain/awn351. Epub 2009 Mar 18.

ReferenceCitation: Jacobs J, Zijlmans M, Zelmann R, Chatillon CE, Hall J, Olivier A, Dubeau F, Gotman J. High-frequency electroencephalographic oscillations correlate with outcome of epilepsy surgery. Ann Neurol. 2010 Feb;67(2):209-20. doi: 10.1002/ana.21847.

ReferenceCitation: Staba RJ, Frighetto L, Behnke EJ, Mathern GW, Fields T, Bragin A, Ogren J, Fried I, Wilson CL, Engel J Jr. Increased fast ripple to ripple ratios correlate with reduced hippocampal volumes and neuron loss in temporal lobe epilepsy patients. Epilepsia. 2007 Nov;48(11):2130-8. Epub 2007 Jul 28.

ReferenceCitation: Worrell GA, Gardner AB, Stead SM, Hu S, Goerss S, Cascino GJ, Meyer FB, Marsh R, Litt B. High-frequency oscillations in human temporal lobe: simultaneous microwire and clinical macroelectrode recordings. Brain. 2008 Apr;131(Pt 4):928-37. doi: 10.1093/brain/awn006. Epub 2008 Feb 7.

ReferenceCitation: Zijlmans M, Jiruska P, Zelmann R, Leijten FS, Jefferys JG, Gotman J. High-frequency oscillations as a new biomarker in epilepsy. Ann Neurol. 2012 Feb;71(2):169-78. doi: 10.1002/ana.22548. Review.


title: Safety of Targeted Therapies in Elderly Patients (Over 5 and 75 Year-old) With Metastatic Melanoma

acronym: TOLBRIPA

summary: Since 2013, therapeutic care of metastatic melanoma (MM) has greatly improved, especially thanks to BRAF and MEK targeted therapies. The efficacy of these treatments that are now used daily at first line for BRAF mutated MM is widely approved. Their toxicities, in monotherapy or in association, are also well-known: fever, arthralgias, digestive disorders, cutaneous rash, fatigue, photosensitivity, alopecia, cutaneous hyperkeratosis, squamous cell carcinomas, keratoacanthomas, de novo melanomas… However, onco-dermatologists are more and more faced with MM of elderly patients. Indeed, life expectancy continues to increase and the over-75-year-old age group is becoming larger. These patients are still active but much more vulnerable. Nevertheless, there is no data in the literature for this fragile population except the MM pivotal studies subgroups of those over 65-year-old. The results vary with different regimens. Therefore, there is a wide lack of information that could help make a therapeutic decision, inform patients, prevent or treat side effects of BRAF and MEK inhibitors in elderly patients

lead_sponsor: University Hospital, Montpellier